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

• Published date: 29 September 2020
• Citation: 85 FR 61114
• Record Number: 2020-20907
• Section: Rules and Regulations
• Court: Centers For Medicare & Medicaid Services

61114

Federal Register / Vol. 85, No. 189 / Tuesday, September 29, 2020 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Medicare & Medicaid

Services

42 CFR Part 512

[CMS–5527–F]

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

: Final rule.

SUMMARY

: This final rule implements

two new mandatory Medicare payment

models under section 1115A of the

Social Security Act—the Radiation

Oncology Model (RO Model) and the

End-Stage Renal Disease (ESRD)

Treatment Choices Model (ETC Model).

The RO Model will promote quality and

financial accountability for providers

and suppliers of radiotherapy (RT). The

RO Model will be a mandatory payment

model and will test whether making

prospective episode payments to

hospital outpatient departments (HOPD)

and freestanding radiation therapy

centers for RT episodes of care preserves

or enhances the quality of care

furnished to Medicare beneficiaries

while reducing Medicare program

spending through enhanced financial

accountability for RO Model

participants. The ETC Model will be a

mandatory payment model focused on

encouraging greater use of home dialysis

and kidney transplants, in order to

preserve or enhance the quality of care

furnished to Medicare beneficiaries

while reducing Medicare expenditures.

The ETC Model adjusts Medicare

payments on certain dialysis and

dialysis-related claims for participating

ESRD facilities and clinicians caring for

beneficiaries with ESRD—or Managing

Clinicians—based on their rates of home

dialysis transplant waitlisting, and

living donor transplants. We believe

that these two models will test ways to

further our goals of reducing Medicare

expenditures while preserving or

enhancing the quality of care furnished

to beneficiaries.

DATES

: These regulations are effective

on November 30, 2020.

FOR FURTHER INFORMATION CONTACT

:

Rebecca Cole, (410) 786–1589,

Rebecca.Cole@cms.hhs.gov, for

questions related to General Provisions.

RadiationTherapy@cms.hhs.gov, or 1–

844–711–2664 Option 5, for questions

related to the Radiation Oncology

Model.

ETC-CMMI@cms.hhs.gov, for

questions related to the ESRD Treatment

Choices Model.

SUPPLEMENTARY INFORMATION

:

Current Procedural Terminology (CPT)

Copyright Notice

Throughout this final rule, we use

CPT

®

codes and descriptions to refer to

a variety of services. We note that CPT

®

codes and descriptions are copyright

2020 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 and Background

A. Executive Summary

1. Purpose

The purpose of this final rule is to

implement and test two new mandatory

models under the authority of the

Center for Medicare and Medicaid

Innovation (Innovation Center), and to

implement certain general provisions

that will 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 furnished 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 payment for fewer items and

services. As a result, care may be

fragmented, unnecessary, or duplicative.

The goal for these models is to

preserve or enhance the quality of care

furnished to beneficiaries while

reducing program spending through

enhanced financial accountability for

model participants. The Model

performance period for the RO Model

will begin on January 1, 2021, and end

December 31, 2025. We will implement

the payment adjustments under the ETC

Model beginning January 1, 2021 and

ending June 30, 2027.

These models will offer participants

the opportunity to examine and better

understand their own care processes

and patterns with regard to beneficiaries

receiving RT services for cancer, and

beneficiaries with ESRD, respectively.

We chose these focus areas for the

models because, as discussed in

sections III. and IV. of this final rule, we

believe that participants in these models

will have a significant opportunity to

redesign care and improve the quality of

care furnished to beneficiaries receiving

these services.

We believe the models will further the

agency’s goal of increasing the extent to

which CMS initiatives pay for value and

outcomes, rather than for volume of

services alone, by promoting the

alignment of financial and other

incentives for health care providers

caring for beneficiaries receiving

treatment for cancer or ESRD. Payments

that are made to health care providers

for assuming financial accountability for

the cost and quality of care create

incentives for the implementation of

care redesign among model participants

and other providers and suppliers.

CMS is testing several models,

including voluntary models focused

specifically on cancer and ESRD. The

RO and ETC Models will require the

participation of providers and suppliers

that might not otherwise participate in

these models, and will be tested in

multiple geographic areas.

The models will allow CMS to test

models with provider and supplier

participation when there are differences

in: (1) Historic care and utilization

patterns; (2) patient populations and

care patterns; (3) roles within their local

markets; (4) volume of services; (5)

levels of access to financial, community,

or other resources; and (6) levels of

population and health care provider

density. As noted in the proposed rule,

we believe that participation in these

models by a large number of providers

and suppliers with diverse

characteristics will result in a robust

data set for evaluating the models’

proposed payment approaches and will

stimulate the rapid development of new

evidence-based knowledge. Testing

these models in this manner will also

allow us to learn more about patterns of

inefficient utilization of health care

services and how to incentivize quality

improvement for beneficiaries receiving

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1

See https://www.census.gov/programs-surveys/

metro-micro/about/omb-bulletins.html.

services for RT and ESRD, which could

inform future model design.

We solicited public comment on our

proposals, and on any alternatives

considered. CMS has made a number of

modifications to the formatting and

language used in the regulation text (for

example, to revise ‘‘pursuant to’’ to

‘‘under’’; and ‘‘shall’’ to ‘‘must’’) to

improve readability. These formatting

and language changes are not intended

to be substantive. Any substantive

change(s) to this final rule is noted in

the specific section(s) affected by the

change(s).

2. Summary of the Major Provisions

a. General Provisions

The general provisions will be

applicable only to participants in the

RO Model and the ETC Model. We

identified the general provisions based

on similar requirements that have been

repeatedly memorialized in various

documents governing participation in

existing model tests. We have made

these provisions applicable to both the

RO Model and ETC Model, with one

exception related to termination of

model participants, so that we may

eliminate repetition in our regulations at

42 CFR part 512. The general provisions

address beneficiary protections, model

evaluation and monitoring, audits and

record retention, rights in data and

intellectual property, monitoring and

compliance, remedial action, model

termination by CMS, limitations on

review, and miscellaneous provisions

on bankruptcy and other notifications.

These provisions are not intended to

comprehensively encompass all the

provisions that will apply to each

model. Both the RO Model and the ETC

Model have unique aspects that will

require additional, more tailored

provisions, including with respect to

payment and quality measurement.

Such model-specific provisions are

described elsewhere in this final rule.

b. Radiation Oncology (RO) Model

In this rule, we are finalizing the

creation and testing of a new payment

model for radiation oncology, the RO

Model. The intent of the RO Model is to

promote quality and financial

accountability for episodes of care

centered on RT services. While

preserving or enhancing the quality of

care for Medicare beneficiaries, the RO

Model will test whether prospective

episode-based payments to physician

group practices (PGPs), HOPDs, and

freestanding radiation therapy centers

for RT episodes of care will reduce

Medicare expenditures. We anticipate

the RO Model will benefit Medicare

beneficiaries by encouraging more

efficient care delivery and incentivizing

higher value care across episodes of

care. The RO Model will have a

performance period of 5 calendar years,

beginning January 1, 2021, and ending

December 31, 2025. The RO Model will

capture all complete RO episodes that

end during the performance period,

which means that the data collection,

RO episode payments, and

reconciliation will continue into

calendar year 2026.

(1) Summary of the RO Provisions

(a) RO Model Overview

RT is a common treatment for patients

undergoing cancer treatment and is

typically furnished by a physician at

either an HOPD or a freestanding

radiation therapy center. The RO Model

will include prospective payments for

certain RT services furnished during a

90-day RO episode for included cancer

types for certain Medicare beneficiaries.

The included cancer types will be

determined by the following criteria: All

are commonly treated with radiation;

make up the majority of all incidence of

cancer types; and have demonstrated

pricing stability. (See section III.C.5.a. of

this final rule for more information.)

This Model will not account for total

cost of all care provided to the

beneficiary during the 90 days of an RO

episode. Rather, the payment will cover

only select RT services furnished during

an RO episode. Payments for RO

episodes will be split into two

components—the professional

component (PC) and the technical

component (TC). This division reflects

the fact that RT professional and

technical services are sometimes

furnished by separate RT providers and

RT suppliers and paid for through

different payment systems (namely, the

Medicare Physician Fee Schedule and

Outpatient Prospective Payment

System).

For example, under the RO Model, a

participating HOPD must have at least

one PGP to furnish RT services at the

HOPD. A PGP will furnish the PC as a

Professional participant and an HOPD

will furnish the TC as a Technical

participant. Both will be participants in

the RO Model, furnishing separate

components of the same RO episode. An

RO participant may also elect to furnish

both the PC and TC as a Dual

participant through one entity, such as

a freestanding radiation therapy center.

The RO Model will test the cost-saving

potential of prospective episode

payments for certain RT services

furnished during an RO episode and

whether shorter courses of RT (that is,

fewer doses, also known as fractions)

will encourage more efficient care

delivery and incentivize higher value

care.

(b) RO Model Scope

We are finalizing criteria for the types

of cancer included under the RO Model

and list 16 cancer types that meet our

criteria. These cancer types are

commonly treated with RT and,

therefore, RT services for such cancer

types can be accurately priced for

purposes of a prospective episode

payment model. RO episodes will

include most RT services furnished in

HOPDs and freestanding radiation

therapy centers during a 90-day period.

We are finalizing that participation in

the RO Model will be mandatory for all

RT providers and RT suppliers within

selected geographic areas. We will use

Core-Based Statistical Areas (CBSAs)

delineated by the Office of Management

and Budget

1

as the geographic area for

the randomized selection of RO

participants. We will 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 will exclude certain providers and

suppliers from participation under the

RO Model as described in section

III.C.3.c. of this final rule.

We are including beneficiaries that

meet certain criteria under the RO

Model. For example, these criteria will

require that a beneficiary have a

diagnosis of at least one of the cancer

types included in the RO Model and

that the beneficiary receive RT services

from a participating provider or supplier

in one of the selected CBSAs.

Beneficiaries who meet these criteria

will be included in RO episodes.

(c) RO Model Overlap With Other CMS

Programs and Models

We expect that there could be

situations where a Medicare beneficiary

included in an RO episode under the

RO Model is also assigned, aligned, or

attributed to another Innovation Center

model or CMS program. Overlap could

also occur among RT providers and RT

suppliers at the individual or

organization level, such as where a

radiation oncologist or his or her PGP

participates in multiple Innovation

Center models. We believe that the RO

Model is compatible with existing

models and programs that provide

opportunities to improve care and

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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).

reduce spending, especially episode

payment models like the Oncology Care

Model. However, we will work to

resolve any potential overlaps between

the RO Model and other CMS models or

programs that could result in repetitive

services, or duplicative payment of

services, and duplicative counting of

savings or other reductions in

expenditures.

(d) RO Model Episodes and Pricing

Methodology

We are setting a separate payment

amount for the PC and the TC of each

cancer type included in the RO Model.

The payment amounts will be

determined based on national base rates,

trend factors, and adjustments for each

participant’s case-mix, historical

experience, and geographic location.

The payment amount will also be

adjusted for withholds for incorrect

payments, quality, and starting in the

third performance year (PY3), patient

experience. The standard beneficiary

coinsurance amounts (typically 20

percent of the Medicare-approved

amount for services) and sequestration

will remain in effect. RO participants

will have the ability to earn back a

portion of the quality and patient

experience withholds based on their

reporting of clinical data, their reporting

and performance on quality measures,

and as of PY3, performance on the

beneficiary-reported Consumer

Assessment of Healthcare Providers and

Systems (CAHPS

®

) Cancer Care

Radiation Therapy Survey.

(e) RO Model Quality Measures and

Reporting Requirements

We are adopting four quality

measures and will collect the CAHPS

®

Cancer Care Radiation Therapy Survey

for the RO Model. Three of the four

measures 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).

23

We selected

all measures based on clinical

appropriateness for RT services

spanning a 90-day period. These

measures will be applicable to the full

range of 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 will 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.

RO participants will be paid for

reporting clinical data in accordance

with our reporting requirements (as

discussed in section III.C.8.e. of this

final rule), and paid for performance on

aggregated quality measure data on

three quality measures and pay-for-

reporting on one quality measure (for

PY1 and PY2) (as discussed in section

III.C.8.f. of this final rule). We are

adding a set of patient experience

measures based on the CAHPS

®

Cancer

Care Survey for Radiation Therapy for

inclusion as pay-for-performance

measures. We will also require

Professional participants and Dual

participants to report all quality data for

all applicable patients receiving RT

services from RO participants based on

numerator and denominator

specifications for each measure (for

example, not just Medicare beneficiaries

or beneficiaries receiving care for RO

episodes).

(f) RO Model Data Sharing Process

We will collect quality and clinical

data for the RO Model. We intend to

share certain data with RO participants

to the extent permitted by the Health

Insurance Portability and

Accountability Act of 1996 (HIPAA)

Privacy Rule and other applicable law.

We are establishing data privacy

compliance standards for RO

participants. We are establishing

requirements around the public release

of patient de-identified information by

RO participants. We will offer RO

participants the opportunity to request a

claims data file that contains patient-

identifiable data on the RO participant’s

patient population for clinical

treatment, care management and

coordination, and quality improvement

activities. Also, we will permit the data

to be reused by RO participants for

provider incentive design and

implementation, and we believe it may

be of use in RO participants’ review of

our calculation of their participant-

specific episode payment amounts and

reconciliation payment amounts or

repayment amounts, as applicable.

Thus, we expect that the data offered

under the RO Model will be used by RO

participants and CMS to better

understand Model effects, establish

benchmarks, and monitor participant

compliance. Again, as previously

described, the data uses and sharing

will be allowed only to the extent

permitted by the HIPAA Privacy Rule

and other applicable law.

When using or disclosing such data,

the RO participant will be required to

make ‘‘reasonable efforts to limit’’ the

information to the ‘‘minimum

necessary’’ as defined by 45 CFR

164.502(b) and 164.514(d) to

accomplish the intended purpose of the

use, disclosure, or request. The RO

participant will be required to further

limit its disclosure of such information

to what is permitted by applicable law,

including the regulations promulgated

under the HIPAA and the Health

Information Technology for 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 final rule.

(g) RO Model Beneficiary Protections

We are requiring Professional

participants and Dual participants to

notify RO beneficiaries of the

beneficiary’s inclusion in this Model

through a standardized written notice to

each RO beneficiary during the

treatment planning service. We intend

to provide a notification template,

which RO participants may personalize

with contact information and logos, but

must otherwise not be changed. Further

explanation of the beneficiary

notification can be found in section

III.C.15. of this final rule.

(h) RO Model Program Policy Waivers

We believe it will be necessary to

waive certain requirements of title XVIII

of the Act solely for purposes of

carrying out the testing of the RO Model

under section 1115A(b) of the Act. We

will issue these waivers using our

waiver authority under section

1115A(d)(1) of the Act. Each of the

waivers is discussed in detail in section

III.C.10. of this final rule, and codified

in our regulations at § 512.280.

c. ESRD Treatment Choices (ETC) Model

The ETC Model will be a mandatory

payment model, focused on encouraging

greater use of home dialysis and kidney

transplants for ESRD Beneficiaries

among ESRD facilities and Managing

Clinicians located in Selected

Geographic Areas. The ETC Model will

include two payment adjustments. The

first payment adjustment, the Home

Dialysis Payment Adjustment (HDPA),

will be a positive adjustment on certain

home dialysis and home dialysis-related

claims during the initial 3 years of the

model. The second payment adjustment,

the Performance Payment Adjustment

(PPA), will be a positive or negative

adjustment on dialysis and dialysis-

related Medicare payments, for both

home dialysis and in-center dialysis,

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based on ESRD facilities’ and Managing

Clinicians’ rates of home dialysis, and of

kidney transplant waitlisting and living

donor transplantation, among attributed

beneficiaries during the applicable MY.

We are implementing the payment

adjustments under the ETC Model

beginning January 1, 2021, and ending

June 30, 2027.

(1) Summary of the ETC Model

Provisions

(a) ETC Model Overview

Beneficiaries with ESRD generally

require some form of renal replacement

therapy, the most common being

hemodialysis (HD), followed by

peritoneal dialysis (PD), or a kidney

transplant. Most beneficiaries with

ESRD receive HD treatments in an ESRD

facility; however, other renal

replacement modalities—including

dialyzing at home or receiving a kidney

transplant—may be better options than

in-center dialysis for more beneficiaries

than currently use them. We are

finalizing the ETC Model to test the

effectiveness of adjusting certain

Medicare payments to ESRD facilities

and Managing Clinicians—clinicians

who furnish and bill the Monthly

Capitation Payment (MCP) for managing

ESRD Beneficiaries—to encourage

greater utilization of home dialysis and

kidney transplantation, support

beneficiary modality choice, reduce

Medicare expenditures, and preserve or

enhance the quality of care. We believe

ESRD facilities and Managing Clinicians

are the key providers and suppliers

managing the dialysis care and

treatment modality options for ESRD

Beneficiaries and have a vital role to

play in beneficiary modality selection

and assisting beneficiaries through the

transplant process. We are adjusting

payments for home dialysis and home

dialysis-related claims with claim

service dates from January 1, 2021,

through December 31, 2023 through the

HDPA. We also will assess the rates of

home dialysis and of kidney transplant

waitlisting and living donor

transplantation, among beneficiaries

attributed to ETC Participants during

the period beginning January 1, 2021,

and ending June 30, 2026, with the PPA

based on those rates applying to claims

for dialysis and dialysis-related services

with claim service dates beginning July

1, 2022, and ending June 30, 2027.

(b) ETC Model Scope

The ETC Model will be a mandatory

payment model focused on encouraging

greater use of home dialysis and kidney

transplants for ESRD Beneficiaries. The

rationale for a mandatory model for

ESRD facilities and Managing Clinicians

within Selected Geographic Areas is

that we seek to test the effect of payment

incentives on availability and choice of

treatment modality among a diverse

group of providers and suppliers. We

will randomly select Hospital Referral

Regions (HRRs) for inclusion in the

Model, and also include all HRRs with

at least 20 percent of ZIP Codes located

in Maryland in addition to those

selected through randomization in

conjunction with the Maryland Total

Cost of Care Model currently being

tested in the state of Maryland.

Managing Clinicians and ESRD facilities

located in these Selected Geographic

Areas will be required to participate in

the ETC Model and will be assessed on

their rates of home dialysis, and of

kidney transplant waitlisting and living

donor transplantation, among their

attributed beneficiaries during each MY;

CMS will then adjust certain of their

Medicare payments upward or

downward during the corresponding

Performance Payment Adjustment

Period (PPA Period). Managing

Clinicians and ESRD facilities located in

the Selected Geographic Areas will also

receive a positive adjustment on their

home dialysis and home dialysis-related

claims for the first 3 years of the ETC

Model to support home dialysis

provision before the PPA begins to

apply.

(c) Home Dialysis Payment Adjustment

(HDPA)

We will make upward adjustments to

certain payments made to participating

ESRD facilities under the ESRD

Prospective Payment System (PPS) on

home dialysis claims, and will make

upward adjustments to the MCP paid to

participating Managing Clinicians on

home dialysis-related claims. The HDPA

will apply to claims with claim service

dates beginning on January 1, 2021, and

ending on December 31, 2023.

(d) Home Dialysis and Transplant

Performance Assessment and

Performance Payment Adjustment (PPA)

We will assess ETC Participants’ rates

of home dialysis, and transplant

waitlisting and living donor

transplantation, during a MY, which

will include 12 months of performance

data. Each MY will overlap with the

previous MY, if any, and the subsequent

MY, if any, for a period of 6 months.

Each MY will have a corresponding PPA

Period—a 6-month period, which will

begin 6 months after the conclusion of

the MY. We will adjust certain

payments for ETC Participants during

the PPA Period based on the ETC

Participant’s home dialysis rate and

transplant rate, calculated as the sum of

the transplant waitlist rate and the

living donor transplant rate, during the

corresponding MY. We will be

measuring rates of home dialysis, and of

transplant waitlisting and living donor

transplantation, for ESRD facilities and

Managing Clinicians using Medicare

claims data, Medicare administrative

data including enrollment data, and the

Scientific Registry of Transplant

Recipients (SRTR) data. We will

measure home dialysis rates for ESRD

facilities and Managing Clinicians in the

ETC Model by calculating the number of

dialysis treatment beneficiary years

during the MY in which attributed

beneficiaries received dialysis at home,

plus one half the total number of

dialysis treatment beneficiary years

during the MY in which attributed

beneficiaries received self dialysis in

center. We will measure transplant rates

for ESRD facilities and Managing

Clinicians by calculating the number of

attributed beneficiary years during the

MY for which attributed beneficiaries

were on the kidney transplant waitlist

and by calculating the number of

attributed beneficiary years during the

MY for which attributed beneficiaries

received living donor transplants. The

ETC Model will make upward and

downward adjustments to certain

payments to participating ESRD

facilities under the ESRD PPS and to the

MCP paid to participating Managing

Clinicians based upon the ETC

Participant’s home dialysis rate and

transplant rate. The magnitude of the

positive and negative PPAs for ETC

Participants will increase over the

course of the Model. These PPAs will

apply to claims with claim service dates

beginning July 1, 2022, and ending June

30, 2027.

(e) ETC Model Overlaps With Other

Innovation Center Models and CMS

Programs

The ETC Model will overlap with

several other CMS programs and

models, including initiatives

specifically focusing on dialysis care.

We believe the ETC Model will be

compatible with other dialysis-focused

CMS programs and models. However,

we will work to resolve any potential

overlaps between the ETC Model and

other CMS models or programs that

could result in repetitive services or

duplicative payment for services. The

payment adjustments made under the

ETC Model will be counted as

expenditures under the Medicare

Shared Savings Program and other

shared savings initiatives. Additionally,

ESRD facilities will remain subject to

the quality requirements in ESRD

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Quality Incentive Program (QIP), and

Managing Clinicians who are MIPS

eligible clinicians will remain subject to

MIPS unless otherwise excluded.

(f) ETC Model Medicare Payment

Waivers

In order to make the proposed

payment adjustments under the ETC

Model, namely the HDPA and PPA, we

will need to waive certain Medicare

program requirements. In particular, we

will waive certain requirements of the

Act for the ESRD PPS, ESRD QIP, and

Medicare Physician Fee Schedule only

to the extent necessary to make the

payment adjustments under the ETC

Model for ETC Participants. In addition,

we will waive certain requirements such

that the payment adjustments made

under the ETC Model will not change

beneficiary cost-sharing from the regular

Medicare program cost-sharing for the

related Part B services that were paid for

beneficiaries who receive services from

ETC Participants.

It will also be necessary to waive

certain Medicare payment requirements

of section 1861(ggg) of the Act and

implementing regulations at 42 CFR

410.48, regarding the use of the Kidney

Disease Education (KDE) benefit, solely

for the purposes of testing the ETC

Model. The purpose of such waivers

will be to give ETC Participants

additional access to the tools necessary

to ensure beneficiaries select their

preferred kidney replacement modality.

As education is a key component of

assisting beneficiaries with making such

selections, we will waive select

requirements regarding the provision of

the KDE benefit, including waiving the

requirement that certain health care

provider types must furnish the KDE

service to allow additional staff to

furnish the service, waiving the

requirement that the KDE service be

furnished to beneficiaries with Stage IV

CKD to allow ETC Participants to

furnish these services to beneficiaries in

later stages of kidney disease, and

waiving certain restrictions on the KDE

curriculum to allow the content to be

tailored to each beneficiary’s needs.

We will issue these waivers using our

waiver authority under section

1115A(d)(1) of the Act.

(g) ETC Model Monitoring and Quality

Measures

Consistent with the monitoring

requirements in the general provisions,

we will closely monitor the

implementation and outcomes of the

ETC Model throughout its duration. The

purpose of this monitoring will be to

ensure that the ETC Model is

implemented safely and appropriately,

the quality or experience of care for

beneficiaries is not harmed, and

adequate patient and program integrity

safeguards are in place.

As part of the monitoring strategy, we

will be using two quality measures for

the ETC Model: The Standardized

Mortality Ratio and the Standardized

Hospitalization Ratio. These measures

are NQF-endorsed, and are currently

calculated at the ESRD facility level for

Dialysis Facility Reports and the ESRD

QIP, respectively. Therefore, we will

require no additional reporting of

quality measures by ETC Participants.

We intend to propose a beneficiary

experience measure in future

rulemaking.

(h) ETC Model Beneficiary Protections

The ETC Model will not allow

beneficiaries to opt out of the payment

adjustments for their ESRD facility or

Managing Clinician; however, the

Model will not restrict a beneficiary’s

freedom to choose an ESRD facility or

Managing Clinician, or any other

provider or supplier, and ETC

Participants will be subject to the

general provisions protecting

beneficiary freedom of choice and

access to medically necessary covered

services. We also will require that ETC

Participants notify beneficiaries of the

ETC Participant’s participation in the

ETC Model by prominently displaying

informational materials in ESRD

facilities and Managing Clinician offices

or facilities where beneficiaries receive

care. Additionally, ETC Participants

will be subject to the general provisions

regarding descriptive model materials

and activities.

B. Background

In the July 18, 2019 Federal Register

(84 FR 34478), we published the

proposed rule titled ‘‘Medicare Program;

Specialty Care Models to Improve

Quality of Care and Reduce

Expenditures’’ that would implement

two new mandatory Medicare payment

models under section 1115A of the

Act—the Radiation Oncology Model

(RO Model) and the End-Stage Renal

Disease (ESRD) Treatment Choices

Model (ETC Model).

As we stated in the proposed rule, we

believe that these two models will test

ways to further our goals of reducing

Medicare expenditures while preserving

or enhancing the quality of care

furnished to beneficiaries.

We received approximately 330

timely pieces of correspondence in

response to our solicitation of public

comments on the proposed rule. While

we are finalizing several of the

provisions from the proposed rule, there

are a number of provisions from the

proposed rule that we intend to address

later and a few that we do not intend to

finalize. We also note that some of the

public comments were outside of the

scope of the proposed rule. These out-

of-scope public comments are not

addressed in this final rule. Summaries

of the public comments that are within

the scope of the proposed rule and our

responses to those public comments are

set forth in the various sections of this

final rule under the appropriate

heading. However, we note that in this

final rule we are not addressing most

comments received with respect to the

provisions of the proposed rule that we

are not finalizing at this time. Rather,

we will address them at a later time, in

a subsequent rulemaking document, as

appropriate.

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 has a specific payment

methodology, quality metrics, and

certain other applicable policies, each

model also has general provisions that

are very similar, including provisions

on monitoring and evaluation;

compliance with model requirements

and applicable laws; and beneficiary

protections.

This section of the final rule finalizes

the implementation of some general

provisions that will be applicable to

both the RO Model and the ETC Model.

These general provisions are only

applicable to model participants in the

RO Model and the ETC Model. The

general provisions being finalized here

are based on similar provisions that

have been repeatedly memorialized in

various documents governing

participation in existing model tests.

As we noted in the proposed rule, we

believe it promotes efficiency to publish

in section II. of this final rule certain

general provisions in each of these areas

that apply to both the RO Model and the

ETC Model. This avoids the need to

restate the same provisions separately

for the two models in this final rule. We

will codify these general provisions in

a new subpart of the Code of Federal

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Regulations (42 CFR part 512, subpart

A). These provisions are not intended to

comprehensively encompass all the

provisions that will apply to each

model. Both the RO Model and the ETC

Model have unique aspects that require

additional, more tailored provisions,

including with respect to payment and

quality measurement. Such model-

specific provisions are described

elsewhere in this final rule.

We received approximately 35 timely

public comments on the general

provisions of the proposed rule. These

comments were submitted by

individuals and entities with an interest

in radiation oncology and kidney

diseases. We note that some of these

public comments were outside the

scope of the proposed rule. These out-

of-scope public comments are not

addressed with the policy responses in

this final rule. Summaries of the public

comments that are within the scope of

the proposed rule and our responses to

those public comments are set forth in

this section of the final rule under the

appropriate headings.

B. Basis and Scope

In § 512.100(a), we proposed to apply

the general provisions in section II. of

the proposed rule only to the RO Model

and the ETC Model, each of which we

proposed to refer to as an ‘‘Innovation

Center model’’ for purposes of these

general provisions. As proposed, this

paragraph indicated that these general

provisions would not, except as

specifically noted in 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 proposed to apply

the general provisions to model

participants in the RO Model (with one

exception described later in this final

rule) and the ETC Model. We proposed

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 part 512; as proposed, the term

‘‘model participant’’ would include,

unless otherwise specified, the terms

‘‘RO participant’’ or ‘‘ETC Participant’’

as those terms are defined in subparts B

and C of part 512. We proposed 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. We proposed that a

downstream participant may include,

but would not be limited to, an

individual practitioner, as defined for

purposes of the RO Model. We proposed

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, as this term is used for

purposes of both the RO Model and the

ETC Model, we proposed 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 solicited public comment on our

proposals regarding the basis and scope

of these general provisions. We received

no comments on these proposals and

therefore we are finalizing these

proposals without modification in our

regulations at § 512.100(a). We similarly

did not receive comments on our

proposed definitions of model

participant, downstream participant, or

U.S. Territories, and are finalizing these

definitions as proposed in our

regulation at § 512.110.

C. Definitions

In our regulation at § 512.110, we

proposed to define certain terms

relevant to the general provisions. We

describe these definitions in context

throughout section II. of this final rule.

To the extent we have received

comments on the definitions we

proposed, we have responded to those

comments throughout section II. of this

final 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, as noted in the proposed

rule, 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 proposed to define the

term ‘‘beneficiary’’ to mean an

individual who is enrolled in Medicare

FFS. As we noted in the proposed rule,

this definition aligns with the scope of

the RO Model and the ETC Model,

which include only Medicare FFS

beneficiaries. We also proposed 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 proposed part 512; as proposed,

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. As

stated in the proposed rule, we believed

it was 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. We received no

comments on these proposed definitions

and therefore are finalizing these

definitions in our regulation at

§ 512.110 without modification.

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 Innovation Center models, we

proposed to require in § 512.120(a)(1)

that model participants and their

downstream participants not restrict a

beneficiary’s ability to choose his or her

providers or suppliers. We proposed

that this policy would apply with

respect to all Medicare FFS

beneficiaries, not just model

beneficiaries, because we believe it is

important to ensure that the Innovation

Center model tests do not interfere with

the general guarantees and protections

for all Medicare FFS beneficiaries.

Also, in § 512.120(a)(2), we proposed

to codify 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. As we noted in

the proposed rule, we believe this

requirement is necessary to ensure that

Innovation Center models do not

prevent beneficiaries from obtaining 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 further

proposed that the model participant and

its downstream participants would be

permitted to communicate to model

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beneficiaries the benefits of receiving

care with the model participant, if

otherwise consistent with the

requirements of part 512 and applicable

law.

In § 512.110, we proposed to define

the terms ‘‘provider’’ and ‘‘supplier,’’ as

used in part 512, in a manner consistent

with how these terms are used in

Medicare FFS generally. Specifically,

we proposed to 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 proposed 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. As stated in the proposed rule,

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 part 512.

We solicited comments on our

proposals related to beneficiary freedom

of choice. In this section of this final

rule, we summarize and respond to the

public comments received on the

beneficiary freedom of choice proposal.

Comment: A few commenters thanked

CMS for the explicit clarification of

beneficiary rights—notably, that

beneficiaries maintain their right to

choose a health care provider that is not

participating in either the RO Model or

the ETC Model.

Response: We thank the commenters

for their support and for their comments

in support of our proposals to maintain

beneficiaries’ freedom of choice and

other beneficiary protections.

Comment: A few commenters

requested that CMS strengthen the

proposed beneficiary protections so that

beneficiaries are adequately educated

about any Innovation Center model in

which they are included. Specifically,

one of the commenters requested that

CMS solicit external feedback on the

contents of any beneficiary notification

letter prior to requiring its use by model

participants. A few commenters also

expressed concern that RO Model

beneficiaries, specifically, would not

have access to the same range of benefits

as other Medicare beneficiaries.

Response: We disagree with the

commenters that additional safeguards

are needed to ensure that model

beneficiaries will be adequately

educated about the Innovation Center

models. Specifically, we believe that

several of our finalized provisions will

provide adequate education to model

beneficiaries regarding the models in

which the beneficiaries are included,

including §§ 512.225 and 512.330

relating to beneficiary notifications for

the RO Model and ETC Model,

respectively, as well as § 512.120(c)

relating to the requirements for

materials and activities used to educate,

notify, or contact beneficiaries regarding

the Innovation Center model (referred to

in this final rule as descriptive model

materials and activities). We would note

that § 512.120(c) allows model

participants to provide additional

descriptive model materials and

activities to model beneficiaries that

could describe in greater detail the

Innovation Center Model and its

expected impacts on model

beneficiaries. We note that this

provision requires that all descriptive

model materials and activities must not

be materially inaccurate or misleading,

and all such materials and activities

may be reviewed by CMS. With respect

to the template beneficiary notifications

that RO participants and ETC

Participants must furnish, we will not

provide a formal process for soliciting

feedback on the content of such

notifications because such a process

may interfere with the model operation

timelines. However, we are open to

receiving such feedback on an informal

basis. We believe the provisions

regarding beneficiary notifications and

descriptive model materials and

activities strike an appropriate balance

between the amount of information that

may be desired by beneficiaries and the

burden of ensuring that such

information is accurate and not

misleading.

Additionally, as described in this

final rule, under our regulations at

§ 512.120(a) and (b), model beneficiaries

will retain the right to receive care from

the providers and suppliers of their

choice as well as access to the same

range of benefits as other Medicare FFS

beneficiaries who are not receiving care

from an Innovation Center model

participant. As such, we believe that our

proposed beneficiary protections will

establish strong beneficiary safeguards

for the two Innovation Center models.

However, as described in section II.H. of

this final rule, we are also finalizing our

proposal to monitor model participant

compliance with model terms and other

applicable program laws and policies,

including requirements related to

beneficiary access to services and the

providers and suppliers of their choice.

If needed, we will propose any

modifications to the applicable

beneficiary protections through future

rulemaking.

After considering public comments,

we are finalizing our proposals on

beneficiary freedom of choice without

modification in our regulation at

§ 512.120(a). We received no comments

on the proposed definitions of provider

and supplier and therefore are finalizing

these definitions without modification

in our regulation at § 512.110.

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, as we noted in the proposed rule,

an important aspect of testing

Innovation Center models is that

beneficiaries continue to access and

receive needed care. Therefore, in

§ 512.120(b)(1), we proposed that model

participants and downstream

participants are 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 proposed 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 proposed 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

proposed 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. As

noted in the proposed rule, 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, in § 512.120(b)(2) we proposed

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

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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. As noted in the proposed

rule, 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 prohibiting lemon dropping is a

necessary safeguard to counter any

incentives created by the 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, in

§ 512.120(b)(3), we proposed an

additional provision to 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.

We solicited comments on our

proposals related to availability of

services and on whether prohibiting

cherry-picking would prevent model

participants from artificially inflating

their financial or quality performance

results. In this section of this final rule,

we summarize and respond to the

public comments received on these

proposals.

Comment: A commenter applauded

CMS’s proposals to prohibit model

participants from ‘‘cherry-picking’’

beneficiaries. This commenter requested

additional details on how CMS plans to

identify model participants that have

‘‘cherry-picked’’ or ‘‘lemon-dropped’’

beneficiaries.

Response: We appreciate the

commenter’s support of our proposal to

prohibit cherry-picking in Innovation

Center models. We will identify model

participants that may have ‘‘cherry-

picked’’ or ‘‘lemon-dropped’’

beneficiaries through various modes of

monitoring set forth in section II.H.

(general provisions), section III.C.14.

(the RO Model), and section IV.C.10.

(ETC Model) of this final rule. In

addition, beneficiary complaints may

alert us to potentially inappropriate

beneficiary selection or avoidance of

certain beneficiaries.

After considering public comments,

we are finalizing our proposed

provisions on the availability of services

without modification in our regulation

at § 512.120(b). We received no

comments on whether prohibiting

cherry-picking will prevent model

participants from artificially inflating

their financial or quality performance

results and therefore are not finalizing

additional provisions against cherry-

picking in this final rule.

3. Descriptive Model Materials and

Activities

In order to protect beneficiaries from

potentially being misled about

Innovation Center models, we proposed

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 part 512,

we proposed 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.

Further, we proposed 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

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, as noted in

the proposed rule, 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

would in no way restrict 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. We did not propose to

regulate information or communication

unrelated to an Innovation Center model

because it would not advance the

purpose of the proposed prohibition,

which is to protect model beneficiaries

from being misled about their inclusion

in an Innovation Center model or their

Medicare rights generally. Accordingly,

we proposed to define the term

‘‘descriptive model materials and

activities’’ such that materials unrelated

to the Innovation Center model are not

subject to the requirements of

§ 512.120(c)(1).

Also, in § 512.120(c)(4) we proposed

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. As noted in the

proposed rule, 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. Furthermore,

to facilitate our ability to conduct this

review and to monitor Innovation

Center models generally, we proposed at

§ 512.120(c)(3) 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

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activities in a manner consistent with

§ 512.135(c) (record retention).

Also in § 512.120(c)(2), we proposed

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

proposed 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 solicited comments on our

proposals related to descriptive model

materials and activities. We also

solicited comment on whether we

should propose a different disclaimer

that alerts beneficiaries that we prohibit

misleading information and gives

beneficiaries contact information so

they could reach out to us if they

suspect the information they have

received regarding an Innovation Center

model is inaccurate.

In this section of this final rule, we

summarize and respond to the public

comments received on these proposals.

Comment: A commenter requested

that CMS review all marketing materials

from model participants prior to those

materials being made available to

beneficiaries in order to prevent

confusion or the dissemination of

misleading information. This

commenter also supported the proposal

that descriptive model materials and

activities include the proposed

disclaimer.

Response: We thank the commenter

for supporting our proposal to require

model participants include a disclaimer

on all descriptive model materials and

activities so that the public, and model

beneficiaries in particular, are not

misled into believing that model

participants are speaking on behalf of

CMS. We also appreciate the

commenter’s recommendation that CMS

review all marketing materials from

model participants prior to their

distribution; however, we believe that

our proposal to reserve the right to

review such materials once distributed

strikes the appropriate balance.

Specifically, our final rule protects

beneficiaries from receiving misleading

information regarding Innovation Center

models without unduly delaying the

release of useful information or

increasing the burden on model

participants and CMS by requiring a

thorough review of all marketing

materials from all model participants

prior to their release.

After considering public comments,

we are finalizing our proposed

provisions on descriptive model

materials and activities without

modification in our regulation at

§ 512.120(c). We did not receive any

comments on whether we should

propose a different disclaimer that alerts

beneficiaries that we prohibit

misleading information and gives them

contact information so they could reach

out to us if they suspect the information

they have received regarding an

Innovation Center model is inaccurate.

Furthermore, we received no comments

on these proposed definition of

descriptive model materials and

activities and therefore are finalizing

this definition without modification in

our regulation at § 512.110.

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 of the Act 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 of the Act, 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 final

rule, these compliance monitoring

activities are an important and

necessary part of the model test.

Therefore, we proposed to codify in

§ 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 the

Innovation Center model evaluation will

consider for the RO Model and ETC

Model can be found in in sections

III.C.16. and IV.C.11. of this final rule,

respectively. Further, we proposed to

conduct monitoring activities according

to proposed § 512.150, described later in

this final 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.

We solicited public comment on our

proposal regarding cooperation with

model monitoring and evaluation

activities. We received no comments on

these proposals and therefore are

finalizing these proposals without

modification in our regulation at

§ 512.130.

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, as noted in the

proposed rule, 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 proposed in

§ 512.120(b)(1) 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, as discussed in the

proposed rule, 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

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part of their participation in the

Innovation Center model. We proposed

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.’’ As noted in the proposed

rule, we believe it is necessary 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 here and in the proposed rule

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 of the Act

(such as under 42 CFR 510.110 for the

Innovation Center’s Comprehensive

Care for Joint Replacement Model).

Building off those existing

requirements, we proposed 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, in § 512.135(b)

and (c) we proposed that the model

participant and its downstream

participants must do the following:

•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 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

proposed that the records must be

maintained for such period of time

determined by CMS. 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. As

noted in the proposed rule, this

provision will ensure that that the

government has access to the records.

To avoid any confusion or disputes

regarding the timelines outlined in these

general provisions, we proposed to

define the term ‘‘days’’ to mean calendar

days.

We solicited 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 solicited public comments on

whether we should require model

participants and downstream

participants to maintain records for

longer than 6 years.

We summarize and respond in this

section of this final rule to the public

comments received on these proposals.

Comment: A few commenters

applauded our proposed requirement

for model participants and their

downstream participants to maintain

records for at least six (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.

Response: We thank the commenters

for their support of this proposed

policy.

Comment: A few commenters, while

generally supporting our proposed

record retention requirements, made

alternative suggestions for how CMS

should collect model-related records

from model participants. Specifically,

both commenters suggested that CMS

expressly allow for e-transmission of

model-related records when requested

by CMS as this would allow additional

flexibility for model participants and be

less burdensome for model participants.

Response: We appreciate the

commenters’ support for our proposed

record retention requirements. While we

did not propose to prohibit e-

transmission of records that are

requested by CMS, we are not finalizing

a provision that would permit the

exclusive use of e-transmission for such

records, as we believe that CMS should

make case-by-case determinations

regarding whether e-transmission is

appropriate.

We received no comments on whether

CMS should require model participants

and downstream participants to

maintain records for longer than 6 years.

After considering public comments, we

are finalizing our proposals on audits

and record retention as proposed in our

regulation at § 512.135. We received no

comments on the proposed definitions

for model-specific payments and days;

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and therefore, are finalizing these

definitions without modification in our

regulation at § 512.110.

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 § 512.150, in §512.140(a)

we proposed to use any data obtained in

accordance with §§ 512.130 and 512.135

to evaluate and monitor the Innovation

Center models. We further proposed

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

proposed 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, in

§ 512.140(c) we proposed 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.

As we noted in the proposed rule, 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 proposed to protect such

information from disclosure to the full

extent permitted under applicable laws,

including the Freedom of Information

Act. Specifically, in § 512.140(b), we

proposed that we would 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.

We solicited public comment on these

proposals. We received no comments on

these proposals and therefore are

finalizing these proposals without

modification in our regulation at

§ 512.140.

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, as noted in the proposed rule,

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.

As noted in the proposed rule, 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 § 512.150(b)(1), we proposed to

continue this standard practice of

conducting monitoring activities for

several reasons: (1) 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; (2) to understand model

participants’ use of model-specific

payments; and (3) 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 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 proposed to codify in

§ 512.150(b)(2), that when we are

conducting compliance monitoring and

oversight activities, CMS or its

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. As

noted in the proposed rule, 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 proposed 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 § 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, in § 512.150(c)(2) we proposed

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, to the

extent practicable, we proposed that

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

participants’ and downstream

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participants’ schedules while not

interfering with the operation of the

Innovation Center model. Further, in

§ 512.150(c)(3) we proposed 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. As noted in the proposed rule, we

believe this proposal is necessary to

ensure an effective site visit and prevent

the need for unnecessary follow-up site

visits.

Also, in § 512.150(c)(4), we proposed

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

provisions. Further, in § 512.150(c)(5)

we proposed that nothing in proposed

part 512 would limit CMS from

performing other site visits as allowed

or required by applicable law. As noted

in the proposed rule, 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 proposed to require

that model participants and each of

their downstream participants must

comply with all applicable laws and

regulations. We noted in the proposed

rule 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, in

§ 512.150(d) we proposed 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. We did not propose a

deadline for making or demanding such

payments, but we stated that we were

considering the imposition of some of

the deadlines set forth in the Medicare

reopening rules at 42 CFR 405.980.

Specifically, we sought 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). As noted in

the proposed rule, 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 proposed 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 for violations of any

statutes, rules, or regulations

administered by the Federal

government. This provision simply

reflects the limits of CMS authority.

We solicited comments on these

proposals related to monitoring and

compliance. In this section of this final

rule, we summarize and respond to the

public comments received on these

proposals and comment solicitations.

Comment: A commenter expressed its

support for our proposal to permit CMS

to make corrections to model-specific

payments. This commenter also

suggested that RO participants be

permitted to initiate requests to make

corrections to model-specific payments

in the RO Model.

Response: We thank this commenter

for their support of the proposed policy.

We would note that in section III.C.12.

of this final rule, we have finalized the

proposed process, with a modification

to allow for 45 days instead of the

proposed 30 days, for RO participants to

notify CMS of suspected errors in the

calculation of their reconciliation

payment amount or repayment amount

or aggregate quality score as reflected on

an RO reconciliation report that has not

been deemed final. In addition, in

section IV.C.5.h. of this final rule, we

have finalized the proposed process for

ETC Participants to request a targeted

review of the calculation of the

Modality Performance Score (MPS).

We understand the commenter to be

advocating that RO participants should

have the right to request reopening of a

model-specific payment determination.

By way of background, a reopening is an

administrative action taken to change a

binding determination or decision that

resulted in either an overpayment or

underpayment, even though the binding

determination or decision may have

been correct at the time it was made

based on the evidence of record (see

§ 405.980(a)). Under the Medicare

reopening rules, a party to an initial

determination may request that the

determination be reopened in a variety

of circumstances, including within one

year for any reason and within four

years for good cause (as defined at

§ 405.986). The Medicare reopening

rules also permit a CMS contractor to

reopen an initial determination on its

own motion for a variety reasons,

including: (1) Within 1 year for any

reason; (2) within 4 years for good cause

(as defined at § 405.986); and (3) at any

time if there is reliable evidence (as

defined at § 405.902) that the initial

determination was procured by fraud or

similar fault (as defined at § 405.902).

Under § 405.986, ‘‘good cause’’ may be

established when there is new and

material evidence that was not available

or known at the time of the

determination or decision and that may

result in a different conclusion or when

the evidence that was considered in

making the determination or decision

clearly shows on its face that an obvious

error was made at the time of the

determination or decision. Under the

existing reopening rules, the decision

whether to grant a request for reopening

is within the sole discretion of CMS and

is not reviewable (see § 405.980(a)(5)).

As noted previously in this final rule,

we did not propose any temporal

restrictions on when CMS could correct

prior payments, but we stated in the

proposed rule that we were considering

the imposition of some of the deadlines

set forth in the Medicare reopening

rules at 42 CFR 405.980. We specifically

sought comment regarding 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

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4 years for good cause (as defined at 42

CFR 405.986). After consideration of the

public comments, we believe that model

participants should have a limited

opportunity to request the reopening of

a model-specific payment

determination. Specifically, we will

permit the reopening of a model-specific

payment determination, whether on

CMS’ own motion or at the request of

a model participant, for good cause (as

defined at § 405.986) within 4 years

after the date of the determination. This

reopening provision will help to ensure

accurate payments under an Innovation

Center model, while the temporal and

‘‘good cause’’ limitations will promote

efficient use of administrative resources

and the eventual finality of payment

determinations. In addition, we are

finalizing a policy that permits CMS to

reopen a model-specific payment

determination at any time if there exists

reliable evidence (as defined at

§ 405.902) that the determination was

procured by fraud or similar fault (as

defined at § 405.902). The purpose of

this provision is to remediate fraud and

abuse that may not be discovered within

four years of the initial payment

determination.

Finally, consistent with the existing

Medicare reopening rules, the decision

to grant or deny a reopening request in

an Innovation Center model with

respect to a model-specific payment is

solely at CMS discretion and not

reviewable. For example, for purposes

of an Innovation Center Model, CMS

may exercise its discretion to reopen a

model-specific payment determination

to correct a clerical error that constitutes

good cause for reopening under

§ 405.986(a)(2). We note that if CMS

reopens a model-specific payment

determination, the revised payment

determination may be appealed in

accordance with the applicable

Innovation Center model regulations,

including § 512.170 (limitations on

review).

We do not believe, however, that it is

necessary to permit the reopening of a

model-specific payment determination

for any reason within 1 year after the

determination has been made. The

reopening rule we are finalizing here

adequately protects payment accuracy,

especially in light of the review

procedures set forth for the RO Model

at § 512.290 and for the ETC Model at

§ 512.390. Moreover, as noted above,

this final rule permits CMS to correct

clerical errors that it determines

constitute ‘‘good cause’’ for reopening.

We are finalizing our reopening policy

at § 512.150(d).

Comment: A commenter stated that

on-site monitoring of RO participants

should be conducted by personnel and

contractors that can provide RO

participants with certification,

licensure, or other form of demonstrated

knowledge in the specific field of

radiation oncology.

Response: We disagree with the

commenters’ belief that site visits of RO

participants must be conducted by

personnel and contractors that have

certification, licensure, or other form of

demonstrated knowledge in the specific

field of radiation oncology. We reiterate

that the proposed site visits were

intended to ensure compliance with the

Innovation Center model terms, to

facilitate the model evaluation, and to

investigate concerns related to the

health or safety of beneficiaries or other

patients or other program integrity

issues.

There are a variety of reasons for us

to conduct site visits. While having a

certain amount of knowledge of the field

of radiation oncology may be necessary

to conduct some site visits of RO

participants, depending on the nature

and purpose of the site visit, knowledge

of the RO Model terms as well as

general Medicare policies and

procedures may be more important. As

such, we are not accepting the

commenters’ suggestion to require the

personnel and contractors conducting

site visits to provide RO participants

with certification, licensure, or other

form of demonstrated knowledge in the

specific field of radiation oncology.

After considering public comments,

we are finalizing our proposals on

monitoring and compliance in our

regulation at § 512.150 with

modification. Specifically, to align the

regulatory text with the proposals

discussed in the preamble to the

proposed rule, we have modified the

regulatory text at § 512.150(b)(1) to

reference additional purposes for which

CMS may conduct monitoring activities,

namely to understand model

participants’ use of model-specific

payments; and to promote the safety of

beneficiaries and the integrity of the

Innovation Center model. In addition, in

response to public comment, we have

modified paragraph (d) of § 512.150 to

codify the reopening process.

Specifically, paragraph (d) has been

revised to state the following: (1) CMS

may reopen a model-specific payment

determination, either on its own motion

or at the request of a model participant,

within four years from the date of the

determination for good cause (as

defined at § 405.986); (2) CMS may

reopen a model-specific payment

determination at any time if there exists

reliable evidence (as defined in

§ 405.902) that the determination was

procured by fraud or similar fault (as

defined in § 405.902); and (3) CMS’s

decision regarding whether to reopen a

model-specific payment determination

is binding and not subject to appeal.

Finally, we have revised paragraph (e)

for brevity, which now states that this

final rule does not limit or restrict the

authority of the OIG or any other

Federal government authority to audit,

evaluate, investigate, or inspect model

participants or their downstream

participants for violations of ‘‘Federal

statutes, rules, or regulations.’’

I. Remedial Action

As stated in the proposed rule and

earlier in this final rule, as part of the

Innovation Center’s monitoring and

assessment of the impact of models

tested under the authority of section

1115A of the Act, 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.

As we noted in the proposed rule, 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 proposed that CMS

would 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;

•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 final

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

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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 proposed 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

§ 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

terminate, 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.

As stated in the proposed rule, we

noted that because the ETC Model is a

mandatory model, we would not expect

to use the 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 would note

that we did not propose and are

therefore not finalizing a provision

authorizing CMS to terminate RO

participants from the RO Model. The

types of providers and suppliers

selected for participation in the RO

Model do not present the same risk of

fraud and abuse that has historically

been present in the dialysis industry,

which includes ESRD facilities, one of

the two types of participants in the ETC

Model. We plan to monitor the RO

Model for program integrity and fraud

and abuse issues, and if necessary, we

may add a termination provision for RO

participants in future rulemaking.

We solicited public comment on these

proposals regarding remedial action. We

received no comments on these

proposals and therefore are finalizing

these proposals our regulation at

§ 512.160.

J. Innovation Center Model Termination

by CMS

In the proposed rule, we proposed

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.

In § 512.165(a), we proposed 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, we

noted in the proposed rule that

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 proposed 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.

We solicited public comment on these

proposals regarding the termination of

an Innovation Center model by CMS.

We received no comments on these

proposals; and therefore, are finalizing

these proposals without modification in

our regulation at § 512.165.

K. Limitations on Review

In § 512.170, we proposed 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 proposed 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 proposed 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 solicited comments on these

proposals regarding limitations on

review. In this section of this final rule,

we summarize and respond to the

public comments received on these

proposals.

Comment: A commenter suggested

that model participants be afforded the

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opportunity to challenge any adverse

assessments relating to that model

participant’s quality of care through

administrative or judicial review.

Response: We reiterate that the

limitations on administrative and

judicial review established in section

1115A(d)(2) of the Act include a

preclusion from review for the elements,

parameters, scope, and duration of such

models for testing or dissemination. We

proposed to interpret this provision as

precluding from review the assessment

by CMS of the quality of care furnished

by the model participant. However, after

reviewing this language in light of the

concern flagged by the commenter, we

realize that our proposed regulatory text

was confusing. Our intent was to

interpret the preclusion in section

1115A(d)(2)(C) of the Act related to the

elements, parameters, scope, and

duration of a model to apply to the

methodology used to assess the quality

of care furnished by a model

participant, as this is an element of the

design of an Innovation Center model.

We did not intend to preclude from

review a determination regarding how

that methodology is applied to a

particular model participant. We are

therefore modifying the text of

§ 512.170(c)(2) to refer to the

methodology used by CMS to assess of

the quality of care furnished by the

model participant. For the same reason,

we are modifying the text of

§ 512.170(c)(3) to similarly refer to the

methodology used by CMS to attribute

model beneficiaries to the model

participant, if applicable. We believe it

is appropriate to codify the statutory

limitations on judicial and

administrative review in our regulations

and that our interpretations thereof,

with these clarifications, are consistent

with the statute. We also agree with the

commenter’s assertion that model

participants should be allowed to

challenge adverse assessments that are

not precluded, and have laid out a

policy specifically allowing this for the

RO Model (section III.C.12. of this final

rule) and the ETC Model (section

IV.C.5.h. of this final rule).

After considering public comments,

we are finalizing our proposals on

limitations on review in our regulation

at § 512.170 with the modifications

described previously in this final rule.

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. As

we noted in the proposed rule, 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 Innovation Center models and

Medicare funds, we proposed 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 § 512.180(a), we proposed

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

proposed 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 proposed that the

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 proposed 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. We proposed that 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.

As we noted in the proposed rule, 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. As we

noted in the proposed rule, we believe

our proposal is necessary to protect the

financial integrity of the 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 stated that we were

considering (and we solicited 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 § 512.180(b), we proposed

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. As we stated

in the proposed rule, the purpose of this

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 solicited 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 considered

requiring notice to be furnished

promptly (for example, within 30 days)

after a change in legal name has become

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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.

effective. We solicited public comment

on this alternative approach.

Third, in § 512.180(c), we proposed

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 proposed that the

written notification must be furnished

in a form and manner specified by CMS.

For purposes of this notice obligation,

we proposed 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. We noted in the

proposed rule that 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 further noted that

we believe this 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 proposed that

if CMS determined in accordance with

§ 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 § 512.160(b). In

addition, to ensure payment of amounts

owed to CMS, we proposed 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 solicited comments on these

proposals. Also, we solicited 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. In this section of this final

rule, we summarize and respond to the

public comments received on the

proposal to require model participants

to notify CMS of a change in legal name.

Comment: A few commenters

generally supported the proposed

procedure for notifying CMS of a name

change. However, the commenters noted

that they would prefer that the model

participant be required to notify CMS 30

days after a legal name change, instead

of 60 days before, as they believe that

would reduce the administrative burden

of complying with the proposed

requirement for model participants.

Response: We solicited comment on

whether to require the model

participant to provide CMS with written

notice 30 days after a legal name

change. We agree with the commenters’

assertion that notifying CMS of a legal

name change 30 days after the name

change occurs would be less

burdensome for model participants. We

further believe that written notice

received within 30 days after the name

change occurs would provide CMS with

sufficient notice to ensure the accuracy

of our records.

We did not receive comments

regarding our proposals to require the

model participant to notify CMS

regarding bankruptcy or a change in

control. After considering public

comments, we are finalizing our

proposals on bankruptcy and other

notifications in our regulation at

§ 512.180, with modification to

§ 512.180(b) to change the timeline

under which a model participant must

provide written notice to CMS regarding

a legal name change from 60 days in

advance of a legal name change to 30

days after the legal name change occurs.

We have also made a non-substantive

modification to our regulation text at

§ 512.110 to correct a drafting error in

the final rule that removes the

duplicative text from the definition of

change in control.

III. Radiation Oncology Model

A. Introduction

As discussed in the proposed rule (84

FR 34478), we proposed to establish a

mandatory Radiation Oncology Model

(RO Model), referred to throughout

section III. of this final rule as ‘‘the

Model’’, to test whether prospective

episode-based payments for

radiotherapy (RT) services,

4

(also

referred to as radiation therapy services)

will 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, as we stated in the

proposed rule, we believe that radiation

oncology is well-suited for testing a

prospective episode payment model.

Under the RO Model proposals,

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. We proposed that 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. We proposed

that the performance period for the RO

Model would be 5 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 (84 FR

34493 through 34503).

We included the following proposals

for the Model in the 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. We solicited

comments on these proposals.

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). As we stated in the proposed

rule (84 FR 34490), we believe that a

model in radiation oncology will further

these efforts to improve cancer care for

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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.

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.

Medicare beneficiaries and reduce

Medicare expenditures.

RT is a common treatment for nearly

two thirds of all patients undergoing

cancer treatment

56

and is typically

furnished by a radiation oncologist. As

we discussed in the proposed rule (84

FR 34490), 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’ 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 (PBT);

intraoperative radiotherapy (IORT);

image-guided radiation therapy (IGRT);

and brachytherapy. As discussed in the

proposed rule (84 FR 34490), we

conducted several analyses of radiation

treatment patterns using that group of

beneficiaries and their associated

Medicare Part A and Medicare Part B

claims.

Our analysis, as discussed in the

proposed rule (84 FR 34490), 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. In the proposed rule we stated

that our intention was 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, and we posted it for

commenters’ reference in conjunction

with the publication of the proposed

rule. In the proposed rule (84 FR 34490),

we discussed that 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 an HOPD. As we stated in

the proposed rule (84 FR 34490), we are

not aware of any clinical rationale that

explains 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 persisted even though

Medicare payments are lower per unit

in freestanding radiation therapy centers

than in HOPDs. Upon further analysis,

as we noted in the proposed rule (84 FR

34490), 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 component of the services

are paid under the PFS. As we

discussed in the proposed rule (84 FR

34490 through 34491), 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

depending on the setting in which it is

furnished. 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 proposed 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 has limited authority to adjust

payments only within established

payment methodologies such as under

section 1848 of the Act governing the

PFS;

•The Practice Expense (PE)

component of the PFS is determined

based on resource inputs (labor,

equipment, and supplies) and input

price estimates from entities paid under

the PFS only, which means the PE

calculation does not consider HOPD

cost data that the RO Model proposed to

use as the basis for national base rates;

•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

•Under the PFS and OPPS, the same

payment rate applies for a service,

irrespective of the diagnosis, whereas

the proposed rule for the RO Model

would establish different payments by

cancer type.

•Neither the PFS nor OPPS payment

systems would allow flexibility in

testing new and comparable approaches

to value-based payment outside of

statutory quality reporting programs.

As we stated in the proposed rule (84

FR 34490 through 34491), we believe a

site-neutral payment policy will 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 stated our belief 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

As discussed in the proposed rule (84

FR 34491), 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.

891011

As

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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.

18

These planning and technical preparation

services include dose planning, treatment aids, CT

simulations, and other services.

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.

21

CY 2014 PFS final rule with comment period

(78 FR 43296, 43286 through 43289, and 43302

through 43311).

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

Based on our review of claims data,

we discussed our belief 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 and suppliers can bill for RT

services and an array of necessary

planning services to make the treatment

successful.

18

We discussed that 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.

As discussed in the proposed rule (84

FR 34491), 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

4. CMS Coding and Payment Challenges

In the proposed rule (84 FR 34491

through 34492) 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

Further, as we discussed in the

proposed rule (84 FR 34492), we

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 use notice and comment

rulemaking to propose and finalize the

code as misvalued, and then review the

Work and PE RVU inputs for the code.

As a result of the review, we may engage

in further rulemaking to adjust the Work

or PE inputs either upward or

downward. The criteria for identifying

potentially misvalued codes are set forth

in section 1848(c)(2)(K)(ii) of the Act.

As described in the proposed rule (84

FR 34492), 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 codes 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 and public

information which 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

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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); and CY

2016 PFS correcting amendment (81 FR 12024).

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.

24

United States Department of Health and Human

Services Report to Congress: Episodic Alternative

Payment Model for Radiation Therapy Services.

(Nov. 2019). https://innovation.cms.gov/resources/

radiationapm-pubforum.html.

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 of 2018 are

discussed in detail in this rule).

Despite the previously discussed

challenges related to information used

to establish payment rates for RT

services, the proposed rule (84 FR

34492) noted that 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.

The proposed rule further explained

that 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 (84 FR 34492). We continue to

use some CMS-specific coding, or

HCPCS codes, in billing and payment

for RT services under the PFS, while we

generally use CPT

®

codes under the

OPPS. 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, as noted in the proposed rule

(84 FR 34492), 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 the fact 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, PFS rates are developed to

maintain relativity among other PFS

office-based services, and generally

without consideration of OPPS payment

rates.

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.

In the proposed rule (84 FR 34493),

we described how the Innovation

Center, in preparing the Report to

Congress, conducted an environmental

scan of current evidence and 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. In

the proposed rule, we stated our belief

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 the proposed rule, we proposed

what the Innovation Center has

determined to be the best design for

testing an episodic APM for RT services.

The following is a summary of

comments we received on the proposed

goals of the RO Model and the issues

addressed in section III.B. of the

proposed rule and our responses to

these comments:

Comment: Many commenters

supported most aspects of the proposed

RO Model and expressed commitment

to fully participating in a value-based

care model. A commenter recommended

that CMS finalize the RO Model as

mandatory, site-neutral, and inclusive of

all proposed modalities. Several

commenters expressed their support

and encouraged CMS to have value-

based programs that allow health care

providers, through shared decision-

making with their patients, to determine

appropriate and convenient delivery

options. A few commenters noted

appreciation for CMS’ commitment to

providing participants with stable rates.

Some commenters expressed support for

clinical episode-related payments and

the removal of payment on a per

fraction basis. A few of these

commenters also expressed their

support of the transition to value-based

care solutions.

Response: We thank these

commenters for their support of our

efforts to move forward with the RO

Model. We are finalizing the RO Model

as mandatory (see section III.C.3.a. of

this final rule) with the modification of

a low volume opt-out (see section

III.C.3.c. of this final rule), site-neutral

(see section III.C.6.c. of this final rule),

and inclusive of all proposed modalities

except for IORT (see section III.C.5.d. of

this final rule).

Comment: A commenter expressed

concern that CMS has not provided

enough evidence to indicate that RT

services for cancer are over utilized and

to support the application of a standard

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set of RT services for cancer patients

through a bundled payment program.

Response: We understand this

commenter’s concerns. However, we

disagree with this commenter. We have

performed extensive research, and we

have received numerous stakeholders’

requests to create an alternative

payment model in the radiotherapy

space. For more information on our

research and rationale, please see

sections III.B.3. and III.B.4. of this final

rule, and 84 FR 34491 through 34493 of

the proposed rule.

Comment: A commenter suggested

that CMS allow RT providers and RT

suppliers to select appropriate radiation

modalities based on nationally

recognized clinical guidelines to ensure

that beneficiaries receive evidence-

based care.

Response: The Model encourages the

use of nationally recognized, evidence-

based clinical treatment guidelines. We

will monitor the use of guidelines

during the Model.

Comment: A commenter requested

that CMS take on more risk sharing,

reduce the savings targets, reimburse

administrative costs of participation,

and have absolute scoring and setting or

thresholds for payment linked to quality

measures.

Response: We have addressed these

comments throughout the applicable

sections of this final rule, including in,

but not limited to, sections III.C.6., C.6.f,

and C.8. of this final rule.

Comment: A commenter expressed

concern for overall payment stability

because disruptions to payment may

have unintended consequences such as

the closure of radiotherapy centers

which could result in a loss of access to

care for Medicare beneficiaries.

Response: One of the objectives of this

Model is to provide site-neutral, more

predictable payments to RO

participants. We believe that the

payment methodology as finalized in

section III.C.6. of this final rule

accomplishes this goal of providing

more predictable or foreseeable

payments to RO participants. We further

believe that having more predictable

payments may mitigate closures of

viable radiotherapy centers.

Additionally, we will be monitoring for

beneficiary access issues throughout the

Model (see section III.C.14).

Comment: A few commenters raised

concerns that the lack of telehealth

discussion in this Model meant that

such connected health technologies

would not have a role in the RO Model.

A commenter requested that CMS

utilize every opportunity to remove

barriers to the use of advanced

technologies within a connected

healthcare system.

Response: Although several

Innovation Center models and programs

include the use of telehealth services, at

this time, there are no permanent

Medicare telehealth codes included in

the list of included RT services in

section III.C.5.c. We note that HCPCS

Code 77427 has been temporarily added

to the list of Medicare telehealth codes

for the public health emergency (PHE)

for the COVID–19 pandemic. RT

services can only be furnished via

telehealth to the extent permitted under

the Medicare telehealth coverage and

payment rules. Participants can

continue to furnish telehealth services

in accordance with current coverage and

payment guidelines. We are taking this

comment into consideration for future

rulemaking.

Comment: Some commenters

expressed concerns with the episode-

based payment concept and indicated

that such programs may put patients’

safety at risk (for example, increased

radiation exposure to healthy tissues).

One of these commenters requested that

CMS prioritize total-cost-of-care models

over other episode-based payment

programs.

Response: We believe that the RO

Model will best meet its objectives of

delivering site-neutral payments for

included radiation therapy modalities

through episode-based payments rather

than total-cost-of-care because radiation

oncology is highly technical and

furnished in well-defined episodes, and

because patient comorbidities generally

do not influence treatment delivery

decisions. We also believe that

providers and suppliers will not

compromise their patients’ safety or

deviate from the standard practice of

care in an attempt to ‘‘game’’ the system.

We believe that the monitoring and

compliance requirements will mitigate

gaming by RO participants. In addition,

we believe that there are sufficient

safeguards in place to prevent providers

and suppliers from engaging in acts that

will harm their patients, including but

not limited to the requirements to

actively participate with an AHRQ-

listed patient safety organization (PSO)

and provide Peer Review (audit and

feedback on treatment plans) (see

section III.C.14).

Comment: Several commenters

requested that the site neutral payment

policy be abandoned. A few

commenters stated that a site neutral

payment approach assumes that care is

equivalent in all settings. A commenter

argued that the site neutral policy

ignores the higher cost of providing

services in an HOPD setting as

compared to the physician office setting

of freestanding radiation therapy centers

as HOPDs provide wraparound services,

such as translators and other social

services that are not otherwise billable,

and face requirements set by regulators

and accreditors to which physician

offices are not subject.

Response: As we documented in the

proposed rule and in the November

2017 Report to Congress (see section

III.B.4 of the proposed rule at 84 FR

34491 through 34493 and this final rule

for background on the November 2017

Report to Congress), differences in the

underlying methodologies used in the

OPPS and PFS for rate setting often

result in differences in the payment rate

for the same RT service depending on

whether the service is furnished in a

freestanding radiation therapy center

paid under the PFS, or an HOPD paid

under the OPPS. We refer to this as the

site-of-service payment differential, and

we believe that such differentials

between HOPDs and freestanding

radiation therapy centers are

unwarranted because the actual

treatment and care received by patients

for a given modality is the same in each

setting. Therefore, we are using HOPD

payment rates to create the RO Model

national base rates. For a detailed

discussion of this Model’s Pricing

Methodology see section III.C.6 of this

final rule.

Comment: A commenter stated that

CMS does not have authority to

implement site-neutral payments and is

using section 1115A to adopt a policy

preference that CMS otherwise could

not adopt.

Response: We disagree with this

commenter, and believe that we are

operating within our authority. Section

1115A of the Social Security Act

authorizes the Secretary to test

innovative payment and service

delivery models expected to reduce

program expenditures while preserving

or enhancing the quality of care

furnished to Medicare, Medicaid, and

Children’s Health Insurance Program

(CHIP) beneficiaries. Section 1115A(b)

provides a non-exhaustive list of models

to be tested. Under this authority, CMS

has broad discretion to design its

payment and service delivery models.

For more discussion about CMS’

statutory authority to conduct the RO

Model under section 1115A of the Act,

please reference section III.C.3.a of this

final rule.

Comment: A few commenters

requested that we abandon the proposal

to have site-neutral payments because

different sites of care have different

operating costs.

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Response: We believe that site-neutral

payment is a necessary component of

the RO Model test to avoid establishing

an incentive for RO participants 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.

Comment: A commenter stated that

the proposed RO Model’s site-neutral

payments do not go far enough and that

these payments should be applied to all

providers and suppliers, regardless of

the Core-Based Statistical Areas

(CBSAs) in which they furnish RT

services. This commenter also does not

believe that a 5-year test is necessary to

conclude that payment rates for RT

services under the OPPS and MPFS

should be equalized.

Response: We agree that payment

rates under the RO Model should be

site-neutral, and are proceeding with the

5-year test of this Model, with CBSAs

selected for participation to understand

the impact of site-neutral payments on

cost and quality of care. We believe that

the Model performance period of 5

years, as opposed to a shorter duration,

is necessary to obtain sufficient data to

compute a reliable impact estimate and

to analyze the data from the Model to

determine next steps regarding potential

expansion or extension of the Model.

Further, we believe that a test period of

5 years is necessary to address and

mitigate any potential implementation

issues or unintended consequences. For

a discussion of the Model performance

period, please see section III.C.1. of this

final rule.

Comment: A commenter requested

clarification on how the RO Model will

impact the budget neutrality

requirements under the OPPS and PFS.

Response: With respect to the budget

neutrality requirements under the

Medicare Physician Fee Schedule (PFS)

and Outpatient Prospective Payment

System (OPPS), absent any further

adjustment, we would expect the RO

Model to pull utilization out of the

traditional fee-for-service payment

systems. The Center for Medicare will

monitor this issue through the duration

of the Model test and account for

utilization for services included in the

RO Model under the PFS and OPPS as

appropriate. In essence, we believe that

this Model will, in time, reduce program

expenditures while preserving or

enhancing the quality of care furnished

to beneficiaries.

Comment: A couple of commenters

opposed paying for radiotherapy

services based on the proposed

prospective payment approach in the

RO Model, and instead suggested that

payment continue to be made on a fee-

for-service basis, with a reduction in the

reimbursement for fractions that are

beyond the average for a particular

diagnosis.

Response: The commenters’ suggested

approach, as we understand it, would

require ongoing adjustments to fee-for-

service payments based on changing

averages for a particular diagnosis. We

believe that the proposed prospective

episode-based payment tested under

this Model would be preferable as this

approach will test whether a modality

agnostic, bundled payment will lead to

more appropriate courses of radiation

treatment for certain cancer types.

Comment: A commenter urged CMS

to establish policies that encourage

participants’ investment in care

transformation to achieve the agency’s

long-term goal of improving quality of

care while reducing costs.

Response: We believe that this Model

embraces our goal of improving quality

of care while reducing costs (see section

III.C.14 of this final rule for the Model’s

monitoring and compliance

requirements). We also believe that this

Model, as finalized, will encourage RO

participants to transform their care.

Comment: A commenter voiced

concern that participants with fewer

resources would attempt high dose

hypofractionation without adequate

equipment and that the proposed rule

did not have a mechanism in place to

test the ‘‘fitness’’ of the

hypofractionation equipment.

Response: At this time, we are unable

to perform such a test as we do not

believe that testing equipment falls

within the Innovation Center’s authority

to test payment and service delivery

models. However, we will be using Peer

Review and patient surveys, among

other monitoring measures (see section

III.C.14 of this final rule), to assess

whether RO participants are engaging in

such egregious behaviors.

Comment: A few commenters

discussed concerns with

hypofractionation. These commenters

generally noted that data supporting

fractionation is limited across cancer

types. A commenter used prostate

cancer as an example, concluding that

the RO Model might make

hypofractionated treatment the only

economically viable option for treating

men with low- and intermediate-risk

prostate cancer. This commenter

believed such a move would be

premature, as the benefits of

hypofractionation for prostate cancer are

unclear.

Another commenter highlighted that

testing whether hypofractionation

lowers costs and improves quality will

require providers and suppliers to

upgrade their technology to provide

lower and more precise fractions of RT.

For this reason, the commenter

recommended that CMS publish the

science underlying its belief that

hypofractionation would be appropriate

for this range of cancer types.

A commenter shared specific

recommendations and evidence for RT

hypofractionation in breast cancer,

prostate cancer, head and neck cancer,

and Central Nervous System (CNS)

cancers, as well as in bone and brain

metastases.

A commenter emphasized that

hypofractionated treatments may

increase acute toxicity and that patients

with pre-existing conditions like

ulcerative colitis or collagen-vascular

disorder are poor candidates for these

types of hypofractionated treatments.

Response: We thank the commenters

for this information. It was not CMS’

intent to encourage hypofractionation

specifically. It was our intent to use

hypofractionation as an example of a

treatment option often cited in

nationally recognized, evidence-based

guidelines. We rely on Medicare

providers and suppliers to furnish

appropriate care to our beneficiaries. As

finalized in section and III.C.14 and

III.C.16, we will monitor for unintended

consequences of the RO Model, and

such monitoring could include

utilization patterns regarding fractions.

Comment: A commenter expressed

concern with the high cost of treating

patients in a rural treatment facility.

Response: We believe that the policies

as finalized in this final rule will help

to address this commenter’s concerns.

In particular, we refer readers to section

III.C.3.c of this final rule for the optional

opt-out for low-volume RO participants,

as well as section III.C.3.d that describes

how CBSAs exclude extreme rural

geographic areas, and section III.C.3.c

that discusses the exclusion of critical

access hospitals.

Comment: A commenter expressed

the desire to maintain current

valuations for Radiation Therapy G-

codes under the PFS (HCPCS Codes

G6001, G6002, G6003, G6004, G6005,

G6006, G6007, G6008, G6009, G6010,

G6011, G6012, G6013, G6014, G6015,

G6016 and G6017), and requested that

these valuations be stable throughout

the Model.

Response: The purpose of the RO

Model is to test whether prospective

episode payments in lieu of traditional

FFS payments for RT services would

reduce Medicare expenditures and

preserve or enhance quality of care for

beneficiaries. Additionally, the RO

Model is designed to test a site-neutral

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and modality agnostic approach to

payment for RT services. Therefore, we

do not believe that continuing to make

payment based on the current

valuations for certain G-codes under the

PFS aligns with the intent of this Model

test. Please refer to section III.C.5.c of

this final rule for a discussion of our

included RT services as well as section

III.C.6 for details regarding the specific

RO Model codes that will be used

during this Model and how their value

will be calculated in each performance

year.

C. RO Model Regulations

In the proposed rule at 84 FR 34493,

we discussed our policies for the RO

Model, including model-specific

definitions and the general framework

for implementing the RO Model. We

defined ‘‘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 proposed to codify the term

‘‘performance year’’ at § 512.205 of our

regulations.

In the proposed rule, we included our

proposed policies for each of the

following: (1) The scope of the RO

Model, including the RO participants,

beneficiary population, and 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.

In the proposed rule, we discussed

codifying RO Model policies at 42 CFR

part 512, subpart B (§§ 512.200 through

512.290). In addition, as we explained

in section II. of the proposed rule, the

general provisions codified at

§§ 512.100 through 512.180 would

apply to the RO Model.

1. Model Performance Period

We proposed to test the RO Model for

five PYs. We proposed 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 (84 FR

34493). Alternatively, we also

considered delaying implementation to

April 1, 2020 to give RO participants

and CMS additional time to prepare. As

we discussed, an April 2020 start date

would only affect the length of PY1

which would be 9 months. All other

PYs would be 12 months. For all

episodes to be completed by December

31, 2024, we proposed that no new

episodes may begin after October 3,

2024. We solicited public comments on

the Model performance period and

potential participants’ ability to be

ready to implement the RO Model by

January 1, 2020. We also solicited

comments on delaying the start of the

Model performance period to April 1,

2020. The following is a summary of

comments received on these proposals

and our responses:

Comment: Many commenters

provided feedback related to the

Model’s start date for the RO Model.

Almost all of the commenters were

opposed to the RO Model beginning on

January 1, 2020. Some commenters

recommended that CMS consider

delaying the implementation of the

Model until the alternatively proposed

date of April 1, 2020, but many still

believed that this date would not allow

sufficient time to prepare. Commenters

believed the April 1, 2020 Model’s start

date fell short of providing adequate

preparation time for RO participants

and proposed alternative start dates of

late spring or early summer of 2020; July

1, 2020; August 1, 2020; October 1,

2020; and January 1, 2021. Commenters

recommended a delay from when the

RO Model is finalized or when the

CBSAs selected for participation are

announced to when it would begin; a

couple of commenters recommended a

6-month delay, some commenters

requested a 9-month delay, and a few

commenters recommended a 12-month

delay.

Response: We appreciate these

commenters’ concerns. Regarding

commenters’ use of the term

‘‘implementation date,’’ we understand

commenters are referring to the

beginning of the Model performance

period. After reviewing these concerns,

we agree with commenters that both the

January 1, 2020 and April 1, 2020 start

dates would not provide RO

participants with sufficient time to

operationalize the RO Model

requirements. We intended to start the

RO Model on July 1, 2020, but as we

were completing this final rule, the

United States began responding to an

outbreak of respiratory disease, referred

to as ‘‘Coronavirus disease 2019’’, which

created a serious public health threat

greatly impacting the U.S. health care

system. The Secretary of the Department

of Health and Human Services, Alex M.

Azar II, declared a Public Health

Emergency (‘‘PHE’’) on January 31,

2020, retroactively effective from

January 27, 2020, to aid the nation’s

healthcare community in responding to

the Coronavirus disease 2019 pandemic.

On July 23, 2020, Secretary Azar

renewed, effective July 25, 2020, the

determination that a PHE exists which

he had previously renewed on April 21,

2020.

In light of this unprecedented PHE,

which continues to strain health care

resources, we are finalizing the RO

Model’s Model performance period to

begin on January 1, 2021. We

understand that RO participants may

have limited capacity to meet the RO

Model requirements in 2020. To ensure

that participation in the RO Model does

not further strain RO participants’

capacity, potentially hindering the

delivery of safe and efficient health care

to beneficiaries receiving RT services,

we are finalizing the RO Model’s Model

performance period to begin on January

1, 2021.

We also believe that finalizing the

Model performance period to begin

January 1, 2021 will give RO

participants sufficient time to learn and

understand the RO billing requirements,

train staff on new procedures, prepare to

report on quality measures and clinical

data elements, evaluate and adjust their

budgets to prepare for the RO Model,

and to allow EHR vendors to begin to

develop mechanisms to comply with the

Model.

Therefore, we are finalizing our

proposed Model performance period at

§ 512.205, with the modification that the

Model performance period begin on

January 1, 2021, where each PY will

consist of a 12-month period beginning

on January 1 and ending on December

31. For all episodes to be completed by

December 31, 2025, we are finalizing

that no new RO episodes may begin

after October 3, 2025. The 5-year

performance period will run from

January 1, 2021, through December 31,

2025.

Comment: One commenter

recommended that CMS issue an

Interim Final Rule with comment

period, identify the selected RO Model

participants in the Interim Final Rule,

and ensure selected participants have at

least six months of advanced notice

before the RO Model begins.

Response: An interim final rule with

comment period (‘‘IFC’’) would be

inappropriate for purposes of finalizing

the RO Model, as the proposed rule for

the RO Model was published July 18,

2019 (84 FR 34478). Further, we believe

the selected RO participants will have

sufficient time to prepare for a Model

performance period that begins January

1, 2021. To ensure that RO participants

have sufficient preparation time, we are

publishing this final rule more than 60

days prior to the beginning of the Model

performance period.

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Comment: Many commenters stated

that RO participants would face

considerable administrative burden, and

would not have the appropriate time to

plan for implementation until the final

rule was issued—noting that 60 days or

fewer would be insufficient. These

commenters identified many reasons for

requesting more time, including that

EHR vendors would need ample time to

design, develop, build, test, validate,

and implement the software to allow RO

participants to fulfill the requirements

of the RO Model in a streamlined

manner through their EHR platforms.

Some of these commenters specified

that it could take 12 to 18 months for

EHR vendors to complete software

development cycles. A few commenters

pointed out that successful

implementation of the RO Model would

require many RO participants as well as

software vendors to change EHR

configurations, organizational policies,

and end user workflows. A commenter

stated that radiation oncology

departments utilize specific electronic

medical record and record-and-

verification systems that are linked to

their linear accelerators, and the

vendors that support those information

systems would not be prepared for

implementation in January 2020. A

commenter also stated that hospitals

and other participants need time to plan

for budget requests and approvals

relating to equipment upgrades and IT

support. A few commenters expressed

concern that EHR vendors would need

to develop and implement complicated

changes to collect information on

clinical data elements in a short period

of time because CMS has yet to publish

the Model-specific clinical data

elements.

Response: We agree with commenters’

concerns that EHR vendors will need

more time to design, develop, build,

test, validate, and implement the

software to allow RO participants to

fulfill the requirements of the RO Model

in a streamlined manner through their

EHR platforms. We understand that

successful implementation of the RO

Model will require many RO

participants as well as software vendors

to change EHR configurations,

organizational policies, and end user

workflows. We also understand that

some radiation oncology departments

utilize specific electronic medical

record and record-and-verification

systems that are linked to their linear

accelerators, and the vendors that

support those information systems

would not have been prepared for

implementation in January 2020. We

further understand that hospitals and

other participants need time to plan for

budget requests and approvals relating

to equipment upgrades and IT support.

Based on these concerns and the PHE,

we are finalizing the Model performance

period to begin on January 1, 2021. The

Model requirements, including measure

data collection and the use of certified

EHR technology (CEHRT), will begin in

PY1 (which begins on January 1, 2021).

We believe that the period of time

between publication of this final rule

and the beginning of the Model

performance period will provide EHR

vendors with sufficient time to

implement the software that RO

participants may need to adhere to the

RO Model requirements.

Comment: Many commenters stated

that RO participants would need

adequate time to prepare for the new

reporting of quality measures and

clinical data required by the RO Model.

These commenters stated that they

would need considerable time to

develop and build a specific clinical

infrastructure to meet the increased

quality data collection and reporting

requirements mandated by the RO

Model. A commenter emphasized that

such a delay would be particularly

important for those RO participants

treating Medicare beneficiaries with

prostate, breast, or lung cancers as well

as bone and brain metastases, given

CMS’ proposal to require those

participants to collect and report

clinical information not currently

available in claims or captured in the

proposed quality measures.

Response: We understand

commenters’ concerns that they will

need considerable time to develop and

build a specific clinical infrastructure to

meet the increased quality data

collection and reporting requirements

mandated by the RO Model. We also

understand that RO participants and

Medicare contractors in the CBSAs

selected for participation would need

adequate time to prepare for the RO

Model requirements, and to successfully

modify operations. We believe that

finalizing the Model performance period

on January 1, 2021 provides sufficient

time for selected RO participants to

develop and build the necessary

infrastructure to meet reporting

requirements of the RO Model.

Comment: Many commenters

requested that the RO Model be delayed

so that RO participants and Medicare

contractors in the CBSAs selected for

participation would have adequate time

to prepare for the RO Model

requirements, and to successfully

modify operations.

Response: We believe that finalizing

the Model performance period to begin

on January 1, 2021 will provide

adequate time for RO participants to

prepare for the RO Model and to modify

their operations to meet the Model

requirements. The Medicare

Administrative Contractors in the

CBSAs selected for participation will be

prepared when the Model begins on

January 1, 2021.

Comment: Many commenters

requested more time to implement the

RO Model, because RO participants

would need adequate time to

operationalize the RO Model’s coding

and billing requirements. Many

commenters stated that they would need

to hire additional staff, and to train and

educate new and existing staff and

clinicians on RO Model procedures,

requirements, billing and other systems.

A few commenters stated that they

would need sufficient time to educate

and engage clinical and operational staff

about the RO billing practices and

processes, and for these participants to

learn and understand changes to coding,

claims generation, claims processing,

participant-specific modifiers and

adjustments, withhold calculations, and

payment programming. A couple of

commenters expressed concern about

the administrative burden of learning a

new billing system under the RO Model

while simultaneously maintaining a

separate billing system for privately

insured patients. One of these

commenters stated that the billing staff

would be burdened with the need to

identify which patients are in the Model

and which are not in order to

appropriately bill claims because the

billing would differ significantly for

each patient and insurer. Many

commenters stated that RO participants

would need more time to make

budgetary accommodations to offset the

perceived additional expenses related to

participation in the RO Model and to re-

evaluate practice budgets to

accommodate for changes in cash flow

as a result of participation in the Model.

Response: We believe that finalizing

the Model performance period to begin

on January 1, 2021 will provide RO

participants with sufficient time to

prepare to meet the billing and coding

requirements, to re-evaluate practice

budgets to accommodate for changes in

the Model, to hire new staff and educate

existing staff, and to address concerns

regarding the administrative burden of

learning a new billing system under the

RO Model. The Model requirements,

codified at § 512.220, will start on

January 1, 2021.

For concerns regarding changes in

billing and coding requirements, we

believe that the finalized billing process

that will be easily implemented within

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current systems because it is based on

how FFS claims are currently

submitted. Section III.C.7 of this final

rule provides information on billing and

coding changes under the RO Model.

Additional guidance on billing and

coding will be made available to RO

participants before the beginning of the

Model performance period through

resources such as the Medicare Learning

Network (MLN Matters) publications,

Model-specific webinars, and/or the RO

Model website.

Comment: A few commenters stated

that they would need to operationalize

the billing requirements of the RO

Model in a shortened time frame, as

they would not be notified of their

selection until the publication of the

final rule.

Response: We believe that finalizing

the Model performance period to begin

on January 1, 2021 will provide RO

participants adequate time to

operationalize the Model’s billing

requirements which are based on the

current FFS claims systems.

Comment: A commenter stressed that

it would take time to operationalize the

beneficiary notification requirement.

Response: We will provide RO Model

participants with a beneficiary

notification letter template that RO

participants may personalize with their

contact information and logo. RO

participants must provide this

beneficiary notification letter to each

beneficiary during the initial treatment

planning session. We refer readers to

section III.C.15 of this final rule for

details regarding the beneficiary

notification letter. We do not believe

that the beneficiary notification letter,

which will require minimal

modification by the RO participant, will

warrant significant additional time to

operationalize.

Comment: A commenter requested

additional time for participants to

receive and review CMS data to better

understand their current care processes

and drive care transformation under the

Model.

Response: We plan to allow RO

participants, to the extent permitted by

HIPAA and other applicable laws, to

request claims data from CMS for

purposes of care coordination and/or

quality improvement work. Please see

section III.C.13.d for more information.

To request this data, RO participants

will submit a Participant Data Request

and Attestation (DRA) form, which will

be available on the Radiation Oncology

Administrative Portal (ROAP).

Comment: A few commenters

suggested that CMS include a

performance year 0 (PY0) for the RO

Model. This PY0 could serve as a

baseline measurement and preparation

period that would allow RO participants

to make practice transformations;

change workflow; review, analyze, and

act on data received from CMS;

understand Model reporting

requirements; and receive additional

education from CMS on Model

parameters and objectives. A couple of

these commenters further suggested that

RO participants could submit no-pay

claims for the PY0 episodes while

continuing their normal billing

practices.

Response: We are finalizing the Model

performance period that will include

performance years (PYs) one through

five (PY1–PY5), and it will not include

a PY0. PY1 of the RO Model will begin

on January 1, 2021. We believe that

finalizing the Model performance period

to begin on January 1, 2021 makes a PY0

unnecessary because RT providers and

RT suppliers will have several months

to prepare for the RO Model and its

requirements.

Comment: A few commenters

recommended reducing the number of

performance years. A commenter

requested that the duration of the Model

be reduced to three years. This

commenter stated that a reduction in

both duration and number of episodes,

coupled with voluntary participation,

would provide sufficient information for

CMS to assess the viability of the Model

and to then scale the Model nationally

if it had achieved its goals of improving

care and reducing costs.

Response: We proposed that the

performance period for the RO Model to

be five performance years because at

least five performance years are

necessary to sufficiently test the

proposed prospective payment

approach, stimulate the development of

new evidence-based knowledge, acquire

additional knowledge relating to

patterns of inefficient utilization of

health care services, and to formulate

methods to incentivize the improvement

of high-quality delivery of RT services.

Based upon our analyses we do not

believe that three years will be sufficient

to test the proposed payment approach.

We believe that a Model performance

period of five years is necessary to

address implementation issues and for

the evaluation to obtain sufficient data

to compute a reliable impact estimate,

and to determine next steps regarding

potential expansion or extension of the

Model. Notably, the evaluation will

analyze data on the impact of the Model

on an ongoing basis, so to the extent that

evaluation results are definitive sooner

than the end of the Model, we will

consider next steps at that time rather

than waiting until the Model ends. For

these reasons, we believe that a Model

performance period of five years is

necessary, and we will not reduce the

Model performance period to less than

five years.

We also would like to clarify that we

proposed that the RO Model would

cover 40 percent of all eligible RO

episodes in eligible CBSAs nationwide

in order to have a nationally

representative sample of RT providers

and suppliers that is sufficiently large

enough to confidently show the impacts

of the Model within five years (84

FR34496). As discussed in section

III.C.3.d, we are finalizing a policy that

includes 30 percent of all eligible RO

episodes in eligible CBSAs nationwide,

and determined that we will still be able

to maintain confidence in estimating the

impacts of the RO Model. Finalizing a

Model performance period to anything

less than five years would not allow us

to maintain that confidence necessary to

show the impacts of the RO Model.

Regarding the commenters suggesting

that the RO Model should be voluntary,

please reference section III.C.3.a of this

final rule for further discussion of why

we believe a mandatory design is

necessary for the testing of the RO

Model.

After considering public comments,

we are finalizing our proposal with

modification to the Model performance

period. Specifically, we are revising the

regulations at § 512.205 to define the

Model performance period to mean

January 1, 2021, through December 31,

2025, the last date during which RO

episodes must be completed, with no

new RO episodes beginning after

October 3, 2025, in order for all RO

episodes to be completed by December

31, 2025. We are also codifying at

§ 512.205 that performance year (PY)

means the 12-month period beginning

on January 1 and ending on December

31 of each year during the Model

performance period.

2. Definitions

In the proposed rule, we proposed to

define certain terms for the RO Model

at § 512.205. We described these

proposed definitions in context

throughout section III of the proposed

rule. In the proposed rule, we solicited

public comments on our proposed

definitions. To the extent we have

received comments relating to the

definitions that we had proposed, we

have responded to those comments in

context throughout section III of this

final rule.

3. Participants

In the proposed rule, we discussed

how certain Medicare participating

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HOPDs, physician group practices

(PGPs), and freestanding radiation

therapy centers that furnish RT services

(RT providers or RT suppliers) in Core-

Based Statistical Areas (CBSAs)

randomly selected for participation,

would be required to participate in the

RO Model either as ‘‘Professional

participants,’’ ‘‘Technical participants,’’

or ‘‘Dual participants’’ (as such terms

are defined at 84 FR 34494). We defined

‘‘RO participant’’ at § 512.205 of the

proposed rule as a PGP, freestanding

radiation therapy center, or HOPD that

participates in the RO Model pursuant

to the criteria that we proposed to

establish at § 512.210 (see section

III.C.3.b in the proposed rule and in this

final rule). In addition, we noted that

the proposed definition of ‘‘model

participant,’’ includes an RO

participant. In the proposed rule, we

discussed 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. Required Participation

In the proposed rule (84 FR 34493

through 343494), we discussed how

certain RT providers and RT suppliers

that furnish RT services within CBSAs

randomly selected for participation

would be required to participate in the

RO Model (as discussed in sections

III.C.3.b and III.C.3.d of this final rule).

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. In the

proposed rule, we discussed our interest

in testing and evaluating the impact of

a prospective payment approach for RT

services in a variety of circumstances.

We stated our belief 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.

As discussed in the proposed rule, we

believe 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 (84

FR 34493). 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

proposed a broad representative sample

of RT providers and RT suppliers in

multiple geographic areas (see section

III.C.3.d of both the proposed rule and

this final rule for a discussion regarding

the Geographic Unit of Selection). We

proposed 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 will

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, in the proposed rule at 84

FR 34493 through 34494, we discussed

actuarial analysis suggesting 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, those 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. We

discussed how 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 believed 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. Therefore, we

proposed that participation in the RO

Model would be mandatory for all RT

providers and RT suppliers furnishing

RT services within the CBSAs randomly

selected for participation (84 FR 34493

through 34494).

We solicited public comments on our

proposal for mandatory participation.

The following is a summary of

comments received on this proposal and

our responses to these comments:

Comment: CMS received many

comments related to the proposed

mandatory participation of the Model.

One commenter agreed with CMS’

decision to make participation in this

Model mandatory for CBSAs randomly

selected for participation.

Response: We appreciate the

commenter’s support. As explained in

the proposed rule (84 FR 34493 through

34496) and in this final rule, mandatory

participation eliminates selection bias,

ensures participation from HOPDs,

provides a representative sample of RT

providers and RT suppliers, and

facilitates a comparable evaluation

comparison group. We maintain that the

mandatory design for the RO Model is

necessary to enable CMS to detect

change reliably in a generalizable

sample of RT providers and RT

suppliers to support a potential model

expansion.

Comment: A few commenters stated

that the mandatory nature of the RO

Model would force some RT providers

and RT suppliers to participate in the

Model that are not operationally ready

while at the same time excluding others

that are well prepared. This could create

challenges for beneficiary access and

could lead to operational issues for

practices.

Response: Mandatory participation

and random selection of participants are

integral to the design and evaluation of

this Model. However, we believe that

finalizing the Model performance period

to on January 1, 2021 will allow RT

providers and RT suppliers sufficient

time to prepare for the RO Model’s

requirements.

Comment: Some commenters stated

that mandatory participation would

have negative consequences on

Medicare beneficiaries, such as

depriving beneficiaries of their freedom

to choose where they receive RT

services, reducing access to care, and

increasing financial and logistical

burdens for beneficiaries that believe

they need to travel outside of their

CBSA to receive care from a non-RO

participant.

Response: We would like to clarify

that the RO Model will not interfere

with the general guarantees and

protections for all Medicare FFS

beneficiaries. We support Medicare

beneficiaries’ rights to seek care

wherever they choose, and we are

codifying at § 512.120(a)(1) the

requirement that RO participants not

restrict a beneficiary’s ability to choose

his or her provider(s) and/or supplier(s).

Further, we are using CBSAs as the unit

of selection for the RO Model. We

selected CBSAs, as opposed to larger

geographic units of selection, in order to

allow beneficiaries to travel to another

area to receive RT services, if they so

wished.

Comment: A couple of commenters

stated that mandatory participation is a

departure from the agency’s previous

approach to model participation, and

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these commenters believed that CMS

had previously indicated that

mandatory models would only be used

judiciously or when the agency could

not guarantee enough participation or

would have an adverse selection for

voluntary models.

Response: We believe that the RO

Model meets these circumstances. As

discussed throughout this section and in

Section III.C.3.d, we designed the RO

Model to require participation by RT

providers and RT suppliers in order to

avoid selection bias. Further, as

discussed earlier in this section, our

actuarial analysis suggests that without

mandatory participation in the RO

Model, there will be limited to no

participation from HOPDs.

Comment: Some commenters

expressed concerns that the proposed

mandatory participation would lack

upside opportunity for high-performing

participants and lead to hospitals and

health systems bearing the expense of

participation in a complicated program

and the burden of generating all of the

identified savings associated with the

Model.

Response: We would like to note that

the RO Model is an Advanced APM and

a MIPS APM. As such, eligible

clinicians who are Professional

participants and Dual participants may

potentially become Qualifying APM

Participants (QPs) who earn an APM

Incentive Payment and are excluded

from the MIPS reporting requirements

and payment adjustments. Under the

current Quality Payment Program rules,

those who are not excluded from MIPS

as QPs or Partial QPs will receive a final

score and payment adjustment under

MIPS, unless otherwise excepted. We

believe these aspects of the RO Model

as an Advanced APM and a MIPS APM

will provide eligible participants with

an example of the upside opportunity

for high-performing participants under

the Model stated by the commenters.

The RO Model also affords all RO

participants the opportunity to actively

participate in the effort of moving

toward and incentivizing value-based

RT care, offering to make certain data

available that RO participants can

request for use in care coordination and

quality improvement, which would

potentially increase beneficiary

satisfaction.

Comment: Many commenters

suggested that other unintended

consequences could result from

mandatory participation in the RO

Model. These commenters listed the

following potential consequences: A

competitive disadvantage for

participants who are subject to new and

uncertain pricing; unfair financial

hardship for participating practices; a

disproportionate effect on cancer

centers with a predominantly Medicare

patient base; Medicare patients being

exposed to unnecessary excess

radiation; stifled innovation; and a

decrease in overall quality of care.

Response: We will conduct ongoing

monitoring and evaluation analyses to

watch for any unintended consequences

of the Model, as finalized in section

III.C.16. Please also refer to sections

III.C.3.d. and III.C.14 of this final rule

for more discussion about how we will

monitor for unintended consequences

under the RO Model.

Specifically regarding the comment

about Medicare patients being exposed

to unnecessary excess radiation, we rely

on Medicare providers and suppliers to

furnish appropriate care to our

beneficiaries. As for concerns regarding

stifled innovation under the RO Model,

we believe these concerns will be

mitigated by the fact that new

technologies, upon receiving an

assigned HCPCS code, would be paid

FFS until such time that they could be

proposed for the RO Model through

future rulemaking. We also believe these

concerns about stifled innovation under

the RO Model will be mitigated by the

trend factor, which will reflect updates

to input prices as reflected in updated

PFS and OPPS rates. Please refer to

section III.C.6 of this final rule for

further discussion about this.

We do not believe that RO

participants will be at a competitive

disadvantage, or subject to uncertain

pricing, because the RO Model pricing

methodology employs a trend factor,

which is applied to an established

national base rate, that is based on

updated PFS and OPPS rates and

ensures that spending under the RO

Model will not diverge too far from

spending under the FFS that non-

participants will receive for the

underlying bundle of services had they

been in the Model. See section III.C.6.d

for more information.

Regarding the comment that the

Model would have a disproportionate

effect on cancer centers with a

predominantly Medicare patient base,

we disagree. Episode payments will be

largely determined by what an RO

participant was historically paid. As

described in section III.C.6, the pricing

methodology as finalized will blend

together the national base rate with an

RO participant’s unique historical

experience. If the RO participant is

historically less efficient than the

national average, the blend in PY1 will

be 90 percent of the RO participant’s

historical payments and 10 percent of

the national base rate. This means that

prior to applying the discount factor and

withholds, payments under the Model

will be between 90 and 100 percent of

the RO participant’s historical

payments. For historically inefficient

RO participants, the blend shifts over

time to a 70/30 blend in PY5. For

historically efficient RO participants,

the blend for the Model performance

period is fixed at 90/10 blend.

Regarding the comment that the

mandatory nature of the RO Model will

result in a decrease in overall quality of

care, we disagree. We specifically

designed the Model to preserve or

enhance quality of care, and we are

putting in place measures, like the

collection of quality measures and

clinical data elements, to help us to

quantify the impact of the RO Model on

quality of care. See section III.C.8 of this

final rule for more information

regarding our finalized provisions for

the quality measures and clinical data

elements that will be collected for the

RO Model.

Comment: Many commenters

suggested that participation in the

Model be voluntary, or that participants

have the option to opt-in or opt-out of

the Model. Many commenters provided

operational suggestions should the

Model be voluntary, including that

participants could choose to participate

for the entirety of the Model

performance period. Many commenters

referenced other voluntary models,

namely the Bundled Payments for Care

Improvement Advanced (BPCI

Advanced) Model and the Oncology

Care Model (OCM), and suggested that

these models have significant health

care provider interest and participation,

and have demonstrated that the RO

Model could be successful and garner

sufficient participation as a voluntary

model. The commenters suggested that

a voluntary model would provide an

opportunity to mitigate unintended

consequences prior to expanding to a

mandatory model. Many commenters

stated that making the RO Model

voluntary would reduce the potential

risk, disruption, and financial hardships

to RO participants.

As an alternate recommendation,

many commenters suggested that the RO

Model have a ‘‘phase in’’ period for

participants such that the Model would

begin as voluntary and transition to

mandatory participation in subsequent

years. One of these commenters

recommended voluntary participation

for the initial two of five performance

years, and then phase in mandatory

participation over the remaining 3-year

period. Another commenter

recommended voluntary participation

for the first performance year (PY) with

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a transition to limited mandatory

participation in the subsequent

performance years. Another commenter

recommended voluntary participation

with a gradual phase in of additional

participants through expansion of the

Model by 10 percent each year.

Another commenter suggested that

providers and suppliers in the selected

geographic areas be allowed to opt out

of participation in the first year of the

Model, and that CMS remove downside

risk for those that do participate. Then,

in the remaining four years of the

Model, all providers and suppliers in

the selected geographic areas would be

required to participate with two-sided

risk. A few commenters recommended

that CMS initiate the Model on a

voluntary basis with little to no risk,

and then transition to a risk-based

Model with opt-in and opt-out

provisions to take place over a period of

time. These commenters compared this

suggested risk approach to those

implemented in both the

Comprehensive Care for Joint

Replacement (CJR) Model and OCM. A

few commenters recommended that

CMS consider a voluntary Model for the

first four years with incentives for

participants, and then subsequently

transition to a limited mandatory

Model. Another commenter suggested

that the RO Model be voluntary for the

initial three years, and then move to

mandatory in PY4 and PY5.

Many commenters recommended that

the Model have voluntary participation

throughout the Model performance

period. A commenter recommended

testing multiple small-scale voluntary

models with differing payment

methodologies simultaneously to

determine which approach would have

the greatest impact with the fewest

unintended consequences. This

commenter recommended that these

tests be conducted with interested RT

providers and RT suppliers before CMS

scaled it to the size proposed in the

NPRM. Another commenter suggested

implementing the Model nationally as a

voluntary model and utilizing the

approach of evaluating the impact

through an interrupted time series

approach rather than a control group. A

commenter recommended voluntary

participation with a 10 percent

reimbursement lift to allow participants

to ramp up for the program and have the

internal administrative and clinical

operations necessary to support and

succeed in the Model.

These commenters provided a variety

of reasons for their recommendations of

a voluntary, phase in approach to the

RO Model. A commenter believed this

approach would promote an equitable

opportunity for success and ensure

accurate and useful results from the

Model. Another commenter believed

this process would allow practices to

transition to the coding and billing

requirements and allow time to build

infrastructures to collect data. A couple

of commenters stated that this approach

would support CMS’ objectives, as well

as allow CMS to build the infrastructure

to administer this program effectively

and to then scale it as additional

participants joined. A few commenters

suggested that this approach would be

more consistent with the processes that

previous CMS models have followed.

One of these commenters stated that this

approach would provide participants

with more feasible pathways to value-

based payment by allowing for

flexibility and time to adjust practice

patterns to best meet the Model’s

requirements. Another commenter

stated that this process would be fairer

to providers and suppliers that are

currently unprepared to participate, and

would avoid penalties on participants

that are unequipped to provide value-

based care and require additional time

to prepare a plan for a successful

transformation.

Response: We appreciate commenters’

suggested alternatives to mandatory

participation for the RO Model.

However, as explained in the proposed

rule (84 FR 34493 through 34496) and

in this final rule, we believe that if the

Model is voluntary for all RT providers

and RT suppliers or allow for a phased-

in approach, then we will face

complications in our ability to

accurately evaluate the RO Model.

Regarding the comment about

voluntary participation with a 10

percent reimbursement lift to allow

participants to ramp up for the program

and have the internal administrative

and clinical operations necessary to

support and succeed in the Model, we

believe, although we are not sure as

more detail was not provided by the

commenter, that the commenter is

suggesting that payments be increased

for participants by 10 percent. We

would like to note that we would not be

able to maintain or reduce costs under

this type of design.

Regarding the comment suggesting

that we implement the Model nationally

as a voluntary model and utilize the

approach of evaluating the impact

through an interrupted time series

approach rather than a control group, as

discussed throughout this section of the

final rule, we maintain that the

mandatory design for the RO Model is

necessary. We have decided not to use

an interrupted time series design for the

RO Model because the use of a

comparison group not exposed to the

intervention improves our ability to

make causal inferences. A time series

analysis is only necessary in

circumstances when a comparison

group does not exist, and under the RO

Model, a control group of

nonparticipants will exist.

While we will not allow for voluntary

participation for the Model, after

considering the concerns raised by the

commenters, including potential

financial hardship for practices under

the RO Model, we are modifying the

proposed policy to include an opt-out

option for RT providers and RT

suppliers that are low volume (see

section III.C.3.c of this final rule for

additional information). While we

appreciate the commenters’ suggestions

to employ a phase in process for the RO

Model, we believe that allowing a phase

in process for participants would create

a selection bias in the early years of the

Model that would hinder robust

evaluation. As we stated in the

proposed rule and in this final rule,

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. These actuarial estimates also

suggest 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

volunteer to participate. Therefore, we

believe that requiring participation in

the RO Model, without a voluntary

phase in option, is necessary to ensure

sufficient proportional participation of

both HOPDs and freestanding radiation

therapy centers, and obtain a diverse,

representative sample of RT providers

and RT suppliers that will allow a

statistically robust test of the

prospective episode payments made

under the RO Model.

Comment: Some commenters

questioned CMS’ statutory authority to

implement the RO Model using section

1115A of the Act. A few of these

commenters stated that the proposal

requiring mandatory participation of

approximately 40 percent of radiation

oncology episodes represents a major

policy change, and not a test of payment

and service delivery models, which is

what CMS is authorized to do in section

1115A of the Act. A few commenters

stated that Innovation Center models

should be implemented on a voluntary

basis as the statute does not authorize

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CMS to mandate participation in any

Innovation Center model, and any

agency interpretation that the statute

permits mandatory models raises issues

of impermissible delegation of

lawmaking authority where none was

intended and is inconsistent with the

expressed mandate of section 1115A. A

commenter stated that making the

Model a mandatory requirement could

be found potentially unlawful and is

unprecedented. A commenter surmised

that the RO Model was not developed

by the Innovation Center, that the

Secretary does not have the authority to

waive Medicare provisions or any

requirements of the Medicare statute

under the RO Model, and that the RO

Model violates section 3601 of the

Patient Protection and Affordable Care

Act (‘‘the ACA’’).

Response: We disagree with these

commenters. The Innovation Center

designed and developed the RO Model,

and we will be testing the RO Model,

consistent with section 1115A of the

Act. We believe that we have the legal

authority to test the RO Model and to

require the participation of all RT

providers and RT suppliers in the

CBSAs selected for participation, and

that this does not constitute an

impermissible delegation of lawmaking

authority that is inconsistent with

section 1115A of the Act. First, we note

that the RO Model will not be the first

Innovation Center model that requires

participation under the authority of

section 1115A of the Act; we refer

readers to the Comprehensive Care for

Joint Replacement (CJR) Payment Model

for Acute Care Hospitals Furnishing

Lower Extremity Joint Replacement

Services Final Rules, and the Home

Health Prospective Payment System

(HHPPS) Final Rules implementing the

Home Health Value-Based Purchasing

(HHVBP) Model. Hospitals in selected

Metropolitan Statistical Area (MSAs)

were required to participate in the CJR

Model beginning in April 2016, and

home health agencies in selected states

were required to participate in the

HHVBP Model beginning in January

2016.

We believe that both section 1115A of

the Act and the Secretary’s existing

authority to operate the Medicare

program authorize us to finalize

mandatory participation in the RO

Model as we have proposed. Section

1115A of the Act authorizes the

Secretary to test payment and service

delivery models intended to reduce

Medicare costs while preserving quality

of care. The statute does not require that

models be voluntary, but rather gives

the Secretary broad discretion to design

and test models that meet certain

requirements as to spending and

quality. Although section 1115A(b) of

the Act describes a number of payment

and service delivery models that the

Secretary may choose to test, the

Secretary is not limited to those models.

Rather, as specified in section

1115A(b)(1) of the Act, models to be

tested under section 1115A of the Act

must address a defined population for

which there are either deficits in care

leading to poor clinical outcomes or

potentially avoidable expenditures.

Here, the RO Model addresses a defined

population (FFS Medicare beneficiaries

who receive included RT services) for

which there are potentially avoidable

expenditures (arising from the lack of

site neutrality for payments, incentives

that encourage volume of services over

the value of services, and coding and

payment challenges in the PFS). We

designed the RO Model to require

participation by RT providers and RT

suppliers in order to avoid the selection

bias inherent to any model in which

providers and suppliers may choose

whether or not to participate. Such a

design will 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 that

will allow a statistically robust test of

the prospective episode payments made

under the RO Model. We believe this is

the most prudent approach for the

following reasons. Under the mandatory

RO Model, we will test and evaluate a

Model across a wide range of RT

providers and RT suppliers,

representing varying degrees of

experience with episode payment. The

information gained from testing the

mandatory RO Model will allow CMS to

comprehensively assess whether RO

episode payments are appropriate for a

potential expansion in duration or

scope, including on a nationwide basis.

Thus, the RO Model meets the criteria

required for Phase I model tests.

Moreover, the Secretary has the

authority to establish regulations to

carry out the administration of

Medicare. Specifically, the Secretary has

authority under sections 1102 and 1871

of the Act to implement regulations as

necessary to administer Medicare,

including testing this Medicare payment

and service delivery model. We note

that the RO Model is not a permanent

feature of the Medicare program; the

Model will test different methods for

delivering and paying for services

covered under the Medicare program,

which the Secretary has clear legal

authority to regulate. The proposed rule

went into detail about the provisions of

the proposed RO Model, enabling the

public to understand how the proposed

Model was designed and could apply to

affected RT providers and RT suppliers.

As permitted by section 1115A of the

Act, we are testing the RO Model within

specified limited geographic areas. The

fact that the Model will require the

participation of certain RT providers

and RT suppliers does not mean it is not

a Phase I Model test. If the Model test

meets the statutory requirements for

expansion, and the Secretary determines

that expansion is appropriate, we would

undertake rulemaking to implement the

expansion of the scope or duration of

the Model to additional geographic

areas or for additional time periods, as

required by section 1115A(c) of the Act.

Furthermore, we wholeheartedly

disagree that the RO Model is in

violation of section 3601 of the ACA.

Section 3601 of the ACA requires that

nothing in the provisions of or

amendments to the ACA, including

models being designed and tested by the

Innovation Center, may result in a

reduction of guaranteed Medicare

benefits. The RO Model is designed not

to result in a reduction of guaranteed

Medicare benefits, and in fact as

finalized in section II.D.2 and codified

at § 512.120(b)(1), we are specifically

requiring RO participants to continue to

make medically necessary covered

services available to beneficiaries to the

extent required by law. Further, we will

monitor compliance with the Model

requirements through monitoring

activities that may include

documentation requests sent to RO

participants and individual

practitioners on the individual

practitioner list; audits of claims data,

quality measures, medical records, and

other data from RO participants and

clinicians on the individual practitioner

list; interviews with members of the

staff and leadership of the RO

participants and clinicians on the

individual practitioner list; interviews

with beneficiaries and their caregivers;

site visits; monitoring quality outcomes

and clinical data, if applicable; and

tracking patient complaints and appeals.

Please see section III.C.14 of this final

rule for further discussion on

monitoring activities.

After considering public comments,

we are finalizing our proposal for

mandatory participation with

modification. Specifically, we are

codifying at § 512.210(a) that any

Medicare-enrolled PGP, freestanding

radiation therapy center, or HOPD,

unless otherwise specified at

§ 512.210(b) or (c), that furnishes

included RT services in a 5-digit ZIP

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Code linked to a CBSA selected for

participation to an RO beneficiary for an

RO episode that begins on or after

January 1, 2021, and ends on or before

December 31, 2025, must participate in

the RO Model.

Further, after considering the

concerns raised by the commenters

regarding the mandatory nature of the

RO Model, we are finalizing required

participation for all RT providers and

RT suppliers located within the CBSAs

selected for participation, with the

modification that the Model size will be

reduced to approximately 30 percent of

eligible episodes in eligible CBSAs (see

section III.C.5 of this final rule), and

with an inclusion of a low volume opt-

out for any PGP, freestanding radiation

therapy center, or HOPD that furnishes

fewer than 20 episodes in one or more

of the CBSAs randomly selected for

participation in the most recent year

with claims data available (see section

III.C.3.c of this final rule). We believe

that these modifications address some of

the commenters’ concerns regarding the

mandatory nature of the RO Model,

including those relating to potential

financial hardship as well as the size

and scope of the Model (see section

III.C.3.d of this final rule for more

information).

As stated in the proposed rule and in

this final rule, 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. We also

believe that a representative sample of

RT providers and RT suppliers would

result in a robust data set for evaluation

of this prospective payment approach,

and would stimulate the 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 finalizing as proposed

the selection of a broad, representative

sample of RT providers and RT

suppliers in multiple geographic areas

(see 84 FR 34495 through 34496, and

section III.C.3.d. of this final rule for a

discussion regarding the Geographic

Unit of Selection) for RO Model

participation. However, in response to

comments, we are reducing the scale of

the RO Model from the proposed

approximately 40 percent of episodes to

approximately 30 percent of eligible

episodes (please reference section

III.C.3.d. of this final rule for more

information).

We have determined that the best

method for obtaining the necessary

diverse, representative group of RT

providers and RT suppliers is random

selection. This is because a randomly

selected sample would provide analytic

results that will be more generally

applicable to all Medicare FFS RT

providers and RT suppliers and will

allow for a more robust evaluation of the

Model. As we explained in the proposed

rule and in this final rule, because

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 and 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, we believe that

requiring participation in the RO Model

will 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 that will allow a

statistically robust test of the

prospective episode payments made

under the RO Model.

For the previously identified 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 are finalizing our

proposal with modification that

participation in the RO Model will be

mandatory.

b. RO Model Participants

An RO participant, a term that we

defined in the proposed rule 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 of the proposed rule. As

discussed in the proposed rule at 84 FR

34494 through 34495, an RO participant

would participate in the Model as a

Professional participant, Technical

participant, or Dual participant.

In the proposed rule, we proposed to

define the term ‘‘Professional

participant’’ as an 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

an HOPD. We proposed at 84 FR 34494

that Professional participants would be

required annually to attest to the

accuracy of an individual practitioner

list provided by CMS, of all of the

eligible clinicians who furnish care

under the Professional participant’s

TIN, as discussed in section III.C.9 of

this final rule. We proposed 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 an RO participant

(84 FR 34494). We further proposed that

an individual practitioner under the RO

Model would be considered a

downstream participant, as discussed in

section II.B. of the proposed rule and

this final rule.

We proposed at 84 FR 34494 to define

the term ‘‘Technical participant’’ to

mean an 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 proposed at 84 FR

34494 to define ‘‘Dual participant’’ to

mean an RO participant that furnishes

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 proposed to codify the

terms ‘‘Professional participant,’’

‘‘Technical participant,’’ ‘‘Dual

participant’’ and ‘‘individual

practitioner’’ at § 512.205.

We also explained in the proposed

rule at 84 FR 34494 that an RO

participant would furnish at least one

component of an episode, which would

have two components: A professional

component and a technical component.

We proposed to define the term

‘‘professional component (PC)’’ to mean

the included RT services that may only

be furnished by a physician. We

proposed 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 the proposed rule at 84 FR

34494 through for a discussion

regarding our proposed included RT

services.) We proposed to codify the

terms ‘‘professional component (PC)’’

and ‘‘technical component (TC)’’ at

§ 512.205 of the proposed rule.

In the proposed rule, we proposed

that an episode of RT under the RO

Model would be furnished by either: (1)

Two separate RO participants, that is, a

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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 an 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.

The following is a summary of the

public comments received on these

proposed definitions related to RO

participants and our responses to those

comments:

Comment: A commenter supported

these key participant distinctions,

appreciated that CMS recognized that

RT services can be delivered at different

sites of service, and stated that this

participant construct lends itself well to

the establishment of separate

professional and technical payment

components.

Response: We appreciate this

commenter’s support on our proposed

definitions for the Professional,

Technical, and Dual participants in the

RO Model.

Comment: A commenter requested

clarification on how RO participants

will be defined if there are multiple

sites of service during an episode. This

commenter provided an example where

a physician delivers EBRT in a

freestanding setting and then chooses to

deliver brachytherapy in the hospital

outpatient department (HOPD) setting.

This commenter asked whether the

physician in this example would be

considered a Dual participant such that

there would be no technical component

payment issued to the HOPD. This

commenter suggested that CMS should

provide clarification regarding how

these types of situations will be handled

and reimbursed within the Model.

Response: As stated in the proposed

rule at 84 FR 34494, a Professional

participant is an 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

an HOPD. A Technical participant is an

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. A Dual

participant is an RO participant that

furnishes both the professional

component and technical component of

an RO episode for RT services through

a freestanding radiation therapy center,

identified by a single TIN. Professional

participant, Technical participant and

Dual participant are similar to the

proposed definitions, RT provider and

RT supplier. In the proposed rule, an RT

provider is defined as a Medicare-

enrolled HOPD that furnished RT

service in a 5-digit ZIP Code linked to

a CBSA selected to participate, and an

RT supplier is defined as a Medicare

–enrolled PGP or freestanding radiation

therapy center that furnishes RT

services in a 5-digit ZIP Code linked to

a CBSA selected to participate. These

definitions taken together with other

proposed definitions, RO participant,

Professional participant, Technical

participant and Dual participant, are

duplicative. For clarification, we are

finalizing proposed definitions for the

Professional, Technical, and Dual

participants in the RO Model without

modification, and finalizing the

proposed definitions for RT provider

and RT supplier with modification. RT

provider will mean any Medicare-

enrolled HOPD that furnishes RT

services and RT supplier will mean any

Medicare-enrolled PGP or freestanding

radiation therapy center that furnishes

RT services.

As for the specific example the

commenter presented, the freestanding

radiation therapy center would be

considered a Dual Participant for

delivery of EBRT, and the HOPD

delivering brachytherapy would bill

traditional Medicare fee-for-service as

described in section III.C.7. In the

example described, FFS payments made

to the HOPD would be considered

duplicate payments during

reconciliation as described in section

III.C.11.

Comment: Some commenters were

concerned with the possibility that

health systems could have some of their

practices participating in the RO Model

and their remaining practices operating

outside of the Model. These commenters

stated that it is common for large health

systems to have a single TIN covering

multiple locations, and that the

proposed RO Model design could allow

practices within the same health system

to fall into different CBSAs. This may

cause challenges for both RT providers

and RT suppliers and patients as well as

cause avoidable complexity in rare

situations where patients shift between

care locations. These commenters,

therefore, recommended that CMS make

accommodations for health systems

with multiple sites, where practices that

span multiple CBSA’s with a single TIN

can request to opt-in or opt-out of the

Model.

Response: We recognize that this

scenario could occur where practices

under the same TIN could fall into

different CBSAs whereas some are

either in the Model and others are out

of the Model. As stated in the proposed

rule in section III.C.3.d (84 FR 34495

through 34496), we are using CBSAs as

the geographic unit of selection for the

RO Model for various reasons, including

that CBSAs are 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. As we have

chosen the method of using randomly

selected stratified CBSAs in the RO

Model, it is unavoidable that some

practices within the same TIN may fall

into different CBSAs, though we

anticipate that the numbers will be

limited. As noted in the commenters’

letters, situations where a beneficiary

changes treatment locations is rare in

radiation oncology, and we believe that

our billing policies would allow

sufficient flexibility to accommodate

these uncommon instances, where the

first treatment provider or supplier

would be paid through the Model and

a subsequent provider or supplier

would bill FFS. We appreciate the

commenters’ concerns on this matter,

and we will monitor this situation for

any issues or complications that may

arise from this policy.

After considering public comments,

we are finalizing our proposed

provisions on the RO Model participant

definitions without change. Specifically,

we will codify at § 512.205 to define an

RO participant as a Medicare-enrolled

physician group practice (PGP),

freestanding radiation therapy center, or

HOPD that is required to participate in

the RO Model pursuant to § 512.210. We

are further finalizing our proposal to

define the term ‘‘Professional

participant’’ at § 512.205 as an RO

participant that is a Medicare-enrolled

PGP identified by a single Taxpayer

Identification Number (TIN) that

furnishes only the professional

component of an RO episode. We are

also finalizing our proposal define the

term ‘‘Technical participant’’ at

§ 512.205 to mean an 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 an

episode. Finally, we are finalizing our

proposal to define ‘‘Dual participant’’ at

§ 512.205 to mean an RO participant

that furnishes both the professional

component and technical component of

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25

Service location means the site of service in

which an RO Participant or any RT provider or RT

supplier furnishes RT services.

an RO episode through a freestanding

radiation therapy center, identified by a

single TIN.

c. RO Model Participant Exclusions

In the proposed rule at 84 FR 34493

through 34494, we proposed 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.

The proposed rule specified that these

exclusion criteria would apply during

the entire Model performance period. If

an RO participant undergoes changes

such that one or more of the 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

an RO participant subject to inclusion

criteria). For example, if an RO

participant moves its only service

location

25

from a CBSA randomly

selected for participation 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 exclusion criteria no longer

apply and the PGP, freestanding

radiation therapy center, or HOPD is

located in one of the CBSAs selected for

participation, 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

CBSAs selected for participation, then

the HOPD would become an RO

participant from the date that the HOPD

became no longer classified as a PPS-

exempt hospital.

We proposed that in the case of

Professional participants and Dual

participants, any episodes in which the

initial RT treatment planning service is

furnished to an 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 an RO beneficiary

and the RT service is furnished on or

after the day of this change would be

included in the Model.

We proposed 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. We

noted in the proposed rule that this

global budget includes payment for RT

services and as such would overlap with

the RO Model payment. Thus, we

proposed to exclude Maryland HOPDs

to avoid double payment for the same

services. We proposed 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.

In the proposed rule, we proposed 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 explained in

the proposed rule that 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 also proposed to exclude HOPDs

that are participating in or eligible to

participate in the Pennsylvania Rural

Health Model from the RO Model.

Hospitals and CAHs that are

participating in the Pennsylvania Rural

Health Model receive a global budget,

much like hospitals participating in the

Maryland Total Cost of Care Model.

Further, we proposed to extend the

exclusion to HOPDs that are eligible to

participate in the Pennsylvania Rural

Health Model because additional

hospitals and CAHs may join that model

in the future or may be included in the

evaluation comparison group for that

model. We stated in the proposed rule

that we would identify the hospitals and

CAHs that are participating in 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/.

We designed the proposed RO Model

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. In the proposed

rule, we discussed our belief that it

would be inappropriate to include these

entities for the reasons previously

described. Also, we proposed to exclude

ASCs and RT providers and RT

suppliers located in the U.S. Territories,

at § 512.210, due to the low volume of

RT services that they provide. In

addition, we proposed to exclude CAHs

and PPS-exempt cancer hospitals due to

the differences in how they are paid by

Medicare.

As a result, we proposed that RT

services furnished by these RT

providers and RT suppliers would be

excluded from the RO Model. We also

stated that if in the future we determine

that providers and suppliers in these

categories should be included in the RO

Model, we would revise our inclusion

criteria through rulemaking.

We proposed to codify these policies

at § 512.210 of our regulations. We

solicited comments on the proposals

related to RO participant exclusions.

The following is a summary of the

comments received on these proposals

and our responses to those comments:

Comment: A commenter supported

CMS’ decision to exclude from the

Model providers and suppliers that

furnish RT services only in Maryland,

Vermont, or U.S. Territories; that are

participating in or eligible to participate

in the Pennsylvania Rural Health

Model; or that are classified as an

ambulatory surgery center, CAH, or

PPS-exempt cancer hospital.

Response: We thank this commenter

for the support on our proposed

exclusions from the RO Model; we are

finalizing these exclusions without

modification.

We would like to clarify that we

recognize HOPDs are not standalone

institutions and, as such, may not,

independent of a hospital or CAH,

participate in or be eligible for

participation in the Pennsylvania Rural

Health Model. We will use the list on

the Pennsylvania Rural Health Model’s

website at https://innovation.cms.gov/

initiatives/pa-rural-health-model/,

which is updated quarterly, to identify

the hospitals and CAHs eligible to

participate in the Pennsylvania Rural

Health Model, and therefore identify the

specific HOPDs that are excluded from

participation in the RO Model. We

would also like to clarify that this

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exclusion of HOPDs associated with

hospitals and CAHs eligible to

participate in the Pennsylvania Rural

Health Model from the RO Model will

apply only during the period of such

eligibility. If the Pennsylvania Rural

Health Model is terminated or if the

HOPD is no longer eligible to participate

in the Pennsylvania Rural Health Model

as part of an eligible hospital or CAH,

and the HOPD otherwise meets the

definition of an RO participant, then the

HOPD will be required to participate in

the RO Model.

Comment: A commenter supported

CMS’ decision to exclude CAHs from

the RO Model, and stated that they

appreciated CMS’ recognition of the

potential negative impact the Model

could have on CAHs. This commenter

also requested that CMS clarify whether

a clinician who provides cancer

treatment services at a CAH would be

considered a Professional participant

under the RO Model. This commenter

also suggested that CMS ensure that the

technical and professional services are

aligned, and further recommended that

if a treatment center is excluded from

the Model, then the clinicians providing

services at that treatment center should

also be excluded.

A few commenters requested

clarification on CMS’ proposed policy

regarding an exclusion for PPS-exempt

cancer hospitals (PCHs) in the Model. A

commenter requested clarification on

whether radiation oncology physicians

who work for a PCH but bill under a

practice TIN, would be considered a

Professional or Dual participant.

Another commenter requested

clarification on how the professional

reimbursement will be handled for

physicians practicing in a PCH, but not

employed by that legal entity. The

commenter asked for clarification on

whether the physicians would also be

exempt. This commenter further stated

that the same physicians may also

practice at other non-PCH, and it is not

uncommon for radiation oncologists to

rotate through multiple facilities in a

given week, depending on the size of

the physician practice and the number

of facilities where they practice.

Response: To clarify, a physician who

provides cancer treatment services at a

CAH, PCH, or ASC, and also provides

services in a freestanding radiation

therapy center or HOPD that is located

in a CBSA selected for participation, in

addition to their services at a CAH,

PCH, or ASC, will be considered either

a Dual participant or Professional

participant, respectively, under the RO

Model. We also want to clarify that a

physician who provides RT services at

a PCH, regardless of their employment

status at the PCH, and also provides

only the professional component of an

RO episode for RT services in a

freestanding radiation therapy center or

HOPD that is located in a CBSA selected

for participation will be considered a

Professional participant under the RO

Model. Similarly, a physician who

provides RT services at a PCH, and also

furnishes both the professional

component and technical component of

an RO episode for RT services through

a freestanding radiation therapy center,

identified by a single TIN, will be

considered a Dual participant under the

RO Model. In contrast, a physician who

provides RT services only at an exempt

facility (PCH, CAH, or ASC) will not be

an RO participant. RT services that are

furnished at an exempt facility (PCH,

CAH, or ASC) will be paid through FFS,

while RO episodes that are furnished at

a PGP, freestanding radiation therapy

center, or HOPD that is in a CBSA

selected for participation will be paid

under the RO Model payment

methodology.

Comment: A few commenters agreed

with CMS’ proposal to exclude from the

Model PCHs, which some commenters

also referred to as DRG-exempt cancer

hospitals. A commenter agreed that

PCHs should be excluded from the

Model, and further requested that all of

the physicians practicing in these PCHs

be exempted from the RO Model

because these physicians practice in the

PCHs as well as eligible community

practices and they all bill under the

same TIN. The commenter indicated

that this would complicate data

submission and analysis as well as

billing practices. A couple of

commenters suggested that CMS expand

the exclusion list to include all National

Cancer Institute (NCI) Designated

Comprehensive Cancer Centers. One of

these commenters stated that this policy

would align with CMS’ proposal to

exempt PCHs. Another commenter

stated that NCI-designated centers

deliver innovative cancer treatments to

patients in communities across the

United States, and dedicate significant

resources toward developing

multidisciplinary programs and

facilities that lead to better and

innovative approaches to cancer

prevention, diagnosis, and treatment.

This commenter stated that introducing

an APM based on complex calculations

and historical rates would represent a

significant burden that would negatively

impact the innovation and discovery

missions of NCI-designated centers.

Response: We appreciate these

commenters’ support of our proposal to

exclude PCHs from the RO Model. With

regard to the comment requesting that

all physicians practicing in a PCH be

exempted from the RO Model because

these physicians practice in the PCHs as

well as eligible community practices

and they all bill under the same TIN, we

would like to clarify that the physicians

will be exempted from the RO Model if

they only provide RT services at a PCH.

However, if the physician also provides

RT services at any other freestanding

radiation therapy center and/or HOPD

that is included in a CBSA selected for

participation, they will be considered a

Dual participant and/or Professional

participant under the RO Model. We

disagree with commenters’ requests to

expand the PCH exclusion list to

include all National Cancer Institute

(NCI) Designated Comprehensive Cancer

Centers as PCHs are reimbursed on a

‘‘reasonable cost’’ basis instead of the

OPPS FFS methodology, and we are

excluding entities that are paid via

reasonable cost or cost-reporting, and

including all HOPDs that are currently

paid through the OPPS/FFS

methodology. Thus, we will be

finalizing our policy as proposed and

without modification to exclude from

the RO Model any PGP, freestanding

radiation therapy center, or HOPD that

is classified as a PCH. However, the RO

Model will include PGPs, freestanding

radiation therapy centers and HOPDs

that are paid under FFS.

Comment: Conversely, some

commenters disagreed with the proposal

to exclude PCHs from the Model. Of

those who disagreed, a couple of

commenters stated that PCHs should be

incentivized to reduce costs, and

pointed to a Government Accountability

Office (GAO) report that advised that

the payment method for PCHs should be

revised to promote efficiency and

reduce costs to Medicare. Another

commenter inquired why PCHs are

exempted when they are among the best

resourced institutions and are

considered high cost centers due to

emerging technologies. Another

commenter sought clarification on why

CMS decided to exclude a set of RT

providers and RT suppliers that

specifically treat the targeted conditions

in the RO Model, and stated that the

largest cancer treatment centers should

not be excluded from a model that seeks

to address utilization for cancer

services. Another commenter stated that

it is difficult to understand why PCHs

would be excluded from the RO Model

on the basis of payment methodology

when payment methodology is the

primary basis of the Model. Another

commenter stated the 11 PCH have large

amounts of grant money, have many

staff, and receive significant Medicare

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payments, and accordingly should be

included in the Model. A commenter

stated that the 11 PCHs should not be

excluded from Model because these

hospitals have developed financial

relationships with many community

hospitals that give those hospitals both

a financial and a marketing advantage.

This commenter stated that if a CBSA is

selected for participation and has one of

these exempt hospitals, that facility will

have a significant advantage over the

other sites of service in that area, and

this would allow that facility to more

heavily market and to purchase

upgraded equipment, which would

threaten the viability of other programs

and decrease access and choice for

Medicare beneficiaries needing RT

services.

Response: The 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 of care. We

proposed to exclude PCHs because of

the differences in how these hospitals

are paid by Medicare. That is, they are

not paid through traditional FFS

payments (see, generally, the Social

Security Amendments of 1983 (Pub. L.

98–21), the Balanced Budget Act of 1997

(Pub. L. 105–33), and the Omnibus

Reconciliation Act of 1989 (Pub. L. 101–

239)), and the RO Model is designed to

test and evaluate the change from

traditional FFS payments to prospective

episode based payments. Regarding the

commenter’s concern about PCHs and

their community hospital partners

potentially having a financial and

marketing advantage, we will monitor

the Model for the occurrence of any

such advantages, by monitoring for

changes in referral patterns. Based on

this monitoring, if we determine to

modify the excluded categories of RT

providers and RT suppliers, including

PCHs, we would revise the RO Model

inclusion criteria through future notice-

and-comment rulemaking. Therefore,

we are finalizing our policy as proposed

without modification to exclude from

RO Model participation any PGP,

freestanding radiation therapy center or

HOPD that is classified as a PPS-exempt

cancer hospital.

Comment: A commenter suggested

that CMS should exclude sole

community hospitals (SCH) and

Medicare dependent hospitals (MDH).

These hospitals are generally rural,

small, and highly dependent on

Medicare and/or Medicaid funding.

This commenter does not believe it

would be appropriate to include these

hospitals in the RO Model as it could

significantly impact the financial

viability of these hospitals or lead to a

reduction in available services for the

community.

Response: We did not propose to

exclude MDH or SCH entities from the

RO Model because, unlike CAHs, these

entities are full service hospitals. If

MDH and SCH entities believe they

qualify for the RO Model’s low volume

opt-out option, please reference the

discussion on the low volume opt-out

option in this section of the final rule

for more information. We will monitor

the extent to which these hospitals are

selected for participation in the Model,

and we will monitor the impact the RO

Model may have on these types of

entities.

Comment: A commenter requested an

exemption to the RO Model for practices

that serve socioeconomically

disadvantaged populations. This

commenter stated that these practices

tend to have higher costs of care because

patients present with advanced stages of

disease often due to the lack of access

to preventative services, and these

practices should not be penalized due to

circumstances that are out of their

control.

Response: We did not propose to

exclude practices that serve

socioeconomically disadvantaged

populations, and we will not be creating

an exemption of this nature at this time.

While we understand the commenter’s

concern, we believe that the RO Model

pricing methodology, through the

historical experience and case mix

adjustments, will account for

differences in RO participants’ historical

care patterns and the demographic

characteristics of their patient

populations. We will monitor the effect

that the RO Model may have on RO

participants that serve these

populations.

Comment: Many commenters stated

that a mandatory RO Model will present

operational, administrative, and

financial challenges for many RT

providers and RT suppliers, and

therefore requested a low-volume or

hardship exemption to allow

participants to opt out of the RO Model.

Many commenters disagreed with CMS’

decision to not include a model

participation hardship exemption for

any providers or suppliers, and

requested an exemption from Model

participation specifically for low-

volume providers and suppliers. These

commenters argued that failure to

include a low-volume exemption could

result in unintended consequences,

such as smaller providers and suppliers

incurring significant financial losses

and potentially ending their programs

due to lower payment through the RO

Model. Additionally, some of these

commenters suggested that that the RO

Model should be limited to large groups

(30 physicians or more), and that the

Model should be limited to large

hospitals with employed physicians.

A couple of commenters stated that a

low-volume exemption is critical in a

shared risk-based model of care, and

should therefore be included in the RO

Model. Another commenter supported

CMS’ proposal to exclude ASCs and RT

providers and suppliers located in the

U.S. Territories due to the low volume

of RT services that they provide because

of the commenter’s belief that such

providers and suppliers lack the

infrastructure and support to achieve

efficiencies. However, the commenter

requested that CMS fully exclude from

the Model providers and suppliers who

furnished fewer than 60 attributed

episodes during the 2015–2017 period,

rather than just making adjustments to

their episode payments. This

commenter further stated that its

analysis found that there is considerable

variation in episode spending relative to

payment amounts for providers and

suppliers that perform a very low

volume of RT, and the commenter

maintained that this analysis suggests

that episode pricing for these providers

and suppliers would be highly random

and, therefore, very difficult to manage.

The commenter finally concluded that

excluding these and other low-volume

providers and suppliers would have a

minimal impact on the RO Model test,

but doing so would prevent these

providers and suppliers from being

inappropriately penalized by being

required to participate in the Model.

Response: We appreciate the

commenters’ comments and feedback

regarding low-volume entities under the

RO Model. We understand the

commenters’ concerns regarding

administrative, financial, and

infrastructural challenges for low-

volume providers and suppliers under

the RO Model. In response to

stakeholder comments, we are finalizing

our mandatory participation proposal,

with a modification for an opt-out

option for low-volume entities, which

we are codifying at § 512.210(c). This

option allows any PGP, freestanding

radiation therapy center, or HOPD to

opt-out of the RO Model, if in the most

recent calendar year with episode data

available, the entity furnishes fewer

than 20 episodes in one or more of the

CBSAs randomly selected for

participation. Please reference the end

of this section for more information on

the low volume opt-out option.

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Regarding the commenters suggested

that that the RO Model should be

limited to large groups (30 physicians or

more), we would like to note that most

RT providers and suppliers have fewer

than 30 oncologists, so this number

would not provide a feasible threshold

for the RO Model.

We agree in part with the commenter

who suggested that we add an exclusion

of entities with fewer than 60 episodes

over the full baseline period of three

years. We are focusing on entities with

fewer than 20 episodes in the most

recent year with available claims data,

and we believe this corresponds with

this commenter’s suggestion. However,

instead of excluding such entities, we

believe that allowing entities with fewer

than 20 episodes to opt-out achieves the

right balance of allowing very small

entities to opt-out if they believe the

burden from participation in the Model

would outweigh the possibility of

benefits from model participation (for

example, potential for care

improvements or increased payments),

while also maintaining a variety of

participant types in the RO Model to

promote generalizability (to the extent

possible) of any impact results. Further,

as discussed in section III.C.6.e(4), we

do not apply adjustments to RO

participant episode payments for

participants that have less than 60

episodes in the last three years of data.

Thus, the opt-out option for entities

with fewer than 20 episodes aligns with

the threshold set for the historical

experience and case mix adjustments.

The low volume opt-out option is

intended to allow RO participants

furnishing a small volume of RT

services in the CBSAs selected for

participation in the Model to opt out if

they so choose given the investment

required to implement the Model versus

the benefit of participating in the Model

for a limited frequency of RT services.

Comment: Some commenters

suggested that CMS apply the MIPS

low-volume threshold or the CJR Model

low-volume exemption as low-volume

participation thresholds for mandatory

RO Model participation.

Response: For the 2020 MIPS

performance period, the MIPS low-

volume threshold excludes from the

definition of a MIPS eligible clinician an

individual eligible clinician, group, or

APM Entity group that, during the MIPS

determination period (consisting of two

12-month segments during 10/1/18–9/

30/19 and 10/1/19–9/30/20), has

allowed charges for covered

professional services less than or equal

to $90,000, furnishes covered

professional services to 200 or fewer

Medicare Part B–enrolled individuals,

or furnishes 200 or fewer covered

professional services to Medicare Part

B–enrolled individuals. RT providers

and RT suppliers tend to see smaller

numbers of patients but at a higher price

per patient than the average MIPS

eligible clinician. Therefore, we

estimate that using the MIPS low-

volume threshold as a threshold for

mandatory participation in the RO

Model would result in a nearly 50

percent reduction in the number of RO

participants. As stated in section

III.C.3.d of this final rule, the number of

RO participants must remain above a

certain level in order to maintain

statistical power for Model evaluation,

and to generate sufficient savings. We

are finalizing our mandatory

participation proposal, with a

modification for an opt-out option for

low-volume entities as described in this

final rule. Similar to the CJR Model’s

policy, this option would allow any

PGP, freestanding radiation therapy

center, or HOPD that furnishes fewer

than 20 episodes in the most recent year

with available claims data within one or

more of the CBSAs randomly selected

for participation to opt-out of the RO

Model, if they so choose. For more

information on this final policy please

see this section of this rule. There are

notable differences between the CJR and

RO Models’ low volume opt-out

options. The CJR Model’s low-volume

policy was a one-time opt-in option for

participants, while the RO Model will

make the low volume opt-out option

available to eligible participants

annually, prior to each year of the

Model.

After considering public comments,

we are finalizing, with one

modification, our proposed provisions

on RO Model participant exclusions. As

proposed, we are finalizing our policy,

and codifying at § 512.210(b), to exclude

from RO Model participation any PGP,

freestanding radiation therapy center, or

HOPD that furnishes RT services only in

Maryland; furnishes RT services only in

Vermont; furnishes RT services 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 by CMS as eligible to

participate in the Pennsylvania Rural

Health Model.

In response to public comments, we

are finalizing with one modification our

proposal regarding mandatory

participation in the Model. A PGP,

freestanding radiation therapy center, or

HOPD which would otherwise be

required to participate in the RO Model

under § 512.210(a) may choose to opt-

out of the RO Model on an annual basis

if the PGP, freestanding radiation

therapy center, or HOPD furnishes fewer

than 20 episodes across all CBSAs

selected for participation in the most

recent calendar year with available

claims data. We are codifying this

modified policy at § 512.210(c) of the

final rule.

Each RO participant’s episode volume

will be assessed at the TIN and CCN

level across all CBSAs randomly

selected for participation, not according

to how many episodes an RO

participant furnishes in a single CBSA.

For example, if an RO participant

furnished 30 episodes in two different

CBSAs and both CBSAs are selected for

participation in the Model, then the RO

participant would not be eligible for the

low volume opt-out option, even if the

RO participant furnished fewer than 20

episodes in each of those CBSAs. If,

however, an RO participant only

furnished 15 episodes in only one CBSA

selected to participate in the Model,

then this RO participant would be

eligible for the low volume opt-out

option.

RO participants that qualify for the

low volume opt-out may still choose to

participate in the Model, as our data

show that many of these RT providers

and RT suppliers may see increased

payments (compared to historical

payments) and improvements in quality

of care under the RO Model despite

having a low volume of episodes. Thus,

we believe it is important to allow them

the option of participating in the RO

Model if they so choose.

Prior to the start of each RO Model

PY, we will identify which RO

participants would be eligible to opt out

of the Model (including the RO Model

payments and participation

requirements) based on the most

recently available claims data. For PY1

(January 1, 2021, through December 31,

2021), we will use 2019 episode data,

for PY2 (January 1, 2022 through

December 31, 2022), we will use 2020

episode data, and so on. The most

current episode data is two years

removed from the period to which it

applies for two reasons. First, as

described in the pricing methodology

section in section C.III.6, if an RO

episode straddles calendar years, the RO

episode and its claims are counted in

the calendar year for which the initial

treatment planning service is furnished.

This means that an RO episode could

carry 89 days into the next performance

year. Second, we will allow for at least

one month of claims run-out after all RO

episodes have been completed. A longer

claims run-out is not necessary since the

low volume opt-out is based on a count

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26

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.

27

Datasets and documentation for HUD USPS Zip

Code Crosswalk Files (which includes the

previously mentioned HUD ZIP–CBSA crosswalk

file) can be found here: https://www.huduser.gov/

portal/datasets/usps_crosswalk.html.

of complete episodes and not on volume

of services during those RO episodes.

For these reasons, the most current

episode data is two years removed from

the period to which it applies.

Broadening the assessment period to

multiple years would even further

remove the opt-out option from current

practice patterns.

We will use only the most recent year

with available claims data rather than a

3-year baseline to identify low-volume

RO participants. This policy would

allow us to better recognize low-volume

RO participants over time and avoid

creating a permanent opt out for new

entities. At the same time, we want to

minimize the possibility that RT

providers and RT suppliers would have

an incentive to create a new billing

identifier each year to get out of the

Model. Thus, we would monitor for this

scenario by examining whether new

TINs/CCNs in the Model geographic

area have the same address as a

previous TIN/CCN to ensure that our

policy is serving its intent.

Eligibility for the opt-out option will

be assessed annually. A participant may

qualify for the opt-out option in one

performance year, but not in another. At

least 30 days prior to the start of each

PY, we will notify participants eligible

for the opt-out option as it concerns that

upcoming PY. Those RO participants

eligible to opt-out of the RO Model must

attest to the intention of opting out of

the Model prior to the start of the

applicable PY (that is, on or before

December 31 of the prior PY in which

the opt-out would occur). We will

provide further instructions on

submitting this attestation through

subregulatory channels of

communication, such as model-specific

webinars, and the RO Model website.

This process would be repeated prior to

each performance year of the Model.

This could result in some RO

participants being eligible for the opt-

out option in some years and not others,

that is, an RO participant could be able

to opt out in one year and then be

required to participate in the subsequent

year. We will notify participants to

remind them to verify their eligibility

for the opt-out option prior to each

performance year.

d. Geographic Unit of Selection

We proposed at 84 FR 34495 through

34496 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 proposed to 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 will permit us to

identify RO participants (see section

III.C.3.c of the proposed rule and this

final rule for a discussion of RO Model

participant exclusions for the RT

providers and RT suppliers we

proposed to exclude from this Model)

while still using CBSA as a geographic

unit of selection. We proposed to codify

the term ‘‘Core-Based Statistical Area

(CBSA)’’ at § 512.205 of our regulations.

The proposed rule explained that

CBSAs are delineated by the Office of

Management and Budget and published

on Census.gov.

26

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, consequently, we

did not propose to include non-CBSA

geographies in the RO Model test.

However, as noted in the proposed

rule, 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 CBSA selected for participation, we

proposed 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 for

participation and CBSAs selected for

comparison under the Model.

As explained in the proposed rule,

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%) 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 health care provider

burden by requiring submission of more

detailed geographic data by RT

providers and RT suppliers, we

proposed 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, we proposed that

the greater portion of business addresses

would take precedence to link the five-

digit ZIP Code to the CBSA.

We proposed to use a five-digit ZIP

Code to CBSA crosswalk found in the

Housing and Urban Development (HUD)

ZIP to CBSA Crosswalk file

27

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.

We indicated in the proposed rule

that we believed that linking a five-digit

ZIP Code to a single CBSA would not

substantially impact statistical estimates

for the RO Model. In addition, we

believed 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. We proposed to provide a

look-up tool that includes all five-digit

ZIP Codes linked to CBSAs selected for

participation in accordance with our

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28

‘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.

selection policy described in this final

rule. This tool will be located on the RO

Model website, as proposed.

In the proposed rule, we discussed

how 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

(84 FR 34496). 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. As

noted in the proposed rule, we will 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 for

participation and comparators under the

Model, we proposed 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 proposed to 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

28

test of the Model

is reached. We noted that 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 will produce mistakes,

that is, show ‘no effect’ when an effect

is actually present (for example, 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 (for example, when a

smoke detector is sounding an alarm

that suggests smoke is detected when

actually no smoke is present). Given

that we proposed to sample

approximately 40 percent of all eligible

RO episodes in eligible CBSAs

nationwide (as discussed in section

III.C.5 of the proposed rule and this

final 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. We proposed that strata

would be divided into five quintiles

based on the total number of episodes

within a given CBSA. The stratification

would improve the balance between the

CBSAs selected for participation and the

CBSAs selected for comparison by

limiting uneven numbers of RT provider

and RT supplier and episodes within

the CBSAs selected for participation and

of CBSAs selected for comparison that

could result from a simple random

sample. We proposed that if a CBSA

were randomly selected to the

participant group, then the RT providers

and RT suppliers who furnish RT

services in that CBSA selected for

participation would be RO participants.

If the CBSA were randomly assigned to

the comparison group, then the

providers and suppliers who furnish RT

services in that CBSA selected for

comparison 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.

As discussed in the proposed rule,

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 stated

in the proposed rule that we determined

that approximately 40 percent of eligible

episodes (as discussed in section III.C.5

of the proposed rule and this final 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. We also stated 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.

The proposed rule explained that

using randomly selected stratified

CBSAs would ensure that the CBSAs

selected for participation and CBSAs

selected for comparison each contain

approximately 40 percent of all eligible

episodes nationally. We proposed that

the CBSAs selected for comparison

would be used to evaluate the impact of

the RO Model on spending, quality, and

utilization. Further, we proposed that

CBSAs would be randomly selected and

the ZIP Codes linked to those CBSAs

selected for participation would be

published on the RO Model website

once the final rule is displayed.

The following is a summary of

comments we received related to the

proposed geographic unit of selection

and our responses to those comments:

Comment: A couple of commenters

believed that approximately 40 percent

of episodes constituted more than a test

and a few requested a reduction in the

scale of the proposed Model. CMS

received many comments related to the

proposed size of the RO Model, where

CMS proposed to include approximately

40 percent of episodes in the Model. All

of the commenters who submitted

feedback on this issue were opposed to

the size of the Model, and many

commenters suggested that the size of

the Model should be decreased from

approximately 40 percent of all eligible

episodes annually. These commenters

suggested many alternatives to CMS’

proposal to include approximately 40

percent of all eligible episodes, most of

which suggested a range of 7 percent to

25 percent of episodes to be included in

the Model; some suggested a gradual

phase in of additional RO participants

over the course of the Model.

Response: Incorporating some public

commenters’ request for a reduced size

of the Model while ensuring sufficient

sample for a robust evaluation, we have

determined that a reduced scale from

approximately 40 percent of eligible

episodes to approximately 30 percent of

eligible episodes, is sufficient to

produce robust evaluation results for the

finalized Model. By requiring

approximately 30 percent of eligible

episodes to be included in the Model,

we expect to be able to detect a savings

of 3.75 percent or greater at a

significance level of 0.05 and with a

power of 0.8.

Based on the comments received, we

are finalizing the proposed scope of the

Model at § 512.210(d) with modification

to reflect a reduced scale to

approximately 30 percent of the eligible

episodes. We note that this decision is

supported by additional power

calculations incorporating updated

episode data from 2016–2018 FFS

claims data that was not available for

reliable analysis at the time of the

proposed rule but became available

during the fall of 2019 in order to

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confirm the appropriateness of the

minimal sample size that would

incorporate the finalized design of the

RO Model.

Comment: Many commenters were

opposed to mandatory participation of

RT providers and RT suppliers located

in a random sample of core-based

statistical areas (CBSAs). A commenter

was concerned that random selection of

participants did not account for

vulnerable beneficiary populations or

vulnerable providers and suppliers.

Another commenter expressed concern

on the potential of certain RT provider

and RT supplier sites being selected in

the Model and the potential payment

reductions they may face due to the

Model, which would prevent them from

subsidizing more rural locations which

currently do not cover the costs of care.

Response: As we explained in the

proposed rule and this final rule, due to

concerns about a voluntary model being

subject to: (1) Selection bias from

limited to no participation from HOPDs;

(2) an even larger geographic scope

requirement for a model with optional

participation to account for the

projected bias and lower participation

rates; (3) the ability of such a model

with optional participation to achieve

savings; and (4) a reduced likelihood of

reliably detecting change to support

Model expansion, we proposed to

require participation of RT providers

and RT suppliers located in a random

sample of core-based statistical areas

(CBSAs). Mandatory participation

among randomly selected providers and

suppliers ensures that the evaluation

results about the RO Model will be

robust (both reliable, in that the effects

in savings we would see are not due to

chance and not biased due to selection

of participants that are not

representative of all RT providers and

RT suppliers), so that these results can

provide for the Chief Actuary of CMS to

certify that expansion of the Model

would reduce (or would not result in

any increase in) net program spending

in the future if the Department chooses

to pursue expansion under 1115A(c) of

the Act. Therefore, we will not be

modifying our proposal to randomly

select CBSAs to identify RT providers

and RT suppliers that are required to

participate in the Model through a

stratified sample design.

The well-being of potentially

vulnerable patients is always of primary

concern to CMS. As such, we will

examine and monitor vulnerable

populations and providers and

suppliers for any unintended

consequences of the random selection of

RO participants in the Model. CMS

expects that the payments to providers

and suppliers under the RO Model will

appropriately cover the costs of

standard operations and profits for RT

providers and suppliers. We appreciate

the possibility of instances where RT

providers and suppliers are cross-

subsidizing finances from high-earning

locations to lower-earning locations, but

this is not directly under CMS control—

these are external financing practices

which CMS does not have authority

over. HHS has additional programs

which provide help with financing for

potentially vulnerable populations and

providers and suppliers (such as HRSA

programs for the vulnerable and

underserved). Additionally, for certain

low volume RT providers and RT

suppliers, we are providing a low

volume opt-out option, as discussed in

section III.C.3.c of this final rule.

Comment: Some commenters

expressed concern that the use of Core-

Based Statistical Areas (CBSAs) to

identify RO participants could result in

unintended consequences, such as

picking ‘winners and losers’ in markets.

These comments largely focused on

‘patient overlap’ and the potential

incentive for patients to travel,

depending on the patient’s preference,

in order to see a RT provider or RT

supplier who either is an RO participant

or a RT provider or RT supplier not

selected to participate in the Model.

Comments appeared to suggest that all

RT providers and RT suppliers in a

particular market be selected to be RO

participants or not. A commenter stated

that patients could be negatively

impacted by the Model as beneficiaries

seeking RT services in included ZIP

Codes must also participate in the

Model or travel to a geographic area not

included in the Model for care

(regardless of their ability to do so). A

commenter was worried about the

potential differences between CBSAs

selected for participation and CBSAs

selected for comparison with respect to

treating prostate cancer if there was an

uneven incidence of prostate cancer

cases between RO participants and

comparators—the comment cited the

‘greater levels of technology’, such as

IMRT (intensity-modulated radiation

therapy) that is often used to treat

prostate cancer. The commenter was

similarly concerned with the potential

for lower-risk patients to be used as a

benchmark in comparison CBSAs while

higher-risk patients would be in the

CBSAs selected for participation,

particularly with regards to race.

One commenter fully agreed with

proposed geography-based

randomization process, stating that the

proposed process was fair and unbiased.

A commenter suggested that site-neutral

payments be applied to all RT providers

and RT suppliers and not restrict this

payment change to the proposed

approximately 40 percent of CBSAs

selected for participation.

Response: In designing the Model, a

driving principle for us was patients

being able to continue to access high-

quality care. As we stated in the

proposed rule and in this final rule,

there are tradeoffs to consider in the

design of a Model with respect to the

unit of selection. The mixture of

concern and support for the proposed

design as expressed through the

comments described here is further

evidence of those tradeoffs.

We do not have data that definitively

delineates markets for RT services.

However, we believe by adopting

CBSAs as proxies for those markets that

we will achieve a reasonable balance

among the tradeoffs raised by

commenters and discussed in the

proposed rule. 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. Please see section III.C.3.d for

a discussion of CBSAs as markets due

to their high degree of social and

economic integration. Because CBSAs

can yield market-like effects, CMS

believes that CBSAs are the best

available option for selection of RT

participation.

We shared the concerns with

commenters that selection of some

CBSAs may create specific situations,

such as a health system having practices

in multiple locations and/or those

located near the border of a CBSA. We

understand the concern that the Model

could potentially result in health

systems having both RO participants

and non-participants, as this could

produce additional burden for these

systems in terms of billing and the

ability to manage patients. This issue is

one such tradeoff in the design of the

Model. We determined that some

systems would have locations providing

RT services that experience the Model

conditions as an RO participant and

other locations providing RT services

that are not RO participants. We chose

CBSAs to attempt to minimize the

number of such occurrences. We would

also like to note that episodes are

assigned to a single CBSA by way of the

ZIP Code of the RT supplier that

furnished the planning service that

triggered the RO episode.

We believe that using stratified

randomization will minimize potential

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selection problems and unintended

consequences, including other potential

imbalances in cancer type (and

corresponding modality) or patient risk.

We can identify and account for

observed imbalances that may result

from randomized selection in the

evaluation. The Model (and its

exclusions) were designed to minimize

the potential consequences. We are

finalizing the adoption of CBSAs as the

geographic unit of selection in the RO

Model.

We seek to support Medicare patients’

rights to seek care wherever they

choose. We do not believe that the

changes in health care provider

payments in the RO model would justify

or lead to beneficiaries travelling to

entirely different CBSAs to seek RO

care, which involves frequent

treatments over a short period. We

designed the model with CBSAs to

prevent RO participants from shifting

patients who require more expensive

care to a site of service which would not

be included in the RO Model. The

CBSAs selected for participation will be

in distinctive locations, and we believe

the potential effects on patient costs

would not substantial. Based on these

facts and the frequency needed for

radiation therapy treatments, we do not

believe that the RO Model would create

an incentive for beneficiaries to avoid

RO participants. In other words, we do

not believe that the RO Model would

create a situation where beneficiaries

systematically choose to receive RT

services from an RT provider or supplier

that they would not otherwise seek care

from in absence of the model. We

believe the compensation we are

providing under this Model is fair and

this should not affect where

beneficiaries seek RT services.

The RO Model’s inclusion of

approximately 30 percent (or a greater

percent) of all RT providers and

suppliers for a finite period of time does

not constitute a program change but a

model test. In order to test the effect of

payments in the RO Model to determine

whether they reduce cost while

maintaining and/or improving quality of

care and patient outcomes, we believe

using both a case (participant) and

control (non-participant) will provide

the most meaningful comparison. We

have designed the Model to include a

limited sample size (that is,

approximately 30 percent of eligible

episodes nationwide), while ensuring

both sufficient sample size and power to

produce robust data that can provide

evidence to certify the Model in the

future if the Department chooses.

Comment: A few commenters

encouraged us to allow public comment

on the particular CBSAs selected for

participation in the RO Model.

Response: We appreciate the

commenters’ concerns regarding an

opportunity to comment on particular

CBSAs selected for participation, but

these comments fall outside the scope of

our proposed policy. We would like to

clarify that we will use the most

recently available HUD USPS ZIP Code

Crosswalk Files (https://

www.huduser.gov/portal/datasets/usps_

crosswalk.html#data) to link a new five-

digit ZIP Code to a CBSA in the manner

as described in section III.C.3.d.

Currently, the HUD USPS ZIP Code

Crosswalk Files are updated quarterly. If

the most recently available HUD USPS

ZIP Code Crosswalk File links any

additional five-digit ZIP Codes to the

CBSAs selected for participation, we

will add those ZIP Codes to the ZIP

Codes included under the Model. The

look-up tool that includes all of the five-

digit ZIP Codes linked to CBSAs

selected for participation will be

updated with the additional ZIP Codes.

Once a five-digit ZIP Code is assigned

to a CBSA selected for participation

under the Model, it will not be removed

from the list of included ZIP Codes.

Comment: A couple of commenters

were concerned that the Model design

had the potential not to include a

sufficient number of proton beam

therapy (PBT) centers to be able

adequately detect the impact of the

Model on proton centers in isolation.

Response: The evaluation of the RO

Model will be primarily interested in

the impacts of the Model on the overall

spending and quality of care across all

included RT services at the population

level, and not the effects on one RT

modality compared to another. While

some future evaluation analyses may

include differences in costs and quality

by modality, we will make no impact

estimates on cost nor quality where we

do not have suitable sample size of

practices or episodes among the

participants and non-participant

comparators, understanding that any

differences we may observe will be

observational and not causative.

Comment: A commenter requested

that CMS should publish online an

explicit list of excluded RT providers

and RT suppliers, including their

names, addresses, and NPIs to ensure

there’s no confusion about excluded

providers and suppliers. This

commenter further stated that it is

important for Professional participants

to have a CMS-approved list that clearly

indicates which RT providers and RT

suppliers are excluded despite the fact

that they are located within a ZIP Code

selected for the RO Model.

Response: We appreciate the

commenter’s suggestion. A look-up tool

that includes all of the five-digit ZIP

Codes linked to CBSAs selected for

participation in accordance with our

finalized selection policy described in

this final rule is located on the RO

Model website (https://

innovation.cms.gov/initiatives/

radiation-oncology-model/). This tool

will allow included entities that furnish

RT services to identify if they are

included or excluded from the RO

Model based on their site of service. We

will refrain from including personal

identification information of specific

physicians in the release of the RT

providers and suppliers selected to

participate. We believe that relevant

entities within selected participating

ZIP Codes will already be aware if they

meet the exclusion criteria for the

Model (for example, if they whether

they are PPS-exempt cancer hospitals,

critical access hospitals (CAHs), or are

located within certain exclude states

(Maryland, Vermont, U.S. Territories) or

are participating in or eligible to

participate in the Pennsylvania Rural

Health Model as codified at § 512.210.

However, any entity who may want to

confirm their exclusion will be free to

contact the RO Model help desk

(RadiationTherapy@cms.hhs.gov).

Comment: A commenter has

requested that we select patients

randomly to be included in the Model.

Response: The Model design is such

that RO participants will be selected

through randomized CBSAs: Those

CBSAs selected for participation and

CBSAs selected for comparison. The

Model is not designed to randomly

select patients from within selected RO

participants. CMS chose not to design

the RO Model to randomly select

patients as this would have created a

much greater burden, administratively

and operationally, for RT providers and

suppliers who see both participating

and non-participating beneficiaries

within a single site of care who would

then need to operationalize 2 different

billing systems (one for participating

beneficiaries, one for non-participating

beneficiaries) within that one site.

Additionally, if the sample size

(approximately 30 percent of episodes)

were calculated at the beneficiary level

(rather than RT provider and supplier

level), a substantially greater number of

RT providers and suppliers would be

included as RO participants to reach the

necessary approximately 30 percent

sample size. We are finalizing as

proposed that patients will be RO

beneficiaries if they receive included RT

services from an RO participant. The

Model will be finalized using the

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29

Please note that this was incorrectly stated in

the section III.C.4 of the preamble to the Notice of

Proposed Rulemaking, as ‘‘Is not in a Medicare

hospice benefit period’’ (at 84 FR 34496), but was

correctly stated in the proposed regulatory text at

84 FR 34585. It has been corrected in the preamble

to this Final Rule to ‘‘Is in a Medicare hospice

benefit period.’’

30

The current Medicare policy on routine cost in

clinical trials is described in Routine Costs in

Clinical Trials 100–3 section 310.1.

proposed random selection of CBSAs as

the method of determining an RT

provider’s or RT supplier’s participation

(or not) in the model.

After considering public comments,

we are finalizing with modification our

proposed provisions on the RO Model’s

geographic unit of selection.

Specifically, we are codifying at

§ 512.210(d) that we will randomly

select CBSAs to identify RT providers

and RT suppliers to participate in the

Model through a stratified sample

design. However, instead of allowing for

participant and comparison groups to

contain approximately 40 percent of all

eligible episodes in eligible geographic

areas as we had proposed, we are

modifying this provision in the final

rule allowing for participant and

comparison groups to contain

approximately 30 percent of all eligible

episodes in eligible geographic areas

(that is, CBSAs). The sample size was

calculated incorporating the final

parameters of the model, and we are

using a sample size that we believe is

necessary to detect the anticipated

impact of the model. Therefore, we are

finalizing that approximately 30 percent

of eligible episodes will be randomly

selected for this Model. For the final

rule, we used Medicare FFS claims from

January 1, 2016 through December 31,

2018 for constructing episodes,

determining sufficient sample size, and

for the eventual selection of participants

and comparators for the RO Model, as

this was the timeliest data available at

the time of this final rule’s release.

4. Beneficiary Population

In the proposed rule at 84 FR 34496,

we proposed that a Medicare FFS

beneficiary would be included in the

RO Model if the beneficiary:

•Receives included RT services in a

five-digit ZIP Code, linked to a CBSA

selected for participation, from an 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 an 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 proposed to exclude

from the RO Model any beneficiary

who, at the time that the initial

treatment planning service of the

episode is furnished by an 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 in a Medicare hospice benefit

period;

29

or

•Is covered under United Mine

Workers.

We explained in the proposed rule

that the RO Model will evaluate RT

services furnished to beneficiaries who

have been diagnosed with one of the

cancer types identified as satisfying our

criteria for inclusion in the Model, as

discussed in section III.C.5.a of the rule

(84 FR 34496 through 34497). Thus, we

stated that we believed 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. We also

stated that a key objective of the RO

Model is 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 FFS to

prospectively determined bundled rates

for an episode. We proposed 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 discussed our belief that these

eligibility criteria for RO beneficiaries

are necessary in order to properly

evaluate this change with minimal

intervening effects in the proposed rule.

We proposed to define a beneficiary

who meets all of these criteria, and who

does not trigger any of the beneficiary

exclusion criteria, a ‘‘RO beneficiary’’.

We proposed to codify the terms ‘‘RO

beneficiary,’’ ‘‘RT provider,’’ and ‘‘RT

supplier’’ at § 512.205.

In addition, we proposed 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 beneficiary

inclusion criteria. The proposed rule

provides that 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.

30

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.

We stated that the RO Model’s 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 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 discussed in

section III.C.6.i of this final rule.

Beneficiaries do have the right to choose

to receive RT services in a geographic

area not included in the RO Model.

We explained in the proposed rule, at

84 FR 34497, that if an RO beneficiary

stops meeting any of the eligibility

criteria or triggers any of the exclusion

criteria before the TC of an episode

initiates, then the episode would be an

incomplete episode as discussed in

section III.C.6.a of the proposed rule (84

FR 34503 through 34504) and this final

rule. Payments to RO participants

would be retrospectively adjusted to

account for incomplete episodes during

the annual reconciliation process, as

described in section III.C.11 of the

proposed rule and this final rule. We

proposed that 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 the proposed rule

and this final rule).

We proposed these beneficiary

eligibility criteria for purposes of

determining beneficiary inclusion in

and exclusion from the Model. The

following is a summary of comments

received related to our proposal on the

RO Model’s beneficiary population and

our responses to those comments:

Comment: A few commenters

requested that all patients enrolled in

clinical trials should be excluded from

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the RO Model. One of these commenters

also stated that some Medicare

contractors provide exceptions to

providers and suppliers with a history

of evidence development and they

suggested that the Innovation Center

consider this as a basis for exclusion as

well.

Response: We thank the commenters

for their suggestions. Medicare pays

routine costs by way of FFS payments

for Medicare beneficiaries participating

in clinical trials when there exists a

benefit category, it is not statutorily

excluded, and there is not a national

non-coverage decision, making it

appropriate to include these

beneficiaries in the RO Model provided

that such beneficiary meets all of the

proposed beneficiary inclusion criteria.

It is important that the RO Model

include clinical trials because the goal

of the Model is to test whether

prospective episode payments for RT

services, in lieu of traditional FFS

payments, would reduce Medicare

expenditures. Therefore, not including

clinical trials that are paid through FFS

could skew the Model results. With

regard to the commenter who suggested

that the Innovation Center provide

exceptions to providers and suppliers

with a history of evidence development,

we appreciate the suggestion, however,

we believe that less experienced RO

participants will benefit from this type

of experience through peer-to-peer

learning activities and performance

reports that will allow for comparison

between participants. We also believe

that including providers and suppliers

with all levels of experience would

result in a more robust data set for

evaluation of the RO Model’s

prospective payment approach. We will

continue to monitor the Model for a

need of this exception in the future.

Comment: A commenter suggested

that CMS should open the RO Model to

voluntary participation by Medicare

Advantage plans and other payers. This

commenter stated that limiting the RO

Model to Medicare fee-for service would

miss an opportunity to allow as many

health care providers and payers as

possible to explore and assess

innovative approaches to delivering care

under a bundled payment model.

Response: At this time, we are

finalizing as proposed that the RO

Model will include only Medicare fee-

for-service beneficiaries receiving RT

services by RO Participants. This Model

was designed to test an alternative

payment approach instead of FFS, and

is therefore limited to only Medicare

FFS beneficiaries and does not include

other payers like Medicare Advantage.

As we discussed in the NPRM, 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 as described in section

III.C.6.c. We proposed these beneficiary

criteria in order to limit participation in

the RO Model to beneficiaries whose RT

providers and/or 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; therefore, we are not including

additional payers such as Medicare

Advantage to the RO Model in this final

rule. We recognize that other payers

may be conducting similar alternative

payment models. Other payers who are

interested in testing an alternative

payment system to FFS are welcome to

align with our RO Model

methodologies. However, we are not

soliciting formal partnerships with other

payers at this time.

Comment: Another commenter

requested clarification on what will

happen if a patient joins a Medicare

Advantage plan during the fall open

enrollment period while in an RO

episode. This commenter expressed

concern that both systems will assume

the other will pay.

Response: In this scenario, if

Medicare FFS stops being the primary

payer during the 90-day episode, this

would be considered an incomplete

episode. Please refer to section III.C.6.a

of the proposed rule (84 FR 34503

through 34504) and this final rule for an

overview of our incomplete episode

policy.

Comment: A commenter stated that

patients should always have a choice in

their care, and therefore a patient opt-

out provision is warranted just as it is

in the OCM.

Response: As we stated in the

proposed rule, the RO Model’s design

will not allow RO beneficiaries to ‘‘opt

out’’ of the Model’s pricing

methodology as described in section

III.C.6 of the proposed rule, as well as

this final rule. Of note, this policy is the

same as in OCM, where beneficiaries

who receive care from an OCM

participant have the same Medicare

rights and protections, including the

right to choose which health care

provider they see, and they may choose

a health care provider who does not

participate in the OCM. However, just as

in OCM, this Model protects beneficiary

choice because beneficiaries have the

right to choose to receive RT services

from a RT provider and/or RT supplier

not included in the RO Model.

Comment: A commenter supported

the participant criteria with the

exception of excluding those in a

Medicare hospice benefit (MHB) period.

This commenter stated that such

patients may benefit from RT services as

a palliative measure and so should be

allowed to participate in this Model if

so. They further stated that while they

agreed this is a reimbursement issue for

hospices, palliative radiation is by its

nature not curative and so should be

covered under the MHB, at least for

those people with cancer participating

in this Model.

Response: We thank the commenter

for their recommendation. Medicare

beneficiaries will be excluded from the

RO Model if they are in a MHB period

at the start of their receipt of RT

services, because the MHB is not paid

FFS. As we previously stated, the goal

of the RO Model is to test whether

prospective episode payments in lieu of

traditional FFS payments for RT

services would reduce Medicare

expenditures; therefore, it is important

that non-FFS beneficiaries be excluded

in order to properly evaluate the results

of the Model. Traditionally, if a

beneficiary receives RT services during

a MHB period, the cost of the treatment

would be covered under the Medicare

hospice per diem. The RO Model allows

for RO Model payments to continue (in

addition to the Medicare hospice per

diem) if a beneficiary selects MHB

during an RO episode so as not to

dissuade RO participants from making a

hospice referral when needed. The

Medicare hospice agency will not be

responsible for the cost of RT services

in this case. This RO Model policy does

not intend to imply that the MHB

should pay for curative treatment. While

we understand the commenter’s

concern, we will not be creating an

exemption of this nature at this time.

Comment: A commenter requested

clarification on the definition of an RO

beneficiary, specifically they would like

clarification on what happens if a

patient starts an episode with inpatient

treatment and then changes to an

outpatient setting, and if a patient

changes ZIP Codes during the course of

treatment.

Response: To the commenter’s

question regarding moving from

inpatient treatment to outpatient

treatment, if a beneficiary starts

inpatient treatment and then changes to

an outpatient setting, this situation

would not be considered an RO episode,

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and treatment would be billed under

traditional fee-for-service.

For the commenter’s question about a

patient changing ZIP Codes during the

course of treatment, we note that the ZIP

Codes are relevant only to the location

of the RO participant, not the residence

of the beneficiary. If the beneficiary

with an included cancer type receives

included professional and technical

services from one or more RO

participants located in one or more ZIP

Codes linked to CBSAs selected for

participation, then the beneficiary will

be an RO beneficiary. If the beneficiary

receives professional RT services from

an RO participant in a ZIP Code linked

to CBSAs selected for participation, but

receives technical RT services from non-

participants (or vice versa), the

beneficiary will not be in the Model,

and this will be an incomplete episode

as defined at § 512.205 and as further

described in section III.C.6.a of this final

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 final

rule.

Comment: A commenter did not

support our proposal regarding the

beneficiaries that will be included and

excluded from the RO Model. This

commenter stated that linking

beneficiaries by ZIP Code could create

adverse selection and skew the results

of the Model. This commenter requested

clarity on whether inclusion and

exclusion is linked to the beneficiary’s

address being in the ZIP Code or the

address of the RO participant. This

commenter also requested clarification

about whether the RO participant is

responsible for the entire ZIP Code even

if the beneficiary goes out-of-area.

Response: We are clarifying that a

beneficiary’s address does not

determine his or her inclusion in the RO

Model, rather it is determined by the

address where the RO participant

furnished the included RT services. Nor

did we propose to link beneficiaries by

ZIP Code. Regarding the requested

clarification about whether the RO

participant is responsible for the entire

ZIP Code even if the beneficiary goes

‘‘out-of-area’’, we take the commenter’s

reference to a beneficiary going ‘‘out-of-

area’’ to mean that the beneficiary has

switched providers and stopped

receiving RT services from the RO

participant that initiated the RO

episode. This would be considered an

incomplete episode. We also note that

in the case of incomplete episodes, RO

participants are owed beneficiary

coinsurance payment of 20 percent of

the FFS amounts that would have been

paid in the absence of the RO Model,

except when the RO beneficiary ceases

to have traditional FFS Medicare as his

or her primary payer at any time after

the initial treatment planning service is

furnished and before the date of service

on a claim with an RO Model-specific

HCPCS code and EOE modifier. In that

case, the RO participant would be owed

beneficiary coinsurance payment would

equal 20 percent of the first installment

of the episode payment amount. See

III.C.6.a of the proposed rule (84 FR

34503 through 34504) and this final rule

for an overview of our incomplete

episode policy. 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.

Comment: A commenter requested

clarification about what will occur if a

beneficiary refuses to participate in the

Model by notifying CMS in writing after

treatment is started and the start of

episode (SOE) HCPCS is submitted to

CMS.

Response: We would like to clarify

that under this Model, RO beneficiaries

will not provide direct notification to

CMS when they do not wish to

participate in the Model. If a beneficiary

does not wish to ‘‘participate’’ in the

Model, (s)he can seek treatment from a

non-participant. The notification that

we believe this commenter is referring

to is in cases where beneficiaries do not

wish to have their claims data shared

with the RO participant for care

coordination and quality improvement

purposes under the Model. In such

cases, the RO participant must notify

CMS in writing within 30 days of when

the RO beneficiary notifies the RO

participant (see section III.C.15 of the

proposed rule and this final rule for

more details on this policy).

Comment: A commenter was

concerned with the potential for adverse

health outcomes for certain vulnerable

populations defined by race, income,

and the presence of prostate cancer

under the Model.

Response: The evaluation of the RO

Model will be taking into account, to the

extent feasible, any potential adverse

health outcomes, and any underlying

differences in patient characteristics,

severity, and the related differences in

technology in the monitoring and

evaluation of this Model.

After considering public comments,

we are finalizing our proposal on the

beneficiary population with

modification. We have made additional

non-substantive changes to the

proposed provisions at § 512.215 in this

final rule to improve readability.

Specifically, we are finalizing, with

modification, the RO Model beneficiary

inclusion criteria as codified at

§ 512.215(a) and illustrated in Figure A.

We have made additional non-

substantive changes to the proposed

provisions at § 512.215 in this final rule

to improve readability. We are also

finalizing with modification at

§ 512.215(a) that an individual is an RO

beneficiary if the individual receives

included RT services from an RO

participant that billed the SOE modifier

for the PC or TC of an RO episode

during the Model performance period

for an included cancer type. An

individual is an RO beneficiary if, at the

time that the initial treatment planning

service of an RO episode is furnished by

an RO participant, the individual is

eligible for Medicare Part A and

enrolled in Medicare Part B, the

individual has traditional FFS Medicare

as his or her primary payer (for

example, is not enrolled in a PACE plan,

Medicare Advantage or another

managed care plan, or United Mine

Workers insurance), and if the

individual is not in a MHB period. We

are further finalizing with modification

at § 512.215(b) that any individual

enrolled in a clinical trial for RT

services for which Medicare pays

routine costs will be an RO Beneficiary

if the individual satisfies all of the

beneficiary inclusion criteria codified at

§ 512.215(a).

Additionally, we are finalizing as

proposed to codify the terms ‘‘RT

provider,’’ and ‘‘RT supplier’’ at

§ 512.205. We are finalizing, with

modification, to codify the term ‘‘RO

beneficiary’’ at § 512.205 to mean a

Medicare beneficiary who meets all of

the beneficiary inclusion criteria at

§ 512.215(a) and whose RO episode

meets all of the criteria defined at

§ 512.245. As explained in the proposed

rule and in this final rule, the RO

Model’s design would not allow RO

beneficiaries to ‘‘opt out’’ of the Model’s

pricing methodology.

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F

IGURE

A—F

INALIZED

RO B

ENEFICIARY

I

NCLUSION

C

RITERIA

The individual receives included RT services:

•From an RO participant that billed the SOE modifier for the PC or TC of an RO episode during the Model performance period for an in-

cluded cancer type.

At the time that the initial treatment planning service of the RO episode is furnished by an RO participant, the individual:

•Is eligible for Medicare Part A and enrolled in Medicare Part B.

•Has traditional Medicare FFS as his or her primary payer (for example, is not enrolled in a PACE plan, Medicare Advantage or another

managed care plan, or United Mine Workers insurance).

•Is not in a Medicare hospice benefit period.

5. RO Model Episodes

We proposed that under the RO

Model, Medicare would pay RO

participants a site-neutral, episode-

based payment amount for all specified

RT services furnished to an RO

beneficiary during a 90-day episode (84

FR 34497). In section III.C.5 of the

proposed rule, we first explained 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

explained our proposal for testing a 90-

day episode and proposed the

conditions that must be met to trigger an

episode.

a. Included Cancer Types

We proposed 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 proposed to codify these criteria

for included cancer types at § 512.230(a)

of our regulation.

We proposed 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

base rates; or

•The Secretary determines a cancer

type not to be suitable for inclusion in

the Model.

We proposed to codify these criteria

for removing cancer types at

§ 512.230(b) of our regulation.

We identified 17 cancer types in

Table 1—Identified Cancer Types and

Corresponding ICD–9 and ICD–10 Codes

of the proposed rule that met our

proposed criteria. We explained in the

proposed rule that 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 of the proposed rule,

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.

As described in the proposed rule, we

used the list of cancer types and

relevant diagnosis codes, to analyze 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.

We stated in the proposed rule that

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 in the proposed rule.

The proposed RO Model’s included

cancer types are commonly treated with

RT and can be accurately priced for

prospective episode payments. As

proposed, an up-to-date list of cancer

types, upon any subsequent revisions,

will be kept on the RO Model website.

We proposed to define the term

‘‘included cancer types’’ to mean the

cancer types determined by the

proposed criteria set forth in § 512.230,

which are included in the RO Model

test.

We proposed to maintain the list of

ICD–10 codes for included cancer types

under the RO Model on the RO Model

website. We indicated in the proposed

rule that any addition or removal of

these codes would be communicated via

the RO Model website and written

correspondence to RO participants. We

proposed to 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 solicited comments on the

proposed cancer types included in the

RO Model. The following is a summary

of the public comments received on this

proposal and our responses to those

comments:

Comment: A couple of commenters

expressed support for the inclusion of

all 17 cancer types named in the

proposed rule, emphasizing that it

expands the benefit to the broadest

population of patients. A few of these

commenters stated that including all 17

cancer types would reduce the overall

administrative burden on RO

participants, as this scale decreases the

burden associated with operationalizing

a model for a few key cancer sites and

not others. Other commenters

emphasized that, since these 17 cancer

types are commonly treated with RT

services, they can be accurately priced.

Response: We thank the commenters

for their support.

Comment: A commenter described

how inaccurate coding could lead to

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misvalued episode payments and

included renal cell carcinoma in one of

the examples.

Response: Based on further clinical

review, kidney cancer is not commonly

treated with radiotherapy and as such it

does not meeting the criteria for

inclusion. Kidney cancer may have been

included as an artifact of inaccurate

coding and we are therefore excluding

it from the RO Model.

Comment: Many commenters

expressed concern over the inclusion of

cervical cancer. A commenter suggested

separate payment for each physician

involved in treating cervical cancer. A

few commenters recommended using

the OPPS Ambulatory Payment

Classification (APC) payment rates

without the comprehensive APC (C–

APC) methodology for the technical

component of the national base rate for

cervical cancer, because they believe

that the C–APC OPPS methodology

undervalues the brachytherapy

reimbursement. Another commenter

called into question the data used to

determine the national base rates for

cervical cancer, stating that the payment

methodology is not well-suited for

cancers commonly treated with multiple

modalities. This commenter also

believed that the RO Episode File

misattributed episodes to cervical

cancer that ought to have fallen under

a different cancer type. This commenter

noted episodes that are inconsistent

with clinical medicine and could be

only partially captured episodes,

incorrectly captured delivery codes, or

misattributed episodes. Regarding

misattribution, the commenter stated

that approximately 2 percent of cervical

cancer episodes include SRS, yet since

SRS is a single fraction of radiation to

the brain, these episodes are likely

treating a metastatic site rather than

treating the primary site of cervical

cancer. Regarding partially captured

episodes, the commenter asserted that

there are 75 episodes from the RO

Episode File where fewer fractions were

provided than is the established clinical

approach.

Response: We believe that the

national base rates represent the average

of all RT services provided to

beneficiaries with a given cancer type,

including cervical cancer, and it is

probable that there will be individual

episodes where there is deviation from

the standard treatment given the clinical

profile of an individual patient. Our

data shows that in addition to episodes

with lower numbers of fractions, there

are other episodes with higher numbers

of fractions than is typically

recommended. Over the past few years,

we have repeatedly examined the C–

APC methodology with regard to

brachytherapy and cervical cancer and

determined that it provides appropriate

reimbursement. For examples, please

see the CY 2020 OPPS/ASC final rule

with comment period (84 FR 61163) and

the CY 2019 OPPS/ASC final rule with

comment period (83 FR 58843). As

such, we believe that the C–APC

methodology is appropriate to use in the

base rate calculations for the RO Model.

We will continue to examine these

concerns. Please refer to the pricing

methodology in section III.C.6 for

further explanation of these points,

including rationale related to APCs and

C–APCs. We rely on Medicare providers

and suppliers to furnish appropriate

care to beneficiaries.

Comment: A commenter suggested

adding a specific category for an

isolated lymph node treated with

radiation, emphasizing that this is a

common clinical situation.

Response: We thank the commenter

for their suggestion. However, we

believe that the treatment of an isolated

lymph node would likely be part of a

treatment plan for an included cancer

type. If it is not part of a treatment plan

for an included cancer type, the

treatment would be paid FFS.

Comment: A few commenters

recommended that CMS remove liver

cancer from the RO Model. These

commenters argued that the treatments

for liver cancer are not well-suited for

the RO Model as treatment can involve

multiple physicians. A few commenters

stated that liver cancer sometimes

involves radioembolization treatment

using Yttrium-90, and that this therapy

frequently involves both a radiation

oncologist and an interventional

oncologist, most likely in the HOPD.

These commenters believed that

including this therapy could trigger

incomplete episodes, as one physician

is typically involved in planning and a

second in delivery. These commenters

also believed that, when the radiation

oncologist triggers the episode, there

would be a separate FFS payment to the

interventional radiologist for their work,

ultimately resulting in a higher payment

from the patient.

Other commenters believed that liver

cancer should be excluded from the

Model, as it is uncommon for a patient

to receive more than one session of

brachytherapy for liver cancer, thus

there is no opportunity to improve

efficiency or reduce spending. A couple

of commenters added that liver cancer

treated with brachytherapy accounts for

only 0.29 percent of all episodes

included in the Model, and, therefore,

any cost savings would be trivial.

Another commenter suggested that this

low percentage indicated that liver

cancer treated with brachytherapy

should fall under the ‘‘certain

brachytherapy surgical services’’

excluded by the proposed rule due to

low volume.

Response: As noted in section III.C.5.c

of this final rule, we are removing

Yttrium-90 from the RT services

included on the list referred to as ‘‘RO

Model Bundled HCPCS’’ (Table 2; as

such, it may be billed FFS. Liver cancer

meets the criteria for inclusion as a

cancer type under the RO Model as

codified at § 512.230(a). The RO Model

is designed to be disease-specific and

agnostic to treatment and modality type.

Liver cancer is commonly treated with

radiation and has associated current

ICD–10 codes that demonstrate pricing

stability. It is important to note, that

when just one treatment is clinically

appropriate and furnished, the RO

participant will be paid more than they

would have under FFS. CMS recognizes

that there is no efficiency or savings to

be earned in these instances, but by

including liver cancer in the RO Model

we will be able to test whether

prospective payments for RT services, as

opposed to traditional FFS payments,

would reduce Medicare expenditures

while preserving or enhancing quality of

care. Thus, we are finalizing our

proposal to include liver cancer in the

RO Model.

Comment: Some commenters

recommended that CMS implement the

Model with fewer cancer types. A

commenter suggested that CMS limit the

number of cancer types to those for

which treatment protocols are the most

standardized across patient cohorts and

with low propensity for outlier cases. A

couple of these commenters expressed

concerns that the administrative burden

imposed by the sheer number of

included cancer types would be too

much for RO participants and CMS to

manage effectively. A commenter noted

the variation in treatment pathways and

requested that CMS consider excluding

treatments that are extensive or serve as

outliers. These commenters indicated

that focusing on fewer cancer types

would allow providers and suppliers to

focus efforts on specific areas of

medicine, causing less disruption to RO

participants.

A few of these commenters had

specific recommendations for which

subset of cancer types should be

included. A couple of commenters

suggested targeting the most prevalent

cancer types: Breast, colon, lung, and

prostate, as treatments for these cancers

are often more homogenous and their

costs are more predictable. A few other

commenters recommended including

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only cancer types that had sufficient

clinical data to support

hypofractionation as clinically

appropriate care. A few commenters

recommended excluding complex

cancer types with variable costs, such as

cancers of the brain and of the head and

neck. Specifically, commenters

emphasized that these cancer types

frequently require more complicated

workup, planning, and technology than

others, and must be adjusted as the

tumor shrinks or the patient loses

weight. A commenter underscored that,

even within these three cancer types,

patients may receive treatments that

vary widely in cost based on clinical

indicators.

A couple of commenters suggested

phasing in the 17 cancer types over

time, beginning with one or two cancer

types and then expanding to the full set

of 17 over the Model performance

period. A couple commenters suggested

reducing the number of cancer types

included and analyzing performance

data before including all 17 cancer types

from the outset of the Model.

Response: The 16 cancer types that

we are finalizing for inclusion in the RO

Model are cancers commonly treated

with RT. The Innovation Center

excluded those cancers that are rarely

treated with radiation. Once an initial

list of cancer types and relevant

diagnosis codes were identified, the

Innovation Center reviewed them for

pricing stability. For example, the

Innovation Center analyzed the

interquartile ranges of the episode

prices across diagnosis codes within

cancer types. There will likely be

individual episodes where there is

deviation from the standard treatment

given the clinical profile of an

individual patient. Our data shows that,

in addition to episodes with lower

numbers of fractions, there are other

episodes with higher numbers of

fractions than is typically

recommended, including but not

limited to as cancers of the brain and of

the head and neck. The final list

includes those cancer types that are

commonly treated with RT and have

demonstrated pricing stability, which

allows them to be accurately priced. The

diagnoses selected to be included in the

RO Model account for over 90 percent

of episodes during the time period that

was analyzed (2016–2018, as discussed

in section III.C.6.d). CMS believes that

phasing in the included cancer types

would prevent a robust evaluation

because doing so would reduce the

amount of available data for any cancer

types phased in at a later time. As

previously stated, we believe that a

Model performance period of at least 5

years is sufficient to obtain data to

compute a reliable impact estimate.

Please refer to section III.C.1 of the rule

for more information on the Model

performance period.

Additionally, CMS believes that

limiting or phasing in the number of

included cancer types would be more

burdensome for most RO participants.

As previously noted, the included

diagnoses accounted for over 90 percent

of episodes from 2016 through 2018.

Thus, for most RO participants, limiting

or phasing in cancer types would mean

that the RO Model requirements and

billing guidance would apply to a subset

of their RT services rather than to than

to the majority of their RT services for

a significant portion of the Model

performance period (or if cancer types

were further limited, for the entire

Model performance period).

As explained earlier in this section of

the final rule, we are modifying the list

of included cancer types to exclude

kidney cancer. We believe that

including the 16 cancer types (Anal

Cancer, Bladder Cancer, Bone

Metastases, Brain Metastases, Breast

Cancer, Cervical Cancer, CNS Tumors,

Colorectal Cancer, Head and Neck

Cancer, Liver Cancer, Lung Cancer,

Lymphoma, Pancreatic Cancer, Prostate

Cancer, Upper GI Cancer, and Uterine

Cancer) that are commonly treated with

RT and that can be accurately priced for

prospective episode payments, is the

best design for testing an episodic APM

for RT services. The list of ICD–10 codes

for the included cancer types under the

RO Model, upon any subsequent

revisions, can be located on the RO

Model website.

After considering public comments,

we are finalizing, without change, our

proposed criteria for included cancer

types and for removing cancer types at

§ 512.230(a) and (b) of our regulations.

Additionally, we are finalizing without

change at § 512.230(c) our proposal to

notify RO participants of any changes to

the diagnosis codes for the included

cancer types by displaying them on the

RO Model website no later than 30 days

prior to each performance year.

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b. Episode Length and Trigger

(1) Episode Length

We proposed to define the length of

an episode under the RO Model as 90

days (84 FR 34498). 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. We proposed that 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. As we explained in the

proposed rule, 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 would have

occurred and any payment will be made

to the RO participant in accordance

with our incomplete episode policy.

(See 84 FR 34498 through 34499.) We

refer readers to sections III.C.5.b and

III.C.6 of the proposed rule and this

final rule for an overview of our episode

trigger and incomplete episode policies,

respectively.

As discussed in the proposed rule (84

FR 3499), 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. As we stated in the proposed

rule, we made a summary-level, de-

identified file titled ‘‘RT Expenditures

by Time’’ available on the RO Model’s

website (https://innovation.cms.gov/

initiatives/radiation-oncology-model/)

that supports our findings in this

preliminary analysis.

Based on our proposed rule 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 proposed a 90-day

episode duration.

(2) Episode Trigger

Because we only want to include

episodes in which beneficiaries actually

receive RT services, we proposed 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 the proposed rule at Table 2)

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

explained in the proposed rule, an

episode that is triggered will 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 instances 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), we proposed

that 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 the

episode start date.

(3) Policy for Multiple Episodes and the

Clean Period

Given our proposed rule findings that

99 percent of Medicare FFS

beneficiaries complete treatment within

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31

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.

90 days of the initial treatment planning

service, and to minimize any potential

incentive for an RO participant to

extend a treatment course beyond the

90-day episode in order to trigger a new

episode, we proposed that another

episode may not be triggered until at

least 28 days after the previous episode

has ended (84 FR 34499). This is

because, while a missed week of

treatment is not uncommon, a break

from RT services for more than four

weeks (or 28 days) generally signals the

start of a new course of treatment.

31

As

we explained in the proposed rule, we

refer to the 28-day period after an

episode has ended as the ‘‘clean

period,’’ and during this time an RO

participant would bill for RT services

furnished to an RO beneficiary as FFS.

We proposed to codify the term ‘‘clean

period’’ at § 512.205 of our regulations.

We proposed that if clinically

appropriate, an RO participant may

initiate another episode for the same

beneficiary after the 28-day clean period

has ended. During the clean period, an

RO participant would be required to bill

for RT services for the beneficiary in

accordance with FFS billing rules. We

proposed that 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 solicited public comment on our

proposal regarding episode length and

trigger. The following is a summary of

the public comments received on this

proposal and our responses to those

comments:

Comment: Some commenters noted

their concern that the 90-day episode

period would inappropriately

incentivize providers and suppliers to

reduce the number of fractions into the

shortest possible course of treatment. A

commenter believed this would have

negative effects on research, as

encouraging providers and suppliers to

opt for the shortest length of treatment

possible would make it more difficult to

study the optimal length of treatment for

different types of patients. Another

commenter suggested that this structure

would disincentivize adoption of

ground-breaking treatment paradigms. A

few commenters requested that CMS

consider the negative impact of the 90-

day episode on services with higher

upfront investment but longer term

value. A couple of these commenters

suggested that the 90-day episode

period is unduly focused on short-term

gains, failing to capture the medium-

and long-term benefits and savings from

treatment modalities like PBT. A few

commenters also suggested that the

financial disincentives created by the

RO Model would lead to long-term

adverse clinical consequences and

additional spending. A commenter

believed that short term savings would

be outweighed by longer term costs.

Response: We appreciate commenters’

concerns. We rely on Medicare

providers and suppliers to furnish

appropriate care to our beneficiaries. We

expect Medicare providers and

suppliers to select the clinically

appropriate treatment modality that will

confer the greatest short-, medium-, or

long-term benefit on the beneficiary.

And, we believe our payment

methodology, with its blend of national

rates with participant-specific case mix

and historical experience, will provide

appropriate payment to incentivize

high-value care, including the

appropriate treatment modality and

number of fractions. Thus, we do not

believe that the Model will lead to long-

term adverse clinical consequences or

additional spending. We will be

monitoring to ensure there are no

unintended consequences.

Comment: A commenter requested

clarification on whether an episode of

care includes any course of treatment

within 90 days or if an episode is

limited to a specific diagnosis. Another

commenter requested clarification

regarding billing practices for patients

who, within a 90-day episode, are found

to have new cancer sites with different

HCPCS codes.

Response: We thank the commenter

for their question. An RO episode

includes all included RT services (See

Table 2) furnished to an RO beneficiary

with an included cancer type during the

90-day episode as codified at §§ 512.205

and 512.245. RT services furnished to

an RO beneficiary for any additional

diagnosis not specified on the list of

included cancer types, the RT provider

and/or RT supplier would bill FFS for

those services.

Comment: Many commenters believed

the 90-day episode period is not

sufficiently responsive to patients

whose cancer might recur, metastasize,

require multiple treatment modalities,

or otherwise require additional

treatments within the 90-day period. A

couple of commenters believed that the

90-day episode structure would

incentivize participants to delay care or

shift patients to other treatment, waiting

to capture payment for those services in

the clean period or a subsequent

episode. A commenter believed this

might limit patient access to life-

extending treatment protocols.

Response: We believe that the RO

Model pricing methodology, with its

reliance on historical experience and

case mix adjustments, accounts for the

range of patient scenarios and provides

appropriate compensation to

participants. We rely on Medicare

providers and suppliers to furnish

appropriate care to our beneficiaries. As

finalized in section III.C.14, we will

monitor for unintended consequences of

the RO Model including but not limited

to stinting on care.

Comment: Some commenters

recommended that CMS reconsider its

methodology in bundling multiple

treatments into a single episode,

factoring in the complexity of multiple

eligible sites requiring treatment within

a 90-day period. Some commenters

specifically suggested that participants

should be eligible for multiple bundles

if they treat distinct disease sites or

diagnoses within a 90-day episode of

care to accurately capture the costs of

multiple treatments. A commenter

suggested that FFS payment should be

permitted for treatment of metastases

within the 90-day episode as long as it

is for a new site. A commenter

recommended eliminating the 90-day

episode to reimburse providers and

suppliers for separate courses of

radiation therapy within this period.

Another commenter requested more

information about what happens to a

course of treatment for a specific

diagnosis that lasts longer than 90 days.

Response: We believe that the RO

Model pricing methodology, through the

historical experience and case mix

adjustments, will account for

differences in RO participants’ historical

care patterns and the demographic

characteristics of their patient

populations and addresses the cost of

treating multiple diagnoses or the cost

of multiple treatments. It is important to

note that, if treatment goes beyond the

end of 90 days, after the RO participant

bills the modifier indicating the end of

an RO episode (EOE) the additional RT

services furnished will be billed and

paid FFS—this does not create an

incomplete episode.

Comment: A couple commenters

recommended that CMS tailor episode

length to the likely pattern and timing

of RT treatment for each cancer type.

Response: We believe that the RO

Model pricing methodology will

adequately reimburse participants for

the patterns and timing of RT services

during a uniform 90-day episode period.

As previously stated, 99 percent of

beneficiaries complete their RT course

within 90 days. Although some cancer

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types might typically complete

treatment in a period of time shorter

than 90 days, our data shows that while

significant expenditures occur through

week 10 of an episode, additional

expenditures occur throughout the

remainder of the episode for all of the

included cancer types. (See RT

Expenditures by Time on the RO Model

website.) As explained in section III.C.7,

we have modified the billing

requirements to allow the EOE claim to

be submitted and paid at the completion

of a planned course of treatment, even

when that course of treatment is shorter

than 90 days. We believe that

participants will be reimbursed for their

services in an appropriate and timely

manner under this structure.

Comment: A few commenters voiced

concern about potential delays or breaks

in therapy caused by adverse patient

response or concurrent patient illness. A

commenter believed that providers and

suppliers could lose reimbursement for

delivered services if a patient cannot

tolerate treatment. A couple such

commenters expressed that the breaks in

treatment could extend the therapy

beyond the 90-day end point,

preventing timely EOE submission and

resulting in an incomplete episode. This

commenter recommended adjusting the

EOE to the completion of the episode.

Response: Such breaks in therapy will

not cause an incomplete episode. It is

important to note that if treatment goes

beyond the end of 90 days, the RO

participant can bill the EOE and the

additional RT services furnished will be

billed and paid FFS.

Comment: A commenter noted that

each clinical scenario is different and

that physicians may have good reasons

for ordering more treatment sessions

with lower intensity. This commenter

believed that CMS should evaluate the

specifics of a clinical scenario that falls

outside the expected parameters as part

of the agency’s data analysis.

Response: We appreciate this

commenter’s concerns. We rely on

Medicare providers and suppliers to

furnish appropriate care to our

beneficiaries. And, we believe that our

cancer-specific bundles strike the right

balance of capturing a range of clinical

scenarios with little variability in

pricing to prohibit setting a base rate. As

described in section III.C.16, we will

monitor for unintended consequences of

the RO Model.

Comment: A commenter emphasized

that the episode length could reduce the

availability of palliative radiotherapy for

pain control, as some evidence suggests

that shorter courses of treatment lead to

increased need for additional treatment

and shortened pain control. Another

commenter, believing that the episodes

do not match standard medically

accepted episodes of care,

recommended that CMS create a

separate category for palliative cases.

Response: 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. The Model does include Brain

Metastasis and Bone Metastasis as

included cancer types. For the other

cancer types, our data shows that

palliative treatment is included when

RT services are being furnished to treat

the primary cancer type and secondary

malignancies and metastases. Thus, we

will not be creating a separate category

for palliative cases or altering the length

of the episode.

Comment: A couple commenters

expressed support of the 28-day

window between the treatment planning

code and the first treatment delivery

service, finding this structure

reasonable.

Response: We thank the commenters

for their support.

Comment: A commenter requested

clarification on how the planning and

simulation of treatment are designated

within an episode. In the event a patient

receives multiple planning services

prior to the commencement of

treatment, this commenter wished to

know which planning service would be

considered the trigger and how multiple

planning sessions are represented in the

national base rates. A commenter

expressed concern about claims

processing for multiple planning

services furnished within a 90-day

episode for metastases identified during

the episode. This commenter

emphasized that the resources expended

for subsequent planning sessions are

equivalent to those expended in the

initial planning session.

Response: The treatment planning

service identified as the ‘‘first’’

treatment planning service is the trigger

for an episode and its corresponding

date of service marks the episode’s start

date. Subsequent planning sessions

occurring within a previously defined

episode are indeed included in the

national base rates. Each treatment

planning service furnished should be

included on the no-pay claims

described in section III.C.7 and codified

at § 512.260(d). We will monitor

utilization of services via these no-pay

claims.

Comment: A few commenters

expressed concern about the 28-day

episode trigger window between the

treatment planning code and the first

treatment delivery service in particular

scenarios. For example, a commenter

stated that some cases of multi-radiation

modalities, like EBRT followed by

brachytherapy, require coordination

with other specialties that might make

it difficult to begin delivering treatment

within a 28-day episode trigger window.

Another commenter recommended that

CMS remove the 28-day episode trigger

window and instead trigger the first

episode payment at the completion of

treatment planning and commencement

of treatment delivery without any

required timeline.

Response: Our data show that

treatment almost always occurs within

this time period. And, if it does not, this

would constitute an incomplete

episode. We are finalizing that an

episode will be triggered only if both of

the following conditions are met: (1)

There is an initial treatment planning

service (HCPCS codes 77261–77263)

furnished by a Professional participant

or a Dual participant; and (2) at least

one radiation treatment delivery service

(See Table 2) is furnished by a

Technical participant or a Dual

participant within the following 28

days.

Comment: A commenter expressed

concern about incomplete episodes

resulting from planning services

provided by an RO participant and

treatment provided in an ASC outside of

the Model, whether or not treatment is

furnished within the 28-day episode

trigger window.

A couple of commenters requested

clarification on how PC and TC claims

will be paid if treatment is not delivered

within the 28-day episode trigger

window. One such commenter advised

that cash flow problems would result if

providers and suppliers are required to

wait until the reconciliation periods and

true-up periods to receive payment for

these incomplete episodes. For this

reason, this commenter recommended

that CMS pay all CPT/HCPCS codes that

are billed outside this 28-day episode

trigger window as FFS.

Response: We thank the commenters

for their inquiry. RT services furnished

in an ASC are not included in the RO

Model. Thus, if the planning service

was provided by a Professional

participant (in an HOPD or a

freestanding radiation therapy center)

and the treatment delivery was

furnished in an ASC, an episode could

be triggered but rendered incomplete,

thus the planning services should be

billed FFS. If the TC is not rendered by

a participant within 28 days, an episode

will be considered incomplete and those

services should be billed FFS. As noted

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32

American Society for Radiation Oncology

(ASTRO). Basics of RO Coding. https://

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

in section III.C.7 of the proposed rule

(84 FR 34512 through 34513) and this

final rule, we expect to provide RO

participants with additional instructions

for billing, particularly as billing

pertains to incomplete episodes,

through the Medicare Learning Network

(MLN Matters) publications, model-

specific webinars, and the RO Model

website.

Comment: A couple of commenters

supported FFS payments for treatments

that exceed the 90-day episode period.

Response: We thank the commenters

for their support. We will be finalizing

as proposed in § 512.260 that an RO

participant shall bill for any medically

necessary RT services furnished to an

RO beneficiary during a clean period

pursuant to existing FFS billing

processes in the OPPS and PFS.

Comment: A commenter supported

the 28-day clean period between

episodes for all but one included cancer

type, metastatic bone disease. Because

metastatic bone disease often requires

ongoing treatment, this commenter

suggested that RO participants have the

ability to initiate subsequent episodes

immediately after the prior episode

ends, eliminating the clean period.

Response: We appreciate the

suggestion, but we do not want to

provide a financial incentive for RO

participants to prolong or delay

treatment for bone metastasis or any

other clinical condition to initiate an

additional episode.

Comment: A commenter

recommended that the clean period be

extended to 60 days to allow for

treatment of secondary cancers.

Response: We appreciate the

comment, but CMS was advised by

radiation oncologists consulting on the

design of the Model that four weeks

typically signals the start of a new

course of treatment. Therefore, we will

not be extending the clean period in this

final rule.

Comment: A commenter requested

clarification on billing practices for

patients who complete one 90-day

episode and then return with a new

diagnosis under their existing diagnosis

code within the clean period.

Response: As stated in sections

III.C.5.b(3) and III.C.7 of this final rule,

any services provided during the 28-day

clean period would be paid FFS.

After considering public comments

received, we are finalizing at § 512.205

the definition of RO episode.

Specifically, we are defining that an RO

episode means the 90-day period that

begins on the date of service that a

Professional participant or a Dual

participant furnishes an initial RT

treatment planning service to an RO

beneficiary, provided that a Technical

participant or the same Dual participant

furnishes a technical component RT

service to the RO beneficiary within 28

days of such RT treatment planning

service, with a modification to clarify

that the initial RT treatment planning

service to the RO beneficiary be

furnished in a freestanding radiation

therapy center or an HOPD. We are

finalizing as proposed that the

circumstance in which an episode does

not occur because a Technical

participant or a Dual participant does

not furnish a technical component to an

RO beneficiary within 28 days following

a Professional participant or the Dual

participant furnishing an initial

treatment planning service to that RO

beneficiary qualifies as an incomplete

episode. In addition, we are finalizing as

proposed at § 512.245(c) that an episode

must not be initiated for the same RO

beneficiary during a clean period.

c. Included RT Services

We proposed at 84 FR 34499 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. As outlined in the

proposed rule, the subcomponents of RT

services have been described in the

following manner:

32

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.

As discussed in the proposed rule (84

FR 34500), 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 proposed

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

proposed 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 for

the proposed rule, 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

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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.

In the proposed rule we noted that we

were 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.

Given that physicians sometimes

contract with others to supply and

administer brachytherapy radioactive

sources (or radioisotopes), we explained

in the proposed rule that we considered

omitting these services from the episode

payment. After considering either

including or excluding brachytherapy

radioelements from the RO Model, we

proposed 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 noted

were proposed to be excluded from the

Model.

We also proposed to exclude low

volume RT services from the RO Model.

These include certain brachytherapy

surgical procedures, neutron beam

therapy, hyperthermia treatment, and

radiopharmaceuticals. We proposed to

exclude these services from the Model

because they are not offered in sufficient

amounts for purposes of evaluation.

We proposed that the RO Model

payments would replace current FFS

payments only for the included RT

services furnished during an episode.

For the included modalities, discussed

in section III.C.5.d of the proposed rule

(84 FR 34502 through 34503), we

proposed that the RO Model episode

include HCPCS codes related to

radiation oncology treatment. Please see

section III.C.7 for a discussion of our

billing guidelines. We have compiled a

list of HCPCS codes that represent

treatment planning, technical

preparation and special services,

treatment delivery, and treatment

management for the included

modalities. As discussed in the

proposed rule, RT services included on

this list are referred to as ‘‘RO Model

Bundled HCPCS’’ when they are

provided during an RO Model episode

since payment for these services is

bundled into the RO episode payment.

Thus, we proposed to codify at

§ 512.270 that these RT services would

not be paid separately during an

episode. In the proposed rule, we

indicated that we may add, remove, or

revise any of the bundled HCPCS codes

included in the RO Model. We proposed

to notify participants of any changes to

the HCPCS codes per the CMS annual

Level 2 HCPCS code file. We proposed

to maintain a list of the HCPCS codes

included in the RO Model on the RO

Model website.

We solicited public comment on our

proposal. The following is a summary of

the public comments received on this

proposal and our responses:

Comment: A commenter

recommended that CMS exclude

consultation services from the Model, as

these services are often provided to

patients seeking second opinions. If

CMS includes consultation services, this

commenter suggested classifying these

services as incomplete episodes when

the patient does not pursue treatment

post-consultation.

Response: Consultations, which are

billed as E/M services, were not

included in the RO Model’s proposed

pricing methodology and are not RT

services, and they are not included in

the final rule.

Comment: A couple of commenters

expressed support for the exclusion of

E/M services from the Model.

Response: We thank these

commenters for their support.

Comment: A few commenters

expressed concern over the bundling of

IMRT planning code 77301 in that it no

longer allows payment for advanced

imaging used in data sets for dose

planning and simulations when charged

with IMRT treatments. The commenter

believed this was inappropriate as it

places a burden on providers and

suppliers that cannot afford to upgrade

their CT, MR or PET equipment used in

planning. The commenters expressed

concern that these costs are not reflected

appropriately in the national base rates.

Response: The episode payment

amounts reflect payments made under

the PFS and OPPS for RT services

furnished during the baseline period. As

such, when determining payment rates,

we look at RT services in the baseline

period that were allowed by Medicare

(such as claims with HCPCS 77301 with

payment amounts allowed), but we do

not assign payment rates to other claims

with other HCPCS codes from the

baseline period that were denied (for

example, in this example because they

were in the range of HCPCS codes not

allowed to be reported in addition to

77301 because they are part of the

valuation of 77301). The RO Model is

not intended to change Medicare policy

on coverage.

Comment: A few commenters

recommended excluding proton beam

therapy (PBT) as a low-volume service.

A couple commenters suggested

specifically excluding neutron beam

therapy, hyperthermia, and

brachytherapy radioactive elements as

low-volume services.

Some commenters requested

clarification on how ‘‘low-volume’’ and

‘‘commonly used’’ will be defined in the

Model. A couple of commenters

suggested that the test for low-volume

services should be conducted on a total

and per cancer type basis.

Response: We used ‘‘low-volume’’

and ‘‘commonly used’’ in several

different places in the proposed rule.

We proposed to exclude certain RT

services as low volume, including

certain brachytherapy surgical

procedures, neutron beam therapy,

hyperthermia treatment, and

radiopharmaceuticals. All of these RT

services are rarely furnished to

Medicare beneficiaries. In contrast, we

proposed to include the ‘‘most

commonly used’’ RT modalities,

including PBT, in the RO Model as they

represent standard approaches to

treatments that are cited in guidelines

for the included cancer types. While we

did not propose a definition for a

commonly used RT modality or RT

service, we used those terms to describe

what is standard practice for radiation

oncology and the included cancer types.

Though we appreciate the suggestion to

look at low-volume RT services on a per

cancer type basis, as described in the

proposed rule, we plan to test the

impact of the RO Model on RT as a

whole, rather than specific RT services

for specific cancer types. Further, we

believe that including certain RT

services for some cancer types but not

others would be burdensome for RO

participants, specifically regarding the

tracking and management of which

beneficiaries are in or out of the Model.

We note that we are finalizing a low

volume opt-out option for RO

participants with fewer than 20

episodes in one or more of the CBSAs

randomly selected for participation in

the most recent calendar year with

available claims data, as described in

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section III.C.3.c. Any PBT providers and

suppliers who believe they qualify for

such an exemption should refer to this

section.

Comment: A couple of commenters

requested clarification on the Model’s

treatment of radiopharmaceuticals.

These commenters emphasized that, in

the case of Radium, treatment often

occurs monthly for six months, far

longer than the 90-day episode. Many

commenters requested the removal of

C2616 for Yttrium 90 or Y90 as it is a

radiopharmaceutical.

Response: We thank these

commenters for this point. As indicated

in the NPRM, radiopharmaceuticals are

excluded from the RO Model, thus

C2616 has been removed from the list of

RO Model Bundled HCPCS.

Comment: Many commenters

recommended that CMS exclude the

radioactive sources from the Model.

These commenters emphasized that

individual patients often require unique

brachytherapy sources, expressing

concern that the Model would not

appropriately compensate for

differences in isotopes and radioactive

intensity. A few believed that the Model

would undermine access to the optimal

isotope. A commenter believed that

brachytherapy sources were more

appropriately considered medical

devices rather than RT procedures.

Some of these commenters

recommended that CMS exclude

specific brachytherapy sources,

primarily the HCPCS A-codes, C-codes,

and Q-codes from the Model. Many

commenters emphasized that

brachytherapy sources alone are

frequently more expensive than the

proposed bundled payments—

particularly for high dose rate

brachytherapy—in the proposed Model

and that hospitals have little control

over these costs. A couple commenters

recommended excluding high dose rate

brachytherapy from the Model.

Response: We thank the commenters

for their suggestion. We package many

expensive and more expensive services

in value-based bundled payment; there

is no reason to treat brachytherapy

sources any differently than other

necessary items and services such as

linear accelerators. We believe that once

the national base rates are adjusted for

the RO participant’s case mix and

historical experience, they will see that

final payments will be reflective of the

inclusion of radioelements. As

discussed in section III.C.14 and III.C.16

of this final rule, we will monitor for

unintended consequences of the RO

Model.

Comment: Several commenters stated

that including medical physics services

in the RO Model will lead to a loss of

direct financial accountability for

providing adequate technical

supervision that is provided to each

patient and could significantly reduce

medical physics resources around the

country. A commenter stated that

medical physicists would move to an

area not participating in the Model in

order to maintain their salary.

Response: It is our understanding that

medical physics is a state licensure

requirement and is an integral to the

delivery of RT services. We do not

anticipate that the Model will have a

detrimental impact on medical physics

resources, as participants would

continue to need these health care

providers for many functions, including

output calibrations and, where

clinically appropriate, hypo

fractionation. As discussed in section

III.C.14 and III.C.16 of this final rule, we

will monitor for unintended

consequences of the RO Model.

Comment: A commenter has

requested that any changes made to the

HCPCS code bundles be made through

notice and comment rulemaking rather

than through a list on the RO Model

website.

Response: We believe that our

proposal allows us to update the list in

an expeditious manner if we detect an

error to facilitate prompt and accurate

payments. Thus, we are finalizing our

policies as proposed, without

modification, to add, remove, or revise

any of the bundled HCPCS codes

included in the RO Model; notify

participants of any changes to the

HCPCS codes per the CMS annual Level

2 HCPCS code file or quarterly update;

and maintain a list of the HCPCS codes

included in the RO Model on the RO

Model website. If CMS intends to add

any new HCPCS codes to the RO Model,

we would go through rulemaking to add

those new codes to the list of RO Model

Bundled HCPCS.

Comment: Several commenters

expressed concern that the proposed

payment methodology was insufficient

for codes 77387 and G6017, as these

commenters believed that there is not

currently sufficient payment under the

PFS for these codes for surface guided

radiation therapy (SGRT). These

commenters believed that by including

these two codes as RT services in the

RO Model, payment under the Model

would not accurately reflect the cost of

all care in an episode. Specifically, a

commenter noted that CMS has not

assigned a relative value unit (RVU) for

HCPCS 77387 or G6017 in the PFS. The

commenter believed that inclusion of

these two codes as RT services in the

RO Model would extend the payment

challenges associated with SGRT

services into the Model. Another

commenter stated that CMS has not

established PFS payment for the G6017

code, which has been in existence since

2015, and recommended CMS pay for

SGRT separately from the Model.

Response: Although CPT

®

code 77387

was active in the PFS or OPPS in some

year prior to the updated baseline

period with spillover (2015–2019), it is

not paid separately. As proposed, the

Model was only to include codes paid

separately. This code was mistakenly

included on the list of include RT

services but not in the pricing

methodology. We would also like to

clarify that the code G6017 is

contractor-priced under the PFS. This

means that CMS has not established

nationally applicable RVUs for the

service. Instead, individual Medicare

Administrative Contractors (MACs)

determine the payment rate for the

service and apply that rate in their

jurisdiction(s). Payment rates across

MAC jurisdictions can vary. Due to the

potential differences across

jurisdictions, we calculated the average

paid amounts for each year in the

baseline period for contractor-priced RT

services to determine their average paid

amount to be included in the

calculation of the national base rates.

We will use the most recent calendar

year with claims data available to

determine the average paid amounts for

these contractor-priced RT services that

will be included in the calculation of

the trend factors for the PC and TC of

each cancer type. For instance, for the

2021 trend factor, we will calculate the

average paid amounts for these

contractor-priced RT services using

their allowed charges listed on the 2019

claims.

Comment: A commenter stated that

inserting a hydrogel spacer between the

prostate and rectum has become a

standard of care at many practices to

reduce the toxicity of radiotherapy, by

decreasing rectal dose exposure. Many

practices have also implanted fiducial

markers into the prostate to improve the

accuracy of targeting. These items,

particularly the hydrogel spacer, have a

significant cost and added physician

work component. The commenter

suggested that payment include a

provision to account for this added

labor and cost.

Response: We believe the commenter

is referring to HCPCS 55784. This is not

an included RT service. Thus, the RO

participant may continue to receive FFS

payment upon furnishing this service.

Comment: Many commenters

expressed concern about the lack of

consideration for emerging or new

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technologies in the Model, and that the

pricing methodology of the RO Model

generally does not provide an incentive

for participants to invest in new

technologies and equipment. A

commenter explained that the incentive

is removed, because 2D, 3D, IMRT, and

HDR treatment courses will be billed at

the same rate, and the latest IGRT

technologies will not be pursued.

Another commenter noted that the RO

Model does not include any approach to

recognize new technology such as the

MRI–LINAC.

Commenters defined emerging and

new technologies differently. A

commenter suggested defining new

technology as any service that has been

granted a new technology APC or pass-

through payment. Another commenter

suggested that devices be granted an

innovative designation if a new

technology and as a result qualify for

additional reimbursement. This

commenter suggested that the

innovative designation would need

approval by the FDA under a Premarket

Approval Process and not be

‘‘substantially equivalent’’ to an existing

device. Another commenter suggested

that new technology could be signaled

through a CPT

®

code transitions from a

Category III code to a Category I code.

This commenter also suggested that new

technology could include the use of

existing CPT

®

/HCPCS codes used in

different combination or in more

fractions than what has historically been

used. A few commenters called

attention to the need to reimburse

HCPCS codes bundled in the RO Model

that come to be used differently than

historical patterns indicate, whether in

frequency or in combination with other

modalities, and this in itself was a new

form of technology.

One commenter recommended adding

a payment adjustment for new

technology in the same way OCM has a

novel therapies adjustment. Another

commenter suggested that CMS consider

modalities with the 510(k) clearances as

innovations that should be paid

separately outside of the RO Model.

A few commenters requested

clarification as to whether new

technologies would be paid FFS. A

couple of commenters requested

clarification concerning CPT

®

and

HCPCS codes established after the

publication of the Final Rule

specifically, and if those code would be

paid FFS.

Response: To the extent that new

technologies and new equipment are

billed under new HCPCS codes, we

would go through rulemaking to add

those new codes to the list of RO Model

Bundled HCPCS list. We believe that

any increased utilization of established

codes that are included RT services over

time will be accounted for with the

trend factor described in section

III.C.6.d. Until new technologies with

corresponding HCPCS codes are added

the list of included services for the RO

Model, they will be paid FFS.

Comment: Many commenters

recommended excluding HCPCS codes

that refer to either brachytherapy

services commonly provided in a

surgical setting or that refer to

brachytherapy sources. These

commenters emphasized that surgical

codes for other modalities were

excluded from the Model and

questioned why surgical codes 57155,

57156, 55920, and 53846 were included

for brachytherapy. These commenters

emphasized that the surgical procedures

often involve sub-specialized

physicians, equipment, and other costs.

By including the surgical component in

the Model, these commenters worried

that it would undermine patient access

to care. As relatively low-volume

services, these commenters believe

excluding them from the Model would

not have a large impact on savings. A

few commenters requested clarification

on the inclusion of brachytherapy

insertion codes.

Response: We have confirmed with

clinical experts that these services are

commonly furnished by radiation

oncologists and thus will be included in

the RO Model. We have not included

brachytherapy surgical codes that are

only provided by other types of

physicians.

Comment: A few commenters agreed

with the inclusion of RT services as

proposed.

Response: We thank these

commenters for their support. See Table

2 for the finalized list of included RT

services.

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33

Falit, B.P., Chernew, M.E., & Mantz, C.A.

(2014). Design and implementation of bundled

payment systems for cancer care and RT.

International Journal of Radiation

Oncology•Biology•Physics, 89(5), 950–953.

34

Ibid.

35

Shen, X., Showalter, T.N., Mishra, M.V., Barth,

S., Rao, V., Levin, D., & Parker, L. (2014). Radiation

oncology services in the modern era: Evolving

patterns of usage and payments in the office setting

for Medicare patients from 2000 to 2010. Journal of

Oncology Practice, 10(4), e201–e207.

36

Spending in PBT rose from $47 million to $115

million, and the number of treatment sessions for

PBT rose from 47,420 to 108,960, during that

period.

After considering public comments,

we are modifying our proposed list of

included RT services to the

corresponding HCPCS codes in Table 2

of this final rule. We are not adding any

HCPCS codes to those identified in the

proposed rule, but are removing HCPCS

codes 77387, 77424, 77425, C1715,

C1728, C2616, and 77469 from the

Model. We are codifying at § 512.235

that only the following RT services

furnished using an included modality

identified at § 512.240 for an included

cancer type are included RT services

that are paid for by CMS under

§ 512.265: (1) Treatment planning; (2)

technical preparation and special

services; (3) treatment delivery; and, (4)

treatment management; and at § 512.270

that these RT services would not be paid

separately during an episode. All other

RT services furnished by an RO

participant during the Model

performance period will be subject to

Medicare FFS payment rules.

d. Included Modalities

We proposed at 84 FR 34502 through

34503 to include the following RT

modalities in the Model: Various types

of external beam RT, including 3-

dimensional conformal radiotherapy

(3DCRT), intensity-modulated

radiotherapy (IMRT), stereotactic

radiosurgery (SRS), stereotactic body

radiotherapy (SBRT), and proton beam

therapy (PBT); intraoperative

radiotherapy (IORT); image-guided

radiation therapy (IGRT); and

brachytherapy. We proposed to include

all of these modalities because they are

the most commonly used to treat the 17

proposed cancer types and including

these modalities would allow us to

determine whether the RO Model is able

to impact RT holistically rather than

testing a limited subset of services.

As discussed in the proposed rule,

because the OPPS and PFS are resource-

based payment systems, higher payment

rates are typically assigned to services

that use more expensive equipment.

Additionally, newer treatments have

traditionally been assigned higher

payment. Researchers have indicated

that resource-based payments may

encourage health care providers to

purchase higher priced equipment and

furnish higher-cost services, if they have

a sufficient volume of patients to cover

their fixed costs.

33

Higher payment rates

for services involving certain treatment

modalities may encourage use of those

modalities over others.

34

In the proposed rule, we explained

that Medicare expenditures for RT have

increased substantially. From 2000 to

2010, for example, the volume of

physician billing for radiation treatment

increased 8.2 percent, while Medicare

Part B spending on RT increased 216

percent.

35

Most of the increase in the

2000 to 2010 time period was due to the

adoption and uptake of IMRT. From

2010 to 2016, spending and volume for

PBT in FFS Medicare grew rapidly,

36

driven by a sharp increase in the

number of proton beam centers and

Medicare’s relatively broad coverage of

this treatment. While we cannot assess

through claims data what caused this

increase in PBT, we can monitor

changes in the utilization of treatment

modalities during the course of the

Model. The previously stated increase

in PBT volume may depend on a variety

of factors.

As stated in the proposed rule, the RO

Model’s episode payment was designed,

in part, to give RT providers and RT

suppliers greater predictability in

payment and greater opportunity to

clinically manage the episode, rather

than being driven by FFS payment

incentives. The design of the payment

model grouped together different

modalities for specific cancer types,

often with variable costs, into a single

payment that reflects average treatment

costs. As explained in the proposed

rule, the Model would include a

historical experience adjustment, which

would account for an RO participant’s

historical care patterns, including an RO

participant’s historical use of more

expensive modalities, and certain

factors that are beyond a health care

provider’s control. We stated in the

proposed rule that we believe that

applying the same payment for the most

commonly used RT modalities would

allow physicians to pick the highest-

value modalities.

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37

Ollendorf, D.A., J.A. Colby, and S.D. Pearson.

2014. Proton beam therapy. Report prepared by the

Institute for Clinical and Economic Review for the

Health Technology Assessment Program,

Washington State Health Care Authority. Olympia,

WA: Washington State Health Care Authority.

https://icer-review.org/wp-content/uploads/2014/

07/pbt_final_report_040114.pdf.

38

http://medpac.gov/docs/default-source/reports/

jun18_ch10_medpacreport_sec.pdf.

We stated in the proposed rule that

given the goals of the RO Model as well

as the payment design, we believe that

it is important to treat all modalities

equally.

With respect to PBT, we noted in the

proposed rule that there has been debate

regarding the benefits of proton beam

relative to other, less expensive

modalities. The Institute for Clinical

and Economic Review (ICER) evaluated

the evidence of the overall net health

benefit (which takes into account

clinical effectiveness and potential

harms) of proton beam therapy in

comparison with its major treatment

alternatives for various types of

cancer.

37

ICER concluded that PBT has

superior net health benefit for ocular

tumors and incremental net health

benefit for adult brain and spinal tumors

and pediatric cancers. ICER judged that

proton beam therapy is comparable with

alternative treatments for prostate, lung,

and liver cancer, although the strength

of evidence was low for these

conditions. In a June 2018 report to

Congress, MedPAC discussed Medicare

coverage policy and use of low-value

care and examined services, including

PBT, which lack evidence of

comparative clinical effectiveness and

are therefore potentially low value.

38

They concluded that there are many

policy tools, including new payment

models, that CMS could consider

adopting to reduce the use of low-value

services. Given the continued debate

around the benefits of PBT, and

understanding that the PBT is more

costly, we discussed in the proposed

rule that we believe that it would be

appropriate to include in the RO

Model’s test, which is designed to

evaluate, in part, site neutral payments

for RT services. We solicited public

comment on our proposal to include

PBT in the RO Model.

As discussed in the proposed rule, we

considered excluding PBT from the

included modalities in instances where

an RO beneficiary is participating in a

federally-funded, multi-institution,

randomized control clinical trial for

PBT so that further clinical evidence

assessing its health benefit comparable

to other modalities can be gathered. We

also solicited public comment on

whether or not the RO Model should

include RO beneficiaries participating

in federally-funded, multi-institution,

randomized control clinical trials for

PBT. The following is a summary of the

public comments received on these

proposals and our responses:

Comment: Some commenters

recommended including PBT in the

final rule. A couple of commenters

believed that including PBT in the

episode payment would create an

incentive to use lower-cost, comparable

modalities. A commenter believed

including PBT would allow the Model

to test whether financial incentives are

driving clinical decision-making.

Another commenter believed the

historical experience adjustment would

compensate RO participants who use

more expensive modalities. A couple of

commenters believed that the evidence

supporting PBT in certain common

types of cancer, such as prostate and

lung, is questionable.

Response: We thank the commenters

for their support and note that we are

finalizing as proposed the inclusion of

PBT in the RO Model with the

exception of when PBT is furnished to

an RO beneficiary participating in a

federally-funded, multi-institution,

randomized control clinical trial for

PBT so that further clinical evidence

assessing its health benefit comparable

to other modalities can be gathered. See

§ 512.240 for the finalized list of

included modalities.

Comment: Many commenters believed

that PBT is of high value and an

effective, evidence-based treatment for

many clinical indications. Some

commenters suggested that CMS should

not use questions about PBT’s clinical

value or high, upfront investment as the

basis for inclusion in the RO Model.

Some of these commenters believed that

PBT was distinct from other forms of RT

and should not be treated as equivalent

to other modalities by the Model. A

couple of commenters also

recommended exemptions for high-cost

services like PBT when its use is

supported by evidence.

Some of these commenters believed

that the 2014 reports from the Institute

for Clinical and Economic Review

(ICER) and Medicare Patient Advisory

Commission (MedPAC), which

suggested PBT was of lower value than

other modalities, were outdated. A few

commenters specified that PBT is

indicated for numerous forms of cancer,

and can be particularly useful for

patients who undergo re-irradiation.

Many these commenters stressed that

patients often have better experiences

with PBT than other forms of radiation,

with improved survival, fewer side

effects, fewer hospitalizations, and

better quality of life.

Some commenters emphasized that,

while PBT is more expensive up-front,

it has significant long-term benefits and

savings that may not be captured within

the 90-day episode. A couple of

commenters emphasized that PBT

improves outcomes and reduces the

total cost of care over 12 months. These

commenters pointed to savings from

lower health care consumption to treat

side effects and lower rates of secondary

malignancies due to more precise

radiation delivery. A couple of

commenters emphasized that PBT’s

precision makes it the safest way to

hypofractionate treatment to sensitive

parts of the body. A commenter

emphasized that PBT is frequently used

to hypofractionate regimens when

proven to be effective, using prostate

cancer as an example.

Response: We appreciate the

commenters’ concerns. The most recent

ICER report focuses primarily on a

pediatric population, whose outcomes

may not be comparable to the Medicare

population. The 2018 MedPAC report

emphasized that the use of PBT has

expanded in recent years from pediatric

and rare adult cancers to include more

common types of cancer, such as

prostate and lung cancer, despite a lack

of evidence that PBT offers a clinical

advantage over alternative treatments

for these types of cancers. The 2019

Washington State Health Care Authority

PBT re-review examined the

comparative effectiveness of PBT over

other forms of RT. For adult tumors, the

report stated that the evidence was

insufficient to evaluate the comparative

effectiveness of PBT for bladder, bone,

and pancreatic cancers; unclear for

brain, spinal, and breast cancers; and

comparable for head and neck, lung,

and prostate cancers. The report did

find that PBT may pose a benefit for

liver and certain ocular cancers under

specific conditions, but concluded that

the strength of evidence for these

benefits was low. As such, we are

including PBT in the RO Model with the

clinical trial exception, which we

believe provides sufficient opportunity

for more conclusive evidence to be

generated around PBT in the Medicare

population. We believe that continuing

to gather such evidence in the excepted

clinical trials will allow CMS to better

address the commenters’ beliefs about

PBT’s long term benefits. We will

continue to review new evidence

generated about PBT’s effectiveness in

the Medicare population as it becomes

available.

Comment: Many commenters

recommended that CMS exclude PBT

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from the RO Model. Many commenters

emphasized that the reimbursement for

PBT under the Model would be too low.

These commenters emphasized the high

operational cost of PBT, which

commenters generally believed would

not be covered by the current Model’s

proposed approach to setting episode

payments. These commenters indicated

that the Model would

disproportionately reduce

reimbursement for PBT as compared to

other modalities. Some commenters

believed that the RO Model would

result in a nearly 50 percent reduction

in payment for PBT, while

reimbursement across all other

modalities would decrease by 4 percent.

A few commenters believed that low

reimbursement under the Model would

further reduce PBT payments outside of

the Model, as commercial insurers and

Medicaid programs would follow suit.

Some commenters believed that the

national base rate did not include a

meaningful volume of proton therapy

episodes, leading to payment rates that

do not reflect the costs of providing

PBT. A couple of these commenters

emphasized that restricting the national

base rate-setting methodology to only

HOPD episodes excludes about 65

percent of PBT episodes. A commenter

recommended that CMS reconsider the

establishment of the national base rate

based only on HOPD episodes due to its

detrimental impact on proton beam

therapy centers. Another commenter

emphasized that PBT services do not

follow the pattern for other RT services

in HOPD and freestanding facilities:

Freestanding RT centers are paid less

than their HOPD counterparts and PBT

has a higher ratio of freestanding to

HOPD providers than other modalities.

This commenter also highlighted that a

significant number of PBT centers have

opened since 2015, meaning that the

CMS data on which the base rates are

founded does not represent the current

state of PBT.

Many commenters believed the

bundled price would either reduce

investment in PBT therapies or cause

existing PBT facilities to close. A couple

of commenters stated their belief that

many PBT facilities operate on thin

margins and believed the Model would

place them in tenuous financial

positions. A commenter emphasized

that such closures would result in the

loss of jobs. A few of commenters

emphasized the uneven geographic

distribution of existing PBT facilities—

a commenter stated that only 35 percent

of the U.S. population has access to PBT

today, and believed that this percentage

would shrink under the Model. These

commenters suggested that PBT center

closures would force patients to travel

significant distances to access PBT or

forgo treatment.

Many commenters believed that the

bundled price would reduce patient

access to PBT. Some believed patient

access would be reduced if PBT

facilities closed due to financial

hardship caused by the RO Model.

Other commenters suggested that

patient access would be reduced by

providers and suppliers prescribing

alternative modalities when PBT would

be more appropriate. A couple

commenters suggested that providers

and suppliers might refer patients to

PBT facilities in CBSAs selected for

comparison. A commenter expressed

that patients should have access to the

treatment modality that affords them a

chance to achieve the best possible

outcome. Other commenters generally

emphasized the value of PBT in

delivering lower and more precise

radiation doses. These commenters

voiced their concern that, in

incentivizing RO participants to utilize

modalities other than PBT, patients

would be exposed to more radiation and

a greater risk of additional, costly

cancers in the future. A couple of

commenters stated that other countries

will have greater access to PBT than the

U.S. by 2024. These commenters

generally believed that excluding PBT

from the Model and continuing to

reimburse it as FFS would prevent these

reductions in patient access.

Some commenters believed that the

impact of any PBT center closures

would have an impact beyond the

Medicare population. These

commenters generally referenced the

value of PBT to certain pediatric

cancers, as well as head and neck

cancer, brain tumors, and thoracic

lymphoma, and feared that PBT center

closures would jeopardize access for

these patient groups. A couple of

commenters believed the Model will

deepen cancer disparities by targeting

freestanding radiation therapy centers.

One such commenter believed that if the

Model forced freestanding PBT facilities

to close, the impact would

disproportionately impact low-income

and minority groups. A commenter

emphasized that the IPPS and OPPS

provide stratifications of cost to avoid

similar reductions in access to

technology.

Some commenters expressed concern

that including PBT in the Model would

reduce the ability of providers and

suppliers to generate evidence about

PBT and stifle innovation in this field.

A couple such commenters emphasized

that slowing innovation could deprive

Medicare of potentially significant long-

term cost savings. A commenter

recommended excluding PBT to allow

the industry to further demonstrate the

value of PBT. A few commenters

emphasized that the cost of PBT has

fallen over the years and believed that

it would continue to fall if excluded

from this rule.

Response: We rely on Medicare

providers and suppliers to furnish

appropriate care to our beneficiaries. We

believe that the clinical trial exception

will continue to enable providers and

suppliers to generate evidence about

PBT, allowing innovation in this field to

continue. Further, our approach to the

calculation of participant-specific

episode payment amounts places great

weight on an individual entity’s

historical experience. This approach

accounts for an entity’s high cost

relative to the national average and

includes a glide path over time.

Furthermore, as described in section

III.C.6.b, to address the concerns

regarding the Model’s national base rate,

the base rates that were calculated for

purposes of this final rule were shifted

forward to 2016–2018, capturing more

recent data from a greater number of

PBT centers compared with the data

used in the proposed rule. As described

in section III.C.6.c, we believe that the

use of HOPD episodes for calculating

the national base rates provides a

stronger empirical foundation. Blending

together the national base rates, which

are derived from HOPD episodes, with

the RO participant’s own historical

experience (whether HOPD or

freestanding radiation therapy center)

will allow the RO participant’s unique

care patterns to be recognized in the

participant-specific episode payment

amounts.

We do not believe that the RO Model,

which as finalized will be tested in

approximately 30 percent of episodes

nationally and which will include a

gradual shift in payments toward the

national average, will affect access to

PBT. We plan to carefully monitor the

RO Model for unintended consequences

as finalized in section III.C.14 and

III.C.16. If our monitoring reveals that

the Model reduces patient access to

PBT, we would consider making

changes to the Model via future

rulemaking. Further, our evaluation will

consider longer-term impacts on health

outcomes associated with the Model.

Comment: If included in the Model,

many commenters had suggestions for

how to structure PBT payments. A

couple of these commenters

recommended creating a separate

bundled price for PBT that is a

percentage of the current medically

accepted case rate instead of the

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proposed APM bundled prices. A

commenter suggested that CMS consider

a step wise reduction in payments,

which would account for the fact that

adoption of this technology is still in the

nascent stages. A couple other

commenters recommended creating a

separate Model for PBT. A few

commenters recommended creating a

separate base rate for PBT. Another

commenter suggested that PBT should

be reconsidered for inclusion at the end

of the five-year pilot phase. Another

commenter recommended exempting

PBT facilities that have yet to be

constructed. MedPAC expressed

support for the inclusion of PBT in the

RO Model because Medicare’s payment

rates for PBT are substantially higher

than for other types of external beam

radiation therapy. In addition, MedPAC

noted that the use of PBT has expanded

in recent years from pediatric and rare

adult cancers to include more common

types of cancer, such as prostate and

lung cancer, despite a lack of evidence

that it offers a clinical advantage over

alternative treatments for these types of

cancer. Therefore, including PBT in the

episode payment would create an

incentive to use lower-cost, comparable

modalities.

Response: We thank the commenters

for their feedback. We believe that our

approach to blending the national base

rates with the RO participant’s historical

experience, with the blend shifting more

to the national base rates over time for

those with historical payments above

the national base rates, provides a

stepwise reduction in payment over the

Model, regardless of modality. We do

not believe a separate model for PBT is

necessary because we have created an

exemption where PBT is not an

included modality when furnished to an

RO beneficiary participating in a

federally-funded, multi-institution,

randomized control clinical trial for

PBT so that further clinical evidence

assessing its health benefit comparable

to other modalities can be gathered. If

we were to exclude all PBT from the RO

Model or to create a separate base rate,

it would undermine the RO Model test,

which is testing an episode-based

payment that does not vary based on

where the services are provided or how

many or which type of RT services are

provided during the episode. Further,

doing either of these recommended

approaches could create an incentive for

RO participants to provide PBT as a way

to avoid being in the Model. In addition,

we do not believe that an exemption is

necessary for PBT facilities that have

not yet been constructed since the

geographic areas selected to participate

in the Model and the national base rates

will be publicly available; new PBT

facilities in a selected geographic area

will have their episode payment

amounts adjusted for case mix once data

are available. We are finalizing the

inclusion of PBT in the RO Model’s

pricing methodology (see section III.C.6)

to maintain our modality agnostic

approach. See § 512.240 for the finalized

list of included modalities.

Comment: A commenter believed that

a randomly selected sample for the RO

Model has a high likelihood of not

selecting an adequate number of centers

that provide PBT. The commenter

believed this would reduce the ability to

statistically validate the impact of

proton therapy in the bundle. This

commenter further believed that the

geographic dispersion of centers means

that only a few centers could contribute

the majority of episodes, leading to

results inconsistent with the industry.

Response: As discussed in section

III.C.16, the evaluation’s focus will be

on the impact of the Model as a whole

rather than on comparing the impact of

the Model on individual modalities,

though subanalyses will be conducted

where feasible.

Comment: Many commenters

recommended that CMS exclude PBT as

a low-volume modality. These

commenters generally believed that PBT

is not commonly used and that there is

insufficient data supporting its

inclusion in the Model. Some

commenters emphasized that PBT only

accounted for 0.7 percent of all episodes

in 2017, while others specified that PBT

episodes would represent more than 1

percent of total episodes for only six of

the 17 cancer types and less than 0.5

percent of the episodes for the

remaining 11. A commenter expressed

concern that including a low-volume

service like PBT would decrease the

rigor of any evaluation, rendering

results unreliable or misleading. A

commenter suggested both limiting low-

volume modalities like PBT to a smaller

percentage of episodes and making

participation voluntary.

Response: We appreciate these

commenters’ suggestions. Per many

commenters as well as claims data, PBT

is one of the standard approaches to

providing radiotherapy for the included

cancer types, and as such, it is

appropriate and important to include

PBT as a modality in the Model.

Although PBT is currently used less

frequently than the other included

modalities, we believe that its exclusion

would undermine our ability to test

whether the Model incentivizes the use

of high-value, appropriate care for RO

beneficiaries. Notably, as discussed in

section III.C.16, the evaluation’s focus

will be on the impact of the Model as

a whole rather than on comparing the

impact of the Model on individual

modalities, though subanalyses will be

conducted where feasible.

Comment: Some commenters

supported the proposed exclusion of

cases where an RO beneficiary is

participating in a federally-funded,

multi-institution, randomized control

clinical trial for PBT. These commenters

generally believed that the exclusion, as

proposed, would permit the generation

of further clinical evidence comparing

PBT to other modalities, while allowing

the Model to include some beneficiaries

who receive PBT. MedPAC added that

if CMS decides to exclude PBT from the

Model when it is part of a research

study, CMS should only do so if the

study is a federally-funded, multi-

institution, randomized control trial.

This requirement would help ensure

that studies of PBT produce robust

information on how it compares with

other modalities. In addition, limiting

this exclusion would allow the Model to

include at least some beneficiaries who

receive PBT.

Many commenters recommended that

CMS expand the proposed exclusion of

cases where an RO beneficiary is

participating in a federally-funded,

multi-institution, randomized control

trial. These commenters generally

believed that the proposed exclusion

might restrict opportunities that would

benefit Medicare FFS beneficiaries.

One commenter believed that CMS

should expand the proposed exclusion

of cases because no existing clinical

trials would meet the proposed criteria.

Some commenters suggested that CMS

use Medicare evidence development

precedent—via a registry structured in

compliance with CMS or AHRQ

guidance or a clinical trial registered on

clinicaltrials.gov—to structure this

exemption. A commenter emphasized

that this approach would be consistent

with existing Local Coverage Decisions

for some proton beam therapy providers

and suppliers. Other commenters

suggested that RT providers or RT

suppliers with a history of evidence

development should be exempt from the

Model.

Some commenters, emphasizing the

extensive evidence generated by recent

PBT studies, recommended expanding

the exclusion to cover all clinical trials,

regardless of whether such trials are

federally funded or randomized

controlled trials. A couple of

commenters emphasized that

randomized clinical trials are

challenging and not always practical in

radiation oncology. These commenters

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39

Baumann, B.C., Mitra, N., Harton, J.G., Xiao, Y.,

Wojciezynski, A.P., Gabriel, P.E., Zhong, H., Geng,

H., Doucette, A., Wei, J., O’Dwyer, P.J., Bekelman,

J.E., & Metz, J.M. (2019). Comparative effectiveness

of proton vs proton therapy as part of concurrent

chemoradiotherapy for locally advanced cancer.

JAMA Oncology, doi:https://doi.org/10.1001/

jamaoncol.2019.4889.

also believed that registry data could

generate clinical evidence. Other

commenters believed that much ongoing

research takes place in academic

institutions without federal funding.

These commenters generally believed

that a broadened exemption would

incentivize the collection of additional

clinical data to determine PBT’s clinical

value, particularly in comparison to

other modalities such as IMRT and

brachytherapy.

An additional commenter suggested

excluding beneficiaries who are

enrolled in an IRB-approved clinical

trial. A commenter recommended using

this regulation to address the scope and

caliber needed for a clinical trial to

become exempt.

A couple of commenters

recommended that the proposed clinical

trial exclusion not be modified. A

commenter recommended that the

exclusion only cover participants in

randomized clinical trials, suggesting

that the payment could be readjusted if

these studies demonstrate a defined

clinical benefit.

A couple of commenters suggested

that CMS decline to expand this

exemption to include registry trials. A

commenter emphasized that in sites

such as breast, head and neck,

esophagus, and prostate cancer, a

registry trial adds only a single arm or

retrospective data that does little to

compare proton to photon therapy in

these sites. Another commenter believed

that an exemption for registry trials

would lead every patient at every proton

center to be put on a registry trial,

adding only to an existing body of

literature on single arm series of proton

therapy. This commenter did not

believe registry trials add sufficient

evidence to change the standard of care.

One commenter emphasized that

proton therapy for primary treatment of

prostate cancer should be performed

within the context of a prospective

clinical trial or registry.

A few commenters recommended that

CMS exempt all care—not just PBT—

provided under a clinical trial protocol

from the Model. A commenter

specifically recommended that CMS

exclude patients enrolled in clinical

trials in which the focus is radiation

oncology treatment or technology,

emphasizing that the costs of these cases

are unique and may influence

adjustment factors or future Model data.

Response: We appreciate these

comments and suggestions. We agree

with commenters that the use of registry

trials is insufficient, as the single-arm

design of registry trials makes them

unlikely to result in published studies

evaluating the comparative effectiveness

of PBT to other RT modalities. We agree

that these registry trials are unlikely to

generate the type of evidence needed to

change the standard of care. We also

note that data collected through registry

trials is often not analyzed or published.

We believe that the inclusion of

federally-funded, multi-institution,

randomized control clinical trial for

PBT is important to include so that

further clinical evidence assessing its

health benefit comparable to other

modalities can be gathered. There are

established procedures that exist in the

Medicare claims systems for identifying

and paying for services furnished during

participation in clinical trials. A recent

study concluded that prospective trials

are warranted to validate studies related

to the use of proton and photon beam

therapies.

39

Comment: Some commenters

supported the inclusion of

brachytherapy in the Model, while

many comments opposed its inclusion.

For those that supported the inclusion

of brachytherapy, they argued that its

inclusion in the Model along with the

other modalities would incentivize the

provision of the most efficacious and

cost-effective treatments and improve

access to brachytherapy as a treatment

option. A couple of commenters

opposed brachytherapy’s inclusion in

the Model, worrying the Model might

disincentivize its use, particularly

among vulnerable cancer populations,

such as women with cervical cancer. A

couple of commenters recommended

excluding brachytherapy on the premise

that it is a low-volume modality.

Many commenters expressed

concerns with the inclusion of

brachytherapy as proposed. Some of

these commenters emphasized

brachytherapy’s unique nature as it is a

standalone treatment and is also used in

combination with external beam

radiotherapy (EBRT). These commenters

were concerned that the RO Model

would not provide adequate payment

for all situations in which

brachytherapy is indicated, particularly

when a single episode involves multiple

treatment modalities, multiple RT

providers or RT suppliers, multiple

disease sites, or multiple treatment

settings.

Some commenters focused on cases

involving multiple modalities. These

commenters emphasized that the

brachytherapy ‘‘boost’’ when

accompanying other modalities is an

important, clinical guideline-driven

treatment for certain patients. These

multimodality cases are particularly

common for treating cervical cancer,

breast cancer, and prostate cancer, and

they require more work than cases

involving a single modality, as each

modality requires unique treatment

planning and delivery services. A

commenter emphasized that patients are

often sent to regional hub facilities for

these boosts, reducing unnecessary

duplication of expensive equipment and

staff. A couple of these commenters

expressed concern that should the

Model not provide adequate

compensation for multiple modalities

furnished within a single episode,

particularly those involving

brachytherapy, providers and suppliers

might be incentivized to delay treatment

or to depart from clinical guidelines.

These commenters emphasized that

these perverse incentives could reduce

patient access to medically necessary

care. Moreover, a couple of commenters

believed that there were problems with

the underlying data and pricing

methodology. A commenter believed

that errors in the claims data stemming

from incorrect attribution of CPT

®

/

HCPCS codes to certain modalities

underrepresented the true cost of

delivering a combination of modalities

like EBRT and brachytherapy.

A few commenters emphasized that

brachytherapy services are often

provided by physicians other than

radiation oncologists, such as

gynecological oncologists, urologists,

interventional radiologists, and surgical

oncologists, and that these physicians

could operate under the same or

different RT provider or RT supplier

when brachytherapy is provided in

conjunction with another modality.

Some commenters expressed concern

that the current RO Model does not

adequately account for the various

combinations of physicians and

treatment settings in which

brachytherapy is furnished. A few

commenters explained that CMS should

not consider multiple modality cases

delivered by two physicians as

duplicate RT services, as these

physicians are working in tandem on a

treatment plan rather than duplicating

one another’s efforts.

A few commenters recommended that

brachytherapy trigger a second RO

Model bundle, with a separate PC and

TC payment, when delivered within a

single 90-day episode that also includes

EBRT. Some commenters suggested that

brachytherapy be reimbursed as FFS

when delivered during an episode

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including EBRT. To implement this

change, a commenter suggested adding

a modifier to episodes in which both

brachytherapy and EBRT are provided.

This modifier would trigger the second

bundled or FFS payment and prevent

the episode from going to reconciliation.

These commenters believed that these

solutions would adequately address the

various combinations of modalities, RT

providers and RT suppliers, and settings

that might arise during brachytherapy

treatment. A commenter further

emphasized that this structure would

alleviate possible negative incentives in

the Model, ensure that patients continue

to receive high-quality care, and have

minimal impact on overall CMS

expenditures.

Response: We thank commenters for

their support of including

brachytherapy as well as those

commenters expressing their concerns

and their suggestions.

An episode-based payment covers all

included RT services furnished to an RO

beneficiary during a 90-day episode.

Bundled episode payment rates are

premised on the notion of averages. The

cases including a combination of EBRT

and brachytherapy described by the

commenters are part of the set of

historical episodes included in the

averages that determine the national

base rates and contribute to how

payment amounts are valued, and,

therefore, an adjustment for multiple

modalities that include brachytherapy is

not warranted at this time. Also, the

case mix and historical experience

adjustments help account for the

costlier beneficiary populations in the

participant-specific episode payment

amounts. We will be monitoring for

change in treatment patterns throughout

the Model performance period and will

consider modifications to the pricing

methodology in future years of the

Model should it be warranted.

We believe that including

brachytherapy in the Model supports

this modality as high value, and also

that including it preserves the goal of

the Model in establishing a true bundled

approach to radiotherapy that is also

site neutral and modality agnostic. And,

we believe that the proposed and

finalized pricing methodology and

subsequent national base rates for each

cancer type accounts for the cost of

brachytherapy as a primary modality

and if furnished in conjunction with

EBRT. We recognize the billing

complexity when separate RT providers

and RT suppliers furnish the

brachytherapy and EBRT and will

address this in billing guidance

provided to RO participants. We will

monitor for any unintended

consequences of the Model on multi-

modality treatment that includes both

external beam and brachytherapy.

As for the concern that errors in the

claims data (specifically those that

commenters believe stem from incorrect

attribution of CPT

®

/HCPCS codes to

certain modalities) underrepresented

the true cost of delivering a combination

of modalities like EBRT and

brachytherapy, we rely on the data

submitted on claims by providers and

suppliers to be accurate per Medicare

rules and regulations. We are finalizing

the provision to include brachytherapy

in the RO Model.

Comment: A commenter specifically

requested that the Model include

electronic brachytherapy (EB).

Response: EB radiation is generated

and delivered in a markedly different

way than traditional brachytherapy, and

its dosing and clinical implications are

still being studied. Until EB is more

commonly used, CMS will continue to

pay FFS for this RT service.

Comment: A few commenters

suggested excluding more modalities

from the Model due to their infrequent

use. A commenter recommended

including only the most common

modalities and excluding

brachytherapy, SRS, SBRT, and PBT. A

commenter recommended excluding

IORT since it is used so rarely. A

commenter was concerned that the

proposed payment structure will

promote the use of short course, less

costly forms of treatment such as IORT

in cases where traditional external beam

radiation would have been preferred.

Response: We thank these

commenters for these suggestions. We

agree with the commenter that it would

be appropriate to exclude IORT from the

RO Model because it is not a standard

approach to treatment, and we believe

that including IORT may incentivize

misuse of this treatment. See § 512.240

for the finalized list of included

modalities.

Comment: A commenter requested

clarity on the codes used to define

stereotactic radiosurgery and also

expressed concern that the RO Episode

File (2015–2017) has SRS attributed to

episodes that are classified as brain

metastasis or CNS. SRS as defined in the

HCPCS should be a single treatment

delivery and directed at an intracranial

brain lesion. It is likely that CMS is

incorrectly including SBRT into the SRS

count, since SRS is typically used for

brain metastases, and SBRT is typically

used for early primary lung cancers or

metastatic disease to various locations

in the body. In addition to

misattribution of the SRS episodes, this

commenter stated that episodes of

brachytherapy, SRS, and 1–10 3D EBRT

occur in clinically unlikely episodes in

the RO Episode File.

Response: We appreciate this

question. We are confirming that SRS

and SBRT are both included in the RO

Episode File (2015–2017) under the

classification of SRS. We understand the

difference between and SRS and SBRT

but erroneously labeled the column in

the file as COUNT_SRS without

explaining in the Data Dictionary posted

on the RO Model website that COUNT_

SRS includes both SRS and SBRT. This

clerical error did not impact our

calculations of the proposed base rates.

Comment: Some commenters

expressed concern that the bundled

payment structure might lead providers

and suppliers to substitute older, less

expensive modalities for newer, more

expensive modalities. One of these

commenters emphasized their concern

for patient access to the most effective

care from the RT provider or RT

supplier, noting that the clinician is best

suited to determine appropriate

treatment for the patient. Another

commenter emphasized that, while an

individual RO participant might save

costs by selecting the cheapest treatment

during the 90-day episode, longer-term

Medicare costs could rise due to later

complications or secondary tumors. A

different commenter stated this Model

incentivizes the use of the cheapest

forms of radiation therapy, which also

deliver the greatest amount of radiation

to healthy tissue.

Response: We appreciate commenters’

concerns. We rely on Medicare

providers and suppliers to furnish

appropriate care to our beneficiaries. As

finalized in section III.C.14, we will

monitor for unintended consequences of

the RO Model including but not limited

to stinting on care.

Comment: A commenter requested

that CMS provide additional

comparative effectiveness data between

included and excluded modalities. This

commenter expressed concern that more

effective, and potentially more

expensive modalities, were not included

because they are not accessible to many

Medicare beneficiaries. This commenter

emphasized that racial and gender

disparities in cancer outcomes may be

due to disparities in treatment options,

and requested that CMS justify how the

inclusion of these modalities addresses

disparities.

Response: We appreciate this

commenter’s concerns. We did not use

comparative effectiveness data to

determine whether modalities were

included/excluded but rather focused

on the most commonly utilized

approaches to radiotherapy for the

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included cancer types. We believe that

the RO Model pricing methodology,

through the historical experience and

case mix adjustments, will account for

differences in RO participants’ historical

care patterns and the demographic

characteristics of their patient

populations. We rely on Medicare

providers and suppliers to furnish

appropriate care to our beneficiaries.

This includes prescribing the most

appropriate modality. If a modality is

not included in the RO Model, it will

continue to be paid FFS. As finalized in

section III.C.14 and III.C.16, we will

monitor for unintended consequences of

the RO Model.

Comment: A couple of commenters

expressed concern about the impact of

the Model not only on Medicare

beneficiaries, but also about the

continued viability of offering PBT to

patients. These commenters stated that

unsustainable payment rates from

Medicare would put centers’ viability at

risk, both operational centers as well as

centers currently under development.

They stated that Medicare is a material

payor for the majority of members,

representing the majority of their payor

mix, and reducing their payment rates

by up to 50 percent below cost will not

be sustainable. They also stated that

while the RO Model is focused on

Medicare fee-for-service, it has

implications for other payors, as many

private payors often use the Medicare

rates as a proxy, which could impact a

center’s broader payor mix. Further,

these commenters stated that viability

impacts not only Medicare beneficiaries

but indirectly affects a broader set of

patients including pediatric cancer

patients who will lose access to a

treatment that is now the standard of

care.

Response: We appreciate these

commenters’ concerns. We disagree

with the commenters on the expected

magnitude of reduction in RO

participants’ payments for PBT

compared to what they currently

receive. As described in section III.C.6,

the pricing methodology as finalized

will blend together the national base

rate with an RO participant’s unique

historical experience. If the RO

participant is historically more costly

than the national average, the blend in

PY1 will be 90 percent of the RO

participant’s historical payments and 10

percent of the national base rate. This

means that, prior to applying the

discount factor and withholds that

payments under the Model will be

between 90 and 100 percent of the RO

participant’s historical payments. For

historically inefficient RO participants,

the blend shifts over time to a 70/30

blend in PY5. This means that in PY5,

prior to applying the discount factor and

withholds that payments under the

model will be more than 70 percent of

the RO participant’s historical

payments. We believe that the pricing

methodology tested under the Model

represents an opportunity to provide

high-value episode-based payments to

RO participants for Medicare FFS

beneficiaries; other payors determine

their own payment approaches for RT

services.

Comment: A commenter

recommended applying savings

proportionately to all modalities,

particularly if CMS has a savings target

under the Patient Access and Medicare

Protection Act.

Response: While the RO Model is

projected to be expenditure neutral or

achieve Medicare savings, we did not

have any specific predefined targets in

mind, and we believe our pricing

methodology has a graduated approach

to setting participant-specific payments

that is heavily weighted to the

participant’s historical experience.

After considering public comments,

we are finalizing our proposed list of

included modalities in the RO Model at

§ 512.240, with the modifications of

removing intraoperative radiotherapy

(IORT) from the list of included

modalities in the RO Model.

6. Pricing Methodology

a. Overview

The proposed pricing methodology in

the proposed rule described the data

and process used to determine the

amounts for participant-specific

professional episode payments and

participant-specific technical episode

payments for each included cancer type

(84 FR 34503). In the proposed rule, we

proposed to define the term

‘‘participant-specific professional

episode payment’’ as a payment made

by CMS to a Professional participant or

Dual participant for the provision of the

professional component of RT services

furnished to an RO beneficiary during

an episode, which is calculated as set

forth in § 512.255. We further proposed

to codify this term, ‘‘participant-specific

professional episode payment,’’ at

§ 512.205 of our regulations.

We proposed to define the term

‘‘participant-specific technical episode

payment’’ as a payment made by CMS

to a Technical participant or Dual

participant for the provision of the

technical component of RT services to

an RO beneficiary during an episode,

which we proposed to calculate as set

forth in § 512.255 of the proposed rule.

Further, we proposed to codify this

term, ‘‘participant-specific technical

episode payment,’’ at § 512.205 of our

regulations.

In the proposed rule, we proposed

eight primary steps to the pricing

methodology (84 FR 34503 through

34504). In the first step, we proposed to

create a set of national base rates for the

PC and TC of the included cancer types,

yielding 34 different national base rates.

Each of the national base rates

represents the historical average cost for

an episode of care for each of the

included cancer types. We proposed

that the calculation of these rates will be

based on Medicare FFS claims paid

during the CYs 2015–2017 that are

included under an episode where the

initial treatment planning service

occurred during the CYs 2015–2017 as

described in section III.C.6.b of the

proposed rule (84 FR 34504 through

34505) and this final rule. If an episode

straddles calendar years, the episode

and its claims are counted in the

calendar year for which the initial

treatment planning service is furnished.

We proposed to exclude those episodes

that do not meet the criteria described

in section III.C.5 of the proposed rule

and this final rule. From the remaining

episodes (that is, not including the

excluded episodes), we proposed to

then calculate the amount CMS paid on

average to providers and suppliers for

the PC and TC for each of the included

cancer types in the HOPD setting,

creating the Model’s national base rates.

Unless a broad rebasing is done after a

later PY in the Model, these national

base rates will be fixed throughout the

Model performance period.

In the second step, we proposed to

apply a trend factor to the 34 different

national base rates to update those

amounts to reflect current trends in

payment for RT services and the volume

of those services outside of the Model

under the OPPS and PFS. We proposed

to define the term ‘‘trend factor’’ to

mean an adjustment applied to the

national base rates that updates those

rates to reflect current trends in the

OPPS and PFS rates for RT services. We

proposed to codify the term ‘‘trend

factor’’ at § 512.205 of our regulations.

In this step, we would calculate separate

trend factors for the PC and TC of each

cancer type using data from HOPDs and

freestanding radiation therapy centers

not participating in the Model. More

specifically, as noted in the proposed

rule, the calculations would update the

national base rates using the most

recently available claims data of those

non-participating providers and

suppliers and the volume at which they

billed for RT services as well as their

corresponding payment rates. Adjusting

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Please note that in the final rule we are

renaming the efficiency factor the ‘‘blend,’’ as

discussed in section III.C.6.e(2) of this final rule.

the national base rates with a trend

factor will help ensure payments made

under the Model appropriately reflect

changes in treatment patterns and

payment rates that have occurred under

OPPS and PFS.

In the third step, we proposed to

adjust the 34 now-trended national base

rates to account for each Participant’s

historical experience and case mix

history. The historical experience and

case mix adjustments account for RO

participants’ historical care patterns and

certain factors that are beyond an RO

participant’s control, which vary

systematically among RO participants so

as to warrant adjustment in payment.

We proposed that there would be one

professional and/or one technical case

mix adjustment per RO participant

depending on the type of component the

RO participant furnished during the

2015–2017 period, just as there would

be one professional and/or one technical

historical experience adjustment per RO

participant, depending on the type of

component the RO Participant furnished

during the 2015–2017 period. We

proposed to generate each RO

participant’s case mix adjustments using

an ordinary least squares (OLS)

regression model that predicts payment

based on a set of beneficiary

characteristics found to be strongly

correlated to cost. In contrast, we

proposed to generate each RO

participant’s historical experience

adjustments based on Winsorized

payment amounts for episodes

attributed to the RO participant during

the calendar years 2015–2017. The

historical experience adjustments for

each RO participant would be further

weighted by an efficiency factor.

40

The

blend measures if an RO participant’s

episodes (from the retrospectively

constructed episodes from 2015–2017

claims data) have historically been more

or less costly than the national base

rates, and this determines the weight at

which each RO participant’s historical

experience adjustments are applied to

the trended national base rates.

In the fourth step, we proposed to

further adjust payment by applying a

discount factor. The discount factor is

the set percentage by which CMS

reduces payment of the PC and TC. The

reduction on payment occurs after the

trend factor and adjustments have been

applied, but before standard CMS

adjustments including the geographic

practice cost index (GPCI),

sequestration, and beneficiary

coinsurance. The discount factor will

reserve savings for Medicare and reduce

beneficiary cost-sharing. We proposed

to codify the term ‘‘discount factor’’ at

§ 512.205.

In the fifth step, we proposed to

further adjust payment by applying an

incorrect payment withhold, and either

a quality withhold or a patient

experience withhold, depending on the

type of component the RO participant

furnished under the Model. The

incorrect payment withhold would

reserve money for purposes of

reconciling duplicate RT services and

incomplete episodes during the

reconciliation process, as discussed in

section III.C.11 of the proposed rule and

this final rule. We proposed to define

the term ‘‘duplicate RT service’’ to mean

any included RT service (as identified at

§ 512.235 of the proposed rule) that is

furnished to a single RO beneficiary by

a RT provider or RT supplier or both

that did not initiate the PC or TC of that

RO beneficiary during the episode. We

proposed to codify ‘‘duplicate RT

service’’ at § 512.205 of the proposed

rule. We proposed that an incomplete

episode means the circumstances in

which an episode does not occur

because: (1) A Technical participant or

a Dual participant does not furnish a

technical component to an RO

beneficiary within 28 days following a

Professional participant or the Dual

participant furnishing the initial RT

treatment planning service to that RO

beneficiary; (2) traditional Medicare

stops being the primary payer at any

point during the relevant 90-day period

for the RO beneficiary; or (3) an RO

beneficiary stops meeting the

beneficiary population criteria under

§ 512.215(a) or triggers the beneficiary

exclusion criteria under § 512.215(b)

before the technical component of an

episode initiates.

We also proposed to adjust for a

quality withhold for the professional

component of the episode. This

withhold would allow the Model to

include quality measure results as a

factor when determining payment to

participants under the terms of the

APM, which is one of the criteria for an

APM to qualify as an Advanced APM as

specified in 42 CFR 414.1415(b)(1). We

proposed to adjust for a patient

experience withhold for the technical

component of the episode starting in

PY3 to account for patient experience in

the Model. We would then apply all of

these adjustments, as appropriate to

each RO participant’s trended national

base rates.

In the sixth step, we proposed to

apply geographic adjustments to

payments. In the seventh and final

eighth step, we proposed to apply

beneficiary coinsurance and a 2 percent

adjustment for sequestration to the

trended national base rates that have

been adjusted as described in steps

three through six, yielding participant-

specific episode payment amounts for

the provision of the PC and TC of each

included cancer type in the Model. We

proposed to calculate a total of 34

participant-specific professional and

technical episode payment amounts for

Dual participants, whereas we would

only calculate 17 participant-specific

professional episode payment amounts

or 17 participant-specific technical

episode payment amounts for

Professional participants and Technical

participants, since they furnish only the

PC or TC, respectively.

Following this description of the data

and process used to determine the

amounts for participant-specific

professional episode payments and

participant-specific technical episode

payments for each included cancer type,

the proposed rule provided a pricing

example for an episode of lung cancer

(at 84 FR 34511). We provided this

example to show how each pricing

component (that is, national base rates,

trend factors, case mix and historical

experience adjustments, withholds,

discount factors, geographic adjustment,

beneficiary coinsurance, and

sequestration) figures into these

amounts. We also provided a summary-

level, de-identified file titled the ‘‘RO

Episode File (2015–2017),’’ on the RO

Model’s website to further facilitate

understanding of the RO Model’s

pricing methodology. The following is a

summary of the public comments

received on this proposal, specifically

those comments related not to particular

pricing components, but rather

comments related to the Model’s pricing

methodology in its general approach,

potential impact, and structure as well

as information provided to thoroughly

review the methodology on these points

and our response:

Comment: Many commenters

requested additional information and

data be provided in order to ascertain

the degree of impact that the Model’s

pricing methodology will have on

participant payment relative to what

participants have historically been paid

under FFS. Some commenters argued

that additional information is needed in

order to justify the RO Model’s pricing

and policies in general. Several other

commenters made requests for

information related to specific pricing

components. Several commenters stated

that the case mix adjustment is not

adequately defined and that more detail

is needed concerning the regression

models used to construct the case mix

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adjustments. A few commenters

requested additional information

regarding the historical experience

adjustments, specifically the number

and type of providers and suppliers that

are classified as efficient versus

inefficient.

Response: Based on a full review of

comments and the detailed analyses

contained within some of them, we

believe that commenters have had

sufficient detail to fully comment on the

proposed RO Model. We prioritize,

however, these comments and along

with the finalized parameters of the

Model, provide additional resources to

include detailed illustrations, examples,

and data, particularly concerning the

case mix and historical experience

adjustments. We refer readers to

sections III.C.6.e.(1) and III.C.6.e.(2) of

the case mix and historical adjustments,

respectively, for that additional detail

and to section III.C.6.j which closes the

pricing methodology section. Here we

list additional data we are able to

provide at request of the commenters.

Comment: Many commenters

expressed support for a prospective

payment model in radiation oncology. A

few commenters took issue with the

prospective nature of the Model’s

payment rates, because they were not

adjusted for factors occurring in the

current performance year. A commenter

suggested that the RO Model change to

a retrospective payment model in that

this would allow for payment rates to be

adjusted for the patient population of

the performance period for which

payment was being allotted. A

commenter opposed the Model

generally, explaining that the RO Model

is an experiment focusing on short-term

effects and costs, and ignores medium-

and long-term complications and the

resulting cost of care, such as costly side

effects and secondary malignancies.

Response: We thank the commenters

for sharing their support and concerns

regarding a prospective payment model

in radiation oncology. It is not the intent

of the Model for payment based on 90-

day episodes to incorporate the long-

term health outcomes of a patient or

associated costs, though the RO Model

evaluation will analyze health outcomes

that occur after RO episodes end to the

extent feasible. The Model is designed

to predict payment based on the

historical characteristics of a

participant’s population based on the

most recent claims data available. In

particular, we refer readers to section

III.C.6.e.(1) concerning the case mix

adjustments. We update the case mix

adjustment for each RO participant

every year to account for the most recent

set of episodes for which claims data is

available. Also, it is important to note

that in analyzing 2015–2017 episode

data, we found that participants’ case

mix is relatively stable over time for

most providers and suppliers.

We believe that this prospective

episode-based payment structure for RT

services is the best design for testing an

episodic APM for RT services. The

payment rates for RO episodes of care

are unambiguous and known to RO

participants prior to furnishing RT

services. We are testing an approach

where prospective episode-based

payments will not be reconciled based

on how many or which individual RT

services are provided by the RO

participant during the RO episode, with

the exception of incomplete episodes

and duplicate RT services. This allows

us to test the impact of episode-based

payments that do not have today’s FFS

incentives.

Comment: Many commenters

expressed concern over the participant-

specific professional episode payment

and technical episode payment amounts

related to what non-participants in the

Model will receive under FFS.

Commenters believed that the proposed

pricing methodology as constructed

with the national base rates based on

HOPD claims data alone along with the

proposed adjustments, discounts, and

withholds, RO participants will be

unable to receive sufficient payment

under the Model or reasonably achieve

savings. A commenter estimated that RO

participants would receive up to 50

percent less in payments under the

Model than non-participants who

continue to be compensated under FFS.

Many commenters stated that the

proposed pricing methodology does not

adequately pay RO participants for labor

and resources required to care for the

most complex patients and that the

Model underestimates the costs and

administrative burden of adjusting to

and complying with the Model. A few

commenters explained that payment

under the Model would represent

significant cuts to what RT providers

and RT suppliers have been historically

paid, particularly because the TC is not

associated with an APM Incentive

Payment. A commenter expressed

concern that there could be a great

degree of variation in episode spending

outside the control of HOPDs,

particularly those with little experience

with episode-based payments.

Several commenters recommended

that CMS limit the downside risk for RO

participants, because as proposed, the

Model provides no safeguard for

excessive financial downside risk. A

few commenters recommended

restructuring the Model altogether to

permit two-sided risk that would allow

providers and suppliers to enter into

risk at a self-determined pace. A few

commenters suggested that the RO

Model take a ‘‘shared savings’’ approach

with RO participants sharing risk for

gains and losses. Another commenter

suggested a graduated glide path to risk

for the RO Model, similar to the

approach adopted in the Medicare

Shared Savings Program (Shared

Savings Program) Pathways to Success

final rule. Another commenter

suggested that payment be set by

optimal actual costs of well-managed

sites of service that furnish radiation

with a margin to allow for innovation

and upgrades. A commenter requested

clarification as to whether RO

participants could reinsure or get stop-

loss insurance to mitigate risk, since RO

participants are at risk for all costs over

the bundled payment amounts.

Response: We thank these

commenters on their feedback and

suggestions related to Model payments

relative to those received under FFS. We

disagree that episode payment amounts

would be reduced by 50 percent as

compared to non-participants. We

designed the pricing methodology so

that participant-specific professional

and technical episode payment amounts

are largely based on what each

participant has been paid historically

under FFS and trended forward based

on latest payment rates under FFS.

Moreover, we adjust for those

beneficiary characteristics that have a

large impact on cost in the case mix

adjustment.

We note, however, that RO

participants that have fewer than 60

episodes in the baseline period do not

have sufficient historical volume to

calculate a reliable historical experience

adjustment. Since these RO participants

will not qualify to receive a historical

experience adjustment and may see

greater increases or reductions as

compared to what they were historically

paid under FFS as a result of not

receiving the adjustment, we believe

that it is appropriate to adopt a stop-loss

limit of 20 percent for RO participants

that have fewer than 60 episodes in the

baseline period and were furnishing

included RT services in the CBSAs

selected for participation at the time of

the effective date of this final rule (see

section III.C.6.e(4) of this final rule). We

are adding a definition at § 512.205 for

‘‘stop-loss limit,’’ which means the set

percentage at which loss is limited

under the Model used to calculate the

stop-loss reconciliation amount. We are

also adding at § 512.205 a definition for

‘‘stop-loss reconciliation amount’’

which means the amount owed to RO

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participants that have fewer than 60

episodes during 2016–2018 and were

furnishing included RT services in the

CBSAs selected for participation at the

time of the effective date of this final

rule for the loss incurred under the

Model as described in § 512.285(f).

Thus, we disagree with the premise

that the proposed pricing methodology

does not adequately pay RO participants

for labor and resources required to care

for the most complex patients. In

particular, we refer readers to section

III.C.6.e.(2) of this final rule for more

information regarding the blend used to

determine how much participant-

specific historical payments and

national base rates figure into payment.

The blend provides a glide path toward

the national average for each cancer

type. Moreover, this is not a total cost

of care model in that each RO episode

covers only RT services. We limited the

Model in this way, because we believe

that these RT services are in control of

the RT provider and RT supplier. For

these reasons, reconfiguring the RO

Model to incorporate either a ‘‘shared

savings’’ element or gradual risk at a

pace determined by RO participants is

not necessary.

To ease any burden of adjusting to

and complying with the Model, we are

finalizing policies that reduce the

discount factor by 0.25 percent for both

the PC and TC, so that the discount rates

are 3.75 percent and 4.75 percent for the

PC and TC, respectively (see sections

III.C.6.a and III.C.6.f). See section

§ 512.205 for the modification to the

proposed discount factors. Also, we are

finalizing policies that reduce the

incorrect payment withhold to 1

percent. See section III.C.6.g(1) for the

modification to the proposed incorrect

payment withhold. These reductions, as

detailed in the pricing methodology

component sections to which they

apply, should further minimize any cost

differential that a participant may

experience under the Model as opposed

to what the participant historically

received in payment under FFS.

Comment: Many commenters

suggested that the payment structure be

adjusted to account for patients

receiving treatment for multiple tumor

sites. A commenter stated that a

diagnosis of primary lung cancer and

prophylactic whole brain treatment

would not both be covered by the

national base rate for lung cancer. A

commenter suggested monitoring the

frequency and cost of care associated

with multiple treatment sites in order to

determine if the pricing methodology

should be modified in future years on

this point.

Response: We thank these

commenters for their feedback regarding

patients receiving treatment for multiple

tumor sites. An episode-based payment

covers all included RT services

furnished to an RO beneficiary during a

90-day RO episode as codified at

§ 512.205 and §512.245. Episodes are

constructed using all Medicare FFS

claims for radiation therapy services

included in the Model. All RT services

included on a paid claim line during the

90-day episode were multiplied by the

OPPS or PFS national payment rate for

that service and were included in the

payment amounts for the PC and TC of

that episode regardless of whether the

service is aimed at treating the

attributed primary disease site or not.

As such, the national base rates

incorporate payments for treatment of

multiple tumor sites to the extent that

more than one site was the focus of RT

services during episodes of care in the

historical period. Bundled episode

payment rates are premised on the

notion of averages. These cases

described by the commenters are part of

the set of historical episodes included in

the averages that determine the national

base rates and contribute to how

payment amounts are valued, and,

therefore, an adjustment for multiple

tumor sites is not warranted at this time.

Yet, we will be monitoring for change in

treatment patterns related to patients

being treated for multiple tumor sites

throughout the Model performance

period and will consider modifications

to the pricing methodology in future

years of the Model should it be

warranted. Any changes to the pricing

methodology will be made via notice

and comment rulemaking.

Comment: Several commenters noted

that the national base rates for prostate

cancer and for gynecological cancers are

not reflective of the increased costs of

combined modality care, but rather

these rates are driven by large volumes

of patients who receive external beam

radiation only. As a consequence, these

commenters argued that RO participants

would not be sufficiently compensated

for these beneficiaries.

Response: As noted in the previous

comment, an episode-based payment

covers all included RT services

furnished to an RO beneficiary during a

90-day episode as codified at § 512.205

and § 512.245. All RT services included

on a paid claim line during the 90-day

episode are multiplied by the OPPS or

PFS national payment rate for that

service and are included in the payment

amounts for the PC and TC of that

episode regardless of the type of

modality used to treat the beneficiary.

As such, the national base rates

incorporate payments for treatment from

multiple modalities to the extent that

more than one modality was furnished

during episodes of care in the historical

period. These cases described by the

commenters are part of the set of

historical episodes included in the

averages that determine the national

base rates and contribute to how

payment amounts are valued, and,

therefore, an adjustment for multiple

modalities is not warranted at this time.

Yet, we will be monitoring for change in

treatment patterns related to patients

being treated with multiple modalities

throughout the Model performance

period and will consider modifications

to the pricing methodology in future

years of the Model should it be

warranted. Any changes to the pricing

methodology will be made via notice

and comment rulemaking.

Comment: A few commenters

requested clarity on whether episode

payment amounts covered all RT

services furnished during a 90-day

period, even in instances where

multiple courses of treatment were

furnished. Several commenters

expressed concern that no adjustment

would be made if multiple courses of

treatment were furnished within that

90-day period.

Response: An RO episode includes all

included RT services (See Table 2)

furnished to an RO beneficiary with an

included cancer type during the 90-day

episode as codified at § 512.205 and

§ 512.245. These cases described by the

commenters are part of the set of

historical episodes included in the

averages that determine the national

base rates and contribute to how

payment amounts are valued and,

therefore, an adjustment for multiple

courses of treatment is not warranted at

this time.

Comment: Many commenters

suggested that the payment structure be

adjusted to account for patients

receiving treatment for secondary

malignancies.

Response: An RO episode includes all

included RT services (See Table 2)

furnished to an RO beneficiary with an

included cancer type during the 90-day

episode. If an RO episode includes RT

services for different included cancer

types (for example, there may be claims

for RT services included in the pricing

for that episode that indicate more than

one cancer type according to the ICD–

10 diagnosis codes listed on the various

claims), those RT services and their

costs are all included in the calculation

of the payment rate for that episode.

We would like to clarify how cancer

type is assigned to an episode for

calculation of the national base rates. It

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is important to note that episodes are

first assigned a cancer type when the

episode is created, whether the cancer

type is included in the Model or not,

and then if that cancer type is not

included in the Model, that episode is

excluded subsequently from Model

pricing. For instance, episodes first

assigned with a secondary malignancy

for cancer type during the episode

construction phase are then excluded

when pricing calculations are

conducted. Our process for assigning a

cancer type to an episode is as follows:

First, ICD–10 diagnosis codes during

an episode were identified from:

(1) E&M services with an included

cancer diagnosis code from Medicare

PFS claim lines with a date of service

during the 30 days before the episode

start date, on the episode start date, or

during the 29 days after the episode

start date.

(2) Treatment planning and delivery

services (See Table 2) with an included

cancer diagnosis code from Medicare

PFS claim lines, or treatment delivery

services from Medicare OPPS claim

lines with an included cancer diagnosis

code on the claim header, with a date

of service on the episode start date or

during the 29 days after the episode

start date. Note that the cancer diagnosis

code from OPPS claims must be the

principal diagnosis to count toward

cancer type assignment; and that

treatment delivery services that concern

image guidance do not count toward

cancer type assignment as we

determined that image guidance was not

an important indicator of cancer type.

Then, these ICD–10 diagnosis codes

are summarized and counted across the

claim lines to determine the episode’s

cancer type assignment according to the

algorithm described in (a) through (c):

(a) If two or more claim lines fall

within brain metastases or bone

metastases or secondary malignancies

(per the mapping of ICD–10 diagnosis

code to cancer type described in Table

1 of Identified Cancer Types and

Corresponding ICD–10 Codes), we set

the episode cancer type to the type

(either brain metastases or bone

metastases) with the highest count. If

the count is tied, we assign the episode

in the following order of precedence:

Brain metastases; bone metastases; other

secondary malignancies.

(b) If there are fewer than two claim

lines for brain metastases, bone

metastases and other secondary

malignancies, we assign the episode the

cancer type with the highest claim line

count among all other cancer types. We

exclude the episode if the cancer type

with the highest claims line count

among other cancer types is not an

included cancer type.

(c) If there are no claim lines with a

cancer diagnosis meeting the previously

discussed criteria, then no cancer type

is assigned to that episode and

therefore, that episode is excluded from

the national base rate calculations.

Comment: A commenter

recommended that a payment

adjustment be made for the increased

use of Magnetic Resonance simulation

that was not present during the baseline

period of 2015–2017 in order to monitor

patient safety and treatment efficacy.

Response: We will be monitoring for

changes in treatment patterns

throughout the Model’s performance

period with particular attention to the

increased use of MR simulation. We will

consider proposing modifications to the

pricing methodology in future years of

the Model should it be warranted.

Comment: Many commenters

expressed concern that the pricing

methodology fails to account for

complex clinical scenarios and

treatment costs. Many commenters

recommended that only standard

medically accepted case rates should be

used to determine payment.

Response: At this time, we have only

claims data available to design and

operationalize the RO Model. The

claims data do not include clinical data.

We are finalizing our proposal to collect

clinical data from RO participants so

that we can assess the potential utility

of additional clinical data for

monitoring and calculating episode

payment amounts (see section III.C.8.e

of this final rule). Further, we believe

that the case mix adjustment

appropriately accounts for the

complexity of an RO participant’s

patient population, and the historical

experience adjustment captures

additional unmeasured factors that may

make one RO participant’s patient

population more complex, and thus

more costly, than another’s. We also

believe that the national base rates

would be lower if we were to use a

standard treatment course to set

payments, since there are situations in

which greater volume is used than

would be prescribed by a standard

course of treatment.

Comment: A commenter suggested

assigning an episode of care initiator,

who would be responsible for total

spending for the PC and TC, similar to

the BPCI Advanced Model.

Response: Similar to the BPCI

Advanced Model, the RO participants

initiate (or trigger) RO episodes of care

with an initial service, which is the

treatment planning service in the RO

Model. In both the RO Model and BPCI

Advanced Model, the model participant

is responsible for Medicare fee-for-

service (FFS) expenditures for all items

and services included in an episode of

care starting with the episode trigger.

However, in the RO Model, we have

limited financial risk to RT services

whereas the BPCI Advanced Model

participants are responsible for the total

amount of Medicare spending for non-

excluded items and services in the

episode of care. As described in section

III.C.5.c, we believe that it is appropriate

to limit risk in the RO Model just to RT

services, which are managed by the

radiation oncologist.

Comment: A commenter expressed

support for the proposed policies

related to the definition of incomplete

episodes. A few commenters requested

that CMS provide an example

calculation for how an incomplete

episode would be paid. Another

commenter requested clarification on

the situation of a beneficiary switching

RT providers and/or RT suppliers and

how each would be paid if both RT

providers and/or RT suppliers were

participants in the Model.

Response: We thank these

commenters for their support and

requests. As noted in the proposed rule

and in this final rule, we expect to

provide RO participants with additional

instructions for billing, particularly as

billing pertains to incomplete episodes

and duplicate RT services, through the

Medicare Learning Network (MLN

Matters) publications, model-specific

webinars, and the RO Model website.

For a subset of incomplete episodes in

which (1) the TC is not initiated within

28 days following the PC; (2) the RO

beneficiary ceases to have traditional

FFS Medicare prior to the date upon

which a TC is initiated, even if that date

is within 28 days following the PC; or

(3) the RO beneficiary switches RT

provider or RT supplier before all RT

services in the RO episode have been

furnished the RO participant is owed

only what it would have received under

FFS for the RT services furnished to that

RO beneficiary, CMS will reconcile the

episode payment for the PC and TC that

was paid to the RO participant with

what the FFS payments would have

been for those RT services using no-pay

claims. When an RO beneficiary

switches RT provider or RT supplier, he

or she is no longer under the care of the

RO participant that initiated the PC and/

or TC of the RO episode.

In the case that traditional Medicare

ceases to be the primary payer for an RO

beneficiary after the TC of the RO

episode has been initiated but before all

included RT services in the RO episode

have been furnished, then each RO

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participant will be paid only the first

installment of the episode payment. The

RO participant will not be paid the EOE

PC or TC for these RO episodes as CMS

cannot process claims for a beneficiary

with dates of service on or after the date

that traditional Medicare is no longer

the primary payer. If the SOE for the PC

is paid and the RO beneficiary ceases to

have traditional Medicare FFS, for

example by switching to a Medicare

Advantage plan, before the TC is

initiated, then during reconciliation,

CMS will calculate what the RO

participant would have received under

FFS for the RT services included in the

PC furnished to that beneficiary prior to

the beneficiary switching from

traditional Medicare to another payer.

We account for duplicate RT services

differently. In the proposed rule, a

duplicate RT service means any

included RT service that is furnished to

a single RO beneficiary by a RT provider

or RT supplier or both that did not

initiate the PC or TC for that RO

beneficiary during the RO episode. We

are finalizing this proposed definition of

duplicate RT service with modification.

Duplicate RT service means any

included RT service identified at

§ 512.235 that is furnished to an RO

beneficiary by an RT provider or RT

supplier that is not excluded from

participation in the RO Model at

§ 512.210(b), and that did not initiate

the PC or TC of the RO beneficiary’s RO

episode. Such services are furnished in

addition to the RT services furnished by

the RO participant that initiated the PC

or TC and continues to furnish care to

the RO beneficiary during the RO

episode. This modification also clarifies

that RT services furnished by a RT

provider or supplier excluded from

participation in the Model (for example,

an ambulatory surgery center, see

section III.C.3.c for exclusion criteria)

are not considered a duplicate RT

service. If the EOE PC and TC payments

have been made to the RO participant

that initiated the PC or TC of that RO

episode, and claims are submitted on

behalf of that same beneficiary for RT

services furnished by another RT

provider or RT supplier during that RO

episode, then during reconciliation,

payments for those duplicate RT

services will be reconciled against the

incorrect payment withhold for the RO

participant that received full payment

for the RO episode. The other RT

provider or RT supplier that furnished

RT services to that beneficiary, whether

an RO participant or not, will be paid

FFS for those RT services.

For any RO episode that involves one

or more duplicate RT services, the

payment for the RO participant that

initiated the PC or TC will be reconciled

by reducing the RO participant’s

episode payment by the FFS amount of

the duplicate RT services furnished by

the RT provider or RT supplier that did

not initiate the PC or TC. The FFS

amount to be subtracted from the RO

participant’s bundled payment,

however, cannot exceed the amount that

the RO participant would receive under

FFS for the RT services they furnished

during the RO episode. We note that a

duplicate RT service is distinct from the

situation where an RO beneficiary

switches to a different RT provider or

RT supplier. As explained above, when

an RO beneficiary switches to a new RT

provider or RT supplier, and is no

longer under the care of the RO

participant that initiated the PC and/or

TC, the RO episode is an incomplete

episode. The RO participant is owed

what it would have received under FFS

for the RT services furnished to that RO

beneficiary, and CMS will use no-pay

claims to reconcile the episode payment

with what the FFS payments would

have been for the RT services. For

further details, see section III.C.11(b) of

this final rule.

In sum, all claims for RT services for

an RO beneficiary with dates of service

during the 90-day RO episode will be

reviewed during annual reconciliation,

to determine if that RO episode qualifies

as complete as stipulated in section

III.C.11 and codified at § 512.285 and if

duplicate RT services occurred as

defined in section III.C.6a and codified

at § 512.205. As a consequence of this

process, CMS will determine how all of

these claims impact the annual

reconciliation amount on an episode-by-

episode basis. The sum of payments for

duplicate RT services and the sum of

payments for RT services during the

incomplete episode represent the

impact of those duplicate RT services

and incomplete episodes across all RO

episodes attributed to the RO

participant for the PY considered in that

annual reconciliation. See section

III.C.11 for further details on this

process. Table 14 in that section is an

example of the annual reconciliation

calculation. For more information on

billing under the RO Model, see section

III.C.7; for more information on

reconciliation during the RO Model, see

section III.C.11.

In our proposed eight primary steps to

the pricing methodology, we are making

one technical change to apply the

geographic adjustment to the trended

national base rates prior to the case mix

and historical experience adjustments

and prior to the discount factor and

withholds. We proposed to apply the

OPPS Pricer as it is automatically

applied under OPPS outside of the

Model at 84 FR 34510 of the proposed

rule, and see section III.C.6.h. of this

final rule. We also proposed to use RO

Model-specific RVU shares to apply PFS

RVU components (Work, PE, and MP) to

the new RO Model payment amounts in

the same way they are used to adjust

payments for PFS services in section

III.C.6.h. In order to use RO Model-

specific RVU shares to apply PFS RVU

components to the new RO Model

payment amounts in the same way they

are used to adjust payments for PFS

services, the geographic adjustment

must be applied to the trended national

base rates prior to the case mix and

historical experience adjustments and

prior to the discount factor and

withholds. We note that, although

modifying the sequence of the pricing

methodology in this way slightly

changes the amount of dollars attributed

to the discount factor and to each

withhold, the participant-specific

professional episode payment amounts

and the participant-specific technical

episode payment amounts do not

change as a result of this modification.

We list all modifications to the pricing

methodology at the end of the pricing

methodology section, section III.C.6 of

this final rule.

b. Construction of Episodes Using

Medicare FFS Claims and Calculation of

Episode Payment

For the purpose of calculating the

national base rates, case mixes, and

historical experience adjustments, we

proposed to construct episodes based on

dates of service for Medicare FFS claims

paid during the CYs 2015–2017 as well

as claims that are included under an

episode where the initial treatment

planning service occurred during the

CYs 2015–2017 as discussed in section

III.C.3.d of the proposed rule and this

final rule. We proposed to exclude those

episodes that do not meet the criteria

discussed in section III.C.5 of this final

rule. Each episode and its

corresponding payment amounts, one

for the PC and one for the TC, would

represent the sum totals of calculated

payment amounts for the professional

services and the technical services of

the radiation treatment furnished over a

defined 90-day period as discussed in

section III.C.5.b of this final rule. We

proposed to calculate the payment

amounts for the PC and TC of each

episode as the product of: (a) The OPPS

or PFS national payment rates for each

of the RT services included in the

Model multiplied by (b) the volume of

each professional or technical RT

service included on a paid claim line

during each episode. We proposed to

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neither Winsorize nor cap payment

amounts nor adjust for outliers in this

step.

So that all payment amounts are in

2017 dollars, we proposed to convert

2015 payment amounts to 2017 by

multiplying: (a) The 2015 payment

amounts by the ratio of (b) average

payment amounts for episodes that

initiated in 2017 to (c) average payment

amounts for episodes that initiated in

2015. We proposed to apply this same

process for episodes starting in 2016. To

weigh the most recent observations

more heavily than those that occurred in

earlier years, we would weight episodes

that initiated in 2015 at 20 percent,

episodes that initiated in 2016 at 30

percent, and episodes that initiated in

2017 at 50 percent.

We proposed that conversion of 2015

and 2016 payment amounts to 2017

dollars would be done differently,

depending on which step of the pricing

methodology was being calculated. For

instance, episode payments for episodes

used to calculate national base rates and

case mix regression models would only

be furnished in the HOPD setting, and

consequently, for purposes of

calculating the national base rates and

case mix regression models, the

conversion of episode payment amounts

to 2017 dollars would be based on

average payments of episodes from only

the HOPD setting. On the other hand,

episode payments for episodes used to

calculate the historical experience

adjustments would be furnished in both

the HOPD and freestanding radiation

therapy center settings (that is, all

episodes nationally), and consequently,

for purposes of calculating the historical

experience adjustments, the conversion

of episode payment amounts to 2017

dollars would be based on average

payments of all episodes nationally

from both the HOPD and freestanding

radiation therapy center settings.

Comment: A few commenters

disagreed with weighting the most

recent episodes more heavily than those

that occurred in earlier years,

specifically weighting episodes that

initiated in 2015 at 20 percent, episodes

that initiated in 2016 at 30 percent, and

episodes that initiated in 2017 at 50

percent. A couple of commenters stated

that the 2017 rates were the lowest rates

of all three years in the baseline, yet

accounts for 50 percent of the national

base rates. A commenter stated that the

average reduction in rates from 2015 to

2017 was 11 percent for all included

modalities except Conformal External

Beam (CEB), which saw an 8 percent

increase. Another commenter stated that

the lower 2017 rates would increase the

net loss that participants are likely to

experience under the Model.

Response: We proposed to weight the

most recent year in the baseline more

heavily because this gives more weight

to the most recent episode data

available, including the most recent

treatment patterns, not because they are

the ‘‘lowest’’ rates. Furthermore, since

we are moving the dates of service for

the construction of episodes up a year

from CYs 2015–2017 to CYs 2016–2018,

episodes initiated in 2017 will be

weighted at 30 percent not 50 percent.

We are finalizing this provision with

modification to construct episodes

based on dates of service for Medicare

FFS claims paid during the CYs 2016–

2018 as well as claims that are included

under an episode where the initial

treatment planning service occurred

during the CYs 2016–2018 as discussed

in section C.III.6 of the proposed rule

and this final rule. To weigh the most

recent observations more heavily than

those that occurred in earlier years as

proposed, we will weight episodes that

initiated in 2016 at 20 percent, episodes

that initiated in 2017 at 30 percent, and

episodes that initiated in 2018 at 50

percent.

c. National Base Rates

We proposed to define the term

‘‘national base rate’’ to mean the total

payment amount for the relevant

component of each episode before

application of the trend factor, discount

factor, adjustments, and applicable

withholds for each of the included

cancer types. We further proposed to

codify this term at § 512.205 of our

regulations.

The proposed rule would exclude the

following episodes from calculations to

determine the national base rates:

•Episodes with any services

furnished by a CAH;

•Episodes without positive (>$0)

total payment amounts for professional

services or technical services;

•Episodes assigned a cancer type not

identified as cancer types that meet our

criteria for inclusion in the Model, as

discussed in section III.C.5.a of the

proposed rule (84 FR 34497 through

34498) and this final rule;

•Episodes that are not assigned a

cancer type;

•Episodes with RT services

furnished in Maryland, Vermont, or a

U.S. Territory;

•Episodes in which a PPS-exempt

cancer hospital furnishes the technical

component (is the attributed technical

provider);

•Episodes in which a Medicare

beneficiary does not meet the eligibility

criteria discussed in section III.C.4 of

this final rule.

We proposed to exclude episodes

without positive (>$0) total payment

amounts for professional services or

technical services, since we would only

use episodes where the RT services

were not denied and Medicare made

payment for those RT services. We

proposed to exclude episodes that are

not assigned a cancer type and episodes

assigned a cancer type not on the list of

Included Cancer Types, since the RO

Model evaluates the furnishing of RT

services to beneficiaries who have been

diagnosed with one of the included

cancer types. The remaining proposals

listed in section III.C.6.c of the proposed

rule excluded episodes that are not in

accordance with section III.C.5 of the

proposed rule.

(1) National Base Rate Calculation

Methodology

When calculating the national base

rates, we proposed to only use episodes

that meet the following criteria: (1)

Episodes initiated in 2015–2017; (2)

episodes attributed to an HOPD; and (3)

during an episode, the majority of

technical services were provided in an

HOPD (that is, more technical services

were provided in an HOPD than in a

freestanding radiation therapy center).

We explained in the proposed rule that

OPPS payments have been more stable

over time and have a stronger empirical

foundation than those under the PFS.

The OPPS coding and payments for

radiation oncology have varied less year

over year than those in the PFS for the

applicable time period. In addition,

generally speaking, the OPPS payment

amounts are derived from information

from hospital cost reports, which are

based on a stronger empirical

foundation than the PFS payment

amounts for services involving capital

equipment.

CMS proposed to publish the national

base rates and provide each RO

participant its participant-specific

professional episode payment amounts

and/or its participant-specific technical

episode payment amounts for each

cancer type no later than 30 days before

the start of the PY in which payments

in such amounts will be made.

Our proposed national base rates for

the Model performance period based on

the criteria set forth for cancer type

inclusion were summarized in Table 3

of the proposed rule.

Comment: Many commenters

disagreed with the proposal for

calculating the national base rates based

on average payment of episodes from

only the HOPD setting. These

commenters stated that utilizing only

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HOPD episodes does not reflect the

actual payment experience for

freestanding radiation therapy centers,

and that it is inappropriate to base a site

neutral test on HOPD episodes alone.

Some commenters questioned CMS’

rationale for excluding freestanding

radiation therapy center data from the

calculation of the national base rates.

The commenters claim that CMS’

rationale (that is, that HOPDs furnished

a lower volume of services and used less

costly modalities within such episodes

than did freestanding radiation therapy

centers even though HOPDs provided

more episodes nationally from 2015

through 2017) is not sufficient to

warrant the exclusion of freestanding

radiation therapy centers from the

calculation of the national base rates.

Another commenter stated that the

analysis conducted by CMS provides no

basis to suggest that higher utilization,

particularly of IMRT in freestanding

radiation therapy centers, is not

medically necessary. Another

commenter stated that particularly with

respect to treatment of prostate cancer,

the number of fractions for a course of

treatment have held constant for nearly

a decade, regardless of site of service. A

few commenters questioned the veracity

of the claim that the vast majority of

increased utilization is occurring in the

freestanding radiation therapy centers

and requested that CMS share the

details of its calculation that

freestanding radiation therapy centers

received 11 percent higher

reimbursement per episode than

HOPDs. MedPAC argued that using

HOPD rates would increase payments to

freestanding radiation therapy centers

and reduce savings for Medicare.

Finally, a few commenters took issues

with the premise that OPPS rates have

been more stable than the PFS rates,

since PFS payments for radiation

therapy codes have been frozen since

2015. Using one or more of the

previously discussed arguments, many

commenters recommended calculating

the national base rates using a blend of

PFS and OPPS rates rather than basing

the rates on OPPS rates alone. These

commenters argued that this blend

would better account for different care

patterns across the different sites of

service. Additionally, several

commenters recommended CMS use

more recent data than 2015–2017, if

available.

Response: We refer readers to the

November 2017 Report to Congress that

discusses FFS incentives and the site-of-

service payment differential between

HOPDs and freestanding radiation

therapy centers in detail. It is true that

the PFS rates have been fixed since 2015

and added stability temporarily, but

these rates were fixed at the behest of

professional organizations in radiation

oncology in large part because of their

concerns that those rates were unstable

and under review as being potentially

misvalued. The OPPS rates are

constructed from hospital cost data.

This cost data provides empirical

support for the OPPS rates. The PFS

rates do not have the same empirical

cost data backing, as we explained in

the proposed rule and in the November

2017 Report to Congress. We would also

like to clarify that, although the national

base rates in the RO Model are

calculated based on episodes occurring

in the HOPD setting, these episodes

include payments made to physicians

under the PFS for the PC and payments

to freestanding radiation therapy centers

for the TC in episodes where

beneficiaries sought treatment from both

HOPDs and freestanding radiation

therapy centers.

We disagree that a blend of PFS and

OPPS rates would better account for

different care patterns across the

different settings of HOPDs and

freestanding radiation therapy centers.

We believe the argument that the

number of fractions has held constant

for nearly a decade for a course of

treatment for prostate cancer, regardless

of site of service, supports the Model’s

move toward site neutrality, in that the

settings are comparable, and no matter

which site of service is used as the basis

for payment, it should make no

difference to treatment outcomes. We

have found no evidence supporting

different utilization rates based on

setting. For clarity, we have found no

evidence to suggest that, on average,

higher utilization rates are warranted for

RT services furnished in freestanding

radiation therapy centers than for RT

services furnished in the HOPD setting.

We proposed to adopt both case mix

and historical experience adjustments to

account for the different care patterns of

each RO participant specifically, not the

different care patterns of HOPDs and

freestanding radiation therapy centers in

general. Furthermore, as patterns of care

change over time, we will apply a trend

factor to the 32 different national base

rates to account for current trends in

payment for RT services and the volume

of those services outside of the Model in

both HOPDs and freestanding radiation

therapy centers. For clarity, we will use

the volume and payment for RT services

experienced in both settings to

determine the trend factor.

As for hypofractionation, the RO

Model is not intended to make

hypofractionation the standard of care

in radiation oncology unless it is

clinically appropriate to do so. We refer

readers to section III.B.3, aligning

payments to quality and value, rather

than volume, where the issue of

hypofractionation is discussed in detail.

We agree with the comment that using

HOPD rates would increase payments to

freestanding radiation therapy centers,

but only if we are considering payment

on a per service basis, not when services

are bundled under an episode of care

and paid for accordingly, as will be

done under the RO Model.

Finally, we agree with the

commenters about using more recent

baseline data, and therefore, we are

finalizing the calculation of national

base rates based on HOPD data as

proposed with modification to change

the baseline from 2015–2017 to 2016–

2018.

Comment: Several commenters raised

concerns regarding the OPPS

comprehensive APC (C–APC)

methodology. CMS applies this policy

to certain RT services under the OPPS

and commenters explained that

radiation oncology is better suited for

component coding to account for several

steps in the process of care. The

commenters also noted that the OPPS

C–APC methodology does not account

for the several steps in the process of

care and fails to capture appropriately

coded claims. A few commenters stated

that the amount a hospital charges for a

service does not have a direct or

consistent relationship to what the

service actually costs, and hospitals

often use monthly or repetitive service

claims. The commenters suggested that

CMS monitor the impact of the OPPS

methodology on payment rates under

the RO Model and consider using the

OPPS APC without the C–APC

methodology for the technical

component of the national base rate for

cervical cancer, in particular.

Response: We thank the commenters

for expressing their concerns regarding

the OPPS C–APC policy that is used to

pay for certain HOPD-furnished RT

services. We also appreciate their

recommendations regarding monitoring

the impact of these policies on the

episode payment amounts under the

Model. We refer readers to section

III.C.5.a, where we discuss the inclusion

of cervical cancer as it relates to the C–

APC methodology.

The purpose of the RO Model is to

test a site-neutral and modality-agnostic

approach to payment for RT services.

We determined it was necessary to

include certain RT services (for

example, Stereotactic Radio Surgery)

which are subject to the packaging

policy under the OPPS in the RO Model

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to help ensure site neutrality and a

modality-agnostic approach. For clarity,

we would have likely had to exclude

certain commonly provided RT services

if we wanted to avoid those codes that

are subject to the OPPS C–APC policy.

In addition, the RO Model will calculate

a single episode payment rate for all of

the included RT services for a 90-day

period. As a result, the impact of any

one code on the overall episode

payment amount is minimal. We will

monitor the impact of the C–APCs on

the episode payment rates.

Comment: Many commenters

expressed concerns regarding the

calculation of the national base rates in

that they believe the rates

inappropriately include palliative care

cases and distort the true cost of cancer

care. A few commenters expressed

concern about the lung cancer national

base rates, in particular, and stated that

47 percent of the cases were palliative

in nature. These commenters argued

that the intent of treatment should

determine pricing in these cases. CMS

should determine whether these cases

are palliative or curative in nature, and

from this, develop separate rates within

this cancer type.

Many commenters suggested that

removing palliative cases would more

accurately account for the cost of

delivering standard of care in radiation

oncology, but commenters differed on

which cases would constitute care that

is palliative in nature. A commenter

suggested removing conformal radiation

therapy treatment with ten or fewer

fractions and then creating a separate

‘‘Cancer symptom palliation, not

otherwise specified’’ episode, asserting

that pulling these cases out would more

accurately account for the cost of care.

A few commenters suggested removing

all episodes of 1–10 fractions with 2D or

3D management and removing non-

SBRT episodes. Another commenter

noted that even treatment courses of 11–

20 fractions have high probability of

being palliative episodes.

Response: In assigning cancer types,

we created the Model to be as sensitive

as possible in identifying palliative

cases, including bone and brain

metastasis cases. We believe the

methodology we use to assign cancer

types, which preferences assignment of

bone and brain metastasis cases,

appropriately captures those clinical

circumstances where a beneficiary was

treated not for cancer at the original site

but for metastasis to the bone or brain,

respectively. Other palliative cases

described by the commenters are part of

the set of historical episodes for other

cancer types and are included in their

national base rates. We refer readers to

the comment responses in the overview

of the pricing methodology in section

III.C.6.a, where we detail how cancer

type is assigned to an episode.

Removing episodes determined to be

palliative based solely on a low number

of treatments would remove cases where

a curative treatment included a low

number of fractions. We cannot

definitively determine if a treatment

was palliative in nature based on count

of fractions, and we do not intend to tie

episode payment to fraction count,

which would keep in place the FFS-

incentive structure the RO Model

intends to change. We will be

monitoring to ensure that episodes of

bone and brain metastasis are

appropriately billed under the Model.

We will not remove cases that are

perceived to be palliative in nature

based on the number of fractions

furnished during the episode.

Comment: Many commenters called

into question the integrity of data used

to generate the national base rates. Many

commenters stated that the national

base rate calculations inappropriately

include incomplete episodes of care. A

commenter stated that 14 percent of

HOPD cases look like incomplete

episodes, because they had technical

charges that were less than $5,000. A

commenter estimated that if these

incomplete episodes of care were to be

excluded, this would increase the

national base rates by approximately 16

percent.

Another commenter expressed

concern about the payment differential

between the average freestanding

radiation therapy center rate and the

average HOPD rate with regard to

prostate cancer. The commenter

attributed the payment differential,

whereby the freestanding radiation

therapy center rate was 7.5 percent

higher than the average HOPD rate, to

the additional $4,000 per episode for

brachytherapy.

A commenter stated that a few

providers and suppliers account for a

large percentage of the total amount of

episodes and that these providers and

suppliers could have a disproportionate

impact on the setting of the national

base rates, homogenizing the data used

to set those rates, and therefore, the

method of calculating the national base

rates should be reconsidered. Several

commenters stated that non-standard

treatment episodes are included in the

calculation of the national base rates,

and as a consequence, artificially

depress actual cost. In a similar vein, a

commenter added that artificially low

payments caused by coding errors and

billing infrequency in the HOPD setting

may cause CMS to qualify otherwise

efficient practices as inefficient

participants. As an example, the

commenter explained that many

episodes had more than 10

brachytherapy treatment delivery

services, while other episodes had

brachytherapy counts 1–10 or 11–20

and also 11–20 or 21–30 IMRT/CEB

counts. This signals an inconsistency in

the way codes were used in COUNT_

BRACHY. The commenter requested

that the code set used for each code

count be provided in the data dictionary

that accompanies the episode file on the

RO Model website.

Several commenters suggested CMS

establish tiered base rates rather than a

single base rate per cancer type. A

commenter suggested developing

different base rates based on resource

levels and clinical complexity

analogous to OPPS ambulatory payment

classification levels. Similarly, a few

commenters recommended the national

base rates be stratified based on the

clinical characteristics of beneficiaries

as this significantly affects the number

and type of treatment received, not just

by the broad category of cancer they

have. A commenter suggested that

cancer stage and intensity of treatment

be considered in payment. A commenter

suggested that CMS use fewer than 34

different national base rates, because so

many different rates would cause

confusion for RO participants that treat

multiple types of cancers.

Response: We thank these

commenters for expressing these

concerns and for their suggestions. We

disagree that incomplete episodes were

inappropriately included in the national

base rates. We used the same criteria to

identify episodes in the baseline as we

will use in the Model. Only episodes

that meet certain criteria, codified at

§ 512.250, would be included in the

national base rate calculation and in the

calculation of the trend factor, case mix

and historical experience adjustments.

We are finalizing episode exclusion

criteria with a few clarifications. We are

clarifying that we exclude episodes in

the baseline which are not attributed to

an RT provider or RT supplier, an

exceedingly rare case (less than 15

episodes out of more than 518,000

episodes in the baseline period) where

the only RT delivery services in the

episode are classified as professional

services (because there are a few

brachytherapy surgery services that are

categorized as professional services). We

are also clarifying that episodes are

excluded if either the PC or TC is

attributed to an RT provider or RT

supplier with a U.S. Territory service

location or to a PPS-exempt entity.

However, services within an episode

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provided in a US Territory or provided

by a PPS-exempt entity are included in

the episode pricing. Thus, for the

constructed episodes used to determine

the baseline, we will include the costs

of any services provided by such an RT

provider or RT supplier, as long as the

RT provider or RT supplier does not

provide the majority of either the

professional or technical services, in

which case the PC or TC would be

attributed to the entity and the episode

would be excluded. We are also

clarifying that episodes are excluded if

they include any RT service furnished

by a CAH. Further, we are clarifying that

we exclude all Maryland and Vermont

claims before episodes are constructed

and attributed to an RT provider or RT

supplier. For this reason, there are not

episodes in which either the PC or TC

is attributed to an RT provider or RT

supplier with a Maryland or Vermont

service location. We similarly exclude

inpatient and ASC claims from episode

construction and attribution.

Episodes are not excluded based on

any clinical standards of care or based

on the size of HOPD that furnished the

episode. We also do not use the size of

RT providers or RT suppliers, that is,

the number of episodes that a given RT

provider or RT supplier furnishes, as a

measure of exclusion. We disagree that

the national base rate calculation should

account for size of the RT provider or

RT supplier, as we do not believe that

large RT providers and RT suppliers

make up a disproportionate share of the

episodes in the calculation of the

national base rates. As long as HOPD

episodes meet inclusion criteria as

stated in section III.C.6.c, they will be

included in the calculation of the

national base rates, regardless of the size

of the RT provider or RT supplier where

the episode was furnished. It is

important to note that the cost of RT

services vary by modality and cancer

type, and although payment

differentials may exist across episodes

due to the use of multiple modalities as

a commenter stated, we believe that

using a blend to determine payment

(that is, a blending of participant-

specific historical payments with

national base rates to determine

payment) allows us to balance the

national context (as represented by the

spectrum of HOPDs nationally) with

participant experience.

Furthermore, we have only claims

data available to design and

operationalize the RO Model. These

claims data do not include clinical data,

which is why we are finalizing our

proposal to collect clinical data from RO

participants to assess the potential

utility of additional data for monitoring

and calculating episode payment

amounts (see section III.C.8.e). We do

not have the clinical or resource level

data to design tiered base rates as

several commenters suggested. Further,

we believe that the case mix adjustment

appropriately accounts for the

complexity of an RO participant’s

patient population, and the historical

experience adjustment captures

additional unmeasured factors that may

make one RO participant’s patient

population more complex, and thus

more costly, than another’s. Similarly,

no resource databases are available that

have the kind of data necessary to

determine national base rates for a

generalizable sample of Medicare FFS

beneficiaries. We believe the best way to

calculate prospective payment rates is to

look to what we have historically paid

for those episodes based on treatment

patterns in claims and historical

payment rates, and then trend these

amounts forward. We believe that

treatment patterns as reflected in the

episode file represent the variation in

care patterns currently delivered

nationally. We can only account for

codes that have been submitted in

claims. We cannot account for coding or

submission errors made on the part of

RT providers or RT suppliers, unless

they have been corrected appropriately

in claims. Furthermore, using fewer

than 32 different national base rates

would not appropriately compensate RO

participants for the cancer type they are

treating and the component they are

furnishing, whether professional or

technical. Based on a full review of

comments and the detailed analyses

contained within some of them, we

believe that commenters have had

sufficient detail to fully comment on the

proposed RO Model.

Comment: Many commenters also

expressed concern about the way in

which primary and secondary

malignancies are coded, suggesting that

improper coding could skew the

national base rates. These commenters

suggested that the presence of low cost

episodes in the episode file posted on

the RO Model website are likely

misattributed to a primary disease site

and should have been attributed to a

palliative care site and should not have

been included in the calculation of the

base rate of the attributed primary

disease site.

Response: The pricing methodology

does not attempt to assign cancer types

using clinical logic of primary and

secondary cancers, but rather follows a

plurality rule based on E&M services,

treatment planning services, and

treatment delivery services. We rely on

the data submitted on claims by

providers and suppliers to be accurate

per Medicare rules and regulations. We

refer readers to the comment responses

in the overview of pricing methodology

in section III.C.6.a, where we detail how

cancer type is assigned to each episode.

We believe this approach appropriately

captures episodes for the treatment of

metastases by prioritizing assignment to

those cancer types.

Comment: Several commenters stated

that data integrity is challenged by the

ICD–9 and ICD–10 diagnosis coding.

Many commenters requested more

detail on how diagnosis codes are

assigned. A few commenters stated that

the episode file on the RO Model

website had each episode classified by

disease site but not by ICD–9 or ICD–10

and requested that ICD–9 and ICD–10

codes be made available in the episode

file for review along with a guide on

how these codes are mapped to the

corresponding disease site. A few

commenters noted concern about the

transition from ICD–9 to ICD–10 coding

systems and called into question

providers’ and suppliers’ coding

accuracy when using the new ICD–10

code set alongside the 1-year grace

period that was granted for using the

ICD–9 code set. A commenters

requested specifically that the algorithm

for metastatic brain and breast ICD

codes be made public.

Response: We rely on the data

submitted on claims by providers and

suppliers to be accurate per Medicare

rules and regulations. The mapping of

ICD–10 diagnosis codes to cancer type

is described in Table 1. We believe

sufficient information was provided in

the episode file available on RO Model

website to allow comment. We are

finalizing the calculation of national

base rates based on HOPD data as

proposed with modification to change

the baseline from 2015–2017 to 2016–

2018. This modification reduces the risk

of coding errors that could result from

the transition from ICD–9 to ICD–10

codes.

Comment: Many commenters

disagreed with the proposal to include

proton beam therapy in the calculation

of the national base rates. MedPAC,

however, expressed support of CMS’

proposal to include PBT in the Model.

MedPAC explained that Medicare’s

payment rates for PBT are substantially

higher than for other types of external

beam radiation therapy. Additionally,

the use of PBT has expanded in recent

years from pediatric and rare adult

cancers to include more common types

of cancer, such as prostate and lung

cancer, despite a lack of evidence that

it offers a clinical advantage over

alternative treatments for these types of

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cancer. Some commenters believe that

including PBT in the episode payment

would create an incentive to use lower-

cost, comparable modalities.

Many commenters stated that the

national base rates do not include a

meaningful volume of PBT episodes in

the calculation and, therefore, the

payment rates are not reflective of the

cost of providing PBT, and, if finalized,

would lead to significant cuts. Several

commenters called attention to the

national base rate for head and neck

cancer in that PBT does not statistically

contribute to that rate, only accounting

for 0.8 percent of all modalities used, 18

of which were boost treatments.

Therefore, a large cohort of patients

incurs costs below the cost of the

standard episode of care for head and

neck cancer. Many commenters

recommended that PBT-specific

national base rates be developed to

reflect the high value resources and

patient complexity that is unique to

patients that require PBT.

Response: We thank these

commenters for expressing their

concerns and for their suggestions. RO

Model payments are designed to be

disease specific and agnostic to

treatment and modality type. We believe

that using a blend to determine payment

(that is, a blending of participant-

specific historical payments with

national base rates to determine

payment), whereby a large share of the

payment calculation is determined by

historical payments will appropriately

account for the difference in payment

for PBT. We refer readers to section

III.C.5.d for discussion of PBT.

Comment: A couple of commenters

noted that the episode file contained

episodes where the professional pay and

technical pay categories had a $0 value

and requested clarity on how this data

would be included in the analysis.

Response: Some payment variables on

the episode file that was made available

under the NPRM had missing values by

design. For example, the RADONC_

PRO_PAY, RADONC_TECH_PAY,

RADONC_PRO_PAY_WINSORIZED_

OPD, and RADONC_TECH_PAY_

WINSORIZED_OPD variables have

values set to ‘‘missing’’ for episodes in

the free-standing facility setting because

they are not used for payment-related

purposes under the Model. The

variables RADONC_PRO_PAY_

WINSORIZED_ALL and RADONC_

TECH_PAY_WINSORIZED_ALL are

fully populated because they are used in

creating historical experience

adjustments. These values are all greater

than $0.

Comment: Several commenters

disagreed with the proposal to provide

each RO participant its participant-

specific professional episode payment

and/or its participant-specific technical

episode payment for each cancer type

no later than 30 days before the start of

the PY in which payments in such

amounts would be made, explaining

that 30-day notice is insufficient. A few

commenters proposed 60-day notice and

a commenter proposed 90-day notice

similar to the notice given to

participants of the CJR Model.

Response: Because the RO payment

amounts incorporate the PFS and OPPS

payment rates in the trend factor, the

participant-specific professional and

technical episode payment amounts are

dependent upon publication of the PFS

and OPPS final payment rules for the

upcoming calendar year. These payment

regulations are statutorily required to be

60 days in advance of the start of a

calendar year. CMS then subsequently

performs calculations to determine the

RO Model trend factor and then creates

the participant-specific professional and

technical episode payment amounts. We

may notify RO participants of these

adjustments prior to the 30-day notice

deadline to the extent possible. As

noted in the proposed rule, even though

the Model will establish a common

payment amount for the same RT

services regardless of where they are

furnished, payment will still be

processed through the current claims

systems, with geographic adjustments as

discussed in section III.C.7 of the

proposed and this final rule, for OPPS

and PFS.

We are noting one technical change.

CMS will provide each RO participant

its case mix and historical experience

adjustments for both the PC and TC in

advance of the PY, rather than their

participant-specific professional and

technical episode payment amounts,

because exact figures for the participant-

specific professional and technical

episode payment amounts cannot be

known prior to claims processing for

several reasons.

First, we are only able to provide

estimates for geographic adjustment

based on the payment area(s) in which

an RO participant furnishes included

RT services. The exact geographic

adjustment will vary based on the

location billed by the RO participant, so

the actual payments calculated by CMS’

payment contractors may be different

from preliminary estimates. Second, any

differences of rounding at one step

versus another during payment

processing between a preliminary

estimate and what actually occurs

during claims processing could create

some small discrepancies. Third, any

estimate of the participant-specific

professional episode payment amounts

would not include any payment

adjustments due under MIPS. Fourth,

the participant-specific technical

payment amounts would not include

possible additional payments that

Medicare would make in the event that

the beneficiary coinsurance is capped at

the inpatient deductible limit under

OPPS. These issues taken together will

leave a discrepancy (and the size of the

discrepancy will vary among RO

participants) between what CMS could

estimate the participant-specific

professional and technical episode

payment amounts to be before the PY

begins and what RO participants

actually receive. Therefore, CMS will

provide each RO participant its case mix

and historical experience adjustments

for both the professional and technical

components, rather than their

participant-specific professional and

technical episode payment amounts, at

least thirty (30) days prior to the start of

the PY to which those adjustments

apply.

After considering public comments on

the proposed national base rates, we are

finalizing as proposed the determination

of national base rate as codified at

§ 512.250. We are finalizing our

proposal with one technical change. We

are modifying the regulatory text at

§ 512.255 to specify that 30 days before

the start of each performance year, CMS

will provide each RO participant its

case mix and historical experience

adjustments for both the professional

and technical components. We are also

finalizing the calculation of national

base rates with a modification from the

proposed rule that changes the baseline

from 2015–2017 to 2016–2018 and a

modification to exclude episodes from

the baseline in which either the PC or

TC is attributed to a provider with a

Maryland, Vermont, or US Territory

service location, rather than exclude

episodes with RT services furnished in

Maryland, Vermont, or a U.S. Territory

as proposed. Our 32 national base rates

for the Model performance period based

on the criteria set forth for cancer type

inclusion are summarized in Table 3

(noting the removal of kidney cancer

from the list of included cancer types

discussed in section III.C.5.c).

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41

The final HCPCS codes specific to the RO

Model would be published in an upcoming

quarterly update of the CY2020 Level 2 HCPCS

code file.

d. Proposal To Apply Trend Factors to

National Base Rates

We proposed to next apply a trend

factor to the 34 different national base

rates in Table 3 of the proposed rule.

For each PY, we would calculate

separate trend factors for the PC and TC

of each cancer type using data from

HOPDs and freestanding radiation

therapy centers not participating in the

Model. The 34 separate trend factors

would be updated and applied to the

national base rates prior to the start of

each PY (for which they would apply)

so as to account for trends in payment

rates and volume for RT services outside

of the Model under OPPS and PFS.

For the PC of each included cancer

type and the TC of each included cancer

type, we proposed to calculate a ratio of:

(a) Volume-weighted FFS payment rates

for RT services included in that

component for that cancer type in the

upcoming PY (that is, numerator) to (b)

volume-weighted FFS payment rates for

RT services included in that component

for that cancer type in the most recent

baseline year (that is, the denominator),

which will be FFS rates from 2017.

To calculate the numerator, we

proposed to multiply: (a) The average

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42

For 2020 (PY1), the most recent year with

complete episode data would be 2017; for 2021

(PY2), the most recent year with complete episode

data would be 2018.

43

The process of cross-walking the volume from

a previous set of codes to the new set of codes in

rate-setting for the PFS was most recently explained

in the CY 2013 PFS Final Rule, 77 FR 68891,

68996–68997.

number of times each HCPCS code

(relevant to the component and the

cancer type for which the trend factor

will be applied) was furnished for the

most recent calendar year with complete

data

42

by (b) the corresponding FFS

payment rate (as paid under OPPS or

PFS) for the upcoming performance

year.

To calculate the denominator, we

proposed to multiply: (a) The average

number of times each HCPCS code

(relevant to the component and the

cancer type for which the trend factor

will be applied) was furnished in 2017

(the most recent year used to calculate

the national base rates) by (b) the

corresponding FFS payment rate in

2017. The volume of HCPCS codes

determining the numerator and

denominator would be derived from

non-participant episodes that would be

otherwise eligible for Model pricing. For

example, for PY1, we would calculate

the trend factor as:

2020 Trend factor = (2017 volume *

2020 corresponding FFS rates as

paid under OPPS or PFS)/(2017

volume * 2017 corresponding FFS

rates as paid under OPPS or PFS)

We proposed to then multiply: (a) The

trend factor for each national base rate

by (b) the corresponding national base

rate for the PC and TC of each cancer

type from Step 1, yielding a PC and a

TC trended national base rate for each

included cancer type. The trended

national base rates for 2020 would be

made available on the RO Model’s

website once CMS issues the CY 2020

OPPS and PFS final rules that establish

payment rates for the year.

To the extent that CMS introduces

new HCPCS codes that CMS determines

should be included in the Model, we

proposed to cross-walk the volume

based on the existing set of codes to any

new set of codes as we do in the PFS

rate-setting process.

43

We proposed to use this trend factor

methodology as part of the RO Model’s

pricing methodology.

The following is a summary of the

public comments received on the

proposal to apply trend factors to

national base rates and our responses to

those comments:

Comment: A few commenters

expressed support for the proposal to

update the trend factor using the most

recent, complete calendar year of data

available. Several commenters,

however, opposed the application of the

trend factor as proposed for various

reasons. Several commenters stated that

the trend factor will reflect macro

changes to reimbursement and

utilization, not practice-specific

technology acquisition and, therefore,

the trend factor will not provide an

adequate safeguard for innovation

before technology has a significant

foothold in the marketplace. Many

commenters stated that the trend factor

is not nuanced enough and will

disadvantage providers and suppliers

who care for higher risk patients. Many

commenters expressed concern with the

delay between any increase in episode

cost occurring outside of the Model

among non-participants and the time it

would take to be reflected in the trend

factor. A commenter opposed the trend

factor as proposed if it would result in

lower base rates.

Many commenters suggested

modifications to the proposed trend

factor. Several commenters suggested

that CMS trend payment amounts based

on changes in the cost of technologies

and the mix of treatments that evidence

indicates is appropriate. In a similar

vein, several commenters suggested that

in addition to the trend factor, CMS

adopt a rate review mechanism whereby

RO participants could make the case for

participant-specific rate modifications

based on added service lines. Similarly,

a few commenters suggested carve out

payments for new service lines. For the

RO participants that introduced a new

radiation oncology service line in a

given period of time, for example, they

would be eligible for a carve-out

payment for part of the Model’s

performance period.

One commenter suggested using only

OPPS data to determine the trend

factors for the TC of the national base

rates. Another commenter suggested

including RO participant data in the

calculation of the trend factor. Another

commenter suggested recalculating the

trend factor denominator based on a

more recent year rather than 2017.

Several commenters requested

clarification as to how the trend factor

is calculated. A few commenters

requested clarity specifically as to

which fee schedules CMS will use to

calculate the trend factors.

Response: We will calculate unique

trend factors for the PC and TC

separately for each cancer type, since

the number and types of RT services

within episodes vary across the PC and

TC of each cancer type, and there is

sufficient national data to develop

separate trend factors for the PC and TC

of each cancer type just as there were for

development of the national base rates.

For the PC of each included cancer type

and the TC of each included cancer

type, we will calculate as proposed a

ratio of: (a) Volume-weighted FFS

payment rates for RT services included

in that component for that cancer type

in the upcoming PY (that is, numerator)

to (b) volume-weighted FFS payment

rates for RT services included in that

component for that cancer type in the

most recent baseline year (that is, the

denominator), which will be FFS rates

from 2018 rather than 2017 as was

proposed.

We would like to clarify how RT

services that are contractor-priced under

MPFS are incorporated into Model

pricing. Instead of relying on the CMS-

determined resource-based relative

value units (RVUs) to establish the

payment rate under the MPFS, Medicare

Administrative Contractors (MACs)

determine the payment rate for

contractor-priced services. This rate is

used by the MAC in their respective

jurisdiction. Payment rates across MAC

jurisdictions can vary. Due to the

potential differences across

jurisdictions, we will calculate the

average paid amounts for each year in

the baseline period for each of these RT

services to determine their average paid

amount that will be used in the

calculation of the national base rates.

We will use the most recent calendar

year with claims data available to

determine the average paid amounts for

these contractor-priced RT services that

will be used in the calculation of the

trend factors for the PC and TC of each

cancer type. For instance, for the 2021

trend factor, we will calculate the

average paid amounts for these

contractor-priced RT services using the

allowed charges listed on 2018 claims.

For the 2022 trend factor, we will

calculate the average paid amounts for

these contractor-priced RT services

using the allowed charges listed on the

2019 claims, and so forth.

We will calculate the numerator as

proposed and multiply: (a) The average

number of times each HCPCS code

(relevant to the component and the

cancer type for which the trend factor

will be applied) was furnished for the

most recent calendar year with complete

data by (b) the corresponding FFS

payment rate (as paid under OPPS or

PFS) for the upcoming PY. It is

important to note that for PY1 (2021),

the most recent year with complete

episode data will be 2018, not 2017, as

proposed. This mirrors the final policy

to change the baseline from 2015–2017

to 2016–2018 with respect to the

calculation of the national base rates.

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We would like to clarify that volume-

weighted FFS payment rate means a

weighted average of all of the included

RT services’ FFS payment rates, where

the frequency of each RT service

determines its relative contribution to

the calculation.

We will calculate the denominator as

proposed and multiply: (a) The average

number of times each HCPCS code

(relevant to the component and the

cancer type for which the trend factor

will be applying) was furnished in 2018

(and not 2017 as proposed), since this

is the most recent year used to calculate

the national base rates by (b) the

corresponding FFS payment rate in

2018 (and not 2017 as proposed). The

volume of HCPCS codes, which

determines the numerator and

denominator of the trend factors, will be

derived as proposed from non-

participant episodes that would be

otherwise eligible for Model pricing. For

example, for PY1, we will calculate the

trend factor as:

2021 (PY1) Trend factor = (2018 volume

* 2021 corresponding FFS rates as

paid under OPPS or PFS)/(2018

volume * 2018 corresponding FFS

rates as paid under OPPS or PFS)

It is important to note that the trend

factors will be based on service volumes

from episodes attributed to both HOPDs

and freestanding radiation therapy

centers, and both PFS and OPPS fee

schedules will be used to create the

annual trend factors. The use of trend

factors based on updated PFS and OPPS

rates ensures that spending under the

RO Model does not diverge too far from

spending under the FFS that non-

participants will receive for the

underlying bundle of services had they

been in the Model. The trend factors

will only generate significant swings if

there are large swings in payment rates

for RT services that are frequently used

during episodes, which is unlikely to be

the case. If there are big swings upward,

that is, OPPS or PFS rates or service

volumes increase, then RO participants

would receive the corresponding

increases. Conversely, if there were big

swings downward, spending under the

RO Model would become unsustainably

high comparable to the FFS alternative

if we did not apply a negative trend

factor, so RO participants would receive

the corresponding decreases.

As for considerations of innovation

and added service lines, the trend factor

will reflect updates to input prices as

reflected in updated PFS and OPPS

rates. Prospective payments in general,

including episode-based payment rates

of the RO Model, are not designed to

reflect specific investment decisions of

individual providers and suppliers,

such as practice-specific technology

acquisition. Furthermore, we do not

want to incorporate RO participants’

episodes (RO episodes) in the trend

factor calculation, because we do not

want to penalize RO participants for any

efficiencies gained during the Model. A

rate-review mechanism is not practical

at this time. We will monitor the

adequacy of payments over time,

including the trend factor and consider

re-baselining in the later PY if analysis

indicates it is necessary.

We are finalizing policies in this

section as proposed with a modification

to the years used in the trend factor’s

numerator and denominator calculation.

For the trend factor’s numerator

calculation, the most recent calendar

year with complete data used to

determine the average number of times

each HCPCS code was furnished will be

2018 for PY1, 2019 for PY2, and so

forth. We note that the corresponding

FFS payment rate (as paid under the

OPPS and PFS) included in the

numerator calculation is still that of the

upcoming PY (2021 payment rates for

PY1, 2022 payment rates for PY2, and

so forth). The trend factor’s denominator

calculation will use data from 2018 to

determine: (a) The average number of

times each HCPCS code (relevant to the

component and the cancer type for

which the trend factor will be applying)

was furnished; and (b) the

corresponding FFS payment rate. As

described in the proposed rule, the

denominator does not change over the

Model’s performance period unless we

propose to rebaseline, which we would

propose through future rulemaking.

e. Adjustment for Case Mix and

Historical Experience

In the proposed rule, we proposed

that after applying the trend factor in

section III.C.6.d of the proposed rule (84

FR 34506 through 34507), we would

adjust the 34 trended national base rates

to account for each RO participant’s

historical experience and case mix

history.

(1) Case Mix Adjustments

As explained in the proposed rule, the

cost of care can vary according to many

factors that are beyond a health care

provider’s control, and the presence of

certain factors, otherwise referred to

here as case mix variables, may vary

systematically among providers and

suppliers and warrant adjustment in

payment. For this reason, we proposed

to apply an RO participant-specific case

mix adjustment for the PC and the TC

that would be applied to the trended

national base rates.

In developing the proposed rule, we

consulted clinical experts in radiation

oncology concerning potential case mix

variables believed to be predictive of

cost. We then tested and evaluated these

potential case mix variables and found

several variables (cancer type; age; sex;

presence of a major procedure; death

during the first 30 days, second 30 days,

or last 30 days of the episode; and

presence of chemotherapy) to be

strongly and reliably predictive of cost

under the FFS payment system.

Based on the results of this testing, we

proposed to develop a case mix

adjustment, measuring the occurrence of

the case mix variables among the

beneficiary population that each RO

participant has treated historically (that

is, among beneficiaries whose episodes

have been attributed to the RO

participant during 2015–2017)

compared to the occurrence of these

variables in the national beneficiary

profile. The national beneficiary profile

was developed from the same episodes

used to determine the Model’s national

base rates, that is 2015–2017 episodes

attributed to all HOPDs nationally. We

would first Winsorize, or cap, the

episode payments in the national

beneficiary profile at the 99th and 1st

percentiles, with the percentiles being

identified separately by cancer type. We

proposed to use OLS regression models,

one for the PC and one for the TC, to

identify the relationship between

episode payments and the case mix

variables. The regression models would

measure how much of the variation in

episode payments can be attributed to

variation in the case mix variables.

The regression models generate

coefficients, which are values that

describe how change in episode

payment corresponds to the unit change

of the case mix variables. From the

coefficients, we proposed to determine

an RO participant’s predicted payments,

or the payments predicted under the

FFS payment system for an episode of

care as a function of the characteristics

of the RO participant’s beneficiary

population. As proposed, for PY1, these

predicted payments would be based on

episode data from 2015 to 2017. These

predicted payments would be summed

across all episodes attributed to the RO

participant to determine a single

predicted payment for the PC or the TC.

This process would be carried out

separately for the PC and the TC.

We proposed to then determine an RO

participant’s expected payments or the

payments expected when a participant’s

case mix (other than cancer type) is not

considered in the calculation. To do

this, we would use the average

Winsorized episode payment made for

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each cancer type in the national

beneficiary profile. These average

Winsorized episode payments by cancer

type would be applied to all episodes

attributed to the RO participant to

determine the expected payments.

These expected payments would be

summed across all episodes attributed

to an RO participant to determine a

single expected payment for the PC or

the TC. The difference between an RO

participant’s predicted payment and an

RO participant’s expected payment,

divided by the expected payment,

would constitute either the PC or the TC

case mix adjustment for that RO

participant. In the proposed rule, we

explained that mathematically this

would be expressed this as follows:

Case mix adjustment = (Predicted

payment ¥ Expected payment)/

Expected payment

The proposed rule noted that neither

the national beneficiary profile nor the

regression model’s coefficients would

change over the course of the Model’s

performance period. The coefficients

would be applied to a rolling 3-year set

of episodes attributed to the RO

participant so that an RO participant’s

case mix adjustments take into account

more recent changes in the case mix of

their beneficiary population. For

example, we proposed to use data from

2015–2017 for PY1, data from 2016–

2018 for PY2, data from 2017–2019 for

PY3, etc.

(2) Historical Experience Adjustments

and Blend (Efficiency Factor in

Proposed Rule)

To determine historical experience

adjustments for an RO participant we

proposed to use episodes attributed to

the RO participant that initiated during

2015–2017. We proposed to calculate a

historical experience adjustment for the

PC (that is, a professional historical

experience adjustment) and the TC (that

is, a technical historical experience

adjustment) based on attributed

episodes. For purposes of determining

historical experience adjustments, we

proposed to use episodes as discussed

in section III.C.6.b of this final rule (that

is, all episodes nationally), except we

proposed to Winsorize, or cap, episode

payments attributed to the RO

participant at the 99th and 1st

percentiles. These Winsorization

thresholds would be the same

Winsorization thresholds used in the

case mix adjustment calculation. We

would then sum these payments

separately for the PC and TC. As with

the case mix adjustments, the historical

experience adjustments will not vary by

cancer type.

As discussed in the proposed rule, the

historical experience adjustment for the

PC would be calculated as the difference

between: The sum of (a) Winsorized

payments for episodes attributed to the

RO participant during 2015–2017 and

(b) the summed predicted payments

from the case mix adjustment

calculation, which will then be divided

by (c) the summed expected payments

used in the case mix adjustment

calculations. We proposed to repeat

these same calculations for the

historical experience adjustment for the

TC. In the proposed rule, we explained

that mathematically, for episodes

attributed to the RO participant, this

would be expressed as:

Historical experience adjustment =

(Winsorized payments ¥ Predicted

payments)/Expected payments

Based on our calculation, if an RO

participant’s Winsorized episode

payments (determined from the

retrospectively constructed episodes

from 2015–2017 claims data) are equal

to or less than the predicted payments

used to determine the case mix

adjustments, then it would have

historical experience adjustments with a

value equal to or less than 0.0, and be

categorized as historically efficient

compared to the payments predicted

under the FFS payment system for an

episode of care as a function of the

characteristics of the RO participant’s

beneficiary population. Conversely, if

an RO participant’s episode payments

are greater than the predicted payments

used to determine the case mix

adjustments, then it would have

historical experience adjustments with a

value greater than 0.0 and be

categorized as historically inefficient

compared to the payments predicted

under the FFS payment system for an

episode of care as a function of the

characteristics of the RO participant’s

beneficiary population. The historical

experience adjustments would be

weighted differently and therefore,

applied to payment (that is the trended

national base rates after the participant-

specific case mix adjustments have been

applied) differently, depending on these

categories. To do this, we proposed to

use an efficiency factor. Efficiency factor

means the weight that an RO

participant’s historical experience

adjustments are given over the course of

the Model’s performance period,

depending on whether the RO

participant’s historical experience

adjustments fall into the historically

efficient or historically inefficient

category.

For RO participants with historical

experience adjustments with a value

greater than 0.0, the efficiency factor

would decrease over time to reduce the

impact of historical practice patterns on

payment over the Model’s performance

period. More specifically, for RO

participants with a PC or TC historical

experience adjustment with a value

greater than 0.0, we proposed that the

efficiency factor would be 0.90 in PY1,

0.85 in PY2, 0.80 in PY3, 0.75 in PY4

and 0.70 in PY5. For those RO

participants with a PC or TC historical

experience adjustment with a value

equal to or less than 0.0, the efficiency

factor would be fixed at 0.90 over the

Model’s performance period. The

following is a summary of the public

comments received on the proposed

case mix adjustment and historical

experience adjustments, and our

responses to those comments.

Comment: Several commenters

expressed support for the proposal to

have case mix and historical experience

adjustments. These commenters stated

that these adjustments would account

for RO participants’ varied historical

uses of more or less expensive

modalities and treatment decisions that

may be impacted by patient

demographics.

Response: We thank these

commenters for their support of these

adjustments.

Comment: A couple of commenters

expressed concern that the Model does

not address equipment replacement or

upgrades. A few commenters suggested

that CMS adopt a rate review

mechanism for new service lines and

upgrades. Another commenter used the

example of providers and suppliers who

add PBT centers and therefore lack

evidence of historical pricing in their

claims data—in such cases, this

commenter recommends exempting

these new service line modalities for

three years until the modality and

higher payment is accurately accounted

for in the practice’s historical claims

data.

Response: We appreciate the

commenters’ recommendations. In

section III.C.6.d of this final rule, we

respond to comments related to added

service lines. We note that prospective

payments in general, including episode-

based payment rates of the RO Model,

are not designed to reflect specific

investment decisions of individual

providers and suppliers, such as

practice-specific technology acquisition.

We did not propose to re-baseline

participants during the model to avoid

a possible reduction in payment due to

participants becoming more efficient

during the model, but we would

consider balancing this consideration

against the issue of new service lines as

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the model is implemented. We will

monitor for this occurrence and if

necessary propose a method to support

this in future rulemaking.

Comment: Several commenters

recommended that CMS design the case

mix and historical experience

adjustments to be cancer-specific rather

than participant-specific as it is

currently proposed.

Response: There are not enough

episodes to design a separate case mix

adjustment approach for each cancer

type, so we have chosen to create a

single case mix adjustment approach

across all cancer types. The case mix

model incorporates cancer type and so

the RO participant-specific case mix

adjustment for the PC and the TC

reflects the case mix of the participant’s

population including variation in the

cancer types treated. The same is true

for the approach taken for the historical

experience adjustment.

Comment: A commenter suggested

that aside from the case mix and

historical experience adjustments, CMS

should adjust payments to account for

the higher cost of delivering RT services

in rural communities than in urban

settings.

Response: Generally, CBSAs do not

include the extreme rural regions. In

cases where RO participants are

furnishing RT services in rural

communities, the historical experience

adjustment will account for those RO

participants’ historical care patterns and

their relative cost.

Comment: Many commenters

expressed concern over the case mix

adjustments. A few commenters

suggested that rather than deriving the

case mix adjustments from a rolling

three-year average, CMS should

implement a static baseline, while other

commenters suggested that the

coefficients of the case mix adjustment

formula should change annually. A

commenter suggested that a health care

provider’s case mix adjustment should

reflect the beneficiaries they treated in

the current performance year rather than

a beneficiary cohort for a few years

earlier. A few commenters stated that

the time lag between the years on which

the adjustment data is based and its

application to payment was especially

problematic for the use of mortality rate

as a case mix variable. These

commenters explained that death during

an episode and the timing of when a

patient died has the largest impact on a

health care provider’s case mix

adjustment. A commenter estimated that

if a beneficiary dies in the first 30 days

of an episode, the TC payment for that

episode would be nearly $6,000 less

than if the patient had survived. A

commenter argued that the case mix

adjustment disregards the differences

between the case mix of freestanding

radiation therapy centers and HOPDs.

Many commenters suggested that the

case mix adjustment be based on

beneficiary characteristics that affect the

appropriate type and amount of

evidence-based treatment that is

reflected in clinical data. These

commenters suggested a variety of

clinical factors should be accounted for

in the case mix adjustment. Commenters

stated such factors as disease stage, line

of treatment, comorbidities, treatment

intent, and change in patient acuity over

the course of the episode. A couple of

commenters recommended that social

determinants of health be incorporated

into the calculation of the case mix

adjustment. A commenter requested that

CMS derive each beneficiary’s HCC

score or NCI comorbidity index, test that

variable in the regression models, and

disclose the results. Another commenter

suggested differing payments based on a

participant’s patient risk levels.

Several commenters requested clarity

on the ordinary least squares regression

model that derives the case mix

adjustments. Several commenters asked

why cancer type is included in the case

mix adjustment. A few commenters

requested that CMS clarify the weight of

each variable used to calculate the case

mix adjustment. A few commenters

requested examples regarding the

calculation of predicted payments and

expected payments that determine the

case mix and historical adjustments. A

commenter specifically requested how

chemotherapy and major procedures are

defined under the RO Model and

suggested that the definitions align with

the OCM to promote alignment between

the two models.

Response: We thank these

commenters for expressing their

concerns and suggestions regarding the

case mix adjustment. The case mix

adjustment is designed to adjust

payment rates for demographic

characteristics, presence of

chemotherapy, presence of major

procedures, and death rates. We call

these the case mix variables. With

respect to chemotherapy, we define

chemotherapy using the same

definitions and coding lists as OCM.

With respect to major procedures, the

list of major procedure codes for

radiation oncology goes beyond the list

of cancer-related surgeries used in

OCM’s risk adjustment to include a

comprehensive set of major procedures

not necessarily related to cancer. As

noted in the proposed rule, we adopted

this approach after consulting with

clinical experts in radiation oncology.

These experts advised that utilization

and expenditures are influenced by the

presence of any major procedure, and

not just cancer-related procedures.

Cancer type is included in the case mix

adjustment to capture the proportionate

share of each cancer type in an RO

participant’s beneficiary population and

assess the resulting effects of the

particular mix of cancer types treated by

that RO participant on cost.

As noted in response to comments

concerning the national base rates, we

have only claims data available to

design and operationalize the RO

Model. The claims data do not include

clinical data. We are finalizing our

proposal to collect clinical data from RO

participants so that we can assess the

potential utility of additional clinical

data for monitoring and calculating

episode payment amounts (see section

III.C.8.e).

The case mix approach we adopt in

the Model has the goal of reflecting the

net impact of the case mix variables

after controlling for cancer type, which

is already accounted for in the national

base rates. We believe that the case mix

adjustment will provide a consistent

adjustment approach to the case mix of

episodes furnished by RO participants

in both the HOPD and freestanding

radiation therapy center settings. It is

true that we have designed the pricing

methodology around HOPD episode

utilization and expenditure patterns,

and that the case mix adjustment is

designed to measure the occurrence of

the case mix variables among the

beneficiary population that each RO

participant has treated historically in

the most recent 3-year set of data with

complete episodes available (that is,

among beneficiaries whose episodes

have been attributed to the RO

participant during 2016–2018 in PY1

and 2017–2019 in PY2, etc.) relative to

the occurrence of these variables in the

national beneficiary profile. The RO

Model, a prospective episode-based

payment model, requires a time lag

between the years on which the

adjustment data is based and the year it

is applied to payment, precisely because

it is prospective in nature. Since the

national base rate calculations are

premised on HOPD episodes nationally,

so too is the case mix model and the

case mix coefficients built upon these

episodes, so differences in

characteristics between that HOPD-

based national beneficiary population

and the beneficiary population the RO

participant has historically treated is

appropriately captured. Recall that the

national beneficiary profile is developed

from the same episodes used to

determine the Model’s national base

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rates, that is the updated 2016–2018

episodes attributed to all HOPDs

nationally. The 2016–2018 episodes

attributed to all HOPDs nationally are

the reference point used for comparison

to measure how much an RO

participant’s case mix should affect

their respective episode payment

amounts, precisely because the national

base rates are derived from those same

episodes.

We will develop a regression model as

proposed that predicts Winsorized

episode payment amounts based on

cancer type and demographic

characteristics, presence of

chemotherapy, presence of major

procedures, and death rates, and we will

also finalize our approach to calculating

the case mix adjustment as the

difference between predicted and

expected payment, which is then

divided by expected payment. To

provide more clarification and simplify

the process for calculating the expected

payment for each RO participant, rather

than using average Winsorized episode

payments for each cancer type as

proposed, we will develop a second

regression model that calculates

expected payment amounts based on

cancer type alone. This will align the

use of regression models in the

numerator and denominator of the case

mix calculation. For a given RO

participant, the difference between

predicted episode payment amounts

from the first regression model and

expected payment amounts from the

second regression model, which is then

divided by the expected payment

amounts, represents the net impact of

demographics, presence of

chemotherapy, presence of major

procedures, and death rates on episode

payment amounts for that RO

participant.

The case mix adjustment will be

updated for each RO participant

annually, based on a three-year rolling

period of episodes attributed to the RO

participant that will be input into the

case mix regression model. We cannot

use the case mix of episodes during the

current PY, because this would prevent

us from making a prospective payment.

As for the suggestion that rather than

deriving the case mix adjustments from

a rolling three-year average, CMS should

implement a static baseline, we note

that we use the same set of episodes to

create the case mix coefficients as we

did to generate the national base rates,

so that the case mix adjustment properly

connects to the starting point of the

national base rates. We will include

examples on the RO Model website that

demonstrate how the case mix and

historical experience adjustments are

calculated.

Comment: Many commenters

expressed concern over the historical

experience adjustments. A commenter

recommended that the historical

experience adjustment be removed

entirely as the national base rates are

disproportionately determined by the

Winsorized historical payment,

preventing the adoption of a truly site

neutral policy for radiation oncology. A

few commenters also recommended

removing the historical experience

adjustment, and adjusting the national

base rates instead through a blend of a

participant’s historical experience with

the national historical experience and

corresponding regional historical

experience.

One commenter requested that CMS

provide the number and type of

providers and suppliers that are

identified as historically efficient and

historically inefficient and how the

adjusted episode rates compare to the

amount providers and suppliers would

receive absent the Model.

Response: Our analyses show that

variation across regions of the country is

low, so we believe that a regional

historical experience adjustment is not

necessary. We identify what proportion

of CCNs and TINs are historically

efficient and what proportion are

historically inefficient based on the

updated 2016–2018 episode data, as

shown in Table 4. We do not want to

remove the historical experience

adjustments as this would cause an

abrupt transition in payment

determined largely or entirely by

national base rate amounts. We are

finalizing the case mix and historical

experience adjustments as proposed

with modification to a component part

of their calculation, the expected

payments as previously discussed in

this section, and with modification to

derive calculations based on episodes

from the same period, 2016–2018, used

to derive the national base rates, as

appropriate.

Comment: A few commenters

supported the proposed efficiency

factor, stating that this will help

practices as they transition into the

Model. Many commenters

recommended that the efficiency factor

be removed for efficient practices.

Several commenters including MedPAC

stated that the historical experience

adjustment as applied under the

efficiency factor would reward

historically inefficient providers and

suppliers and penalize historically

efficient providers and suppliers, paying

them more and less than the base rate,

respectively. A commenter added that

the efficiency factor does not protect

efficient participants from experiencing

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payment cuts under the Model. Several

commenters disagreed with the

efficiency factor proposal on the

grounds that it would financially

penalize participants that appropriately

treat beneficiaries who require more

expensive or more frequent treatments.

A few commenters suggested that

CMS should determine annually

whether a participant is efficient or not

based on more recent data, so that

participants that become efficient over

the course of the Model are rewarded

with an efficiency factor fixed at 0.90

over the Model performance period.

Response: We thank these

commenters for expressing both their

support and their concerns as well as

suggestions for the proposed efficiency

factor. We believe that renaming the

efficiency factor as the ‘‘blend,’’ will

help clarify what it represents and call

attention to its purpose of setting the

precise level of impact that the RO

participant’s specific historical

experience has on the episode payment

amounts. We calculate episode-based

payments under the RO Model based on

the average spend for each episode in all

HOPDs nationally. If RO participants

spent less historically (on average) than

the average spend of all HOPDs

nationally, then their payment amount

is 90 percent of what they would have

been paid historically for the PC and/or

TC of the respective cancer type

furnished and 10 percent of the

corresponding national base rate. This

will result in the historically efficient

RO participant seeing an increase in

payment compared to historical

amounts prior to the discount and

withholds being applied; for some of

these participants, the payment amounts

will be an increase under the Model

even with the discount and withholds

being applied. If we remove the

efficiency factor for efficient providers

and suppliers, this would prevent the

Model from maintaining costs or

achieving savings. For instance, see

Table 5 for an example of an efficient

RO participant in this section of this

final rule.

Similarly, if RO participants spent

more historically (on average) than the

average spend of all HOPDs nationally,

then their payment amount begins at 95

percent of what would have been paid

historically for the PC and/or TC of the

respective cancer type furnished and 5

percent of the corresponding national

base rate. This will result in the

historically inefficient RO participant

seeing a decrease in payment compared

to historical amounts, but the difference

would be gradual over time to allow the

RO participant to gradually adjust to the

new model payments. An RO

participant that is categorized as

historically inefficient, but becomes

more efficient over time, is rewarded

under this Model design, specifically as

the blend is designed. These RO

participants are privy to the sliding-

scale blend factor where payment each

PY is determined more and more by the

national base rates. If a historically

inefficient RO participant becomes more

efficient than the national average,

payment would be higher than what

they would receive under FFS because

the payment would be based on the

blend of the RO participant’s historical

payments and the national base rate,

both of which would be higher than

what they would receive under FFS

during the model for less costly care.

See Table 6 for examples of inefficient

RO participants in this section of this

final rule.

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We believe that historical payment is

the proper basis for comparison, and to

this effect, historically efficient RO

participants will experience an increase

in payment. In contrast, historically

inefficient RO participants will

experience an incremental decrease in

payment over the Model’s performance

period as the national base rates come

to account for incrementally more of the

payment outcomes. The RO Model is

not designed to create equal rates for all

RO participants as the only way to do

this without significantly decreasing

some RO participants’ payments

compared to their historical would be to

pay all RO participants at the highest

levels of any in the historical period. If

we were to do so, the RO Model would

result in much higher spending during

its performance period than would

occur absent the Model. Rather, the RO

Model is designed to create participant-

specific professional and technical

episode payment amounts that draw RO

participants as a group toward an

average payment over time. In order to

soften the transition from a FFS

payment system to an episode-based

one for RO participants, we designed a

pricing methodology that hews closely

to historical payment amounts. Finally,

we believe the case mix and historical

experience adjustments account for

beneficiaries who require more

expensive or more frequent treatments.

After considering the comments

received, we will finalize the case mix

adjustment with modification. The

formula that constitutes either the PC or

the TC case mix adjustment for an RO

participant, that is the difference

between an RO participant’s predicted

payment and an RO participant’s

expected payment, divided by the

expected payment, will not be modified.

We modified the way in which we will

calculate the expected payments. For

calculating the expected payment for

each RO participant, rather than using

average Winsorized episode payments

for each cancer type as proposed, we

will use a second regression model that

calculates expected payment amounts

based on cancer type alone.

After considering the comments

received, we will finalize the historical

experience adjustment as proposed, and

we will finalize the efficiency factor,

henceforth called the ‘‘blend,’’ with

modification. We refer readers to our

regulation at § 512.255(d). For RO

participants with a PC or TC historical

experience adjustment with a value

greater than zero (that is, historically

inefficient), the blend will be 90/10 in

PY1 where 90 percent of payment is

determined by the historical experience

of the RO participant and 10 percent of

payment is determined by the national

base rates. The blend will be finalized

as proposed to be 90/10 in PY1, 85/15

in PY2, 80/20 in PY3, 75/25 in PY4 and

70/30 in PY5. For those RO participants

with a PC or TC historical experience

adjustment with a value equal to or less

than zero (that is, historically efficient),

the blend will be finalized as proposed

to be fixed at 90/10 over the Model’s

performance period (PY1–PY5).

(3) Proposal To Apply the Adjustments

To apply the case mix adjustment, the

historical experience adjustment, and

the efficiency factor (now referred to as

the blend) as discussed in section

III.C.6.e of the proposed rule (84 FR

34507 through 34509) and this final rule

to the trended national base rates

detailed in Step 2, for the PC we

proposed to multiply: (a) The

corresponding historical experience

adjustment by (b) the corresponding

efficiency factor, and then add (c) the

corresponding case mix adjustment and

(d) the value of one. This formula

creates a combined adjustment that can

be multiplied with the national base

rates. In the proposed rule, we

expressed this mathematically as:

Combined Adjustment = (Historical

experience adjustment * Efficiency

factor) + Case mix adjustment + 1.0

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The combined adjustment would then

be multiplied by the corresponding

trended national base rate from Step 2

for each cancer type. We proposed to

repeat these calculations for the

corresponding case mix adjustment,

historical experience adjustment, and

blend for the TC, yielding a total of 34

RO participant-specific episode

payments for Dual participants and a

total of 17 RO participant-specific

episode payments for Professional

participants and Technical participants

(now 32 RO participant-specific episode

payments for Dual participants and a

total of 16 RO participant-specific

episode payments for Professional

participants and Technical participants

with the removal of kidney cancer).

We proposed to use these case mix

adjustments, historical experience

adjustments, and efficiency factors to

calculate the adjustments under the RO

Model’s pricing methodology.

We received no comments on this

proposal and, therefore, are finalizing

this provision with only the

modification that reflects the removal of

kidney cancer. We are finalizing this

provision with modification in that

calculations for the corresponding case

mix adjustment, historical experience

adjustment, and blend for the PC and

TC, yielding a total of 32 (not 34) RO

participant-specific episode payments

for Dual participants and a total of 16

(not 17) RO participant-specific episode

payments for Professional participants

and Technical participants.

(4) Proposal for HOPD or Freestanding

Radiation Therapy Center With Fewer

Than Sixty Episodes During 2015–2017

Period

In the proposed rule (84 FR 34508),

we proposed that if an HOPD or

freestanding radiation therapy center

(identified by a CCN or TIN) furnished

RT services during the Model

performance period within a CBSA

selected for participation and was

required to participate in the Model

because it meets eligibility

requirements, but had fewer than 60

episodes attributed to it during the

2015–2017 period, then the RO

participant’s participant-specific

professional episode payment and

technical episode payment amounts

would equal the trended national base

rates in PY1. In PY2, if an RO

participant with fewer than 60 episodes

attributed to it during the 2015–2017

period continued to have fewer than 60

episodes attributed to it during the

2016–2018 period, then we proposed

that the RO participant’s participant-

specific professional episode payment

and technical episode payment amounts

would continue to equal the trended

national base rates in PY2. However, if

the RO participant had 60 or more

attributed episodes during the 2016–

2018 period, then we proposed that the

RO participant’s participant-specific

professional episode payment and

technical episode payment amounts for

PY2 would equal the trended national

base rates with the case mix adjustment

added. In PY3–PY5, we proposed to

reevaluate those same RO participants

as we did in PY2 to determine the

number of episodes in the rolling three-

year period used in the case mix

adjustment for that performance year

(for example, PY3 will be 2017–2019).

RO participants that continue to have

fewer than 60 attributed episodes in the

rolling three year period used in the

case mix adjustment for that

performance year would continue to

have participant-specific professional

episode payment and technical episode

payment amounts that equal the trended

national base rates, whereas those that

have 60 or more attributed episodes

would have participant-specific

professional episode payment and

technical episode payment amounts that

equal the trended national base rates

with the case mix adjustment added.

The following is a summary of the

public comments we received on the

proposal related to RO participants with

fewer than 60 episodes during the 2015–

2017 period, and our responses to those

comments.

Comment: A few commenters

expressed support for the proposal that

if an RO participant had fewer than 60

episodes during the 2015–2017 period,

then that RO participant’s participant-

specific professional episode payment

and technical episode payment amounts

would equal the trended national base

rates. These commenters supported this

gradual approach to establishing

payment rates for low volume

participants that are typically small or

new practices that are likely to

gradually ramp up services over the life

of the Model.

Several commenters recommended

CMS exclude providers and suppliers

with fewer than 60 episodes during the

2015–2017 period, rather than just

making adjustments to their episode

payments. Another commenter noted

that for participants without historical

experience, the reduction in payment,

particularly for those delivering PBT,

would be immediate and could be as

high as 50 percent. Several commenters

proposed that a stop-loss policy be

added to protect those participants at

risk for significant loss. A few of those

commenters suggested that CMS pay

participants amounts that correspond to

the no-pay HCPCS codes in the amount

participants would have been paid

absent the RO Model if it exceeds

episode payments by a certain

percentage and referenced CMS APMs

such as the BPCI Advanced Model, the

CJR Model, Medicare Shared Savings

Program (MSSP), and OCM, which all

cap downside risk.

Response: We thank these

commenters for their support and

suggestions. We refer readers to the low

volume opt-out option in section

III.C.3.c, which applies to those

providers and suppliers that furnish

fewer than 20 episodes during the most

recent calendar year with claims data in

the CBSAs randomly selected for

participation. We agree with

commenters that if an RO participant

has fewer than 60 episodes during the

2016–2018 period (rather than 2015–

2017 period), then the RO participant

will not have a historical experience

adjustment unless we find the need to

rebaseline, which would require future

rulemaking. Furthermore, if an RO

participant has fewer than 60 episodes

during the 2016–2018 period, then the

RO participant will not receive a case

mix adjustment for PY1. Therefore, we

are finalizing our policy at

§ 512.255(c)(7) with the modification

that if an RO participant continues to

have fewer than 60 episodes attributed

to it during the 2017–2019 period, then

the RO participant will not have a case

mix adjustment for PY2. However, if the

RO participant has 60 or more attributed

episodes during the 2017–2019 period

that had fewer than 60 episodes in both

the 2016–2018 period, then the RO

participant will have a case mix

adjustment for PY2 and the remaining

PYs of the Model. In PY3–PY5, we will

reevaluate those same RO participants

that did not receive a case mix

adjustment the previous PY to

determine the number of episodes in the

rolling three-year period used in the

case mix adjustment for that

performance year (for example, PY3 will

be 2018–2020). Please see Table 10 that

summarizes data sources and time

periods used to determine the values of

key pricing components.

We also agree with commenters

regarding their concerns for RO

participants without historical

experiences and the payment reduction

that would result in the absence of a

historical experience. In response to

comments, we are including a stop-loss

limit of 20 percent for the RO

participants that have fewer than 60

episodes during the baseline period and

were furnishing included RT services in

the CBSAs selected for participation at

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the time of the effective date of this final

rule.

Using no-pay claims to determine

what these RO participants would have

been paid under FFS as compared to the

payments they received under the

Model, CMS will pay these RO

participants retrospectively for losses in

excess of 20 percent of what they would

have been paid under FFS. Payments

under the stop-loss policy are

determined at the time of reconciliation.

We are finalizing this stop-loss policy

at § 512.255(b)(7).

(5) Apply Adjustments for HOPD or

Freestanding Radiation Therapy Center

With a Merger, Acquisition, or Other

New Clinical or Business Relationship,

With or Without a CCN or TIN Change

We proposed that a new TIN or CCN

that results from a merger, acquisition,

or other new clinical or business

relationship that occurs prior to October

3, 2024, meets the Model’s proposed

eligibility requirements discussed in

section III.C.3 of the proposed rule and

this final rule. If the new TIN or CCN

begins to furnish RT services within a

CBSA selected for participation, then it

must participate in the Model. We

proposed this policy in order to prevent

HOPDs and freestanding radiation

therapy centers from engaging in

mergers, acquisitions, or other new

clinical or business relationships so as

to avoid participating in the Model.

We proposed for the RO Model to

require advanced notification so that the

appropriate adjustments are made to the

new or existing RO participant’s

participant-specific professional episode

payment and participant-specific

technical episode payment amounts.

This requirement for the RO Model is

the same requirement as at § 512.180(c)

of the proposed rule, except that under

the RO Model, RO participants must

also provide a notification regarding a

new clinical relationship that may or

may not constitute a change in control.

If there is sufficient historical data from

the entities merged, absorbed, or

otherwise changed as a result of this

new clinical or business relationship,

then this data would be used to

determine adjustments for the new or

existing TIN or CCN. For our policy

regarding change in legal name and

change in control provisions, we refer

readers to discussion at 84 FR 34489 of

the proposed rule and in section II.L

this final rule and our regulations at

§ 512.180(b) and (c).

We received no comments on this

proposal. We are finalizing our proposal

at § 512.255(b)(5), with modification to

align with the finalized Model

performance period so that this

provision would apply to a new TIN or

CCN that results from a merger,

acquisition, or other new clinical or

business relationship that occurs prior

to October 3, 2025 (changed from

October 3, 2024).

f. Applying a Discount Factor

After applying participant-specific

adjustments under section III.C.6.e of

the proposed rule to the trended

national base rates, we proposed, at 84

FR 34509, to next deduct a percentage

discount from those amounts for each

performance year. The discount factor

would not vary by cancer type. We

proposed that the discount factor for the

PC be 4 percent and the discount factor

for the TC be 5 percent. We proposed to

use the 4 and 5 percent discounts based

on discounts in other models tested

under section 1115A and private payer

models. We believed these figures for

the discount factor, 4 and 5 percent for

the PC and TC, respectively, struck an

appropriate balance in creating savings

for Medicare while not creating

substantial financial burden on RO

participants with respect to reduction in

payment.

We proposed to apply these discount

factors to the RO participant-adjusted

and trended payment amounts for each

of the RO Model’s performance years.

The following is a summary of the

public comments received on this

proposal to apply a discount factor and

our responses to those comments:

Comment: Many commenters

suggested reducing the discount factors

for both the PC and TC down within the

1 and 3 percent range or phasing in the

percentage of the discount factor over

several PYs. These commenters cited

the BPCI Advanced Model, the CJR

Model, and the proposed Episode

Payment Model along with the

downside track of the OCM, all of which

had lower discount factors than what is

currently proposed for the RO Model.

Many commenters expressed

particular concern about the discount

factor related to the TC. A few suggested

that RO participants should receive a 5

percent incentive payment based on

both the PC and TC as part of their APM

Incentive Payment. Alternatively, if

there is no opportunity to include the

TC payments in calculating the 5

percent APM Incentive Payment, then

the commenters recommended that

there should be no discount factor for

the TC. These commenters explained

that RO participants rely on technical

payments to invest in technologies,

which can increase the value of care and

decrease the long-term toxicity of RT

services.

Several commenters stated that the

discount factors create an un-level

playing field between RO participants

and non-participants. A commenter

questioned the validity of using private

payer models as a guide to setting

discount factor amounts in a Medicare

model, given the meaningful differences

in rate structures. A few commenters

requested that a rationale be given as to

why the discount factor for the TC is

higher than that of the PC.

Response: We thank these

commenters for expressing their

concerns and for their suggestions. We

designed the RO Model to test whether

prospective episode payments in lieu of

traditional FFS payments for RT

services would reduce Medicare

expenditures while preserving or

enhancing quality. We believe that

reducing the discount factors to 3.75

percent and 4.75 percent for the PC and

TC, respectively, balances the need for

the Model to achieve savings while also

reducing the impact on payment to RO

participants as initially proposed. The

level of discounts is based on actuarial

projections for how the Model as a

whole will impact Medicare payments;

the level of discounts is not based on

the percentage rate of the APM

Incentive Payments. We believe that RO

participants will benefit from their

participation in this alternative payment

model, and we disagree that the Model

will create an un-level playing field

between RO participants and non-

participants. Also, given that the 2

percent quality withhold applies to the

PC whereas the TC will have a 1 percent

patient experience withhold beginning

in PY3 (see section III.C.6.g), we believe

that the PC should have a lower

discount factor than the TC.

We are finalizing this provision with

modification in section III.C.6.f in that

the discount factors for the PC and TC

will each be reduced by 0.25 percent.

The discount factor for the PC will be

3.75 percent. The discount factor for the

TC will be 4.75 percent. Additionally,

we are modifying the regulatory text at

§ 512.205 to specify the Discount factor

means the set percentage by which CMS

reduces payment of the PC and TC. The

reduction on payment occurs after the

trend factor and model-specific

adjustments have been applied but

before beneficiary cost-sharing and

standard CMS adjustments, including

the geographic practice cost index

(GPCI) and sequestration, have been

applied.

g. Applying Withholds

We proposed to withhold a

percentage of the total episode

payments, that is the payment amounts

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after the trend factor, adjustments, and

discount factor have been applied to the

national base rates, to address payment

issues and to create incentives for

furnishing high quality, patient-centered

care. We outlined our proposals for

three withhold policies in section

III.C.6.g of the proposed rule and in this

section of this final rule.

(1) Incorrect Payment Withhold

We proposed to withhold 2 percent of

the total episode payments for both the

PC and TC of each cancer type. This 2

percent would reserve money to address

overpayments that may result from two

situations: (1) Duplicate RT services as

discussed in section III.C.6.a of the

proposed rule; and (2) incomplete

episodes as discussed in section III.C.6.a

of the proposed rule.

We proposed a withhold for these two

circumstances in order to decrease the

likelihood of CMS needing to recoup

payment, which could cause

administrative burden on CMS and

potentially disrupt an RO participant’s

cash flow. We believe that a 2 percent

incorrect payment withhold would set

aside sufficient funds to capture an RO

participant’s duplicate RT services and

incomplete episodes during the

reconciliation process. In the proposed

rule, we stated that we anticipate that

duplicate RT services requiring

reconciliation will be uncommon, and

that few overpayments for such services

will therefore be subject to our

reconciliation process. Claims data from

January 1, 2014 through December 31,

2016 show less than 6 percent of

episodes had more than one unique TIN

or CCN billing for either professional RT

services or technical RT services within

a single episode. Similarly, our analysis

showed that it is uncommon that a RT

provider or RT supplier does not furnish

a technical component RT service to a

beneficiary within 28 days of when a

radiation oncologist furnishes an RT

treatment planning service to such RO

beneficiary.

We proposed to use the annual

reconciliation process described in

section III.C.11 of this final rule to

determine whether an RO participant is

eligible to receive back the full 2 percent

withhold amount, a portion of it, or

must repay funds to CMS. We proposed

to define the term ‘‘repayment amount’’

to mean the amount owed by an RO

participant to CMS, as reflected on a

reconciliation report. We proposed to

codify the term ‘‘repayment amount’’ at

§ 512.205 of our regulations. In addition,

we proposed to define the term

‘‘reconciliation report’’ to mean the

annual report issued by CMS to an RO

participant for each performance year,

which specifies the RO participant’s

reconciliation payment amount or

repayment amount. Further, we

proposed to codify the term

‘‘reconciliation report’’ at § 512.205.

(2) Quality Withhold

We proposed to also apply a 2 percent

quality withhold for the PC to the

applicable trended national base rates

after the case mix and historical

experience adjustments and discount

factor have been applied. This would

allow the Model to include quality

measure results as a factor when

determining payment to participants

under the terms of the APM, which is

one of the Advanced APM criteria as

codified in 42 CFR 414.1415(b)(1).

Professional participants and Dual

participants would be able to earn back

up to the 2 percent withhold amount

each performance year based on their

aggregate quality score (AQS). We

proposed to define the term ‘‘AQS’’ to

mean the numeric score calculated for

each RO participant based on its

performance on, and reporting of,

quality measures and clinical data, as

described in section III.C.8.f of the

proposed rule, which is used to

determine an RO participant’s quality

reconciliation payment amount. We

proposed to codify this definition at

§ 512.205 of our regulations. We

proposed that the annual reconciliation

process described in section III.C.11 of

the proposed rule would determine how

much of the 2 percent withhold a

Professional participant or Dual

participant would receive back.

(3) Patient Experience Withhold

We proposed to apply a 1 percent

withhold for the TC to the applicable

trended national base rates after the case

mix and historical experience

adjustments and discount factor have

been applied starting in PY3 (January 1,

2022 through December 31, 2022) to

account for patient experience in the

Model. Under this proposal, Technical

participants and Dual participants

would be able to earn back up to the full

amount of the patient experience

withhold for a given PY based on their

results from the patient-reported

Consumer Assessment of Healthcare

Providers and Systems (CAHPS

®

)

Cancer Care Survey for Radiation

Therapy (CAHPS

®

Cancer Care survey)

as discussed in section III.C.8.b of the

proposed rule.

Like the incorrect payment and

quality withholds, the initial

reconciliation process discussed in

section III.C.11 of the proposed rule

would determine how much of the 1

percent patient experience withhold a

participant will receive back.

We proposed the incorrect payment

withhold, the quality withhold, and the

patient experience withhold be

included in the RO Model’s pricing

methodology. The following is a

summary of the public comments we

received on this proposal and our

responses to those comments:

Comment: Many commenters

expressed concerns with the incorrect

payment withhold, the quality

withhold, and the patient experience

withhold and the financial burden that

these withholds could pose for RO

participants. A few commenters

requested that CMS explain the

rationale for the withholds over other

means of accounting for patient

experience and quality in the Model. A

few commenters stated that the

withholds are punitive in nature as they

occur prior to the delivery of services.

A commenter noted that the funds

withheld, which are eventually paid to

the participant through the

reconciliation process, are not subject to

coinsurance collection from

beneficiaries or from beneficiaries’

supplemental insurance. A commenter

stated that withholds applied to the TC

in particular will make it difficult to

keep up with debt service.

Several commenters expressed

concern over the incorrect payment

withhold in particular. A few

commenters suggested eliminating the

incorrect payment withhold. A

commenter called attention to the CMS

claim that it is uncommon that a RT

provider or RT supplier does not furnish

a technical component RT service to a

beneficiary within 28 days of when the

radiation oncologist furnishes an RT

treatment planning service to such RO

beneficiary, and that, therefore, the

additional cash flow burden the

incorrect episode withhold would place

on RO participants is not warranted. A

commenter suggested recouping funds

from participants for duplicate services

and incomplete episodes in the

subsequent performance year rather

than implementing a withhold structure

to prospectively account for those

funds. The commenter argued that this

would reduce RO participants’ financial

exposure.

One commenter specifically

addressed the patient experience

withhold. This commenter disagreed

with the 1 percent patient experience

withhold starting in PY3, stating that

patient experience surveys that are

mailed out have varying response rates,

do not adequately capture performance,

and as such the 1 percent patient

experience withhold is unreasonable.

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This commenter argued that the patient

experience surveys should only serve as

supplemental data collection.

Response: We thank these

commenters for expressing their

concerns and for their suggestions.

Although we expect incomplete

episodes and duplicate payments to be

uncommon, we believe that the burden

of recoupment (if we were to not do a

withhold) would outweigh the burden

of withholding funds until annual

reconciliation for those RO episodes

that require reconciliation.

Yet, given stakeholders’ concerns

regarding the cash flow burden that the

withholds may cause and given that

funds withheld are not subject to

coinsurance collection from

beneficiaries or from beneficiaries’

supplemental insurance, we are

finalizing a reduced incorrect payment

withhold of 1 percent rather than 2

percent. The reduction of this withhold

will also ease the burden of keeping up

with debt service as a commenter noted.

We believe that the upfront quality

withhold will provide the incentive for

RO participants to provide high-quality

care. Further, we believe that the

predetermined withholds help support

the Model goal of providing RO

participants with prospective,

predictable payments. As for

effectiveness of the patient experience

surveys, we refer commenters to section

III.C.8, where quality measures are

discussed in detail. We note that we

would propose specific benchmarks for

the patient experience measures in

future rule-making.

After considering public comments,

we are finalizing our proposals on

incorrect payment withhold, quality

withhold, and patient experience

withhold, with modifications. We are

finalizing the quality withhold amounts

as proposed beginning in PY1 (January

1, 2021, through December 31, 2021)

and the patient experience withhold as

proposed beginning in PY3 (January 1,

2023 through December 31, 2023), but

we will reduce the incorrect payment

withhold to 1 percent beginning in PY1.

Based on the concerns raised by

commenters, we intend to reevaluate

this amount and need for the incorrect

payment withhold in PY3. Additionally,

we have modified the text of the

regulation at § 512.255(h), (i), and (j) to

describe how incorrect payment

withhold, quality withhold, and patient

experience withhold would be applied

to the national base rates, in a manner

consistent with the regulatory text for

how other adjustments (for example, the

discount factor and geographic

adjustment) are applied to the national

base rate.

h. Adjustment for Geography

As noted in the proposed rule,

geographic adjustments are standard

Medicare adjustments that occur in the

claims system. Even though the Model

will establish a common payment

amount for the same RT services

regardless of where they are furnished,

payment will still be processed through

the current claims systems, with

adjustments as discussed in section

III.C.7 of the proposed and this final

rule, for OPPS and PFS. We proposed

that geographic adjustments would be

calculated within those shared systems

after CMS submits RO Model payment

files to the Medicare Administrative

Contractors that contain RO participant-

specific calculations of payment from

steps (a) through (g). We proposed to

adjust the trended national base rates

that have been adjusted for each RO

participant’s case mix, historical

experience and after which the discount

factor and withholds have been applied,

for local cost and wage indices based on

where RT services are furnished,

pursuant to existing geographic

adjustment processes in the OPPS and

PFS.

OPPS automatically applies a wage

index adjustment based on the current

year post-reclassification hospital wage

index to 60 percent (the labor-related

share) of the OPPS payment rate. We

stated in the proposed rule that no

additional changes to the OPPS Pricer

are needed to ensure geographic

adjustment.

The PFS geographic adjustment has

three components that are applied

separately to the three RVU components

that underlie the PFS—Work, PE and

MP. To calculate a locality-adjusted

payment rate for the RO participants

paid under PFS, we proposed to create

a set of RO Model-specific RVUs using

the national (unadjusted) payment rates

for each HCPCS code of the included RT

services for each cancer type included

in the RO Model. First, the trended

national base rates for the PC and TC

would be divided by the PFS conversion

factor (CF) for the upcoming year to

create an RO Model-specific RVU value

for the PC and TC payment amounts.

Next, since the PFS geographic

adjustments are applied separately to

the three RVU components (Work, PE,

and MP), these RO Model-specific RVUs

would be split into RO Model-specific

Work, PE, and MP RVUs. The 2015–

2017 episodes that had the majority of

radiation treatment services furnished at

an HOPD and that were attributed to an

HOPD would be used to calculate the

implied RVU shares, or the proportional

weights of each of the three components

(Work, PE, and MP) that make up the

value of the RO Model-specific RVUs.

Existing radiation oncology HCPCS

codes that are included in the bundled

RO Model codes but paid only through

the OPPS would not be included in the

calculation. The RVU shares would be

calculated as the volume-weighted

Work, PE, and MP shares of each

included existing HCPCS code’s total

RVUs in the PFS. The PCs and TCs for

the RO episodes would have different

RO Model-specific RVU shares, but

these shares would not vary by cancer

type. Table 4 of the proposed rule (at 84

FR 34510) provided the proposed

relative weight of each for the PCs and

TCs of the RO Model-specific RVUs

share.

We indicated in the proposed rule

that we would include these RO Model-

specific RVUs in the same process that

calculates geographically adjusted

payment amounts for other HCPCS

codes under the PFS with Work, PE, and

MP and their respective RVU value

applied to each RO Model HCPCS code.

We proposed to apply the OPPS

Pricer as is automatically applied under

OPPS outside of the Model. We

proposed to use RO Model-specific RVU

shares to apply PFS RVU components

(Work, PE, and MP) to the new RO

Model payment amounts in the same

way they are used to adjust payments

for PFS services. See RVU shares in

Table 7.

The following is a summary of the

public comments we received on the

proposal to adjust for geography, and

our responses to those comments:

Comment: A few commenters stated

that all components of the pricing

methodology should be based on

geographically standardized payments

as it would be inappropriate for CMS to

compare geographically-adjusted

historical payments with non-

geographically-adjusted predicted

payments. A couple of commenters

stated that the adjustment for geography

was unnecessary or inappropriate. A

commenter explained that the

geographic adjustment was

inappropriate, because the national

market determines competition and

purchase price in the field of radiation

oncology. Another commenter agreed

that the adjustment was unnecessary,

but explained that it was unnecessary

not because of the national market

argument, but because the national base

rates are set using 2015–2017 claims

data to which the GPCI had already

been applied.

Response: We thank these

commenters for these suggestions. We

would like to clarify that we construct

and calculate the payment amounts for

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the PC and TC of each episode as the

product of: (a) The OPPS or PFS

national payment rates for each of the

RT services included in the Model

multiplied by (b) the volume of each

professional or technical RT service

included on a paid claim line during

each episode. Episode payments under

the Model are standardized in the sense

that their basis is service volume and

national fee schedule prices. Moreover,

the calculations that determine the

trend factors as well as the case mix and

historical experience adjustments are

based on these standardized payments

that are without geographic adjustment.

As previously stated, this method of

geographic adjustment is the standard

way we pay through PFS and OPPS, and

we want to recognize differences in

payment based on geographic area. We

have no way of determining whether the

national market determines competition

or purchase price in the field of

radiation oncology, as a commenter

suggested. Importantly, we want to

design episode payments in such a way

that they could be implemented on a

broader scale, if the Model is successful.

After considering public comments,

we are finalizing our proposal on the

geographic adjustment with

modification to clarify that although the

RO Model-specific RVU values are

derived from the national base rates

which we are finalizing to be based on

2016–2018 episodes that had the

majority of radiation treatment services

furnished at an HOPD and that were

attributed to an HOPD, we will use only

2018 episodes to calculate the implied

RVU shares, or the proportional weights

of each of the three components (Work,

PE, and MP). These RVU shares are part

of the calculus determining the RO

Model-specific RVU values.

i. Applying Coinsurance

We proposed to calculate the

coinsurance amount for an RO

beneficiary after applying, as

appropriate, the case mix and historical

experience adjustments, withholds,

discount factors, and geographic

adjustments to the trended national base

rates for the cancer type billed by the

RO participant for the RO beneficiary’s

treatment. Under current policy,

Medicare FFS beneficiaries are generally

required to pay 20 percent of the

allowed charge for services furnished by

HOPDs and physicians (for example,

those services paid for under the OPPS

and PFS, respectively). We proposed

that this policy remain the same under

the RO Model. RO beneficiaries will pay

20 percent of each of the bundled PC

and TC payments for their cancer type,

regardless of what their total

coinsurance payment amount would

have been under the FFS payment

system.

In the proposed rule (84 FR 34510

through 34511), we stated that

maintaining the 20 percent coinsurance

payment would help preserve the

integrity of the Model test and the goals

guiding its policies. Adopting an

alternative coinsurance policy that

would maintain the coinsurance that

would apply in the absence in the

Model, where volume and modality

type would dictate coinsurance

amounts, would change the overall

payment that RO participants would

receive. This would skew Model results

as it would preserve the incentive to use

more fractions and certain modality

types so that a higher payment amount

could be achieved.

In the proposed rule, we noted that,

depending on the choice of modality

and number of fractions administered

by the RO participant during the course

of treatment, the coinsurance payment

amount of the bundled rate may

occasionally be higher than what a

beneficiary or secondary insurer would

otherwise pay under Medicare FFS.

However, because the PC and TC would

be subject to withholds and discounts

described in the previous section, we

stated in the proposed rule that we

believed that, on average, the total

coinsurance paid by RO beneficiaries

would be lower than what they would

have paid under Medicare FFS for all of

the services included in an RO episode.

In other words, the withholds and

discount factors would, on average, be

expected to reduce the total amount RO

beneficiaries or secondary insurers will

owe RO participants.

In the proposed rule, we also

explained that because episode payment

amounts under the RO Model would

include payments for RT services that

would likely be provided over multiple

visits, the beneficiary coinsurance

payment for each of the episode’s

payment amounts would consequently

be higher than it would otherwise be for

a single RT service visit. For RO

beneficiaries who do not have a

secondary insurer, we stated in the

proposed rule that we would encourage

RO participants to collect coinsurance

for services furnished under the RO

Model in multiple installments via a

payment plan (provided the RO

participants would inform patients of

the installment plan’s availability only

during the course of the actual billing

process).

In addition, for the TC, we proposed

to continue to apply the limit on

beneficiary liability for copayment for a

procedure (as described in in section

1833(t)(8)(C)(i) of the Act) to the

applicable trended national base rates

after the case mix and historical

experience adjustments, discount factor,

applicable withholds, and geographic

adjustment have been applied.

We solicited public comment on our

proposal to apply the standard

coinsurance of 20 percent to the trended

national base rates for the cancer type

billed by the RO participant for the RO

beneficiary’s treatment after the case

mix and historical experience

adjustments, withholds, discount

factors, and geographic adjustments

have been applied.

The following is a summary of the

public comments received on this

proposal and our responses:

Comment: Many commenters

requested clarification as to the role of

secondary payers, MediGap, and

Medicaid and whether secondary payers

would be held accountable if the RO

episode is not allowed and payment is

recouped. A commenter requested

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clarification as to whether CMS would

provide information to insurance

entities that receive crossover or

secondary claims under the Model. A

commenter recommended that CMS

follow current Coordination of Benefits

rules and transmit no-pay claims for RT

services under the RO Model as ‘‘paid’’

to supplemental insurers for secondary

payment under FFS.

Response: We appreciate the

commenters concerns. CMS liaisons to

the secondary payers will provide RO

Model-specific information to those

payers including how the RO Model-

specific HCPCS shall be processed.

Current Coordination of Benefits rules

shall continue to apply. As noted in the

proposed rule, we expect to provide RO

participants with additional instructions

for billing, particularly as it pertains to

secondary payers and collecting

beneficiary coinsurance. Additional

instructions will be made available

through the Medicare Learning Network

(MLN Matters) publications, model-

specific webinars, and the RO Model

website.

Comment: A few commenters

expressed concern that the Model’s

policy of imposing a 20 percent

coinsurance payment on the episode

payment amount will be confusing to

beneficiaries. Some commenters

requested specific guidance on creating

a payment plan for beneficiaries and

expressed concern that participants will

not have the billing staff to implement

payment plans for beneficiaries. A few

commenters disagreed with CMS’

proposal to encourage RO participants

to implement payment plans for

beneficiaries but to restrict RO

participants’ ability to inform patients of

the payment plan’s availability to the

time of the actual billing process. Those

commenters argue that this delay,

waiting until the course of the actual

billing process, conflicts with CMS’

price transparency proposal that

patients know their financial

responsibilities prior to receiving

services. A few commenters added that

CMS should not dictate when this

discussion occurs. A commenter

requested clarification as to whether

uncollected beneficiary coinsurance

under the RO Model remains subject to

additional payment under the Medicare

bad debt provision.

Response: It is important to note that

RO participants should expect to receive

beneficiary coinsurance in the same

manner as they do for FFS. All the

standard rules and regulations under

FFS pertaining to beneficiary

coinsurance apply under the RO Model,

including the Medicare bad debt

provision. We do not believe that

beneficiaries would be confused by 20

percent of episode payment as 20

percent is the standard coinsurance

policy under Medicare. Although we

encourage RO participants to implement

payment plans for RO beneficiaries,

neither the proposed rule nor the final

rule requires RO participants to

implement payment plans. At this time,

we are not providing specific guidance

on creating payment plans because we

believe that RO participants who choose

to implement a payment plan for

beneficiaries should have the flexibility

to create one that meets their needs. We

agree with the commenter that patients

should be informed of the availability of

the payment plan before they receive

services under the RO Model. However,

the availability of payment plans may

not be used as a marketing tool to

influence beneficiary choice of health

care provider. Accordingly, we are

finalizing at § 512.255(b)(12) a provision

that (1) permits RO participants to

collect beneficiary coinsurance

payments for services furnished under

the RO Model in multiple installments

via a payment plan, (2) prohibits RO

participants from using the availability

of payment plans as a marketing tool to

influence beneficiary choice of health

care provider, and (3) provides that an

RO participant offering such a payment

plan may inform the beneficiary of the

availability of the payment plan prior to

or during the initial treatment planning

session and as necessary thereafter.

Comment: Several commenters

expressed concerns that beneficiaries

who receive fewer or lower-cost RT

services than average for their cancer

type would pay more in cost-sharing in

a participating region than if they had

received the same treatment in a non-

participating region. A commenter

noted that although many patients have

supplemental insurance that will shield

them from higher cost-sharing amounts,

some beneficiaries may be financially

harmed by this approach. A few

commenters suggested CMS set

beneficiary cost-sharing at the lesser of

(a) what the beneficiary would have

paid in cost-sharing under Medicare

FFS payment amounts for the specific

services the patient received, or (b) 20

percent of the bundled payment

amount. Several commenters suggested

that CMS should base beneficiary

coinsurance on no-pay FFS claims for

services provided during an RO episode.

A commenter suggested removing the

requirement of beneficiary coinsurance

of 20 percent on each of the episode’s

payment amounts in a specific instance,

such as when a beneficiary ends

treatment after receiving a single

radiation treatment.

Response: We thank these

commenters for expressing their

concerns and for their suggestions.

Although a beneficiary’s coinsurance

obligation under most RO episodes may

not be the same as it would be under

Medicare FFS, we believe that, on

average, the total coinsurance paid by

RO beneficiaries would be lower than

what they would have paid under

Medicare FFS for all of the services

included in an RO episode. The average

payment amounts from which the 20

percent of coinsurance is determined is

reduced by both the discount factor and

the withholds. There may be cases

where the beneficiary coinsurance is

slightly higher than what the RO

beneficiary would have owed under

FFS. Yet, for a bundled payment

approach that moves away from FFS

volume-based incentives to payment

based on the average cost of care, this

is unavoidable. This would present a

payment issue in that either CMS or the

RO participant may need to absorb any

potential reduction in episode payment.

Furthermore, we did not propose to base

beneficiary coinsurance on no-pay FFS

claims because, if we did so, then a

significant portion of the payments that

an RO participant received under the

Model would be premised on FFS

payment and be subject to the usual FFS

volume-based incentives. To avoid

compromising the integrity of the Model

test in this way, we are not waiving the

20 percent beneficiary coinsurance

requirement based on the beneficiary

receiving a limited number of RT

services, such as one RT service.

However, we are not finalizing our

coinsurance proposal with respect to a

subset of incomplete episodes,

specifically those in which: (1) The TC

is not initiated within 28 days following

the PC; (2) the RO beneficiary ceases to

have traditional FFS Medicare prior to

the date upon which a TC is initiated,

even if that date is within 28 days

following the PC; or (3) the RO

beneficiary switches RT provider or RT

supplier before all RT services in the RO

episode have been furnished.

Thus, the beneficiaries who receive

RT services in this subset of incomplete

episodes would pay the coinsurance

amount of 20 percent of the FFS

amounts for those services. We note that

RO participants that set up coinsurance

payment plans may be able to charge

and adjust coinsurance more timely and

accurately for incomplete episodes; but

in some circumstances the true amount

owed by the beneficiary may not be

determined until the reconciliation

process has occurred.

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In instances where an RO beneficiary

ceases to have traditional FFS Medicare

as his or her primary payer at any time

after the initial treatment planning

service is furnished and before the date

of service on a claim with an RO Model-

specific HCPCS code and EOE modifier,

provided that a Technical participant or

the same Dual participant furnishes a

technical component RT service to the

RO beneficiary within 28 days of such

initial treatment planning service, the

RO beneficiary would pay 20 percent of

the first installment of the RO episode.

However, if the RO participant bills the

Model-specific HCPCS code and EOE

modifier with a date of service that is

prior to the date that the RO beneficiary

ceases to have traditional FFS Medicare,

then the beneficiary coinsurance

payment equals 20 percent of the full

episode payment amount for the PC or

TC, as applicable. Because these

policies would only apply to a relatively

small number of RO episodes, we do not

believe that it would be unduly

burdensome for RO participants to

administer or affect the integrity of the

Model test and the goals guiding its

policies.

We are finalizing, in part, our

proposal related to coinsurance.

Specifically, we are codifying at

512.255(b)(12) the requirement that RO

participants offering a payment plan

may not use the availability of the

payment plan as a marketing tool and

may inform the beneficiary of the

availability of the payment plan prior to

or during the initial treatment planning

session and as necessary thereafter.

With respect to a subset of incomplete

episodes, we are not finalizing our

proposal that beneficiaries pay 20

percent of the episode payment.

Accordingly, the beneficiary will owe

20 percent of the FFS amount for RT

services furnished during an incomplete

episode in which (1) the TC is not

initiated within 28 days following the

PC, (2) the RO beneficiary ceases to have

traditional FFS Medicare prior to the

date upon which a TC is initiated, even

if that date is within 28 days following

the PC, or (3) the RO beneficiary

switches RT provider or RT supplier

before all RT services in the RO episode

have been furnished.

j. Example of Participant-Specific

Professional Episode Payment and

Participant-Specific Technical Episode

Payment for an Episode Involving Lung

Cancer in PY1

Table 8 and Table 9 illustrate possible

participant-specific professional and

technical episode payments paid by

CMS to one entity (Dual participant) or

two entities (Professional participant

and Technical participant) for the

furnishing of RT professional services

and RT technical services to an RO

beneficiary for an RO episode of lung

cancer. Table 8 and Table 9 are updated

versions of Table 5 and Table 6 of the

proposed rule, respectively, that reflect

policies described in section III.C.5. of

this final rule. Table 5 and Table 6 are

displayed in the proposed rule at 84 FR

34511 and 34512. Tables 8 and 9 also

reflect the following technical changes:

(1) The change in sequence related to

the geographic adjustment discussed in

section III.C.6.h. of this final rule; (2) a

change in the way the withhold

calculation is displayed in the proposed

rule example; (3) a change in the way

discount factor and withholds are

displayed in the proposed rule example;

and (4) a change in the way the total

episode payment amount is split

between the SOE payment and EOE

payment. As a result of these technical

changes, Tables 8 and 9 properly reflect

the way in which the claims systems

process payment. First, the geographic

adjustment comes in the proper

sequence, prior to the case mix and

historical experience adjustments,

discount factor and withholds. Second,

the withhold calculation properly

accounts for 1 percent for the incorrect

payment withhold and 2 percent for the

quality withhold for the professional

component. The corresponding

proposed rule table, Table 5, incorrectly

had the withholds multiplied together,

resulting in slightly lower withheld

amounts. Third, the discount factor and

withholds now display the percentage

of reduction as finalized, rather than the

inverse of those percentages as was

shown in the proposed rule at Tables 5

and 6.

Finally, Tables 8 and 9 properly

reflect the way in which the claims

systems split total payment between

SOE and EOE payments. The claims

systems begin with half the trended

national base rate amount that

corresponds with the RO Model-specific

HCPCS code listed on the claim

submitted by the RO participant for the

cancer type and component

(professional or technical) billed. The

claims systems then apply the

appropriate adjustments, discount

factor, and withholds to that amount.

Tables 8 and 9 reflect this by splitting

payment at the offset (see Tables 8 and

9, row (d)) rather than at the end, as the

proposed rule example has displayed

(see rows (s) and (t) in Table 5 at 84 FR

34511 and Table 6 at 84 FR 3512).

Please note that Table 8, which

displays the participant-specific

professional episode payment example

does not include any withhold amount

that the RO participant would be

eligible to receive back or repayment if

more money was needed beyond the

withhold amount from the RO

participant. It also does not include any

MIPS adjustment that applies to the RO

participant.

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Table 9 details the participant-specific

technical episode payment paid by CMS

to a single TIN or single CCN for the

furnishing of RT technical services to an

RO beneficiary for an RO episode of

lung cancer. The participant-specific

technical episode payment in this

example does not include any rural sole

community hospital adjustment that the

RO participant would be eligible to

receive. Also, please note that for the

participant-specific technical payment

amount, the beneficiary coinsurance

cannot exceed the inpatient deductible

limit under OPPS.

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After considering public comments on

our proposed pricing methodology, as

previously summarized, we are

finalizing the pricing methodology as

proposed with the following

modifications. We are also providing

Table 10, which summarizes the data

sources and time periods used to

determine the values of key pricing

components as a result of these

modifications.

(1) Change the name of the ‘‘efficiency

factor’’ of the historical experience

adjustment to ‘‘blend.’’

(2) Reduce the discount rate of the PC

and TC from 4 and 5 percent to 3.75 and

4.75 percent, respectively.

(3) Reduce the incorrect payment

withhold from 2 percent to 1 percent.

(4) Apply a stop-loss limit of 20

percent for the RO participants that

have fewer than 60 episodes during

2016–2018 and that were furnishing

included RT services in the CBSAs

selected for participation at the time of

the effective date of this final rule.

We are also making the following

modifications, which are not being

codified in regulation text, to our

pricing methodology policy:

(1) Change the baseline from which

the national base rates, Winsorization

thresholds, case mix coefficients, case

mix values, and historical experience

adjustments are derived from 2015–

2017 to 2016–2018.

(2) Change the sequence of the

proposed eight primary steps to the

pricing methodology, that is apply the

geographic adjustment to the trended

national base rates prior to the case mix

and historical experience adjustments

and prior to the discount factor and

withholds.

(3) Update the years used in the trend

factor’s numerator and denominator

calculation. For the trend factor’s

numerator calculation, the most recent

calendar year with complete data used

to determine the average number of

times each HCPCS code was furnished

will be 2018 for PY1, 2019 for PY2, and

so forth. The trend factor’s denominator

calculation will use data from 2018 to

determine (a) the average number of

times each HCPCS code (relevant to the

component and the cancer type for

which the trend factor will be applying)

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was furnished and (b) the corresponding

FFS payment rate.

(4) Update the years used to

determine the case mix values,

beginning with 2016–2018 for PY1,

2017–2019 for PY2, and so on.

(5) Align the approach to deriving

expected payment amounts for each

episode in the case mix adjustment with

how the predicted payment amounts are

calculated by using regression models

for both calculations; for the expected

payment amounts, the regression model

would be a simple one that contains

cancer type only on the right hand side

rather than using the average

Winsorized baseline expenditures by

cancer type).

(6) Update the years used to

determine whether an HOPD or

freestanding radiation therapy center

has fewer than sixty episodes, making

them ineligible to receive a historical

experience adjustment, from 2015–2017

to 2016–2018 to mirror the change in

baseline noted in (1).

(7) Update the years used to

determine whether an HOPD or

freestanding radiation therapy center

has fewer than sixty episodes, making

them ineligible to receive case mix

adjustment, beginning with 2016–2018

for PY1, 2017–2019 for PY2, and so on.

(8) Update the episodes used to

determine the RVU shares of the PFS

geographic adjustment from 2015–2017

episodes to 2018 episodes.

Please note that we will review

utilization data in non-RO participants’

2020 episodes to assess the impact of

the PHE on RT treatment patterns and

whether an alternative method is

needed to determine the trend factor for

PY3 to prevent the PY3 trend factor

from being artificially low or high due

to the PHE. If we find an alternative

method is necessary, we will propose

this in future rulemaking.

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7. Professional and Technical Billing

and Payment

Similar to the way many procedure

codes have professional and technical

components as identified in the CMS

National PFS Relative Value File, we

proposed that all RO Model episodes

would be split into two components, the

PC and the TC, to allow for use of

current claims systems for PFS and

OPPS to be used to adjudicate RO

Model claims. As stated in the proposed

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rule, we believe that the best design for

a prospective episode payment system

for RT services would be to pay the full

participant-specific professional and

technical episode payment amounts in

two installments. We believe that two

payments reduce the amount of money

that may need to be recouped due to

incomplete episodes and the likelihood

that the limit on beneficiary liability for

copayment for a procedure provided in

an HOPD (as described in section

1833(t)(8)(C)(i) of the Act) is met.

Accordingly, we proposed that we

would pay for complete episodes in two

installments: One tied to when the

episode begins, and another tied to

when the episode ends. Under this

proposed policy, a Professional

participant would receive two

installment payments for furnishing the

PC of an episode, a Technical

participant would receive two

installment payments for furnishing the

TC of an episode, and a Dual participant

would receive two installment

payments for furnishing the PC and TC

of an episode.

To reduce burden on RO participants,

we proposed that we would make the

prospective episode payments for RT

services covered under the RO Model

using the existing Medicare payment

systems by making RO Model-specific

revisions to the current Medicare FFS

claims processing systems. We proposed

that we would make changes to the

current Medicare payment systems

using the standard Medicare Fee for

Service operations policy related

Change Requests (CRs).

As proposed, our design for testing a

prospective episode payment model

(that is, the RO Model) for RT services

would require making prospective

episode payments for all RT services

included in an episode, as discussed in

section III.C.5 of this final rule, instead

of using Medicare FFS payments for

services provided during an episode.

We proposed that local coverage

determinations (LCDs), which provide

information about the conditions under

which a service is reasonable and

necessary, would still apply to all RT

services provided in an episode.

In the proposed rule, we stated that

Professional participants and Dual

participants would be required to bill a

new model-specific HCPCS code and a

modifier indicating the start of an

episode (SOE modifier) for the PC once

the treatment planning service is

furnished. We proposed that we would

develop a new HCPCS code (and

modifiers, as appropriate) for the PC of

each of the included cancer types under

the Model. The two payments for the PC

of the episode would cover all RT

services provided by the physician

during the episode. As stated in the

proposed rule, payment for the PC

would be made through the PFS and

would only be paid to physician group

practices (as identified by their

respective TINs).

Under our proposed billing policy, a

Professional participant or Dual

participant that furnishes the PC of the

episode would be required to bill one of

the new RO Model-specific HCPCS

codes and an SOE modifier. As stated in

the proposed rule, this would indicate

within the claims systems that an

episode has started. Upon submission of

a claim with an RO Model-specific

HCPCS code and an SOE modifier, we

would pay the first half of the payment

for the PC of the episode to the

Professional participant or Dual

participant. A Professional participant

or Dual participant would be required to

bill the same RO Model-specific HCPCS

code that initiated the episode with a

modifier indicating the EOE after the

end of the 90-day episode. This would

indicate that the episode has ended.

Upon submission of a claim with an RO

Model-specific HCPCS codes and EOE

modifier, we proposed that we would

pay the second half of the payment for

the PC of the episode to the Professional

participant or Dual participant.

Under our proposed billing policy, a

Technical participant or a Dual

participant that furnishes the TC of an

episode would be required to bill a new

RO Model-specific HCPCS code with a

SOE modifier. We proposed that we

would pay the first half of the payment

for the TC of the episode when a

Technical participant or Dual

participant furnishes the TC of the

episode and bills for it using an RO

Model-specific HCPCS code with a SOE

modifier. We proposed that we would

pay the second half of the payment for

the TC of the episode after the end of

the episode. We proposed that the

Technical participant or Dual

participant would be required to bill the

same RO Model-specific HCPCS code

with an EOE modifier that initiated the

episode. As stated in the proposed rule,

this would indicate that the episode has

ended.

Similar to the way PCs are billed, we

proposed that we would develop new

HCPCS codes (and any modifiers) for

the TC of each of the included cancer

types. We proposed that payment for the

TC would be made through either the

OPPS or PFS to the Technical

participant or Dual participant that

furnished TC of the episode. We

proposed that the two payments for the

TC of the episode would cover the

provision of equipment, supplies,

personnel, and costs related to the

radiation treatment during the episode.

We proposed that the TC of the

episode would begin on or after the date

that the PC of the episode is initiated

and that it would last until the PC of the

episode concludes. Accordingly, the

portion of the episode during which the

TC is furnished may be up to 90 days

long, but could be shorter due to the

time between when the treatment

planning service is furnished to the RO

beneficiary and when RT treatment

begins. We proposed this because the

treatment planning service and the

actual RT treatment do not always occur

on the same day.

We proposed that RO participants

would be required to submit encounter

data (no-pay) claims that would include

all RT services identified on the RO

Model Bundled HCPCS list (See Table

2) as those services are furnished and

that would otherwise be billed under

the Medicare FFS systems. We proposed

that we would monitor trends in

utilization of RT services during the RO

Model. We proposed that these claims

would not be paid because the bundled

payments cover RT services provided

during the episode. We proposed that

the encounter data would be used for

evaluation and model monitoring,

specifically trending utilization of RT

services, and other CMS research.

We proposed that if an RO participant

provides clinically appropriate RT

services during the 28 days after an

episode ends, then that RO participant

would be required to bill Medicare FFS

for those RT services. We proposed that

a new episode would not be initiated

during the 28 days after an episode

ends. As we explain in section

III.C.5.b(3) of this final rule, we refer to

this 28-day period as the ‘‘clean

period.’’

In the event that an RO beneficiary

changes RT provider or RT supplier

after the SOE claim has been paid, we

proposed that CMS would subtract the

first episode payment paid to the RO

participant from the FFS payments

owed to the RO participant for services

furnished to the beneficiary before the

transition occurred and listed on the no-

pay claims. We proposed that this

adjustment would occur during the

annual reconciliation process described

in section III.C.11 of this final rule. We

proposed that the subsequent provider

or supplier (whether or not they are an

RO participant) would bill FFS for

furnished RT services.

Similarly, in the event that a

beneficiary dies, or chooses to defer

treatment after the PC has been initiated

and the SOE claim paid but before the

TC of the episode has been initiated

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(also referred to as an incomplete

episode), during the annual

reconciliation process we proposed that

CMS would subtract the first episode

payment paid to the Professional

participant or Dual participant from the

FFS payments owed to that RO

participant for services furnished to the

beneficiary and listed on the no-pay

claims before the transition occurred.

In the event that traditional Medicare

stops being the primary payer after the

SOE claims for the PC and TC were

paid, we proposed that any submitted

EOE claims would be returned and the

RO participant(s) would only receive

the first episode payment, regardless of

whether treatment was completed. If a

beneficiary dies or selects the Medicare

hospice benefit (MHB) after both the PC

and the TC of the episode have been

initiated, we proposed that the RO

participant(s) would be instructed to bill

EOE claims and would be paid the

second half of the episode payment

amounts regardless of whether

treatment was completed.

In the proposed rule we

acknowledged that there may be

instances where new providers and

suppliers begin furnishing RT services

in a CBSA selected for participation in

the RO Model. We proposed that these

new providers and suppliers would be

RO participants and noted that they

would have to be identified as such in

the claims systems. When a claim is

submitted with an RO Model-specific

HCPCS code for a site of service that is

located within one of the CBSAs

randomly selected for participation, as

identified by the service location’s ZIP

Code, but the CCN or TIN is not yet

identified as an RO participant in the

claims systems, we proposed that the

claim would be paid using the rate

assigned to that RO Model-specific

HCPCS code without the adjustments.

Once we are aware of these new

providers and suppliers, we proposed

that they would be identified in the

claims system and would be paid using

Model-specific HCPCS code with or

without the adjustments, depending on

whether the TIN or CCN new to the

Model is a result of a merger,

acquisition, or other new clinical or

business relationship and whether there

is sufficient data to calculate those

adjustments as described in the pricing

methodology section III.C.6 of this final

rule.

We proposed that lists of RO Model-

specific HCPCS codes would be made

available on the RO Model website prior

to the Model performance period. In

addition, we noted in the proposed rule

that we expect to provide RO

participants with additional instructions

for billing the RO Model-specific

HCPCS codes through the Medicare

Learning Network (MLN Matters)

publications, model-specific webinars,

and the RO Model website.

The following is a summary of the

public comments received on these

proposals and our response:

Comment: Several commenters

expressed concern that billing systems

are not ready for a prospective payment

model as they are designed to bill after

the services are furnished and not

before, and that this could pose

significant financial risk. Commenters

stated that the RO Model as proposed

introduces new billing and collection

processes to include new HCPCS and

modifiers, billing at the start of and at

the end of services, and the submission

of no-pay claims detailing the actual

services provided. Commenters further

stated that the complexity of learning

new codes and tracking episode dates

creates administrative burden for RO

participants. Commenters noted that

many health care providers and health

systems do not complete their billing

internally, and instead rely on external

third party vendors so RO participants

will require time to determine how to

best partner with these vendors to

ensure appropriate billing.

Many commenters expressed concern

around the lack of details regarding

billing requirements for the proposed

RO Model. Multiple commenters

requested that we clarify in our billing

instructions that we will require

providers and suppliers billing

individual patient encounters to use

HIPAA-mandated transaction code sets

(that is, CPT

®

and HCPCS Level II

codes) for Professional/Dual participant

services on 1500/837P claims and

hospital outpatient participant services

on UB04/837I. Commenters stated that

it was particularly important that

charges meet the requirements of the

Provider Reimbursement Manual Part 1

section 2202.4, which mandate that

charges be related consistently to the

cost of the services and uniformly

applied to all patients, whether

Medicare, Medicaid, or commercial

patients. Commenters stated that the RO

Model cannot alter these requirements

because doing so could undermine the

validity of the hospital cost reporting

process. Commenters requested that we

address the following items for the new

prospective HCPCS codes and the no-

pay claims: (1) The type of claim form;

(2) necessary claim lines; (3) items that

should be excluded from the claim; and

(4) ability to move the zero-pay HCPCS

codes to the non-billable column on the

claim. Commenters asked for

clarification on encounter claim data

submission under the Model. A

commenter noted operational concerns

with the zero charge encounter bills the

RO Model requires participants to

submit. The commenter stated that

automated internal accounting software

generates both claims and internal cost

accounting reports and that setting

charges to zero dollars would wreak

havoc on internal cost tracking and

would create significant administrative

burden. The commenter requested that

CMS permit the original HCPCS charges

to be listed in the non-covered charges’

claim column while zero dollars would

be submitted in the covered charges

field.

Response: We appreciate the

commenters concern. We believe that

we have created a billing process that

will be easily implemented within

current systems because it is based on

how FFS claims are submitted today. To

facilitate understanding and

implementation, we encourage RO

participants to access forthcoming

instructions for billing the RO Model-

specific HCPCS codes and related

modifiers and condition code provided

by CMS through the Medicare Learning

Network (MLN Matters) publications,

model-specific webinars, and the RO

Model website.

Comment: A commenter requested

that CMS not withhold payments due to

incomplete episodes during the test

period, as this could ultimately create

significant cash flow issues. Instead, the

commenter suggested that CMS could

utilize the new HCPCS codes and

modifiers intended as no-pay, initial

and ending payments as place holders

to assess the various scenarios for at

least 3 years. This 3-year testing period

would at a minimum identify the

scenarios and allow time for CMS to

assess, realize impact, and provide data

to the public for public comment.

Response: We thank the commenter

for the suggestion. In the final rule at

§ 512.255(h), we have reduced the

incorrect payment withhold from the

proposed 2 percent to 1 percent, which

is proportional to the occurrence of

incomplete episodes per our claims

data. The amount of the incorrect

withhold that the RO participant earns

back is determined during the annual

reconciliation process described in

section III.C.11.

Comment: Many commenters

expressed concern around the proposed

billing timing requirements, stating that

it was not clear from the proposed rule

how Technical participants would know

when a Professional participant started

an episode for one of their patients at

the time that patient presented for

radiation therapy treatment.

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Commenters were concerned that

without this knowledge, unnecessary

incomplete episodes might result.

However, these commenters were also

concerned that the burden of

coordination of episode start dates

between professional and Technical

participants could greatly increase the

administrative burden of the Model.

One commenter stated that unique

logic would have to be established for

each patient to track how many days the

Technical participant’s billing team

would need to zero out claims since RT

start dates within the 90-day period will

vary. Other commenters noted that

when entities billing TC and PC services

are clinically, financially, and legally

separate, the likelihood of their ability

to coordinate care declines. Noting that

Health Information Exchanges are not

yet broadly available and that sharing of

information is not the same as

coordinating care, a commenter

requested a delay in implementation to

allow participants to establish the

formal or informal relationships likely

necessary to succeed in the proposed

Model. Another commenter

recommended that CMS include in the

Model a methodology by which it

would notify Technical participants of

the start of an episode. A commenter

noted that CMS stated that the technical

billing component will be driven off a

signed radiation prescription. As there

is a professional as well as technical

component of the simulation session,

the commenter stated that CMS should

use the professional simulation session

claim to trigger for the technical SOE.

Response: We appreciate the

commenters’ concerns. We believe it to

be an established standard of care that

RT delivery services cannot be

administered to a patient without a

signed radiation prescription and the

final treatment plan. Thus, we proposed

that the Professional participant will

provide the Technical participant with

a signed and dated radiation

prescription and treatment plan, all of

which is usually done electronically.

This will inform the Technical

participant of when the RO episode

began, allowing them to determine the

date of the end of the RO episode. The

submission and payment of TC claims is

not dependent on the submission of PC

claims. If the TC claim with the SOE

modifier is received first, the claims

system will estimate the first day of the

episode. A similar process will occur for

EOE claims. When claims for only one

component are submitted (either PC or

TC), an RO episode would not have

occurred because an RO episode begins

when both the PC is initiated and the

TC is initiated within 28 days. In these

circumstances, the component that is

submitted will be addressed during the

reconciliation process finalized in

section III.C.11, and the payments will

be reconciled so that the RO participant

receives the FFS amount based on the

no-pay claims instead of the participant-

specific episode payment. We encourage

RO participants to access forthcoming

instructions provided by CMS for billing

the RO Model-specific HCPCS codes

and related modifiers and condition

code provided by CMS through the

Medicare Learning Network (MLN

Matters) publications, model-specific

webinars, and the RO Model website.

Comment: Commenters requested

clarification on how billing was to be

done when either the technical

component of the services and/or the

professional component of the services

extends beyond the 90-day episode

triggered by the planning services.

Response: To clarify, as stated in the

proposed rule, all RT services provided

within the 28-day clean period (that is,

days 91–118) following a 90-day RO

episode will be billed FFS. In these

situations, the RT provider or RT

supplier will bill individual HCPCS or

CPT

®

codes for each RT service

furnished as they would outside of the

RO Model. If RT services are still being

provided after 118 days, the RO

participant will submit a SOE claim for

a new RO episode. We encourage RO

participants to access forthcoming

instructions for billing RT services

during the Model performance period

provided by CMS through the Medicare

Learning Network (MLN Matters)

publications, model-specific webinars,

and the RO Model website.

Comment: Multiple commenters

expressed concerns about the timing of

our proposed payments. A commenter

stated that the time estimates CMS has

made available show that almost two

thirds of all episodes are completed

within 50 days while other commenters

noted most services are completed

within a month of initiating treatment.

Commenters noted that under our

proposal, most providers and suppliers

would have to wait more than a month

to be able to bill for care that has already

been provided. Commenters expressed

concerns that delayed payments will

impact their cash flows, creating

hardships in their ability to pay bills, to

order medical supplies and to provide

the necessary staffing coverage.

Commenters also expressed concern

that patient access might become an

issue due to these cash flow delays and

that beneficiaries might have to drive

further to get care when staffing is

compromised because of delayed

payments. A commenter suggested that

full payment at the beginning of the

episode, rather than payment in two

installments, would improve cash flow

and reduce administrative burden by

not requiring an EOE claim. Other

commenters requested that providers

and suppliers be able to receive the 2nd

payment sooner than 90 days, ideally

when the services complete. A

commenter requested that CMS consider

adding a modifier to signal a course of

radiation is completed and that CMS

should make the 2nd half of the

payment at the time that completion

claim is submitted rather than waiting

for the end of the 90-day period. In

addition, that commenter also stated

that adding a modifier to the start and

end of a course of treatment would

signal if a new course, not related to

previous course, started during the 90-

day time frame.

Response: We thank the commenters

for expressing their concerns and for

their suggestions. Based on these

comments, we are modifying our policy

to permit an RO participant to submit

the EOE claim after the RT course of

treatment has ended, but no earlier than

28 days after the initial treatment

planning service was furnished. We

believe that 28 days after the initial

treatment planning service was

furnished is the earliest that EOE claims

should be submitted, because if the TC

has not been furnished to an RO

beneficiary after 28 days, this would be

an incomplete episode, as defined at

§ 512.205. To ensure that a Professional

participant or a Dual participant does

not bill an EOE claim for an incomplete

episode, they should not submit an EOE

claim before 28 days after the initial

treatment planning service has been

furnished to minimize the need to

reconcile the EOE payments against the

incorrect payment withhold. Regardless

of when the EOE claim is submitted, the

episode duration remains 90 days. Any

RT services furnished after the EOE

claim is submitted will not be paid

separately during the remainder of the

RO episode. We will monitor the

Medicare claims system to identify

potentially adverse changes in referral,

practice, or treatment delivery patterns

and subsequent billing patterns. This

modification does not require a change

to the regulatory text at § 512.260.

Comment: Some commenters stated

that CMS does not describe how a

Professional participant (that is, the

individual radiation oncologist or the

radiation oncology physician group/

practice TIN) who is selected to be in

the Model via an included ZIP Code, but

who furnishes their RT services at an

exempt facility (ASC, PCH, CAH), is to

bill for those encounters. The

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commenters questioned how a non-

participant RT provider or RT supplier

would be protected from having a large

volume of incomplete episodes. A

commenter noted that during the

August 22, 2019 Open Door Forum

Listening Session on the Radiation

Oncology Model, CMS staff stated they

would create a modifier for Professional

participants to use to indicate that RT

services were furnished by a non-

participant. Commenters requested that

CMS consider an alternative to a new

modifier that does not require any

changes in how professionals bill their

radiation oncologist services. A

commenter suggested that CMS use the

location of services in item number 32

and the NPI in item 32a on the 837P/

1500 claim form, which is mandated on

the 837P/1500 claim form, to exclude

the services from the RO Model.

Commenters also suggested that instead

of creating another modifier, CMS could

direct Professional participants who

deliver services at exempt facilities to

bill the usual radiation oncology HCPCS

codes, and to not initiate an episode by

excluding the RO Model-specific

HCPCS code. Commenters further

requested that if CMS believes it must

require the use of a new modifier to

signify services in an exempt facility,

we should allow the modifier to be

reported with the usual RT planning,

simulation, and management CPT

®

and

HCPCS codes rather than asking for the

RO Model-specific HCPCS code to be

reported.

Response: CMS worked closely with

the Provider Billing Group in the Center

for Medicare, the Medicare

Administrative Contractors, and the

Shared System Maintainers to establish

the least burdensome way to submit

claims for instances that do not follow

the standard course of an episode. We

determined that the use of an

established modifier for professional

claims and a condition code for HOPD

claims would be the best way to

indicate that certain services fall outside

of an RO episode and should be paid

FFS. When services are furnished by a

participant and a non-participant, these

scenarios would be considered

incomplete episodes. We encourage RO

participants to access forthcoming

instructions for billing RT services

during the Model performance period

provided by CMS through the Medicare

Learning Network (MLN Matters)

publications, model-specific webinars,

and the RO Model website.

Comment: A commenter requested

clarification on billing when one

physician provides EBRT and a different

physician, either co-located in the same

facility or in a different facility,

provides brachytherapy services. The

commenter wanted clarification on

when the brachytherapy physician

would be considered part of the RO

Model and when the brachytherapy

physician would be paid FFS. A

commenter requested that CMS provide

clarification regarding how the agency

will handle a second claim for a case

that has already received an episodic

payment associated with a second

physician who bills the brachytherapy

insertion codes. The commenter stated

that accommodations should be made to

pay the insertion codes at the FFS rate

when a second physician is involved to

prevent cash flow issues that could

result if the second claim were held up

as part of the RO Model reconciliation

process.

Response: When RT services are

furnished by an RO participant and a

non-participant or when the PC is

furnished by more than one Professional

participant or Dual participant, or when

the TC is provided by more than one

Technical participant or Dual

participant, these scenarios would be

considered duplicate services. The RO

beneficiary would remain under the

care of the RO participant that initiated

the PC and/or TC, and in many

circumstances, the duplicate RT service

would be a different modality than what

is furnished by the RO participant. The

RO participant(s) that bills the SOE and

EOE claims would receive the bundled

payment and the RT provider and/or RT

supplier furnishing one or more

duplicate RT services would bill claims

using the designated modifier or

condition code to indicate that they

should be paid FFS. Thus, cash flow

would not be affected by this. We

encourage RO participants to access

forthcoming instructions for billing RT

services during the Model performance

period provided by CMS through the

Medicare Learning Network (MLN

Matters) publications, model-specific

webinars, and the RO Model website.

Comment: Some commenters

expressed concerned about specific

considerations related to the proposed

90-day episodic billing time frame.

Commenters agreed with our

assumption that RT services would

generally be completed within the 90-

day episodic period and a new RO

episode would not begin until at least

28 days have elapsed, but commenters

noted that there are times when

extenuating circumstances like an

inpatient admission or preplanned

patient travel that can cause the

outpatient RT services to begin after the

28-day window. From an operational

standpoint, commenters were concerned

that if the treatment does not begin

within the 28-day period, but the

physician plans to treat the patient with

RT services, that there may be no

‘‘trigger’’ to begin an episode of care.

Commenters requested that we clarify

how Medicare Administrative

Contractors will manage PC and TC

claims after the 28-day window between

the treatment planning code and the

treatment delivery code has passed

without triggering an episode.

Commenters also requested that we

provide answers to the following

questions: Would all subsequent PC and

TC claims be paid as FFS? Would the

TC claims (either with the RO Model-

specific HCPCS code or FFS HCPCS

code) and the second PC episode

payment claims be denied and then

reconciled as per the incomplete

episode policy in the proposal? Would

all TC claims after the 28-day window

be paid under FFS and the initial

episode PC payment be the only amount

reconciled? The commenter urged CMS

to pay all CPT

®

/HCPCS codes that are

billed outside of the 28-day window

(that is an incomplete episode) as FFS.

Response: We appreciate the

commenters’ concerns. Medicare claims

data analyzed during the design of the

RO Model, show that in 84 percent of

episodes RT is delivered within 14 days

of the planning service and within 28

days for the remaining 16 percent. There

will be billing instructions that address

how to submit claims for those

instances that do not follow the

standard course of an episode. In these

situations, the RT provider or RT

supplier will bill individual HCPCS or

CPT

®

codes for each RT service

furnished as they would outside of the

RO Model. These scenarios would be

considered incomplete episodes. We

encourage RO participants to access

forthcoming instructions for billing RT

services during the Model performance

period provided by CMS through the

Medicare Learning Network (MLN

Matters) publications, model-specific

webinars, and the RO Model website.

Comment: A commenter expressed

appreciation that CMS has taken into

consideration situations in which a

patient passes or is transferred to

hospice care during an RO episode,

noting that in these situations, CMS

proposed to provide full payment and

not to consider these two scenarios as

incomplete episodes.

Response: We thank the commenter

for the support and note that we are

finalizing the policy to provide full

payment for RO episodes in which a

patient passes or is transferred to

hospice care during an RO episode.

Comment: A commenter requested

that we change the proposed policy in

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cases where the patient moves from

traditional Medicare FFS as their

primary payer to a Medicare Advantage

plan during an episode. As proposed,

the commenter noted that CMS would

pay 50 percent of both the PC and TC

to participants, regardless of whether

the RT was complete. The commenter

stated that they believe this payment

policy would not fairly reimburse RO

participants for services rendered, and

recommended that we drop these

episodes and revert retrospectively to

FFS payments for the services that were

billed to Medicare Part A and B, in the

same manner that we proposed to do for

other categories of incomplete episodes.

Response: We thank the commenter

for their concern and suggestion. Our

analysis indicates that for episodes

where a beneficiary moves from

traditional Medicare as their primary

payer to a Medicare Advantage plan

during the RO episode, the average cost

is less than 50 percent of those episodes

when compared to episodes where a

beneficiary had Medicare as their

primary payer for the full 90-day

episode. Thus, we believe that paying

the SOE PC and TC only in these cases

is appropriate. Our data also shows that

switching payers during an episode

rarely occurs. When an RO beneficiary

ceases to have traditional Medicare as

his or her primary payer during an RO

episode, the RO participant will not be

paid the EOE PC or TC because CMS

cannot process claims for a beneficiary

with dates of service on or after the date

that traditional Medicare is no longer

the primary payer. We believe that

finalizing our proposal with the

modification allowing the EOE claim to

be submitted and paid at the completion

of the planned course of treatment,

instead of waiting for 90 days, will

mitigate this concern. If the RO

beneficiary has traditional Medicare as

of the date of service on the EOE claim,

the RO participant will be paid both

installments of the episode payment.

Comment: Several commenters

expressed concern about our proposed

policy that local coverage

determinations would still apply to all

RT services provided in an episode. A

commenter noted that at this time, there

are few LCDs in publication and that

most radiation oncology specific LCDs

have been retired, with the exception of

those for proton therapy and a few other

LCDs for IMRT, SRS and SBRT. The

commenter further noted that currently

there are no active LCDs for standard

external beam, 3D conformal,

brachytherapy or radiopharmaceutical

therapy, and that multiple MACs have

never published radiation oncology

LCDs. The commenter stated that the

IOM publications by CMS provide few

instructions specific to radiation

oncology techniques, required

documentation, and coverage

requirements, which leads to

inconsistency across the specialty. The

commenter asked if there is a reason

there are not more LCDs or possible

National Coverage Determinations

(NCDs) if there is an expectation that

radiation oncology facilities are to

follow a common set of guidelines and

expectations for coverage. Another

commenter stated that LCDs are a form

of prior authorization and requested that

CMS abandon the use of LCDs to

determine coverage for those services

delivered to Medicare beneficiaries as

part of the RO Model. The commenter

stated that the establishment of episode-

based payments effectively decouples

payment from modality of treatment and

that LCDs or other methods of prior

authorization should not apply for the

RO Model.

Response: LCDs are decisions made

by a Medicare Administrative

Contractor (MAC) whether to cover a

particular item or service in a MAC’s

jurisdiction (region) in accordance with

section 1862(a)(1)(A) of the Social

Security Act. The MAC’s decision is

based on whether the service or item is

considered reasonable and necessary.

The MACs will not have the ability to

apply LCDs to RO Model claims because

only the RO Model-specific HCPCS

codes appear on the claim and these

codes are not included in any current

LCDs. When we monitor utilization of

RT services during the Model, as

described in section III.C.14.a, we will

use the reasonable and necessary

provisions as stated in applicable LCDs

as one of our monitoring tools.

Comment: A commenter requested

that we address prior authorization,

which the commenter asserted could

impact the outcomes and treatment

choices in this Model. The commenter

expressed concern that prior

authorization requirements could

increase administrative burden on

participating clinicians who seek to

deliver the highest quality of care and

delay timely payment for covered

services.

Response: We thank the commenter

for voicing these concerns. RO Model

services are not subject to prior

authorization.

Comment: Commenters asked if

allowable rates will be available for the

new codes 30 days prior to program

start date. Commenters asked if there

will be an RVU associated with the new

start and end codes and if there be

unique start and end codes per

diagnosis.

Response: The RO Model-specific

HCPCS codes will be posted on the RO

Model website at least 30 days prior to

the start of the Model. As described in

section III.C.6.h, there are RVUs

associated with the RO Model-specific

HCPCS codes, but the SOE and which

are modifiers, not codes do not have

RVUs associated with them.

Comment: A commenter stated that

the RO Model will require staff to

determine which patients are primary

Medicare from all other payers and

establish separate processes between

payers and between those who fall

under the RO Model parameters and

those who do not. The commenter

stated this would include creating two

sets of coding and billing processes just

for primary Medicare beneficiaries: One

to report services included in the RO

Model and one to report services not

included and billed as fee-for-service for

those services provided to a beneficiary

who must participate in the Model but

for whom some services provided are

not included and billed differently.

Response: It is our understanding that

RT providers and RT suppliers furnish

and bill for RT services for patients with

a variety of insurers and thus already

have processes in place to accommodate

multiple payer requirements. To clarify,

non-included services will be billed

separately and in the same manner as

they would in the absence of the RO

Model.

Comment: A commenter asked us to

clarify if the 8 percent non-sequestration

reconciliation withhold will be

processed at the claim level so that

adjustments can be applied to the

original claims via remits.

Response: We believe the ‘‘8 percent’’

used by the commenter refers to the

total of the discounts and withholds.

The discounts and withholds are not

subject to sequestration upon

submission of an RO Model claim.

Sequestration will be applied to

reconciliation payment calculation that

are based on FFS payments.

Comment: Commenters expressed

concern about specific billing situations

and asked for clarification on several

situations. A commenter asked for

clarification on how organizations

should handle or bill for treatment of

new manifestations of same cancer

diagnosis within the same 90-day

window (estimated 10–20 percent of

patients). Another commenter, citing an

example of a prostate cancer patient

with bone metastasis or a lung cancer

patient with brain metastasis, inquired

if a patient presents with two separate

diagnoses that are included within the

Model, would the HCPCS codes be

reported for both cancer type codes or

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would one take precedence over

another? Commenters asked if this

would this be considered a single

episode or separate episodes?

Commenters also sought clarification on

billing for non-RO Model codes. If a

patient in an RO episode also is treated

for a non-model code (for example,

metastasis to adrenal gland), would

those services be billed and paid for

under FFS even though an RO episode

is running concurrently? A commenter

also asked for clarification on how RO

participants should bill for non-model

services which, if not for the Model,

would be bundled under the existing

OPPS RO Comprehensive ambulatory

payment classification (C–APC)? The

commenter recommended that

providers and suppliers be permitted to

bill separately under the OPPS for these

other non-Model HCPCS and CPT

®

codes.

Response: Only one RO Model-

specific HCPCS code will apply to an

RO episode even if the RO beneficiary

has more than one included cancer type

for which they are receiving RT

services. The RO participant can choose

which RO Model-specific HCPCS to

include on both the SOE and EOE

claims. For example, the RO beneficiary

is being treated with RT services for

breast cancer and brain metastasis, the

RO participant would likely choose the

RO Model-specific HCPCS for breast

cancer, which is appropriate. If an RO

beneficiary has more than one included

cancer type, but is receiving RT services

for just one, the RO participant is

expected to put the corresponding RO

Model-specific HCPCS code on the SOE

and EOE claims. For example, the RO

beneficiary has breast cancer, but is

being treated with RT services for just

their brain metastasis, the RO

participant must choose the RO Model-

specific HCPCS for brain metastasis. If

an RO beneficiary also receives

included RT services for a non-included

cancer type, FFS claims would be

submitted with the corresponding ICD–

10 codes and HCPCS codes. As

proposed, the SOE and EOE claims must

include the same RO Model-specific

HCPCS code. RT services not included

in Table 2 shall be billed FFS. To

clarify, non-included services will be

billed separately and in the same

manner as they would in the absence of

the RO Model.

Comment: Commenters sought

clarification on secondary billing under

the Model, requesting that we provide

clarification in the final rule regarding

the role of secondary payers and how

they will be engaged as part of the

claims processing and billing associated

with implementing the Model.

Typically, a secondary bill is sent

directly from Medicare to the secondary

payer. If a no-pay bill is sent to a

secondary payer, it would not be paid.

Commenters noted that it was

particularly important for all

participants to follow usual coding and

billing pursuant to HIPAA transaction

sets due to the impact on a beneficiary’s

secondary and MediGap insurance.

Commenters noted that CMS did not

address this topic in the Proposed Rule

and stated that they expect that the

Innovation Center would define new

claim adjustment reason codes (CARC)

and remittance advice reason codes

(RARC) so this insurance, when

secondary to Medicare, will not process

co-payments for individual services.

Instead, they will process applicable co-

payments associated with each of the

professional, dual, and technical

episode payments when made and

explained on the remittance advice from

Medicare. Commenters asked that CMS

verify and explain this process in the

Final Rule to enable RO participants to

better understand these important

operational issues.

Commenters requested that CMS

verify and explain the process for

communication to secondary and

MediGap insurance (that is, CARC/

RARC codes) to ensure all participants

have a clear understanding of the

operational process for reimbursement.

Commenters also noted that as other

payers would be following typical FFS

payment methodology, the ‘‘M’’ codes

would not be accepted either.

Commenters requested that we address

the following questions: Will the

Medicare beneficiary then be at risk for

the 20 percent liability if denied? How

would secondary payers adjudicate

these claims? Many payers have 60-day

timely filing deadline. With the

proposed billing model, commenters

expressed concern that they would be at

risk of timely filing for certain payers if

those claims are not adjudicated.

Response: CMS liaisons to the

secondary payers will provide RO

Model-specific information to those

payers including how the RO Model-

specific HCPCS shall be processed. As

noted in the proposed rule, we expect

to provide RO participants with

additional instructions for billing,

particularly as it pertains to secondary

payers and collecting beneficiary

coinsurance. Additional instructions

will be made available through the

Medicare Learning Network (MLN

Matters) publications, model-specific

webinars, and the RO Model website.

Comment: A commenter asked if

hospitals are still allowed to add facility

fees to their fees under the Model. If so,

the commenter stated that the playing

field would not be level and would

favor HOPD over freestanding radiation

therapy centers. The commenter also

requested that we clarify if facility fees

were included in our computation

finding that freestanding centers billed

more than HOPPS facilities. If so, the

commenter requested that hospitals not

be allowed to charge facility fees under

the RO Model.

Response: As proposed, only RO

Model-specific HCPCS codes are

allowed on the SOE and EOE claims.

Thus, this should not be a concern.

Comment: A commenter suggested

that CMS should publish online an

explicit list of providers and suppliers

excluded from the Model including

their names, addresses, and NPIs to

ensure there’s no confusion about which

providers and suppliers are excluded

from the Model. The commenter stated

that this information would also

emphasize that, should any of the

professionals furnish services at a

location included in the RO Model and

their TIN/ZIP Code is not otherwise

excluded from the Model, the

participant would be required to report

the HCPCS Level II code for the cancer

type and the appropriate modifier(s).

The commenter also suggested that, if

CMS believes it must require the use of

a new modifier to signify services in a

provider or supplier excluded from the

Model, the agency allow the modifier to

be reported with the usual RT planning,

simulation, and management CPT

®

and

HCPCS codes rather than ask for the

cancer type HCPCS code to be reported.

The PRT recommends that CMS utilize

the information already required by

HIPAA transaction sets (NPI, names,

and addresses) for professional claims

in order to determine if a provider or

supplier is excluded from the Model,

rather than creating a new modifier and

additional operational burden for RT

professionals.

Response: Only RO participants can

use the RO Model-specific HCPCS

codes. The claims system will

determine inclusion in the Model by the

site of service ZIP Code included on the

claim. Non-participants would not be

required to use a modifier to indicate

they are not subject to RO Model billing

requirements. To facilitate

understanding and implementation of

the billing and payment requirements,

we encourage RO participants to access

additional instructions for billing during

the RO Model and using the RO Model-

specific HCPCS codes provided by CMS

through the Medicare Learning Network

(MLN Matters) publications, model-

specific webinars, and the RO Model

website.

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We are finalizing the inclusion of quality

measures in the RO Model in section III.C.8.b, and

finalizing that the first annual quality measure data

submission will occur in March 2022 as finalized

in section III.C.8.c.

45

National Quality Forum.

Comment: A commenter stated that

freestanding centers are not authorized

to bill directly to Medicare due to the

consolidated billing requirements for

SNF and hospital inpatient stays. In this

scenario, the commenter believed the

treatment delivery code would not be

received for beneficiaries during a SNF

or hospital inpatient stay who are also

treated with RT services in a

freestanding radiation therapy center.

Response: We have programmed the

claims system to bypass all professional

and institutional SNF consolidated

billing edits/IURs for RO Model claims

for any RO beneficiary that is currently

in a Skilled Nursing Facility (SNF) stay.

Based on these public comments we

are finalizing our proposals related to

billing and payment at § 512.260 and

§ 512.265, with modification.

Specifically, we are adding a new

paragraph (d) to § 512.260 to codify the

requirement that an RO participant

submit no-pay claims for any medically

necessary RT services furnished to an

RO beneficiary during an RO episode

pursuant to existing FFS billing

processes in the OPPS and PFS, as was

described in this section of the final

rule. Additionally, as noted earlier in

this section of the final rule, we are

permitting an RO participant to submit

the EOE claim after the RT course of

treatment has ended, but no earlier than

28 days after the initial treatment

planning service was furnished.

Regardless of when the EOE claim is

submitted, the episode duration remains

90 days. Any RT services furnished after

the EOE claim is submitted will not be

paid separately during the remainder of

the RO episode.

Further, we would like to clarify that

we are finalizing at § 512.245(b) that if

an RO beneficiary dies after both the PC

and the TC of the RO episode have been

initiated, we proposed that the RO

participant(s) would be instructed to bill

EOE claims and would be paid the

second half of the episode payment

amounts regardless of whether

treatment was completed. And, if an RO

beneficiary elects the MHB not only

after the PC and TC of an RO episode

has been initiated but also before the TC

is initiated as long as the TC is initiated

within 28 days following the initial

treatment planning service (PC), the RO

participant(s) will receive both

installments of the episode payment

amount (upon billing the RO Model-

specific HCPCS codes and the SOE and

EOE modifiers) regardless of whether

the RO episode has been completed. We

recognize that the TC may not always be

furnished on the same day, as the PC,

or within a few weeks of the PC, and we

would like our policy not to delay

hospice referrals.

8. Quality

We proposed to implement and score

a set of quality measures, along with the

clinical data elements (proposed in

section III.C.8.e of the proposed rule (84

FR 34514) and discussed in section

III.C.8.e of this final rule) according to

the Aggregate Quality Score (AQS)

methodology (described in section

III.C.8.f of the proposed rule (84 FR

34519)). We proposed that beginning in

PY1, the AQS would be applied to the

quality withhold (described in section

III.C.6.g(2) of proposed rule (84 FR

34509) and discussed in this final rule)

to calculate the quality reconciliation

payment amount due to a Professional

participant or Dual participant as

specified in section III.C.11 of the

proposed rule (84 FR 34527) and this

final rule. As proposed, results from

selected patient experience measures

based on the CAHPS

®

Cancer Care

survey would be incorporated into the

AQS for Professional participants and

Dual participants starting in PY3. For

Technical participants, results from

these patient experience measures

would be incorporated into the AQS

starting in PY3 and applied to the

patient experience withhold described

in section III.C.6.g(3) of the proposed

rule (84 FR 34509 through 34510) and

this final rule.

a. Measure Selection

We proposed that the following set of

quality measures would be included in

the RO Model in order to assess the

quality of care provided during episodes

(84 FR 34514). We proposed that we

would begin requiring annual quality

measure data submission by

Professional participants and Dual

participants in March of 2021

44

for

episodes starting and ending in PY1.

Participants would continue to be

required to submit quality measure data

annually every March through the

remainder of the Model performance

period as described in section III.C.8.c

of the proposed rule (84 FR 34517

through 34518) and this final rule.

These quality measures would be used

to determine a participant’s AQS, as

described in section III.C.8.f of the

proposed rule (84 FR 34519) and this

final rule, and subsequent quality

reconciliation amount, as described in

section III.C.11 of the proposed rule (84

FR 34527) and this final rule.

We proposed that the AQS would be

based on each Professional participant’s

and Dual participant’s: (1) Performance

on the set of evidenced-based quality

measures in section III.C.8.b of the

proposed rule (84 FR 34515 through

34517) and this final rule compared to

those measures’ quality performance

benchmarks; (2) reporting of data for the

pay-for-reporting measures (those

without established performance

benchmarks) in section III.C.8.b(4) of the

proposed rule (84 FR 34515 through

34517) and this final rule; and (3)

reporting of clinical data elements on

applicable RO beneficiaries in section

III.C.8.e of the proposed rule (84 FR

34518) and this final rule. As stated in

the section III.C.8.f.(1) of the proposed

rule (84 FR 34519), in the absence of a

MIPS performance benchmark, national

benchmark, or historical performance

from which to calculate a Model-

specific benchmark from previous years’

historical performance, a quality

measure will be included in the

calculation of the AQS as pay-for-

reporting until a benchmark is

established that will enable it to be pay-

for-performance. Based on the

considerations set forth in the proposed

rule, we proposed the following

measures for the RO Model beginning in

PY1 and continuing thereafter:

•Oncology: Medical and Radiation—

Plan of Care for Pain—NQF

45

#0383;

CMS Quality ID #144

•Preventive Care and Screening:

Screening for Depression and Follow-

Up Plan—NQF #0418; CMS Quality ID

#134

•Advance Care Plan—NQF #0326; CMS

Quality ID #047

•Treatment Summary

Communication—Radiation Oncology

We proposed adopting this set of

quality measures for the RO Model for

two reasons. First, the RO Model is

designed to preserve or enhance quality

of care, and these quality measures

would allow us to quantify the impact

of the RO Model on quality of care, RT

services and processes, outcomes,

patient satisfaction, and organizational

structures and systems. Second, we

believe the RO Model measure set

would satisfy the quality measure-

related requirements for the RO Model

to qualify as an Advanced APM, and a

MIPS APM, which we discuss in greater

detail in section III.C.9 of this final rule.

Because they have already been adopted

in MIPS, we believe that the following

measures meet the requirements of 42

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46

When there is reason to believe that the

continued collection of a measure as it is currently

specified raises potential patient safety concerns,

CMS will take immediate action to remove a

measure from the program and not wait for the

annual rulemaking cycle. In such situations, we

would promptly retire such measures followed by

subsequent confirmation of the retirement in the

next rulemaking. When we do so, we will notify

participants and the public through the usual

communication channels, which include RO Model

website and emails to participants.

47

https://www.cms.gov/Medicare/Quality-

Initiatives-Patient-Assessment-Instruments/

QualityInitiativesGenInfo/MMF/General-info-Sub-

Page.html.

CFR 414.1415(b)(2): (1) Oncology:

Medical and Radiation—Plan of Care for

Pain; (2) Preventive Care and Screening:

Screening for Depression and Follow-

Up Plan; and (3) Advance Care Plan. We

further believe that the Treatment

Summary Communication—Radiation

Oncology measure is evidence-based,

reliable, and valid because it has been

developed by stakeholders to ensure

timely handoff communication and care

coordination to referring health care

providers and patients receiving

radiation therapy treatment. We

acknowledge that we did not propose an

outcome measure for the RO Model as

required under 42 CFR 414.1415;

however, as we explained in the

proposed rule (84 FR 34515), this is

because there are no available or

applicable outcome measures included

in the MIPS final quality measures list

for the Advanced APM’s first Qualifying

APM Participants (QP) Performance

Period. We have determined there are

currently no outcome measures

available or applicable for the RO Model

so this requirement does not apply to

the RO Model. However, if a potentially

relevant outcome measure becomes

available, we would consider whether it

is applicable and should be proposed to

be included in the RO Model’s measure

set.

As stated in the proposed rule, we

believe our proposed use of quality

measures as described in our AQS

scoring methodology in section III.C.8.f

of the proposed rule (84 FR 34519) and

this final rule would meet the current

quality measure and cost/utilization

MIPS APM criterion under 42 CFR

414.1370(b)(3). In selecting the

proposed measure set for the RO Model,

we sought to prioritize quality measures

that have been endorsed by a consensus-

based entity or have a strong evidence-

based focus and have been tested for

reliability and validity. We focused on

measures that would provide insight

and understanding into the Model’s

effectiveness and that would facilitate

achievement of the Model’s care quality

goals. We also sought to include quality

measures that align with existing quality

measures already in use in other CMS

quality reporting programs, such as

MIPS, so that Professional and Dual

participants would be familiar with the

measures used in the Model. Finally, we

considered cross-cutting measures that

would allow comparisons of quality

across episode payment models and

other CMS model tests.

As we stated in the proposed rule, we

believe the proposed measure set would

provide the Model with sufficient

measures for the Model performance

period to monitor quality improvement

in the radiation oncology sector, and to

calculate overall performance using the

AQS methodology; however, CMS may

adjust the measure set in future PYs by

adding or removing measures as needed.

If changes to the measure set are

necessary, we will propose those

changes in future rulemaking.

46

We solicited comment on this

proposal. The following is a summary of

the public comments received on this

proposal and our response:

Comment: Several commenters

supported CMS’ proposal to include

quality measures and believed that

quality measures will ensure that

quality care is delivered under the RO

Model.

Response: We thank the commenters

and appreciate their support.

Comment: A few commenters

expressed support for use of NQF-

endorsed measures generally. Other

commenters specifically opposed the

inclusion of any measure that is not

NQF-endorsed in the RO Model.

Response: While NQF endorsement is

not required when selecting measures

for the RO Model, we agree with the

commenters that NQF endorsement is

one of several important criteria to

consider. Three of the quality measures

that we proposed for the Model are

currently NQF-endorsed. A fourth, the

measure ‘‘Treatment Summary

Communication,’’ was initially

endorsed by NQF in 2008, but was not

subsequently brought by the measure

steward for maintenance/re-

endorsement. However, we believe the

information captured by this measure is

relevant to the RO Model and critical to

patients’ care continuity and

coordination. We believe that any

measure that is evidence based and

would support the goals of the Model,

that has been tested to produce valid

and reliable results, and that is effective

without being overly burdensome, may

be appropriate for inclusion in the

Model. Therefore, we do not believe that

the lack of current NQF endorsement

alone should preclude a measure’s

adoption since endorsement, as it is

only one of several considerations.

Comment: A commenter

recommended that CMS add additional

measures to the RO Model and allow

participants the opportunity to select a

subset of measures from the larger set to

report.

Response: In selecting measures for

the RO Model, we sought to include a

set of meaningful, parsimonious

measures, reflective of the CMS

Meaningful Measures framework

47

that

balances the need for data about

participant performance without

creating undue burden on participants.

One set of measures used by all RO

participants will provide insight for

CMS and the field as a whole into how

care quality compares across multiple

markets. Selective reporting of measures

would hinder the ability of CMS to

measure or analyze the impact of the

Model on quality.

Comment: A few commenters

expressed their belief that the Model

should only include measures related to

patient safety and health care provider

engagement to ensure the delivery of

high-quality care within the Model.

Response: We agree that patient safety

is of paramount importance; we will

assess patient safety via claims, site

visits, and data that RO participants are

required to submit for monitoring and

evaluation. However, we believe it is

important to capture elements of quality

care that go beyond patient safety and

health care provider engagement. The

selected measures will encourage

providers and suppliers to engage with

CMS and their patients to ensure that

patients are receiving high-quality care.

All measures were selected based on

clinical appropriateness for RT services

spanning a 90-day episode period.

Additionally the Model must include a

sufficient set of quality measures to

qualify as a MIPS APM and an

Advanced APM.

Comment: A couple of commenters

recommended that national

accreditation through the American

College of Radiology (ACRO) or

American Society for Radiation

Oncology (ASTRO) should be sufficient

to meet quality standards for the Model

and that accredited PGPs in the Model

should not need to report additional

quality data to CMS. The commenters

believed that the collection and

submission of additional quality data to

CMS is unlikely to add value to the

effort to improving radiation oncology

care. A commenter supported

accreditation and believed it enhances

quality of care. Another commenter

supported American College of

Radiology (ACR) accreditation for larger

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centers with a full-time radiologist on

site.

Response: We agree with the

commenters that accreditation by

nationally recognized organizations,

such as the ACR, ACRO, and ASTRO,

may be an indicator of the overall

quality of care provided by a RT

provider or RT supplier. However, we

do not believe that accreditation

provides a full picture of quality care

delivery in radiation oncology. As noted

earlier in this final rule, the Model must

include a set of quality measures to

qualify as a MIPS APM and an

Advanced APM, and as such,

accreditation is not able to replace the

RO quality measures without

compromising the Model’s qualification

as a MIPS APM and Advanced APM. In

addition, while we are not using

accreditation status as a proxy for

quality, as stated in section III.C.13.c we

may at some point use an optional web-

based survey to gather data from

participants on administrative data

points, including their accreditation

status, indicating the importance of this

information to understanding

participants’ activities.

Comment: We received numerous

comments requesting the addition or

development of additional RT measures

to ensure the provision of high-quality

care. Commenters specifically

recommended the following topics for

measures: Tracking the toxicity of

treatment; the utilization of surface

guided radiation therapy (SGRT);

compliance with dose limits and

radiation exposure; hospice referrals;

and innovation in patient care

management (for example, phone and

email contact). Other commenters

recommended that CMS consider

quality measures supported by ASTRO,

including: Cancer Stage Documented;

External Beam Radiotherapy for Bone

Metastases; Hormonal Therapy for Stage

IC–IIIC; ER/PR Positive Breast Cancer;

Adjuvant Hormonal Therapy for High-

Risk Patients; and Chemotherapy for

AJCC Stage III Colon Cancer Patients. A

commenter recommended that CMS

communicate a commitment to adopt

clinical and staging measures by PY2.

Another commenter requested CMS

develop a process to accept

recommendations of potential measures

to be considered for implementation in

the RO Model.

Response: We appreciate the

suggestions of additional quality

measures. As previously discussed, we

proposed the four measures and the

CAHPS

®

Cancer Care survey described

in the proposed rule for PY1 because we

believe these measures will allow us to

monitor and evaluate quality in the

radiation oncology sector; they align

with existing measures being used in

quality programs; and they will allow

the Model to qualify as an Advanced

APM and a MIPS APM. However, we

will consider revisions to this measure

set for future model years. We will

continue to monitor other measures that

become available and meet the criteria

for the Model, including seeking

opportunities to align with quality

measure efforts conducted by

professional societies. As we consider

additional measures for inclusion in the

Model, we will consider which

measures will allow the most

meaningful and parsimonious measure

set to ensure continued RT quality,

while requiring the least amount of

burden on providers and suppliers.

Throughout the Model performance

period, we will be seeking input from

stakeholders on potential quality

measure while continuing to monitor

the RT field for new and promising

measures.

Comment: We received many

comments related to measuring RO

Model outcomes addressing multiple

topics including: (1) The importance of

including an outcome measure in

APMs; (2) suggestions for making

progress on creating a radiation therapy-

specific outcome measure for future

implementation; and (3) alternatives to

a clinical outcomes measure that CMS

can use to track outcomes for RO

beneficiaries. Many commenters

expressed support for inclusion of an

outcome measure related to RT care,

with some commenters noting that an

outcome measure is preferred for an

Advanced APM.

Some commenters believe that an

outcome measure is important for the

Model to evaluate whether a high level

of care quality is maintained throughout

the Model performance period, with a

commenter requesting an outcome

measure specifically to ensure that

hypofractionation does not cause harm.

A commenter recommended that quality

programs should have outcome, patient

experience, and value measures. On the

topic of outcome measure development,

several commenters suggested that CMS

collaborate with professional and

specialty societies to identify metrics

that meaningfully measure quality of

cancer care and impact on outcomes

(including survival). A commenter also

recommended that CMS track patient

outcomes via a Medicare-certified

Qualified Clinical Data Registry (QCDR).

Another commenter recommended

using a clinical outcomes measures

related to patient safety (including the

incidence of various side effects that

may accompany overexposure of

healthy tissue to radiation) and the

efficacy of treatment.

MedPAC specifically recommended

using three claims-based measures, the

second and third of which are currently

used in the OCM: (1) The risk-adjusted

proportion of patients with all-cause

hospital admissions within the six-

month episode, (2) risk-adjusted

proportion of patients with all-cause

emergency department (ED) visits or

observation stays that did not result in

a hospital admission within the six-

month episode, and (3) proportion of

patients that died who were admitted to

hospice for three days or more.

Response: For PY1, we proposed four

measures. Several outcome measures

(some of which are registry-based

measures), including those suggested by

commenters, were considered prior to

the publication of the proposed rule. In

the end, we did not include these

outcome measures in the proposed

measure set due to concerns over the

significant challenge of attributing

outcomes—such as those suggested by

MedPAC including hospital admissions,

ED visits, or proportion of patients that

died who were admitted to hospice—

directly to RT services.

We would have liked to use the same

OCM outcome measures for the RO

Model, but ultimately decided that it

would be difficult to discern whether

these outcomes occurred due to

complications from RT service,

chemotherapy by medical oncologists,

or for other various reasons. As such, we

believe that these measures would not

meaningfully indicate high- versus low-

quality RO participants. As stated in the

proposed rule (84 FR 34514), while we

believe it is preferable to include an

outcome measure in an Advanced APM,

there are currently no outcome

measures specific to RO available for

implementation. We appreciate

commenters’ suggestions for

understanding outcomes related to care

delivered under the RO Model,

including the suggestion that CMS use

QCDRs to track outcomes. We will

monitor the progress in this area but

note that Professional participants and

Dual participants are not required to

contract with a QCDR; thus we will not

use these entities as a means of

collecting outcome measures. We will

continue to assess and consider

advancements made by professional and

specialty societies in the development

of quality metrics to identify the

availability of metrics that meaningfully

measure quality of RT care and impact

on outcomes (including survival). As

these are identified, we will consider

proposing an appropriate outcome

measure in future rulemaking.

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NQF endorsement summaries: http://

www.qualityforum.org/News_And_Resources/

Endorsement_Summaries/Endorsement_

Summaries.aspx.

49

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

50

Baseline performance is based on the entirety

of data submitted to meet MIPS data reporting

Comment: A commenter

recommended developing an outcome

registry for incidents such as bone

marrow transplants, CAR–T cell

therapy, fractures, pain,

hospitalizations, and other

complications. Another commenter

encouraged CMS to develop a central

reporting mechanism for patients

receiving relatively new, relatively

expensive technologies and their

outcomes.

Response: CMS is not developing a

registry for use in the RO Model, but we

appreciate this comment and

acknowledge the value of registries to

track treatment effects and health

outcomes, while not increasing data

collection burden for providers and

suppliers. We will monitor registry

development and assess the feasibility

of using such registry data in the future.

Comment: A commenter urged CMS

to consider the relationship between the

90-day episode period and the timing

included in the RO Model’s measure

specifications, and requested CMS

properly scope the measures to reflect

care that is within the control of the

radiation oncologist specifically within

the 90-day episode window.

Response: We believe that the

measures we are adopting are

appropriate for inclusion in the RO

Model. We selected all measures based

on clinical appropriateness for RT

services spanning a 90-day episode

period. The measures are scoped to

certain specifications, including time,

which are important for validity and

reliability of the measure results. We

believe that radiation oncologists have

an important role to play in ensuring

that their patients have a plan to address

beneficiary pain, that they communicate

treatment with other providers and

suppliers to ensure the RO beneficiaries

are receiving coordinated care, and that

they have been screened for depression

and have an advance care plan. By

encouraging radiation oncologists to

provide guidance and care coordination

as well as engage with patients

throughout their treatments, we believe

these measures will improve both

patients’ outcomes and their experience

of care. We believe both depression

screening and advance care planning

help RO beneficiaries ensure they are

engaged and pursuing the best course of

treatment for them.

Comment: A commenter expressed

concern that the proposed quality

measures are insufficient to measure

whether RO participants are using high-

quality equipment and other

infrastructure they believe correlate

with providing high-value care. This

commenter recommended including

quality measures that reflect variation in

accreditation and equipment used for

treatment.

Response: We appreciate the role of

high-quality equipment in the delivery

of care. We also understand that to

achieve accreditation, a clinical

organization must demonstrate high

standards of patient care. We also note

that, as discussed in section III.C.13.c,

we may request the optional submission

of additional administrative data

through web-based surveys, such as

how frequently the radiation machine is

used on an average day and the RO

participant’s accreditation status.

However, we continue to believe that

quality measurement must be outcome-

based, focusing on the patient and the

episode of care, and not be based solely

on the equipment or accreditation

status. We will use clinical data

elements in the RO Model to support

monitoring and evaluation of the Model

and may use these data to begin

developing new outcome-based quality

measures that may capture the effect of

quality equipment and infrastructure.

Comment: Several commenters

recommended a voluntary phase-in

period to collect quality measure data,

which they believe would allow

practices to become operational within

the Model and provide better data. A

couple of commenters urged CMS to

provide additional details on quality

measure and clinical data element

collection and submission processes to

give RO participants additional time to

prepare their systems and comply with

these requirements.

Response: We do not believe a

voluntary phase-in period is necessary

for the RO Model. RO participants’ first

submission for the set of quality

measures for PY1 (beginning on January

1, 2021) as described in section III.C.8.b

will begin in March 2022, as finalized

in section III.C.8.c. We believe

beginning the Model performance

period on January 1, 2021 Model will

allow RO participants to review and to

develop best practices to facilitate their

data collection and to work with EHR

vendors to seek additional EHR support.

We will provide additional information

about measure collection on the RO

Model website: https://

innovation.cms.gov/initiatives/

radiation-oncology-model/.

Comment: A commenter expressed

concern that EHR vendors will use the

new requirements to generate additional

fees for their products, thereby placing

RO participants, especially those that

are small and rural, at greater financial

risk.

Response: We understand the

commenter’s concern about the cost of

these requirements, but we note that

three of the four proposed quality

measures are already included in the

MIPS program, so we expect that some

of these measures may already be

familiar to EHR vendors. In regard to

small and rural providers and suppliers,

please see section III.C.3.c of this final

rule, which outlines the opt-out option

for low-volume providers and suppliers.

Comment: A few commenters

opposed the implementation of quality

measures in the RO Model and

suggested not implementing quality

measures in the Model at all, stating

their view that the measures would not

yield information reflective of quality in

a radiation oncology practice and would

do little to encourage actual

improvement in the quality of patient

care.

Response: We disagree with

commenters’ assertions regarding the

impact of quality measurement in the

RO Model. We believe that including

appropriate quality measures in the RO

Model—as in other Innovation Center

Alternative Payment Models (APMs)—is

critical to monitoring beneficiary care

and ensuring that quality of care is

preserved or enhanced within an

episode payment model in which CMS

expenditures are reduced. Quality

measures are in alignment with the CMS

and Innovation Center goals of

providing effective, safe, efficient,

patient-centered, equitable, and timely

care. Furthermore, if we did not finalize

quality measures for the RO Model, it

would not satisfy the requirements of an

Advanced APM, nor a MIPS APM.

b. RO Model Measures and CAHPS

®

Cancer Care Survey for Radiation

Therapy

As we discussed in the proposed rule

(84 FR 34515), we selected the four

quality measures for the RO Model after

conducting a comprehensive

environmental scan that included

stakeholder and clinician input and

compiling a measure inventory. Three of

the four measures are currently NQF-

endorsed

48

process measures approved

for MIPS.

49

We proposed for the three

NQF-endorsed measures approved for

MIPS (Plan of Care for Pain; Screening

for Depression and Follow-Up Plan; and

Advance Care Plan) to be applied as

pay-for-performance, given that baseline

performance data has been

established.

50

The fourth measure in the

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requirements for these measures and are not

specific to radiation oncology performance.

51

As discussed in section III.C.8.b(5) and III.C.8.f,

the CAHPS

®

Cancer Care survey would be

administered beginning in October, 2020, and we

would seek to include measures in the aggregate

quality score beginning in PY3.

52

Oncology: Medical and Radiation—Plan of Care

for Pain. American Society of Clinical Oncology. In

Review for Maintenance of Endorsement by the

National Quality Forum (NQF #0383). Last

Updated: June 26, 2018.

53

Swarm RA, Abernethy AP, Anghelescu DL, et

al. Adult Cancer Pain: Clinical Practice Guidelines

in Oncology. Journal of the National

Comprehensive Cancer Network: JNCCN.

2013;11(8):992–1022. Available at: https://

www.ncbi.nlm.nih.gov/pmc/articles/PMC5915297/.

54

We note that we proposed to use ‘‘registry

specifications.’’ For consistency with QPP, we are

now referring to registry specifications as CQM

specifications to align with QPP’s terminology.

RO Model (Treatment Summary

Communication) would be applied as

pay-for-reporting until such time that a

benchmark can be developed, which is

expected to be PY3, as discussed in

section III.C.8.b of the proposed rule (84

FR 34515) and this final rule. As

described in the proposed rule, all four

measures are clinically appropriate for

radiation oncology and were selected

based on clinical appropriateness to

cover RT spanning the 90-day episode

period. These measures ensure coverage

across the full range of cancer types

included in the RO Model, and provide

us the ability to accurately measure

changes or improvements related to the

Model’s aims. In addition, we proposed

the CAHPS

®

Cancer Care survey to

collect information we believe is

appropriate and specific to a patient’s

experience during an episode. We noted

in the proposed rule that we believe

these measures and the CAHPS

®

Cancer

Care survey

51

will allow the RO Model

to develop an Aggregate Quality Score

(AQS) in our pay-for-performance

methodology (described in section

III.C.8.f of this final rule) that

incorporates performance measurement

with a focus on clinical care and patient

experience.

(1) Oncology: Medical and Radiation—

Plan of Care for Pain (NQF #0383; CMS

Quality ID #144)

We proposed the Oncology: Medical

and Radiation—Plan of Care for Pain

(‘‘Plan of Care for Pain’’) measure in the

RO Model (84 FR 34515). This is a

process measure that assesses whether a

plan of care for pain has been

documented for patients with cancer

who report having pain. This measure

assesses the ‘‘[p]ercentage of patients,

regardless of age, with a diagnosis of

cancer who are currently receiving

chemotherapy or RT that have moderate

or severe pain for which there is a

documented plan of care to address pain

in the first two visits.’’

52

As stated in

the FY 2014 IPPS/LTCH PPS final rule

(78 FR 50843), pain is the most common

symptom in cancer, occurring ‘‘in

approximately one quarter of patients

with newly diagnosed malignancies,

one third of patients undergoing

treatment, and three quarters of patients

with advanced disease.’’

53

Proper pain

management is critical to achieving pain

control. This measure aims to improve

attention to pain management and

requires a plan of care for cancer

patients who report having pain to

allow for individualized treatment.

As we noted in the proposed rule (84

FR 34515), we believe this measure is

appropriate for inclusion in the RO

Model because it is specific to an

episode of care. It considers the quality

of care of medical and radiation

oncology and is NQF-endorsed. As we

proposed, the RO Model would adopt

the measure according to the most

recent specifications, which are under

review at NQF in Fall 2019 (and as of

the drafting of this final rule are still

under review). The current measure

specifications are being used for

payment determination within the PPS-

Exempt Cancer Hospital Quality

Reporting (PCHQR) Program (beginning

in FY2016 as PCH–15), the Oncology

Care Model (OCM) (beginning in 2016

as a component of OCM–4), and the

Merit-Based Incentive Payment System

(MIPS) (beginning in CY2017 as CMS

#144). We explained in the proposed

rule that as long as the measure remains

reliable and relevant to the RO Model’s

goals, we would continue to include the

measure in the Model regardless of

whether or not the measure is used in

other CMS programs. If in the future we

believe it necessary to remove the

measure from the RO Model, then we

will propose to do so through notice and

comment rulemaking.

We noted in the proposed rule that

this measure was currently undergoing

triennial review for NQF endorsement

via the NQF’s Fall 2019 Cycle and while

we expected changes to the measure

specifications, we did not believe these

changes would change the fundamental

basis of the measure, nor did we believe

they would impact the measure’s

appropriateness for inclusion in the RO

Model. As of the drafting of this final

rule, this measure is still under NQF

review, but as we explained in the

proposed rule, NQF endorsement is a

factor in our decision to implement the

Plan of Care for Pain measure, but it is

not the only factor. If the measure were

to lose its NQF endorsement, we noted

in the proposed rule that we may choose

to retain it so long as we believe it

continues to support CMS and HHS

policy goals. Therefore, we proposed the

Plan of Care for Pain measure with the

associated specifications available

beginning in PY1. This measure would

be a pay-for-performance measure and

scored in accordance with our

methodology in section III.C.8.f of this

final rule.

As proposed (84 FR 34517), and as

discussed further in section III.C.8.c of

this final rule, we would require

Professional participants and Dual

participants to report quality measure

data to the RO Model secure data portal

in the manner consistent with that

submission portal and the measure

specification. At the time of the

proposed rule and at the time of the

writing of the final rule, the current

version of the Plan of Care for Pain

measure specification requires that data

will be reported for the performance

year that covers the date of encounter.

The measure numerator includes patient

visits that included a documented plan

of care to address pain. The measure

denominator includes all visits for

patients, regardless of age, with a

diagnosis of cancer currently receiving

chemotherapy or radiation therapy who

report having pain. Any exclusions can

be found in the detailed measure

specification linked in this section of

this final rule.

For the RO Model, we proposed to use

the CQM

54

specifications for this

measure. Detailed measure

specifications may be found at: https://

qpp.cms.gov/docs/QPP_quality_

measure_specifications/CQM-Measures/

2020_Measure_144_MIPSCQM.pdf.

The following is a summary of the

public comments received on this

proposal and our response:

Comment: A few commenters

expressed support for implementing the

Plan of Care for Pain measure, believing

that the assessment reflected by this

measure will improve the quality of

patient care. A commenter asked CMMI

to clarify the measure specification that

would be used beginning in 2020,

noting the specifications were changed

for the 2019 MIPS performance year, but

the measure steward is reverting to the

2018 specifications (to include those

who report all pain, versus the 2019

specifications that only included reports

of moderate or severe pain).

Response: We agree that this measure

reflects an important area of assessment.

We also note that where one measure is

being used in multiple CMS programs,

we seek to align measure specifications

across programs and use the most up-to-

date version as appropriate. As

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55

We intend to align with the most recent MIPS

year specifications for each measure that is

included in MIPS because such alignment will

reduce burden for RO participants and permit

comparisons between the MIPS and RO

participants.

56

Preventive Care and Screening: Screening for

Depression and Follow-Up Plan. Centers for

Medicare & Medicaid Services. Endorsed by the

National Quality Forum (NQF #0418). Last

Updated: Jun 28, 2017.

57

Siu AL, and the U.S. Preventive Services Task

Force USPSTF. Screening for Depression in Adults:

U.S. Preventive Services Task Force

Recommendation Statement. JAMA.

2016;315(4):380–387. doi:10.1001/jama.2015.18392,

https://jamanetwork.com/journals/jama/fullarticle/

2484345.

58

Meijer, A., Roseman, M., Milette, K., Coyne,

J.C., Stefanek, M.E., Ziegelstein, R.C., . . . Thombs,

B.D. (2011). Depression screening and patient

outcomes in cancer: A systematic review. PloS one,

6(11), e27181. https://doi.org/10.1371/

journal.pone.0027181.

59

Li, M., Kennedy, E.B., Byrne, N., Ge

´rin-Lajoie,

C., Katz, M.R., Keshavarz, H., . . . Green, E. (2016).

Management of Depression in Patients With Cancer:

A Clinical Practice Guideline. Journal of Oncology

Practice, 12(8), 747–756. https://ascopubs.org/doi/

10.1200/JOP.2016.011072.

60

Pinquart, M., & Duberstein, P.R. (2010).

Depression and cancer mortality: A meta-analysis.

Psychological Medicine, 40(11), 1797–1810.

doi:10.1017/s0033291709992285, https://

pubmed.ncbi.nlm.nih.gov/20085667/.

61

Massie, M.J. (2004). Prevalence of Depression

in Patients With Cancer. Journal of the National

Cancer Institute Monographs, 2004(32), 57–71.

https://doi.org/10.1093/jncimonographs/lgh014.

62

Linden, W., Vodermaier, A., Mackenzie, R., &

Greig, D. (2012). Anxiety and depression after

cancer diagnosis: Prevalence rates by cancer type,

gender, and age. Journal of Affective Disorders,

141(2–3), 343–351. doi:10.1016/j.jad.2012.03.025,

https://pubmed.ncbi.nlm.nih.gov/22727334/.

63

We note that we proposed to use ‘‘registry

specifications.’’ For consistency with QPP, we are

now referring to registry specifications as CQM

specifications to align with QPP’s terminology.

discussed in section III.C.8.d, measures

also undergo non-substantive technical

maintenance and we intend to use the

most recent specifications unless those

specifications are inconsistent with the

specifications used in MIPS. In those

situations, we would use the MIPS

specifications. Thus, for each PY, we

will utilize the specifications of the

measure that aligns with the most recent

MIPS year specifications.

55

After consideration of the comments

we received, we are finalizing as

proposed to include the Oncology:

Medical and Radiation—Plan of Care for

Pain (NQF #0383; CMS Quality ID #144)

Measure as a pay-for-performance

measure beginning in PY1.

(2) Preventive Care and Screening:

Screening for Depression and Follow-

Up Plan (NQF #0418; CMS Quality ID

#134)

We proposed the Preventive Care and

Screening: Screening for Depression and

Follow-Up Plan (‘‘Screening for

Depression and Follow-Up Plan’’)

measure in the RO Model (84 FR 34516).

This is a process measure that assesses

the ‘‘[p]ercentage of patients screened

for clinical depression with an age-

appropriate, standardized tool and who

have had a follow-up care plan

documented in the medical record.’’

56

As we noted in the proposed rule, we

believe this clinical topic is appropriate

for an episode of care even though it is

not specific to RT. We explained that we

believe inclusion of this measure is

desirable to screen and treat the

potential mental health effects of RT,

which is important because some of the

side effects of RT have been identified

as having a detrimental effect on a

patient’s quality of life and could

potentially impact the patient beyond

physical discomfort or pain.

57 58 59 60 61 62

We noted that this measure has been

used for payment determination within

OCM (beginning in 2016 as OCM–5) and

MIPS (beginning in CY2018 as CMS

#134) and is NQF endorsed. We also

indicated that if we were to remove the

measure from the RO Model, we would

use notice and comment in rulemaking.

As proposed, this measure would be a

pay-for-performance measure beginning

in PY1 and scored in accordance with

our methodology described in section

III.C.8.f of this final rule.

As noted in the proposed rule,

discussed further in section III.C.8.c of

this final rule, we would require

Professional participants and Dual

participants to report quality measure

data to the RO Model secure data portal

in the manner consistent with that

submission portal and the measure

specification. The Screening for

Depression and Follow-Up Plan

measure specification states the data

will be reported for the performance

year that covers the date of encounter.

The measure numerator includes

patients screened for depression on the

date of the encounter using an age-

appropriate standardized tool and, if the

screening is positive, a follow-up plan is

documented on the date of the positive

screen. The measure denominator

includes all patients aged 12 years and

older before the beginning of the

measurement period with at least one

eligible encounter during the

measurement period. Any exclusions

can be found in the detailed measure

specification linked in this section in

this final rule.

For the RO Model, we would use the

CQM

63

specifications for this measure.

Detailed measure specifications may be

found at: https://qpp.cms.gov/docs/

QPP_quality_measure_specifications/

CQM-Measures/2020_Measure_134_

MIPSCQM.pdf.

The following is a summary of the

public comments received on this

proposal and our response:

Comment: A few commenters

supported this measure. A commenter

asserted the measure should be

broadened to include screening for

distress (for example, anxiety, stress,

and social isolation) and whether

follow-up care is being sought. Another

commenter who supported the measure

recommended an exception be written

into the specifications to exclude

patients who were screened less than

six months prior to the encounter

within the measurement period. The

commenter explained that this

exception could be utilized to guard

against the perception of gaming that

the commenter believes exists in OCM

practices that are screening patients for

depression on a quarterly (or more

frequent) basis, to perform better on the

measure. This commenter also noted

that the frequency of screening places

burden on patients.

Response: We appreciate commenters’

support for including this measure in

the Model. We respect the commenter’s

concerns regarding the perception of

gaming as related to this measure. While

we understand the importance of

mitigating gaming, we do not concur

with the commenter’s perception of

gaming in OCM practices. CMS is not

the measure steward, however, we will

share the commenters’ feedback on

potential changes to the specifications

with the measure steward for

consideration especially with respect in

recognition of the perception of gaming.

Comment: A few commenters

recommended against adopting this

measure, noting that (1) it is considered

topped-out; (2) it is outside of the direct

control of radiation oncologists (that is,

typically the responsibility of primary

care physicians or medical oncologists),

and therefore not directly applicable to

the RO Model; and (3) calculating the

measure imposes a burden on providers

and suppliers because the data is not

captured in a discrete field in the

medical record. These commenters

suggested that CMS work with specialty

societies, radiation oncologists, and

other stakeholders to develop and

validate appropriate measures for

radiation therapy.

Response: We appreciate all of the

comments regarding this measure and

acknowledge the concerns that some

commenters expressed. The RO Model

will use the MIPS CQM version of this

measure. For providers and suppliers

that participated in MIPS and submitted

the measure through the MIPS CQM,

this measure is not topped-out. Further,

even if this measure were to become

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64

As of April 2020 this measure is undergoing an

annual endorsement update review at NQF. A

modified specification was submitted for review by

the measure developer.

65

We note that we proposed to use ‘‘registry

specifications.’’ For consistency with QPP, we are

now referring to registry specifications as CQM

specifications to align with QPP’s terminology.

topped-out for the population of

providers and suppliers who participate

in MIPS, there is value to implementing

measures that have topped-out in order

to prevent a decrease in performance on

this aspect of care. Further, establishing

continuity in the quality measures

implemented in the RO Model and

MIPS will be a key factor in our

assessment of the RO Model’s

performance over time, as it will allow

for data comparison between the

participating entities in each respective

program. While screening for depression

and follow-up care is not traditionally

within the purview of radiation

oncologists, we believe the RO Model

presents an opportunity to address the

need for more comprehensive

understanding of patients’ health when

undergoing RT services. Care can be

delivered more effectively when RO

participants understand their patients’

mental health, and the ramifications of

their mental health on their care

planning and care delivery. Specifically,

we note this measure requires that a

follow-up plan is documented on the

day of a positive screening. In regard to

provider and supplier burden, we

expect that—given this is an existing

MIPS measure—data are captured in

EHRs, and/or EHR vendors will have

capacity to establish needed collection

fields. We will continue to monitor our

measure set and other measures as they

become available to ensure the RO

Model measure set remains appropriate,

meaningful and parsimonious.

Comment: A commenter

recommended categorizing this measure

as pay-for-reporting in the AQS

methodology (as opposed to pay-for-

performance) until a benchmark is

established specific to radiation

oncology patients, noting that the

current MIPS benchmark for this

measure would create an inappropriate

cohort comparison.

Response: We believe that setting

discrete benchmarks for different

specialties does not align with CMS’

goals for quality improvement. In

addition, discrete benchmarks would

create undue complexity and possible

confusion for RO participants who also

participate in MIPS to have potentially

two different benchmarks. Therefore, we

will use the MIPS benchmark and

finalize this measure as Pay-for-

Performance in PY1.

After consideration of the comments

we received, we are finalizing the

proposal to include the Preventive Care

and Screening: Screening for Depression

and Follow-Up Plan (NQF #0418; CMS

Quality ID #134) Measure as a pay-for-

performance measure beginning in PY1.

(3) Advance Care Plan (NQF #0326;

CMS Quality ID #047)

We proposed to include the Advance

Care Plan measure in the RO Model (84

FR 34517). The Advance Care Plan

measure is a process measure that

describes percentage of patients aged 65

years and older that have an advance

care plan or surrogate decision maker

documented in the medical record or

documentation in the medical record

that an advance care plan was discussed

but the patient did not wish or was not

able to name a surrogate decision maker

or provide an advance care plan. This

measure is not unique to the radiation

oncology, but, as proposed, we believe

that it would be appropriate for the RO

Model because we believe that it is

essential that a patient’s wishes

regarding medical treatment are

established as much as possible prior to

incapacity.

This measure is NQF endorsed

64

and

has been collected for MIPS (beginning

in CY2018 as CMS #047), making its

data collection processes reasonably

well established. If it becomes necessary

to remove the measure from the Model,

we would do so through notice and

comment rulemaking. As proposed, this

measure would be a pay-for-

performance measure beginning in PY1

and scored in accordance with our

methodology in section III.C.8.f of this

rule.

As proposed (84 FR 34517), and as

discussed further in section III.C.8.c of

this rule, we would require Professional

participants and Dual participants to

report quality measure data the RO

Model secure data portal in the manner

consistent with that submission portal

and the measure specification. The

current version (at the time of the

proposed rule and the drafting of this

final rule) of the Advance Care Plan

measure specification states the data

will be reported for the performance

year that covers the date of

documentation in the medical record.

The measure numerator includes

patients who have an advance care plan

or surrogate decision maker

documented in the medical record or

documentation in the medical record

that an advance care plan was discussed

but patient did not wish or was not able

to name a surrogate decision maker or

provide an advance care plan. The

measure denominator includes all

patients aged 65 years and older. Any

exclusions can be found in the detailed

measure specification linked in this

section of this final rule.

As proposed, for the RO Model, we

would use the CQM

65

specifications for

this measure. Detailed measure

specifications may be found at: https://

qpp.cms.gov/docs/QPP_quality_

measure_specifications/CQM-Measures/

2020_Measure_047_MIPSCQM.pdf.

The following is a summary of the

public comments received on this

proposal and our response:

Comment: A few commenters

supported implementing the Advance

Care Plan measure. A commenter noted

advance care planning is associated

with lower rates of ventilation,

resuscitation, intensive care unit

admission, earlier hospice enrollment,

and decreased cost of care at the end of

life. Another commenter noted advance

care planning is a key activity in cancer

care planning and documenting a

patient’s goals and values can result in

more personalized care plans. Finally, a

commenter supported this measure but

recommended allowing an exclusion for

those patients who do not want to

participate in advance care planning.

Response: We thank the commenters

for their support. Regarding the

comment to exclude patients who do

not want to participate in advance care

planning, we are implementing the

measure using the current

specifications, which have been tested

and validated for reliability. We note

that within the current specifications,

the numerator captures how many

patients were asked if they have an

advance care plan and is agnostic as to

whether or not they have a plan. Thus,

an exclusion for those patients who

chose not to have such a plan is not

necessary to performance on this

measure.

Comment: A few commenters

recommended not finalizing the

Advance Care Plan measure, because

they believe: (1) It is topped-out; (2) it

is outside the direct control of radiation

oncologists; (3) calculating the measure

imposes a substantial burden on RO

participants; and (4). this measure does

not account for patients’ receipt of

survivorship care plans and may create

duplication of effort.

Response: We appreciate all of the

comments regarding this measure and

acknowledge the concerns that some

commenters expressed. As we stated in

our discussion of the Screening for

Depression and Follow-Up Plan

measure, we are using the MIPS CQM

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https://www.cancer.net/survivorship/follow-

care-after-cancer-treatment/asco-cancer-treatment-

and-survivorship-care-plans.

67

Oncology: Treatment Summary

Communication—Radiation Oncology. American

Society for Radiation Oncology. Endorsement

removed by the National Quality Forum (NQF

#0381). Last Updated: Mar 22, 2018.

68

Treatment Summary Communication had

previously been endorsed by NQF but was not

brought by the measure steward for measure

maintenance and re-endorsement; thus it is

currently not endorsed.

version of this measure. This measure is

not topped-out for the population of

providers and suppliers who participate

in MIPS and submitted their data

through the MIPS CQM. There is also

value to implementing measures that

have topped-out, to prevent a decrease

in performance on this aspect of care.

While advance care planning may not

be traditionally within the purview of

radiation oncologists, we believe the

Model presents an opportunity for RO

participants to engage patients in care

planning. Further, establishing

continuity in the quality measures

implemented in the RO Model and

MIPS will be a key factor in our

assessment of the RO Model’s

performance over time, as it will allow

for data comparison between the

participating entities in each respective

program. In regard to provider and

supplier burden, we expect that—given

this is an existing MIPS measure—data

are captured in EHRs, and/or EHR

vendors will have capacity to establish

needed collection fields. Finally, we

seek to clarify that the Advance Care

Plan measure quantifies the number of

patients who have an advance care plan

or a surrogate decision-maker

documented in the medical record, or

documentation that an advance care

plan was discussed but the patient did

not wish or was not able to name a

surrogate. We do not see any overlap

between this measure, and the process

of providers and suppliers working with

patients to develop Survivorship Care

Plans. Survivorship Care Plans include

information about a patient’s treatment,

the need for future check-ups and

cancer tests, and potential long-term late

effects of treatment, as well as ideas for

health improvement.

66

After consideration of the comments

we received, we are finalizing as

proposed to include the Advance Care

Plan (NQF #0326; CMS Quality ID #047)

Measure as a pay-for-performance

measure beginning in PY1.

(4) Treatment Summary

Communication—Radiation Oncology

We proposed the Treatment Summary

Communication—Radiation Oncology

(‘‘Treatment Summary

Communication’’) measure in the RO

Model (84 FR 34517). The Treatment

Summary Communication measure is a

process measure that assesses the

‘‘[p]ercentage of patients, regardless of

age, with a diagnosis of cancer that have

undergone brachytherapy or external

beam RT who have a treatment

summary report in the chart that was

communicated to the physician(s)

providing continuing care and to the

patient within one month of completing

treatment.’’

67

As proposed, we believe

this measure is appropriate for inclusion

in the RO Model because it is specific

to an episode of care. This measure

assesses care coordination and

communication between health care

providers during transitions of cancer

care treatment and recovery. While this

measure is not currently NQF

endorsed

68

and has not been used in

previous or current CMS quality

reporting, it has been used in the

oncology field for quality improvement

efforts, making considerations regarding

data collection reasonably well-

established. We would include the

measure because, as we stated in the

proposed rule, we believe it is valid and

relevant to meeting the RO Model’s

goals. As proposed, this measure would

be the one pay-for reporting measure

included in the calculation of the AQS

until a benchmark is established that

will enable it to be pay-for-performance,

which is expected to be beginning in

PY3.

As proposed (84 FR 34517), and as

discussed further in section III.C.8.c of

this final rule, we would require

Professional participants and Dual

participants to report quality measure

data to the RO Model secure data portal

in the manner consistent with that

submission portal and the measure

specification. The current version (at the

time of the proposed rule and the

drafting of this final rule) of the

Treatment Summary Communication

measure specification states the data

will be reported for the performance

year that covers the date of the

treatment summary report in the chart.

The measure numerator includes

patients who have a treatment summary

report in the chart that was

communicated to the physician(s)

providing continuing care and to the

patient within one month of completing

treatment. The measure denominator

includes all patients, regardless of age,

with a diagnosis of cancer who have

undergone brachytherapy or external

beam radiation therapy. Any exclusions

can be found in the detailed measure

specification linked in this section of

this final rule.

For the RO Model, we would use the

registry specifications for this measure.

Detailed measure specifications may be

found at: http://www.qualityforum.org/

QPS/0381.

The following is a summary of the

public comments received on this

proposal and our response:

Comment: A few commenters

expressed support for the measure

Treatment Summary Communication. A

couple of commenters noted their desire

for CMS to collect data beyond what

this measure captures, and look at

multidisciplinary treatment planning

efforts across radiation oncology,

surgery, and medical oncology. A

couple of commenters expressed

support for implementing this measure

as pay-for-reporting in PYs 1–2 and

encouraged CMS to test the measure for

reliability and validity, and provide

additional information to RO

participants, before transitioning it to a

pay-for-performance measure.

Response: We appreciate commenters’

support and are finalizing this measure,

using the current specifications, which

have been tested and validated for

reliability, in the RO Model as described

in the proposed rule: Pay-for-reporting

in PY1 and PY2; and pay-for-

performance in PYs 3–5. We believe the

measure must be pay-for-reporting in

PY1 and PY2 in order to establish

historical data to set a benchmark for

use during the pay-for-performance

years. We plan to provide information

regarding the benchmark for the

measure Treatment Summary

Communication to RO participants via

the RO Model website.

Comment: A few commenters

expressed concerns regarding the

specifications and/or endorsement

status of this measure. A commenter

specifically noted the measure was

withdrawn from NQF consideration by

the developer, and not submitted for

NQF measure maintenance evaluation,

thus it is no longer endorsed.

Commenters noted that the lack of

endorsed measure specifications can

create inconsistency in how the measure

is utilized; they also noted that this

measure is not widely integrated into

EHRs, thus creating burden for RO

participants who will need to integrate

the measure’s data points into their

EHRs. Another commenter noted that

the measures should be implemented

with the original specifications to

document treatment summary

communications that take place over a

four-week period of a patient’s care and

recommended that CMS align how this

measure’s data is collected and

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reported—using the original four-week

specification—across all CMS reporting

programs.

Response: We appreciate commenters’

concerns and will finalize the measure

specifications as proposed. Where one

measure is being used in multiple CMS

programs or models, we seek to align

measure specifications across programs

and models and use the most up-to-date

version as appropriate. Regarding NQF

endorsement, we agree that NQF

endorsement is an important, but not

the sole, criterion for identifying

measures for implementation. RO

participants will be provided with

educational materials that provide the

specification details for each measure,

which addresses the concerns expressed

by commenters that lack of current NQF

endorsement may lead to inconsistency

in how the measure is operationalized

within the RO Model.

Comment: A commenter requested

clarification about how this measure

would be fielded. Another commenter

requested clarification that RO

participants do not need to send a

treatment summary to other PGPs if

both have access to the same EHR.

Response: The intent of this measure

is to ensure that the radiation oncology

treatment documentation is

appropriately transitioned to the

physician responsible for the patient’s

ongoing care, as well as to the patient,

to ensure safe and timely care

coordination and care continuity post-

treatment. If the referring PGP and RO

participant are using the same EHR,

appropriate communication must still

occur with the patient, and referring

PGP as appropriate, in order to meet the

criteria for the measure numerator.

After consideration of the comments

we received, we are finalizing as

proposed to include the Treatment

Summary Communication—Radiation

Oncology as a pay-for-reporting measure

beginning in PY1.

(5) CAHPS

®

Cancer Care Survey for

Radiation Therapy

We proposed to have a CMS-approved

contractor administer the CAHPS

®

Cancer Care Survey for Radiation

Therapy (‘‘CAHPS

®

Cancer Care

Survey’’), beginning April 1, 2020 and

ending in 2025, to account for episodes

that were completed in the last quarter

of 2024 (84 FR 32517). We would use

the CAHPS

®

Cancer Care Survey for

inclusion in the Model as it is

appropriate and specific to patient

experience of care within an RO

episode. Variations of the CAHPS

®

survey are widely used measures of

patient satisfaction and experience of

care and are responsive to the increasing

shift toward incorporation of patient

experience into quality measurement

and pay-for-performance programs.

Variations of the CAHPS

®

survey have

been used within the PCHQR Program,

Hospital OQR Program, MIPS, OCM,

and others, making considerations

regarding data collection reasonably

well-established.

As we indicated in the proposed rule,

we plan to propose a set of patient

experience domains based on the

CAHPS

®

Cancer Care Survey, which

would be included in the AQS as pay-

for-performance measures beginning in

PY3, in future rulemaking.

The CAHPS

®

Cancer Care Survey

proposed for inclusion in the RO Model

may be found at https://www.ahrq.gov/

cahps/surveys-guidance/cancer/

index.html.

We solicited public comment on our

proposal to administer the CAHPS

®

Cancer Care Survey for Radiation

Therapy for purposes of testing the RO

Model.

Comment: A couple of commenters

recommended CMS implement the

CAHPS

®

Cancer Care Survey in the

Model earlier than PY3 due to the

importance of collecting patient

experience data to inform clinical care.

Response: We appreciate commenter’s

recommendations and agree with

sentiment that collecting patient

experience data is critical. We will

begin fielding the CAHPS

®

Cancer Care

Survey in PY1. The inclusion of patient

experience measures in the calculation

of the AQS will not begin until PY3,

after future rulemaking, due to the time

needed to derive and test which

domains should be included in the AQS

using data collected from the early years

of the Model.

Comment: A few commenters

requested clarification regarding who

would administer the CAHPS

®

Cancer

Care Survey. These commenters also

expressed concern that the RO

participant would have to bear the

administrative and financial cost of

fielding the survey.

Response: We would like to clarify

that CMS will be accountable for

fielding the CAHPS

®

Cancer Care

Survey to RO beneficiaries. RO

participants should not experience any

additional cost as a result of

implementation of the survey.

Comment: Several commenters did

not support adopting, or recommended

delaying implementation of, the

CAHPS

®

Cancer Care Survey. A

commenter asserted the timing of

implementation of the RO Model would

not allow participants enough time to

prepare for fielding the survey. Another

commenter stated the lack of current

benchmarks would make it difficult to

incorporate the measure into the AQS at

PY3, and recommended delaying until

PY4. A third commenter suggested CMS

pilot the CAHPS

®

Cancer Care Survey

before including it as a measure in the

AQS. Some commenters did not support

adopting the CAHPS

®

Cancer Care

Survey because they believe that it does

not elicit meaningful data from patients.

The commenters argued that: (1) The

time lag between when a patient

finishes a course of radiotherapy and

when they receive the CAHPS

®

Cancer

Care Survey makes it challenging to

remember the specifics of their care

experience; (2) the multi-disciplinary

nature of oncology care, including RT

services, makes it difficult for patients

to tease out their specific RT experience;

(3) the length of the survey and current

administration modes (by mail or

telephone, with no electronic option) is

overwhelming to patients; (4) the mail

or phone nature of fielding CAHPS

®

has

the potential to be viewed by patients as

a scam; and (5) the burden on patients

who have to fill out multiple surveys,

which may create timing issues for RO

participants to comply with RO Model

deadlines.

Response: We acknowledge there are

significant challenges to implementing

patient experience measures in any

model or program; however, those

challenges should not preclude making

the effort to collect and analyze data on

the patient experience, to achieve the

ultimate goal of improving patient care.

We note that AHRQ has tested the

survey for reliability and validity to

address issues of comparability across

practices and patient characteristics. As

such, we do not believe it is necessary

to implement a pilot period prior to

including this survey as a part of the

AQS. Further, we reiterate that the

CAHPS

®

Cancer Care Survey be fielded

starting in PY1 but not included in the

AQS methodology as a pay-for-reporting

measure until PY3, after future

rulemaking. Finally, we do not believe

a delay in implementation to help RO

participants prepare for fielding the

survey is needed, given that CMS will

administer the survey.

Comment: Some commenters

expressed concern with the use of the

CAHPS

®

Cancer Care Survey for other

methodological reasons, including: (1)

The survey is not endorsed by NQF; (2)

lack of sufficient testing of the survey to

ensure comparability of performance

scores based on practice size and type,

patient characteristics, and/or

geographic regions; (3) the need to

harmonize the survey with the CAHPS

®

Hospice survey; (4) the lack of a strategy

for ensuring that RO beneficiaries do not

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69

CAHPS

®

Cancer Care Survey. https://

www.ahrq.gov/cahps/surveys-guidance/cancer/

index.html.

70

42 CFR 414.1380(b)(1)(iii).

receive both surveys during what is

already a stressful and anxious time; (5)

inherent biases against HOPDs that may

be found in patient experience surveys,

due to HOPDs often having fewer

resources for staffing, capital, and

amenities compared to PGPs and free

standing radiation therapy centers,

which may correlate with lower patient

experience scores; and (6) potential

overlap in the CAHPS

®

Cancer Care

Survey and the Outpatient and

Ambulatory Surgery (OAS) CAHPS

®

survey, which could negatively affecting

response rates for either or both

survey(s). A commenter recommended

that CMS investigate electronic modes

of fielding the CAHPS

®

Cancer Care

Survey.

Response: We appreciate commenters

sharing their methodological concerns

and acknowledge that collecting patient

experience data is a challenging effort.

We will consider these comments as we

implement the Model and begin

reviewing the survey data, and where

necessary, we will seek to address them

in future rulemaking. Regarding NQF

endorsement, we agree that NQF

endorsement is an important, but not

the sole, criterion for identifying

measures for implementation. Regarding

testing the survey in the Model, AHRQ

has tested the survey for reliability and

validity to address issues of

comparability across practices and

patient characteristics.

We will begin administering the

survey in PY1 for baseline data

collection, to set appropriate

benchmarks, and to identify other

methodological issues such as effects of

overlap with OAS CAHPS

®

on the

response rate. We plan to propose via

rulemaking a set of patient experience

domains based on the CAHPS

®

Cancer

Care Survey, which would be included

in the AQS as pay-for-performance

measures beginning in PY3. Information

on the established benchmarks will be

made available on the RO Model

website. Regarding survey mode(s) and

administration, CMS will be responsible

for survey administration to

beneficiaries in the RO Model and will

ensure survey methods are consistent

with the CAHPS

®

specifications,

including potential overlap with other

CAHPS

®

surveys. CMS will field the

survey as specified to ensure reliability

and validity of survey response data.

Further information about the survey

development, testing, and fielding can

be found on the survey website.

69

We

note that the version of the CAHPS

®

Cancer Care Survey that will be used

was specifically developed for radiation

therapy, which we believe addresses the

commenter’s concern about being able

to appropriately consider RT care

experiences.

Comment: A few commenters

suggested creating a new patient

experience measure to replace the use of

the CAHPS

®

Cancer Care Survey. A

commenter suggested that the patient

experience measure should be

developed in a way that eliminates bias

against HOPDs, which the commenter

says often have a less favorable payer

mix than PGPs and freestanding

radiation therapy centers. Another

commenter noted that while patient

experience measures are good indicators

of whether and how changes are being

implemented in care, an actual patient

experience measure that reflects the RO

Model should be developed at an

accelerated pace.

Response: We agree that innovation in

the collection of patient experience data

is important to pursue, and we welcome

advancements in this area. However, we

also believe that the need to understand

patients’ experiences of care is critical,

and cannot be delayed while other

measures are being developed. For these

reasons, we are finalizing adoption of

the CAHPS

®

Cancer Care Survey and

will continue to evaluate new measures

of patient experience for future

consideration.

After reviewing the comments

received on our proposed quality

measures, we are finalizing, with one

modification in regard to the start date,

our proposal to include a set of four

quality measures for PY1. Instead of

submitting quality measures data

beginning in March, 2021, as proposed,

RO participants will submit data

beginning in March, 2022, based on RO

episodes in PY1 (January 1, 2021,

through December 31, 2021), consistent

with other changes to the timing of

Model implementation. We are also

finalizing our proposal to have a CMS-

approved contractor administer the

CAHPS

®

Cancer Care Survey for

Radiation Therapy, with a modification

that the survey will be administered

beginning in April 2021 rather than in

2020.

c. Form, Manner, and Timing for

Quality Measure Data Reporting

We proposed to use the following data

collection processes for the four quality

measures described in section

III.C.8.b(1) through (4) of this final rule

beginning in PY1 (84 FR 34517).

First, we proposed requiring

Professional participants and Dual

participants to report aggregated quality

measure data, instead of beneficiary-

level quality measure data. These data

would be used to calculate the

participants’ quality performance, as

discussed in section III.C.8.f(1) of the

proposed rule (84 FR 34519) and this

final rule, and subsequent quality

reconciliation payments on an annual

basis.

Second, we proposed requiring that

quality measure data be reported for all

applicable patients (that is, not just

Medicare beneficiaries or beneficiaries

with episodes under the Model) based

on the numerator and denominator

specifications for each measure (84 FR

34517). As proposed, we believe

collecting data for all patients who meet

the denominator specifications for each

measure from a Professional participant

or Dual participant, and not just

Medicare beneficiaries, is appropriate

because it is consistent with the

applicable measure specifications, and

any segmentation to solely the Medicare

populations would be inconsistent with

the measure and add substantial

reporting burden to RO participants. If

a measure is already reported in another

program, then the measure data would

be submitted to that program’s reporting

mechanism in a form, manner, and at a

time consistent with the other program’s

requirements, and separately submitted

to the RO Model secure data portal in

the form, manner and at the time

consistent with the RO Model

requirements.

As proposed, similar to the approach

taken for the QPP,

70

the RO Model

would not score measures for a given

Professional participant or Dual

participant that does not have at least 20

applicable cases according to each

measure’s specifications. However,

unlike the Quality Payment Program, if

measures do not have at least 20

applicable cases for the participant, we

would not require the measures to be

reported. In this situation, an RO

participant would enter ‘‘N/A-

insufficient cases’’ to note that an

insufficient number of cases exists for a

given measure.

As proposed, we would provide

Professional participants and Dual

participants with a mechanism to input

quality measure data. We would create

a template for Professional participants

and Dual participants to complete with

the specified numerator and

denominator for each quality measure

(and the number of cases excluded and

exempt from the denominator, as per

measure specifications’ exclusions and

exemptions allowances), provide a

secure portal, the RO Model secure data

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portal, for data submission, and provide

education and outreach on how to use

these mechanisms for data collection

and where to submit the data prior to

the first data submission period.

We proposed that Professional

participants and Dual participants

would be required to submit quality

measure data annually by March 31

following the end of the previous PY to

the RO Model secure data portal (84 FR

34518). In developing the March 31

deadline, we considered the quality

measure reporting deadlines of other

CMS programs in conjunction with the

needs of the Model. For PY1,

participants will submit quality measure

data for the time period noted in the

measure specifications. We stated if a

measure is calculated on an annual CY

basis, participants would not be

required to adjust the reporting period

to reflect the model time period. We

stated that alignment to the measure

specifications used in MIPS would

likely reduce measure reporting burden

for RO participants. RO participants

would submit measure data based on

the individual measure specifications

set forth in sections III.C.8.b(1) through

(4), unless CMS were to specify different

individual measure specifications. RO

Model measure submissions would only

satisfy the RO Model requirements.

Measures submitted to any other CMS

program would need to continue to be

made in accordance with that program’s

requirements unless specifically noted.

A schedule for data submission would

be posted on the RO Model website:

https://innovation.cms.gov/initiatives/

radiation-oncology-model/.

We proposed to determine that

Professional participants and Dual

participants successfully collected and

submitted quality measure data if the

data are accepted in the RO Model

secure data portal. Failure to submit

quality measure data within the

previously discussed requirements

would impact the RO participant’s AQS,

as discussed in section III.C.8.f of the

proposed rule (84 FR 34519) and this

final rule.

We proposed that the CAHPS

®

Cancer

Care Survey for Radiation Therapy

would be administered by a CMS

contractor according to the guidelines

set forth in the survey administration

guide or otherwise specified by CMS.

Prior to the first administration of the

survey, we would perform education

and outreach so RO participants will

have the opportunity to become more

familiar with the CAHPS

®

Cancer Care

Survey process and ask any questions.

The following is a summary of public

comments received and our response:

Comment: Several commenters

recommended that CMS pay for RO

participants to establish quality data

reporting because of the potential for

high costs required to collect and report

Model quality metrics. A couple of

commenters drew comparison to OCM,

which the commenters stated included

additional payment for collecting

quality data. A commenter suggested

that CMS could assist with reporting

cost by adding a patient management

fee.

Response: We thank the commenters

for their suggestions. We note that the

OCM does not include a payment to

participants to collect quality data. To

the extent that commenters may be

referring to the Monthly Enhanced

Oncology Services (MEOS) payment, we

note that this payment is for the

provision of Enhanced Services, as

defined in the OCM Participation

Agreement, to OCM Beneficiaries. We

would also clarify that CMS will be

paying for the administration of the

CAHPS

®

Cancer Care Survey and RO

participants will not have additional

costs for the survey. We do not believe

additional payments or an additional

patient management fee are warranted at

this time.

Comment: A commenter supported

CMS’ proposal to align the RO Model

with other quality reporting programs

and require at least 20 applicable cases

according to each measure’s

specification for scoring purposes.

Response: We thank the commenter

for their support.

Comment: A few commenters

requested clarity on how participants

will report aggregated quality measure

data and whether the RO Model secure

data portal will function similarly to the

MIPS portal.

Response: RO participants will be

required to report aggregated numerator

and denominator data, not individual

patient-level data, for all patients as

defined in the measure specifications.

The process for submitting data through

the RO Model secure data portal will be

provided via technical support and

education efforts that take place

following the final rule publication. We

intend to announce the availability of

these support and education

opportunities on the RO Model website.

Comment: A commenter requested

more information on the quality

measure and clinical data elements

template, and noted that use of a

template will increase staff time,

practice overhead costs, and because

these data elements may not be discrete

fields within the EHR, someone may

have to transcribe information out of the

medical record for submission in either

electronic form, or via a template.

Response: We will provide education

and outreach to help RO participants

understand the quality measures and

clinical data elements collection and

submission systems, including the

template. As discussed in section

III.C.8.b, based on stakeholder feedback,

we are finalizing the collection of

quality measures data beginning in PY1

(January 1, 2021) with the first

submission due in March 2022, so RO

participants will have additional time to

become familiar with the template. As

discussed in section III.C.8.e, based on

stakeholder feedback, we are finalizing

the collection of clinical data elements

beginning in PY1 (January 1, 2021) with

the first submission due in July 2021.

We also note that we plan to provide the

final list of clinical data elements on the

RO Model website prior to the start of

PY1, and provide similar education and

outreach. We are committed to working

with EHR vendors to facilitate data

collection for quality measures and

clinical data element.

Comment: A couple of commenters

urged CMS to consider allowing

practices to use relevant third parties for

data collection and reporting, as it does

in other quality reporting programs.

Response: We intend to provide

additional information about the

submission of data, prior to the PY1

data reporting start date on the RO

Model website. This information will

include whether we find it would be

appropriate to permit third-party data

submission.

Comment: Many commenters opposed

the inclusion of all patients in the

measure collection, asserting the

Model’s quality measure requirements

should only include Medicare patients.

Several of these commenters noted that

including all patients is outside the

scope of the Model. Others stated

including non-Medicare patients will

create additional labor and require

additional electronic health record

(EHR) updates and, if those updates are

not successful, that RO participant will

have to provide manual collection and

reporting, which they argue is unduly

burdensome, especially on mid-size and

smaller practices. A couple of

commenters expressed concern that

reporting data on non-Medicare

beneficiaries may result in a violation of

privacy.

Response: We are requiring RO

participants to report aggregated

numerator and denominator data, not

individual patient-level data, for all

patients as defined in the measure

specifications in the manner consistent

with the quality measure specifications,

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71

https://www.cms.gov/About-CMS/story-page/

patients-over-paperwork.html.

and not just Medicare patients. It is

important that the Model collect

measures in the manner specified to

ensure submission consistency, and

reliability of the data to comport with

how the measure is currently specified

and implemented in MIPS and other

quality initiatives. In addition, there is

inherent value to including all patients,

regardless of payer type, when assessing

quality. We believe a policy of

submitting aggregated quality measure

information in a manner consistent with

the measure specifications is not a

violation of patient privacy because it

does not include the sharing of

personally identifiable information.

Further, this is consistent with data

submission policy in MIPS. Finally,

aggregated data can provide valuable

population-level perspective on the

quality of care delivery.

Comment: A few commenters

opposed the proposal to use a separate

portal and a new website for data

collection and quality measure reporting

for measures already submitted to CMS,

stating this would create additional

operational burden for providers and

suppliers. Other commenters expressed

concern about the burden, and the

potentially significant programming

changes required, if RO Model measures

were separated from MIPS, and if

hospitals were not developing similar

systems. Commenters encouraged CMS

to simplify quality reporting by using

the current quality reporting

mechanisms instead of creating yet

another process for reporting quality

data. A commenter requested

clarification on whether quality measure

reporting could come from clinical

pathways and/or Clinical Decision

Support (CDS) systems.

Response: We appreciate the concern

regarding establishment of a new

infrastructure specific to this model.

However, because the RO Model reaches

across three different care settings,

operational considerations necessitate

the creation of one portal that all

entities can use. The process for

submitting data through the RO Model

secure data portal will be provided via

technical support and education efforts

that take place following the final rule

publication, so all RO participants have

time to become familiar with the

infrastructure and processes prior to

required reporting. In addition, we note

that the RO Model secure data portal

will serve not only as a data submission

system, but also as the portal for RO

participants to access claims data that

they can request through the Model.

Comment: Several commenters

opposed the Model’s reporting

requirements and suggested they be

reduced or not finalized because they

believe the requirements constitute

significant new administrative and

financial burdens on providers and

suppliers, especially on small providers

and suppliers. A couple of commenters

urged CMS to carefully consider the

burden associated with quality and

clinical data collection requirements,

and ensure that only the most

meaningful and least burdensome

information is collected. Commenters

noted that RO participants will be

spending a significant amount of time

and resources shifting their business

models to the new alternative payment

model.

Response: As part of the Meaningful

Measures Initiative, we are committed

to quality priorities that align CMS’

strategic goals and individual measures

and initiatives that demonstrate that

quality for our beneficiaries is being

achieved. The quality measures chosen

for the RO Model address concrete

quality topics, which reflect core issues

that are important to ensuring high

quality care and better patient outcomes

during RT treatment. We acknowledge

the burden that reporting places on RO

participants, and we seek to reduce

unnecessary burden, to increase

efficiencies, and to improve the

beneficiary experience in alignment

with the Patients Over Paperwork

Initiative.

71

We believe the quality

measures selected for inclusion in the

RO Model balance both the importance

of quality measurement and the

concerns regarding burden as we strive

to select the most parsimonious measure

set to ensure quality and support RO

Model compliance with other

concurrent programs, including MIPs

and QPP. Finally, for those practices

that have concerns about burden in

relation to their volume of radiotherapy

patients, we note that the Model

includes a low volume opt-out option,

described in detail in section III.C.3.c.

Comment: A commenter was

supportive of the proposal to not require

that measures be submitted via CEHRT.

Response: We appreciate the

commenter’s support.

Comment: A few commenters

recommended that all of the Model’s

quality measures be scoped as eCQMs

so RO participants can use the certified

EHR in which they have already

invested, instead of utilizing a third-

party registry or reverting to claims-

based measurement. A commenter

strongly rejected any non-eCQMs

because of its belief that registry-based

measures will significantly increase the

burden associated with quality reporting

by forcing providers and suppliers to

utilize a third-party registry at costs over

and above previous investments in

EHRs.

Response: We are using the registry

specifications for the measures in the

RO Model because they are the most

widely used method of data submission,

which will enable more participants to

submit data with the least impact on

workflow. Additionally, we believe the

data from registry measures are both

highly reliable and valid. Further, we

agree that eCQMs and CEHRT are

valuable tools to help provide patient-

centric care and we plan to provide

structured data reporting standards so

that existing EHRs can be adjusted if

necessary in anticipation of the RO

Model. Some EHRs may support data

extraction, reducing any additional

reporting burden on RO participants,

which may increase the quality and

volume of reporting. We also believe

that it is important that RO participants

have the option to extract the necessary

data elements manually to ensure all RO

participants are able to submit the

required data.

Comment: A commenter opposed

submitting registry-based measures,

noting it would stymie CMS’ move

toward interoperability and electronic

end-to-end reporting. The commenter

argued that it would require new

workflows that will need to be

developed in order to accurately

attribute patients to the Model from

multiple outpatient sites that are not

historically attached to our electronic

data base.

Response: While we remain

committed to moving towards increased

interoperability and electronic

reporting, we are using the registry

specifications for measures in the RO

Model because registry data is the most

widely used type of data submission

tool, which will enable more RO

participants to submit data with least

impact on workflow. We note that while

the data collected via registries are

considered reliable and valid, we are

not requiring that RO participants

utilize a registry data system to satisfy

data submission to CMS. The Model

will implement this measure based on

the specifications used in MIPS, that is,

registry data. Additionally, we are not

asking RO participants to attribute

patients; participants will report

aggregate performance, consistent with

the measure specifications.

Comment: A few commenters

supported the use of EHRs but

expressed concern with the feasibility of

EHR development in accordance with

the Model start date. These commenters

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We are clarifying that the first submission for

PY1 would be made in July of PY1 and the second

submission for clinical data for PY1 would be made

in January of PY2. The submission schedule for the

following PYs would be similar and the final

submission for PY5 would occur in January 2026.

asserted their belief that it is unlikely

that many, if any, EHR vendors will

have adequate time to make meaningful

changes to the EHR to reduce the

reporting burden on RO participants.

Commenters further stated EHR vendors

must assess their priorities and planned

projects to accommodate the timing of

CMS models, and noted this

requirement would impact planning

because participants must financially

plan for the likely significant charges to

upgrade current systems, or to plan for

new systems, putting them at significant

financial risk. These commenters

therefore requested CMS delay

implementation of this requirement

until vendors have enough time to

implement and upgrade current

systems.

Response: We appreciate commenter’s

concerns regarding the feasibility of

EHR development in accordance with

the Model start date. Continued EHR

development is an important part of our

ongoing effort to support electronic

health record data. The Model

performance period begins on January 1,

2021, which means the first submission

of clinical data elements will not occur

until July of 2021 (this submission

timeframe is different than that for

submitting quality measures, which

occurs in March following a PY). This

will allow RO participants additional

time to work with EHR vendors to

develop appropriate fields. We will also

provide which clinical data elements

are included in the RO Model on the RO

Model website and will provide those

reporting standards to EHR vendors and

the radiation oncology specialty

societies prior to their inclusion in the

Model. Our goal is to structure data

reporting standards so that existing

EHRs could be adjusted, if necessary, in

anticipation of the measure and clinical

date element requirements.

Additionally, we note that RO

participants will continue to have the

option to extract the necessary data

elements manually.

After consideration of the

commenters’ feedback, we are finalizing

our proposals for the data collection

processes for the four quality measures

described in section III.C.8.b(1) through

(4) of this final rule beginning in PY1

with the first annual submission in

March 2022 and continuing thereafter.

The process for submitting data through

the RO Model secure data portal will be

provided via technical support and

education efforts that take place

following the final rule publication. We

intend to announce the availability of

these support and education

opportunities on the RO Model website.

d. Maintenance of Technical

Specifications for Quality Measures

As part of its regular maintenance

process for NQF-endorsed performance

measures, NQF requires measure

stewards to submit annual measure

maintenance updates and undergo

Maintenance of Endorsement review

every three years. In the measure

maintenance process, the measure

steward (owner/developer) is

responsible for updating and

maintaining the currency and relevance

of the measure and will confirm existing

or minor specification changes with

NQF on an annual basis. NQF solicits

information from measure stewards for

annual reviews, and reviews measures

for continued endorsement in a specific

three-year cycle. We noted in the

proposed rule that NQF’s annual and/or

triennial maintenance processes for

endorsed measures may result in the

NQF requiring updates to the measures.

Additionally, as described in the

proposed rule, the Model includes

measures that are not NQF-endorsed,

but we anticipate they would similarly

require non-substantive technical

updates to remain current.

We received no comments on this

proposal and therefore are finalizing

this policy as proposed.

e. Clinical Data Collection

We proposed to collect clinical

information on certain RO beneficiaries

included in the Model from Professional

participants and Dual participants that

furnish the PC of an episode for use in

the RO Model’s pay-for-reporting

approach and for monitoring and

compliance, which we discussed more

fully in sections III.C.8.f(1) and III.C.14

of the proposed rule (84 FR 34519; 84

FR 34531) and this final rule. As

proposed (84 FR 34518), on a pay-for-

reporting basis, we would require

Professional participants and Dual

participants to report basic clinical

information not available in claims or

captured in the quality measures, such

as cancer stage, disease involvement,

treatment intent, and specific treatment

plan information, on RO beneficiaries

treated for five types of cancer under the

Model: (1) Prostate; (2) breast; (3) lung;

(4) bone metastases; and (5) brain

metastases, which we proposed to

require as part of § 512.275. We would

determine the specific data elements

and reporting standards prior to PY1 of

the Model and would communicate

them on the Model website. In addition,

as we described in the proposed rule,

we proposed to provide education,

outreach, and technical assistance in

advance of this reporting requirement.

We believe this information is

necessary to achieve the Model’s goals

of eliminating unnecessary or low-value

care. We have also heard from many

stakeholders that they believe

incorporating clinical data is important

for developing accurate episode prices

and understanding the details of care

furnished during the episode that are

not available in administrative data

sources. As proposed, we would use

these data to support clinical

monitoring and evaluation of the RO

Model. These data may also be used to

inform future refinements to the Model.

We also proposed that we may also use

it to begin developing and testing new

radiation oncology-specific quality

measures during the Model.

To facilitate data collection, we

proposed to share the clinical data

elements and reporting standards with

EHR vendors and the radiation oncology

specialty societies prior to the start of

the Model. Our goal is to structure data

reporting standards so that existing

EHRs could be adjusted in anticipation

of this Model. Such changes could allow

for seamless data extraction, reduce the

additional reporting burden on

providers and suppliers, and may

increase the quality of reported data.

Providers and suppliers may also opt to

extract the necessary data elements

manually. All Professional participants

and Dual participants with RO

beneficiaries treated for the five cancer

types, as previously listed, would be

required to report clinical data through

the RO Model secure data portal. We

would create a template for RO

participants to complete with the

specified clinical data elements, provide

a secure RO Model secure data portal for

data submission, and provide education

and outreach on how to use these

mechanisms for data collection and

where to submit the data prior to the

first data submission period.

We also proposed to establish

reporting standards. All Professional

and Dual participants would be required

to submit clinical data twice a year, in

July and January,

72

each PY for RO

beneficiaries with the applicable cancer

types that completed their 90-day RO

episode within the previous 6 months.

This would be in addition to the

submission of quality measure data as

described in section III.C.8.c of the

proposed rule (84 FR 34519).

We solicited specific comment and

feedback on the five cancer types for

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which we proposed to collect clinical

data, which data elements should be

captured for the five cancer types, and

potential barriers to collecting data of

this type. The following is a summary

of the public comments received and

our response.

Comment: A couple of commenters

supported the collection of clinical data

elements because it would require

Professional participants and Dual

participants to report basic clinical

information not available in claims or

captured in the proposed quality

measures, which the commenters

believe will encourage better care.

Another commenter supported tracking

data on clinical care because it improves

patients care.

Response: We thank commenters for

supporting our proposal to collect

information on clinical data elements.

Comment: A few commenters

responded to our request for comments

on clinical data elements reporting. A

commenter recommended that CMS

only request clinical data elements that

guide treatment decisions. Another

commenter recommended including

only the most clinically relevant

information. Some commenters

provided suggestions for the following

clinical data elements: Clinical

treatment plan; therapeutic status;

elements that would align with the

Surveillance, Epidemiology, and End

Results (SEER) cancer database; the

results of Prostate-Specific Antigen

(PSA) tests; information related to the

American Joint Committee on Cancer

(AJCC) staging system and the histology

of the malignancy for lung, breast and

prostate; ‘‘D’Amico’’ or the National

Comprehensive Cancer Network (NCCN)

risk grouping; site of the lesion

information; existence, and number, of

metastases; patient performance status

submitted (Karnofsky Performance

Status or Eastern Cooperative Oncology

Group (ECOG) status); and information

relating to whether medical physicists

have reviewed the chart. Other

commenters recommended collecting

data on RO participants’ use of

standardized clinical pathways and/or

CDS and whether the treatment is

curative, palliative, or benign. A

commenter recommended including the

reporting of site of treatment, dose

specification (for example, ‘‘95 percent

of specified dose to 95 percent of the

planning treatment volume’’) and

number of fractions as clinical data

elements. Other commenters suggested

that clinical and staging data elements

should be collected for complete RO

episodes and original primary cancer

type for brain and bone metastases.

Response: We thank commenters for

their suggestions. We will review each

suggestion carefully as we consider

which clinical data elements to include

as part of the RO Model.

Comment: A few commenters

opposed all clinical data reporting

requirements. Some commenters

opposed the clinical data elements

because of the perceived financial

burden, noting that without structured

EHR fields to report, participants have

increased burden to report the measures

manually or through a registry, without

significant benefit to patients. One of

these commenters also expressed

concern with the lack of information

about how CMS would use this data.

Another commenter argued that CMS

should only require clinical data

submissions once it commits to

incorporating those data into payment

rates’ risk adjustments.

Other commenters urged CMS to

carefully weigh the necessary and

appropriate uses for the data against the

significant time, effort, and

administrative burden required in order

to report those data. Another commenter

opposed clinical data elements

reporting because it believes the

reporting would be uncompensated and

reduce productivity. Another

commenter strongly opposed the

collection of clinical data elements

because the commenter believes much

of the clinical data element information

that CMS is considering is already

available in Surveillance, Epidemiology,

and End Results (SEER) Incidence Data.

Response: We believe that collecting

clinical data elements for use in the RO

Model is necessary to achieve the

Model’s goals of supporting evidence-

based care. We appreciate the

recommendation that the Model align

with the SEER Incidence Database,

however we believe that the geographic

areas captured by SEER do not align

with the RO Model CBSAs. We have

heard from many stakeholders that they

believe incorporating clinical data is

important for developing accurate

episode prices and understanding the

details of care furnished during an RO

episode that are not available in

administrative data sources, specifically

claims. We will use these data to

support clinical monitoring and

evaluation of the RO Model. These data

may also be used to inform future

refinements to the Model. We may also

use it to begin developing and testing

new radiation oncology-specific quality

measures during the Model. In keeping

with our goal of reducing burden, we

intend to align with other federal

programs to the greatest extent

practicable while continuing to collect

meaningful and parsimonious data sets.

Comment: A few commenters

expressed concern about requiring the

reporting of clinical data elements for

patients not participating in Medicare.

One was concerned that such reporting

could impose significant administrative

burdens on RO participants in order to

ensure compliance with the Health

Insurance Portability and

Accountability Act (HIPAA).

Response: We would like to clarify

that while quality measures used in the

RO Model will include non-Medicare

beneficiary data collected in the

aggregate, we intend only to require

clinical elements data reporting for

Medicare beneficiaries in the Model (RO

beneficiaries).

Comment: Several commenters

recommended delaying or phasing-in

the implementation of the clinical data

requirement until the data can be

submitted by all RO participants in a

useful and meaningful way. A few

commenters urged CMS to delay the

quality reporting requirements for the

Model for at least six months, while

another requested 18 months, asserting

the lack of granularity in the proposed

rule will prevent vendors from updating

reporting specifications. A couple of

commenters recommended delaying

clinical data element collection until

PY2.

Response: We thank the commenters

for their suggestions on either delaying

or phasing in the implementation of the

clinical data elements requirement. As

discussed in section III.C.1 we are

finalizing the Model performance period

to begin January 1, 2021, and publishing

the final rule several months in advance

of this start date, in order to provide RO

participants with sufficient time to

prepare for their inclusion in the Model.

During this time, we plan to provide the

clinical data elements on the RO Model

website and provide education and

outreach support to encourage the

efficient collection and submission of

this data. We believe finalizing the

Model performance period to begin on

January 1, 2021, will allow RO

participants time to develop best

practices to facilitate their data

collection, and work with EHR vendors

to seek additional EHR support as

needed.

Comment: Several commenters urged

CMS to consider the HL7

®

FHIR

®

-based

mCODE

TM

(Minimal Common Oncology

Data Elements) to collect and assemble

a core set of structured data elements for

oncology EHRs. Commenters

recommended mCODE

TM

based on their

belief that the use of mCODE

TM

would

structure data reporting standards so

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73

https://www.federalregister.gov/documents/

2019/04/23/2019-08178/21st-century-cures-act-

interoperability-information-blocking-and-the-onc-

health-it-certification.

that existing EHRs could be adjusted in

anticipation of this Model, which would

allow better data extraction and reduce

the additional reporting burden on

providers and suppliers, and may

increase the quality of reporting and

their belief that clinical data elements

considered by mCODE

TM

would address

CMS’ goal of collecting meaningful

clinical data elements information.

Another commenter recommended

HL7

®

more generally because of its

belief that it would reduce duplicative

entries and reduce errors.

Response: Participants will be

required to report clinical data through

the RO Model secure data portal at the

time and in a manner specified by CMS.

While we are aware of HL7

®

mCODE

TM

,

we are not confident that it will be

immediately accessible to the full

breadth of RO participants due to

technical requirements of HL7

®

and it

may not be feasible to test and

implement by the beginning of the

Model performance period; therefore,

we believe that our RO Model secure

data portal will provide the easiest,

most accessible access for most RO

participants. We continue to monitor

developments in EHR and

interoperability. We also continue to

engage with health care providers and

EHR vendors to align the information

about the most meaningful clinical data

elements to include in the RO Model,

and ensure that the greatest number of

RO participants can implement the data

collection process with the least amount

of burden.

Comment: A commenter strongly

urged CMS to encourage

implementation of bidirectional data

flow between the applicable clinical

pathways and/or CDS systems, and the

EHR, which it believes would reduce

duplicative data entry and time-

intensive information searches by the

physician when a data element is

already present in the EHR.

Response: We thank the commenter

for their suggestion and support the

improvement of reporting pathways. We

encourage RO participants to explore

efficiencies within their EHR systems

and other data platforms; however, we

do not wish to prescribe EHR

requirements to participants and

vendors.

Comment: A couple of commenters

encouraged CMS to partner with the

Office of the National Coordinator for

Health Information Technology (ONC)

to require that certified EHRs store and

transmit a minimum set of oncology

data elements, which would allow their

use under current and future Innovation

Center models. Another commenter

requested clarification regarding the

applicability of the ONC 21st Century

Cures Act: Interoperability, Information

Blocking, and the ONC Health IT

Certification Program proposed rule and

expressed concern that while vendors

have to comply with federal regulations,

they could pass these costs to

physicians.

73

Response: We believe advancing

interoperability is an important step in

healthcare quality improvement and

that putting patients at the center of

their health care and ensuring they have

access to their health information is

highly desirable. We are committed to

working with the ONC to address

interoperability issues and achieve

complete access to health information

for patients in the health care system.

We will continue to work with ONC and

other federal partners toward

interoperability and the secure and

timely exchange of health information

with the clear objectives to improve

patient access and care, alleviate health

care provider burden, and reduce

overall health care costs while

considering provider and supplier costs.

We will also assess opportunities to

coordinate on a minimum set of

oncology data elements. Finally, we

appreciate and understand the concern

that EHR vendors may pass some of the

costs of regulatory compliance on to the

physicians; however, we believe that is

it possible that most of the information

requested will already be included as

part of the EHR and will provide

valuable information to RT providers

and RT suppliers.

Comment: A few commenters

recommended that CMS should narrow

the focus and use of clinical data

required for reporting and ensure that

all required data elements are

consistently documented in structured

and discrete fields, and further asserted

CMS should not require the submission

of any data elements that are not

captured in structured fields by most

major EHR vendors. These commenters

urged CMS to work with EHR vendors

prior to the Model start date to establish

structured fields for all mandatory

reporting requirements.

Response: As we review which

clinical data elements are appropriate

for inclusion in the RO Model, we will

consider which clinical data elements

are already documented and available in

the structured and discrete fields of the

EHR; however, availability in the EHR

will not be the sole consideration in

determining which clinical data

elements to include because we believe

that the highest priority with respect to

any clinical data elements collected is

that they inform our understanding of

RT services, and this priority should not

be limited to clinical data elements that

are already collected. CMS will notify

participants via the RO Model website

prior to the start of PY1 about which

clinical data elements will be included

in the Model. RO participants will be

required to report clinical data through

the RO Model secure data portal.

Comment: A couple of commenters

recommended that CMS establish

reporting standards and timelines that

provide enough time for EHR vendors to

implement corresponding report

updates that enable discrete capture,

and for RO participants to collect

complete and accurate clinical data.

Response: We plan to share the

proposed clinical data elements and

procedural instructions for reporting

information at a time and manner

specified by CMS with EHR vendors

and the radiation oncology specialty

societies prior to the start of PY1. Our

goal is to structure data reporting so that

existing EHRs could be adjusted in

anticipation of the RO Model. Such

changes could allow for seamless data

extraction and reduce the additional

reporting burden on RO participants,

and may increase the quality of

reporting.

Comment: A commenter appreciated

the decision that CMS share the planned

elements, and procedures for reporting

them, with EHR vendors and radiation

oncology specialty societies, and

requested that CMS also share this

information with oncology clinical

pathways developers. This commenter

encouraged CMS to consider taking

clinical pathway extracts of these data

to satisfy requisite reporting.

Response: We thank the commenter

for the suggestion that CMS consider

allowing the submission of clinical

pathway extracts of data elements to

satisfy this aspect of the reporting

requirements. In the process of

determining the clinical data elements,

CMS will conduct outreach with

multiple stakeholders, including

oncology clinical pathways developers.

However, we do not believe that only

using the clinical pathways is a feasible

way to collect clinical data elements

information across all RO participants at

this time. In the future, we will consider

ways to integrate clinical pathways into

the clinical data element collection

process.

After considering public comments,

we are finalizing at § 512.275(c) the

proposal to collect basic clinical

information not available in claims or

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74

Benchmarks will be based on existing MIPS

benchmarks, or other national benchmark where

available. For measures without existing

benchmarks, we plan to develop our own

benchmarks.

captured in the quality measures,

describing cancer stage, disease

characteristics, treatment intent, and

specific treatment plan information, on

RO beneficiaries treated for five types of

cancer under the Model: (1) Prostate; (2)

breast; (3) lung; (4) bone metastases; and

(5) brain metastases. We will determine

the specific data elements prior to PY1

of the Model and will communicate

them on the RO Model website, with

data collection starting in PY1.

We are also clarifying that clinical

data will be submitted to CMS

consistent with the instructions for

reporting such as at the time and

manner specified by CMS. We have

modified the text of the regulation at

§ 512.275(c) to clarify that paragraph (c)

applies to the reporting of quality

measures and clinical data elements and

that such reporting is in addition to the

reporting described in other sections of

this rule. We have also modified the

regulatory text at § 512.275(c) such that

the list of clinical data element

categories we proposed in the proposed

rule (that is, cancer stage, disease

characteristics, treatment intent, and

specific treatment plan information on

beneficiaries treated for specific cancer

types) is an exhaustive list.

Table 11 includes the four RO Model

quality measures and CAHPS

®

Cancer

Care Survey, the level at which

measures will be reported, and the

measures’ status as pay-for-reporting or

pay-for-performance, as described in

section III.C.8.b of this final rule. The

table also includes the RO Model

clinical data elements collection, and

years, also documented in section

III.C.8.e of this final rule.

f. Connect Performance on Quality

Measures to Payment

(1) Calculation for the Aggregate Quality

Score

We proposed that the AQS would be

based on each Professional participants

and Dual participant’s: (1) Performance

on the set of evidenced-based quality

measures in section III.C.8.b of the

proposed rule (84 FR 34515 through

34517) and this final rule compared to

those measures’ quality performance

benchmarks; (2) reporting of data for the

pay-for-reporting measures (those

without established performance

benchmarks) in section III.C.8.b(4) of the

proposed rule (84 FR 34515 through

34517) and this final rule; and (3)

reporting of clinical data elements on

applicable RO beneficiaries in section

III.C.8.e of the proposed rule (84 FR

34518) and this final rule.

A measure’s quality performance

benchmark is the performance rate a

Professional participant or Dual

participant must achieve to earn quality

points for each measure in section

III.C.8.b.

74

We believe a Professional

participant’s or Dual participant’s

performance on these quality measures,

as well as successful reporting of pay-

for-reporting measures and clinical data

elements, would appropriately assess

the quality of care provided by the

Professional participant or Dual

participant.

Given the importance of clinical data

for monitoring and evaluation of the RO

Model, and the potential to use the data

for model refinements or quality

measure development, we proposed to

weight 50 percent of the AQS on the

successful reporting of required clinical

data and the other 50 percent of the

AQS on quality measure reporting and,

where applicable, performance on those

measures. Mathematically, this

weighting would be expressed as

follows:

Aggregate Quality Score = Quality

measures (0 to 50 points based on

weighted measure scores and

reporting) + Clinical data (50 points

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75

The benchmarks are published annually at this

CMS site: https://qpp.cms.gov/about/resource-

library.

when data is submitted for ≥95% of

applicable RO beneficiaries)

We proposed that quality measures

would be scored as pay-for-performance

or pay-for-reporting, depending on

whether established benchmarks exist,

as stated in section III.C.8 of this rule.

To score measures as pay-for-

performance, each Professional

participant’s and Dual participant’s

performance rates on each measure

would be compared against applicable

MIPS program benchmarks, where such

benchmarks are available for the

measures. We proposed to select the

measures as pay-for-performance for

PY1 from the list of MIPS quality

measures: (1) Advance Care Plan; (2)

Preventive Care and Screening:

Screening for Depression and Follow-

Up Plan; (3) Oncology: Medical and

Radiation—Plan of Care for Pain. The

MIPS Program awards up to ten points

(including partial points) to participants

for their performance rates on each

measure, and we would score RO

participants’ quality measure

performance similarly using MIPS

benchmarks.

75

For example, when a

Professional or Dual participant’s

measured performance reaches the

performance level specified for three

points, we will award the participant

three points. If applicable MIPS

benchmarks are not available, we would

use other appropriate national

benchmarks for the measure where

appropriate. If a national benchmark is

not available, we would calculate

Model-specific benchmarks from the

previous year’s historical performance

data. If historical performance data are

not available, then we would score the

measure as pay-for-reporting and will

provide credit to the Professional

participant or Dual participant for

reporting the required data for the

measure. We would specify quality

measure data reporting requirements on

the RO Model website. Once

benchmarks are established for the pay-

for-reporting measures, we would seek

to use the benchmarks to score the

measures as pay-for-performance in

subsequent years.

As stated earlier in this rule, measures

may also be scored as pay-for-reporting.

Professional participants and Dual

participants that report a pay-for-

reporting measure in the form, time, and

manner specified in the measure

specification would receive ten points

for the measure. Professional

participants and Dual participants that

do not submit the measure in the form,

time, and manner specified would

receive zero points. As discussed in

section III.C.8.b(4) of the proposed rule

(84 FR 34517) and this final rule, the

Treatment Summary Communication

measure will be the only pay-for-

reporting measure in PY1.

The total points awarded for each

measure included in the AQS would

also depend on the measure’s weight.

We would weight all four quality

measures (those deemed pay-for-

performance as well as pay-for-

reporting) equally and aggregate them as

half of the AQS. To accomplish that

aggregation as half of the AQS, we

would award up to ten points for each

measure, then recalibrate Professional

participants’ or Dual participants’

measure scores to a denominator of 50

points. CAHPS

®

Cancer Care Survey for

Radiation Therapy results discussed in

section III.C.8.b(5) of this final rule

would be added into the AQS beginning

in PY3, and we would propose the

specific weights of the selected

measures from the CAHPS

®

survey in

future rulemaking. We would also

specify weights for new measures if and

when the Model adopts additional

measures in the future.

In cases where Professional

participants and Dual participants do

not have sufficient cases for a given

measure—for example, if a measure

requires 20 cases during the applicable

period for its calculation to be

sufficiently reliable for performance

scoring purposes—that measure would

be excluded from the participant’s AQS

denominator calculation and the

denominator would be recalibrated

accordingly to reach a denominator of

50 points. This recalibration is intended

to ensure that Professional participants

and Dual participants do not receive any

benefit or penalty for having insufficient

cases for a given measure.

For example, a Professional or Dual

participant might have sufficient cases

to report numerical data on just three of

five RO Model measures, meaning that

it has a total of 30 possible points for the

quality measures component of its AQS.

If the Professional participant or Dual

participant received scores on those

measures of nine points, four points,

and seven points, it will have scored 20

out of 30 possible points on the quality

measures component. That score is

equivalent to 33.33 points after

recalibrating the denominator to 50

points ((20/30) * 50 = 33.33). In

instances where a Professional

participant or Dual participant fails to

report quality reporting data for a

measure in the time, form and manner

required by the RO Model as described

in section III.C.8.c will not meet the

reporting requirements and will receive

zero out of ten for that measure in the

quality portion of the AQS, as the

example in Table 13 represents. If the

same Professional participant or Dual

participant scored the same 20 points on

three measures, but failed to report the

necessary data on a fourth measure, its

AQS denominator would be set at 40

possible points. Its AQS would then be

equivalent to 25 points after

recalibrating the denominator to 50

points ((20/40) * 50 = 25).

In the proposed rule, we stated that

our assessment of whether the

Professional or Dual participant has

successfully reported clinical data

would be based on whether the

participant has submitted the data in the

time period identified and has furnished

the clinical data elements to us as

requested, as discussed in section

III.C.8.c of the proposed rule (84 FR

34517 through 34518) and this final

rule. We stated that Professional

participants and Dual participants

would either be considered ‘‘successful’’

reporters and receive full credit for

meeting our requirements, or ‘‘not

successful’’ reporters and not receive

credit. We stated that we would define

successful reporting as the submission

of clinical data for 95 percent of RO

beneficiaries with any of the five

diagnoses listed in section III.C.8.e of

the proposed rule (84 FR 34518 through

34519) and this final rule. We also

stated that if the Professional participant

or Dual participant does not

successfully report sufficient clinical

data to meet the 95 percent threshold,

it would receive 0 out of 50 points for

the clinical data elements component of

the AQS. As previously discussed, we

are finalizing our proposed clinical data

elements reporting requirements, and

we plan to post these requirements via

the RO Model website prior to PY1.

To calculate the AQS, we proposed to

sum each Professional or Dual

participant’s points awarded for clinical

data reporting with its aggregated points

awarded for quality measures to reach a

value that would range between 0 and

100 points. As discussed earlier in this

rule, we would recalibrate the points we

award for measures to a denominator of

50 points. We would then divide the

AQS by 100 points to express it as a

percentage.

To illustrate the calculation of the

AQS score, two examples are included

in this final rule. Table 12 details the

AQS calculation for a Professional

participant or Dual participant that did

not meet the minimum case

requirements for one of the pay-for-

performance measures.

BILLING CODE 4120–01–P

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Table 13 details the AQS calculation

for a Professional or Dual participant that did not meet the reporting

requirements for the clinical data elements or the pay-for-reporting

measure.

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BILLING CODE 4120–01–C

We believe that this method has the

benefits of simplicity, normalization of

differences in reported measures

between RO participants, and

appropriate incorporation of clinical

data reporting.

We solicited public comment on the

calculation for the AQS methodology.

The following is a summary of the

public comments received on this

proposal and our response:

Comment: Several commenters

opposed the 95 percent threshold for

successful clinical data element

reporting based on their belief this

threshold would not allow for the

various scenarios where obtaining

clinical data, especially from the time of

initial diagnosis, is not feasible, would

require significant time and resources to

obtain, or be overly burdensome. A

couple of commenters recommended

that CMS begin with a 70 percent

reporting requirement and reassess

whether that level can be increased in

future years. A few commenters

recommended a score of 75 percent

rather than 95 percent. A commenter

recommended a score of 80 percent to

receive full credit for reporting clinical

data elements in the AQS. A commenter

recommended that we adopt a partial

points policy for clinical data elements

reporting so that participants are not

confronted with a pass/fail requirement

in the AQS.

Response: We thank commenters for

this feedback. We remain concerned

that adopting a lower threshold than the

proposed 95 percent for successful

clinical data elements reporting would

result in RO participants reporting data

that is less useful for future quality

measure development.

Comment: A commenter urged CMS

to adopt a three- to six-month reporting

window for clinical data elements,

which would allow RO participants to

abstract and validate data for reporting

to CMS following completion of an RO

episode. The commenter suggested that

the time period for submission should

be contingent on volume and practice

resources and suggested that RO

participants should be given 90 days for

75 percent of submissions, and 180 days

for 85 percent submissions.

Response: We believe 95 percent is

the appropriate threshold for clinical

data element reporting because of the

value in obtaining this information,

which we believe will allow us to

ensure that the data collected are as

complete as practicable and provide an

accurate reflection of the clinical profile

of the RO participant’s patient

population. We believe that staggering

the requirements will increase the

operational complexity of the Model

and make it harder for participants to

comply with the requirements, whereas

maintaining the 95 percent requirement

as a consistent and simple standard of

reporting submitted twice a year in July

and in January ensures that RO

participants understand what is

expected of them well ahead of time.

Comment: A commenter encouraged

CMS to maintain the link between

quality measures and prospective

payments, which would allow the

Model to qualify as an Advanced APM

because then the Advanced APM bonus

would be available to participating

radiation oncologists if they are

designated as Qualified APM

Participants.

Response: We thank the commenter

and agree regarding the benefits

associated with maintaining the link

between quality measures and

prospective payments. Our intent is to

ensure that the Model will qualify as an

Advanced APM starting in PY1.

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This number refers to the result in line (j) in

Table 5 from the proposed rule.

Comment: A commenter argued that

the Model’s relative scoring

methodology, where RO participants are

assessed against each other rather than

against absolute benchmarks, means

that RO participants can be penalized

significantly on measures even when

they perform at high levels, as measured

by percentages. The commenter noted

that this result means little

differentiation among health care

providers’ performance but significant

differences in payments and suggested

that CMS instead consider adopting an

absolute scoring method. The

commenter also argued that scoring RO

participants against each other

discourages sharing lessons learned or

best practices, which the commenter

believed is not an optimal quality

improvement strategy.

Response: We understand the

commenter’s concerns but disagree with

the commenter’s assessment of a relative

scoring method rather than absolute

performance scoring. The principal

advantage of a relative performance

scoring system is that it bases

performance goals on real-world

performance rather than on goals that

could otherwise be perceived as

arbitrary. While MIPS benchmarks are

adopted in advance, they are based on

historical performance data and thus

allow us to assess practices based on

real-world performance. We expect RO

participants to strive to deliver high

quality evidence-based care for all

patients consistent with established and

emerging best practices. However, we

will consider the commenter’s concern

as we adopt benchmarks in future years

for the Treatment Summary

Communication and CAHPS

®

Cancer

Care survey measures.

Comment: A few commenters noted

that the proposed rule did not specify

which benchmarks or data collection

types CMS would use for RO Model

measures. A commenter recommended

CMS adopt MIPS benchmarks and data

collections to ensure an easy transition

and maintain alignment between quality

reporting programs. A commenter

suggested that an RO participant’s

performance could be based on regional

or national comparisons, while another

recommended using performance-level

quintiles. A commenter recommended

using the MIPS benchmarks to align the

Model’s quality reporting with other

CMS programs.

Response: We would like to clarify

that, as stated in the proposed rule

(footnote 57 at 84 FR 34519), we would

base benchmarks on MIPS benchmarks

where available, and that we would

develop benchmarks for those measures

that do not have MIPS benchmarks. We

agree with the commenter that adopting

MIPS benchmarks where available will

align the Model and MIPS. We would

also like to clarify that we proposed to

adopt the registry specifications for the

Model’s measures—see, for example, 84

FR 34516 (‘‘For the RO Model, we

propose to use the registry

specifications for [the Plan of Care for

Pain] measure’’) which include data

collection procedures.

Comment: Some commenters noted

that some of the 2019 MIPS benchmarks

are topped-out for some of the Model’s

measures and expressed concern that

RO participants will therefore not

receive the full 10 points for submitting

data on those measures. A commenter

argued that CMS should provide as

much flexibility as possible to RO

participants earning points so that they

can earn back their quality withholds.

Another commenter recommended that

scoring should be stratified by

performance-level quintiles.

Response: We thank the commenters

for this feedback. As we noted in section

III.C.8.b, there can be value to retaining

topped-out measures. We further note

that in the absence of other clinically

appropriate measures, retaining topped-

out measures may give us the best

possible assessment of clinical care

quality available. We believe we have

adopted an effective and parsimonious

measure set aimed precisely at the

commenter’s goal of providing as much

flexibility as possible to RO participants

to earn points. We are finalizing the list

of measures and scoring methodology as

proposed and encourage stakeholders to

continue new measure development

efforts.

Comment: Some commenters

recommended that CMS calculate the

AQS using pay-for-reporting on the four

quality measures for at least the Model’s

first year—with a commenter extending

that recommendation to the second

year—before transitioning to a pay-for-

performance program. A commenter

asserted this delay would permit

participants to become familiar with the

Model’s quality measures and

implement workflow changes. Another

commenter argued that such a delay

would enable the agency to clarify its

benchmarks for quality reporting and

provide participants enough time to

become familiar with them. The

commenter also recommended that we

provide confidential feedback reports

with performance information that can

be reviewed and corrected, as done in

other CMS quality programs.

Response: We thank the commenters

for this feedback. We note that RO

participants will not be required to

submit quality measure data on PY1 RO

episodes until March 2022, which also

provides time for familiarization. During

PY1 and before the first submission in

March 2022, we will provide education,

outreach, and feedback reports to help

participants understand the quality and

clinical data elements collection and

submission systems. Between the

availability of national benchmarks for

the three pay-for-performance measures

and the time period in which RO

participants will have access to

information about these measures, we

believe it is appropriate to retain these

measures as pay-for-performance

beginning in PY1 as originally

proposed. Starting in PY2 (once quality

measure data for PY1 has been

submitted) and continuing thereafter,

we intend to provide detailed and

actionable information to RO

participants related to their performance

in the Model, as described in section

III.C.14.c. of the proposed rule (84 FR

34532). We intend to determine the

design of and frequency of those reports

in conjunction with the RO Model

implementation and monitoring

contractor.

Comment: A commenter stated its

appreciation for our proposals to align

our quality programs and for

establishing a clear distinction between

pay-for-performance and pay-for-

reporting requirements.

Response: We thank the commenter

for supporting our plan to align quality

programs and distinguish our reporting

requirements.

After consideration of the public

comments that we have received, we are

finalizing the AQS calculation as

proposed and finalizing the definition of

the AQS at § 512.205.

(2) Applying the AQS to the Quality

Withhold

We proposed to use the following

method to apply the AQS to the amount

of the quality withhold that could be

earned back by an RO participant (84 FR

34522). We would multiply the

Professional participant’s or Dual

participant’s AQS (as a percentage)

against the 2 percent quality withhold

amount. For example, if a Professional

participant or Dual participant received

an AQS of 88.3 out of a possible 100,

then the Professional participant or Dual

participant would receive a 1.77 percent

quality reconciliation payment amount

(0.883 * 2.0 = 1.77%). If the total

episode payment amount for this RO

participant after applying the trend

factor, adjustments, and discount factor

was $2,465.68,

76

the example AQS of

88.3 would result in a quality

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77

This number is prior to the geographic

adjustment and sequestration being applied.

reconciliation payment amount of

$43.64 ($2,465.68 * 1.77% = $43.64).

77

We proposed to continue to weight

measures equally in PY1 through PY5

unless we determined that the Model

needs to emphasize specific clinical

transformation priorities or added new

measures. Any updates to the scoring

methodology in future PYs will be

proposed and finalized through notice

and comment rulemaking. There may be

some variation in the measures that we

score to calculate the AQS for

Professional participants and Dual

participants should they be unable to

report numerical data for certain

measures due to sample size constraints

or other reasons. However, as discussed

in the proposed rule, we do not

anticipate that variation will create any

methodological problems for the

Model’s scoring purposes.

The AQS would be calculated

approximately eight months after the

end of each PY and applied to calculate

the quality withhold payment amount

for the relevant PY. Any portion of the

quality withhold that is earned back

would be distributed in an annual lump

sum during the reconciliation process as

described in section III.C.11 of this final

rule.

We solicited public comments on our

proposal to apply the AQS to the

amount of the quality withhold in

section III.C.6.g(2) of the proposed rule

(84 FR 34509).

The following is a summary of the

public comments received on this

proposal and our response:

Comment: A commenter expressed

concern about the AQS’s structure and

its interactions with incentives, noting

that every participant would receive the

quality withhold, but top performers

would receive incentive payments over

a year later. The commenter also

asserted that most practices would

receive a net payment cut because they

would not earn the full withhold back.

Response: We thank the commenter

for these concerns. However, we view

the trade-offs associated with the

Model’s incentive payment timing as

necessary within the framework of an

episode-payment model that will, by

design, accelerate much of the episode-

based payments to RO participants. We

will endeavor to calculate individual

quality measure scores and an annual

AQS, produce reports, and determine

payment adjustments as swiftly as

possible. While we agree with the

commenter’s sentiment that some RO

participants will see a payment

reduction, we note that the number of

participants and the amount of the

reduction will depend on a number of

factors, including episode price as

determined by the pricing methodology

discussed in section III.C.6, and their

performance on the AQS. We note that

in any case, one of the benefits of the

RO Model is bundling payments for all

included RT services rather than

remitting them piecemeal over the

course of the RO episode. Finally, we

note that section III.C.7 of this final rule

states that RO participants will be able

to receive EOE payments as early as day

28 of the RO episode, a change from the

proposal to reimburse the final half of

the episode payment after the 90-day

episode period is over.

Comment: A commenter suggested

that CMS consider rewarding top-

performing providers and suppliers

with additional reimbursements rather

than subjecting them to a quality

withhold. The commenter argued that

this type of incentive structure would be

consistent with the Quality Payment

Program and would move Medicare

policy away from focusing on penalties,

as the commenter suggested has been

prevalent in hospital quality programs.

Response: With respect to the AQS,

RO participants will not be able to earn

back more than the quality withhold.

However, we believe that top performers

in the Model will have the opportunity,

via the Model’s payment methodology,

and the Advanced APM and MIPs

incentives, to earn total payments in

excess of their historical payments. For

this reason, we believe that the Model’s

design serves to incentivize all RO

participants to strive for high quality

and earn the available incentive

payments.

Comment: A commenter expressed

support for the Model’s proposed

measures but argued that it is unrealistic

to expect RO participants to score 100

percent for all measures. The

commenter suggested that we adopt an

80 percent performance threshold for

full credit within the quality portion of

the AQS.

Response: We thank the commenter

for this suggestion, but we do not

believe that establishing firm thresholds

within the AQS calculation would serve

our quality improvement goals. We

continue to believe that the Model’s

scoring structure must encourage

consistent improvement in the Model’s

quality metrics, and we are concerned

that establishing a scoring threshold as

suggested by the commenter would offer

disincentives for continued

improvement. While we agree with the

commenter that we do not expect RO

participants to score 100 percent on all

quality measures, we do not agree that

we should therefore adopt a scoring

‘‘curve’’ or other form of adjustment that

would offer full credit for performance

at levels below the measure’s

benchmark.

After consideration of the public

comments that we have received, we are

finalizing our proposed policy to apply

the AQS to the Quality Withhold to

begin in PY1 as finalized in section

III.6.g(2).

9. The RO Model as an Advanced

Alternative Payment Model (Advanced

APM) and a Merit-Based Incentive

Payment System APM (MIPS APM)

As we stated in the proposed rule, we

anticipate that the RO Model will be

both an Advanced APM and a MIPS

APM. For purposes of the Quality

Payment Program, the RO participant,

specifically either a Dual participant or

a Professional participant, would be the

APM Entity.

We proposed that we would establish

an ‘‘individual practitioner list’’ under

the RO Model (84 FR 34522). We

proposed that this list would be created

by CMS and sent to Dual participants

and Professional participants to review,

revise, certify, and return to CMS so that

CMS would be able to make QP

determinations and calculate any

applicable APM Incentive Payments,

and to identify any MIPS eligible

clinicians who would be scored for

MIPS based on their participation in

this MIPS APM. The individual

practitioner list would serve as the

Participation List (as defined in the

Quality Payment Program regulations at

42 CFR 414.1305) for the RO Model. We

proposed to codify the term ‘‘individual

practitioner list’’ for purposes of the RO

Model in § 512.205 of our proposed

regulations.

We proposed, at 84 FR 34522, that the

individuals included on the individual

practitioner list would include

physician radiation oncologists who are

eligible clinicians participating in the

RO Model with either a Dual participant

or a Professional participant as

described in section III.C.3.b of this final

rule. Eligible clinicians who are

identified on the Participation List for

an Advanced APM during a QP

Performance Period may be determined

to be Qualifying APM Participants (QPs)

as specified in our regulations at 42 CFR

414.1425, 414.1435, and 414.1440.

Similarly, under the current Quality

Payment Program rules, MIPS eligible

clinicians identified on the Participation

List for the performance period of an

APM Entity participating in a MIPS

APM would be scored for MIPS using

the APM scoring standard as provided

in our regulation at 42 CFR 414.1370.

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We proposed that only Professional

participant physicians and Dual

participant physicians included on the

individual practitioner list would be

considered eligible clinicians

participating in the RO Model, for

purposes of the Quality Payment

Program.

We proposed that we would create

and provide each Dual participant and

Professional participant with an

individual practitioner list prior to the

start of each PY (84 FR 34522). We

proposed that the Dual participants and

Professional participants must review

and certify the individual participant

list within 30 days of receipt of such list

in a form and manner specified by CMS.

In the case of a Dual participant or

Professional participant that begins the

RO Model after the start of PY, but at

least 30 days prior to the final QP

snapshot date of that PY, we proposed

that CMS would create and provide the

new Dual participant or Professional

participant with an individual

practitioner list.

In order to certify the list, we

proposed that an individual with the

authority to legally bind the RO

participant must certify the accuracy,

completeness, and truthfulness of the

list (84 FR 34522). We proposed that the

certified individual practitioner list

would include all individual

practitioners who have reassigned their

rights to receive Medicare payment for

the provision of RT services to the TIN

of the RO participant. We proposed that

the individual with the authority to

bind the RO participant must agree to

comply with the requirements of the RO

Model before the RO participant

certifies the list. We note that we did

not propose that HOPDs that are

Technical participants be a part of this

list process because as HOPDs they are

paid by OPPS, which is not subject to

the Quality Payment Program. The RO

participants may make changes to the

individual practitioner list that has been

certified at the beginning of the

performance year. In order to make

additions to the list, we proposed that

the RO participant must notify CMS

within 15 days of an individual

practitioner becoming a Medicare-

enrolled supplier that bills for RT

services under a billing number

assigned to the TIN of the RO

participant; the timely addition would

be effective on the date specified in the

notice furnished to CMS, but not earlier

than 15 days before the date of the

notice. If the RO participant fails to

submit timely notice of the addition, the

addition would be effective on the date

of the notice. We proposed that the

notice must be submitted in a form and

manner specified by CMS.

We proposed that in order to remove

an individual practitioner from the list,

the RO participant must notify CMS

within 15 days after an individual

practitioner ceases to be a Medicare-

enrolled supplier that bills for RT

services under a billing number

assigned to the TIN of the RO

participant; the timely removal would

be effective on the date specified in the

notice furnished to CMS, but not earlier

than 15 days before the date of the

notice (84 FR 34522). If the RO

participant fails to submit timely notice

of the removal, the removal would be

effective on the date of the notice. The

notice must be submitted in a form and

manner specified by CMS. Further, we

proposed that the RO participant must

ensure that the individuals included on

the individual practitioner list maintain

compliance with the regulation at

§ 424.516, including notifying CMS of

any reportable changes in status or

information (84 FR 34522–34523). We

proposed that the certified individual

practitioner list would be used for

purposes related to QP determinations

as specified in 42 CFR part 414 subpart

O. We also stated that if the Dual

participant or Professional participant

did not verify and certify the individual

practitioner list by the deadline

specified by CMS, the unverified list

would be used for scoring under MIPS

using the APM scoring standard (84 FR

34523). We proposed to codify these

provisions relating to the individual

practitioner list at § 512.217.

We proposed that in order to be an

Advanced APM, the RO Model must

meet the criteria specified in our

regulation at 42 CFR 414.1415 (84 FR

34523). First, in order to be an

Advanced APM, an APM must require

participants to use certified EHR

technology (CEHRT). For QP

Performance Periods beginning in 2019,

to meet this requirement, an Advanced

APM must require at least 75 percent of

eligible clinicians in the APM Entity or,

for APMs in which HOPDs are the APM

Entities, each HOPD, to use CEHRT to

document and communicate clinical

care to their patients or other health care

providers pursuant to 42 CFR

414.1415(a)(1)(i). We proposed that

during the Model performance period,

the RO participant would be required to

annually certify its intent to use CEHRT

throughout such model year in a

manner sufficient to meet the

requirements pursuant to 42 CFR

414.1415(a). Further, we proposed that

within 30 days of the start of PY1, the

RO participant would be required to

certify its intent to use CEHRT

throughout such model year in a

manner sufficient to meet the

requirements pursuant to 42 CFR

414.1415(a). Annual certification would

be required prior to the start of each

subsequent PY.

We solicited public comments on our

proposal. The following is a summary of

the public comments received on this

proposal and our responses:

Comment: A commenter commended

CMS’ dedication to implementing more

Advanced APMs that would allow

specialists the opportunity to become a

QP. Specifically, the commenter

suggested that there is insufficient

opportunity for specialists to qualify for

QP status under the Quality Payment

Program, and therefore the commenter

applauds CMS’ dedication to improving

this.

Response: We appreciate this

commenter’s support of our proposal.

Comment: A commenter requested

clarification on the RO Model’s status as

an Advanced APM. Specifically, this

commenter stated that its radiation

oncologists are part of a larger multi-

specialty practice that currently reports

to CMS under the MIPS program. The

commenter requested clarification on

whether the entire group would be

participating as an Advanced APM

Entity or just the radiation oncologists.

Response: In the proposed rule, we

proposed that we will provide RO

participants with an individual

practitioner list. We also proposed a

process whereby RO participants would

review, have the opportunity to modify,

and certify this list. The certified list

that includes only physician radiation

oncologists who have reassigned their

rights to receive Medicare payment for

the provision of RT services to the TIN

of the RO participant would be used for

purposes related to QP determinations

as specified in 42 CFR part 414 subpart

O. Only those individual practitioners

included on the certified list would be

considered participants under the RO

Model for purposes of the Quality

Payment Program, including identifying

eligible clinicians who would be eligible

to attain QP status under the Model. On

further reflection, we have reconsidered

our statement in the proposed rule that

an unverified list would be used for

scoring under MIPS. After further

consideration, we are concerned that

use of an unverified list might result in

incorrect or unauthorized payments and

adjustments under the Quality Payment

Program, potentially jeopardizing

program integrity.

Comment: A couple of commenters

opposed the processes proposed around

the Individual Practitioner List. One

commenter opposed the proposal that

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the Individual Practitioner List must be

reviewed and certified annually, stating

that this was too great an administrative

burden for participants. Another

commenter requested that CMS allow

participants to have 60 days to notify

CMS of changes to the QP list, rather

than 15 days as proposed. This

commenter suggested that if RO

participants meet this 60-day reporting

deadline, the changes would take effect

as of the effective date specified in the

notice to CMS. If participants do not

meet this deadline, then addition or

removal would be effective on the date

that the participant notifies CMS.

Response: We disagree with the

commenter who believes the annual

certification process of the individual

practitioner list is unduly burdensome.

We have proposed this certification

process so that the RO participant

would have the chance to review and

verify that the list we intend to use for

QP determinations is accurate, and if it

is not accurate, to notify us of the

inaccuracies so a correct list can be used

for those determinations. We proposed

this process to limit burden on RO

participants, as we will be creating a

draft version for their review rather than

asking RO participants to draft and

compile a list for our review that would

then need to be certified. Further, we

proposed that if the RO participant does

not certify the list we will still use the

uncertified list for MIPS scoring. While

we had previously proposed to still use

an uncertified list, we are not finalizing

this provision. Upon further

consideration and based on

commenters’ requests for clarity around

the RO Model’s status as an Advanced

APM, we are instead finalizing that RO

participants on an uncertified list would

not be considered participants in an

APM Entity for purposes of the Quality

Payment Program as defined at

§ 414.1305. We are codifying these

provisions relating to the individual

practitioner list at § 512.217.

We also disagree with the commenter

who proposed that RO participants

should have 60 days to notify us of

changes to their individual practitioner

list. However, we agree that 15 days

may be an insufficient period of time for

participants to review, correct, and

return the list to us. We will modify this

proposal to allow for a 30-day period.

We believe 30 days will be a sufficient

amount of time for RO participants to

review and submit corrections, as other

models currently being tested by the

Innovation Center also require 30-day

period to review and return similar lists.

Further, we believe 30 days is a

reasonable compromise between the

commenter’s proposed 60-day period

and our original 15-day proposal.

Comment: A few commenters stated

that some practices may need a

hardship exemption from the proposed

Model requirements to use the 2015

Edition CEHRT due to insufficient

internet connectivity, extreme and

uncontrollable circumstances, or lack of

control over the availability of CEHRT.

One of these commenters stated that

low-volume practices are excluded from

the Quality Payment Program’s Merit-

based Incentive Payment System (MIPS)

and its Promoting Interoperability

performance category requirement to

use 2015 Edition CEHRT, which is a

proposed requirement for the RO Model.

This commenter further maintained that

including low-volume practices in the

RO Model would require these

practices, which haven’t had to use

2015 Edition CEHRT under MIPS, to

make significant financial investments

in technology and substantial time

investments in software installations

and training while adapting to the new

value-based reimbursement

methodology, which would be

detrimental to these practices’ ability to

continue operations and reduce access

for patients to receive radiation therapy.

This commenter also stated that

practices with insufficient internet

connectivity, which are typically

located in rural areas, are allowed to

annually apply for a hardship exception

from the MIPS Promoting

Interoperability performance category

and its requirement to use 2015 Edition

CEHRT, and if these practices are

included in the RO Model, they will be

forced to invest significant resources

and time as participants of the RO

Model and could be forced to

discontinue operations, decreasing

access to cancer treatment options for

patients.

Response: There are very few RT

providers and RT suppliers in these

rural areas such that, if included in the

RO Model, the rural areas would likely

not generate enough episodes to be

included in the Model. As such, we

believe that our proposed CEHRT

requirements are not unduly

burdensome for rural RT providers and

RT suppliers, and a hardship exemption

from the CEHRT requirement is

unnecessary. We would note that while

we do not believe a hardship exemption

is necessary for the CEHRT requirement,

we are finalizing in section III.C.3.c a

low volume opt-out that may help

address these commenters’ concerns.

Comment: A couple of commenters

requested clarification on which edition

of CEHRT CMS is requiring for RO

participants to use. One of these

commenters recommended that the

edition that RO uses should align with

other quality reporting programs. This

commenter also questioned why

participants must certify their intent to

use CEHRT at the beginning of the

performance year, and not at the end.

Response: In the RO Model, we have

proposed to align our CEHRT

requirements with the regulatory

requirements of the Quality Payment

Program as stated at 42 CFR 414.1415(a).

This relies on the definition of CEHRT

as defined, and periodically updated, at

42 CFR 414.1305, which currently

specifies the use of 2015 Edition Base

EHR edition (as defined at 45 CFR

170.102) and has been certified to the

2015 Edition health IT certification

criteria. Using this definition of CEHRT

aligns RO Model requirements with the

requirements of the Quality Payment

Program as well as other Advanced

APMs being tested by the Innovation

Center. We believe certifying an intent

to use CEHRT at the beginning of the

performance year, as opposed to the end

of the performance year, is appropriate

and it aligns with requirements in other

Advanced APMs being tested by the

Innovation Center.

After considering public comments,

we are finalizing with modification our

proposals relating to the RO Model as an

Advanced APM regarding the CEHRT

and Participation List requirements. We

clarify that MIPS eligible clinicians

identified on the Participation List of an

APM Entity participating in a MIPS

APM for the performance period are

eligible to be scored as part of an APM

Entity group, as described at 42 CFR

414.1305. We are also finalizing, with

modification, that if the Dual participant

or Professional participant does not

verify and certify the individual

practitioner list by the deadline

specified by CMS, RO participants on

the unverified list are not recognized as

participants in an APM Entity for

purposes of the Quality Payment

Program. We have codified at

§ 512.217(a) that we will create and

provide each Dual participant and

Professional participant with an

individual practitioner list, upon the

start of each performance year. We have

made edits to § 512.217(b) for clarity

and readability. That provision has been

revised to state that, within 30 days of

receipt of the individual practitioner

list, the RO participant must review the

individual practitioner list, correct any

inaccuracies in accordance with to

§ 512.217(d), and certify the list (as

corrected, if applicable) in a form and

manner specified by CMS and in

accordance with § 512.217(c).

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We have also made edits to

§ 512.217(d) for clarity and readability.

This provision has been revised to state

that, the RO participant must notify

CMS of a change, including additions or

removals, to its individual practitioner

list within 30 days. Further, we have

clarified at § 512.217(d)(2)(i) that the

removal of an individual practitioner

from the RO participant’s individual

practitioner list is effective on the date

that the individual ceases to be an

individual practitioner as defined at

§ 512.205.

Next in the proposed rule, at 84 FR

34523, we explained the second

criterion to be an Advanced APM,

which is that an APM must include

quality measure performance as a factor

when determining payment to

participants for covered professional

services under the terms of the APM as

specified at 42 CFR 414.145(b)(1).

Effective January 1, 2020 at least one of

the quality measures upon which the

APM bases payment must meet at least

one of the following criteria: (a)

Finalized on the MIPS final list of

measures, as described in 42 CFR

414.1330; (b) endorsed by a consensus-

based entity; or (c) determined by CMS

to be evidenced-based, reliable, and

valid.

We noted in the proposed rule that we

discussed the RO Model’s quality

measure set in section III.C.8.b of the

proposed rule. We discussed our

intention to use the results of the

following quality measures when

determining payment to Professional

participants and Dual participants

under the terms of the RO Model, as

discussed in detail in section III.C.8.f of

the proposed rule and this final rule: (1)

Oncology: Medical and Radiation—Plan

of Care for Pain; (2) Preventive Care and

Screening: Screening for Depression and

Follow-Up Plan; and (3) Advance Care

Plan; and (4) Treatment Summary

Communication—Radiation Oncology.

The quality measures we proposed to

use for the RO Model are measures that

are either finalized on the MIPS final

list of measures, or determined by CMS

to be evidence based, reliable, and valid.

As we indicated in the proposed rule,

we believe that these measures would

meet the criteria under 42 CFR

414.1415(b) (84 FR 34523).

In addition to the quality measure

requirements listed earlier, under 42

CFR 414.1415(b)(3), the quality

measures upon which an Advanced

APM bases payment must include at

least one outcome measure. This

requirement does not apply if CMS

determines that there are no available or

applicable outcome measures included

in the MIPS quality measures list for the

APM’s first QP Performance Period. We

noted in the proposed rule that there

currently are no such outcome measures

available or applicable for the RO

Model’s first QP Performance Period (84

FR 34523). If a potentially relevant

outcome measure becomes available, we

would consider it for inclusion in the

RO Model’s measure set.

The third criterion to be an Advanced

APM is that the APM must require

participating APM Entities to bear

financial risk for monetary losses of

more than a nominal amount or, be a

Medical Home Model expanded under

the Innovation Center’s authority, in

accordance with section 1115A(c) of the

Act. As we stated in the proposed rule,

we expect that the RO Model will meet

the generally applicable financial risk

standard in accordance with 42 CFR

414.1415 because there is no minimum

(or maximum) financial stop-loss for RO

participants, meaning RO participants

would be at risk for all of the RT

services beyond the episode payment

amount (84 FR 34523).

The regulation at 42 CFR

414.1415(c)(1) requires that ‘‘to be an

Advanced APM, an APM must, based

on whether an APM Entity’s actual

expenditures for which the APM Entity

is responsible under the APM exceed

expected expenditures during a

specified QP Performance Period, do

one or more of the following: (i)

Withhold payment for services to the

APM Entity or the APM Entity’s eligible

clinicians; (ii) Reduce payment rates to

the APM Entity or the APM Entity’s

eligible clinicians; or (iii) Require the

APM Entity to owe payment(s) to CMS.’’

We stated in the proposed rule that the

RO Model would meet this standard

because CMS would not pay the RO

participant more for RT services than

the episode payment amount (84 FR

34523).

The regulation at 42 CFR

414.1415(c)(3) sets the standard for a

nominal amount of risk for Advanced

APMs other than Medical Home Models

at either ‘‘eight percent of the average

estimated total Medicare Parts A and B

revenues of participating APM Entities’’

for QP Performance Periods in 2017

through 2024 or ‘‘three percent of the

expected expenditures for which the

APM Entity is responsible for under the

APM’’ for all QP Performance Periods.

For the RO Model, as we discussed in

the proposed rule (84 FR 34523), the

APM Entities would be at risk for all

costs associated with RT services as

discussed in section III.C.5.c of the

proposed rule and this final rule beyond

those covered by the participant-specific

professional episode payment or the

participant-specific technical episode

payment, and therefore, would be at 100

percent risk for all expenditures in

excess of the expected amount of

expenditures, which are the previously

discussed episode payments. As

proposed, RO participants would not

receive any additional payment or

reconciliation from CMS (beyond the

participant-specific professional episode

payment or participant-specific

technical episode payment) to account

for any additional medically necessary

RT services furnished during the 90-day

episode. Effectively, this means that

when actual expenditures for which the

APM Entity was responsible under the

APM exceed expected expenditures, the

RO participant would be responsible for

100 percent of those costs without any

stop-loss or cap on potential losses. This

would satisfy the requirement under 42

CFR 414.1415(c)(3)(i)(B) because, for

example, if actual expenditures are 3

percent more, or 5 percent more, or 7

percent more than the expected

expenditures for which an RO

participant is responsible under the

model, the RO participant is 100 percent

liable for those additional 3 percent, 5

percent, or 7 percent of costs without

any limit to the total amount of losses

they may incur.

Additionally, as we stated in the

proposed rule (84 FR 34523–34524), we

anticipated that the RO Model would

meet the criteria to be a MIPS APM

under the Quality Payment Program

starting in PY1 (January 1, 2020) if the

start date is finalized as January 1, 2020

or in PY2 (January 1, 2021) if finalized

as April 1, 2020. MIPS APMs, as defined

in 42 CFR 414.1305, are APMs that meet

the criteria specified under 42 CFR

414.1370(b). Currently, pursuant to 42

CFR 414.1370(a), MIPS eligible

clinicians who are identified on a

Participation List for the performance

period of an APM Entity participating in

a MIPS APM are scored under MIPS

using the APM scoring standard. We

proposed to use the same individual

practitioner list developed to identify

the relevant eligible clinicians for

purposes of making QP determinations

and applying the APM scoring standard

under the Quality Payment Program.

In the CY 2021 PFS proposed rule, we

proposed to terminate the APM scoring

standard effective January 1, 2021 (85

FR 50303). We also proposed to

establish a new APM Performance

Pathway, which, if finalized, would be

an optional MIPS reporting and scoring

pathway for MIPS eligible clinicians

identified on the Participation List or

Affiliated Practitioner List of a MIPS

APM (85 FR 50285). We also proposed

to allow APM Entities to report to MIPS

via any available submission

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mechanism, on behalf of all MIPS

eligible clinicians in the APM Entity

group (85 FR 50304). If these proposals

are finalized in the forthcoming CY

2021 PFS final rule, MIPS eligible

clinicians participating in the RO Model

would have the option to report to MIPS

using the APM Performance Pathway,

and they would have the option to

report to MIPS as individuals, groups, or

APM Entities.

In the proposed rule we noted that the

following proposals would apply to any

APM Incentive Payments made for

eligible clinicians who become QPs

through participation in the RO Model:

•Our proposals regarding

monitoring, audits and record retention,

and remedial action, as discussed in

section II.F and III.C.14 of the proposed

rule. Under our monitoring policy, RO

participants would be monitored for

compliance with the RO Model

requirements. CMS may, based on the

results of such monitoring, deny an

eligible clinician who is participating in

the RO Model QP status if the eligible

clinician or the eligible clinician’s APM

entity (that is, the respective RO

participant) is non-compliant with RO

Model requirements.

•Our proposal in section III.C.10.c, of

the proposed rule which explains that

technical component payments under

the RO Model would not be included in

the aggregate payment amount for

covered professional services that is

used to calculate the amount of the

APM Incentive Payment.

We solicited comment on our

proposals. The following is a summary

of the public comments received on

these proposals and our responses:

Comment: A few commenters

expressed concern regarding the risk

that will be involved for participants in

the RO Model. A commenter stated that

if the RO Model is structured as largely

as proposed, then participation will be

a significant, risky, and costly

undertaking. One of these commenters

requested that CMS redesign the Model

payment to allow for two-sided risk.

Another commenter expressed concern

with the lack of a cap on downside risk

and opposed the current, uncapped risk

structure. This commenter suggested

that the RO Model should establish risk

at the levels finalized by CMS for other

APMs. A few commenters requested

that CMS include stop-loss provisions

in the RO Model. These commenters

stated that RO Participants would bear

100 percent of the risk for all RT

services provided in excess of the

bundle payments, and that this high

degree of risk is inappropriate for a

mandatory model. They also maintained

that this lack of stop-loss protection

runs counter to the majority of CMS

APMs such as the BPCI Advanced

Model, the CJR Model, the Shared

Savings Program, and OCM, which all

cap downside risk. These commenters

suggest that CMS should establish a

stop-loss provision to mitigate this high

degree of risk and to ensure that the RO

Model does not place substantial

financial burden on RO participants. A

commenter suggested implementing a

stop-loss provision using the encounter

data CMS proposes to require

participants to submit.

Response: We appreciate the

commenters’ concerns and feedback

around the level of risk in the RO

Model, and regarding a stop-loss

provision under the Model. We believe

that the heavy weight of the RO

participants’ historical experience in

their participant-specific RO payment

amount, combined with the low volume

opt-out option (see section III.C.3.c),

minimizes the potential losses that an

RO participant may face. However, we

understand that there are some

circumstances where RO participants

that have fewer than 60 episodes in the

baseline period will not qualify to

receive a historical experience

adjustment and may experience

significant increases or reductions to

what they were historically paid in FFS.

We are adopting a stop-loss limit of 20

percent to the RO Model for these RO

participants that were furnishing

included RT services in the CBSAs

selected for participation at the time of

the effective date of this final rule.

Please reference section III.C.6.e(4) for

more information on the stop-loss

policy.

We understand the commenters’

concerns with the level of risk in this

Model compared with other Innovation

Center models. Section 1833(z)(3)(D) of

the Act, as added by the Medicare

Access and CHIP Reauthorization Act

(MACRA) of 2015 (Pub. L. 114–10),

established certain requirements for

APMs including a requirement that an

APM Entity bear financial risk for

monetary losses that are in excess of a

nominal amount or be a medical home

expanding under 111A(c) of the Act. In

rulemaking, we have established this

generally applicable nominal amount

standard to mean that an Advanced

APM must put the APM Entities at risk

for at least eight percent of the average

estimated total Medicare Parts A and B

revenue of all providers and suppliers

participating APM Entities or at least 3

percent of the expected expenditures for

which an APM Entity is responsible

under the APM, as codified in

§ 410.1415(c)(3). In designing and

implementing other models, we have

established various levels of risk at and

above these minimum amounts. As

such, we believe that the level of risk we

have established for the RO Model, is

above the minimum level specified in

the generally applicable nominal

amount standard that we established for

the Quality Payment Program.

Furthermore, the level of risk is

appropriate and in line with the levels

of risk of other Advanced APMs being

tested by the Innovation Center,

including the stop-loss policy described

in section III.C.6e(4) The stop-loss limit

of 20 percent aligns with stop-loss limits

set by other models such as the BPCI

Advanced and CJR Models. Further, we

would like to note that the RO Model

does have two-sided risk; participants

that provide services more efficiently

than the RO episode price yield savings,

while those that provide services less

efficiently than the RO episode price

yield losses.

Comment: A commenter requested

that providers and suppliers that are

required to participate in the RO Model

should have every possible assurance

that their participation will qualify them

for exemption from MIPS and will earn

them the APM incentive for

participation in an Advanced APM.

This commenter stated that they

understand that CMS cannot guarantee

that providers and suppliers will meet

the minimum payment or patient

volume requirement to be a qualifying

participant, but the agency should

finalize a structure that squarely

satisfies each of the requirements for an

Advanced APM.

Response: We appreciate the

commenter’s views on the design of the

RO Model as an Advanced APM. We

believe that we have designed the

Model in such a way that we expect that

the RO Model will be determined to be

both an Advanced APM and a MIPS

APM starting on January 1, 2021. As

such, all eligible clinicians participating

in the RO Model will have the

opportunity to become QPs or Partial

QPs based on meeting the relevant

payment or patient count thresholds,

and thereby exempt from the MIPS

reporting requirements and payment

adjustment for the relevant year. Under

the structure of the Quality Payment

Program, not all eligible clinicians in

the RO Model will necessarily achieve

QP status or earn an APM Incentive

Payment for their participation in the

Advanced APM, but we believe there

are other inherent benefits to the RO

participant. Furthermore, based on our

actuarial analysis we believe that most

eligible clinicians will achieve QP status

during the course of the RO Model.

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Other benefits for participating in the

RO Model as it is designed as an

Advanced APM and a MIPS APM

include a chance to be an early adopter

of a value-based payment arrangement

model. As CMS in general, and the

health care industry specifically, turns

to more value-based payment

arrangements, early adopters of these

models may have an advantage over

their peers who have not participated in

these models. Additionally, eligible

clinicians in the RO Model who are

MIPS eligible clinicians (those not

excluded from MIPS as QPs, Partial

QPs, or on another basis) will be

considered participants in a MIPS APM

for purposes of MIPS reporting and

scoring rules.

Comment: MedPAC did not support

CMS’ proposal that the RO Model

would qualify to be an Advanced APM.

MedPAC stated that the RO Model does

not meet two of the principles that

MedPAC has developed for Advanced

APMs: Clinicians should receive a 5

percent incentive payment only if the

eligible entity in which they participate

is successful in controlling cost,

improving quality, or both; and the

eligible entity should be at financial risk

for total Part A and Part B spending.

MedPAC stated that incentive payments

should not be awarded for simply

participating in an APM entity but

should be contingent on quality and

spending performance. They stated that

the RO Model does not follow this first

principle, as clinicians who participate

in the RO Model through an eligible

entity and have a sufficient share of

revenue coming through the Model

would receive an incentive payment,

whether or not the entity limits costs

per episode or improves quality.

MedPAC also stated that the RO Model

does not follow their second principle,

to help move the fee-for-service (FFS)

payment system from volume to value,

encourage care coordination, and more

broadly reform the delivery system, as

the RO Model entities are only

responsible for spending on certain RT

services within a 90-day episode of care.

They are not held accountable for

spending on other services provided to

beneficiaries in the Model, such as E&M

visits, tests, ED visits, or hospital

admissions. Entities would also have an

incentive to reduce the cost per episode

while increasing the total number of

episodes. In addition, there is not a

single entity that would be responsible

for episode spending because CMS

would make separate episode payments

for the TC and PC portions of the

episode, unless an entity is a Dual

participant that provides both the TC

and PC portions of an episode. MedPAC

further disagreed with CMS’ decision to

not propose any outcome measures for

the Model, and they disagree with CMS’

determination that there are currently

no outcome measures available or

applicable for the RO Model. MedPAC

states that OCM uses three claims-based

outcome measures to determine

performance-based payments: Risk-

adjusted proportion of patients with all-

cause hospital admissions within the

six-month episode, risk-adjusted

proportion of patients with all-cause

emergency department (ED) visits or

observation stays that did not result in

a hospital admission within the six-

month episode, and proportion of

patients that died who were admitted to

hospice for three days or more. MedPAC

stated that CMS should consider using

similar outcome measures for the RO

Model, as both OCM and the RO Model

focus on cancer treatment. They also

stated that use of claims-based outcome

measures in the RO Model would enable

CMS to hold providers and suppliers

accountable for the quality of their care

and allow CMS to evaluate whether

prospective episode payments for RT

services reduce spending without

causing negative outcomes. Finally,

MedPAC stated that claims-based

outcome measures, such as readmission

rates, do not impose a reporting burden

on providers and suppliers and are part

of MIPS.

Response: We appreciate MedPAC’s

analysis of the Quality Payment

Program and the RO Model, but we

disagree that the RO Model should not

qualify as an Advanced APM. We

believe the additional principles that

MedPAC has established can be used as

analytic tools when analyzing Advanced

APMs, they do not align with or take the

place of the statutory criteria for APMs

and eligible APM Entities established in

§ 1833(z)(3)(C) and (D) of the Act and

codified at 42 CFR 414.1415, and as

such are not necessary requirements

when making an Advanced APM

determination. Specifically, as codified

at 42 CFR 414.1415, the criteria for

Advanced APMs are as follows: (1) The

APM requires use of CEHRT, (2)

payment under the APM is based on

MIPS-comparable quality measures, and

(3) the APM requires participants to

assume more than nominal financial

risk. As articulated in this section of this

final rule, we believe that the RO Model

satisfies each of these criteria.

Required use of CEHRT: During the

Model performance period, the RO

participant will be required to annually

certify its intent to use CEHRT

throughout such model year in a

manner sufficient to meet the

requirements pursuant to 42 CFR

414.1415(a). Further, within 30 days of

the start of PY1, the RO participant will

be required to certify its intent to use

CEHRT throughout such model year in

a manner sufficient to meet the

requirements pursuant to 42 CFR

414.1415(a).

Payment based on MIPS-comparable

quality measures: We intend to use the

results of the following quality measures

when determining payment to

Professional participants and Dual

participants under the terms of the RO

Model, as discussed in detail in section

III.C.8.f of this final rule: (1) Oncology:

Medical and Radiation—Plan of Care for

Pain; (2) Preventive Care and Screening:

Screening for Depression and Follow-

Up Plan; and (3) Advance Care Plan;

and (4) Treatment Summary

Communication—Radiation Oncology.

Further, the quality measures we use for

the RO Model are measures that are

either finalized on the MIPS final list of

measures, or determined by CMS to be

evidence-based, reliable, and valid. In

addition to the quality measure

requirements listed earlier, under 42

CFR 414.1415(b)(3), the quality

measures upon which an Advanced

APM bases payment must include at

least one outcome measure. This

requirement does not apply if CMS

determines that there are no available or

applicable outcome measures included

in the MIPS quality measures list for the

APM’s first QP Performance Period.

CMS has determined that there

currently are no such outcome measures

available or applicable for the RO

Model’s first QP Performance Period.

Furthermore, with regards to

MedPAC’s comments about the RO

Model using similar outcome measures

that are employed by OCM, we thank

MedPAC for the suggestion. We

considered using the same OCM

outcome measures for the RO Model,

but ultimately decided that it would be

difficult to discern whether these

outcomes occurred due to complications

from RT services, chemotherapy by

medical oncologists, or for other various

reasons. As such, we believe that these

measures would not meaningfully

indicate high- versus low-quality RO

participants.

Financial Risk: The regulation at 42

CFR 414.1415(c)(1) requires that ‘‘to be

an Advanced APM, an APM must, based

on whether an APM Entity’s actual

expenditures for which the APM Entity

is responsible under the APM exceed

expected expenditures during a

specified QP Performance Period, do

one or more of the following: (i)

Withhold payment for services to the

APM Entity or the APM Entity’s eligible

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clinicians; (ii) Reduce payment rates to

the APM Entity or the APM Entity’s

eligible clinicians; or (iii) Require the

APM Entity to owe payment(s) to CMS.’’

As we explained in the proposed rule

and in this section of the final rule, the

RO Model would meet this standard

because CMS would not pay the RO

participant more for RT services than

the episode payment amount.

The regulation at 42 CFR

414.1415(c)(3) sets the standard for a

nominal amount of risk for Advanced

APMs other than Medical Home Models

at either ‘‘eight percent of the average

estimated total Medicare Parts A and B

revenues of participating APM Entities’’

for QP Performance Periods in 2017

through 2024 or ‘‘three percent of the

expected expenditures for which the

APM Entity is responsible for under the

APM’’ for all QP Performance Periods.

For the RO Model, most APM Entities,

with the exception of those RO

participants that qualify for the stop-loss

policy as described in section III.C.6.e(4)

and codified at § 512.285(f), would be at

risk for all costs associated with RT

services (described in section III.C.5.c of

this final rule) beyond those covered by

the participant-specific professional

episode payment or the participant-

specific technical episode payment, and

therefore, would be at 100 percent risk

for all expenditures in excess of the

expected amount of expenditures,

which are the previously discussed

episode payments. RO participants

would not receive any additional

payment or reconciliation from CMS

(beyond the participant-specific

professional episode payment or

participant-specific technical episode

payment) to account for any additional

medically necessary RT services

furnished during the 90-day episode.

Effectively, this means that when actual

expenditures for which the APM Entity

was responsible under the APM exceed

expected expenditures, the RO

participant would be responsible for 100

percent of those costs without any stop-

loss or cap on potential losses, except

for the participants that qualify for the

stop-loss policy, as previously stated.

This would satisfy the requirement

under 42 CFR 414.1415(c)(3)(i)(B)

because, for example, if actual

expenditures are 3 percent more, or 5

percent more, or 7 percent more than

the expected expenditures for which RO

participants are responsible under the

Model, RO participants are 100 percent

liable for those additional 3 percent, 5

percent, or 7 percent of costs. Most

participants are without any limit to the

total amount of losses they may incur.

For the subset of RO participants that

are limited to the total amount of losses

they may incur because they are eligible

for the stop-loss policy, that limit is set

to 20 percent of expected expenditures

for which the RO participants are

responsible for under the RO Model.

Finally, while MedPAC has created

these additional principles that it

believes should be achieved for a model

to be an Advanced APM, these

additional principles have not been

codified in the Quality Payment

Program regulations as necessary

requirements of Advanced APMs. Even

though meeting these principles is not

a requirement for Advanced APM

status, we are responding to these

comments to better explain our

reasoning behind the RO Model being

proposed as an Advanced APM.

First, regarding the APM Incentive

Payment, MedPAC believes the APM

incentive payment should only be paid

if the APM participant is successful in

controlling cost, improving quality, or

both, and if the APM participant is at

financial risk for total Part A and Part

B spending. The Quality Payment

Program statute and regulations provide

different standards for eligible clinicians

to earn an APM incentive payment, and

for an APM to be considered an

Advanced APM, based on the required

assumption of financial risk; the Quality

Payment Program provides for the APM

incentive payment to encourage

clinicians to move into value-based

payment through Advanced APMs.

Additionally, in the RO Model we are

specifically testing different pricing

methodologies for the RT services

provided, not the other costs associated

with the beneficiary’s care.

Second, regarding the move from FFS

payments to a value-based payment

system, MedPAC believes that since RO

participants are only held accountable

for spending on certain RT services

within the episode of care and not held

accountable for spending on other

services provided to the RO beneficiary,

the RO participants are not properly

incentivized to reduce the total cost of

care. We generally disagree that such

broad incentives are necessary for

Advanced APM status. Specifically, the

Advanced APM criterion codified at 42

CFR 414.1415(c) does not specify that a

financial risk must be based on a total

cost of care arrangement. Additionally,

we did not design the RO Model to be

a total cost of care model. Instead it was

designed so that each RO episode only

covers RT services. We limited the

Model in this way because we believe

that these services are in the control of

the RT provider and RT supplier, and

they are the entities at risk in the Model.

Further, there has never been a

requirement in the Quality Payment

Program that one entity must be at risk

for the entire cost of the episode. As we

have previously stated, in the RO Model

we are specifically testing different

pricing methodologies for the RT

services provided, not the other costs

associated with the beneficiary.

Comment: A commenter suggested

that CMS should structure the final RO

Model so that all RO participants will be

QPs in an Advanced APM for purposes

of the Quality Payment Program,

assuming minimum participation

requirements are met. Additionally,

although we did not request comments

on our projection, discussed further in

section VII.C.3 of the Regulatory Impact

Analysis, that 83 percent of physician

participants, measured by their unique

NPI, would achieve QP status and

receive the APM Incentive Payment

under the Quality Payment Program at

some point (for at least one QP

Performance Period) during the Model

performance period, some commenters

suggested that all physicians

participating in the RO Model should

receive the APM incentive payment as

compensation for participation in a

mandatory model that requires quality

measure and clinical data reporting.

Commenters stated that CMS was

issuing an unfunded mandate in cases

where physicians did not receive the

APM Incentive Payment.

Response: Under the structure of the

Quality Payment Program, not all

eligible clinicians will necessarily earn

an APM Incentive Payment for their

participation in an Advanced APM.

Specifically, in accordance with 42 CFR

414.1430, eligible clinicians must

achieve certain threshold levels of

participation in the Advanced APM in

terms of payment amounts or patient

counts in order to achieve QP status and

qualify for an APM Incentive Payment.

Therefore, we believe there are other

inherent benefits to the RO participant

including the chance to be an early

adopter of a value-based payment

arrangement. As CMS in general, and

the health care industry specifically,

turns to more value-based payment

arrangements, early adopters of these

models will have an advantage over

their peers who have not participated in

these models. Additionally, eligible

clinicians in the RO Model who are

MIPS eligible clinicians (those not

excluded from MIPS as QPs, Partial

QPs, or on another basis) will be

considered participants in a MIPS APM

for purposes of MIPS reporting and

scoring rules.

We appreciate the comments on our

QP projections, but we must use the

APM Incentive Payment calculation

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methodology as specified at 42 CFR

414.1450 to determine which eligible

clinicians meet the QP threshold

required to achieve QP status and

receive the APM Incentive Payment. As

such, just as we cannot summarily

award QP status to all RO participants,

we cannot automatically make an APM

Incentive Payment to all eligible

clinicians in the RO Model. All eligible

clinicians are required to meet the QP

threshold for Medicare Part B

professional services payments or

patients in an Advanced APM in order

to achieve QP status and receive the

APM incentive payment. In addition to

the 83 percent of RO Model physicians

who are expected to be QPs, 9 percent

are expected to be partial QPs at some

point during the Model performance

period, resulting in 92 percent of RO

Model physicians becoming QPs or

partial QPs at some point. We would

note that while partial QPs do not earn

the APM Incentive Payment, they do

have the option to decide whether to be

subject to the MIPS reporting

requirements and payment adjustment,

which would otherwise be required.

Comment: A commenter requested

that the 5 percent APM incentive

payment that is available through 2024

should be extended as the RO Model is

just becoming available to radiation

oncologists, and prior to this, the

radiation oncology community has not

had an Advanced APM available that

would qualify physicians in the

radiation oncology specialty for this

bonus.

Response: We appreciate the

commenter’s feedback on the

availability of the APM Incentive

Payment to eligible clinicians who have

been determined to be QPs participating

in Advanced APMs. The APM Incentive

Payment is limited based on statute to

payment years 2019 through 2024 as

specified in section 1833(z)(1)(A) of the

Act.

After considering public comments,

we are finalizing our proposals, with

modification, that, effective January 1,

2021, at least one of the quality

measures upon which the RO Model

bases payment will meet at least one of

the following criteria: (a) Finalized on

the MIPS final list of measures, as

described in 42 CFR 414.1330; (b)

endorsed by a consensus-based entity;

or (c) determined by CMS to be

evidenced-based, reliable, and valid.

This modification means that quality

data collection and reporting for the RO

Model will begin with PY1 on January

1, 2021, which means that we expect the

Model to qualify as both an Advanced

APM and a MIPS APM beginning on

January 1, 2021. Final CMS

determinations of Advanced APMs and

MIPS APMs for the 2021 performance

period will be announced via the

Quality Payment Program website at

https://qpp.cms.gov/. We are finalizing

our proposal to use the results of the

following quality measures, finalized in

section III.C.8.b of this final rule, when

determining payment to Professional

participants and Dual participants

under the terms of the RO Model, as

discussed in detail in section III.C.8.f:

(1) Oncology: Medical and Radiation—

Plan of Care for Pain; (2) Preventive

Care and Screening: Screening for

Depression and Follow-Up Plan; and (3)

Advance Care Plan; and (4) Treatment

Summary Communication—Radiation

Oncology. As there currently are no

available or applicable outcome

measures included in the MIPS quality

measures list for the RO’s Model’s first

QP Performance Period, we will not be

including an outcome measure in this

final rule. However, if a potentially

relevant outcome measure becomes

available, we would consider whether

such an outcome measure should be

included in the RO Model’s measure set,

and if so, use notice and comment

rulemaking to propose adding it.

We are finalizing with modification,

that most APM Entities, the RO

participants, with the exception of those

RO participants that qualify for the stop-

loss provision as described in (see

section III.C.6.e(4) and codified at

§ 512.285(f), will be at risk for all costs

associated with RT services, as defined

in section III.C.5.c of this final rule,

beyond those covered by the

participant-specific professional episode

payment or the participant-specific

technical episode payment, and

therefore, will be at 100 percent risk for

all expenditures in excess of the

expected amount of expenditures,

which are the previously discussed

episode payments. As discussed earlier

in this section, based on these finalized

provisions, the RO Model would meet

the criteria to be an Advanced APM.

Based on the changes we made to the

start date of the Model performance

period in this final rule, we anticipate

that the finalized RO Model will meet

the criteria to be a MIPS APM under the

Quality Payment Program starting in

PY1 on January 1, 2021, instead of the

proposed PY1 (January 1, 2020) or PY2

(January 1, 2021) as we had indicated in

the proposed rule. We are also finalizing

with modification to use the individual

practitioner list to identify the relevant

eligible clinicians for purposes of

making QP determinations and

determining those MIPS eligible

clinicians who are also considered

participants in a MIPS APM under the

Quality Payment Program. We also

clarify that currently, MIPS APMs, as

defined in 42 CFR 414.1305, are APMs

that meet the criteria specified under 42

CFR 414.1370(b). As indicated in the

current 42 CFR 414.1370(a), participants

in a MIPS APM are those MIPS eligible

clinicians who are identified on a

Participation List of an APM Entity

participating in a MIPS APM for the

performance period. We are using the

same individual practitioner list

developed to identify the eligible

clinicians in the APM Entity for

purposes of the Quality Payment

Program.

We also note that we are finalizing

that all requirements concerning the

review and certification of the

individual practitioner list will be

required in PY1 (beginning January 1,

2021). This includes the requirement

that Dual participants and Professional

participants must review and certify the

first individual practitioner list within

30 days of receiving the list upon the

start of PY1. Further, we are finalizing

as proposed, and codified at

§ 512.220(b), that participants must use

certified EHR technology (CEHRT), that

the RO participant must annually certify

its intent to use CEHRT during the

Model performance period, and that the

RO participant will be required to

certify its intent to use CEHRT within

30 days of the start of PY1.

Finally, we note that the following

provisions being finalized in other

sections of this final rule will apply to

any APM Incentive Payments made for

eligible clinicians who become QPs

through participation in the RO Model:

•Our finalized provisions regarding

monitoring, audits and record retention,

and remedial action, as described in

section II.F and III.C.14.

•Our finalized provision in section

III.C.10.c, which explains that technical

component payments under the RO

Model will not be included in the

aggregate payment amount for covered

professional services that is used to

calculate the amount of the APM

Incentive Payment.

10. Medicare Program Waivers

As explained in the proposed rule, 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. Each of the

waivers, which we discussed in detail,

would be necessary to ensure that the

Model test’s design provides additional

flexibilities to RO participants,

including flexibilities around certain

Medicare program requirements.

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a. Waiver of Hospital Outpatient Quality

Reporting (OQR) Program Payment

Adjustment

In the proposed rule, we stated that

we believe that it would be necessary

for purposes of testing the RO Model to

waive the Hospital OQR Program

payment reduction authorized under

section 1833(t)(17)(A) of the Act. Under

the Hospital OQR Program, subsection

(d) hospitals are required to submit data

on measures on the quality of care

furnished by hospitals in outpatient

settings. Further, section

1833(t)(17)(A)(i) of the Act states that

subsection (d) hospitals that fail to meet

Hospital OQR Program requirements

receive a two percentage point

reduction to their outpatient department

(OPD) fee schedule increase factor. The

fee schedule increase factor is applied

annually to increase the OPPS

conversion factor, which is then

multiplied by the relative payment

weight for a particular Ambulatory

Payment Classification (APC) to

determine the payment amount for the

APC. Not all OPPS items and services

are included in APCs for which the

payment is determined using the

conversion factor. For this reason, we

only apply the 2 percent reduction to

APCs—identified by status indicators—

for which the payment is calculated by

multiplying the relative payment weight

by the conversion factor.

Section 1833(t)(17) of the Act, which

applies to subsection (d) hospitals (as

defined in section 1886(d)(1)(B) of the

Act), states that hospitals that fail to

report data required to be submitted on

measures selected by the Secretary, in a

form and manner, and at a time,

specified by the Secretary will incur a

2.0 percentage point reduction to their

Outpatient Department (OPD) fee

schedule increase factor; that is, the

annual payment update factor. The

national unadjusted payment rates for

many services paid under the OPPS

equal the product of the OPPS

conversion factor and the scaled relative

payment weight for the APC to which

the service is assigned. The OPPS

conversion factor, which is updated

annually by the OPD fee schedule

increase factor, is used to calculate the

OPPS payment rate for many services

under the OPPS. To reduce the OPD fee

schedule increase factor for hospitals

that fail to meet the Hospital OQR

Program reporting requirements, we

calculate two conversion factors—a full

market basket conversion factor (that is,

the full conversion factor), and a

reduced market basket conversion factor

(that is, the reduced conversion factor).

We then calculate a reduction ratio by

dividing the reduced conversion factor

by the full conversion factor. We refer

to this reduction ratio as the ‘‘reporting

ratio’’ to indicate that it applies to

hospitals that fail to meet their reporting

requirements. Applying this reporting

ratio to the OPPS payment amounts

results in reduced national unadjusted

payment rates that are mathematically

equivalent to the reduced national

unadjusted payment rates that would

result if we multiplied the scaled OPPS

relative payment weights by the reduced

conversion factor. Thus, our policy is to

apply the reduction of the OPD fee

schedule increase factor through the use

of a reporting ratio for those hospitals

that fail to meet the Hospital OQR

Program requirements for a year (83 FR

59108–59110).

In the proposed rule, we proposed

that for purposes of APCs that contain

RO Model-specific HCPCS codes, we

would waive the requirement under

section 1833(t)(17)(A)(i) of the Act that

the Secretary reduce the OPD fee

schedule increase factor under section

1833(t)(3)(C)(iv) of the Act for a year by

2.0 percentage points for a subsection

(d) hospital that does not submit, to the

Secretary in accordance with paragraph

(17), data required to be submitted on

measures selected under that paragraph

with respect to such a year. RO Model-

specific HCPCS codes would be mapped

to RO Model-specific APCs for payment

purposes under the OPPS. This waiver

would apply only to the APCs that

include only the new HCPCS codes that

are created for the RO Model, rather

than all APCs that package radiation

HCPCS codes, and would only apply

when a hospital does not meet

requirements under the Hospital OQR

Program and would otherwise be subject

to the 2.0 percentage point reduction.

Only Technical participants using the

RO Model-specific HCPCS codes would

be paid under the Model; APCs not

included in the Model, and thus not

using the RO Model-specific HCPCS

codes, would continue to be paid under

the OPPS and subject to the 2.0

percentage point reduction under the

Hospital OQR Program when applicable.

We stated in the proposed rule that we

believed this waiver would be necessary

in order to equally evaluate

participating HOPDs and freestanding

radiation oncology centers on both cost

and quality.

The RO Model is a test of a site-

neutral pricing methodology, where

payment rates are calculated in the same

manner regardless of the setting (in this

case, HOPDs and freestanding radiation

therapy centers) and paid prospectively

based on episodes of care. While

payment amounts may vary across RO

participants, the calculation of how

much each RO participant would be

paid for the PC and TC of the RO

episode is designed to be as similar as

possible, irrespective of whether the RO

participant is an HOPD or a freestanding

radiation therapy center. Therefore, in

the proposed rule we stated our belief

that applying the Hospital OQR Program

payment reduction would undermine

our goal of site-neutral payments under

the RO Model because it could affect

HOPDs, but not freestanding radiation

therapy centers, creating additional

variables that could complicate a

neutral comparison. As we stated in the

proposed rule, if the requirement to

apply the Hospital OQR Program

payment reduction were not waived, the

participant-specific technical episode

payments made with respect to services

furnished by RO participants in HOPDs

that are billed under the technical RO

Model-specific HCPCS codes may be

decreased due to the Hospital OQR

Program payment reduction.

Meanwhile, the Hospital OQR Program

payment reduction would not apply to

participating freestanding radiation

therapy centers, which are paid under

the PFS not OPPS. In the proposed rule,

we discussed our belief that the

potential differences between

participant-specific technical episode

payments made for services furnished in

HOPDs and those made under the PFS

that would be caused by the application

of the Hospital OQR Program payment

reduction would be problematic for the

RO Model test by creating potentially

misaligned incentives for RO

participants. The Hospital OQR Program

payment reduction may interfere with

how the RO Model pricing methodology

has been conceptualized and therefore

impact the model evaluation by

introducing additional variability into

RO participants’ payments, thereby

making it harder to discern whether the

episode-based bundled payment

approach is successful.

For these reasons, we believed that it

would be necessary to waive the

requirement to apply the Hospital OQR

Program payment reduction under

section 1833(t)(17)(A)(i) of the Act and

42 CFR 414.1405(e) that may otherwise

apply to payments made for services

billed under the technical RO Model-

specific HCPCS codes. As such, we

proposed to waive application of the 2.0

percentage point reduction under

section 1833(t)(17) of the Act for only

those APCs that include only RO Model-

specific HCPCS codes during the Model

performance period.

We solicited comment on our

proposal to waive application of the

Hospital OQR Program 2.0 percentage

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point reduction through use of the

reporting ratio for APCs that include the

new HCPCS codes that are created for

the RO Model during the Model

performance period. We received no

comments, and therefore, are finalizing

our proposal as proposed.

b. Waiver of the Requirement To Apply

the MIPS Payment Adjustment Factors

to Certain RO Model Payments

As we stated in the proposed rule,

under section 1848(q)(6)(E) of the Act

and 42 CFR 414.1405(e), the MIPS

payment adjustment factor, and, as

applicable, the additional MIPS

payment adjustment factor (collectively

referred to as the MIPS payment

adjustment factors) generally apply to

the amount otherwise paid under

Medicare Part B with respect to covered

professional services furnished by a

MIPS eligible clinician during the

applicable MIPS payment year. We

proposed to waive the requirement to

apply the MIPS payment adjustment

factors under section 1848(q)(6)(E) of

the Act and 42 CFR 414.1405(e) that

may otherwise apply to payments made

for services furnished by a MIPS eligible

clinician and billed under the

professional RO Model-specific HCPCS

codes because we believed that it would

be necessary solely for purposes of

testing the RO Model.

The RO Model is a test of a site-

neutral pricing methodology, where

payment rates are calculated in the same

manner regardless of the setting and

paid prospectively based on episodes of

care. While payment amounts may vary

across RO participants, the calculation

of how much each RO participant

would be paid for the PC and TC of the

RO episode is designed to be as similar

as possible, irrespective of whether the

RO participant is an HOPD or a

freestanding radiation therapy center.

Therefore, in the proposed rule we

stated our belief that applying the MIPS

payment adjustment factors would

undermine our goal of site-neutral

payments under the RO Model.

As we stated in the proposed rule, if

the requirement to apply the MIPS

payment adjustment factors were not

waived, the participant-specific

technical episode payments made with

respect to services furnished by MIPS

eligible clinicians in freestanding

radiation therapy centers that are billed

under the professional RO Model-

specific HCPCS codes may be increased

or decreased due to the MIPS payment

adjustment factors. In contrast, the MIPS

payment adjustment factors would not

apply to payments of claims processed

under the OPPS, and as a result, would

not apply to the participant-specific

technical episode payments made to

participating HOPDs. In the proposed

rule, we stated our belief that the

potential differences between

participant-specific technical episode

payments made for services furnished in

freestanding radiation therapy centers

and those made under the OPPS that

would be caused by the application of

the MIPS payment adjustment factors

would be problematic for the RO Model

test by creating potentially misaligned

incentives for RO participants as well as

other challenges for the Model

evaluation. Further we stated our belief

that without this waiver, RO

participants may be incentivized to

change their behavior and steer

beneficiaries towards freestanding

radiation therapy centers if they expect

the MIPS payment adjustment factors

will be positive, and away from

freestanding radiation therapy centers if

they expect the MIPS payment

adjustment factors will be negative.

Dual and professional RO participants

that bill for the participant-specific

professional episode payments for RT

services using RO Model-specific

HCPCS codes will be subject to payment

adjustments under the Model based on

quality performance through the quality

withhold. The MIPS payment

adjustment factors are determined in

part based on a MIPS eligible clinician’s

performance on quality measures for a

performance period. In the proposed

rule, we stated our belief that subjecting

an RO participant to payment

consequences under both MIPS and the

Model for potentially the same quality

performance could have unintended

consequences. The MIPS payment

adjustment factors may interfere with

how the RO Model pricing methodology

has been conceptualized and therefore

impact the model evaluation by

introducing additional variability into

RO participants’ payments thereby

making it harder to discern whether the

episode-based bundled payment

approach is successful. For these

reasons, in the proposed rule we stated

our belief that it would be necessary to

waive the requirement to apply the

MIPS payment adjustment factors under

section 1848(q)(6)(E) of the Act and 42

CFR 414.1405(e) that may otherwise

apply to payments made for services

billed under the professional RO Model-

specific HCPCS codes.

We solicited comment on our

proposal to waive the MIPS payment

adjustment factors. The following is a

summary of the public comments

received on this proposal and our

response:

Comment: Many commenters

disagreed with this proposal, arguing

that it would unfairly penalize

clinicians for their efforts to comply

with MIPS requirements, particularly in

MIPS performance years 2018 and 2019,

prior to the Model start. In particular,

clinicians who performed well in MIPS

believed that waiving MIPS payment

adjustments would result in lower RO

Model payments than they were due,

based on their positive performance in

MIPS.

Response: We understand

commenters’ concerns regarding fair

payment for participation in MIPS.

Upon further consideration, we are not

finalizing our proposal to waive the

MIPS payment adjustment factors for

the PC of RO Model payments. We

believe the concerns raised by

commenters outweigh our original

policy rationale in that CMS does not

want to create a general disincentive for

participation in Advanced APMs by

waiving MIPS Adjustments that may

positively impact RO participants’

payments. As such, we are finalizing

that the MIPS payment adjustment

factors will apply to participant-specific

professional episode payments for the

PC of RT services furnished by a MIPS

eligible clinician. The MIPS payment

adjustment factors will also continue to

apply to RO participants’ payments for

covered professional services furnished

by a MIPS eligible clinician that are

outside the RO Model as they usually

would. Because we expect that the RO

Model will be an Advanced APM, we

anticipate that many eligible clinicians

in the Model will achieve the Qualifying

APM Participant (QP) threshold and

will be excluded from MIPS, starting in

QPP performance year 2021 (payment

year 2023).

After considering public comments,

we are finalizing our proposal at

§ 512.280(c) with modification to only

waive the MIPS payment adjustment

factors for the TC of RO Model

payments. We are not finalizing our

proposal to waive the MIPS payment

adjustment factors for the PC of RO

Model payments. We have modified the

text of the regulation at § 512.280(c) to

more closely align with the proposed

policy as described in the preamble to

the proposed rule. If an RO participant

does not earn a positive MIPS

adjustment, payments for the PC will be

reduced by the MACs as they would be

outside the RO Model.

c. Waiver of Requirement To Include

Technical Component Payments in

Calculation of the APM Incentive

Payment Amount

In the proposed rule, we stated that

we believed that it would be necessary

for purposes of testing the RO Model to

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exclude payments for the technical RO

Model-specific HCPCS codes (to the

extent they might be considered

payments for covered professional

services as defined in section

1848(k)(3)(A) of the Act) from the

‘‘estimated aggregate payment amounts

for covered professional services’’ used

to calculate the APM Incentive Payment

amount under § 1833(z)(1)(A) of the Act

and codified at 42 CFR 414.1450(b). We

specifically believe it is necessary to

exclude the technical RO Model-specific

HCPCS codes from the calculation of

estimated aggregate payments for

covered professional services as defined

in 42 CFR 414.1450(b)(1). The RO

Model HCPCS codes are split into a

professional component and a technical

component to reflect the two types of

services provided in the Model by the

three different RO participant types:

PGPs, HOPDs, and freestanding

radiation therapy centers, across

different service sites. RO participants

will bill the Model-specific HCPCS

codes that are relevant to their RO

participant type.

In the proposed rule, we discussed

our belief that this waiver was necessary

because, under 42 CFR 414.1450, the

APM Incentive Payment amount for an

eligible clinician who is a QP is equal

to 5 percent of his/her prior year

estimated aggregate payments for

covered professional services as defined

in section 1848(k)(3)(A) of the Act. The

technical RO Model-specific HCPCS

codes include the codes that we have

developed to bill the services on the

included RT services list that are

considered ‘‘technical’’ (those that

represent the cost of the equipment,

supplies and personnel used to perform

the procedure).

If the requirement to include

payments for the technical RO Model-

specific HCPCS codes in the calculation

of the APM Incentive Payment amount

were not waived, PGPs furnishing RT

services in freestanding radiation

therapy centers (which are paid under

the PFS) participating in the Model will

have technical RT services included in

the calculation of the APM Incentive

Payment amount, but PGPs furnishing

RT services in HOPDs (which are paid

under OPPS) participating in the Model

would not have technical RT services

included in the calculation of the APM

Incentive Payment amount. We believe

these potential differences between

participant-specific technical episode

payments processed and made under

the PFS and those made under the OPPS

would be problematic for the Model test

by creating potentially misaligned

incentives between and among RO

participants, as well as other challenges

for the Model evaluation. Specifically,

we believe that, without this waiver,

some RO participants may change their

billing behavior by shifting the setting

in which they furnish RT services from

HOPDs to freestanding radiation therapy

centers in order to increase the amount

of participant-specific technical episode

payments, producing unwarranted

increases in their APM Incentive

Payment amount. In the proposed rule,

we discussed our belief that this would

prejudice the model testing of site

neutral payments as well as potentially

interfering with the Model’s design to

incentivize participants to preserve or

improve quality by tying performance to

incentive payments if participant

behavior is focused on maximizing the

APM Incentive Payment.

For these reasons, we stated our belief

that it would be necessary to waive the

requirements of 42 CFR 414.1450(b) to

the extent they would require inclusion

of the technical RO Model-specific

HCPCS codes as covered professional

services when calculating the APM

Incentive Payment amount.

We solicited public comments on our

proposal to exclude the Technical

Component from the APM Incentive

Payment calculation. The following is a

summary of the public comments

received on this proposal and our

response:

Comment: Many commenters

disagreed with this proposal, stating

that not including the TC in the

payment amount used to calculate the

APM Incentive Payment could make it

difficult to offset any reduced payments

that occur as a result of RO Model

participation. Several commenters

stated that not including the TC in the

APM Incentive Payment calculation

undercuts the spirit and letter of

MACRA’s intent of encouraging

clinicians to assume risk and participate

in APMs. These commenters stated this

was the case because a lower APM

Incentive Payment, resulting from

exclusion of the TC in the payment

calculation, would fail to adequately

compensate eligible clinicians for

participation in the RO Model, which is

an Advanced APM. A few commenters

suggested including a portion of the TC

payment in the APM Incentive

calculation, as opposed to none of it.

Response: We disagree with

commenters’ recommendations to

include part or all of the TC in the

payment amount used to calculate the

APM Incentive Payment. The reasons

for this policy are threefold. First, the

TC payment of the RO Model is,

generally speaking, not a payment for

professional services. Rather, it is a

payment for technical services (those

that represent the cost of equipment,

supplies, and personnel used to perform

a procedure). We do not believe it

would be appropriate under the RO

Model for payments for technical

services to be included in the APM

Incentive Payment calculation. Second,

inclusion of the TC payment of the RO

Model in the APM Incentive Payment

calculation would potentially prejudice

the Model testing of site neutral

payments, since PGPs furnishing RT

services in HOPDs (which are paid

under OPPS) would not have the TC

included in the calculation. We believe

that if we included the TC payment of

the RO Model in the APM Incentive

Payment calculation, we would create a

situation that may inadvertently

incentivize Professional participants to

change their treatment pathways so that

TC services are furnished in a

freestanding radiation therapy center

instead of an HOPD in an attempt to

increase the amount of services

rendered that would count towards their

APM Incentive Payment. By not

including the TC payment of the RO

Model in the APM Incentive Payment

calculation, we will be treating the TC

payment the same no matter where the

location the service is rendered and thus

preventing potentially prejudicing the

Model testing of site neutral payments.

After considering public comments,

we are finalizing our proposal at

§ 512.280(d) to exclude the TC payment

of the RO Model from the APM

Incentive Payment calculation, with a

modification to clarify that CMS is

waiving the requirements of

§ 414.1450(b) of 42 CFR chapter IV for

this purpose. Additionally, we would

note that we have revised our

projections regarding the number of

expected QPs in the RO Model to also

include physicians participating in the

RO Model who we would expect to

qualify as partial QPs under the Quality

Payment Program.

d. General Payment Waivers

In the proposed rule, we discussed

our belief that it is necessary for

purposes of testing the RO Model to

waive requirements of certain sections

of the Act, specifically with regard to

how payments are made, in order to

allow the RO Model’s prospective

episode payment to be fully tested.

Therefore, we proposed to waive:

•Section 1848(a)(1) of the Act that

requires payment for physicians’

services to be determined under the PFS

to allow the professional and technical

component payments for RT services to

be made as set forth in the RO Model.

We believe that waiving section

1848(a)(1) of the Act will be necessary

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because otherwise many of the RO

Model payment rates will be set by the

PFS;

•Section 1833(t)(1)(A) of the Act that

requires payment for outpatient

department (OPD) services to be

determined under the OPPS to allow the

payments for technical component

services to be paid as set forth in the RO

Model because otherwise the

participant-specific technical episode

payment will be set by the OPPS (we

note that the waiver of OPPS payment

will be limited to RT services under the

RO Model); and

•Section 1833(t)(16)(D) of the Act

regarding payment for stereotactic

radiosurgery (a type of RT covered by

the RO Model) to allow the payments

for technical component services to be

paid as set forth in the RO Model

because RO Model payment amounts

would be modality agnostic and

episodic such that all treatments and

duration of treatment for this cancer

type are paid the same amount.

We proposed to waive these

requirements because these statutory

provisions establish the current

Medicare FFS payment methodology.

Without waiving these specific

provisions of the Act, we would not be

able to fully test whether the

prospective episode pricing

methodology tested under the RO Model

(as discussed in section III.C.6 of this

final rule) was effective at reducing

program expenditures while preserving

or enhancing the quality of care.

Specifically, the RO Model will test

whether adjusting the current fee-for-

service payments for RT services to a

prospective episode-based payment

model will incentivize physicians to

deliver higher-value RT care. Without

waiving the requirements of statutory

provisions that currently determine

payments for RT services, payment for

RT services would be made using the

current FFS payment methodology and

not the pricing methodology we are

testing through the Model.

We solicited public comments on the

general payment waivers. The following

is a summary of the public comments

received on this proposal and our

response:

Comment: Some commenters stated

that CMS will not be able to fully test

the RO Model as proposed unless CMS

also waives section 1833(t)(2)(H) of the

Act, which provides that ‘‘with respect

to devices of brachytherapy consisting

of a seed or seeds (or radioactive

source), the Secretary shall create

additional groups of covered [outpatient

department services] that classify such

devices separately from the other

services (or group of services)’’ paid

under the OPPS ‘‘in a manner reflecting

the number, isotope, and radioactive

intensity of such devices furnished,

including separate groups for

palladium-103 and iodine-125 devices

and for stranded and non-stranded

devices furnished on or after July 1,

2007.’’

Response: We appreciate these

comments and agree that in order to

finalize the RO Model as proposed a

waiver of section 1833(t)(2)(H) is

necessary. In particular, section

1833(t)(2)(H) requires separate payment

for devices of brachytherapy, but the RO

Model will utilize episode-based

payment, which means that CMS will

make a single payment for the radiation

service including for brachytherapy and

any other services that were furnished

as part of the episode.

Comment: A commenter stated that

CMS should not waive section

1833(t)(2)(H) of the Act, but should

instead incorporate the requirements of

that provision into the proposed RO

Model by paying separately for

brachytherapy sources outside of the RO

Model payment bundles using

Medicare’s current system of coding and

reimbursement for brachytherapy

sources.

Response: We appreciate the

comment, but disagree that we should

pay separately in the RO Model for

brachytherapy source payments

provided in HOPDs. One of the primary

objectives for the RO Model is to test an

episode-based payment. Without

waiving this provision, we would not be

testing the RO Model as an episode-

based payment model as proposed and

intended.

We received no comments on the

general payment waivers we proposed

and therefore are finalizing these

provisions without modification.

Additionally, after considering public

comments, we are also finalizing an

additional waiver of section

1833(t)(2)(H) of the Act as some

commenters have suggested. This

provision requires separate payment of

brachytherapy sources provided in

HOPDs. As we are testing new payment

methodologies for RT services including

brachytherapy sources provided in

HOPDs, we believe that it is necessary

to waive this provision of the Act.

e. Waiver of Appeals Requirements

In the proposed rule, we discussed

our belief that it was necessary for

purposes of testing the RO Model to

waive section 1869 of the Act specific

to claims appeals to the extent

otherwise applicable. We proposed to

implement this waiver so that RO

participants may utilize the timely error

and reconsideration request process

specific to the RO Model in section

III.C.12 of this rule to review potential

RO Model reconciliation errors. We

noted in the proposed rule that, if RO

participants have general Medicare

claims issues they wish to appeal

(Medicare claims issues experienced by

the RO participant that occur outside

the scope of the RO Model, but during

their participation in the RO Model),

then the RO participants should

continue to use the standard CMS

claims appeals procedures under

section 1869 of the Act.

We proposed to implement this

waiver because the pricing methodology

for the RO Model is unique and as such

we have developed a separate timely

error notice and reconsideration request

process that RO participants will use in

lieu of the claims appeals process under

section 1869 of the Act.

In section III.C.12 of the proposed rule

(84 FR 34528 through 34529), we

discussed the process for RO

participants to contest the calculation of

their reconciliation payment amounts,

the calculation of their reconciliation

repayment amounts, and the calculation

of their AQS. Reconciliation payment

amount means a payment made by CMS

to an RO participant as determined in

accordance with § 512.285. This process

would ensure that individuals involved

in adjudicating these timely error

notices and reconsideration requests on

these issues would be familiar with the

payment model being implemented and

would ensure that these issues are

resolved in an efficient manner by

individuals with knowledge of the

payment model.

Our proposal does not limit Medicare

beneficiaries’ right to the claims appeals

process under section 1869. We noted,

in the specific circumstance wherein a

health care provider acts on behalf of

the beneficiary in a claims appeal,

section 1869 applies.

We solicited public comments on the

waiver of appeal requirements. The

following is a summary of the public

comments received on this proposal and

our response:

Comment: A commenter supported

the fact that our proposal does not limit

Medicare beneficiaries’ right to the

claims appeals process under section

1869. The commenter believed it is

imperative that RO beneficiaries have

the same rights as other Medicare

beneficiaries to appeal coverage

decisions they believe to be unfounded.

Response: We appreciate the

commenter’s support.

After considering public comments,

we are finalizing, without modification,

our proposed waiver of appeals

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78

Claims run-out is the period of time that CMS

allows for the timely submission of claims by

providers and suppliers before reconciliation.

requirements, specifically to waive

section 1869 of the Act specific to

claims appeals for RO Model claims.

f. Waiver of Amendments Made by

Section 603 of the Bipartisan Budget Act

of 2015

In the proposed rule, we discussed

our belief that it was necessary for

purposes of testing the RO Model to

waive application of the PFS relativity

adjuster which applies to payments

under the PFS for ‘‘non-excepted’’ items

and services identified by section 603 of

the Bipartisan Budget Act of 2015 (Pub.

L. 114–74), which amended section

1833(t)(1)(B)(v) of the Act and added

paragraph (t) (21) to the Social Security

Act. Sections 1833(t)(1)(B)(v) and (t) (21)

of the Act exclude certain items and

services furnished by certain off-campus

provider-based departments (non-

excepted off-campus provider-based

departments (PBDs)) from the definition

of covered outpatient department

services for purposes of OPPS payment,

and direct payment for those services to

be made ‘‘under the applicable payment

system’’ beginning January 1, 2017. We

established the PFS as the ‘‘applicable

payment system’’ for most non-excepted

items and services furnished in non-

excepted off-campus PBDs (81 FR

79699) and, in order to facilitate

payment under the PFS, we apply a PFS

relativity adjuster that is currently set at

40 percent of the OPPS rate (82 FR

53027). We also require OPDs to use the

modifier ‘‘PN’’ on applicable OPPS

claim lines to identify non-excepted

items and services furnished in non-

excepted off-campus PBDs. The

modifier triggers application of the PFS

relativity adjuster in CMS’ claims

processing systems.

Under the RO Model, we proposed to

waive requirements under section

1833(t)(1)(B)(v) and (t)(21) of the Act for

all RO Model-specific payments to

applicable OPDs. If a non-excepted off-

campus PBD were to participate in the

RO Model, it would be required to

submit RO Model claims consistent

with our professional and technical

billing proposals in section III.C.7. In

addition, we proposed to not apply the

PFS relativity adjuster to the RO Model

payment and instead pay these

participants in the same manner as

other RO participants because the RO

Model pricing methodology’s design as

discussed in section III.C.6.c of this final

rule sets site-neutral national base rates,

and adding the PFS relativity adjuster to

the RO Model payment for RO

participants that are non-excepted off-

campus PBDs would disrupt this

approach and introduce a payment

differential. In the proposed rule, we

discussed our belief that this waiver was

necessary to allow for consistent model

evaluation and ensure site neutrality in

RO Model payments, which is a key

feature of the RO Model.

We solicited public comments on

payment waivers. We received no

comments on this policy and are

finalizing it as proposed.

11. Reconciliation Process

We proposed that we would conduct

an annual reconciliation for each RO

participant after each PY to reconcile

payments owed to the RO participant

with payments owed to CMS due to the

withhold policies discussed in section

III.C.6.g of the proposed rule (84 FR

34527). We proposed that this annual

reconciliation would occur in the

August following a PY in order to allow

time for claims run-out, data collection,

reporting, and calculating results.

78

In the example we provided in the

proposed rule, the annual reconciliation

for PY1 would apply to episodes

initiated January 1, 2020 (or April 1,

2020) through December 31, 2020, and

the annual reconciliation for PY1 would

occur in August of 2021. We stated that

an annual reconciliation is appropriate

because incomplete episodes and

duplicate RT services as described in

section III.C.6.a of the proposed rule and

this final rule may result in additional

payment owed to an RO participant or

owed to CMS for RT services furnished

to an RO beneficiary in those cases.

The following is a summary of the

comments we received on the proposal

for the annual reconciliation to occur in

August following a PY and our

responses to these comments:

Comment: Many commenters

expressed concern about the annual

reconciliation taking place in August of

the following PY, citing issues of health

care provider burden, financial

hardship, and patient access to care. A

commenter requested that CMS

prospectively reimburse RO participants

for their payment withholds to ensure

that they do not have a gap in revenue.

Another commenter recommended that

reconciliation should be conducted

every six months. Another commenter

suggested that the RO Model implement

a reconciliation to occur immediately

following the performance year with a

final reconciliation to account for claims

runout.

Response: Changes made elsewhere in

this final rule reduce the financial

burden associated with the timing of

reconciliations. Specifically, as noted in

section III.C.6.g of this final rule, we

will reduce the incorrect payment

withhold from 2 percent to 1 percent

and not begin the quality withhold until

PY1. The patient experience withhold

will not begin until PY3. If

reconciliation were to be conducted

every six months, this would require RO

participants to submit quality measure

data more frequently, which would

increase provider burden.

We would like to clarify that we are

adding a definition at § 512.205 for

‘‘initial reconciliation,’’ which means

the first reconciliation of a PY that

occurs as early as August following the

applicable PY. We also are finalizing the

definition of ‘‘true-up reconciliation’’ at

§ 512.205 to mean the process to

calculate additional reconciliation

payments or repayment amounts for

incomplete episodes and duplicate RT

services that are identified after the

initial reconciliation and after a 12-

month claims run out for all RO

episodes initiated in the applicable PY.

We also would like to clarify that the

true-up reconciliation process is only

related to the incorrect payment

withhold, and we will not conduct a

true-up reconciliation for the quality

withhold or the patient experience

withhold.

Moreover, an additional

reconciliation, if done a few months

prior to what we call the initial

reconciliation before allowing for a

reasonable claim run-out, would be

based on incomplete data. We believe

this would unduly complicate the

reconciliation process. In the case of an

initial reconciliation, CMS calculations

will use claims data available at that

time for claims run-out and expect to

provide RO participants with a

reconciliation report in August of the

subsequent year following the

applicable PY. With respect to the

concerns about patient access to care,

the commenter did not explain how the

timing of reconciliation in a mandatory

model would affect patient access to

care. We do not expect that

reconciliation timing will have any

impact on patient access to care. With

respect to the commenter who requested

that CMS prospectively reimburse RO

participants for their payment

withholds, we understand the

commenter to be requesting that CMS

eliminate the payment withhold. We

decline to do so because the withhold

reserves money for purposes of

reconciling duplicate RT services and

incomplete episodes, which protects the

financial integrity of the model and

reduces any immediate negative

financial impact on RO participants due

to reconciliation. As a result of the stop-

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Please note that the final rule reduced the

incorrect payment withhold amount from the

proposed 2 percent to 1 percent, discussed in

section III.C.6.g of this final rule.

loss policy described in section

III.C.6.e(4) we are finalizing this

provision with modification to add a

stop-loss reconciliation amount to the

reconciliation process, as codified at

§ 512.285(f). We would like to clarify

that we are adding a definition at

§ 512.205 for ‘‘stop-loss reconciliation,’’

which means the amount owed to RO

participants that have fewer than 60

episodes during 2016–2018 for the loss

incurred under the Model and were

furnishing included RT services at

November 30, 2020 in the CBSAs

selected for participation as described in

§ 512.285(f).

We have also modified the text of the

regulation at § 512.285 to describe how

reconciliation payments and repayment

amounts are calculated and what details

are provided in the reconciliation report

as described in the preamble to the

proposed rule. We have made a number

of non-substantive editorial and

organizational changes to streamline

and improve the clarity of the regulation

text at § 512.285. We note that the

proposed rule indicated that

reconciliation would occur annually in

August. Although this final rule

provides that reconciliation will occur

annually, we are removing the language

indicating that reconciliation will

always occur in August, and instead

state that initial reconciliation could

occur as early as August, because we

may require additional flexibility

depending on the availability of data

and other considerations. If the RO

participant fails to timely pay the full

repayment amount, CMS will recoup

the repayment amount from any

payments otherwise owed by CMS to

the RO participant, including Medicare

payments for items and services

unrelated to the RO Model, and interest

will be charged in accordance with 42

CFR 405.378.

a. True-Up Process

We proposed that we would conduct

an annual true-up of reconciliation for

each PY. We proposed to define the

term ‘‘true-up’’ as the process to

calculate additional payments or

repayments for incomplete episodes and

duplicate RT services that are identified

after claims run-out. More specifically,

we proposed that we would true-up the

PY1 reconciliation approximately one

year after the initial reconciliation

results were calculated. This would

align the PY2 reconciliation of the

following year with the PY1 true-up,

thereby allowing for a full claims run-

out on PY1, and reducing any potential

confusion for RO participants that may

be caused by receiving multiple

reconciliation reports in close

succession. We proposed to follow the

same process for each subsequent

performance year. Under our proposal,

we would conduct a true-up of PY1 in

August 2022, a true-up of PY2 in August

2023, and so forth.

We solicited public comments on our

proposal for a true-up process. The

following is a summary of the comment

we received on our proposal and our

response to the comment:

Comment: A commenter

recommended eliminating the true-up

process to streamline the reconciliation

process.

Response: We thank this commenter

for the suggestion. We believe that the

true-up process requires little effort on

the part of RO participants and that it

is necessary to properly account for

additional reconciliation payments or

repayment amounts for incomplete

episodes and duplicate RT services that

are identified after a full 12-month

claims run-out. Eliminating the true-up

process could lead to a gaming

opportunity where RO participants

might wait to submit claims until after

the claims run-out period used in the

first reconciliation for a PY. The net

reconciliation payment or repayment

amount owed for the PY is the sum of

(h)(1) and (f)(2) in the reconciliation

example provided in section III.C.11.b.

We are finalizing this provision

concerning the true-up process with

modification to codify the true-up

process at § 512.285(g). We note that in

the proposed rule we provided

examples of the timing of the PY1 and

PY2 true-ups. Given the change in the

Model performance period, we are

clarifying that we will conduct the PY1

true-up reconciliation as early as August

2023, and the PY2 true-up

reconciliation as early as August 2024,

and so forth. While we have every

expectation that all reconciliations and

true-up reconciliations will occur in

August, we recognize that in

exceptional circumstances, there could

be a modest delay in performing such

reconciliations. For this reason, we are

revising the regulation text at

§ 512.285(a) to remove reference to

conducting annual reconciliations ‘‘in

August.’’

We are finalizing our definition of

‘‘true-up’’ with technical modifications

to read as follows: ‘‘True-up

reconciliation means the process to

calculate additional reconciliation

payments or repayment amounts for

incomplete episodes and duplicate RT

services that are identified after the

initial reconciliation and after a 12-

month claims run-out for all RO

episodes initiated in the applicable PY.’’

Specifically, the proposed definition has

been revised to replace the term

‘‘payments or repayments’’ with the

defined terms ‘‘reconciliation

payments’’ and ‘‘repayment amounts.’’

In addition, we have replaced the

phrase ‘‘that are identified after claims

run-out’’ with the more precise ‘‘that are

identified after initial reconciliation’’

and included the time frame for claims

run-out.

b. Reconciliation Amount Calculation

To calculate a reconciliation payment

amount either owed to an RO

participant by CMS or a reconciliation

repayment amount owed to CMS by an

RO participant, we proposed to use the

following process:

•Calculate the incorrect episode

payment amount. We proposed to sum

all money the RO participant owes CMS

due to incomplete episodes and

duplicate services, and subtract the

amount from the incorrect payment

withhold amount (that is, the

cumulative withhold of 2 percent on

episode payment amounts for all RO

episodes furnished during that PY by

that RO participant).

79

This would

determine the amount owed to the RO

participant by CMS based on total

payments made to the RO participant

for incomplete episodes and duplicate

RT services for a given PY, if applicable.

An RO participant would receive the

full incorrect payment withhold amount

if it had no duplicate RT services or

incomplete episodes (as explained in

section III.C.6.g). In instances where

there are duplicate RT services or

incomplete episodes, the RO participant

would owe a repayment amount to CMS

if the amount of all duplicate RT

services and incomplete episodes

exceeds the incorrect payment withhold

amount.

•For Professional participants during

the Model’s performance period: We

proposed that if the RO participant is a

Professional participant, then we would

add the Professional participant’s

incorrect episode payment amount to

the quality reconciliation amount. The

quality reconciliation amount would be

determined by multiplying the

participant’s AQS (as a percentage)

against the total two-percentage point

maximum amount as described in

section III.C.8.f(2).

•For Technical participants in PY1

and PY2: We proposed that if the RO

participant is a Technical participant

then the Technical participant’s

reconciliation amount would be equal to

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the incorrect episode payment amount.

There would be no further additions or

subtractions.

•For Technical participants in PY3,

PY4, and PY5: We proposed to add the

Technical participant’s incorrect

episode payment amount to the patient

experience reconciliation amount, in

section III.C.6.g(3). Technical

participants and Dual participants could

earn up to the full amount of the patient

experience withhold (1 percent of the

technical episode payment amounts) for

a given performance year based on their

results from the patient-reported

CAHPS

®

Cancer Care Radiation Therapy

Survey.

•For Dual participants in PY1 and

PY2: We proposed to add the Dual

participant’s incorrect episode payment

amount to the quality reconciliation

amount. The quality reconciliation

amount would be determined by

multiplying the Dual participant’s AQS

(in percentage terms) against the total

two-percentage point maximum

withhold amount as described in

section III.C.8.f(2).

•For Dual participants in PY3, PY4,

and PY5: We proposed to add the Dual

participant’s incorrect episode payment

amount to the quality reconciliation

amount. The quality reconciliation

amount would be determined by

multiplying the participant’s AQS (in

percentage terms) against the total two-

percentage point maximum withhold

amount as described in section

III.C.8.f(2). Then, we would add the

Dual participant’s patient experience

reconciliation amount to this total.

The geographic adjustment and the 2

percent adjustment for sequestration

would be applied to the incorrect

payment withhold, quality withhold,

and patient experience withhold

amounts during the reconciliation

process. Beneficiary coinsurance would

be waived for the reconciliation

payment and repayment amounts,

meaning that the RO participant may

not collect 20 percent of what is owed

to CMS from the RO beneficiary, and

CMS will not collect 20 percent of what

it owes the RO participant from the RO

beneficiary.

We provided an example

reconciliation calculation for a

Professional participant in Table 10 of

the proposed rule. The numbers listed

in that table are illustrative only. In the

example in the proposed rule, the

incorrect payment withhold amount for

the Professional participant would be

$6,000 or 2 percent of $300,000 (the

total payments for the participant after

the trend factor, adjustments, and

discount factor have been applied). The

Professional participant would owe

CMS $3,000 for duplicate payments due

to claims submitted on behalf of

beneficiaries who received RT services

by another RT provider or RT supplier

during their RO episode. Lastly, the

Professional participant would owe

CMS $1,500 for cases of incomplete

episodes whereby the PC of the RO

episode was billed and due to death or

other reason, the TC was not billed by

the time of reconciliation. In the

example in the proposed rule, the

payments for duplicate RT services and

incomplete episodes would be

subtracted from the incorrect payment

withhold amount to render $1,500 due

to the RO participant from CMS for the

incorrect episode payment amount (a).

This amount would then be added to

the quality reconciliation amount (b).

The quality withhold amount for this

RO participant would be $6,000 or 2

percent of $300,000. This RO

participant’s performance on the AQS

would entitle them to 85 percent of the

quality withhold, and, therefore, when

the quality reconciliation amount (b) is

added to the incorrect payment

withhold amount (a), and a total

reconciliation payment of $6,600 (c) is

due to the RO participant from CMS for

that performance year. We note that the

example in the proposed rule does not

include the geographic adjustment or

the 2 percent adjustment for

sequestration.

We solicited public comment on our

proposal on calculating reconciliation

amounts. The following is a summary of

the comments we received on our

proposal and our responses to these

comments:

Comment: A commenter requested

clarification as to how beneficiary

coinsurance would be accounted for in

reconciliation and repayment amounts,

stating that there are conflicting

interpretations of ‘‘waiving’’ beneficiary

coinsurance.

Response: To clarify, we are waiving

the beneficiary coinsurance obligation

when an RO participant owes CMS

money (repayment amount) or CMS

owes the RO participant money

(reconciliation payment). Thus, no

beneficiary coinsurance will be

collected on these amounts. We have

clarified our regulation text on this issue

at § 512.285(i)(3). We will provide RO

participants with additional instructions

for billing, particularly as it pertains to

how beneficiary coinsurance will be

accounted for in reconciliation.

Additional instructions will be made

available through the Medicare Learning

Network (MLN Matters) publications,

model-specific webinars, and the RO

Model website.

Comment: A commenter requested

that detailed information be provided

on reconciliation reports so that RO

participants could attribute data by

clinician and category.

Response: We thank the commenter

for this suggestion and we will take this

into consideration as we design the

reconciliation reports.

After considering public comments on

section III.C.11 of the proposed rule, we

are finalizing our proposed provisions at

§ 512.285 that the reconciliation process

will occur annually, with each RO

participant receiving a reconciliation

report that indicates the reconciliation

payment amount they are due or the

repayment amount owed to CMS. Please

note that because of the change to the

incorrect payment withhold in this final

rule, described in section III.C.11 of this

rule, we have provided an updated

example reconciliation calculation for a

Professional participant in Table 14,

which reflects that change. The numbers

listed in the table are illustrative only.

In this example, the total incorrect

payment withhold amount for this

Professional participant is $3,000 or 1

percent of $300,000 (the total payment

amounts for the RO episodes initiated in

the PY for this RO participant after the

trend factor, adjustments, and discount

factor have been applied). The

Professional participant owes CMS

$3,000 for duplicate RT services due to

claims submitted on behalf of RO

beneficiaries who received any included

RT services (duplicate RT services) from

another RT provider or RT supplier

during their RO episode. Lastly, in this

example, the Professional participant

owes CMS $1,500 for cases of

incomplete episodes where the PC of

the RO episode was billed, and due to

death or another reason, the TC was not

billed by the time of reconciliation and

for cases of incomplete episodes where

the RO beneficiary switched RT

provider or RT supplier before all the

included RT services in the RO episode

had been furnished. In this example, the

payments for duplicate RT services and

incomplete episodes would be

subtracted from the incorrect payment

withhold amount to render $1,500 due

to CMS from the RO participant for the

incorrect episode payment amount (a).

This amount is then added to the

quality reconciliation amount (b). The

quality withhold amount for this

participant is $6,000 or 2 percent of

$300,000. This RO participant’s

performance on the AQS entitles him or

her to 85 percent of the quality

withhold, and, therefore, when the

quality reconciliation amount (b) is

added to the incorrect payment

withhold amount (a), and a total

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reconciliation payment of $3,600 (d) is

due to the RO participant from CMS for

that performance year. We note that in

this example the RO participant did not

qualify to receive a stop-loss

reconciliation amount (c) as codified at

§ 512.285(f) and, therefore, no value is

listed. We note that this example does

not include the geographic adjustment

or the 2 percent adjustment for

sequestration.

We are finalizing the reconciliation

process at § 512.285 as proposed with

the following clarification: CMS uses

the reconciliation process to identify

any reconciliation payment owed to an

RO participant or any repayment

amount owed by an RO participant to

CMS. For instance, in the case where

the SOE for the PC is billed, yet the SOE

for the TC is not billed, CMS will owe

the RO participant only the FFS amount

for the RT services included in the PC

that was billed by the RO participant for

that RO beneficiary. If, in this case, the

RO participant was paid $2,000 for the

first episode payment of the PC and

only furnished one planning service,

which under FFS would be reimbursed

at $200, and no SOE for the TC was

billed within 28 days, then the RO

participant’s repayment amount would

be $1,800 for this RO episode, and this

would be accounted for during

reconciliation. Also, for any incomplete

episode that is reconciled to FFS

amounts because the RO beneficiary

switches RT provider or RT supplier

before all RT services in the RO episode

have been furnished, the RO beneficiary

owes the RO participant(s) that initiated

the PC or TC 20 percent of the FFS

amount for the RT services that were

furnished during that RO episode, not

20 percent of the episode bundled

payment (see section III.C.6.i of this

final rule). For any RO episode that

involves one or more duplicate RT

services, the payment for the RO

participant that initiated the PC or TC

will be reconciled by reducing the RO

participant’s episode payment by the

FFS amount of the duplicate RT services

furnished by the RT provider or RT

supplier that did not initiate the PC or

TC.

This means that for any RO episode

that involves one or more duplicate RT

services, the RO participant that

initiated the PC or TC is owed the

bundled payment less the FFS amount

for the RT services furnished by the RT

provider or RT supplier that did not

initiate the PC or TC. The other RT

provider or RT supplier that furnished

RT services to that beneficiary, whether

an RO participant or not, will be paid

FFS for those RT services. The FFS

amount to be subtracted from the

bundled payment of the RO participant

that initiated the PC or TC of that RO

episode, however, cannot exceed the

participant-specific professional episode

payment amount or the participant-

specific technical episode payment

amount that the RO participant received

for the RO episode. If the FFS amount

to be subtracted for duplicate RT

services exceeds the participant-specific

professional episode payment amount

or the participant-specific technical

episode payment amount, CMS will not

subtract more than the participant-

specific professional episode payment

amount or participant-specific technical

episode payment amount received by

the RO participant.

12. Timely Error Notice and

Reconsideration Request Processes

In the proposed rule, we stated that

we believed it would be necessary to

implement timely error notice and

reconsideration request processes under

which RO participants may dispute

suspected errors in the calculation of

their reconciliation payment amount or

repayment amount (in section III.C.11 of

the proposed rule and this final rule), or

AQS (in section III.C.8.f of the proposed

rule and this final rule) as reflected on

an RO reconciliation report that has not

been deemed final. Therefore, we

proposed a policy that would permit RO

participants to contest errors found in

the RO reconciliation report, but not the

RO Model pricing methodology or AQS

methodology. We note that, if RO

participants have Medicare FFS claims

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or decisions they wish to appeal (that is,

Medicare FFS issues experienced by the

RO participant that occur outside the

scope of the RO Model but during their

participation in the RO Model), then the

RO participants should continue to use

the standard CMS procedures through

their Medicare Administrative

Contractor.

Section 1869 of the Act provides for

a process for Medicare beneficiaries,

providers, and suppliers to appeal

certain claims decisions made by CMS.

However, we proposed that we would

waive the requirements of section 1869

of the Act specific to claims appeals as

necessary solely for purposes of testing

the RO Model. Specifically, we believe

it would be necessary to establish a

means for RO participants to dispute

suspected errors in the calculation of

their reconciliation payment amount,

repayment amount, or AQS. Having RO

participants utilize the standard claims

appeals process under section 1869 of

the Act to appeal the calculation of their

reconciliation payment amount,

repayment amount, or AQS would not

lead to timely resolution of disputes

because MACs and other CMS officials

would not have access to beneficiary

attribution data, and the standard claims

appeals process hierarchy would not

engage the Innovation Center and its

contractors until late in the process.

Accordingly, we proposed a two-level

process for RO participants to request

reconsideration of determinations

related to calculation of their

reconciliation payment, repayment

amount, or AQS under the RO Model.

The first level would be a timely error

notice process and the second level to

be reconsideration review process, as

subsequently discussed. The processes

here are based on the processes

implemented under certain models

currently being tested by the Innovation

Center.

As proposed, only RO participants

may utilize the first and second level of

the reconsideration process, unless

otherwise stated in other sections of this

subpart. We believe that only RO

participants should be able to utilize the

process because non-participants would

not receive calculation of a

reconciliation payment amount,

repayment amount, or AQS, and would

generally have access to the section

1869 claims appeals processes to appeal

the payments they receive under the

Medicare program.

1. Timely Error Notice

As we explained in the proposed rule,

in some models currently being tested

by the Innovation Center, CMS provides

model participants with a courtesy copy

of the settlement report for their review,

allowing them to dispute suspected

calculation errors in that report before

the payment determination is deemed

final. Other models currently being

tested by the Innovation Center make

model-specific payments in response to

claims or on the basis of model

beneficiary attribution that are similarly

subject to a model-specific process for

resolving disputes. In some models

currently being tested by the Innovation

Center, these reconsideration processes

involve two levels of review.

Building off of these existing

processes, we proposed for the first

level of the reconsideration process to

be a timely error notice. Specifically, RO

participants could provide written

notice to CMS of a suspected error in

the calculation of their reconciliation

payment amount, repayment amount, or

AQS for which a determination has not

yet been deemed to be final under the

terms of this part. As proposed, the RO

participant would have 30 days from the

date the RO reconciliation report is

issued to provide their timely error

notice (see § 512.290). This would be

subject to the limitations on

administrative and judicial review as

previously described in section II.K.

Specifically, an RO participant could

not use the timely error notice process

to dispute a determination that is

precluded from administrative and

judicial review under section

1115A(d)(2) of the Act and § 512.170.

We proposed that this written notice

must be submitted in a form and

manner specified by CMS. Unless the

RO participant provides such notice, the

RO participant’s reconciliation payment

amount, repayment amount, or AQS

would be deemed final after 30 days,

and CMS would proceed with payment

or repayment, as applicable. If CMS

receives a timely notice of an error, we

would respond in writing within 30

days to either confirm that there was a

calculation error or to verify that the

calculation is correct. CMS would

reserve the right to an extension upon

written notice to the RO participant. We

proposed to codify this timely error

notice policy at § 512.290(a).

We solicited comment on this

proposal. The following is a summary of

the public comments received on this

proposal and our response:

Comment: Two commenters requested

additional time to review reconciliation

reports and submit potential errors to

CMS. A commenter suggested extending

the timeline to a 90-day period for

participants to review and submit a

timely error notice. Another commenter

suggested extending the timeline to a

45-day period for participants to review

and submit a timely error notice.

Response: We agree with commenters

that providing additional time may

benefit some RO participants in

identifying and understanding

calculation errors. We would note that

increasing the timeline to 45 days, as a

commenter suggested, would align our

processes with those used in the CJR

model. We want to reiterate that we are

committed to paying RO participants

accurately and correctly and believe that

the calculation error process serves an

important function in achieving that

goal. The procedures for processing and

issuing reconciliation payment amounts

and repayment amounts that we are

finalizing in section III.C.11 of this final

rule require specific timeframes in order

to process these payments properly and

promptly. As such we believe the need

for extending the deadline for

submission of notices of calculation

error should be balanced with our goal

to issue reconciliation payment amounts

and repayment amounts promptly.

Therefore, to address the commenters’

concerns while balancing our need to

finalize payment determinations

promptly, this final rule provides that a

notice of calculation error must be

received by CMS within 45 days after

the issuance of a reconciliation report.

After considering public comments,

we are finalizing our proposed timely

error notice provisions with a

modification of extending the amount of

time that RO participants have to submit

their timely error notice, which must be

received by CMS within 45 days after

the issuance of a reconciliation report,

at § 512.290(a). Additionally, we are

modifying the regulatory text at

§ 512.290(a) to align the regulatory text

with the proposal discussed in the

preamble of the proposed rule that

would permit RO participants to contest

errors found in the RO reconciliation

report, but not the RO Model pricing

methodology or AQS methodology. We

are removing proposed § 512.290(a)(4),

which stated that an RO participant

must have submitted a timely error

notice on an issue not precluded from

administrative or judicial review as a

condition of using the reconsideration

review process described in

§ 512.290(b). That provision is

unnecessary because § 512.290(b)

specifies that the reconsideration

process may be invoked only to contest

CMS’ response to a timely error notice.

Finally, we have made technical

changes in § 512.290(a) to refer to the

timely error notice in a consistent

manner.

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2. Reconsideration Review

We also proposed a second level of

the reconsideration process that would

permit RO participants to dispute CMS’

response to the RO participant’s

identification of errors in the timely

error notice, by requesting a

reconsideration review by a CMS

reconsideration official. As is the case

for many models currently being tested

by the Innovation Center, we proposed

that the CMS reconsideration official

will be a designee of CMS who is

authorized to receive such requests who

was not involved in the responding to

the RO participant’s timely error notice.

To be considered, we proposed that the

reconsideration review request must be

submitted to CMS within 10 days of the

issue date of CMS’ written response to

the timely error notice. The

reconsideration review request would

be submitted in a form and manner

specified by CMS.

As there will not otherwise be a

timely error notice response for the

reconsideration official to review, in

order to access the reconsideration

review process, we proposed that an RO

participant must have timely submitted

a timely error notice to CMS in the form

and manner specified by CMS, and this

timely error notice must not have been

precluded from administrative and

judicial review. Specifically, where the

RO participant does not timely submit

a timely error notice with respect to a

particular reconciliation payment

amount, reconciliation repayment

amount, or AQS, we proposed that the

reconsideration review process would

not be available to the RO participant

with respect to the RO participant’s

reconciliation payment amount, the

calculation of the RO participant’s

repayment amount, or the calculation of

the RO participant’s AQS.

In the proposed rule, we explained

that if the RO participant did timely

submit a timely error notice and the RO

participant is dissatisfied with CMS’

response to the timely error notice, the

RO participant would be permitted to

request reconsideration review by a

CMS reconsideration review official. To

be considered, we proposed that the

reconsideration review request must be

submitted within 10 days of the date of

CMS’s response to the timely error

notice and must provide a detailed

explanation of the basis for the dispute,

including supporting documentation for

the RO participant’s assertion that CMS

or its representatives did not accurately

calculate the reconciliation payment

amount, repayment amount, or AQS in

accordance with the terms of the RO

Model.

As proposed, the reconsideration

review would be an on-the-record

review (a review of the memoranda or

briefs and evidence only) conducted by

a CMS reconsideration official. The

CMS reconsideration official would

make reasonable efforts to notify the RO

participant and CMS in writing within

15 days of receiving the RO participant’s

reconsideration review request of the

following: The issues in dispute, the

briefing schedule, and the review

procedures. The briefing schedule and

review procedures would lay out the

timing for the RO participant and CMS

to submit their position papers and any

other documents in support of their

position papers; the review procedures

would lay out the procedures the

reconsideration official will utilize

when reviewing the reconsideration

review request. In the proposed rule, we

proposed that the CMS reconsideration

official would make all reasonable

efforts to complete the on-the-record

review of all the documents submitted

by the RO participant and issue a

written determination within 60 days

after the submission of the final position

paper in accordance with the

reconsideration official’s briefing

schedule. As this would be the final

step of the Innovation Center

administrative dispute resolution

process, we proposed that the

determination made by the CMS

reconsideration official would be

binding and not subject to further

review. This reconsideration review

process is consistent with other

resolution processes used throughout

the agency. We proposed to codify this

reconsideration review process at

§ 512.290(b).

We solicited public comment on our

provisions regarding the reconsideration

review process. The following is a

summary of the public comments

received on this proposal and our

responses to these comments:

Comment: A few commenters

requested additional time for RO

participants to submit a reconsideration

request.

Response: We appreciate these

comments and are sympathetic to the

requests from commenters for more time

for RO participants during the

reconsideration review process,

however we believe our modification to

the timeline of the timely error notice

deadline allows RO participants more

time to contemplate their error notice

because we have given them more time

to flesh out the issues before submitting

a timely error notice. Further, with the

extended timeline for submission of

timely error notices and the 10-day

deadline for reconsideration requests is

consistent with the timelines around

timely error and reconsideration

requests in the CJR Model.

We are committed to paying RO

participants accurately and correctly

and believe that the timely error and

reconsideration review processes as

proposed serve an important function in

achieving that goal. The procedures for

processing and issuing reconciliation

payment amounts and repayment

amounts that we are finalizing in

section III.C.11 of this final rule require

specific timeframes in order to process

these payments properly and promptly.

Similar processes have been developed

and are utilized in other CMS models.

As such we believe the need for

extending the deadline for submission

of reconsideration review requests

should be balanced with our goal to

issue reconciliation payment amounts

and repayment amounts promptly.

Comment: A commenter suggested

that CMS should be held to a similarly

strict time standard for the

reconsideration review process as the

RO participant is. They further suggest

that CMS should be strictly bound to a

timeline, and not have the flexibility

allowed by making all reasonable efforts

to respond to the reconsideration review

within 60 days of receipt of the final

position paper. The commenter believes

CMS and the RO participant should be

given the same amount of time during

their portions of the reconsideration

review, and if CMS goes over that time

limit, the RO participant’s position

should be accepted and the final

payment amount, repayment amount, or

AQS should reflect that.

Response: We appreciate the

commenter’s suggestion that we must

also adhere to a time standard when

responding to the RO participant during

the reconsideration review process. We

would reiterate that we are committed

to paying RO participants accurately

and correctly, and we believe that the

timely error and reconsideration review

processes as proposed serve an

important function in achieving that

goal. We note that the proposed timeline

and the flexibility proposed for our final

decision on the reconsideration review

aligns with the timelines being utilized

in other models being tested by the

Innovation Center. As such, we believe

the timeline as proposed is appropriate,

and we will commit to sticking to the

timeline as proposed unless it is wholly

unreasonable for the CMS

reconsideration official to fully review

and decide upon the issue in the time

given.

After considering public comments,

we are finalizing our proposed

reconsideration review provisions with

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non-substantive editorial and

organizational changes to streamline

and improve the clarity of the regulation

text at § 512.290(b).

13. Data Sharing

CMS has experience with a range of

efforts designed to improve care

coordination and the quality of care,

and decrease the cost of care for

beneficiaries, including models tested

under section 1115A, most of which

make certain types of data available

upon request to model participants.

Based on the design elements of each

model, the Innovation Center may offer

participants the opportunity to request

different types of data, so that they can

redesign their care pathways to preserve

or improve quality and coordinate care

for model beneficiaries. Furthermore, as

described in sections II.E and II.G of this

final rule, we believe it is necessary for

the Innovation Center to require certain

data to be reported by model

participants to CMS in order to evaluate

and monitor the model, including the

model participant’s participation in the

model, which could then also be used

to inform the public and other model

participants regarding the impact of the

model on both program spending and

the quality of care.

a. Data Privacy Compliance

In § 512.275(a), we proposed that as a

condition of their receipt of patient-

identifiable data from CMS for purposes

of the RO Model, RO participants would

be required to comply with all

applicable laws pertaining to any

patient-identifiable data requested from

CMS under the terms of the RO Model

and the terms of any other written

agreement entered into by the RO

participant and CMS as a condition of

the RO participant receiving such data

(84 FR 34530). Such laws could include,

without limitation, the privacy and

security standards promulgated under

the Health Insurance Portability and

Accountability Act of 1996 (HIPAA), as

modified, and the Health Information

Technology for Economic and Clinical

Health Act (HITECH). Additionally, we

proposed to require RO participants

contractually bind all downstream

recipients of CMS data to the same

terms and conditions to which the RO

participant was itself bound in its

agreements with CMS as a condition of

the downstream recipient’s receipt of

the data from the RO participant. As we

noted in the proposed rule, binding RO

participants and their downstream

recipients to such written requirements

was necessary if CMS was to protect the

individually identifiable health

information data that it be shared with

RO participants and their downstream

recipients for care redesign and other

forms of quality improvement as well as

care coordination purposes.

The following is a summary of the

public comments received on this

proposal and our responses to the

comments:

Comment: A commenter expressed

concern that the use of third party

companies to collect and analyze data

on the RO participants’ behalf will

cause additional burdens on RO

participants to ensure that no HIPAA

requirements or agreement terms and

conditions violations occur with the

handling of patient-identifiable data by

multiple parties.

Response: The requirement that RO

participants contractually bind their

downstream recipients in writing to

comply with applicable law and the

program requirements in the RO

participants’ agreements with CMS is

necessary to protect the individually

identifiable health information data.

Furthermore, in the case of covered

entities and their business associates,

the privacy and security requirements

promulgated under HIPAA, as modified,

and HITECH would have applied to

such parties regardless of what these

program regulations provide—we

merely highlighted the applicability of

these and other legal mandates.

Therefore, in light of our program

interests and the various already

applicable laws, we are finalizing this

policy with references to the existing

privacy and security requirements

under HIPAA, as modified, and

HITECH.

Comment: A commenter

recommended that CMS add an

additional requirement to this Model

such that data related to cancer staging

information be stored as discrete data in

the EHR or specialty-focused health IT

record, and made available to external

systems through a FHIR

®

(Fast

Healthcare Interoperability Resources)-

based application programming

interface.

Response: We appreciate this

commenter’s suggestion. We believe that

the requirement that RO participants

comply with all applicable laws relating

to patient-identifiable data is sufficient

and that adding additional requirements

as suggested by the commenter at this

time may present a logical outgrowth

problem as well as a burden for the RO

participants. However, we will take this

recommendation under consideration

for future rulemaking.

After considering public comments,

we are finalizing the provisions at

§ 512.275(a), with modifications to the

regulatory text to align the regulatory

text with the proposals discussed in the

preamble. These modifications

specifically add ‘‘patient-identifiable

derivative data’’ to the regulatory text.

Although this language was included in

the proposed rule’s preamble text, it was

inadvertently left out of the regulatory

text.

b. RO Participant Public Release of

Patient De-Identified Information

We did not propose to restrict RO

participants’ ability to publicly release

patient de-identified information that

references the RO participant’s

participation in the RO Model. In the

proposed rule, we stated our belief that

such information could potentially be

included in press releases, journal

articles, research articles, descriptive

articles, external reports, and statistical/

analytical materials describing the RO

participant’s participation and patient

results in the RO Model if such

information has been de-identified in

accordance with HIPAA requirements in

45 CFR 164.514(b) (84 FR 34530). Those

requirements define the data elements

that would need to be removed to

qualify as de-identified under that

regulatory scheme. However, in order to

ensure external stakeholders understand

that information the RO participant

releases represents their own content

and opinions, and does not reflect the

input or opinions of CMS, we proposed

to require the RO participant to include

a disclaimer on the first page of any

such publicly released document, the

content of which materially and

substantially references or relies upon

the RO participant’s participation in the

RO Model. We proposed to codify such

a disclaimer at § 512.120(c)(2)

(providing ‘‘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 proposed to require the

use of this disclaimer so that the public,

and RO beneficiaries in particular, are

not misled into believing that RO

participants are speaking on behalf of

the agency.

The following is a summary of the

public comment received on this

proposal and our response to the

comment:

Comment: We received a comment

supporting our proposal to require RO

participants to include a disclaimer on

all descriptive model materials and

activities.

Response: We thank you for your

support.

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After considering the public comment

received on this proposal, we are

finalizing this proposal without

modification at § 512.275(b).

c. Data Submitted by RO Participants

In addition to the quality measures

and clinical data discussed in section

III.C.8 of the proposed rule (84 FR 34514

through 34522) and this final rule, we

proposed that RO participants supply

and/or confirm a limited amount of

summary information to CMS. This

information includes the RO

participant’s TIN in the case of a

freestanding radiation therapy center

and PGP, or CCN in the case of an

HOPD. We proposed to require RO

participants supply and/or confirm the

NPIs for the physicians who bill for RT

services using the applicable TINs. In

the proposed rule, we also proposed

that RO participants may be required to

provide information on the number of

Medicare and non-Medicare patients

treated with radiation during their

participation in the Model. We

proposed to require RO participants’

submission of additional administrative

data upon a request from CMS, such as

the RO participant’s costs to provide

care (such as the acquisition cost of a

linear accelerator) and how frequently

the radiation machine is used on an

average day; current EHR vendor(s); and

accreditation status. We proposed to

elicit this through annual web-based

surveys. We stated in the proposed rule

that we would use the data requested

under the RO Model to monitor and

assess participants’ office activities,

benchmarks, and track to participant

compliance with applicable laws and

program requirements. 84 FR 34530.

The following is a summary of the

public comments received on this

proposal and our responses to these

comments:

Comment: A commenter expressed

support of requiring RO participants’

submission of their accreditation status.

Response: We thank this commenter

for supporting this proposed policy.

Comment: A few commenters

requested that comprehensive radiation

oncology accreditation standards be

used to ensure that the quality and

compliance standards are met. One of

these commenters argued that utilizing

such accreditation programs as a part of

CMS’ monitoring and assessment to

efforts to ensure compliance with legal

and model agreement requirements

would ensure that facilities demonstrate

their systems, personnel, policies and

procedures meet standards for high-

quality patient care. That commenter

also requested that the accreditation

requirement take effect in 2024,

allowing for a phase-in/transition period

so that all RO Participants could prepare

and complete the RO Model review

process. This commenter further

requested that accreditation be used in

lieu of the monitoring requirements.

Response: We agree with the

commenters that accreditation by

nationally recognized organizations,

such as the ACR, ACRO, and ASTRO,

may be an indicator of the overall

quality of care provided by a RT

provider or RT supplier. As noted

earlier in this final rule, the Model must

include a set of quality measures to

qualify as a MIPS APM and an

Advanced APM, and as such,

accreditation is not able to replace the

RO quality measures without

compromising the Model’s qualification

as a MIPS APM and Advanced APM. In

addition, we do not believe that

accreditation provides a full picture of

quality care delivery in radiation

oncology. Although we are not using

accreditation status as a proxy for

quality, as stated in section III.C.13.c we

may at some point use an optional web-

based survey to gather data from

participants on administrative data

points, including their accreditation

status, indicating the importance of this

information to understanding

participants’ activities. To add clarity to

this policy, CMS will not use the

submission of accreditation status

information in lieu of the quality and

compliance reporting requirements. We

are finalizing this policy with

modification that in response to a

request made by CMS, RO participants

may volunteer to submit administrative

data related to their accreditation status.

Comment: A couple of commenters

indicated that the proposed annual

mandatory survey that CMS may use to

request additional information, such as

the cost of providing care, frequency of

equipment use, EHR vendors, and

accreditation status does not have a

direct relation to the Model. A

commenter further believed that such

information may include proprietary

information and requested that the data

collected by CMS be aggregated and

blinded.

Response: We thank these

commenters for their feedback on our

proposed annual survey. We disagree

with the commenter that the additional

administrative data does not have a

direct relation to the RO Model. As

stated in the proposed rule at 84 FR

34530, the data requested will be used

to better understand participants’ office

activities, benchmarks, and to track

participant compliance with the RO

Model requirements. We agree with the

commenter that the data could contain

proprietary information and note that

we will handle the data in accordance

with applicable laws, including but not

limited to FOIA. In light of these

commenters’ concerns, we are

modifying the proposal such that if

additional administrative data is

requested, the RO participants’

submission of such administrative data

will be optional.

After considering public comments,

we are finalizing this proposal with

modification. Requests by CMS for

administrative data related to the cost of

providing care, frequency of equipment

use, EHR vendors, and accreditation

status will be optional for RO

participants.

d. Data Provided to RO Participants

Thirty (30) days prior to the start of

each PY, we proposed to provide RO

participants with updated participant-

specific professional episode payment

and technical episode payment amounts

for each included cancer type. RO

participants, to the extent allowed by

HIPAA and other applicable law, could

reuse individually identifiable claims

data that they request from CMS for care

coordination or quality improvement

work in their assessment of CMS’

calculation of their participant-specific

episode payment amounts and/or

amounts included in the reconciliation

calculations used to determine the

reconciliation payment amount or

repayment amount, as applicable. To

seek such care coordination and quality

improvement data, we proposed that RO

participants should use a Participant

Data Request and Attestation (DRA)

form, if appropriate for that RO

participant’s situation, which will be

available on the Radiation Oncology

Administrative Portal (ROAP).

Throughout the Model performance

period, RO participants may request to

continue to receive these data until the

final reconciliation and final true-up

process has been completed if they

continue to use such data for care

coordination and quality improvement

purposes. At the conclusion of this

process, the RO participant would be

required to maintain or destroy all data

in its possession in accordance with the

DRA and applicable law.

We proposed that the RO participant

may reuse original or derivative data

without prior written authorization from

us for clinical treatment, care

management and coordination, quality

improvement activities, and provider

incentive design and implementation,

but would not be permitted to

disseminate individually identifiable

original or derived information from the

files specified in the Model DRA to

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anyone who is not a HIPAA Covered

Entity Participant or individual

practitioner in a treatment relationship

with the subject Model beneficiary; a

HIPAA Business Associate of such a

Covered Entity Participant or individual

practitioner; the participant’s business

associate, where that participant is itself

a HIPAA Covered Entity; the

participant’s sub-business associate,

which is hired by the RO participant to

carry out work on behalf of the Covered

Entity Participant or individual

practitioners; or a non-participant

HIPAA Covered Entity in a treatment

relationship with the subject Model

beneficiary.

When using or disclosing PHI or

personally identifiable information (PII)

obtained from files specified in the

DRA, we proposed that 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 regulations promulgated

under the HIPAA and HITECH laws at

45 CFR part 160 and subparts A and E

of part 164, and the types of disclosures

that the Innovation Center itself would

be permitted to make under the ‘‘routine

uses’’ in the applicable systems of

records notices listed in the DRA. The

RO participant may link individually

identifiable information specified in the

DRA (including directly or indirectly

identifiable data) or derivative data to

other sources of individually

identifiable health information, such as

other medical records available to the

participant and its individual

practitioner. The RO participant would

be authorized to disseminate such data

that has been linked to other sources of

individually identifiable health

information provided such data has

been de-identified in accordance with

HIPAA requirements in 45 CFR

164.514(b).

We solicited public comment on our

proposal. The following is a summary of

the public comment received on this

proposal and our response:

Comment: A commenter requested

that CMS provide RO participants with

data on a monthly basis, as this

commenter believed this is the standard

in other APMs. Some commenters

requested that the participant-specific

professional episode payment and

participant-specific technical episode

payment amounts for each included

cancer type be provided to RO

participants 90 to 180 days prior to the

start of each PY. These commenters

believed that 30 days in advance is

inadequate to analyze the data and take

appropriate action with participant

partners on a timely basis.

Response: We understand these

commenters’ concerns, yet there are a

number of reasons why CMS is unable

to provide participant-specific

professional episode payment and

participant-specific technical episode

payment amounts and these amounts 90

to 180 days prior to the start of each PY.

First, certain pricing components used

to determine the participant-specific

professional episode payment and

technical payment amounts are derived

from current Medicare rates, which are

not published until November before

the start of the PY for which they would

apply (see section III.C.6.c(1)). Instead,

as explained in section III.C.6.c(1) of

this final rule, CMS will provide each

RO participant its case mix and

historical experience adjustments for

both the PC and TC, rather than their

participant-specific professional and

technical episode payment amounts,

because exact figures for the participant-

specific professional and technical

episode payment amounts will not be

known to CMS prior to the start of the

PY for which they would apply.

Furthermore, we disagree with the

commenter that it is standard practice in

other APMs to provide participants with

data on a monthly basis. The data

provided to model participants varies

across APMs and many factors

contribute to the feasibility of providing

such data (for example, such as scope of

the model). At this time, given the scope

of this Model, we believe it is

impracticable to provide RO

participants with data on a monthly

basis. Therefore, we are finalizing with

the modification that we will provide

RO participants with their case mix and

historical experience adjustments for

the professional and technical

components at least thirty (30) days

prior to the start of each PY (see

regulatory text at § 512.255).

f. Access To Share Beneficiary

Identifiable Data

As discussed earlier in this final rule,

in advance of each PY and any other

time deemed necessary by us, we will

offer the RO participant an opportunity

to request certain data and reports

through a standardized DRA, if

appropriate to that RO participant’s

situation. The data and reports provided

to the RO participant in response to a

DRA will not include any beneficiary-

level claims data regarding utilization of

substance use disorder services unless

the requestor provides a 42 CFR part 2-

compliant authorization from each

individual about whom they seek such

data. While the proffered DRA form was

drafted with the assumption that most

RO participants seeking claims data will

do so under the HIPAA Privacy Rule

provisions governing ‘‘health care

operations’’ disclosures under 45 CFR

164.506(c)(4), in offering RO

participants the opportunity to use that

form to request beneficiary-identifiable

claims data, we do not represent that the

RO participant or any of its individual

practitioners has met all applicable

HIPAA requirements for requesting data

under 45 CFR 164.506(c)(4). The RO

participant and its individual

practitioners should consult their own

counsel to make those determinations

prior to requesting data using the DRA

form.

Agreeing to the terms of the DRA, the

RO participant, at a minimum, will

agree to establish appropriate

administrative, technical, and physical

safeguards to protect the confidentiality

of the data and to prevent unauthorized

use of or access to it. The safeguards

will be required to provide a level and

scope of security that is not less than the

level and scope of security requirements

established for federal agencies by the

Office of Management and Budget

(OMB) in OMB Circular No. A–130,

Appendix I—Responsibilities for

Protecting and Managing Federal

Information Resources (available at

https://www.whitehouse.gov/omb/

information-for-agencies/circulars/) as

well as Federal Information Processing

Standard 200 entitled ‘‘Minimum

Security Requirements for Federal

Information and Information Systems’’

(available at http://csrc.nist.gov/

publications/fips/fips200/FIPS-200-

final-march.pdf); and, NIST Special

Publication 800–53 ‘‘Recommended

Security Controls for Federal

Information Systems’’ (available at

http://nvlpubs.nist.gov/nistpubs/

SpecialPublications/NIST.SP.800-

53r4.pdf). We proposed that the RO

participant would be required to

acknowledge that the use of unsecured

telecommunications, including

insufficiently secured transmissions

over the internet, to transmit directly or

indirectly identifiable information from

the files specified in the DRA or any

such derivative data files will be strictly

prohibited. Further, the RO participant

would be required to agree that the data

specified in the DRA will not be

physically moved, transmitted, or

disclosed in any way from or by the site

of the Data Custodian indicated in the

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DRA without written approval from

CMS, unless such movement,

transmission, or disclosure is required

by a law. At the conclusion of the RO

Model and reconciliation process, the

RO participant would be required to

maintain or destroy all CMS data and

any individually identifiable derivative

in its possession as provided by the

DRA and any other applicable written

agreements with CMS.

The following is a summary of the

public comment received on section

III.13.f of the proposed rule and our

response:

Comment: A commenter requested

that beneficiaries be informed, prior to

participating in the RO Model, that CMS

proposes to collect quality, clinical, and

administrative data and would share

with RO participants certain de-

identified beneficiary data, and how it

will be used by CMS and RO

participants.

Response: For information relating to

the data that CMS proposes to collect

from RO participants, please see

sections III.C.8, III.C.8.c (quality

measures) and III.C.8.e (clinical data

elements) of this rule. We are finalizing

as proposed that RO participants will be

required to provide beneficiaries with

the beneficiary notification letter during

the initial treatment planning session

which will detail, among other things,

the RO beneficiary’s right to refuse

having his or her Medicare claims data

shared with the RO participant for care

coordination and quality improvement

purposes under § 512.225(a)(2).

Beneficiaries who do not wish to have

their claims data shared with the RO

participant for care coordination and

quality improvement purposes under

the Model would be able to notify their

respective RO participant; in such cases

the RO participant must provide

notification in writing to CMS within 30

days of when the beneficiary notifies the

RO participant.

After considering public comments,

we are finalizing our proposed data

sharing policies with the modification

that requests by CMS for administrative

data related to the cost of providing

care, frequency of equipment use, EHR

vendors, and accreditation status will be

optional for the RO participant. We are

codifying these policies at our

regulation at § 512.275(a)–(b).

14. Monitoring and Compliance

We proposed at 84 FR 34531 that the

general provisions relating to

monitoring and compliance in section

II.I of this rule would apply to the RO

Model. Specifically, RO participants

would be required to cooperate with the

model monitoring and evaluation

activities in accordance with § 512.130,

comply with the government’s right to

audit, inspect, investigate, and evaluate

any documents or other evidence

regarding implementation of the RO

Model under § 512.135(a), and to retain

and provide the government with access

to records in accordance with

§§ 512.135(b) and (c). Additionally,

CMS would conduct model monitoring

activities with respect to the RO Model

in accordance with § 512.150(b). In the

proposed rule we discussed our belief

that the general provisions relating to

monitoring and compliance would be

appropriate for the RO Model, because

we must closely monitor the

implementation and outcomes of the RO

Model throughout its duration. The

purpose of monitoring would be to

ensure that the Model is implemented

safely and appropriately; that RO

participants comply with the terms and

conditions of this rule; and to protect

RO beneficiaries from potential harms

that may result from the activities of an

RO participant.

Consistent with § 512.150(b), we

anticipated that monitoring activities

may include documentation requests

sent to RO participants and individual

practitioners on the individual

practitioner list; audits of claims data,

quality measures, medical records, and

other data from RO participants and

clinicians on the individual practitioner

list; interviews with members of the

staff and leadership of the RO

participant and clinicians on the

individual practitioner list; interviews

with beneficiaries and their caregivers;

site visits; monitoring quality outcomes

and clinical data, if applicable; and

tracking patient complaints and appeals.

We also discussed in the proposed rule

(84 FR 34531 through 34532) that we

anticipated using the most recent claims

data available to track utilization as

described in section III.C.7 of this final

rule, and beneficiary outcomes under

the Model. More specifically, we

proposed to track utilization of certain

types of treatments, beneficiary

hospitalization and emergency

department use, and fractionation

(numbers of treatments) against

historical treatment patterns for each

participant. In the proposed rule, we

discussed our belief that this type of

monitoring was important because as

RO participants transition from

receiving FFS payment to receiving new

(episode-based) payment, and we noted

that we want to ensure to the greatest

extent possible that the Model is

effective and that RO Model

beneficiaries continue to receive high-

quality and medically appropriate care.

Additionally, we explained in the

proposed rule that we may employ

longer-term analytic strategies to

confirm our ongoing analyses and detect

subtler or hard-to-determine changes in

care delivery and beneficiary outcomes.

Some determinations of beneficiary

outcomes or changes in treatment

delivery patterns may not be able to be

built into ongoing claims analytic efforts

and may require longer-term study. This

work may involve pairing clinical data

with claims data to identify specific

issues by cancer type.

The following is a summary of the

public comments received on this

proposal and our responses to the

comments:

Comment: A commenter expressed

support of the proposed monitoring

activities. Another commenter

expressed support of our proposal to

monitor longer-term analytic strategies

to confirm ongoing analyses.

Response: We thank these

commenters for their support.

Comment: A commenter requested

that CMS clearly define the monitoring

activities and the effect the RO Model

will have on beneficiaries. This

commenter has also requested details on

how CMS will ensure patient

stakeholder groups have access to

resulting data as well as how patient

advocate groups will be able to provide

input on what is and is not working

from the patient perspective.

Response: We believe that the RO

Model will improve quality of care for

RO beneficiaries receiving treatment

from RO participants, and we believe

that the monitoring activities as

described in section III.C.14 will help us

to understand whether there are any

unintended consequences. As it relates

to beneficiaries, we will closely monitor

beneficiary and patient complaints and

survey responses to determine what is

or is not working during the test of the

Model and to mitigate unforeseen

adverse impact on RO beneficiaries.

With respect to patient stakeholder

groups having access to resulting data,

while we did not propose to share

specific data from our monitoring and

oversight of the Model with patient

stakeholder groups, we will consider

that in future rulemaking. Additionally,

as discussed in section III.C.13.b, we

finalized our proposal to not restrict RO

participants’ ability to publicly release

patient de-identified information that

references the RO participant’s

participation in the RO Model. Thus,

RO participants may share with patient

stakeholder groups the information CMS

shares with the RO participants based

on monitoring and oversight of their

performance. Therefore, patient

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stakeholder groups may have access to

such resulting data that is released by

RO participants. We welcome input

from patient advocate groups on the

patient perspective on the RO Model at

any time.

We note that an Annual Evaluation

Report will be publicly released for each

year of the RO Model, as is required for

all Innovation Center models by section

1115A(b)(4). The independent

evaluation will rigorously assess the

impact of the RO Model on quality,

expenditures, utilization, RO

beneficiary and RO participant

experiences with RT service use, and

quality of care, as well as on costs to RO

beneficiaries and to Medicare. Detailed

methodologies and data sources used to

create these estimates will be included

in each Annual Evaluation Report

(additional information on the

Evaluation can be found in section

III.C.16).

Comment: A commenter expressed

concern that this Model will cause a

shift in treatment to modalities that treat

tumors with large doses of radiation

over a shorter time frame, and that

providers and suppliers will rapidly

transition to stereotactic radiosurgery

(SRS) and stereotactic body radiation

therapy (SBRT) without having the

proper staff or necessary equipment to

safely perform such procedures. This

commenter has requested that CMS

implement a program to track

beneficiary outcomes both in terms of

survival and toxicity to avoid

unintended consequences. The

commenter recommended that

providers and suppliers track and report

this outcomes data via a Medicare

Certified Quality Clinical Data Registry

(QCDR) like the Registry for

Performance and Clinical Outcomes in

Radiology (RPCR).

Response: We thank the commenter

for this comment and appreciate their

concern. CMS will take these

suggestions into consideration. At this

time, we believe that the Model is

designed in a way that we will be able

to adequately monitor RO beneficiary

outcomes and treatment delivery

patterns to assess whether there are

unintended consequences without

needing to use a Medicare QCDR. Please

see section III.C.14.b for more

information relating to the monitoring

activities.

Comment: A commenter requested

clarification regarding onsite quality

and clinical element data audits.

Response: To clarify, we may utilize

onsite audits, conducted by a contractor,

of quality and clinical data elements to

monitor RO Participants for model

compliance. Audits of quality and

clinical data may also be used to ensure

that the Model is effective and that RO

Model beneficiaries continue receiving

high-quality and medically appropriate

care. Site visits may be used to better

understand how RO participants

manage services, use evidence-based

care, and practice patient-centered care.

Site visit activities may include, but are

not limited to, interviewing RO

participant(s) and staff, reviewing

records, and observing treatments.

a. Monitoring for Utilization/Costs and

Quality of Care

We proposed to monitor RO

participants for compliance with RO

Model requirements. We anticipated

monitoring to detect possible attempts

to manipulate the system through

patient recruitment and billing

practices. The pricing methodology

requires certain assumptions about

patient characteristics, such as

diagnoses, age, and stage of disease,

based on the historical case mix of the

individual participants. It also assigns

payments by cancer type. Because of

these features, participants could

attempt to manipulate patient

recruitment in order to maximize

revenue (for example, cherry-picking,

lemon-dropping, or shifting patients to

a site of service for which the

participant bills Medicare that is not in

a CBSA randomly selected for

participation). As explained in the

proposed rule, we anticipated

monitoring compliance with RO Model-

specific billing guidelines and

adherence to current LCDs, which

provide information about the only

reasonable and necessary conditions of

coverage allowed. We also intended to

monitor patient and provider and

supplier characteristics, such as

variations in size, profit status, and

episode utilization patterns, over time to

detect changes that might suggest

attempts at such manipulation.

To allow us to conduct this

monitoring, we proposed that RO

participants would report data on

program activities and beneficiaries

consistent with the data collection

policies in section III.C.8 of this rule.

These data would be analyzed by CMS

or our designee for quality, consistency,

and completeness; further information

on this analysis would be provided to

RO participants in a time and manner

specified by CMS prior to collection of

this data. We would use existing

authority to audit claims and services,

to use the Quality Improvement

Organization (QIO) to assess for quality

issues, to investigate allegations of

patient harm, and to monitor the impact

of the RO Model quality metrics. We

noted in the proposed rule that we may

monitor participants to detect issues

with beneficiary experience of care,

access to care, or quality of care. We

also indicated that we may monitor the

Medicare claims system to identify

potentially adverse changes in referral,

practice, or treatment delivery patterns.

We solicited public comment on our

proposal. The following is a summary of

the public comments received on this

proposal and our responses to the

comments:

Comment: A commenter indicated

that discriminatory practices and

attempts to game the system must be

prevented and eliminated.

Response: As we discussed in the

proposed rule and this final rule, we are

aware that RO participants might

manipulate patient recruitment to

maximize revenue. For that reason, we

explained that we would be monitoring

compliance with RO Model-specific

billing guidelines and adherence to

LCDs, as well as our intention to

monitor patient and provider and

supplier characteristics over time to

detect changes that might suggest

attempts at such manipulation. We

believe that the monitoring and

compliance requirements will mitigate

gaming and discriminatory practices by

RO participants.

Comment: A commenter appreciated

the decision that CMS share the planned

clinical data elements and reporting

standards with EHR vendors and

radiation oncology specialty societies,

and requested that CMS also share this

information with oncology clinical

pathways developers.

Response: We plan to share the

clinical data elements and the reporting

process publicly via the RO Model

website (see sections III.C.8 and III.C.8.e

of this final rule). We appreciate the

suggestion specific to pathway

developers and will take this into

consideration.

Comment: Two commenters asked

CMS to provide specifics on how it will

monitor and intervene on potential

unintended consequences of the Model.

Response: As we previously stated,

data submitted by RO participants will

be analyzed by CMS or our designee for

quality, consistency, and completeness.

Further information on this analysis

will be provided to RO participants in

a time and manner specified by CMS

prior to collection of this data. We will

use existing authority to audit claims

and services, to use the QIO to assess for

quality issues, to use our authority to

investigate allegations of patient harm,

and to monitor the impact of the RO

Model quality metrics. We may monitor

RO participants to detect issues with

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beneficiary experience of care, access to

care, or quality of care. We may monitor

the Medicare claims system to identify

potentially adverse changes in referral,

practice, or treatment delivery patterns.

Should unforeseen consequences arise

during the Model test, we will take

appropriate measures, including those

outlined in § 512.160 or modifying the

regulatory requirements for compliance,

to mitigate such consequences.

b. Monitoring for Model Compliance

We had proposed to require all

participants to annually attest in a form

and manner specified by CMS that they

will use CEHRT throughout such PY in

a manner sufficient to meet the

requirements as set forth in 42 CFR

414.1415(a)(1)(i), and as stated in the

proposed rule at 84 FR 34522 through

34524. In addition, we proposed that

each Technical participant and Dual

participant be required to attest

annually that it actively participates in

a radiation oncology-specific AHRQ-

listed patient safety organization (PSO).

This attestation would be required to

ensure compliance with this RO Model

requirement. CMS may change these

attestation intervals throughout the

Model upon advanced written notice to

the RO participants. We proposed to

codify these RO Model requirements at

§ 512.220(a)(3). We noted that CMS may

monitor the accuracy of such

attestations and that false attestations

will be punishable under applicable

federal law, including but not limited to

the remedial action set forth in

§ 512.160(b).

In addition, we proposed to monitor

for compliance with the other RO Model

requirements listed in this section

through site visits and medical record

audits conducted in accordance with

§ 512.150, and as stated in the proposed

rule at 84 FR 34581 through 34582. We

proposed to codify at § 512.220(a)(2) our

requirement that all Professional

participants and Dual participants

document in the medical record that the

participant: (i) Has discussed goals of

care with each RO beneficiary before

initiating treatment and communicated

to the RO beneficiary whether the

treatment intent is curative or palliative;

(ii) adheres to nationally recognized,

evidence-based clinical treatment

guidelines when appropriate in treating

RO beneficiaries, or documents in the

medical record the rationale for the

departure from these guidelines; (iii)

assesses the RO beneficiaries’ tumor,

node, and metastasis (TNM) cancer

stage for the CMS-specified cancer

diagnoses; (iv) assesses the RO

beneficiary’s performance status as a

quantitative measure determined by the

physician; (v) sends a treatment

summary to each RO beneficiary’s

referring physician within three months

of the end of treatment to coordinate

care; (vi) discusses with each RO

beneficiary prior to treatment delivery

his or her inclusion in, and cost-sharing

responsibilities under, the RO Model;

and (vii) performs and documents Peer

Review (audit and feedback on

treatment plans) for 50 percent of new

patients in PY1, for 55 percent of new

patients in PY2, for 60 percent of new

patients in PY3, for 65 percent of new

patients in PY4, and for 70 percent of

new patients in PY5 preferably before

starting treatment, but in all cases before

25 percent of the total prescribed dose

has been delivered and within 2 weeks

of the start of treatment, as stated in the

proposed rule at 84 FR 34585 through

34586.

The following is a summary of the

public comments received on this

proposal and our responses to these

comments:

Comment: A commenter expressed

support of the required medical record

documentation regarding the goals of

care, the treatment intent, the

beneficiary’s inclusion in the RO Model,

and the cost-sharing responsibilities.

This commenter urged CMS to develop

and consumer test language for

providers and suppliers to use in

discussing these complex issues.

Response: We appreciate the

commenter’s support and suggestion.

We will consider developing guidance

materials that RO participants may use

to ensure adherence to the Model

requirements. Should such materials be

developed, the RO participants will be

notified and those materials will be

made available on the RO Model

website at https://innovation.cms.gov/

initiatives/radiation-oncology-model/.

Comment: A commenter expressed

concern that the Innovation Center

would not have the resources to

effectively monitor the number of

proposed RO participants.

Response: We will be utilizing a

contractor to effectively monitor the

activities of the RO participants.

Comment: A couple of commenters

expressed frustration with the EHR data

reporting requirements and asserted that

these requirements would be

administratively burdensome for RO

participants.

Response: We appreciate the

commenters’ concerns; however, we

disagree with these commenters’

argument that such reporting

requirements are excessively

burdensome. Many of these

requirements are already being captured

by RT providers and RT suppliers prior

to the implementation of this Model as

part of the Quality Payment Program,

accreditation, licensing, and delivery of

high-quality care. Furthermore, these

seven medical record documentations

are critical for high-quality care and

necessary for evaluation of this Model.

Therefore, we are finalizing this policy

as proposed.

Comment: A couple of commenters

requested that the EHR/medical record

documentation requirements be

eliminated from the Model

requirements. These commenters

indicated that these data elements are

not always captured in discrete fields.

Response: We will not be eliminating

these documentation requirements from

the Model as they are a necessary

component of the Model. As stated

earlier in this rule’s comments and

responses, we believe that delaying the

start date for the Model, and therefore

the collection of clinical data elements,

until January 1, 2021, and publishing

the final rule several months before the

Model performance period, will allow

participants time to become comfortable

with other aspects of the Model and

develop best practices to facilitate their

data collection and work with EHR

vendors to seek additional EHR support.

As such, we are finalizing the

requirement that RO participants

document the seven medical record

documentations set forth in section

III.C.14.b with the modification that this

requirement begin in PY1 instead of at

the start of the Model.

Comment: A commenter expressed

support for the PSO participation

requirement.

Response: We thank the commenter

for this support.

Comment: A few commenters were

concerned with the proposed

requirement of attesting annually to

active participation in a radiation

oncology-specific PSO. These

commenters requested clarity on the

PSO requirement and asked whether

participation in any PSO could meet the

compliance requirement as one of these

commenters noted that there are fees

associated with joining a PSO. There

were also concerns with the time and

resources it takes to join a PSO.

Response: After reviewing these

comments, we are finalizing this

proposed policy with modification. RO

participants will annually attest to

whether they actively participate in a

patient safety organization, but we will

no longer require that the participant be

in a radiation oncology-specific PSO.

Instead, RO participants will be in

compliance so long as they annually

attest to active participation with any

PSO. We believe that this modification

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will alleviate the commenter’s concern

of paying additional fees to participate

with a radiation oncology-specific PSO

when an RO participant is already

participating in a non-radiation

oncology-specific PSO. We are also

removing the text ‘‘PSO provider service

agreement’’ and replacing it with ‘‘for

example, by maintaining a contractual

or similar relationship with a PSO for

the receipt and review of patient safety

work product’’ for alignment with the

terminology used by AHRQ.

Additionally, the PSO requirement will

be effective beginning in PY1. For those

RO participants that are not in a PSO,

they can use the time period from the

publication of this final rule until the

attestation period near the end of PY1

to initiate participation with a PSO.

Comment: A commenter

recommended that we collect data on

participation in the Radiation Oncology

Incident Learning System (RO–ILS).

Response: We thank this commenter

for the suggestion. At this time, we will

not be modifying our proposed

monitoring policies to include data

collection on participation in the RO–

ILS because we believe that our

monitoring policies as finalized are

appropriate for the monitoring and

evaluation of this Model.

Comment: A commenter thanked

CMS for recognizing the importance of

nationally recognized, evidence-based

clinical practice guidelines. This

commenter has noted that CMS can

determine guideline adherence through

the use of various HIT systems and real-

time clinical decision support

applications which can be integrated

into electronic health record (EHR)

systems. A couple of commenters

requested clarification on the

requirement to discuss goals of care

with each Medicare beneficiary as the

treatment intent is not always provided

as a data field in oncologist’s

information systems.

Response: We appreciate the

commenter bringing HIT systems and

real-time clinical decision support

applications to our attention, and we

note that we do not believe that these

systems are necessary at this point. We

also appreciate the commenters’

requests for clarification on the

requirement to discuss goals of care

with each RO beneficiary. To add

clarity, we are committed to supporting

the efforts of RO participants to work

with their EHR vendors to facilitate this

change to capture the seven activities

required under the Model. We believe

that publishing the final rule several

months before the Model performance

period will allow RO participants and

EHR vendors to prepare for

participation in the Model. Therefore,

we are finalizing our monitoring

policies related to the use of nationally

recognized, evidence-based clinical

practice guidelines as proposed.

Comment: A commenter requested

that CMS provide a list of approved,

nationally recognized, evidence-based

clinical treatment guidelines to RO

participants.

Response: We do not believe that it is

necessary for us to provide such a list

as radiation oncologists have the

knowledge and ability to determine

what nationally recognized, evidence-

based clinical treatment guidelines are

applicable to their patient population.

Comment: A commenter requested

clarification on how clinical decision

support will be assessed and

documented if it is not common in

radiation oncology software.

Specifically, this commenter expressed

concerns with documenting adherence

to nationally recognized, evidence-

based treatment guidelines or rationale

for departure from those guidelines.

Response: We believe that publishing

the final rule more than 60 days prior

to the start date will provide RO

participants with time to facilitate

medical record software updates to

include appropriate fields to comply

with the data submission and

monitoring requirements of the Model.

Comment: A commenter supported

the qualified peer review requirement as

being consistent with the CMS ‘‘Patients

over Paperwork’’ initiative.

Response: We thank the commenter

for this support.

Comment: Some commenters

expressed concerns with the peer

review requirements as being onerous

for RO participants, particularly single

practitioners and those practicing in

underserved areas (that is, rural and

some urban settings). These commenters

asked for either the elimination of or a

phased-in approach for the peer review

requirements. A commenter requested

that there be an exemption to those

small/rural practices that show good-

faith in trying to comply.

Response: We understand

commenters’ concerns with the

proposed policy on peer review as this

currently may not be a common practice

among certain RT providers and RT

suppliers, but this is common practice

for larger RT providers and RT suppliers

and those seeking accreditation. After

considering comments received, we are

finalizing with modification the peer

review requirement. The peer review

requirements will be finalized as

proposed with reporting to begin in

PY1. A good faith exemption for those

small/rural practices would require

future rulemaking with a public

comment period. We will take your

request for an exemption for small/rural

practices under consideration and

proceed with future rulemaking should

it become necessary during the test of

this Model. However, we believe that

the use of CBSAs as the geographic unit

of selection minimizes the number of

rural providers and suppliers that will

be selected in the Model. We have also

finalized an option for low-volume RT

providers and RT suppliers to opt out of

the Model as described in section

III.C.3.c of this final rule and codified at

§ 512.210(c).

Comment: A commenter has inquired

how TNM staging will be used by CMS,

and specifically asked whether it would

be used in the AJCC staging system.

Additionally, this commenter has

requested clarification on how CMS will

handle cancer types that do not have a

TNM staging system.

Response: We appreciate the

importance of staging in the diagnosis,

prognosis, and treatment of cancer. The

four quality measures for the RO Model

beginning in PY1 and continuing

thereafter, as described in section

III.C.8.b of this rule, do not rely on

staging data. As we review which

clinical data elements are appropriate

for inclusion in the RO Model, we will

consider staging data if these elements

are determined to meet RO Model goals

of eliminating unnecessary or low-value

care, developing accurate episode

prices, or developing new radiation

oncology-specific quality measures.

After considering public comments,

we are finalizing our proposed policies

on monitoring for Model compliance

with the modifications, as previously

discussed, related to active participation

in a PSO (the PSO requirement will be

effective beginning in PY1, but RO

participants are not required to be in a

radiation oncology-specific PSO) and

peer review (will begin in PY1). We are

codifying these policies at §§ 512.150

and 512.220.

c. Performance Feedback

We proposed to provide detailed and

actionable information regarding RO

participant performance related to the

RO Model. We stated in the proposed

rule that we intend to leverage the

clinical data to be collected through the

RO Model secure data portal, quality

measure results reported by RO

participants, claims data, and

compliance monitoring data to provide

information to participants on their

adherence to evidence-based practice

guidelines, quality and patient

experience measures, and other quality

initiatives. We discussed our belief that

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these reports can drive important

conversations and support quality

improvement progress. The design of

and frequency with which these reports

would be provided to participants

would be determined in conjunction

with the RO Model implementation and

monitoring contractor.

We solicited public comment on our

proposal. We received no comments on

this proposal and therefore are

finalizing this policy as proposed.

d. Remedial Action for Non-Compliance

We refer readers to section II.I of this

final rule for our proposals regarding

remedial action.

15. Beneficiary Protections

We proposed to require Professional

participants and Dual participants to

notify RO beneficiaries that the RO

participant was participating in this RO

Model by providing written notice to

each RO beneficiary during the RO

beneficiary’s initial treatment planning

session. In the proposed rule, we noted

that we intended to provide a

notification template that RO

participants may personalize with their

contact information and logo, which

would explain that the RO participant is

participating in the RO Model and

would include information regarding

RO beneficiary cost-sharing

responsibilities and an RO beneficiary’s

right to refuse having his or her data

shared under § 512.225(a)(2).

Beneficiaries who do not wish to have

their claims data shared for care

coordination and quality improvement

purposes under the Model would be

able to notify their respective RO

participant. In such cases, the RO

participant must notify in writing CMS

within 30 days of when the RO

beneficiary notifies the RO participant.

We discussed in our proposed rule

our belief that it will be important that

RO participants provide RO

beneficiaries with a standardized, CMS-

developed RO beneficiary notice in

order to limit the potential for fraud and

abuse, including patient steering. The

required RO Model beneficiary notice

would be exempt from the provision at

§ 512.120(c)(2), and discussed in section

II.D.3 of this rule, that requires a

standard disclaimer statement on all

descriptive model materials. In the

proposed rule, we discussed our belief

that the disclaimer statement should not

apply to the RO Model beneficiary

notice, because RO participants would

be required to use standardized

language developed by CMS. We

proposed for these policies to be in

§ 512.225(c).

The beneficiary notice would include,

along with other pertinent information,

how to contact CMS with questions.

Specifically, if beneficiaries have any

questions or concern with their

physicians, we stated in the proposed

rule that we encouraged them to

telephonically contact the CMS using 1–

800–MEDICARE, or their local

Beneficiary and Family Centered Care-

Quality Improvement Organizations

(BFCC–QIOs) (local BFCC–QIO contact

information can be located here: https://

www.qioprogram.org/locate-your-qio).

We solicited public comment on the

beneficiary protections. In this section

of this rule, we summarize and respond

to the public comments received on this

proposal.

Comment: A commenter requested

that CMS make a concerted public effort

toward educating all beneficiaries who

may be impacted by the Model about

the unique coinsurance requirements

inherent to the Model’s design.

Response: As required by

§ 512.225(a)(3) of this final rule, RO

participants must notify all RO

beneficiaries to whom they furnish

included RT services regarding their

cost-sharing responsibilities. Such

notice will be furnished through the

beneficiary notification letter provided

by the RO participant during the initial

treatment planning session and may be

discussed prior in accordance with

§ 512.225(a)–(c) of this final rule. The

beneficiary notification requirement

will begin in PY1.

Comment: We received some

comments on the beneficiary

notification letter. These commenters

requested that we eliminate the

requirement for the RO participant to

notify the beneficiaries as such

notification is administratively

burdensome. A commenter also

expressed concerns with the timing of

the beneficiary notification letter. A

commenter requested that CMS provide

this notice within the Medicare & You

annual publication as well as on the

Medicare.gov website. Another

commenter requested that if we finalize

the notification letter as proposed then

to draft the notice with simple language

at less than a 6th grade reading level.

Response: After considering

comments, we are finalizing as

proposed that we will draft the

beneficiary notification template that

RO participants may personalize with

their contact information and logo,

which will explain that the RO

participant is participating in the RO

Model and will include information

regarding RO beneficiary cost-sharing

responsibilities and an RO beneficiary’s

right to refuse having his or her data

shared under § 512.225(a)(2). We believe

that having a template with only

minimal modifications (RO participant

contact information, logo, and date) will

not lead to potentially inaccurate

information being delivered to

beneficiaries. Further, after considering

comments regarding administrative

burden, we are finalizing as proposed

that RO participants provide this

written notice to each beneficiary

during the initial treatment planning

session. We do not believe that a written

notice that has minimal modification by

the RO participant is an administrative

burden on RO participants.

Additionally, we believe that this notice

serves an important function to ensure

that beneficiaries are aware of the Model

and how they may be impacted by it, as

well as allowing them to choose a non-

participant health care provider should

they wish.

We appreciate the comment about

having additional sources for the

beneficiary notification such as the

Medicare.gov website, and we will

consider ways to provide RO

beneficiaries with details about the RO

Model. We recognize that the Medicare

& You publication has included

language about model tests in the past.

However, that publication cannot

provide beneficiaries with the specific

details and parameters for every model

test. Therefore, we will consider other

ways to provide RO beneficiaries with

details about the RO Model.

Additionally, as we draft the beneficiary

notification letter, we will ensure that

the language used is simple to provide

beneficiaries with the necessary

information to convey that they are

receiving treatment from an RO

participant.

Comment: A commenter supported

the proposal that CMS draft the

beneficiary notification letter template.

Response: We appreciate this

commenter’s support.

Comment: A commenter noted that

the RO Model references patient

navigators in its discussion of the

Oncology Care Model, but there is an

absence of provisions calling for the

inclusion of such within the RO Model.

This commenter believes that the

episodic nature of radiation oncology

coupled with the potential number of

health care provider touchpoints for

patients in the RO Model augments the

importance of patient navigators in

ensuring an effective continuum of care

for patients receiving RT. This

commenter voiced a strong

recommendation to include a prominent

role for patient navigators in the RO

Model.

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80

Difference-in-difference is a statistical

technique that compares the intervention (in this

case, the RO participant) and comparison (in this

case, the Comparison group) groups during the

period before the RO Model goes into effect (pre-

intervention) and the period during and after the

RO Model goes into effect (post-intervention) and

uses the difference between intervention and

comparison in both periods to estimate the effect of

the intervention. A comparison group that is similar

to the intervention group is used to help measure

the size of the intervention effect by providing a

comparison (or ‘counterfactual’) to what would

have happened to the intervention group had the

intervention not occurred. This helps the evaluation

distinguish between changes occurring for reasons

unrelated to the Model when estimating the

changes that occurred because of the Model.

Response: We thank this commenter

for highlighting the important role

patient navigators have. To the extent

that an RO participant wishes to include

patient navigators in the care team, this

will be permissible, but at this time, we

will not be formally incorporating a

requirement that RO participants

include patient navigators in the care of

RO beneficiaries. We do not believe that

there is a demonstrated need for patient

navigation at this time in radiation

oncology, particularly as many radiation

oncology patients who also receive

chemotherapy typically receive care

management services from their medical

oncologist. However, after the Model is

implemented, we will assess the need

for patient navigators and, if needed,

make modifications to the RO Model

through future rulemaking.

Comment: A commenter has

expressed concerns that the proposed

RO Model will create a burden on

patients, such as increasing the need for

those patients to drive farther to obtain

the same quality of care.

Response: We do not agree with the

commenter’s assertion that the Model

will increase the need for beneficiaries

to drive farther. We believe that

providing site-neutral, more predictable

or foreseeable payments to RO

participants will help patients because

we anticipate that the Model will lead

to lower costs overall while maintaining

or improving quality of care. The RO

beneficiaries receiving care from RO

participants will maintain the same

protections as those beneficiaries

outside of the Model, including the right

to choose their health care providers.

After considering public comments,

we are finalizing our proposed

provisions on beneficiary protections

with the modification of non-

substantive changes to the proposed

provisions at § 512.225 in this final rule

to improve readability. The beneficiary

notification requirement will begin in

PY1. Specifically, we are codifying the

beneficiary notification requirement at

§ 512.225. Furthermore, we are

codifying at § 512.225(a)(1) that starting

in PY1, Professional participants and

Dual participants must notify each RO

beneficiary to whom it furnishes

included RT services that the RO

participant is participating in the RO

Model. We are codifying at

§ 512.225(a)(2) that starting in PY1,

Professional participants and Dual

participants must notify each RO

beneficiary to whom it furnishes

included RT services that the RO

beneficiary has the opportunity to

decline claims data sharing for care

coordination and quality improvement

purposes; and that if an RO beneficiary

declines claims data sharing for care

coordination and quality improvement

purposes, then the RO participant must

inform CMS within 30 days of receiving

notification from the RO beneficiary that

the beneficiary is declining to have their

claims data shared in that manner. We

are codifying at § 512.225(a)(3) that

starting in PY1, Professional

participants and Dual participants must

notify each RO beneficiary to whom it

furnishes included RT services of the

RO beneficiary’s cost-sharing

responsibilities.

16. Evaluation

As stated in the proposed rule, an

evaluation of the RO Model would be

required to be conducted in accordance

with section 1115A(b)(4) of the Act,

which requires the Secretary to evaluate

each model tested by the Innovation

Center (84 FR 34533).

As stated in the proposed rule our

evaluation would focus primarily on the

question: Do the changes that comprise

the RO Model result in improved

quality or reduced spending for those

beneficiaries receiving RT services

during the model period? Conversely, if

the RO Model has no effect we would

expect that Medicare spending per

episode or quality measures for

beneficiaries associated with those

episodes do not differ between RT

providers and suppliers in CBSAs

selected as Participants in the Model

compared to those in the comparison

group. We will also analyze other data

to understand how the Model is

successful in achieving improved

quality and reduced expenditures.

These analyses may include changes in

RT utilization patterns (including the

number of fractions and types of RT),

RT costs for Medicare FFS beneficiaries

in the RO Model (including Medicare-

Medicaid dually eligible beneficiaries),

changes in utilization and costs with

other services that may be affected as a

result of the RO Model (such as

emergency department services,

imaging, prescription drugs, and

inpatient hospital care), performance on

clinical care process measures (such as

adhering to evidence-based guidelines),

patient experience of care, and provider

and supplier experience of care. The

evaluation would inform the Secretary

and policymakers about the impact of

the model relative to the current

Medicare fee structure for RT services,

assessing the impacts on beneficiaries,

health care providers, markets, and the

Medicare program. The evaluation

would take into account other models

and any changes in Medicare payment

policy during the Model performance

period (84 FR 34533).

In addition to assessing the impact of

the Model in achieving improved

quality and reduced Medicare

expenditures, we stated in the proposed

rule that the evaluation is likely to

address secondary questions to provide

context for answers to the primary

question. As stated in the proposed rule,

these questions include (but will not be

limited to): Did utilization patterns with

respect to modality or number of

fractions per episode change under the

model? If the Model results in lower

Medicare expenditures, what aspects of

the Model reduced spending and were

those changes different across

subgroups of beneficiaries or related to

observable geographic or socio-

economic factors? Did any observed

differences in concordance with

evidence-based guidelines vary by

cancer type or by treatment modality?

Did patient experience of care improve?

Did the Model affect access to RT or

other services overall or for vulnerable

populations? Were there design and

implementation issues with the RO

Model? What changes did participating

radiation oncologists and other RO care

team members experience under the

Model? Did any unintended

consequences of the Model emerge? Was

there any observable overlap between

the RO Model and other Innovation

Center models or CMS/non-CMS

initiatives and how could they impact

the evaluation findings (84 FR 34533)?

As stated in the proposed rule, CMS

anticipated that the evaluation will

include a difference-in-differences

80

or

similar analytic approach to estimate

model effects (84 FR 34533). Where it is

available, baseline data for the

participants would be obtained for at

least one year prior to model

implementation. Data would also be

collected during model implementation

for both participant and comparison

groups. The evaluation would control

for patient differences and other factors

that directly and indirectly affect the RO

Model impact estimate, including

demographics, comorbidities, program

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eligibility, and other factors. Data to

control for patient differences would be

obtained primarily from claims and

patient surveys.

The evaluation would use a

multilevel approach. We would conduct

analyses at the CBSA-level, participant-

level, and the beneficiary-level. The

CBSAs and RT providers and RT

suppliers contained within CBSA

geographic areas selected for

participation, as discussed in section

III.C.3.d, will have been randomly

assigned for the duration of the

evaluation, allowing us to use

scientifically rigorous methods for

evaluating the effect of the Model.

We referred readers to section II.E of

the proposed rule for our proposed

policy on RO participant cooperation

with the RO Model’s evaluation and

monitoring policies. We solicited public

comment on our proposed approach

related to the evaluation of the RO

Model. In this section of the rule, we

summarize and respond to the public

comments received on this proposal.

Comment: A few commenters

expressed concern about possible

unforeseen circumstances and

unintended consequences as a result of

the Model. A couple of these

commenters urged us to evaluate model

effects on quality of care and patient

access and were concerned the RO

Model may impact these outcomes

negatively. A commenter suggested we

did not have sufficient evidence to

proceed with the Model. A different

commenter offered support for the

proposed evaluation and highlighted the

importance of patient experience

measures with regards to cancer care.

Response: We appreciate and share

the commenters’ interest in outcomes

related to the Model. In designing the

Model and planning the Model’s

evaluation, CMS considers access to

care and quality of care to be outcomes

that must be examined. We have a

monitoring plan for tracking, and an

evaluation plan to assess, the Model’s

impact on these outcomes. We believe

collecting and analyzing measures of

quality and access to care will help

assess the Model’s impact on

beneficiaries’ outcomes and experience

during RO episodes. We have detailed

the methodology used to create the

episodes, set payment rates, and the

random selection of Participants in the

NPRM, using national FFS Medicare

claims. We are finalizing the evaluation

and monitoring methods as proposed.

Comment: A commenter encouraged

the agency to make it a priority to

minimize provider and supplier burden

resulting from this Model.

Response: We agree that burden on

RO participants should be minimized to

the extent possible, and we kept this in

mind in the design of the RO Model,

including the evaluation. We included

features in the Model such as RO

participants continuing to submit claims

through the existing FFS claims process,

and identifying RO participants by ZIP

Code (rather than CBSA) to limit

burden. We have been mindful to

minimize RO participant burden in the

design of the evaluation (such as relying

on secondary data sources such as FFS

claims), but there will be some

additional data collection necessary to

fully evaluate the Model and conduct all

impact estimates.

Comment: A couple of commenters

expressed concern that the Model as

proposed may lack sufficient data to

evaluate the effects of including PBT

centers.

Response: We focused the evaluation

design on the impacts of the Model at

the population level for overall

spending and quality across all RT

services furnished and not the effects on

one potential modality compared to

another. While some future sub-analyses

may include differences in costs and

quality by modality, we will make no

impact estimates on cost nor quality

where we do not have suitable sample

size of RO participants or RO episodes,

understanding that any differences we

may observe are observational and not

causative.

After considering public comments,

we are finalizing our proposals on

evaluation as proposed.

17. Termination of the RO Model

In the proposed rule, we stated that

the general provisions relating to

termination of the Model by CMS in

section II.J of the proposed rule would

apply to the RO Model. We received no

comments on the termination of the RO

Model. As explained in section II.J. of

this final rule, we are finalizing our

proposal to apply § 512.165 to the RO

Model.

18. Potential Overlap With Other

Models Tested Under Section 1115A

Authority and CMS Programs

a. Overview

We stated in the proposed rule (84 FR

34533 through 34535) that the RO

Model would leverage existing

Innovation Center work and initiatives,

broadening that experience to RT

providers and RT suppliers, a

professional population that is not

currently the focus of other models

tested by the Innovation Center. In the

proposed rule, we discussed our belief

that the RO Model would be compatible

with other CMS models and programs

that also provide health care entities

with opportunities to improve care and

reduce spending. We expected that

there would be situations where a

Medicare beneficiary in an RO Model

episode would also be assigned to, or

engage with, another payment model

being tested by CMS. Overlap could also

occur among providers and suppliers at

the individual or organization level; for

example, a physician or organization

could be participating in multiple

models tested by the Innovation Center.

We stated that we believe that the RO

Model would be compatible with other

CMS initiatives that provide

opportunities to improve care and

reduce spending, especially population-

based models, though we recognize the

design of some models being tested by

the Innovation Center under its section

1115A authority could create

unforeseen challenges at the

organization, clinician, or beneficiary

level. We stated in the proposed rule

that we do not envision that the

prospective episode payments made

under the RO Model would need to be

adjusted to reflect payments made

under any of the existing models being

tested under 1115A of the Act or the

Shared Savings Program under section

1899 of the Act. We stated in the

proposed rule that if, in the future, we

determined that such adjustments are

necessary, we would propose overlap

policies for the RO Model through

notice and comment rulemaking. In this

section of this rule, we summarize and

respond to the public comments

received on the proposal in section

III.C.18.a.

Comment: A few commenters

generally agreed with CMS’ approach

not to propose to adjust the RO Model’s

prospective episode payments to reflect

payments made under any of the

existing models being tested under

section 1115A of the Act or under the

Shared Savings Program. They also

agreed that other models and programs

should be responsible for factoring RO

Model payments into their

reconciliation calculations.

Response: We appreciate the

commenters’ support.

Comment: Some commenters

requested more information and clearer

guidance from CMS on overlap between

the RO Model and other CMS

initiatives, including all models tested

under section 1115A, the Shared

Savings Program, and the Quality

Payment Program. One of these

commenters stated that without details

of how CMS proposes to resolve

overlaps, providers and suppliers are

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81

The statutory limitation under section

1899(b)(4) of the Social Security Act, only applies

to providers and suppliers that participate in

Shared Savings Program ACOs. As a policy matter,

CMS has elected to impose a similar restriction on

some participants in other ACO initiatives through

the participation agreements for the various models.

unable to accurately forecast how the

models may impact future revenues,

and they requested that, in the future,

CMS needs to provide more specific

guidance during the proposal phase, so

stakeholders can comment on any

potential issues prior to

implementation. Another commenter

encouraged CMS to provide additional

clarity on payment adjustment changes

and overlap between the RO model and

Quality Payment Program, and stated

that such clarity will greatly help them

develop forecasting models that can in

turn help better support their patient

care operations. Another commenter

stated that the lack of clarity on model

overlap continues to be an issue, and

that they have long encouraged CMS to

be more deliberate and specific in

providing Innovation Center model

participants with clear guidance on how

scenarios in which Innovation Center

models overlap will be treated. This

commenter further stated that such

clarity is not only beneficial for those

providers and suppliers that will be

required to participate under the RO

Model but, importantly, for those

providers and suppliers participating in

the other models identified by CMS in

the proposed rule. Another commenter

agreed with CMS’ acknowledgement

that accounting resolution will be

needed for overlap between the RO

Model and other initiatives, but they

believe that it is not clear how this

accounting resolution would be

handled, and specifically requested that

CMS clarify how the overlap of the RO

Model with other models and programs

would be operationalized through

program accounting, so that providers

and suppliers that participate in

multiple initiatives have a clear

understanding of the process. Another

commenter requested specific

clarification on how CMS will resolve

the separation of radiation oncologists

from overlapping initiatives, for

example, the MIPS adjustment earned in

previous years and OCM inclusion up to

the start date of the RO Model.

Response: We appreciate the

commenters’ comments, feedback, and

suggestions regarding overlap between

the RO Model and other CMS

initiatives. We will take all of these

suggestions into consideration as we

implement the RO Model. As stated in

the proposed rule, if, in the future, we

determine that RO Model payment

adjustments are necessary to reflect

payments made under any of the

existing models being tested under

section 1115A of the Act or the Shared

Savings Program under section 1899 of

the Act, we will propose overlap

policies for the RO Model through

notice and comment rulemaking.

Further, we are not including further

explanation in this final rule regarding

overlap policies for the RO Model,

because we are not putting in place any

overlap accounting policies for this

Model at this time. As explained

previously, the financial methodology

and accounting policies under the

applicable model tested under section

1115A of the Act or the Shared Savings

Program will govern the way in which

RO payments are factored into

reconciliation calculations under that

initiative.

Comment: A few commenters

expressed concern that CMS does not

have a clear overlap policy that is

applied across all programs and models.

One of these commenters stated that it

is very important for CMS to consider

model overlap in the design of new

APMs, and they recommended that the

goal of CMS models should be to

provide APM participants with

adequate flexibility to manage overlap

based on their unique market situation

and fundamentally change care delivery

and improve population health, rather

than seeking opportunities to leverage

market dynamics to reduce costs. This

commenter also expressed concern that

the proposed models do not place

sufficient emphasis on population

health and encouraging providers and

suppliers to keep patients from getting

to later disease stages in the first place.

Another commenter stated that CMS

must consider how models will interact

with one another and what this means

for participation in different models.

This commenter recommended that

CMS should focus on supporting

providers and suppliers currently not

participating in an APM and

encouraging these providers and

suppliers to participate, rather than

requiring some providers and suppliers

to participate, in a second model,

especially without sufficient clarity on

how these models may interact. The

commenter also supported CMS’ goal to

transition providers and suppliers to

risk-bearing programs and believed CMS

will most effectively achieve this goal

by focusing on providers and suppliers

not currently participating. Another

commenter stated concern that the lack

of a strict overlap structure undermines

the financial integrity of early adopters

in high-risk Advanced APM models, as

the absence of an established overlap

framework effectively creates a

disincentive for providers and suppliers

to voluntarily bear heightened risk for a

total population. The commenter further

stated that providers and suppliers are

not equipped with enough information

to evaluate the potential effect of

specialty and other episode payment

models on global payments and total

cost of care, and there is a finite

opportunity for these organizations to

reduce costs while maintaining access

and quality. To address these concerns,

this commenter recommended a

hierarchical approach to CMS’ and the

Innovation Center’s model overlap, in

which precedence is given to

population health risk-bearing entities.

The commenter also suggested that CMS

use the existing payment model

classification framework refined by the

Health Care Payment Learning & Action

Network (LAN) as a basis for its overlap

policy.

Response: We thank the commenters

for their comments and suggestions

regarding a larger CMS overlap policy.

We appreciate this feedback, and will

consider all of these recommendations

moving forward, in the event that a

broader overlap policy is developed for

CMS. As stated in the proposed rule, we

do not envision that the prospective

episode payments made under the RO

Model will need to be adjusted to reflect

payments made under any of the

existing models being tested under

section 1115A of the Act or the Shared

Savings Program under section 1899 of

the Act, but as stated in the proposed

rule, if we determine in the future that

such adjustments are necessary, we

would propose overlap policies for the

RO Model through notice and comment

rulemaking.

b. Accountable Care Organizations

(ACOs)

In the proposed rule, we discussed

our belief that there would be potential

overlap between the RO Model and

ACO initiatives. ACO initiatives include

a shared savings component. As a result,

providers and suppliers that participate

in an ACO are generally prohibited from

participating in other CMS models or

initiatives involving shared savings.

81

We believed there would be potential

for overlap between the RO Model and

ACO initiatives but, because the RO

Model is an episode-based payment

initiative, providers and suppliers

participating in the RO Model would

not be precluded from also participating

in an ACO initiative. Specifically, we

believed overlap could likely occur in

two instances: (1) The same provider or

supplier participates in both a Medicare

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ACO initiative and the RO Model; or (2)

a beneficiary that is aligned to an ACO

participating in a Medicare ACO

initiative receives care at a radiation

oncology provider or supplier outside

the ACO that is participating in the RO

Model.

While shared savings payments made

under an ACO initiative have the

potential to overlap with discounts and

withholds in the RO Model, as we

explained in the proposed rule it is

difficult to determine the level of

potential overlap at this time. It is also

difficult to determine how many ACO-

aligned beneficiaries will require RT

services or if those beneficiaries would

seek care from an RO participant. Given

that the RO Model is expected to reduce

Medicare spending in aggregate, we

anticipated that in most cases payments

under the RO Model would be less than

what Medicare would have paid outside

the Model. However, we also noted that

it would be possible for RO participants

to receive higher Medicare payments

under the Model than they did

historically, for example, if they have

certain experience adjustments. While

we expected overall payments for RT

services to be lower than they would be

absent the Model, we wanted to ensure

that a significant proportion of the RO

Model discounts, which represent

Medicare savings, would not be paid out

to ACOs as shared savings.

Due to these factors, in the proposed

rule we stated that we intended to

continue to review the potential overlap

with the ACO initiatives as the RO

Model is launched. If substantial

overlap occurs, we would consider

adjusting the RO Model payments

through future rulemaking to ensure

Medicare retains the discount amount.

ACO initiatives could also consider

accounting for RO Model overlap in

their own reconciliation calculations.

Any changes to the payment

calculations under these ACO initiatives

that might be necessary to account for

overlap with the RO Model would need

to be made using the relevant

procedures for the applicable ACO

initiative. For example, if the Next

Generation ACO Model makes any

changes to their current payment

methodologies to account for the RO

Model, it would update their governing

documentation as necessary, and would

provide information to their participants

through their typical channels of

communication.

In this section of this rule, we

summarize and respond to the public

comments received on this proposal.

Comment: A few commenters

recommended that CMS not negatively

adjust ACO shared savings calculations

to account for discounts embedded in

RO Model payments.

Response: At this time, we are not

planning to negatively adjust ACO

financial calculations to account for the

RO discount. ACO financial calculations

rely on Medicare Part A and Part B

claims data as well as non-claims-based

payments that are individually

identifiable final payments made under

a demonstration, pilot, or time limited

program and paid from the Medicare

Trust Funds. Under the Shared Savings

Program, use of a regional growth rate

should ultimately account for changes

in payment due to the RO Model, in

cases where overlap occurs between the

RO Model and Shared Savings Program

ACOs. The application of a regional

growth rate under the Shared Savings

Program would account for changes in

payment due to the RO Model because

the historical benchmark calculated for

an ACO would be updated for each

performance year of the agreement

period using a blend of the national

growth rate and a regional growth rate

based on the actual Medicare FFS

experience in counties where the ACO’s

beneficiaries reside. Thus, the use of

this regional growth rate will naturally

update the historical benchmarks of

ACOs to account for the effects on

spending resulting from implementation

of other value-based payment models,

including the RO Model, in those

counties. For ACO initiatives other than

the Shared Savings Program, CMS will

determine whether an adjustment to the

initiative’s calculations is necessary

based, for example, on the extent of

health care practitioner or beneficiary

overlap between that initiative and the

RO Model. We intend to continue to

review the potential overlap with ACO

initiatives as the RO Model is launched.

If CMS determines that adjustment to

the calculations used in any of these

other ACO initiatives is necessary to

account for overlap with the RO Model,

CMS would make changes to the

governing documentation for that ACO

initiative, as necessary, and would

provide information to the participants

in that ACO initiative through its typical

channels of communication at that time

in the future. Similarly, we will

consider adjusting the RO Model

payments through future rulemaking if

necessary to ensure Medicare retains the

discount amount. However, for the

reasons as previously described, we are

not currently applying any adjustments

to the RO Model payments or ACO

financial calculations at this time.

Comment: A few commenters

recommended that CMS finalize a

policy to exclude beneficiaries aligned

to an ACO who receive included RT

services from attribution to an RO

participant under the RO Model. One of

these commenters requested that CMS

‘‘provide an exemption for practices that

are already contracted with ACOs to

provide a four percent or greater

discount.’’ This commenter believes that

‘‘two percent to four percent should not

automatically be withheld up front

under the assumption that there were

errors in billing’’ and that ‘‘this practice

is unfair to those that work diligently to

bill with accuracy and effectively under

ethical billing practices.’’ Another

commenter suggested that CMS should

exclude all beneficiaries aligned to

ACOs from attribution to participants in

any other payment models to reduce

duplicative care coordination efforts

and create a clear, transparent and

understandable policy across all models

tested under section 1115A of the Act.

Response: We appreciate the

commenters’ feedback. We did not

propose to exclude RT practices

participating in ACOs from the RO

Model, and we are finalizing our

proposed policy to allow ACO-aligned

beneficiaries to be attributed to practices

participating in the RO Model for the

following reasons. First, we believe that

excluding beneficiaries that have been

aligned to an ACO from the RO Model

would be operationally challenging for

RO participants who will be billing

prospective RO Model payments and

may not be aware in real time that the

beneficiaries are aligned to an ACO.

Further, we believe the incentives under

the RO Model and the ACO initiatives

are aligned appropriately to support

high-quality care, and to the extent that

RO participants provide more efficient

care to ACO-aligned beneficiaries, this

could benefit the performance of the

ACO and provide higher-quality care to

Medicare beneficiaries with cancer who

receive RT services.

c. Oncology Care Model (OCM)

OCM seeks to provide higher quality,

more highly coordinated oncology care

at the same or lower cost to Medicare.

OCM episodes encompass a 6-month

period that is triggered by the receipt of

chemotherapy and incorporate all

aspects of care during that timeframe,

including RT services. Because OCM

and the RO Model both involve care for

patients with a cancer diagnosis who

receive RT services, we stated in the

proposed rule that we expect that there

will be beneficiaries who would be in

both OCM episodes and the RO Model

episodes.

Under OCM, physician practices may

receive a performance-based payment

(PBP) for episodes of care surrounding

chemotherapy administration to cancer

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patients. OCM is an episode payment

model that incentivizes care

coordination and management and

seeks to improve care and reduce costs

for cancer patients receiving

chemotherapy. Given the significant

cost of RT, OCM episodes that include

RT services receive a risk adjustment

when calculating episode benchmarks,

with the goal of mitigating incentives to

shift these services outside the episode

(for example, by delaying the provision

of RT services until after the 6-month

episode ends).

As we explained in the proposed rule,

practices participating in OCM receive a

monthly payment per OCM beneficiary

to support enhanced services such as

patient navigation and care planning.

Practices may also earn a PBP for

reductions in the total cost of care

compared to episodes’ target amount,

with the amount of PBP being adjusted

by the practice’s performance on quality

measures. OCM offers participating

practices the option of requesting a two-

sided risk arrangement, in which

episode expenditures that exceed the

target amount or the target amount plus

the minimum threshold for OCM

recoupment (depending on the specific

two-sided risk arrangement requested)

would be recouped by CMS from the

practice. OCM requires participating

practices who have not earned a PBP by

the initial reconciliation of the model’s

fourth performance period to move to a

two-sided risk arrangement or terminate

their participation in the model.

As we proposed in section III.C.7 of

the proposed rule and are finalizing in

section III.C.7 of this final rule, the RO

Model will include prospective episode

payments for RT services furnished

during a 90-day episode of care. The RO

Model is not a total cost of care model

and includes only RT services in the

episode payment. Since the RO Model

makes prospective payments for only

the RT services provided during an

episode, a practice participating in the

RO Model would receive the same

prospective episode payment for RT

services regardless of its participation in

OCM.

Conversely, OCM is a total cost of care

model so any changes in the cost of RT

services during an OCM episode could

affect OCM episode expenditures, and

therefore, have the potential to affect a

participating practice’s PBP or

recoupment. We stated in the proposed

rule that when the RO Model episode

occurs completely before or completely

after the OCM episode, then the RT

services that are part of that RO Model

episode would not be included in the

OCM episode, and the OCM

reconciliation calculations would be

unaffected. If an entire RO Model

episode (90-days of RT services) occurs

completely during a 6-month OCM

episode, then the associated RO

payments for RT services would be

included in the OCM episode. In

addition, to account for the savings

generated by the RO Model discount

and withhold amounts, we stated in the

proposed rule that we would add the

RO Model’s discount and withhold

amounts to the total cost of the OCM

episode during OCM’s reconciliation

process to ensure that there is no double

counting of savings and no double

payment of the withhold amounts

between the two models.

In those cases where the RO Model

episode would occur partially within an

OCM episode and partially before or

after the OCM episode, we proposed to

allocate the RO Model payments for RT

services and the RO Model discount and

withhold amounts to the OCM episode

on a prorated basis, based on the

number of days of overlap. In this case,

the prorated portion of the payment

under the RO Model, based on the

number of days of overlap with the

OCM episode, would be included in the

OCM episode’s expenditures as well as

the prorated portion of the RO Model

discount and withhold amounts, again

based on the number of days of overlap

with the OCM episode. We stated that

including the prorated discount and

withhold amounts would ensure that

there is no double counting of savings

and no double payment of the withhold

amounts between the two models.

In those cases where the RO Model

episode occurs entirely within or

partially before or after the OCM

episode, for the purpose of calculating

OCM episode costs, we stated in the

proposed rule that we would assume

that all withholds are eventually paid to

the RO Participant under the RO Model,

and that there are no payments to

recoup. We stated that we believe a

process to allocate exact amounts paid

to the participants with different

reconciliation timelines between the

two models would be operationally

complex.

We stated in the proposed rule that

we intend to continue to review the

potential overlap with OCM if the RO

Model is finalized, including whether

there are implications for OCM’s

prediction model for setting risk-

adjusted target episode prices, which

include receipt of RT services. We

further stated that since prospective

episode payments made under the RO

Model would not be affected by OCM,

OCM would account for RO Model

overlap in its reconciliation

calculations, and OCM participants

would be notified and provided with

further information through OCM’s

typical channels of communication. In

this section of this rule, we summarize

and respond to the public comments

received on this proposal.

Comment: Many commenters agreed

with CMS’ proposed approach for

accounting for overlap between OCM

and the RO Model. Some commenters

requested additional details regarding

the proration methodology, and a

commenter specifically requested

further clarification regarding how

prorated payments will be determined

and how prorated payments will be

distributed to providers and suppliers.

One commenter requested that CMS

clarify and reconsider how the RO

Model will overlap with the OCM in a

manner that allows for full and fair

participation in both models. This

commenter suggested that it would be

more appropriate and fairer to RT

providers and RT suppliers

participating in both models to use the

final discounted amount of the RO

Model payment as the payment to the

RO participant for purposes of the OCM

reconciliation calculation. This

commenter stated that RO participants

would receive no financial credit under

the RO Model for adjusting their

spending to make do with lower

payment under the discounts, so there

is no double-counting of savings if that

discount is also included in the OCM

calculation. The commenter also stated

that there is no guarantee that RO

participants will earn the withhold

amounts back after reconciliation under

the RO Model; and that even if they do,

it likely will not be without the RO

participant incurring other costs to

comply with quality reporting

requirements. Therefore, this

commenter suggested that the fairer and

more accurate approach would be to

deduct the discount amount from the

OCM reconciliation calculation, and to

deduct the amount of withholding that

is not regained through quality

performance.

Response: We appreciate the

commenters’ support for the proposed

approach to account for overlap

between the OCM and RO Model. We

anticipate that roughly 30 percent of

OCM practices that provide RT services

will participate in the RO Model. Since

OCM is a total cost of care model, any

changes in the cost of RT services

during an OCM episode could affect

OCM episode expenditures, and

therefore have the potential to affect a

participating practice’s PBP or

recoupment. We proposed a proration

approach to account for changes in

OCM episode expenditures due to RO

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Major joint replacement of the lower extremity

is a multi-setting Clinical Episode category. Total

Knee Arthroplasty (TKA) procedures can trigger

episodes in both inpatient and outpatient settings.

Model overlap, and to ensure there is no

double counting of savings or double

payment of the withhold amounts

between the two models.

Regarding the comments about the

proration methodology, we refer readers

to our description of the OCM proration

methodology set forth in the proposed

rule, where we described how, in cases

where the RO episode occurs partially

within an OCM episode and partially

before or after the OCM episode, we

proposed to allocate the RO Model

payments for RT services and the RO

Model discount and withhold amounts

to the OCM episode’s expenditures on a

prorated basis, based on the number of

days of overlap. As we discussed in the

proposed rule, including the RO

discount and withhold amounts (on a

prorated basis for cases where the RO

episode occurs partially within an OCM

episode and partially before or after the

OCM episode) in the calculation of

OCM episode expenditures would

ensure that there is no double counting

of savings and no double payment of the

withhold amounts between the two

models. For cases where the RO episode

occurs entirely within or partially before

or after the OCM episode, for the

purpose of calculating OCM episode

costs, we stated that we would assume

that all withholds are eventually paid to

the RO participant under the RO Model,

and that there are no payments to

recoup. As we discussed in the

proposed rule, we believe a process to

allocate exact amounts paid to the RO

participants when the OCM and the RO

Model have different reconciliation

timelines would be operationally

complex. Further detail about how OCM

will account for RO Model overlap in its

reconciliation calculations will be

provided to OCM practices through

OCM’s typical communication

channels. Of note, any RO episode

payments that are prorated as part of the

OCM reconciliation calculations will

not be distributed to the RO participant

or OCM participant; rather, these

amounts will be included in the OCM

reconciliation calculations that

determine the amount of any OCM PBP

or OCM recoupment. RO episode

payments would not change as a result

of any overlap with an OCM episode.

We believe the proposed approach to

handling the RO Model discount and

withholds in the OCM reconciliation

calculation is fair to participants in both

models and allows for full participation

in both models, while also preventing

us from double-counting and double-

paying savings to Medicare. Of note, RO

participants receive the same RO

payment amount regardless of how

many RT services are delivered; thus,

RO participants may keep the savings

that accrue for RO episodes where

payment under Medicare FFS would

have been less than the RO participant-

specific episode payment. Since the RO

participant would retain these savings,

we continue to believe that the best way

to ensure that Medicare savings

(captured through the RO Model

discount) are not paid out through the

OCM reconciliation is by adding the RO

Model discounts and withholds to the

RO participant-specific episode

payments included in the OCM

reconciliation calculations.

Additionally, we are not able to

synchronize the timing of the OCM and

RO Model reconciliations such that we

could incorporate the amount of the

quality withhold that is paid to the RO

participant during reconciliation.

Comment: A few commenters

requested that CMS not make changes to

the OCM target price setting

methodology based on RO Model

payments.

Response: We noted in the proposed

rule that overlap with the RO Model

may have implications for the

appropriateness of OCM’s prediction

model for setting risk-adjusted target

prices. We are continuing to consider

whether any potential changes to OCM’s

prediction model would be needed, and

we appreciate this input from the

commenters. If we make changes to the

OCM prediction model, OCM practices

would be notified through OCM’s

typical communication channels.

Comment: A few commenters

requested clarity and guidance from

CMS about whether the RO Model and

OCM payments are paid separately or

bundled together.

Response: The RO Model and OCM

are separate and distinct payment

models and any model payments will be

paid separately and not bundled

together. Furthermore, as stated in the

proposed rule, a practice participating

in the RO Model will receive the same

prospective episode payment for RT

services, regardless of its participation

in OCM, because the RO Model makes

prospective payments for only the RT

services provided during an RO episode.

Comment: A commenter suggested the

OCM participants should be exempt

from the RO Model. A couple of

commenters suggested that OCM

participants should not be required to

participate in the RO Model until their

performance under OCM has been

completed.

Response: We appreciate the

commenter’s suggestion about excluding

OCM participants from the RO Model.

However, we disagree with the

commenters’ recommendation that OCM

participants should be exempt from the

RO Model, and with the

recommendation that OCM participants

not be required to participate in the RO

Model until performance under OCM

has concluded. We believe that it is

important to allow eligible health care

providers to participate in both models

because both models involve care for

patients with a cancer diagnosis. We

also believe that participation in both

models could benefit beneficiaries in

both the RO Model and OCM by

aligning payment incentives across both

models. We did not propose to exclude

OCM participants from the RO Model as

we believe that this approach would

curtail the number, and potentially alter

the composition, of RT providers and

RT suppliers available to participate in

the RO Model, which could affect our

ability to detect an impact of the RO

Model. Further, by not excluding

voluntary OCM participants, we could

avoid a possible selection effect in the

RO Model.

After review of public comments and

for the reasons discussed, we are

finalizing our proposed approach for

addressing overlap between OCM and

the RO Model as proposed.

d. Bundled Payments for Care

Improvement (BPCI) Advanced

As we explained in the proposed rule,

the BPCI Advanced Model is testing a

new iteration of bundled payments for

34 clinical episodes (30 inpatient and 3

outpatient, and 1 multi-setting).

82

The

BPCI Advanced Model is based on a

total cost of care approach with certain

MS–DRG exclusions. While there are no

cancer episodes included in the design

of the BPCI Advanced Model, a

beneficiary in an RO episode could be

treated by a provider or supplier that is

participating in the BPCI Advanced

Model for one of the 34 clinical

episodes included in the BPCI

Advanced Model. Since prospective

episode payments made under the RO

Model would not be affected by the

BPCI Advanced Model, the BPCI

Advanced Model would determine

whether to account for RO Model

overlap in its reconciliation

calculations, and CMS would provide

further information to the BPCI

Advanced Model participants through

an amendment to their participation

agreement. In this section of this rule,

we summarize and respond to the

public comments received on this

proposal.

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83

United States Renal Data System. 2018 USRDS

annual data report: Epidemiology of kidney disease

in the United States. National Institutes of Health,

National Institute of Diabetes and Digestive and

Kidney Diseases, Bethesda, MD, 2018. Volume 2:

End-stage Renal Disease (ESRD) in the United

States. Chapter 11: International Comparisons.

Figures 11–15, 11–16.

Comment: A commenter

recommended that potential RO Model

overlap with the BPCI Advanced Model

be addressed through a notice and

public comment process, rather than

through a mandatory amendment to the

BPCI Advanced Model participant

agreements. A commenter stated that

there may be potential overlap with the

BPCI Advanced Model, as a Medicare

beneficiary in an RO episode could be

treated by a health care provider that is

participating in the BPCI Advanced

Model. This commenter requested

clarification in this case, on how to

know which model the patient would be

attributed to and how the services

would be reimbursed. This commenter

also recommended that CMS address

the potential overlap on how patients

should be attributed between the BPCI

Advanced Model and the RO Model,

and they requested further clarification

regarding how services will be

reimbursed under the RO and BPCI

Advanced Models before the start date

to assist hospitals in effective planning

for their participation.

Response: We appreciate the

commenter’s concerns and suggestions.

The BPCI Advanced Model payment

polices are governed by participation

agreements with each model

participant; we cannot amend those

agreements by notice and comment

rulemaking. Accordingly, we are

finalizing as proposed (84 FR 34535)

that the BPCI Advanced Model team

will determine whether and how to

account for RO Model overlap in its

reconciliation calculations. Regarding

the commenter who requested

clarification on how to know which

model the patient would be attributed to

and how the services would be

reimbursed, as we stated in the

proposed rule, a beneficiary in an RO

episode could be treated by a provider

or supplier that is participating in the

BPCI Advanced Model, and prospective

episode payments made under the RO

Model would not be affected by the

BPCI Advanced Model. As such, the

BPCI Advanced Model would determine

whether to account for RO Model

overlap in its reconciliation

calculations, and the BPCI Advanced

Model participants will receive further

information from CMS if the BPCI

Advanced Model team determines to

make changes to their reconciliation

policy.

19. Decision Not To Include a Hardship

Exemption

As discussed in the proposed rule (84

FR 34535), we did not believe that a

hardship exemption for participation in

the Model is necessary, since the

Model’s pricing methodology gives

significant weight to historical

experience in determining the amounts

for participant-specific professional

episode payments and participant-

specific technical episode payments.

This is particularly evident in PY1,

where the efficiency factor in section

III.C.6.e(2) of the proposed and final

rules is 0.90 for all RO participants.

Accordingly, we did not propose such

an exemption in the proposed rule, and

will not include such an exemption in

this final rule.

However, in the proposed rule, we

welcomed public input on whether a

possible hardship exemption for RO

participants under the Model might be

necessary or appropriate, and if so, how

it might be designed and structured

while still allowing CMS to test the

Model. As we stated in the proposed

rule, we intend to use the input we

received on this issue to consider

whether a hardship exemption might be

appropriate in subsequent rulemaking

for a future PY. In this section of this

rule, we summarize the public

comments we received.

Comment: Many commenters

disagreed with CMS’ decision not to

include a model participation hardship

exemption for RO participants. A

commenter requested that CMS

establish a hardship exemption process

for RT providers and RT suppliers that

can show they serve a patient base

consisting predominantly of Medicare

beneficiaries, given that these providers

and suppliers would face

disproportionate impact from

mandatory participation in the Model

and would be at a significant

disadvantage compared to other

participants as well as RT providers and

RT suppliers not included in the Model.

Some commenters requested a

hardship exemption specific to rural

practices. These commenters

maintained that patients living in rural

areas would be disparately impacted by

the mandatory requirement of the

proposed RO Model, and other

commenters stated that rural practices

will experience undue burdens if they

are required to participate in the RO

Model.

A few commenters recommended that

CMS provide hardship exemptions for

RO participants facing public health

emergencies or natural disasters, such as

wild fires, earthquakes, or hurricanes, to

ensure that they are not unfairly

penalized due to these circumstances.

These commenters stated that hardship

exemptions for extreme and

uncontrollable circumstances have

recently been implemented in other

APMs, including the Shared Savings

Program and the Comprehensive Care

for Joint Replacement Model, and also

in the Quality Payment Program.

We appreciate the commenters’

feedback on this issue. We will consider

these comments when determining

whether a hardship exemption is

appropriate for proposing in subsequent

rulemaking for a future PY. We will

continue to monitor the need for a

hardship exemption under the RO

Model.

IV. End-Stage Renal Disease (ESRD)

Treatment Choices Model

A. Introduction

The purpose of this section of the

final rule is to implement a new

payment model called the End-Stage

Renal Disease (ESRD) Treatment

Choices (ETC) Model, referred to in this

section IV of the final rule as ‘‘the

Model,’’ under the authority of the

Innovation Center. The intent of the

ETC Model is to test whether adjusting

the current Medicare fee-for-service

(FFS) payments for dialysis services will

incentivize ESRD facilities and

clinicians managing adult Medicare FFS

beneficiaries with ESRD, referred to

herein as Managing Clinicians, to work

with their patients to achieve increased

rates of home dialysis utilization and

kidney transplantation and, as a result,

improve or maintain the quality of care

and reduce Medicare expenditures. Both

of these modalities (home dialysis and

transplantation) have support among

health care providers and patients as

preferable alternatives to in-center

hemodialysis (HD), but the utilization

rate of these services in the United

States (U.S.) has been below such rates

in other developed nations.

83

On July

18, 2019, we published a proposed rule

in the Federal Register titled ‘‘Medicare

Program; Specialty Care Models To

Improve Quality of Care and Reduce

Expenditures’’ (84 FR 34478) and sought

public comment on the proposed ETC

Model. In response, CMS received 104

comment submissions from physicians,

dialysis providers, patient groups,

industry groups, and others. Summaries

of these comments, and our responses,

are found throughout this section of the

final rule.

In the ETC Model, CMS will adjust

Medicare payments under the ESRD

Prospective Payment System (PPS) to

ESRD facilities and payments under the

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84

Kirchoff SM. Medicare Coverage of End-Stage

Renal Disease (ESRD). Congressional Research

Service. August 16, 2018. p. 1.

85

Foley RN, Hakim RM. Why Is the Mortality of

Dialysis Patients in the United States Much Higher

than the Rest of the World? Journal of the American

Society of Nephrology. 2009; 20(7):1432–1435.

doi:https://doi.org/10.1681/ASN.2009030282.

86

Robinson B, Zhang J, Morgenstern H, et al.

Worldwide, mortality is a high risk soon after

initiation of hemodialysis. Kidney

International.2014;85(1):158–165. Doi:10.1038/

ki.2013.252.

87

United States Renal Data System, Annual Data

Report, 2018. Volume 2. Chapter 1: Incidence,

Prevalence, Patient Characteristics, and Treatment

Modalities. https://www.usrds.org/2018/view/v2_

01.aspx.

88

United States Renal Data System, Annual Data

Report, 2018. Volume 2. Chapter 1: Incidence,

Prevalence, Patient Characteristics, and Treatment

Modalities. https://www.usrds.org/2018/view/v2_

01.aspx.

Medicare Physician Fee Schedule (PFS)

to Managing Clinicians paid the ESRD

Monthly Capitation Payment (MCP)

selected for participation in the Model.

The payment adjustments will include

an upward adjustment on home dialysis

and home dialysis-related claims with

claim service dates during the initial

three years of the ETC Model, that is,

between January 1, 2021 and December

31, 2023. In addition, we will make an

upward or downward performance-

based adjustment on all dialysis claims

and dialysis-related claims with claim

service dates between July 1, 2022 and

June 30, 2027, depending on the rates of

home dialysis utilization, and of kidney

transplant waitlisting and living donor

transplants among the beneficiaries

attributed to these participating ESRD

facilities and Managing Clinicians. The

ETC Model will test whether such

payment adjustments can reduce total

program expenditures and improve or

maintain quality of care for Medicare

beneficiaries with ESRD.

B. Background

1. Rationale for the ESRD Treatment

Choices Model

As discussed in the proposed rule,

beneficiaries with ESRD are among the

most medically fragile and high-cost

populations served by the Medicare

program. ESRD Beneficiaries require

dialysis or kidney transplantation in

order to survive, as their kidneys are no

longer able to perform life-sustaining

functions. In recent years, ESRD

Beneficiaries have accounted for about 1

percent of the Medicare population and

accounted for approximately 7 percent

of total fee-for-service Medicare

spending.

84

Beneficiaries with ESRD

face the need for coordinating treatment

for many disease complications and

comorbidities, while experiencing high

rates of hospital admissions and

readmissions and a mortality rate

greatly exceeding that of the general

Medicare population. In addition,

studies during the past decade have

reported higher mortality rates for

dialysis patients in the U.S. compared to

other countries.

85 86

ESRD is a uniquely burdensome

condition; with uncertain survival,

patient experience represents a critical

dimension for assessing treatment. The

substantially higher expenditures and

hospitalization rates for ESRD

Beneficiaries compared to the overall

Medicare population, and higher

mortality than in other countries

indicate a population with poor clinical

outcomes and potentially avoidable

expenditures. We anticipate that the

ETC Model will maintain or improve

the quality of care for ESRD

Beneficiaries and reduce expenditures

for the Medicare program by creating

incentives for health care providers to

assist beneficiaries, together with their

families and caregivers, to choose the

optimal renal replacement modality for

the beneficiary.

As we discussed in the proposed rule,

the majority of ESRD patients receiving

dialysis receive HD in an ESRD facility.

At the end of 2016, 63.1 percent of all

prevalent ESRD patients—meaning

patients already diagnosed with ESRD—

in the U.S. were receiving HD, 7.0

percent were being treated with

peritoneal dialysis (PD), and 29.6

percent had a functioning kidney

transplant.

87

Among HD cases, 98.0

percent used in-center HD, and 2.0

percent used home hemodialysis

(HHD).

88

PD is rarely conducted within

a facility. In the proposed rule and in

section IV.B.2 of this final rule, we

describe how current Medicare payment

rules and a lack of beneficiary education

result in a bias toward in-center HD,

which is often not preferred by patients

or practitioners. With the ETC Model,

we will test whether new payment

adjustments will lead to greater rates of

home dialysis (both PD and HHD) and

kidney transplantation. In both the

proposed rule and this final rule, we

provide evidence from published

literature to support the projection that

higher utilization rates for these specific

interventions would likely reduce

Medicare expenditures, while

preserving or enhancing the quality of

care for beneficiaries and, at the same

time, enhance beneficiary choice,

independence, and quality of life.

The following is a summary of the

comments received on the rationale for

testing the proposed ETC Model and our

responses.

Comment: Several commenters stated

that they support the rationale, as

described in the proposed rule and

previously in this final rule, for testing

the ETC Model. Several commenters

stated that the evidence suggests that

home dialysis and transplantation are

associated with lower costs and better

outcomes than in-center dialysis for

patients with ESRD, and that the current

payment system does not encourage the

use of these alternative modalities. A

few commenters stated that payment

adjustments like those we proposed for

use in the ETC Model can impact

participant behavior in supporting these

alternative modalities. A few

commenters stated that containment of

dialysis costs is an important goal for

the Model.

Response: We thank the commenters

for their feedback and support.

Comment: Several commenters stated

that they did not believe payment

adjustments could change participant

behavior to increase rates of home

dialysis and transplantation. A

commenter stated that any payment

adjustments are unlikely to overcome

barriers that currently prevent the use of

home dialysis and transplantation such

as socioeconomic issues, race,

immunologic barriers, a lack of

caregiver support, housing insecurity

and home environments that are unable

to store supplies and equipment. A

commenter stated that the evidence that

home dialysis is associated with better

outcomes and lower costs is mixed, so

the payment adjustments proposed for

use in the Model are unlikely to achieve

the stated goals. A commenter stated

that, if under current payment

conditions patient preference is not

driving renal replacement modality

selection, then changing payment

incentives will not move patient

preference to the center of the decision-

making process.

Response: We thank the commenters

for their feedback. The purpose of the

ETC Model is to test whether the

payment adjustments included in the

Model will reduce Medicare

expenditures while improving or

maintaining quality of care. CMS

believes that these payment adjustments

will accomplish these goals by

encouraging participating Managing

Clinicians and ESRD facilities to

support beneficiaries choosing home

dialysis and transplantation. The

purpose of the Model and CMS’s

evaluation thereof is to determine if this

is the case.

a. Home Dialysis

As we noted in the proposed rule,

there are two general types of dialysis:

HD, in which an artificial filter outside

of the body is used to clean the blood;

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Stack AG. Determinants of Modality Selection

among Incident US Dialysis Patients: Results from

a National Study. Journal of the American Society

of Nephrology. 2002; 13: 1279–1287. Doi 1046–

6673/1305–1279.

90

Miskulin DC, et al. Comorbidity and Other

Factors Associated With Modality Selection in

Incident Dialysis Patients: The CHOICE Study.

American Journal of Kidney Diseases. 2002; 39(2):

324–336. Doi 10.1053/ajkd.2002.30552.

91

Blagg CR. A Brief History of Home

Hemodialysis. Annals in Renal Replacement

Therapy. 1996; 3: 99–105.

92

Unites States Government Accountability

Office. End Stage Renal Disease: Medicare Payment

Refinements Could Promote Increased Use of Home

Dialysis (GAO–16–125). October 2015.

93

United States Renal Data System, Annual Data

Report, 2018. Volume 2, Chapter 11: International

Comparisons. Figure F11.12.

94

Golper TA, Saxena AB, Piraino B, Teitelbaum,

I, Burkart, J, Finkelstein FO, Abu-Alfa A. Systematic

Barriers to the Effective Delivery of Home Dialysis

in the United States: A Report from the Public

Policy/Advocacy Committee of the North American

Chapter of the International Society for Peritoneal

Dialysis. American Journal of Kidney Diseases.

2011; 58(6): 879–885.doi:10.1053/

j.ajkd.2011.06.028.

95

Ghaffarri A, Kalantar-Zadeh K, Lee J, Maddux

F, Moran J, Nissenson A. PD First: Peritoneal

Dialysis as the Default Transition to Dialysis

Therapy. Seminars in Dialysis. 2013; 26(6): 706–

713. doi: 10.1111/sdi.12125.

96

Finkelstein FO, Story K, Firanek C, Barr P, et

al. Perceived knowledge among patients cared for

by nephrologists about chronic kidney disease and

end-stage renal disease therapies. Kidney

International 2008; 9: 1178–1184. https://doi.org/

10.1038/ki.2008.376.

97

Mendelssohn DC. Mujais SK, Soroka, SD, et al.

A prospective evaluation of renal replacement

therapy modality eligibility. Nephrology Dialysis

Transplantation. 2009; 24(2): 555–561. doi: https://

doi.org/10/1093/ndt/gfn484.

98

Mehrotra R, Marsh D, Vonesh E, Peters V,

Nissenson A. Patient education and access of ESRD

patients to renal replacement therapies beyond in-

center hemodialysis. Kidney International. 2005;

68(1):378–390.

99

Lacson E, Wang W, DeVries C, Leste K, Hakim

RM, Lazarus M, Pulliam J. Effects of a Nationwide

Predialysis Educational Program on Modality

Choice, Vascular Access, and Patient Outcomes.

American Journal of Kidney Diseases. 2011; 58(2):

235–242.doi:10.1053/j.ajkd.2011.04.015.

and PD, in which the patient’s

peritoneum, covering the abdominal

organs, is used as the dialysis

membrane. HD is conducted at an ESRD

facility, usually 3 times a week, or at a

patient’s home, often at a greater

frequency. PD most commonly occurs at

the patient’s home. (Although PD can be

furnished within an ESRD facility, it is

very rare. In providing background

information for the ETC Model in the

proposed rule and in this final rule, we

consider PD to be exclusively a home

modality.) Whether a patient selects HD

or PD may depend on a number of

factors, such as patient education before

dialysis initiation, social and care

partner support, socioeconomic factors,

and patient perceptions and

preference.

89 90

As discussed in the proposed rule,

when Medicare began coverage for

individuals on the basis of ESRD in

1973, more than 40 percent of dialysis

patients in the U.S. were on HHD. More

favorable reimbursement for outpatient

dialysis and the introduction in the

1970s of continuous ambulatory

peritoneal dialysis, which required less

intensive training, contributed to a

relative decline in HHD utilization.

91

Overall, the proportion of home dialysis

patients in the U.S. declined from 1988

to 2012, with the number of home

dialysis patients increasing at a slower

rate relative to the total number of all

dialysis patients. As cited in a U.S.

Government Accountability Office

(GAO) report, according to U.S. Renal

Data System (USRDS) data,

approximately 16 percent of the 104,000

dialysis patients in the U.S. received

home dialysis in 1988; however, by

2012, the rates of HHD and PD

utilization were 2 and 9 percent,

respectively.

92

Additionally, as outlined in the

proposed rule, an annual analysis

performed by the USRDS in 2018

compared the rates of dialysis

modalities for prevalent dialysis

patients in the U.S. to 63 selected

countries or regions around the world.

In 2016, the U.S. ranked 27th in the

percentage of beneficiaries that were

dialyzing at home (12 percent). For

example, the U.S. rate of home dialysis

is significantly below those of Hong

Kong (74 percent), New Zealand (47

percent), Australia (28 percent), and

Canada (25 percent).

93

As discussed in the proposed rule, a

2011 report on home dialysis in the U.S.

related the relatively low rate of home

dialysis in this country to factors that

included educational barriers, the

monthly visit requirement for the MCP

under the PFS, the need for home care

partner support, as well as philosophies

and business practices of dialysis

providers, such as staffing allocations,

lack of independence for home dialysis

clinics, and business-oriented

restrictions that lead to inefficient

supply distribution. The report

recommended consolidated,

collaborative efforts to enhance patient

education among nephrology practices,

dialysis provider organizations, hospital

systems and kidney-related

organizations, as well as additional

educational opportunities and training

for nephrologists and dialysis staff. With

regard to CMS’s requirement starting in

2011 that the physician or non-

physician practitioner furnish at least

one in-person patient visit per month

for home dialysis MCP services, the

report noted that CMS allows discretion

to Medicare contractors to allow

payment without a visit so long as there

is evidence for the provision of services

throughout the month. Nevertheless, the

report concluded that notwithstanding

this allowance the stated policy might

potentially be a disincentive for

physicians to promote home dialysis.

The report further commented that the

low rate of home dialysis in the U.S.

may result in part from patients’

inability to perform self-care, and

suggested providing support for home

care partners. With respect to dialysis

providers’ business practices and

philosophies, the report noted that

dialysis providers differ in many ways

and have different experiences that

deserve attention and consideration

with regard to potentially posing a

barrier to the provision of home

dialysis.

94

As we noted in the proposed rule, the

high rate of incident dialysis patients

beginning dialysis through in-center HD

in the U.S. is driven by a variety of

factors including ease of initiation,

physician experience and training,

misinformation around other

modalities, inadequate education for

chronic kidney disease (CKD)

beneficiaries, built-up capacity at ESRD

facilities, and a lack of infrastructure to

support home dialysis.

95

(Provision of

home dialysis requires a system of

distribution of supplies to patients, as

well as allocation of staff and space

within facilities for education, training,

clinic visits, and supervision). One

study indicated that patients’ perceived

knowledge about various ESRD

therapies was correlated with their

understanding of the advantages and

disadvantages of the available treatment

options.

96

As discussed in the proposed

rule, researchers have reported that

greater support, training, and education

to nephrologists, other clinicians, and

patients would increase the use of both

HHD and PD. A prospective evaluation

of dialysis modality eligibility among

patients with CKD stages III to V

enrolled in a North American cohort

study showed that as many as 85

percent were medically eligible for

PD.

97

However, in one study, only one-

third of ESRD patients beginning

maintenance dialysis were presented

with PD as an option, and only 12

percent of patients were presented with

HHD as an option.

98

As shown by a

national pre-ESRD education initiative,

pre-dialysis education results in a 2- to

3- fold increase in the rate of patients

initiating home dialysis compared with

the U.S. home dialysis rate.

99

Another

study reported 42 percent of patients

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Bargman J, Vonesh E. Similar Outcomes With

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Medicine. 2011; 171(2): 110–118. Doi:10.1001/

archinternmed.2010.352.

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Ghaffari et al. 2013.

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about renal replacement therapy among nephrology

professionals. Nephrology News & Issues.

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McFarlane P, Howard K. The cost-effectiveness of

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review of full economic evaluations. Nephrology.

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hemodialysis: A comprehensive review of patient-

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Chadban S, Craig J, Cass A. The cost effectiveness

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Austin P, Zacharias JM, Johnson JF, Padeya S,

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preferring PD when the option was

presented to them.

100

Recent studies show substantial

support among nephrologists and

patients for dialysis treatment at

home.

101 102 103 104 105

As we noted in the

proposed rule, we believe that

increasing rates of home dialysis has the

potential to not only reduce Medicare

expenditures, but also to preserve or

enhance the quality of care for ESRD

Beneficiaries.

As discussed in the proposed rule,

research suggests that dialyzing at home

is associated with lower overall medical

expenditures than dialyzing in-center.

Key factors that may be related to lower

expenditures include potentially lower

rates of infection associated with

dialysis treatment, fewer

hospitalizations, cost differentials

between PD and HD services and

supplies, and lower operating costs for

dialysis providers for providing home

dialysis.

106 107 108 109 110

(Most studies on

the comparative cost and effectiveness

of different dialysis modalities assess

PD versus HD. As noted in the proposed

rule, we believe that since the extent of

in-center PD is negligible, and only

approximately 2 percent of HD occurs at

home, these studies are suitable for

drawing conclusions regarding home

versus in-center dialysis.) However,

research on cost differences between in-

center dialysis and home dialysis is

limited to comparing costs for patients

who currently dialyze at home to those

who do not. As previously discussed in

the proposed rule and in this final rule,

there are currently barriers to dialyzing

at home that may result in selection

bias. Put another way, beneficiaries who

currently dialyze at home may be

different in some way from beneficiaries

who dialyze in-center that is otherwise

the cause of the observed difference in

overall medical expenditures. Patients

may differ in terms of age, gender, race,

and clinical issues such as presence of

diabetes and origin of ESRD.

111

Despite

selection bias present in existing

research, we stated in the proposed rule

our expectation that increasing rates of

home dialysis will likely decrease

Medicare expenditures for ESRD

Beneficiaries, and this is something we

would assess as part of our evaluation

of the ETC Model.

In addition, as we discussed in the

proposed rule, current research on

patients in the U.S. and Canada

indicates similar, or better, patient

survival outcomes for PD compared to

HD.

112 113 114

(As previously noted, most

research on the comparative

effectiveness of different dialysis

modalities compares PD to HD, but—as

noted in the proposed rule—we believe

these studies are suitable for comparing

home to in-center dialysis, given that in-

center PD is negligible and only

approximately 2 percent of HD is

conducted at home.) The USRDS shows

lower adjusted all-cause mortality rates

for 2013 through 2016 for PD compared

to HD.

115

Therefore, as noted in the

proposed rule, we believe increased

rates of PD associated with increased

rates of home dialysis prompted by the

proposed Model would at least

maintain, and may improve, quality of

care provided to ESRD Beneficiaries.

While studies from several nations

observe that the survival advantage for

PD may be attenuated following the

early years of dialysis treatment (1 to 3

years), and also that advanced age and

certain comorbidities among patients

are related to less favorable outcomes

for PD, as we discussed in the proposed

rule, a component of the Model’s

evaluation would be to assess the

applicability of these findings to the

U.S. population and Medicare

beneficiaries, specifically if

there is sufficient statistical power

to detect meaningful

variation.

116 117 118 119 120 121 122

Patient

benefits of HHD and PD also can

include better quality of life and greater

independence.

123 124 125

As described in

greater detail in the proposed rule and

throughout section IV of this final rule,

one of the aims of the ETC Model is to

test whether new payment incentives

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126

E.O. 13879 of July 10, 2019.

would lead to greater rates of home

dialysis.

The following is a summary of the

comments received on the benefits of

and barriers to home dialysis and our

responses.

Comment: Several commenters

expressed support for the association

between home dialysis and improved

health outcomes in comparison to in

center dialysis. Commenters stated that

research suggests that HHD facilitates

longer, more frequent dialysis, or

optimal dialysis dosing for the

individual patient, which in turn leads

to better health outcomes and quality of

life. Commenters also stated that

research suggests other benefits to home

dialysis, including need for fewer

medications, less frequent

hospitalizations, and better quality of

life. A commenter stated that there is

evidence that suggests that HHD can

have long term outcomes that are equal

to or better than deceased donor

transplants. A commenter stated that

they believe home dialysis can preserve

or enhance the quality of care for ESRD

Beneficiaries while reducing Medicare

expenditures. Another commenter

stated that shifting dialysis provision

from in-center dialysis to home dialysis

would have positive economic effects,

including decreasing costs for dialysis

providers, creating economies of scale

for home dialysis supplies and logistics,

and increasing research and

development into new home dialysis

technologies.

Response: We thank the commenters

for their feedback and support. If the

Model increases rates of home dialysis

as intended, we will assess the impact

of increased rates of home dialysis on

quality of care, including—to the extent

possible—those particular aspects of

care quality identified by commenters.

The evaluation plan for the Model is

discussed in section IV.C.11 of this final

rule.

Comment: Multiple commenters

expressed agreement with barriers to the

provision of home dialysis services as

previously identified in this final rule

and in the proposed rule. Commenters

specifically identified barriers

surrounding limited patient education

about and awareness of home dialysis,

and lack of familiarity and comfort with

prescribing home dialysis among

Managing Clinicians. Commenters also

identified additional factors that may

prevent beneficiaries from selecting

home dialysis, including: clinical,

mental, and social stability; inadequate

or unstable housing conditions;

socioeconomic factors; and patient

preference. Several commenters

identified aspects of the Medicare FFS

payment system that disincentivize

home dialysis, including the ability for

Managing Clinicians to maximize

revenue through in-center dialysis over

home dialysis, and Medicare

requirements around MCP monthly in-

person visits for home dialysis

beneficiaries. A commenter stated that

the requirements for an ESRD facility to

become certified to provide home

dialysis are burdensome and prevent

some ESRD facilities from seeking

certification to begin a home dialysis

program. Commenters identified

system-level factors related to the

supply of goods and services necessary

to conduct home dialysis, including

dialysis supplies in general and PD

solution in particular, availability of

vascular access services, and lack of

new technology and innovation in the

home dialysis industry. Commenters

discussed a lack of access to primary

care, lack of screening for CKD in a

primary care setting, and lack of patient

education about ESRD and dialysis

options before beneficiaries initiate

dialysis, as beneficiaries who have

access to these services are more likely

to initiate dialysis at home. Commenters

stated that many of these barriers to

home dialysis are outside of the control

of Managing Clinicians and ESRD

facilities.

Response: We thank the commenters

for their feedback. CMS recognizes that

there are a variety of barriers that

prevent ESRD Beneficiaries from

choosing home dialysis at present.

ESRD facilities and Managing Clinicians

are the clinical experts in dialysis

provision in general, and in the clinical

and non-clinical needs of individual

ESRD Beneficiaries specifically. We

therefore believe that ESRD facilities

and Managing Clinicians are uniquely

positioned to assist ESRD Beneficiaries

in overcoming these barriers, given their

close care relationship to and frequent

interaction with ESRD Beneficiaries.

Therefore, we have designed the ETC

Model to test whether outcomes-based

payment adjustments for ESRD facilities

and Managing Clinicians can maintain

or improve quality and reduce costs by

increasing rates of home dialysis

transplant waitlisting, and living donor

transplants. The ETC Model is one piece

of the Advancing American Kidney

Health initiative, a larger HHS effort

focused on improving care for patients

with kidney disease.

126

The payment

adjustments in the ETC Model test one

approach to addressing existing

disincentives to home dialysis and

transplant in the current Medicare FFS

payment system.

We recognize that educating patients

about their renal replacement options is

key to supporting modality selection. As

such, we are waiving certain

requirements for the Kidney Disease

Education (KDE) benefit to allow

Managing Clinicians who are ETC

Participants additional flexibility to

furnish and bill for these educational

services under the Model. These

waivers are detailed in section IV.C.7.b

of this final rule.

In response to the commenters’

concerns about system-level factors,

including products and services

necessary to home dialysis provision,

we have designed the benchmarking

and scoring methodology, described in

section IV.C.5.d of this final rule, to be

comparative to account for these types

of system-level factors. In the initial

years of the Model, participant

achievement will be assessed in relation

to home dialysis rates among non-

participants. As such, any system-level

limitations that affect home dialysis

rates for ETC Participants are also

reflected in the ESRD facilities and

Managing Clinicians not participating in

the Model that form the basis for the

benchmarks.

In response to the commenters’

concerns about certification

requirements deterring ESRD facilities

from operating home dialysis programs,

we did not propose to waive Medicare

certification requirements as part of this

Model, in order to preserve patient

health and safety. Additionally, the

aggregation approach for this Model, in

which all ESRD facilities owned in

whole or in part by the same dialysis

organization within a Selected

Geographic Area are assessed as one

aggregation group with respect to their

performance on the home dialysis rate,

alleviates the need for individual ESRD

facilities to become certified to perform

home dialysis.

Comment: Several commenters stated

that comparing U.S. rates of home

dialysis to other countries, particularly

other countries with very high home

dialysis rates, is inappropriate, because

those countries have different

demographic, socioeconomic, and

health system factors that impact home

dialysis utilization. Several commenters

stated that other countries that are more

similar to the U.S. in demography,

socioeconomic status, and health system

structure have home dialysis rates closer

to that of the U.S.

Response: We appreciate the

commenters’ concerns about comparing

home dialysis rates in the U.S. to home

dialysis rates in other countries. We

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Tonelli M, Weibe N, Knoll G, Bello A, Browne

S. Jadhav D, Klarenbach S, Gill J. Systematic

Review: Kidney Transplantation Compared with

Dialysis in Clinically Relevant Outcomes. American

Journal of Transplantation. 2011; 11(10). doi:

https://doi.org/10.1111/j.1600-6143.2011.03686.x.

128

Tonelli, M. et al. 2011.

129

United States Renal Data System.Annual Data

Report, 2018. Volume 2. Chapter 9: Healthcare

expenditures for Persons with ESRD. Figure F9.8.

130

United States Renal Data System. Annual Data

Report, 2018; Volume 2, Chapter 4:

Hospitalizations, Readmissions, Emergency

Department Visits, and Observation Stays. Tables

F4–1, F4–8.

131

United States Renal Data System. Annual Data

Report, 2018: Volume 2, Chapter 4:

Hospitalizations, Readmissions, Emergency

Department Visits, and Observation Stays. Tables

F4.1, F4.8, and F4.14.

132

United States Renal Data System. Annual Data

Report, 2018; Volume 2. Chapter 1: Incidence,

Prevalence, Patient Characteristics, and Treatment

Modalities. https://www.usrds.org/2018/view/v2_

01.aspx.

133

United States Renal Data System. Annual Data

Report, 2018. Volume 2. Chapter 11. International

Comparisons. Figure 11.16.

134

United States Renal Data System. Annual Data

Report, 2018: Volume 2. Chapter 11. International

Comparisons. https://www.usrds.org/2018/view/v2_

11.aspx.

135

Serur D, Bingaman A, Smith B. Kidney

Transplantation 2017 Breaking Down Barriers and

Building Bridges. American Society of Nephrology:

Kidney News Online. 2017; 9(4): kidneynews.org/

kidney-news/practice-pointers/kidney-

transplantation-2017-breaking-down-barriers-and-

building-bridges.

136

Segev D, Gentry S, Warren D. Kidney Paired

Donation and Optimizing the Use of Live Donor

Organs. JAMA. 2005;293(15):1883–1890.

doi:10.1001/jama.293.15.1883.

137

Redfield RR, Scalea JR, Odoricio JS.

Simultaneous pancreas and kidney transplantation:

Current trends and future directions. Current

Opinion in Organ Transplantation. 2015; 20(1): 94–

102. Doi:10.1097/MOT.0000000000000146.

acknowledge that there are differences

between the U.S. and other countries

that may make direct comparisons

challenging. We provided the

comparison in the proposed and final

rules for context but have designed the

Model specifically for the U.S. market,

in particular the Medicare program.

b. Kidney Transplants

As we discussed in the proposed rule,

a kidney transplant involves surgically

transplanting one healthy kidney from a

living or deceased donor. A kidney-

pancreas transplant involves

simultaneously transplanting both a

kidney and a pancreas, for patients who

have kidney failure related to type 1

diabetes mellitus. While the kidney in a

kidney transplant may come from a

living or deceased donor, a kidney

transplant in conjunction with a

pancreas or other organ can only come

from a deceased donor. As noted in the

proposed rule, candidates for kidney

transplant undergo a rigorous evaluation

by a transplant center prior to

placement on a waitlist, and once

placed on the waitlist, potential

recipients must maintain active status

on the waitlist. The United Network for

Organ Sharing (UNOS) maintains the

waitlist for and conducts matching of

deceased donor organs. ESRD

Beneficiaries already on dialysis

continue to receive regular dialysis

treatments while waiting for an

appropriate organ.

As cited in the proposed rule, a

systematic review of studies worldwide

found significantly lower mortality and

risk of cardiovascular events associated

with kidney transplantation compared

with maintenance dialysis.

127

Additionally, this review found that

beneficiaries who receive transplants

experience a better quality of life than

those who receive treatment with

chronic dialysis.

128

As we noted in the proposed rule,

per-beneficiary-per-year Medicare

expenditures for beneficiaries receiving

kidney or kidney-pancreas transplants

are often substantially lower than for

those on dialysis.

129

The average

dialysis patient is admitted to the

hospital nearly twice a year, often as a

result of infection, and approximately

35.4 percent of dialysis patients who are

discharged are re-hospitalized within 30

days of being discharged.

130

Among

transplant recipients, there are lower

rates of hospitalizations, emergency

department visits, and readmissions.

131

As discussed in the proposed rule,

while comparisons between patients on

dialysis and those with functioning

transplants rely on observational data,

due to the ethical concerns with

conducting clinical trials, the data

nonetheless suggest better outcomes for

ESRD patients that receive transplants.

Notwithstanding these outcomes, as

we discussed in the proposed rule, only

29.6 percent of prevalent ESRD patients

in the U.S. had a functioning kidney

transplant and only 2.8 percent of

incident ESRD patients—meaning

patients new to ESRD—received a pre-

emptive kidney transplant in 2016.

132

A

pre-emptive transplant is a kidney

transplant that occurs before the patient

requires dialysis. These rates are

substantially below those of other

developed nations. The U.S. was ranked

39th of 61 reporting countries in kidney

transplants per 1,000 dialysis patients in

2016, with 39 transplants per 1,000

dialysis patients in 2016.

133

While the

relatively low rate of transplantation in

the U.S. may partly reflect the high

numbers of dialysis patients and

differences in the relative prevalence

and incidence of ESRD, as we noted in

the proposed rule, there are other likely

contributing causes, such as differences

in health care systems, the

infrastructure supporting

transplantation, and cultural factors.

134

As we discussed in the proposed rule,

the main barrier to kidney transplant is

the supply of available organs. Medicare

is undertaking regulatory efforts to

increase organ supply, discussed in the

proposed rule and in section IV.B.3.a of

this final rule. Further, as discussed in

the proposed rule, we believe there are

a number of things ESRD facilities and

Managing Clinicians can do to assist

their beneficiaries in securing a

transplant. Access to kidney

transplantation can be improved by

increasing referrals to the transplant

waiting list, increasing rates of deceased

and living kidney donation, expanding

the pools of potential donors and

recipients, and reducing the likelihood

that potentially viable organs are

discarded.

135

We noted in the proposed

rule that we anticipated Managing

Clinicians and ESRD facilities selected

for participation in the ETC Model

would address these areas of

improvement through various strategies

in order to improve their rates of

transplantation. As we noted in the

proposed rule, these strategies could

include educating beneficiaries about

transplantation, coordinating care for

beneficiaries as they progress through

the transplant waitlist process, and

assisting beneficiaries and potential

donors with issues surrounding living

donation, including support for paired

donations and donor chains. In paired

donations and donor chains, willing

donors who are incompatible with their

intended recipient can donate to other

candidates on the transplant waitlist in

return for a donation from another

willing donor who is compatible with

their intended recipient.

136

After increasing during the 1990s, the

volume of simultaneous pancreas and

kidney transplants has either remained

stable or declined slightly since the

early 2000s. As we noted in the

proposed rule, the reason for this

decline is not clear, but is likely to be

multifactorial, possibly including a

decrease in patients being placed on the

waiting list for this procedure, more

stringent donor selection, and greater

scrutiny of transplant center

outcomes.

137

As we discussed in the proposed rule,

under current Medicare payment

systems, an ESRD Beneficiary receiving

a kidney transplant represents a loss of

revenue to the ESRD facility and, to a

lesser extent, the Managing Clinician.

After a successful transplant occurs, the

ESRD facility no longer has a care

relationship with the beneficiary, as the

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United States Renal Data System. Annual Data

Report, 2018: Volume 2. Chapter 11. International

Comparisons. https://www.usrds.org/2018/view/v2_

11.aspx.

beneficiary no longer requires

maintenance dialysis. While the

Managing Clinician may continue to

have a care relationship with the

beneficiary post-transplant, payment for

physicians’ services related to

maintaining the health of the

transplanted kidney is lower than the

MCP for managing dialysis. Whereas a

Managing Clinician sees a beneficiary

on dialysis and bills for the MCP each

month, a post-transplant beneficiary

requires fewer visits per year, and these

visits are of a lower intensity. As

described in greater detail in the

proposed rule and throughout this

section IV of this final rule, one of the

aims of the ETC Model is to test whether

new payment incentives would lead to

greater rates of kidney transplantation.

The following is a summary of the

comments received on the benefits of

and barriers to transplantation and our

responses.

Comment: Multiple commenters

expressed support for the premise that

transplantation is the best treatment

option for most patients with ESRD.

These commenters also stated that

research shows that transplantation is

associated with better health outcomes,

better quality of life, and lower health

care expenditures.

Response: We thank the commenters

for their feedback and support.

Comment: A commenter stated that

rates of transplantation in the U.S. are

not directly comparable to rates of

transplantation in other countries due to

different population characteristics.

Response: We thank the commenter

for this feedback. As stated in the

proposed rule and earlier in this final

rule, we acknowledge that, in addition

to variations in the relative prevalence

and incidence of ESRD, there are other

likely contributing causes to the

relatively low rate of transplantation in

the U.S. relative to other countries, such

as differences in health care systems,

the infrastructure supporting

transplantation, and cultural factors.

138

As such, while we included information

about transplant rates in other countries

for comparison, we did not propose to

base the design of the Model’s

transplant component on transplant

rates in other countries. We believe that

the transplant rate in the U.S. can be

higher than it is now, and to that end

are testing this Model in conjunction

with other efforts to increase transplant

rates described in section IV.B.1.a of

this final rule.

Comment: Multiple commenters

expressed agreement with the barriers to

transplantation identified in the

proposed rule (also discussed earlier in

this final rule). Commenters specifically

identified the limited supply of organs

for transplantation as the key barrier to

transplantation. Several commenters

stated that there is significant variation

nationally in the patient experience of

transplantation, including the supply of

organs and transplant center practices.

A commenter stated that each transplant

center sets its own guidelines for

transplant waitlisting, and that some

centers exclude patients who do not

have financial resources or health

insurance coverage beyond Medicare. A

commenter described factors that

patients have identified as limiting their

access to transplant waitlisting,

including: The complexity, intensity,

and difficulty of the waitlisting process;

uncertainty and lack of social, financial,

and medical support; cost; and fear of

loss of Medicare coverage post-

transplant. A commenter stated that lack

of access to primary care and early

detection of kidney disease is associated

with lower likelihood of receiving a

transplant.

Response: We thank the commenters

for their feedback. CMS recognizes that

there are a variety of barriers that

prevent ESRD Beneficiaries from

receiving a transplant at present. As

noted previously in this final rule, we

believe that ESRD facilities and

Managing Clinicians are uniquely

positioned to assist beneficiaries in

overcoming barriers to transplantation,

for both deceased donor transplantation

and living donor transplantation, given

their close care relationship to and

frequent interaction with ESRD

Beneficiaries. Therefore, we have

designed the ETC Model to test whether

outcomes-based payment adjustments

for ESRD facilities and Managing

Clinicians can maintain or improve

quality and reduce costs by increasing

rates of home dialysis and

transplantation. As also noted

previously in this final rule, the ETC

Model is one piece of a larger HHS effort

focused on improving care for patients

with kidney disease. In particular, we

recognize that other transplant

providers, including transplant centers

and organ procurement organizations

(OPOs) are central to the supply and use

of deceased donor organs. As such, we

are implementing the ETC Learning

Collaborative, described in section

IV.C.12 of this final rule, to increase the

supply and use of deceased donor

organs. CMS and HHS have also

undertaken other regulatory efforts to

increase the supply of organs, including

the proposed rule issued December 23,

2019 entitled ‘‘Medicare and Medicaid

Programs; Organ Procurement

Organizations Conditions for Coverage:

Revisions to the Outcome Measure

Requirements for Organ Procurement

Organization[s]’’ (84 FR 70628), and the

proposed rule published December 20,

2019 entitled ‘‘Removing Financial

Disincentives to Living Organ

Donation’’ (84 FR 70139). The payment

adjustments in the ETC Model test one

approach for addressing existing

disincentives to transplantation in the

current Medicare FFS payment system,

including to create incentives to support

a beneficiary through the complexity of

the transplant process. As described in

greater detail in section IV.C.1 of this

final rule, we are altering the PPA

calculation such that ETC Participant

performance will be assessed based on

a transplant rate calculated as the sum

of the transplant waitlist rate and the

living donor transplant rate, rather than

a transplant rate focused on the receipt

of all kidney transplants including

deceased donor transplants. We made

this alteration to recognize the role that

ETC Participants can currently play in

getting patients on the transplant

waitlist rate and in increasing the rate of

living donor transplants described later

on in the rule while allowing the ETC

Learning Collaborative and these other

CMS and HHS rules (if finalized) time

to take effect and to increase the supply

of available deceased donor organs.

However, as described in greater detail

in section IV.C.5.c.(2) of this final rule,

it is also our intent to observe the

supply of deceased donor organs

available for transplantation. Any

change from holding ETC Participants

accountable for the rate of all kidney

transplants including deceased donor

transplantation, rather than the rate of

kidney transplant waitlisting and living

donor transplantation would be

proposed through notice and comment

rulemaking in the future.

In the final rule, we are clarifying that

when referencing kidney transplants in

this final rule and the ETC Model

regulations, CMS is including any

kidney transplant, alone or in

conjunction with any other organ, not

just a kidney transplant or kidney-

pancreas transplant. As discussed in

more detail in section IV.C.5 of this final

rule, we received a comment that urged

CMS to include in the ETC Model

kidney transplants in conjunction with

any other organ, in addition to the

kidney transplants and kidney-pancreas

transplants referenced in the proposed

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rule. By specifying in the proposed rule

that we were including kidney and

kidney-pancreas transplants under the

Model, it was not our intent to imply

that we were excluding kidney

transplants in conjunction with any

other organ. Therefore, as discussed in

section IV.C.5 of this final rule, we are

clarifying as part of the final definition

of kidney transplant that the ETC Model

includes kidney transplants that occur

alone or in conjunction with any other

organ.

c. Addressing Care Deficits Through the

ETC Model

Considering patient and clinician

support for home dialysis and kidney

transplant for ESRD patients, along with

evidence that use of these treatment

modalities could be increased with

education, we proposed to implement

the ETC Model to test whether adjusting

Medicare payments to ESRD facilities

under the ESRD PPS and to Managing

Clinicians under the PFS would

increase rates of home dialysis, both

HHD and PD, and kidney and kidney-

pancreas transplantation.

We proposed that the ETC Model

would include two types of payment

adjustments: The Home Dialysis

Payment Adjustment (HDPA) and the

Performance Payment Adjustment

(PPA). The HDPA would be a positive

payment adjustment on home dialysis

and home dialysis-related claims during

the initial three years of the Model, to

provide an up-front incentive for ETC

Participants to provide additional

support to beneficiaries choosing to

dialyze at home. The PPA would be a

positive or negative payment

adjustment, which would increase over

time, on dialysis and dialysis-related

claims, both home and in-center, based

on the ETC Participant’s home dialysis

rates and transplant rates during a

Measurement Year in comparison to

achievement and improvement

benchmarks, with the aim of increasing

the percent of ESRD Beneficiaries either

having received a kidney transplant or

receiving home dialysis over the course

of the ETC Model. We proposed that the

magnitude of the HDPA would decrease

as the magnitude of the PPA increases,

to shift from a process-based incentive

approach (the HDPA) to an outcomes-

based incentive approach (the PPA).

The proposed payment adjustments

under the ETC Model would apply to all

Medicare-certified ESRD facilities, and

Managing Clinicians enrolled in

Medicare located within Selected

Geographic Areas. While we proposed

to apply the HDPA to all ETC

Participants, the PPA would not apply

to certain ESRD facilities and Managing

Clinicians managing low volumes of

adult ESRD Medicare beneficiaries.

Under our proposal, one or both of the

payment adjustments under the ETC

Model would apply to payments on

claims for dialysis and certain dialysis-

related services with through dates from

January 1, 2020 through June 30, 2026,

with the goal of reducing Medicare

spending, preserving or enhancing

quality of care for beneficiaries, and

increasing beneficiary choice regarding

ESRD treatment modality.

The following is a summary of the

comments received on addressing care

deficits through the ETC Model, and our

responses.

Comment: Multiple commenters

expressed support for the goals of the

proposed Model. Commenters expressed

support for increasing rates of home

dialysis and transplantation, on the

grounds that these alternative renal

replacement modalities are better for

patients with ESRD than in-center

dialysis. Several commenters expressed

support for the proposed Model’s

approach to increasing home dialysis

and transplantation through payment

adjustments, as well as the proposed

Model’s geographic scope and its

mandatory design. These commenters

also stated that the proposed Model had

the potential to: Create system-wide

change; support technological

innovation; and facilitate research into

factors that impact the provision of

dialysis, clinical outcomes related to

dialysis modality selection, and patient

outcomes.

Response: We thank the commenters

for their feedback and support of the

Model’s goals.

Comment: Multiple commenters

stated that they supported the goals of

the proposed Model, but expressed

reservations about aspects of the

Model’s design. Several commenters

stated that any payment incentives for

providers and suppliers need to be

balanced against patient preferences and

minimizing or avoiding unintended

consequences. Several commenters

stated that the ETC Model, as proposed,

would not address some or all of the key

barriers to home dialysis and

transplantation, including that the

Model, as proposed, had an insufficient

focus on prevention and patient

education, organ availability, and the

supply of trained home dialysis staff

including home dialysis nurses, and did

not adequately take into account the

unique structure of the dialysis market.

Several commenters stated that the

proposed Model would not sufficiently

incentivize ETC Participants to take

patient choice into account. Several

commenters expressed concern that the

ETC Model would harm the KCC Model

because the national impact of the ETC

Model would deter participation in and

the evaluation of the KCC Model.

Response: We thank the commenters

for their feedback and support of the

Model’s goals. In terms of the

commenters’ concerns that the Model

does not address some or all of the key

barriers to home dialysis and

transplantation and does not sufficiently

incentivize supporting patient choice,

this Model is one piece of the larger

HHS effort to improve care for

beneficiaries with kidney disease,

which also includes the KCC Model.

While the ETC Model focuses primarily

on modality selection, other parts of the

HHS effort focus more directly on other

ways to improve care for beneficiaries

with kidney disease, including

education and prevention, care

coordination, organ supply, and

technological innovation. We agree that

supporting patient choice in modality

selection is vital, and we believe the

ETC Model will support providers and

suppliers in their ability to assist

beneficiaries choosing renal

replacement modalities other than in-

center dialysis. We address the

commenters’ specific comments about

the interaction with the KCC Model in

section IV.C.6 of this final rule, and in

other sections of this final rule where

particular policies are discussed.

Comment: Multiple commenters

stated that they supported the goals of

the proposed ETC Model but opposed

the Model itself. Several commenters

stated that the proposed Model had

significant methodological limitations

that would lead to unintended

consequences and adverse patient

outcomes. A commenter stated that the

proposed Model would amount to a

payment reduction for all dialysis

providers. Several commenters stated

that, as proposed, methodological flaws

with the Model’s design would prevent

participants from being successful in the

Model. In particular, a few commenters

stated that small dialysis organizations

and rural ESRD facilities would be

harmed due to the financial risk in the

Model. Several commenters stated that

rather than implement the ETC Model,

CMS should focus on implementing

voluntary models that incentivize

dialysis providers to collaborate around

care coordination, such as the CEC

Model. A commenter stated that, as the

current organ allocation system may

change, it is inappropriate to test a

model around transplantation at this

time.

Response: We thank the commenters

for their feedback and support of the

Model’s goals. We address commenters’

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specific comments about

methodological concerns, the impact of

the Model on small and rural ESRD

facilities, and the organ allocation

system in later sections of this final rule

where particular policies are discussed.

Comment: Several commenters stated

that supporting patient choice and

informed decision-making are vital, and

should be the focus of the proposed

Model.

Response: We thank the commenters

for their feedback, and we agree that

supporting patient choice in modality

selection is vital. We believe this Model

will support beneficiaries’ ability to

choose renal replacement modalities

other than in-center HD.

Comment: Many commenters

recommended additional or alternative

approaches, outside of the ETC Model,

that CMS could take to improve quality

of care for Medicare beneficiaries with

kidney disease.

Response: We thank commenters for

their feedback; however, these

suggestions did not address the ETC

Model and therefore are out of scope for

this rulemaking. We may consider these

comments in developing future policies

related to beneficiaries with kidney

disease.

2. The Medicare ESRD Program

In the proposed rule and in this

section of the final rule, we describe

current Medicare payment rules and

how they may create both positive and

negative incentives for the provision of

home dialysis services and kidney

transplants.

a. History of the Medicare ESRD

Program

Section 299I of the Social Security

Amendments of 1972 (Pub. L. 92–603)

extended Medicare coverage to

individuals regardless of age who have

permanent kidney failure, or ESRD,

requiring either dialysis or kidney

transplantation to sustain life, and who

meet certain other eligibility

requirements. Individuals who become

eligible for Medicare on the basis of

ESRD are eligible for all Medicare-

covered items and services, not just

those related to ESRD. Subsequently,

the ESRD Amendments of 1978 (Pub. L.

95–292) amended Title XVIII of the Act

by adding section 1881.

Section 1881 of the Act establishes

Medicare payment for services

furnished to individuals who have been

determined to have ESRD, including

payments for self-care home dialysis

support services furnished by a provider

of services or renal dialysis facility,

home dialysis supplies and equipment,

and institutional dialysis services and

supplies. Section 1881(c)(6) of the Act

states: It is the intent of the Congress

that the maximum practical number of

patients who are medically, socially,

and psychologically suitable candidates

for home dialysis or transplantation

should be so treated. This provision also

directs the Secretary of HHS to consult

with appropriate professional and

network organizations and consider

available evidence relating to

developments in research, treatment

methods, and technology for home

dialysis and transplantation.

Prior to 2011 and the implementation

of the ESRD PPS, Medicare had a

composite payment system for the costs

incurred by ESRD facilities furnishing

outpatient maintenance dialysis,

including some routinely provided

drugs, laboratory tests, and supplies,

whether the services were furnished in

a facility or at home. (For a discussion

of the composite payment system,

please see 75 FR 49032). Under this

methodology, prior to 2009, CMS

differentiated between hospital-based

and independent facilities for purposes

of setting the payment rates. (Effective

January 1, 2009, CMS discontinued the

policy of separate payment rates based

on this distinction, 75 FR 49034).

However, the same rate applied

regardless of whether the dialysis was

furnished in a facility or at a

beneficiary’s home (75 FR 49058). The

system was relatively comprehensive

with respect to the renal dialysis

services included as part of the

composite payment, but over time a

substantial portion of expenditures for

renal dialysis services such as drugs and

biologicals were not included under the

composite payment and paid separately

in accordance with the respective fee

schedules or other payment

methodologies (75 FR 49032). With the

enactment of the Medicare

Improvements for Patients and

Providers Act of 2008 (MIPPA) (Pub. L.

110–275), the Secretary was required to

implement a payment system under

which a single payment is made for

renal dialysis services in lieu of any

other payment.

As we described in the proposed rule,

in 2008, CMS issued a final rule entitled

‘‘Medicare and Medicaid Programs;

Conditions for Coverage for End-Stage

Renal Disease Facilities,’’ which was the

first comprehensive revision since the

outset of the Medicare ESRD program in

the 1970s. The Conditions for Coverage

(CfC) established by this final rule

include separate, detailed provisions

applicable to home dialysis services,

setting substantive standards for

treatment at home to ensure that the

quality of care is equivalent to that for

in-center patients. (73 FR 20369, 20409,

April 15, 2008).

As we also noted in the proposed

rule, on January 1, 2011, CMS

implemented the ESRD PPS, a case-mix

adjusted, bundled PPS for renal dialysis

services furnished by ESRD facilities as

required by section 1881(b)(14) of the

Act, as added by section 153(b) of

MIPPA. The ESRD PPS is discussed in

detail in the following section.

b. Current Medicare Coverage of and

Payment for ESRD Services

The Medicare program covers a range

of services and items associated with

ESRD treatment. Medicare Part A

generally includes coverage of inpatient

dialysis for patients admitted to a

hospital or skilled nursing facility for

special care, as well as inpatient

services for covered kidney transplants.

Medicare Part B generally includes

coverage of renal dialysis services

furnished by Medicare-certified

outpatient facilities, including certain

dialysis treatment supplies and

medications, home dialysis services,

support and equipment, and doctor’s

services during a kidney transplant.

Costs for medical care for a kidney

donor are covered under either Part A

or B, depending on the service. To date,

Medicare Part C has been available to

ESRD Beneficiaries only in limited

circumstances, such as when an

individual already was enrolled in a

Medicare Advantage (MA) plan at the

time of ESRD diagnosis; however, as

required under section 17006 of the 21st

Century Cures Act, ESRD Beneficiaries

will be allowed to enroll in MA plans

starting with 2021. Medicare Part D

generally provides coverage for

outpatient prescription drugs not

covered under Part B, including certain

renal dialysis drugs with only an oral

form of administration (oral-only drugs),

and prescription medications for related

conditions.

(1) The ESRD PPS Under Medicare

Part B

As we discussed in the proposed rule,

under the ESRD PPS, a single per

treatment payment is made to an ESRD

facility for all of the renal dialysis

services and items defined in section

1881(b)(14)(B) of the Act and furnished

to beneficiaries for the treatment of

ESRD in a facility or in a patient’s home.

The ESRD PPS includes patient-level

adjustments for case mix, facility-level

adjustments for wage levels, low-

volume facilities and rural facilities,

and, when applicable, a training add-on

for home and self-dialysis modalities, an

additional payment for high cost

outliers due to unusual variations in the

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139

After we published the proposed rule to

implement the ETC Model, CMS established the

TPNIES under the ESRD PPS as part of the CY 2020

ESRD PPS final rule (84 FR 60648). We discuss the

implications of this change for the ETC Model

payment adjustments in sections IV.C.4.b, and

IV.C.5.e(1) of this final rule.

140

Medicare Claims Processing Manual, Chapter

8, 140; https://www.cms.gov/Regulations-and-

Guidance/Manuals/Downloads/clm104.c08.pdf.

141

United States Government Accountability

Office, 2015.

142

United States Government Accountability

Office, 2015.

type or amount of medically necessary

care, a transitional drug add-on payment

adjustment (TDAPA), and a transitional

add-on payment adjustment for new and

innovative equipment and supplies

(TPNIES).

139

Under section

1881(b)(14)(F) of the Act, the ESRD PPS

payment amounts are increased

annually by an ESRD market basket

increase factor, reduced by the

productivity adjustment described in

section 1886(b)(3)(B)(xi)(II) of the Act.

As we noted in the proposed rule, in

implementing the ESRD PPS, we have

sought to create incentives for providers

and suppliers to offer home dialysis

instead of just dialysis at a facility. In

the CY 2011 ESRD PPS final rule, we

noted that in determining payment

under the ESRD PPS, we took into

account all costs necessary to furnish

home dialysis treatments including

staff, supplies, and equipment. In that

rule, we described that Medicare would

continue to pay, on a per treatment

basis, the same base rate for both in-

facility and home dialysis, as well as for

all dialysis treatment modalities

furnished by an ESRD facility (HD and

the various forms of PD) (75 FR 49057,

49059, 49064). The CY 2011 ESRD PPS

final rule also finalized a wage-adjusted

add-on per treatment adjustment for

home and self-dialysis training under 42

CFR 413.235(c), as CMS recognized that

the ESRD PPS base rate alone does not

account for the staffing costs associated

with one-on-one focused home dialysis

training treatments furnished by a

registered nurse (75 FR 49064). CMS

noted, however, that because the costs

associated with the onset of dialysis

adjustment and the training add-on

adjustment overlap, ESRD facilities

would not receive the home dialysis

training adjustment in addition to the

add-on payment under the ESRD PPS

for the first 4 months of dialysis for a

Medicare patient (75 FR 49063, 49094).

As we noted in the proposed rule,

ESRD PPS payment requirements are set

forth in 42 CFR part 413, subpart H.

Since the implementation of the ESRD

PPS, CMS has published annual rules to

make routine updates, policy changes,

and clarifications. Payment to ESRD

facilities under the ESRD PPS for a

calendar year might also be reduced by

up to two percent based on their

performance under the ESRD QIP,

which is authorized by section 1881(h)

of the Act. Section 1881(h) of the Act

requires the Secretary to select

measures, establish performance

standards that apply to the measures,

and develop a methodology for

assessing the total performance for each

renal dialysis facility based on the

performance standards established with

respect to the measures for a

performance period. CMS uses notice

and comment rulemaking to make

substantive updates to the ESRD PPS

and ESRD QIP program requirements.

(2) The MCP

As we discussed in the proposed rule,

Medicare pays for routine professional

services relating to dialysis care directly

to a billing physician or non-physician

practitioner. When Medicare pays the

physician or practitioner separately for

routine dialysis-related physicians’

services furnished to a dialysis patient,

the payment is made under the

Medicare physician fee schedule using

the MCP method as specified in 42 CFR

414.314. The per-beneficiary per-month

MCP is for all routine physicians’

services related to the patient’s renal

condition. Whereas the MCP for patients

dialyzing in-center varies based on the

number of in-person visits the physician

has with the patient during the month,

the MCP for patients dialyzing at home

is the same regardless of the number of

in-person visits.

140

(3) The Kidney Disease Education

Benefit

As we discussed in the proposed rule,

in addition to establishing the ESRD

PPS, the MIPPA, in section 152(b),

amended section 1861(s)(2) of the Act

by adding a new subparagraph (EE)

‘‘kidney disease education services’’ as

a Medicare-covered benefit under Part B

for beneficiaries with Stage 4 CKD.

Medicare currently covers up to 6 1-

hour sessions of KDE services,

addressing the choice of treatment (such

as in-center HD, home dialysis, or

kidney transplant) and the management

of comorbidities, among other topics (74

FR 61737, 61894).

However, utilization of KDE services

has been low. As we described in the

proposed rule, citing the USRDS, GAO

reported that less than 2 percent of

eligible Medicare beneficiaries used the

KDE benefit in 2010 and 2011, the first

2 years it was available, and that use of

the benefit has decreased since then.

141

According to GAO, stakeholders have

attributed this low usage to the statutory

restrictions on which practitioners can

provide this service, and also the

limitation of eligibility to the specific

category of Stage 4 CKD patients. As we

noted in the proposed rule, these

restrictions are specified in section

1861(ggg)(1) and (2) of the Act. A

‘‘qualified person’’ is a physician,

physician assistant, or nurse

practitioner, or a provider of services

located in a rural area. GAO cited

literature emphasizing the importance

of pre-dialysis education in helping

patients to make informed treatment

decisions, and indicating that patients

who have received such education

might be more likely to choose home

dialysis.

c. Impacts of Medicare Payment Rules

on Home Dialysis

As we discussed in the proposed rule,

in the CY 2011 ESRD PPS final rule, we

acknowledged concerns from

commenters that the proposed ESRD

PPS might contribute to decreasing rates

of home dialysis. In particular,

commenters stated that the single

payment method would require ESRD

facilities to bear the supply and

equipment costs associated with home

dialysis modalities, and thus make them

less economically feasible. We noted in

response that while home dialysis

suppliers may not achieve the same

economies of scale as ESRD facilities,

suppliers would remain able to provide

equipment and supplies to multiple

ESRD facilities and be able to negotiate

competitive prices with ESRD

equipment and supply manufacturers

(75 FR 49060). Nevertheless, we stated

that we would monitor utilization of

home dialysis under the ESRD PPS (75

FR 49057, 49060).

As we further discussed in the

proposed rule, a May 2015 report from

GAO examined the incentives for home

dialysis associated with Medicare

payments to ESRD facilities and

physicians. Citing the USRDS, GAO

found a decrease in the percentage of

home dialysis patients as a percentage

of all dialysis patients between 1988

and 2008, but then a slight increase to

11 percent in 2012.

142

According to

GAO, the more recent increase in use of

home dialysis was also reflected in CMS

data for adult Medicare dialysis

patients, showing an increase from 8

percent using home dialysis in January

2010 to about 10 percent as of March

2015.

Although this increase was generally

concurrent with the phase-in of the

ESRD PPS, the GAO report identified

factors that might undermine incentives

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United States Government Accountability

Office, 2015.

144

United States Government Accountability

Office, 2015.

145

United States Government Accountability

Office, 2015.

146

Marrufo G, et al. Comprehensive End-Stage

Renal Disease Care (CEC) Model: Performance Year

2 Annual Evaluation Report. CMS Innovation

Center. September 2019; innovation.cms.gov/Files/

reports/cec-annrpt-py2.pdf.

to encourage home dialysis. According

to interviews with stakeholders,

facilities’ costs for increasing provision

of in-center HD may be lower than for

either HHD or PD. Although the average

cost of an in-center HD treatment is

typically higher than the average cost of

a PD treatment, ESRD facilities may be

able to add an in-center patient without

incurring the cost of an additional

dialysis machine because each machine

can be used by 6 to 8 patients. In

contrast, when adding a home dialysis

patient, facilities generally incur costs

for additional equipment specific to

individual patients.

143

Similarly, GAO received comments

from physicians and physician

organizations that Medicare payment

may lead to a disincentive to prescribe

home dialysis, because management of

a home dialysis patient often occurs in

a private setting and tends to be more

comprehensive, while visits to multiple

in-center patients may be possible in the

same period of time. The GAO report

noted, on the other hand, that monthly

physician payments for certain patients

under 65 who undergo home dialysis

training may begin the first month,

instead of the fourth, of dialysis, which

may provide physicians with an

incentive to prescribe home dialysis. In

addition, the GAO report stated that

Medicare makes a one-time payment for

each patient who has completed home

dialysis training under the physician’s

supervision.

144

The GAO report concluded that

interviews with stakeholders indicated

potential for further growth, noting that

the number and percentage of patients

choosing home dialysis had increased in

the recent years. The report stated that

Medicare payments to facilities and

physicians would need to be consistent

with the goal of encouraging home

dialysis when appropriate. A specific

recommendation was to examine

Medicare policies regarding monthly

Medicare payments to physicians and

revise them if necessary to encourage

physicians to prescribe home dialysis

for patients for whom it is

appropriate.

145

As discussed in the proposed rule, in

the CY 2017 ESRD PPS final rule, CMS

finalized an increase to the home and

self-dialysis training add-on payment

adjustment (81 FR 77856), to provide an

increase in payment to ESRD facilities

for training beneficiaries to dialyze at

home.

3. CMS Efforts To Support Modality

Choice

While CMS has taken steps in the past

to support modality choice, the deficits

in care previously described—low rates

of home dialysis and kidney

transplantation—remain. We noted in

the proposed rule our belief that the

proposed ETC Model is consistent with

several different recent actions to

support modality choice for ESRD

Beneficiaries, which are described in

the proposed rule as well as this final

rule.

a. Regulatory Efforts

As discussed in the proposed rule, on

September 20, 2018, we published in

the Federal Register a proposed rule

entitled ‘‘Medicare and Medicaid

Programs; Regulatory Provisions to

Promote Program Efficiency,

Transparency, and Burden Reduction’’

(83 FR 47686). This rule was finalized

without change on September 30, 2019

(84 FR 51732). This final rule, among

other things, removed the requirements

at 42 CFR 482.82 that required

transplant centers to submit clinical

experience, outcomes, and other data in

order to obtain Medicare re-approval.

CMS removed these requirements in

order to address the unintended

consequences that occurred as a result

of the Medicare re-approval

requirements, which have resulted in

transplant programs potentially

avoiding performing transplant

procedures on certain patients and

many organs with perceived risk factors

going unused out of fear of being

penalized for outcomes that are non-

compliant with § 482.82. Although CMS

removed certain requirements at

§ 482.82, CMS emphasized that

transplant programs should focus on

maintaining high standards that protect

patient health and safety and produce

positive outcomes for transplant

recipients. As we noted in this final

rule, CMS will also do complaint

investigations based on public or

confidential reports about outcomes or

adverse events. These efforts, and the

survey of the other Conditions of

Participation, will provide sufficient

oversight to ensure that transplant

programs will continue to achieve and

maintain high standards of care. (84 FR

51749).

In addition, as we discussed in the

proposed rule, on November 14, 2018,

CMS published in the Federal Register

a final rule entitled ‘‘Medicare Program;

End-Stage Renal Disease Prospective

Payment System, Payment for Renal

Dialysis Services Furnished to

Individuals With Acute Kidney Injury,

End-Stage Renal Disease Quality

Incentive Program, Durable Medical

Equipment, Prosthetics, Orthotics and

Supplies (DMEPOS) Competitive

Bidding Program (CBP) and Fee

Schedule Amounts, and Technical

Amendments To Correct Existing

Regulations Related to the CBP for

Certain DMEPOS’’ (CY 2019 ESRD PPS

final rule) (83 FR 56922). In that final

rule, CMS adopted a new measure for

the ESRD Quality Incentive Program

(QIP) beginning with PY 2022, entitled

the Percentage of Prevalent Patients

Waitlisted (PPPW) measure, and placed

that measure in the Care Coordination

domain for purposes of performance

scoring under the program. We stated

that the adoption of this measure

reflects CMS’s belief that ESRD facilities

should make better efforts to ensure that

their patients are appropriately

waitlisted for transplants (83 FR 57006).

We also noted in the proposed rule that

the proposed ETC Model would provide

greater incentives for ESRD facilities

and Managing Clinicians participating

in the Model to assist ESRD

Beneficiaries with navigating the

transplant process, including

coordinating care to address clinical and

non-clinical factors that impact

eligibility for wait-listing and

transplantation.

b. Alternative Payment Models

Recognizing the importance of

ensuring quality coordinated care to

beneficiaries with ESRD, in 2015, CMS

began testing the Comprehensive ESRD

Care (CEC) Model. As we noted in the

proposed rule, the CEC Model is an

accountable care model in which

dialysis facilities, nephrologists, and

other health care providers join together

to form ESRD Seamless Care

Organizations (ESCOs) that are

responsible for the cost and quality of

care for aligned beneficiaries. Although

there are no specific incentives under

the CEC Model relating to home

dialysis, CMS evaluated whether total

cost of care incentives caused an

increase in the rate of home dialysis, as

would be predicted by some of the

literature, during the first two years of

the CEC Model. To date, the evaluation

has not shown any statistically

significant impact on the rates of home

dialysis among CEC Model

participants.

146

Although the evaluation

results available for the CEC Model thus

far are limited, as we noted in the

proposed rule, based on these

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preliminary findings CMS believes that

more targeted, system-wide incentives

may be necessary to encourage modality

choices and that the agency must

provide explicit incentives in order to

affect behavior changes by providers

and suppliers.

On July 10, 2019, CMS announced the

Kidney Care Choices (KCC) Model

(formerly the Comprehensive Kidney

Care (CKC) Model). The KCC Model

builds on the existing CEC Model, and

includes incentives for coordinating

care for aligned beneficiaries with CKD

or ESRD and for reducing the total cost

of care for these beneficiaries, as well as

providing financial incentives for

successful transplants. As we noted in

the proposed rule, we view the KCC

Model as complementary to the ETC

Model, as both models incentivize a

greater focus on kidney transplants. We

proposed that ESRD facilities and

Managing Clinicians may participate in

both models, as discussed in the

proposed rule and section IV.C.6 of this

final rule.

C. Provisions of the Proposed Regulation

1. Proposal To Implement the ETC

Model

In this section IV of the final rule, we

discuss the policies that we proposed

for the ETC Model, including model-

specific definitions and the general

framework for implementation of the

ETC Model. The payment adjustments

for the proposed ETC Model were

designed to support increased

utilization of home dialysis modalities

and kidney and kidney-pancreas

transplants that may, according to the

literature described earlier in this

section IV of the rule, be subject to

barriers. Specifically, with regard to

home dialysis, we acknowledged in the

proposed rule the possible need for

ESRD facilities to invest in new systems

that ensure that appropriate equipment

and supplies are available in an

economical manner to support greater

utilization by beneficiaries. We also

recognized in the proposed rule that

dialysis providers, nephrologists, and

other clinicians would need to enhance

education and training, both for patients

and professionals, that there are barriers

to patients choosing and accepting

home dialysis modalities, and that the

appropriateness of home dialysis as a

treatment option varies among patients

according to demographic and clinical

characteristics, as well as personal

choice.

We proposed that the duration of the

payment adjustments under the ETC

Model would be 6 years and 6 months,

beginning on January 1, 2020, and

ending on June 30, 2026. We also

considered an alternate start date of

April 1, 2020, to allow more time to

prepare for Model implementation. We

noted in the proposed rule that, if the

ETC Model were to begin April 1, 2020,

all intervals within the timelines

outlined in the proposed rule, including

the periods of time for which claims

would be subject to adjustment by the

HDPA and the Measurement Years and

Performance Payment Adjustment

Periods used for purposes of applying

the PPA, would remain the same length,

but start and end dates would be

adjusted to occur three months later.

We also included in the proposed rule

the following proposals for the Model:

(a) The method for selecting ESRD

facilities and Managing Clinicians for

participation; (b) the schedule and

methodologies for payment adjustments

under the Model, and waivers of

Medicare payment requirements

necessary solely to test these

methodologies under the Model; (c) the

performance assessment methodology

for ETC Participants, including the

proposed methodologies for beneficiary

attribution, benchmarking and scoring,

and calculating the Modality

Performance Score; (d) monitoring and

evaluation, including quality measure

reporting; and (e) overlap with other

CMS models and programs.

We proposed to codify the definitions

and policies of the ETC Model at

subpart C of part 512 of 42 CFR

(proposed §§ 512.300 through 512.397).

We discuss the proposed definitions in

section IV.C.2 of this final rule and each

of the proposed regulatory provisions

under the applicable subject area later.

Section II of this final rule provides that

the general provisions codified at

§§ 512.100 through 512.180 apply to

both the ETC Model and the RO Model

described in section III of this rule.

The following is a summary of the

comments received on the proposal to

implement the Model, including the

proposed start date and duration of the

Model, and our responses.

Comment: Many commenters opposed

starting the model on January 1, 2020.

Commenters stated that January 1, 2020

was too soon, and would not provide

ETC Participants sufficient advance

notice to prepare for successful

participation in the Model and begin

working to address barriers to home

dialysis and transplantation. In

particular, commenters pointed to

specific areas in which ETC Participants

would need time to prepare, including:

Design and implementation of new care

processes; development of new

relationships with other care providers,

particularly transplant providers and

vascular access providers; securing

supplies necessary to operate and

maintain a home dialysis program;

training of clinical staff, particularly

home dialysis nurses; development of

new health information and data

systems to track and manage patients;

and making decisions about

participating in other CMS models and

programs. Commenters also

recommended delaying the start date to

allow CMS to resolve outstanding

concerns from the stakeholder

community, and to assess the efficacy of

the model design. Several commenters

suggested that CMS delay the start date

to no sooner than April 1, 2020, the

alternative start date included in the

proposed rule. Several other

commenters suggested a longer delay,

including suggestions of July 1, 2020,

October 1, 2020, and January 1, 2021.

Several commenters suggested an

indefinite delay, such that the Model

would not begin until CMS further

consulted with stakeholders to resolve

their concerns, including through a

second round of notice and comment

rulemaking. A commenter suggested

that the Model be delayed until

potential changes to the organ allocation

system are resolved.

Response: We appreciate the feedback

from the commenters. After reviewing

the concerns raised in the comments

received, we agree that implementing

the ETC Model on January 1, 2020

would not allow ETC Participants

sufficient time to prepare for successful

participation in the Model. We

appreciate the feedback from the

commenters about alternative start dates

for the Model that would allow ETC

Participants sufficient time to prepare

for the Model. We had intended to delay

the ETC Model implementation date

until July 1, 2020, as had been

recommended by some of the

commenters, but as we were completing

this final rule, the U.S. began

responding to an outbreak of respiratory

disease caused by a novel coronavirus,

referred to as ‘‘coronavirus disease

2019’’ (COVID–19), which created a

serious public health threat greatly

impacting the U.S. health care system.

The Secretary of the Department of

Health and Human Services, Alex M.

Azar II, declared a Public Health

Emergency (PHE) on January 31, 2020,

retroactively effective from January 27,

2020, to aid the nation’s healthcare

community in responding to the

COVID–19 pandemic. On July 23, 2020,

Secretary Azar renewed, effective July

25, 2020, the determination that a PHE

exists.

In light of this unprecedented PHE,

which continues to strain health care

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resources, as well as our understanding

that ETC Participants may have limited

capacity to meet the ETC Model

requirements in 2020, we are delaying

implementation until January 1, 2021 to

ensure that participation in the ETC

Model does not further strain the ETC

Participants’ capacity, potentially

hindering the delivery of safe and

efficient dialysis care. We believe this

delayed implementation will provide

ETC Participants with sufficient time to

prepare for participation in the Model

and adhere to Model requirements.

Since the Model will begin on January

1, 2021, rather than January 1, 2020

(that is, 12 months later than proposed),

all time intervals outlined in the

proposed rule, including the periods of

time for which claims are adjusted for

the HDPA and Measurement Years and

Performance Payment Adjustment

Periods for the purposes of applying the

PPA, will remain the same in length, but

will begin and end 12 months later than

proposed. For detailed descriptions of

these time periods, see sections IV.C.5.d

(HDPA) and IV.C.5.a (MYs and PPA

Periods) of this final rule. Also, as this

final rule was published to the Federal

Register in September, 2020, ETC

Participants have more than 90 days to

prepare to participate in the Model,

which we believe is sufficient.

In response to the commenters’

recommendations that we delay

implementation of the ETC Model until

we have gone through another round of

rulemaking, we have made certain

changes to the policies we proposed for

the Model in response to the comments

we received, as discussed in subsequent

sections of this final rule, and we do not

believe that it is necessary to conduct an

additional round of notice and comment

rulemaking before finalizing the rule

and implementing the ETC Model. With

respect to comments recommending that

CMS delay implementation of the

Model until changes to the transplant

system have had time to take effect, as

discussed in section IV.C.5.c.(2) of this

final rule, we are altering the MPS

calculation such that ETC Participant

performance will be assessed based on

a transplant rate calculated as the sum

of the transplant waitlist rate and the

living donor transplant rather than a

transplant rate focused on all kidney

transplants including deceased donor

transplants. We made this alteration to

recognize the role that ETC Participants

can currently play in getting patients on

the transplant waitlist rate and in

increasing the rate of donor transplants

while allowing the effects from the ETC

Learning Collaborative time to take

effect, together with the other proposed

rules addressing the transplant system

(if finalized), and we do not believe that

any further delays are necessary. As

discussed in section IV.C.5.c.(2) of this

final rule, it is our intent to observe the

supply of deceased donor organs

available for transplantation.

Comment: Several commenters

suggested that the Model have a

staggered implementation, with some

components of the Model beginning

right away and other components

phasing in over the duration of the

Model. Several commenters suggested

using a ‘‘Year 0’’ approach, in which

ETC Participants would be in the Model

for one year before payment adjustments

begin. Similarly, several commenters

suggested that the downward payment

adjustments in the PPA be delayed for

some amount of time, either until

Measurement Year (MY) 3 or MY4, to

give ETC Participants more time to

implement changes before they would

be subject to downside financial risk,

and to allow other changes to the

transplant system time to take effect. A

commenter suggested that downward

payment adjustments should begin in

2021 for large dialysis organizations

(LDOs) and in 2022 for all other dialysis

organizations.

Response: We do not believe it is

necessary to phase-in our

implementation of the Model, including

the onset of downward payment

adjustments. The payment adjustments

under the Model already begin with the

HDPA, which is an upward payment

adjustment only. The Model will be

ongoing for 1 year and 6 months before

the PPA begins, functionally phasing-in

the Model’s downward payment

adjustment. As discussed in section

IV.C.3.a of this final rule, the size of the

Model is determined based on the

necessary participation and duration to

detect a statistically meaningful effect. If

we were to further phase-in the

implementation of the downward

payment adjustments, we would not

have sufficient duration to evaluate the

effectiveness of the payment

adjustments at achieving the Model’s

goals. While we appreciate the

commenters’ recommendation that CMS

adopt a ‘‘Year 0’’ approach, and note

that CMS has taken this approach in

other models, in the case of the ETC

Model a ‘‘Year 0’’ would amount to

nothing more than a delayed

implementation. As discussed earlier in

this section IV.C.1 of this final rule, we

believe that delaying the

implementation of this Model to January

1, 2021, is sufficient to address the

commenters’ concerns about the lead

time needed prior to participation in the

Model. We do not believe it is

appropriate to stagger the

implementation of the payment

adjustments to ESRD facilities based on

dialysis organization type, as a

commenter suggested, as this approach

could unfairly advantage ESRD facilities

owned by certain types of dialysis

organizations over others.

Comment: A few commenters

recommended that CMS shorten the

duration of the Model test to 3 years,

with two optional extension years.

Commenters stated that this approach

would allow for a more limited test of

the Model, and would facilitate

extension of the Model if the Model

appears to be achieving the intended

goals during the initial 3 years.

Additionally, commenters suggested

that the initial years of the Model be

limited to a smaller portion of the

country, such as 10 percent, and that

CMS increase the size of the Model in

future years.

Response: As discussed in the

proposed rule and in section IV.C.3.a of

this final rule, the geographic scope of

the Model is determined based on the

scope of participation necessary to

detect a statistically meaningful effect.

We do not anticipate that we would be

able to determine whether the Model is

achieving its goals after three years,

particularly as we are limiting the

Model to a smaller portion of the

country than originally proposed, such

that we could decide to extend the

Model at that time.

Comment: Several commenters stated

that CMS should conduct subsequent

rulemaking through the duration of the

Model to adapt the Model based on

observations made during the operation

of the Model.

Response: We agree that if it becomes

apparent that changes to the Model are

needed during the Model’s

implementation, any potential changes

to the ETC Model provisions would be

made through subsequent notice and

comment rulemaking. As discussed in

section II.J of this final rule, we note

that section 1115A(b)(3)(B) of the Act

requires CMS to modify or terminate the

design or implementation of a model

test under certain circumstances.

Comment: Several commenters

recommended that CMS separate the

ETC Model into two separate payment

models, one focused on home dialysis

and one focused on kidney

transplantation. Commenters stated that

this approach would account for

differences in the barriers to home

dialysis and transplantation and the

different incentives needed to overcome

those barriers. Commenters also stated

that this approach would allow CMS to

operate smaller model tests that would

produce more actionable results.

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Response: The ETC Model is designed

to test whether the mechanisms

included in the Model will achieve the

Model’s goals, through incentivizing

Managing Clinicians and ESRD facilities

to support modality choice. We view

home dialysis and transplantation as

complementary alternative renal

replacement modalities, not as separate

aims. Therefore, we do not see them as

separable into two separate model tests.

We disagree that testing two separate

models would be needed to produce

more actionable results, as the

evaluation of the ETC Model is designed

to detect an increase in either home

dialysis rates, transplant rates, or both.

After considering public comments,

we are finalizing our proposed

provisions regarding implementation of

the ETC Model, with modification to

our regulation at § 512.320 to adjust the

dates for application of the payment

adjustments under the ETC Model. The

start date for application of the ETC

Model’s payment adjustments has

changed from applying to claims with a

claim through date beginning January 1,

2020, to claims with a claim service date

beginning on or after January 1, 2021.

The end date for application of such

payment adjustments has changed from

applying to claims with a claim through

date ending June 30, 2026, to claims

with a claim service date ending on or

before June 30, 2027. We also are

modifying which date associated with

the claim we are using to determine if

the claim is subject to the payment

adjustments under the Model. Whereas

we proposed using the claim through

date, which is the last day on the billing

statement for services furnished to the

beneficiary, we are finalizing using the

date of service on the claim, which is

the date on which the service was

furnished. We are making this change

from using claim through date to using

date of service to align with Medicare

claims processing standards. While

Medicare claims data contains both

claim through dates and dates of

service, Medicare claims are processed

based on dates of service. Therefore, in

order to process payment adjustments,

we will use the date of service to

determine the claims subject to

adjustment under the Model.

2. Definitions

We proposed at § 512.310 to define

certain terms for the ETC Model. We

describe these proposed definitions in

context throughout the proposed rule

and section IV of this final rule. In

addition, we proposed that the

definitions proposed in section II of the

proposed rule also would apply to the

ETC Model. We received comments on

our proposed definitions.

After considering public comments,

we are finalizing our proposed

provisions on the definitions with

modification, as described elsewhere in

this section IV of this final rule.

Specifically, we are codifying in our

regulations at § 512.310 to define certain

terms for the ETC Model. We have

summarized the comments received and

responded to them through this section

IV of the final rule, where relevant.

3. ETC Participants

a. Mandatory Participation

We proposed to require all Managing

Clinicians and all ESRD facilities

located in Selected Geographic Areas to

participate in the ETC Model. We

proposed to define ‘‘selected geographic

area(s)’’ as those Hospital Referral

Regions (HRRs) selected by CMS, as

described in the proposed rule and in

section IV.C.3.b of this final rule, for

purposes of selecting ESRD facilities

and Managing Clinicians required to

participate in the ETC Model as ETC

Participants. Our proposed definition of

‘‘Hospital Referral Regions (HRRs)’’ is

described in the proposed rule and in

section IV.C.3.b of this final rule.

For purposes of the ETC Model, we

proposed to define ‘‘ESRD facility’’ as

defined in 42 CFR 413.171. As we

described in the proposed rule, under

§ 413.171, an ESRD facility is an

independent facility or a hospital-based

provider of services (as described in 42

CFR 413.174(b) and (c)), including

facilities that have a self-care dialysis

unit that furnish only self-dialysis

services as defined in § 494.10 and

meets the supervision requirements

described in 42 CFR part 494, and that

furnishes institutional dialysis services

and supplies under 42 CFR 410.50 and

410.52. We proposed this definition

because this is the definition used by

Medicare for the ESRD PPS. We

considered creating a definition specific

to the ETC Model; however, as noted in

the proposed rule, we believe that the

ESRD PPS definition of ESRD facility

captures all facilities that furnish renal

dialysis services that we are seeking to

include as participants in the ETC

Model.

For purposes of the ETC Model, we

proposed to define ‘‘Managing

Clinician’’ as a Medicare-enrolled

physician or non-physician practitioner

who furnishes and bills the MCP for

managing one or more adult ESRD

Beneficiaries. In the proposed rule, we

considered limiting the definition to

nephrologists, or other specialists who

furnish dialysis care to beneficiaries

with ESRD, for purposes of the ETC

Model. However, as we noted in the

proposed rule, analyses of claims data

revealed that a variety of clinician

specialty types manage ESRD

Beneficiaries and bill the MCP,

including non-physician practitioners.

We continue to believe that the

proposed approach to defining

Managing Clinicians more accurately

captures the set of practitioners we are

seeking to include as participants in the

ETC Model, rather than limiting the

scope to self-identified nephrologists.

As proposed, the ETC Model would

require the participation of ESRD

facilities and Managing Clinicians in

Selected Geographic Areas that might

not otherwise participate in a payment

model involving payment adjustments

based on participants’ rates of home

dialysis and kidney transplants.

Participation in other CMS models

focused on ESRD, such as the CEC

Model and the KCC Model, is optional.

Interested individuals and entities must

apply to such models during the

applicable application period(s) to

participate. To date, we have not tested

an ESRD-focused payment model in

which ESRD facilities and Managing

Clinicians have been required to

participate. We considered using a

voluntary design for the ETC Model as

well; however, as noted in the proposed

rule, we believe that a mandatory design

has advantages over a voluntary design

that are necessary to test this Model, in

particular. First, we believe that testing

a new payment model specific to

encouraging home dialysis and kidney

transplants may require the engagement

of an even broader set of ESRD care

providers than have participated in

CMS models to date, including

providers and suppliers who would

participate only in a mandatory ESRD

payment model. As we discussed in the

proposed rule, we are concerned that

only a non-representative and relatively

small sample of providers and

suppliers, namely those that already

have higher rates of home dialysis or

kidney transplants relative to the

national benchmarks, would participate

in a voluntary model, which would not

provide a robust test of the proposed

payment incentives. In addition,

because kidney and kidney-pancreas

transplants are rare events—fewer than

4 percent of ESRD Beneficiaries

received such a transplant in 2016—we

noted in the proposed rule that we

would need a large number of

beneficiaries to be included in the

model test and comparison groups in

order to detect a change in the rate of

transplantation under the ETC Model.

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Second, as noted in the proposed rule,

we believe that a mandatory design

combined with randomized selection of

a subset of geographic areas would

enable CMS to better assess the effect of

the Model’s interventions on ETC

Participants against a contemporaneous

comparison group. As described in the

proposed rule and elsewhere in this

section IV of the final rule, we proposed

to require participation by a subset of all

ESRD facilities and Managing Clinicians

in the U.S., selected based on whether

they are located in a Selected

Geographic Area. Also, we proposed to

evaluate the impact of adjusting

payments to Managing Clinicians and

ESRD facilities by comparing the

clinical and financial outcomes of ESRD

facilities and Managing Clinicians

located in these Selected Geographic

Areas against that of ESRD facilities and

Managing Clinicians located in

Comparison Geographic Area(s), which

we proposed to define as those HRRs

that are not Selected Geographic Areas.

Because both ETC Participants and

those ESRD facilities and Managing

Clinicians not selected for participation

in the Model would be representative of

the larger dialysis market, many of the

stakeholders in which operate on a

nationwide basis, CMS would be able to

generate more generalizable results,

assuming randomization creates two

groups that are similar to each other. As

we noted in the proposed rule, this

proposed model design would therefore

make it easier for CMS to evaluate the

impact of the Model, as required under

section 1115A(b)(4) of the Act, and to

predict the impact of expanding the

Model under section 1115A(c) of the

Act, if authorized, while also limiting

the scope of the model test to Selected

Geographic Areas.

The following is a summary of the

comments received on our proposed

definitions for Managing Clinician and

ESRD facility and our proposal to

require participation in the Model by

Managing Clinicians and ESRD facilities

located in Selected Geographic Areas,

and our responses.

Comment: A commenter stated that,

for the purposes of the ETC Model, CMS

should modify the proposed definition

of ESRD facility to require that a facility

must either have or be in a network

under common ownership with ESRD

facilities that have the capacity to

furnish in-center dialysis.

Response: We believe that adopting

this commenter’s recommendation

would be equivalent to excluding ESRD

facilities owned by dialysis

organizations that provide home

dialysis only. We do not believe that it

is necessary to exclude ESRD facilities

owned by dialysis organizations that

provide only home dialysis services

from participation in the Model. The

ETC Model is designed to test the

effectiveness of the Model’s payment

adjustments at improving or

maintaining quality and reducing costs

through increased provision of home

dialysis and transplants throughout the

dialysis market as a whole, including

among ESRD facilities and dialysis

organizations that currently provide

only home dialysis. Excluding ESRD

facilities and dialysis organizations that

do not offer in-center dialysis could

discourage new entrants to the dialysis

market who use innovative care models

that do not include in-center dialysis.

Discouraging this type of innovation

could limit the availability of home

dialysis overall.

Comment: A commenter supported

the proposal to include non-physician

practitioners in the definition of

Managing Clinician for the purposes of

the Model, as this recognizes the care

provided by other clinicians, including

nurse practitioners, who manage

dialysis patients.

Response: We appreciate the

commenters’ feedback and support.

Comment: Several commenters stated

that they support CMS’s proposal to

require participation in the ETC Model

by ESRD facilities and Managing

Clinicians located in Selected

Geographic Areas.

Response: We appreciate the

commenters’ feedback and support.

Comment: Many commenters opposed

requiring ESRD facilities and Managing

Clinicians to participate in the ETC

Model. Several commenters asserted

that requiring participation by

approximately half of the country does

not constitute a model test, but rather a

substantive change to Medicare

payment policy. Some commenters

stated that this exceeds the scope of the

Innovation Center’s authority. Some

commenters stated that, the scope and

mandatory nature of the Model, coupled

with the downward payment

adjustments, constitute an overall

payment reduction for ESRD facilities

and Managing Clinicians, which will

cause unintended consequences,

including market consolidation,

decrease in availability of services, and

disruption of patient care.

Response: We do not believe that the

size, scope, and duration of the Model

constitute a substantive change to

Medicare payment policy, as the model

test is limited in duration and is not a

permanent change to the Medicare

program. We also believe that both

section 1115A of the Act and the

Secretary’s existing authority to operate

the Medicare program authorize the ETC

Model as we have proposed and are

finalizing it.

Section 1115A of the Act authorizes

the Secretary to test payment and

service delivery models expected to

reduce Medicare costs while preserving

or enhancing care quality. The statute

does not require that models be

voluntary, but rather gives the Secretary

broad discretion to design and test

models that meet certain requirements

as to spending and quality. Although

section 1115A(b) of the Act describes a

number of payment and service delivery

models that the Secretary may choose to

test, the Secretary is not limited to those

models. Rather, models to be tested

under section 1115A of the Act must

address a defined population for which

there are either deficits in care leading

to poor clinical outcomes or potentially

avoidable expenditures. Here, the ETC

Model addresses a defined population

(FFS Medicare beneficiaries with ESRD)

for which there are potentially

avoidable expenditures (arising from

less than optimal modality selection).

For the reasons described elsewhere in

this final rule, we have determined that

it is necessary to test this Model among

varying types of ESRD facilities and

Managing Clinicians that may not have

chosen to voluntarily participate in

another kidney care model, such as the

CEC Model or KCC Model.

As noted elsewhere in this final rule,

we are currently testing a number of

voluntary kidney models. We have

designed the ETC Model to require

participation by ESRD facilities and

Managing Clinicians in order to avoid

the selection bias inherent to any model

in which providers and suppliers may

choose whether to participate. As

discussed in the proposed rule and

previously in this final rule, such a

design will enable us to obtain a

representative sample, to detect a

change in the rate of transplantation

under the ETC Model, and to better

assess the effect of the Model’s

interventions on ETC Participants

against a contemporaneous comparison

group. Under the ETC Model, we will

have tested and evaluated such a model

across a wide range of ESRD facilities

and Managing Clinicians. We believe it

is important to gain knowledge from a

variety of perspectives in considering

whether and which models merit

expansion (including on a nationwide

basis). Thus, the ETC Model meets the

criteria required for an initial model

test.

Moreover, the Secretary has the

authority to establish regulations to

carry out the administration of

Medicare. Specifically, the Secretary has

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authority under both sections 1102 and

1871 of the Act to implement

regulations as necessary to administer

Medicare, including testing this

payment and service delivery model.

We note that, while the ETC Model will

be a model, and not a permanent feature

of the Medicare program, the Model will

test different methods for delivering and

paying for services under the Medicare

program, which the Secretary has the

clear authority to regulate. The

proposed rule went into great detail

about the proposed provisions of the

proposed ETC Model, enabling the

public to fully understand how the

proposed model was designed and

could apply to affected providers and

suppliers.

We also note that this is a new model,

not an expansion of an existing model.

As permitted by section 1115A of the

Act, we are testing the ETC Model

within Selected Geographic Areas. The

fact that the Model will require the

participation of certain ESRD facilities

and Managing Clinicians does not mean

it is not an initial model test. If the ETC

Model is successful such that it meets

the statutory requirements for

expansion, and the Secretary determines

that expansion is warranted, we would

undertake further rulemaking to expand

the duration and the scope of the Model,

as required by section 1115A(c) of the

Act.

We appreciate the concerns from

commenters about the potential impact

of the Model on patient care, the

structure of the dialysis market, and the

availability of dialysis services. We do

not expect the Model will result in

adverse results such as market

consolidation, decrease in availability of

services, or disruption of patient care. In

contrast, CMS believes that the Model

will have the opposite effects. The

payment adjustments in the Model are

designed to incentivize innovative care

delivery methods that focus on

expanding access to renal replacement

therapies other than in center

hemodialysis, that are associated with

better clinical outcomes for patients.

However, we intend to monitor the

impact of the Model closely, as

described in section IV.C.10.a of this

final rule. In the event that adverse

outcomes such as these arise, CMS

would modify or terminate the Model

accordingly.

Comment: Several commenters stated

that previous mandatory models have

been of smaller size, and a commenter

stated that CMS has cancelled proposed

mandatory models in the past, due to

further analysis, feedback that

mandatory participation would have

negative impact on CMS’s flexibility to

design and test other models, and the

possibility of reduction of participation

in other voluntary models. Several

commenters asserted that the use of

mandatory models undermines the

creation of and participation in

voluntary models.

Response: CMS believes that it is

important to test both the mandatory

ETC Model and the voluntary KCC

Model at the same time, as both of these

models test different frameworks. The

solicitation for applicants for the KCC

Model for PY 1 was completed on

January 22, 2020. CMS is satisfied with

the number of applications that were

submitted. We believe that we will have

sufficient participation to be able to test

the different options in the KCC Model.

Though previous mandatory models

tested by the Innovation Center may

have been smaller or cancelled in the

past, we believe that requiring

participation by ESRD facilities and

Managing Clinicians in the ETC Model

is necessary to achieve the level of

model participation needed to detect

changes in the rates of dialysis modality

choice and for the power calculations

discussed in this section of this final

rule. As discussed in section IV.C.3.b of

this final rule, we are decreasing the

size of the Model. This decrease from

50% of HRRs in the country to 30% of

HRRs in the country brings the size of

the Model more in line with other

mandatory models.

Comment: A commenter stated that

they agree that the Innovation Center

has the authority to proceed with

mandatory initiatives, and they support

the testing of mandatory models

established through the rulemaking

process.

Response: We appreciate this

feedback and support from the

commenter.

Comment: Several commenters stated

that CMS should test this model on a

voluntary basis. A commenter stated

that ESRD facilities and Managing

Clinicians located in Comparison

Geographic Areas should be allowed to

opt in to the ETC Model.

Response: We appreciate this

feedback. However, as stated previously

in this final rule, we considered using

a voluntary design for the Model, but we

concluded that we do not believe we

can adequately test this Model on a

voluntary or opt in basis. Specifically,

we do not believe that if the Model were

voluntary we would have a sufficient

number and diversity of ESRD facilities

and Managing Clinicians to conduct a

robust test. Additionally, allowing ESRD

facilities and Managing Clinicians

located in Comparison Geographic

Areas to opt-in to the ETC Model could

skew the model test through selection

effects. We assume that only ESRD

facilities and Managing Clinicians who

already have high rates of home dialysis

and transplantation would opt in to

participation. This behavior would

produce the appearance of artificially

high performance among ETC

Participants, because any observed

increase in performance could be due to

selection effects rather than change in

performance related to the Model’s

payment adjustments. This behavior

would also remove high performers

from the benchmarking group, which

would lower benchmarks for ETC

Participants, and therefore not provide

as great an incentive for ETC

Participants to improve their

performance under the Model.

After considering public comments,

we are finalizing the provisions

regarding mandatory participation in

the Model in our regulations at

§ 512.325(a) as proposed. We are also

finalizing the definition of Selected

Geographic Area(s) in our regulations at

§ 512.310, as proposed, with a technical

change to capitalize ‘‘Selected

Geographic Area(s)’’ in the final rule,

rather than use ‘‘selected geographic

area(s)’’ as we did in the proposed rule.

In addition, we are finalizing the

definitions of ESRD facility in our

regulations at § 512.310, as proposed.

We are finalizing the definition of

Managing Clinician in our regulation at

§ 512.310 with modification.

Specifically, we made a technical

change to capitalize ‘‘Managing

Clinician’’ in the final rule.

Additionally, we have added new

language to our regulation to clarify that

Managing Clinicians will be identified

by an National Provider Identifier (NPI),

because an NPI uniquely identifies

individual clinicians regardless of the

location the Managing Clinician

furnishes a particular service, which is

necessary for purposes of attributing

services to each individual Managing

Clinician, as described further in section

IV.C.5.b.(2).(b) of this final rule.

b. Selected Geographic Areas

We proposed to use an ESRD facility’s

or Managing Clinician’s location in

Selected Geographic Areas, randomly

selected by CMS, as the mechanism for

selecting ETC Participants. We stated in

the proposed rule that we believe that

geographic areas provide the best means

to establish the group of providers and

suppliers selected for participation in

the Model and the group of providers

and suppliers not selected for

participation in the Model to answer the

primary evaluation questions described

in the proposed rule and section IV.C.11

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147

United States Renal Data System, Annual Data

Report, 2018. Volume 2. Chapter 1: Incidence,

Prevalence, Patient Characteristics, and Treatment

Modalities. https://www.usrds.org/2018/view/v2_

01.aspx.

148

United States Renal Data System, Annual Data

Report, 2018. Volume 2. Chapter 6: Transplantation.

https://www.usrds.org/2018/view/v2_06.aspx.

149

This URL has been updated relative to the

URL included in the proposed rule.

of this final rule. Specifically, by using

geographic areas as the unit for

randomized selection, we will be able to

study the impact of the Model on

program costs and quality of care, both

overall and between ESRD facilities and

Managing Clinicians selected for

participation in the Model and those

ESRD facilities and Managing Clinicians

not selected for participation in the

Model.

To improve the statistical power of

the Model’s evaluation, we noted in the

proposed rule our aim of including in

the Model approximately 50 percent of

adult ESRD Beneficiaries. To achieve

this goal, we proposed to assign all

geographic areas, specifically HRRs, into

one of two categories: Selected

Geographic Areas (those geographic

areas for which ESRD facilities and

Managing Clinicians located in the area

would be selected for participation in

the ETC Model and would be subject to

the Model’s Medicare payment

adjustments for ESRD care); and

Comparison Geographic Areas (those

geographic areas for which ESRD

facilities and Managing Clinicians

located in the area would not be

selected for participation in the ETC

Model and thus would be subject to

customary Medicare payment for ESRD

care). Given the national scope of the

major stakeholders in the dialysis

market and the magnitude of the

payment adjustments proposed for this

Model, as stated in the proposed rule,

we believe a broad geographic

distribution of participants would be

necessary to effectively test the impact

of the proposed payment adjustments.

We proposed to use HRRs as the

geographic unit of selection for selecting

ETC Participants. An HRR is a unit of

analysis created by the Dartmouth Atlas

Project to distinguish the referral

patterns to tertiary care for Medicare

beneficiaries, and is composed of groups

of zip codes. The Dartmouth Atlas

Project data source is publicly available

at https://www.dartmouthatlas.org/.

Therefore, we proposed to define the

term ‘‘HRRs’’ to mean the regional

markets for tertiary medical care derived

from Medicare claims data as defined by

the Dartmouth Atlas Project at https://

www.dartmouthatlas.org.

With 306 HRRs in the U.S., we noted

in the proposed rule that we believe

there will be a sufficient number of

HRRs to support random selection and

improve statistical power of the

proposed Model’s evaluation. As noted

in the proposed rule, we conducted

power calculations for the outcomes of

home dialysis and kidney and kidney-

pancreas transplant utilization. For

home dialysis, the CMS Office of the

Actuary (OACT) forecasted an average

increase of 1.5 percentage points per

year. With a current home dialysis rate

of 8.6 percent,

147

this represents an

increase of 18 percent. To detect an

effect size of this magnitude with 80

percent power and an alpha of 0.05, we

would need few HRRs included in the

intervention group. However, for

transplants, which are rare events, a

substantial number of HRRs would be

needed to detect changes. OACT did not

assume any change in its main

projections but estimated that an

additional 2,360 transplants would

occur over the course of the proposed

Model due to a lower discard rate for

deceased donor organs. With 20,161

transplants currently conducted on an

annual basis,

148

this represents an 11.7

percent increase over 5 years. To detect

an effect size of this magnitude with 80

percent power and an alpha of 0.05, we

would need approximately 153 HRRs in

the intervention group, which

represents 50 percent of the 306 HRRs

in the US. As noted in the proposed

rule, we believe random selection with

a large sample of units, such as the 306

HRRs, would safeguard against uneven

distributions of factors among Selected

Geographic Areas and Comparison

Geographic Areas, such as urban or

rural markets, dominance of for-profit

dialysis organizations, and dense

population areas with greater access to

transplant centers.

In the proposed rule, we considered

using Core Based Statistical Areas

(CBSAs) or Metropolitan Statistical

Areas (MSAs) as the geographic unit of

selection. However, as we noted in the

proposed rule, neither CBSAs nor MSAs

include rural areas and, due to the

nature of dialysis treatment, we believe

inclusion of rural providers and

suppliers is vital to testing the Model.

Specifically, as a significant proportion

of beneficiaries receiving dialysis live in

rural areas and receive dialysis

treatment from providers and suppliers

located in rural areas, we believe using

a geographic unit of selection that does

not include rural areas would limit the

generalizability of the model findings to

this population.

In the proposed rule, we also

considered using counties or states as

the geographic unit of selection.

However, as noted in the proposed rule,

we determined that counties would be

too small and therefore too

operationally challenging to use for this

purpose, both due to the high number

of counties and the relatively small size

of counties such that a substantial

number of Managing Clinicians practice

in multiple counties. We also

determined that states would be too

heterogeneous in population size, and

that using states could confound the

evaluation of the Model due to potential

variation in state-level regulations

relating to ESRD care. Additionally, the

use of counties or states could introduce

confounding spillover effects, such as

where ESRD Beneficiaries receive care

from a Managing Clinician in a county

or state selected for the Model and

dialyze in a county or state not selected

for the Model, thus mitigating the effect

of the Model’s incentives on the

beneficiary’s overall care. As we noted

in the proposed rule, HRRs are derived

from Medicare data based on hospital

referral patterns, which are correlated

with dialysis and transplant referral

patterns and which would therefore

mitigate potential spillover effects of

this nature.

We proposed to establish the Selected

Geographic Areas by selecting a random

sample of 50 percent of HRRs in all 50

states and the District of Columbia,

stratified by region. Regional

stratification would use the four Census-

defined geographic regions: Northeast,

South, Midwest, and West. Information

about Census-defined geographic

regions is available at https://

www2.census.gov/geo/pdfs/maps-data/

maps/reference/usus_regdiv.pdf.

149

As

proposed, the stratification would

control for regional patterns in practice

variation. If an HRR spans two or more

Census-defined geographic regions, the

HRR would be assigned to the region in

which the HRR’s associated state is

located. For example, the Rapid City

HRR centered in Rapid City, South

Dakota, contains zip codes located in

South Dakota and Nebraska, which are

in the Midwest Census Region, and zip

codes located in Montana and

Wyoming, which are in the West Census

Region. For the purposes of the regional

stratification, we would consider the

Rapid City HRR and all zip codes

therein to be in the Midwest region, as

its affiliated state, South Dakota, is in

the Midwest region.

We proposed that the U.S. Territories,

as that term is defined in section II of

the proposed rule and of this final rule,

would be excluded from selection, as

HRRs are not constructed to include

these areas.

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In addition, outside of the

randomization, we proposed that all

HRRs for which at least 20 percent of

the component zip codes are located in

Maryland would be selected for

participation in the ETC Model, in

conjunction with the Maryland Total

Cost of Care (TCOC) Model currently

being tested in Maryland. These HRRs

would not be included in the

randomization process previously

described. We stated in the proposed

rule that CMS believes that the

automatic inclusion of ESRD facilities

and Managing Clinicians in these HRRs

as participants in the ETC Model would

be necessary because, while the

Maryland TCOC Model includes

incentives to lower the Medicare TCOC

in the state, including state

accountability for meeting certain

Medicare TCOC targets, as well as global

budget payments that hold Maryland

hospitals accountable for the Medicare

TCOC, there currently is no direct

mechanism to lower the cost of care for

ESRD Beneficiaries specifically under

the Maryland TCOC Model. As noted in

the proposed rule, we believe that

adding Maryland-based ESRD facilities

and Managing Clinicians as participants

in the ETC Model will assist the state of

Maryland and hospitals located in that

state to meet the Medicare TCOC targets

established under the Maryland TCOC

Model.

We proposed that all HRRs that are

not Selected Geographic Areas would be

referred to as ‘‘Comparison Geographic

Area(s).’’ We proposed that Comparison

Geographic Areas would be used for the

purposes of constructing performance

benchmarks (as discussed in the

proposed rule and in section IV.C.5.d of

this final rule), and for the Model

evaluation (as discussed in the proposed

rule and in section IV.C.11 of this final

rule).

The following is a summary of the

comments received on Selected

Geographic Areas, including the size

and scope of the Model, geographic

units used for Selected Geographic

Areas, and the inclusion or exclusion of

certain geographic areas in the Model,

and our responses.

Comment: Multiple commenters

opposed our proposal to require

participation in the ETC Model by ESRD

facilities and Managing Clinicians

located in 50 percent of the 306 HRRs

in the country because doing so would

require significant change to the

infrastructure of ETC Participants and to

the care delivery system nationally.

Commenters stated that the change in

payments under the Model

implemented over the proposed

geographic area within the timeframe

proposed for the Model could lead to

unintended consequences and

disruption in care, and several

commenters stated that this would harm

smaller health care providers, in

particular. A commenter stated that this

national impact would undermine the

integrity of the model test.

Response: We appreciate the feedback

from commenters raising concerns

around the impact of the proposed

scope of the model test on health care

providers and beneficiaries. We

acknowledge that the scope and

timeframe for implementing the Model

will require changes on the part of ETC

Participants, which may take time to

implement. As discussed previously in

this final rule, we believe we have

addressed commenters’ concerns

regarding the time needed to make these

changes by delaying the Model start

date to January 1, 2021. We further

believe we have addressed the

commenters’ concerns regarding the

potential for unintended consequences

through the benchmarking and scoring

methodology (described in section

IV.C.5.d of this final rule) and have

addressed the commenters’ concerns

regarding smaller health care providers

through the low volume exclusions from

the PPA (described in section IV.C.5.f of

this final rule). We do not believe that

the scope of the ETC Model harms the

integrity of the model test. Rather, as

discussed in the proposed rule and

previously in this final rule, we

designed the Model based on power

calculations about the scope of

participation necessary for CMS to be

able to evaluate whether the Model

increased the rate of transplants.

However, as described in section IV.C.5

of this final rule, we have modified the

Model to assess ETC Participant

performance on the transplant rate,

which includes both the transplant

waitlist rate and living donor transplant

rate. As such, we have revised the scope

of the Model based on power

calculations about the level of

participation necessary for CMS to be

able to evaluate whether the Model

increased the rate of transplant

waitlisting, living donor transplants,

and the rate of home dialysis, as

described in section IV.C.5 of this final

rule. We discuss our plan for

conducting the Model’s evaluation in

section IV.C.11 of this final rule.

Comment: Several commenters stated

that implementing the Model with this

proposed geographic scope would

constitute a permanent change in

Medicare policy, rather than a model

test.

Response: We disagree that this

Model would constitute a permanent

change in Medicare policy. Section

1115A of the Act authorizes the

Secretary to test payment and service

delivery models intended to reduce

Medicare costs while preserving or

improving care quality. The ETC Model

would be a model tested under this

authority, and not a permanent feature

of the Medicare program.

Comment: Several commenters

expressed concern that requiring

participation by ESRD facilities and

Managing Clinicians located in 50

percent of the 306 HRRs in the U.S. is

beyond the level of participation

necessary to evaluate the Model. Several

commenters suggested reducing the

geographic scope of the Model to 20

percent, 25 percent, or no larger than 25

percent of HRRs in the country. Several

commenters suggested starting the

Model with a smaller geographic scope,

and increasing the scope in subsequent

years if the Model is successful.

Response: We appreciate the

commenters’ feedback. In response to

comments, and because we will now

evaluate changes to transplant

waitlisting, including beneficiaries who

receive living donor transplantation we

conducted a revised power calculation.

We performed the revised power

calculation to determine the minimum

sample size of ETC Participants and

Managing Clinicians and ESRD facilities

located in Comparison Geographic

Areas necessary to produce robust and

reliable results. Our assumptions

included a two percentage point

increase to the transplant waitlist rate,

which is currently 16%. To detect an

effect size of this magnitude with 80

percent power and an alpha of 0.05, we

would need approximately 30 percent of

the 306 HRRs in the US to minimize the

risk of false positive and false negative

results. This number of HRRs will also

be sufficient to detect a one and one-half

percent change in home dialysis. As a

result, we are finalizing our proposal to

require participation in the Model by

ESRD facilities and Managing Clinicians

located in 30 percent of the HRRs in the

country.

Comment: A few commenters noted

that the proposed geographic scope of

the Model may lead to a spillover effect

for ESRD facilities located in the

Comparison Geographic Areas given

that ownership of ESRD facilities can

span across HRRs in Selected

Geographic Areas and Comparison

Geographic Areas.

Response: We share the commenters’

concern that the impact of the model

test may extend to the Model’s

Comparison Geographic Areas through

common facility ownership and this

may influence our evaluation of the

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Model. We plan to examine the

variation in the outcome measures prior

to and during the model intervention for

facilities with common ownership, and

if necessary, consider modifications to

the Model in future notice-and-

comment rulemaking.

Comment: A commenter supported

randomizing geographic areas to select

ETC Participants. Several commenters

opposed randomization of geographic

areas as the mechanism for selecting

ETC Participants. Several commenters

noted that the method proposed for

randomization would not sufficiently

account for non-random differences

between HRRs or ESRD facilities. A few

commenters suggested that CMS use

covariate-based constrained

randomization for purposes of selecting

model participants because the

commenters claimed that this approach

would ensure comparability across

treatment and control groups and allow

for a smaller model.

Response: We appreciate the

comments on the proposed

randomization method. As we noted in

the proposed rule and previously in this

final rule, our proposal to stratify by

region would help control for regional

patterns in practice variation. We also

believe that stratification will help

ensure that ETC Participants are

geographically dispersed across the

country and do not find it necessary to

use covariate-based constrained

randomization for purposes of selecting

model participants, as suggested by

some of the commenters. In addition,

with the evaluation approach that will

be used, we can account for known,

measurable differences between ETC

Participants in Selected Geographic

Areas and those ESRD facilities and

Managing Clinicians located in the

Comparison Geographic Areas through

rigorous statistical methods.

Specifically, as we outlined in the

proposed rule, the evaluator would

match Managing Clinicians and ESRD

facilities located in Comparison

Geographic Areas with Managing

Clinicians and ESRD facilities that are

located in Selected Geographic Areas

(that is, ETC Participants) using

propensity scores or other accepted

statistical techniques.

Comment: Several commenters stated

that randomization cannot ensure that

50 percent of ESRD Beneficiaries are

included in the Model.

Response: While the aim stated in the

proposed rule was to include

approximately 50 percent of adult

beneficiaries with ESRD in the Model,

as described in the proposed rule, our

determination regarding the size of the

geographic area necessary to test the

Model is based around the number of

HRRs in which ESRD facilities and

Managing Clinicians would be required

to participate in the Model, not the

proportion of individual beneficiaries

included in the model test. The same

holds true for this final rule; our

determination regarding the size of the

geographic area necessary to test the

Model is based around the number of

HRRs in which ESRD facilities and

Managing Clinicians are required to

participate in the Model, rather than the

proportion of individual beneficiaries

included in the model test. We are

therefore finalizing the randomization

method, as proposed.

Comment: A commenter stated that

CMS should select regions where home

dialysis and transplant rates are

particularly low to focus resources on

areas with the most need.

Response: As stated in the proposed

rule and previously in this final rule,

the intent of the model test is to

determine whether adjusting the current

Medicare FFS payments for dialysis and

dialysis-related services would

incentivize ESRD facilities and

Managing Clinicians to work with their

patients to achieve increased rates of

home dialysis utilization and kidney

transplantation and, as a result, reduce

Medicare expenditures while improving

or maintaining quality of care. If we

were to select ETC Participants from

only those geographic areas that had

particularly high or particularly low

rates of home dialysis or transplants, as

the commenter suggested, we would not

be able to determine if the Model’s

payment adjustments would have the

same effect nationally.

Comment: Several commenters

opposed the use of geographic areas to

select model participants. These

commenters stated that, due to the

national nature of the dialysis market,

selecting ESRD facilities for

participation based on their location

could change the nature of the dialysis

market for the entire country or create

unintended consequences for the

dialysis market nationally. In particular,

commenters stated that the Model could

make national dialysis companies

provide different levels of care to

patients in Selected Geographic Areas

than in Comparison Geographic Areas

and delay the implementation of best

practices nationally, or divert resources

from Comparison Geographic Areas to

Selected Geographic Areas.

Response: We appreciate the feedback

from commenters about the national

nature of segments of the dialysis

market and how this may interact with

our proposal to select ETC Participants

based on geographic areas. We

acknowledge the possibility that

national dialysis providers will behave

differently, in terms of resource

allocation or adoption of best practices

in Selected Geographic Areas versus

Comparison Geographic Areas, or that

they will adopt best practices nationally

resulting in broader changes to dialysis

provision. However, we believe that, for

dialysis providers that operate

nationally, either outcome would be

true regardless of what mechanism we

use to select ESRD facilities for model

participation. As described in section

IV.C.10.a of this final rule, we will

monitor for unintended consequences

that arise as a result of the Model.

Comment: Several commenters

recommended that CMS should select

individual participants, rather than

selecting participants based on

geographic location.

Response: We did not propose

selecting individual participants

because we believe that this approach

would not work for this Model. A

design feature of the Model is aligning

the incentives for key dialysis providers,

namely Managing Clinicians and ESRD

facilities, to support beneficiaries in

choosing alternative renal replacement

modalities. Managing Clinicians refer

ESRD Beneficiaries to multiple ESRD

facilities, and ESRD facilities furnish

dialysis to beneficiaries under the care

of multiple Managing Clinicians. By

selecting ETC Participants based on

location, we are increasing the

likelihood that, for any given ESRD

Beneficiary, both the beneficiary’s

Managing Clinician and ESRD facility

are participants in the Model.

Comment: Several commenters

recommended that CMS release the

Selected Geographic Areas with the

proposed rule to allow for public

comment or for potential model

participants to have sufficient time to

prepare for participation. A commenter

stated that while they understand that

CMS has withheld information about

Selected Geographic Areas to assure that

CMS receives stakeholder feedback from

the entire nation, ETC Participants

should have no fewer than 90 days’

notice prior to implementation to

prepare for participation in the Model.

Response: We appreciate the

commenters’ suggestions about releasing

information about Selected Geographic

Areas in advance of the start of the

Model, and the need for ETC

Participants to have sufficient time to

prepare for participation in the Model.

We did not provide information about

the specific Selected Geographic Areas

in the proposed rule because, as the

commenters noted, we wanted to ensure

that we received feedback from the

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public generally, not just those

stakeholders located in Selected

Geographic Areas. CMS is posting a list

of Selected Geographic Areas on the

Innovation Center website concurrent

with the release of this final rule, thus

notifying the public and ETC

Participants of the Selected Geographic

Areas more than 90 days in advance of

the start of the Model on January 1,

2021.

Comment: Commenters expressed

concerns about how the method for

randomly selecting participating HRRs

will interact with the benchmarking

methodology using data from

Comparison Geographic Areas.

Commenters stated that random

selection does not address other

covariates that impact home dialysis

and transplant rates, including current

rates of home dialysis and

transplantation, urbanicity, population

density, percentage of dual-eligible

beneficiaries, and the availability of

transplant centers. Commenters stated

that, if balance on these covariates is not

observed, model participants could be

unfairly compared to ESRD facilities

and Managing Clinicians located in

Comparison Geographic Areas that face

different factors that contribute to home

dialysis and transplant rates.

Response: We appreciate the

commenters’ concern that underlying

regional variation in home dialysis and

transplant rates may mean that ETC

Participants and ESRD facilities and

Managing Clinicians located in

Comparison Geographic Areas will face

varying factors that affect their rates of

home dialysis and transplants.

However, as we noted in the proposed

rule and earlier in this final rule, our

proposal to stratify by region would

help control for regional patterns in

practice variation. We also believe that

inclusion of improvement scoring in the

scoring methodology, described in the

proposed rule and in section IV.C.5.d. of

this final rule, which awards points

based on an ETC Participant’s

improvement against its own past

performance, will help compensate for

any underlying regional variation in

these factors.

Comment: Several commenters stated

that, due to the national nature of the

dialysis market, large dialysis

companies will have ESRD facilities

located in both Selected Geographic

Areas and in the Comparison

Geographic Areas used for

benchmarking under the ETC Model.

These commenters stated that dialysis

companies could face incentives to

either not improve on or not maintain

current home dialysis and transplant

performance in ESRD facilities located

in Comparison Geographic Areas to

attempt to keep benchmarks low, to

improve relative performance for their

ESRD facilities located in Selected

Geographic Areas.

Response: We appreciate the feedback

from commenters about the potential for

dialysis organizations operating in both

Selected Geographic Areas and

Comparison Geographic Areas to

manipulate the Model’s benchmarks.

However, we believe that the

achievement benchmarking

methodology, described in the proposed

rule and in section IV.C.5.d of this final

rule, mitigates this risk. First, the

proposed achievement benchmarks

would use only data from home dialysis

and transplant rates among ESRD

facilities and Managing Clinicians

located in Comparison Geographic

Areas. Because we will construct these

benchmarks using 12 months of data

beginning 18 months before the start of

the MY and ending 6 months before the

start of the MY, the time periods for

determining achievement benchmarks

for MY1 and MY2 occurred primarily

before the proposal or finalization of the

rule to implement the Model. For MY3,

the proposed achievement benchmarks

would include 6 months of data from

before the Model and 6 months of data

after the Model began. Only in MY4

would all data used to construct the

achievement benchmarks be from after

the Model began. It would therefore be

difficult for dialysis organizations to

alter their past performance in order to

manipulate these achievement

benchmarks for the initial years of the

Model. Additionally, we stated in the

proposed rule that it is our intent to

increase achievement benchmarks above

the rates observed in Comparison

Geographic Areas for future MYs

through subsequent rulemaking. For

these subsequent MYs, we are

considering an approach under which

achievement benchmarks would not be

tied to performance in Comparison

Geographic Areas, so there would not be

an opportunity for LDOs to manipulate

the achievement benchmarks by

changing their performance in

Comparison Geographic Areas if this

approach is finalized.

Comment: Several commenters stated

that HRRs may not be reflective of how

dialysis care is delivered, how organ

transplants are allocated, or referral

patterns between Managing Clinicians

and ESRD facilities. Commenters

pointed out that HRRs are designed to

capture patterns of care in hospitals for

Medicare beneficiaries, but may not be

reflective of other segments of the health

care market, including dialysis services.

These commenters further stated that, as

a result of this misalignment, using

HRRs may have unintended

consequences. A commenter stated that

the misalignment between dialysis

company markets and HRRs could

create a situation where ESRD facilities

owned by a dialysis organization with a

centralized home dialysis facility are

selected to participate in the Model but

the affiliated home dialysis facility is

not selected to participate, which would

not accurately reflect the provision of

home dialysis by that company in that

area. Other commenters stated that

beneficiaries or ETC Participants may

move between HRRs, or may seek or

provide care in multiple HRRs.

Response: We appreciate commenters’

concerns about the relationship between

the geographic distribution of providers

and suppliers involved in the provision

of services to ESRD Beneficiaries and

the geographic unit of selection used in

the ETC Model. Providing care to ESRD

Beneficiaries involves multiple parts of

the health care system—including ESRD

facilities and dialysis organizations, as

well as Managing Clinicians and the

practices in which they operate—each

of which furnishes care in a unique

geographic area or set of geographic

areas. Because there are so many

overlapping geographies served by these

providers and suppliers, it is unlikely

that there is one type of geographic unit

that would align perfectly, such that no

dialysis organization market is in both

Selected Geographic Areas and

Comparison Geographic Areas, or that

no Managing Clinician sees patients in

both Selected Geographic Areas and

Comparison Geographic Areas. We

continue to believe that HRRs are the

most appropriate geographic unit of

selection for the Model, for the reasons

described in the proposed rule and

elsewhere in this section of the final

rule. Also, we believe that the

aggregation methodology used in

assessing ETC Participant performance

(described in section IV.C.5.c.(4) of this

final rule) addresses concerns about

individual ETC Participant performance

assessment in relation to geography. We

acknowledge that ETC Participants may

move between HRRs or provide care in

multiple HRRs, and we do not believe

that this harms the model test. It is

commonplace for participants to move

into and out of Innovation Center

models on occasion, and this movement

generally does not harm model

evaluations. As to the movement of

ESRD Beneficiaries, because the level at

which performance is being assessed is

the ETC Participant, not the beneficiary,

and attribution of ESRD Beneficiaries to

ETC Participants occurs in units of one

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month, we do not believe that

beneficiaries moving between HRRs will

impact the model test.

Comment: Several commenters

suggested using different geographic

units to select ETC Participants,

including CBSAs. A commenter

supported using CBSAs instead of HRRs

because CBSAs are well understood by

health care providers. Other

commenters opposed using CBSAs

instead of HRRs for several reasons,

including that CBSAs are smaller than

HRRs and would therefore exacerbate

divisions of participants and

beneficiaries because the likelihood of a

beneficiary being attributed to a

participating ESRD facility and non-

participating Managing Clinician (and

vice versa) would increase, and that

CBSAs do not include rural counties

and CMS did not propose a method for

associating rural counties with CBSAs.

Others suggested alternative geographic

units for selecting ETC Participants. A

commenter suggested that CMS use

regions that align with market areas for

other payers, such as Medicare

Advantage plans and other private

payers, to prevent ETC Participants from

having to ask other clinicians (such as

primary care providers.) to provide

different levels of care to ESRD patients

based on participation in the Model.

That commenter also suggested that

CMS use a variety of geographic units to

select participants similar to the method

used in the design of the Civil Justice

Reform Act experiments in the 1990s, in

particular that CMS select participants

in those states that have expressed

interest in and wish to implement

regulatory changes in conjunction with

the Model, as states play a regulatory

role in the provision of dialysis care. A

commenter suggested using the ESRD

Networks as the geographic units to

select ETC Participants, as the ESRD

Networks have longstanding

relationships with dialysis and

transplant programs, personnel, and

patients, and could support participants

to achieve the goals of the Model. A

commenter suggested incorporating

Donation Service Areas (DSAs) into the

geographic unit selection process.

Response: We appreciate the feedback

from commenters about the use of

alternative geographic units to select

ETC Participants. We acknowledge that

there are a variety of types of geographic

units we could use to select ETC

Participants, and that there are benefits

and challenges associated with each

option. We continue to believe that

HRRs are the most appropriate unit of

geographic selection for this Model, for

the reasons described in the proposed

rule and elsewhere in this section of the

final rule.

Comment: A commenter supported

our proposal to select for participation

all HRRs for which at least 20 percent

of the component zip codes are located

in Maryland, outside of the

randomization, in conjunction with the

Maryland TCOC Model currently being

tested in Maryland. A commenter

opposed including these Maryland

HRRs, or any other states participating

in Innovation Center models, outside of

the randomization, as states are large

geographic units and the commenter

opposes the size of the Model.

Response: We appreciate the feedback

from commenters about the inclusion of

HRRs predominantly located in

Maryland. We do not believe that

including these HRRs outside of the

randomization harms the

randomization, or represents a

significant increase in the size of the

Model. We are therefore finalizing this

policy as proposed.

Comment: Several commenters stated

that they support the proposed

exclusion of the U.S. Territories from

the Selected Geographic Areas under

the ETC Model.

Response: We appreciate the feedback

and support from the commenters.

After considering public comments,

we are finalizing our proposed

provisions on Selected Geographic

Areas in our regulations at § 512.325(b),

with modification. We are modifying

the proportion of HRRs randomly

selected for inclusion in the Model as

Selected Geographic Areas from 50

percent to 30 percent. We are finalizing

the definition of Selected Geographic

Area(s) as proposed with the technical

change to capitalize the term ‘‘Selected

Geographic Area(s)’’ in the final rule.

We are also finalizing as proposed the

definition of hospital referral regions

(HRRs), and we are clarifying that we

will use the 2017 HRRs for the duration

of the ETC Model. HRRs are

recalculated periodically to reflect

changes in patterns of care over time. At

the time of publication of the proposed

rule, the 2017 HRRs are the most current

available. We are also finalizing as

proposed the definition of Comparison

Geographic Area(s), with the technical

change to capitalize the term

‘‘Comparison Geographic Area(s)’’ in the

final rule. We are codifying these

definitions in our regulations at

§ 512.310.

c. Participant Selection for the ETC

Model

We proposed to define ‘‘ETC

Participant’’ as an ESRD facility or

Managing Clinician that is required to

participate in the ETC Model pursuant

to § 512.325(a), which describes the

selection of model participants based on

their location within a Selected

Geographic Area, as described in the

proposed rule and previously in this

final rule. In addition, we noted in the

proposed rule that the definition of

‘‘model participant,’’ as defined in

section II of this final rule, would

include an ETC Participant.

The following is a summary of the

comments received on providers and

suppliers included as ETC Participants

and our responses.

Comment: Several commenters stated

that the ETC Model should include

transplant providers as participants,

including transplant centers, transplant

physicians, transplant surgeons, OPOs,

donor hospitals, and other transplant

providers in order to achieve the

Model’s focus on increasing rates of

kidney transplantation. Commenters

asserted that transplant providers hold

more control over the transplant process

than Managing Clinicians and ESRD

facilities, so including them in the

Model’s payment adjustments would be

necessary for or would increase the

likelihood of Model success.

Response: We appreciate the

suggestions from commenters about

including transplant providers in the

Model. We agree that transplant

providers are central to increasing

transplant rates. However, we do not

believe that it is necessary to include

transplant providers as participants

receiving payment adjustments in this

Model. First, the ETC Model is designed

to test the effectiveness of a particular

set of policy interventions, namely

adjusting certain Medicare payments for

Managing Clinicians and ESRD facilities

to increase rates of home dialysis and

kidney transplants. As noted previously

in this final rule, we selected Managing

Clinicians and ESRD facilities as

participants in this Model because we

believe these two groups of health care

providers have the most direct

relationship with ESRD Beneficiaries.

Second, CMS and HHS are undertaking

other activities targeting the availability

of organs for transplantation. These

efforts include the ETC Learning

Collaborative described in section

IV.C.12 of this final rule, which

includes transplant centers and OPOs.

As previously noted, HHS published a

proposed rule in the Federal Register on

the December 23, 2019, entitled

‘‘Medicare and Medicaid Programs;

Organ Procurement Organizations

Conditions for Coverage: Revisions to

the Outcome Measure Requirements for

Organ Procurement Organization[s]’’ (84

FR 70628). This proposed rule would,

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among other things, update the OPO

Conditions for Coverage to support

higher donation rates and reduce

discard rates of viable organs. The

Health Resources and Services

Administration (HRSA) also published a

proposed rule in the Federal Register on

December 20, 2019, entitled ‘‘Removing

Financial Disincentives to Living Organ

Donation’’ (84 FR 70139) to remove

financial barriers to organ donation by

expanding the scope of reimbursable

expenses incurred by living organ

donors to include lost wages and

childcare and elder-care expenses

incurred by a primary care giver. We

believe that the increased volume of

beneficiaries on the transplant waitlist

driven by the payment adjustments in

the ETC Model, together with the

increased organ availability from other

HHS and CMS efforts and the ETC

Learning Collaborative, will serve as an

incentive for transplant providers to

support increasing rates of

transplantation. As discussed in section

IV.C.5.c.(2) of this final rule, it is our

intent to observe organ availability.

After considering public comments,

we are finalizing our proposed

definition of ETC Participant without

modification, and codifying this

definition in our regulations at

§ 512.310.

(1) ESRD Facilities

We proposed that all Medicare-

certified ESRD facilities located in a

Selected Geographic Area would be

required to participate in the ETC

Model. We proposed to determine ESRD

facility location based on the zip code

of the practice location address listed in

the Medicare Provider Enrollment,

Chain, and Ownership System (PECOS).

We considered using the zip code of the

mailing address listed in PECOS.

However, we concluded that mailing

address is a less reliable indicator of

where a facility is physically located

than the practice location address, as

facilities may receive mail at a different

location than where they are physically

located.

The following is a summary of the

comments received on required

participation for all ESRD facilities

located in Selected Geographic Areas

and our responses.

Comment: Several commenters

suggested that CMS exclude certain

ESRD facilities from selection for

participation in the ETC Model. In

particular, these commenters stated that

ESRD facilities owned by small dialysis

organizations would face substantial

hardship and financial risk if selected

for participation. Several of these

commenters specifically recommended

that ESRD facilities owned in whole or

in part by a dialysis organization

owning 35 or fewer ESRD facilities

should be excluded from the Model,

while another commenter recommended

that ESRD facilities owned by these

smaller dialysis organizations be

allowed to opt in to the Model on a

voluntary basis. A commenter

recommended that CMS exclude

dialysis organizations with fewer than

100 patients in a market area. A

commenter suggested that no more than

25 percent of a dialysis organization’s

ESRD facilities should be included in

the Model, while another commenter

suggested that any health care provider

that would have more than 10 percent

of all of their treatments subject to the

Model’s payment adjustments should be

excluded from the Model. A commenter

recommended that ESRD facilities that

decide that it is not logical or possible

for them to offer home dialysis should

be allowed to opt out of participation in

the Model.

Response: The Model was designed to

test the proposed payment adjustments

for all types of ESRD facilities

nationally, including those owned by

both large and small dialysis

organizations. To determine if payment

adjustments can achieve the Model’s

goals of increasing rates of home

dialysis utilization and kidney

transplantation and, as a result,

improving or maintaining the quality of

care while reducing Medicare

expenditures among all types of ESRD

facilities, we need to test the model with

ESRD facilities owned by all types of

dialysis organizations. Additionally,

while we include all ESRD facilities in

the HDPA, as described in the proposed

rule and in section IV.C.5.e.(1) of this

final rule, the Model excludes certain

ESRD facilities that fall below the low

volume threshold from the application

of the PPA. We believe that this

approach balances the need to include

all types of ESRD facilities in the model

test with the need to increase statistical

reliability and to exclude low-volume

ESRD facilities from the PPA, which is

the only downside financial risk

included in the Model. We do not

believe that it is appropriate to allow

ESRD facilities to opt in or out of the

Model for the purposes of the model

test, as this would exacerbate potential

selection effects.

Comment: Several commenters

recommended that CMS adopt

requirements around what types of

dialysis an ESRD facility, or its parent

dialysis organization, must provide in

order to be selected for participation in

the Model. Some commenters stated

that only ESRD facilities that are

currently certified to provide home

dialysis should be selected for

participation, to preserve the quality of

care associated with centralization of

home dialysis, to avoid unintended

adverse outcomes, and/or to avoid

penalizing ESRD facilities that cannot

become certified to provide home

dialysis in a timely manner. Several

commenters stated that the Model

should exclude from participation those

ESRD facilities that are owned by

dialysis organizations that own only

ESRD facilities that provide home

dialysis or that provide home dialysis

only in a Selected Geographic Area to

avoid ‘‘cherry picking’’ by home

dialysis-only organizations, resulting in

unfair comparisons in the PPA

benchmarking methodology.

Response: We do not believe that it is

necessary to exclude ESRD facilities that

do not currently provide home dialysis

services from the Model, nor do we

believe that it is necessary to exclude

ESRD facilities owned by dialysis

organizations that provide only home

dialysis. The ETC Model is designed to

test the effectiveness of the Model’s

payment adjustments at improving or

maintaining quality and reducing costs

through increased provision of home

dialysis and transplants on the dialysis

market as a whole, including ESRD

facilities new to the provision of home

dialysis, as well as new entrants to the

dialysis market who offer innovative

approaches to dialysis provision that do

not include in-center dialysis.

Excluding these ESRD facilities from the

model test could limit the Model’s

ability to increase provision of home

dialysis services by these dialysis

providers by discouraging new entrants

to the market who may employ

innovative approaches to home dialysis.

After considering public comments,

we are finalizing our proposal in our

regulation at § 512.325(a) to require all

Medicare-certified ESRD facilities

located in a Selected Geographic Area to

participate in the Model, without

modification.

(2) Managing Clinicians

We proposed that all Medicare-

enrolled Managing Clinicians located in

a Selected Geographic Area would be

required to participate in the ETC

Model. We proposed identifying the

Managing Clinician’s location based on

the zip code of the practice location

address listed in PECOS. If a Managing

Clinician has multiple practice location

addresses listed in PECOS, we proposed

to use the practice location through

which the Managing Clinician bills the

plurality of his or her MCP claims. In

the proposed rule, we considered using

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the zip code of the mailing address

listed in PECOS. However, as noted in

the proposed rule, we determined that

mailing address is a less reliable

indicator of where a clinician physically

practices than the practice location

address, as clinicians may receive mail

at a different location from where they

physically practice.

The following is a summary of the

comments received on required

participation for all Managing Clinicians

located in Selected Geographic Areas

and our responses.

Comment: A commenter asked for

clarification as to whether individual

Managing Clinicians would be selected

for participation based on their location

or if practices with Managing Clinicians

would be selected for participation

based on their location.

Response: Managing Clinicians will

be selected individually based on their

location and not the practice location.

However, as described in the proposed

rule and in section IV.C.5.c.(4) of this

final rule, the performance of Managing

Clinicians that bill through the same

practice TIN will be aggregated to the

practice level for purposes of

determining the PPA.

Comment: A commenter

recommended that CMS not determine

a Managing Clinician’s location based

on where he or she provides the

plurality of his or her MCP claims. The

commenter stated that this could create

misalignment between incentives for

Managing Clinicians and ESRD facilities

if a Managing Clinician has patients

who dialyze at ESRD facilities that are

ETC Participants as well as at ESRD

facilities located in Comparison

Geographic Areas, and therefore CMS

should select Managing Clinicians based

on the location where dialysis services

are provided to their patients.

Response: We recognize that

Managing Clinicians provide dialysis

management services included in the

MCP to ESRD Beneficiaries that dialyze

at multiple ESRD facilities, and that in

some cases, this may mean that a

Managing Clinician may have ESRD

Beneficiaries who dialyze at ESRD

facilities that are ETC Participants and

ESRD Beneficiaries that dialyze at ESRD

facilities located in Comparison

Geographic Areas. However, selecting

Managing Clinicians based on where

their attributed beneficiaries dialyze

would not solve this issue, as a

Managing Clinician could still provide

dialysis management services to ESRD

Beneficiaries who dialyze at ESRD

facilities that are ETC Participants and

at ESRD facilities that are located in

Comparison Geographic Areas. Also, we

believe that the commenter’s suggested

selection method would be more

complex, and would make it more

difficult for Managing Clinicians to

understand whether they are ETC

Participants in real time, as beneficiary

attribution occurs after each MY has

ended.

After considering public comments,

we are finalizing our proposal in our

regulation at § 512.325(a) to require all

Medicare-enrolled Managing Clinicians

located in a Selected Geographic Area to

participate in the ETC Model, without

modification.

4. Home Dialysis Payment Adjustment

We proposed to positively adjust

payments for home dialysis and home

dialysis-related services billed by ETC

Participants for claims with claim

through dates during the first three CYs

of the ETC Model (CY 2021–CY 2023).

We stated that the HDPA would provide

an up-front positive incentive for ETC

Participants to support ESRD

Beneficiaries in choosing home dialysis.

The HDPA would complement the PPA,

described in the proposed rule and

section IV.C.5 of this final rule, which

under our proposal would begin in mid-

CY 2021 and increase in magnitude over

the duration of the Model; as such we

proposed that the HDPA would decrease

over time as the magnitude of the PPA

increases. There would be two types of

HDPAs: The Clinician HDPA and the

Facility HDPA. We proposed to define

the ‘‘Clinician HDPA’’ as the payment

adjustment to the MCP for a Managing

Clinician who is an ETC Participant for

the Managing Clinician’s home dialysis

claims, as described in § 512.345

(Payments Subject to the Clinician

HDPA) and § 512.350 (Schedule of

Home Dialysis Payment Adjustments).

We proposed to define the ‘‘Facility

HDPA’’ as the payment adjustment to

the Adjusted ESRD PPS per Treatment

Base Rate (discussed in section IV.B of

this final rule) for an ESRD facility that

is an ETC Participant for the ESRD

facility’s home dialysis claims, as

described in § 512.340 (Payments

Subject to the Facility HDPA) and

§ 512.350 (Schedule of Home Dialysis

Payment Adjustments). We proposed to

define the ‘‘HDPA’’ as either the Facility

HDPA or the Clinician HDPA. As we

noted in the proposed rule, we do not

believe that an analogous payment

adjustment is necessary for increasing

kidney transplant rates during the initial

years of the ETC Model. Rather, instead

of creating a payment adjustment, we

proposed to implement the ETC

Learning Collaborative that focuses on

disseminating best practices to increase

the supply of deceased donor kidneys

available for transplant. For a

description of the learning collaborative,

see section IV.C.12 of this final rule.

The following is a summary of the

comments received on the HDPA and

our responses.

Comment: A commenter expressed

support for the proposed HDPA because

it would enable the increased use of

home dialysis for appropriate ESRD

Beneficiaries. Another commenter

expressed concern that, while CMS

recognized that the initial transition

period onto dialysis is important for

supporting ESRD Beneficiaries in

selecting home dialysis, the proposed

HDPA is tied to claims submitted for

home dialysis, and would thus provide

the largest benefit to ESRD facilities and

Managing Clinicians that already have

the infrastructure in place to support

increased use of home dialysis. A

commenter expressed opposition to

providing the HDPA to ESRD facilities,

given that, in the commenter’s view,

ESRD facilities already have an

incentive to furnish home dialysis

services over in-center dialysis services.

According to the commenter, the profit

margin for home dialysis is generally

higher than or equal to in-center dialysis

for ESRD facilities, but the returns on

capital are substantially higher when

providing home dialysis services, as

fewer fixed assets are required to

furnish home dialysis services than in-

center dialysis.

Response: We thank the commenters

for their feedback. CMS recognizes that

by tying the HDPA to home dialysis and

home dialysis-related claims, ETC

Participants who furnish higher

numbers of home dialysis and home

dialysis-related services at the outset of

the Model will receive more HDPA

payments under the Model. However,

this does not detract from the incentives

to increase rates of home dialysis

created by the HDPA, particularly in

combination with the PPA, and CMS

believes the proposed HDPA is an

appropriate means to incentivize the

increased provision of home dialysis

and home dialysis-related services

while also rewarding those who are

already furnishing high rates of home

dialysis and home dialysis-related

services. CMS disagrees with the

commenter’s suggestion to eliminate the

Facility HDPA. The commenter’s

statement that ESRD facilities currently

have a greater incentive to provide

home dialysis over in-center dialysis is

directly contradicted by the data on

relative rates of in-center and home

dialysis described in the proposed rule

and previously in this final rule. The

overwhelming majority of ESRD

Beneficiaries, including ESRD

Beneficiaries for whom Medicare is a

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secondary payer, currently receive in-

center dialysis rather than home

dialysis.

Comment: A commenter

recommended that CMS apply the

HDPA to payments for devices and

procedures related to creation of

vascular access for dialysis, and reduce

payments for interventions, such as

angioplasty and stenting, which are

performed when a vascular means of

access becomes clogged.

Response: It is not clear whether the

commenter was suggesting that CMS

adjust payments for vascular access

device and procedures to supplement or

supplant our proposed payment

adjustments to claims for home dialysis

and home dialysis-related services.

Either way, if ETC Participants use

devices and procedures related to

creating vascular access for dialysis, and

the ESRD Beneficiaries who acquire

vascular access then receive home

dialysis or home dialysis-related

services, Medicare payments for those

home dialysis and home dialysis-related

services will be adjusted by the HDPA.

Moreover, vascular access, while an

important consideration for

beneficiaries on dialysis, is not the focus

of this Model.

Comment: A commenter opined that

the payment adjustments proposed for

the ETC Model are reminiscent of the

‘‘bonus-and-penalty payment

methodology’’ used in the Premier

Hospital Quality Incentive

Demonstration (‘‘Premier’’), launched by

CMS in 2003, which the commenter

described as unsophisticated compared

to more recent payment methodologies

used in Innovation Center models. The

commenter further noted that Premier

did not yield improved patient

outcomes.

Response: CMS disagrees with the

commenter’s comparison between

Premier and the ETC Model. In Premier,

CMS offered high achieving participants

either a 1 percent or 2 percent positive

adjustment on certain claims, and did

not incorporate downside risk. While

the HDPA may resemble the Premier

payment adjustment, under the ETC

Model the HDPA will be applied

concurrently with the PPA, which

provides both upward and downward

adjustments to certain payments, and at

a notably larger magnitude than the

payment adjustments under Premier.

After considering public comments,

we are finalizing our general proposal

regarding the HDPA, as proposed. We

are also finalizing the proposed

definitions for the Home Dialysis

Payment Adjustment (HDPA), Clinician

Home Dialysis Payment Adjustment

(Clinician HDPA), and Facility Home

Dialysis Payment Adjustment (Facility

HDPA) in our regulation at § 512.300

without modification, other than the

technical change to capitalize every

word of each of these terms (for

example, in the proposed rule, we

proposed to define ‘‘Home dialysis

payment adjustment,’’ but in this final

rule we are defining the term ‘‘Home

Dialysis Payment Adjustment’’).

a. Payments Subject to the HDPA

We proposed that the HDPA would

apply to all ETC Participants for those

payments described in the proposed

rule and in sections IV.C.4.b and

IV.C.4.c of this final rule, according to

the schedule described in the proposed

rule and section IV.C.4.d of this final

rule. We solicited comment on our

proposal to apply the HDPA with

respect to all ETC Participants, without

exceptions.

We also proposed that the HDPA

would apply to claims where Medicare

is the secondary payer for coverage

under section 1862(b)(1)(C) of the Act.

We explained that when a beneficiary

eligible for coverage under an employee

group health plan becomes eligible for

Medicare because he or she has

developed ESRD, there is a 30-month

coordination period during which the

beneficiary’s group health plan remains

the primary payer if the beneficiary was

previously insured. During this time,

Medicare is the secondary payer for

these beneficiaries. We proposed to

apply the HDPA to Medicare as

secondary payer claims because the

initial transition period onto dialysis is

important for supporting beneficiaries

in selecting home dialysis, as

beneficiaries who begin dialysis at home

are more likely to remain on a home

modality. As we noted in the proposed

rule, the HDPA would adjust the

Medicare payment rate for the initial

claim, and then the standard Medicare

Secondary Payer calculation and

payment rules would apply, possibly

leading to an adjustment to the

Medicare Secondary Payer amount. We

sought comment on the proposal to

apply the HDPA to Medicare as

secondary payer claims.

The following is a summary of the

comments received on payments subject

to the HDPA and our proposal to apply

the HDPA to claims where Medicare is

a secondary payer, and our responses.

Comment: A commenter expressed

support for CMS’s proposal to apply the

HDPA to all ETC Participants, reasoning

that the HDPA incentivizes an increase

in home dialysis rates, which aligns

with the Model’s goals. Another

commenter recommended that CMS

apply the HDPA to all ESRD providers.

Response: We thank the commenters

for their feedback. We agree that CMS’s

proposal to apply the HDPA to all ETC

Participants aligns with the Model’s

goals by incentivizing an increase in

home dialysis rates, which we expect to

improve or maintain quality while

reducing costs. Regarding the

commenter’s recommendation that CMS

apply the HDPA to all ESRD providers,

we are finalizing our proposal to apply

the HDPA only to ETC Participants to

allow us to compare the rates of home

dialysis between ETC Participants (who

are subject to the HDPA) and ESRD

facilities and Managing Clinicians

located in Comparison Geographic

Areas (who are not subject to the HDPA)

for purposes of evaluating whether the

HDPA statistically impacts the

provision of home dialysis.

Comment: A commenter expressed

strong support for CMS’s proposal to

apply the HDPA to claims where

Medicare is the secondary payer.

Response: We thank the commenter

for the feedback and support.

After considering public comments,

we are finalizing our general proposals

regarding payments subject to the

HDPA, without modification.

b. Facility HDPA

For ESRD facilities that are ETC

Participants, we proposed to adjust

Medicare payments under the ESRD

PPS for home dialysis services by the

HDPA according to the schedule

described in the proposed rule and

section IV.C.4.d of this final rule. As

noted in the proposed rule and

previously in this final rule, under the

ESRD PPS, a single per treatment

payment is made to an ESRD facility for

all renal dialysis services, which

includes home dialysis services,

furnished to beneficiaries. This payment

is subject to a number of adjustments,

including patient-level adjustments,

facility-level adjustments, and, when

applicable, a training adjustment add-on

for home and self-dialysis modalities, an

outlier payment, and the TDAPA. We

explained in the proposed rule that, at

that time, the formula for determining

the final ESRD PPS per treatment

payment amount was as follows:

Final ESRD PPS Per Treatment Payment

Amount = (Adjusted ESRD PPS

Base Rate + Training Add On +

TDAPA) * ESRD QIP Factor +

Outlier Payment * ESRD QIP Factor

We proposed to apply the Facility

HDPA to the Adjusted ESRD PPS per

Treatment Base Rate on claims

submitted for home dialysis services.

For purposes of the ETC Model, we

proposed to define the ‘‘Adjusted ESRD

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PPS per Treatment Base Rate’’ as the per

treatment payment amount as defined in

42 CFR 413.230, including patient-level

adjustments and facility-level

adjustments, and excluding any

applicable training adjustment add-on

payment amount, outlier payment

amount, and TDAPA amount. We stated

in the proposed rule that the proposed

formula for determining the final ESRD

PPS per treatment payment amount

with the Facility HDPA would be as

follows:

Final Per Treatment Payment Amount

with Facility HDPA = ((Adjusted

ESRD PPS per Treatment Base Rate

* Facility HDPA) + Training Add

On + TDAPA) * ESRD QIP Factor +

Outlier Payment * ESRD QIP Factor

In the proposed rule, we considered

adjusting the full ESRD PPS per

treatment payment amount by the

Facility HDPA, including any applicable

training adjustment add-on payment

amount, outlier payment amount, and

TDAPA. However, we concluded that

adjusting these additional payment

amounts was not necessary to create the

financial incentives we seek to test

under the proposed ETC Model. We

sought comment on our proposed

definition of Adjusted ESRD PPS per

Treatment Base Rate, and the

implications of excluding from the

definition the adjustments and payment

amounts previously listed, such that

those amounts would not be adjusted by

the Facility HDPA under the ETC

Model.

As discussed previously in section

IV.B.1 of this final rule, after we

published the proposed rule for the ETC

Model, CMS established a new payment

adjustment under the ESRD PPS called

the TPNIES, which could apply to

certain claims as soon as CY 2021. The

TPNIES is part of the calculation of the

ESRD PPS per treatment payment

amount under 42 CFR 413.230 and, like

the TDAPA, is applied after the facility-

level and patient-level adjustments. We

discuss the implications of this change

for the Facility HDPA later in this

section of the final rule.

In the proposed rule, we proposed in

§ 512.340 to apply the Facility HDPA to

the Adjusted ESRD PPS per Treatment

Base Rate on claim lines with Type of

Bill 072X, where the type of facility

code is 7 and the type of care code is

2, and with condition codes 74, 75, 76,

or 80, when the claim is submitted by

an ESRD facility that is an ETC

Participant with a claim through date

during a CY subject to adjustment, as

described in the proposed rule and

section IV.C.4.d of this final rule, where

the beneficiary is age 18 or older during

the entire month of the claim. We

explained that facility code 7 (the

second digit of Type of Bill) paired with

type of care code 2 (the third digit of

Type of Bill), indicates that the claim

occurred at a clinic or hospital-based

ESRD facility. Type of Bill 072X

captures all renal dialysis services

furnished at or through ESRD facilities.

We stated in the proposed rule that

condition codes 74 and 75 indicate

billing for a patient who received

dialysis services at home, and condition

code 80 indicates billing for a patient

who received dialysis services at home

and the patient’s home is a nursing

facility. Condition code 76 indicates

billing for a patient who dialyzed at

home but received back-up dialysis in a

facility. We noted in the proposed rule

that, taken together, we believed these

condition codes capture home dialysis

services furnished by ESRD facilities,

and therefore were the codes we

proposed to use to identify those

payments subject to the Facility HDPA.

We sought comment on this proposed

provision.

As further described in the proposed

rule and in section IV.C.7.a of this final

rule, we also proposed that the Facility

HDPA would not affect beneficiary cost

sharing. Beneficiary cost sharing instead

would be based on the amount that

would have been paid under the ESRD

PPS absent the Facility HDPA.

The following is a summary of the

comments received on the Facility

HDPA and our responses.

Comment: Many commenters

recommended that CMS adjust the

home and self-dialysis training add-on

payment adjustment under the ESRD

PPS by the Facility HDPA. One such

commenter opined that the training add-

on payment adjustment is directly

related to the Model’s goal of shifting

beneficiaries to home dialysis

modalities. A commenter recommended

that CMS adjust the TDAPA by the

Facility HDPA, asserting that new renal

dialysis drugs and biological products

pending FDA approval that could be

furnished to beneficiaries receiving

home dialysis services may be found to

better support implementation of home

dialysis delivery services. A commenter

expressed support for CMS’s proposal to

exclude the outlier payment from the

definition of the Adjusted ESRD PPS per

Treatment Base Rate.

Response: We thank the commenters

for their feedback. As we stated in the

proposed rule, we believe adjusting the

training add-on payment adjustment

amount and the TDAPA amount by the

Facility HDPA is not necessary to create

the financial incentives we seek to test

under the ETC Model. Regarding the

commenter’s suggestion that CMS apply

the Facility HDPA to the training add-

on payment adjustment, while we agree

with the commenter that beneficiary

training is necessary prior to initiating

home dialysis, CMS believes that

adjusting the Adjusted ESRD PPS per

Treatment Base Rate by the Facility

HDPA for claims submitted for home

dialysis will provide a sufficient

financial incentive to shift beneficiaries

to home dialysis. Regarding the

commenter’s suggestion that CMS

should apply the Facility HDPA to the

TDAPA, the commenter discussed drugs

for which drug sponsors are seeking

FDA approval. CMS does not find it

appropriate to change its proposed

application of the Facility HDPA in

anticipation of certain renal dialysis

drugs that may or may not be approved

by the FDA. Further, even if these drugs

were already approved or become

approved by the FDA during the Model,

that would not change CMS’s position,

as the Model is not focused on drug

innovation or designed to encourage

pharmaceutical companies to create and

release more drugs. Rather, the Model is

designed to increase rates of home

dialysis and transplantation.

While we are not modifying the

proposed application of the Facility

HDPA, we are updating the formula for

calculating the final ESRD PPS per

treatment payment amount with the

Facility HDPA to reflect the addition of

the TPNIES. Because CMS would apply

the TPNIES in the calculation of the per

treatment payment amount after the

application of the patient-level

adjustments and facility-level

adjustments, in the same manner as the

TDAPA, the TPNIES does not alter the

proposed application of the Facility

HDPA. We had proposed to apply the

Facility HDPA to the Adjusted ESRD

PPS per Treatment Base Rate, meaning

the per treatment payment amount as

defined in 42 CFR 413.230, including

patient-level adjustments and facility-

level adjustments and excluding any

applicable training adjustment add-on

payment amount, outlier payment

amount, and TDAPA amount. To take

into account the TPNIES payment

adjustment that could apply beginning

in CY2021, we are finalizing the formula

for determining the final ESRD PPS per

treatment payment amount with the

Facility HDPA, with the TPNIES as

follows:

Final Per Treatment Payment Amount

with Facility HDPA = ((Adjusted

ESRD PPS per Treatment Base Rate

* Facility HDPA) + Training Add

On + TDAPA + TPNIES) * ESRD

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QIP Factor + Outlier Payment *

ESRD QIP Factor

Comment: A commenter expressed

general support for CMS’s proposed

approach for identifying home dialysis

services for the purposes of applying the

Facility HDPA, but recommended that

CMS also apply the Facility HDPA to

claims with condition code 73. The

commenter asserted that for

beneficiaries who qualify for Medicare

based on ESRD diagnosis, CMS

considers Medicare coverage to begin

when a beneficiary participates in a

home dialysis training program offered

by a Medicare-approved training

facility, and ESRD facilities report such

home dialysis training using condition

code 73 on claims. Other commenters

similarly suggested that CMS apply the

Facility HDPA to claims for home

dialysis-related services with condition

code 73.

Response: We thank the commenters

for their feedback. CMS understands

that condition code 73 relates to training

a beneficiary on home dialysis, and that

one way CMS determines the start of

Medicare coverage for an ESRD

Beneficiary is when an ESRD facility

bills Medicare using condition code 73

for that beneficiary. However, under the

ETC Model, CMS seeks to adjust

payments for and incentivize the

provision of home dialysis services, and

not home dialysis training per se. CMS

recognizes that training is necessary for

a beneficiary to succeed in home

dialysis; however, adjusting payments

for claims that include condition code

73 may encourage impermissible

‘‘gaming’’ wherein ETC Participants

train all beneficiaries on home dialysis,

regardless of whether the ETC

Participant believes home dialysis is the

most appropriate modality for the

beneficiary. In such a case, CMS would

be compensating ETC Participants for

simply training beneficiaries, rather

than for starting and maintaining

trained Beneficiaries on home dialysis.

Further, any home dialysis claim

submitted for an ESRD Beneficiary after

the claim containing condition code 73

would be adjusted by the Facility

HDPA, providing a robust enough

incentive to ETC Participants to increase

the provision of home dialysis services.

Comment: A commenter expressed

support for CMS’s proposal that the

Facility HDPA would not affect

beneficiary cost sharing.

Response: We thank the commenter

for the feedback and support.

After considering public comments,

we are finalizing our proposed

provisions on payments subject to the

Facility HDPA with modification.

Specifically, we are codifying in our

regulation at § 512.340 that we will

adjust the Adjusted ESRD PPS per

Treatment Base Rate by the Facility

HDPA for claim lines with Type of Bill

072X and with condition codes 74 or 76

where the claim is submitted by an

ESRD facility that is an ETC Participant

with a claim service date during a

calendar year subject to adjustment as

described in § 512.350, where the

beneficiary is at least 18 years old before

the first day of the month. We are

modifying which date associated with

the claim we are using to determine if

the claim occurred during the

applicable MY. Whereas we proposed

using the claim through date, we are

finalizing using the date of service on

the claim, to align with Medicare claims

processing standards. Specifically,

while Medicare claims data contains

both claim through dates and dates of

service, Medicare claims are processed

based on dates of service. Thus, we

must use the claim date of service to

identify the MY in which the service

was furnished. In addition, while we

had proposed to apply the Facility

HDPA only to claims for which the

beneficiary was at least 18 years old for

the entire month of the claim, in the

final rule, we are changing the language

to state that the beneficiary must be at

least 18 years of age ‘‘before the first day

of the month,’’ which is easier for CMS

to operationalize and has the same

practical effect (that is, a beneficiary

who is at least 18 years old before the

first date of a month will be at least 18

years old for that entire month). While

we proposed to apply the Facility HDPA

to claims with condition code 75, we

have since learned that this condition

code is no longer valid and therefore

will be removed for the final rule.

Additionally, in this final rule, we will

not apply the Facility HDPA to claims

with condition code 80, as we had

proposed, because condition code 80

indicates billing for a patient who

received dialysis services at home and

the patient’s home is a nursing facility.

As described in greater detail in section

IV.C.5.b.(1) of this final rule, we are

excluding beneficiaries who reside in or

receive dialysis services in a SNF or

nursing facility from attribution to ETC

Participants for purposes of calculating

the PPA. We will exclude home dialysis

claims for these beneficiaries from the

application of the Facility HDPA for the

same reason. We are finalizing the

definition of Adjusted ESRD PPS per

Treatment Base Rate in our regulation at

§ 512.310 with one modification to

reflect that the Adjusted ESRD PPS per

Treatment Base Rate calculation

excludes any applicable TPNIES

amount, with a technical change to

capitalize every word in the term

‘‘Adjusted ESRD PPS per Treatment

Base Rate.’’

c. Clinician HDPA

For Managing Clinicians that are ETC

Participants, we proposed to adjust the

MCP by the Clinician HDPA when

billed for home dialysis services. We

proposed to define the ‘‘MCP’’ as the

monthly capitated payment made for

each ESRD Beneficiary to cover all

routine professional services related to

treatment of the patient’s renal

condition furnished by a physician or

non-physician practitioner as specified

in 42 CFR 414.314. We considered

adjusting all Managing Clinician claims

for services furnished to ESRD

Beneficiaries, including those not for

dialysis management services. However,

as described in the proposed rule, we

concluded that adjusting claims for

services other than dialysis management

was not necessary to create the financial

incentives we seek to test under the ETC

Model.

We proposed to specify in our

regulation at § 512.345 that we would

adjust the amount otherwise paid under

Part B with respect to MCP claims by

the Clinician HDPA when the claim is

submitted by a Managing Clinician who

is an ETC Participant. MCP claims

would be identified by claim lines with

CPT

®

codes 90965 or 90966. We would

adjust MCP claims with a claim through

date during a CY subject to adjustment,

as described in the proposed rule and

section IV.C.4.d of this final rule, where

the beneficiary is 18 years or older for

the entire month of the claim. CPT

®

code 90965 is for ESRD-related services

for home dialysis per full month for

patients 12–19 years of age. CPT

®

code

90966 is for ESRD-related services for

home dialysis per full month for

patients 20 years of age and older. These

two codes are used to bill the MCP for

patients age 18 and older who dialyze

at home, and therefore are the codes we

proposed to use to identify those

payments subject to the HDPA. As noted

in the proposed rule and previously in

this final rule, we proposed to adjust the

amount otherwise paid under Part B by

the Clinician HDPA so that beneficiary

cost sharing would not be affected by

the application of the Clinician HDPA.

The Clinician HDPA would apply only

to the amount otherwise paid for the

MCP absent the Clinician HDPA.

The following is a summary of the

comments received on the Clinician

HDPA and our responses.

Comment: Two commenters

expressed support for our proposal that

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the Managing Clinician HDPA would

not affect beneficiary cost sharing. One

such commenter reasoned that

beneficiaries included in the Model

should not be financially harmed or

experience perverse incentives to obtain

care not resulting in optimal patient

health outcomes. Another commenter

expressed concern that CMS did not

explain in the proposed rule how the

HDPA would impact beneficiary co-

insurance.

Response: We thank the commenters

for their feedback. As we noted in the

proposed rule, the Clinician HDPA is

applied to the Part B paid amount.

Beneficiary cost sharing (for example,

beneficiary coinsurance) is not subject

to the HDPA adjustment.

Comment: A commenter suggested

that, during the Model, CMS increase

the payment amount for physicians’

services for patients in training for self-

dialysis.

Response: We thank the commenter

for this feedback. CMS disagrees with

the commenter’s suggestion that CMS

increase the PFS payment amount for

services furnished to patients in training

for self-dialysis, as (1) the Model uses

percentages for its payment adjustments

to give each ETC Participant a

percentage (rather than flat-dollar)

increase or decrease in payment, and (2)

CMS has modified its proposal to

include self-dialysis services for

purposes of calculating the home

dialysis rate, as described in section

IV.C.5.c.(1) of this final rule.

After considering public comments,

we are finalizing our proposals on the

application of the Clinician HDPA to

MCP claims with modifications.

Specifically, we are codifying in our

regulation at § 512.345 that we will

adjust the amount that is otherwise paid

under Medicare Part B with respect to

MCP claims, identified by claim lines

with CPT

®

codes 90965 or 90966, by the

Clinician HDPA when the claim is

submitted by a Managing Clinician who

is an ETC Participant and with a claim

service date during a calendar year

subject to adjustment described in

§ 512.350, where the beneficiary is at

least 18 years old before the first day of

the month. As noted elsewhere, we are

modifying which date associated with

the claim we are using to determine if

the claim occurred during the

applicable MY. Whereas we proposed

using the claim through date, we are

finalizing using the date of service on

the claim, to align with Medicare claims

processing standards. Specifically,

while Medicare claims data contains

both claim through dates and dates of

service, Medicare claims are processed

based on dates of service. Thus, we

must use the claim date of service to

identify the MY in which the service

was furnished. In addition, while we

had proposed to apply the Clinician

HDPA only to claims for which the

beneficiary was at least 18 years old for

the entire month of the claim, in the

final rule, we are changing the language

to state that the beneficiary must be at

least 18 years ‘‘before the first day of the

month,’’ which is easier for CMS to

operationalize and has the same

practical effect (that is, a beneficiary

who is at least 18 years old before the

first date of a month will be at least 18

years old for that entire month). Finally,

we are finalizing the definition of

Monthly capitation payment (MCP), as

proposed, in our regulation at § 512.310.

d. HDPA Schedule and Magnitude

We proposed to specify in our

regulations at § 512.350 that the

magnitude of the HDPA would decrease

over the years of the ETC Model test, as

the magnitude of the PPA increases. In

this way, we would transition from

providing additional financial

incentives to support the provision of

home dialysis through the HDPA in the

initial three CYs of the ETC Model, to

holding ETC Participants accountable

for attaining the outcomes that the

Model is designed to achieve via the

PPA. In the proposed rule, we

considered alternative durations of the

HDPA, including limiting the HDPA to

one year such that there would be no

overlap between the HPDA and the

PPA, or extending the HDPA for the

entire duration of the Model. However,

we did not elect to propose these

approaches in the proposed rule. We

explained that if the HDPA applied for

only the first year of the Model, there

would be a six-month gap between the

end of the HDPA (December 31, 2020)

and the start of the first PPA period

(July 1, 2021), during which there

would be no model-related payment

adjustment. If the HDPA applied for the

duration of the Model, there would be

two sets of incentives in effect: A

process-based incentive from the HDPA

and an outcomes-based incentive from

the home dialysis component of the

PPA. As we explained in the proposed

rule, while we believe that the time-

limited overlap between the two

payment adjustments is acceptable to

smoothly transition ETC Participants

from process-based incentives to

outcomes-based incentives, we do not

believe this structure is beneficial to the

Model test over the long term.

We proposed the payment adjustment

schedule in Table 11:

Under this proposed schedule, the

HDPA would no longer apply to claims

submitted by ETC Participants with

claim through dates on or after January

1, 2023. We sought input from the

public about the proposed magnitude

and duration of the proposed HDPA.

The following is a summary of the

comments received on the proposed

HDPA schedule and magnitude and our

responses.

Comment: Several commenters

recommended that we continue to apply

the HDPA beyond the first 3 years of the

Model, and some suggested that we

continue to apply the HDPA for the

entire duration of the Model. A

commenter recommended that the

period during which the HDPA is

applied be increased from 3 years to 4

years. Several commenters expressed

concern regarding the proposal to

reduce the magnitude of the HDPA after

the first year, and otherwise taper down

the magnitude of the HDPA over the

course of the first three years of the

Model. Commenters also expressed

concern regarding the proposal to apply

the HDPA during only the first three

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years of the Model. Several commenters

expressed concern that building up the

infrastructure necessary to increase the

provision of home dialysis will take

time, and that it would be more

appropriate to apply the HDPA to

claims submitted by ETC Participants

for more years of the Model. Some

commenters explained that the sources

of delay and difficulty in establishing or

building upon a home dialysis program

include: Capital investments; hiring

staff, particularly dialysis nurses who

are in short supply across the nation;

receiving local zoning and building

permits; and obtaining federal and state

regulatory approval. Commenters

expressed concern that going through

the required processes and obtaining the

appropriate equipment and staffing can

easily take a year or more, at which time

the magnitude of the HDPA will have

already decreased.

Response: Regarding the comments

recommending that CMS extend the

duration of time during which the

HDPA would be applied, CMS indicated

in the proposed rule that applying the

HDPA for the duration of the Model

would create an overlap between a

payment adjustment that is process-

based, the HDPA, and another that is

outcomes-based, the PPA, that would

not be beneficial to the Model test over

the long-term. Applying the HDPA for

another year would similarly not be

beneficial to the Model over the long-

term. The Model is designed to more

heavily emphasize, in the beginning of

the Model, the process of building up

necessary infrastructure to provide more

home dialysis services, and to more

heavily emphasize, in later years of the

Model, the outcomes of increased home

dialysis and transplants. CMS

recognizes that building the necessary

infrastructure will take time, and that is

why CMS proposed to apply the HDPA

for the first three years of the Model.

CMS believes that three years is more

than enough time to take all necessary

steps to increase utilization of home

dialysis.

Comment: A commenter

recommended that CMS wait to apply

the HDPA to claims submitted by an

ETC Participant until after a patient has

been on home dialysis for three months.

The same commenter expressed concern

that ETC Participants will start patients

on home dialysis who will not do well

on home dialysis so that the ETC

Participants could potentially receive a

short-term increase in payment via the

application of the HDPA.

Response: While CMS appreciates the

commenter’s suggestion that CMS wait

to apply the HDPA to claims submitted

by an ETC Participant until the

beneficiary has been on home dialysis

for 3 months, CMS believes it is

important to apply the HDPA sooner so

as to better position ETC Participants to

immediately begin making investments

to increase the provision of home

dialysis to beneficiaries for whom this

modality is clinically appropriate. CMS

also appreciates the commenter’s

concern over the possibility of ETC

Participants gaming the HDPA when the

HDPA applies immediately and not after

a particular ESRD Beneficiary has been

on home dialysis for a certain amount

of time, but CMS believes the overall

payment methodology under the Model

eliminates a gaming incentive of this

nature. Part of the calculation for the

PPA derives from the ETC Participant

showing improvement in its home

dialysis rate in a given year. An ETC

Participant will need to increase its

beneficiary population receiving home

dialysis in a sustainable fashion for its

data to reflect an improvement, creating

an incentive for ETC Participants to

identify suitable candidates for home

dialysis and to keep such candidates on

home dialysis over the course of months

and years, as appropriate.

Comment: Some commenters

expressed general support for the

magnitude of the HDPA as proposed. A

few commenters expressed agreement

with the idea that payment incentives

have a role in achieving higher value

care for kidney patients. One such

commenter noted that rates of PD have

increased due to aligning the

reimbursement for in-center dialysis

with home-based modalities. Similarly,

another such commenter noted that

ESRD facilities have proven remarkably

responsive to policy changes that are

tied to payment adjustments, such as

the ESRD PPS and ESRD QIP initiatives.

That same commenter expressed a belief

that the payment adjustments under the

ETC Model are far milder than the ESRD

PPS and QIP initiatives, and expressed

confidence that Managing Clinicians

and ESRD facilities that are ETC

Participants will quickly adopt new

treatment and process innovations to

maximize their performance within the

Model.

Response: We thank the commenters

for the feedback and support. We also

appreciate the comment regarding the

increase in the provision of PD, but note

that the ESRD PPS base payment rate is

modality neutral, and that the identified

increase in rates of PD could be

explained by a higher profit margin for

providing PD over HD, and not because

the Medicare payment is higher.

Comment: A commenter expressed

support for the proposed magnitude of

the HDPA, but expressed concern that

the uptake of home dialysis may be

slower than CMS anticipates, and thus

suggested that CMS consider

implementing a performance benchmark

that an ETC Participant must reach

before CMS lowers the magnitude of

that ETC Participant’s HDPA. The same

commenter also recommended that the

duration of the HDPA should be

different for LDOs versus non-LDOs,

such that the HDPA would apply to

claims submitted by non-LDOs for a

longer period of time than for claims

submitted by LDOs, or that the

magnitude of the HDPA applied to

claims submitted by non-LDOs would

taper down more slowly than it would

for the LDOs. Several commenters

expressed concern that the Facility

HDPA and Clinician HDPA adjustments

are too low to adequately incentivize

behavioral change.

Response: We appreciate the

commenters’ feedback. CMS does not

believe it would be beneficial to the

Model to require a performance

benchmark for an ETC Participant to

reach before CMS decreases the

magnitude of the Participant’s HDPA, as

the intent of the HDPA is to incentivize

investments in home dialysis in the

early years of the Model. In later years,

such incentives would be created by the

application of the PPA. CMS also

disagrees with the recommendation that

CMS differentiate the duration or

magnitude of the HDPA between LDOs

and non-LDOs, as such a distinction

fails to consider differences in current

home dialysis service provision across

LDOs and non-LDOs. CMS believes that

the HDPA and PPA, in combination,

provide an equally strong incentive to

LDOs and non-LDOs alike toward

establishing or building out home

dialysis programs. Further, to the extent

that the HDPA will result in a greater

revenue increase to LDOs over non-

LDOs early in the Model, such a

disparity is appropriate given the larger

volume of patients that LDOs, by

definition, serve. An ESRD facility

furnishing services to a larger volume of

patients will require a larger investment

in infrastructure compared to an ESRD

facility furnishing services to a smaller

volume of patients. CMS further

believes that the magnitude of the

Facility HDPA and Clinician HDPA,

especially when coupled with the

respective PPAs, are adequate to

incentivize ETC Participants to create or

build out their home dialysis programs.

Comment: Many commenters noted

that establishing a home dialysis

program or building upon an existing

program requires hiring and training

staff, particularly dialysis nurses, who

several commenters noted are in short

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supply; securing additional space and

equipment; establishing training

protocols for patients; undergoing a

survey and certification process

(depending on the State); obtaining

zoning and building permits; and

obtaining federal and State regulatory

approval. Commenters stated that the

magnitude of the HDPA is not large

enough to cover these significant up-

front costs. Other commenters expressed

concern that the HDPA would prove

inadequate to help small and

independent ESRD facilities increase

their provision of home dialysis, as such

facilities often have low margins and

fewer resources than LDOs. A

commenter expressed concern that the

HDPA would favor chain ESRD facilities

with several ESRD facilities within close

proximity who can hire one dialysis

nurse to cover multiple ESRD facilities,

and will lead smaller health care

providers to sell their facility to large

chain ESRD facilities, causing further

consolidation. Still other commenters

expressed concern that CMS did not

attempt to quantify the investment

required by ESRD facilities and

Managing Clinicians to establish or

build upon home dialysis programs,

which those commenters believed

should have informed the proposed

magnitude and duration of the HDPA. A

commenter expressed concern that CMS

did not indicate, in the proposed rule,

that the HDPA as proposed would be

adequate to allow ETC Participants to

increase their capacity to provide home

dialysis services.

Response: CMS believes that

providing positive payment adjustments

via the HDPA over the first three years

of the Model will provide sufficient

time for ETC Participants to build out

infrastructure to establish or build upon

home dialysis programs. CMS

recognizes that market realities impose

significant barriers to increasing

capacity to offer home dialysis

programs, which is exactly why CMS

proposed to apply the HDPA. While

CMS cannot easily affect the supply of

dialysis nurses or the number of

vendors in the home dialysis market, it

can provide ETC Participants with

positive payment adjustments through

the HDPA to help overcome these

market obstacles. Regarding the

commenter’s concern about chain ESRD

facilities that have several clinics in

close proximity being able to hire one

nurse to cover multiple ESRD facilities,

such ESRD facilities would have that

advantage regardless of the payment

adjustments made under this Model.

The ETC payment methodology does

not create or increase this advantage

that chain ESRD facilities have over

others. Moreover, we believe that non-

chain ESRD facilities can innovate their

business practices to overcome the

identified advantage that chain ESRD

facilities currently have. For example,

non-chain ESRD facilities could hire a

part-time nurse rather than a full-time

nurse, or collaborate with other nearby

non-chain ESRD facilities to contract

with a nurse to mimic the approach that

the commenter anticipates chain ESRD

facilities will take. Regarding the

comments expressing concern that CMS

did not quantify the investment

required by ESRD facilities and

Managing Clinicians to establish or

build upon home dialysis programs,

CMS could not have adequately

quantified such investments for all ETC

Participants. ESRD facilities and

Managing Clinicians are heterogeneous,

and costs will differ greatly among

ESRD facilities and Managing

Clinicians. Regional differences in cost,

differing patient population sizes,

differing relationships with community

partners, and differences in margins,

funding, and business models make it

impossible for CMS to accurately

identify the cost of creating or building

upon a home dialysis program for each

ESRD facility or Managing Clinician.

The HDPA will provide ETC

Participants with upfront revenue that

the ETC Participant can use to increase

provision of home dialysis.

Comment: Several commenters

expressed concern that the Clinician

HDPA, as proposed, is too small in

amount to effectively address the

current gap in reimbursement between

providing in-center dialysis compared

to home dialysis. Several commenters

expressed concern that even with the 3

percent HDPA, Managing Clinicians are

still paid more under current Medicare

rules for providing four or more in-

center dialysis treatments a month than

for providing home dialysis in a month.

Noting that CMS acknowledged in the

proposed rule that current Medicare

payment rates and mechanisms may

create a disincentive to prescribe and

furnish home dialysis, the commenters

suggested the HDPA for Managing

Clinicians should be set at a magnitude

such that the Clinician HDPA plus the

MCP for home dialysis exceeds the

current MCP for four or more in-center

dialysis visits in a given month. The

same commenters recommended that

following the end of the proposed

HDPA period, CMS should include a

payment adjustment to the MCP that

equalizes the MCP for home dialysis

and the MCP for four or more in-center

visits. A commenter stated that the

proposed Clinician HDPA of 3 percent

still leaves the payment amount for

home dialysis services below the in-

center MCP payment for four or more

visits during a month.

Response: CMS recognizes that for

physicians, the MCP for in-center

dialysis is currently higher than the

MCP for home dialysis. However, CMS

firmly believes that moving

beneficiaries to home dialysis will

ultimately be cost saving for ETC

Participants by the end of the model

period and that the Clinician HDPA

adjustments, as proposed, are

sufficiently large to encourage ETC

Participants create or build out home

dialysis programs to realize those long

term savings. The infrastructure and

equipment necessary for providing

home dialysis may be expensive up-

front, but once the infrastructure and

equipment have been acquired, home

dialysis will be less costly for the ETC

Participant to provide compared to

providing four or more in-center

dialysis sessions. Even though the

Clinician HDPA is not large enough to

make payment for providing home

dialysis equal to or higher than payment

for providing four or more in-center

dialysis sessions, it is large enough to

sufficiently lessen the up-front costs of

establishing or building out home

dialysis capability and allow the ETC

Participant to realize the benefits

associated with moving appropriate

ESRD Beneficiaries away from in-center

services to home dialysis. For ETC

Participants, these benefits may include:

Reduced labor costs and capital

depreciation associated with reduced

provision of in-center services; the

capacity to increase the total number of

patients served at any given time and

overall given that fewer patients will

use in-center space, which can only

accommodate so many patients at any

one time, allowing the ETC Participant

to more rapidly expand the patient

population it serves; and generally

decreased operating costs in the

medium- and long-run. For ESRD

Beneficiaries, the benefits may include

reduced or eliminated commuting to

ESRD facilities for treatment, greater

involvement in the ESRD Beneficiary’s

own treatment, and generally greater

autonomy.

Comment: Several commenters

recommended that the HDPA be

increased in magnitude. Some of these

commenters recommended that the

magnitude of the HDPA be increased

significantly. Some commenters

suggested certain specific amounts for

the HDPA. A few commenters

recommended that the magnitude of the

HDPA be increased to 3–5 percent.

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Other commenters suggested that the

magnitude of the HDPA stay at 3

percent for all three years it is applied,

or that it remain at 3 percent for the

duration of the Model. Another

commenter recommended that the

HDPA be maintained at 3 percent for all

three years, but alternatively suggested

that the magnitude of the HDPA start at

1 percent in year one, increase to 2

percent in year 2, and to 3 percent in

year three. Another commenter more

generally suggested that the HDPA be

established at a set amount for every

year of the Model and not be tapered

down in magnitude, as proposed. Some

commenters expressed concern that the

HDPA would be too small to make an

impact on home dialysis rates when

combined with the PPA, given that the

PPA could impose a large downward

adjustment on certain payments for ETC

Participants.

Response: CMS does not believe the

magnitude of the HDPA needs to be

increased. Increasing the HDPA by any

amount, including maintaining the

HDPA at 3 percent for two additional

years or for the duration of the Model,

would serve to undermine the Model’s

emphasis on improving outcomes. CMS

believes that the proposed magnitude of

the HDPA will be adequate to make an

impact on home dialysis rates

notwithstanding the PPA, and that

increasing the magnitude of the HDPA

beyond what was proposed would

undercut the focus on outcomes under

the Model.

After considering public comments,

we are finalizing our proposed

provisions on the HDPA schedule and

magnitude, with one modification.

Specifically, in order to accommodate

the start date for the payment

adjustments under the ETC Model

finalized in our regulations at § 512.320,

we are codifying in our regulations at

§ 512.350 that CMS adjusts the

payments specified in § 512.340 by the

Facility HDPA and that CMS adjusts the

payments specified in § 512.345 by the

Clinician HDPA according to the

schedule in Table 11.a:

5. Performance Payment Adjustment

We proposed to adjust payment for

claims for dialysis services and dialysis-

related services submitted by ETC

Participants based on each ETC

Participant’s Modality Performance

Score (MPS), calculated as described in

the proposed rule and section IV.C.5.d

of this final rule. We proposed to define

the ‘‘Modality Performance Score

(MPS)’’ as the numeric performance

score calculated for each ETC

Participant based on the ETC

Participant’s home dialysis rate and

transplant rate, as described in

§ 512.370(d) (Modality Performance

Score), which is used to determine the

amount of the ETC Participant’s PPA, as

described in § 512.380 (PPA Amounts

and Schedule). We sought comment on

the composition of the MPS,

particularly the inclusion of the

transplant rate in the MPS.

We proposed that there would be two

types of PPAs: The Clinician PPA and

the Facility PPA. We proposed to define

the ‘‘Clinician PPA’’ as the payment

adjustment to the MCP for a Managing

Clinician who is an ETC Participant

based on the Managing Clinician’s MPS,

as described in our regulations at

§ 512.375(b) (Payments Subject to

Adjustment) and § 512.380 (PPA

Amounts and Schedule). We proposed

to define the ‘‘Facility PPA’’ as the

payment adjustment to the Adjusted

ESRD PPS per Treatment Base Rate for

an ESRD facility that is an ETC

Participant based on the ESRD facility’s

MPS, as described in § 512.375(a)

(Payments Subject to Adjustment) and

§ 512.380 (PPA Amounts and Schedule).

We proposed to define the ‘‘PPA’’ as

either the Facility PPA or the Clinician

PPA.

The following is a summary of the

comments received on the calculation of

the proposed PPA, and in particular the

inclusion of the transplant rate in the

MPS used to calculate the PPA, and our

responses.

Comment: Several commenters

expressed concern about the level of

control ETC Participants have over

transplants. Commenters expressed

concern that the average waitlist stay for

a patient is around 4.6 years, and

therefore ETC Participants may not be

able to receive credit for a transplant

that results from getting a beneficiary on

the transplant waitlist given the Model’s

duration. A commenter recommended

that we delay the inclusion of the

transplant rate in the calculation of the

PPA until there are system-wide

improvements in the availability of

organs for transplant, the transplant rate

is redesigned to enhance patient

protections, and the Model explicitly

accounts for regional variation in

transplant rates. Several commenters

recommended that CMS use transplant

waitlisting instead of actual transplant

rates in calculating the PPA, noting that

ESRD facilities and Managing Clinicians

have influence over waitlisting rates,

but not over the actual transplant rates.

Some commenters suggested that CMS

simply eliminate the transplant rate

from the PPA calculation. Some

commenters suggested that though

organ supply is outside of the control of

ESRD facilities and managing clinicians,

there are other aspects of the process

that can and should be in their control

such as how they educate patients and

families about living donation and how

effectively they interact with transplant

centers. They remarked that there is an

opportunity for ESRD facilities and

managing clinicians to increase care

coordination and patient education with

respect to living donor transplantation.

A commenter expressed concern about

the calculation of the MPS, asserting

that the proposed home dialysis rate

and transplant rate calculations, risk

adjustments, reliability adjustments,

and comparison benchmarks seem

complex and would make it difficult for

ETC Participants to monitor, gauge, and

ultimately improve performance.

Response: We thank the commenters

for their feedback. CMS believes that

using a performance measure related to

transplants to determine, in part, an

ETC Participant’s PPA is vital to incent

meaningful behavior change. While

CMS does recognize that ETC

Participants, as ESRD facilities and

Managing Clinicians, do not have

control over every step of the transplant

process, CMS continues to believe it is

appropriate to include a transplant

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component in the MPS calculation used

to determine the PPA. As the health care

providers that ESRD beneficiaries see

most frequently, ETC Participants play a

pivotal role in the transplant process,

including: Educating beneficiaries about

their transplant options, including

living donation; helping beneficiaries

navigate the transplant process,

including helping beneficiaries

understand the process; providing

referrals for care necessary to meet

clinical transplant requirements, and

referrals for transplant waitlisting; and

coordinating care during the transplant

process.

Based on feedback from commenters,

however, CMS is drawing a distinction

between living donor transplants, which

are not subject to the same supply

constraints brought up by commenters,

and deceased donor transplants, which

currently have a more limited supply.

For the living donation process, CMS

recognizes the important role that ETC

Participants have in helping inform and

support their patients in the living

donor process, and will therefore retain

the living donor transplant rate in the

transplant rate calculation.

In contrast, CMS recognizes that the

current process for deceased donor

organ allocation and the current

shortage of available deceased donor

kidneys makes it difficult to hold ETC

Participants accountable for the rate of

deceased donor kidney transplants at

this time. The proposed rule calculated

the transplant rate by adding together all

transplants, including pre-emptive

transplants. However, based on

feedback from commenters the rate of

deceased donor transplants will not be

a part of the transplant rate calculation.

The transplant rate will still include

living donor transplants, including

preemptive transplants, but we replaced

the deceased donor transplants in the

transplant rate calculation with the

transplant waitlist rate because CMS

also recognizes that ESRD facilities and

Managing Clinicians play an essential

role in supporting beneficiaries in

selecting transplantation and referring

beneficiaries to a transplant waitlist,

and are well-positioned to work with

OPOs and transplant centers to further

increase transplant waitlisting. The ETC

Model is designed in part to encourage

health care providers to form these

relationships. The ETC Learning

Collaborative, described in section

IV.C.13 of this final rule, is designed to

facilitate these relationships as part of

the dissemination of best practices to

increase organ recovery and utilization.

We therefore agree with commenters

that it is appropriate to hold ETC

Participants accountable for transplant

waitlisting while implementing other

policies to increase the supply of

available deceased donor kidneys.

These modifications to the transplant

component of the MPS calculation is

further discussed in section IV.C.5.c.(2)

of this final rule.

CMS recognizes that 88.5% of all

deceased donor kidney transplants

occurred among patients who had been

on the waitlist for less than five years.

Given that the ETC Model will last over

5 years, the average Medicare

beneficiary placed on a waitlist in the

first year is expected to receive a

transplant by the end of the Model.

Accordingly, CMS may consider

incorporating a transplant rate into the

PPA calculation for later years of the

Model through subsequent rulemaking.

Comment: Commenters expressed a

desire for other stakeholders like OPOs

to also be held financially accountable

for transplant rates under the Model if

CMS is going to proceed with holding

ETC Participants financially

accountable for actual transplants. One

such commenter expressed concern that

ETC Participants may be unfairly

disadvantaged if a transplant program

does not put higher risk patients

referred by the ETC Participant on the

transplant waitlist that other transplant

programs might accept.

Response: As discussed in response to

the preceding comment and as

described in section IV.C.5.d of this

final rule, we will not be holding ETC

Participants accountable for deceased

donor transplants under the ETC Model.

Rather, we will use a transplant rate

calculated as the sum of the transplant

waitlist rate and the living donor

transplant rate for purposes of the

transplant component of the MPS.

Regarding the concern that ETC

Participants may be unfairly

disadvantaged if a transplant program

does not put higher risk patients

referred by ETC Participants on the

transplant waitlist that other transplant

programs might accept, CMS

acknowledges that transplant programs

have different criteria for accepting

patients on transplant waitlists. ETC

Participants can work with transplant

programs in their respective

communities to encourage the

acceptance of a particular ESRD

Beneficiary on the waitlist. ETC

Participants could also recommend that

their patients register with a particular

transplant program that accepts patients

with their levels of risk. ETC

Participants can also support ESRD

Beneficiaries pursuing living donor

transplants by educating beneficiaries

about their transplant options, including

living donation; helping beneficiaries

navigate the transplant process,

including helping beneficiaries

understand the process; providing

referrals for care necessary to meet

clinical transplant requirements, and

referrals for transplant waitlisting; and

coordinating care during the transplant

process.

Comment: Some commenters

recommended that CMS create a

blended home dialysis-transplant

measure for determining an ETC

Participant’s PPA. For example, one

commenter suggested using a composite

endpoint, where home dialysis and

transplantation are measured in one

rate, rather than two separate rates,

using the same numerator and

denominator. Another commenter

suggested including an appropriate

patient acuity measure and measures

that assess social determinants of health

and unmet social needs in calculating

the home dialysis and transplant rates

and issuing the PPA.

Response: We appreciate the

commenter’s suggestion that we create a

blended home dialysis and transplant

rate to determine an ETC Participant’s

PPA and recognize that some ETC

Participants may excel at supporting

beneficiaries in selecting one alternative

to in-center HD and not the other.

However, we believe it is important that

ESRD Beneficiaries receive the support

they need to select either home dialysis

or transplantation, regardless of the ETC

Participant from which they receive

dialysis care. As such, we believe it is

important to assess ETC Participant

performance on the home dialysis rate

and transplant rate separately, rather

than using a blended approach.

Comment: A commenter

recommended that CMS provide an

increased payment to dialysis providers

for transplants as part of the ETC Model,

similar to the transplant bonus payment

in the KCC Model.

Response: CMS disagrees with the

commenter’s suggestion to provide ETC

Participants with a bonus payment for

transplants, as ETC Participants can

receive such a bonus by participating

concurrently in the KCC Model.

Comment: A commenter suggested

that CMS adjust payment to ESRD

facilities using performance data on

quality measures that facilities have

publicly reported for a period of time

because that would allow stakeholders

to assess the reliability and validity of

the measures, as well as the proposed

scoring methodology, and to identify

any potential unintended consequences

that may be occurring.

Response: CMS disagrees with the

comment regarding deriving

performance-based quality adjustments

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150

CAHPS

®

is a registered trademark of the

Agency for Health Research and Quality, U.S.

Department of Health and Human Services.

for ESRD facilities under the ETC Model

from previously publicly reported

measures. CMS understands the

commenter’s assertion that measures

that have been in use for some time and

have been publicly reported

demonstrate reliability, validity, and

transparency to stakeholders. However,

the home dialysis rate and transplant

rate used in the ETC Model are part of

the model test, and have been

constructed solely for the purposes of

the model test. For the purposes of

testing this Model, we do not believe

that it is necessary for these rates to

have been publicly reported in advance

of the Model. As described in section

IV.C.10 of this final rule, we will

monitor for unintended consequences

and make modifications to the Model,

including the home dialysis rate and

transplant rate, if necessary, through

subsequent rulemaking.

Comment: Many commenters

recommended that CMS use validated

measures that are endorsed by the

National Quality Forum (NQF).

Response: We appreciate the feedback

from commenters that CMS should use

NQF-endorsed measures to measure

ETC Participant performance under the

Model. We note that, at present, there

are no NQF-endorsed measures for rates

of home dialysis, kidney transplants, or

inclusion on the kidney transplant

waitlist. However, we believe that it is

appropriate to use the rates constructed

specifically for the purposes of this

Model, as our intent is to measure the

impact of the Model’s payment

adjustments on the rates of home

dialysis and transplants. Given the

tailored nature of the home dialysis and

transplant rates and the lack of extant

alternatives, we believe it is appropriate

to use these rates for this Model.

Comment: A commenter

recommended that CMS add shared

decision-making measures (that is,

measures demonstrating that a patient

and clinician made treatment decisions

together based on what is best for the

patient), such as the Decision Conflict

Scale or those shared decision-making

measures in NQF’s National Quality

Partners Playbook

TM

Shared Decision

Making in Healthcare. The same

commenter noted that the Consumer

Assessment of Healthcare Providers and

Systems (CAHPS) survey for In-Center

Hemodialysis (ICH CAHPS)

150

includes

questions related to home modality

options and transplantation, but does

not include shared-decision making

questions and is limited to beneficiaries

using in-center dialysis. The same

commenter therefore also suggested

using decision-making tools for the

ESRD population, such as the

Empowering Patients on Choices for

Renal Replacement Therapy (EPOCH).

Some commenters offered to work with

CMS to construct a shared-decision

making measure to supplement the

proposed home dialysis rate and

transplant rate to assess the performance

of ETC Participants under the Model

and would also protect a beneficiary’s

choice and patient protections.

Response: CMS appreciates the

feedback to include measures of shared

decision making so that beneficiaries

have a choice in dialysis treatment

modality. CMS believes that the

informational material required to be

posted in the facility, described in

§ 512.330(a), addresses the need for

beneficiaries to be educated about the

Model and the beneficiary protections

described in section II of this final rule

adequately protect beneficiaries’

freedom of choice. While education

regarding treatment modality is

important, CMS will not adopt this

recommendation as it does not fit with

the Model’s goals of adjusting payments

in order to improve or maintain quality

while reducing costs through increased

rates of home dialysis use, ultimately,

and kidney transplants.

Comment: A commenter

recommended that CMS define a

pathway of supportive care services and

allow beneficiaries enrolled in the

pathway be included in calculation of

the proposed home dialysis rate and

transplant rate. According to the

commenter, supportive care services

include medical management, defined

as planned, holistic, person-centered

care such as interventions to delay

progression of kidney disease and

minimize risk of adverse events or

complications; shared decision making;

active symptom management; detailed

communication including advance care

planning; psychological support; as well

as social and family support. The same

commenter similarly recommended that

CMS explicitly acknowledge, in the

final rule, the need for supportive care

services for seriously ill beneficiaries

with CKD Stage IV, CKD Stage V, and

ESRD.

Response: We agree with the

commenter that supportive care services

are important for seriously ill

beneficiaries with CKD Stage IV, CKD

Stage V, and ESRD. CMS also

appreciates the commenter’s

recommendation that CMS define a

pathway of supportive care services and

allow beneficiaries enrolled in such

pathway to count toward the calculation

of the home dialysis and transplant

rates. However, this Model is designed

to improve or maintain quality while

decreasing costs by creating incentives

for Managing Clinicians and ESRD

facilities to increase rates of home

dialysis and transplants. We believe that

the proposed rates, with the

modifications described elsewhere in

this final rule, best accomplish this goal.

Further, to the extent that supportive

care services result in beneficiaries

initiating home dialysis, receiving a

living donor transplant, or being

included on the kidney transplant

waitlist, their use will be indirectly

counted towards the calculation of the

home dialysis rate or the transplant rate,

respectively.

Comment: A commenter

recommended that CMS include kidney

transplants with any other organ, and

not just with pancreas.

Response: We appreciate the

commenter’s feedback. We are clarifying

that, in referring to a kidney transplant

in the proposed rule, we intended to

refer to kidney transplants alone or in

conjunction with any other organ

transplant. By referring to both kidney

transplants and kidney-pancreas

transplants, our intent was not to

exclude kidney transplants in

conjunction with organs other than the

pancreas. Accordingly, we are defining

the term ‘‘kidney transplant’’ in our

regulations at § 512.310 to mean the a

kidney transplant, alone or in

conjunction with any other organ.

Accordingly, the transplant waitlist rate

calculation included in the transplant

rate will include ESRD Beneficiaries

listed on a waitlist for any kind of

kidney transplant, and the living donor

transplant rate calculation included in

the transplant rate will include

beneficiaries who receive any kind of

kidney transplant from a living donor.

Comment: A commenter expressed

concern about a proposed measure in

ESRD QIP—the Percentage of Prevalent

Patients Waitlisted Measure—that, if

finalized, may subject an ETC

Participant to a second source of

negative payment adjustment.

Response: We note that CMS finalized

the adoption of the PPPW measure in

the CY 2019 ESRD PPS final rule (83 FR

57008). We appreciate the commenter’s

concern that ESRD facilities that are

ETC Participants will receive more than

one payment adjustment based on

transplant waitlisting. However, we

believe that the adjustments under the

ESRD QIP and the ETC Model are

sufficiently different, in construction,

payment adjustment scope and

magnitude, and purpose, to support the

overlap.

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After considering public comments,

we are finalizing our general proposals

for the Performance Payment

Adjustment, with certain modifications.

Specific provisions and modifications

are described in the following sections

of this final rule. We received no public

comment on our proposed definitions of

the Performance Payment Adjustment

(PPA), Facility Performance Payment

Adjustment (Facility PPA), or Clinician

Performance Payment Adjustment

(Clinician PPA). As such, we are

finalizing these definitions in our

regulation at § 512.310 as proposed. We

received no public comment on our

proposed definition of the Modality

Performance Score (MPS), and are

finalizing this definition in our

regulation at § 512.310 with

modification to correct an error in an

internal cross-reference. Specifically,

the proposed definition of MPS referred

to § 512.310(a) of our regulations, but

we had meant to refer to the MPS

calculation in § 512.310(d). We are

adding a definition for ‘‘kidney

transplant waitlist’’ to our regulations at

§ 512.310, for the reasons described in

section IV.C.5.c(2) of this final rule.

a. Annual Schedule of Performance

Assessment and PPA

We proposed to assess ETC

Participant performance on the home

dialysis rate and the transplant rate,

described in the proposed rule and in

sections IV.C.5.c.1 and IV.C.5.c.2,

respectively, of this final rule, and to

make corresponding payment

adjustments according to the proposed

schedule described later. We proposed

in § 512.355(a) that we would assess the

home dialysis rate and transplant rate

for each ETC Participant during each of

the Measurement Years, which would

include 12 months of performance data.

For the ETC Model, we proposed to

define ‘‘Measurement Year (MY)’’ as the

12-month period for which achievement

and improvement on the home dialysis

rate and transplant rate are assessed for

the purpose of calculating the ETC

Participant’s MPS and corresponding

PPA. Further, we proposed in

§ 512.355(b) that we would adjust

payments for ETC Participants by the

PPA during each of the PPA periods,

each of which would correspond to a

Measurement Year. We proposed to

define ‘‘Performance Payment

Adjustment Period (PPA Period)’’ as the

6-month period during which a PPA is

applied pursuant to § 512.380 (PPA

Amounts and Schedule). Each MY

included in the ETC Model and its

corresponding PPA Period would be

specified in § 512.355(c) (Measurement

Years and Performance Payment

Adjustment Periods).

Under our proposal, each MY would

overlap with the subsequent MY, if any,

for a period of 6 months, as ETC

Participant performance would be

assessed and payment adjustments

would be updated by CMS on a rolling

basis. As we noted in the proposed rule,

we believe that this method of making

rolling performance assessments

balances two important factors: The

need for sufficient data to produce

reliable estimates of performance, and

the effectiveness of incentives that are

proximate to the period for which

performance is assessed. Beginning with

MY2, there would be a 6-month period

of overlap between a MY and the

previous MY. For example, MY1 would

begin January 1, 2020, and would run

through December 31, 2020; and MY2

would begin 6 months later, running

from July 1, 2020, through June 30,

2021. Each MY would have a

corresponding PPA Period, which

would begin 6 months after the

conclusion of the MY.

Table 12, we proposed the following

schedule of MYs and PPA Periods:

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We received no public comment on

our proposed schedule of performance

assessment and PPA. We are finalizing

the proposed provisions with

modification to reflect the start date of

the model, January 1, 2021, as described

elsewhere in this final rule. Specifically,

we are codifying at § 512.355 that the

PPA will be applied based on the

schedule of MYs and PPA Periods in

Table 12.a, to accommodate the start

date for the payment adjustments under

the ETC Model finalized in our

regulations at § 512.320. As such, we are

finalizing the definition of MY as the

12-month period for which achievement

and improvement on the home dialysis

rate and transplant rate are assessed for

the purpose of calculating the ETC

Participant’s MPS and corresponding

PPA. Each MY included in the ETC

Model and its corresponding PPA

Period are specified in § 512.355(c). We

are finalizing the definition of

Performance Payment Adjustment

Period (PPA Period), as proposed.

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b. Beneficiary Population and

Attribution

We proposed that, in order to assess

the home dialysis rate and transplant

rate for ETC Participants, ESRD

Beneficiaries would be attributed to

participating ESRD facilities and to

participating Managing Clinicians. For

purposes of the ETC Model, we

proposed to define ‘‘ESRD Beneficiary’’

as a beneficiary receiving dialysis or

other services for end-stage renal

disease, up to and including the month

in which he or she receives a kidney or

kidney-pancreas transplant. As we

noted in the proposed rule, this would

include beneficiaries who are on

dialysis for treatment of ESRD, as well

as beneficiaries who were on dialysis for

treatment of ESRD and received a

kidney or kidney-pancreas transplant up

to and including the month in which

they received their transplant.

Also, we proposed to attribute pre-

emptive transplant beneficiaries to

Managing Clinicians for purposes of

calculating the transplant rate,

specifically. We proposed to define a

‘‘pre-emptive transplant beneficiary’’ as

a Medicare beneficiary who received a

kidney or kidney-pancreas transplant

prior to beginning dialysis. We stated

that this definition would be mutually

exclusive of the proposed definition of

an ESRD Beneficiary, as a pre-emptive

transplant beneficiary receives a kidney

or kidney-pancreas transplant prior to

initiating dialysis and therefore is not an

ESRD Beneficiary. In the proposed rule,

we considered defining this concept as

pre-emptive transplant recipients, as

there are patients who receive pre-

emptive transplants who are not

Medicare beneficiaries, but who would

have become eligible for Medicare if

they did not receive a pre-emptive

transplant and progressed to ESRD,

requiring dialysis. We noted that this

definition would more accurately reflect

the total number of transplants

occurring in the population of patients

who could receive pre-emptive

transplants, and including these

additional patients who receive pre-

emptive transplants in the calculation of

the transplant rate could better

incentivize Managing Clinicians to

support kidney transplants via the

Clinician PPA. Due to data limitations

about patients who are not Medicare

beneficiaries, however, we concluded

that we could not include patients who

received pre-emptive transplants but

were not Medicare beneficiaries in the

construction of the transplant rate.

Therefore, we proposed to limit the

definition of pre-emptive transplant

beneficiary to include Medicare

beneficiaries only.

We proposed to attribute ESRD

Beneficiaries and pre-emptive

transplant beneficiaries, where

applicable, to ETC Participants for each

month of each MY, and we further

proposed that such attribution would be

made after the end of each MY. In the

proposed rule, we considered

attributing beneficiaries to participating

ESRD facilities and Managing Clinicians

for the entire MY; however, as noted in

the proposed rule, we believe monthly

attribution would more accurately

capture the care relationship between

beneficiaries and their ESRD providers

and suppliers. As ETC Participant

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behavior and care relationships with

beneficiaries may change as a result of

the ETC Model, we stated in the

proposed rule that we believe that the

level of precision associated with

monthly attribution of beneficiaries

would better support the ETC Model’s

design. Under our proposal, an ESRD

Beneficiary may be attributed to

multiple ESRD facilities and Managing

Clinicians in one MY, but would be

attributed to only one ESRD facility and

one Managing Clinician for a given

month during the MY. As we stated in

the proposed rule, we believe that

conducting attribution retrospectively,

after the completion of the MY, would

better align with the design of the PPA

in the ETC Model. We invited public

comment on the proposal to attribute

beneficiaries on a monthly basis after

the end of the relevant MY.

In the proposed rule, we considered

conducting attribution prospectively,

before the beginning of the MY.

However, we concluded that

prospective attribution would not be

appropriate given the nature of ESRD

and the ESRD Beneficiary population.

CKD is a progressive illness, with

patients moving from late stage CKD to

ESRD—requiring dialysis or a

transplant—throughout the course of the

year. As noted in the proposed rule, we

therefore believe prospective attribution

would functionally exclude incident

beneficiaries new to dialysis from

inclusion in the home dialysis and

transplant rates of ETC Participants

until the following MY. Additionally,

we stated our belief that prospective

attribution would not work well for the

particular design of this Model. In

particular, we noted in the proposed

rule that, because the PPA would be

determined based on home dialysis and

transplant rates during the MY, limiting

attribution to beneficiaries with whom

the ETC Participant had a care

relationship prior to the MY would not

accurately capture what occurred during

the MY. As we stated in the proposed

rule, we believe that conducting

attribution retrospectively, after the

completion of the MY, would better

align with the design of the PPA in the

ETC Model. We invited public comment

on the proposal to attribute beneficiaries

on a monthly basis after the end of the

relevant MY.

We proposed to provide ETC

Participants lists of their attributed

beneficiaries after attribution has

occurred, after the end of the MY. In the

proposed rule, we considered providing

lists in advance of the MY, or on a more

frequent basis. However, we determined

that, since we would be conducting

attribution after the conclusion of the

MY, prospective lists of attributed

beneficiaries that attempted to simulate

which beneficiaries would be attributed

to a participant during the MY would be

potentially misleading. Additionally, we

noted in the proposed rule that, as the

calculation of the home dialysis rate and

transplant rate among attributed

beneficiaries would be conducted only

once every 6 months due to overlapping

MYs, we believe providing lists after the

MY would provide ETC Participants

sufficient information about their

attributed beneficiary populations to

understand the basis of their rates of

home dialysis and transplants.

The following is a summary of the

comments received on beneficiary

attribution and our responses.

Comment: A commenter agreed that

using retrospective attribution is an

appropriate approach for beneficiary

attribution in a fee for service model.

Another commenter agreed with using

pre-emptive transplantation for

beneficiary attribution.

Response: We thank the commenters

for their feedback and support. CMS

will use retrospective beneficiary

attribution as proposed. However, as

described elsewhere in this final rule,

we will use the transplant rate

calculated as the sum of the transplant

waitlist rate and the living donor

transplant rate, rather than the

transplant rate as proposed, to assess

ETC Participant performance under the

Model. Because the living donor

transplant rate calculation will include

only pre-emptive transplants from living

donors, rather than all pre-emptive

transplants, we will only attribute

beneficiaries who received pre-emptive

transplants from living donors prior to

beginning dialysis (defined as pre-

emptive living donor transplant (LDT)

beneficiaries) to Managing Clinicians.

After considering public comments,

we are finalizing our proposed

provisions on beneficiary attribution,

with modification. Specifically, we are

codifying in our regulations at

§ 512.360(a) that CMS will attribute

ESRD Beneficiaries to ETC Participants

for each month of each MY for the

purposes of assessing an ETC

Participant’s performance on the home

dialysis rate and transplant rate during

that MY. We also are codifying in our

regulations at § 512.360(a) that an ESRD

Beneficiary can be attributed to only one

ESRD facility and only one Managing

Clinician for a given month during a

given MY, and that attribution takes

place at the end of the MY. We are

codifying in our regulations at § 512.310

the definition of ESRD Beneficiary as

proposed, with modification to clarify

that a beneficiary who has received a

transplant will be considered to be an

ESRD Beneficiary if the beneficiary

either has a non-AKI dialysis or MCP

claim at least 12 months after the

beneficiary’s latest transplant date, or

has a non-AKI dialysis or MCP claim

less than 12 months after the

beneficiary’s latest transplant date and

has a kidney transplant failure diagnosis

code documented in any Medicare

claim. We are making this clarification

because, while beneficiaries are

excluded from the ESRD Beneficiary

definition beginning the month after the

beneficiary receives a kidney transplant,

it was our intent that any beneficiary

receiving dialysis or other services for

ESRD would be considered an ESRD

Beneficiary, subject to the exclusions

described elsewhere in this final rule.

As modified, this definition makes clear

that beneficiaries who have already

received a kidney transplant in the past

will be eligible for attribution to ETC

Participants once they restart dialysis or

other services for ESRD.

We are modifying several beneficiary

attribution provisions in order to

address the modification to the

transplant rate to include the transplant

waitlist rate and the living donor

transplant rate, as described in section

IV.C.5 of this final rule. We are

finalizing the definition of ‘‘living donor

transplant (LDT) Beneficiary’’ as an

ESRD Beneficiary who received a

kidney transplant from a living donor.

We are also replacing the term ‘‘Pre-

emptive transplant beneficiary’’ with

the term ‘‘Pre-emptive LDT

Beneficiary,’’ which we define a

beneficiary who received a kidney

transplant from a living donor prior to

beginning dialysis. We are modifying

the attribution of pre-emptive transplant

beneficiaries to Managing Clinicians in

§ 512.360(a), to apply solely to Pre-

emptive LDT Beneficiaries and solely

for purposes of assessing the Managing

Clinician’s performance on the living

donor transplant rate, in accordance to

the change from the proposed transplant

rate to a transplant rate that includes the

living donor transplant rate described

elsewhere in this final rule.

(1) Beneficiary Exclusions

We proposed to exclude certain

categories of beneficiaries from

attribution to ETC Participants,

consistent with other CMS models and

programs for purposes of calculating the

PPA. Specifically, we proposed to

exclude an ESRD Beneficiary or a pre-

emptive transplant beneficiary if, at any

point during the month, the beneficiary:

•Is not enrolled in Medicare Part B,

because Medicare Part B pays for the

majority of ESRD-related items and

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services, for which Part B claims are

necessary for evaluation of the Model.

•Is enrolled in Medicare Advantage,

a cost plan, or other Medicare managed

care plans, because these plans have

different payment structures than

Medicare Parts A and B and do not use

FFS billing.

•Does not reside in the United

States, because it is more difficult to

track and assess the care furnished to

beneficiaries who might have received

care outside of the U.S.

•Is younger than age 18 at any point

in the month, because beneficiaries

under age 18 are more likely to have

ESRD from rare medical conditions that

have different needs and costs

associated with them than the typical

ESRD Beneficiary.

•Has elected hospice, because

hospice care generally indicates

cessation of dialysis treatment and

curative care.

•Is receiving any dialysis for acute

kidney injury (AKI) because renal

dialysis services for AKI differ in care

and costs from a typical ESRD

Beneficiary who is not receiving care for

AKI. AKI is usually a temporary loss of

kidney function. If the kidney injury

becomes permanent, such that the

beneficiary is undergoing maintenance

dialysis, then the beneficiary would be

eligible for attribution.

•Has a diagnosis of dementia

because conducting dialysis at home

may present an undue challenge for

beneficiaries with dementia, and such

beneficiaries also may not prove to be

appropriate candidates for transplant.

In the proposed rule, we considered

excluding beneficiaries from attribution

for the purposes of calculating the home

dialysis rate whose advanced age (for

example, ages 70 and older) could make

home dialysis inappropriate; however,

we did not ascertain a consensus in the

literature that supported any specific

age cut-off. In the proposed rule, we also

considered excluding beneficiaries with

housing insecurity from attribution for

the purposes of calculating the home

dialysis rate, but did not find an

objective way to measure housing

instability.

The following is a summary of the

comments received on beneficiary

exclusions from attribution to ETC

Participants and our responses.

Comment: Some commenters

suggested that CMS not exclude any

categories of beneficiaries from

attribution to ETC Participants under

the Model, allowing the Model to be as

inclusive as possible to beneficiaries,

despite the beneficiaries’ medical

conditions or age. A commenter stated

that, after searching peer-reviewed

literature and clinical guidelines, the

commenter did not find obvious

exclusion criteria for home dialysis

patients. Another commenter suggested

that if a beneficiary is able to receive a

transplant or dialyze at home, despite

being on the exclusion list, CMS should

still include that beneficiary in the

numerator and denominator for the ETC

Participant, in order to give the ETC

Participant credit for all transplants and

home dialysis treatments.

Response: CMS appreciates this

feedback regarding our proposed

beneficiary exclusion criteria under the

Model. Like one of the commenters

noted, the literature and clinical

guidelines do not have clear exclusions

for home dialysis beneficiaries.

However, our proposed exclusions were

intended to exclude from attribution to

ETC Participants those categories of

beneficiaries more likely to be

inappropriate candidates for home

dialysis and/or transplant in order to

track Managing Clinicians’ and ESRD

facilities’ ability to provide appropriate

care to patients who can, in fact, safely

have the opportunity to receive a kidney

transplant or home dialysis. Although

an otherwise excluded beneficiary that

receives home dialysis, receives a LDT,

or is placed on the transplant waitlist

could be placed in the numerator and

the denominator, in aggregate, we

believe that these exclusions are

appropriate for the reasons described in

the proposed rule and previously in this

final rule and will apply them in

attributing ESRD Beneficiaries to ETC

Participants under the Model.

Comment: Commenters supported our

proposal to exclude from attribution to

ETC Participants those beneficiaries

who are not enrolled in Medicare Part

B or who do not reside in the United

States. A commenter agreed with our

proposed exclusion for patients enrolled

in Medicare Advantage; however, one

physician group suggested attributing

beneficiaries with Medicare Advantage

plans to ETC Participants in order to

appropriately assess the risk pool for the

ETC Model since ESRD Beneficiaries

may begin enrolling in Medicare

Advantage plans beginning in 2021.

Response: CMS appreciates the

feedback and support. After considering

the public comments, we are finalizing

our proposal to exclude beneficiaries

not enrolled in Medicare Part B,

enrolled in Medicare Advantage or other

managed plans, and those not residing

in the United States from attribution to

ETC Participants under the Model. With

respect to the commenter’s suggestion

that CMS attribute Medicare Advantage

beneficiaries to ETC Participants, the

ETC Model is a Medicare FFS model

and Medicare Advantage plans have

different payment structures than

Medicare Parts A and B and do not use

FFS billing. Including these

beneficiaries in the Model’s financial

calculations could create unintended

consequences for ETC Participants and

may complicate our evaluation of the

Model.

Comment: Multiple commenters

recommended that CMS exclude

beneficiaries from attribution to ETC

Participants based on factors such as

socioeconomic status, homelessness,

housing instability, lack of

transportation, and lack of caregiver or

social support. One of those

commenters listed other International

Classification of Diseases, 10th Revision

(ICD–10) codes that address the issues

of social determinations of health

around housing economic insecurity,

specifically ICD–10 codes Z59.1, Z59.7,

Z59.8, and Z59.9. Another commenter

suggested using the homelessness ICD–

10 code Z59.0 for purposes of

implementing exclusions specific to

homelessness, though the commenter

acknowledged that this code may be

underutilized. Another commenter

suggested excluding dual eligible

beneficiaries from attribution to ETC

Participants as this group generally

represents a population with lower

socioeconomic status.

Response: CMS agrees that housing

insecurity, transportation issues, and

other social determinants of health

affect patient choice of renal

replacement modality. We also

appreciate the few comments

mentioning the ICD–10 codes that could

be used to identify homelessness and

other social determinants of health.

However, we also agree with the

commenter who stated that the

homelessness ICD–10 code Z59.0 is

underutilized, and we believe that

adopting an exclusion for homelessness

based on this code could be subject to

gaming, such that this code would not

be an objective measure for housing

insecurity. CMS also believes that the

other codes of Z59.1, Z59.7, Z59.8, and

Z59.9 could be subject to gaming.

Accordingly, we are not adopting the

commenters’ suggestions to use these

codes for purposes of the Model.

However, CMS will assess the use of

these and other codes for purposes of

adding any additional beneficiary

exclusions from attribution to ETC

Participants based on socioeconomic

status, homelessness, or other social

determinants of health through future

rulemaking.

Comment: Several commenters

appreciated our proposal to exclude

pediatric ESRD Beneficiaries from

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attribution to ETC Participants due to

the unique medical needs of this

population. A commenter expressed

concern about of the lack of quality

measures for this small population of

patients and suggested implementing

different pediatric payment

reimbursements for traditional Medicare

payment for the pediatric renal

beneficiaries.

Response: CMS acknowledges the

importance of kidney health in the

pediatric population, including the need

for quality measures specific to this

population, and believe that other HHS

initiatives outside of the ETC Model,

such as Kidney X and the broader

Advancing American Kidney Health

Initiative, may address this need.

Comments related to provider

reimbursement in the Medicare program

generally are outside the scope of this

final rule.

Comment: Several commenters

supported excluding beneficiaries from

attribution to ETC Participants due to

old age. These commenters suggested

excluding beneficiaries over the ages of

65, 70, or 75 from the calculation of

either the transplant rate, home dialysis

rate, or both, since these patients often

do not receive a kidney transplant or

have limited access to the caregiver

support required for home dialysis. A

few commenters recommended that

CMS not exclude beneficiaries from

attribution to ETC Participants due to

age, particularly due to the aging

population, and instead stressed the

importance of other factors to determine

a beneficiary’s exclusion under the

Model, such as functional status and

clinical contradictions for home dialysis

and kidney transplantation in order to

align with a beneficiary’s treatment

choice and suitable care.

Response: CMS appreciates the

comments on possible beneficiary

exclusions due to age but notes that

there is no objective scientific evidence

to tie old age to incompatibility with

home dialysis. Moreover, we believe an

age restriction would undermine the

Model’s focus on providing

beneficiaries the opportunity to select

home dialysis. Therefore, CMS will not

restrict beneficiary attribution due to

age. However, as described in section

§ 512.365(c) of this final rule, we are

finalizing our proposal to exclude

beneficiaries over the age of 75 from the

numerator and the denominator of the

transplant rate calculation since these

patients usually are not candidates for

transplants.

Additionally, we decline to adopt the

commenters’ recommendations that

CMS establish exclusions based on

functional status and clinical

contraindications because clinical

guidelines for home dialysis or

transplant beneficiaries do not have

such exclusions. Moreover, the

beneficiary attribution exclusions

finalized in our regulations at

§ 512.360(b) are intended to address

common contraindications for home

dialysis and kidney transplant while

allowing the maximum number of

beneficiaries to benefit from the

opportunity to select the renal

replacement modality of their choice.

Comment: Several commenters

supported our proposal to exclude

beneficiaries with AKI from attribution

to ETC Participants. A commenter

requested clarification on how an AKI

diagnosis in one month will affect the

application of this exclusion for

subsequent months for attribution to

ETC Participants.

Response: We thank the commenters

for their feedback and support and

clarify that receipt of dialysis services

for an AKI diagnosis in one month

makes a beneficiary ineligible for

attribution to an ETC Participant for that

month, but if the AKI does not resolve

and/or transitions to ESRD, the

beneficiary will become eligible for

attribution in a subsequent month. CMS

acknowledges that patient health status

may change over time.

Comment: Many commenters

identified possible additional

beneficiary exclusions due to clinical

contradictions that prevent patients

from meeting the clinical criteria for

home dialysis or transplant. Examples

included: Severe diabetic neuropathy or

congestive heart failure, recent vascular

disease, significant physical disability

(Karnofsky Score <40 percent),

cardiomyopathy with EF<20 percent,

severe pulmonary or cardiovascular

issues, cirrhosis, documented recent

cardiac surgery, severe morbid obesity

(BMI>50), documented status that a

patient is unsuitable for a transplant or

home dialysis, active infection,

medication non-compliance,

uncontrolled psychiatric illness or

substance abuse, or blindness. Several

commenters also recommended certain

exclusion criteria specific to home

dialysis, including: Recent abdominal

surgery, abdominal abscess, peritoneal

scarring or failed PD attempts, blindness

or impaired vision, irritable bowel

syndrome, and diabetic gastroparesis. If

these beneficiaries are not excluded

from attribution, commenters urged

CMS to include these more seriously ill

populations in the risk adjustment and

PPA in order appropriately compare

group benchmarks, align beneficiaries,

and provide the ideal care in the ideal

setting for these beneficiaries.

Response: CMS appreciates the

suggestions from commenters regarding

clinical contradictions for home dialysis

and kidney transplantation. CMS has

responded to comments and concerns

related to risk adjustment for seriously

ill populations in section IV.C.5.d

(Benchmarking and scoring) and section

IV.C.5.c.(3) (Risk Adjustment) of this

final rule. CMS believes the beneficiary

exclusions in proposed § 512.360(b),

with the modifications described

elsewhere in this final rule, address

common clinical contraindications for

home dialysis and kidney

transplantation. AKI involves short term

use of dialysis, making home dialysis

impractical and transplant unnecessary,

and as such, the AKI exclusion exists

because the Model tests incentives

specific to chronic dialysis services.

Beneficiaries diagnosed with dementia

or who reside in or receive dialysis in

a skilled nursing facility (SNF) or

nursing facility may not be suitable

candidates for both home dialysis or

transplantation. The exclusions still

provide suitable incentives for ETC

Participants to support the greatest

number of ESRD Beneficiaries in

receiving home dialysis or being added

to the kidney transplant waitlist with

the ultimate goal of receiving a kidney

transplant. We also note that many of

the clinical contraindications suggested

by commenters for home dialysis are in

fact potential contraindications for PD,

and are not contraindications for HHD.

Adding a large number of beneficiary

exclusion criteria would run counter to

the Model’s focus on increasing the

utilization of home dialysis and

transplants for ESRD Beneficiaries, and

adopting exclusions based on

documentation of clinical condition

could be subject to gaming.

Comment: Multiple commenters

recommended that CMS exclude from

attribution to ETC Participants those

beneficiaries with cancer, including

those diagnosed with recent solid organ

malignancy and patients currently

receiving related treatment, as cancer is

a contraindication for transplantation

candidacy and may result in variable

dialysis use, in which a beneficiary’s

ESRD treatment modality may change

frequently based on adjustments in

cancer treatment such as chemotherapy

timing and dosage. Some commenters

stated that home dialysis may be

inappropriate for beneficiaries with

cancer due to complex needs, need for

a caregiver, and challenging care

coordination and thus these patients

often prefer receiving dialysis in the

same setting, suggesting that these

patients may prefer in-center dialysis.

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Response: CMS appreciates the

suggestion to exclude beneficiaries with

a diagnosis of cancer and acknowledges

commenters’ concerns of treatment

appropriateness. While CMS

understands the burden of cancer for

both caregivers and beneficiaries, this

exclusion would not advance the Model

test because it would not result in the

greatest number of ESRD Beneficiaries

in receiving home dialysis or being

added to the kidney transplant waitlist

with the ultimate aim of receiving a

kidney transplant. Moreover, there are

no clear exclusion criteria for home

dialysis for beneficiaries with any

cancer diagnosis, and it is CMS’s belief

that these beneficiaries often are not

automatically ineligible for

transplantation. CMS would like to

encourage ETC Participants to provide

home dialysis and transplantation for as

many beneficiaries that would benefit

from these care modalities.

Comment: Multiple commenters

supported our proposed exclusion of

beneficiaries with a diagnosis of

dementia. Some of these commenters

who supported excluding beneficiaries

with a diagnosis of dementia suggested

modifying our proposal to nonetheless

include beneficiaries with a diagnosis of

mild dementia to allow health

professionals to determine the

appropriateness of home dialysis for the

patient, especially for patients with

access to assisted home dialysis

programs.

Response: CMS appreciates the

commenters’ suggestion that CMS

attribute beneficiaries with a diagnosis

of mild dementia to ETC Participants in

order to preserve clinical judgement.

While CMS understands that

beneficiaries with mild dementia may

be covered by the exclusion criteria, and

thus be excluded from attribution to

ETC Participants, we clarify that in

order to objectively identify patients

with dementia, as described in greater

detail later in this final rule, we will use

the most current Hierarchical Condition

Category (HCC) model codes that assess

dementia, and note that there is no

objective way to track dementia

progression or deterioration. HCC

dementia codes that specify ‘‘without

behavioral disturbance’’ cannot

objectively track progression of

dementia.

Comment: Multiple commenters

recommended that CMS exclude from

attribution to ETC Participants those

beneficiaries who reside in group homes

or nursing homes, pointing out that

SNFs construct an in-center dialysis

facility inside the nursing facility and

that once beneficiaries are discharged

from the SNF, they most often transition

back to in-center dialysis. A few

commenters suggested altering the

exclusion for beneficiaries by including

beneficiaries diagnosed with dementia

who reside in a SNF or are treated for

AKI at a SNF, as SNFs provide a safer

alternative than home dialysis for such

beneficiaries needing dialysis.

Response: CMS appreciates the

feedback recommending that CMS

exclude from attribution to ETC

Participants those beneficiaries residing

in SNFs and nursing facilities. We share

the commenters’ concerns about dialysis

provided in SNFs, particularly around

the misalignment of dialysis utilization

in SNFs and nursing facilities with the

Model’s focus on promoting beneficiary

choice of treatment modality. In

addition, CMS is concerned that the

population of beneficiaries who reside

in SNFs and nursing facilities is

particularly frail, including beneficiaries

diagnosed with dementia, and therefore

may not be appropriate candidates for

home dialysis. Accordingly, we believe

that attributing these ESRD Beneficiaries

to ETC Participants would not advance

the Model goals of improving or

maintaining quality while reducing cost

by increasing home dialysis rates and

transplant rates with the ultimate aim of

receiving a kidney transplant. As such,

CMS will exclude all beneficiaries

residing in or receiving dialysis in a

SNF or nursing facility from attribution

to ETC Participants under the Model.

We also recognize that some

beneficiaries may benefit from the level

of care in a SNF or nursing facility, such

as beneficiaries with dementia.

Dementia beneficiaries are excluded

from the attribution to ETC Participants.

Including beneficiaries residing in SNFs

and nursing facilities does not align

with the Model’s goals of increase home

dialysis in a beneficiaries’ home.

Comment: A few commenters

supported our proposed exclusion of

beneficiaries who have elected hospice

from attribution to ETC Participants

since hospice care generally indicates

cessation of dialysis treatment and

dialysis care. A couple of commenters

recommended not excluding

beneficiaries who have elected hospice

for purposes of calculating the home

dialysis rate specifically, since PD is

less costly than in-center HD and offers

patients treatment options.

Response: We appreciate the feedback

from commenters. While we appreciate

the commenters’ recommendation to

include beneficiaries who have elected

hospice in the Model’s attribution

methodology, we do not believe that

doing so would offer more treatment

choices to beneficiaries because in

general, hospice care focuses on

palliative care in a beneficiary’s final

phase of life rather than dialysis

services. We agree with the commenters

who suggested excluding beneficiaries

who elect hospice since hospice care is

by definition time limited and indicates

that the beneficiary is close to the end

of life.

Comment: A few commenters

suggested excluding beneficiaries who

choose palliative care for their renal

care modality. One of these commenters

suggested tracking these more seriously

ill beneficiaries differently from the

healthier ESRD population and

rewarding medical management for

these patients receiving any type of

ESRD care, including those not utilizing

dialysis and instead receiving palliative

or hospice care.

Response: CMS appreciates the

feedback to exclude beneficiaries

choosing supportive care. CMS will

exclude beneficiaries who have elected

hospice; however, we believe rewarding

medical management of hospice

beneficiaries is outside the scope of the

Model and addressed in other HHS and

CMS initiatives, such as the Medicare

Care Choices Model.

Comment: A commenter agreed with

our proposals to attribute beneficiaries

to ETC Participants on a monthly basis

and not exclude beneficiaries with

Medicare as a secondary payer from

attribution. However, the commenter

suggested that we provide beneficiary

attribution data to ETC Participants on

a more frequent basis.

Response: CMS appreciates the

feedback and support. Beneficiary

attribution will occur on a monthly

basis. However, attribution will occur

after the MY is over. Thus, while CMS

will endeavor to provide attribution

data to ETC Participants on a timely

basis, these data will be provided only

after the MY is over. CMS believes

providing accurate beneficiary

attribution data is vital to ETC

participants. Because the MYs overlap,

beneficiary attribution data for one MY

will be available during the fourth

quarter of the following MY, which will

provide the most accurate information

within a reasonable amount of time.

After considering public comments,

we are finalizing our proposed

provisions regarding the exclusion of

certain categories of beneficiaries from

attribution to ETC Participants with

modification. CMS will use the claim

service date for purposes of the general

attribution criteria described in

§ 512.360. However, Managing

Clinicians and ESRD Facilities utilize

different billing requirements and

forms. For consistency with these

billing requirements and forms, CMS

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will use the claim service date at the

claim line through date to attribute

beneficiaries to Managing Clinicians

and will use the claim service date at

the claim header through date to

attribute beneficiaries to ESRD

Facilities.

In addition, in this final rule, we are

modifying our proposed exclusions

from attribution for ESRD Beneficiaries

with a diagnosis of dementia to clarify

that such diagnosis must be made at any

point during the month or the preceding

12 months, as identified using the most

recent dementia criteria at the time of

beneficiary attribution, defined using

the dementia-related codes from the

Hierarchical Condition Category (HCC)

Risk Adjustment Model ICD–10–CM

Mappings. We will use the HCC Risk

Adjustment Model because it includes

all objectively related dementia

diagnosis codes. A 13-month lookback

period, which includes the entire month

in question plus the preceding 12

months lookback period for the

dementia exclusion aligns with the

periodicity with which the HCC Risk

Adjustment Model codes are updated,

and will ensure that CMS has sufficient

data to identify a dementia diagnosis,

while also ensuring that any such

diagnoses are still relevant and current

for the beneficiary. For reference, the

2020 Midyear Final ICD–10–CM

Mappings are found at https://

www.cms.gov/Medicare/Health-Plans/

MedicareAdvtgSpecRateStats/Risk-

Adjustors-Items/Risk2020.

In addition, we are modifying our

exclusion for beneficiaries younger than

18 years of age to state that a beneficiary

will be excluded from attribution to an

ETC Participant if he or she is younger

than 18 years old before the first day of

the month of the claim service date. We

will identify the beneficiary’s age on the

first day of the month (rather than for

the entire month), as it is easier for CMS

to operationalize and has the same

practical effect (that is, a beneficiary

who is at least 18 years old before the

first date of a month will be at least 18

years old for that entire month). In

addition, because we will be assessing

ETC Participant performance on the

transplant rate calculated as the sum of

the transplant waitlist rate and the

living donor transplant rate in response

to public comments, we have removed

references to pre-emptive transplant

beneficiaries from our regulation at

§ 512.360(b), and replaced them with

references to Pre-emptive LDT

Beneficiaries, where appropriate.

In sum, we are codifying in our

regulation at § 512.360(b) that ESRD

Beneficiaries that fall in the enumerated

categories, with the modifications

described, will be excluded from

attribution to ETC Participants for a

month for the purposes of calculating

the transplant rate and home dialysis

rate under the Model. In addition, based

on public comments, we are also

excluding beneficiaries from attribution

for any month in which they receive

dialysis in or reside in a SNF or nursing

facility.

(2) Attribution Services

(a) Attribution to ESRD Facilities

We proposed that, to be attributed to

an ESRD facility for a month, an ESRD

Beneficiary must have received renal

dialysis services, other than renal

dialysis services for AKI, during the

month from the ESRD facility. Because

it is possible that a single ESRD

Beneficiary receives dialysis treatment

from more than one ESRD facility

during a month, we further proposed

that ESRD Beneficiaries would be

attributed to an ESRD facility for a given

month based on the ESRD facility at

which the ESRD Beneficiary received

the plurality of his or her dialysis

treatments in that month. As we noted

in the proposed rule, we believe the

plurality rule would provide a sufficient

standard for attribution because it

ensures that ESRD Beneficiaries would

be attributed to an ESRD facility when

they receive more renal dialysis services

from that ESRD facility than from any

other ESRD facility. In the event that an

ESRD Beneficiary receives an equal

number of dialysis treatments from two

or more ESRD facilities in a given

month, we proposed that the ESRD

Beneficiary would be attributed to the

ESRD facility at which the beneficiary

received the earliest dialysis treatment

that month.

We proposed that we would identify

dialysis claims as those with Type of

Bill 072X, where the type of facility

code is 7 and the type of care code is

2, and that have a claim through date

during the month for which attribution

is being determined. Type of Bill 072X

captures all renal dialysis services

furnished at or through ESRD facilities.

Facility code 7 paired with type of care

code 2 indicates that the claim occurred

at a clinic or hospital based ESRD

facility.

In the proposed rule we considered,

in the alternative, attributing ESRD

Beneficiaries to the ESRD facility at

which they had their first dialysis

treatment for which a claim was

submitted in a given month. However,

we determined that using the plurality

of claims rather than earliest claim

better identifies the ESRD facility that

has the most substantial care

relationship with the ESRD Beneficiary

in question for the given month. For

example, using the earliest claim

approach could result in attributing a

beneficiary that received dialysis

treatments from Facility A once during

a given month and dialysis treatments

from Facility B at all other times during

that month to Facility A, even though

Facility B is the facility where the

beneficiary received most of his or her

dialysis treatments that month. As noted

in the proposed rule, we would,

however, plan to use the earliest date of

service in the event that two or more

ESRD facilities have furnished the same

amount of services to a beneficiary

because, as between two or more

facilities that performed the same

number of dialysis treatments for the

beneficiary during a month, the facility

that furnished services to the

beneficiary first may have established

the beneficiary’s care plan and therefore

is the one more likely to have the most

significant treatment relationship with

the beneficiary.

In the proposed rule we also

considered using a minimum number of

treatments at an ESRD facility for

purposes of ESRD Beneficiary

attribution. However, we determined

that, because we are attributing ESRD

Beneficiaries on a month-by-month

basis, the plurality of treatments method

would be more appropriate because it

would result in a greater number of

ESRD Beneficiaries attributed to the

ESRD facilities where they receive care,

which may enhance the viability of the

ETC Model test. In the proposed rule we

also considered including a minimum

duration that an ESRD Beneficiary must

be on dialysis before the beneficiary can

be attributed to an ESRD facility. We

determined that this approach was not

suitable for this model test, however, as

a key factor that influences whether or

not a beneficiary chooses to dialyze at

home is if the beneficiary begins

dialysis at home, rather than in-center.

Requiring a minimum duration on

dialysis would exclude these early

months of dialysis treatment from

attribution, which may be key to a

beneficiary’s modality choice, and

would therefore run counter to the

intent of the ETC Model.

We proposed that CMS would not

attribute pre-emptive transplant

beneficiaries to ESRD facilities because

beneficiaries who receive pre-emptive

transplants do so before they have

initiated dialysis and thus do not have

a care relationship with the ESRD

facility.

The following is a summary of the

comments received on ESRD

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151

Medicare Claims Processing Manual, Chapter

8; https://www.cms.gov/Regulations-and-Guidance/

Manuals/Downloads/clm104.c08.pdf.

Beneficiary attribution to ESRD facilities

and our responses.

Comment: A commenter

recommended that CMS exclude from

attribution to an ESRD facility those

ESRD Beneficiaries who have three or

more dialysis treatments in another

ESRD facility for that month. The

commenter instead suggested that CMS

attribute an ESRD Beneficiary to the

ESRD facility at which the ESRD

Beneficiary received the most

treatments, which the commenter

referenced as the ESRD Beneficiary’s

‘‘home facility.’’

Response: As noted in the proposed

rule, we believe that the plurality of

dialysis treatments approach for

attributing ESRD Beneficiaries to ESRD

facilities provides a sufficient standard

for attribution because it ensures that

ESRD Beneficiaries will be attributed to

an ESRD facility that has the primary

responsibility for the beneficiary’s renal

dialysis services.

After considering public comments,

we are finalizing our proposed

provisions on the services used to

attribute ESRD Beneficiaries to ESRD

facilities with modification.

Specifically, we are codifying in our

regulations at § 512.360(c)(1) that ESRD

Beneficiaries will be attributed to an

ESRD facility for a given month based

on the ESRD facility at which the ESRD

Beneficiary received the plurality of his

or her dialysis services in that month,

other than renal dialysis services for

AKI, based on claims with claim service

date at the claim header date during that

month with Type of Bill 072X. We are

modifying the regulation text to clarify

that an ESRD Beneficiary would not be

attributed to an ESRD facility if the

beneficiary is excluded from attribution

based on the criteria specified in our

regulations at § 512.360(b), described

elsewhere in this final rule. We are

modifying which date associated with

the claim we are using to determine if

the claim occurred during the

applicable PPA Period. Whereas we

proposed using the claim through date,

we are finalizing using the date of

service on the claim, to align with

Medicare claims processing standards.

We are making this change because

while Medicare claims data contains

both claim through dates and dates of

service, Medicare claims are processed

based on dates of service, requiring us

to use claim date of service to identify

the PPA Period in which the service was

furnished. We are also codifying in our

regulation at § 512.360(c)(1) that, in the

event that an ESRD Beneficiary receives

an equal number of dialysis treatments

from two or more ESRD facilities in a

given month, the ESRD Beneficiary will

be attributed to the ESRD facility at

which the beneficiary received the

earliest dialysis treatment that month, as

proposed. We clarify that this policy for

attributing ESRD Beneficiaries who have

received an equal number of dialysis

treatments from two or more ESRD

facilities would apply regardless of

whether the ESRD facility is an ETC

Participant or an ESRD facility located

in a Comparison Geographic Area. As

described elsewhere in this final rule,

we have modified our proposal to

attribute pre-emptive transplant

beneficiaries to Managing Clinicians

such that we will attribute only pre-

emptive LDT beneficiaries. We therefore

modified our regulation at

§ 512.360(c)(1) to clarify that CMS does

not attribute pre-emptive LDT

beneficiaries to ESRD facilities.

(b) Attribution to Managing Clinicians

We proposed that, for Managing

Clinicians, an ESRD Beneficiary would

be attributed to the Managing Clinician

who submitted an MCP claim with a

claim through date in a given month for

certain services furnished to the ESRD

Beneficiary. Per the conditions for

billing the MCP, the MCP can only be

billed once per month for a given

beneficiary.

151

Therefore, as noted in

the proposed rule, we believe there is no

need to create a decision rule for

attributing ESRD Beneficiaries to a

Managing Clinician for a given month if

there are multiple MCP claims that

month, as that should never happen. We

proposed that, for purposes of ESRD

Beneficiary attribution to Managing

Clinicians, we would include MCP

claims with CPT

®

codes 90957, 90958,

90959, 90960, 90961, 90962, 90965, or

90966. CPT

®

codes 90957, 90958,

90959, 90960, 90961, and 90962 are for

ESRD-related services furnished

monthly, and indicate beneficiary age

(12–19, or 20 years of age and older) and

the number of face-to-face visits with a

physician or other qualified health care

professional per month (1, 2–3, 4 or

more). CPT

®

codes 90965 and 90966 are

for ESRD-related services for home

dialysis per full month, and indicate the

age of the beneficiary (12–19, or 20

years of age and older). We explained in

the proposed rule that, taken together,

these are all the CPT

®

codes that are

used to bill the MCP that include

beneficiaries 18 years old or older,

including patients who dialyze at home

and patients who dialyze in-center.

Additionally, for the transplant rate

for Managing Clinicians, we proposed to

attribute pre-emptive transplant

beneficiaries to Managing Clinicians.

Because pre-emptive transplant

beneficiaries have not started dialysis at

the time of their transplant, we

explained we would not be able to

attribute them to Managing Clinicians

based on MCP claims, as we would for

ESRD Beneficiaries. Rather, we

proposed that pre-emptive transplant

beneficiaries would be attributed to a

Managing Clinician based on the

Managing Clinician with whom the

beneficiary had the most services

between the start of the MY and the

month in which the beneficiary received

the transplant, and that the pre-emptive

transplant beneficiary would be

attributed to the Managing Clinician for

all months between the start of the MY

and the month in which the beneficiary

received the transplant. In the proposed

rule we considered attributing pre-

emptive transplant beneficiaries on a

month-by-month basis, mirroring the

month-by-month attribution of ESRD

Beneficiaries. However, we concluded

that this approach would under-

attribute beneficiary months to the

denominator. Unlike ESRD Beneficiaries

who see their Managing Clinician every

month for dialysis management, pre-

emptive transplant beneficiaries

generally do not see a Managing

Clinician every month because they

have not started dialysis. However, that

does not mean that an ongoing care

relationship does not exist between the

pre-emptive transplant beneficiary and

the Managing Clinician in a month with

no claim.

The following is a summary of the

comments received on beneficiary

attribution to Managing Clinicians and

our responses.

Comment: A commenter stated that

some complex patients have two

nephrologists managing their care and

suggested that both of these Managing

Clinicians should receive attribution in

these scenarios. Another commenter

suggested that pre-emptive transplant

beneficiaries be attributed to the

Managing Clinician who initiated the

referral to the transplant center to allow

‘‘proactive management.’’ Other

commenters stressed the importance of

educating beneficiaries on renal

replacement modality options and the

shared decision-making process in order

to empower beneficiaries to select from

among the available treatment choices

and suggested that CMS attribute

beneficiaries to ESRD facilities and

Managing Clinicians that, through

extensive education, time, and effort,

refer ESRD Beneficiaries to facilities that

offer home dialysis. Many of these same

commenters suggested attribution based

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on the Managing Clinician who

educated the beneficiary on treatment

modality instead of the Managing

Clinician providing a certain dialysis-

related service.

Response: CMS appreciates the

feedback from the commenters about

beneficiary attribution to Managing

Clinicians. While CMS acknowledges

that two or more Managing Clinicians

may manage care for a given ESRD

Beneficiary, for the purposes of this

Model, we believe that attribution to

one Managing Clinician is most

appropriate because generally only one

MCP is billed for a given ESRD

Beneficiary during a month, even if

multiple Managing Clinicians are

involved in beneficiary’s care. In

addition, if the ESRD Beneficiary

receives care from one or more other

clinicians within the practice of the

Managing Clinician to whom the ESRD

Beneficiary is attributed, the care

furnished to that ESRD Beneficiary will

be considered in assessing the

performance for all such clinicians

under the aggregation methodology

described elsewhere in section IV of this

final rule. Additionally, while we

appreciate feedback about the

attribution of pre-emptive transplant

beneficiaries, we do not believe that

attributing pre-emptive transplant

beneficiaries to the Managing Clinician

who refers them to the transplant center

is appropriate for the Model. As

described elsewhere in this final rule,

we are now only attributing Pre-emptive

LDT Beneficiaries to Managing

Clinicians given the change to the

calculation of the transplant rate.

Attributing these Pre-emptive LDT

Beneficiaries to Managing Clinicians

based on who refers a Pre-emptive LDT

Beneficiary to a transplant center may

not identify the Managing Clinician

primarily responsible for supporting the

beneficiary through the living donor

transplant process. Rather, we believe

that the main care relationship between

Pre-emptive LDT Beneficiary and

Managing Clinician is more accurately

identified using the methodology

included in this final rule.

After considering public comments,

we are finalizing our proposed

provisions on the services used to

attribute beneficiaries to Managing

Clinicians, with modification. We are

finalizing in our regulation at

§ 512.360(c)(2) that we will attribute

ESRD Beneficiaries to the Managing

Clinician who bills an MCP for services

furnished to the beneficiary claim

service date at the claim line through

date during the entire month in

question, and that such claims will be

identified by CPT

®

codes 90957, 90958,

90959, 90960, 90961, 90962, 90965, or

90966. We stated in the proposed rule

that there is no need to create a decision

rule for attributing ESRD Beneficiaries

to a Managing Clinician for a given

month because the full month MCP

CPT

®

codes can only be billed once per

month for a given beneficiary. However,

we found a very small number of

instances where the full month MCP

code was billed by multiple Managing

Clinicians for a given beneficiary. To

address the rare case that an MCP is

billed in a single month by more than

one Managing Clinician, we also added

new text to our regulation at

§ 512.360(c)(2) to clarify that, in cases

where more than one Managing

Clinician submits a claim for the MCP

furnished to a single ESRD Beneficiary

with a claim service date at the claim

line through date in a month, the ESRD

Beneficiary will be attributed to the

Managing Clinician associated with the

earliest claim service date at the claim

line through date that month. In cases

where more than one Managing

Clinician submits a claim for the MCP

furnished to a single ESRD Beneficiary

for the same earliest claim service date

at the claim line through date for that

month, the ESRD Beneficiary will be

randomly attributed to one of these

Managing Clinicians.

In addition, we are modifying our

proposed method for attributing pre-

emptive transplant beneficiaries to

Managing Clinicians. As described in

section IV.C.5 of this final rule, the

transplant rate calculation will include

only living donor transplants, rather

than all kidney transplants including

those received from deceased donors.

As such, we are modifying pre-emptive

transplant beneficiary attribution to

Managing Clinicians in § 512.360(c)(2)

of our regulation to include only Pre-

emptive LDT Beneficiaries, rather than

all beneficiaries who receive a kidney

transplant prior to beginning dialysis,

including from deceased donors.

Consistent with our approach for

attributing pre-emptive transplant

beneficiaries to Managing Clinicians, we

are finalizing that a Pre-emptive LDT

Beneficiary will be attributed to the

Managing Clinician with whom the

beneficiary had the most claims

between the start of the MY and the

month of the transplant. We are also

finalizing that, in the event that no

Managing Clinician had the plurality of

claims for a given Pre-emptive LDT

Beneficiary, such that multiple

Managing Clinicians each had the same

number of claims for that beneficiary

during the MY, that beneficiary will be

attributed to the Managing Clinician

with the latest claim service date at the

claim line through date for the

beneficiary, up to and including the

month of the transplant. If more than

one of these Managing Clinicians has

the latest claim service date at the claim

line through date for that beneficiary,

the Pre-emptive LDT Beneficiary will be

randomly attributed to one of those

Managing Clinicians.

In addition, we are modifying which

date associated with the claim we are

using to determine if the claim occurred

during the applicable PPA Period.

Whereas we proposed using the claim

through date, we are finalizing using the

date of service on the claim, to align

with Medicare claims processing

standards. We are making this change

because while Medicare claims data

contains both claim through dates and

dates of service, Medicare claims are

processed based on dates of service,

requiring us to use claim date of service

to identify the PPA Period in which the

service occurred. We have revised

§ 512.360(c)(2) of this final rule

accordingly.

c. Performance Measurement

We proposed to calculate the home

dialysis and transplant rates for ESRD

facilities and Managing Clinicians using

Medicare claims data and Medicare

administrative data about beneficiaries,

providers, and suppliers. We noted in

the proposed rule that Medicare

administrative data refers to non-claims

data that Medicare uses as part of

regular operations. This includes

information about beneficiaries, such as

enrollment information, eligibility

information, and demographic

information. Medicare administrative

data also refers to information about

Medicare-enrolled providers and

suppliers, including Medicare

enrollment and eligibility information,

practice and facility information, and

Medicare billing information. For the

transplant rate calculations, we also

proposed to use data from the Scientific

Registry of Transplant Recipients

(SRTR), which contains comprehensive

information about transplants that occur

in the U.S., to identify transplants

among attributed beneficiaries for

inclusion in the numerator about the

occurrence of kidney and kidney-

pancreas transplants. In the proposed

rule, we considered requiring ETC

Participants to report on their home

dialysis and transplant rates, as this

would give ETC Participants more

transparency into their rates. However,

as noted in the proposed rule, we

believe basing the rates on claims data,

supplemented with Medicare

administrative data about beneficiary

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enrollment and transplant registry data

about transplant occurrences, will

ensure there is no new reporting burden

on ETC Participants. Additionally, using

these existing data sources would be

more cost effective for CMS, as it would

not require the construction and

maintenance of a new reporting portal,

or changes to an existing reporting

portal to support this data collection.

We solicited comment on our

proposed use of claims data, Medicare

beneficiary enrollment data, and

transplant registry data to calculate the

home dialysis rate and transplant rate.

The following is a summary of the

comments received and our responses.

Comment: A commenter supported

our proposal to use Medicare claims

data and Medicare administrative data

for purposes of calculating the home

dialysis rate and the transplant rate, and

our proposal to use data from the SRTR

for purposes of calculating the

transplant rate.

Response: We appreciate the feedback

and support from the commenter. As

described in the proposed rule, we

proposed to use these existing data

sources to avoid imposing an

administrative burden on ETC

Participants.

After considering public comments,

we are finalizing our proposed

provisions on the sources of data used

for measuring the performance of ETC

Participants under the Model with

modification. Specifically, as the

transplant rate calculation will include

only living donor transplants, rather

than all kidney transplants including

those received from deceased donors,

we are modifying our regulation at

§ 512.365(a) to refer to Pre-emptive LDT

Beneficiaries rather than pre-emptive

transplant beneficiaries.

(1) Home Dialysis Rate

We proposed to define ‘‘home dialysis

rate’’ as the rate of ESRD Beneficiaries

attributed to the ETC Participant who

dialyzed at home during the relevant

MY, as described in § 512.365(b) (Home

Dialysis Rate). We proposed to construct

the home dialysis rate for ETC

Participants that are ESRD facilities as

described in the proposed rule and

section IV.C.5.c.1.a of this final rule and

for ETC Participants who are Managing

Clinicians as described in the proposed

rule and section IV.C.5.c.1.b of this final

rule. We described in the proposed rule

and describe later in this final rule our

proposed plan for risk adjusting and

reliability adjusting these rates.

The following is a summary of the

comments received on the home

dialysis rate and our responses.

Comment: Multiple commenters

stated that it is important to protect

patient choice of treatment modality,

which may depend on the beneficiary’s

financial resources, housing, social

support, and personal preference even

after proper education on all possible

ESRD treatment choices. These

commenters recommended that CMS

consider revising the home dialysis rate

to include shared-decision making

measures that take into account the

treatment modality most clinically and

socially appropriate for the beneficiary.

Response: We agree with commenters

that it is important to protect patient

choice of treatment modality, but

disagree that a shared decision measure

should be included in the home dialysis

rate calculation due to possible gaming

and lack of shared decision making

measures specific to home dialysis.

Comment: A few commenters

suggested including ESRD Beneficiaries

enrolled in Medicare Advantage plans

in the numerator of the home dialysis

rate calculation, with one of those

commenters explaining that these

beneficiaries often utilize in-center self-

care dialysis. According to the

commenters, adding these beneficiaries,

presumably to the numerator of the

home dialysis rate calculation, could

mitigate risks that Managing Clinicians

have for these more serious, medically

complex beneficiaries for whom in-

center self-care dialysis is a safer option

than home dialysis.

Response: Consistent with the

beneficiary exclusions from attribution

codified in our regulations at

§ 512.360(b), we will not include ESRD

Beneficiaries enrolled in Medicare

Advantage in the calculation of the

home dialysis rate because the ETC

Model is not a test of the Medicare

Advantage program or payment.

Specifically, the ETC Model is designed

as a test within Medicare FFS, which

excludes Medicare Advantage enrollees

from attribution to ETC Participants for

purposes of the Model’s financial

calculations, including the PPA. As

such, it would be inappropriate to

include beneficiaries enrolled in

Medicare Advantage in the construction

of the home dialysis rate.

Comment: Several commenters

recommended that we exclude

beneficiaries residing in or receiving

dialysis in a SNF or nursing facility

from our calculation of the home

dialysis rate. Some commenters clarified

that beneficiaries often reside in a

nursing facility or utilize a SNF as a

more permanent residence, and as such,

the dialysis received in a SNF more

resembles in-center dialysis. A

commenter suggested that we apply the

exclusion only to the denominator of

the home dialysis rate such that such

beneficiaries would be included in the

numerator if they received home

dialysis. A commenter recommended

classifying SNFs, inpatient

rehabilitation facilities, and long-term

care hospitals (LTCH) as a home dialysis

site for patients that receive on-site

dialysis at one of the respective

locations.

Multiple commenters supported the

inclusion of beneficiaries who dialyze at

SNFs in the calculation of the home

dialysis rate, with some commenters

pointing out that ESRD facilities may

provide dialysis services to SNF

residents within an approved home

training and support modality in cases

where beneficiaries, such as those with

AKI or dementia, may have better

quality of life when receiving dialysis in

a SNF.

Response: We appreciate these

comments, and share the commenters’

concerns about including beneficiaries

residing in or receiving dialysis in a

SNF or nursing facility in the home

dialysis rate calculations. We disagree

with commenters that support including

these beneficiaries in the home dialysis

rate. As described previously in section

IV.B.1 of this final rule, in our

regulations at § 512.360(b), we are

excluding beneficiaries who are residing

in or receiving dialysis services in SNFs

and nursing facilities from attribution to

ETC Participations for purposes of the

PPA calculation generally for the

reasons described in section IV.B.1.

After considering public comments,

we are finalizing our general proposal

regarding the home dialysis rate as

proposed. We are also finalizing the

definition of the home dialysis rate as

proposed without modification in our

regulation at § 512.310. Specific

provisions regarding the home dialysis

rate calculation for ESRD facilities and

Managing Clinicians are detailed in the

following sections of this final rule.

(a) Home Dialysis Rate for ESRD

Facilities

We proposed that the denominator of

the home dialysis rate for ESRD

facilities would be the total dialysis

treatment beneficiary years for

attributed ESRD Beneficiaries during the

MY. Dialysis treatment beneficiary years

included in the denominator would be

composed of those months during

which attributed ESRD Beneficiaries

received maintenance dialysis at home

or in an ESRD facility, such that one

beneficiary year is comprised of 12

beneficiary months. We would identify

months during which an attributed

ESRD Beneficiary received maintenance

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dialysis based on claims, specifically

claims with Type of Bill 072X, where

the type of facility code is 7 and the

type of care code is 2. Facility code 7

paired with type of care code 2,

indicates that the claim occurred at a

clinic or hospital based ESRD facility,

and the Type of Bill 072X captures all

renal dialysis services furnished at or

through ESRD facilities.

We proposed that the numerator of

the home dialysis rate for ESRD

facilities would be the total number of

dialysis treatment beneficiary years

during the MY in which attributed

ESRD Beneficiaries received

maintenance dialysis at home. Home

dialysis treatment beneficiary years

included in the numerator would be

composed of those months during

which attributed ESRD Beneficiaries

received maintenance dialysis at home,

such that one beneficiary year is

comprised of 12 beneficiary months. We

would identify maintenance dialysis at

home months based on claims,

specifically claims with Type of Bill

072X, where the type of facility code is

7 and the type of care code is 2, with

condition codes 74, 75, 76, or 80.

Facility code 7 paired with type of care

code 2, indicates that the claim occurred

at a clinic or hospital based ESRD

facility. Type of Bill 072X captures all

renal dialysis services furnished at or

through ESRD facilities. We stated in

the proposed rule that condition codes

74 and 75 indicate billing for a patient

who received dialysis services at home,

and condition code 80 indicates billing

for a patient who received dialysis

services at home and the patient’s home

is a nursing facility. Condition code 76

indicates billing for a patient who

dialyzes at home but received back-up

dialysis in a facility. As noted in the

proposed rule, taken together, we

believe these condition codes capture

home dialysis services furnished by

ESRD facilities. Information used to

calculate the ESRD facility home

dialysis rate includes Medicare claims

data and Medicare administrative data.

In the proposed rule, we considered

including beneficiaries whose dialysis

modality is self-dialysis or temporary

PD furnished in the ESRD facility at a

transitional care unit in the numerator,

given that these modalities align with

one of the overarching goals of the

proposed ETC Model, to increase

beneficiary choice regarding ESRD

treatment modality. However, we

concluded that these modalities lack

clear definitions in the literature and

delivery of care for these modalities is

billed through the same codes as in-

center HD, making it impossible for

CMS to identify the relevant claims.

The following is a summary of the

comments received on the home

dialysis rate calculation for ESRD

facilities and our responses.

Comment: Some commenters agreed

with the primary construction of the

home dialysis rate, as proposed. Other

commenters argued that condition codes

of 74, 75, 76, and 80 provide little

predictive value. Many commenters

stated that self-dialysis should be

included in the home dialysis rate

numerator, particularly for patients who

may be more seriously ill and for whom

self-care in-center dialysis is a better

treatment modality. CMS received a

letter from a coalition of 26 stakeholders

including nephrologists, ESRD facilities,

patients, and manufacturers, which

recommended that self-dialysis should

be included in the numerator for home

dialysis rate calculation for ESRD

facilities. The coalition’s letter also

urged that the definition of self-dialysis

be further clarified beyond what is

already present in 42 CFR 494.10 and

recommended that CMS identify self-

dialysis using condition code 72, since

self-care in-center dialysis is tracked

through this code. Other commenters

similarly suggested a broader definition

for self-care dialysis or suggested that

CMS use the commenters’ ESRD

facilities’ criteria for establishing a

patient as ‘‘self-care’’, such as a patient

setting up the machine without

assistance or pulling the needle at the

end of treatment. A commenter

suggested treating homeless

beneficiaries receiving self-dialysis in-

center as a home dialysis patient for

purposes of calculating the home

dialysis rate, since these patients do not

have the option of dialyzing at home.

Response: CMS appreciates the

commenters’ suggestions for identifying

self-care in-center dialysis patients. We

agree with commenter feedback that

self-dialysis can be identified with

condition code 72. We also appreciate

that self-dialysis may serve as a way to

provide a gradual transition from in-

center dialysis to home dialysis,

allowing patients to become comfortable

with conducting dialysis under medical

supervision. We considered including

beneficiaries whose treatment modality

is self-dialysis in the numerator of the

home dialysis rate in the proposed rule,

pointing out that it was consistent with

the overarching goals of the ETC Model

and helped to promote beneficiary

choice of treatment modalities. Our

concern in the proposed rule was that

there was not a clear, universally

accepted definition of self-care dialysis

in the literature or a clear way for CMS

to identify these claims. However,

commenters pointed out that there is an

already defined condition code under

the ESRD PPS for self-dialysis.

Therefore, we are finalizing the home

dialysis rate numerator for ESRD

facilities to include self-dialysis, as

identified by condition code 72, at one

half of the value of home dialysis. We

believe this policy will effectively

balance the benefits of self-dialysis and

its ability to help beneficiaries transition

to home dialysis with the recognition

that self-dialysis is not home dialysis

and does not have all of the same

benefits. Specifically, each beneficiary

month for which an attributed

beneficiary receives self-dialysis will

contribute one half month to the

numerator.

Comment: Several commenters

suggested including beneficiaries who

have received home dialysis training, as

identified by claims with condition

code 73, in the numerator of the home

dialysis rate calculation for ESRD

facilities. Other commenters suggested

that CMS include in the numerator

beneficiaries who have received re-

training treatment (as identified by

conditions code 87 and full care in unit

(as identified by condition code 71),

when used in combination with the

Revenue Code 0831 (urgent start PD) to

encourage transitions to home dialysis

as well as to capture patients who

require abdominal surgery and hope to

transition back to home dialysis. A

commenter suggested that we allow at

least 90 days to classify patients under

these PD condition codes before

including these beneficiaries in the

numerator of the home dialysis rate

calculation to take into account delays

of PD use for various health reasons that

would not negatively affect ETC

Participants.

Response: We appreciate the feedback

from the commenters, and recognize the

importance of home dialysis training, as

well as retraining and full care in unit.

We believe that including beneficiaries

who have received these services in the

numerator of the home dialysis rate for

ESRD facilities is not necessary to create

the financial incentives we seek to test

under the proposed ETC Model and that

training incentives are captured through

training add-on payment adjustment for

home dialysis under the ESRD PPS.

After considering public comments,

we are finalizing our proposed

provisions on the calculation of the

home dialysis rate for ESRD facilities,

with modifications. Specifically, we are

codifying in our regulation at

§ 512.365(b)(1) that the denominator of

the home dialysis rate for ESRD

facilities will be the total dialysis

treatment beneficiary years for

attributed ESRD Beneficiaries during the

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MY, as proposed. We are codifying in

our regulation at § 512.365(b)(1) that the

numerator of the home dialysis rate for

ESRD facilities will be the total number

of dialysis treatment beneficiary years

during the MY in which attributed

ESRD Beneficiaries received

maintenance dialysis at home, as

identified by claims with Type of Bill

072X, with condition codes 74 or 76.

While we proposed to include claims

with condition code 75, we are no

longer including these claims because

we have since learned that this

condition code is no longer valid.

Additionally, in this final rule, we will

not include claims with condition code

80, as proposed, because condition code

80 indicates billing for a patient who

received dialysis services at home and

the patient’s home is a SNF or nursing

facility, and we are excluding

beneficiaries residing in or receiving

dialysis in a SNF or nursing facility

from attribution to ETC Participants for

purposes of the PPA calculation

generally, as described elsewhere in this

final rule. We are further modifying this

proposal to also include one half of the

total number of dialysis treatment

beneficiary years during the MY in

which attributed ESRD Beneficiaries

received maintenance dialysis via self-

dialysis, as identified by claims with

Type of Bill 072X and condition code

72, and are clarifying that self-dialysis

treatment beneficiary years included in

the numerator are those months in

which attributed ESRD Beneficiaries

received self-dialysis in-center, such

that one beneficiary year is comprised of

12 beneficiary months. Of note, we have

removed references to the risk

adjustment methodology as we are not

finalizing the proposed risk adjustment

methodology for the home dialysis rate

for ESRD facilities, as described in

section IV.C.5.c.(3) of this final rule. We

are also modifying references to the

proposed reliability adjustment

methodology and are replacing them

with references to the aggregation

methodology for the home dialysis rate

for ESRD facilities, as described in

section IV.C.5.c.(4) of this final rule.

(b) Home Dialysis Rate for Managing

Clinicians

We proposed that the denominator of

the home dialysis rate for Managing

Clinicians would be the total dialysis

treatment beneficiary years for

attributed ESRD Beneficiaries during the

MY. Dialysis treatment beneficiary years

included in the denominator would be

composed of those months during

which an attributed ESRD Beneficiary

received maintenance dialysis at home

or in an ESRD facility, such that one

beneficiary year is comprised of 12

beneficiary months. We noted that we

would identify maintenance dialysis

months based on claims, specifically

claims with CPT

®

codes 90957, 90958,

90959, 90960, 90961, 90962, 90965, or

90966. CPT

®

codes 90957, 90958,

90959, 90960, 90961, and 90962 are for

ESRD-related services furnished

monthly, and indicate beneficiary age

(12–19 years of age or 20 years of age

and older) and the number of face-to-

face visits with a physician or other

qualified health care professional per

month (1, 2–3, 4 or more). CPT

®

codes

90965 and 90966 are for ESRD related

services for home dialysis per full

month, and indicate the age of the

beneficiary (12–19 years of age or 20

years of age and older). Taken together,

these codes are used to bill the MCP for

beneficiaries aged 18 or older, including

patients who dialyze at home and

patients who dialyze in-center.

As proposed, the numerator for the

home dialysis rate for Managing

Clinicians would be the total number of

dialysis treatment beneficiary years

during the MY in which attributed

ESRD Beneficiaries received

maintenance dialysis at home. Home

dialysis treatment beneficiary years

included in the numerator would be

composed of those months during

which an attributed ESRD Beneficiary

received maintenance dialysis at home,

such that one beneficiary year is

comprised of 12 beneficiary months. We

would identify maintenance dialysis at

home months based on claims,

specifically claims with CPT

®

codes

90965 or 90966. CPT

®

code 90965 is for

ESRD related services for home dialysis

per full month for patients 12–19 years

of age. CPT

®

code 90966 is for ESRD

related services for home dialysis per

full month for patients 20 years of age

and older. These two codes are used to

bill the MCP for beneficiaries aged 18

and older who dialyze at home.

Information used to calculate the

Managing Clinician home dialysis rate

includes Medicare claims data and

Medicare administrative data.

In the proposed rule, we considered

including beneficiaries whose dialysis

modality is self-dialysis or temporary

PD furnished in the ESRD facility at a

transitional care unit in the numerator,

given that these modalities align with

one of the overarching goals of the

proposed ETC Model, to increase

beneficiary choice regarding ESRD

treatment modality. However, we noted

in the proposed rule that these

modalities lack clear definitions in the

literature and delivery of care for these

modalities is billed through the same

codes as in-center HD, making it

impossible for CMS to identify the

relevant claims.

The following is a summary of the

comments received on the home

dialysis rate calculation for Managing

Clinicians and our responses.

Comment: Many commenters

suggested including self-care in-center

dialysis patients in the numerator of the

home dialysis rate calculation for ESRD

facilities using condition code 72, and

one of these commenters suggested

removing these patients from the

denominator of the home dialysis rate

calculation so that these patients do not

count against the ESRD facilities or

Managing Clinicians. CMS received a

letter from a coalition of 26 stakeholders

including nephrologists, dialysis

facilities, patients, and manufacturers

urging that the definition of self-dialysis

be further clarified beyond what is

already present in 42 CFR 494.10 and

that self-dialysis should be included in

the numerator for the ETC Model and be

monitored using condition code 72

since self-care in-center dialysis is

tracked through this code.

Response: CMS appreciates the

commenters’ suggestions for identifying

self-care in-center dialysis patients. We

agree with commenter feedback that

self-dialysis can be identified with

condition code 72. We also appreciate

that self-dialysis may serve as a way to

provide a gradual transition from in-

center dialysis to home dialysis,

allowing patients to become comfortable

with conducting dialysis under medical

supervision. We considered including

self-dialysis in the numerator of the

proposed rule, pointing out that it was

consistent with the overarching goals of

the ETC Model and helped to promote

beneficiary choice of treatment

modalities. The concern we expressed

in the proposed rule was that there was

not a clear, consistent definition of self-

dialysis in the literature or a clear way

for CMS to identify these claims.

However, comments from stakeholders

point out that there is an already

defined claim code in the ESRD PPS

and a clear definition in federal law at

42 CFR 494.10.

After considering public comments,

we are finalizing our proposed

provisions on the home dialysis rate

calculation for Managing Clinicians,

with modification. Specifically, we are

codifying in our regulation at

§ 512.365(b)(2) that the denominator of

the home dialysis rate for Managing

Clinicians will be the total dialysis

treatment beneficiary years for

attributed ESRD Beneficiaries during the

MY, as proposed. We are codifying in

our regulation at § 512.365(b)(2) that the

numerator of the home dialysis rate for

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Managing Clinicians will be the total

number of dialysis treatment beneficiary

years during the MY in which attributed

ESRD Beneficiaries received

maintenance dialysis at home, as

identified by CPT

®

codes 90965 or

90966; however, we are modifying this

proposal to also include one half of the

total number of dialysis treatment

beneficiary years during the MY in

which attributed ESRD Beneficiaries

received maintenance dialysis via self-

dialysis. Specifically, each beneficiary

month for which an attributed

beneficiary receives self-dialysis will

contribute one half month to the

numerator. Self-dialysis treatment

beneficiary years included in the

numerator are composed of those

months during which an attributed

ESRD Beneficiary received self-dialysis

in center, such that one beneficiary year

is comprised of 12 beneficiary months.

Months in which an attributed ESRD

Beneficiary received self-dialysis will be

identified by claims with Type of Bill

072X, with condition code 72. We are

using condition code 72 because self-

dialysis cannot be identified using CPT

®

codes submitted by Managing

Clinicians. We are making this change

for consistency with the modifications

made to the home dialysis rate

calculation for ERSD facilities in

response to comments, and similarly

believe this policy change, as applied to

the home dialysis rate for Managing

Clinicians, will effectively balance the

benefits of self-dialysis and its ability to

help beneficiaries transition to home

dialysis with the recognition that it is

not home dialysis and does not have all

of the same benefits. Of note, we have

removed references to the risk

adjustment methodology because we are

not finalizing the proposed risk

adjustment methodology for the home

dialysis rate for Managing Clinicians, as

described in section IV.C.5.c.(3) of this

final rule. We are also modifying

references to the proposed reliability

adjustment methodology and are

replacing them with references to the

aggregation methodology for the home

dialysis rate for Managing Clinicians, as

described in section IV.C.5.c.(4) of this

final rule.

(2) Transplant Rate

We proposed to define the ‘‘transplant

rate’’ as the rate of ESRD Beneficiaries

and, if applicable, pre-emptive

transplant beneficiaries attributed to the

ETC Participant who received a kidney

or kidney-pancreas transplant during

the MY, as described in proposed

§ 512.365(c) (Transplant Rate). We

proposed to construct the transplant rate

for ETC Participants that are ESRD

facilities as described in the proposed

rule and section IV.C.5.c.(2)(a) of this

final rule, and for ETC Participants who

are Managing Clinicians as described in

the proposed rule and section

IV.C.5.c.(2)(b) of this final rule.

For purposes of constructing the

transplant rate, we proposed two

transplant rate-specific beneficiary

exclusions. Specifically, we proposed to

exclude an attributed beneficiary from

the transplant rate calculations for any

months during which the beneficiary

was 75 years of age or older at any point

during the month, and for any months

in which the beneficiary was in a SNF

at any point during the month. We

proposed these additional exclusions to

recognize that, while these beneficiaries

can be candidates for home dialysis,

they are generally not considered

candidates for transplantation. As we

noted in the proposed rule, these

exclusions would be similar to the

exclusions used in the PPPW measure

that has been adopted by the ESRD QIP.

We sought comment on the proposal to

exclude from the transplant rate

beneficiaries aged 75 or older and

beneficiaries in SNFs. The transplant

rate calculations would also exclude

beneficiaries who elected hospice, as we

proposed to exclude beneficiaries who

have elected hospice from attribution

generally under the ETC Model and

therefore they would be excluded from

the calculation of both the transplant

rate and the home dialysis rate.

In the proposed rule, we considered

using rates of transplant waitlisting

rather than the actual transplant rate.

However, for the ETC Model, we

proposed to test the effectiveness of the

Model’s incentives on outcomes, rather

than on processes. We stated in the

proposed rule that the relevant outcome

for purposes of the ETC Model is the

receipt of a kidney or kidney-pancreas

transplant, not getting on and remaining

on the kidney transplant waitlist. While

we acknowledged in the proposed rule

that getting a beneficiary on the

transplant waitlist is more directly

influenced by the ESRD facility and/or

the Managing Clinician than the

beneficiary actually receiving the

transplant, we stated that we believed

that ESRD facilities and Managing

Clinicians are well positioned to assist

beneficiaries through the transplant

process, and we wanted to incentivize

this focus. We also acknowledged in the

proposed rule that transplant waitlist

measures do not capture living

donation, which is an additional path to

a successful kidney transplant, and

ESRD facilities and Managing Clinicians

may support this process. Details about

the PPPW Clinical Measure can be

found in the CY 2019 ESRD PPS final

rule (83 FR 56922, 57003–08). We

solicited comment on our proposal to

not test the effectiveness of the Model’s

incentives on increasing the number of

patients added to the kidney transplant

waitlist. Additionally, we solicited

comment on an alternative transplant

waitlist measure that would also capture

living donation.

We proposed using one year of data,

from an MY, to construct the transplant

rate to align with the construction of the

home dialysis rate. However, we noted

that because transplants are rare events

for statistical purposes, we may not

have sufficient statistical power to

detect meaningful variation using only

one year of performance information at

the ETC Participant level. In order to

ensure that we would have sufficient

statistical power to detect meaningful

variation in performance, in the

proposed rule we also considered the

alternative of using 2, 3, or 4 years of

data, corresponding with the MY plus

the calendar year or years immediately

prior to the MY, to construct the

transplant rate. However, we wanted to

avoid adjusting ETC Participant

payment based on performance that

occurred prior to the implementation of

the ETC Model, if finalized, and

concluded that the proposed reliability

adjustment aggregation methodology,

described in the proposed rule and

section IV.C.5.c.(4) of this final rule,

would compensate for any lack of

statistical power, and would therefore

eliminate the need to include data from

calendar years prior to the MY in order

to produce a reliable and valid

transplant rate. We discuss later in this

final rule our proposal for risk adjusting

and reliability adjusting these rates.

The following is a summary of the

comments received on the use of the

transplant rate and the alternatives

considered, and our responses.

Comment: Several commenters agreed

with CMS’s proposal to use

transplantation to assess ESRD facility

performance on the transplant rate since

transplantation generally provides the

best outcomes for patients and promotes

collaboration for transplant efforts.

Some of these same commenters

suggested that increasing the number of

patients on the transplant waitlist may

not correlate with an increase in

transplantation rates. Instead of the

transplant rate, some commenters

suggested a focus on patient education

around treatment modality choices or

the transplant process. However,

multiple other commenters stated that

they are concerned that complexities

outside of health care providers’ and

patients’ control, including policy

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barriers, lack of available organs, which

is often due to the way deceased organs

are procured, long waitlist times, patient

choice, and the lack of a clinical fit for

transplant do not support the proposed

methodology to assess ETC Participant

performance based on a transplant rate.

Some commenters instead suggested

using the PPPW measure and

Standardized First Kidney Transplant

Waitlist Ratio for Incident Dialysis

Patients (SWR) measure, but pointed out

that the SWR does not include pre-

emptive transplants in its data and that

the PPPW measures prevalence of

beneficiaries on the waitlist, which

includes beneficiaries who have been on

the waitlist for a long duration and may

not account for other barriers to

transplantation.

Response: CMS appreciates this

feedback. In the proposed rule, we

specifically solicited comment on our

proposal not to test the effectiveness of

the Model’s incentives on increasing the

number of patients added to the

transplant waitlist. We appreciate

commenters concerns that certain

factors that impact the transplant rate

are beyond the control of the ETC

Participant, particularly regarding the

supply of deceased donor organs

available for transplantation. While we

believe that other efforts intended to

increase the supply of deceased donor

organs, including the ETC Learning

Collaborative (described in section

IV.C.12 of this final rule) and extending

the Kidney Disease Education benefit to

multiple provider types (described in

section IV.C.7.b of this final rule) will

help to address this concern, we also

acknowledge that these efforts will take

time to produce results. As such, we are

modifying our proposed transplant rate

and will instead use a transplant rate

that is calculated as the sum of the

transplant waitlist rate and the living

donor transplant rate for purposes of the

PPA calculation under the Model. This

policy change aligns with suggestions

from commenters that, particularly in

light of the current shortage of deceased

donor organs for transplant, a transplant

waitlist rate is more within the control

of the ETC Participant. This approach

will allow the changes made by the

proposed rule issued December 23, 2019

entitled Organ Procurement

Organizations Conditions for Coverage:

Revisions to the Outcome Measure

Requirements for Organ Procurement

(CMS–3380–P) and the proposed rule

published December 20, 2019 entitled

Removing Financial Disincentives to

Living Organ Donation, if finalized, as

well as the ETC Learning Collaborative

under the Model time to have an effect

on deceased donor organ supply before

holding ETC Participants accountable

for their performance on the transplant

rate that includes deceased donor organ

transplants. It is our intent to observe

the supply of deceased donor organs

available for transplantation. Any

change to the composition of the

transplant rate to include the rate of

deceased donor kidney transplants for

the purposes of the PPA calculation

under the Model would be established

through future rulemaking.

We also sought comment on an

alternative transplant waitlist measure

that would capture living donation,

which is an alternative path to a

successful kidney transplant. We did

not receive any suggestions of

alternative measures of transplant

waitlisting that would capture living

donation. However, we wanted to

recognize the important role that ETC

Participants, as ESRD facilities and

Managing Clinicians, can play in

increasing the rates of living donor

kidney transplants outside the

transplant waitlist process and are

keeping living donor transplants in the

transplant rate calculation alongside the

transplant waitlist rate, instead of

deceased donor transplants as was in

the proposed rule. We define the ‘‘living

donor transplant rate’’ as the rate of

ESRD Beneficiaries and, if applicable,

Pre-emptive LDT Beneficiaries

attributed to the ETC Participant who

received a kidney transplant from a

living donor during the MY.

To accommodate this change, we are

modifying the definition of the

‘‘transplant rate’’ as the sum of the

transplant waitlist rate and the living

donor transplant rate. We define the

‘‘transplant waitlist rate’’ as the rate of

ESRD Beneficiaries attributed to the

ETC Participant who were on the kidney

transplant waitlist during the MY, as

described in § 512.365(c)(1)(i) and

§ 512.365(c)(2)(i). We acknowledge that

there are existing transplant waitlist

measures, including the PPPW and SWR

identified by commenters. However, we

believe that constructing a transplant

waitlist rate specific to the ETC Model

is the best approach. The transplant

waitlist rate for the ETC Model is

similar in concept to the PPPW but uses

the attribution methodology specific to

the ETC Model. As noted previously in

this final rule, we may seek to modify

the ETC Model in the future to use a

transplant rate that includes deceased

donor transplants, and would do so

through subsequent rulemaking. In the

final rule, we are clarifying that CMS

will obtain data about the kidney

transplant waitlist from SRTR, which

maintains all transplant waitlists.

Comment: Several commenters

recommended that we exclude

beneficiaries in SNFs from our

calculation of the transplant rate. Other

commenters stated that CMS should

factor the longevity of the organ

transplant into the transplant rate. A

commenter stated that CMS should add

in beneficiaries who have received a

transplant into the denominator of the

transplant rate calculation. Several

commenters suggesting removing from

the denominator of the transplant rate

calculation those beneficiaries who are

ineligible for transplant.

Response: CMS appreciates the

feedback. CMS is now excluding ESRD

Beneficiaries who reside in or receive

dialysis at a SNF or nursing home

facility from attribution to ETC

Participants for purposes of calculating

the PPA, as described in section

IV.C.5.b.(1) of this final rule, and

therefore these beneficiaries will be

excluded from the calculation of the

transplant rate well as the home dialysis

rate. We believe that the beneficiary

attribution exclusions as well as not

including beneficiaries over the age of

75 in the transplant rate calculation

remove the majority of beneficiaries

who are ineligible for transplantation

from the denominator of the transplant

rate. In addition, because we are

modifying our proposal and will use the

transplant rate calculated as the sum of

the transplant waitlist rate and the

living donor transplant rate rather than

the transplant rate including deceased

donor transplants, the longevity of the

organs is no longer a relevant

consideration. If the transplant rate

originally proposed is adopted for later

years of the Model through subsequent

rulemaking, CMS may consider

incorporating organ longevity as part of

the transplant rate and/or altering the

denominator of the transplant rate

calculation in a manner suggested by

the commenters, and would solicit

public comment on such a change

through a future notice of proposed

rulemaking. We also note that organ

longevity is a consideration for the KCC

Model, which is testing the efficacy of

payment incentives on post-transplant

care via a kidney transplant bonus.

Through this kidney transplant bonus,

CMS aims to test the impact of making

a payment reward to model participants

for each aligned beneficiary who

receives a kidney transplant. This

kidney transplant bonus payment would

be made in each of the three years

following the transplant in which the

transplant remains successful, meaning

the beneficiary does not return to

dialysis.

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In terms of the recommendation that

CMS add in beneficiaries who have

received a transplant into the

denominator of the transplant rate

calculation, as described elsewhere in

this final rule, CMS is modifying the

definition of ESRD Beneficiary to clarify

that a beneficiary who has received a

kidney transplant would be considered

an ESRD Beneficiary (and therefore

included in the denominator of the

transplant waitlist rate and the living

donor transplant rate) if the beneficiary

either: (1) Has a dialysis or MCP claim

at least 12 months after the beneficiary’s

latest transplant date; or (2) has a

dialysis or MCP claim less than 12

months after the beneficiary’s latest

transplant date that includes a kidney

transplant failure diagnosis code

documented in any Medicare claim.

These beneficiaries also would be

included in the numerator of the

transplant waitlist rate if the beneficiary

is added to the kidney transplant

waitlist, and in the numerator of the

living donor transplant rate if the

beneficiary received a transplant from a

living donor.

After considering public comments,

we are finalizing our general proposal

on the transplant rate, with

modifications. Specifically, in response

to comments received, we are replacing

the transplant rate we had proposed to

use for purposes of calculating the PPA

with the transplant rate calculated as

the sum of the living donor transplant

rate that had been included as part of

the original transplant rate calculation

and the transplant waitlist rate on

which we had solicited comments. In

addition, we are not finalizing the

definition of transplant rate as

proposed. Rather, in our regulation at

§ 512.310, we are modifying the

definition of ‘‘transplant rate’’ to mean

the sum of the transplant waitlist rate

and the living donor transplant rate. We

are defining the term ‘‘transplant

waitlist rate’’ to mean the rate of ESRD

Beneficiaries attributed to the ETC

Participant who were on the kidney

transplant waitlist during the MY, as

described in § 512.365(c). We are also

defining the term ‘‘living donor

transplant rate’’ to mean the rate of

ESRD Beneficiaries and, if applicable,

Pre-emptive LDT Beneficiaries

attributed to the ETC Participant who

received a kidney transplant from a

living donor during the MY.

(a) Transplant Rate for ESRD Facilities

For ESRD facilities, we proposed that

the denominator for the transplant rate

would be the total dialysis treatment

beneficiary years for attributed ESRD

Beneficiaries during the MY, subject to

the aforementioned exclusions. Dialysis

treatment beneficiary years included in

the denominator would be composed of

those months during which attributed

ESRD Beneficiaries received

maintenance dialysis at home or in an

ESRD facility, such that 1 beneficiary

year would be comprised of 12

attributed beneficiary months. Months

during which an attributed ESRD

Beneficiary received maintenance

dialysis would be identified by claims

with Type of Bill 072X. We explained

in the proposed rule that Facility code

7 paired with type of care code 2,

indicates that the claim occurred at a

clinic or hospital based ESRD facility.

Type of Bill 072X captures all renal

dialysis services furnished at or through

ESRD facilities. However, in order to

effectuate the exclusions previously

described, we would exclude claims for

attributed ESRD Beneficiaries who were

75 years of age or older at any point

during the month or were in a SNF at

any point during the month.

We proposed that the numerator for

the transplant rate for ESRD facilities

would be the total number of attributed

beneficiaries who received a kidney

transplant or a kidney-pancreas

transplant during the MY. We would

identify kidney and kidney-pancreas

transplants using Medicare claims data,

Medicare administrative data, and SRTR

data. For Medicare claims data, we

would use claims with Medicare

Severity Diagnosis Related Groups (MS–

DRGs) 008 (simultaneous pancreas-

kidney transplant) and 652 (kidney

transplant); and claims with ICD–10

procedure codes 0TY00Z0

(transplantation of right kidney,

allogeneic, open approach), 0TY00Z1

(transplantation of right kidney,

syngeneic, open approach), 0TY00Z2

(transplantation of right kidney,

zooplastic, open approach) 0TY10Z0

(transplantation of left kidney,

allogeneic, open approach), 0TY10Z1

(transplantation of left kidney,

syngeneic, open approach), and

0TY10Z2 (transplantation of left kidney,

zooplastic, open approach). Because

kidney-pancreas transplants are billed

by including an ICD–10 procedure code

for the type of kidney transplant and a

separate ICD–10 procedure code for the

type of pancreas transplant, in the

proposed rule we determined that we

would not need to include additional

ICD–10 codes to capture kidney-

pancreas transplants beyond the ICD–10

codes for kidney transplants listed. We

proposed that we would supplement

Medicare claims data on kidney and

kidney-pancreas transplants with

information from the SRTR Database

and Medicare administrative data about

the occurrence of kidney and kidney-

pancreas transplants not identified

through claims. If a beneficiary who

receives a transplant during a MY

returns to dialysis during the same MY,

the beneficiary would remain in the

numerator.

In the proposed rule, we also

considered constructing the numerator

for the ESRD facility transplant rate

such that the number of attributed

beneficiaries who received transplants

during a MY would remain in the

numerator for every MY after the

transplant during which the

transplanted beneficiary does not return

to dialysis, for the duration of the

proposed ETC Model. Keeping

attributed beneficiaries who received

transplants in a MY in the numerator for

MYs subsequent to the MY in which the

transplant occurs would acknowledge

the significant efforts made by ESRD

facilities to successfully assist

beneficiaries through the transplant

process. However, as noted in the

proposed rule, we believe this approach

would artificially inflate transplant rates

in later years of the Model and

disproportionately disadvantage new

ESRD facilities who begin providing

care to ESRD Beneficiaries in later years

of the Model. In the proposed rule we

concluded that this potential for

artificially inflated rates and the

disadvantage that would result for new

ESRD facilities outweighed the

advantage of accruing transplants over

time.

The following is a summary of the

comments received on the proposed

transplant rate for ESRD facilities and

our responses.

Comment: Multiple commenters

mentioned that ESRD facilities can

control only evaluation and referral of

patients to transplant centers. A

commenter suggested that ETC

Participants be required to refer any

patient with an Estimated Post

Transplant Survival (EPTS) Score of 75

percent or below to receive a transplant

evaluation.

Response: We appreciate the feedback

from the commenters. As described in

section IV.C.5 of this final rule, we

appreciate the complexity of the

transplant process, including the

number of transplant providers involved

and the different roles they play. For

this reason, we are modifying our

proposal and will instead use a

transplant rate calculated as the sum of

the transplant waitlist rate and the

living donor transplant rate for purposes

of calculating the Facility PPA. As the

health care providers that ESRD

beneficiaries see most frequently, ESRD

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facilities play a pivotal role in the living

donor and transplant waitlist process,

including: Educating beneficiaries about

their transplant options, including

living donation; helping beneficiaries

navigate the transplant process,

including helping beneficiaries

understand the process; providing

referrals for care necessary to meet

clinical transplant requirements, and

referrals for transplant waitlisting; and

coordinating care during the transplant

process.

As noted previously in this final rule,

we may seek to modify the ETC Model

through subsequent rulemaking to use a

transplant rate that incorporates the rate

of deceased donor transplants.

After considering public comments,

we are finalizing our proposed

provisions on the transplant rate for

ESRD facilities in our regulations at

§ 512.365(c)(1), with modifications.

Specifically, in response to comments

received, the transplant rate for ESRD

facilities is calculated as the sum of the

transplant waitlist rate for ESRD

facilities and the living donor transplant

rate for ESRD facilities. As was the case

with the proposed transplant rate for

ESRD facilities, the denominator for the

transplant waitlist rate for ESRD

facilities and the living donor transplant

rate for ESRD facilities is the total

dialysis treatment beneficiary years for

attributed ESRD Beneficiaries during the

MY. Dialysis treatment beneficiary years

included in the denominator are

composed of those months during

which attributed ESRD Beneficiaries

received maintenance dialysis at home

or in an ESRD facility, such that 1

beneficiary year is comprised of 12

attributed beneficiary months. Months

during which an attributed ESRD

Beneficiary received maintenance

dialysis are identified by claims with

Type of Bill 072X. Beneficiaries who are

75 years of age or older at any point

during the month are excluded from the

denominator. Because beneficiaries who

reside in SNFs or nursing facilities are

now excluded from attribution to ETC

Participants for purposes of the PPA

calculation in general, it is not

necessary to specifically exclude

beneficiaries who were in a SNF from

the transplant waitlist rate denominator,

as we had proposed to do for purposes

of the transplant rate.

The numerator for the transplant

waitlist rate for ESRD facilities is the

number of beneficiary years for which

attributed ESRD Beneficiaries were on

the kidney transplant waitlist during the

MY. As noted previously, we are

clarifying in this final rule that CMS

will obtain transplant waitlist data from

SRTR, which maintains data on all

transplant waitlists.

The denominator for the living donor

transplant rate for ESRD facilities will

be calculated in the same manner as the

denominator for the transplant waitlist

rate finalized for ESRD facilities. The

numerator for the living donor

transplant rate for ESRD facilities is the

total number of attributed beneficiary

years for LDT Beneficiaries during the

MY. Beneficiary years for LDT

Beneficiaries included in the numerator

are composed of the number of months

from the beginning of the MY up to and

including the month of the transplant

for LDT Beneficiaries attributed to the

ESRD facility during the month of the

transplant. This method of determining

the number of months associated with a

LDT mirrors the method for determining

beneficiary attribution for pre-emptive

transplant beneficiaries included in the

proposed rule and for determining

beneficiary attribution for Pre-emptive

LDT Beneficiaries as described in

section IV.C.5.b.(2)(b) of this final rule.

This method is necessary in order to

transform a singular event, in particular

receipt of a living donor transplant, into

a number of beneficiary months such

that the numerators for the transplant

waitlist rate and the living donor

transplant rate can be combined into the

transplant rate. CMS will obtain living

donor transplant data from SRTR, which

maintains data on all transplant,

including living donor transplants, and

from Medicare claims. We would

identify kidney transplants using

Medicare claims and administrative

data, and SRTR data. As was the case in

the proposed rule, to identify kidney

transplants using Medicare claims data,

we will use claims with Medicare

Severity Diagnosis Related Groups (MS–

DRGs) 008 (simultaneous pancreas-

kidney transplant) and 652 (kidney

transplant); and claims with ICD–10

procedure codes 0TY00Z0

(transplantation of right kidney,

allogeneic, open approach), 0TY00Z1

(transplantation of right kidney,

syngeneic, open approach), 0TY00Z2

(transplantation of right kidney,

zooplastic, open approach) 0TY10Z0

(transplantation of left kidney,

allogeneic, open approach), 0TY10Z1

(transplantation of left kidney,

syngeneic, open approach), and

0TY10Z2 (transplantation of left kidney,

zooplastic, open approach) We are also

defining LDT Beneficiary in our

regulations at § 512.310 to mean an

ESRD Beneficiary who received a

kidney transplant from a living donor

during the MY.

Of note, we are modifying references

to the proposed reliability adjustment

methodology and are replacing them

with references to the aggregation

methodology for the transplant rate for

ESRD facilities, as described in section

IV.C.5.c.(4) of this final rule.

(b) Transplant Rate for Managing

Clinicians

As we noted in the proposed rule,

whereas ESRD facilities provide care to

beneficiaries only once they have begun

dialysis, Managing Clinicians provide

care for beneficiaries before they begin

dialysis. Therefore, we proposed to use

a numerator and denominator for the

transplant rate for Managing Clinicians

that would include pre-emptive

transplant beneficiaries, that is,

beneficiaries who receive transplants

before beginning dialysis, in addition to

ESRD Beneficiaries. In this construction,

a pre-emptive transplant beneficiary

would be included in the numerator for

the Managing Clinician as a transplant

and in the denominator for the

Managing Clinician for the number of

months from the beginning of the MY

up to and including the month of the

transplant. In the proposed rule, we

considered including pre-emptive

transplants during the MY among

attributed pre-emptive transplant

beneficiaries in the numerator, to

acknowledge Managing Clinician efforts

in assisting ESRD Beneficiaries with

pre-emptive transplants, without

including them in the denominator.

However, we concluded that this would

disproportionately favor pre-emptive

transplants in the construction of the

rate. We sought comment on the

proposed inclusion of pre-emptive

transplants in both the numerator and

the denominator for the Managing

Clinician transplant rate calculation.

We proposed that the denominator for

the transplant rate for Managing

Clinicians would be the total dialysis

treatment beneficiary years for

attributed ESRD Beneficiaries during the

MY, plus the total number of attributed

beneficiary years for pre-emptive

transplant beneficiaries during the MY.

Dialysis treatment beneficiary years

included in the denominator would be

composed of those months during

which an attributed ESRD Beneficiary

received maintenance dialysis at home

or in an ESRD facility, such that one

beneficiary year is comprised of 12

beneficiary months. Months during

which an attributed ESRD Beneficiary

received maintenance dialysis would be

identified based on claims, specifically

claims with CPT

®

codes 90957, 90958,

90959, 90960, 90961, 90962, 90965, or

90966. CPT

®

codes 90957, 90958,

90959, 90960, 90961, and 90962 are for

ESRD related services monthly, and

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indicate beneficiary age (12–19 or 20

years of age or older) and the number of

face-to-face visits with a physician or

other qualified health care professional

per month (1, 2–3, 4 or more). CPT

®

codes 90965 and 90966 are for ESRD

related services for home dialysis per

full month, and indicate the age of the

beneficiary (12–19 or 20 years of age or

older). Taken together, these codes are

used to bill the MCP, including patients

who dialyze at home and patients who

dialyze in-center. However, in order to

effectuate the exclusions previously

described, we proposed to exclude

claims for attributed ESRD Beneficiaries

who were 75 years of age or older at any

point during the month or were in a

SNF at any point during the month.

For pre-emptive transplant

beneficiaries, attributed beneficiary

years included in the denominator

would be composed of those months

during which a pre-emptive transplant

beneficiary is attributed to the Managing

Clinician, between the start of the MY

and the month of the transplant. In the

proposed rule we recognized that

including pre-emptive transplant

beneficiary years in the denominator

may create a bias in favor of pre-emptive

transplants occurring at the beginning of

the MY, which may influence Managing

Clinician behavior. As pre-emptive

transplant beneficiaries only contribute

months to the denominator from the

start of the MY to the month of the

transplant, the earlier in the MY the

transplant occurs, the fewer months are

included in the denominator, and the

higher the Managing Clinician’s

transplant rate. However, as noted in the

proposed rule, we believed that the

potential for this bias to impact

Managing Clinician behavior is small

due to the complexity of scheduling in

the pre-emptive transplant process

(such as surgeon availability, donor and

recipient schedules, etc.).

We proposed that the numerator for

the transplant rate for Managing

Clinicians would be the number of

attributed ESRD Beneficiaries who

received a kidney transplant or a

kidney-pancreas transplant during the

MY, plus the number of pre-emptive

transplant beneficiaries attributed to the

Managing Clinician for the MY. We

proposed to identify kidney and kidney-

pancreas transplants using Medicare

claims data, Medicare administrative

data, and SRTR data. For Medicare

claims data, we would use claims with

Medicare Severity Diagnosis Related

Groups (MS–DRGs) 008 (simultaneous

pancreas-kidney transplant) and 652

(kidney transplant); and claims with

ICD–10 procedure codes 0TY00Z0

(transplantation of right kidney,

allogeneic, open approach), 0TY00Z1

(transplantation of right kidney,

syngeneic, open approach), 0TY00Z2

(transplantation of right kidney,

zooplastic, open approach) 0TY10Z0

(transplantation of left kidney,

allogeneic, open approach), 0TY10Z1

(transplantation of left kidney,

syngeneic, open approach), and

0TY10Z2 (transplantation of left kidney,

zooplastic, open approach). Because

kidney-pancreas transplants are billed

by including an ICD–10 procedure code

for the type of kidney transplant and a

separate ICD–10 procedure code for the

type of pancreas transplant, we

concluded that we would not need to

include additional ICD–10 codes to

capture kidney-pancreas transplants

beyond the ICD–10 codes for kidney

transplants listed. We proposed that we

would supplement Medicare claims

data on kidney and kidney-pancreas

transplants with information from the

SRTR Database and Medicare

administrative data about the

occurrence of kidney and kidney-

pancreas transplants not identified

through claims. We stated that if a

beneficiary who receives a transplant

during an MY returns to dialysis during

the same MY, the beneficiary would

remain in the numerator, to

acknowledge the efforts of the Managing

Clinician in facilitating the transplant

but also to hold the Managing Clinician

harmless for transplant failure, which

may be outside of the Managing

Clinician’s control.

In the proposed rule we also

considered constructing the numerator

for the Managing Clinician transplant

rate such that the number of attributed

beneficiaries who received transplants

during a MY would remain in the

numerator for every MY after the

transplant for which the transplanted

beneficiary does not return to dialysis,

for the duration of the ETC Model.

Keeping transplants in the numerator

for MYs subsequent to the MY in which

the transplant occurs would

acknowledge the significant efforts

made by Managing Clinicians to

successfully assist beneficiaries through

the transplant process. However, as

noted in the proposed rule, we believed

this approach would artificially inflate

transplant rates in later years of the

Model and disproportionately

disadvantage new Managing Clinicians

who begin providing care to ESRD

Beneficiaries in later years of the Model.

We concluded that this potential for

artificially inflated rates and the

disadvantage that would result for new

ESRD facilities outweighed the

advantage of accruing transplants over

time.

The following is a summary of the

comments received on the proposed

transplant rate for Managing Clinicians

and our responses.

Comment: We received one comment

recommending that CMS include claims

for beneficiaries who have received a

transplant in the numerator of the

transplant rate for Managing Clinicians,

even for the MYs after the transplant, to

give Managing Clinicians credit for

helping to manage patient care and

improve post-transplant outcomes for

these beneficiaries.

Response: We appreciate the feedback

from the commenter. As we are

modifying the transplant portion of the

MPS used in calculating the PPA to use

the transplant rate calculated as the sum

of the transplant waitlist rate and the

living donor transplant rate, instead of

the transplant rate as proposed, we do

not believe it would be appropriate to

include beneficiaries in the transplant

waitlist rate calculation post-transplant,

as there would generally be no need for

Managing Clinicians to add these

beneficiaries to a transplant waitlist. We

also do not believe it would be

necessary to include post-transplant

LDT Beneficiaries or Pre-emptive LDT

Beneficiaries in the living donor

transplant rate beyond the MYs in

which the transplant occurs, as the

focus of the rate is whether or not a

transplant occurred, not what occurs

post-transplant. However, if we modify

the MPS calculation to use a transplant

rate that includes deceased donor

transplants or a similar measure for

future MYs through subsequent

rulemaking, we may consider proposing

to incorporate post-transplant outcomes

through such subsequent rulemaking.

After considering public comments,

we are finalizing our proposed

provisions on the transplant rate for

Managing Clinicians in our regulation at

§ 512.356(c)(2), with modification. The

transplant rate for Managing Clinicians

is calculated as the sum of the

transplant waitlist rate for Managing

Clinicians and the living donor

transplant rate for Managing Clinicians.

The denominator for the transplant

waitlist rate for Managing Clinicians is

the total dialysis treatment beneficiary

years for attributed ESRD Beneficiaries

during the MY. As was the case with the

proposed transplant rate for Managing

Clinicians, dialysis treatment

beneficiary years included in the

denominator are composed of those

months during which attributed ESRD

Beneficiaries received maintenance

dialysis at home or in an ESRD facility,

such that 1 beneficiary year is

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152

CMS. Report to Congress: Risk adjustment in

Medicare Advantage. December 2018; cms.gov/

Medicare/Health-Plans/

MedicareAdvtgSpecRateStats/Downloads/RTC-

Dec2018.pdf.

comprised of 12 attributed beneficiary

months. Months during which an

attributed ESRD Beneficiary received

maintenance dialysis are identified

based on claims, specifically claims

with CPT

®

codes 90957, 90958, 90959,

90960, 90961, 90962, 90965, or 90966.

Beneficiaries who are 75 years of age or

older at any point during the month are

excluded from the denominator.

Because beneficiaries who reside in or

receive dialysis in SNFs or nursing

facilities during the month are now

excluded from attribution in general, we

are also excluding beneficiaries who

were residing in or receiving dialysis a

skilled nursing facility or nursing home

facility from the transplant waitlist rate

denominator. Of note, the denominator

for the Managing Clinician transplant

waitlist rate does not include attributed

Pre-emptive LDT Beneficiaries, as these

beneficiaries do not have to be on the

transplant waitlist to receive their

transplant because living donor organs

are not allocated through the transplant

waitlist.

The numerator for the transplant

waitlist rate for Managing Clinicians is

the number of beneficiary years for

which attributed ESRD Beneficiaries

were on the kidney transplant waitlist

during the MY. We are clarifying in this

final rule that CMS will identify months

during which an attributed ESRD

beneficiary was on the kidney

transplant waitlist using data from the

SRTR database, which maintains data

on all transplant waitlists.

The denominator for the living donor

transplant rate for Managing Clinicians

is the sum of total dialysis treatment

beneficiary years for attributed ESRD

Beneficiaries during the MY and the

total number of attributed beneficiary

years for attributed Pre-emptive LDT

Beneficiaries during the MY. We define

a Pre-emptive LDT Beneficiary in our

regulations at § 512.310 as a beneficiary

who received a pre-emptive kidney

transplant from a living donor during

the MY. Including Pre-emptive LDT

Beneficiaries in the living donor

transplant rate denominator for

Managing Clinicians follows the same

reasoning and method as described in

the proposed rule for including pre-

emptive transplant beneficiaries in the

transplant rate for Managing Clinicians.

That is, whereas ESRD facilities provide

care to beneficiaries only once they have

begun dialysis, Managing Clinicians

provide care for beneficiaries before

they begin dialysis. However, the

construction of the denominator for the

living donor transplant rate differs from

the proposed construction of the

denominator for the proposed transplant

rate because the living donor transplant

rate includes only pre-emptive

transplants that came from living

donors. As such, the denominator for

the living donor transplant rate for

Managing Clinicians does not include

beneficiaries who received a pre-

emptive transplant from a deceased

donor. Dialysis treatment beneficiary

years included in the denominator of

the living donor transplant rate for

Managing Clinicians are the same as

those included in the denominator of

the transplant waitlist rate, as described

above. As was the case for preemptive

transplant beneficiary years in the

proposed rule, pre-emptive LDT

beneficiary years included in the

denominator are composed of those

months during which a Pre-emptive

LDT Beneficiary is attributed to the

Managing Clinician, between the start of

the MY and up to and including the

month of the transplant. The numerator

for the living donor transplant rate for

Managing Clinicians is the total number

of attributed beneficiary years for LDT

Beneficiaries during the MY plus the

total number of attributed beneficiary

years for Pre-emptive LDT Beneficiaries

during the MY. Beneficiary years for

LDT Beneficiaries included in the

numerator are composed of the number

of months from the beginning of the MY

up to and including the month of the

transplant for LDT Beneficiaries

attributed to the Managing Clinician

during the month of the transplant. As

described above in regards to the living

donor transplant rate for ESRD facilities,

this method is necessary in order to

transform a singular event, in particular

a living donor transplant, into a number

of beneficiary months such that the

numerators for the transplant waitlist

rate and the living donor transplant rate

can be combined into the transplant

rate. As with the denominator for the

living donor transplant rate for

Managing Clinicians, pre-emptive LDT

beneficiary years included in the

numerator are composed of those

months during which a Pre-emptive

LDT Beneficiary is attributed to the

Managing Clinician, between the start of

the MY and up to and including the

month of the transplant.

CMS will obtain transplant waitlist

data from SRTR, which maintains status

data for all transplant waitlists and

transplants, including living donor

transplants. CMS will obtain living

donor transplant data from SRTR, which

contains comprehensive information

about transplants that occur in the U.S.,

as well as from Medicare claims. Of

note, we are modifying references to the

proposed reliability adjustment

methodology and are replacing them

with references to the aggregation

methodology for the transplant rate for

Managing Clinicians, as described in

section IV.C.5.c.(4) of this final rule.

(3) Risk Adjustment

In order to account for underlying

variation in the population of

beneficiaries attributed to participating

ESRD facilities and Managing

Clinicians, we proposed that CMS

would risk adjust both the home

dialysis rate and the transplant rate.

For the home dialysis rate, we

proposed to use the most recent final

risk score for the beneficiary, calculated

using the CMS–HCC (Hierarchical

Condition Category) ESRD Dialysis

Model used for risk adjusting payment

in the Medicare Advantage program, to

risk adjust the home dialysis rate under

the proposed ETC Model. As noted in

the proposed rule, internal analyses

completed by CMS show that lower

HCC risk scores are associated with

beneficiaries on home dialysis than with

beneficiaries on in-center HD. The risk

adjustment methodology we proposed

for the ETC Model home dialysis rate

would account for ESRD facilities and

Managing Clinicians with a population

that is relatively sicker than the general

Medicare population. As we explained

in the proposed rule, the CMS–HCC risk

adjustment models were developed for

the Medicare Advantage program and

use a Medicare beneficiary’s medical

conditions and demographic

information to predict Medicare

expenditures for the next year. In the

Medicare Advantage context, the per-

person capitation amount paid to each

Medicare Advantage plan is adjusted

using a risk score calculated using the

CMS–HCC Models.

152

We proposed to

use the most recent final risk score

calculated for the beneficiary that is

available at the time of the calculation

of ESRD facility and Managing Clinician

home dialysis rates to risk adjust the

ETC Model home dialysis rate for that

MY and corresponding PPA Period.

In the proposed rule, we summarized

at a high level how the CMS–HCC

Models are developed and used in risk

adjusting payment to Medicare

Advantage plans.

We explained that CMS proposes and

adopts the CMS–HCC ESRD Dialysis

Model for risk adjusting payments to

Medicare Advantage organizations for a

particular payment year through the

Advance Notice and Rate

Announcement for the Medicare

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153

For example, CMS, Advance Notice of

Methodological Changes for Calendar Year (CY)

2020 for Medicare Advantage (MA) Capitation

Rates, Part C and Part D Payment Policies and 2020

Draft Call Letter, January 30, 2019. cms.gov/

Medicare/Health-Plans/MedicareAdvtgSpecRate

Stats/Downloads/Advance2020Part2.pdf and CMS,

Announcement of Calendar Year (CY) 2020

Medicare Advantage Capitation Rates and Medicare

Advantage and Part D Payment Policies and Final

Call Letter, April 1, 2019; https://www.cms.gov/

Medicare/Health-Plans/MedicareAdvtgSpecRate

Stats/Downloads/Announcement2020.pdf.

Advantage program.

153

This happens

the year before the payment year begins,

meaning that the CMS–HCC ESRD

Dialysis Model used to risk adjust

payments for 2020 was adopted and

announced in April 2019. However,

CMS does not calculate final risk scores

for a particular payment year until

several months after the close of the

payment year.

We explained in the proposed rule

that using risk scores developed using

the CMS–HCC ESRD Dialysis Model to

risk adjust the ETC Model home dialysis

rate would be appropriate as it can be

more difficult to transition sicker

beneficiaries to home dialysis, and risk

adjusting the home dialysis rate using

risk scores calculated using the CMS–

HCC ESRD Dialysis Model would

account for the relative sickness of the

population of ESRD Beneficiaries

attributed to each ETC Participant

relative to the national benchmark. We

also stated that use of these final risk

scores for the ETC Model would mean

use of the same methodology and the

same coefficients for the relevant HCCs

as the CMS–HCC ESRD Dialysis Model

used for the prior Medicare Advantage

payment year. The CMS–HCC ESRD

Dialysis Model includes the risk factors

outlined in § 422.308(c)(1) and (c)(2)(ii),

so those risk factors would be used in

risk adjustment for the ETC Model.

Under our proposal, the risk scores used

for the ETC Model would also be

adjusted with the same coding pattern

and normalization factors that are

adopted for the CMS–HCC ESRD

Dialysis Model for the relevant year but,

for the ETC Model, we did not propose

to use a frailty adjustment (for example,

outlined in § 422.308(c)(4)) as is used in

the Medicare Advantage program for

certain special needs plans.

In the proposed rule, we also

considered not applying a risk

adjustment methodology to the ETC

Model home dialysis rate in recognition

of the limitations of existing risk

adjustment methodologies to account

for housing instability, which is a key

factor preventing utilization of home

dialysis. However, we concluded that

not risk adjusting the home dialysis rate

would disproportionately disadvantage

ETC Participants that provide care to

sicker beneficiaries. We also stated that

we considered creating a custom risk-

adjustment methodology for the ETC

Model based on certain factors found in

the literature to affect rates of home

dialysis, but said that we believed that

the HCC system currently in use in the

Medicare Advantage program would be

sufficient for the purposes of this

Model, without the effort required to

develop a new methodology.

We proposed that the risk-adjustment

methodologies for the home dialysis rate

and transplant rate would be applied

independently. In the proposed rule we

also considered using the same risk

adjustment strategy for both rates, but

recognized that the risk factors that may

impact the ability of an ESRD

Beneficiary to successfully dialyze at

home are different from the risk factors

that may impact the ability of an ESRD

Beneficiary or pre-emptive transplant

beneficiary to receive a kidney

transplant. We further noted that, even

in the Medicare Advantage program, a

different CMS–HCC Model is used for

beneficiaries who have received a

transplant and stated our belief that the

benefit of separate risk adjustment

methodologies would outweigh the

additional complexity. For the

transplant rate, we noted in the

proposed rule that we wanted to use a

risk adjustment methodology that aligns

with a risk adjustment methodology

with which ESRD facilities and

Managing Clinicians are likely to be

familiar and that similarly would not

require development of a new and

unfamiliar methodology. In the

proposed rule we noted that we believe

that the methodology used for purposes

of risk adjusting the PPPW satisfies

these criteria and would be appropriate

to apply in risk adjusting the transplant

rate. Specifically, we proposed that the

ESRD facility and Managing Clinician

transplant rates would be risk adjusted

for beneficiary age, using the similar age

categories, with corresponding risk

coefficients, used for purposes of the

PPPW measure described earlier (83 FR

57004).

Although age alone is not a

contraindication to transplantation, we

stated in the proposed rule that older

patients are likely to have more

comorbidities and generally be more

frail, thus making them potentially less

suitable candidates for transplantation,

and therefore some may be

appropriately excluded from waitlisting

for transplantation. The risk adjustment

model for the PPPW contains risk

coefficients specific to each of the

following age categories of beneficiaries

(with age computed on the last day of

each reporting month): Under 15; 15–55;

56–70; and 71–74. Given that the ETC

Model would exclude beneficiaries

under 18 from the attribution

methodology used for purposes of

calculating the transplant rates, we

proposed to use the risk coefficients

calculated for the PPPW for the

populations aged 18–55, 56–70, and 71–

74, with age computed on the last day

of each month of the MY. Transplant

rates for ESRD facilities and Managing

Clinicians would be adjusted to account

for the relative percentage of the

population of beneficiaries attributed to

each ETC Participant in each age

category relative to the national age

distribution of beneficiaries not

excluded from attribution. Further

information on the risk adjustment

model used for purposes of the PPPW

can be found in the PPPW Methodology

Report (https://www.cms.gov/Medicare/

Quality-Initiatives-Patient-Assessment-

Instruments/ESRDQIP/Downloads/

Report-for-Percentage-of-Prevalent-

Patients-Waitlisted.pdf).

In the proposed rule, we stated that

we had considered using the risk

adjustment methodology used in the

Standardized Waitlist Ratio available

online at https://www.cms.gov/

Medicare/Quality-Initiatives-Patient-

Assessment-Instruments/ESRDQIP/

Downloads/Report-for-Standardized-

First-Kidney-Transplant-Waitlist-Ratio-

for-Incident-Dialysis-Facilities.pdf for

risk adjusting the ETC Model transplant

rate. However, we decided not to as this

measure is focused only on incident

beneficiaries in their first year of

dialysis, rather than the broader

population of beneficiaries that would

be included in the ETC Model.

In the proposed rule we also

considered using the CMS–HCC ESRD

Transplant Model for risk adjusting the

ETC Model transplant rate. However, we

decided not to as the model is focused

on costs once a beneficiary receives a

transplant, rather than the beneficiary’s

suitability for receiving a transplant.

The following is a summary of the

comments received on the risk

adjustment methodology for the home

dialysis rate, the risk adjustment

methodology for the transplant rate, and

our responses.

Comment: We received several

comments urging CMS to not use the

CMS ESRD–HCC Risk Score

methodology for risk adjusting the home

dialysis rate as proposed. Many

commenters commented that although

there is a correlation between healthier

beneficiaries and home dialysis

utilization, the relationship is not

causative, nor is beneficiary health

status the most important factor

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154

https://www.govinfo.gov/content/pkg/FR-

2017-08-14/pdf/2017-16434.pdf.

affecting home dialysis uptake rates.

Other commenters commented that the

CMS ESRD–HCC Risk Score

methodology is built using fee for

services data to project Medicare

Advantage spending, not relative levels

of illness; the commenters also pointed

out that a beneficiary whose risk score

is twice that of another is not

necessarily half as likely to be an

effective candidate for home dialysis.

Commenters also raised concerns that

this proposed methodology was not

transparent as ESRD facilities and

Managing Clinicians do not necessarily

receive the CMS ESRD–HCC risk score

information for their patients. One

dialysis company noted in its comments

that the CMS ESRD–HCC risk score

methodology has a different

methodology for beneficiaries who are

new to the Medicare program and that

the HCC risk scores may be less

predictive for this population given the

increased rates of home dialysis

utilization among beneficiaries who are

new to dialysis.

Response: After receiving comments

on the proposed rule, we performed an

additional analysis that showed a

correlation between lower CMS–HCC

risk scores and an increased likelihood

to receive home dialysis as opposed to

in-center dialysis. The average CMS–

HCC risk score for a beneficiary

receiving home dialysis is 0.9, while the

average CMS–HCC risk score for a

beneficiary receiving in-center

hemodialysis is 1.03, and this difference

is statistically significant with a p-value

of .02. However, the same analysis done

by CMS after receiving comments on the

proposed rule showed that, although the

difference in CMS–HCC risk scores

between these two populations is

statistically significant, CMS–HCC risk

scores have an explanatory ability of

only 1.5 percent for determining

whether a beneficiary will receive home

dialysis rather than in-center dialysis,

and vice versa. Based on the low

explanatory power of the CMS–HCC risk

score in predicting whether a

beneficiary will receive home dialysis,

together with the other issues with the

proposed risk-adjustment methodology

raised by the commentators, we do not

believe that there is a significant value

in risk adjusting the home dialysis rate

based on this proposed methodology,

and therefore we are not finalizing this

approach. We are instead finalizing the

home dialysis rate calculation without a

risk-adjustment methodology and we

seek input from commenters about risk

adjustment methodologies to be

proposed in future rulemaking. We

recognize that in the proposed rule, we

stated that we believed that not risk

adjusting the home dialysis rate would

disproportionately disadvantage ETC

Participants that provide care to sicker

beneficiaries. However, our subsequent

analysis indicated that although there is

a statistically significant correlation

between beneficiary risk scores and

propensity for home dialysis, the

relationship had very little explanatory

power, meaning that we do not believe

our proposed risk adjustment

methodology will help to address this

issue. We intend to monitor for whether

the lack of a risk-adjustment

methodology for the home dialysis rate

has any negative consequences for ETC

Participants and ESRD Beneficiaries and

may modify the ETC Model to add a

risk-adjustment methodology for

calculation to the home dialysis rate

through subsequent rulemaking.

Comment: Many commenters

recommended that CMS consider using

socioeconomic factors for purposes of

risk adjusting the home dialysis rate, as

these factors can preclude beneficiaries

from being appropriate candidates for

home dialysis. The commenters asserted

that beneficiaries suffering from housing

insecurity or homelessness are not good

candidates for the home dialysis

modality and that peritonitis, an

infection of the perineum that can result

from PD and prevents beneficiaries from

being able to continue receiving PD is

more common among socially

disadvantaged groups. Commenters had

several suggestions as to which

socioeconomic factors CMS could use to

risk-adjust the home dialysis rate,

including using dual eligibility status as

a proxy for socioeconomic status, using

the ZIP code or the ZIP+4 based on the

location of the beneficiary or the ESRD

facility, using Z-codes in ICD–10 to

track socioeconomic status or

homelessness, looking at the urban/rural

divide, using presence on the kidney

transplant waitlist as a proxy for health

status, or setting up a standardized ratio

measure based on projected rates of

transplants.

Three separate commenters—

including a dialysis company, a patient

advocacy group, and a nephrology

practice—each independently

recommended that CMS use the risk

adjustment methodology from the

Hospital Readmissions Reduction

Program, as laid out in the FY 2018 IPPS

final rule

154

(82 FR 37990, 38221

(August 14, 2017)) in order to risk-adjust

the home dialysis rate for

socioeconomic factors.

Response: We thank the commenters

for their recommendations and believe

that risk adjusting the home dialysis rate

based on socioeconomic factors may

have merit. However, risk adjusting the

home dialysis rate based on

socioeconomic factors would represent

a significant departure from the risk

adjustment methodology outlined in the

proposed rule. Accordingly, we are not

finalizing a risk-adjustment

methodology based on socioeconomic

factors at this time. As described

previously in this final rule, we are

finalizing the home dialysis rate

calculation without a risk adjustment

methodology. We seek input from the

public on how to construct a risk

adjustment methodology for the home

dialysis rate that could account for

socioeconomic factors, like the one from

the Hospital Readmissions Reduction

Program, to inform any future

rulemaking on this topic.

Comment: We received several

comments critiquing the risk adjustment

methodology from the PPPW measure

we proposed to apply to the transplant

rate. A commenter raised issues with

the methodology, pointing out that it

was not NQF endorsed and that it risk

adjusts by age in a way that has abrupt

cut points, rather than using age as a

continuous variable.

Response: We continue to believe that

the risk adjustment methodology for the

PPPW measure is appropriate to use for

the transplant waitlist rate, which we

are finalizing as part of the transplant

rate. We extensively tested the PPPW

measure, including its risk adjustment

methodology, before we adopted that

measure for the ESRD QIP, and our

rationale supporting the use of a similar

risk adjustment methodology for the

transplant waitlist rate is consistent

with the rationale that supports our use

of that methodology for the ESRD QIP.

The specific design of the risk

adjustment methodology for the PPPW

measure, including the cut points, is

designed to best fit the transplant

waitlist data in the PPPW measure.

Though it is not an NQF-endorsed

measure, this is a measure currently

used by CMS and we believe the

methodology to be sound.

Comment: Some commenters asserted

that the proposed risk adjustment

methodology for the transplant rate

should also include other factors related

to the transplant process, including

diagnoses of malignancy, cardiac

surgery, or other comorbidities that

could prevent a beneficiary from being

a transplant candidate. Other

commenters urged CMS to consider

other factors related to transplant

eligibility or to recognize different levels

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of access to kidneys in different

geographies.

Response: CMS believes that by

modifying the transplant rate to remove

deceased donor organ transplants, as

described previously in this final rule,

we do not need to risk adjust the

transplant rate for these specific issues

around organ supply that may affect

access to kidneys, in particular deceased

donor organs, in different geographies.

In addition, though there are disparaties

in the transplant process, CMS also

decided not to include other factors in

risk adjusting the transplant waitlist rate

to align with the risk adjustment

methodology for the PPPW measure,

which also did not include these factors.

Additionally, we believe that the

exclusions from beneficiary attribution

to ETC Participants described in section

IV.C.5.b.(1) of this final rule sufficiently

account for relevant contraindications to

transplant and that additional risk

adjustment for these factors is not

necessary.

After considering public comments,

we are finalizing our proposed

provisions for risk adjusting the home

dialysis rate and the transplant rate,

with modifications. Specifically, in

response to the methodological

concerns highlighted by commenters

regarding our proposed methodology for

risk adjusting the home dialysis rate and

subsequent analysis conducted by CMS,

we are finalizing the home dialysis rate

calculation without a risk adjustment

methodology. CMS may add a risk

adjustment methodology to the home

dialysis rate calculation, taking into

account the comments received and any

additional feedback received from the

public, in future rulemaking. We are

finalizing in our regulation at

§ 512.365(d) that the transplant waitlist

rate portion of the transplant rate will be

risk adjusted based on beneficiary age

with separate risk coefficients for the

following age categories of beneficiaries,

with age computed on the last day of

each month of the MY: 18 to 55; 56 to

70; and 71 to 74. We are also finalizing

in our regulation at § 512.365(d) that the

transplant waitlist rate portion of the

transplant rate will be adjusted to

account for the relative percentage of

the population of beneficiaries

attributed to the ETC Participant in each

age category relative to the national age

distribution of beneficiaries not

excluded from attribution. The living

donor transplant rate portion of the

transplant rate will not be risk adjusted

due to small sample sizes.

(4) Reliability Adjustments and

Aggregation

In order to overcome low reliability of

the home dialysis rate and transplant

rate related to small numbers of

beneficiaries attributed to individual

ETC Participants, we proposed to

employ a reliability adjustment. Under

this approach, we proposed using

statistical modeling to make reliability

adjustments such that the home dialysis

rate and the transplant rate would

produce reliable estimates for all ETC

Participants, regardless of the number of

beneficiaries for whom they provide

care. We also proposed this approach to

improve comparisons between ETC

Participants and those ESRD facilities

and Managing Clinicians not selected

for participation in the Model for

purposes of achievement benchmarking

and scoring, described in the proposed

rule and section IV.C.5.d of this final

rule. The proposed reliability

adjustment approach would create a

weighted average between the

individual ETC Participant’s home

dialysis rate and transplant rate and the

home dialysis rate and transplant rate

among the ETC Participant’s aggregation

group (previously described), with the

relative weights of the two components

based on the statistical reliability of the

individual ETC Participant’s home

dialysis rate and transplant rate, as

applicable. For example, if an ETC

Participant’s home dialysis rate has high

statistical reliability, then the ETC

Participant’s individual home dialysis

rate would contribute a large portion of

the ETC Participant’s reliability-

adjusted home dialysis rate and the

aggregation group’s home dialysis rate

would contribute a small portion of the

ETC Participant’s reliability-adjusted

home dialysis rate. We currently employ

this technique in a variety of settings,

including the measures used in creating

hospital ratings for Hospital Compare.

We explained in the proposed rule that

the advantage of using this approach is

that we could use one method to

produce comparable performance rates

for ESRD facilities and Managing

Clinicians across the size spectrum. We

also noted that the disadvantage of

using this approach is that reliability

adjusted performance rankings do not

necessarily reflect absolute or observed

performance, and may be difficult to

interpret directly. We stated that we

believed this approach balanced the

need for individualized performance

assessment and incentives with the

importance of reliably assessing the

performance of each ETC Participant.

For Managing Clinicians, we

proposed that the performance on these

measures would be first aggregated up

to the practice level, as identified by the

practice Taxpayer Identification

Number (TIN) for Managing Clinicians

who are in a group practice, and at the

individual National Provider Identifier

(NPI) level for Managing Clinicians who

are not in a group practice, that is, solo

practitioners. We proposed to define

‘‘TIN’’ as a Federal taxpayer

identification number or employer

identification number as defined by the

Internal Revenue Service in 26 CFR

301.6109–1. We proposed to define

‘‘NPI’’ as the standard unique health

identifier used by health care providers

for billing payers assigned by the

National Plan and Provider

Enumeration System (NPPES) in 45 CFR

part 162. We proposed these definitions

because they are used elsewhere by the

Medicare program (see 42 CFR 414.502).

Performance would then be aggregated

to the aggregation group level. We

proposed that the aggregation group for

Managing Clinicians, once aggregated to

the group practice or solo practitioner

level, as applicable, would be all

Managing Clinicians within the HRR in

which the group practice is located (for

group practices) or the Managing

Clinician’s HRR (for solo practitioners).

For ESRD facilities, we proposed that

the individual unit would be the ESRD

facility. We proposed to define a

‘‘Subsidiary ESRD facility’’ as an ESRD

facility owned in whole or in part by

another legal entity. We proposed this

definition in recognition of the structure

of the dialysis market, as described in

this rule. We proposed that the

aggregation group for Subsidiary ESRD

facilities would be all ESRD facilities

located within the ESRD facility’s HRR

owned in whole or in part by the same

company, and that ESRD facilities that

are not Subsidiary ESRD facilities

would be in an aggregation group with

all other ESRD facilities located within

the same HRR (with the exception of

those ESRD facilities that are Subsidiary

ESRD facilities).

We sought input on our proposal to

use reliability adjustments to address

reliability issues related to small

numbers, as well as on our proposed

aggregation groups for conducting the

reliability adjustment for ESRD facilities

and Managing Clinicians that are ETC

Participants.

In the proposed rule, we

acknowledged that for some segments of

the dialysis market, companies

operating ESRD facilities may operate

specific ESRD facilities that focus on

home dialysis, which furnish home

dialysis services to all patients receiving

home dialysis through that company in

a given area. Therefore, assessing home

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dialysis rates at the individual ESRD

facility level may not accurately reflect

access to home dialysis for beneficiaries

receiving care from a specific company

in the area. In the proposed rule, we

stated that we believed that the

reliability adjustment approach would

help to address this concern, because

the construction of the reliability

adjustment for Subsidiary ESRD

facilities would aggregate to the

company level within a given HRR and

thus incorporate this dynamic. In the

proposed rule, we considered using a

single aggregated home dialysis rate for

all ESRD facilities owned in whole or in

part by the same company within a

given HRR to account for this market

dynamic. However, in the proposed rule

we stated that producing individual

ESRD facility rates and reliability

adjusting individual ESRD facility

scores would be necessary to incentivize

ESRD facilities within the same

company in the same HRR to provide

the same level of care to all of their

attributed beneficiaries.

The following is a summary of the

comments received on the proposed

reliability adjustment and aggregation

methodologies and our responses.

Comment: We received comments

that our proposed reliability adjustment

lacked transparency and was difficult to

understand. Commenters noted that

there was not sufficient detail for them

to assess the potential impacts of the

proposed policy.

Response: We appreciate the feedback

from commenters about the proposed

reliability adjustment. In response to

these comments, we are not finalizing

the proposed reliability adjustment

policy. CMS no longer believes that the

reliability adjustment is necessary for

Managing Clinicians or for ESRD

facilities in light of the changes to the

aggregation policies described in this

section of this final rule, under which

the performance of Managing Clinicians

will be assessed at the practice level, if

applicable, and the performance of

ESRD facilities will be assessed at the

aggregation group level instead of at the

individual facility level. In addition, as

discussed in section IV.C.5.f of this final

rule, we have increased the low-volume

threshold relative to the low-volume

threshold outlined in the proposed rule,

which will remove greater numbers of

the smallest ETC Participants from the

application of the PPA, further

increasing the statistical reliability of

the rates used as part of the PPA

calculation.

Comment: We received comments in

support of our proposal to aggregate

performance on the home dialysis rate

and transplant rate for Managing

Clinicians in a group practice at the TIN

level. We also received comments

recommending that performance for a

Managing Clinician should be assessed

only based on the performance of other

Managing Clinicians with whom the

Managing Clinician shares a business

relationship.

Response: We appreciate the

commenters’ support and are finalizing

our proposal to assess the performance

of Managing Clinicians in a group

practice at the TIN level and to assess

the performance of Managing Clinicians

who are not in a group practice, that is,

solo practitioners at the NPI level.

However, we no longer plan to further

aggregate performance for Managing

Clinicians up to the HRR level, as

proposed. Based on comments received,

we recognize that it is most appropriate

to aggregate performance for Managing

Clinicians only for Managing Clinicians

practicing under a common group

practice (as identified by a TIN), and

that the performance of solo practitioner

Managing Clinicians should not be

aggregated with that of any other

Managing Clinicians. Specifically, we

do not believe the Managing Clinician

should be held accountable for the

performance of Managing Clinicians in

unaffiliated practices at the HRR level

because of their lack of business

relationships.

Comment: We received multiple

comments objecting to our proposed

aggregation methodology for ESRD

facilities, pointing out that dialysis

companies often concentrate their home

dialysis patients at certain regional

centers that solely focus on home

dialysis. Additionally, we received

comments that requiring a home

dialysis program to be built at each

ESRD facility would be duplicative and

would not necessarily improve patient

care. We also received comments that

ESRD Beneficiaries who receive

treatment from ESRD facilities that are

ETC Participants may receive home

dialysis services from a home dialysis

facility that is owned in whole or in part

by the same dialysis company, but that

is not necessarily within the same HRR

as the ESRD facility.

Response: Based on comments

received from the public, we believe

that the nature of the dialysis market

means that assessing home dialysis rates

at the individual ESRD facility level

may not accurately reflect access to

home dialysis through that company in

a given area. Our intent is to ensure that

home dialysis is available to every ESRD

Beneficiary, not necessarily at every

individual ESRD facility. In order to

better align with market dynamics, we

will assess ESRD facility performance at

the aggregation group level, rather than

at the facility level. However, as

proposed, the aggregation group for a

Subsidiary ESRD facility will include

only those ESRD facilities owned in

whole or in part by the same company

located in the same HRR. Based off of

our analyses, CMS found rare instances

of typographical errors for facility

information in PECOS. We will address

these inconsistencies by identifying

those ESRD facilities owned in whole or

in part by the same company using the

Chain TIN and Chain Name from

PECOS with adjustments made for any

mismatches arising from typographical

errors in those fields in PECOS using

CrownWEB and other CMS data

sources.

While we understand the

commenters’ concerns that dialysis

companies may operate across multiple

HRRs, as described in sections

IV.C.5.3.b and IV.C.5.3.c.(1) of this final

rule, we believe HRRs are the best

representation of patterns of care and,

unlike other geographic units of

selection considered in the proposed

rule, also include rural areas.

Additionally, CMS does not have

sufficient information regarding the

location of home dialysis facilities

relative to other Subsidiary ESRD

facilities of the same dialysis companies

in order to make informed aggregation

decisions on that basis (also, these

arrangements are likely subject to

change). Moreover, tailoring ESRD

facility aggregation based on each

dialysis company’s corporate structure

would be difficult to administer for

CMS and could be subject to gaming by

the dialysis companies.

Comment: We received multiple

comments in support of our proposal

that the aggregation group for

Subsidiary ESRD Facilities should be all

ESRD facilities located within the ESRD

facility’s HRR owned in whole or in part

by the same company. Additionally, we

received comments suggesting that all

ESRD facilities located in the same HRR

should receive a single combined score

regardless of their ownership status.

Response: We appreciate comments

supporting our proposal that the

aggregation group for Subsidiary ESRD

facilities would be all ESRD facilities

owned in whole or in part by the same

company within an HRR. We believe

this is a fair approach that allows the

performance for ESRD facilities to be

assessed based solely on the

performance of facilities that are owned

in whole or in part by the same

company, rather than facilities that may

be owned by different companies.

Additionally, we see the benefits of

grouping ESRD facilities within the

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same HRR, as the boundaries of the

HRRs reflect referral patterns and

because an ESRD facility is more likely

to refer patients for home dialysis and

other services to an ESRD facility

located in the same geographic area than

to an ESRD facility located farther away.

Comment: We received a comment

recommending that CMS create a virtual

group for small or low-volume ESRD

facilities with a smaller presence in the

specific HRR to aggregate performance.

Response: We appreciate this

recommendation but do not believe that

creating a virtual group will be

necessary to improve the reliability of

the home dialysis rates and transplant

rates for low-volume ESRD facilities. In

addition to the operational complexities

that implementing a virtual group

would present for CMS, we believe that

the increased low-volume threshold

described in section IV.C.5.f. of this

final rule will help to improve the

statistical reliability of the home

dialysis rates and transplant rates for

small ESRD facilities, while ensuring a

viable model test.

After considering public comments,

we are finalizing our proposed

provisions for reliability adjustment and

aggregation of the home dialysis rate

and transplant rate, with modifications.

Specifically, we are removing the

reliability adjustment for both ESRD

facilities and Managing Clinicians.

Additionally, we are codifying in our

regulation at § 512.365(e)(2) that a

Managing Clinician’s performance on

the home dialysis rate and transplant

rate will be aggregated to the Managing

Clinician’s aggregation group, which is

identified at the TIN level for Managing

Clinicians in a group practice and at the

individual NPI level for Managing

Clinicians who are solo practitioners.

We are not finalizing our proposal to

further aggregate Managing Clinician

performance with all other Managing

Clinicians located within the HRR.

Additionally, in § 512.365(e)(1), we are

finalizing our proposal that ESRD

facilities’ home dialysis rate and

transplant rate will be aggregated to the

ESRD facility’s aggregation group,

which is defined as all ESRD facilities

owned in whole or in part by the same

company within an HRR for a

Subsidiary ESRD facility. As discussed

previously in this final rule rule, CMS

is finalizing its proposal to use PECOS

to verify the correct zip code of the

ESRD facility location for purposes of

selecting ESRD facilities for

participation in the Model. However,

CMS received public comments

regarding our proposed aggregation

policy suggesting that CMS use

resources in addition to PECOS to

correctly identify ESRD facilities.

Subsequent CMS analyses also found

rare instances of typographical errors for

facility information in PECOS. In

response, we are modifying our policy

in this final rule such that Subsidiary

ESRD facilities will be identified using

the Chain TIN and Chain Name from

PECOS and that CMS will use other

CMS data sources, including

CrownWEB, to identify and correct any

mismatches arising from typographical

errors in those fields in PECOS. CMS

may notify ESRD facilities of their status

as a Subsidiary ESRD Facility and, if

applicable, the other Subsidiary ESRD

Facilities with which CMS has

identified a common ownership

relationship during the MY to allow

ESRD facilities the opportunity to

confirm and provide feedback before

CMS calculates the PPA for that MY. We

are also modifying our aggregation

approach for ESRD facilities that are not

Subsidiary ESRD facilities, such that

these ESRD facilities will not be

aggregated with other facilities located

within the HRR in which the facility is

located or otherwise. We are also

finalizing the Taxpayer Identification

Number (TIN), National Provider

Identifier (NPI), and Subsidiary ESRD

facility definitions, as proposed, in our

regulation at § 512.310.

d. Benchmarking and Scoring

We proposed calculating two types of

benchmarks for rates of home dialysis

and transplants against which to assess

ETC Participant performance in MY1

and MY2 (both of which would begin in

CY 2020). Under our proposal, risk-

adjusted and reliability-adjusted ETC

Participant performance for the home

dialysis rate and the transplant rate

would be assessed against these

benchmarks on both achievement and

improvement at the ETC Participant

level.

The first set of benchmarks would be

used in calculating an achievement

score for the ETC Participant on both

the home dialysis rate and the

transplant rate. This set of benchmarks

would be constructed based on

historical rates of home dialysis and

transplants in Comparison Geographic

Areas. We proposed constructing the

benchmarks using 12 months of data,

beginning 18 months before the start of

the MY and ending 6 months before the

start of the MY, to allow time for claims

run-out and calculation. We proposed to

refer to this period of time as the

‘‘benchmark year.’’ We proposed using

data from ESRD facilities and Managing

Clinicians located in Comparison

Geographic Areas to construct these

benchmarks. In the proposed rule, we

alternatively considered using national

performance rates to construct these

benchmarks. However, in order to

prevent the impact of the model

intervention altering benchmarks for

subsequent MYs, we decided against

this alternative in the proposed rule. We

proposed to calculate the home dialysis

rate and transplant rate benchmarks for

ESRD facilities and Managing Clinicians

located in Comparison Geographic

Areas during the Benchmark Year using

the same methodologies that we use to

calculate the home dialysis rate and

transplant rate for ESRD facilities and

Managing Clinicians located in Selected

Geographic Areas during the MYs. We

stated our intent to establish the

benchmarking methodology for future

MYs through subsequent rulemaking.

As stated in the proposed rule, our

intent in future MYs is to increase

achievement benchmarks among ETC

Participants above the rates observed in

Comparison Geographic Areas. By MY9

and MY10, in order to receive the

maximum achievement score, as noted

in the proposed rule, we were

considering that an ETC Participant

would have to have a combined home

dialysis rate and transplant rate

equivalent to 80 percent of attributed

beneficiaries dialyzing at home and/or

having received a transplant. We sought

public comment on our intent to

increase achievement benchmarks over

the duration of the Model.

The second set of benchmarks would

be used in calculating an improvement

score for the ETC Participant on both

the home dialysis rate and the

transplant rate. This set of benchmarks

would be constructed based on

historical rates of home dialysis and

transplants by the ETC Participant

during the Benchmark Year. We

proposed to calculate the improvement

score by comparing MY performance on

the home dialysis rate and transplant

rate against past ETC Participant

performance to acknowledge efforts

made in practice transformation to

improve rates of home dialysis and

transplants. However, we proposed that

an ETC Participant could not attain the

highest scoring level through

improvement scoring. Specifically,

while an ETC Participant could earn an

achievement score of up to 2 points for

the transplant rate and the home

dialysis rate, the maximum possible

improvement score is 1.5 points for each

of the rates. We explained that this

policy would be consistent with other

CMS programs and initiatives

employing similar improvement scoring

methodologies, including the CEC

Model.

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In the proposed rule, we considered

not including improvement scoring for

the first two MYs, as this would mean

assessing improvement in the MY

against ETC Participant performance

before the ETC Model would begin.

However, as noted in the proposed rule,

we believe that including improvement

scoring for the first two MYs is

appropriate, as it acknowledges

performance improvement gains while

participating in the ETC Model. We

sought input on the use of improvement

scoring in assessing ETC Participant

performance for the first two MYs. Table

13 details the proposed scoring

methodology for assessment of MY1 and

MY2 achievement scores and

improvement scores on the home

dialysis rate and transplant rate.

Under our proposal, the ETC

Participant would receive the higher of

the achievement score or improvement

score for the home dialysis rate and the

higher of the achievement score or

improvement score for the transplant

rate, which would be combined to

produce the ETC Participant’s Modality

Performance Score (MPS). We proposed

the following formula for determining

the MPS:

MPS = 2 × (The higher of the home

dialysis rate achievement or

improvement score) + (The higher

of the transplant rate achievement

or improvement score)

We proposed that the home dialysis

rate score would constitute two thirds of

the MPS, and that the transplant rate

score would constitute one third of the

MPS. In the proposed rule, we

considered making the home dialysis

rate score and the transplant rate score

equal components of the MPS, to

emphasize the importance of both home

dialysis and transplants as alternative

renal replacement therapy modalities.

However, we recognized that transplant

rates may be more difficult for ETC

Participants to improve than home

dialysis rates, due to the limited supply

of organs and the number of other

providers and suppliers that are part of

the transplant process but are not

included as participants in the ETC

Model. For this reason, we proposed

that the home dialysis rate component

take a greater weight than the transplant

rate component of the MPS.

The following is a summary of the

comments received on the proposed

benchmarking and scoring methodology

and our responses.

Comment: Several commenters

opposed our proposal to use a

comparative or percentile based

methodology for purposes of calculating

the achievement benchmarks.

According to some of these commenters,

this comparative approach would not

accurately reflect ETC Participant

performance or the care being provided.

Some of these commenters stated that

this comparative approach serves only

as a way for CMS to ensure Model

savings, as some ETC Participants’

performance would fall below the

achievement benchmarks, resulting in a

negative payment adjustment. A

commenter opined that the percentile

based achievement scoring approach

would not be operational at the ESRD

facility level because, based on the

commenter’s analysis, there would be

no differentiation in home dialysis rates

for the three lowest scoring groups. This

comment was cited by several other

commenters.

Response: We disagree that using a

comparative approach for calculating

achievement benchmarks, percentile-

based or otherwise, does not reflect ETC

Participant performance or the care

being provided. On the contrary,

comparative benchmarks reflect the

performance of the ETC Participant

relative to their peers. We also disagree

that a comparative approach serves only

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as a way to ensure Model savings for

two reasons. First, because achievement

benchmarks are constructed based on

performance of those not selected for

participation in the Model, it is possible

that many ETC Participants will meet or

exceed the level of performance

necessary to not receive a negative

adjustment through achievement

scoring alone. Second, the use of

improvement scoring alongside

achievement scoring means that ETC

Participants can avoid negative payment

adjustments through improvement

alone, regardless of their performance in

relation to the achievement benchmarks.

We disagree with the commenter’s

analysis suggesting that there would be

no differentiation between the lowest

three benchmark groups if home

dialysis rates were assessed at the ESRD

facility level based on our analyses of

claims data conducted in the

development of this final rule.

Specifically, our analyses indicated that

after the application of the aggregation

group methodology to the performance

of ESRD facilities located in Selected

Geographic Areas, there is

differentiation in the home dialysis rates

among ESRD facilities at or below the

50th percentile of benchmark rates for

Comparison Geographic Areas, which

corresponds with the lowest three

groups used for purposes of assessing an

ESRD facility’s achievement score. We

also note that, as proposed, we will

calculate the benchmarks for the home

dialysis rate and the transplant rate for

ESRD facilities and Managing Clinicians

located in Comparison Geographic

Areas during the Benchmark Year using

the same methodologies that we use to

calculate the home dialysis rate and

transplant rates for ESRD facilities and

Managing Clinicians located in Selected

Geographic Areas during the MYs.

Accordingly, we will be aggregating

Subsidiary ESRD facilities with all

ESRD facilities owned in whole or in

part by the same dialysis organization

located in the same HRR when

constructing the benchmarks, as

described in section IV.C.5.c.(4) of this

final rule.

Comment: A commenter supported

our proposal to use Comparison

Geographic Areas to create achievement

benchmarks, and concurred with CMS’s

decision not to use national

performance rates to construct these

benchmarks because the model design

adequately controls for any spillover

effects due to the national nature of the

dialysis market.

Response: We appreciate the feedback

and support from the commenter and

agree that the model design adequately

controls for any spillover effects due to

the national nature of the dialysis

market.

Comment: Several commenters

opposed the construction of

achievement benchmarks based on rates

in Comparison Geographic Areas, for

the following reasons. First, several of

these commenters pointed out that, due

to the national nature of the dialysis

market, dialysis companies operating

nationally may implement practices that

improve rates nationwide, not just in

Selected Geographic Areas, so

achievement benchmarks based on rates

in Comparison Geographic Areas would

not remain constant over time. Second,

one of these commenters stated that

basing achievement benchmarks on

Comparison Geographic Areas when

dialysis organizations have ESRD

facilities in both Selected Geographic

Areas and Comparison Geographic

Areas creates an incentive for those

dialysis organizations to lower rates of

home dialysis and transplants in

Comparison Geographic Areas to

improve the performance of their

locations that are ETC Participants.

A commenter recommended that CMS

monitor the rates of home dialysis and

transplants between Selected

Geographic Areas and Comparison

Geographic Areas to determine whether

the Model is resulting in unintended

consequences—including market

consolidation, manipulation of

achievement benchmarks, declining

rates of home dialysis or transplant in

Comparison Geographic Areas, or

adverse patient outcomes—due to the

distribution of LDOs in both Selected

Geographic Areas and Comparison

Geographic Areas. A commenter

recommended that the use of

Comparison Geographic Areas for

achievement benchmarks be contingent

on achieving statistical balance on

certain covariates that may impact rates

of home dialysis and transplantation

between Selected Geographic Areas and

Comparison Geographic Areas, to avoid

making inappropriate comparisons

between the two.

Response: We anticipate that rates for

home dialysis, transplant waitlisting,

and living donor transplants will change

in Selected Geographic Areas, and may

change in Comparison Geographic

Areas, over the course of the Model. As

stated in the proposed rule and in

section IV.C.5.d of this final rule, we

intend to establish a different method

for establishing achievement

benchmarks for future years of the

Model through subsequent rulemaking.

We expect that this method would not

be based solely based on rates in

Comparison Geographic Areas, and

would be designed to incentivize

improved performance in Selected

Geographic Areas. We believe that this

approach would mitigate concerns that

dialysis organizations operating ESRD

facilities in both Selected Geographic

Areas and Comparison Geographic

Areas may exert influence on

achievement benchmarks by altering the

provision of home dialysis or transplant

services in Comparison Geographic

Areas. As described in section IV.C.10

of this final rule, we intend to monitor

for unintended consequences, such as

those enumerated by commenters, and

to make adjustments to the Model

through subsequent rulemaking should

such unintended consequences arise.

We appreciate the suggestion that we

check for balance on certain covariates

that may impact rates of home dialysis

and transplantation between Selected

Geographic Areas and Comparison

Geographic Areas. However, we believe

that our policy of establishing Selected

Geographic Areas by stratified

randomization of a sufficiently large

number of HRRs adequately accounts

for underlying variation.

Comment: A commenter

recommended calculating achievement

benchmarks separately for each Selected

Geographic Area, or including a

geographic adjustment factor in the

achievement benchmark calculation, to

account for regional variation in rates. A

commenter recommended that CMS

create achievement benchmarks for each

Selected Geographic Area for the

transplant rate, to account for historical

variation in the availability of organs

and rates of transplantation across the

country. Another commenter opined

that achievement benchmarks for home

dialysis rates should not be the same

nationally because there may be

underlying factors that vary across the

country that impact patient preference

for home dialysis. A commenter

opposed constructing benchmarks

specific to each Selected Geographic

Area, opining that this would be overly

complicated.

Response: We appreciate the

commenters’ recommendations that we

calculate more regionally specific

achievement benchmarks. However, we

agree with the commenter that stated

that calculating achievement

benchmarks specific to each Selected

Geographic Area would be overly

complicated, and we also believe that

this approach would perpetuate regional

differences in home dialysis and

transplant rates that are not beneficial

for beneficiaries. Accordingly, we are

finalizing our proposal to establish a

single achievement benchmark for each

MY based on rates of home dialysis,

transplant waitlisting, and living donor

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transplants in the Comparison

Geographic Areas.

Comment: A commenter stated that

any changes to the organ allocation

system, such as those under

consideration by the Organ Procurement

and Transplant Network (OPTN), may

make achievement benchmarks for

transplant rates based on historical

performance in Comparison Geographic

Areas an inappropriate comparison for

purposes of assessing current transplant

rates due to intervening changes in

organ availability by region.

Response: We appreciate the feedback

from this commenter. As described in

section IV.C.5.c.(2) of this rule, we are

modifying the transplant rate used to

assess ETC Participant performance

such that it no longer includes deceased

donor transplants. As such, we do not

believe that changes to the organ

allocation system will impact

performance benchmark construction,

as these changes do not directly impact

transplant waitlisting or living donation.

Additionally, as discussed in the

proposed rule and previously in this

final rule, we intend to make changes to

the achievement benchmarking

approach for future MYs through

subsequent rulemaking, including to set

benchmarks that are not dependent on

historical rates of transplants in

Comparison Geographic Areas. We will

take this comment into consideration as

we consider any such future changes, to

ensure that any changes in the organ

allocation system will not

disproportionately impact the

achievement benchmarks used in future

MYs.

Comment: A commenter

recommended that CMS establish

achievement benchmarks that are not

based on Comparison Geographic Areas.

Response: We appreciate the input

from the commenter. We continue to

believe that using Comparison

Geographic Areas to establish

achievement benchmarks for the initial

years of the Model is appropriate.

However, we will consider this input

about establishing achievement

benchmarks that are not based on

Comparison Geographic Areas if we

make changes to the achievement

benchmarking methodology for future

years of the Model through subsequent

rulemaking.

Comment: Several commenters

opposed our stated intent to increase

achievement benchmarks for future MYs

through subsequent rulemaking. Some

commenters opined that this approach

lacks transparency, unfairly penalizes

ETC Participants by changing the target

over time, and undermines ETC

Participant success in the Model.

Several commenters expressed concern

that CMS would adjust the

benchmarking methodology for future

MYs to achieve Model savings rather

than to accurately reflect ETC

Participant performance and incentivize

ETC Participants to achieve the Model’s

goals of improving or maintaining

quality and reducing costs by increasing

rates of home dialysis and

transplantation. Several commenters

recommended that CMS maintain the

benchmarking methodology proposed

for MY1 and MY2 for the duration of the

Model. Several commenters stated that

CMS should establish the benchmarking

methodology for all MYs before the

Model begins to give ETC Participants

the opportunity to plan accordingly.

Response: We appreciate the

commenters’ concerns about the need

for transparency and for ETC

Participants to be successful in the

Model. However, we believe that our

approach would be transparent, as any

changes to the achievement

benchmarking methodology for

subsequent MYs would be established

through notice and comment

rulemaking. While we do not intend to

maintain the benchmarking

methodology we are finalizing now

through the duration of the Model, as

we expect that this methodology would

not provide a sufficient incentive for

ETC Participants to raise home dialysis

and transplant rates at a rate faster than

would occur absent the Model, we do

acknowledge that finalizing our

proposal to apply this methodology only

for MY1 and MY2 would create some

uncertainty about the benchmarking

methodology for MYs immediately

following MY2. For this reason, we are

specifying that we will continue to use

the achievement benchmarking

methodology we proposed and are

finalizing for MY1 and MY2 for future

MYs if subsequent rulemaking cannot

be completed with sufficient notice in

advance of those MYs.

Comment: Several commenters

expressed support for setting ambitious

goals for home dialysis and transplant

rates, and stated that higher rates of

home dialysis and transplantation are

achievable. A commenter who

expressed such support recommended

lowering our goal for future MYs from

a combined home dialysis rate and

transplant rate equivalent to 80 percent

of attributed beneficiaries dialyzing at

home and/or having received a

transplant to 50 percent, which they

suggested was still ambitious but more

attainable for ETC Participants. Another

commenter recommended that our goal

for future MYs should be reduced to a

more attainable level in consultation

with the kidney community.

Response: We appreciate this

feedback from the commenters and the

support for setting ambitious goals.

While we did not codify these goals in

the final rule, we anticipate that we will

codify more ambitious achievement

goals in subsequent rulemaking. We

appreciate the commenter’s concern

about setting the achievement goal at 80

percent, as well as the suggestion of

using 50 percent as the goal. We will

take these comments into consideration

as we consider any future changes to the

achievement benchmark methodology.

Comment: Multiple commenters

expressed opposition to the goal of

having 80 percent of attributed

beneficiaries dialyzing at home and/or

receiving a kidney or kidney-pancreas

transplant. Commenters stated that there

is not empirical or clinical evidence that

the 80 percent goal is achievable or

desirable in the U.S., or within the

timeframe of the Model. Several

commenters stated that this goal would

lead to inappropriate pressure on

beneficiaries to select home dialysis,

when home dialysis may not be their

preferred form of renal replacement

therapy. A commenter stated that this

goal would ensure that ETC Participants

are not successful in future MYs. A

commenter pointed out that the

Regulatory Impact Analysis for the

proposed ETC Model projected a

conservative growth rate in home

dialysis and no growth in

transplantation, which contradicts the

80 percent goal. A commenter pointed

out that without significant increases in

organ availability, it would not be

possible for ETC Participants to achieve

increases in the transplant rate over the

duration of the Model necessary to

achieve the 80 percent goal. A

commenter stated that CMS should raise

achievement benchmarks over the

duration of the Model at a rate that is

reasonable in relation to historic

performance.

Response: We clarify that, as

described in the proposed rule, the 80

percent goal would be the target for

receiving the highest payment

adjustment in the final MYs of the

Model. However, any changes to the

achievement benchmark methodologies

for the later MYs of the Model would be

made through subsequent rulemaking.

We appreciate this feedback from

commenters about the feasibility of the

goal we are considering for MY9 and

MY10 and will take these comments

into consideration as we consider any

future changes to the achievement

benchmark methodology.

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Comment: A commenter stated that

CMS should propose all benchmarks

through notice and comment

rulemaking. A commenter suggested

that the achievement benchmarks not be

communicated to ETC Participants in

advance of the MY to which they apply,

in order to avoid a ‘‘performance floor’’

effect in which ETC Participants aim to

meet only the minimum necessary

performance.

Response: We proposed the

achievement benchmark methodology

for the initial MYs of the Model in the

proposed rule, which we are finalizing

with modification in this final rule, and

will establish any changes to these

benchmarking methodologies through

notice and comment rulemaking.

However, in order to provide

achievement benchmarks for each MY

that reflect changing rates of home

dialysis and transplant in a timely

manner, we do not intend to propose

the benchmarks themselves through

rulemaking. Rather, we will use the

methodologies finalized through

rulemaking to calculate the applicable

achievement benchmark in advance of

each MY. We do not believe that it

would be fair to ETC Participants not to

announce achievement benchmarks in

advance of the period to which those

benchmarks apply and therefore decline

to adopt the commenter’s suggestion

that benchmarks should not be

communicated to participants in

advance of the MY.

Comment: A commenter stated that

CMS should consider geographic and

socioeconomic factors that impact home

dialysis and transplant rates when

establishing achievement benchmarks.

Response: We appreciate the feedback

from the commenter, and recognize that

there is variation in rates of home

dialysis and transplantation by region

and by socioeconomic status. Were we

to make adjustments to account for

these factors, we would do so in the risk

adjustment methodology for the home

dialysis rate and transplant rate, rather

than by adjusting the achievement

benchmarks for each ETC Participant

such that we would be able to provide

one set of general achievement

benchmarks rather than achievement

benchmarks specific to particular

regions or populations. In section

IV.C.5.c.(3) of this final rule, we discuss

the risk adjustment methodology for the

ETC Model.

Comment: Several commenters

supported the proposed inclusion of

improvement scoring, but opposed our

proposal that ETC Participants cannot

obtain full points on the basis of

improvement scoring. Several

commenters stated that it would be

inappropriate to limit ETC Participants’

ability to achieve the highest score

based on improvement scoring,

particularly because the proposed

achievement benchmarks would not

account for regional variation in home

dialysis rates and transplant rates. A

commenter pointed out that ETC

Participants that improve significantly

on the home dialysis rate may

nonetheless not receive an upward

payment adjustment if their home

dialysis rates are below the 50th

percentile achievement benchmark or

their transplant rates are not above the

50th percentile achievement

benchmark. Several commenters

recommended changing the

improvement scoring methodology to

provide greater recognition of

improvement over time. In particular,

commenters recommended that

improvement greater than 10 percent be

awarded two points.

Response: We appreciate the feedback

from these commenters, and

acknowledge the importance of

incentivizing improvement over time.

However, as stated in the proposed rule

and previously in this final rule, we

proposed not to award full points for

improvement for consistency with other

CMS programs and initiatives

employing similar improvement scoring

methodologies. The ETC Model is

designed to focus on outcomes. While

improvement is laudable and deserving

of recognition through improvement

scoring, awarding maximum points for

improvement scoring is inconsistent

with the Model’s focus. As such, we

will award full points for achievement

scoring only.

Comment: A commenter raised

concerns that the proposed construction

of the MPS places greater weight on

home dialysis rates, and therefore gives

ETC Participants a greater incentive to

improve rates of home dialysis than

transplantation rates, when the goal of

the Model should be to ensure that all

appropriate ESRD Beneficiaries receive

transplants. A commenter stated that the

proposed approach for weighting home

dialysis rates and transplant rates in

calculating the MPS penalizes small

ESRD facilities that cannot develop and

maintain home dialysis programs. A

commenter stated that, given how little

control ESRD facilities have over who

receives a kidney transplant, the

inclusion of the transplant rate as one

third of the MPS does not accurately

reflect dialysis provider efforts or

performance.

Response: We appreciate the feedback

from commenters on the relative

weights of the home dialysis portion

and the transplant portion of the MPS.

We disagree that the goal of the Model

should be to ensure that all appropriate

ESRD Beneficiaries receive transplants,

as the stated goal is to maintain or

improve quality and reduce Medicare

expenditures through increased rates of

home dialysis and transplants. As we

stated in the proposed rule, we

considered making the home dialysis

rate score and the transplant rate score

equal components of the MPS, to

emphasize the importance of both home

dialysis and transplants as alternative

renal replacement therapy modalities.

However, we recognized that transplant

rates may be more difficult for ETC

Participants to improve than home

dialysis rates, due to the limited supply

of organs and the number of other

providers and suppliers that are part of

the transplant process. The transplant

portion of the MPS is now based on

performance on the transplant rate

calculated as the sum of the transplant

waitlist rate and the living donor

transplant rate, as described in sections

IV.C.5 and IV.C.5.c.(2) of this final rule,

which addresses the commenter’s

concern that the transplant rate does not

accurately reflect ESRD facility

performance due to factors outside of

their control, given that the main

limiting factor is the availability of

deceased donor organs. Despite this

change to the transplant portion of the

MPS, we continue to believe that the

transplant waitlist and living donor

processes involve similar challenges for

ETC Participants as the transplant

process overall, including the number of

other providers and suppliers that are

part of the transplant process. Therefore,

we continue to believe that it is

appropriate that the home dialysis rate

constitute two thirds of the MPS and

that the transplant rate constitute one

third of the MPS.

Comment: Several commenters

recommended that CMS use the

benchmarking and scoring methodology

used by the ESRD QIP for purposes of

the MPS calculation. These commenters

stated that ESRD facilities are familiar

with these methodologies, and that

using them in this Model would make

the two initiatives more consistent with

each other. A commenter recommended

that CMS adapt the quality

benchmarking and scoring methodology

used by the CEC Model for purposes of

the MPS calculation under the Model.

Response: While we acknowledge that

ESRD facilities are familiar with the

ESRD QIP benchmarking and scoring

methodologies, we do not believe these

methodologies are well suited to this

Model. The ETC Model is designed to

test the ability of the Model’s payment

adjustments to improve or maintain

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quality while reducing costs through

increased rates of home dialysis and

transplantation. The benchmarking

methodology for the ETC Model must be

designed with this goal in mind. While

the ESRD QIP performance standard

setting methodology substitutes

performance standards from previous

years if those performance standards are

higher than the performance standards

that would otherwise apply, it does not

ensure escalating performance standards

over time. Rather, the ESRD QIP

performance standard setting

methodology ensures that performance

standards do not decrease over time. As

stated in the proposed rule and

elsewhere in this final rule, we may

consider increasing the achievement

benchmarks used under this Model for

future MYs. Any such changes would be

made through future rulemaking. While

we may consider increasing the

performance standards, we do not

intend to adopt a policy to specifically

prevent that achievement benchmarks

do not decrease. Additionally, Managing

Clinicians are not subject to the ESRD

QIP, and therefore may not be familiar

with the ESRD QIP methodology. We

believe it is important to maintain

consistency within the ETC Model for

the two types of ETC Participants—

namely ESRD facilities and Managing

Clinicians. We point out that we are

using the same benchmarking and

scoring methodology as the one used by

the CEC Model for scoring quality

performance.

After considering public comments,

we are finalizing our proposed

provisions on the benchmarking and

scoring methodology in our regulation

at § 512.370(a), with modification.

Specifically, while we proposed to

apply our proposed achievement

benchmark policy only for MY1 and

MY2, in response to public comments,

we will apply the achievement

benchmarking methodology we are

finalizing in this final rule for MY1

(January 1, 2021 to December 31, 2021)

and MY2 (July 1, 2021 to June 30, 2022),

and for subsequent MYs, if not first

modified by subsequent rulemaking. We

are also finalizing our proposal to define

the ‘‘Benchmark Year’’ as the 12-month

period of data that begins 18 months

prior to the start of a given MY from

which data is used to construct

benchmarks against which to score an

ETC Participants achievement and

improvement on the home dialysis rate

and transplant rate for the purpose of

calculating the ETC Participant’s MPS

in our regulation at § 512.310. In

addition, we are making a technical

change to capitalize the term

‘‘Benchmark Year’’ in the final rule.

e. Performance Payment Adjustments

We proposed that CMS would make

upward and downward adjustments to

payments for claims for dialysis and

dialysis-related services, described in

the proposed rule and in section

IV.C.5.e of this final rule, submitted by

each ETC Participant with a claim

through date during the applicable PPA

period based on the ETC Participant’s

PPA. We proposed that the magnitude

of the potential positive and negative

payment adjustments would increase

over the PPA Periods of the ETC Model.

The magnitude of the PPAs were

designed to be comparable to the MIPS

payment adjustment factors for MIPS

eligible clinicians, as described in the

proposed rule and in sections

IV.C.5.e.(1) and IV.C.5.e.(2) of this final

rule. Specifically, the PPAs were

designed to be substantial enough to

incentivize appropriate behavior

without overly harming ETC

Participants through reduced payments.

The payment adjustments proposed for

the ETC Model would start at the same

5 percent level in 2020 as the MIPS

payment adjustment at 42 CFR

414.1405(c). As discussed in the

proposed rule, the PPAs proposed for

the ETC Model were also designed to

increase over time and to be

asymmetrical—with larger negative

adjustments than positive adjustments—

in order to create stronger financial

incentives.

As we noted in the proposed rule,

CMS believes that downside risk is a

critical component of this Model in

order to create strong incentives for

behavioral change among ETC

Participants. We proposed that the

negative adjustments would be greater

for ESRD facilities than for Managing

Clinicians, in recognition of the ESRD

facilities’ larger size and ability to bear

downside financial risk relative to

individual clinicians. As noted in the

proposed rule, we believe that the

exclusion of ESRD facilities that fall

below the low-volume threshold

described in the proposed rule and in

section IV.C.5.f.(1) of this final rule

would ensure that only those ESRD

facilities with the financial capacity to

bear downside risk would be subject to

application of the Facility PPA.

The following is a summary of the

comments received on the proposed

PPA and our responses.

Comment: A commenter expressed

support for our proposal to subject

Managing Clinicians to less downside

risk than ESRD facilities. A commenter

recommended that CMS not apply a

negative PPA to ESRD facility home

dialysis treatments, even if an ESRD

facility earns a negative PPA. The same

commenter recommended that CMS

remove negative payment adjustments

from the Model altogether, and instead

create upside financial incentives for

the more than 50 percent of ESRD

facilities that currently do not offer

home dialysis. Another commenter

recommended that CMS apply any

negative PPA amount only to in-center

treatment payments, and not to home

dialysis treatment or home training

payments.

Response: We thank the commenters

for their feedback. CMS believes that

negatively adjusting home dialysis

claims is appropriate when an ETC

Participant earns a negative PPA, just as

CMS believes it is appropriate to

positively adjust home dialysis claims

when an ETC Participant earns a

positive PPA. As discussed in the

proposed rule, the PPA is designed to be

substantial enough to provide an

incentive robust enough to spur positive

behavior change without overly harming

ETC Participants through reduced

payments.

CMS disagrees that eliminating the

negative payment adjustment or

subjecting ESRD facilities that currently

do not furnish home dialysis to upside

financial incentives only would be

appropriate given the goals of the

Model. Specifically, CMS intends for

the ETC Model to both encourage ESRD

facilities who do not currently offer

home dialysis to establish home dialysis

programs, and for ESRD facilities who

currently do offer home dialysis to

increase the provision of these services.

The proposed PPA accomplishes this

goal by holding all ESRD facilities

accountable for their rates of home

dialysis, which CMS believes provides a

powerful incentive to establish

successful home dialysis programs. We

further believe that imposing the HDPA

only, or a similar upside financial

incentive, to ESRD facilities that do not

currently provide home dialysis would

not provide a strong enough incentive to

create the behavior change CMS seeks in

implementing this Model.

In addition, CMS believes that

negatively adjusting claims for in-center

dialysis only would not produce a

sufficient incentive to encourage the

behavior change that the Model is

designed to produce.

Comment: Many commenters

expressed concerns about our proposal

to apply significant downside risk for

MY1, reasoning that ETC Participants

would not have sufficient time to build

out a clinical model and the necessary

infrastructure to establish or build upon

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a home dialysis program before being

subject to downside financial risk for

their rates of home dialysis. Several

commenters recommended that CMS

delay implementing the PPA for one

year. Other commenters recommended

that CMS delay implementing the PPA

for two years. Those commenters

recommending that the PPA be delayed

asserted that such a change would allow

more time for ETC Participants to

receive positive adjustments from the

HDPA and ensure that ETC Participants

would have access to performance data

before being subjected to downside risk.

Other commenters asserted that

delaying the implementation of the PPA

would better allow ETC Participants to

build infrastructure, gather necessary

resources and equipment, and spread

out the potential for financial losses,

without risking closure of ESRD

facilities and possibly limiting patients’

access to care, particularly in urban and

rural areas where ESRD facility margins

are low and housing instability rates are

high. Some commenters recommended

that CMS delay implementing downside

risk related to transplant until CMS can

learn from the many comments

submitted in response to the request for

information in the CY 2020 Hospital

Outpatient Prospective Payment System

proposed rule (84 FR 39398) related to

OPOs and transplant centers (84 FR

39597).

Response: CMS believes that applying

downside financial risk via the PPA, as

proposed, is more appropriate than the

alternatives suggested by the

commenters. CMS believes it is

important to apply downside risk at the

beginning of the Model to create strong

incentives for behavior change. As

described in the proposed rule and

earlier in this final rule, CMS carefully

considered the timeline for applying the

HDPA and the PPA, and CMS continues

to believe that the proposed schedules

of each optimally balances the timing

and magnitude of the process-based

incentive, the HDPA, with the outcome-

based incentive, the PPA. Further, the

PPA starts at its lowest point while the

HDPA starts at its highest point, which

gives ETC Participants the time to build

out their clinical models and necessary

infrastructure to establish or build upon

their home dialysis programs. While

CMS understands the commenters’ view

that delays in the application of the PPA

would allow ETC Participants more

time to take all steps necessary to

increase provision of home dialysis,

CMS intends for the ETC Model to

incent behavior change, and CMS

continues to believe that the proposed

PPA and HDPA schedule best

accomplishes that goal.

Regarding the comments that CMS

can learn from the comments submitted

in response to the request for

information in the CY 2020 Hospital

Outpatient Prospective Payment System

proposed rule (84 FR 39398) related to

OPOs and transplant centers (84 FR

39597), CMS will not change the PPA

policy in this final rule based on those

comments, but those comments may

inform future policy changes under the

Model.

Comment: A commenter that

supported a delay in implementing

downside financial risk under the

Model recommended that CMS

implement a transplant bonus to

incentivize ETC Participants and other

stakeholders to implement new

programs and processes needed to

support transplant rate growth.

Response: CMS disagrees with the

recommendation to implement a

transplant bonus in the ETC Model.

CMS believes that the PPA sufficiently

rewards high performing ETC

Participants for successfully increasing

their transplant waitlisting rate and

living donor transplant rate, which may

ultimately result in higher rates of

kidney transplants. Further, ETC

Participants may simultaneously

participate in the KCC Model, which

includes a kidney transplant bonus

payment. It is likely that at least some

ETC Participants will also participate in

the KCC Model, such that implementing

a kidney transplant bonus payment

under the ETC Model would present the

risk of ‘‘double paying’’ ETC

Participants for successful transplants.

In addition, using distinct payment

methodologies in the KCC Model, which

has a kidney transplant bonus payment,

and the ETC Model, which does not,

will better allow CMS to determine the

effectiveness of a transplant bonus in

incentivizing support and care for

beneficiaries through the kidney

transplant process, including after

transplantation, as CMS will be able to

test the effects of different payment

methodologies under the two models as

well as the effects of overlapping

incentives.

Comment: A commenter expressed

support for the ETC Model’s two-sided

risk structure. Another commenter

expressed general support for both the

Clinician PPA and Facility PPA.

Response: We appreciate the feedback

and support from the commenters.

Comment: Several commenters

expressed concern that the PPA could

have unintended consequences,

including ESRD facility closure,

reduced patient choice, reduced quality

of care for beneficiaries, and/or

beneficiaries who receive in-center

dialysis being required to travel longer

distances to receive treatment. Some of

these commenters articulated specific

reasons why they expected the PPA

would result in such unintended

consequences, such as smaller entities

needing to expend substantial capital to

prepare for the Model, hire nephrology

nurses, build or expand training space,

and increase administrative capabilities.

A few of these commenters expressed

concern that the PPA could lead to

facility closures for small, independent,

and/or rural ESRD facilities, which the

commenters suggested are less able than

LDOs to absorb financial losses that may

result from the application of the PPA.

A commenter expressed concern that

the PPA would destabilize the Medicare

ESRD benefit, which the commenter

asserted is already underfunded. Some

commenters expressed concern that

potential for downside risk due to the

application of the PPA would

incentivize ETC Participants to push

ESRD Beneficiaries to home dialysis

modalities even when it is not clinically

or socially appropriate. One such

commenter identified housing

insecurity and social isolation as social

factors that may make a beneficiary ill-

suited for home dialysis, and

recommended that CMS consider social

and clinical factors in determining the

magnitude of an ESRD facility’s PPA.

Response: CMS disagrees with the

comments expressing concern that the

PPA will cause ESRD facility closure,

reduce patient choice, reduce quality of

care, and/or force ESRD Beneficiaries to

travel longer distances to receive

treatment. The Model aims to increase

choice by addressing a notable lack of

home dialysis provision, and thus

increase ESRD Beneficiary choice

among renal replacement modalities

and, in many cases, eliminate the

commutes ESRD Beneficiaries must

currently make to receive treatment in

center. CMS also disagrees with

comments expressing concern that the

PPA will especially harm small,

independent, and/or rural ESRD

facilities, as opposed to LDOs, since the

PPA uses percentages rather than

absolute figures in making its

adjustments. While LDOs are larger and,

as a result, may be better able to absorb

financial losses, an LDO and a non-LDO

who perform equally poorly will face

proportionate reductions in Medicare

reimbursement under the Model, and

vice versa. Moreover, even if the

proposed PPA would have the

unintended consequences cited by

commenters, as discussed later in this

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final rule, CMS is finalizing a reduction

in the magnitude of the Clinician PPA

and Facility PPA in response to the

comments received. CMS also disagrees

that the proposed PPA would incent

ETC Participants to push ESRD

Beneficiaries into clinically or socially

inappropriate modalities. CMS believes

that ESRD facilities and Managing

Clinicians alike will continue to act in

their patients’ best interest, and will

respond to the Model’s financial

incentives, including the PPA, with

positive behavior change and creativity

in appropriately increasing beneficiary

access to home dialysis while being

mindful of social issues, such as social

isolation.

Comment: A few commenters

expressed concern that the proposed

PPA appeared to be designed to reduce

Medicare payments to ESRD facilities

and Managing Clinicians over the

duration of the Model. One such

commenter expressed opposition to

using the ETC Model to cut Medicare

payments, reasoning that ETC

Participants would need to make

increased investments to achieve the

delivery system reform that CMS

envisions, which would be more

difficult with less money. A few

commenters recommended that CMS

proceed with a budget-neutral or

budget-saving model. One such

commenter recommended that a budget-

neutral or budget-saving model could

provide positive incentives and

resources for ESRD facilities to increase

their provision of home dialysis and

transplant-related services, while

reducing the total cost of care to

Medicare in the long run by generating

savings through improved care quality.

Other commenters recommended that

CMS eliminate the downside risk in the

proposed PPA and provide only bonus

payments. A few commenters expressed

concern that the proposed PPA was set

arbitrarily or without a rationale for its

magnitude, and/or that CMS failed to

provide an articulated and substantial

defense of the magnitude of the PPA

under the Model. One such commenter

characterized the PPA as reducing

Medicare payments to ESRD facilities

and Managing Clinicians every year,

even if those ESRD facilities and

Managing Clinicians improve their

performance.

Response: Congress established the

Innovation Center to design and test

innovative payment and service

delivery models, like this ETC Model,

that are expected to reduce Medicare

expenditures while preserving or

enhancing the quality of care. While

CMS understands the commenters’

concerns that moving toward more

home dialysis therapy may require

investments on the part of ETC

Participants, the Model provides higher

payments to those ETC Participants who

produce results. Regarding the

commenters’ suggestion that CMS

proceed with a budget-neutral or

budget-saving model, CMS expects the

ETC Model will be a budget-saving

model. Specifically, CMS anticipates

that the Model will reduce Medicare

expenditures, and will likely generate

long-term cost savings by reducing the

total costs of care, just as the commenter

suggested. Regarding the rationale for

the magnitude of the PPAs, CMS

proposed the magnitude of the Facility

PPA and Clinician PPA after careful

consideration, hoping to provide a

robust incentive to drive significant

behavior change among ETC

Participants without causing harm to

beneficiaries. As described later in this

final rule, CMS is reducing the

magnitude of the PPAs in response to

comments received, which should

lessen the concerns expressed by

commenters that the PPA will impose

too much downside risk on ETC

Participants. Finally, CMS disagrees

with the comments recommending that

CMS either eliminate the downside risk

of the PPA but keep the upward

adjustment or simply eliminate the PPA

altogether. The PPA, by providing

meaningful downside risk, represents

the most important incentive in the

Model for encouraging ESRD facilities

and Managing Clinicians to increase the

volume of home dialysis services and

transplants.

Comment: Several commenters

expressed concern over the proposed

magnitude of the PPA, especially the

magnitude of the potential downward

adjustments from the PPA. Some

commenters recommended that CMS

reduce the magnitude of the PPA as

compared to what was proposed. A

commenter recommended that CMS

reduce the downward payment

adjustments for the initial MYs to

encourage ETC Participants to commit

resources and make early investments in

infrastructure needed to succeed in the

Model. A commenter recommended that

CMS modify the PPA such that potential

upward adjustments exceed potential

downward adjustments. Another

commenter expressed concern over the

proposed magnitude of the negative

PPA adjustment given the commenter’s

belief that the home dialysis rate and

transplant rate measures are often

unrelated to providers’ and suppliers’

actual rates of performance. Other

commenters offered more concrete

alternatives. A commenter

recommended that CMS reduce the

Facility PPA adjustments from +10

percent and ¥13 percent for MY9 and

MY10 to +2.75 percent and ¥3.25

percent for MY9 and MY10, reasoning

that these lower margins are similar to

those used in ESRD QIP, which the

commenter believed has been successful

in driving behavior. Other commenters

similarly urged CMS to align the

magnitude of the PPA adjustments to

that seen in the ESRD QIP. Two

commenters recommended that the

negative PPA adjustment be limited to

a maximum of ¥2 percent, one of

whom viewed as aligning with the

ESRD QIP, and other commenters

expressed a belief that the ¥2 percent

penalty from the ESRD QIP has

produced results. One of these two

commenters also recommended that this

reduction to the negative PPA

adjustment could be accompanied by a

corresponding reduction in the positive

PPA adjustment. Another commenter

recommended that CMS implement a

payment methodology similar to that

used in the ESRD QIP, wherein

attainment and improvement would be

determined using a method like that

used in the ERSD QIP rather than based

on performance relative to Comparison

Geographic Areas or the ETC

Participant’s own historical

performance.

Response: CMS understands the

commenters’ concern about the

magnitude of the PPA, and specifically

the downside risk of the PPA. After

taking into consideration these

comments, CMS also agrees that the

proposed magnitudes of the Facility

PPA and Clinician PPA were higher

than necessary to achieve the Model’s

goals. However, CMS believes that they

were not much higher than necessary.

Thus, while CMS is reducing the

magnitude of the PPAs in response to

comments received, which should

lessen the concerns expressed by

commenters that the PPA will impose

too much downside risk on ETC

Participants, CMS declines to adopt the

specific alternatives suggested by the

commenters. First, CMS notes that the

PPA adjustments are structured

differently from the ESRD QIP

adjustments in that an ETC Participant

can receive a positive PPA, whereas the

ESRD QIP adjustments do not offer the

possibility of a positive adjustment to

facilities (which are the only entities

that can participate in the program).

Second, commenters’ recommendations

that CMS reduce the magnitude of the

PPA adjustments to as low as +2.75

percent/¥3.25 percent (or lower) would

not provide the level of incentive to

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increase home dialysis and transplant

rates that CMS sees as necessary to

effectuate meaningful behavior change.

The PPA amounts that CMS is finalizing

in this rule optimally balance CMS’s

interests in achieving the Model’s goals

while not imposing too much financial

risk on ETC Participants. The PPA

amounts begin at around the same level

of the payment adjustments under MIPS

(which, for 2020, generally are +/¥5

percent subject to a scaling factor), and

then gradually increase in magnitude

over time. CMS believes that generally

following the MIPS payment adjustment

amounts in PPA Period 1 of the ETC

Model will provide an initial incentive

amount that some ETC Participants have

become accustomed to under MIPS, and

thus which should be manageable,

before the magnitude of the PPA

gradually increases. The financial risk

imposed on ETC Participants by the

PPA will be incremental given this

gradual increase, and will eventually

provide a stronger incentive than that

currently offered under MIPS or the

ESRD QIP program, but without asking

ETC Participants to take on the same

level of risk they might under another

model tested under section 1115A of the

Act, such as the KCC Model. For

example, under the CMS Kidney Care

First (KCF) option of the KCC Model,

KCF Participants that perform poorly in

terms of quality and utilization may

receive a downward adjustment of up to

20 percent to certain payments under

the model.

Comment: Several commenters

recommended that CMS redesign the

PPA such that the ETC Model is an

Advanced APM. Another commenter

who recommended that CMS eliminate

the PPA altogether reasoned that

nephrologists who are MIPS eligible

clinicians already participate in MIPS,

which subjects those nephrologists to

positive or negative payment

adjustments based on performance, and

that unless the ETC Model is redesigned

to qualify as an Advanced APM, such

nephrologists will be subjected to two

uncoordinated pay-for-performance

initiatives. Two commenters

recommended that CMS exempt

Managing Clinicians participating in the

ETC Model from MIPS.

Response: We appreciate the

recommendations from the commenters,

but we decline to adopt either. We

received many comments expressing

concern about the magnitude of the

PPA, and nearly as many comments

recommending that we reduce the

magnitude, especially the negative

magnitude, of the PPA. We have

responded to those comments by

modifying the proposed PPA such that

its magnitude is reduced, and we find

this change to be most appropriate in

light of the comments received globally.

Modifying this Model to be an

Advanced APM would require that we

subject ETC Participants to significant

downside risk starting in MY1, which

we believe would put many ETC

Participants in a difficult financial

position. Instead, we believe that

adjusting payments by the HDPA only

during the first two MYs and then

introducing the PPA adjustments is the

most appropriate design given the

Model’s articulated goals and the

comments received. Regarding the

recommendation that CMS exempt

Managing Clinicians who are ETC

Participants from MIPS, it is not clear

that the Innovation Center has the

authority to categorically exempt any

eligible clinicians, including Managing

Clinicians as that term is defined for

purposes of this Model, from MIPS.

Moreover, even if CMS had the

authority to exempt Managing

Clinicians from MIPS, CMS believes this

would undermine MIPS. MIPS provides

important incentives based on, among

other things, performance on quality

and cost measures that this Model does

not. This Model is not intended to

replace MIPS, but instead to place

emphasis on increasing rates of home

dialysis and transplants.

After reviewing public comments, we

are finalizing our general proposals

regarding the Performance Payment

Adjustment, with modifications. CMS

will modify the proposed schedule for

the Facility PPA and Clinician PPA in

our regulation at § 512.380 in

accordance with the revised start date

for the payment adjustments under the

ETC Model, described in section IV.C.1

of this final rule. In addition, after

reviewing the comments regarding the

proposed magnitude of the PPA

amounts, we are reducing the

magnitude of the PPA amounts.

Specifically, relative to the magnitude of

the PPA amounts described in the

proposed rule, CMS is reducing the

magnitude of the maximum PPA

amounts each PPA period by 2 percent.

We chose to reduce the PPA amounts by

2 percentages points in response to

commenter feedback that the proposed

PPA amounts were too high, and to

more closely align the finalized PPA

amounts with the payment adjustments

under MIPS, which generally will be +/

¥7% in 2021 and +/¥9% in 2022,

subject to a scaling factor. The specific

final magnitudes of the Facility PPA and

the Managing Clinician PPA are

discussed in sections IV.C.5.e.(1) and

IV.C.5.e.(2) of this final rule.

(1) Facility PPA

For ESRD facilities that are ETC

Participants, as described in proposed

§ 512.325(a) (Selected Participants), we

proposed to adjust certain payments for

renal dialysis services by the Facility

PPA. Specifically, we would adjust the

Adjusted ESRD PPS per Treatment Base

Rate for claim lines with Type of Bill

072x, where the type of facility code is

7 and the type of care code is 2, and for

which the beneficiary is 18 or older for

the entire month and where the claim

through date is during the applicable

PPA Period as described in proposed

§ 512.355(c) (Measurement Years and

Performance Payment Adjustment

Periods). We explained in the proposed

rule that facility code 7 paired with type

of care code 2 indicates that the claim

occurred at a clinic or hospital based

ESRD facility. Type of Bill 072X

therefore captures all renal dialysis

services furnished at or through ESRD

facilities. As with the HDPA, we

proposed to apply the Facility PPA to

claims where Medicare is the secondary

payer.

We proposed that the formula for

determining the final ESRD PPS per

treatment payment amount with the

Facility PPA would be as follows:

Final ESRD PPS Per Treatment Payment

Amount with PPA = ((Adjusted

ESRD PPS per Treatment Base Rate

* Facility PPA) + Training Add On

+ TDAPA) * ESRD QIP Factor +

Outlier Payment * ESRD QIP Factor

We further proposed that, for time

periods and claim lines for which both

the Facility HDPA and the Facility PPA

apply, the formula for determining the

final ESRD PPS per treatment payment

amount would be as follows:

Final ESRD PPS Per Treatment Payment

Amount with PPA and HDPA =

((Adjusted ESRD PPS per Treatment

Base Rate* (Facility HDPA +

Facility PPA)) + Training Add On +

TDAPA) * ESRD QIP Factor +

Outlier Payment * ESRD QIP Factor

As discussed previously in sections

II.B.1 and IV.C.4.b of this final rule, after

we published the proposed rule for the

ETC Model, CMS established a new

payment adjustment under the ESRD

PPS called the TPNIES, which could

apply to certain claims as soon as CY

2021. The TPNIES is part of the

calculation of the ESRD PPS per

treatment payment amount under 42

CFR 413.230 and, like the TDAPA, is

applied after the facility-level and

patient-level adjustments. We discuss

the implications of this change for the

Facility PPA later in this section of the

final rule.

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Table 14 depicts the proposed

amounts and schedule for the Facility

PPA over the ETC Model’s PPA periods,

which we proposed to codify in

proposed § 512.380.

Also, as we described in the proposed

rule and in section IV.C.7.a of this final

rule, we proposed that the Facility PPA

would not affect beneficiary cost

sharing. Beneficiary cost sharing would

instead be based on the amount that

would have been paid under the ESRD

PPS absent the Facility PPA.

The following is a summary of the

comments received on the proposed

Facility PPA and our responses.

Comment: A few commenters

expressed support for the proposal to

apply the Facility PPA to claims where

Medicare is the secondary payer.

Response: We appreciate this

feedback and support from the

commenters.

Comment: A few commenters

recommended that CMS include

condition code 73 in the types of claims

adjusted by the Facility PPA, as

condition code 73 corresponds to home

dialysis training.

Response: We thank the commenters

for their feedback. As noted previously

in this final rule, condition code 73 is

related to training a beneficiary on home

dialysis and the inclusion of this code

on a claim is one way in which CMS

determines the start of Medicare

coverage for an ESRD Beneficiary. CMS

believes it is unnecessary and

inappropriate to include condition code

73 in the payments adjusted by the PPA.

First, as noted previously in this final

rule, under the ETC Model, CMS seeks

to adjust payments for and incentivize

the provision of home dialysis services,

and not home dialysis training per se,

and adjusting payments for claims that

include condition code 73 may

encourage ‘‘gaming’’ wherein ETC

Participants train all beneficiaries on

home dialysis, regardless of whether the

ETC Participant believes home dialysis

is the most appropriate modality for the

beneficiary. Second, we note that any

dialysis claim submitted for an ESRD

Beneficiary after the claim containing

condition code 73 would be adjusted by

the Facility PPA, providing a robust

enough incentive to ETC Participants to

increase the provision of home dialysis

services. Further, if CMS were to adjust

claims containing condition code 73 by

the Facility PPA and an ESRD facility

received a negative Facility PPA, the

ESRD facility would face a disincentive

to train ESRD Beneficiaries on home

dialysis. CMS therefore believes it is

most appropriate to exclude claims with

condition code 73 from the payments

adjusted by the Facility PPA.

Comment: A commenter expressed

support for the proposal that the Facility

PPA would not affect beneficiary cost

sharing, reasoning that beneficiaries

included in the Model should not be

financially harmed or be discouraged

from obtaining care necessary to obtain

optimal patient health outcomes. A

commenter expressed concern that CMS

did not explain in the proposed rule

how the PPA would impact ESRD

Beneficiary co-insurance.

Response: We thank the commenters

for their feedback and support. In the

proposed rule, we indicated that the

PPA would not affect beneficiary cost

sharing. We clarify that cost sharing

refers to both the deductible and

beneficiary co-insurance. As described

in the proposed rule, beneficiary cost

sharing would instead be based on the

amount that would have been paid

under the ESRD PPS absent the Facility

PPA.

In addition, we are clarifying that the

formula for calculating the final ESRD

PPS per treatment payment amount

with the Facility PPA will reflect the

addition of the TPNIES. Because CMS

would apply the TPNIES in the

calculation of the per treatment

payment amount after the application of

the patient-level adjustments and

facility-level adjustments, in the same

manner as the TDAPA, the TPNIES does

not alter the proposed application of the

Facility PPA. We had proposed to adjust

the Adjusted ESRD PPS per Treatment

Base Rate, meaning the per treatment

payment amount as defined in

§ 413.230, including patient-level

adjustments and facility-level

adjustments and excluding any

applicable training adjustment add-on

payment amount, outlier payment

amount, and TDAPA amount, by the

Facility PPA. We are revising the

formula for determining the final ESRD

PPS per treatment payment amount

with the Facility PPA alone and the

Facility PPA and Facility HDPA to

reflect the addition of the TPNIES be as

follows:

Final ESRD PPS Per Treatment Payment

Amount with PPA = ((Adjusted

ESRD PPS per Treatment Base Rate

* Facility PPA)) + Training Add On

+ TDAPA + TPNIES) * ESRD QIP

Factor + Outlier Payment * ESRD

QIP Factor

Final ESRD PPS Per Treatment Payment

Amount with PPA and HDPA =

((Adjusted ESRD PPS per Treatment

Base Rate* (Facility HDPA +

Facility PPA)) + Training Add On +

TDAPA + TPNIES) * ESRD QIP

Factor + Outlier Payment * ESRD

QIP Factor

We note that, under our regulations at

§ 512.355, the PPA will not apply to any

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claims until the first PPA Period, which

starts on July 1, 2022.

After considering public comments,

we are finalizing our proposed

provisions for the Facility PPA, with

modification. Specifically, we are

modifying the magnitude of the Facility

PPA for each MPS and each PPA Period

relative to what we proposed, as

described in Table 14.a, and codifying

the modified Facility PPA in Table 1 to

our regulation at § 512.380. We are

finalizing in our regulation at

§ 512.375(a) that the PPA will adjust the

Adjusted ESRD PPS per Treatment Base

Rate, as proposed, as well as that the

PPA will apply only to claims for

beneficiaries 18 years of age or older.

While we had proposed to apply the

PPA only to claims for which the

beneficiary was 18 years of age or older

for the entire month of the claim, in the

final rule we are modifying the language

to state that the beneficiary must be age

18 or older ‘‘before the first day of the

month,’’ which is easier for CMS to

operationalize and has the same

practical effect (that is, a beneficiary

who is at least 18 years old before the

first date of a month will be at least 18

years old for that entire month). We are

also modifying which date associated

with the claim we are using to

determine if the claim occurred during

the applicable PPA Period. Whereas we

proposed using the claim through date,

we are finalizing using the date of

service on the claim, to align with

Medicare claims processing standards.

Specifically, while Medicare claims data

contains both claim through dates and

dates of service, Medicare claims are

processed based on dates of service.

Thus, we must use the claim date of

service to identify the PPA Period in

which the service was furnished. We are

also modifying the definition of

Adjusted ESRD PPS per Treatment Base

Rate in our regulation at § 512.310 to

reflect that it excludes any applicable

TPNIES amount, as discussed

previously in section IV.C.4.a and this

section of the final rule.

(2) Clinician PPA

For Managing Clinicians that are ETC

Participants, as described in proposed

§ 512.325(a) (Selected Participants), we

proposed to adjust payments for

managing dialysis beneficiaries by the

Clinician PPA. Specifically, we would

adjust the amount otherwise paid under

Part B with respect to the MCP claims

on claim lines with CPT

®

codes 90957,

90958, 90959, 90960, 90961, 90962,

90965, or 90966, by the Clinician PPA

when the claim is submitted by an ETC

Participant who is a Managing Clinician

and the beneficiary is 18 or older for the

entire month and where the claim

through date is during the applicable

PPA Period as described in proposed

§ 512.355(c) (Measurement Years and

Performance Payment Adjustment

Periods). We explained in the proposed

rule that CPT

®

codes 90957, 90958,

90959, 90960, 90961, and 90962 are for

ESRD-related services furnished

monthly, and indicate beneficiary age

(12–19 or 20 years of age or older) and

the number of face-to-face visits with a

physician or other qualified health care

professional per month (1, 2–3, 4 or

more). CPT

®

codes 90965 and 90966 are

for ESRD-related services for home

dialysis per full month, and indicate the

age of the beneficiary (12–19 or 20 years

of age or older). Taken together, these

codes are used to bill the MCP for

ESRD-related services furnished to

beneficiaries age 18 and older, including

patients who dialyze at home and

patients who dialyze in-center. As with

the HDPA, we proposed to apply the

Clinician PPA to claims where Medicare

is the secondary payer.

Table 15 depicts the proposed

amounts and schedule for the Clinician

PPA over the ETC Model’s PPA periods,

which we proposed to codify in

proposed § 512.380.

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We proposed to adjust the amount

otherwise paid under Part B by the

Clinician PPA so that beneficiary cost

sharing would not be affected by the

application of the Clinician PPA. The

Clinician PPA would apply only to the

amount otherwise paid for the MCP

absent the Clinician PPA.

The following is a summary of the

comments received on the proposed

Clinician PPA and our responses.

Comment: A commenter expressed

support for CMS’s proposal to apply the

Clinician PPA to claims where Medicare

is the secondary payer.

Response: We thank the commenter

for the feedback and support.

After considering public comments,

we are finalizing our proposed

provisions for the Clinician PPA, with

modification. Specifically, we are

modifying the amounts of the Clinician

PPA from those proposed, to reduce the

magnitude of the Clinician PPA for each

MPS and PPA Period relative to what

we proposed, as described in Table 15.a,

and codifying the modified Clinician

PPA in Table 2 to our regulation at

§ 512.380. We are finalizing that the

Clinician PPA will adjust the amount

otherwise paid for the MCP as proposed,

as well as that the Clinician PPA will

only apply to claims for beneficiaries 18

years of age or older. While we had

proposed to apply the Clinician PPA

only to claims for which the beneficiary

was 18 years of age or older during the

entire month of the claim, we are

changing the language to state that the

beneficiary must be at least 18 years of

age ‘‘before the first date of the month,’’

which is easier for CMS to

operationalize and has the same

practical effect (that is, a beneficiary

who is at least 18 years old on the first

date of the month will be at least 18

years old for that entire month). We are

modifying which date associated with

the claim we are using to determine if

the claim occurred during the

applicable PPA Period. Whereas we

proposed using the claim through date,

we are finalizing using the date of

service on the claim, to align with

Medicare claims processing standards.

Specifically, while Medicare claims data

contains both claim through dates and

dates of service, Medicare claims are

processed based on dates of service.

Thus, we must use the claim service

date to identify the PPA Period in which

the service was furnished.

f. Low-Volume Threshold Exclusions for

the PPA

(1) ESRD Facilities

We proposed excluding ETC

Participants that are ESRD facilities that

have fewer than 11 attributed

beneficiary-years during a given MY

from the application of the PPA during

the corresponding PPA Period. Each

beneficiary-year would be equivalent to

12 attributed beneficiary months, where

a beneficiary month is one calendar

month for which an ESRD Beneficiary is

attributed to an ETC Participant using

the attribution methodology described

in the proposed rule and in section

IV.C.5.b of this final rule, meaning that

an ESRD facility must have at least 132

total attributed beneficiary months for a

MY in order to be subject to the PPA for

the corresponding PPA Period. Under

our proposal, a beneficiary year could

be comprised of attributed beneficiary

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months from multiple beneficiaries. We

proposed this exclusion threshold to

increase statistical reliability and to

exclude low-volume ESRD facilities

from the application of the Facility PPA.

We selected this particular threshold

because it is similar to the 11 qualifying

patient minimum threshold that the

ESRD QIP uses for purposes of scoring

certain measures during the

performance period. In the proposed

rule, we stated that we had considered

using the 11 qualifying patients

threshold used for purposes of scoring

some measures under the ESRD QIP, but

due to differences in beneficiary

attribution methodologies between the

ESRD QIP and the proposed ETC Model,

we concluded that using beneficiary-

years was more appropriate for purposes

of testing the ETC Model, as the rates

proposed for the ETC Model are based

on beneficiary-years.

We invited public comment on our

proposal for excluding ESRD facilities

with fewer than 11 attributed

beneficiary-years from the application of

the PPA during the applicable PPA

Period, as well as the alternatives

considered.

The following is a summary of the

comments received on the proposed

low-volume exclusion from the

application of the PPA for ESRD

facilities and our responses.

Comment: A commenter expressed

opposition to the proposed low-volume

exclusion for ESRD facilities, opining

that CMS’s reasons for proposing the

low-volume exclusion for ESRD

facilities do not outweigh the need to

promote home dialysis to patients of

low-volume facilities who want such

services. The same commenter

recommended that instead of a low-

volume exclusion for ESRD facilities,

CMS should create a mechanism for

small and low-volume ESRD facilities to

aggregate their performance to a virtual

group to strengthen the ability of these

ESRD facilities to perform in the Model.

The same commenter expressed concern

that excluding ESRD facilities from the

application of the PPA based on volume

alone may not be sufficiently nuanced

to account for ESRD facilities that serve

an important access need, and thus

serve a relatively high volume of ESRD

Beneficiaries, but that are unable to bear

downside financial risk.

On the other hand, another

commenter expressed concern that the

proposed low-volume exclusion for

ERSD facilities would cover only a

small number of ESRD facilities which

operate with narrow profit margins or

even narrow losses. The same

commenter provided data suggesting of

the 353 rural ESRD facilities reporting

financial losses in 2017, only 64 of these

ESRD facilities would be designated as

‘‘low-volume’’ under the Model and

thus be excluded from the application of

the Facility PPA. Another commenter

expressed concern that rural ESRD

facilities, which often have few insured

patients and high numbers of patients

with little support at home, will not and

cannot perform well in the Model, and

may be forced to close, leaving rural

beneficiaries without access to care. A

commenter recommended that an ESRD

facility farther than 20 miles away from

the next nearest ESRD facility should

not be subjected to negative payment

adjustments, but still be able to receive

positive payment adjustments,

reasoning that if such an ESRD facility

performs poorly, it may have to close

and cause its patients to travel much

farther to receive care. Another

commenter suggested that CMS use the

ESRD PPS definition of a ‘‘low-volume

facility’’ and not apply negative PPA

adjustments to those ESRD facilities.

Another commenter recommended that

CMS still apply positive PPA

adjustments to ESRD facilities excluded

under the low-volume exclusion, but

not subject them to negative PPA

adjustments.

Another commenter recommended

that CMS broaden the proposed low-

volume exclusion for ESRD facilities to

exclude from the application of the PPA

all low-volume and rural ESRD facilities

owned by organizations with 35 or

fewer ESRD facilities, unless the ESRD

facility voluntarily elects to be subject to

the PPA, reasoning that low-volume and

rural ESRD facilities are

disproportionately less likely to offer

home dialysis therapy, and that a

substantial number of low-volume and

rural ESRD facilities are small and

independent providers that operate with

negative Medicare margins and lack

sufficient resources to make the

investments necessary to establish a

home dialysis program. The same

commenter expressed concern that the

current low-volume exclusion policy for

ESRD facilities is inadequate to protect

beneficiary access to care and prevent

further market consolidation. Another

commenter recommended that CMS

provide an exclusion for low-volume

ESRD facilities and for Managing

Clinicians providing services at low-

volume ESRD facilities. The same

commenter expressed concern that

small and independent facilities that

have 12 ESRD Beneficiaries (and thus

would not be excluded from the

application of the Facility PPA under

our proposed low-volume exclusion), all

of whom are unable or unwilling to

receive home dialysis or a transplant,

would be forced to close due to the

application of the Facility PPA. The

same commenter recommended that

CMS make its low-volume exclusion

based on an attestation that the ESRD

facility is a low-volume facility.

Response: We thank the commenters

for their feedback. Regarding the

comment that the need to promote home

dialysis outweighs the reasons CMS

cited for proposing the low-volume

exclusion for ESRD facilities, we must

underscore that statistical reliability is

essential for determining whether the

financial incentives offered in this

Model can significantly alter the

provision of home dialysis. Further,

CMS hopes that all ESRD facilities,

regardless of participation in the ETC

Model, will promote home dialysis and

educate their patients regarding all renal

replacement modalities, including home

dialysis modalities. Moreover, creating a

virtual group for small and low-volume

ESRD facilities, as suggested by the

commenter, would be unduly complex

operationally, as described previously

in this final rule. We are also concerned

that it would be difficult to define

virtual groups for purposes of the low-

volume threshold for ESRD facilities

without inadvertently giving either the

virtual group, or those ESRD facilities

not in the virtual group, an unfair

advantage. In addition, as discussed

later in this section of the final rule,

CMS will calculate the low-volume

threshold for ESRD facilities at the level

of the aggregation group (as described in

our regulation at § 512.365(e)(1)), under

which CMS will aggregate all ESRD

facilities that are not Subsidiary ESRD

facilities with all other ESRD facilities

that are not Subsidiary ESRD facilities

located within the same HRR. Because

CMS is not aggregating independent or

ESRD facilities that are not Subsidiary

ESRD facilities, CMS will apply the low-

volume threshold exclusion policy to

ESRD facilities that are not Subsidiary

facilities at the facility level. As

described elsewhere in this final rule,

an aggregation group pools the

performance of several ESRD facilities

in a particular HRR and thus strengthen

their ability to perform in the Model.

Applying the low-volume threshold

exclusion policy at the aggregation

group level, as discussed below, allows

CMS to more precisely exclude ESRD

facilities who may be unlikely to

perform adequately under the Model

due to low historical beneficiary

attribution, while bolstering statistical

reliability. CMS believes that this policy

sufficiently addresses the concerns the

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commenter intended to address in

recommending the virtual group policy.

While we agree with the commenter

that volume alone may not be

sufficiently nuanced to account for all

ESRD facilities that serve an important

access need but are unable to bear

downside financial risk, part of CMS’s

reasoning for pursuing the low-volume

exclusion is to bolster statistical

reliability, which ultimately benefits

ETC Participants. Similarly, even if

CMS’s proposed low-volume exclusion

does not exclude from the application of

the PPA all ESRD facilities operating

with a near-zero or negative profit

margin, (1) CMS reiterates its need to

assure statistical reliability in the

calculation of the PPA, and (2) the ETC

Model offers such ESRD facilities an

opportunity to increase revenue through

the payment adjustments, depending

upon their performance. Similarly, CMS

believes that the commenter’s concerns

about rural ESRD facilities are

unfounded, as the home dialysis rate

measure captures the percentage of an

ESRD facility’s ESRD Beneficiaries who

use a home dialysis modality. ESRD

facilities currently operating with thin

profit margins could see those margins

grow by investing capital in creating or

building upon home dialysis or self-

dialysis programs, thus reducing their

costs associated with providing dialysis

services in-center multiple days a week

and potentially earning them a positive

PPA or increasing the magnitude of the

PPA earned. Similarly, while rural

ESRD facilities may have high numbers

of patients without support at home, the

Model is designed to incent ESRD

facilities to consider how to increase

access to home dialysis modalities for

their ESRD Beneficiaries, and CMS will

be including self-dialysis in the home

dialysis rate measure, as discussed

elsewhere in this final rule. If an ESRD

facility has many ESRD Beneficiaries

lacking support at home, such an ESRD

facility could prioritize training its

ESRD Beneficiaries on self-dialysis

rather than home dialysis, which would,

like home dialysis, give the beneficiaries

greater agency in their treatment and

help the ESRD facility improve its

performance under the Model. CMS

believes that the proposed low-volume

exclusion, with the modifications

described in this section of the final

rule, is sufficient to ensure beneficiary

access to care and will not result in

market consolidation, and that the

Model, through the HDPA, will provide

ESRD facilities that are not excluded

from the application of the PPA with

greater financial resources during the

initial years of the Model to establish or

build upon home dialysis programs,

which will help position ESRD facilities

to earn a higher PPA. While it is

possible that an ESRD facility could

have 12 ESRD Beneficiaries, all of

whom are not appropriate candidates

for either home dialysis or a transplant,

CMS finds this situation to be highly

unlikely. However, if an ESRD facility

found itself in that situation, the ESRD

facility could still perform well under

the Model by focusing attention on

educating its ESRD Beneficiaries on self-

dialysis and transplantation, and

encouraging and helping its ESRD

Beneficiaries to register for a transplant

waitlist.

Regarding the comment that CMS

should provide an exclusion for low-

volume ESRD facilities, this is what we

proposed to do; however, we disagree

with the alternative low-volume

thresholds recommended by the

commenters. Regarding the comment

suggesting that CMS make its low-

volume exclusion for ESRD facilities

based on an attestation that the facility

is low-volume, CMS is concerned that

such a policy would lead to gaming and

abuse in the context of this Model.

While CMS requires attestations from

ESRD facilities that qualify as ‘‘low

volume’’ under the ESRD PPS, the

Model is using a different policy for

identifying ‘‘low volume’’ than that

used under the ESRD PPS, and

operational limitations render

attestations and subsequent

confirmation by CMS or its Medicare

Administrative Contractors (MACs), as

is done under the ESRD PPS, unsuitable

for this Model. CMS also finds its policy

for identifying a low-volume ESRD

facility under the Model to be more

appropriate than the ESRD PPS

definition for purposes of the Model, in

light of the goals of the Model and

CMS’s need for statistically reliable

data.

CMS also declines to include the

commenter’s recommended exclusion

for ESRD facilities located more than 20

miles away from another ESRD facility

at this time. While CMS understands the

commenter’s concern, an exclusion of

this nature could give rise to gaming,

insofar as ETC Participants that are

newly building spaces for home dialysis

training and self-dialysis could

strategically position new ESRD

facilities more than 20 miles away from

other ESRD facilities. Finally, regarding

the comment recommending that CMS

apply positive PPAs to ESRD facilities

otherwise excluded from the application

of the PPA, but exclude such facilities

from any negative PPAs, CMS believes

this would not produce a strong enough

financial incentive for such ESRD

facilities to improve home dialysis and,

ultimately, transplant rates.

After considering public comments,

we are finalizing our proposed

provisions on the low volume exclusion

for ESRD facilities, with modification.

Specifically, in an effort to limit the

scope of the low-volume exclusion in

order to promote modality choice with

the need for statistical reliability, CMS

is modifying its proposal such that,

under the ETC Model, CMS will exclude

aggregation groups (as described in our

regulation at § 512.365(e)(1)) of ESRD

facilities with fewer than 11 attributed

ESRD beneficiary years during an MY

from the application of the Facility PPA

for the corresponding PPA Period. CMS

will similarly exclude ESRD facilities

that are not Subsidiary ESRD facilities

with fewer than 11 attributed ESRD

beneficiary years during an MY from the

application of the Facility PPA for the

corresponding PPA Period. This policy

is also consistent with our final policy

for assessing ESRD facility performance

for purposes of the MPS calculation,

which will also occur at the aggregation

group level. Because the low-volume

threshold determination will generally

be made at the aggregation group level

(that is, across multiple Subsidiary

ESRD facilities), under this final policy,

fewer ESRD facilities will be excluded

from the application of the Facility PPA

as compared to the number that would

have been excluded under the policy we

proposed. This low-volume exclusion is

also narrower than the ESRD PPS

definition suggested by the commenter

and accordingly better ensures that a

greater number of ESRD Beneficiaries

will receive the benefit of receiving care

from an ESRD facility incentivized by

the Model to provide home dialysis

services, self-dialysis services, and a

robust pathway to transplantation. By

contrast, the ESRD PPS definition of

‘‘low-volume facility’’ is an ESRD

facility that (1) furnished less than 4,000

treatments in each of the three ‘‘cost

reporting years . . . preceding the

payment year;’’ and (2) ‘‘[h]as not

opened, closed, or received a new

provider number due to a change of

ownership’’ in the same time period. 42

CFR 413.232(b). This definition captures

a larger number of ESRD facilities than

does the low-volume facility provision

in this final rule.

We are codifying the modified low-

volume threshold for ESRD facilities in

§ 512.385(a) of our regulation.

(2) Managing Clinicians

We proposed excluding ETC

Participants that are Managing

Clinicians who fall below a specified

low-volume threshold during an MY

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from the application of the PPA during

the corresponding PPA Period. The low-

volume exclusion would ensure that we

would be adjusting payment based on

reliable measurement of Managing

Clinician performance. We noted that

Managing Clinicians with sufficiently

small attributed beneficiary populations

may serve unique patient populations,

such as children, such that we may not

be able to produce statistically reliable

transplant rates and home dialysis rates

for these Managing Clinicians. We

proposed that the low-volume threshold

would be set at the bottom five percent

of ETC Participants who are Managing

Clinicians in terms of the number of

beneficiary-years for which the

Managing Clinician billed the MCP

during the MY. We stated in the

proposed rule that we considered using

11 beneficiary-years as the low-volume

exclusion for Managing Clinicians, to

mirror the proposed exclusion for ESRD

facilities. However, we recognized that

ESRD facilities and Managing Clinicians

are different in that Managing Clinicians

are more diverse, as compared to ESRD

facilities, in terms of both volume of

services furnished to beneficiaries

related to receiving dialysis and services

furnished that are not related to dialysis.

Therefore, we proposed using a

percentile-based low-volume exclusion

threshold for Managing Clinicians that

would help to ensure statistical

soundness while recognizing the

diversity of the Managing Clinician

population. In the proposed rule, we

alternatively considered establishing the

low-volume threshold based on the

bottom five percent of Managing

Clinicians who are ETC Participants in

the total dollar value of Medicare claims

paid. However, as Managing Clinicians

are in a variety of specialties and

provide a wide range of services that are

paid at a variety of rates, we concluded

that a dollar-value threshold was not

suitable for purposes of this proposed

exclusion.

We invited public comment on this

proposal for excluding certain Managing

Clinicians from the application of the

PPA during the applicable PPA Period

based on our proposed low volume

threshold, as well as the alternatives

considered.

The following is a summary of the

comments received on the proposed

low-volume exclusion from the

application of the PPA for Managing

Clinicians and our responses.

Comment: A commenter expressed

support for the proposed low-volume

exclusion for Managing Clinicians.

Another commenter expressed support

for the proposed low-volume exclusion

for Managing Clinicians, but suggested

that CMS give otherwise excluded

Managing Clinicians the option to opt in

to the application of the PPA under

Model.

Response: We thank the commenters

for their feedback and support.

Regarding the commenter’s suggestion

that CMS allow otherwise excluded

Managing Clinicians to opt in to the

application of the PPA under the Model,

we decline to adopt this

recommendation because Managing

Clinicians who are ETC Participants

must treat at least a minimum volume

of ESRD Beneficiaries in order for CMS

to produce statistically reliable

transplant rates and home dialysis rates

for purposes of calculating the

Managing Clinicians’ MPS and

corresponding Clinician PPA. However,

CMS determined, after publishing the

NPRM, that the policy described in the

NPRM would not exclude Managing

Clinicians with adequate precision. In

other words, our proposed policy would

result in CMS applying the PPA to

Managing Clinicians who have far fewer

attributed beneficiary years than we

expected and need for the purpose of

achieving statistical reliability.

Accordingly, CMS is modifying its

proposal for the Managing Clinician

low-volume threshold exclusion, as

described below.

After considering public comments,

we are modifying our proposed

provisions on the low volume exclusion

for Managing Clinicians. Specifically,

we are changing the low-volume

threshold for excluding Managing

Clinicians from the application of the

PPA during the applicable PPA Period

from excluding Managing Clinicians in

the bottom five percent of ETC

Participants who are Managing

Clinicians in terms of the number of

beneficiary-years for which the

Managing Clinicians billed the MCP

during the MY, as proposed, to

excluding Managing Clinicians in an

aggregation group (as described in our

regulation at § 512.365(e)(2)) with fewer

than 11 attributed ESRD beneficiary-

years during an MY. Determining the

low-volume threshold for a Managing

Clinician at the aggregation group level

conforms to changes CMS made to the

ESRD facility low-volume exclusion

policy, described above, and also is

consistent with our final policy for

assessing ESRD facility performance for

purposes of the MPS calculation, which

will also occur at the aggregation group

level. CMS is similarly changing its

policy from setting the exclusion level

at the bottom five percent of ETC

Participants who are Managing

Clinicians in terms of the number of

beneficiary-years to fewer than 11

attributed ESRD beneficiary years. As

with the modified low-volume

exclusion policy for ESRD facilities

described elsewhere in this section of

the final rule, this modified low-volume

exclusion policy for Managing

Clinicians allows CMS to more precisely

exclude groups of ETC Participants that

have low historical beneficiary

attribution from application of the PPA,

while bolstering statistical reliability.

CMS noted in the proposed rule that

ESRD facilities and Managing Clinicians

are different, in that Managing

Clinicians are more diverse as compared

to ESRD facilities, in terms of both

volume of services furnished to

beneficiaries related to receiving

dialysis and services furnished that are

not related to dialysis. While CMS still

believes this to be true, CMS determined

subsequent to publishing the NPRM that

the Managing Clinician low-volume

threshold exclusion policy described in

the NPRM would not precisely exclude

Managing Clinicians with too few

attributed ESRD beneficiary years to

obtain statistical reliability.

Accordingly, to obtain statistical

reliability, CMS must modify its

proposal to set the Managing Clinician

low-volume threshold exclusion at 132

attributed ESRD beneficiary months, or

11 attributed ESRD beneficiary years.

This modification will result in a higher

number of Managing Clinicians being

excluded from the Model. Finally, CMS

is making the change from considering

‘‘beneficiary-years’’ to ‘‘attributed ESRD

beneficiary-years’’ to conform to the

low-volume threshold exclusion for

ESRD facilities, as ESRD facilities will

not have attributed Pre-emptive LDT

Beneficiaries. We are codifying this low-

volume exclusion in § 512.385(b) of our

regulation.

g. Notification

Per the PPA schedule, we proposed

that payment adjustments would be

made during the PPA period that begins

6 months after the end of the MY. This

6-month period would allow for 3

months claims run-out to account for lag

in claims processing, and for CMS to

calculate and validate the MPS and the

corresponding PPA for each ETC

Participant. After we calculate ETC

Participant MPSs and PPAs, we

proposed to notify ETC Participants of

their attributed beneficiaries, MPSs and

corresponding PPAs. We proposed

notification of ETC Participants no later

than 1 month before the start of the PPA

Period in which the PPA would go into

effect. As stated in the proposed rule,

we believe this notification period

balances the need for sufficient claims

run-out to ensure accuracy, as well as

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sufficient time for MPA and PPA

calculation and validation by CMS, with

our interest in providing sufficient

advanced notification regarding the

resulting payment adjustments to ETC

Participants.

We proposed to conduct notifications

in a form and manner determined by

CMS. The following is a summary of the

comment received on proposed

notifications and our response.

Comment: A commenter expressed

concern that providing reports regarding

the ETC Participant’s attributed

beneficiaries, MPS, and PPA for a PPA

Period only once per year would be

insufficient and would not provide the

information necessary for ETC

Participants to measure their

performance and take corrective action

when necessary.

Response: We thank the commenter

for the feedback. As described in the

proposed rule and previously in this

final rule, each PPA Period will be 6

months long and will begin 6 months

after the last date of the corresponding

MY. As a result, ETC Participants will

receive notifications regarding

beneficiary attribution, MPS, and PPA

twice per year (that is, every six

months)—one month prior to each PPA

Period. We believe this notification

schedule affords CMS the time needed

collect data, attribute beneficiaries,

calculate the MPS and PPA, validate

those calculations, and distribute this

information to ETC Participants in

accordance with the requirements set

forth in this final rule, while protecting

the ETC Participant’s interest in timely

receiving the data, reviewing for

suspected errors, and implementing

performance improvement strategies for

current and subsequent MYs.

After considering the public

comment, we are finalizing our

proposed notification provision in our

regulation at § 512.390(a) without

modification.

h. Targeted Review

We noted in the proposed rule that we

believe that it would be advisable to

provide a process according to which an

ETC Participant would be able to

dispute errors that it believes to have

occurred in the calculation of the MPS.

Therefore, we proposed a policy that

would permit ETC Participants to

contest errors found in their MPS, but

not in the ETC Model home dialysis rate

calculation methodology, transplant rate

calculation methodology, achievement

and improvement benchmarking

methodology, or MPS calculation

methodology. We noted that, if ETC

Participants have Medicare FFS claims

or decisions they wish to appeal (that is,

Medicare FFS issues experienced by the

ETC Participant that occur during their

participation in the ETC Model that do

not involve the calculation of the MPS),

then the ETC Participant should

continue to use the standard CMS

procedures through their MAC. Section

1869 of the Act provides for a process

for Medicare beneficiaries, providers,

and suppliers to appeal certain claims

and decisions made by CMS.

We proposed that ETC Participants

would be able to request a targeted

review of the calculation of their MPS.

ETC Participants would be able to

request a targeted review for certain

considerations, including, but not

limited to, when: The ETC Participant

believes an error has occurred in the

home dialysis rate or transplant rate

used in the calculation of the MPS due

to data quality or other issues; or the

ETC Participant believes that there are

certain errors, such as misapplication of

the home dialysis rate or transplant rate

benchmark in determining the ETC

Participant’s achievement score,

improvement score, or the selection of

the higher score for use in the MPS. We

noted in the proposed rule that the

targeted review process would be

subject to the limitations on

administrative and judicial review as

previously described. Specifically, an

ETC Participant could not use the

targeted review process to dispute a

determination that is precluded from

administrative and judicial review

under section 1115A(d)(2) of the Act

and our regulation at § 512.170.

To request a targeted review, we

proposed that the ETC Participant

would provide written notice to CMS of

a suspected error in the calculation of

their MPS no later than 60 days after we

notify ETC Participants of their MPS, or

at a later date as specified by CMS. We

proposed that this written notice must

be submitted in a form and manner

specified by CMS. The ETC Participant

would be able to include additional

information in support of its request for

targeted review at the time the request

is submitted.

We proposed that we would respond

to each request for targeted review

submitted in writing in a timely

manner, and determine within 60 days

of receipt of the request whether a

targeted review is warranted. We

proposed that we would either accept or

deny the request for targeted review, or

request additional information from the

ETC Participant that we would deem

necessary to make such a decision. If we

were to request additional information

from the ETC Participant, we would

require that it be provided and received

within 30 days of the request. Non-

responsiveness to the request for

additional information would

potentially result in the closure of the

targeted review request. If we were to

find, after conducting a targeted review,

that there had been an error in the

calculation of the ETC Participant’s

MPS, we would notify the ETC

Participant within 30 days of the

finding. If the error in the MPS were

such that it caused us to apply an

incorrect PPA during the PPA Period

associated with the incorrect MPS, we

would notify the ETC Participant and

resolve the payment discrepancy during

the next PPA Period following

notification of the MPS error. We

proposed that decisions based on the

targeted review process would be final,

and there would be no further review or

appeal.

In the proposed rule, we considered

compressing the duration of the targeted

review process such that it could be

completed before the PPA Period for

which the MPS in question sets the

PPA. However, we stated that we

believe that this would be an

insufficient amount of time for ETC

Participants to review their MPS,

consider the possibility of a calculation

or data error, request a targeted review,

and provide additional information to

CMS if requested.

The following is a summary of the

comment received on the proposed

targeted review process and our

response.

Comment: We received one comment

that 60 days would be insufficient time

for ETC Participants to review their

MPS, identify potential errors, and

request a targeted review from CMS.

The commenter suggested 90 days as an

alternative.

Response: We thank the commenter

for the feedback. After considering the

comment, we will adopt a final policy

that ETC Participants must provide

written notice to CMS of a suspected

error in the calculation of their MPS no

later than 90 days after we notify ETC

Participants of their MPS, or at a later

date as specified by CMS. This

modification would be an increase from

the 60-day period discussed in the

proposed rule.

After considering the public comment

received, we are finalizing our targeted

review proposal in our regulation at

§ 512.390(b), with modification. As

noted previously in this section of the

final rule, we are increasing the amount

of time that an ETC Participant will

have to request a targeted review from

60 days to 90 days after the ETC

Participant is notified of their MPS. We

are also modifying the regulatory text at

§ 512.390(b)(1) to specify that the ETC

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155

The KCC Model was referred to as the

Comprehensive Kidney Care Contracting and

Kidney Care First Models in the proposed rule, but

has since undergone a rebranding. References in

this final rule have been updated to reflect the name

of the model in use as of the date of the publication

of the final rule.

156

This timing has been updated from what

appeared in the proposed rule to reflect the current

anticipated timeline for this model as of the date

of publication of this final rule.

157

Abecassis M, Bartlett ST, Collins AJ, Davis CL,

Delmonico FL, Friedewald JJ et al. Kidney

transplantation as primary therapy for end-stage

renal disease: A National Kidney Foundation/

Kidney Disease Outcomes Quality Initiative (NKF/

KDOQITM) conference. Clinical Journal of the

American Society of Nephrology. 2008;3(2):471–80.

Participant may request a targeted

review at a later date as specified by

CMS to align with the proposed policy

as described in the preamble to the

proposed rule. In addition, we are

modifying the regulatory text at

§ 512.390(b)(4) of our regulations to

clarify that CMS must resolve any

resulting discrepancy in payment that

arises from the application of an

incorrect PPA in a time and manner

determined by CMS, as opposed to

during the next PPA Period that begins

after the notification of the ETC

Participant, as we had proposed. We

believe this flexibility will allow CMS to

more quickly and effectively resolve

PPA payment discrepancies than the

more specific time frame described in

the proposed rule.

6. Overlap With Other Innovation

Center Models and CMS Programs

As proposed, the ETC Model would

overlap with several other CMS

programs and models, and we sought

comment on our proposals to account

for overlap:

•ESRD Quality Incentive Program

(ESRD QIP)—The ESRD QIP reduces

payment to a facility under the ESRD

PPS for a calendar year by up to 2

percent if the facility does not meet or

exceed the total performance score

established by CMS for the

corresponding ESRD QIP payment year

with respect to measures specified for

that payment year. We proposed that the

ETC Model’s Facility HDPA and Facility

PPA would be applied prior to the

application of the ESRD QIP payment

adjustment to the ESRD PPS per

treatment payment amount, as we were

proposing that the Facility HDPA and

the Facility PPA would adjust the

Adjusted ESRD PPS per Treatment Base

Rate, as previously discussed in the

proposed rule and in section IV.C.4.b of

this final rule.

•Merit-based Incentive Payment

System (MIPS)—Under section

1848(q)(6) of the Act and 42 CFR

414.1405(e), the MIPS payment

adjustment factor, and, as applicable,

the additional MIPS payment

adjustment factor (collectively referred

to as the MIPS payment adjustment

factors) generally apply to the amount

otherwise paid under Medicare Part B

with respect to covered professional

services furnished by a MIPS eligible

clinician during the applicable MIPS

payment year. We proposed that the

Clinician HDPA and the Clinician PPA

in the ETC Model would similarly apply

to the amount otherwise paid under

Medicare Part B, but would occur prior

to the application of the MIPS payment

adjustment factors. This was designed to

ensure that the MIPS payment

adjustment factors would still have a

significant weight for Managing

Clinicians.

•Kidney Care Choices (KCC)

Model

155

—The KCC Model is an

optional Innovation Center model for

nephrologists, dialysis facilities,

transplant providers, and other

providers and suppliers that will be

focused on beneficiaries with CKD and

beneficiaries with ESRD. The KCC

Model is scheduled to begin with an

implementation period for a portion of

2020 and 2021, with the performance

period of the model beginning on April

1, 2021, and continuing through

December 31, 2023, with the option for

the Innovation Center to extend the

model by one or two additional

performance years.

156

Thus, the KCC

Model will have up to nearly five years

of financial accountability overlap with

the ETC Model beginning April 1, 2021.

We proposed that the types of entities

eligible to participate in the KCC Model

as Kidney Care First (KCF) practices and

Kidney Contracting Entities (KCEs)

would be permitted to participate in the

KCC Model within regions where the

ETC Model would be in effect. We

stated in the proposed rule that not

allowing these entities to participate as

KCF practices or KCEs in the KCC

Model within the ETC Model’s Selected

Geographic Areas would limit

participation in the KCC Model, and

could prevent a sufficient number of

KCF practices or KCEs from

participating in the KCC Model, such

that the KCC Model would not have

sufficient participation to be evaluated.

We explained that we believed it was

important to test both models in order

to evaluate payment incentives inside

and outside the coordinated care

context. As stated in the proposed rule,

the ETC Model would allow for a

broader scope of test due to its

mandatory nature across half the

country, while the KCC Model will test

the effects on outcomes of higher levels

of risk for a self-selected group of

participants. We proposed that payment

adjustments under the ETC Model

would be counted as expenditures for

purposes of the KCC Model. We

designed both models to include

explicit incentives for participants when

beneficiaries receive kidney transplants;

and we proposed that a participant in

both models would be eligible to receive

both types of adjustments under the

ETC Model (the HDPA and PPA), as

well as a kidney transplant bonus

payment under the KCC Model. Kidney

transplants represent the most desired

and cost effective treatment for most

beneficiaries with ESRD, but providers

and suppliers may currently have

insufficient financial incentives to assist

beneficiaries through the transplant

process because dialysis generally

results in higher reimbursement over a

more extended period of time than a

transplant.

157

As a result, we stated that

we believed it would be appropriate to

test incentives in both the ETC Model

and KCC Model simultaneously to

assess their effects on the transplant

rate.

•Comprehensive ESRD Care (CEC)

Model—The CEC Model is a voluntary

model for ESRD dialysis facilities,

nephrologists, and other providers and

suppliers that focuses on beneficiaries

with ESRD. We noted in the proposed

rule that the CEC Model will end on

December 31, 2020, and therefore,

would overlap for one year with the

proposed ETC Model, though the

models will now only overlap for three

months from January 1, 2021 to March

31, 2021 due to the updated timeline for

the ETC and CEC Models. We proposed

that ETC Participants could be selected

from regions where there are

participants in the CEC Model. Given

the national distribution of CEC ESCOs,

we noted in the proposed rule that we

do not believe the overlap between the

two Models would impact the validity

of the ETC Model test, as ESCOs would

be equally likely to be located in

Selected Geographic Areas as in

Comparison Geographic Areas, creating

a net neutral effect. We also stated that

we do not believe that the proposed ETC

Model would significantly affect the

CEC Model because the payment

incentives under the ETC Model would

be smaller in 2020 when the CEC Model

is active and because the CEC Model is

focused on total cost of care, the

majority of which is non-dialysis care.

In the proposed rule we noted our belief

that not allowing CEC ESCOs to

participate in the CEC Model within the

ETC Model’s Selected Geographic Areas

would require either terminating ESCOs

that participate in the CEC Model in the

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ETC Model’s Selected Geographic

Areas, which we believe would

negatively impact the CEC Model test,

or altering ETC Model randomization to

exclude regions in which CEC ESCOs

are participating in the CEC Model,

which we believe would negatively

impact the ETC Model by interfering

with the proposed randomization.

•All other APMs with Medicare—For

other Medicare APMs, such as the

Medicare Shared Savings Program or the

Next Generation ACO Model, that focus

on total cost of care, we proposed that

any increase or decrease in program

expenditures that is due to the ETC

Model would be counted as program

expenditures to ensure that the

Medicare APM continues to measure the

total cost of care to the Medicare

program. The Medicare Shared Savings

Program regulations include a policy for

addressing payments under a model,

demonstration, or other time-limited

program. Specifically, in conducting

payment reconciliation for the Medicare

Shared Savings Program, CMS considers

‘‘individually beneficiary identifiable

final payments made under a

demonstration, pilot, or time limited

program’’ (see, for example,

§ 426.610(a)(6)(ii)(B)). In the proposed

rule we stated our belief that this

existing policy sufficiently addresses

overlaps that would arise between the

Medicare Shared Savings Program and

the proposed ETC Model. We also stated

that CMS would review any other

models where this form of

reconciliation may not be possible and

make an assessment as to what changes,

if any, may be necessary to account for

the effects of testing the ETC Model.

We invited public comments on our

proposals to account for overlaps with

other CMS programs and models.

The following is a summary of the

comments received on overlaps between

the ETC Model and other CMS programs

and models, and our responses.

Comment: We received several

comments urging the Innovation Center

to test potential methods to increase

home dialysis and transplant rates

solely through a voluntary model or

coordinated care framework, rather than

with the proposed framework of the

ETC Model.

Response: We appreciate the

feedback. However, as discussed in

section IV.C.3.a of this final rule, we

believe that both voluntary and

mandatory frameworks can be used by

the Innovation Center to test models and

can accomplish different goals. As

described in the proposed rule and

previously in section IV.C.3.a of this

final rule, for the ETC Model, we believe

that a mandatory framework is critical

to avoid selection bias and to ensure a

broad representation of participants.

Concurrent with the ETC Model test, we

plan to test the voluntary KCC Model to

test the efficacy of coordinated care for

beneficiaries with advanced kidney

disease.

Comment: We received several

comments urging CMS to exclude from

the ETC Model beneficiaries aligned to

coordinated care models, particularly

beneficiaries aligned to participants in

the CEC Model or the KCC Model.

Response: We appreciate the

feedback; however, we believe that

these models are testing different policy

questions and that beneficiaries should

be aligned or attributed to participants

in more than one model if such

alignment or attribution is consistent

with the methodologies for the models.

The CEC and KCC Models are focused

around incentives for managing total

cost of care and for managing

beneficiary care across different

providers, while the ETC Model is

focused specifically on dialysis

modality selection. While both the KCC

and ETC Models include financial

incentives around kidney

transplantation, we believe that the

incentives are different enough in

structure, including with respect to the

entity to whom the incentive payments

are made, that both are worth testing.

We view this payment overlap between

the ETC Model and the KCC Model as

similar to how an ESRD facility may

both participate in the CEC Model and

be subject to payment adjustments

under the ESRD PPS based on the

facility’s performance under the ESRD

QIP. Additionally, we are concerned

about having a sufficiently large

beneficiary population to be able to

evaluate the results from the ETC Model

if KCC Participants are excluded and are

also concerned about a situation where

ETC Participants could control whether

a beneficiary is aligned to them under

the ETC Model by taking steps to ensure

that the beneficiary is aligned to an

entity participating in either the CEC

Model or the KCC Model.

Comment: We received comments

urging that any payment adjustments

under the ETC Model be excluded from

the payment calculations under the

Medicare Shared Savings Program or

under models tested by the Innovation

Center under section 1115A of the Act.

Response: We believe that excluding

ETC Model payments from the payment

calculations under these other

initiatives would compromise the

design of these other initiatives, many of

which are focused on accountability for

the total cost of care. For example, the

Medicare Shared Savings Program

considers all Medicare Part A and B

expenditures, only excluding Inpatient

Medical Education and

Disproportionate Share Hospital

payments, while explicitly including

individually beneficiary identifiable

final payments made under a

demonstration, pilot or time limited

program when performing financial

calculations under the program (see, for

example, 42 CFR 425.601(c)(2)). We

view the inclusion of payment

adjustments made under the ETC Model

as similar to how the payment

adjustments for CMS quality programs,

like the ESRD QIP, are incorporated into

expenditure calculations under the

Medicare Shared Savings Program and

models tested by the Innovation Center

under section 1115A.

Comment: We received a comment

urging CMS to adopt quality measures

around home dialysis and kidney

transplants under the ESRD QIP, rather

than testing the separate ETC Model.

Response: CMS is proposing to

implement these payment adjustments

in the ETC Model rather than the ESRD

QIP because it is our intention to apply

these incentives to Managing Clinicians

in addition to ESRD facilities. The

incentives in the ESRD QIP program

apply to ESRD facilities, and not to

Managing Clinicians, yet CMS believes

that Managing Clinicians are a key part

of supporting beneficiary modality

choice and should also face payment

incentives to increase utilization of

home dialysis and transplants.

Additionally, the maximum penalty for

the ESRD QIP is 2 percent and we

believe that increasing rates of home

dialysis and the inclusion of

beneficiaries on transplant waitlists are

important enough areas to focus on that

ETC Participants should have a larger

potential downside and the potential for

upside for succeeding in improving

their rates in these areas.

Comment: We received a comment

from a group representing physicians

pointing out that Managing Clinicians

who are MIPS eligible clinicians are

already subject to MIPS and would be

subject to a second set of payment

adjustments under the ETC Model. They

urged that nephrologist payments only

be adjusted by MIPS.

Response: The MIPS program was

designed to tie payments to quality and

cost efficient care, drive improvement in

care processes and health outcomes,

increase the use of healthcare

information, and reduce the cost of care,

while the ETC Model has a narrower

focus on kidney replacement modality

choice. CMS believes that both are

important focuses for Managing

Clinicians. Accordingly, CMS believes it

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is appropriate for Managing Clinicians

participating in the ETC Model to have

their payments adjusted under both the

MIPS program and the ETC Model.

After considering the public

comments, we are finalizing the

overlaps in policy as proposed without

modification.

7. Medicare Program Waivers

We noted in the proposed rule our

belief that it was necessary and

appropriate to provide additional

flexibilities to ETC Participants for

purposes of testing the ETC Model. The

purpose of such flexibilities would be to

give ETC Participants additional access

to the tools necessary to ensure ESRD

Beneficiaries can select their preferred

treatment modality, resulting in better,

more coordinated care for beneficiaries

and improved financial efficiencies for

Medicare, providers, suppliers, and

beneficiaries.

We proposed to implement these

flexibilities using our waiver authority

under section 1115A of the Act. Section

1115A(d)(1) of the Act provides

authority for the Secretary to waive such

requirements of title XVIII of the Act as

may be necessary solely for purposes of

carrying out section 1115A of the Act

with respect to testing models described

in section 1115A(b) of the Act. This

provision affords broad authority for the

Secretary to waive Medicare program

requirements as necessary to test models

under section 1115A of the Act.

The following is a summary of the

comments we received suggesting that

CMS issue additional waivers and our

responses.

Comment: We received many

comments urging CMS to waive other

requirements. Many commenters

requested CMS to waive requirements

similar to those we have indicated that

we intend to waive for purposes of

testing the voluntary KCC Model, such

as the requirements that will be waived

for purposes of testing the Concurrent

Care for Beneficiaries that Elect the

Medicare Hospice Benefit Enhancement,

the Home Health Benefit Enhancement,

Telehealth Benefit Enhancement, and

Post-Discharge Home Visits Benefit

Enhancement under that Model, as well

as requirements we have waived for

purposes of testing the voluntary Next

Generation Accountable Care

Organization Model, including the

waivers necessary for testing the Care

Management Home Visits Benefit

Enhancement. A commenter also

specifically requested that CMS waive

certain telehealth requirements as

necessary to test allowing nurses to

provide home dialysis visits via

telemedicine under the Model.

Another commenter asked CMS to

waive back-up arrangement

requirements for certifications of home

dialysis providers, and instead allow

licensed home-dialysis providers to

provide back-up hemodialysis in the

space licensed for home dialysis. CMS

also received a comment requesting to

include a waiver to permit advanced

practice providers under the general

supervision of a Managing Clinician to

manage a patient’s home dialysis care.

A commenter urged CMS include

waivers necessary to allow renal

dieticians to bill for services of nutrition

education under this Model. According

to the commenter, nutrition therapy and

education provided by a renal dietician

can improve the patient’s quality of life

and delay the progress of kidney

disease. We received a comment

suggesting that CMS issue a waiver to

allow certified dialysis technicians,

without the physical presence of a

licensed nurse, and clinicians providing

remote monitoring to qualify as

caregivers who may perform Medicare-

covered home dialysis.

Response: We thank all of the

commenters for their feedback. The

suggested benefit enhancements and

other waivers were not included in the

proposed rule, and we therefore are not

finalizing these benefit enhancements or

other waivers suggested by the

commenters in this final rule. CMS will

take the commenters’ feedback into

consideration as we consider potential

future changes to the model design.

a. Medicare Payment Waivers

In order to make the proposed

payment adjustments under the ETC

Model, namely the HDPA and PPA

discussed in the proposed rule and in

sections IV.C.4 and IV.C.5 of this final

rule, respectively, we stated in the

proposed rule that we believe we would

need to waive certain Medicare program

rules.

Therefore, in accordance with the

authority granted to the Secretary in

section 1115A(d)(1) of the Act, we

proposed to waive requirements of the

Act for the ESRD PPS and PFS payment

systems 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.

Also, we proposed to waive the

requirement in section 1881(h)(1)(A) of

the Act that payments otherwise made

to a provider of services or a renal

dialysis facility under the system under

section 1881(b)(14) of the Act for renal

dialysis services be reduced by up to 2.0

percent if the provider of services or

renal dialysis facility does not meet the

requirements of the ESRD QIP for a

payment year, as may be necessary

solely for purposes of ensuring that the

ESRD QIP payment reduction would be

applied to ESRD PPS payments that

have been adjusted by the HDPA and

the PPA. In addition, we proposed that

the payment adjustments made under

this Model 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 proposed to make

payment adjustments without impacting

beneficiary cost sharing because, if

beneficiary cost sharing changed as a

result of the HDPA and the PPA, this

would create a perverse incentive in

which beneficiaries would pay less to

receive services from ETC Participants

with lower rates of home dialysis and

transplants, potentially increasing

beneficiary interest in receiving care

from providers and suppliers

performing poorly on the rates the ETC

Model intends to improve, which would

be contrary to the purpose of the Model.

Therefore, we proposed to waive the

requirements of sections 1833(a),

1833(b), 1848(a)(1), 1881(b), and

1881(h)(1)(A) of the Act to the extent

that these requirements otherwise

would apply to payments made under

the ETC Model. We sought comment on

our proposed waivers of Medicare

payment requirements related to the

HDPA and PPA and beneficiary cost

sharing.

The following is a summary of the

comments we received on the proposed

Medicare payment waivers and our

responses.

Comment: We received comments

supporting our proposal that beneficiary

cost-sharing would be unaffected by the

HDPA and the PPA.

Response: We thank the commenters

for their feedback and support and will

finalize this policy as proposed.

Comment: A commenter asked CMS

to consider including a waiver for

payment modifications for surgeons,

hospitals, and surgery centers within

the Model to bring reimbursement for

PD catheter placement in-line with

arteriovenous fistula reimbursement.

Additionally, the commenter

recommended adding a PD catheter

placement diagnosis related group

payment to further incentivize surgeons,

hospitals, and surgery centers to

perform this procedure.

Response: We thank the commenter

for these suggestions. This type of

waiver was not included in the

proposed rule, and we therefore are not

finalizing a waiver of this nature in this

final rule. Additionally, the

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158

United States Government Accountability

Office, 2015.

159

United States Government Accountability

Office, 2015.

commenter’s recommendation to add a

PD catheter placement diagnosis related

group payment is outside the scope of

this rulemaking. CMS will take the

commenter’s other recommendations

into consideration for future potential

changes to the model design.

After considering the public

comments received, CMS will finalize

the Medicare payment waivers,

including our policy with respect to

beneficiary cost-sharing, as proposed

without modification in our regulation

at 42 CFR 512.397(a).

b. Waiver of Select KDE Benefit

Requirements

We stated in the proposed rule our

belief that it is necessary for purposes of

testing the ETC Model to waive select

requirements of the KDE benefit

authorized in section 1861(ggg)(1) of the

Act and in the implementing regulation

at 42 CFR 410.48. Medicare currently

covers up to 6, 1-hour sessions of KDE

services for beneficiaries that have Stage

IV CKD. While the KDE benefit is

designed to educate and inform

beneficiaries about the effects of kidney

disease, their options for

transplantation, dialysis modalities, and

vascular access, the uptake of this

service has been low at less than 2

percent of eligible patients. As noted in

the proposed rule, we believe that the

KDE benefit is one of the best tools to

promote treatment modalities other than

in-center HD and that this waiver is

necessary to test ways to increase its

utilization from its current low rate as

part of the model test.

We proposed to waive the following

requirements for ETC Participants

billing for KDE services:

•Currently, doctors, physician

assistants (PAs), nurse practitioners

(NPs), and clinical nurse specialists

(CNSs) are the only clinician types that

can furnish and bill for KDE services as

required by section 1861(ggg)(2)(A)(i) of

the Act and its implementing regulation

at 42 CFR 410.48(a) and 42 CFR

410.48(c)(2)(i). However, the payment

for KDE is lower than a typical

evaluation and management (E/M) visit,

so there may be limited financial

incentive for these clinician types to

conduct the KDE sessions. There are

various other types of health care

providers that also may be well-suited

to educate beneficiaries about kidney

disease, such as registered dieticians

and nephrology nurses. In its 2015

report on home dialysis, GAO

recommended allowing other types of

health care providers to perform KDE to

increase uptake of the benefit.

158

We

proposed to waive the requirement that

KDE be performed by a physician, PA,

NP or CNS, to allow additional clinical

staff such as dietitians and social

workers to furnish the service under the

direction of a Medicare-enrolled

participating Managing Clinician. The

staff would not need to be Medicare-

enrolled, but would furnish these

services incident to the services of a

clinician authorized to bill Medicare for

KDE services as specified in section

1861(ggg)(2)(B)(i). In the proposed rule,

we considered also waiving the

requirement under section

1861(ggg)(2)(B) of the Act and the

implementing regulation at 42 CFR

410.48(c)(2)(ii) restricting ESRD

facilities from billing for KDE directly,

but decided not to, as we did not believe

it is necessary for testing the Model.

Moreover, ESRD facilities are already

required to provide information to

beneficiaries about their treatment

modality options in the ESRD facility

conditions for coverage at § 494.70(a)(7);

and to develop and implement a plan of

care that addresses the patient’s

modality of care, at § 494.90(a)(7).

•KDE is now covered only for

Medicare beneficiaries with Stage IV

CKD as required by section

1861(ggg)(1)(A) of the Act and in the

implementing regulations at 42 CFR

410.48(b)(1). As we noted in the

proposed rule, we understood this

prevents many beneficiaries in Stage V

of CKD from receiving the benefits of

KDE before starting dialysis or pursuing

a transplant. In the proposed rule, we

hypothesized that beneficiaries with

ESRD could also benefit from this

education in the first 6 months after an

ESRD diagnosis. While CKD Stage V and

early ESRD patients’ disease may be

more advanced and the prospect of

dialysis or transplant more certain than

for patients with Stage IV CKD, there is

still opportunity to improve beneficiary

knowledge to ensure the best patient-

centered care and outcomes. GAO

recommended covering the KDE benefit

for beneficiaries with Stage V CKD.

159

We proposed to waive the requirement

that KDE is covered only for Stage 4

CKD patients for purposes of testing the

ETC Model and to permit beneficiaries

with CKD Stage V and those in the first

6 months of receiving an ESRD

diagnosis to receive the benefit, when

billed by an ETC Participant who is a

Managing Clinician.

•Under 42 CFR 410.48(d)(1), at least

one of the KDE sessions must be

dedicated to management of

comorbidities, including delaying the

need for dialysis. Because we proposed

a waiver that would extend the KDE

benefit to beneficiaries with CKD Stage

V and ESRD in the first 6 months of

diagnosis, this KDE topic may no longer

be relevant to patients who are facing a

more immediate decision to commence

dialysis or arrange for a kidney

transplant. We proposed to waive the

requirement that KDE include the topic

of managing comorbidities and delaying

the need for dialysis under the ETC

Model, when furnishing KDE to

beneficiaries with CKD Stage V and

ESRD. We proposed further clarifying,

however, that ETC Participants who are

Managing Clinicians furnishing KDE

(either personally or with clinical staff

incident to their services) must still

cover this topic if relevant to the

beneficiary, for example, if the

beneficiary has not yet started dialysis

and can still benefit from education

regarding delaying dialysis.

•Under 42 CFR 410.48(d)(5)(iii), an

outcomes assessment designed to

measure beneficiary knowledge about

CKD and its treatment must be

performed by a qualified clinician

during one of the 6 sessions. This

requirement presents two challenges;

first that it may take away time from a

session that could be dedicated

exclusively to education, and second

that if a beneficiary demonstrates

inadequate knowledge, there may not be

sufficient time in one session to address

all areas in which a beneficiary might

need assistance. If the outcomes

assessment could be performed by

qualified staff during a follow-up visit to

the Managing Clinician, there would

still be 6 full KDE sessions available to

beneficiaries, and we believe there

would be more flexibility for the

qualified staff to reinforce what the

beneficiary learned during the KDE

sessions and fill in any gaps. We

proposed to maintain the requirement

that an outcomes assessment be

performed by qualified staff in some

manner within one month of the final

KDE session, but to waive the

requirement that it be conducted within

a KDE session.

In the proposed rule, we also

considered waiving the co-insurance

requirement for the KDE benefit and

certain telehealth requirements to allow

the KDE benefit to be delivered via

telehealth for beneficiaries outside of

rural areas and other applicable

limitations on telehealth originating

sites, but did not believe those waivers

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were necessary for purposes of testing

the Model.

The following is a summary of the

comments received on the proposed

waivers of select requirements of the

KDE benefit for purposes of testing the

ETC Model and the alternatives

considered and our responses.

Comment: We received several

comments, supporting CMS’ proposal to

waive select requirements of the KDE

Benefit for the purposes of testing the

ETC Model. However, many

commenters asked CMS to further

increase the scope of the KDE benefit

under the proposed waivers, specifically

in order to allow additional clinicians

and health care sites provide the KDE

benefit, including dieticians, social

workers, ambulance providers, home

health aides, and other clinicians who

work in nursing homes or ESRD

facilities. Additionally, a commenter

asked CMS not to increase the scope of

the KDE benefit to dialysis provider

staff, while another requested that CMS

issue additional waivers in order to

provide more flexibility around the

timeframe within which the KDE benefit

could be provided. Finally, a

commenter expressed concern that the

KDE Benefit would permit health care

providers to give beneficiaries

incomplete information.

Response: We appreciate the

commenters’ support for our proposals

to waive select requirements of the KDE

benefit for purposes of testing the ETC

Model. While we understand the

commenter’s interest in increasing even

further the types of clinicians and

entities that may provide the KDE

benefit, we believe that our proposed

policy provides the necessary flexibility

to test the Model and will finalize the

types of clinicians and entities that may

provide the KDE benefit as proposed.

We also understand the commenter’s

concern that the proposed waivers of

certain KDE Benefit requirements would

allow health care providers to give

beneficiaries less information than is

currently required. However, we

proposed to waive the requirement to

include managing comorbidities and

delaying the need for dialysis as a

required topic as part of a KDE session

because those topics may not be

relevant to beneficiaries with CKD Stage

V and ESRD, who will be able to receive

the KDE Benefit under the ETC Model.

We also will finalize our proposed

clarification that ETC Participants who

are Managing Clinicians furnishing KDE

(either personally or with clinical staff

incident to their services) must still

cover this topic if relevant to the

beneficiary, for example, if the

beneficiary has not yet started dialysis

and can still benefit from education

regarding delaying dialysis.

Comment: We received comments

urging CMS to waive additional

categories of beneficiary cost sharing in

this Model, including cost-sharing for

the KDE benefit or home-dialysis

treatments.

Response: We thank the commenters

for their feedback. While we considered

waiving the coinsurance for the KDE

benefit, the ETC Model aims to test the

use of financial incentives for ETC

Participants (namely Managing

Clinicians and ESRD facilities), rather

than beneficiary incentives, and we are

concerned that testing a financial

incentive for ETC Participants in

conjunction with additional behavioral

incentives for beneficiaries could

confound the Model test. Specifically, it

would be difficult to determine whether

the impacts observed in the Model are

a result of the Model’s financial

incentives or beneficiary incentives.

Additionally, CMS is concerned that

including waivers for additional

categories of beneficiary cost-sharing

could influence beneficiaries to choose

health care providers based on the lower

cost of treatment, rather than the quality

of care that the health care providers

deliver. CMS will take the commenters’

recommendations into consideration for

future potential changes to the model

design.

Comment: We received one comment

asking CMS to change payment for KDE

to ‘‘per treatment-hour reimbursement’’

to incentivize ESRD facilities to educate

patients as early as possible for

transition to home dialysis. The

commenter also suggested that ‘‘highly

skilled, 24/7 centralized real-time

equipment and clinical telephone

support’’ must be in place after patients

begin dialyzing at home.

Response: We thank the commenter

for this feedback. We did not propose to

change payment for the KDE benefit in

the proposed rule, nor did we propose

to require that ‘‘highly skilled, 24/7

centralized real-time equipment and

clinical telephone support’’ be in place

after patients begin dialyzing at home,

and we therefore are not finalizing these

policies in this final rule. CMS will take

the commenter’s recommendations into

consideration for future potential

changes to the model design.

Comment: A commenter

recommended the commenter’s

proprietary tool for patient education

programs for home dialysis and asked

CMS to require ETC Participants to use

this tool in all educational programs

related to home dialysis.

Response: While we encourage

innovation in both the private and

public sectors, CMS is not permitted to

endorse any particular product.

After considering the public

comments, we are finalizing the

proposed waivers of select requirements

of the KDE Benefit for purposes of

testing the ETC Model, with changes, in

our regulation at § 512.397(b).

Specifically, we will waive the

requirement that only doctors,

physician assistants, nurse practitioners,

and clinical nurse specialists can

furnish KDE services to allow KDE

services to be provided by clinical staff

under the direction of and incident to

the services of the Managing Clinician

who is an ETC Participant. Our

regulation at § 512.397(b) will now list

the Supplier and Non-Physician

Practitioner types that will be able to

furnish and bill for the KDE benefit

under this waiver. This list does not

exclude any supplier types that would

otherwise have been permitted to

furnish the KDE benefit. Specifically,

the waiver will allow the KDE benefit to

be furnished and billed by a physician,

as well as a clinical nurse specialist,

licensed clinical social worker, nurse

practitioner, physician assistant,

registered dietician/nutrition

professional, and supplier specialty

listed as clinic/group practice to test

greater use of the KDE benefit. We also

will waive the requirement that KDE is

covered only for Stage 4 CKD patients

to permit beneficiaries with CKD Stage

V and those in the first 6 months of

starting dialysis to receive the KDE

benefit. In the proposed rule, we stated

that we would waive this requirement to

permit beneficiaries with CKD Stage V

and those in the first 6 months of an

ESRD diagnosis to receive the KDE

benefit. However, we have since

determined that using ESRD diagnosis

codes to identify beneficiaries in the

first 6 months of an ESRD diagnosis in

order to determine eligibility for the

KDE benefit would be difficult to

operationalize due to the potential for

delays in reporting of the diagnosis, as

well as incomplete reporting of

diagnosis codes on Medicare claims. By

contrast, CMS can use Medicare claims

data to more quickly and accurately

identify ESRD Beneficiaries based on

the submission of claims for the

initiation of dialysis, which is

consistent with how Medicare FFS

identifies ESRD Beneficiaries generally.

We are therefore modifying our

regulation at 512.397(b)(2) to permit

KDE services to be furnished to

beneficiaries in the first 6 months of

starting dialysis (rather than the first 6

months of receiving an ESRD diagnosis).

Therefore, in the final rule, we will

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waive this requirement to permit

beneficiaries with CKD Stage IV, CKD

Stage V, and those in the first 6 months

of dialysis to receive the KDE benefit.

Also, as we noted in the preamble to the

proposed rule, we clarify that this

waiver applies only when claims for

such services are billed by an ETC

Participant who is a Managing

Clinician. We will also waive the

requirement that the content of the KDE

sessions include the topic of managing

comorbidities and delaying the need for

dialysis under the ETC Model, when

such services are furnished to

beneficiaries with CKD Stage V or

ESRD. However, we will require that

ETC Participants who are Managing

Clinicians furnishing KDE (either

personally or with clinical staff incident

to their services) must still cover this

topic if relevant to the beneficiary, for

example, if the beneficiary has not yet

started dialysis and can still benefit

from education regarding delaying

dialysis. As proposed, we will waive the

requirement that an outcomes

assessment designed to measure

beneficiary knowledge about CKD and

its treatment be performed by qualified

staff as part of one of the KDE sessions,

provided that such outcomes

assessment is performed in some

manner within one month of the final

KDE session by qualified staff.

8. Compliance With Fraud and Abuse

Laws

The authority for the ETC Model is

section 1115A of the Act. Under section

1115A(d)(1) of the Act, the Secretary of

Health and Human Services may waive

such requirements of Titles XI and XVIII

and of sections 1902(a)(1), 1902(a)(13),

1903(m)(2)(A)(iii), and certain

provisions of section 1934 as may be

necessary solely for purposes of carrying

out section 1115A with respect to

testing models described in section

1115A(b). For this Model and consistent

with this standard, the Secretary may

consider issuing waivers of certain fraud

and abuse provisions in sections 1128A,

1128B, and 1877 of the SSA. However,

CMS proposed that no fraud and abuse

waivers would be issued for this Model.

Thus, notwithstanding any other

provision of this final regulation, all

ETC Participants must comply with all

applicable laws and regulations.

The following is a summary of the

comments received on compliance with

fraud and abuse laws and our responses.

Comment: We received several

requests from commenters to include

waivers of the physician self-referral

law (commonly referred to as the ‘‘Stark

law’’), Federal Anti-Kickback Statute,

and the Beneficiary Inducements Civil

Monetary Penalty to provide ETC

Participants with the flexibilities found

in other models tested under the

authority of section 1115A of the Act.

Commenters asserted that these fraud

and abuse waivers are necessary to

improve care coordination, population

health management, patient education

on home dialysis, and post-transplant

care.

Response: We appreciate the

commenters’ interest in this matter.

However, as we stated in the proposed

rule (84 FR 34563), no fraud and abuse

waivers are being issued for this Model.

At this time, we believe that the

arrangements contemplated by this

Model can be executed in a manner that

complies with existing fraud and abuse

laws and that fraud and abuse waivers

are not necessary to test this Model.

Thus, notwithstanding any other

provisions of this final regulation, all

ETC Participants must comply with all

applicable laws and regulations.

9. Beneficiary Protections

As we discussed in the proposed rule

and in section IV.C.4.b of this final rule,

we proposed to attribute non-excluded

ESRD Beneficiaries and, as applicable,

pre-emptive transplant beneficiaries to

the ETC Participant that furnishes the

plurality of the beneficiary’s dialysis

and other ESRD-related services.

Although the ETC Model would not

allow ESRD Beneficiaries to opt out of

the payment adjustment methodology

being applied to the Medicare payments

made for their care, the Model would

not affect beneficiaries’ freedom to

choose their dialysis services provider

or supplier, meaning that beneficiaries

may elect to see any Medicare-enrolled

provider or supplier including those

selected and not selected to participate

in the Model based on geography. In

addition, the general beneficiary

protections described in the proposed

rule and section II.B.2.a.(8) of this final

rule would apply to the ETC Model;

accordingly, ETC Participants would be

prohibited from restricting beneficiary

freedom of choice or access to medically

necessary covered services, which

includes the beneficiary’s choice

regarding the appropriate modality to

receive covered services. ETC

Participants also would be prohibited

from using or distributing descriptive

model materials and activities that are

materially inaccurate or misleading. We

proposed to prohibit ETC Participants

from offering or paying any

remuneration to influence a

beneficiary’s choice of renal

replacement modality, unless such

remuneration complied with all

applicable law. We stated in the

proposed rule that we believed this

policy is necessary to help ensure that

beneficiary modality selection is based

on the care of the beneficiary and the

beneficiary’s needs and preferences,

rather than financial or other incentives

the beneficiary may have received or

been offered.

Furthermore, we explained in the

proposed rule, beneficiaries with

disabilities who receive care from ETC

Participants, including dementia and

cognitive impairments, remain

protected under Federal disability rights

laws including, but not limited to,

section 504 of the Rehabilitation Act of

1973, the Americans with Disabilities

Act of 1990, as amended, and section

1557 of the Patient Protection and

Affordable Care Act. These beneficiaries

cannot be denied access to home

dialysis or kidney transplant due to

their disability. We stated that ETC

Participants may not apply eligibility

criteria for participation in programs,

activities, and services that screen out or

tend to screen out individuals with

disabilities; nor may ETC Participants

provide services or benefits to

individuals with disabilities through

programs that are separate or different,

excepting those separate programs that

are necessary to ensure that the benefits

and services are equally effective.

In addition, as described in the

proposed rule and in sections IV.C.4.c

and IV.C.5.e.(2) of this final rule, we

proposed to apply the Clinician HDPA

and the Clinician PPA to the amount

otherwise paid under Medicare Part B

and furnished by the Managing

Clinician during the CY subject to

adjustment, which would mean that

beneficiary cost sharing would not be

affected by the application of the

Clinician HDPA and the Clinician PPA.

Similarly, as described in the proposed

rule and section IV.C.7.a. of this final

rule, we proposed to use our waiver

authority under section 1115A(d)(1) of

the Act to issue certain payment

waivers, pursuant to which beneficiaries

would be held harmless from any

model-specific payment adjustments

made to Medicare payments under this

Model.

We proposed to specify in our

regulations at § 512.330(a) that ETC

Participants would be required to

prominently display informational

materials in each of their offices or

facility locations where beneficiaries

receive treatment to notify beneficiaries

that the ETC Participant is participating

in the ETC Model. This notification

would serve to inform a beneficiary that

his or her provider or supplier is

participating in a model that

incentivizes the use of home dialysis

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and kidney transplants and who to

contact if they have questions or

concerns. As we stated in the proposed

rule, we proposed this notification to

further non-speculative government

interests including transparency and

beneficiary freedom of choice. So as not

to be unduly burdensome, we stated in

the proposed rule that CMS intends to

provide a template for these materials to

ETC Participants, which would identify

required content that the ETC

Participant must not change and places

where the ETC Participant may insert its

own original content. This template

would include information for

beneficiaries about how to contact the

ESRD Network Organizations with any

questions or concerns regarding

participation in the ETC Model by their

health care provider(s). (The 18 ESRD

Network Organizations serve distinct

geographical regions and operate under

contract to CMS; their responsibilities

include oversight of the quality of care

to ESRD Beneficiaries, the collection of

data to administer the national Medicare

ESRD program, and the provision of

technical assistance to ESRD providers

and patients in areas related to ESRD).

We noted in the proposed rule that all

other ETC Participant communications

with beneficiaries that are descriptive

model materials and activities would be

subject to the requirements for such

materials and activities included in the

general provisions, as discussed in the

proposed rule and section II.D.3 of this

final rule.

The following is a summary of the

comments received on the proposed

beneficiary protections and our

responses.

Comment: We received multiple

comments expressing concern that the

structure and incentives of the Model

could produce unintended

consequences that would be contrary to

beneficiary freedom of choice and

access to medically necessary covered

services. Many commenters stressed

that the criteria for ESRD Beneficiaries

to be excluded from attribution to ETC

Participants under the ETC Model,

described in § 512.360(b) of the

regulatory text, should include an

exclusion for patient treatment choice.

Additionally, a commenter

recommended that beneficiaries be

allowed to opt of out the Model. The

rationale for these suggestions was that

patients could choose other treatment

modalities or supportive care due to

religious reasons, patients’ need or

desire to travel for work or leisure, or

reliance on inpatient facilities due to

other confounding co-morbidities or

factors. Several commenters

acknowledged that patients may choose

other treatment modalities besides home

dialysis or transplant despite adequate

education on treatment choices.

Accordingly, a commenter suggested

adding in a quality measure for

physician-patient relationship and the

shared decision making process.

Response: CMS appreciates the

feedback to include additional

provisions regarding patient choice in

the design of the model, but believes

patient choice is adequately protected in

the provision to be finalized in our

regulation at § 512.120. As applied to

the ETC Model, this provision prohibits

ETC Participants from inhibiting a

beneficiary’s freedom to choose the

provider and supplier from which they

receive care. The ETC Model would not

restrict beneficiaries from choosing in-

center dialysis as their treatment choice.

We are, however, making certain

modifications to our proposed

beneficiary notification requirements in

light of the comments received. As

proposed, each ETC Participant will be

required to prominently display

informational materials in each of their

office or facility locations where

beneficiaries receive treatment to notify

beneficiaries that the ETC Participant is

participating in the ETC Model. Also as

proposed, CMS will provide a template

for these materials, which will include

information for beneficiaries about how

to contact the ESRD Network

Organizations with any questions or

concerns regarding participation in the

ETC Model by their health care

provider(s). To promote CMS’s interest

in ensuring that beneficiaries are not

mislead into believing that the Model in

any way restricts their freedom of

choice, the CMS-provided template for

the beneficiary notification materials

will also include an affirmation of a

beneficiary’s protections under

Medicare, including the freedom to

choose his or her provider or supplier

and to select the treatment modality of

his or her choice. We have revised our

regulation at § 512.330(a) to specify that

the CMS-provided template for the

beneficiary notification will include,

without limitation, this information.

Additionally, ETC Participants must

continue to make medically necessary

covered services available to

beneficiaries and cannot target or avoid

treating beneficiaries on the basis of

their income levels or other factors that

would render a beneficiary an at-risk

beneficiary as that term is defined for

purposes of the Medicare Shared

Savings Program, and similarly may not

selectively target or engage beneficiaries

who are relatively healthy or otherwise

expected to improve the ETC

Participant’s financial or quality

performance in the ETC Model. We

address comments related to beneficiary

exclusions under section IV.C.B.1 of this

final rule. Beneficiaries are not Model

participants and while they cannot opt

out of the ETC Model’s payment

methodology, attributed beneficiaries

retain all existing beneficiary rights and

protections regarding Medicare Parts A

and B services, including choice of

providers, suppliers and treatment

modality.

Comment: We received one comment

requesting that we create an Alternative

Payment Models Beneficiary

Ombudsman to cast a wide net for

beneficiary issues.

Response: We disagree that a

Beneficiary Ombudsman is necessary

for the testing of the ETC Model. As

previously noted, beneficiaries are not

Model participants and while they

cannot opt out of the ETC Model’s

payment methodology, attributed

beneficiaries retain all existing

beneficiary rights and protections

regarding Medicare Parts A and B

services, including choice of providers,

suppliers and treatment modality. In

addition, as described elsewhere in this

final rule, we plan to conduct the

monitoring activities described in our

regulation at § 512.150 to determine

whether the Model is resulting in

unintended consequences, including

impact on beneficiary choice. We thank

the commenter for this feedback and are

finalizing the rule without the addition

of a Beneficiary Ombudsman.

Comment: We received two comments

in support of the beneficiary protection

provisions identified in § 512.120 of the

proposed rule and their application to

the ETC Model. Multiple commenters

appreciated CMS proposals to protect

beneficiaries’ freedom to choose

services providers and suppliers by

applying the general beneficiary

protection provisions identified in

§ 512.120 to the ETC Model and the

proposed requirement for ETC

Participants to notify beneficiaries of

such participation under proposed

§ 512.330(a).

Response: We thank the commenters

for their feedback and support.

Comment: A commenter

recommended that beneficiaries be

provided optional assistance in

transferring to a provider or supplier not

participating in the ETC Model without

undue hardship, including assistance

with any transportation barriers. Some

commenters asked for beneficiaries to

have the ability to formally indicate

they are not interested in home dialysis

or kidney transplantation and, as a

result, to be excluded from the home

dialysis rate and transplant rate

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calculations for purposes of the ETC

Model.

Response: We disagree with these

recommendations and will finalize the

rule without this modification. Nothing

in this final rule prohibits a practice

from offering beneficiaries the optional

assistance described by the commenter,

as long as the assistance complies with

all applicable laws and regulations,

including the Federal anti-kickback

statute and the civil monetary penalty

provision prohibiting inducements to

beneficiaries. To the extent the

commenter is advocating that the

Secretary waive one or more laws

pursuant to section 1115A(d)(1) of the

Act to enable the provision of

transportation or other assistance, we

note that the statutory standard for

issuance of such a waiver would not be

satisfied because we have determined

that offering transportation or other

assistance to beneficiaries is not

necessary to test the ETC Model. The

Model would not affect beneficiaries’

freedom to choose their dialysis services

provider or supplier, meaning that

beneficiaries may elect to see any

Medicare-enrolled provider or supplier

including those selected and not

selected to participate in the Model

based on geography. We decline to

modify the Model terms to permit

beneficiaries to opt out of the Model

payment adjustment methodology being

applied to the Medicare payments made

for their care because their attribution

and inclusion are necessary to

determine if Model payment

adjustments can achieve the Model’s

goals of increasing rates of home

dialysis utilization and kidney

transplantation and, as a result,

improving or maintaining the quality of

care while reducing Medicare

expenditures among all types of ESRD

facilities and for a full representation of

beneficiaries receiving services at those

ESRD facilities. In addition, while

payment adjustments to the Managing

Clinicians and ESRD facilities are being

tested under the Model, the health care

services available to Beneficiaries likely

will not change since the Beneficiary

will retain their existing Medicare right

to choose their providers and suppliers,

as identified in § 512.120 of the final

rule. The notification required under

§ 512.330 will also include an

affirmation of the ESRD Beneficiary’s

protections under Medicare, including

the beneficiary’s freedom to choose his

or her provider or supplier and to select

the treatment modality of his or her

choice.

Comment: A commenter

recommended that we require ETC

Participants to inform beneficiaries

about all available coverage options and

disclose relevant information about

payments to patients and insurers.

Response: We disagree that

beneficiary notifications beyond those

identified in §§ 512.330 and 512.120 of

the final rule are necessary for the

testing of this Model. As noted in the

proposed rule and elsewhere in this

final rule, beneficiaries will retain all

existing beneficiary rights and

protections regarding Medicare Parts A

and B services, including choice of

providers, suppliers, and treatment

modality.

After considering the public

comments, we are finalizing the

proposed beneficiary notification

requirements in our regulation at

§ 512.330 with modification. In

§ 512.330(b) of the final rule, we are

making a change to the applicability of

our regulation at § 512.120(c) (regarding

descriptive model materials and

activities) to the CMS-provided

templates for the informational

materials required to be displayed in the

office or facilities of ETC Participants

where beneficiaries receive treatment

described in our regulation at

§ 512.330(a). In the proposed rule, we

had proposed that the entirety of

§ 512.120(c) would not apply to such

CMS-provided materials. However, this

was a drafting error. We had intended

to refer only to the requirement in

512.120(c)(2), such that the requirement

to include the disclaimer that ‘‘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’’ would not

apply to those CMS-provided materials.

Because the purpose of these materials

is to educate beneficiaries about the

Model and because our regulation at

§ 512.330(a) will permit an ETC

Participant to insert its own original

content to the CMS-provided templates,

where indicated by CMS, we believe

that it is important that the other

requirements of § 512.120(c) apply to

those materials, including the

requirement that such materials not be

materially inaccurate or misleading, that

ETC Participants retain copies of such

materials, and that CMS reserve the

right to review such materials to

determine whether the content added by

the ETC Participant is materially

inaccurate or misleading. Also, we have

revised § 512.330(a) of our regulations to

specify that the CMS-provided template

for the beneficiary notification will

include, without limitation, a

notification that the ETC Participant is

participating in the ETC Model;

instructions on how to contact the ESRD

Network Organizations with any

questions or concerns about the ETC

Participant’s participation in the Model;

and an affirmation of the ESRD

beneficiary’s protections under

Medicare, including the beneficiary’s

freedom to choose his or her provider or

supplier and to select the treatment

modality of his or her choice.

10. Monitoring

a. Monitoring Activities

We proposed that the general

provisions relating to monitoring

described in the proposed rule and in

section II.I of this final rule would apply

to ETC Participants, including but not

limited to cooperating with the model

monitoring activities under § 512.150,

granting the government the right to

audit under § 512.135(a), and retaining

and providing access to records under

§§ 512.135(c) and 512.135(b),

respectively. CMS would conduct the

model monitoring activities in

accordance with the proposed

§ 512.150. We stated in the proposed

rule that we believed that we must

closely monitor the implementation and

outcomes of the ETC Model throughout

its duration. As described in the

proposed rule, the purpose of

monitoring would be to ensure that the

Model is implemented safely and

appropriately; that ETC Participants

comply with all the terms and

conditions of the ETC Model; and to

protect beneficiaries from potential

harms that may result from the activities

of an ETC Participant. All monitoring

activities under the ETC Model would

focus exclusively on Medicare FFS

beneficiaries.

Consistent with proposed § 512.150,

we proposed that monitoring activities

may include documentation requests

sent to the ETC Participant; audits of

claims data, quality measures, medical

records, and other data from the ETC

Participant; interviews with members of

the staff and leadership of the ETC

Participant; interviews with

beneficiaries and their caregivers; site

visits to the ETC Participant; monitoring

quality outcomes and clinical data; and

tracking patient complaints and appeals.

Specific to the ETC Model, we would

use the most recent claims data

available to track utilization of certain

types of treatments, beneficiary

hospitalization and Emergency

Department use, and beneficiary referral

patterns to make sure the utilization and

beneficiary outcomes are in line with

the Model’s intent. We stated in the

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proposed rule that we believe this type

of monitoring is important because as

ETC Participants adapt to new payment

incentives, we want to ensure to the

greatest extent possible that the Model

is effective and Medicare beneficiaries

continue to receive high quality, low

cost, and medically appropriate care.

In the proposed rule, we recognized

that one of the likely outcomes of this

Model would be an increase in

utilization of home dialysis. However,

in testing payment incentives aimed at

increasing utilization of this modality,

there may be a risk of inappropriate

steering of ESRD Beneficiaries who are

unsuitable for home dialysis. As

described in the proposed rule and

section IV.C.5.b.(1) of this final rule, we

proposed to exclude from beneficiary

attribution certain categories of

beneficiaries not well suited to home

dialysis, including beneficiaries with a

diagnosis of dementia. We proposed

these eligibility criteria to exclude

certain categories of beneficiaries from

attribution up front so Managing

Clinicians and ESRD facilities that are

ETC Participants do not attempt or

believe that it is wise to attempt to place

these particular beneficiaries on home

dialysis. In addition, we proposed that

CMS would monitor for inappropriate

encouragement or recommendations for

home dialysis through the proposed

monitoring activities. We stated in the

proposed rule that instances of

inappropriate home dialysis would

show up through increases in patient

hospitalization, infection, or incidence

of peritonitis. For example, multiple

incidences of peritonitis would be a

good indicator that the patient should

not be on PD. If claims data show

unusual patterns, we proposed to

review a sample of medical records for

indicators that a beneficiary was not

suited for home dialysis. In the

proposed rule, we discussed using

patient surveys and interviews to look

for instances of coercion on beneficiary

choice of modality against beneficiary

wishes. If such instances of coercion

were found, we stated that we would

take one or more remedial action(s) as

described at § 512.160 against the ETC

Participant and refer the case to CMS for

further investigation and/or remedial

action.

Additionally, we noted in the

proposed rule that we would employ

longer-term analytic strategies to

confirm our ongoing analyses and detect

more subtle or hard-to-determine

changes in care delivery and beneficiary

outcomes. Some determinations of

beneficiary outcomes or changes in

treatment delivery patterns may not be

able to be built into ongoing claims

analytic efforts and may require longer-

term study. We stated in the proposed

rule that we believe it is important to

monitor the transplant and home

dialysis trends over a longer period of

time to make sure the incentives are not

adversely affecting the population of

beneficiaries included in the Model.

We also stated in the proposed rule

that we would examine the extent of

any unintended consequences,

including any increase in adverse

clinical events such as graft failures,

returns to dialysis, peritonitis and other

health incidents due to home dialysis,

fluctuations in machine and supplies

markets, lemon-dropping clinically

complex patients, cherry-picking of less

clinically complex patients, increase in

referrals to home dialysis for patients

that are not physically or cognitively

able to safely handle the responsibility

of dialyzing at home, or an increase in

referrals to Comparison Geographic

Areas. Specifically, we would monitor

the rate at which back-up in-center

dialysis (Claim Code 76) and ESRD self-

care retraining (Claim Code 87) are used

for home dialysis beneficiaries. The use

of back-up dialysis for a home dialysis

beneficiary can also be an indicator of

equipment malfunction. Under the

Innovation Center’s authority in 42 CFR

403.1110, and built upon in our

regulation at § 512.130, we would seek

to obtain clinical data for home dialysis

patients such as an increase in instances

of fever, abnormal bleeding, access

point issues, and changes in vitals or

weight, from ETC Participants for

monitoring purposes and also would

use applicable Medicare claims data.

In the proposed rule, we welcomed

input about how to best track issues

with home dialysis equipment and

machines and the format of any

proposed documentation for any

incidents that occur, and how CMS

should share any information about

incidents that occur.

For those beneficiaries attributed to

ETC Participants who have received a

kidney transplant, we proposed to

monitor transplant registry data from

the SRTR, Medicare claims data

available for life of transplant, post-

transplant rates of hospitalization and

ED visits, infection and rejection rates,

and cost of care compared to the

beneficiaries who have received a

kidney transplant and are not included

in the ETC Model test.

We stated in the proposed rule that a

key pillar of our monitoring strategy for

both transplant, pre-emptive transplant

and home dialysis beneficiaries would

be stakeholder engagement, and we

would continue conversations and

relationships with patient-advocate

groups and closely monitor patient

surveys to uncover any of the

unintended consequences listed earlier

or others that may be unforeseen. We

noted in the proposed rule that we

believe beneficiary and/or care partner

feedback would be a tremendous asset

to help CMS determine and resolve any

issues directly affecting beneficiaries.

In addition, we sought comment on

how the payment adjustments under the

ETC Model may influence delivery-

oriented interventions among

participating ESRD facilities and

Managing Clinicians (for example,

increased Managing Clinician

knowledge of dialysis modalities,

greater patient education, increased

investment in equipment and supplies),

as well as how the Model’s financial

incentives may affect the resourcing of

these endeavors, and what are the

barriers to change. The following is a

summary of the comments received on

monitoring and our responses.

Comment: We received multiple

comments expressing support for our

proposed monitoring plan for the ETC

Model.

Response: We thank the commenters

for their support and are finalizing this

monitoring policy for the ETC Model

without modification.

Comment: We received multiple

comments recommending additional

events and conditions for monitoring

under the ETC Model. A commenter

recommended that we monitor for

frequent hospitalizations, patient non-

compliance and non-adherence,

tracheotomy, patients who have a

catheter in certain cases, acute blood

loss due to surgical intervention,

unknown acute blood loss including

gastrointestinal bleeds, heart failure

exacerbation, endocarditis, stroke,

sepsis, septic shock, surgical procedures

(for example, heart surgery,

amputations, etc.), active malignancies,

diabetic ketoacidosis, Methicillin-

resistant Staphylococcus aureus

(MRSA), Methicillin-susceptible

Staphylococcus aureus (MSSA), ulcers

(for example, decubitus or foot ulcers),

open wounds (for example, bed sores),

abscess (stump or other diabetic-related

abscess), peri-anal abscess,

osteomyelitis, bowel perforation,

cardiac arrest, cellulitis, leg and hip

fractures, cholecystitis, ulcerative

colitis, substance abuse, active lupus,

active Polycystic Kidney Disease (PKD),

behavioral problems, especially those

associated with mental illness

diagnosis, bariatric issues, especially

those patients with weighing in excess

of 500 lbs., and chronic hypertension

related to cardiac disease such as

cardiomyopathy. Another commenter

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160

For the specifications for these measures, see

‘‘CMS ESRD Measures Manual for the 2018

Performance Period/2020 Payment Year’’, June 20,

2018, https://www.cms.gov/Medicare/Quality-

Initiatives-Patient-Assessment-Instruments/

ESRDQIP/Downloads/ESRD-Manual-v30.pdf.

recommended that we look for blood

stream infections for beneficiaries

receiving HHD and peritonitis for

beneficiaries receiving PD. Another

commenter recommended that we

monitor for resource shifting between

the Comparison Geographic Areas and

Selected Geographic Areas, lemon-

dropping and cherry-picking patients

who are more likely to receive a

transplant, market exits and reduction

of in-center chairs in small and low-

volume facilities serving a critical need,

rates of peritonitis, bloodstream

infections in home HD patients, and

attrition from home dialysis.

Response: We thank the commenters

for their feedback, which will be

informative and helpful as we further

develop our monitoring strategy for the

ETC Model. We note that

hospitalizations, infections and

peritonitis were identified in the

preamble to the proposed rule as items

for monitoring and we intend to monitor

for these events under the ETC Model.

Comment: A commenter expressed

concern that the monitoring approach

described in the proposed rule is too

vague and requested that CMS provide

additional information on our plans to

monitor for beneficiary choice and

medical appropriateness under the

Model.

Response: We thank the commenter

for the feedback and are finalizing our

monitoring policy for the ETC Model

without modification. We disagree with

the comment that our monitoring policy

for the ETC Model is too vague. In the

proposed rule, we provided a list of

monitoring activities we would plan to

implement in the ETC Model. We

identified a number of areas of ETC

Model-specific risk and provided

specific examples of data,

documentation and activities that we

would monitor to address that risk.

Within a broad outline of monitoring

activities described in the regulatory

text and preamble of the final rule, we

will retain discretion and flexibility as

to the specific risks, subject matter,

timing, items to be reviewed and

mechanics of our monitoring strategy

and activities during the model test to

be responsive and devote resources to

areas of high priority as they become

identified. In the proposed rule, we also

identified that we may review medical

records and clinical data, perform

interviews with beneficiaries,

caregivers, and ETC Participant

leadership and staff, implement surveys,

review complaints and appeals, and

engage with stakeholders and including

patient advocacy groups. We believe

these activities will support our

monitoring for restrictions on

beneficiary choice and medical

appropriateness.

Comment: A commenter

recommended that we consider whether

monitoring could be accomplished

through an existing network or survey

rather than a separate, model-specific

monitoring process and, in the

alternative, requested clarification on

how the ETC Model monitoring process

would align with existing monitoring

processes.

Response: As noted in the proposed

rule and previously in this final rule,

the ETC Model is aimed at increasing

utilization of home dialysis and thus

may create a risk of inappropriate

steering ESRD Beneficiaries who are

unsuitable for home dialysis. This

unique risk created under this Model

requires model-specific monitoring

activities, in addition to the existing

CMS monitoring processes to protect

ESRD Beneficiaries. We thank the

commenter for the feedback and are

finalizing our proposed monitoring

strategy without modification.

Comment: A commenter expressed

concern that peritonitis is not included

in hospital acquired infection reporting

and is not accounted for in hospital

payment, and asked that facilities that

accept PD patients and place PD

catheters be accountable for clinical

competency and infections.

Response: We thank the commenter

for this feedback and note this specific

item is beyond the scope of this

rulemaking. The ETC Model, as

described in the final rule, would not

change or modify hospital quality

reporting or payment methodology to

account for incidences of peritonitis that

occur in their facility or otherwise.

Comment: A commenter expressed

concern that our proposed monitoring

plan would be too retrospective and

would not identify issues quickly

enough. The commenter cited the

timing for the availability of claims data

as an example. In addition, the

commenter expressed concern that

certain risks are difficult or impossible

to identify through claims data,

including peritonitis and partner

burnout.

Response: We thank the commenter

for the feedback. However, we note that

in addition to reviewing claims data, we

also may review medical records and

clinical data, perform interviews with

beneficiaries, caregivers, and ETC

Participant leadership and staff,

implement surveys, review complaints

and appeals, and engage with

stakeholders including patient advocacy

groups. We believe these monitoring

strategies will provide us timely

feedback and will supplement the

information made available through

claims data.

After consideration of the public

comments, we are finalizing the

monitoring policy for the ETC Model as

proposed, without modification.

b. Quality Measures

In addition to the monitoring

activities discussed previously, we

proposed two ESRD facility quality

measures for the ETC Model:

•Standardized Mortality Ratio

(SMR); NQF #0369—Risk-adjusted

standardized mortality ratio of the

number of observed deaths to the

number of expected deaths for patients

at the ESRD facility.

•Standardized Hospitalization Ratio

(SHR); NQF #1463—Risk-adjusted

standardized hospitalization ratio of the

number of observed hospitalizations to

the number of expected hospitalizations

for patients at the ESRD facility.

We explained in the proposed rule

that SMR and SHR measures are

currently calculated and displayed on

Dialysis Facility Compare, a public

reporting tool maintained by CMS. The

SHR is also included in the ESRD QIP

measure set as a clinical measure on

which ESRD facilities’ performance is

scored.

160

Because data collection and

measure reporting are ongoing, there

would be no additional burden to ETC

Participants to report data on these

measures for the ETC Model. We stated

in the proposed rule that, although CMS

has in a previous rule acknowledged

concerns that the SMR might not be

adequately risk adjusted (78 FR 72208),

we believe this measure is appropriate

for purposes of the ETC Model, under

which the SMR would not be used for

purposes of determining payment.

Mortality is a key health care outcome

used to assess quality of care in different

settings. We noted in the proposed rule

that while we recognize that the ESRD

population is inherently at high risk for

mortality, we believe that mortality rates

are susceptible to the quality of care

provided by dialysis facilities, and note

that the measure is currently being used

in the CEC Model. The SMR is NQF

endorsed, indicating that it serves as a

reliable and valid measure of mortality

among ESRD Beneficiaries who receive

dialysis at ESRD facilities.

We stated in the proposed rule that

we considered including the In-Center

Hemodialysis (ICH) CAHPS

®

survey to

monitor beneficiary perceptions of

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changes in quality of care as a result of

the ETC Model. However, the ICH

CAHPS survey includes only

beneficiaries who receive in-center

dialysis. The survey specifically

excludes the two beneficiary

populations that the ETC Model would

focus on, namely beneficiaries who

dialyze at home and beneficiaries who

receive transplants and, therefore, we

did not propose to use this measure for

purposes of the ETC Model.

We noted in the proposed rule that we

considered including quality measures

for Managing Clinicians that are

reported by Managing Clinicians for

MIPS or other CMS programs. However,

whereas all ESRD facilities are subject to

the same set of quality measures under

the ESRD QIP, there is no analogous

source of quality measure data for

Managing Clinicians. We stated that

Managing Clinicians may be subject to

MIPS, or they may be participating in a

different CMS program—or an

Advanced APM—which has different

quality requirements. In addition, most

Managing Clinicians participating in

MIPS select the quality measures on

which they report. Taken together, these

factors mean that we would be unable

to ensure that all Managing Clinicians in

the ETC Model are already reporting on

a given quality measure, and therefore

would be unable to compare quality

performance across all Managing

Clinicians without imposing additional

burden.

We proposed that the SHR and SMR

measures would not be tied to payment

under the ETC Model. However, we

stated in the proposed rule that we

believe that the collection and

monitoring of these measures would be

important to guard against adverse

events or decreases in quality of care

that may occur as a result of the

performance-based payment

adjustments in the ETC Model. We

noted that we believe we would be able

to observe changes over time in

individual ESRD facility level scores on

these measures, as well as comparing

change over time for ESRD facilities that

are ETC Participants against change over

time in those that are not ETC

Participants. In the aggregate, these

measures should capture any increase in

adverse events, particularly for patients

on home dialysis, as home dialysis

patients are included in both the

numerators and denominators of these

measures. We stated in the proposed

rule that home dialysis patients

primarily receive care through ESRD

facilities, and barring beneficiaries

excluded from the measures per the

measure specifications, the majority of

ESRD Beneficiaries attributed to an ETC

Participant would be captured in these

measures. These measures also include

ESRD Beneficiaries before they receive a

kidney transplant; however,

beneficiaries post-transplant would not

be included, per the measure

specifications.

We invited public comment on the

proposed quality measures and whether

their proposed use would enable CMS

to sufficiently monitor for adverse

conditions for ESRD Beneficiaries, in

combination with the monitoring

activities previously described. We also

invited other suggestions as to measures

that would support monitoring

beneficiary health and safety under the

Model, while minimizing provider

burden.

Additionally, as described in the

proposed rule and in section IV.C.6 of

this final rule, we proposed that ETC

Participants that are ESRD facilities

would still be included in the ESRD QIP

and required to comply with that

program’s requirements, including being

subject to a sliding scale payment

reduction if an ESRD facility’s total

performance score does not meet or

exceed the minimum total performance

score specified by CMS for the payment

year. We explained that ETC

Participants who are Managing

Clinicians and are MIPS eligible

clinicians would still be subject to MIPS

requirements and payment adjustment

factors, and those in a MIPS APM would

be scored using the APM scoring

standard. ETC Participants who are

Managing Clinicians and who are in an

Advanced APM would still be assessed

to determine whether they are

Qualifying APM Participants (QPs) who,

as such, would earn the APM incentive

payment and would not be subject to

the MIPS reporting requirements or

payment adjustment. We did not

propose to waive any of these

requirements for purposes of testing the

ETC Model.

The following is a summary of the

comments received on the quality

measures included in the Model and our

responses.

Comment: CMS received supportive

comments for our proposal to use the

two quality measures and not tie them

to payment. However, a commenter

stated that the measures incentivize

increase utilization rather than

performance improvement.

Response: CMS appreciates the

feedback from these commenters. Both

the SMR and the SHR are NQF-endorsed

outcome measures for patients who

receive dialysis at a given ESRD facility.

The measures were chosen for the

purpose of monitoring for adverse

events that may occur as an unintended

consequence of performance-based

payment adjustments for home dialysis

and transplant. While there are

currently no measures of adverse events

for beneficiaries who dialyze at home,

CMS believes that adverse events at

ESRD facilities is a suitable proxy, as

the measures include both beneficiaries

who dialyze at home and beneficiaries

who dialyze in-center for a given ESRD

facility.

Comment: We received several

comments emphasizing the importance

of beneficiary experience and requesting

that CMS include a formal measure of

beneficiary experience in this Model. A

couple comments suggested that CMS

develop a CAHPS measure for home

dialysis.

Response: CMS considered the

inclusion of ICH CAHPS to monitor

beneficiary perceptions of change in

quality of care as a result of the ETC

Model. However, as we stated in the

proposed rule, because the ICH CAHPS

survey includes only beneficiaries who

receive in-center dialysis, and

specifically excludes the beneficiary

populations that this Model is

specifically focused on, namely

beneficiaries moving away from in-

center hemodialysis to alternative renal

replacement therapies, ICH CAHPS does

not reach the target beneficiary

population. Because there is no

equivalent CAHPS or other survey for

home dialysis patients, or for post-

transplant patients, CMS intends to

develop a beneficiary experience

measure, similar to the CAHPS survey,

that could influence Model payments to

participants as early as the third year of

the Model. We intend to propose and

incorporate a beneficiary experience

measure in the ETC Model in the near

future.

The Model’s evaluation will examine

the effect of the ETC Model on such key

outcomes as improved quality of care

and quality of life. Data collection

activities performed for purposes of the

evaluation may include patient surveys

and beneficiary focus groups.

Comment: Multiple commenters

encouraged CMS to add additional

quality measures. The commenters

suggested measures including: ED

utilization; peritonitis in hospital

acquired infections; provision of

supportive care services; behavioral and

mental health; care coordination; safety

and reliability; provider engagement;

and Advanced Care Plans. In addition,

commenters recommended that CMS

develop a measure for referrals into the

transplantation process as well as

hospice. A commenter noted the burden

of manual data collection and the

impact on patient care.

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Response: CMS chose the SMR and

SHR measures, essential indicators for

the ESRD population, because they are

already reported in Dialysis Facility

Reports and the ESRD QIP, respectively.

These are programs run by CMS/CCSQ

that produce dialysis facility-level

quality data annually and, therefore,

impose no additional administrative

burden on ESRD facilities. We

appreciate commenters suggestions

about other potential quality measures

that we could include in the ETC Model

that may benefit the patient population.

However, we believe that the two

quality measures we have included are

sufficient for the purposes of monitoring

to guard against adverse events or

decreases in quality of care that may

occur as a result of the performance-

based payment adjustments in the

Model. All ETC Participants remain

subject to other applicable CMS quality

programs unless otherwise exempt, so

we believe that other potential aspects

of quality of care are sufficiently

captured and incentivized by those

quality programs. In addition, the

purpose of the measures is solely for

monitoring for adverse events that may

occur as an unintended consequence of

performance-based payment

adjustments for home dialysis and

transplant, and will have no impact on

the payment adjustments under the ETC

Model. Therefore, CMS believes these

two measures are adequate and no

additional measures are needed at this

time.

Comment: CMS received one

comment urging CMS to use mortality

and hospitalization rates rather than

ratios because ratio measures have wide

confidence intervals that potentially

lead to incorrect information about

facility performance being reported. In

addition, the commenter recommended

that CMS work with NQF to develop

social-demographic adjusters.

Response: CMS appreciates the

feedback. Both of the proposed

measures are NQF-endorsed measures

for renal conditions and are already

reported through CMS reporting

systems, Dialysis Facility Compare for

SHR and SMR, and ESRD QIP for SHR.

We believe it is appropriate to use the

ratio measures for the purposes of the

Model because they align with existing

CMS programs. Additionally, we do not

believe that the statistical features of

these ratio measures referenced, namely

the wide confidence intervals,

contributes to incorrect information

about facility performance being

reported. These measures are already

reported publicly at the facility level

through Dialysis Facility Compare and

the ESRD QIP, with explanation of the

statistical properties of the ratios.

Additionally, the measures are being

used in the Model for monitoring

purposes, and are not intended to

convey specific information about

individual facility performance to the

public.

Comment: A commenter requested

that CMS acknowledge that palliative

dialysis is a patient-preference option

that should not result in penalties under

the ESRD QIP.

Response: CMS appreciates the

feedback from our stakeholders.

However, the comment pertains to the

ESRD QIP generally and is therefore not

within the scope of this final rule.

Based on the comments received, we

are finalizing the quality measures as

proposed without modification.

11. Evaluation

As we described in the proposed rule,

an evaluation of the ETC Model would

be conducted in accordance with

section 1115A(b)(4) of the Act, which

requires the Secretary to evaluate each

model tested by the Innovation Center.

We noted in the proposed rule that we

believe an independent evaluation of

the Model is necessary to understand its

impacts of the Model on quality of care

and Medicare program expenditures and

to share with the public. We would

select an independent evaluation

contractor to perform this evaluation. As

specified in the proposed rule and

section II.E of this final rule, all ETC

Participants would be required to

cooperate with the evaluation.

We stated in the proposed rule that

research questions addressed in the

evaluation would include, but not be

limited to, whether or not the ETC

Model results in a higher rate of

transplantation and home dialysis,

better quality of care and quality of life,

and reduced utilization and

expenditures for ESRD Beneficiaries in

Selected Geographic Areas in relation to

Comparison Geographic Areas. The

evaluation would also explore

qualitatively what changes Managing

Clinicians and ESRD facilities

implemented in response to the ETC

Model, what challenges they faced, and

lessons learned to inform future policy

developments.

We proposed that the ETC Model

evaluation would employ a mixed-

methods approach using quantitative

and qualitative data to measure both the

impact of the Model and

implementation effectiveness. The

impact analysis would examine the

effect of the ETC Model on key

outcomes, including improved quality

of care and quality of life, and decreased

Medicare expenditures and utilization.

The implementation component of the

evaluation would describe and assess

how ETC Participants implement the

Model, including barriers to and

facilitators of change. We noted in the

proposed rule that findings from both

the impact analysis and the

implementation assessment would be

synthesized to provide insight into what

worked and why, and to inform the

Secretary’s potential decision regarding

model expansion.

We would use multi-pronged data

collection efforts to gather the

quantitative and qualitative data needed

to understand the context of the Model

implemented at participating ESRD

facility and Managing Clinician

locations and the perspectives of

different stakeholders. Data for the

analyses would come from sources

including, but not limited to, payment

and performance data files,

administrative transplant registry data,

beneficiary focus groups, and interviews

with ETC Participants.

As described in the proposed rule, the

quantitative impact analysis would

compare performance and outcome

measures over time, using a difference-

in-differences or a similar approach to

compare beneficiaries treated by ETC

Participants to those treated by ESRD

facilities and Managing Clinicians in

Comparison Geographic Areas. We

would examine both cumulative and

year-over-year impacts. The quantitative

analyses conducted for the evaluation

would take advantage of the mandatory

nature of the ETC Model for ESRD

facilities and Managing Clinicians

located in Selected Geographic Areas.

We explained in the proposed rule

that, while the model design would

control for the selection bias inherent in

voluntary models, a comparison group

would still be necessary to determine if

any changes in outcomes are due to the

ETC Model or to secular trends in CKD

and ESRD care. The comparison group

would be those Managing Clinicians

and ESRD facilities located in

Comparison Geographic Areas which

would not be subject to the ETC Model

payment adjustments. The evaluator

would match Managing Clinicians and

ESRD facilities located in Comparison

Geographic Areas with Managing

Clinicians and ESRD facilities that are

located in Selected Geographic Areas

(that is, ETC Participants) using

propensity scores or other accepted

statistical techniques. Beneficiaries who

receive care from ESRD facilities and

Managing Clinicians in these Selected

Geographic Areas and Comparison

Geographic Areas would be identified

using the ETC Model claims-based

eligibility criteria, and would be

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attributed using the same claims-based

beneficiary attribution methods we

proposed to use for purposes of

calculating the MPS.

We stated in the proposed rule that

the evaluation would account for any

interaction with other CKD- and ESRD-

related initiatives at CMS, such as the

ESRD QIP, the CEC Model, and the KCC

Model (formerly the CKC Model). For

example, the evaluator would look for

disparate outcomes that could arise in

the ESRD QIP between facilities that are

also participating in the ETC Model and

facilities that are not participating in the

ETC Model and also assess whether

performance in the ETC Model varies

for Managing Clinicians and ESRD

Facilities who are also participating in

the CEC or KCC Models.

We invited public comment on our

proposed approach related to the

evaluation of the ETC Model.

Comment: A commenter noted that

CMS did not specify the timing of the

ETC Model evaluation.

Response: We thank the commenter

for this feedback. The evaluation will be

active during and after the Model test

period to allow for data collection and

analysis. We expect the evaluation will

have annual reports covering the

assessment of the Model using available

data, including a summative report

following the conclusion of the model

test.

Comment: A commenter

recommended that the evaluation take

into account any possible negative

impacts or lack of impact of the Model.

Should the latter occur, the commenter

suggested that the Model should be

terminated.

Response: We agree with the

commenter regarding the need to assess

potential negative impacts of the Model.

We clarify here that the evaluation will

account for potential impacts of the

Model including positive, negative, or a

lack thereof, in terms of both Medicare

expenditures and the quality of care and

we would determine the appropriate

actions, including potential termination

of the Model, based upon an analysis of

the evaluation findings.

Comment: A commenter noted that

the Model evaluation should measure

the impact of concurrent hospice

dialysis access; specifically, patient and

family experience with care satisfaction

and costs at the end of life.

Response: We appreciate this

comment suggesting a measure to assess

in evaluating the Model. The Model

evaluation’s questions around quality of

care and quality of life and expenditures

include questions regarding patient and

family experience and costs at the end

of life, and we will analyze these

questions to the extent feasible.

Comment: Several commenters

expressed concern that 50 percent of the

306 HRRs in the US is larger than is

necessary to evaluate a change in the

transplantation rate as a result of the

Model.

Response: As previously noted, we

performed a power calculation to

determine the minimum sample size of

the participant and comparison groups

in the Model in order to produce robust

and reliable results. We determined

from these tests that 30 percent of the

HRRs are needed to minimize the risk

of false positive and false negative

results, and the minimum detectable

effect of a two percentage point increase

or decrease in the rate of transplant wait

listing and a one and one-half

percentage point increase or decrease in

home dialysis Since this approach

provides sufficient statistical power, we

are finalizing our evaluation approach

as proposed.

12. Learning System

We proposed that in conjunction with

the ETC Model, CMS would operate a

voluntary learning system focused on

increasing the availability of deceased

donor kidneys for transplantation. The

learning system would work with,

regularly convene, and support ETC

Participants and other stakeholders

required for successful kidney

transplantation, such as transplant

centers, OPOs, and large donor

hospitals. We proposed that these ETC

Participants and stakeholders would

utilize learning and quality

improvement techniques to

systematically spread the best practices

of highest performers. The application

of broad scale learning and other

mechanisms for rapid and effective

transfer of knowledge within a learning

network would also be used. Quality

improvement approaches would be

employed to improve performance by

collecting and analyzing data to identify

the highest performers, and to help

others to test, adapt and spread the best

practices of these high performers

throughout the entire national organ

recovery system. We stated in the

proposed rule that we believed that

implementation of the learning system

would help to increase the supply of

transplantable kidneys, which would

help ETC Participants achieve the goals

of the Model.

Comment: We received several

comments in this area, all supporting

CMS’s proposal to implement the

proposed learning system. A commenter

proposed working with the Quality

Improvement Organizations (QIOs) to

help implement the learning system and

branding the learning collaborative as

the ‘‘Transplant First’’ initiative.

Another commenter proposed delaying

implementation of the transplant

component of the PPA until the learning

collaborative has been implemented for

multiple years.

Response: We appreciate the

commenters’ support for the proposed

learning system and are finalizing our

proposal to implement it as proposed.

We plan to refer to the learning system

as the ETC Learning Collaborative as it

is a part of the ETC Model test and we

do not wish to confuse ETC Participants

or the public by giving the learning

system a name with no clear connection

to the Model. We appreciate the

suggestion about the QIOs, but we do

not believe that QIO involvement is

necessary given their other priority

areas that they are working on. In terms

of the comment recommending that

CMS delay implementation of the

transplant component of the PPA until

the learning collaborative has been

implemented for multiple years, while

we hope that the ETC Learning

Collaborative will be successful at

improving utilization of available

kidneys, such a delay is not necessary

because, as previously described in

section IV.C of this final rule, we are

now assessing ESRD facilities and

Managing Clinicians based on their

ability to impact transplant rates

calculated as the sum of the transplant

waitlist rate and the living donor

transplant rate, rather than overall

transplant rates including deceased

donor transplants, for purposes of the

ESRD PPA and Managing Clinician

PPA, respectively.

After considering the public

comments, we are implementing the

learning system under this Model as

proposed.

13. Remedial Action

As described in the proposed rule and

in section 512.160 of this final rule, the

remedial actions outlined in the general

provisions in § 512.160 would apply to

the ETC Model. Accordingly, if CMS

determines that an ETC Participant has

engaged in one or more of the actions

listed under § 512.160(a) (Grounds for

Remedial Action), CMS may take one or

more of the remedial actions listed

under § 512.160(b).

We did not receive comments on our

proposals relating to remedial action in

the ETC Model. Therefore, we are

finalizing these proposals without

modification.

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14. Termination of the ETC Model

As described in the proposed rule, the

general provisions relating to

termination of the Model that CMS

proposed in the proposed rule and

discussed in section II.J of this final rule

would apply to the ETC Model.

Consistent with these provisions, in the

event we terminate the ETC Model, we

would provide written notice to ETC

Participants specifying the grounds for

termination and the effective date of

such termination or ending. As

provided by section 1115A(d)(2) of the

Act and § 512.170, termination of the

Model under section 1115A(b)(3)(B) of

the Act would not be subject to

administrative or judicial review.

We did not receive comments on the

proposals relating to termination of the

ETC Model. Therefore, we are finalizing

our proposals without modification.

V. Collection of Information

Requirements

As stated in section 1115A(d)(3) of the

Act, Chapter 35 of title 44, United States

Code, shall not apply to the testing,

evaluation, and expansion of models

under section 1115A of the Act. As a

result, the information collection

requirements contained in this final rule

need not be reviewed by the Office of

Management and Budget. However, we

have summarized the anticipated

information collection requirements in

section VI.C.4. of this final rule.

VI. Regulatory Impact Analysis

We have examined the impact of this

final rule as required by Executive

Order 12866 and other laws and

Executive Orders, requiring economic

analysis of the effects of final rules. A

regulatory impact analysis (RIA) must

be prepared for major rules with

economically significant effects ($100

million or more in any 1 year). We

estimate that this rulemaking is

‘‘economically significant’’ as measured

by the $100 million threshold and also

a major rule under the Congressional

Review Act. Accordingly, we have

prepared a RIA that, to the best of our

ability, reflects the economic impact of

the policies contained in this final rule.

A. Statement of Need

1. Need for the Radiation Oncology (RO)

Model

Radiotherapy (RT) services represent

a promising area of health care for

payment and service delivery reform.

First, RT services are furnished in both

freestanding radiation therapy centers

paid under the Medicare Physician Fee

Schedule (PFS) and the Outpatient

Prospective Payment System (OPPS).

There are site-of-service payment

differentials between the OPPS and PFS

payment systems, which can result in

financial incentives to offer care in one

setting over another. Second, as in other

health care settings, health care

providers are financially incentivized to

provide more services to patients

because they are paid based on the

volume of care they provide, not value.

We believe that these incentives are

misaligned with evidence-based

practice, which is moving toward

furnishing fewer radiation treatments

for certain cancer types. Third,

difficulties in coding and setting

payment rates for RT services have led

to volatility in Medicare payment for

these services under the PFS and

increased coding complexity and

administrative burden. As part of the

RO Model’s design, we will examine

whether the model leads to higher

quality care by encouraging improved

adherence to clinical guidelines and by

collecting information related to quality

performance and clinical practice. The

RO Model aims to incentivize RO

participants to maintain high quality

care with the opportunity to earn back

a withheld payment amount through

successful quality outcomes and clinical

data reporting.

As described in detail in section

III.C.8. of this final rule, RO participants

are required to collect and submit data

on quality measures, clinical data, and

patient experience throughout the

course of the RO Model, beginning

January 1, 2021, with the final data

submission ending in 2026.

We refer readers to section III.B. of

this final rule for more information on

our research and rationale for the RO

Model, including summaries of

stakeholder comments on this rationale

and our response. We refer readers to

section III.C for more information on

policy-related stakeholder comments,

our responses to those comments, and

statements of final policy.

2. Need for End-Stage Renal Disease

(ESRD) Treatment Choices (ETC) Model

Beneficiaries with ESRD are among

the most medically fragile and high-cost

populations served by the Medicare

program. One of CMS’ goals in

designing the ETC Model is to test ways

to incentivize home dialysis and kidney

transplants, so as to enhance beneficiary

choice of modality for renal replacement

therapy, and improve or maintain

quality of care while reducing Medicare

program expenditures. The substantially

higher expenditures, mortality, and

hospitalization rates for dialysis patients

in the U.S. compared to those for

individuals with ESRD in other

countries indicate a population with

poor clinical outcomes and potentially

avoidable expenditures. We anticipate

preservation or improvement in quality

of care for beneficiaries and reduced

expenditures under the ETC Model

inasmuch as the Model will create

incentives for beneficiaries, along with

their families and caregivers, to choose

the optimal kidney replacement

modality.

In section IV.B of this final rule, we

describe how current Medicare payment

rules and a deficit in beneficiary

education result in a bias toward in-

center hemodialysis, which is often not

preferred by patients or physicians

relative to home dialysis or kidney

transplantation. We provide evidence

from published literature to support the

projection that higher rates of home

dialysis and kidney transplants will

reduce Medicare expenditures, and, not

only enhance beneficiary choice,

independence, and quality of life, but

also preserve or enhance the quality of

care for ESRD beneficiaries.

As described in detail in sections II.

and IV. of this final rule, ETC

Participants will be subject to payment

adjustments under the ESRD

Prospective Payment System (ESRD

PPS) and Physician Fee Schedule (PFS),

as applicable, and will be required to

comply with certain requirements,

including to cooperate with CMS’s

monitoring and evaluation activities, for

the duration of the ETC Model.

3. Impact of RO Model and ETC Model

In the proposed rule (84 FR 34567),

we estimated, as detailed in Table 16A

of the proposed rule, a net impact of

$260 million in net savings to the

Medicare program due to the RO Model

from January 1, 2020 through December

31, 2024, with a range of impacts

between $50 million and $460 million

in net Medicare savings. Alternatively,

as detailed in Table 16B of the proposed

rule, we estimated a net impact of $250

million in net savings to the Medicare

program due to the RO Model from

April 1, 2020 through December 31,

2024, with a range of impacts between

$40 million and $450 million in net

Medicare savings.

As detailed in Table 17 of the

proposed rule, we estimated the

Medicare program would save a net

total of $185 million from the PPA and

HDPA, which would be applied under

the ETC Model between January 1, 2020

through June 30, 2026. We also stated

our expectation that the ETC Model

would cost an additional $15 million,

resulting from increases in education

and training costs. Therefore, we

estimated the net impact to Medicare

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spending to be $169 million in savings

as a result of the ETC Model.

We solicited comment on the

assumptions and analysis presented

throughout the regulatory impact

section of the proposed rule.

Comment: A few commenters stated

that the RO Model’s estimates of $250-

$260 million in savings over a 5-year

period are understated. One commenter

suggested that total savings would be

closer to $320 million over 5 years

based on volume and intensity (V&I)

calculations of the bundled services per

episode, which remain unchanged

between the period used for rate setting

and when payments are made.

Response: We thank these

commenters for expressing their

concerns. Policy impact estimates may

vary depending on a number of factors.

Our estimate reflects a net Medicare Part

B financial impact. Therefore, our

impact analysis includes changes to

Medicare Trust Fund payments and

other Medicare financing interaction

effects such as changes in Part B Trust

Fund revenue, MA capitation rates,

APM incentive payments, and the BBA

1999 IPPS Part A deductible cap.

Moreover, the impact estimate excluded

changes in beneficiary cost sharing

liability to the extent it is not shifted to

being a Federal outlay by the policy.

Our estimate also assumed the V&I of

the bundled services per episode

remains unchanged between the period

used for rate setting and when payments

are made. We estimated that if V&I were

to decrease by 1.0 percent annually for

the bundled services absent the model,

then Medicare would reduce net outlays

by $50 million ($40 million with an

April 1, 2020 start date) between 2020

and 2024. Similarly, if V&I increases by

1.0 percent annually then net outlays

would be reduced by $460 million ($450

million with an April 1, 2020 start date)

for the projection period. While we

noted in the proposed rule that although

V&I growth from 2014 through 2017 fell

within this 1.0 percent range and did

not exhibit a secular trend, actual

experiences may vary. We are finalizing

a different Model performance period

and Model geographic scope than

proposed, and have updated

assumptions and estimates in VI.C of

this final rule.

Based on the finalized policy, we

have updated our net estimate of the RO

Model impact and now expect a savings

of $230 million for Medicare. We have

also updated our net estimate of the ETC

Model impact and now expect a savings

of $23 million for Medicare. We discuss

our analysis in greater detail in sections

VI.C.1(a) and VI.C.2.a(3) of this final

rule.

B. Overall Impact

We have examined the impacts of this

final rule as required by Executive

Order 12866 on Regulatory Planning

and Review (September 30, 1993),

Executive Order 13563 on Improving

Regulation and Regulatory Review

(January 18, 2011), the Regulatory

Flexibility Act (RFA) (September 19,

1980, Pub. L. 96–354), section 1102(b) of

the Social Security Act, section 202 of

the Unfunded Mandates Reform Act of

1995 (March 22, 1995; Pub. L. 104–4),

Executive Order 13132 on Federalism

(August 4, 1999), the Congressional

Review Act (5 U.S.C. 804(2)), and

Executive Order 13771 on Reducing

Regulation and Controlling Regulatory

Costs (January 30, 2017).

Executive Orders 12866 and 13563

direct agencies to assess all costs and

benefits of available regulatory

alternatives and, if regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety

effects, distributive impacts, and

equity). Section 3(f) of Executive Order

12866 defines a ‘‘significant regulatory

action’’ as an action that is likely to

result in a rule: (1) Having an annual

effect on the economy of $100 million

or more in any one year, or adversely

and materially affecting a sector of the

economy, productivity, competition,

jobs, the environment, public health or

safety, or state, local or tribal

governments or communities (also

referred to as ‘‘economically

significant’’); (2) creating a serious

inconsistency or otherwise interfering

with an action taken or planned by

another agency; (3) materially altering

the budgetary impacts of entitlement

grants, user fees, or loan programs or the

rights and obligations of recipients

thereof; or (4) raising novel legal or

policy issues arising out of legal

mandates, the President’s priorities, or

the principles set forth in the Executive

Order. As stated previously in this final

rule, this final rule triggers these

criteria.

C. Anticipated Effects

1. Scale of the Model

As we stated in the proposed rule (84

FR 34569 through 34570), there is no

one-size-fits-all approach to designing,

implementing, and evaluating models.

Each payment and service delivery

model tested by the Innovation Center is

unique in its goals, and thus its design.

Models vary in size in order to

accommodate various design features

and satisfy a variety of priorities.

Decisions made regarding the features

and design of the model strongly

influence the extent to which the

evaluation will be able to accurately

assess the effect of a given model test

and produce clear and replicable

results.

The Innovation Center conducts

analyses to determine the ideal number

of participants for each model for

evaluation purposes. This analysis

considers a variety of factors including

the target population (for example,

Medicare beneficiaries with select

medical conditions), model eligibility

(for example, beneficiary eligibility

criteria for inclusion in the model),

participant enrollment strategy (for

example, mandatory versus voluntary)

and, the need to test effects on

subgroups. Model size can also be

influenced by the type and size of

hypothesized effect on beneficiary

outcomes, such as quality of care, or the

target level of model savings. The

smaller the expected impact a model is

hypothesized to achieve, the larger a

model needs to be for CMS to have

confidence in the observed impacts.

An insufficient number of

participants increases the risk that the

evaluation will be imprecise in

detecting the true effect of a model,

potentially leading, for example, to a

false negative or false positive result.

The goal is to design a model that is

sufficiently large to achieve adequate

precision but not so large as to waste

CMS’s limited resources. These

decisions affect the quality of evidence

CMS is able to present regarding the

impacts of a model on quality of care,

utilization, and spending.

a. Radiation Oncology (RO) Model

In the case of the RO Model, in the

proposed rule we determined the

sample size necessary for a minimum

estimated savings impact of 3 percent

(84 FR 34568). While a savings higher

than 3 percent would require a smaller

sample size from an evaluation

perspective, if we were to reduce the

size of the RO Model and if the actual

savings are at or just below the 3 percent

level, then we would increase the risk

of being unable to detect whether the

RO Model resulted in savings.

We refer readers to the proposed rule

where we proposed that the RO Model

would include 40 percent of radiation

oncology episodes in eligible geographic

areas and our simulation based on this

proposal. In section III.C.3.c of this final

rule, we finalized our policy to include

30 percent of radiation oncology

episodes and a low-volume exception.

We performed a simulation based on

our finalized policies. Based on this

simulation, we expect to have

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approximately 500 physician group

practices (PGPs) (of which 275 are

freestanding radiation therapy centers)

and 450 HOPDs furnishing RT services

in those simulated selected CBSAs. We

further expect the RO Model to include

approximately 348,000 episodes,

309,000 beneficiaries, and $5.3 billion

in total episode spending of allowed

charges over the Model performance

period. To determine the number of

PGPs, we counted the number of TINs

that furnished at least one professional

or technical component in 2018 in one

of the CBSAs selected for Model

participation as recorded in the 2016–

2018 episode file. To determine the

number of HOPDs, we counted the

number of facility CCNs that furnished

at least one technical component in

2018 in the CBSAs selected for Model

participation as recorded in the 2016–

2018 episode file. Similarly, to

determine episode count, beneficiary

count, and total spending estimates, we

drew upon the historical data of RO

participants simulated into CBSAs

selected for participation. These

estimates represent the Model size of 30

percent of RO episodes in eligible

geographic areas

b. End-Stage Renal Disease (ESRD)

Treatment Choices (ETC) Model

The ETC Model will include

approximately 30 percent of ESRD

beneficiaries, through the ESRD

facilities and Managing Clinicians

selected for participation in the Model.

The Innovation Center will randomly

select 30 percent of HRRs, stratified by

region, and include separate from

randomization all HRRs for which at

least 20 percent of the component zip

codes are located in Maryland. All

ESRD facilities and Managing Clinicians

in selected HRRs, referred to as Selected

Geographic Areas, will be required to

participate in the Model. There are

currently 7,196 ESRD facilities and

2,286 Managing Clinicians enrolled in

Medicare, distributed across 306 HRRs

and providing care for 383,057 ESRD

beneficiaries that meet the eligibility

criteria for attribution to ETC

Participants under the Model. Only

approximately 10 percent of

beneficiaries on dialysis received home

dialysis in 2017. The ETC Model will

apply the payment adjustments

described in section IV. of this final rule

to claims with ‘‘claim service dates’’

between January 1, 2021 through June

30, 2027, and over that time period, will

randomize 30 percent of the HRRs that

the ESRD facilities and Managing

Clinicians align with and generate $23

million in net Medicare savings. See

Table 2 for an annual breakdown.

c. Aggregate Effects on the Market

As we noted in the proposed rule,

there may be spillover effects in the

non-Medicare market, or in non-ESRD

areas of the Medicare market because of

the implementation of these models.

Testing changes in Medicare payment

policy may have implications for non-

Medicare payers. As an example, non-

Medicare patients may benefit if

participating providers and suppliers

introduce system-wide changes that

improve the coordination and quality of

health care. Other payers may also be

developing payment models and may

align their payment structures with

CMS or may be waiting to utilize results

from CMS’ evaluations of payment

models. Because there is uncertainty

whether and how this evidence applies

to a test of these new payment models,

our analyses assume that spillover

effects on non-Medicare payers will not

occur, although this assumption is

subject to considerable uncertainty. We

solicited comments on this assumption

and evidence on how this rulemaking

would impact non-Medicare payers and

patients.

Comment: A couple of commenters

expressed concern that the RO Model

payment methodology could the impact

practices where commercial payers use

Medicare rates as a proxy.

Response: As stated in the proposed

rule for the RO Model (84 FR 34568),

although we assume that spillover

effects on non-Medicare payers will not

occur, we understand that considerable

uncertainty surrounds this assumption.

However, no evidence has been found to

support this assumption that that the

RO Model will impact non-Medicare

payers either. In our analyses, we

assume growth of FFS Medicare Part B

enrollment as projected in the 2018

Medicare Trustees Report. We also

assume that providers and suppliers

would not change payer mix as a

response to the RO Model. However, we

hope that, at the end of the RO Model’s

evaluation, information learned can

move Medicare and non-Medicare

payment to more accurately and

appropriately reimburse high-value RT

services.

2. Effects on the Medicare Program

a. Radiation Oncology Model

(1) Overview

Under the current FFS payment

system, RT services are paid on a per

service basis to both PGPs (including

freestanding radiation therapy centers)

and HOPDs through the PFS and the

OPPS, respectively. The RO Model will

be a mandatory model designed to test

a prospectively determined episode

payment for RT services furnished to

Medicare beneficiaries during episodes

initiated between January 1, 2021 and

December 31, 2025.

The RO Model will test differences in

payment from traditional FFS Medicare

by paying RO participants two equal

lump-sum payments, once at the start of

the RO episode and again at the end, for

episodes of care. RO episode means the

90-day period that, as set forth in

§ 512.245, begins on the date of service

that a Professional participant or a Dual

participant furnishes an initial

treatment planning service to an RO

beneficiary in a freestanding radiation

therapy center or an HOPD, provided

that a Technical participant or the same

Dual participant furnishes a technical

component RT service to the RO

beneficiary within 28 days of such RT

treatment planning service. RO episodes

include all Medicare items and services

described in § 512.235 that are

furnished to an RO beneficiary

described in § 512.215. Once an RO

episode is initiated, RO participants will

no longer be allowed to separately bill

other HCPCS codes or APC codes for

activities related to radiation treatment

for the RO beneficiary in that RO

episode.

For each participating entity, the

participant-specific professional episode

payment and participant-specific

technical episode payment amounts

would be determined as described in

detail in section III.C.6. of this final rule.

The RO Model is not a total cost of

care model. RO participants will still

bill traditional FFS Medicare for

services not included in the episode

payment and, in some instances, for less

common cancers not included in the

model and other exclusion criteria. A

list of cancer types that meet the criteria

for inclusion in the RO Model and

associated FFS procedure codes are

included in section III.C.5. of this final

rule.

(2) Data and Methods

Similar to the analysis performed for

regulatory impact analysis for the

proposed rule (84 FR 34571), a

stochastic simulation based on the

finalized policies was created to

estimate the financial impacts of the RO

Model relative to baseline expenditures.

The simulation relied upon statistical

assumptions derived from

retrospectively constructed RT episodes

between 2016 and 2018 (updated from

the 2015–2017 episodes used in the

proposed rule to reflect finalized

policy). This information was reviewed

and determined to be reasonable for the

estimates.

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To project baseline expenditures,

traditional FFS payment system billing

patterns are assumed to continue under

current law. Forecasts of the Medicare

Part A and Part B deductibles were

obtained from the 2019 Medicare

Trustees Report and applied to

simulated episode payments to estimate

interactions of lump sum payments with

the HOPD line item cap as described in

section 1833(t)(8)(C)(i) of the Act. We

assumed that the current relative value

units under the PFS and relative

payment weights under the OPPS in the

updated episode data from 2016 through

2018 would continue into the future,

which is consistent with the updates we

made for the payment methodology in

section III.C.6 of this final rule.

Similarly, conversion factors in both the

PFS and OPPS were indexed to the

appropriate update factors under

current law. Payment rate updates to

future PFS conversion factors are

legislated at 0.25 percent in 2019 and

0.0 percent for 2020 through 2025 under

the Medicare Access and CHIP

Reauthorization Act of 2015. OPPS

conversion factors are updated by the

productivity-adjusted inpatient hospital

market basket update in our simulation.

We forecast that net OPPS updates will

outpace the PFS by 3.0 percent on

average annually between 2019 and

2025.

(3) Medicare Estimate

Table 1 summarizes the estimated

impact of the RO Model. The estimated

impact reflects the finalized policies,

which are different than some of the

proposed rule policies. For instance, we

are finalizing policies for reduced

discount factors, a smaller Model size of

30 percent of RO episodes in eligible

geographic areas, a low volume opt-out

option, a stop-loss policy for RO

participants with fewer than 60

episodes during 2016–2018 and were

furnishing included RT services in the

CBSAs selected for participation at the

time of the effective date of this final

rule, and a Model performance period of

January 1, 2021 through December 31,

2025. Thus, we are now estimating that

on net the Medicare program will save

$230 million over the Model

performance period. As in the proposed

rule, this is the net Medicare Part B

impact that includes both Part B

premium and Medicare Advantage

United States Per Capita Costs (MA

USPCC) rate financing interaction

effects. This estimate excludes changes

in beneficiary cost sharing liability to

the extent it is not a Federal outlay

under the policy.

On net, we project a lower spending

reduction per RO episode and that

slightly more RO episodes (2,000 more

RO episodes) would be paid through the

RO Model. As for the stop-loss policy,

it applies only to RO participants with

fewer than 60 episodes during 2016–

2018 and were furnishing included RT

services in the CBSAs selected for

participation at the time of the effective

date of this final rule. Under the stop-

loss policy, if payments under the

Model resulted in more than 20 percent

loss as compared to the amount the RO

participant would have received under

FFS, then CMS owes the RO participant

the amount that exceeds that 20 percent.

Recall that RO participants with fewer

than 60 episodes during 2016–2018 do

not receive a historical experience

adjustment. The stop-loss payments for

these RO participants were projected

under the assumption that similar

qualification rates and FFS claims

volatility for these eligible providers

experienced during 2016–2018 would

occur within no-pay claims submitted

during the Model test. The RO

participants eligible for the stop-loss

policy are projected to account for 1.2

percent of the Model episode spending,

and we estimate the five-year cost of

this policy to be $0.3 million, an

immaterial impact on the savings

estimate as displayed in Table 1.

Revisions to the projected impacts

primarily reflect the net effects of

changes to the Model start and end

dates, refinements to the randomization

procedures used for CBSA selection,

and a reduction in the proposed

discount factors by 0.25 percent.

We project that 83 percent of

physician participants (measured by

unique NPI) would receive the APM

incentive payment under the Quality

Payment Program at some point (at least

one QP Performance Period) during the

model performance period. This

assumption is based on applying the

2020 QPP final rule qualification criteria

to simulated billing and treatment

patterns for each QPP performance year

during the RO Model test. Episode-

initiating physicians were assumed to

form an APM entity with the TIN(s)

under which they bill for RT services.

For each APM entity, counts of total

treated patients and spending for

covered physician services under the

RO Model were estimated and applied

to QPP qualification criteria based on

CY2018 provider billing patterns.

As explained in section III.C.9 of this

final rule, the APM incentive payment

will apply only to the professional

episode payment amounts and not the

technical episode payment amounts and

that APM incentive payments will be

paid based on participation in the RO

Model during 2021 and 2022. Due to the

2-year lag between the QPP performance

and payment periods, these APM

incentive payments are therefore

assumed to be made during 2023 and

2024.

Complete information regarding the

data sources and underlying

methodology used to determine

amounts for reconciliation were not

available at the time of this forecast. In

the case of the incomplete payment

withhold, we assumed CMS retains

payment only in the event that offsetting

payment errors were made elsewhere.

Past CMS experience in other value-

based payment initiatives that included

a penalty for not reporting have shown

high rates of reporting compliance.

Given the limited spending being

withheld, scoring criteria, and specified

timeframes involved, we assume that

quality and patient experience

withholds, on net, have a negligible

financial impact to CMS.

A key assumption underlying of the

impact estimate is that the volume and

intensity (V&I) of the bundled services

per episode remains unchanged

between the period used for rate setting

and when payments are made. If V&I

were to decrease by 1.0 percent

annually for the bundled services absent

the RO Model, then we estimate the

impact of the RO Model to Medicare

spending to be approximately budget

neutral between January 1, 2021 and

2025. Similarly if V&I increases by 1.0

percent annually then net outlays would

be reduced by $470 million for the

projection period. Although V&I growth

from 2014 through 2018 fell within this

1.0 percent range and did not exhibit a

secular trend, actual experience may

differ. Please also note that due to the

current public health crisis caused by

the COVID–19 virus, the forecasted

impacts for the RO Model are subject to

an additional level of uncertainty. The

duration of the current COVID–19

pandemic, its severity, and the policy

measures taken as a response are

variables that are significant but

unknown at this time. This forecast

assumes that Medicare FFS billing and

treatment patterns for beneficiaries

observed during the 2016–2018 baseline

period resume by the start of 2021. To

the extent that this assumption does not

hold, actual experience may vary

significantly.

This table summarizes our estimated

impacts of this final rule:

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b. ESRD Treatment Choices Model

(1) Overview

Under the ESRD Prospective Payment

System (PPS) under Medicare Part B, a

single per-treatment payment is made to

an ESRD facility for all of the renal

dialysis services defined in section

1881(b)(14)(B) of the Act and furnished

to individuals for the treatment of ESRD

in the ESRD facility or in a patient’s

home. Under the Physician Fee

Schedule, medical management of an

ESRD beneficiary receiving dialysis by a

physician or other practitioner is paid

through the MCP. The ETC Model is a

mandatory payment model designed to

test payment adjustments to certain

dialysis and dialysis-related payments,

as discussed in section IV. of this final

rule, for ESRD facilities and for

Managing Clinicians for claims with

dates of service from January 1, 2021 to

June 20, 2027.

Under the ETC Model, there will be

two payment adjustments designed to

increase rates of home dialysis and

kidney transplants through financial

incentives. The HDPA is an upward

payment adjustment on certain home

dialysis claims for ESRD facilities, as

described in §§ 512.340 and 512.350,

and to certain home dialysis-related

claims for Managing Clinicians, as

described in §§ 512.345 and 512.350,

during the initial 3 years of the ETC

Model.

The PPA is an upward or downward

payment adjustment on certain dialysis

and dialysis-related claims submitted by

ETC Participants, as described in

§§ 512.375(a) and 512.380 for ESRD

facilities and §§ 512.375(b) and 512.380

for Managing Clinicians, which will

apply to claims with claim service dates

beginning on July 1, 2022 and increase

in magnitude over the duration of the

Model. We will assess each ETC

Participant’s home dialysis rate, as

described in § 512.365(b), and ETC

Participant’s transplant rate, as

described in § 512.365(c), for each

Measurement Year. The ETC

Participant’s transplant rate, which is

calculated as the sum of the risk

adjusted transplant waitlist rate and

living donor transplant rate, will be

aggregated, as described in 512.365(e),

and the ETC Participant’s home dialysis

rate will be aggregated, as described in

§ 512.365(e). The ETC Participant will

receive a Modality Performance Score

(MPS) based on the weighted sum of the

higher of the ETC Participant’s

achievement score or improvement

score for the home dialysis rate and the

higher of the ETC Participant’s

achievement score or improvement

score for the transplant rate, as

described in § 512.370(d). The

achievement scores will be calculated in

relation to a set of benchmarks based on

the historical rates of home dialysis and

inclusion on the transplant waitlist

among ESRD facilities and Managing

Clinicians located in Comparison

Geographic Areas. As discussed in the

proposed rule and section IV.C.5.d. of

this final rule, we intend to increase

these benchmarks over time. Any such

changes would be made through

subsequent notice and comment

rulemaking. The improvement score

will be calculated in relation to a set of

benchmarks based on the ETC

Participant’s own historical

performance. The ETC Participant’s

MPS for a MY will determine the

magnitude of its PPA during the

corresponding 6-month PPA Period,

which will begin 6 months after the end

of the MY. An ETC Participant’s MPS

will be updated on a rolling basis every

6 months.

The ETC Model will not be a total cost

of care model. ETC Participants will still

bill FFS Medicare, and items and

services not subject to the ETC Model’s

payment adjustments will continue to

be paid as they would in the absence of

the Model.

(2) Data and Methods

A stochastic simulation was created to

estimate the financial impacts of the

Model relative to baseline expenditures.

The simulation relied upon statistical

assumptions derived from

retrospectively constructed ESRD

facilities’ and Managing Clinicians’

Medicare dialysis claims and transplant

waitlist data reported during 2016 and

2017, the most recent years with

complete data available. Both datasets

and the risk-adjustment methodologies

for the ETC Model were developed by

the CMS Office of the Actuary.

The ESRD facilities and Managing

Clinicians datasets were restricted to the

following eligibility criteria.

Beneficiaries must be residing in the

United States, 18 years of age or older,

and enrolled in Medicare Part B.

Beneficiaries enrolled in Medicare

Advantage or other cost or Medicare

managed care plans, who have elected

hospice, receiving dialysis for acute

kidney injury (AKI) only, is residing in

or receiving dialysis in a skilled nursing

facility (SNF) or nursing facility, or has

a diagnosis of dementia were excluded.

In addition, the HRR was matched to the

claim service facility zip code or the

rendering physician zip code for ESRD

facility and Managing Clinician,

respectively.

For the modeling exercise used to

estimate changes in payment to

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161

UNOS. 2020. COVID–19 and Solid Organ

Transplants. Transplant and Waitlist Data

Visualizations. https://unos.org/covid/.

providers and suppliers and the

resulting savings to Medicare, OACT

maintained the previous method

proposed to identify ESRD facilities

with common ownership, the low-

volume exclusion threshold, and the

aggregation assumptions as these

proposed changes are unlikely to have

a significant impact in terms of our

modeling. To clarify OACT’s

methodology, the ESRD facilities data

were aggregated to the CMS

Certification Number (CCN) level for

beneficiaries on dialysis identified by

outpatient claims with Type of Bill

072X to capture all dialysis services

furnished at or through ESRD facilities.

Beneficiaries receiving home dialysis

services were defined as condition

codes 74, 75, 76, and 80. Beneficiaries

receiving in-center dialysis services

were defined using condition codes 71,

72, and 73. For consistency with the

exclusion in § 512.385(a), after grouping

within each HRR, aggregated ESRD

facilities with less than 132 total

attributed beneficiary months during a

given MY were excluded. When

constructing benchmarks, for

consistency with the methodology for

aggregating performance for purposes of

the PPA calculation, we aggregated all

ESRD facilities owned in whole or in

part by the same dialysis organization

located in the same HRR.

The Managing Clinicians’

performance data were aggregated to the

TIN level (for group practices) and the

individual NPI level (for solo

practitioners). For purposes of

calculating the home dialysis rate,

beneficiaries on home dialysis and were

identified using outpatient claims with

CPT

®

codes 90965 and 90966.

Beneficiaries receiving in-center dialysis

were identified by outpatient claims

with CPT

®

codes 90957, 90958, 90959,

90960, 90961, and 90962. Similar to our

decision for the ESRD facilities, we did

not expect the proposed changes to the

low-volume threshold for the Managing

Clinicians to have a significant impact

on the model’s estimate. To clarify,

within each HRR, OACT applied a low-

volume exclusion to Managing

Clinicians in the bottom 5 percent in

terms of beneficiary-years for which the

Managing Clinician billed the MCP

during the year. The aggregation method

may vary when the ETC Model is

executed.

The Scientific Registry of Transplant

Recipients (SRTR) transplant waitlist

data were obtained from the Center for

Clinical Standards and Quality (CCSQ).

To construct the transplant waitlist rate,

the numerator was based on per-patient

counts and included every addition to

the waitlist for a patient in any past

year. The waitlist counts for the

numerator included waitlists for kidney

transplants, alone or with another organ,

active and inactive records, multi-organ

listings, and patients that have

subsequently been removed from the

waitlist. The denominator was a unique

count of prevalent dialysis patients as of

the end of the year. Only patients on

dialysis as of December 31st for the

selected year were included. Facility

attribution was based on the facility the

patient was admitted to on the last day

of the year.

The effects of the living donor

transplants are described in two

sections of this RIA. First, we provide a

sensitivity estimate in the ‘‘Effects on

Kidney Transplantation’’ section that

includes the impact of living donor

transplants. Since the sensitivity

estimate is not part of the main model’s

calculations, the overall savings to

Medicare estimate was not impacted.

Second, we describe the modified

transplant rate that includes two parts,

the transplant waitlist rate and the

living donor transplant rate in the

‘‘Effects of the Revised Transplant Rate’’

section. OACT’s conclusion of the

modified transplant rate was that the

preemptive and living donor transplants

are limited in frequency among the

Medicare primary payer population;

therefore, their inclusion in the

transplant waitlist scores is not

estimated to significantly impact overall

payments under the Model.

The home dialysis score and

transplant waitlist score for the PPA

were calculated using the following

methodology for the ESRD facilities and

Managing Clinicians. ETC Participant

behavior for each year was simulated by

adjusting the ETC Participant’s baseline

home dialysis (or transplant waitlist)

rate for a simulated statistical

fluctuation and then summing with the

assumed increase in home dialysis (or

transplant waitlist) rate multiplied by a

randomly generated improvement

scalar. The achievement and

improvement scores were assigned by

comparing the ETC Participant’s

simulated home dialysis (or transplant

waitlist) rate for the MY to the

percentile distribution of home dialysis

(or transplant waitlist) rates in the prior

year. Last, the MPS was calculated using

the weighted sum of the higher of the

achievement or improvement score for

the home dialysis rate and the

transplant waitlist rate. The home

dialysis rate constituted two-thirds of

the MPS, and the transplant waitlist rate

one-third of the MPS.

In addition, the waitlist benchmarks

were annually inflated by

approximately 2 percentage points

growth observed during years 2017

through 2019 in the CCSQ data, to

project rates of growth. The annual

growth rate was from the median

transplant waitlist rate across HRR

condensed facilities growing from 8

percent in 2017 to 10 percent in 2018

to 13 percent in 2019 (that is, not a

growth rate of 1.02 percent per year).

To assess the impact of COVID–19 on

the kidney transplant waitlist, we

analyzed data from the United Network

for Organ Sharing (UNOS).

161

The

UNOS data suggest that the number of

new patients added to the kidney

transplant waitlist steadily decreased

between the weeks of March 15, 2020

through May 3, 2020, when between 16

to 81 percent of patients listed on the

weekly kidney transplant waitlist

became inactive due to COVID–19

precautions. During June and July 2020,

the number of new patients added to the

kidney transplant waitlist increased to

near pre-pandemic levels with an

average of less than 4 percent of patients

listed as inactive due to COVID–19.

Therefore, we assume that the number

of new patients added to the waitlist

will not decrease as a result of the

pandemic and the linear 2 percentage

point growth rate for the transplant

waitlist calculated using years 2017

through 2019 CCSQ data does not need

to be revised to account for COVID–19.

The HDPA calculation required a

simplified methodology, with home

dialysis and home dialysis-related

payments adjusted by decreasing

amounts (3, 2, and 1 percent) during

each of the first 3 years of the Model.

The Kidney Disease Education (KDE)

benefit utilization and cost data were

identified by codes G0420 and G0421, to

capture face-to-face individual and

group training sessions for chronic

kidney disease beneficiaries on

treatment modalities. The home dialysis

training costs for incident beneficiaries

on home dialysis for Continuous

Ambulatory Peritoneal Dialysis (CAPD)

or Continuous Cycler-Assisted

Peritoneal Dialysis (CCPD) were defined

using CPT

®

codes 90989 and 90993 for

complete and incomplete training

sessions, respectively.

Data from calendar year 2017 were

used to project baseline expenditures

and the traditional FFS payment system

billing patterns were assumed to

continue under current law.

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(3) Medicare Estimate—Primary

Specification, Assume Rolling

Benchmark

Table 2 summarizes the estimated

impact of the ETC Model when

assuming a rolling benchmark where the

achievement benchmarks for each year

are set using the average of the home

dialysis rates for year t-1 and year t-2 for

the HRRs randomly selected for

participation in the ETC Model. We

estimate the Medicare program will save

a net total of $32 million from the PPA

and HDPA between January 1, 2021 and

June 30, 2027 less $9 million in

increased training and education

expenditures. Therefore, the net impact

to Medicare spending is estimated to be

$23 million in savings. In Table 2,

negative spending reflects a reduction in

Medicare spending, while positive

spending reflects an increase. The

results were generated from an average

of 500 simulations under the

assumption that benchmarks are rolled

forward with a 1.5-year lag. The

projections do not include the Part B

premium revenue offset because the

payment adjustments under the ETC

Model will not affect beneficiary cost-

sharing. Any potential effects on

Medicare Advantage capitation

payments were also excluded from the

projections. This approach is consistent

with how CMS has previously conveyed

the primary Fee-For-Service effects

anticipated for an uncertain model

without also assessing the potential

impact on Medicare Advantage rates.

As anticipated, the expected Medicare

program savings were driven by the net

effect of the Facility PPA; a reduction in

Medicare spending of $57 million over

the period from July 1, 2022 through

June 30, 2027. In comparison, the net

effect of the Clinician PPA was only $1

million in Medicare savings. This

estimate was based on an empirical

study of historical home dialysis

utilization and transplant waitlist rates

for Medicare FFS beneficiaries that CMS

virtually attributed to ESRD facilities

and to Managing Clinicians based on the

plurality of associated spending at the

beneficiary level. We analyzed the base

variation in those facility/practice level

measures and simulated the effect of the

payment policy assuming providers and

suppliers respond by marginally

increasing their share of patients

utilizing home dialysis. Random

variables were used to vary the

effectiveness that individual providers

and suppliers might show in such

progression over time and to simulate

the level of year-to-year variation

already noted in the base multi-year

data that was analyzed. The uncertainty

in the projection was illustrated through

an alternate scenario assuming that the

benchmarks against which ETC

Participants are measured were to not be

updated as well as a discussion of the

10th and 90th percentiles of the

actuarial model output. These

sensitivity analyses are described in

sections VII.C.2.b.(3)(a) and

VII.C.2.b.(3)(b) of this final rule,

respectively. KDE sessions on treatment

modalities and home dialysis (HD)

training for incident dialysis

beneficiaries are relatively small outlays

and were projected to represent only

relatively modest increases in Medicare

spending each year.

The key assumptions underlying the

impact estimate are that each

consolidated ESRD facility or Managing

Clinician’s share of total maintenance

dialysis provided in the home setting

was assumed to grow by up to an

assumed maximum growth averaging 3

percentage points per year. Factors

underlying this assumption about the

home dialysis growth rate include:

Known limitations that may prevent

patients from being able to dialyze at

home, such as certain common disease

types that make peritoneal dialysis

impractical (for example, obesity);

current equipment and staffing

constraints; and the likelihood that a

patient new to maintenance dialysis

starts dialysis at home compared to the

likelihood that a current dialysis patient

who dialyzes in center switches to

dialysis at home. The 3 percentage point

per year max growth rate will, in effect,

move the average market peritoneal

dialysis rate (about 10 percent) to the

highest market baseline peritoneal

dialysis rate (for example, Bend, Oregon

HRR at about 25 percent), which we

believe is a reasonable upper bound on

growth over the duration of the ETC

Model for the purposes of this actuarial

model.

Consolidated ESRD facilities at the

HRR level or Managing Clinicians were

assumed to achieve anywhere from zero

to 100 percent of such maximum growth

in any given year. Thus, the average

projected growth for the share of

maintenance dialysis provided in the

home was 1.5 percentage points per

year. Projected forward, this will result

in home dialysis ultimately representing

approximately 19 percent of overall

maintenance dialysis in Selected

Geographic Areas by the end of 2027. In

contrast, we do not include an official

assumption that the overall number of

kidney transplants will increase and

provide justification for this assumption

in section VII.C.2.b.(4). of this final rule.

However, as part of the sensitivity

analysis for the savings calculations for

the model, we lay out different savings

scenarios if the incentives under the

ETC Model were to cause an increase in

living donation and if the ETC Learning

Collaborative described in section

IV.C.12 of this final rule were to be

successful in decreasing the discard rate

of deceased donor kidneys and

increasing the utilization rate of

deceased donor kidneys that have been

retrieved.

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(a) Sensitivity Analysis: Medicare

Estimate—Assume Fixed Benchmark for

Home Dialysis and Fixed Benchmark for

Transplants

An alternative model specification

was analyzed where benchmarks remain

fixed at baseline year 0 over time

(results available upon request). Both

the rolling and fixed benchmark

assumptions projected $12 and $11

million, respectively, in increased

overall HDPA Medicare payments to

ESRD facilities and Managing Clinicians

in the first year of the Model. We project

about $1 million in additional HD

training add-on payments. This will

represent $13 and $12 million in

increased Medicare expenditures in the

first year of the Model overall. The

rolling and fixed specifications of the

benchmark also projected the net impact

of approximately $7 and $8 million,

respectively, in increased Medicare

expenditures in the second year of the

Model.

The two scenarios diverge after the

second year of the Model, with large

differences observed in overall net PPA

and HDPA savings/losses. Table 2

illustrates that when benchmarks are

rolled forward, using the methodology

described in section VII.C.2.b.(3). of this

final rule, the overall savings in PPA net

and HDPA increase each year during the

2022–2026 period. Peak savings of $15

million occurs in 2026, followed by a

slight deceleration in 2027 to $7 million

in savings. In contrast, when benchmark

targets are fixed, losses are projected for

the net impact to Medicare spending

(net of education and training but before

administrative cost) in years 2022–2026

of $4, $7, $22, $39, and $26 million,

respectively. The fixed benchmark will

allow the ESRD facilities and Managing

Clinicians to have more favorable

achievement and improvement scores

over time compared to the rolling

benchmark method. In summary, the

total of overall net PPA and HDPA from

January 1, 2021 through June 30, 2027,

with the fixed benchmark, was $102

million in losses, compared to a total of

$32 million in savings with the rolling

benchmark method. The net impact on

Medicare spending for the PPA and

HDPA using the fixed benchmark

method is $117 million in losses.

(b) Sensitivity Analysis: Medicare

Estimate—Assume Rolling Benchmark

for Home Dialysis and Fixed Benchmark

for Transplants in Response to COVID–

19

At the time of writing, there were only

six months of data available on COVID–

19 in the United States. A few recent

publications cite advantages of home

dialysis in combination with telehealth

in comparison to in-center dialysis by

reducing the vulnerable ESRD

population’s exposure to COVID–19. In

July 2020, CMS proposed expanding the

transitional add-on payment adjustment

for new and innovative equipment and

supplies, or TPNIES, to include certain

capital-related assets that are home

dialysis machines, which would make it

easier to get them to Medicare

beneficiaries. If finalized, this policy

would take effect January 1, 2021. Since

we have not been able to observe the

impact of this rule on potential changes

to the home dialysis rates, we propose

to keep the benchmark for home dialysis

as rolling.

The UNOS data show that after the

first wave of COVID–19, the number of

new patients being added to the kidney

transplant waitlist was approaching pre-

pandemic levels by July 2020.

Specifically, the number of kidney

transplants experienced a slight decline

starting April 12, 2020 in response to

fewer living donor transplants; however,

the overall kidney transplant rate

remained stable when comparing the

slope for the same dates in 2019. It is

unknown how future waves of COVID–

19 may affect the kidney transplant

waitlist and the transplant rate. To

address this uncertainty, we tested the

actuarial model by setting the

benchmark to be rolling for home

dialysis and fixed for transplants and

did not find the model to be sensitive

to incremental changes in the transplant

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162

United States Renal Data System. 2018. ‘‘ADR

Reference Table 6 Renal Transplants by Donor

Type.’’

163

Salomon DR, Langnas AN, Reed AI, et al.

2015. ‘‘AST/ASTS Workshop on Increasing Organ

Donation in the United States: Creating an ’Arc of

Change’ From Removing Disincentives to Testing

Incentives.’’ American Journal of Transplantation

15: 1173–1179.

164

Tong A, Chapman JR, Wong G, Craig JC. 2014.

‘‘Perspectives of Transplant Physicians and

Surgeons on Reimbursement, Compensation, and

Incentives for Living Kidney Donors.’’ American

Journal of Kidney Disorders 64(4):622–632.

165

Public Law 108–216 (section 377 of the Public

Health Service (PHS) Act, 42 U.S.C. 274f).

166

OPTN & SRTR 2017 Annual Report. Section KI

Kidney Transplants. https://www.srtr.org/reports-

tools/srtroptn-annual-data-report/.

167

Axelrod DA, Schnitzler MA, Xiao H, et al.

2018. ‘‘An Economic Assessment of Contemporary

Kidney Transplant Practice.’’ American Journal of

Transplantation 18: 1168–1176.

rate because most of the weighting is

determined by the home dialysis score.

(c) Sensitivity Analysis: Medicare

Savings Estimate—Results for the 10th

and 90th Percentiles

Returning to the primary specification

used for the Medicare estimate with

rolling benchmarks for home dialysis

and transplants, we compare the results

(available upon request) for the top 10th

and 90th percentiles of the 500

individual simulations to the average of

all simulation results reported in Table

2. Since the impact on Medicare

spending for the ETC Model using the

rolling benchmark method is estimated

to be in savings rather than losses, the

top 10th and 90th percentiles represent

the most optimistic and conservative

projections, respectively. The overall

net PPA and HDPA for the top 10th and

90th percentiles using the rolling

benchmark method are $79 million in

savings and $7 million in losses

(encompassing the mean estimate of $32

million in savings in Table 2).

(4) Effects on Kidney Transplantation

Kidney transplantation is considered

the optimal treatment for most ESRD

beneficiaries. However, while the PPA

includes a one-third weight on the

ESRD facilities’ or Managing Clinician’s

transplant rate, calculated as the sum of

the transplant waitlist rate and living

donor transplant rate, with the ultimate

goal of increasing the rate of kidney

transplantation including from deceased

donors, we decided to not include an

assumption that the overall number of

kidney transplants will increase. The

number of ESRD patients on the kidney

transplant waitlist has for many years

far exceeded the annual number of

transplants performed. Transplantation

rates have not increased to meet such

demand because of the limited supply

of deceased donor kidneys. The United

States Renal Data System

162

reported

20,161 kidney transplants in 2016

compared to an ESRD transplant waiting

list of over 80,000. Living donor kidney

transplantation (LDKT) has actually

declined in frequency over the last

decade while deceased donor kidney

transplantation (DDKT) now represent

nearly three out of four transplants as of

2016.

The PPA’s transplant incentive will

likely increase the share of ESRD

beneficiaries who join the transplant

waitlist but is unlikely to impact the

deceased donor kidney supply

limitation. There is evidence that the

overall quantity of transplants could be

positively impacted by reducing the

discard rate for certain DDKT with

lower quality, high-Kidney Donor

Profile Index (KDPI) organs. However,

while such transplantation has been

shown to improve the quality of

outcomes for patients, kidney transplant

centers have reported barriers to their

use including a higher cost of providing

care in such relatively complex

transplant cases relative to Medicare’s

standard payment. Because the PPA will

not impact payment to transplant

centers, the ETC Model will not mitigate

the barrier to increased marginal kidney

transplantations. Furthermore, even to

the extent that marginal DDKT were

somehow improved because of PPA

incentives, evidence also suggests that

the impact of DDKT with high-KDPI

organs may not reduce overall spending

despite improving the quality of

outcomes for patients.

It is possible that the ETC Model

could generate additional living donor

kidney donations for which significant

Medicare program savings could be

realized. given that the living donor

transplant rate is a component of the

transplant rate used in calculating the

PPA. In addition, additional patient

education could lead more beneficiaries

to find donors by tapping into resources

already available to remove financial

disincentives to donors (for example,

payment for travel, housing, loss of

wages, and post-operative care).

163 164

The ETC Model does not include a

policy to assist with minimizing

disincentives to living donors for their

kidney donation; however, qualified

donors may apply for financial

assistance through the National Living

Donor Assistance Center (NLDAC),

which administers federal funding

received from HRSA under the federal

Organ Donation Recovery and

Improvement Act.

165

All applicants

under this Act are means tested, with

preference given to recipients and

donors who are both below 300 percent

of the federal poverty line (FPL).

Approved applicants can receive up to

$6,000 to cover travel, lodging, meals,

and incidental expenses. In 2017, only

8.38 percent of the approximate 6,000

total living kidney donations

166

received NLDAC support, resulting in

up to $3 million in paid expenses per

year. Additional methods are necessary

to decrease financial disincentives for

kidney donors and their recipients who

exceed the means testing criteria of the

NLDAC.

The costs/savings incurred by kidney

transplantation vary by donor type.

Axelrod et al. (2018) used Medicare

claims data with Medicare as the

primary payer linked to national registry

and hospital cost-accounting data

provides evidence for the cost-savings of

kidney transplantations by donor type

compared to dialysis.

167

The authors

estimated ESRD expenditures to be

$292,117 over 10 years per beneficiary

on dialysis. LDKT was cost-saving at 10

years, reducing expected expenditures

for ESRD treatment by 13 percent

($259,119) compared to maintenance

dialysis. In contrast, DDKT with low-

KDPI organs was cost-equivalent at

$297,286 over 10 years compared to

dialysis. Last, DDKT with high-KDPI

organs resulted in increased spending of

$330,576 over 10 years compared to

dialysis.

The approximately $33,000 in savings

per beneficiary over 10 years for LDKT

compared to maintenance dialysis is

likely a lower bound since living

donation will help reduce the number of

beneficiaries under the age of 65 who

will be eligible for Medicare enrollment.

The lower bound conditional savings

can be adjusted to account for

additional savings through reduced

Medicare enrollment by considering the

share of potential new live donations

across three main scenarios.

The LDKT expected cost of $259,119

over 10 years per beneficiary projected

by Axelrod et al. (2018) assumes

Medicare primary payer status. For

roughly 25 percent of LDKTs, Medicare

can be assumed to be the primary payer

regardless of transplant success;

therefore, the projected spending need

not be adjusted. For the next 25 percent

of LDKTs, we assumed the beneficiary

is on dialysis and Medicare is the

primary payer, but they will eventually

leave Medicare enrollment if they had a

transplant. We adjusted the expected

Medicare spending for these cases

downward by 33 percent. This projected

a savings of approximately $119,000

over 10 years relative to the baseline

spending projection of $292,117 over 10

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168

OPTN & SRTR 2017 Annual Report. Section KI

Kidney Transplants. https://www.srtr.org/reports-

tools/srtroptn-annual-data-report/.

169

SRTR 2018 Annual Report. Section KI Kidney

Transplants. https://srtr.transplant.hrsa.gov/

annual_reports/2018/Kidney.aspx#KI_8_char_

adult_tx_dem.

170

Chan CT, Wallace E, Golper TA, et al. 2018.

‘‘Exploring Barriers and Potential Solutions in

Home Dialysis: An NKF–KDOQI Conference

Outcomes Report.’’ American Journal of Kidney

Disease 73(3): 363–371.

years for beneficiaries on dialysis. The

third scenario—covering the remaining

50 percent of LDKTs– assumes Medicare

is not the primary payer when the

transplant occurs. In this case, we

assumed that Medicare spending is

nominal relative to baseline spending

and we adjust downward by 33 percent

(that is, the beneficiary will take up to

30 months to become a Medicare

primary payer enrollee absent the

transplant), which projected a savings of

approximately $195,000 over 10 years.

The projected weighted average program

savings for LDKT is $136,000 over 10

years per beneficiary.

Therefore, a 20 percent increase in the

rate of LDKT in model markets in a

single year, representing about 300 new

transplants mainly from relatives of

recipients, will produce approximately

$41 million in program savings over 10

years (and multiples thereof for each

successive year the living donor

transplant rate were thusly elevated).

The model also includes an

investment in learning and diffusion for

improving the utilization of deceased

donor kidneys that are currently

discarded at a rate of approximately 19

percent nationally.

168

Similar to the

previously discussed estimate on the

average impact to Medicare spending for

LDKT, we estimated an average

marginal savings to Medicare for DDKT

by adjusting costs reported by Axelrod

et al. (2018) for DDKT with high-KDPI

to account for effects on Medicare payer

status. We include three scenarios based

on type of payer.

First, we assumed 50 percent of newly

harvested deceased-donor kidneys will

be for beneficiaries enrolled in

Medicare, regardless of ESRD status.

This scenario aligns with the Medicare

primary payer estimates from the study,

approximately $38,000 higher spending

for DDKT with high-KDPI over 10 years

relative to maintenance dialysis.

Second, we assumed 30 percent of

marginal DDKT will be for beneficiaries

with Medicare as their primary coverage

where the transplant spending was

adjusted downward by 33 percent to

account for reduced liability for patients

returning to non-Medicare status. Third,

we assumed 20 percent of DDKT with

high-KDPI will involve beneficiaries not

yet under Medicare as their primary

payer. For this scenario, we adjusted the

baseline dialysis spending downward

by 33 percent to account for initial non-

Medicare status during the waiting

period and for the transplant spending

we assumed 25 percent of baseline

Medicare spending will still be present

due to early graft failure before the end

of the 10-year window (recognizing the

shorter lifespan high-KDPI organs tend

to offer recipients).

Combining these assumptions

produced an average 10-year savings to

Medicare of approximately $32,000 per

beneficiary for DDKT with high-KDPI.

Overall, we found an increase in

marginal kidney utilization such that

the national discard rate will drop to 15

percent by the end of the model testing

period, representing approximately

2,360 additional transplants and an

estimated $76 million in federal savings.

For both living and deceased donor

transplants, the illustrated potential

effect of the model will reduce long run

program spending by $116 million.

Costs for this effort include a learning

and diffusion investment of $15 million

in section 1115A administrative funds

over the model testing period and a

potential increase in PPA adjustments to

clinician and facility payments of

approximately $20 million. The

projected increase in transplantation is

estimated to produce a net savings of

$81 million—a net return on investment

of approximately 2.3.

(5) Effects of the Revised Transplant

Rate

This final rule includes a modified

transplant rate that includes two parts,

the ‘‘transplant waitlist rate’’ and the

‘‘living donor transplant rate.’’ The

ESRD facility transplant rate is

calculated as the sum of the transplant

waitlist rate for ESRD facilities, risk

adjusted based on age strata, and the

living donor transplant rate for ESRD

facilities. For purposes of calculating

the transplant waitlist rate for ESRD

facilities, the sum of the attributed

ESRD beneficiary waitlist years is

divided by the total attributed ESRD

beneficiary dialysis treatment years. For

purposes of calculating the living donor

transplant rate for ESRD facilities, the

living donor transplant years for

attributed ESRD beneficiaries is divided

by the total attributed ESRD beneficiary

dialysis treatment years. The Managing

clinician transplant rate is calculated as

the sum of the transplant waitlist rate

for Managing clinicians, risk adjusted

based on age strata, and the living donor

transplant rate for Managing clinicians.

For purposes of calculating the

transplant waitlist rate for Managing

clinicians, the sum of the attributed

ESRD beneficiary waitlist years is

divided by the total attributed ESRD

beneficiary dialysis treatment years. For

purposes of calculating the living donor

transplant rate for Managing clinicians,

the living donor transplant years for

attributed ESRD beneficiaries is divided

by the total attributed ESRD beneficiary

dialysis treatment years.

The goal of these revised formulas is

to give credit to model participants with

beneficiaries who are on the kidney

transplant waitlist and who receive a

transplant from a living donor

transplant. Data from the SRTR show

that in 2018, 1.8 percent of all living

donor transplant recipients had a

preemptive transplant and 62.3 percent

had a wait time of less than 1 year.

169

The SRTR data also report that only 39.7

percent of all living donor transplants

(including preemptive) had Medicare as

the primary payer. We also used the

SRTR data to confirm that year 2018, the

most recent year with data available,

was not an anomaly and we found that

years 2016–2018 had similar rates of

wait time for living donor transplants.

In addition, we calculated total member

months from the Medicare data in the

IDR and found that in 2018, all living

donor transplant member months

(regardless of wait time) accounted for

only 0.6 percent of total member months

among beneficiaries on dialysis.

Because the living donor transplants

and pre-emptive living donor

transplants (variables ‘‘d’’ and ‘‘c’’ in the

proposed formulas) are limited in

frequency among the Medicare primary

payer population, their inclusion in the

transplant waitlist scores is not

estimated to significantly impact overall

payments under the model. This is

partly due to limited effects expected for

the transplant waitlist score at the

clinician and facility levels, but also

because model payments are more

heavily weighted on the home dialysis

measure.

(6) Effects on the KDE Benefit and HD

Training Add-Ons

The KDE benefit has historically

experienced very low uptake, with less

than 2 percent of eligible Medicare

beneficiaries utilizing this option. A

recent report summarized barriers to

adequate education on home dialysis.

170

According to this report, kidney disease

education may: Not be provided at all,

be done only once, not be appropriate

for patient’s literacy level or not

provided in patient’s native language,

not be done until after patient starts in-

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171

Da

˛browska-Bender M, Dykowska G, Zuk W, et

al. 2018. ‘‘The impact on quality of life of dialysis

patients with renal insufficiency.’’ Patient Prefer

Adherence 12: 577–583.

172

Makkar V, Kumar M, Mahajan R, Khaira NS.

2015. ‘‘Comparison of Outcomes and Quality of Life

between Hemodialysis and Peritoneal Dialysis

Patients in Indian ESRD Population.’’ J Clin Diagn

Res. 9(3): OC28–OC31.

173

Van Eps CL, Jeffries JK, Johnson DW, et al.

2010. ‘‘Quality of life and alternate nightly

nocturnal home hemodialysis.’’ Hemodial

Int.14(1):29–38.

174

https://aspe.hhs.gov/system/files/pdf/242926/

HHS_RIAGuidance.pdf.

175

For the RO Model, we use the estimated

median hourly wage of $19.40 per hour, plus 100

percent overhead and fringe benefits. Estimating the

hourly wage is necessarily a rough adjustment, both

because fringe benefits and overhead costs vary

significantly from employer-to-employer and

because methods of estimating these costs vary

widely from study-to-study. Nonetheless, we

believe that doubling the hourly wage rate to

estimate total cost is a reasonably accurate

estimation method and allows for a conservative

estimate of hourly costs.

Continued

center hemodialysis, and/or not be

provided to caregivers.

The ETC Model will incorporate

waivers of select KDE benefit

requirements that should make these

educational sessions on treatment

modality options more accessible to

beneficiaries targeted by the model and

address some of the barriers previously

described. We assume the KDE benefit

utilization rate to increase from 2.2 in

2021 to 3.2 in 2027. To arrive at this

assumption, we began with the current

low utilization of the benefit. The

utilization rate of the KDE benefit

during the first year of the Model was

set to 2 percent of beneficiaries eligible

to use the KDE benefit, which is

consistent with the current rate of

utilization of the benefit. We set the

utilization growth rate to increase by 0.2

percentage points each year from 2021

to 2027. This results in a projected

doubling of the costs attributed to the

KDE benefit to approximately $1 million

in 2027. Although the ETC Model will

allow different types of health care

providers to furnish the KDE benefit to

beneficiaries, there is no direct evidence

that this will cause an increase in the

utilization growth rate that differs

significantly from the historical rate.

Challenges to increasing the utilization

rate include: the beneficiary’s Managing

Clinician may not inform the

beneficiary of the option to seek KDE

benefit sessions for a variety of reasons

(for example—the Managing Clinician is

unaware of the KDE benefit, alternative

treatment modalities are not feasible for

the beneficiary, or the clinician believes

that the beneficiary will not be able to

make an informed choice about dialysis

modality after receiving the KDE

benefit); if informed of the KDE benefit

option, the beneficiary may prefer to

rely on their Managing Clinician’s

recommendation rather than receive

education about their treatment options;

and the beneficiary may not want to

have an additional one to six sessions

with a health care provider for the

provision of the KDE benefit, as

beneficiaries with late stage CKD and

ESRD are medically fragile and already

in frequent contact with the health care

system.

The impacts of increased utilization

of the home dialysis (HD) training add-

on payment adjustment under the ESRD

PPS are expected to be larger than the

KDE benefit costs as these trainings will

be required for all incident beneficiaries

on home dialysis. Assuming a stable 3

percent growth rate in home dialysis per

year, the 7-year total in HD training

costs is projected to be $10 million.

3. Effects on Medicare Beneficiaries

a. Radiation Oncology Model

We anticipate that the RO Model will

modestly reduce the cost to

beneficiaries receiving RT services on

average. Under current policy, Medicare

FFS beneficiaries are generally required

to pay 20 percent of the allowed charge

for services furnished by HOPDs and

physicians (for example, those services

paid for under the OPPS and MPFS,

respectively). This policy will remain

the same under the RO Model. More

specifically, beneficiaries will be

responsible for 20 percent of each of the

PC and TC episode payments made

under the RO Model. Since we are

finalizing our proposal to take a

percentage ‘‘discount’’ off of the total

payment to participants for both PC and

TC episode payment amounts (this

discount representing savings to

Medicare), the total allowed charge for

services furnished by HOPDs and

physicians is expected to decrease.

Thus, beneficiary cost-sharing, on

average, should be reduced relative to

what typically would be paid under

traditional Medicare FFS for an episode

of care. In addition, the limit on

beneficiary cost-sharing in the HOPD

setting to the inpatient deductible will

continue under the RO Model.

In addition, we note that, because

episode payment amounts under the RO

Model will include payments for RT

services that will be provided over

multiple visits, individual beneficiary

coinsurance payments will be higher

than they would otherwise be for an

individual RT service visit. We

encourage RO participants to collect

coinsurance for services furnished

under the RO Model in multiple

installments.

We received a few comments

regarding the application of

coinsurance. Summaries of these

comments, our response, and the details

on our final policy related to

coinsurance are available in section

III.C.6.i. of this final rule.

b. ESRD Treatment Choices Model

We anticipate that the ETC Model will

have a negligible impact on the cost to

beneficiaries receiving dialysis. Under

current policy, Medicare FFS

beneficiaries are generally responsible

for 20 percent of the allowed charge for

services furnished by providers and

suppliers. This policy will remain the

same under the ETC Model. However,

we will waive certain requirements of

title XVIII of the Act as necessary to test

the PPA and HDPA under the Model

and to hold beneficiaries harmless from

any effect of these payment adjustments

on cost sharing. We received a few

comments regarding the application of

cost sharing under the ETC Model.

Summaries of these comments, our

response, and the details of our final

policy related to cost sharing are

available in section IV.C.7.a of this final

rule. In addition, the Medicare

beneficiary’s quality of life has the

potential to improve if the beneficiary

elects to have home dialysis as opposed

to in-center dialysis. Studies have found

that home dialysis patients experienced

improved quality of life as a result of

their ability to continue regular work

schedules or life plans;

171

as well as

better overall, physical, and

psychological health

172 173

in

comparison to other dialysis options.

4. Effects on RO Participants and ETC

Participants

RO participants will be given

instructions on how to bill for patients,

using RO Model-specific HCPCS codes.

We expect it will take medical coding

staff approximately 0.72 hours [(((∼36

pages * 300 words/per page)/250 words

per minute)/60 minutes) = 0.72]

174

to

read and learn the payment

methodology and billing sections of the

rule. In addition, we estimate an

additional 1 hour to review the relevant

MLN Matters publication, 1 hour to read

the RO Model billing guide, 1 hour to

attend the billing guidance webinar, and

1 hour to review the pricing

methodology training materials for a

total of 4.72 hours. We estimate the

median salary of a Medical Records and

Health Information Technician is $19.40

per hour, at 100 percent fringe benefit

for a total of $38.80, using the wage

information from the BLS.

175

The total

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https://www.bls.gov/ooh/Healthcare/Medical-

records-and-health-information-technicians.htm.

176

Please note these numbers are updated from

the proposed rule due to an update on SBA

categorizations. The small business revenue

numbers were previously $11.5 million and 38.5

million, respectively.

177

Office of Advocacy, Small Business

Administration. (2012). A Guide for Government

Agencies, How to Comply with the Regulatory

Flexibility Act, Implementing the President’s Small

Business Agenda and Executive Order 13272,

Retrieved from www.sba.gov/sites/default/files/

rfaguide_0512_0.pdf (accessed March 18, 2019).

178

This figure comes from the 2018 Medicare

Trustees Report, Table IV.V1, p151 from the

footnote that has the A and B share.

cost of learning the billing system for

the RO Model thus is $183.14 per

participant, or approximately

$173,983.00 in total (950 expected

participants × $183.14/participant =

$173,983 total).

The ETC Model will not alter the way

ETC Participants bill Medicare.

Therefore, we believe that there will be

no additional burden for ETC

Participants related to billing practices.

We believe the audit and retention

policies of the RO Model and ETC

Model are generally consistent with

existing policies under Medicare.

Additionally, the monitoring

requirements for the RO Model and ETC

Model are consistent with the

monitoring and evaluation requirements

already in place under 42 CFR

405.1110(b) for participants in models

tested under section 1115A of the Act.

Therefore, we believe the audit and

retention policies and the monitoring

and evaluation requirements do not add

additional regulatory burden on

participants.

The model evaluation for both the RO

Model and the ETC Model will include

beneficiaries and providers completing

surveys. Burden for these surveys will

depend on the length, complexity, and

frequency of surveys administered as

needed to ensure confidence in the

survey findings. We will make an effort

to minimize the length, complexity, and

frequency of the surveys. A typical

survey on average would require about

20 minutes of the respondent’s time. In

other evaluations of models where a

survey is required, the frequency of

surveys varies from a minimum of one

round of surveys to annual surveys.

We believe the burden estimate for

quality measure and clinical data

element reporting requirements that is

provided for Small Businesses in

section VII.C.5.a. of this final rule apply

to RO participants that are not

considered small entities. The burden

estimate for collecting and reporting

quality measures and clinical data for

the RO Model may be equal to or less

than that for small businesses, which we

estimate to be approximately $1,743.07

per entity per year. We estimate

approximately 950 RO participants,

then total burden estimate for collecting

and reporting quality measures and

clinical data was approximately

$1,655,916.50.

Additionally, the ETC Model does not

require any additional quality measure

or clinical data element reporting by

ETC Participants. Therefore, we believe

that there is no additional burden for

ETC Participants related to quality

measures or clinical data reporting.

Finally, we believe the burden

estimate for reading and interpreting

this final rule that is provided for Small

Businesses apply to RO participants and

ETC Participants that are not considered

small entities. The burden estimate for

reading and interpreting this final rule

may be equal to or less than that for

small businesses. We estimate that cost

of reading the rule for RO participants

would be approximately $1,093.26 per

entity with a total cost of approximately

$3,170,454.00 (2,900 eligible entities ×

$1,093.269/participant). In sum, we

estimate that reading the RO Model rule,

learning the RO billing system, the

pricing methodology and submitting

quality measures and clinical data to the

RO Model will cost approximately

$3,019.47 per RO participant ($1,093.26

to read the rule, $183.14 to attend and

learn the billing guidance, and

$1,743.07 to submit quality measure and

CDE information), and collectively cost

approximately $2,868,496.50 across the

950 RO participants, and an additional

$2,131,350.00 for those providers and

suppliers who read the rule, but are not

ultimately selected as RO participants,

for a total cost $4,999,846.50. Similarly,

we base our estimate for the cost of

reading the final rule for ETC

Participants on the same cost per

participant as used for the RO Model,

that is, $1,093.26 per entity. We assume

that all ESRD facilities and Managing

Clinicians will read the rule, even

though only a subset of each category

will participate in the Model. Therefore,

the collective cost will be $6,714,000

(14,380 entities reading the rule (7,097

ESRD facilities plus 7,283 Managing

Clinicians) times $466.89).

5. Regulatory Flexibility Act (RFA)

The RFA, as amended, requires

agencies to analyze options for

regulatory relief of small entities, if a

rule has a significant impact on a

substantial number of small entities. For

purposes of the RFA, small entities

include small businesses, nonprofit

organizations, and small governmental

jurisdictions. As discussed in sections

VII.5.a and VII.5.b. of this final rule, the

Secretary has considered small entities

and has determined and certifies that

this final rule will not have a significant

economic impact on a substantial

number of small entities.

a. Radiation Oncology Model

This final rule affects: (1) Radiation

oncology PGPs that furnish RT services

in both freestanding radiation therapy

centers and HOPDs; (2) PGPs that

furnish RT services only in HOPDs; (3)

PGPs that are categorized as

freestanding radiation therapy centers;

and (4) HOPDs. The majority of HOPDs

and other RT providers and RT

suppliers are small entities, either by

being nonprofit organizations or by

meeting the SBA definition of a small

business (defined as having minimum

revenues of less than $12 million to

$41.5 million

176

in any 1 year,

depending on the type of provider; the

$41.5 million per year threshold is for

hospitals, whereas the $12 million per

year threshold is for other entities).

(https://www.sba.gov/document/

support--table-size-standards). States

and individuals are not included in the

definition of small entity.

HHS uses an RFA threshold of at least

a 5 percent impact on revenues of small

entities to determine whether a final

rule is likely to have ‘‘significant’’

impacts on small entities.

177

Throughout the rule we describe how

the changes to a prospective episode

payment may affect PGPs and HOPDs.

In the proposed rule, we provided an

analysis for the RO Model’s impact on

small businesses based on the proposed

policies and following analysis (84 FR

34575 through 34577). Our analysis was

based on the assumption that the RO

Model would include only Medicare

FFS beneficiaries receiving RT services

by selected PGPs (including

freestanding radiation therapy centers)

and HOPDs. During 2018, 39 percent of

Medicare beneficiaries with both Part A

and B coverage on average are estimated

to have enrolled in Medicare Advantage

plans.

178

PGPs and HOPDs also serve

patients with other coverage, for

example, through Medicare or

commercial insurance. We believed that

on average, Medicare FFS payments to

PGPs would be reduced by 5.9 percent

and Medicare FFS payments to HOPDs

would be reduced by 4.2 percent and

would not change with an April 1 start

date. Given that this Model is limited to

only Medicare FFS beneficiaries, not

other payers including Medicare

Advantage and commercial insurance,

which combined we expect to be about

50 to 60 percent of total HOPD and PGP

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https://www.bls.gov/ooh/Healthcare/Medical-

records-and-health-information-technicians.htm.

180

https://aspe.hhs.gov/system/files/pdf/242926/

HHS_RIAGuidance.pdf.

181

For the RO Model, we use an estimated

median hourly wage of $47.95 per hour, plus 100

percent overhead and fringe benefits. https://

www.bls.gov/oes/current/oes119111.htm.

revenue for RT services, we expected

that the anticipated average impact of

revenue based solely on Medicare FFS

payments to be less than 1 percent.

Therefore, we determined that the

proposed rule would not have a greater

than 5 percent impact on total revenues

on a substantial number of small entities

(84 FR 34577). We estimated the

administrative costs of adjusting to and

complying with the quality measure and

clinical data element reporting

requirements for RO Model for small

entities to be approximately $388.00 per

entity per year. To estimate the costs per

small entity, we assumed that a Medical

Records & Health Information

Technician with an Hourly salary (from

BLS) plus 100 percent fringe benefits

would cost $38.80/hour

179

and would

report the information on quality

measures and clinical data elements. We

expected submission of the 4 quality

data measures would take

approximately 8 hours and would

require submission once a year, ($38.80

× 8.0 hours × 1 submission) = $310.40.

In the proposed rule, also we estimated

that the submission of clinical data

elements would take up to an hour, but

occur twice a year, that is, ($38.80 × 1-

hour × 2 submission) = $77.60 per year

(84 FR 34577).

Based on the final design of the RO

Model, we believe that on average,

Medicare FFS payments to PGPs will be

reduced by 6.0 percent and Medicare

FFS payments to HOPDs will be

reduced by 4.7 percent. We believe that

this impact would be less for small

providers that provide fewer than 20

episodes in the previous year and

choose to opt out of the Model under

the low volume opt out policy (see

section III.C.3.c. of this final rule)

because they would continue to bill FFS

for RT services furnished during their

opt out year(s). In response to

commenter feedback, we are updating

our estimate for the administrative costs

of adjusting to and complying with the

quality measure and clinical data

element reporting requirements for RO

Model for small entities to be

approximately $1,743.06 per entity per

year. We assume that our estimate for

the submission of quality measures

remains an accurate estimate at $310.40

per year. We revisited our clinical data

element estimates and now expect the

total cost of submission of the clinical

data elements would be approximately

$1,432.67 per entity ($38.80 × 18.5

hours × 2 submissions) per year. Our

estimate was updated based on our

review of the potential list of the

clinical data elements which may be

included across the five cancer types

(prostate, breast, lung, bone and brain)

finalized in section III.C.8. of this final

rule. We note that the final list will be

communicated prior to the start of PY1,

so our estimate may slightly overstate or

understate the final number of CDEs

(and thus may slightly understate or

overstate the burden) and each RO

participant’s experience may vary. We

still expect the burden costs per small

entity associated with measure and data

reporting to be small because three of

the four measures for the RO Model are

already in use in other CMS programs;

and compliance with the Treatment

Summary Communication (the measure

not currently in use) is a best practice

that should already be the standard of

care across PGPs and HOPDs.

In the proposed rule, we further

estimated the administrative cost of

reading and interpreting this final rule

per small entity at approximately

$446.89 (84 FR 34577). We are updating

our estimate to approximately $1,093.26

for reading the rule and an additional

$183.14 to learn the billing system. We

expect that a medical health service

manager reading 250 words per minute

could review the rule in approximately

11.4 hours [(approximately 569 pages *

300 words/per page)/250 words per

minute)

180

60 minutes)]. We estimated

the salary of a medical and health

service manager is $95.90 per hour,

using the wage information from the

BLS including overhead and fringe

benefits.

181

Assuming an average

reading speed for pages relevant to the

RO Model, we estimated that it would

take approximately 11.4 hours for the

staff to review the RO portion of this

final rule. For each provider that

reviews the rule, the estimated cost

based on the expected time and salary

of the person reviewing the rule

($1,093.26 = ($95.90 * 11.4 hrs). RO

participants would also review the

billing guidance, which we would

expect to cost approximately $183.14 as

discussed in section VI.C.4. of this final

rule.

We solicited public comments on our

estimates and analysis of the impact of

the final rule on those small entities.

Comment: A commenter expressed

concern with the RO Model’s payment

rates estimates based on their belief that

Medicare is a material payer for the

majority of providers. The commenter

added that Medicare is, or may exceed,

46 percent of their payer mix and that

this coupled with episode payment

amounts that would reduce payment by

up to 50 percent from what participants

would have received under FFS, makes

furnishing RT services under the Model

unsustainable.

Response: We thank this commenter

for their feedback. First, as we stated in

section III.C.6. of this final rule, we

disagree that episode payment amounts

would be reduced by 50 percent as

compared to non-participants. This

might be true for some participants if

the case mix and historical experience

adjustments were removed from the

Model’s pricing methodology. We

designed the pricing methodology so

that episode payment amounts for

Professional participants, Dual

participants, and Technical participants

are largely based on what each

participant has been paid historically

under FFS and trended forward based

on latest payment rates under FFS. In

particular, we refer readers to section

III.C.6.e.(2). of this final rule for more

information regarding the blend used to

determine how much participant-

specific historical payments and

national base rates figure into payment.

Second, RT services furnished under the

RO Model were assumed to grow with

FFS Medicare Part B enrollment as

projected in the 2018 Medicare Trustees

Report. We assume that participants do

not change payer mix as a response to

the RO Model. No explicit assumptions

were made about the relative amount of

RT services paid through private or

other forms of insurance.

Comment: A commenter stated that

providers and suppliers chosen for the

Model will see reductions to their

payments under the Hospital Outpatient

PPS or PFS, respectively, between 3.9

percent and 4.4 percent (PC) and

between 5.7 and 5.1 percent (TC) on

average, with participants furnishing RT

services in freestanding radiation

therapy centers experiencing a higher

reduction than those furnishing RT

services in the HOPD setting. According

to this commenter, the combined effect

of the discount factor and efficiency

factor, now termed, ‘‘blend,’’ will

reduce payments by 6.6 percent in the

fifth year and the commenter expressed

concern that this reduction would not

be offset by the APM bonus incentive

for technical payments, and even so,

this is waived under the Model as

proposed.

Response: We appreciate the

commenters concerns regarding the

combined effect of the discount factor

and blend. We believe that the

commenters’ estimates are consistent

with our analysis, though we note, we

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are finalizing policies that reduce the

discount factor by 0.25 percent for both

the PC and TC, so that the discount rates

are 3.75 percent and 4.75 percent for the

PC and TC, respectively as we discussed

in section III.C.6. We are also finalizing

the Model performance period to begin

January 1, 2021 in order to give RO

participants the necessary time to

prepare for implementation.

Comment: A few of commenters

stated their belief that the regulatory

impact analysis severely underestimates

burden on participants. A commenter

estimated that the cost of adjusting to

the Model could be well over $400,000

in PY1 and $350,000 in each successive

PY. Another commenter estimated that

0.3 FTEs per physician would be

needed to account for the newly created

workflow related to the revenue cycle

processes as well as quality metric and

data documentation, collection and

reporting that will exist alongside the

current workflow already established for

patients outside of the RO Model.

To better account for cost, a couple of

commenters suggested that CMS

consider the following: The additional

administrative tasks and requirements

that the Model imposes, the use of

certified EHR technology, the need to

prepare multiple billings and participate

in a radiation oncology-specific AHRQ

patient safety organization, and the need

to participate in CMS site visits and

medical record audits. A few

commenters recommended a review of

OCM’s cost and utilization reports,

which they believe would show that

manual data abstraction alone

represents 45–90 minutes per patient

and requires thousands of dollars in

human resources to implement. Another

commenter claimed that OCM practices

also spend tens of thousands of dollars

each year to meet the clinical data

element and quality measure reporting

requirements under that model, as

captured in the OCM cost and resource

utilization reports that are submitted to

CMS.

Response: We thank these

commenters for explaining their

concerns. First, we believe the

administrative, monitoring, and

compliance requirements for the RO

Model will not substantially diverge

from general monitoring requirements

for Medicare Part B providers. RO

participants are already subject to site

visits and record audits as part of their

participation in Medicare, so we do not

expect the Model requirements to create

additional burden. Second, we disagree

that the use of EHR technology should

be included in the regulatory impact

analysis as part of the cost of the Model.

An entity’s EHR has many uses within

the clinical setting and is not solely

used for RO Model measures reporting.

The cost of the EHR system should not

be reflected in the burden estimates

developed specifically for the RO

Model. We also note that American

Recovery and Reinvestment Act of 2009

(ARRA) (Pub. L. 111–5) and Meaningful

Use require providers to use EHRs to

avoid Medicare payment reductions,

which is independent of any proposals

in the RO Model. Third, and as we

stated in section III.C.7. of this final

rule, we believe that we have created a

billing process that will be easily

implemented within current systems,

because it is based on how FFS claims

are submitted today and may reduce the

amount of time spent billing because

coding will be submitted at the

beginning and end of the episode.

Lastly, we believe that the 45–60

minutes per patient file that one

stakeholder estimates is an overestimate

of the time it will take to review a chart

and submit quality measures for the RO

Model, nor do we believe the cost and

utilization reports of OCM are

comparable to that of the RO Model.

The RO Model does not mandate the

same OCM reporting requirements. We

also believe that we have included

measures that are commonly used in the

field and reflect common treatment

practices. However, as discussed earlier

in this section, we are updating our

estimates for the burden associated with

quality measure and clinical data

element submission and our estimates

of the cost it would take to read the rule

and learn the billing.

We believe that on average the

updated policies contained in this final

rule will result in reductions of 5.9

percent to underlying fee schedules for

RT services over the course of the model

test, which is similar to the proposed

rule. The final rule payment reduction

was estimated by simulating RT

episodes using 2018 claims and

assuming that the relative value units

under the PFS and relative payment

weights under the OPPS by providers

would remain unchanged in the future.

Another key assumption is that the

distribution of provider efficiency as

defined in (section III.C.1. of this final

rule) during 2018 would remain

unchanged in future years under the

current FFS payment system. Although

discounts were reduced by 0.25 percent

between the proposed and final rule,

this was approximately offset by an

additional year of data underlying the

distribution of provider efficiency.

Moreover, these estimated fee schedule

reductions do not include APM bonuses

payable to participants. APM bonuses to

providers were forecasted to be 0.5

percent of RO episode allowed charges.

Please note that for any individual

provider a range of potential outcomes

may occur due to the RO model and that

actual experience may vary.

We expect the anticipated average

impact of revenue based solely on

Medicare FFS payments to be less than

1 percent. We therefore expect that this

final rule would not have a greater than

5 percent impact on total revenues on a

substantial number of small entities.

b. ESRD Treatment Choices Model

This final rule includes as ETC

Participants Managing Clinicians and

ESRD facilities required to participate in

the Model pursuant to § 512.325(a). We

assume for the purposes of the

regulatory impact analysis that the great

majority of Managing Clinicians are

small entities and that the greater

majority of ESRD facilities are not small

entities. Throughout the final rule we

describe how the adjustments to certain

payments for dialysis services and

dialysis-related services furnished to

ESRD beneficiaries may affect Managing

Clinicians and ESRD facilities

participating in the ETC Model. The

great majority of Managing Clinicians

are small entities by meeting the SBA

definition of a small business (having

minimum revenues of less than $11

million to $38.5 million in any 1 year,

varying by type of provider and highest

for hospitals) with a minimum

threshold for small business size of

$38.5 million (https://www.sba.gov/

document/support--table-size-standards

http://www.sba.gov/content/small-

businesssize-standards). The great

majority of ESRD facilities are not small

entities, as they are owned, partially or

entirely by entities that do not meet the

SBA definition of small entities.

The HDPA in the ETC Model would

be a positive adjustment on payments

for specified home dialysis and home

dialysis-related services. The PPA in the

ETC Model, which includes both

positive and negative adjustments on

payments for dialysis services and

dialysis-related services, excludes

aggregation groups with fewer than 132

attributed beneficiary-months during

the relevant year.

For the remaining small entities that

are above the low-volume exclusion

threshold and randomly selected for

participation, the design of the ETC

Model will incorporate a risk

adjustment of the transplant waitlist rate

and aggregation of the home dialysis

rate and transplant waitlist rate to allow

for the calculation of home dialysis rates

and transplant waitlist rates for both

small entities that may be owned in

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whole or in part by another company.

The transplant waitlist rate is risk

adjusted based on age, as described in

section IV.C.5.b.(3). of the final rule.

The aggregation methodology groups

ESRD facilities owned in whole or in

part by the same dialysis organization

within a Selected Geographic Area and

Managing Clinicians billing under the

same TIN within a Selected Geographic

Area. This aggregation policy increases

the number of beneficiary months, and

thus statistical reliability, of the ETC

Participant’s home dialysis and

transplant rate for ESRD facilities that

are owned in whole or in part by the

same dialysis organization and for

Managing Clinicians that share a TIN

with other Managing Clinicians.

Taken together, the low volume

threshold exclusions, risk adjustments

of the transplant rate, and aggregation

policies previously described, coupled

with the fact that the ETC Model will

affect Medicare payment only for select

services furnished to Medicare FFS

beneficiaries; we have determined that

the provisions of this final rule will not

have a significant impact on spending

for a substantial number of small

entities (defined as greater than 5

percent impact). No comments were

received regarding the impact of the

ETC Model that were not addressed

elsewhere.

5. Effects on Small Rural Hospitals

Section 1102(b) of the Act requires

CMS to prepare a RIA if a rule may have

a significant impact on the operations of

a substantial number of small rural

hospitals. This analysis must conform to

the provisions of section 604 of the

RFA. For purposes of section 1102(b) of

the Act, we define a small rural hospital

as a hospital that is located outside a

Metropolitan Statistical Area and has

fewer than 100 beds.

We are not preparing an analysis for

section 1102(b) of the Act because we

have determined, and the Secretary

certifies, that the RO Model and ETC

Model will not have a significant impact

on the operations of a substantial

number of small rural hospitals.

We received a number of comments

regarding the impact of certain RO

Model policies on rural hospitals. We

direct readers to section III of this final

rule and in the policy sections to which

they applied where addressed these

comments. We also note that in

response to stakeholder feedback, we

are finalizing a low volume opt out

policy, described in section III.C.3.(c). of

this final rule.

6. Unfunded Mandates Reform Act

Section 202 of the Unfunded

Mandates Reform Act of 1995 (UMRA)

(Pub. L. 104–04, enacted on March 22,

1995) also requires that agencies assess

anticipated costs and benefits before

issuing any rule whose mandates

require spending in any 1 year of $100

million in 1995 dollars, updated

annually for inflation. In 2020, that is

approximately $168 million. This final

rule does not mandate any requirements

for State, local, or tribal governments, or

for the private sector.

7. Federalism

Executive Order 13132 establishes

certain requirements that an agency

must meet when it promulgates a

proposed rule (and subsequent final

rule) that imposes substantial direct

requirement costs on state and local

governments, preempts state law, or

otherwise has Federalism implications.

This rule would not have a substantial

direct effect on state or local

governments, preempt state law, or

otherwise have a Federalism

implication because both the RO Model

and ETC Model are Federal payment

programs impacting Federal payments

only and do not implicate local

governments or state law. Therefore, the

requirements of Executive Order 13132

are not applicable.

D. Reducing Regulation and Controlling

Regulatory Costs

Executive Order 13771, titled

Reducing Regulation and Controlling

Regulatory Costs (82 FR 9339), was

issued on January 30, 2017. This final

rule is not expected to be subject to the

requirements of E.O. 13771 because it is

estimated to result in no more than de

minimis costs.

E. Alternatives Considered

Throughout this final rule, we have

identified our policies and alternatives

that we have considered, and provided

information as to the likely effects of

these alternatives and the rationale for

each of our policies. We solicited

comments on our proposals, on the

alternatives we have identified, and on

other alternatives that we should

consider, as well as on the costs,

benefits, or other effects of these.

This final rule contains a model

specific to radiation oncology. It

provides descriptions of the

requirements that we will waive,

identifies the payment methodology to

be tested, and presents rationales for our

decisions and, where relevant,

alternatives that we considered. We

carefully considered the alternatives to

this final rule, including whether the

RO Model should be implemented by all

RT providers and RT suppliers

nationwide. We concluded that it would

be best to test the model using a subset

of all RT providers and RT suppliers in

order to compare them to the RT

providers and RT suppliers that would

not be participating in the RO Model.

This final rule also contains a model

specific to ESRD. It provides

descriptions of the requirements that we

will waive, identifies the performance

metrics and payment adjustments to be

tested, and presents rationales for our

decisions, and where relevant,

alternatives that we considered. We

carefully considered the alternatives to

this final rule, including whether the

model should be implemented to

include more or fewer ESRD facilities

and Managing Clinicians. We concluded

that it would be best to test the model

with approximately 30 percent of ESRD

facilities and Managing Clinicians in the

U.S. in order to have an effective

comparison group and to provide the

best opportunity for an accurate and

thorough evaluation of the model’s

effects.

We solicited comments on our

proposals and on any Model alternatives

and consequent policies that should be

considered. We refer readers to section

III.C and IV.C of this final rule for more

information on policy-related

stakeholder comments, our responses to

those comments, and statements of final

policy.

F. Accounting Statement and Table

As required by OMB Circular A–4

under Executive Order 12866 (available

at http://www.whitehouse.gov/omb/

circulars_a004_a4) in Tables E3 and E4,

we have prepared an accounting

statement showing the classification of

transfers which represent savings

associated with the provisions in this

final rule. The accounting statement is

based on estimates provided in this

regulatory impact analysis.

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G. Conclusion

This analysis, together with the

remainder of this preamble, provides

the Regulatory Impact Analysis of a rule

with a significant economic effect. As a

result of this final rule, we estimate that

the financial impact of the Radiation

Oncology Model and ESRD Treatment

Choices Model will net a federal savings

of $253 million over a 6.5-year

performance period (2021 through

2027).

In accordance with the provisions of

Executive Order 12866, this final rule

was reviewed by the Office of

Management and Budget.

List of Subjects in 42 CFR Part 512

Administrative practice and

procedure, Health facilities, Medicare,

Reporting and recordkeeping

requirements.

■For the reasons set forth in the

preamble and under the authority at 42

U.S.C. 1302, 1315a, and 1395hh, the

Centers for Medicare & Medicaid

Services amends 42 CFR chapter IV by

adding part 512 to read as follows:

PART 512—RADIATION ONCOLOGY

MODEL AND END STAGE RENAL

DISEASE TREATMENT CHOICES

MODEL

Subpart A—General Provisions Related to

Innovation Center Models

Sec.

512.100 Basis and scope.

512.110 Definitions.

512.120 Beneficiary protections.

512.130 Cooperation in model evaluation

and monitoring.

512.135 Audits and record retention.

512.140 Rights in data and intellectual

property.

512.150 Monitoring and compliance.

512.160 Remedial action.

512.165 Innovation center model

termination by CMS.

512.170 Limitations on review.

512.180 Miscellaneous provisions on

bankruptcy and other notifications.

Subpart B—Radiation Oncology Model

General

512.200 Basis and scope of subpart.

512.205 Definitions.

RO Model Participation

512.210 RO participants and geographic

areas.

512.215 Beneficiary population.

512.217 Identification of individual

practitioners.

512.220 RO participant compliance with

RO Model requirements.

512.225 Beneficiary notification.

Scope of RO Episodes Being Tested

512.230 Criteria for determining cancer

types.

512.235 Included RT services.

512.240 Included modalities.

512.245 Included RO episodes.

Pricing Methodology

512.250 Determination of national base

rates.

512.255 Determination of participant-

specific professional episode payment

and participant-specific technical

episode payment amounts.

Billing and Payment

512.260 Billing.

512.265 Payment.

512.270 Treatment of add-on payments

under existing Medicare payment

systems.

Data Reporting

512.275 Quality measures, clinical data,

and reporting.

Medicare Program Waivers

512.280 RO Model Medicare program

waivers.

Reconciliation and Review Process

512.285 Reconciliation process.

512.290 Timely error notice and

reconsideration review process.

Subpart C—ESRD Treatment Choices Model

General

512.300 Basis and scope.

512.310 Definitions.

ESRD Treatment Choices Model Scope and

Participants

512.320 Duration.

512.325 Participant selection and

geographic areas.

512.330 Beneficiary notification.

Home Dialysis Payment Adjustment

512.340 Payments subject to the facility

HDPA.

512.345 Payments subject to the clinician

HDPA.

512.350 Schedule of home dialysis payment

adjustments.

Performance Payment Adjustment

512.355 Schedule of performance

assessment and performance payment

adjustment.

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512.360 Beneficiary population and

attribution.

512.365 Performance assessment.

512.370 Benchmarking and scoring.

512.375 Payments subject to adjustment.

512.380 PPA amounts and schedule.

512.385 PPA exclusions.

512.390 Notification and targeted review.

Quality Monitoring

512.395 Quality measures.

Medicare Program Waivers

512.397 ETC Model Medicare program

waivers.

Authority: 42 U.S.C. 1302, 1315a, and

1395hh.

Subpart A—General Provisions

Related to Innovation Center Models

§ 512.100 Basis and scope.

(a) Basis. This subpart implements

certain general provisions for the

Radiation Oncology Model

implemented under subpart B (RO

Model) and the End-Stage Renal Disease

(ESRD) Treatment Choices Model

implemented under subpart C (ETC

Model), collectively referred to in this

subpart as Innovation Center models.

Except as specifically noted in this part,

the regulations do not affect the

applicability of other provisions

affecting providers and suppliers under

Medicare Fee-For-Service (FFS),

including provisions regarding

payment, coverage, or program integrity.

(b) Scope. The regulations in this

subpart apply to model participants in

the RO Model (except as otherwise

noted in § 512.160(b)(6)) and to model

participants in the ETC Model. This

subpart sets forth the following:

(1) Basis and scope.

(2) Beneficiary protections.

(3) Model participant requirements for

participation in model evaluation and

monitoring, and record retention.

(4) Rights in data and intellectual

property.

(5) Monitoring and compliance.

(6) Remedial action and termination

by CMS.

(7) Limitations on review.

(8) Miscellaneous provisions on

bankruptcy and notification.

§ 512.110 Definitions.

For purposes of this part, the

following terms are defined as follows

unless otherwise stated:

Beneficiary means an individual who

is enrolled in Medicare FFS.

Change in control means any of the

following:

(1) The acquisition by any ‘‘person’’

(as this 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), 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.

(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.

Covered services means 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.

Days means calendar days.

Descriptive model materials and

activities means 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.

The following communications are not

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.

Downstream participant means an

individual or entity that has entered

into a written arrangement with a model

participant under which the

downstream participant engages in one

or more Innovation Center model

activities.

Innovation Center model means the

RO Model implemented under subpart

B or the ETC Model implemented under

subpart C.

Innovation Center model activities

means any activities impacting the care

of model beneficiaries related to the test

of the Innovation Center model under

the terms of this part.

Medically necessary means reasonable

and necessary for the diagnosis or

treatment of an illness or injury, or to

improve the functioning of a malformed

body member.

Model beneficiary means a beneficiary

attributed to a model participant or

otherwise included in an Innovation

Center model under the terms of this

part.

Model participant means an

individual or entity that is identified as

a participant in the Innovation Center

model under the terms of this part.

Model-specific payment means 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.

Provider means a ‘‘provider of

services’’ as defined under section

1861(u) of the Act and codified in the

definition of ‘‘provider’’ at § 400.202 of

this chapter.

Supplier means a supplier as defined

in section 1861(d) of the Act and

codified at § 400.202 of this chapter.

U.S. Territories means American

Samoa, the Federated States of

Micronesia, Guam, the Marshall Islands,

and the Commonwealth of the Northern

Mariana Islands, Palau, Puerto Rico,

U.S. Minor Outlying Islands, and the

U.S. Virgin Islands.

§ 512.120 Beneficiary protections.

(a) Beneficiary freedom of choice. (1)

The model participant and its

downstream model participants must

not restrict beneficiaries’ ability to

choose to receive care from any provider

or supplier.

(2) The model participant and its

downstream model 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 provider or supplier or from any

health care provider who has opted out

of Medicare. The model participant and

its downstream model participants may

communicate to model beneficiaries the

benefits of receiving care with the

model participant, if otherwise

consistent with the requirements of this

part and applicable law.

(b) Availability of services. (1) The

model participant and its downstream

participants must continue to make

medically necessary covered services

available to beneficiaries to the extent

required by applicable law. Model

beneficiaries and their assignees retain

their rights to appeal claims in

accordance with part 405, subpart I of

this chapter.

(2) The model participant and its

downstream participants must not take

any action to select or avoid treating

certain Medicare beneficiaries based on

their income levels or based on factors

that would render the beneficiary an

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‘‘at-risk beneficiary’’ as defined at

§ 425.20 of this chapter.

(3) The model participant and its

downstream participants must not take

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.’’

(c) Descriptive model materials and

activities. (1) The model participant and

its downstream participants must not

use or distribute descriptive model

materials and activities that are

materially inaccurate or misleading.

(2) The model participant and its

downstream participants must include

the following statement 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.’’

(3) The model participant and its

downstream participants must retain

copies of all written and electronic

descriptive model materials and

activities and appropriate records for all

other descriptive model materials and

activities in a manner consistent with

§ 512.135(c).

(4) CMS reserves the right to review,

or have a designee review, descriptive

model materials and activities to

determine whether or not the content is

materially inaccurate or misleading.

This review takes place at a time and in

a manner specified by CMS once the

descriptive model materials and

activities are in use by the model

participant.

§ 512.130 Cooperation in model evaluation

and monitoring.

The model participant and its

downstream participants must comply

with the requirements of § 403.1110(b)

of this chapter 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 and

to conduct monitoring activities under

§ 512.150, 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.

§ 512.135 Audits and record retention.

(a) Right to audit. The Federal

government, including CMS, HHS, and

the Comptroller General, or their

designees, has the right to audit,

inspect, investigate, and evaluate any

documents and other evidence

regarding implementation of an

Innovation Center model.

(b) Access to records. The model

participant and its downstream

participants must maintain and give the

Federal government, including CMS,

HHS, and the Comptroller General, or

their designees, access to all such

documents and other evidence

sufficient to enable the audit,

evaluation, inspection, or investigation

of the implementation of the Innovation

Center model, including without

limitation, documents and other

evidence regarding all of the following:

(1) The model participant’s and its

downstream participants’ compliance

with the terms of the Innovation Center

model, including this subpart.

(2) The accuracy of model-specific

payments made under the Innovation

Center model.

(3) The model participant’s payment

of amounts owed to CMS under the

Innovation Center model.

(4) Quality measure information and

the quality of services performed under

the terms of the Innovation Center

model, including this subpart.

(5) Utilization of items and services

furnished under the Innovation Center

model.

(6) The ability of the model

participant to bear the risk of potential

losses and to repay any losses to CMS,

as applicable.

(7) Patient safety.

(8) Other program integrity issues.

(c) Record retention. (1) The model

participant and its downstream

participants must maintain the

documents and other evidence

described in paragraph (b) of this

section and other evidence for a period

of six 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—

(i) 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

(ii) There has been a termination,

dispute, or allegation of fraud or similar

fault against the model participant or its

downstream participants, in which case

the records must be maintained for an

additional 6 years from the date of any

resulting final resolution of the

termination, dispute, or allegation of

fraud or similar fault.

(2) If CMS notifies the model

participant of the special need to retain

records in accordance with paragraph

(c)(1)(i) of this section or there has been

a termination, dispute, or allegation of

fraud or similar fault against the model

participant or its downstream

participants described in paragraph

(c)(1)(ii) of this section, the model

participant must notify its downstream

participants of this need to retain

records for the additional period

specified by CMS.

§ 512.140 Rights in data and intellectual

property.

(a) CMS may—

(1) Use any data obtained under

§§ 512.130, 512.135, and 512.150 to

evaluate and monitor the Innovation

Center model; and

(2) Disseminate quantitative and

qualitative results and successful care

management techniques, including

factors associated with performance, to

other providers and suppliers and to the

public. Data disseminated may include

patient—

(i) De-identified results of patient

experience of care and quality of life

surveys, and

(ii) De-identified measure results

calculated based upon claims, medical

records, and other data sources.

(b) Notwithstanding any other

provision of this part, for all data that

CMS confirms to be proprietary trade

secret information and technology of the

model participant or its downstream

participants, CMS or its designee(s) will

not release this data without the express

written consent of the model participant

or its downstream participant, unless

such release is required by law.

(c) If the model participant or its

downstream participant wishes to

protect any proprietary or confidential

information that it submits to CMS or its

designee, the model participant or its

downstream participant must label or

otherwise identify the information as

proprietary or confidential. Such

assertions are subject to review and

confirmation by CMS prior to CMS’

acting upon such assertions.

§ 512.150 Monitoring and compliance.

(a) Compliance with laws. The model

participant and each of its downstream

participants must comply with all

applicable laws and regulations.

(b) CMS monitoring and compliance

activities. (1) CMS may conduct

monitoring activities to ensure

compliance by the model participant

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and each of its downstream participants

with the terms of the Innovation Center

model including this subpart; 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 may

include, without limitation, all of the

following:

(i) Documentation requests sent to the

model participant and its downstream

participants, including surveys and

questionnaires.

(ii) Audits of claims data, quality

measures, medical records, and other

data from the model participant and its

downstream participants.

(iii) Interviews with members of the

staff and leadership of the model

participant and its downstream

participants.

(iv) Interviews with beneficiaries and

their caregivers.

(v) Site visits to the model participant

and its downstream participants,

performed in a manner consistent with

paragraph (c) of this section.

(vi) Monitoring quality outcomes and

clinical data, if applicable.

(vii) Tracking patient complaints and

appeals.

(2) In conducting monitoring and

oversight activities, CMS or its

designees may use any relevant data or

information including without

limitation all Medicare claims

submitted for items or services

furnished to model beneficiaries.

(c) Site visits. (1) In a manner

consistent with § 512.130, the model

participant and its downstream

participants must cooperate in periodic

site visits performed by CMS or its

designees in order to facilitate the

evaluation of the Innovation Center

model and the monitoring of the model

participant’s compliance with the terms

of the Innovation Center model,

including this subpart.

(2) CMS or its designee provides, to

the extent practicable, the model

participant or downstream participant

with no less than 15 days advance

notice of any site visit. CMS—

(i) Will attempt, to the extent

practicable, to accommodate a request

for particular dates in scheduling site

visits.

(ii) Will not accept a date request from

a model participant or downstream

participant that is more than 60 days

after the date of the CMS initial site visit

notice.

(3) The model participant and its

downstream participants must ensure

that personnel with the appropriate

responsibilities and knowledge

associated with the purpose of the site

visit are available during all site visits.

(4) Additionally, CMS may perform

unannounced site visits at the office of

the model participant and any of its

downstream participants at any time to

investigate concerns about the health or

safety of beneficiaries or other patients

or other program integrity issues.

(5) Nothing in this part shall be

construed to limit or otherwise prevent

CMS from performing site visits

permitted or required by applicable law.

(d) Reopening of payment

determinations. (1) CMS may reopen a

model-specific payment determination

on its own motion or at the request of

a model participant, within 4 years from

the date of the determination, for good

cause (as defined at § 405.986 of this

chapter).

(2) CMS may reopen a model-specific

payment determination at any time if

there exists reliable evidence (as defined

in § 405.902 of this chapter) that the

determination was procured by fraud or

similar fault (as defined in § 405.902 of

this chapter).

(3) CMS’s decision regarding whether

to reopen a model-specific payment

determination is binding and not subject

to appeal.

(e) OIG authority. Nothing contained

in the terms of the Innovation Center

Model or this part limits or restricts the

authority of the HHS Office of Inspector

General or any other Federal

government authority, including its

authority to audit, evaluate, investigate,

or inspect the model participant or its

downstream participants for violations

of any Federal statutes, rules, or

regulations.

§ 512.160 Remedial action.

(a) Grounds for remedial action. CMS

may take one or more remedial actions

described in paragraph (b) of this

section if CMS determines that the

model participant or a downstream

participant:

(1) Has failed to comply with any of

the terms of the Innovation Center

Model, including this subpart.

(2) Has failed to comply with any

applicable Medicare program

requirement, rule, or regulation.

(3) Has taken any action that threatens

the health or safety of a beneficiary or

other patient.

(4) Has submitted false data or made

false representations, warranties, or

certifications in connection with any

aspect of the Innovation Center model.

(5) Has undergone a change in control

that presents a program integrity risk.

(6) Is subject to any sanctions of an

accrediting organization or a Federal,

State, or local government agency.

(7) Is subject to investigation or action

by HHS (including the HHS Office of

Inspector General 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.

(8) Has failed to demonstrate

improved performance following any

remedial action imposed under this

section.

(b) Remedial actions. If CMS

determines that one or more grounds for

remedial action described in paragraph

(a) of this section has taken place, CMS

may take one or more of the following

remedial actions:

(1) Notify the model participant and,

if appropriate, require the model

participant to notify its downstream

participants of the violation.

(2) Require the model participant to

provide additional information to CMS

or its designees.

(3) Subject the model participant to

additional monitoring, auditing, or both.

(4) Prohibit the model participant

from distributing model-specific

payments, as applicable.

(5) Require the model participant to

terminate, immediately or by a deadline

specified by CMS, its agreement with a

downstream participant with respect to

the Innovation Center model.

(6) In the ETC Model only, terminate

the ETC Participant from the ETC

Model.

(7) Require the model participant to

submit a corrective action plan in a form

and manner and by a deadline specified

by CMS.

(8) Discontinue the provision of data

sharing and reports to the model

participant.

(9) Recoup model-specific payments.

(10) Reduce or eliminate a model-

specific payment otherwise owed to the

model participant.

(11) Such other action as may be

permitted under the terms of this part.

§ 512.165 Innovation center model

termination by CMS.

(a) CMS may terminate an Innovation

Center model for reasons including, but

not limited to, the following:

(1) CMS determines that it no longer

has the funds to support the Innovation

Center model.

(2) CMS terminates the Innovation

Center model in accordance with

section 1115A(b)(3)(B) of the Act.

(b) If CMS terminates an Innovation

Center model, CMS provides written

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notice to the model participant

specifying the grounds for model

termination and the effective date of

such termination.

§ 512.170 Limitations on review.

There is no administrative or judicial

review under sections 1869 or 1878 of

the Act or otherwise for all of the

following:

(a) The selection of models for testing

or expansion under section 1115A of the

Act.

(b) The selection of organizations,

sites, or participants, including model

participants, to test the Innovation

Center models selected, including a

decision by CMS to remove a model

participant or to require a model

participant to remove a downstream

participant from the Innovation Center

model.

(c) The elements, parameters, scope,

and duration of such Innovation Center

models for testing or dissemination,

including without limitation the

following:

(1) The selection of quality

performance standards for the

Innovation Center model by CMS.

(2) The methodology used by CMS to

assess the quality of care furnished by

the model participant.

(3) The methodology used by CMS to

attribute model beneficiaries to the

model participant, if applicable.

(d) Determinations regarding budget

neutrality under section 1115A(b)(3) of

the Act.

(e) The termination or modification of

the design and implementation of an

Innovation Center model under section

1115A(b)(3)(B) of the Act.

(f) Determinations about expansion of

the duration and scope of an Innovation

Center model under section 1115A(c) of

the Act, including the determination

that an Innovation Center model is not

expected to meet criteria described in

paragraph (a) or (b) of such section.

§ 512.180 Miscellaneous provisions on

bankruptcy and other notifications.

(a) Notice of bankruptcy. If the model

participant has filed a bankruptcy

petition, whether voluntary or

involuntary, the model participant must

provide written notice of the bankruptcy

to CMS and to the U.S. Attorney’s Office

in the district where the bankruptcy was

filed, unless final payment has been

made by either CMS or the model

participant under the terms of each

model tested under section 1115A of the

Act 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. The notice of

bankruptcy must be sent by certified

mail no later than 5 days after the

petition has been filed and 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. This list need not identify

a model tested under section 1115A of

the Act 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 at 7500 Security

Boulevard, Mailstop C3–01–24,

Baltimore, MD 21244 or such other

address as may be specified on the CMS

website for purposes of receiving such

notices.

(b) Notice of legal name change. A

model participant must furnish written

notice to CMS at least 30 days after any

change in its legal name becomes

effective. The notice of legal name

change must be in a form and manner

specified by CMS and must include a

copy of the legal document effecting the

name change, which must be

authenticated by the appropriate State

official.

(c) Notice of change in control. (1) A

model participant must furnish written

notice to CMS in a form and manner

specified by CMS at least 90 days before

any change in control becomes effective.

(2)(i) If CMS determines, in

accordance with § 512.160(a)(5), that a

model participant’s change in control

would present a program integrity risk,

CMS may take remedial action against

the model participant under

§ 512.160(b).

(ii) CMS may also require immediate

reconciliation and payment of all

monies owed to CMS by a model

participant that is subject to a change in

control.

Subpart B—Radiation Oncology Model

General

§ 512.200 Basis and scope of subpart.

(a) Basis. This subpart implements the

test of the Radiation Oncology (RO)

Model under section 1115A(b) of the

Act. Except as specifically noted in this

subpart, the regulations under this

subpart do not affect the applicability of

other regulations affecting providers and

suppliers under Medicare FFS,

including the applicability of

regulations regarding payment,

coverage, and program integrity.

(b) Scope. This subpart sets forth the

following:

(1) RO Model participation.

(2) Episodes being tested under the

RO Model.

(3) Methodology for pricing.

(4) Billing and payment under the RO

Model.

(5) Data reporting requirements.

(6) Medicare program waivers.

(7) Payment reconciliation and review

processes.

(c) RO participants are subject to the

general provisions for Innovation Center

models specified in subpart A of this

part 512 and in subpart K of part 403 of

this chapter.

§ 512.205 Definitions.

For purposes of this subpart, the

following definitions apply:

Aggregate quality score (AQS) means

the numeric score calculated for each

RO participant based on its performance

on, and reporting of, quality measures

and clinical data. The AQS is used to

determine an RO participant’s quality

reconciliation payment amount.

APM means Alternative Payment

Model.

ASC means Ambulatory Surgery

Center.

Blend means the weight given to an

RO participant’s historical experience

adjustment relative to the

geographically-adjusted trended

national base rate in the calculation of

its participant-specific episode payment

amounts.

CAH means Critical Access Hospital.

CEHRT means Certified Electronic

Health Record Technology.

Clean period means the 28-day period

after an RO episode has ended, during

which time an RO participant must bill

for medically necessary RT services

furnished to the RO beneficiary in

accordance with Medicare FFS billing

rules.

Core-Based Statistical Area (CBSA)

means a statistical geographic area,

based on the definition as identified by

the Office of Management and Budget,

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).

Discount factor means the set

percentage by which CMS reduces

payment of the professional component

and technical component.

(1) The reduction on payment occurs

after the trend factor, the geographic

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adjustment, and the RO Model-specific

adjustments have been applied but

before beneficiary cost-sharing and

standard CMS adjustments, including

sequestration, have been applied.

(2) The discount factor does not vary

by cancer type.

(3) The discount factor for the

professional component is 3.75 percent;

the discount factor for the technical

component is 4.75 percent.

Dual participant means an RO

participant that furnishes both the

professional component and technical

component of RT services of an RO

episode through a freestanding radiation

therapy center, identified by a single

TIN.

Duplicate RT service means any

included RT service that is furnished to

an RO beneficiary by an RT provider or

RT supplier that is not excluded from

participation in the RO Model at

§ 512.210(b), and that did not initiate

the PC or TC of the RO beneficiary’s RO

episode. Such services are furnished in

addition to the RT services furnished by

the RO participant that initiated the PC

or TC and continues to furnish care to

the RO beneficiary during the RO

episode.

Episode means the 90-day period of

RT services that begins on the date of

service that an RT provider or RT

supplier that is not an RO participant

furnishes an initial treatment planning

service to a beneficiary, provided that

an RT provider or RT supplier furnishes

a technical component RT service to the

beneficiary within 28 days of such

initial treatment planning service.

Additional criteria for constructing

episodes to be included in determining

the national base rates are set forth in

§ 512.250.

EOE stands for ‘‘end of episode’’ and

means the end of an RO episode.

HCPCS means Healthcare Common

Procedure Coding System.

HOPD means hospital outpatient

department.

Included cancer types means the

cancer types determined by the criteria

set forth in § 512.230, which are

included in the RO Model test.

Included RT services means the RT

services identified at § 512.235, which

are included in the RO Model test.

Incomplete episode means an RO

episode that is deemed not to have

occurred because:

(1) A Technical participant or a Dual

participant does not furnish a technical

component to an RO beneficiary within

28 days following a Professional

participant or the Dual participant

furnishing an initial treatment planning

service to that RO beneficiary;

(2) An RO beneficiary ceases to have

traditional FFS Medicare as his or her

primary payer at any time after the

initial treatment planning service is

furnished and before the date of service

on a claim with an RO Model-specific

HCPCS code and an EOE modifier; or

(3) An RO beneficiary switches RT

provider or RT supplier before all

included RT services in the RO episode

have been furnished.

Individual practitioner means a

Medicare-enrolled physician (identified

by an NPI) who furnishes RT services to

Medicare FFS beneficiaries, and has

reassigned his or her billing rights to the

TIN of an RO participant.

Individual practitioner list means a

list of individual practitioners who

furnish RT services under the TIN of a

Dual participant or a Professional

participant, which is annually compiled

by CMS and which the RO participant

must review, revise, and certify in

accordance with § 512.217. The

individual practitioner list is used for

the RO Model as a Participation List as

defined in § 414.1305 of this chapter.

Initial reconciliation means the first

reconciliation of a PY that occurs as

early as August following the applicable

PY.

MIPS means Merit based Incentive

Payment System.

Model performance period means,

January 1, 2021, through December 31,

2025, the last date on which an RO

episode may end under the RO Model.

No new RO episodes may begin after

October 3, 2025, in order for all RO

episodes to end by December 31, 2025.

National base rate means the total

payment amount for the relevant

component of an RO episode, before

application of the trend factor, discount

factor, adjustments, and applicable

withholds, for each of the included

cancer types.

NPI means National Provider

Identifier.

OPPS means outpatient prospective

payment system.

Participant-specific professional

episode payment means a payment

which is calculated by CMS as set forth

in § 512.255 and which is paid by CMS

to a Professional participant or Dual

participant as set forth in § 512.265, for

the provision of the professional

component to an RO beneficiary during

an RO episode.

Participant-specific technical episode

payment means a payment which is

calculated by CMS as set forth in

§ 512.255 and which is paid by CMS to

a Technical participant or Dual

participant in accordance with

§ 512.265, for the provision of the

technical component to an RO

beneficiary during an RO episode.

Performance year (PY) means the 12-

month period beginning on January 1

and ending on December 31 of each year

during the Model performance period.

PGP means physician group practice.

PPS means prospective payment

system.

Professional component (PC) means

the included RT services that may only

be furnished by a physician.

Professional participant means an RO

participant that is a Medicare-enrolled

PGP identified by a single TIN that

furnishes only the PC of an RO episode.

PSO means patient safety

organization.

PY means performance year.

QP means Qualifying APM

Participants.

Reconciliation payment means a

payment made by CMS to an RO

participant, as determined in

accordance with § 512.285.

Repayment amount means the

amount owed by an RO participant to

CMS, as determined in accordance with

§512.285.

Reconciliation report means the

annual report issued by CMS to an RO

participant for each PY, which specifies

the RO participant’s reconciliation

payment amount or repayment amount.

RO beneficiary means a Medicare

beneficiary who meets all of the

beneficiary inclusion criteria at

§ 512.215(a) and whose RO episode

meets all the criteria defined at

§ 512.245.

RO episode means the 90-day period

that, as set forth in § 512.245, begins on

the date of service that a Professional

participant or a Dual participant

furnishes an initial treatment planning

service to an RO beneficiary in a

freestanding radiation therapy center or

an HOPD, provided that a Technical

participant or the same Dual participant

furnishes a technical component RT

service to the RO beneficiary within 28

days of such RT treatment planning

service.

RO participant means a Medicare-

enrolled PGP, freestanding radiation

therapy center, or HOPD that

participates in the RO Model in

accordance with § 512.210. An RO

participant may be a Dual participant,

Professional participant, or Technical

participant.

RT provider means a Medicare-

enrolled HOPD that furnishes RT

services.

RT services are the treatment

planning, technical preparation, special

services (such as simulation), treatment

delivery, and treatment management

services associated with cancer

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treatment that uses high doses of

radiation to kill cancer cells and shrink

tumors.

RT supplier means a Medicare-

enrolled PGP or freestanding radiation

therapy center that furnishes RT

services.

SOE stands for ‘‘start of episode’’ and

means the start of an RO episode.

Stop-loss limit means the set

percentage at which loss is limited

under the Model used to calculate the

stop-loss reconciliation amount.

Stop-loss reconciliation amount

means the amount owed to RO

participants that have fewer than 60

episodes during 2016–2018 and that

were furnishing included RT services on

November 30, 2020 in the CBSAs

selected for participation for the loss

incurred under the Model as described

in § 512.285(f).

Technical component (TC) means the

included RT services that are not

furnished by a physician, including the

provision of equipment, supplies,

personnel, and administrative costs

related to RT services.

Technical participant means an 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 TC of an RO

episode.

TIN means Taxpayer Identification

Number.

Trend factor means an adjustment

applied to the national base rates that

updates those rates to reflect current

trends in the OPPS and PFS rates for RT

services.

True-up reconciliation means the

process to calculate additional

reconciliation payments or repayment

amounts for incomplete episodes and

duplicate RT services that are identified

after the initial reconciliation and after

a 12-month claims run-out for all RO

episodes initiated in the applicable PY.

RO Model Participation

§ 512.210 RO participants and geographic

areas.

(a) RO participants. Unless otherwise

specified in paragraph (b) or (c) of this

section, any RO participant that

furnishes included RT services in a 5-

digit ZIP Code linked to a CBSA

selected for participation to an RO

beneficiary for an RO episode that

begins on or after January 1, 2021, and

ends on or before December 31, 2025,

must participate in the RO Model.

(b) Participant exclusions. A PGP,

freestanding radiation therapy center, or

HOPD is excluded from participation in

the RO Model if it:

(1) Furnishes RT services only in

Maryland;

(2) Furnishes RT services only in

Vermont;

(3) Furnishes RT services only in U.S.

Territories;

(4) Is classified as an ambulatory

surgery center (ASC), critical access

hospital (CAH), or Prospective Payment

System (PPS)-exempt cancer hospital; or

(5) Participates in or is identified by

CMS as eligible to participate in the

Pennsylvania Rural Health Model.

(c) Low Volume Opt-Out. A PGP,

freestanding radiation therapy center, or

HOPD, which would otherwise be

required to participate in the RO Model

may choose to opt-out of the RO Model

for a given PY if it has fewer than 20

episodes of RT services across all

CBSAs selected for participation in the

most recent year with claims data

available prior to the applicable PY. At

least 30 days prior to the start of each

PY, CMS notifies RO participants

eligible for the low volume opt-out for

the upcoming PY. The RO participant

must attest to its intention of opting out

of the RO Model prior to the start of the

upcoming PY.

(d) Selected CBSAs. CMS randomly

selects CBSAs to identify RT providers

and RT suppliers to participate in the

RO Model through a stratified sample

design, allowing for participant and

comparison groups to contain

approximately 30 percent of all episodes

in eligible geographic areas (CBSAs).

§ 512.215 Beneficiary population.

(a) Beneficiary inclusion criteria. An

individual is an RO beneficiary if:

(1) The individual receives included

RT services from an RO participant that

billed the SOE modifier for the PC or TC

of an RO episode during the Model

performance period for an included

cancer type; and

(2) At the time that the initial

treatment planning service of an RO

episode is furnished by an RO

participant, the individual:

(i) Is eligible for Medicare Part A and

enrolled in Medicare Part B;

(ii) Has traditional FFS Medicare as

his or her primary payer (for example,

is not enrolled in a PACE plan,

Medicare Advantage or another

managed care plan, or United Mine

Workers insurance); and

(iii) Is not in a Medicare hospice

benefit period.

(b) Any individual enrolled in a

clinical trial for RT services for which

Medicare pays routine costs is an RO

beneficiary if the individual satisfies all

of the beneficiary inclusion criteria in

paragraph (a) of this section.

§ 512.217 Identification of individual

practitioners.

(a) General. Upon the start of each PY,

CMS creates and provides to each Dual

participant and Professional participant

an individual practitioner list

identifying by NPI each individual

practitioner associated with the RO

participant.

(b) Review of individual practitioner

list. Within 30 days of receipt of the

individual practitioner list, the RO

participant must review and certify the

individual practitioner list, correct any

inaccuracies in accordance with

paragraph (d) of this section, and certify

the list (as corrected, if applicable) in a

form and manner specified by CMS and

in accordance with paragraph (c) of this

section or correct the individual

practitioner list in accordance with

paragraph (d) of this section.

(c) List certification. (1) Within 30

days of receipt of the individual

practitioner list, and at such other times

as specified by CMS, an individual with

the authority to legally bind the RO

participant must certify the accuracy,

completeness, and truthfulness of the

individual practitioner list to the best of

his or her knowledge, information, and

belief.

(2) All Medicare-enrolled individual

practitioners that have reassigned their

right to receive Medicare payment for

provision of RT services to the TIN of

the RO participant must be included on

the RO participant’s individual

practitioner list and each individual

practitioner must agree to comply with

the requirements of the RO Model

before the RO participant certifies the

individual practitioner list.

(3) If the RO participant does not

certify the individual practitioner list:

(i) Eligible clinicians in the RO Model

will not be considered participants in a

MIPS APM for purposes of MIPS

reporting and scoring rules; and

(ii) Eligible clinicians in the RO

Model will not have Qualifying APM

Participant (‘‘QP’’) determinations made

based on their participation in the RO

Model.

(d) Changes to the individual

practitioner list. (1) Additions.

(i) An RO participant must notify

CMS of an addition to its individual

practitioner list within 30 days of when

an eligible clinician reassigns his or her

rights to receive payment from Medicare

to the RO participant. The notice must

be submitted in the form and manner

specified by CMS.

(ii) If the RO participant timely

submits notice to CMS, then the

addition of an individual practitioner to

the RO participant’s individual

practitioner list is effective on the date

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specified in the notice furnished to

CMS, but no earlier than 30 days before

the date of the notice. If the RO

participant fails to submit timely notice

to CMS, then the addition of an

individual practitioner to the individual

practitioner list is effective on the date

of the notice.

(2) Removals. (i) An RO participant

must notify CMS no later than 30 days

of when an individual on the RO

participant’s individual practitioner list

ceases to be an individual practitioner.

The notice must be submitted in the

form and manner specified by CMS.

(ii) The removal of an individual

practitioner from the RO participant’s

individual practitioner list is effective

on the date specified in the notice

furnished to CMS. If the RO participant

fails to submit a timely notice of the

removal, then the removal is effective

on the date that the individual ceases to

be an individual practitioner.

(e) Update to Medicare enrollment

information. The RO participant must

ensure that all changes to enrollment

information for an RO participant and

its individual practitioners, including

changes to reassignment of the right to

receive Medicare payment, are reported

to CMS consistent with § 424.516 of this

chapter.

§ 512.220 RO participant compliance with

RO Model requirements.

(a) RO participant-specific

requirements. (1) RO participants must

satisfy the requirements of this section

to qualify for the APM Incentive

Payment.

(2) Each Professional participant and

Dual participant must ensure its

individual practitioners:

(i) Starting in PY1, discuss goals of

care with each RO beneficiary before

initiating treatment and communicate to

the RO beneficiary whether the

treatment intent is curative or palliative;

(ii) Starting in PY1, adhere to

nationally recognized, evidence-based

clinical treatment guidelines when

appropriate in treating RO beneficiaries

or, alternatively, document in the

medical record the extent of and

rationale for any departure from these

guidelines;

(iii) Starting in PY1, assess each RO

beneficiary’s tumor, node, and

metastasis cancer stage for the CMS-

specified cancer diagnoses;

(iv) Starting in PY1, assess the RO

beneficiary’s performance status as a

quantitative measure determined by the

physician;

(v) Starting in PY1, send a treatment

summary to each RO beneficiary’s

referring physician within 3 months of

the end of treatment to coordinate care;

(vi) Starting in PY1, discuss with each

RO beneficiary prior to treatment

delivery his or her inclusion in, and

cost-sharing responsibilities under, the

RO Model; and

(vii) Starting in PY1, perform and

document Peer Review (audit and

feedback on treatment plans) before 25

percent of the total prescribed dose has

been delivered and within 2 weeks of

the start of treatment for:

(A) 50 percent of new patients in PY1,

(B) 55 percent of new patients in PY2,

(C) 60 percent of new patients in PY3,

(D) 65 percent of new patients in PY4,

(E) 70 percent of new patients in PY5.

(3) Starting in PY1, at such times and

in the form and manner specified by

CMS, each Technical participant and

Dual participant must annually attest to

whether it actively participates with a

AHRQ-listed patient safety organization

(PSO). Examples include maintaining a

contractual or similar relationship with

a PSO for the receipt and review of

patient safety work product.

(b) CEHRT. (1) Each RO participant

must use CEHRT, and ensure that its

individual practitioners use CEHRT, in

a manner sufficient to meet the

applicable requirements of the

Advanced APM criteria codified in

§ 414.1415(a)(1)(i) of this chapter. Before

each PY, each RO participant must

certify in the form and manner, and by

a deadline specified by CMS, that it uses

CEHRT throughout such PY in a manner

sufficient to meet the requirements set

forth in § 414.1415(a)(1)(i) of this

chapter.

(2) Within 30 days of the start of PY1,

the RO participant must certify its intent

to use CEHRT throughout PY1 in a

manner sufficient to meet the

requirements set forth in

§ 414.1415(a)(1)(i) of this chapter.

§ 512.225 Beneficiary notification.

(a) General. Starting in PY1, each

Professional participant and Dual

participant must notify each RO

beneficiary to whom it furnishes

included RT services—

(1) That the RO participant is

participating in the RO Model;

(2) That the RO beneficiary has the

opportunity to decline claims data

sharing for care coordination and

quality improvement purposes. If an RO

beneficiary declines claims data sharing

for care coordination and quality

improvement purposes, then the RO

participant must inform CMS within 30

days of receiving notification from the

RO beneficiary that the beneficiary is

declining to have his or her claims data

shared in that manner; and,

(3) Of the RO beneficiary’s cost-

sharing responsibilities.

(b) Form and manner of notification.

Notification of the information specified

in paragraph (a) of this section must be

carried out by an RO participant by

providing each RO beneficiary with a

CMS-developed standardized written

notice during the RO beneficiary’s

initial treatment planning session. The

RO participants must furnish the notice

to the RO beneficiary in the form and

manner specified by CMS.

(c) Applicability of general Innovation

Center provisions. The beneficiary

notifications under this section are not

descriptive model materials and

activities under § 512.120(c). The

requirement described in § 512.120(c)(2)

does not apply to the standardized

written notice described in paragraph

(b) of this section.

Scope of RO Episodes Being Tested

§ 512.230 Criteria for determining cancer

types.

(a) Included cancer types. CMS

includes in the RO Model test cancer

types that satisfy all of the following

criteria. The cancer type:

(1) Is commonly treated with

radiation; and

(2) Has associated current ICD–10

codes that have demonstrated pricing

stability.

(b) Removing cancer types. CMS

removes cancer types in the RO Model

if it determines:

(1) RT is no longer appropriate to treat

a cancer type per nationally recognized,

evidence-based clinical treatment

guidelines;

(2) CMS discovers a ≥10 percent error

in established national base rates; or

(3) The Secretary determines a cancer

type not to be suitable for inclusion in

the RO Model.

(c) ICD–10 codes for included cancer

types. CMS displays on the RO Model

website no later than 30 days prior to

each PY the ICD–10 diagnosis codes

associated with each included cancer

type.

§ 512.235 Included RT services.

(a) Only the following RT services

furnished using an included modality

identified at § 512.240 for an included

cancer type are included RT services

that are paid for by CMS under

§ 512.265:

(1) Treatment planning;

(2) Technical preparation and special

services;

(3) Treatment delivery; and,

(4) Treatment management.

(b) All other RT services furnished by

an RO participant during the Model

performance period are subject to

Medicare FFS payment rules.

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§ 512.240 Included modalities.

The modalities included in the RO

Model are 3-dimensional conformal RT

(3DCRT), intensity-modulated RT

(IMRT), stereotactic radiosurgery (SRS),

stereotactic body RT (SBRT), proton

beam therapy (PBT), image-guided

radiation therapy (IGRT), and

brachytherapy.

§ 512.245 Included RO episodes.

(a) General. Any RO episode that

begins on or after January 1, 2021, and

ends on or before December 31, 2025, is

included in the Model performance

period.

(b) Death or election of hospice

benefit. An RO episode is included in,

and paid for under, the RO Model if the

RO beneficiary dies after the TC of an

RO episode has been initiated, or if the

RO beneficiary elects the Medicare

hospice benefit after the initial

treatment planning service, provided

that the TC is initiated within 28 days

following the initial treatment planning

service. Each RO participant will

receive both installments of the episode

payment under such circumstances,

regardless of whether the RO beneficiary

dies or elects the Medicare hospice

benefit before the relevant course of RT

treatment has ended.

(c) Clean periods. An RO episode

must not be initiated for the same RO

beneficiary during a clean period.

Pricing Methodology

§ 512.250 Determination of national base

rates.

CMS determines a national base rate

for the PC and TC for each included

cancer type.

(a) National base rates are the

historical average cost for an episode of

care for each of the included cancer

types prior to the Model performance

period.

(b) National base rates are determined

in the following manner:

(1) CMS excludes claims from RT

suppliers and RT providers in Maryland

and Vermont and all inpatient and ASC

claims from the construction of episodes

and;

(2) CMS excludes the following:

(i) episodes with any RT services

furnished by a CAH,

(ii) episodes that are not attributed to

an RT provider or RT supplier, and

(iii) episodes in which either the PC

or TC is attributed to an RT provider or

RT supplier with a U.S. Territory

service location.

(3) CMS calculates the episode

amount CMS paid on average to RT

providers and RT suppliers for the PC

and TC for each of the included cancer

types in the HOPD setting, creating the

RO Model’s national base rates.

§ 512.255 Determination of participant-

specific professional episode payment and

participant-specific technical episode

payment amounts.

(a) Thirty days before the start of each

PY, CMS provides each RO participant

its case mix and historical experience

adjustments for both the PC and TC as

calculated in paragraphs (c)(3) and (4) of

this section. If an RO participant is not

eligible to receive a historical

experience adjustment or case mix

adjustment as described under

paragraph (c)(7) of this section, then

CMS provides a zero value for those

adjustments.

(b) Any episode used to calculate the

participant-specific professional episode

payment amounts and the participant-

specific technical episode payment

amounts for an RO participant is subject

to the exclusions described in

§ 512.250(b)(1) and (2).

(c) CMS calculates the participant-

specific professional episode payment

amounts and participant-specific

technical episode payment amounts for

each included cancer type using the

following:

(1) Trend factors. For every PY, CMS

adjusts the national base rates for the PC

and TC of each cancer type by

calculating a separate trend factor for

the PC and TC of each included cancer

type.

(2) Geographic adjustment. CMS

adjusts the trended national base rates

prior to applying each RO participant’s

case mix and historical experience, and

prior to applying the discounts and

withholds, for local cost and wage

indices based on where RT services are

furnished, as described by existing

geographic adjustment processes in the

OPPS and PFS.

(3) Case mix adjustment. CMS

establishes and applies a case mix

adjustment to the national base rate after

the trend factor and geographic

adjustment have applied. The case mix

adjustment reflects episode or RO

episode characteristics that may be

beyond the control of RO participants

such as cancer type, age, sex, presence

of a major procedure, death during the

episode, and presence of chemotherapy.

(4) Historical experience adjustment.

CMS establishes and applies a historical

experience adjustment to the national

base rate after the trend factor,

geographic adjustment, and case mix

adjustment have been applied. The

historical experience adjustments reflect

each RO participant’s actual historical

experience.

(5) Blend. CMS blends each RO

participant’s historical experience

adjustment and the geographically-

adjusted trended national base rate. The

blend for RO participants with a

professional historical experience

adjustment or technical historical

experience adjustment with a value

equal to or less than zero is 90/10,

meaning the calculation of the

participant-specific episode payment

amount is weighted according to 90

percent of the RO participant’s

historical experience adjustment and 10

percent of the geographically-adjusted

trended national base for PY1 through

PY5. The blend for RO participants with

a professional historical experience

adjustment or technical historical

experience adjustment of more than

zero is 90/10 in PY1, 85/15 in PY2, 80/

20 in PY3, 75/25 in PY4, and 70/30 in

PY5.

(6) Changes in business structure. (i)

RO participants must notify CMS in

writing of a merger, acquisition, or other

new clinical or business relationship, at

least 90 days before the date of the

change as described in § 424.516.

(ii) CMS updates case mix and

historical experience adjustments

according to the relevant treatment

history that applies as a result of a

merger, acquisition, or other new

clinical or business relationship in the

RO participant’s case mix and historical

experience adjustment calculations from

the effective date of the change.

(7) Adjustments for RO participants

with fewer than 60 episodes during

2016–2018.

(i) RO participants that have fewer

than 60 episodes from 2016–2018 do not

receive a historical experience

adjustment during the Model

performance period.

(ii) RO participants that have fewer

than 60 episodes from 2016–2018 do not

receive a case mix adjustment for PY1.

(iii) RO participants described in

§ 512.255(b)(7)(ii) that continue to have

fewer than 60 episodes in the rolling 3-

year period used to determine the case

mix adjustment for each PY (2017–2019

for PY2, 2018–2020 for PY3, 2019–2021

for PY4, and 2020–2022 for PY5) and

that have never received a case mix

adjustment do not receive a case mix

adjustment for that PY.

(iv) RO participants that have fewer

than 60 episodes from 2016–2018 and

were furnishing included RT services in

the CBSAs selected for participation on

November 30, 2020 are eligible to

receive a stop-loss reconciliation

amount, if applicable, for the loss

incurred under the RO Model as

described in § 512.285(f).

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(8) Discount factor. CMS deducts a

percentage discount from each episode

payment after applying the trend factor,

geographic adjustment, and case mix

and historical experience adjustments to

the national base rate. The discount

factor for the PC is 3.75 percent. The

discount factor for TC is 4.75 percent.

(9) Incorrect payment withhold. To

account for duplicate RT services and

incomplete episodes:

(i) CMS withholds from each RO

participant 1 percent from each episode

payment, after applying the trend factor,

geographic adjustment, case mix and

historical experience adjustments, and

discount to the national base rate.

(ii) CMS determines during the

annual reconciliation process set forth

at § 512.285 whether an RO participant

is eligible to receive a portion or all of

the withheld amount or whether any

payment is owed to CMS.

(10) Quality withhold. In accordance

with § 414.1415(b)(1) of this chapter,

CMS withholds 2 percent from each

professional episode payment after

applying the trend factor, geographic

adjustment, case mix and historical

experience adjustments, and discount

factor to the national base rate. RO

participants may earn back this

withhold, in part or in full, based on

their AQS.

(11) Patient experience withhold.

Starting in PY3,

(i) CMS withholds 1 percent from

each technical episode payment after

applying the trend factor, geographic

adjustment, case mix and historical

experience adjustments, and discount

factor to the national base rate.

(ii) RO participants may earn back

their patient-experience withhold, in

part or in full, based on their results

from the CAHPS

®

Cancer Care

Radiation Therapy survey.

(12) Coinsurance. RO participants

may collect beneficiary coinsurance

payments for services furnished under

the RO Model in multiple installments

under a payment plan.

(i) The availability of payment plans

may not be used as a marketing tool to

influence beneficiary choice of health

care provider.

(ii) RO participants offering a

payment plan may inform the RO

beneficiary of the availability of the

payment plan prior to or during the

initial treatment planning session and as

necessary thereafter.

(iii) The beneficiary coinsurance

payment equals 20 percent of the

episode payment amount to be paid to

the RO participant(s) prior to the

application of sequestration for the

billed RO Model-specific HCPCS code

with a SOE modifier and for the billed

RO Model-specific HCPCS code with an

EOE modifier for the PC and TC, except

as provided in paragraph (c)(12)(iv)

and(v) of this section.

(iv) In the case of incomplete episodes

(A) The beneficiary coinsurance

payment equals 20 percent of the FFS

amounts that would have been paid in

the absence of the RO Model for the

services furnished by the RO participant

that initiated the PC and the RO

participant that initiated the TC (if

applicable), except for a subset of

incomplete episodes described in

paragraph (c)(12)(iv)(B); or

(B) If an RO beneficiary ceases to have

traditional FFS Medicare as his or her

primary payer any time after the initial

treatment planning service is furnished

and before the date of service on a claim

with an RO Model-specific HCPCS code

and EOE modifier, provided a Technical

participant or the same Dual participant

that provided the initial treatment

planning service furnishes a a technical

component RT service to the RO

beneficiary within 28 days of such

initial treatment planning service, the

beneficiary coinsurance payment equals

20 percent of the first installment of the

episode payment amount to be paid to

the RO participant(s) prior to the

application of sequestration for the

billed RO Model-specific HCPCS code

with an SOE modifier for the PC and

TC. If an RO participant bills the RO

Model-specific HCPCS code and EOE

modifier with a date of service that is

prior to the date that the RO beneficiary

ceases to have traditional FFS Medicare,

then the beneficiary coinsurance

payment equals 20 percent of the full

episode payment amount for the PC or

TC, as applicable.

(v) In the case of duplicate RT

services, the beneficiary coinsurance

payment equals 20 percent of the

episode payment amount to be paid to

the RO participant(s) per

§ 512.255(c)(12)(iii) and 20 percent of

the FFS amount to the RT provider and/

or RT supplier furnishing one or more

duplicate RT services.

(13) Sequestration. CMS deducts 2

percent from each episode payment

after applying the trend factor,

geographic adjustment, case mix and

historical experience adjustments,

discount, withholds, and coinsurance to

the national base rate.

Billing and Payment

§ 512.260 Billing.

(a) Reassignment of billing rights.

Each Professional participant and Dual

participant must ensure that its

individual practitioners reassign their

billing rights to the TIN of the

Professional participant or Dual

participant.

(b) Billing under the RO Model. (1)

Professional participants and Dual

participants must bill an RO Model-

specific HCPCS code and a SOE

modifier to indicate that the treatment

planning service has been furnished and

that an RO episode has been initiated.

(2) Dual participants and Technical

participants must bill an RO Model-

specific HCPCS code and SOE modifier

to indicate that a treatment delivery

service was furnished.

(3) RO participants must bill the same

RO Model-specific HCPCS code that

initiated the RO episode and an EOE

modifier to indicate that the RO episode

has ended.

(4) RO participants may submit a

claim with an EOE modifier only after

the RT course of treatment has ended,

except that such claim must not be

submitted earlier than 28 days after the

date of the initial treatment planning

service.

(c) Billing for RT services performed

during a clean period. RO participants

must bill for any medically necessary

RT services furnished to an RO

beneficiary during a clean period in

accordance with existing FFS billing

processes in the OPPS and PFS.

(d) Submission of no-pay claims. RO

participants must submit no-pay claims

for any medically necessary included

RT services furnished to an RO

beneficiary during an RO episode

pursuant to existing FFS billing

processes in the OPPS and PFS.

§ 512.265 Payment.

(a) Payment for episodes. CMS pays

an RO participant for all included RT

services furnished to an RO beneficiary

during a completed RO episode as

follows:

(1) CMS pays a Professional

participant a participant-specific

professional episode payment for the

professional component furnished to an

RO beneficiary during an RO episode.

(2) CMS pays a Technical participant

a participant-specific technical episode

payment for the technical component

furnished to an RO beneficiary during

an RO episode.

(3) CMS pays a Dual participant a

participant-specific professional episode

payment and a participant-specific

technical episode payment for the

professional component and technical

component furnished to an RO

beneficiary during an RO episode.

(b) Payment installments. CMS makes

each of the payments described in

paragraph (a) of this section in two

equal installments, as follows:

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(1) CMS pays one-half of a

participant-specific professional episode

payment to a Professional participant or

Dual participant or one-half of the

participant-specific technical episode

payment to a Technical participant or

Dual participant after the RO participant

bills an RO Model-specific HCPCS code

with a SOE modifier.

(2) CMS pays the remaining half of a

participant-specific professional episode

payment to a Professional participant or

Dual participant or one-half of the

participant-specific technical episode

payment to a Technical participant or

Dual participant after the RO participant

bills an RO Model-specific HCPCS code

with an EOE modifier.

(c) Duplicate RT services. Duplicate

RT services are reimbursed at the FFS

amount, whether or not the RT provider

or RT supplier that furnished such

services is an RO participant.

§ 512.270 Treatment of add-on payments

under existing Medicare payment systems.

(a) CMS does not make separate

Medicare FFS payments to RO

participants for any included RT

services that are furnished to an RO

beneficiary during an RO episode.

(b) An RO participant may receive

Medicare FFS payment for items and

services furnished to an RO beneficiary

during an RO episode, provided that

any such other item or service is not an

included RT service.

Data Reporting

§ 512.275 Quality measures, clinical data,

and reporting.

(a) Data privacy compliance. The RO

participant must—

(1) Comply with all applicable laws

pertaining to any patient-identifiable

data requested from CMS under the

terms of the Innovation Center model,

including any patient-identifiable

derivative data, as well as the terms of

any attestation or agreement entered

into by the RO participant with CMS as

a condition of receiving that data. Such

laws may include, without limitation,

the privacy and security rules

promulgated under the Health Insurance

Portability and Accountability Act of

1996 (HIPAA), as modified, and the

Health Information Technology for

Economic and Clinical Health Act

(HITECH).

(2) Contractually bind all downstream

recipients of CMS data to the same

terms and conditions to which the RO

participant was itself bound in its

agreements with CMS as a condition of

the downstream recipient’s receipt of

the data from the RO participant.

(b) RO participant public release of

patient de-identified information. The

RO participant must include the

disclaimer codified at § 512.120(c)(2) on

the first page of any publicly-released

document, the contents of which

materially and substantially references

or is materially and substantially based

upon the RO participant’s participation

in the RO Model, including but not

limited to press releases, journal

articles, research articles, descriptive

articles, external reports, and statistical/

analytical materials.

(c) Reporting quality measures and

clinical data elements. In addition to

reporting described in other provisions

in this part, Professional participants

and Dual participants must report

selected quality measures on all patients

and clinical data elements describing

cancer stage, disease characteristics,

treatment intent, and specific treatment

plan information on beneficiaries

treated for specified cancer types, in the

form, manner, and at a time specified by

CMS.

Medicare Program Waivers

§ 512.280 RO Model Medicare program

waivers.

(a) General. The Secretary may waive

certain requirements of title XVIII of the

Act as necessary solely for purposes of

testing of the RO Model. Such waivers

apply only to the participants in the RO

Model.

(b) Hospital Outpatient Quality

Reporting (OQR) Program. CMS waives

the application of the Hospital OQR

Program 2.0 percentage point reduction

under section 1833(t)(17) of the Act for

only those Ambulatory Payment

Classifications (APCs) that include only

RO Model-specific HCPCS codes during

the Model performance period.

(c) Merit-based Incentive Payment

System (MIPS). CMS waives the

requirement under section 1848(q)(6)(E)

of the Act and § 414.1405(e) of this

chapter to apply the MIPS payment

adjustment factor, and, as applicable,

the additional MIPS payment

adjustment factor (collectively referred

to as the MIPS payment adjustment

factors) to the TC of RO Model

payments to the extent that the MIPS

payment adjustment factors would

otherwise apply to the TC of RO Model

payments.

(d) APM Incentive Payment. CMS

waives the requirements of

§ 414.1450(b) of this chapter such that

technical component payment amounts

under the RO Model shall not be

considered in calculation of the

aggregate payment amount for covered

professional services as defined in

section 1848(k)(3)(A) of the Act for the

APM Incentive Payment made under

§ 414.1450(b)(1) of this chapter.

(e) PFS Relativity Adjuster. CMS

waives the requirement to apply the PFS

Relativity Adjuster to RO Model-specific

APCs for RO participants that are non-

excepted off-campus provider-based

departments (PBDs) identified by

section 603 of the Bipartisan Budget Act

of 2015 (Pub. L. 114–74), which

amended section 1833(t)(1)(B)(v) and

added paragraph (t)(21) to the Social

Security Act.

(f) General payment waivers. CMS

waives the following sections of the Act

solely for the purposes of testing the RO

Model:

(1) 1833(t)(1)(A).

(2) 1833(t)(16)(D).

(3) 1848(a)(1).

(4) 1833(t)(2)(H).

(5) 1869 claims appeals procedures.

Reconciliation and Review Process

§ 512.285 Reconciliation process.

(a) General. CMS conducts an initial

reconciliation and a true-up

reconciliation for each RO participant

for each PY in accordance with this

section.

(b) Annual reconciliation

calculations. (1) To determine the

reconciliation payment or the

repayment amount based on RO

episodes initiated in a PY, CMS

performs the following steps:

(i) CMS calculates an RO participant’s

incorrect episode payment

reconciliation amount as described in

paragraph (c) of this section.

(ii) CMS calculates the RO

participant’s quality reconciliation

amount as described in paragraph (d) of

this section, if applicable.

(iii) CMS calculates the RO

participant’s patient experience

reconciliation amount, as described in

paragraph (e) of this section, if

applicable.

(iv) CMS calculates the stop-loss

reconciliation amount, as described in

paragraph (f) of this section, if

applicable.

(v) CMS adds, as applicable, the

incorrect episode payment

reconciliation amount, any quality

reconciliation payment amount, any

patient experience reconciliation

amount, and any stop-loss

reconciliation payment amount. The

sum of these amounts results in a

reconciliation payment or repayment

amount.

(2) CMS calculations use claims data

available at the time of reconciliation.

(c) Incorrect episode payment

reconciliation amount. CMS calculates

the incorrect episode payment

reconciliation amount as follows:

(1) Total incorrect payment withhold

amount. CMS calculates the total

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incorrect payment withhold amount by

adding the incorrect payment withhold

amount for each episode initiated in the

PY.

(2) Total duplicate RT services

amount. CMS calculates the total

duplicate RT services amount by adding

all FFS amounts for duplicate RT

services furnished during each episode

initiated in the PY. The duplicate RT

services amount is capped for each

episode and will not be more than the

participant-specific professional episode

payment amount or participant-specific

technical episode payment amount

received by the RO participant for an

RO episode, even if the duplicate RT

services amount exceeds the

participant-specific professional episode

payment amount or the participant-

specific technical episode payment

amount.

(3) Total incomplete episode amount.

CMS calculates the total incomplete

episode amount for a subset of

incomplete episodes.

(i) Incomplete episodes in which an

RO beneficiary ceases to have

traditional FFS Medicare as his or her

primary payer at any time after the

initial treatment planning service is

furnished and before the date of service

on a claim with an RO Model-specific

HCPCS code and EOE modifier,

provided an RO participant furnishes a

technical component RT service to the

RO beneficiary within 28 days of such

initial treatment planning service, are

not included in the incomplete episode

amount.

(ii) For all other incomplete episodes

initiated in the PY, CMS determines the

total incomplete episode amount by

calculating the difference between the

following amounts:

(A) The sum of all FFS amounts that

would have been paid to the RO

participant in the absence of the RO

Model for any included RT services

furnished during such incomplete

episodes, as determined by no-pay

claims. This sum is what CMS owes the

RO participant for such incomplete

episodes.

(B) The sum of the participant-

specific episode payment amounts paid

to the relevant RO participant for such

incomplete episodes initiated in the PY.

(4) Total incorrect episode payment

amount. CMS calculates the total

incorrect episode payment amount as

follows:

(i) If the sum described in paragraph

(c)(3)(ii)(A) of this section is more than

the sum described in paragraph

(c)(3)(ii)(B) of this section, the difference

is subtracted from the total duplicate RT

services amount and the resulting

amount is the total incorrect episode

payment amount.

(ii) If the sum described in paragraph

(c)(3)(ii)(A) of this section is less than

the sum described in paragraph

(c)(3)(ii)(B) of this section, the difference

is added to the total duplicate RT

services amount and the resulting

amount is the total incorrect episode

payment amount.

(5) Incorrect episode payment

reconciliation amount. If the total

incorrect episode payment amount

represents money owed by the RO

participant to CMS, CMS subtracts the

total incorrect episode payment amount

from the total incorrect payment

withhold amount. In the case that the

total incorrect episode payment amount

represents money owed by CMS to the

RO participant, CMS adds the total

incorrect episode payment amount to

the total incorrect payment withhold

amount. The resulting amount is the RO

participant’s incorrect episode payment

reconciliation amount.

(d) Quality reconciliation payment

amount. For Professional participants

and Dual participants, CMS determines

the quality reconciliation payment

amount for each PY by multiplying the

participant’s AQS (as a percentage) by

the total quality withhold amount for all

RO episodes initiated during the PY.

(e) Patient experience reconciliation

amount. For PY3 and subsequent PYs,

CMS determines the patient experience

reconciliation amount for RO

participants by multiplying the

participant’s AQS (as a percentage) by

the total patient experience withhold

amount for all RO episodes initiated

during the PY.

(f) Stop-loss reconciliation amount.

CMS determines the stop-loss

reconciliation amount for RO

participants that have fewer than 60

episodes during 2016 through 2018 and

were furnishing included RT services at

November 30, 2020 in the CBSAs

selected for participation by—

(1) Using no-pay claims, CMS

calculates the total FFS amount by

summing the FFS amounts that would

have been paid to the RO participant in

the absence of the RO Model for all

included RT services furnished during

the RO episodes initiated in the PY; and

(2) CMS calculates the sum of all

participant-specific professional episode

payments and participant-specific

technical episode payments paid to the

RO participant for the RO episodes

initiated in the PY.

(3) If the total FFS amount exceeds

the sum of the participant-specific

episode payment amounts for the PY by

more than 20 percent then CMS owes

the RO participant the amount that

exceeds 20 percent, either increasing the

amount of the RO participant’s

reconciliation payment or reducing the

amount of the RO’s participant’s

reconciliation repayment.

(g) True-up reconciliation. CMS

conducts a true-up reconciliation in the

same manner described in paragraph (b)

of this section (except that the quality

reconciliation payment amount and the

patient experience reconciliation

amount are not calculated) to determine

any additional reconciliation payment

or repayment amount that are identified

using 12-months of claims run-out.

(h) Reconciliation report. CMS issues

each RO participant a reconciliation

report for each PY. Each reconciliation

report contains the following:

(1) The RO participant’s

reconciliation payment or repayment

amount, if any, for the relevant PY.

(2) Any additional reconciliation

payment or repayment amount owed for

a previous PY as a result of the true-up

reconciliation.

(3) The net reconciliation payment or

repayment amount owed.

(i) Payment of amounts owed. (1)

CMS issues a reconciliation payment to

the RO participant in the amount

specified in the reconciliation report 30

days after the reconciliation report is

deemed final.

(2) The RO participant must pay a

repayment amount to CMS in the

amount specified in the reconciliation

report by a deadline specified by CMS.

If the RO participant fails to timely pay

the full repayment amount, CMS

recoups the repayment amount from any

payments otherwise owed by CMS to

the RO participant, including Medicare

payments for items and services

unrelated to the RO Model.

(3) No coinsurance is owed by an RO

beneficiary with respect to any

repayment amount or reconciliation

payment.

§ 512.290 Timely error notice and

reconsideration review process.

(a) Timely error notice. Subject to the

limitations on review in § 512.170, an

RO participant that identifies and

wishes to contest a suspected error in

the calculation of its reconciliation

payment or repayment amount or AQS

must provide written notice of the

suspected calculation error to CMS

within 45 days of the date of the

reconciliation report. Such timely error

notice must be in a form and manner

specified by CMS. RO participants are

not permitted to contest the RO Model

pricing methodology or AQS

methodology.

(1) Unless a timely error notice is

received by CMS within 45 days of the

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date of issuance of a reconciliation

report, the reconciliation payment or

repayment amount determination

specified in that reconciliation report is

deemed binding and not subject to

further review.

(2) If CMS receives a timely error

notice, then CMS responds in writing

within 30 days either to confirm that

there was an error in the calculation or

to verify that the calculation is correct.

CMS may extend the deadline for its

response upon written notice to the RO

participant.

(3) Only the RO participant may use

the timely error notice process

described in this paragraph and the

reconsideration review process

described in paragraph (b) of this

section.

(b) Reconsideration review. (1)

Reconsideration request by an RO

participant. (i) If the RO participant is

dissatisfied with CMS’ response to the

timely error notice, then the RO

participant may request a

reconsideration review as specified in

paragraph (b)(2) of this section.

(ii) If CMS does not receive a request

for reconsideration from the RO

participant within 10 days of the issue

date of CMS’ response to the RO

participant’s timely error notice, then

CMS’ response to the timely error notice

is deemed binding and not subject to

further review.

(2) Submission of a reconsideration

request. (i) Information needed in the

reconsideration request. The

reconsideration review request must—

(A) Provide a detailed explanation of

the basis for the dispute; and

(B) Include supporting documentation

for the RO participant’s assertion that

CMS or its representatives did not

accurately calculate the reconciliation

payment or repayment amount or AQS

in accordance with the terms of this

subpart.

(3) Form, manner, and deadline for

submission of the reconsideration

request. The information specified in

paragraph (b)(2)(i) of this section must

be submitted—

(i) In a form and manner specified by

CMS; and

(ii) Within 10 days of the date of the

CMS response described in paragraph

(a)(2) of this section.

(4) Designation of and notification

from a CMS-designated reconsideration

official.

(i) Designation of reconsideration

official. CMS designates a

reconsideration official who—

(A) Is authorized to receive such

requests; and

(B) Was not involved in the

responding to the RO participant’s

timely error notice.

(ii) Notification to the RO participant.

The CMS-designated reconsideration

official makes reasonable efforts to

notify the RO participant and CMS in

writing within 15 days of receiving the

RO participant’s reconsideration review

request of the following:

(A) The issue(s) in dispute;

(B) The briefing schedule; and

(C) The review procedures.

(5) Resolution review. The CMS

reconsideration official makes all

reasonable efforts to complete the on-

the-record resolution review and issue a

written determination no later than 60

days after the submission of the final

position paper in accordance with the

reconsideration official’s briefing

schedule.

Subpart C—ESRD Treatment Choices

Model

General

§ 512.300 Basis and scope.

(a) Basis. This subpart implements the

test of the End-Stage Renal Disease

(ESRD) Treatment Choices (ETC) Model

under section 1115A(b) of the Act.

Except as specifically noted in this

subpart, the regulations under this

subpart must not be construed to affect

the applicability of other provisions

affecting providers and suppliers under

Medicare FFS, including the

applicability of provisions regarding

payment, coverage, or program integrity.

(b) Scope. This subpart sets forth the

following:

(1) The duration of the ETC Model.

(2) The method for selecting ETC

Participants.

(3) The schedule and methodologies

for the Home Dialysis Payment

Adjustment and Performance Payment

Adjustment.

(4) The methodology for ETC

Participant performance assessment for

purposes of the Performance Payment

Adjustment, including beneficiary

attribution, benchmarking and scoring,

and calculating the Modality

Performance Score.

(5) Monitoring and evaluation,

including quality measure reporting.

(6) Medicare payment waivers.

§ 512.310 Definitions.

For purposes of this subpart, the

following definitions apply.

Adjusted ESRD PPS per Treatment

Base Rate means the per treatment

payment amount as defined in § 413.230

of this chapter, including patient-level

adjustments and facility-level

adjustments, and excluding any

applicable training adjustment, add-on

payment amount, outlier payment

amount, transitional drug add-on

payment adjustment (TDAPA) amount,

and transitional add-on payment

adjustment for new and innovative

equipment and supplies (TPNIES)

amount.

Benchmark Year (BY) means the 12-

month period that begins 18 months

prior to the start of a given measurement

year (MY) from which data are used to

construct benchmarks against which to

score an ETC Participant’s achievement

and improvement on the home dialysis

rate and transplant rate for the purpose

of calculating the ETC Participant’s

MPS.

Clinician Home Dialysis Payment

Adjustment (Clinician HDPA) means the

payment adjustment to the MCP for a

Managing Clinician who is an ETC

Participant, for the Managing Clinician’s

home dialysis claims, as described in

§§ 512.345 and 512.350.

Clinician Performance Payment

Adjustment (Clinician PPA) means the

payment adjustment to the MCP for a

Managing Clinician who is an ETC

Participant based on the Managing

Clinician’s MPS, as described in

§§ 512.375(b) and 512.380.

Comparison Geographic Area(s)

means those HRRs that are not Selected

Geographic Areas.

ESRD Beneficiary means a beneficiary

who meets either of the following:

(1) Is receiving dialysis or other

services for end-stage renal disease, up

to and including the month in which

the beneficiary receives a kidney

transplant up to and including the

month in which the beneficiary receives

a kidney transplant.

(2) Has already received a kidney

transplant and has a non-AKI dialysis or

MCP claim—

(i) At least 12 months after the

beneficiary’s latest transplant date; or

(ii) Less than 12 months after the

beneficiary’s latest transplant date and

has a kidney transplant failure diagnosis

code documented on any Medicare

claim.

ESRD facility means an ESRD facility

as specified in § 413.171 of this chapter.

ETC Participant means an ESRD

facility or Managing Clinician that is

required to participate in the ETC Model

pursuant to § 512.325(a).

Facility Home Dialysis Payment

Adjustment (Facility HDPA) means the

payment adjustment to the Adjusted

ESRD PPS per Treatment Base Rate for

an ESRD facility that is an ETC

Participant for the ESRD facility’s home

dialysis claims, as described in

§§ 512.340 and 512.350.

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Facility Performance Payment

Adjustment (Facility PPA) means the

payment adjustment to the Adjusted

ESRD PPS per treatment base rate for an

ESRD facility that is an ETC Participant

based on the ESRD facility’s MPS, as

described in §§ 512.375(a) and 512.380.

Home Dialysis Payment Adjustment

(HDPA) means either the Facility HDPA

or the Clinician HDPA.

Home dialysis rate means the rate of

ESRD Beneficiaries attributed to the

ETC Participant who dialyzed at home

during the relevant MY, as described in

§ 512.365(b).

Hospital referral regions (HRRs)

means the regional markets for tertiary

medical care derived from Medicare

claims data as defined by the Dartmouth

Atlas Project at https://

www.dartmouthatlas.org/.

Kidney transplant means a kidney

transplant, alone or in conjunction with

any other organ.

Living donor transplant (LDT)

Beneficiary means an ESRD Beneficiary

who received a kidney transplant from

a living donor.

Living donor transplant rate means

the rate of ESRD Beneficiaries and, if

applicable, Pre-emptive LDT

Beneficiaries attributed to the ETC

Participant who received a kidney

transplant from a living donor during

the MY, as described in

§ 512.365(c)(1)(ii) and §512.365(c)(2)(ii).

Managing Clinician means a

Medicare-enrolled physician or non-

physician practitioner, identified by a

National Provider Identifier (NPI), who

furnishes and bills the MCP for

managing one or more adult ESRD

Beneficiaries.

Measurement Year (MY) means the

12-month period for which achievement

and improvement on the home dialysis

rate and transplant rate are assessed for

the purpose of calculating the ETC

Participant’s MPS and corresponding

PPA. Each MY included in the ETC

Model and its corresponding PPA

Period are specified in § 512.355(c).

Modality Performance Score (MPS)

means the numeric performance score

calculated for each ETC Participant

based on the ETC Participant’s home

dialysis rate and transplant rate, as

described in § 512.370(a), which is used

to determine the amount of the ETC

Participant’s PPA, as described in

§ 512.380.

Monthly capitation payment (MCP)

means the monthly capitated payment

made for each ESRD Beneficiary to

cover all routine professional services

related to treatment of the patient’s

renal condition furnished by the

physician or non-physician practitioner

as specified in § 414.314 of this chapter.

National Provider Identifier (NPI)

means the standard unique health

identifier used by health care providers

for billing payors, assigned by the

National Plan and Provider

Enumeration System (NPPES) in 45 CFR

part 162.

Performance Payment Adjustment

(PPA) means either the Facility PPA or

the Clinician PPA.

Performance Payment Adjustment

Period (PPA Period) means the six-

month period during which a PPA is

applied in accordance with § 512.380.

Pre-emptive LDT Beneficiary means a

beneficiary who received a kidney

transplant from a living donor prior to

beginning dialysis.

Selected Geographic Area(s) are those

HRRs selected by CMS pursuant to

§ 512.325(b) for purposes of selecting

ESRD facilities and Managing Clinicians

required to participate in the ETC Model

as ETC Participants.

Subsidiary ESRD facility is an ESRD

facility owned in whole or in part by

another legal entity.

Taxpayer Identification Number (TIN)

means a Federal taxpayer identification

number or employer identification

number as defined by the Internal

Revenue Service in 26 CFR 301.6109–1.

Transplant rate means the sum of the

transplant waitlist rate and the living

donor transplant rate, as described in

§ 512.365(c).

Transplant waitlist rate means the

rate of ESRD Beneficiaries attributed to

the ETC Participant who were on the

kidney transplant waitlist during the

MY, as described in § 512.365(c)(1)(i)–

(ii) and § 512.365(c)(2)(i)–(ii).

ESRD Treatment Choices Model Scope

and Participants

§ 512.320 Duration.

CMS will apply the payment

adjustments described in this subpart

under the ETC Model to claims with

claim service dates beginning on or after

January 1, 2021, and ending on or before

June 30, 2027.

§ 512.325 Participant selection and

geographic areas.

(a) Selected participants. All

Medicare-certified ESRD facilities and

Medicare-enrolled Managing Clinicians

located in a selected geographic area are

required to participate in the ETC

Model.

(b) Selected Geographic Areas. CMS

establishes the Selected Geographic

Areas by selecting all HRRs for which at

least 20 percent of the component zip

codes are located in Maryland, and a

random sample of 30 percent of HRRs,

stratified by Census-defined regions

(Northeast, South, Midwest, and West).

CMS excludes all U.S. Territories from

the Selected Geographic Areas.

§ 512.330 Beneficiary notification.

(a) General. ETC Participants must

prominently display informational

materials in each of their office or

facility locations where beneficiaries

receive treatment to notify beneficiaries

that the ETC Participant is participating

in the ETC Model. CMS provides the

ETC Participant with a template for

these materials, indicating the required

content that the ETC Participant must

not change and places where the ETC

Participant may insert its own original

content. The CMS-provided template for

the beneficiary notification will include,

without limitation, the following

information:

(1) A notification that the ETC

Participant is participating in the ETC

Model;

(2) Instructions on how to contact the

ESRD Network Organizations with any

questions or concerns about the ETC

Participant’s participation in the Model;

(3) An affirmation of the ESRD

Beneficiary’s protections under

Medicare, including the beneficiary’s

freedom to choose his or her provider or

supplier and to select the treatment

modality of his or her choice.

(b) Applicability of general Innovation

Center model provisions. The

requirement described in § 512.120(c)(2)

shall not apply to the CMS-provided

materials described in paragraph (a) of

this section. All other ETC Participant

communications that are descriptive

model materials and activities as

defined under § 512.110 must meet the

requirements described in § 512.120(c).

Home Dialysis Payment Adjustment

§ 512.340 Payments subject to the Facility

HDPA.

CMS adjusts the Adjusted ESRD PPS

per Treatment Base Rate by the Facility

HDPA on claim lines with Type of Bill

072X, and with condition codes 74 or

76, when the claim is submitted by an

ESRD facility that is an ETC Participant

with a claim service date during a

calendar year subject to adjustment as

described in § 512.350 and the

beneficiary is at least 18 years old before

the first day of the month.

§ 512.345 Payments subject to the

Clinician HDPA.

CMS adjusts the amount otherwise

paid under Medicare Part B with respect

to MCP claims on claim lines with CPT

codes 90965 and 90966 by the Clinician

HDPA when the claim is submitted by

a Managing Clinician who is an ETC

Participant with a claim service date

during a calendar year subject to

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adjustment as described in § 512.350

and the beneficiary is at least 18 years

old before the first day of the month.

§ 512.350 Schedule of home dialysis

payment adjustments.

CMS adjusts the payments specified

in § 512.340 by the Facility HDPA and

adjusts the payments specified in

§ 512.345 by the Clinician HDPA,

according to the following schedule:

(a) Calendar year 2021: +3 percent.

(b) Calendar year 2022: +2 percent.

(c) Calendar year 2023: +1 percent.

Performance Payment Adjustment

§ 512.355 Schedule of performance

assessment and performance payment

adjustment.

(a) Measurement Years. CMS assesses

ETC Participant performance on the

home dialysis rate and the transplant

rate during each of the MYs. The first

MY begins on January 1, 2021, and the

final MY ends on June 30, 2026.

(b) Performance Payment Adjustment

Period. CMS adjusts payments for ETC

Participants by the PPA during each of

the PPA Periods, each of which

corresponds to a MY. The first PPA

Period begins on July 1, 2022, and the

final PPA Period ends on June 30, 2027.

(c) Measurement Years and

Performance Payment Adjustment

Periods. MYs and PPA Periods follow

the following schedule:

§ 512.360 Beneficiary population and

attribution.

(a) General. Except as provided in

paragraph (b) of this section, CMS

attributes ESRD Beneficiaries to an ETC

Participant for each month during a MY

based on the ESRD Beneficiary’s receipt

of services specified in paragraph (c) of

this section during that month, for the

purpose of assessing the ETC

Participant’s performance on the home

dialysis rate and transplant rate during

that MY. Except as provided in

paragraph (b) of this section, CMS

attributes Pre-emptive LDT Beneficiaries

to a Managing Clinician for one or more

months during a MY based on the Pre-

emptive LDT Beneficiary’s receipt of

services specified in paragraph (c)(2) of

this section during that MY, for the

purpose of assessing the Managing

Clinician’s performance on the living

donor transplant rate during that MY.

CMS attributes ESRD Beneficiaries and,

if applicable, Pre-emptive LDT

Beneficiaries to the ETC Participant for

each month during a MY retrospectively

after the end of the MY. CMS attributes

an ESRD Beneficiary to no more than

one ESRD facility and no more than one

Managing Clinician for a given month

during a given MY. CMS attributes a

Pre-emptive LDT Beneficiary to no more

than one Managing Clinician for a given

MY.

(b) Exclusions from attribution. CMS

does not attribute an ESRD Beneficiary

or Pre-emptive LDT Beneficiary to an

ETC Participant for a month if, at any

point during the month, the

beneficiary—

(1) Is not enrolled in Medicare Part B;

(2) Is enrolled in Medicare Advantage,

a cost plan, or other Medicare managed

care plan;

(3) Does not reside in the United

States;

(4) Is younger than 18 years of age

before the first day of the month of the

claim service date;

(5) Has elected hospice;

(6) Is receiving dialysis only for any

acute kidney injury (AKI);

(7) Has a diagnosis of dementia at any

point during the month of the claim

service date or the preceding 12 months,

as identified using the most recent

dementia-related criteria at the time of

beneficiary attribution, using the CMS–

HCC (Hierarchical Condition Category)

Risk Adjustment Model ICD–10–CM

Mappings; or

(8) Is residing in or receiving dialysis

in a skilled nursing facility (SNF) or

nursing facility.

(c) Attribution services. (1) ESRD

facility beneficiary attribution. To be

attributed to an ESRD facility that is an

ETC Participant for a month, an ESRD

Beneficiary must not be excluded based

on the criteria specified in paragraph (b)

of this section and must have received

renal dialysis services during the month

from the ESRD facility. CMS does not

attribute Pre-emptive LDT Beneficiaries

to ESRD facilities.

(i) An ESRD Beneficiary is attributed

to the ESRD facility at which the ESRD

Beneficiary received the plurality of his

or her dialysis treatments in that month,

other than renal dialysis services for

AKI, as identified by claims with Type

of Bill 072X, with claim service dates at

the claim header through date during

the month.

(ii) If the ESRD Beneficiary receives

an equal number of dialysis treatments

from two or more ESRD facilities in a

given month, CMS attributes the ESRD

Beneficiary to the ESRD facility at

which the beneficiary received the

earliest dialysis treatment that month. If

the ESRD Beneficiary receives an equal

number of dialysis treatments from two

or more ESRD facilities in a given

month and the ESRD beneficiary

received the earliest dialysis treatment

that month from more than one ESRD

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facility, CMS attributes the beneficiary

to one of the ESRD facilities that

furnished the earliest dialysis treatment

that month at random.

(2) Managing Clinician beneficiary

attribution. (i) An ESRD beneficiary who

is not excluded based on the criteria in

paragraph (b) of this section is attributed

to a Managing Clinician who is an ETC

Participant for a month if that Managing

Clinician submitted an MCP claim for

services furnished to the beneficiary,

identified with CPT codes 90957, 90958,

90959, 90960, 90961, 90962, 90965, or

90966, with claim service dates at the

claim line through date during the

month.

(A) If more than one Managing

Clinician submits a claim for the MCP

furnished to a single ESRD Beneficiary

with a claim service date at the claim

line during the month, the ESRD

Beneficiary is attributed to the

Managing Clinician associated with the

earliest claim service date at the claim

line through date during the month.

(B) If more than one Managing

Clinician submits a claim for the MCP

furnished to a single ESRD Beneficiary

with the same earliest claim service date

at the claim line through date for the

month, the ESRD Beneficiary is

randomly attributed to one of these

Managing Clinicians.

(ii) A Pre-emptive LDT Beneficiary

who is not excluded based on the

criteria in paragraph (b) of this section

is attributed to the Managing Clinician

with whom the beneficiary has had the

most claims between the start of the MY

and the month in which the beneficiary

received the transplant for all months

between the start of the MY and the

month of the transplant.

(A) If no Managing Clinician has had

the plurality of claims for a given Pre-

emptive LDT Beneficiary such that

multiple Managing Clinicians each had

the same number of claims for that

beneficiary during the MY, the Pre-

emptive LDT Beneficiary is attributed to

the Managing Clinician associated with

the latest claim service date at the claim

line through date during the MY up to

and including the month of the

transplant.

(B) If no Managing Clinician had the

plurality of claims for a given Pre-

emptive LDT Beneficiary such that

multiple Managing Clinicians each had

the same number of services for that

beneficiary during the MY, and more

than one of those Managing Clinicians

had the latest claim service date at the

claim line through date during the MY

up to and including the month of the

transplant, the Pre-emptive LDT

Beneficiary is randomly attributed to

one of these Managing Clinicians.

§ 512.365 Performance assessment.

(a) General. For each MY, CMS

separately assesses the home dialysis

rate and the transplant rate for each ETC

Participant based on the population of

ESRD Beneficiaries and, if applicable,

Pre-emptive LDT Beneficiaries

attributed to the ETC Participant under

§ 512.360. Information used to calculate

the home dialysis rate and the

transplant rate includes Medicare

claims data, Medicare administrative

data, and data from the Scientific

Registry of Transplant Recipients.

(b) Home dialysis rate. CMS calculates

the home dialysis rate for ESRD

facilities and Managing Clinicians as

follows.

(1) Home dialysis rate for ESRD

facilities. (i) The denominator is the

total dialysis treatment beneficiary years

for attributed ESRD Beneficiaries during

the MY. Dialysis treatment beneficiary

years included in the denominator are

composed of those months during

which an attributed ESRD Beneficiary

received maintenance dialysis at home

or in an ESRD facility, such that one

beneficiary year is composed of 12

beneficiary months. Months during

which attributed ESRD Beneficiaries

received maintenance dialysis are

identified by claims with Type of Bill

072X.

(ii) The numerator is the total number

of home dialysis treatment beneficiary

years plus one half the total number of

self dialysis treatment beneficiary years

for attributed ESRD Beneficiaries during

the MY.

(A) Home dialysis treatment

beneficiary years included in the

numerator are composed of those

months during which attributed ESRD

Beneficiaries received maintenance

dialysis at home, such that one

beneficiary year is comprised of 12

beneficiary months. Months in which an

attributed ESRD Beneficiary received

maintenance dialysis at home are

identified by claims with Type of Bill

072X and condition codes 74 or 76.

(B) Self dialysis treatment beneficiary

years included in the numerator are

composed of those months during

which attributed ESRD Beneficiaries

received self dialysis in center, such

that one beneficiary year is comprised of

12 beneficiary months. Months in which

an attributed ESRD Beneficiary received

self dialysis are identified by claims

with Type of Bill 072X and condition

code 72.

(iii) Information used to calculate the

ESRD facility home dialysis rate

includes Medicare claims data and

Medicare administrative data.

(iv) The ESRD facility home dialysis

rate is aggregated, as described in

paragraph (e)(1) of this section.

(2) Home dialysis rate for Managing

Clinicians. (i) The denominator is the

total dialysis treatment beneficiary years

for attributed ESRD Beneficiaries during

the MY. Dialysis treatment beneficiary

years included in the denominator are

composed of those months during

which an attributed ESRD Beneficiary

received maintenance dialysis at home

or in an ESRD facility, such that one

beneficiary year is comprised of 12

beneficiary months. Months during

which an attributed ESRD Beneficiary

received maintenance dialysis are

identified by claims with CPT codes

90957, 90958, 90959, 90960, 90961,

90962, 90965, or 90966.

(ii) The numerator is the total number

of home dialysis treatment beneficiary

years for attributed ESRD Beneficiaries

during the MY plus one half the total

number of self dialysis treatment

beneficiary years.

(A) Home dialysis treatment

beneficiary years included in the

numerator are composed of those

months during which an attributed

ESRD Beneficiary received maintenance

dialysis at home, such that one

beneficiary year is comprised of 12

beneficiary months. Months in which an

attributed ESRD Beneficiary received

maintenance dialysis at home are

identified by claims with CPT codes

90965 or 90966.

(B) Self-dialysis treatment beneficiary

years included in the numerator are

composed of those months during

which an attributed ESRD Beneficiary

received self dialysis in center, such

that one beneficiary year is comprised of

12 beneficiary months. Months in which

an attributed ESRD Beneficiary received

self dialysis are identified by claims

with Type of Bill 072X and condition

code 72.

(iii) Information used to calculate the

Managing Clinician home dialysis rate

includes Medicare claims data and

Medicare administrative data.

(iv) The Managing Clinician home

dialysis rate is aggregated, as described

in paragraph (e)(2) of this section.

(c) Transplant rate. CMS calculates

the transplant rate for ETC Participants

as follows.

(1) Transplant rate for ESRD facilities.

The transplant rate for ESRD facilities is

the sum of the transplant waitlist rate

for ESRD facilities, as described in

paragraph (c)(1)(i) of this section, and

the living donor transplant rate for

ESRD facilities, as described in

paragraph (c)(1)(ii) of this section.

(i) Transplant waitlist rate for ESRD

facilities. (A) The denominator is the

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total dialysis treatment beneficiary years

for attributed ESRD Beneficiaries during

the MY. Dialysis treatment beneficiary

years included in the denominator are

composed of those months during

which an attributed ESRD beneficiary

received maintenance dialysis at home

or in an ESRD facility, such that one

beneficiary year is comprised of 12

beneficiary months. Months during

which an attributed ESRD Beneficiary

received maintenance dialysis are

identified by claims with Type of Bill

072X, excluding claims for beneficiaries

who were 75 years of age or older at any

point during the month.

(B) The numerator is the total number

of attributed beneficiary years for which

attributed ESRD Beneficiaries were on

the kidney transplant waitlist. Months

during which an attributed ESRD

Beneficiary was on the kidney

transplant waitlist are identified using

data from the SRTR database.

(ii) Living donor transplant rate for

ESRD facilities. (A) The denominator is

the total dialysis treatment beneficiary

years for attributed ESRD Beneficiaries

during the MY. Dialysis treatment

beneficiary years included in the

denominator are composed of those

months during which an attributed

ESRD Beneficiary received maintenance

dialysis at home or in an ESRD facility,

such that one beneficiary year is

comprised of 12 beneficiary months.

Months during which an attributed

ESRD Beneficiary received maintenance

dialysis are identified by claims with

Type of Bill 072X, excluding claims for

beneficiaries who were 75 years of age

or older at any point during the month.

(B) The numerator is the total number

of attributed beneficiary years for LDT

Beneficiaries during the MY.

Beneficiary years for LDT Beneficiaries

included in the numerator are

composed of those months between the

beginning of the MY up to and

including the month of the transplant

for LDT Beneficiaries attributed to an

ESRD facility during the month of the

transplant. LDT Beneficiaries are

identified using information about

living donor transplants from the SRTR

Database and Medicare claims data.

(iii) The ESRD facility transplant

waitlist rate is risk adjusted, as

described in paragraph (d) of this

section. The ESRD facility transplant

rate is aggregated, as described in

paragraph (e)(1) of this section.

(2) Transplant rate for Managing

Clinicians. The transplant rate for

Managing Clinicians is the sum of the

transplant waitlist rate for Managing

Clinicians, as described in paragraph

(c)(2)(i) of this section, and the living

donor transplant rate for Managing

Clinicians, as described in paragraph

(c)(2)(ii) of this section.

(i) Transplant waitlist rate for

Managing Clinicians. (A) The

denominator is the total dialysis

treatment beneficiary years for

attributed ESRD Beneficiaries during the

MY. Dialysis treatment beneficiary years

included in the denominator are

composed of those months during

which an attributed ESRD Beneficiary

received maintenance dialysis at home

or in an ESRD facility, such that one

beneficiary year is comprised of 12

beneficiary months. Months during

which an attributed ESRD Beneficiary

received maintenance dialysis are

identified by claims with CPT codes

90957, 90958, 90959, 90960, 90961,

90962, 90965, or 90966, excluding

claims for beneficiaries who were 75

years of age or older at any point during

the month.

(B) The numerator is the total number

of attributed beneficiary years for which

attributed ESRD Beneficiaries were on

the kidney transplant waitlist. Months

during which an attributed ESRD

Beneficiary was on the kidney

transplant waitlist are identified using

data from the SRTR database.

(ii) Living donor transplant rate for

Managing Clinicians. (A) The

denominator is the sum of the total

dialysis treatment beneficiary years for

attributed ESRD Beneficiaries during the

MY and the total Pre-emptive LDT

beneficiary years for attributed

beneficiaries during the MY.

(1) Dialysis treatment beneficiary

years included in the denominator are

composed of those months during

which an attributed ESRD Beneficiary

received maintenance dialysis at home

or in an ESRD facility, such that one

beneficiary year is comprised of 12

beneficiary months. Months during

which an attributed ESRD Beneficiary

received maintenance dialysis are

identified by claims with CPT codes

90957, 90958, 90959, 90960, 90961,

90962, 90965, or 90966, excluding

claims for beneficiaries who were 75

years of age or older at any point during

the month.

(2) Pre-emptive LDT beneficiary years

included in the denominator are

composed of those months during

which a Pre-emptive LDT Beneficiary is

attributed to a Managing Clinician, from

the beginning of the MY up to and

including the month of the living donor

transplant. Pre-emptive LDT

Beneficiaries are identified using

information about living donor

transplants from the SRTR Database and

Medicare claims data.

(B) The numerator is the sum of the

total number of attributed beneficiary

years for LDT Beneficiaries during the

MY and the total number of attributed

beneficiary years for Pre-emptive LDT

Beneficiaries during the MY.

(1) Beneficiary years for LDT

Beneficiaries included in the numerator

are composed of those months during

which an LDT Beneficiary is attributed

to a Managing Clinician, from the

beginning of the MY up to and

including the month of the transplant.

LDT Beneficiaries are identified using

information about living donor

transplants from the SRTR Database and

Medicare claims data.

(2) Beneficiary years for Pre-emptive

LDT Beneficiaries included in the

numerator are composed of those

months during which a Pre-emptive

LDT Beneficiary is attributed to a

Managing Clinician, from the beginning

of the MY up to and including the

month of the transplant. Pre-emptive

LDT Beneficiaries are identified using

information about living donor

transplants from the SRTR Database and

Medicare claims data.

(iii) The Managing Clinician

transplant waitlist rate is risk adjusted,

as described in paragraph (d) of this

section. The Managing Clinician

transplant rate is aggregated, as

described in paragraph (e)(2) of this

section.

(d) Risk adjustment. (1) CMS risk

adjusts the transplant waitlist rate based

on beneficiary age with separate risk

coefficients for the following age

categories of beneficiaries, with age

computed on the last day of each month

of the MY:

(i) 18 to 55.

(ii) 56 to 70.

(iii) 71 to 74.

(2) CMS risk adjusts the transplant

waitlist rate to account for the relative

percentage of the population of

beneficiaries attributed to the ETC

Participant in each age category relative

to the national age distribution of

beneficiaries not excluded from

attribution.

(e) Aggregation. (1) Aggregation for

ESRD facilities. An ESRD facility’s

home dialysis rate and transplant rate

are aggregated to the ESRD facility’s

aggregation group. The aggregation

group for a Subsidiary ESRD facility

includes all ESRD facilities owned in

whole or in part by the same legal entity

located in the HRR in which the ESRD

facility is located. An ESRD facility that

is not a Subsidiary ESRD facility is not

included in an aggregation group.

(2) Aggregation for Managing

Clinicians. A Managing Clinician’s

home dialysis rate and transplant rate

are aggregated to the Managing

Clinician’s aggregation group. The

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aggregation group for a Managing

Clinician who is—

(i) In a group practice is the practice

group level, as identified by practice

TIN; or

(ii) A solo practitioner is the

individual clinician level, as identified

by NPI.

§ 512.370 Benchmarking and scoring.

(a) General. (1) CMS assesses the

home dialysis rate and transplant rate

for each ETC Participant against the

applicable benchmarks to calculate an—

(i) Achievement score, as described in

paragraph (b) of this section; and

(ii) Improvement score, as described

in paragraph (c) of this section.

(2)(i) CMS calculates the ETC

Participant’s MPS as the weighted sum

of the higher of the achievement score

or the improvement score for the ETC

Participant’s home dialysis rate and

transplant rate, as described in

paragraph (d) of this section.

(ii) The ETC Participant’s MPS

determines the ETC Participant’s PPA,

as described in § 512.380.

(b) Achievement scoring. CMS

assesses ETC Participant performance at

the aggregation group level on the home

dialysis rate and transplant rate against

benchmarks constructed based on the

home dialysis rate and transplant rate

among aggregation groups of ESRD

facilities and Managing Clinicians

located in Comparison Geographic

Areas during the Benchmark Year. CMS

uses the following scoring methodology

to assess an ETC Participant’s

achievement score.

(1) 90th+ Percentile of benchmark

rates for comparison geographic areas

during the benchmark year: 2 points.

(2) 75th+ Percentile of benchmark

rates for comparison geographic areas

during the benchmark year: 1.5 points.

(3) 50th+ Percentile of benchmark

rates for comparison geographic areas

during the benchmark year: 1 point.

(4) 30th+ Percentile of benchmark

rates for comparison geographic areas

during the benchmark year: 0.5 points.

(5) <30th Percentile of benchmark

rates for comparison geographic areas

during the benchmark year: 0 points.

(c) Improvement scoring. CMS

assesses ETC Participant improvement

on the home dialysis rate and transplant

rate against benchmarks constructed

based on the ETC Participant’s

aggregation group’s historical

performance on the home dialysis rate

and transplant rate during the

Benchmark Year. CMS uses the

following scoring methodology to assess

an ETC Participant’s improvement

score.

(1) Greater than 10 percent

improvement relative to the Benchmark

Year rate: 1.5 points.

(2) Greater than 5 percent

improvement relative to the Benchmark

Year rate: 1 point.

(3) Greater than 0 percent

improvement relative to the Benchmark

Year rate: 0.5 points.

(4) Less than or equal to the

Benchmark Year rate: 0 points.

(d) Modality Performance Score. CMS

calculates the ETC Participant’s MPS as

the higher of ETC Participant’s

achievement score or improvement

score for the home dialysis rate, together

with the higher of the ETC Participant’s

achievement score or improvement

score for the transplant rate, weighted

such that the ETC Participant’s score for

the home dialysis rate constitutes

2

⁄

3

of

the MPS and the ETC Participant’s score

for the transplant rate constitutes

1

⁄

3

of

the MPS. CMS uses the following

formula to calculate the ETC

Participant’s MPS:

Modality Performance Score = 2 ×

(Higher of the home dialysis

achievement or improvement score)

+ (Higher of the transplant

achievement or improvement score)

§ 512.375 Payments subject to adjustment.

(a) Facility PPA. CMS adjusts the

Adjusted ESRD PPS per Treatment Base

Rate by the Facility PPA on claim lines

with Type of Bill 072X, when the claim

is submitted by an ETC Participant that

is an ESRD facility and the beneficiary

is at least 18 years old before the first

day of the month, on claims with claim

service dates during the applicable PPA

Period as described in § 512.355(c).

(b) Clinician PPA. CMS adjusts the

amount otherwise paid under Medicare

Part B with respect to MCP claims on

claim lines with CPT codes 90957,

90958, 90959, 90960, 90961, 90962,

90965 and 90966 by the Clinician PPA

when the claim is submitted by an ETC

Participant who is a Managing Clinician

and the beneficiary is at least 18 years

old before the first day of the month, on

claims with claim service dates during

the applicable PPA Period as described

in § 512.355(c).

§ 512.380 PPA Amounts and schedules.

CMS adjusts the payments described

in § 512.375 based on the ETC

Participant’s MPS calculated as

described in § 512.370(d) according to

the following amounts and schedules in

Table 1 and Table 2 to § 512.380.

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§ 512.385 PPA exclusions.

(a) ESRD facilities. CMS excludes an

aggregation group (as described in

§ 512.365(e)(1) of Subsidiary ESRD

facilities with fewer than 11 attributed

ESRD beneficiary years during an MY

from the applicability of the Facility

PPA for the corresponding PPA Period.

CMS excludes ESRD facilities that are

not Subsidiary ESRD facilities with

fewer than 11 attributed ESRD

beneficiary years during an MY from the

applicability of the Facility PPA for the

corresponding PPA Period.

(b) Managing Clinicians. CMS

excludes an aggregation group (as

described in § 512.365(e)(2)) of

Managing Clinicians with fewer than 11

attributed ESRD beneficiary years

during an MY from the applicability of

the Clinician PPA for the corresponding

PPA Period.

§ 512.390 Notification and targeted review.

(a) Notification. CMS will notify each

ETC Participant, in a form and manner

determined by CMS, of the ETC

Participant’s attributed beneficiaries,

MPS, and PPA for a PPA Period no later

than one month before the start of the

applicable PPA Period.

(b) Targeted review process. An ETC

Participant may request a targeted

review of the calculation of the MPS.

Requests for targeted review are limited

to the calculation of the MPS, and may

not be submitted in regards to: The

methodology used to determine the

MPS; or the establishment of the home

dialysis rate methodology, transplant

rate methodology, achievement and

improvement benchmarks and

benchmarking methodology, or PPA

amounts. The process for targeted

reviews is as follows:

(1) An ETC Participant has 90 days (or

a later date specified by CMS) to submit

a request for a targeted review, which

begins on the day CMS makes available

the MPS.

(2) CMS will respond to each request

for targeted review timely submitted

and determine whether a targeted

review is warranted.

(3) The ETC Participant may include

additional information in support of the

request for targeted review at the time

the request is submitted. If CMS

requests additional information from the

ETC Participant, it must be provided

and received within 30 days of the

request. Non-responsiveness to the

request for additional information may

result in the closure of the targeted

review request.

(4) If, upon completion of a targeted

review, CMS finds that there was an

error in the calculation of the ETC

Participant’s MPS such that an incorrect

PPA has been applied during the PPA

period, CMS shall notify the ETC

Participant and must resolve any

resulting discrepancy in payment that

arises from the application of an

incorrect PPA in a time and manner

determined by CMS.

(5) Decisions based on targeted review

are final, and there is no further review

or appeal.

Quality Monitoring

§ 512.395 Quality measures.

CMS collects data on these two

quality measures for ESRD facilities that

are ETC Participants to monitor for

changes in quality outcomes. CMS

conducts data collection and measure

calculation using claims data and other

Medicare administrative data, including

enrollment data:

(a) Standardized Mortality Ratio

(SMR); NQF #0369.

(b) Standardized Hospitalization Ratio

(SHR); NQF #1463.

Medicare Program Waivers

§ 512.397 ETC Model Medicare program

waivers.

The following provisions are waived

solely for purposes of testing the ETC

Model.

(a)(1) Medicare payment waivers.

CMS waives the requirements of

sections 1833(a), 1833(b), 1848(a)(1),

1881(b), and 1881(h)(1)(A) of the Act

only to the extent necessary to make the

payment adjustments under the ETC

Model described in this subpart.

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(2) Beneficiary cost sharing. The

payment adjustments under the ETC

Model described in this subpart do not

affect the beneficiary cost-sharing

amounts for Part B services furnished by

ETC Participants under the ETC Model.

(b) CMS waives the following

requirements of title XVIII of the Act

solely for purposes of testing the ETC

Model:

(1) CMS waives the requirement

under section 1861(ggg)(2)(A)(i) of the

Act and § 410.48(a) and (c)(2)(i) of this

chapter that only doctors, physician

assistants, nurse practitioners, and

clinical nurse specialists can furnish

KDE services to allow KDE services to

be provided by clinical staff under the

direction of and incident to the services

of the Managing Clinician who is an

ETC Participant. The KDE benefit must

be furnished and billed by a Physician,

clinical nurse specialist, licensed social

worker, nurse practitioner, physician

assistant, registered dietician/nutrition

professional, or a clinic/group practice.

(2) CMS waives the requirement that

the KDE is covered only for Stage IV

chronic kidney disease (CKD) patients

under section 1861(ggg)(1)(A) of the Act

and § 410.48(b)(1) of this chapter to

permit beneficiaries diagnosed with

CKD Stage V or within the first 6

months of starting dialysis to receive the

KDE benefit.

(3) CMS waives the requirement that

the content of the KDE sessions include

the management of co-morbidities,

including delaying the need for dialysis,

under § 410.48(d)(1) of this chapter

when such services are furnished to

beneficiaries with CKD Stage V or

ESRD, unless such content is relevant

for the beneficiary.

(4) CMS waives the requirement that

an outcomes assessment designed to

measure beneficiary knowledge about

chronic kidney disease and its treatment

be performed by a qualified clinician as

part of one of the KDE sessions under

§ 410.48(d)(5)(iii) of this chapter,

provided that such outcomes

assessment is performed within 1 month

of the final KDE session by qualified

staff.

Dated: September 4, 2020.

Seema Verma,

Administrator, Centers for Medicare &

Medicaid Services.

Dated: September 9, 2020.

Alex M. Azar II,

Secretary, Department of Health and Human

Services.

[FR Doc. 2020–20907 Filed 9–21–20; 11:15 am]

BILLING CODE 4120–01–P

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