[Federal Register Volume 84, Number 138 (Thursday, July 18, 2019)]
[Proposed Rules]
[Pages 34478-34595]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14902]
[[Page 34477]]
Vol. 84
Thursday,
No. 138
July 18, 2019
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Part 512
Medicare Program; Specialty Care Models To Improve Quality of Care and
Reduce Expenditures; Proposed Rule
Federal Register / Vol. 84 , No. 138 / Thursday, July 18, 2019 /
Proposed Rules
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 512
[CMS-5527-P]
RIN 0938-AT89
Medicare Program; Specialty Care Models To Improve Quality of
Care and Reduce Expenditures
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule proposes to implement two new mandatory
Medicare payment models under section 1115A of the Social Security
Act--the Radiation Oncology Model (RO Model) and the End-Stage Renal
Disease (ESRD) Treatment Choices Model (ETC Model). The proposed RO
Model would promote quality and financial accountability for providers
and suppliers of radiotherapy (RT). The RO Model would test whether
making prospective episode payments to hospital outpatient departments
(HOPD) and freestanding radiation therapy centers for RT episodes of
care preserves or enhances the quality of care furnished to Medicare
beneficiaries while reducing Medicare program spending through enhanced
financial accountability for RO Model participants. The proposed ETC
Model would be a mandatory payment model focused on encouraging greater
use of home dialysis and kidney transplants, in order to preserve or
enhance the quality of care furnished to Medicare beneficiaries while
reducing Medicare expenditures. The ETC Model would include ESRD
facilities and certain clinicians caring for beneficiaries with ESRD--
or Managing Clinicians--located in selected geographic areas as
participants. CMS would assess the performance of participating
Managing Clinicians and ESRD facilities on their rates of home dialysis
and kidney and kidney-pancreas transplants during each Measurement Year
(MY), and would subsequently adjust certain of their Medicare payments
upward or downward during the corresponding performance payment
adjustment period based on their home dialysis rate and transplant
rate. CMS would also positively adjust certain Medicare payments to
participating ESRD facilities and Managing Clinicians for home dialysis
and home dialysis-related claims in the initial 3 years of the ETC
Model.
We believe that these two proposed models would test ways to
further our goals of reducing Medicare expenditures while preserving or
enhancing the quality of care furnished to beneficiaries.
DATES: Comment period: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
Eastern Standard Time on September 16, 2019.
ADDRESSES: In commenting, please refer to file code CMS-5527-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-5527-P, P.O. Box 8013,
Baltimore, MD 21244-1850.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-5527-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-8013.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Rebecca Cole (410) 786-1589.
[email protected], for questions related to General Provisions.
[email protected], for questions related to the Radiation
Oncology Model. [email protected], for questions related to the ESRD
Treatment Choices Model.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to
view public comments.
Electronic Access
This Federal Register document is also available from the Federal
Register online database through Federal Digital System (FDsys), a
service of the U.S. Government Publishing Office. This database can be
accessed via the internet at http://www.gpo.gov/fdsys/.
Current Procedural Terminology (CPT) Copyright Notice
Throughout this proposed rule, we use CPT[supreg] codes and
descriptions to refer to a variety of services. We note that
CPT[supreg] codes and descriptions are copyright 2019 American Medical
Association. All Rights Reserved. CPT[supreg] is a registered trademark
of the American Medical Association (AMA). Applicable Federal
Acquisition Regulations (FAR) and Defense Federal Acquisition
Regulations (DFAR) apply.
I. Executive Summary
A. Purpose
The purpose of this proposed rule is to propose the implementation
and testing of two new mandatory models under the authority of the
Innovation Center, as well as to propose certain general provisions
that would be applicable to both the RO Model and the ETC Model.
Section 1115A of the Social Security Act (the Act) authorizes the
Innovation Center to test innovative payment and service delivery
models expected to reduce Medicare, Medicaid, and Children's Health
Insurance Program (CHIP) expenditures while preserving or enhancing the
quality of care furnished to the beneficiaries of such programs. Under
the Medicare fee-for-service (FFS) program, Medicare generally makes a
separate payment to providers and suppliers for each item or service
furnished to a beneficiary during the course of treatment. Because the
amount of payments received by a provider or supplier for such items
and services varies with the volume of items and services furnished to
a beneficiary, some providers and suppliers may be financially
incentivized to inappropriately increase the volume of items and
services to receive higher payments. Medicare FFS may also detract from
a provider's or supplier's incentive to invest in quality improvement
and care coordination activities if it means those activities will
result in a lower volume of items and
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services. As a result, care may be fragmented, unnecessary, or
duplicative.
The goal for the proposed models is to preserve or enhance the
quality of care furnished to beneficiaries while reducing program
spending through enhanced financial accountability for model
participants. We propose that the performance period of the proposed RO
Model would begin in 2020, and end December 31, 2024. We propose to
implement the proposed payment adjustments under the proposed ETC Model
over the course of 6 and a half years, beginning January 1, 2020, and
ending June 30, 2026.
The proposed models would offer participants the opportunity to
examine and better understand their own care processes and patterns
with regard to beneficiaries receiving RT services for cancer, and
beneficiaries with ESRD, respectively. We chose these focus areas for
the proposed models because, as discussed in depth in sections III and
IV of this proposed rule, we believe that participants in these models
would have significant opportunity to redesign care and improve the
quality of care furnished to beneficiaries receiving these services.
We believe the proposed models would further the agency's goal of
increasing the extent to which CMS initiatives pay for value and
outcomes, rather than for volume of services alone, by promoting the
alignment of financial and other incentives for health care providers
caring for beneficiaries receiving treatment for cancer or ESRD.
Payments that are made to health care providers for assuming financial
accountability for the cost and quality of care create incentives for
the implementation of care redesign among model participants and other
providers and suppliers.
CMS is testing several models, including voluntary models focused
specifically on cancer and ESRD. The proposed RO and ETC Models would
require the participation of providers and suppliers that might not
otherwise participate in these models, and would be tested in multiple
geographic areas.
The proposed models would allow CMS to test models with provider
and supplier participation when there are differences in: (1) Historic
care and utilization patterns; (2) patient populations and care
patterns; (3) roles within their local markets; (4) volume of services;
(5) levels of access to financial, community, or other resources; and
(6) levels of population and health care provider density. We believe
that participation in the proposed models by a large number of
providers and suppliers with diverse characteristics would result in a
robust data set for evaluating the models' proposed payment approaches
and would stimulate the rapid development of new evidence-based
knowledge. Testing the proposed models in this manner would also allow
us to learn more about patterns of inefficient utilization of health
care services and how to incentivize quality improvement for
beneficiaries receiving services for RT and ESRD, which could inform
future model design.
We seek public comment on the proposals contained in this proposed
rule, and also on any alternatives considered.
B. Summary of the Major Proposed Provisions
1. General Provisions
The proposed general provisions would be applicable only to
participants in the RO Model and the ETC Model. We have identified the
proposed general provisions based on standardized parameters that have
been repeatedly memorialized in various documents governing
participation in existing model tests and propose to make them
applicable to both proposed models so that we may eliminate repetition
in the proposed 42 CFR part 512. The proposed general provisions
address beneficiary protections, model evaluation and monitoring,
audits and record retention, monitoring and compliance, remedial or
administrative action, model termination by CMS, limitations on review,
and miscellaneous provisions on bankruptcy and other notifications.
These provisions are not intended to comprehensively encompass all the
provisions that would apply to each model. Both the RO Model and the
ETC Model have unique aspects that would require additional, more
tailored provisions, including with respect to payment and quality
measurement. Such model-specific provisions are described elsewhere in
this proposed rule.
2. Model Overview--Proposed Radiation Oncology Model
In this proposed rule, we propose the creation and testing of a new
payment model for radiation oncology, the RO Model. The intent of the
proposed RO Model is to promote quality and financial accountability
for episodes of care centered on RT services. The RO Model would test
whether prospective episode-based payments to physician group practices
(PGPs), HOPDs, and freestanding radiation therapy centers for RT
episodes of care would reduce Medicare expenditures while preserving or
enhancing the quality of care for Medicare beneficiaries. We anticipate
the proposed RO Model would benefit Medicare beneficiaries by
encouraging more efficient care delivery and incentivizing higher value
care across episodes of care. We propose that the RO Model would have a
performance period of five calendar years, beginning in 2020, and
ending December 31, 2024. We propose to test the RO Model to capture
all episodes that finish within the performance period, which means
that the data collection, episode payments, and reconciliation would
continue into calendar year 2025.
a. Summary of Major Provisions
(1) Proposed RO Model Overview
RT is a common treatment for patients undergoing cancer treatment
and is typically furnished by a physician at either a HOPD or a
freestanding radiation therapy center. We are proposing the RO Model to
include prospective payments for certain RT services furnished during a
90-day episode for included cancer types for certain Medicare
beneficiaries. The included cancer types would be determined by the
following criteria: all are commonly treated with radiation; make up
the majority of all incidence of cancer types; and have demonstrated
pricing stability. (See section III.C.5.a of this proposed rule for
more information.) This model would not account for total cost of all
care provided to the beneficiary during the 90 days of an episode.
Rather, the payment would cover only select RT services furnished
during an episode. Episode payments would be split into two
components--the professional component (PC) and the technical component
(TC). This division reflects the fact that RT professional and
technical services are sometimes furnished by separate providers and
suppliers and paid for through different payment systems (namely, the
Medicare Physician Fee Schedule and Outpatient Prospective Payment
System).
For example, under the RO Model, a participating HOPD would have at
least one PGP to furnish RT services at the HOPD. A PGP would furnish
the PC as a professional participant and a HOPD would furnish the TC as
a technical participant. Both would be participants in the RO Model,
furnishing separate components of the same episode. A participant may
also elect to furnish both the PC and TC as a Dual participant through
one entity, such as a freestanding radiation therapy center. The
proposed RO Model would test the
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cost-saving potential of prospective episode payments for certain RT
services furnished during a 90-day episode and whether shorter courses
of RT (that is, fewer doses, also known as fractions) would encourage
more efficient care delivery and incentivize higher value care.
(2) Model Scope
We propose criteria for the types of cancer included under the RO
Model and list 17 cancer types that meet our proposed criteria. These
cancer types are commonly treated with RT and, therefore, RT services
for such cancer types can be accurately priced for purposes of a
prospective episode payment model. RO Model episodes would include most
RT services furnished in HOPDs and freestanding radiation therapy
centers during a 90-day episode.
We propose that participation in the RO Model be mandatory for all
RT providers and suppliers within selected geographic areas. We propose
to use Core Based Statistical Areas (CBSAs) delineated by the Office of
Management and Budget \1\ as the geographic area for the randomized
selection of RO participants. We would link RT providers and RT
suppliers to a CBSA by using the five digit ZIP Code of the location
where RT services are furnished permitting us to identify RO Model
participants while still using CBSA as a geographic unit of selection.
In addition, we propose to exclude certain providers and suppliers from
participation under the model as described in section III.C.3.c. of
this proposed rule.
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\1\ See https://www.census.gov/programs-surveys/metro-micro/about/omb-bulletins.html.
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We propose to include beneficiaries that meet certain criteria
under the RO Model. For example, the proposed criteria would require
that a beneficiary have a diagnosis of at least one of the cancer types
included in the RO Model and that the beneficiary receive RT services
from a participating provider or supplier in one of the selected CBSAs.
Beneficiaries who meet these criteria would be included in the RO
Model's episodes of care.
(3) Overlap With Other CMS Programs and Models
We expect that there could be situations where a Medicare
beneficiary included in an episode under the RO Model is also assigned,
aligned, or attributed to another Innovation Center model or CMS
program. Overlap could also occur among providers and suppliers at the
individual or organization level, such as where a radiation oncologist
or his or her PGP participates in multiple Innovation Center models. We
believe that the RO Model is compatible with existing models and
programs that provide opportunities to improve care and reduce
spending, especially episode payment models like the Oncology Care
Model. However, we would work to resolve any potential overlaps between
the RO Model and other CMS models or programs that could result in
repetitive services, or duplicative payment of services, and
duplicative counting of savings or other reductions in expenditures.
(4) Episodes and Episode Pricing Methodology
We propose to set a separate payment amount for the PC and the TC
of each of the cancer types included in the RO Model. The payment
amounts would be determined based on proposed national base rates,
trend factors, and adjustments for each participant's case-mix,
historical experience, and geographic location. The payment amount
would also be adjusted for withholds for incomplete episodes, quality,
and starting in performance year (PY) 3 beneficiary experience. The
standard beneficiary coinsurance amounts (typically 20 percent of the
Medicare-approved amount for services) and sequestration would remain
in effect. RO participants would have the ability to earn back a
portion of the quality and patient experience withholds based on their
reporting of clinical data, their reporting and performance on quality
measures, and as of PY3 performance on the beneficiary-reported
Consumer Assessment of Healthcare Providers and Systems (CAHPS[supreg])
Cancer Care Radiation Therapy Survey.
(5) Quality Measures and Reporting Requirements
We propose to adopt four quality measures and collect the
CAHPS[supreg] Cancer Care Radiation Therapy Survey for the RO Model.
Three of the four measures that we are proposing are National Quality
Forum (NQF)-endorsed process measures that are clinically appropriate
for RT and are approved for the Merit-based Incentive Payment System
(MIPS).2 3 We selected all proposed measures based on
clinical appropriateness for RT services spanning a 90-day episode
period. These measures would be applicable to the full range of
proposed included cancer types and provide us the ability to accurately
measure changes or improvements in the quality of RT services. Further,
we believe that these measures would allow the RO Model to apply a pay-
for-performance methodology that incorporates performance measurement
with a focus on clinical care and beneficiary experience with the aim
of identifying a reduction in expenditures with preserved or enhanced
quality of care for beneficiaries.
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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).
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We propose that RO participants would be paid for reporting
clinical data in accordance with our proposed reporting requirements as
discussed in section III.C.8.e, and paid for performance on aggregated
quality measure data on three proposed quality measures and pay-for-
reporting on one proposed quality measure (for PY1 and PY2) as
discussed in section III.C.8.f. By PY3, we plan to propose to add a set
of patient experience measures via rulemaking based on the
CAHPS[supreg] Cancer Care Survey for Radiation Therapy for inclusion as
pay-for-performance measures. We would also require Professional
participants and Dual participants to report all quality data for all
applicable patients receiving RT services from RO participants based on
numerator and denominator specifications for each measure (for example,
not just Medicare beneficiaries or beneficiaries receiving care for RT
episodes under the RO Model).
(6) Data Sharing Process
We propose to collect quality, clinical, and administrative data
for the RO Model. We intend to share certain data with participants to
the extent permitted by the Health Insurance Portability and
Accountability Act of 1996 (HIPAA) Privacy Rule and other applicable
law. We propose to establish data privacy compliance standards for RO
participants. We propose to establish requirements around the public
release of patient de-identified information by RO participants. We
propose to offer RO participants the opportunity to request a claims
data file that contains patient-identifiable data on the RO
participant's patient population for clinical treatment, care
management and coordination, and quality improvement activities. Also,
we propose to permit the data to be reused by RO participants for
provider incentive design and implementation, and we believe it may be
of use in RO participants' review of our calculation of their
participant-specific episode payment amounts and reconciliation
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payment amounts or recoupment amounts, as applicable. Thus, we expect
that the data offered under the RO Model would be used by RO
participants and CMS to better understand model effects, establish
benchmarks, and monitor participant compliance. Again, as previously
described, the data uses and sharing would be allowed only to the
extent permitted by the HIPAA Privacy Rule and other applicable law.
When using or disclosing such data, the RO participant would be
required to make ``reasonable efforts to limit'' the information to the
``minimum necessary'' as defined by 45 CFR 164.502(b) and 164.514(d) to
accomplish the intended purpose of the use, disclosure, or request. The
RO participant would be required to further limit its disclosure of
such information to what is permitted by applicable law, including the
regulations promulgated under the HIPAA and the Health Information
Technology for Economic and Clinical Health (HITECH) laws at 45 CFR
part 160 and subparts A and E of part 164. Further discussion of data
sharing can be found in section III.C.13 of this proposed rule.
(7) Beneficiary Protections
We propose to require professional participants and dual
participants to notify RO beneficiaries of the beneficiary's inclusion
in this model through a standardized written notice to each RO
beneficiary during the treatment planning session. We intend to provide
a notification template, which RO participants may personalize with
contact information and logos, but must otherwise not be changed.
Further explanation of the beneficiary notification can be found in
section III.C.15. of this proposed rule.
(8) Program Policy Waivers
We believe it would be necessary to waive certain requirements of
title XVIII of the Act solely for purposes of carrying out the testing
of the RO Model under section 1115A(b) of the Act. We propose to issue
these waivers using our waiver authority under section 1115A(d)(1) of
the Act. Each of the waivers is discussed in detail in section
III.C.10. of this proposed rule, and proposed to be codified in our
regulations at Sec. 512.280.
3. Model Overview--Proposed ESRD Treatment Choices (ETC) Model
The proposed ETC Model would be a mandatory payment model, focused
on encouraging greater use of home dialysis and kidney transplants for
ESRD Beneficiaries among ESRD facilities and Managing Clinicians
located in selected geographic areas. The proposed ETC Model would
include two payment adjustments. The first adjustment, the Home
Dialysis Payment Adjustment (HDPA), would be a positive adjustment on
certain home dialysis and home dialysis-related claims during the
initial three years of the model. The second adjustment, the
Performance Payment Adjustment (PPA), would be a positive or negative
adjustment on dialysis and dialysis-related Medicare payments, for both
home dialysis and in-center dialysis, based on ESRD facilities' and
Managing Clinicians' rates of kidney and kidney-pancreas transplants
and home dialysis among attributed beneficiaries during the applicable
MY. We propose to implement the payment adjustments under the ETC Model
beginning January 1, 2020, and ending June 30, 2026.
a. Summary of Major Provisions
(1) Proposed ETC Model Overview
Beneficiaries with ESRD generally require some form of renal
replacement therapy, the most common being hemodialysis (HD), followed
by peritoneal dialysis (PD), or a kidney transplant. Most beneficiaries
with ESRD receive HD treatments in an ESRD facility; however, other
renal replacement modalities--including dialyzing at home or receiving
a kidney transplant--may be better options than in-center dialysis for
more beneficiaries than currently use them. We propose the ETC Model to
test the effectiveness of adjusting certain Medicare payments to ESRD
facilities and Managing Clinicians--clinicians who bill the Monthly
Capitation Payment (MCP) for managing ESRD Beneficiaries--to encourage
greater utilization of home dialysis and kidney transplantation,
support beneficiary modality choice, reduce Medicare expenditures, and
preserve or enhance the quality of care. We believe ESRD facilities and
Managing Clinicians are the key providers and suppliers managing the
dialysis care and treatment modality options for ESRD Beneficiaries and
have a vital role to play in beneficiary modality selection and
assisting beneficiaries through the transplant process. We propose to
adjust payments for home dialysis claims with claim through dates from
January 1, 2020, through December 31, 2022 through the HDPA, and to
assess the rates of home dialysis and kidney transplant among
beneficiaries attributed to ETC Participants during the period
beginning January 1, 2020, and ending June 30, 2025, with the PPA based
on those rates applying to claims for dialysis and dialysis-related
services with claim-through dates beginning January 1, 2021, and ending
June 30, 2026.
(2) Model Scope
The proposed ETC Model would be a mandatory payment model focused
on encouraging greater use of home dialysis and kidney transplants for
ESRD Beneficiaries. The rationale for a mandatory model for ESRD
facilities and Managing Clinicians within selected geographic areas is
that we seek to test the effect of payment incentives on availability
and choice of treatment modality among a diverse group of providers and
suppliers. We would randomly select Hospital Referral Regions (HRRs)
for inclusion in the Model, and also include all HRRs with at least 20
percent of zip codes located in Maryland in addition to those selected
through randomization. Managing Clinicians and ESRD facilities located
in these selected geographic areas would be required to participate in
the ETC Model and would be assessed on their rates of kidney and
kidney-pancreas transplant and home dialysis among their attributed
beneficiaries during each MY; CMS would then adjust certain of their
Medicare payments upwards or downwards during the corresponding
performance payment adjustment period. Managing Clinicians and ESRD
facilities located in the selected geographic areas would also receive
a positive adjustment on their home dialysis claims for the first three
years of the ETC Model.
(3) Home Dialysis Payment Adjustment (HDPA)
We propose that CMS would make upward adjustments to the certain
payments to participating ESRD facilities under the ESRD Prospective
Payment System (PPS) on home dialysis claims, and would make upward
adjustments to the MCP paid to participating Managing Clinicians on
home dialysis claims. The HDPA would apply to claims with claims
through dates beginning on January 1, 2020, and ending on December 31,
2022.
(4) Home Dialysis and Transplant Performance Assessment and Performance
Payment Adjustment (PPA)
We propose to assess ETC Participants' rates of home dialysis and
kidney and kidney-pancreas transplants during a MY, which would include
12 months of performance data. Each MY would overlap with the previous
MY, if any, and the subsequent MY, if any, for a period of 6 months.
Each MY would have a corresponding PPA Period--a 6-
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month period, which would begin 6 months after the conclusion of the
MY. CMS would adjust certain payments for ETC Participants during the
PPA Period based on the ETC Participant's home dialysis rate and
transplant rate during the corresponding MY. We propose measuring rates
of home dialysis and transplants for ESRD facilities and Managing
Clinicians using Medicare claims data, Medicare administrative data
including enrollment data, and the Scientific Registry of Transplant
Recipients (SRTR) data. We propose to measure home dialysis rates for
ESRD facilities and Managing Clinicians in the ETC Model by calculating
the percent of dialysis treatment beneficiary years during the MY in
which attributed beneficiaries received dialysis at home. We propose to
measure transplant rates for ESRD facilities and Managing Clinicians
based on the number of attributed beneficiaries who received a kidney
or kidney-pancreas transplant during the MY out of all attributed
dialysis treatment beneficiary years (and attributed beneficiary years
for pre-emptive transplant beneficiaries for Managing Clinicians)
during the MY. For both Managing Clinicians and ESRD facilities, we
propose to calculate the rates of home dialysis and kidney and kidney-
pancreas transplants among attributed ESRD Beneficiaries. For Managing
Clinicians, we propose to also include attributed beneficiaries who
receive preemptive transplants--transplants that occur before the
beneficiary begins dialysis--in the calculation of the transplant rate.
We propose that the ETC Model would make upward and downward
adjustments to certain payments to participating ESRD facilities under
the ESRD PPS and to the MCP paid to participating Managing Clinicians
based upon the ETC Participant's rates of home dialysis and
transplants. The magnitude of the positive and negative PPAs for ETC
Participants would increase over the course of the Model. These PPAs
would begin July 1, 2021, and end June 30, 2026.
(5) Overlaps With Other Innovation Center Models and CMS Programs
The ETC Model would overlap with several other CMS programs and
models, including initiatives specifically focusing on dialysis care.
We believe the ETC Model would be compatible with other dialysis-
focused CMS programs and models. However, we would work to resolve any
potential overlaps between the ETC Model and other Innovation Center
models or CMS programs that could result in repetitive services or
duplicative payment of services. The payment adjustments made under the
ETC Model would be counted as expenditures under the Medicare Shared
Savings Program and other shared savings initiatives. Additionally,
ESRD facilities would remain subject to the quality requirements in
ESRD Quality Incentive Program (QIP), and Managing Clinicians who are
MIPS eligible clinicians would remain subject to MIPS.
(6) Medicare Payment Waivers
In order to make the proposed payment adjustments under the ETC
Model, namely the HDPA and PPA, we believe we would need to waive
certain Medicare program rules. In particular, we would waive certain
requirements of the Act for the ESRD PPS, ESRD QIP, and Medicare
Physician Fee Schedule only to the extent necessary to make these
payment adjustments under this proposed payment model for ETC
Participants selected in accordance with CMS's proposed selection
methodology. In addition, we propose that the payment adjustments made
under the ETC Model, if finalized, would not change beneficiary cost-
sharing from the regular Medicare program cost-sharing for the related
Part B services that were paid for beneficiaries who receive services
from ETC Participants.
We also believe it would be necessary to waive certain Medicare
payment requirements of 1861(ggg) of the Act and implementing
regulations at 42 CFR 410.48, regarding the use of the Kidney Disease
Education (KDE) benefit, solely for the purposes of testing the ETC
Model. The purpose of such waivers would be to give ETC Participants
additional access to the tools necessary to ensure beneficiaries select
their preferred kidney replacement modality. As education is a key
component of assisting beneficiaries with making such selections, we
propose to waive select requirements regarding the provision of the KDE
benefit, including waiving the requirement that certain health care
provider types must furnish the KDE service to allow additional staff
to furnish the service, waiving the requirement that the KDE service be
furnished to beneficiaries with Stage IV CKD to allow ETC Participants
to furnish these services to beneficiaries in later stages of kidney
disease, and waiving certain restrictions on the KDE curriculum to
allow the content benefit to be tailored to each beneficiary's needs.
We propose to issue these waivers using our waiver authority under
section 1115A(d)(1) of the Act.
(7) Monitoring and Quality Measures
Consistent with the monitoring requirements proposed in the general
provisions, we propose to closely monitor the implementation and
outcomes of the ETC Model throughout its duration. The purpose of this
monitoring would be to ensure that the ETC Model is implemented safely
and appropriately, the quality or experience of care for beneficiaries
is not harmed, and adequate patient and program integrity safeguards
are in place.
As part of the monitoring strategy, we propose using two quality
measures for the ETC Model: The Standardized Mortality Ratio and the
Standardized Hospitalization Ratio. These measures are NQF-endorsed,
and are currently calculated at the ESRD facility level for Dialysis
Facility Reports and the ESRD QIP, respectively, and so would require
no additional reporting by ETC Participants.
(8) Beneficiary Protections
As proposed, the ETC Model would not allow beneficiaries to opt out
of the payment methodology; however, the model would not restrict a
beneficiary's freedom to choose an ESRD facility or Managing Clinician,
or any other provider or supplier, and ETC Participants would be
subject to the general provisions protecting beneficiary freedom of
choice and access to medically necessary services. We also would
require that ETC Participants notify beneficiaries of the ETC
Participant's participation in the ETC Model by prominently displaying
informational materials in ESRD facilities and Managing Clinician
offices or facilities where beneficiaries receive care. Additionally,
ETC Participants would be subject to the general provisions regarding
descriptive model materials and activities.
II. General Provisions
A. Introduction
Section 1115A of the Act authorizes the Innovation Center to test
innovative payment and service delivery models expected to reduce
Medicare, Medicaid, and CHIP expenditures while preserving or enhancing
the quality of care furnished to such programs' beneficiaries. The
Innovation Center has designed and tested numerous models governed by
participation agreements, cooperative agreements, model-specific
addenda to existing contracts with CMS, and regulations. While each of
these models have a specific payment methodology, quality metrics, and
certain other applicable policies, they also have general provisions
that are
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very similar, including provisions on monitoring and evaluation;
compliance with model requirements and applicable laws; and beneficiary
protections. We believe it would promote efficiency to propose and seek
comment on certain general provisions in each of these areas that would
apply to both the RO Model and the ETC Model in this section II of the
proposed rule. This would avoid the need to restate the same provisions
separately for the two models in this proposed rule. We propose to
codify these general provisions in a new subpart of the Code of Federal
Regulations (42 CFR part 512, subpart A).
B. Effective Date and Scope
In Sec. 512.100(a), we propose that the proposed general
provisions in this section II of the proposed rule would apply only to
the RO Model and the ETC Model, each of which we are proposing to refer
to as an ``Innovation Center model'' for purposes of this section II.
of the proposed rule. These proposed general provisions would not,
except as specifically noted in proposed new part 512, affect the
applicability of other provisions affecting providers and suppliers
under Medicare FFS, including the applicability of provisions regarding
payment, coverage, and program integrity (such as those in parts 413,
414, 419, 420, and 489 of chapter IV of 42 CFR and those in parts 1001-
1003 of chapter V of 42 CFR).
In Sec. 512.100(b), we propose that the proposed general
provisions in this section II of the proposed rule would be applicable
to model participants in both the RO Model (with one exception,
described in this document) and the ETC Model. We are proposing to
define the term ``model participant'' to mean an individual or entity
that is identified as a participant in an Innovation Center model under
the terms of proposed part 512; the term ``model participant'' as
defined in this section II of the proposed rule includes, unless
otherwise specified, the terms ``RO Model participant'' or ``ETC
Participant'' as those terms are defined in proposed subparts B and C
of proposed part 512. We propose to define ``downstream participant''
to mean an individual or entity that has entered into a written
arrangement with a model participant pursuant to which the downstream
participant engages in one or more Innovation Center model activities.
A downstream participant may include, but would not be limited to, an
individual practitioner, as defined for purposes of the RO Model. We
propose to define ``Innovation Center model activities'' to mean any
activities impacting the care of model beneficiaries related to the
test of the Innovation Center model performed under the terms of
proposed part 512. While not used in the general provisions described
in this section II of the proposed rule, as this term is used for
purposes of both the RO Model and the ETC Model, we propose to define
``U.S. Territories'' to mean American Samoa, the Federated States of
Micronesia, Guam, the Marshall Islands, the Commonwealth of the
Northern Mariana Islands, Palau, Puerto Rico, U.S. Minor Outlying
Islands, and the U.S. Virgin Islands.
We invite public comment on the proposed general provisions
discussed in this section II of the proposed rule.
C. Definitions
We propose at Sec. 512.110 to define certain terms relevant to the
general provisions proposed in this section II. of the proposed rule.
We describe these proposed definitions in context throughout this
section II. of the proposed rule.
D. Beneficiary Protections
As we design and test new models at the Innovation Center, we
believe it is necessary to have certain protections in place to ensure
that beneficiaries retain their existing rights and are not harmed by
the participation of their health care providers in Innovation Center
models. Therefore, we believe it is necessary to propose certain
provisions regarding beneficiary choice, the availability of services,
and descriptive model materials and activities.
For purposes of the general provisions, we are proposing to define
the term ``beneficiary'' to mean an individual who is enrolled in
Medicare FFS. This definition aligns with the proposed scope of the RO
Model and the ETC Model, in which we propose to include only Medicare
FFS beneficiaries. We also are proposing to define the term ``model
beneficiary'' to mean a beneficiary attributed to a model participant
or otherwise included in an Innovation Center model under the terms of
this proposed part; the term ``model beneficiary'' as defined in this
section would include, unless otherwise specified, the term ``RO
Beneficiary'' and beneficiaries attributed to ETC participants under
Sec. 512.360. We believe it is necessary to propose this definition of
model beneficiary so as to differentiate between Medicare FFS
beneficiaries generally and those specifically included in an
Innovation Center model.
1. Beneficiary Freedom of Choice
A beneficiary's ability to choose his or her provider or supplier
is an important principle of Medicare FFS and is codified in section
1802(a) of the Act. To help ensure that this protection is not
undermined by the testing of the two proposed Innovation Center models,
we are proposing to codify at Sec. 512.120(a)(1) a requirement that
model participants and their downstream participants not restrict a
beneficiary's ability to choose his or her providers or suppliers. The
proposed policy would apply with respect to all Medicare FFS
beneficiaries, not just model beneficiaries, because we believe it is
important to ensure that the proposed Innovation Center model tests do
not interfere with the general guarantees and protections for all
Medicare FFS beneficiaries.
Also, we propose to codify at Sec. 512.120(a)(2) that the model
participant and its downstream participants must not commit any act or
omission, nor adopt any policy that inhibits beneficiaries from
exercising their freedom to choose to receive care from any Medicare-
participating provider or supplier, or from any health care provider
who has opted out of Medicare. We believe this requirement is necessary
to ensure Innovation Center models do not prevent beneficiaries from
the general rights and guarantees provided under Medicare FFS. However,
because we believe that it is important for model participants to have
the opportunity to explain the benefits of care provided by them to
model beneficiaries, we also are proposing that the model participant
and its downstream participants would be permitted to communicate to
model beneficiaries the benefits of receiving care with the model
participant, if otherwise consistent with the requirements of proposed
part 512 and applicable law.
We propose at Sec. 512.110 to define the terms ``provider'' and
``supplier,'' as used in proposed part 512, in a manner consistent with
how these terms are used in Medicare FFS generally. Specifically, we
would define the term ``provider'' to mean a ``provider of services''
as defined under section 1861(u) of the Act and codified in the
definition of ``provider'' at 42 CFR 400.202. We similarly propose to
define the term ``supplier'' to mean a ``supplier'' as defined in
section 1861(d) of the Act and codified at 42 CFR 400.202. We believe
it is necessary to define ``provider'' and ``supplier'' in this way as
a means of noting to the general public that we are using the generally
[[Page 34484]]
applicable Medicare definitions of these terms for purposes of proposed
part 512.
2. Availability of Services
Models tested under the authority of section 1115A of the Act are
designed to test potential improvements to the delivery of and payment
for health care to reduce Medicare, Medicaid, and CHIP expenditures
while preserving or enhancing the quality of care for the beneficiaries
of these programs. As such, an important aspect of testing Innovation
Center models is that beneficiaries continue to access and receive
needed care. Therefore, we are proposing in Sec. 512.120(b)(1) that
model participants and downstream participants would be required to
continue to make medically necessary covered services available to
beneficiaries to the extent required by law. Consistent with the
limitation on Medicare coverage under section 1862(a)(1)(A) of the Act,
we propose to define ``medically necessary'' to mean reasonable and
necessary for the diagnosis or treatment of an illness or injury, or to
improve the functioning of a malformed body member. Also, we propose to
define ``covered services'' to mean the scope of health care benefits
described in sections 1812 and 1832 of the Act for which payment is
available under Part A or Part B of Title XVIII of the Act, which
aligns with Medicare coverage standards and the definition of ``covered
services'' used in other models tested by the Innovation Center. Also,
we propose that model beneficiaries and their assignees, as defined in
42 CFR 405.902, would retain their rights to appeal Medicare claims in
accordance with 42 CFR part 405, subpart I. We believe that model
beneficiaries and their assignees should not lose the right to appeal
claims for Medicare items and services furnished to them solely because
the beneficiary's provider or supplier is participating in an
Innovation Center model.
Also, we are proposing in Sec. 512.120(b)(2) to prohibit model
participants and downstream participants from taking any action to
avoid treating beneficiaries based on their income levels or based on
factors that would render a beneficiary an ``at-risk beneficiary'' as
that term is defined for purposes of the Medicare Shared Savings
Program at 42 CFR 425.20, a practice commonly referred to as ``lemon
dropping.'' For example, 42 CFR 425.20 defines an ``at-risk
beneficiary'' to include, without limitation, a beneficiary who has one
or more chronic conditions or who is entitled to Medicaid because of
disability. As such, a model participant or downstream participant
would be prohibited from taking action to avoid treating beneficiaries
with chronic conditions such as obesity or diabetes, or who are
entitled to Medicaid because of disability. We believe it is necessary
to specify prohibitions on avoiding treating at-risk beneficiaries,
including those with obesity or diabetes, or who are eligible for
Medicaid because of disability, to prevent potential lemon dropping of
beneficiaries. Further, we believe this proposal prohibiting lemon
dropping is a necessary precaution to counter any incentives created by
the proposed Innovation Center models for model participants to avoid
treating potentially high-cost beneficiaries who are most in need of
quality care. This prohibition has been incorporated into the governing
documentation of many current models being tested by the Innovation
Center for this same reason. Also, we are proposing in Sec.
512.120(b)(3) an additional provision that would prohibit model
participants from taking any action to selectively target or engage
beneficiaries who are relatively healthy or otherwise expected to
improve the model participant's or downstream participant's financial
or quality performance, a practice commonly referred to as ``cherry-
picking.'' For example, a model participant or downstream participant
would be prohibited from targeting only healthy, well educated, or
wealthy beneficiaries for voluntary alignment, the receipt of permitted
beneficiary incentives or other interventions, or the reporting of
quality measures. Further, we are seeking comments on whether
prohibiting cherry-picking will prevent model participants from
artificially inflating their financial or quality performance results.
3. Descriptive Model Materials and Activities
In order to protect beneficiaries from potentially being misled
about Innovation Center models, we are proposing at Sec. 512.120(c)(1)
to prohibit model participants and their downstream participants, from
using or distributing descriptive model materials and activities that
are materially inaccurate or misleading. For purposes of proposed part
512, we propose to define the term ``descriptive model materials and
activities'' to mean general audience materials such as brochures,
advertisements, outreach events, letters to beneficiaries, web pages,
mailings, social media, or other materials or activities distributed or
conducted by or on behalf of the model participant or its downstream
participants when used to educate, notify, or contact beneficiaries
regarding the Innovation Center model. We are further proposing that
the following communications would not be descriptive model materials
and activities: Communications that do not directly or indirectly
reference the Innovation Center model (for example, information about
care coordination generally); information on specific medical
conditions; referrals for health care items and services; and any other
materials that are excepted from the definition of ``marketing'' as
that term is defined at 45 CFR 164.501. The potential for model
participants to receive certain payments under the two proposed
Innovation Center models may be an incentive for model participants and
their downstream participants to engage in marketing behavior that may
confuse or mislead beneficiaries about the Innovation Center model or
their Medicare rights. Therefore, we believe it is necessary to ensure
that those materials and activities that are used to educate, notify,
or contact beneficiaries regarding the Innovation Center model are not
materially inaccurate or misleading because these materials might be
the only information that a model beneficiary receives regarding the
beneficiary's inclusion in the model. Additionally, we understand that
not all communications between the model participant or downstream
participants and the model beneficiaries would address the model
beneficiaries' care under the model. As such, we would note that this
proposed prohibition in no way restricts the ability of a model
participant or its downstream participants to engage in activism or
otherwise alert model beneficiaries to the drawbacks of mandatory
models in which they would otherwise decline to participate, provided
that such statements are not materially inaccurate or misleading.
Because regulating information or communication not related to the
model does not advance CMS's interest in ensuring model beneficiaries
are not misled about their inclusion in an Innovation Center model or
their Medicare rights generally, we have proposed to define the term
``descriptive model materials and activities'' such that these
materials are not subject to the requirements of proposed Sec.
512.120(c)(1).
Also, we propose in Sec. 512.120(c)(4) to reserve the right to
review, or have our designee review, descriptive model materials and
activities to determine whether the content is materially inaccurate or
misleading; this review would not be a preclearance by CMS, but would
take place at a time and in
[[Page 34485]]
a manner specified by CMS once the materials and activities are in use
by the model participant. We believe it would be necessary for CMS to
have this ability to review descriptive model materials and activities
in order to protect model beneficiaries from receiving misleading or
inaccurate materials regarding the Innovation Center model. Further, to
facilitate our ability to conduct this review and to monitor Innovation
Center models generally, in proposed Sec. 512.120(c)(3) we are
proposing to require model participants and downstream participants, to
retain copies of all written and electronic descriptive model materials
and activities and to retain appropriate records for all other
descriptive model materials and activities in a manner consistent with
Sec. 512.135(c) (record retention).
Also, we are proposing in Sec. 512.120(c)(2) to require model
participants and downstream participants to include the following
disclaimer on all descriptive model materials and activities: ``The
statements contained in this document are solely those of the authors
and do not necessarily reflect the views or policies of the Centers for
Medicare & Medicaid Services (CMS). The authors assume responsibility
for the accuracy and completeness of the information contained in this
document.'' We are proposing to require the use of this disclaimer so
that the public, and beneficiaries in particular, are not misled into
believing that model participants or their downstream participants are
speaking on behalf of the agency. We seek comment on whether we should
propose a different disclaimer that alerts beneficiaries that we
prohibit misleading information and give them contact information where
a beneficiary could reach out to us if they suspect the information
they have received regarding an Innovation Center model is inaccurate.
E. Cooperation With Model Evaluation and Monitoring
Section 1115A(b)(4) of the Act requires the Secretary to evaluate
each model tested under the authority of section 1115A and to publicly
report the evaluation results in a timely manner. The evaluation must
include an analysis of the quality of care furnished under the model
and the changes in program spending that occurred due to the model.
Models tested by the Innovation Center are rigorously evaluated. For
example, when evaluating models tested under section 1115A, we require
the production of information that is representative of a wide and
diverse group of model participants and includes data regarding
potential unintended or undesirable effects, such as cost-shifting. The
Secretary must take the evaluation into account if making any
determinations regarding the expansion of a model under section
1115A(c) of the Act.
In addition to model evaluations, the Innovation Center regularly
monitors model participants for compliance with model requirements. For
the reasons described in section II.H of this proposed rule, these
compliance monitoring activities are an important and necessary part of
the model test.
Therefore, we are proposing to codify at Sec. 512.130, that model
participants and their downstream participants must comply with the
requirements of 42 CFR 403.1110(b) (regarding the obligation of
entities participating in the testing of a model under section 1115A of
the Act to report information necessary to monitor and evaluate the
model), and must otherwise cooperate with CMS' model evaluation and
monitoring activities as may be necessary to enable CMS to evaluate the
Innovation Center model in accordance with section 1115A(b)(4) of the
Act. This participation in the evaluation may include, but is not
limited to, responding to surveys and participating in focus groups.
Additional details on the specific research questions that we propose
that the Innovation Center model evaluation will consider for the
Radiation Oncology Model and ESRD Treatment Choices Model can be found
in sections III.C.16. and IV.C.11. of this proposed rule, respectively.
Further, we propose to conduct monitoring activities according to
proposed Sec. 512.150, described later in this proposed rule,
including producing such data as may be required by CMS to evaluate or
monitor the Innovation Center model, which may include protected health
information as defined in 45 CFR 160.103 and other individually
identifiable data.
F. Audits and Record Retention
By virtue of their participation in an Innovation Center model,
model participants and their downstream participants may receive model-
specific payments, access to payment rule waivers, or some other model-
specific flexibility. Therefore, we believe that CMS's ability to
audit, inspect, investigate, and evaluate records and other materials
related to participation in Innovation Center models is necessary and
appropriate. In addition, we are proposing in Sec. 512.110 to require
model participants and their downstream participants to continue to
make medically necessary covered services available to beneficiaries to
the extent required by law. Similarly, in order to expand a phase 1
model tested by the Innovation Center, among other things, the
Secretary must first determine that such expansion would not deny or
limit the coverage or provision of benefits under the applicable title
for applicable individuals. Thus, there is a particular need for CMS to
be able to audit, inspect, investigate, and evaluate records and
materials related to participation in Innovation Center models to allow
us to ensure that model participants are in no way denying or limiting
the coverage or provision of benefits for beneficiaries as part of
their participation in the Innovation Center model. We propose to
define ``model-specific payment'' to mean a payment made by CMS only to
model participants, or a payment adjustment made only to payments made
to model participants, under the terms of the Innovation Center model
that is not applicable to any other providers or suppliers; the term
``model-specific payment'' would include, unless otherwise specified,
the terms ``home dialysis payment adjustment (HDPA),'' ``performance
payment adjustment (PPA),'' ``participant-specific professional episode
payment,'' or ``participant-specific technical episode payment.'' We
believe it is necessary to propose this definition in order to
distinguish payments and payment adjustments applicable to model
participants as part of their participation in an Innovation Center
model, from payments and payment adjustments applicable to model
participants as well as other providers and suppliers, as certain
provisions of proposed part 512 would apply only to the former category
of payments and payment adjustments.
We note that there are audit and record retention requirements
under the Medicare Shared Savings Program (42 CFR 425.314) and in
current models being tested under section 1115A (such as under 42 CFR
510.110 for the Innovation Center's Comprehensive Care for Joint
Replacement Model). Building off those existing requirements, we
propose in Sec. 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
[[Page 34486]]
the Innovation Center, we are proposing in Sec. 512.135(b) and (c)
that the model participant and its downstream participants must:
Maintain and give the Federal Government, including, but
not limited to, CMS, HHS, and the Comptroller General, or their
designees, access to all documents (including books, contracts, and
records) and other evidence sufficient to enable the audit, evaluation,
inspection, or investigation of the Innovation Center model, including,
without limitation, documents and other evidence regarding all of the
following:
++ Compliance by the model participant and its downstream
participants with the terms of the Innovation Center model, including
proposed new subpart A of proposed part 512.
++ The accuracy of model-specific payments made under the
Innovation Center model.
++ The model participant's payment of amounts owed to CMS under the
Innovation Center model.
++ Quality measure information and the quality of services
performed under the terms of the Innovation Center model, including
proposed new subpart A of proposed part 512.
++ Utilization of items and services furnished under the Innovation
Center model.
++ The ability of the model participant to bear the risk of
potential losses and to repay any losses to CMS, as applicable.
++ Patient safety.
++ Any other program integrity issues.
Maintain the documents and other evidence for a period of
6 years from the last payment determination for the model participant
under the Innovation Center model or from the date of completion of any
audit, evaluation, inspection, or investigation, whichever is later,
unless--
++ CMS determines there is a special need to retain a particular
record or group of records for a longer period and notifies the model
participant at least 30 days before the normal disposition date; or
++ There has been a termination, dispute, or allegation of fraud or
similar fault against the model participant in which case the records
must be maintained for an additional six (6) years from the date of any
resulting final resolution of the termination, dispute, or allegation
of fraud or similar fault.
If CMS notifies the model participant of a special need to retain a
record or group of records at least 30 days before the normal
disposition date, we propose that the records must be maintained for
such period of time determined by CMS. We also propose that, if CMS
notifies the model participant of a special need to retain records or
there has been a termination, dispute, or allegation of fraud or
similar fault against the model participant or its downstream
participants, the model participant must notify its downstream
participants of the need to retain records for the additional period
specified by CMS. This provision will ensure that that the government
has access to the records.
To avoid any confusion or disputes regarding the timelines outlined
in this section II.G of the proposed rule, we propose to define the
term ``days'' to mean calendar days.
We invite public comment on these proposed provisions regarding
audits and record retention.
Historically, the Innovation Center has required participants in
section 1115A models to retain records for at least 10 years, which is
consistent with the outer limit of the statute of limitations for the
Federal False Claims Act and is consistent with the Shared Savings
Program's policy outlined at 42 CFR 425.314(b)(2). For this reason, we
also solicit public comments on whether we should require model
participants and downstream participants to maintain records for longer
than 6 years.
G. Rights in Data and Intellectual Property
To enable CMS to evaluate the Innovation Center models as required
by section 1115A(b)(4) of the Act and to monitor the Innovation Center
models pursuant to proposed Sec. 512.150, described later in this
rule, we are proposing to allow CMS to use any data obtained in
accordance with proposed Sec. 512.130 and proposed Sec. 512.135 to
evaluate and monitor the proposed Innovation Center models. We further
propose that, consistent with section 1115A(b)(4)(B) of the Act, that
CMS would be allowed to disseminate quantitative and qualitative
results and successful care management techniques, including factors
associated with performance, to other providers and suppliers and to
the public. We propose that the data to be disseminated would include,
but would not be limited to, patient de-identified results of patient
experience of care and quality of life surveys, as well as patient de-
identified measure results calculated based upon claims, medical
records, and other data sources.
In order to protect the intellectual property rights of model
participants and downstream participants, we propose in Sec.
512.140(b) to require model participants and their downstream
participants to label data they believe is proprietary that they
believe should be protected from disclosure under the Trade Secrets
Act. We would note that this approach is already in use in other models
currently being tested by the Innovation Center, including the Next
Generation Accountable Care Organization Model. Any such assertions
would be subject to review and confirmation prior to CMS's acting upon
such assertion.
We further propose to protect such information from disclosure to
the full extent permitted under applicable laws, including the Freedom
of Information Act. Specifically, in proposed Sec. 512.140(b), we
propose to not release data that has been confirmed by CMS to be
proprietary trade secret information and technology of the model
participant or its downstream participants without the express written
consent of the model participant or its downstream participant, unless
such release is required by law.
H. Monitoring and Compliance
Given that model participants may receive model-specific payments,
access to payment rule waivers, or some other model-specific
flexibility while participating in an Innovation Center model, we
believe that enhanced compliance review and monitoring of model
participants is necessary and appropriate to ensure the integrity of
the Innovation Center model. In addition, as part of the Innovation
Center's assessment of the impact of new Innovation Center models, we
have a special interest in ensuring that model tests do not interfere
with ensuring the integrity of the Medicare program. Our interests
include ensuring the integrity and sustainability of the Innovation
Center model and the underlying Medicare program, from both a financial
and policy perspective, as well as protecting the rights and interests
of Medicare beneficiaries. For these reasons, as a part of the models
currently being tested by the Innovation Center, CMS or its designee
monitors model participants to assess compliance with model terms and
with other applicable program laws and policies. We believe our
monitoring efforts help ensure that model participants are furnishing
medically necessary covered services and are not falsifying data,
increasing program costs, or taking other actions that compromise the
integrity of the model or are not in the best interests of the model,
the Medicare program, or Medicare beneficiaries.
In proposed Sec. 512.150(b), we propose to continue this standard
practice of
[[Page 34487]]
conducting compliance monitoring activities to ensure compliance by the
model participant and each of its downstream participants with the
terms of the Innovation Center model, including the requirements of
proposed subpart A of proposed part 512, including to understand model
participants' use of model-specific payments and to promote the safety
of beneficiaries and the integrity of the Innovation Center model. Such
monitoring activities would include, but not be limited to: (1)
Documentation requests sent to the model participant and its downstream
participants, including surveys and questionnaires; (2) audits of
claims data, quality measures, medical records, and other data from the
model participant and its downstream participants; (3) interviews with
members of the staff and leadership of the model participant and its
downstream participants; (4) interviews with beneficiaries and their
caregivers; (5) site visits to the model participant and its downstream
participants, which would be performed in a manner consistent with
proposed Sec. 512.150(c), described later in this rule; (6) monitoring
quality outcomes and registry data; and (7) tracking patient complaints
and appeals. We believe these specific monitoring activities, which
align with those currently used in other models being tested by the
Innovation Center, are necessary in order to ensure compliance with the
terms and conditions of the Innovation Center model, including proposed
subpart A of proposed part 512, and to protect beneficiaries from
potential harms that may result from the activities of a model
participant or its downstream participants, such as attempts to reduce
access to or the provision of medically necessary covered services.
We propose to codify in Sec. 512.150(b)(2), that when we are
conducting compliance monitoring and oversight activities, CMS or our
designees would be authorized to use any relevant data or information,
including without limitation Medicare claims submitted for items or
services furnished to model beneficiaries. We believe that it is
necessary to have all relevant information available to us during our
compliance monitoring and oversight activities, including any
information already available to us through the Medicare program.
We propose to require in Sec. 512.150(c)(1) that model
participants and their downstream participants cooperate in periodic
site visits conducted by CMS or its designee in a manner consistent
with proposed Sec. 512.130, described previously. Such site visits
would be conducted to facilitate the model evaluation performed
pursuant to section 1115A(b)(4) of the Act and to monitor compliance
with the Innovation Center model terms (including proposed subpart A of
proposed part 512).
In order to operationalize this proposal, we further propose in
Sec. 512.150(c)(2) that CMS or its designee would provide the model
participant or its downstream participant with no less than 15 days
advance notice of a site visit, to the extent practicable. Furthermore,
we propose that, to the extent practicable, CMS would attempt to
accommodate a request that a site visit be conducted on a particular
date, but that the model participant or downstream participant would be
prohibited from requesting a date that was more than 60 days after the
date of the initial site visit notice from CMS. We believe the 60 day
period would reasonably accommodate model participant's and downstream
participants' schedules while not interfering with the operation of the
Innovation Center model. Further, we propose in Sec. 512.150(c)(3) to
require the model participant and their downstream participants to
ensure that personnel with the appropriate responsibilities and
knowledge pertaining to the purpose of the site visit be available
during any and all site visits. We believe this proposal is necessary
to ensure an effective site visit and prevent the need for unnecessary
follow-up site visits.
Also, we are proposing in Sec. 512.150(c)(4) that CMS or its
designee could perform unannounced site visits to the offices of model
participants and their downstream participants at any time to
investigate concerns related to the health or safety of beneficiaries
or other patients or other program integrity issues, notwithstanding
these proposed provisions. Further, we propose in Sec. 512.150(c)(5)
that nothing in proposed part 512 would limit CMS from performing other
site visits as allowed or required by applicable law. We believe that,
regardless of the model being tested, CMS must always have the ability
to timely investigate concerns related to the health or safety of
beneficiaries or other patients, or program integrity issues, and to
perform functions required or authorized by law. In particular, we
believe that it is necessary for us to monitor, and for model
participants and their downstream participants to be compliant with our
monitoring efforts, to ensure that they are not denying or limiting the
coverage or provision of medically necessary covered services to
beneficiaries in an attempt to change model results or their model-
specific payments, including discrimination in the provision of
services to at-risk beneficiaries (for example, due to eligibility for
Medicaid based on disability).
Model participants that are enrolled in Medicare will remain
subject to all existing requirements and conditions for Medicare
participation as set out in Federal statutes and regulations and
provider and supplier agreements, unless waived under the authority of
section 1115A(d)(1) of the Act solely for purposes of testing the
Innovation Center model. Therefore, in Sec. 512.150(a), we propose to
require that model participants and each of their downstream
participants must comply with all applicable laws and regulations. We
note that a law or regulation is not ``applicable'' to the extent that
its requirements have been waived pursuant to section 1115A(d)(1) of
the Act solely for purposes of testing the Innovation Center model in
which the model participant is participating.
To protect the financial integrity of each Innovation Center model,
we propose in Sec. 512.150(d) that if CMS discovers that it has made
or received an incorrect model-specific payment under the terms of an
Innovation Center model, CMS may make payment to, or demand payment
from, the model participant. Also, we are considering the imposition of
some of the deadlines set forth in the Medicare reopening rules at 42
CFR 405.980, et seq.; specifically we seek comment on whether CMS
should be able to reopen an initial determination of a model-specific
payment for any reason within 1 year of the model-specific payment, and
within 4 years for good cause (as defined at 42 CFR 405.986). We
believe this may be necessary to ensure we have a means and a timeline
to make redeterminations on incorrect model-specific payments that we
have made or received in conjunction with the proposed Innovation
Center models.
We propose to codify at Sec. 512.150(e) that nothing contained in
the terms of the Innovation Center model or proposed part 512 would
limit or restrict the authority of the HHS Office of Inspector General
(OIG) or any other Federal Government authority, including its
authority to audit, evaluate, investigate, or inspect the model
participant or its downstream participants. This provision simply
reflects the limits of CMS authority.
We invite public comment on these proposed provisions regarding
monitoring of the proposed models and compliance by model participants.
[[Page 34488]]
I. Remedial Action
As stated earlier in this proposed rule, as part of the Innovation
Center's monitoring and assessment of the impact of models tested under
the authority of section 1115A, we have a special interest in ensuring
that these model tests do not interfere with the program integrity
interests of the Medicare program. For this reason, we monitor for
compliance with model terms as well as other Medicare program rules.
When we become aware of noncompliance with these requirements, it is
necessary for CMS to have the ability to impose certain administrative
remedial actions on a noncompliant model participant.
The terms of many models currently being tested by the Innovation
Center permit CMS to impose one or more administrative remedial actions
to address noncompliance by a model participant. We propose that CMS
may impose any of the remedial actions set forth in proposed Sec.
512.160(b) if we determine that the model participant or a downstream
participant--
Has failed to comply with any of the terms of the
Innovation Center model, including proposed subpart A of proposed part
512, if finalized;
Has failed to comply with any applicable Medicare program
requirement, rule, or regulation;
Has taken any action that threatens the health or safety
of a beneficiary or other patient;
Has submitted false data or made false representations,
warranties, or certifications in connection with any aspect of the
Innovation Center model;
Has undergone a change in control (as defined in section
II.L. of this proposed rule) that presents a program integrity risk;
Is subject to any sanctions of an accrediting organization
or a Federal, state, or local government agency;
Is subject to investigation or action by HHS (including
the HHS-OIG and CMS) or the Department of Justice due to an allegation
of fraud or significant misconduct, including being subject to the
filing of a complaint or filing of a criminal charge, being subject to
an indictment, being named as a defendant in a False Claims Act qui tam
matter in which the Federal Government has intervened, or similar
action; or
Has failed to demonstrate improved performance following
any remedial action imposed by CMS.
In Sec. 512.160(b), we propose to codify that CMS may take one or
more of the following remedial actions if CMS determined that one or
more of the grounds for remedial action described in proposed Sec.
512.160(a) had taken place--
Notify the model participant and, if appropriate, require
the model participant to notify its downstream participants of the
violation;
Require the model participant to provide additional
information to CMS or its designees;
Subject the model participant to additional monitoring,
auditing, or both;
Prohibit the model participant from distributing model-
specific payments;
Require the model participant to remove, immediately or by
a deadline specified by CMS, its agreement with a downstream
participant with respect to the Innovation Center model;
In the ETC Model only, terminate the ETC Participant from
the ETC Model;
Require the model participant to submit a corrective
action plan in a form and manner and by a deadline specified by CMS;
Discontinue the provision of data sharing and reports to
the model participant;
Recoup model-specific payments;
Reduce or eliminate a model specific payment otherwise
owed to the model participant, as applicable; or
Such other action as may be permitted under the terms of
proposed part 512.
We would note that because the ETC Model is a mandatory model, we
would not expect to use the proposed provision that would allow CMS to
terminate an ETC Participant's participation in the ETC Model, except
in circumstances in which the ETC Participant has engaged, or is
engaged in, egregious actions.
We invite public comment on these proposed provisions regarding the
proposed grounds for remedial actions, remedial actions generally, and
whether additional types of remedial action would be appropriate.
J. Innovation Center Model Termination by CMS
We are proposing certain provisions that would allow CMS to
terminate an Innovation Center model under certain circumstances.
Section 1115A(b)(3)(B) of the Act requires the Innovation Center to
terminate or modify the design and implementation of a model, after
testing has begun and before completion of the testing, unless the
Secretary determines, and the Chief Actuary certifies with respect to
program spending, that the model is expected to: improve the quality of
care without increasing program spending; reduce program spending
without reducing the quality of care; or improve the quality of care
and reduce spending.
We propose at Sec. 512.165(a) that CMS could terminate an
Innovation Center model for reasons including, but not limited to, the
following circumstances:
CMS determines that it no longer has the funds to support
the Innovation Center model; or
CMS terminates the Innovation Center model in accordance
with section 1115A(b)(3)(B) of the Act.
As provided by section 1115A(d)(2)(E) of the Act and proposed Sec.
512.170, termination of the Innovation Center model in accordance with
section 1115A(b)(3)(B) of the Act would not be subject to
administrative or judicial review.
To ensure model participants had appropriate notice in the case of
the termination of the Innovation Center model by CMS, we also propose
to codify at Sec. 512.165(b) that we would provide model participants
with written notice of the model termination, which would specify the
grounds for termination as well as the effective date of the
termination.
K. Limitations on Review
In proposed Sec. 512.170, we propose to codify the preclusion of
administrative and judicial review under section 1115A(d)(2) of the
Act. Section 1115A(d)(2) of the Act states that there is no
administrative or judicial review under section 1869 or 1878 of the Act
or otherwise for any of the following:
The selection of models for testing or expansion under
section 1115A of the Act.
The selection of organizations, sites, or participants to
test models selected.
The elements, parameters, scope, and duration of such
models for testing or dissemination.
Determinations regarding budget neutrality under section
1115A(b)(3) of the Act.
The termination or modification of the design and
implementation of a model under section 1115A(b)(3)(B) of the Act.
Determinations about expansion of the duration and scope
of a model under section 1115A(c) of the Act, including the
determination that a model is not expected to meet criteria described
in paragraph (1) or (2) of such section.
We propose to interpret the preclusion from administrative and
judicial review regarding the Innovation Center's selection of
organizations, sites, or participants to test models selected to
preclude from administrative and judicial review our selection of a
model participant, as well as our decision to terminate a model
participant, as these determinations are part of our selection
[[Page 34489]]
of participants for Innovation Center model tests.
In addition, we propose to interpret the preclusion from
administrative and judicial review regarding the elements, parameters,
scope, and duration of models for testing or dissemination to preclude
from administrative and judicial review the following CMS
determinations made in connection with an Innovation Center model:
The selection of quality performance standards for the
Innovation Center model by CMS.
The assessment by CMS of the quality of care furnished by
the model participant.
The attribution of model beneficiaries to the model
participant by CMS, if applicable.
We invite public comment on the proposed codification of these
statutory preclusions of administrative and judicial review for models,
as well as our proposed interpretations regarding their scope.
L. Miscellaneous Provisions on Bankruptcy and Other Notifications
Models currently being tested by the Innovation Center usually have
a defined period of performance, but final payment under the model may
occur long after the end of this performance period. In some cases, a
model participant may owe money to CMS. We recognize that the legal
entity that is the model participant may experience significant
organizational or financial changes during and even after the period of
performance for an Innovation Center model. To protect the integrity of
the proposed Innovation Center models and Medicare funds, we are
proposing a number of provisions to ensure that CMS is made aware of
events that could affect a model participant's ability to perform its
obligations under the Innovation Center model, including the payment of
any monies owed to CMS.
First, in proposed Sec. 512.180(a), we propose that a model
participant must promptly notify CMS and the local U.S. Attorney Office
if it files a bankruptcy petition, whether voluntary or involuntary.
Because final payment may not take place until after the model
participant ceases active participation in the Innovation Center model
or any other model in which the model participant is participating or
has participated (for example, because the period of performance for
the model ends, or the model participant is no longer eligible to
participate in the model), we further propose that this requirement
would apply until final payment has been made by either CMS or such
model participant under the terms of each model in which the model
participant is participating or has participated and all administrative
or judicial review proceedings relating to any payments under such
models have been fully and finally resolved.
Specifically, we propose that notice of the bankruptcy must be sent
by certified mail within 5 days after the bankruptcy petition has been
filed and that the notice must contain a copy of the filed bankruptcy
petition (including its docket number) and a list of all models tested
under section 1115A of the Act in which the model participant is
participating or has participated. To minimize the burden on model
participants, while ensuring that CMS obtains the information necessary
from model participants undergoing bankruptcy, we propose that the list
need not identify a model in which the model participant participated
if final payment has been made under the terms of the model and all
administrative or judicial review proceedings regarding model-specific
payments between the model participant and CMS have been fully and
finally resolved with respect to that model. The notice to CMS must be
addressed to the CMS Office of Financial Management, Mailstop C3-01-24,
7500 Security Boulevard, Baltimore, Maryland 21244 or to such other
address as may be specified for purposes of receiving such notices on
the CMS website.
By requiring the submission of the filed bankruptcy petition, CMS
would obtain information necessary to protect its interests, including
the date on which the bankruptcy petition was filed and the identity of
the court in which the bankruptcy petition was filed. We recognize that
such notices may already be required by existing law, but CMS often
does not receive them in a timely fashion, and they may not
specifically identify the models in which the individual or entity is
participating or has participated. The failure to receive such notices
on a timely basis can prevent CMS from asserting a claim in the
bankruptcy case. We are particularly concerned that a model participant
may not furnish notice of bankruptcy after it has completed its
performance in a model, but before final payment has been made or
administrative or judicial proceedings have been resolved. We believe
our proposal is necessary to protect the financial integrity of the
proposed Innovation Center models and the Medicare Trust Funds. Because
bankruptcies filed by individuals and entities that owe CMS money are
generally handled by CMS regional offices, we are considering (and
solicit comment on) whether we should require model participants to
furnish notice of bankruptcy to the local CMS regional office instead
of, or in addition to, the Baltimore headquarters.
Second, in proposed Sec. 512.180(b), we propose that the model
participant, including model participants that are individuals, would
have to provide written notice to CMS at least 60 days before any
change in the model participant's legal name became effective. The
notice of legal name change would have to be in a form and manner
specified by CMS and include a copy of the legal document effecting the
name change, which would have to be authenticated by the appropriate
state official. The purpose of this proposed notice requirement is to
ensure the accuracy of our records regarding the identity of model
participants and the entities to whom model-specific payments should be
made or against whom payments should be demanded or recouped. We
solicit comment on the typical procedure for effectuating a legal
entity's name change and whether 60 days' advance notice of such a
change is feasible. Alternatively, we are considering requiring notice
to be furnished promptly (for example, within 30 days) after a change
in legal name has become effective. We invite public comment on this
alternative approach.
Third, in proposed Sec. 512.180(c), we propose that the model
participant would have to provide written notice to CMS at least 90
days before the effective date of any change in control. We propose
that the written notification must be furnished in a form and manner
specified by CMS. For purposes of this notice obligation, we propose
that a ``change in control'' would mean any of the following: (1) The
acquisition by any ``person'' (as such term is used in sections 13(d)
and 14(d) of the Securities Exchange Act of 1934) of beneficial
ownership (within the meaning of Rule 13d-3 promulgated under the
Securities Exchange Act of 1934), of beneficial ownership (within the
meaning of Rule 13d-3 promulgated under the Securities Exchange Act of
1934), directly or indirectly, of voting securities of the model
participant representing more than 50 percent of the model
participant's outstanding voting securities or rights to acquire such
securities; (2) the acquisition of the model participant by any
individual or entity; (3) the sale, lease, exchange or other transfer
(in one transaction or a series of transactions) of all or
substantially all of the assets of the model participant; or (4) the
approval and completion of a plan of liquidation of the model
participant, or an
[[Page 34490]]
agreement for the sale or liquidation of the model participant. The
proposed requirement and definition of change in control are the same
requirements and definition used in certain models that are currently
being tested under section 1115A authority. We believe this proposed
notice requirement is necessary to ensure the accuracy of our records
regarding the identity of model participants and to ensure that we pay
and seek payment from the correct entity. For this reason, we propose
that if CMS determined in accordance with proposed Sec. 512.160(a)(5)
that a model participant's change in control would present a program
integrity risk, CMS could take remedial action against the model
participant under proposed Sec. 512.160(b). In addition, to ensure
payment of amounts owed to CMS, we propose that CMS may require
immediate reconciliation and payment of all monies owed to CMS by a
model participant that is subject to a change in control.
We invite public comment on these proposed notification
requirements. Also, we solicit comment as to whether the requirement to
provide notice regarding changes in legal name and changes in control
are necessary, or are already covered by existing reporting
requirements for Medicare-enrolled providers and suppliers.
III. Proposed Radiation Oncology Model
A. Introduction
We are proposing a mandatory Radiation Oncology Model (RO Model),
referred to in this section III. of the proposed rule as ``the Model,''
that would test whether prospective episode-based payments for
radiotherapy (RT) services,\4\ (also referred to as radiation therapy
services) would reduce Medicare program expenditures and preserve or
enhance quality of care for beneficiaries. As radiation oncology is
highly technical and furnished in well-defined episodes, and because
patient comorbidities generally do not influence treatment delivery
decisions, we believe that radiation oncology is well-suited for
testing a prospective episode payment model. Under this proposed RO
Model, Medicare would pay participating providers and suppliers a site-
neutral, episode-based payment for specified professional and technical
RT services furnished during a 90-day episode to Medicare fee-for-
service (FFS) beneficiaries diagnosed with certain cancer types. The
base payment amounts for RT services included in the Model would be the
same for hospital outpatient departments (HOPDs) and freestanding
radiation therapy centers. The performance period for the proposed RO
Model would be five performance years (PYs), beginning in 2020, and
ending December 31, 2024, with final data submission of clinical data
elements and quality measures in 2025 to account for episodes ending in
2024.
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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.
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We are including the following proposals for the Model in this
proposed rule: (1) The scope of the Model, including required
participants and episodes under the Model test; (2) the pricing
methodology under the Model and necessary Medicare program policy
waivers to implement such methodology; (3) the quality measures
selected for the Model for purposes of scoring a participant's quality
performance; (4) the process for payment reconciliation; and, (5) data
collection and sharing.
B. Background
1. Overview
CMS is committed to promoting higher quality of care and improving
outcomes for Medicare beneficiaries while reducing costs. Accordingly,
as part of that effort, we have in recent years undertaken a number of
initiatives to improve cancer treatment, most notably with our Oncology
Care Model (OCM). We believe that a model in radiation oncology would
further these efforts to improve cancer care for Medicare beneficiaries
and reduce Medicare expenditures.
RT is a common treatment for nearly two thirds of all patients
undergoing cancer treatment 5 6 and is typically furnished
by a radiation oncologist. We analyzed Medicare FFS claims between
January 1, 2015, and December 31, 2017, to examine several aspects
(including but not limited to modalities, number of fractions, length
of episodes, Medicare payments and sites of service, as described in
this section) of radiation services furnished to Medicare beneficiaries
during that period. We used HOPD and Medicare Physician Fee Schedule
(PFS) claims, accessed through CMS's Chronic Conditions Data Warehouse
(CCW), to identify all FFS beneficiaries who received any radiation
treatment delivery services within that 3-year period. These radiation
treatment delivery services included various types of modalities.\7\
Such modalities included external beam radiotherapy (such as 3-
dimensional conformal radiotherapy (3DCRT), intensity-modulated
radiotherapy (IMRT), stereotactic radiosurgery (SRS), stereotactic body
radiotherapy (SBRT), and proton beam therapy), intraoperative
radiotherapy (IORT), image-guided radiation therapy (IGRT), and
brachytherapy. We conducted several analyses of radiation treatment
patterns using that group of beneficiaries and their associated
Medicare Part A and Medicare Part B claims.
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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.
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Our analysis showed that from January 1, 2015 through December 31,
2017, HOPDs furnished 64 percent of episodes nationally, while
freestanding radiation therapy centers furnished the remaining 36
percent of episodes. We intend to make this data publically accessible
in a summary-level, de-identified file titled the ``RO Episode File
(2015-2017),'' on the RO Model's website. Our analysis also showed
that, on average, freestanding radiation therapy centers furnished (and
billed for) a higher volume of RT services within such episodes than
did HOPDs. Based on our analysis of Medicare FFS claims data from that
time period, episodes of care in which RT was furnished at a
freestanding radiation therapy center were, on average, paid
approximately $1,800 (or 11 percent) more by Medicare than those
episodes of care where RT was furnished at a HOPD. We are not aware of
any clinical rationale that explains for these differences, which
persisted after controlling for diagnosis, patient case mix (to the
extent possible using data available in claims), geography, and other
factors. These differences also persist even though Medicare payments
are lower per unit in freestanding radiation therapy centers than in
HOPDs. Upon further analysis, we observed that freestanding radiation
therapy centers use more IMRT, a type of RT associated with higher
Medicare payments, and perform more fractions (that is, more RT
treatments) than HOPDs.
2. Site-Neutral Payments
Under Medicare FFS, RT services furnished in a freestanding
radiation therapy center are paid under the
[[Page 34491]]
Medicare PFS at the non-facility rate including payment for the
professional and technical aspects of the services. For RT services
furnished in an outpatient department of a hospital, the facility
services are paid under the Hospital Outpatient Prospective Payment
System (OPPS) and the professional services are paid under the PFS.
Differences in the underlying rate-setting methodologies used in the
OPPS and PFS to establish payment for RT services in the HOPD and in
the freestanding radiation therapy centers respectively help to explain
why the payment rate for the same RT service could be different. This
difference in payment rate, which is commonly referred to as the site-
of-service payment differential, may incentivize Medicare providers and
suppliers to deliver RT services in one setting over another, even
though the actual treatment and care received by Medicare beneficiaries
for a given modality is the same in both settings. We propose to test a
site-neutral payment in the RO Model rather than implementing a payment
adjustment in the OPPS or PFS because--
The Secretary of Health and Human Services does not have
the authority to adjust payments outside of established payment
methodologies under the Section 1848 governing the PFS;
The Practice Expense (PE) component of the PFS is
determined based on inputs (labor, equipment, and supplies) and input
price estimates from entities paid under the PFS only, which means the
PE calculation cannot consider HOPD cost data that the RO Model
proposes to use as the basis for national base rates;
(1) Further, the PE methodology itself calculates a PE
amount for each service relative to all of the other services paid
under the PFS in a budget neutral manner and consistent with estimates
of appropriate division of PFS payments between PE, physician work, and
malpractice resource costs; and
(2) Both the PFS and OPPS make the same payment for a
service, irrespective of the diagnosis, whereas the RO Model
establishes different payments by cancer type.
(3) Neither payment system would allow flexibility in
testing new and comparable approaches to value-based payment outside of
statutory quality reporting programs.
We believe a site-neutral payment policy would address the site-of-
service payment differential that exists under the OPPS and PFS by
establishing a common payment amount to pay for the same services
regardless of where they are furnished. In addition, we believe that
site-neutral payments would offer RT providers and RT suppliers more
certainty regarding the pricing of RT services and remove incentives
that promote the provision of RT services at one site of service over
another. The RO Model is designed to test these assumptions regarding
site-neutrality.
3. Aligning Payments to Quality and Value, Rather Than Volume
For some cancer types, stages, and characteristics, a shorter
course of RT treatment with more radiation per fraction may be
appropriate. For example, several randomized controlled trials have
shown that shorter treatment schedules for low-risk breast cancer yield
similar cancer control and cosmetic outcomes as longer treatment
schedules.8 9 10 11 As another example, research has shown
that radiation oncologists may split treatment for bone metastases into
5 to 10 fractions, even though research indicates that one fraction is
often sufficient.12 13 14 15 In addition, recent clinical
trials have demonstrated that, for some patients in clinical trials
with low- and intermediate-risk prostate cancer, courses of RT lasting
4 to 6 weeks lead to similar cancer control and toxicity as longer
courses of RT lasting 7 to 8 weeks.16 17
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\8\ Whelan, T.J. et al. Long-term Results of Hypofractionated
Radiation Therapy for Breast Cancer. N. Engl. J. Med. 2010 Feb. 11;
362(6):513-20. https://www.ncbi.nlm.nih.gov/pubmed/20147717.
\9\ Bentzen, S.M. et al. The UK Standardisation of Breast
Radiotherapy (START) Trial A of Radiotherapy Hypofractionation for
Treatment of Early Breast Cancer: A Randomised Trial. Lancet Oncol.
2008 Apr.; 9(4):331-41. https://www.ncbi.nlm.nih.gov/pubmed/18356109.
\10\ Bentzen, S.M. et al. The UK Standardisation of Breast
Radiotherapy (START) Trial B of Radiotherapy Hypofractionation for
Treatment of Early Breast Cancer: A Randomised Trial. Lancet Oncol.
2008 Mar. 29; 371(9618): 1098-107. https://www.ncbi.nlm.nih.gov/pubmed/18355913.
\11\ Haviland, J.S. et al. The UK Standardisation of Breast
Radiotherapy (START) Trials of Radiotherapy Hypofractionation for
Treatment of Early Breast Cancer: 10-Year Follow-Up Results of Two
Randomised Controlled Trials. Lancet Oncol. 2013 Oct.; 14(11): 1086-
94. https://www.ncbi.nlm.nih.gov/pubmed/24055415.
\12\ Sze, W.M. et al. Palliation of Metastatic Bone Pain: Single
Fraction Versus Multifraction Radiotherapy--A Systematic Review of
The Randomised Trials. Cochrane Database Syst. Rev. 2004;
(2):CD004721. https://www.ncbi.nlm.nih.gov/pubmed/15106258.
\13\ Chow, E. et al. Update on the Systematic Review of
Palliative Radiotherapy Trials for Bone Metastases. Clin. Oncol. (R.
Coll. Radiol.). 2012 Mar; 24 (2):112-24. https://www.ncbi.nlm.nih.gov/pubmed/22130630.
\14\ Chow, Ronald et al. Efficacy of Multiple Fraction
Conventional Radiation Therapy for Painful Uncomplicated Bone
Metastases: A Systematic Review. Radiotherapy & Oncology: March 2017
Volume 122, Issue 3, Pages 323-331. http://www.thegreenjournal.com/article/S0167-8140(16)34483-8/abstract.
\15\ Lutz, Stephen et al. Palliative Radiation Therapy for Bone
Metastases: Update of an ASTRO Evidence-Based Guideline. Practical
Radiation Oncology (2017) 7, 4-12. http://www.practicalradonc.org/article/S1879-8500(16)30122-9/pdf.
\16\ D. Dearnaley, I. Syndikus, H. Mossop, et al. Conventional
versus hypofractionated high-dose intensity-modulated radiotherapy
for prostate cancer: 5-Year outcomes of the randomised, non-
inferiority, phase 3 CHHiP trial. Lancet Oncol, 17 (2016), pp. 1047-
1060. http://www.sciencedirect.com/science/article/pii/S1470204516301024.
\17\ W.R. Lee, J.J. Dignam, M.B. Amin, et al. Randomized phase
III noninferiority study comparing two radiotherapy fractionation
schedules in patients with low-risk prostate cancer. J Clin Oncol,
34 (2016), pp. 2325-2332. http://ascopubs.org/doi/full/10.1200/JCO.2016.67.0448.
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Based on this review of claims data, we believe that the current
Medicare FFS payment systems may incentivize selection of a treatment
plan with a high volume of services over another medically appropriate
treatment plan that requires fewer services. Each time a patient
requires radiation, providers can bill for RT services and an array of
necessary planning services to make the treatment successful.\18\ This
structure may incentivize providers and suppliers to furnish longer
courses of RT because they are paid more for furnishing more services.
Importantly, however, the latest clinical evidence suggests that
shorter courses of RT for certain types of cancer would be equally
effective and could improve the patient experience, potentially reduce
cost for the Medicare program, and lead to reductions in beneficiary
cost-sharing.
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\18\ These planning and technical preparation services include
dose planning, treatment aids, CT simulations, and other services.
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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\
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\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.
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4. CMS Coding and Payment Challenges
We identified several coding and payment challenges for RT
services. Under the PFS, payment is set for each service using
resource-based relative value units (RVUs). The RVUs have three
components: Clinician work (Work), practice expense (PE), and
[[Page 34492]]
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\
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\21\ CY 2014 PFS final rule with comment period, 78 FR 43296,
43286-43289, 43302-43311.
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Further, we have examined RT services and their corresponding codes
under our potentially misvalued codes initiative based on their high
volume and increasing use of new technologies. Specifically, we
reviewed codes for RT services for Calendar Years (CYs) 2009, 2012,
2013, and 2015 as potentially misvalued services. In general, when a
code is identified as potentially misvalued, we finalize the code as
misvalued and then review the Work and PE RVU inputs for the code. As a
result of the review, the inputs can be adjusted either upward or
downward. The criteria for identifying potentially misvalued codes are
set forth in section 1848(c)(2)(K)(ii) of the Act.
Through annual rulemaking for the PFS, we review and adjust values
for potentially misvalued services, and also establish values for new
and revised codes. We establish Work and PE RVU inputs for new,
revised, and potentially misvalued codes based on a review of
information that generally includes, but is not limited to,
recommendations received from the American Medical Association's RVS
Update Committee (AMA/RUC), Health Care Professional Advisory Committee
(HCPAC), Medicare Payment Advisory Commission (MedPAC), and other
public commenters; medical literature and comparative databases; a
comparison of the work for other codes within the PFS; and consultation
with other physicians and health care professionals within CMS and
other federal government agencies. We also consider the methodology and
data used to develop the recommendations submitted to us by the RUC and
other public commenters, and the rationale for their recommendations.
Through the annual rulemaking process previously described, we have
reviewed and finalized payment rates for several RT codes over the past
few years. The American Medical Association identified radiation
treatment coding for review because of site of service anomalies. We
first identified these codes as potentially misvalued services during
CY 2012 under a screen called ``Services with Stand-Alone PE Procedure
Time.'' We observed significant discrepancies between the 60-minute
procedure time assumptions for IMRT. Public information suggested that
the procedure typically took between 5 and 30 minutes. In CY 2015, the
American Medical Association CPT[supreg] Editorial Panel revised the
entire code set that describes RT delivery. CMS proposed values for
these services in the CY 2016 proposed rule but, due to challenges in
revaluing the new code set, finalized the use of G-codes that we
established to largely mirror the previous radiation treatment coding
structure.\22\ The Patient Access and Medicare Protection Act (PAMPA)
(Pub. L. 114-115), enacted on December 28, 2015, addressed payment for
certain RT delivery and related imaging services under the PFS, and the
Bipartisan Budget Act (BBA) of 2018 (Pub. L. 115-123) required the PFS
to use the same service inputs for these codes as existed in 2016 for
CY 2017, 2018, and 2019. (The PAMPA and BBA are discussed in detail in
this rule).
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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; CY 2016 PFS correcting amendment, 81 FR 12024.
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Despite the aforementioned challenges related to information used
to establish payment rates for RT services, we have systematically
attempted to improve the accuracy of payment for these codes under the
PFS. While the potentially misvalued code review process is essential
to the PFS, some stakeholders have expressed concern that changes in
Work and PE RVUs have led to fluctuations in payment rates.
Occasionally, changes in PE RVUs for one or more CPT[supreg] codes
occur outside of the misvalued code review cycle if there are updates
to the equipment and supply pricing. Any changes to CPT[supreg] code
valuations, including supply and equipment pricing changes, are subject
to public comment and review.
Although the same code sets generally are used for purposes of the
PFS and OPPS, there are differences between the codes used to describe
RT services under the PFS and the OPPS, and those in commercial use
more broadly. We continue to use some CMS-specific coding, or HCPCS
codes, in billing and payment for RT services under the PFS while OPPS
is largely based on CPT[supreg] codes. As a result of coding and other
differences, these payment systems utilize different payment rates and
reporting rules for the same services, which contribute to site-of-
service payment differentials. These differences in payment systems can
create confusion for RT providers and RT suppliers, particularly when
they furnish services in both freestanding radiation therapy centers
and HOPDs.
Finally, there are coding and payment challenges specific to
freestanding radiation therapy centers. Through the annual PFS
rulemaking process, we receive comments from stakeholders representing
freestanding radiation therapy centers and physicians who furnish
services in freestanding radiation therapy centers. In recent years,
these stakeholder comments have noted the differences and complexity in
payment rates and policies for RT services between the PFS and OPPS;
expressing particular concerns about differences in payment for RT
services furnished in freestanding radiation therapy centers and HOPDs
despite that the fixed, capital costs associated with linear
accelerators that are used to furnish these services do not differ
across settings; and raising certain perceived deficiencies in the PFS
rate-setting methodology as it applies to RT services delivered in
freestanding radiation therapy centers.\23\ It is also important to
note that even if we were able to obtain better pricing information for
inputs, due to the differing rate-setting methodologies, PFS rates are
developed in relation to other PFS office-based services, not to OPPS
payment rates.
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\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.
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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
[[Page 34493]]
of RT services and payment, and reviewed model design considerations
for a potential APM for RT services.
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\24\ https://innovation.cms.gov/resources/radiationapm-pubforum.html.
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In preparing the Report to Congress, the Innovation Center
conducted an environmental scan of current evidence, as well as held a
public listening session followed by an opportunity for RT stakeholders
to submit written comments about a potential APM. A review of the
applicable evidence cited in the Report to Congress demonstrated that
episode payment models can be a tool for improving quality of care and
reducing expenditures. Episode payment models pay a fixed price based
on the expected costs to deliver a bundle of services for a clinically
defined episode of care. We believe that radiation oncology is a
promising area of health care for episode payments, in part, based on
the findings in the Report to Congress. While the report discusses
several options for an APM, in this proposed rule, we propose what the
Innovation Center has determined to be the best design for testing an
episodic APM for RT services.
C. RO Model Proposed Regulations
In this proposed rule, we propose our policies for the RO Model,
including model-specific definitions and the general framework for
implementing the RO Model. We propose to define ``performance year''
(PY) as the 12-month period beginning on January 1 and ending on
December 31 of each year during the model performance period. We
propose to codify the term ``performance year'' at Sec. 512.205 of our
regulations.
In this proposed rule, we are including our proposed policies for
each of the following: (1) The scope of the RO Model, including the
Model participants, beneficiary population, and RT episodes that would
be included in the test; (2) the pricing methodology under the Model
and the Medicare program policy waivers necessary to implement such
methodology; (3) the measure selection for the model, including
performance scoring methodology and applying quality to payment; (4)
the process for payment reconciliation; and (5) data collection and
sharing.
We propose to codify RO Model policies at 42 CFR part 512, subpart
B (proposed Sec. Sec. 512.200 through 512.290). In addition, as we
explain in section II of this proposed rule, if finalized, the general
provisions proposed to be codified at Sec. Sec. 512.100 through
512.180 would apply to the proposed RO Model.
1. Proposed Model Performance Period
We propose to test the RO Model for 5 PYs. We propose to define
``model performance period'' to mean January 1, 2020, the date the
Model begins, through December 31, 2024, the last date during which
episodes under the Model must be completed. Alternatively, we are
considering delaying implementation to April 1, 2020 to give RO
participants and CMS additional time to prepare. An April 2020 start
date would only affect the length of PY1 which would be nine months.
All other PYs would be 12 months. For all episodes to be completed by
December 31, 2024, no new episodes may begin after October 3, 2024. We
invite public comments on the proposed model performance period and
potential participants' ability to be ready to implement the RO Model
by January 1, 2020. We also seek comments on delaying the start of the
model performance period to April 1, 2020.
2. Proposed Definitions
We propose at Sec. 512.205 to define certain terms for the RO
Model. We describe these proposed definitions in context throughout
this section III of this proposed rule. We invite public comments on
these proposed definitions.
3. Proposed Participants
We propose that certain Medicare participating HOPDs, physician
group practices (PGPs), and freestanding radiation therapy centers that
furnish RT services (RT providers or RT suppliers) in randomly selected
Core-Based Statistical Areas (CBSAs), would be required to participate
in the RO Model either as ``Professional participants,'' ``Technical
participants,'' or ``Dual participants'' (as such terms are defined in
section III.C.3.b of this proposed rule). We propose to define ``RO
participant'' at Sec. 512.205 as a PGP, freestanding radiation therapy
center, or HOPD that participates in the RO Model pursuant to the
criteria that we propose to establish at Sec. 512.210. (See III.C.3.b
Proposed RO Model Participants.) In addition, we note that the proposed
definition of ``model participant,'' as defined in section III.C.3.b of
this rule, would include a RO participant. In this section, we explain
our proposals regarding mandatory participation, the types of entities
that would be required to participate, and the geographic areas that
would be subject to the RO Model test.
a. Proposed Required Participation
We propose that certain RT providers and RT suppliers that furnish
RT services within randomly selected CBSAs would be required to
participate in the RO Model (see III.C.3.b. of this proposed rule
(Proposed RO Model Participants) and III.C.3.d. of this proposed rule
(Geographic Unit of Section)). To date, the Innovation Center has
tested one voluntary prospective episode payment model, Bundled
Payments for Care Improvement (BPCI) Model 4 that attracted only 23
participants, of which 78 percent withdrew from the initiative. As
such, we are interested in testing and evaluating the impact of a
prospective payment approach for RT services in a variety of
circumstances. We believe that by requiring the participation of RT
providers and RT suppliers, we would have access to more complete
evidence of the impact of the Model.
A representative sample of RT providers and RT suppliers for the
proposed Model would result in a robust data set for evaluation of this
prospective payment approach, and would stimulate the rapid development
of new evidence-based knowledge. Testing the Model in this manner would
also allow us to learn more about patterns of inefficient utilization
of health care services and how to incentivize the improvement of
quality for RT services. This learning could potentially inform future
Medicare payment policy. Therefore, we are proposing a broad,
representative sample of RT providers and RT suppliers in multiple
geographic areas (see Section III.C.3.d. of this proposed rule for a
discussion regarding the Geographic Unit of Selection). We determined
that the best method for obtaining the necessary diverse,
representative group of RT providers and RT suppliers would be random
selection. This is because a randomly selected sample would provide
analytic results that would be more generally applicable to all
Medicare FFS RT providers and RT suppliers and would allow for a more
robust evaluation of the Model.
In addition, actuarial analysis suggests that the difference in
estimated price updates for rates in the OPPS and PFS systems from 2019
through 2023, in which the OPPS rates are expected to increase
substantially more than PFS rates, would result in few to no HOPDs
electing to voluntarily participate in the Model. Further, actuarial
estimates suggested that freestanding radiation therapy centers with
historically lower RT costs compared to the national average would most
likely choose to participate, but those with historically higher costs
would be less likely to voluntarily participate. Requiring
[[Page 34494]]
participation in the RO Model would ensure sufficient proportional
participation of both HOPDs and freestanding radiation therapy centers,
which is necessary to obtain a diverse, representative sample of RT
providers and RT suppliers and to help support a statistically robust
test of the prospective episode payments made under the RO Model.
For these reasons, we believe that a mandatory model design would
be the best way to improve our ability to detect and observe the impact
of the prospective episode payments made under the RO Model. We
therefore propose that participation in the RO Model would be mandatory
for all RT providers and RT suppliers furnishing RT services within the
randomly selected CBSAs.
We invite public comments on our proposal for mandatory
participation.
b. Proposed RO Model Participants
A RO participant, a term that we propose to define at Sec.
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 Sec. 512.210. A RO participant would participate in the
Model as a Professional participant, Technical participant, or Dual
participant.
We propose to define the term ``Professional participant'' as a RO
participant that is a Medicare-enrolled physician group practice (PGP),
identified by a single Taxpayer Identification Number (TIN) that
furnishes only the professional component of RT services at either a
freestanding radiation therapy center or a HOPD. Professional
participants would be required annually to attest to the accuracy of an
individual practitioner list, as described in section III.C.9, provided
by CMS, of all of the eligible clinicians who furnish care under the
Professional participant's TIN. We propose to define the term
``individual practitioner'' to mean a Medicare-enrolled physician
(identified by an NPI) who furnishes RT services to Medicare FFS
beneficiaries, and have reassigned his/her billing rights to the TIN of
a RO participant. We further propose that an individual practitioner
under the RO Model would be considered a downstream participant, as
defined in section II.B. of this proposed rule.
We propose to define the term ``Technical participant'' to mean a
RO participant that is a Medicare-enrolled HOPD or freestanding
radiation therapy center, identified by a single CMS Certification
Number (CCN) or TIN, which furnishes only the technical component of RT
services. Finally, we propose to define ``Dual participant'' to mean a
RO participant that furnishes for both the professional component and
technical component of an episode for RT services through a
freestanding radiation therapy center, identified by a single TIN. We
propose to codify the terms ``Professional participant,'' ``Technical
participant,'' ``Dual participant'' and ``individual practitioner'' at
Sec. 512.205.
As previously explained, a RO participant would furnish at least
one component of an episode, which we are proposing to have two
components: A professional component and a technical component. We
propose to define the term ``professional component (PC)'' to mean the
included RT services that may only be furnished by a physician. We
propose to define the term ``technical component (TC)'' to mean the
included RT services that are not furnished by a physician, including
the provision of equipment, supplies, personnel, and costs related to
RT services. (See section III.C.5.c. of this proposed rule for a
discussion regarding our proposed included RT services.) We propose to
codify the terms ``professional component (PC)'' and ``technical
component (TC)'' at Sec. 512.205.
An episode of RT under the RO Model would be furnished by either:
(1) Two separate RO participants, that is, a Professional participant
that furnishes only the PC of an episode, and a Technical participant
that furnishes only the TC of an episode; or (2) a Dual participant
that furnishes both the PC and TC of an episode. For example, if a PGP
furnishes only the PC of an episode at a HOPD that furnishes the TC of
an episode, then the PGP would be a Professional participant and the
HOPD would be a Technical participant. In other words, the PGP and HOPD
would furnish separate components of the same episode and would be
separate participants under the Model.
c. Proposed RO Model Participant Exclusions
We propose to exclude from RO Model participation any PGP,
freestanding radiation therapy center, or HOPD that--
Furnishes RT only in Maryland;
Furnishes RT only in Vermont;
Furnishes RT only in U.S. Territories;
Is classified as an ambulatory surgery center (ASC),
critical access hospital (CAH), or Prospective Payment System (PPS)-
exempt cancer hospital; or
Participates in or is identified as eligible to
participate in the Pennsylvania Rural Health Model.
These exclusion criteria would apply during the entire model
performance period. If a RO participant undergoes changes such that one
or more of the proposed exclusion criteria becomes applicable to the RO
participant during the model performance period, then that RO
participant would be excluded from the RO Model (that is, it would no
longer be a RO participant subject to inclusion criteria). For example,
if a RO participant moves its only service location \25\ from a
randomly selected CBSA in Virginia to Maryland, it would be excluded
from the RO Model from the date of its location change. Conversely, if
a PGP, freestanding radiation therapy center, or HOPD satisfies the
exclusion criteria when the Model begins, and subsequently experiences
a change such that the proposed exclusion criteria no longer apply and
the PGP, freestanding radiation therapy center, or HOPD is located in
one of the randomly selected CBSAs, then participation in the RO Model
would be required. For example, if an HOPD is no longer classified as a
PPS-exempt hospital and the HOPD is located in one of the randomly
selected CBSAs, then the HOPD would become an RO participant from the
date that the HOPD became no longer classified as a PPS-exempt
hospital.
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\25\ Service location means the site of service in which a RO
Participant or any RT provider or RT supplier furnishes RT services.
---------------------------------------------------------------------------
In the case of Professional participants and Dual participants, any
episodes in which the initial RT treatment planning service is
furnished to a RO beneficiary on or after the day of this change would
be included in the Model. In the case of Technical participants, any
episodes where the RT service is furnished within 28 days of a RT
treatment planning service for a RO beneficiary and the RT service is
furnished on or after the day of this change would be included in the
Model.
We propose to exclude RT providers and RT suppliers in Maryland due
to the unique statewide payment model being tested there (the Maryland
Total Cost of Care Model), in which Maryland hospitals receive a global
budget. This global budget includes RT services and as such would
overlap with the RO Model payment; thus, we propose to exclude Maryland
HOPDs to avoid double payment for the same services. We propose to
extend the exclusion to all RT providers and RT suppliers in Maryland
to avoid creating a gaming opportunity where certain beneficiaries
[[Page 34495]]
could be shifted away from PGPs and freestanding centers to HOPDs.
We propose to exclude RT providers and RT suppliers in Vermont due
to the Vermont All-Payer ACO Model, which is a statewide model in which
all-inclusive population-based payments (AIPBPs) are currently made to
the participating ACO for Medicare FFS services furnished by all
participating HOPDs and an increasing number of participating PGPs.
Given the scope of this model as statewide and inclusive of all
significant payers, we believe excluding RT providers and RT suppliers
in Vermont from the RO Model is appropriate to avoid any potential
interference with the testing of the Vermont All-Payer ACO Model.
We propose to exclude HOPDs that are participating in or eligible
to participate in the Pennsylvania Rural Health Model. HOPDs that are
participating in the model receive a global budget similar to the
Maryland Total Cost of Care Model. Further, we propose to extend the
exclusion to HOPDs that are eligible to participate in the Pennsylvania
Rural Health Model because they may be added to that model in the
future or may be included in the evaluation comparison group for that
model. We would identify the CAHs and acute care hospitals that are
participating or are eligible to participate in the Pennsylvania Rural
Health Model on a list to be updated quarterly and made available on
the Pennsylvania Rural Health Model's website at https://innovation.cms.gov/initiatives/pa-rural-health-model/.
The proposed RO Model is designed to test whether prospective
episode payments in lieu of traditional FFS payments for RT services
would reduce Medicare expenditures by providing savings for Medicare
while preserving or enhancing quality. We believe it would be
inappropriate to include these entities for the reasons previously
described. Also, we are proposing to exclude ASCs and RT providers and
RT suppliers located in the U.S. Territories, as proposed at Sec.
512.210, due to the low volume of RT services that they provide. In
addition, we are proposing to exclude CAHs and PPS-exempt cancer
hospitals due to the differences in how they are paid by Medicare.
As a result, we propose that RT services furnished by these RT
providers and RT suppliers would be excluded from participation in the
RO Model. If in the future we determine that providers and suppliers in
these categories should be included in the RO Model, we would propose
to revise our inclusion criteria through rulemaking.
We further propose to codify these policies at Sec. 512.210 of our
regulations.
We invite public comments on these proposals.
d. Proposed Geographic Unit of Selection
We propose that the geographic unit of selection for the RO Model
would be OMB's Core Based Statistical Areas (CBSAs). Due to geographic
data limitations on Medicare claim submissions, we would link RT
providers and RT suppliers to a CBSA by using the five-digit ZIP Code
of the location where RT services are furnished. This would permit us
to identify RO Model participants (see section III.C.3.c. of this
proposed rule RO Model Participant Exclusions for the RT providers and
RT suppliers we are proposing to exclude from the RO Model) while still
using CBSA as a geographic unit of selection. We further propose to
codify the term ``Core Based Statistical Area (CBSA)'' at Sec. 512.205
of our regulations.
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
as such, we do not propose to include non-CBSA geographies in the RO
Model test.
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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.
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However, most RT providers and RT suppliers may not know in what
CBSA they furnish RT services. In order to simplify the notification
process to inform RT providers and RT suppliers whether or not they
furnish RT services in a selected CBSA, we are proposing to use an RT
provider's or RT supplier's service location five-digit ZIP Code found
on the RT provider's or RT supplier's claim submissions to CMS to link
them to CBSAs selected under the Model.
Not all five-digit ZIP Codes fall entirely within OMB delineated
CBSA boundaries, resulting in some five-digit ZIP Codes assigned to two
different CBSAs. Approximately 15 percent (15 percent) of five-digit
ZIP Codes have portions of their addresses located in more than one
CBSA. If each ZIP Code was assigned only to the CBSA with the largest
portion of delivery locations in it, about 5 percent of all delivery
locations in ZIP Codes would be assigned to a different CBSA. Rather
than increase provider burden by requiring submission of more detailed
geographic data by RT providers and RT suppliers, we propose to assign
the entire five-digit ZIP Code to the CBSA where the ZIP code has the
greatest portion of total addresses (business, residence, and other
addresses) such that each five-digit ZIP Code is clearly linked to a
unique CBSA or non-CBSA geography. In the event that the portion of
total addresses within the five-digit ZIP Code is equal across CBSAs
and cannot be used to make the link, the greater portion of business
addresses would take precedence to link the five-digit ZIP Code to the
CBSA.
CMS would use a five-digit ZIP Code to CBSA crosswalk found in the
Housing and Urban Development (HUD) ZIP to CBSA Crosswalk file \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.
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\27\ Datasets and documentation for HUD USPS Zip Code Crosswalk
Files (which includes the above mentioned HUD ZIP-CBSA crosswalk
file) can be found here: https://www.huduser.gov/portal/datasets/usps_crosswalk.html.
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We believe that linking a five-digit ZIP Code to a single CBSA
would not substantially impact statistical estimates for the RO Model.
In addition, we believe that using a service location's five-digit ZIP
Code to determine
[[Page 34496]]
whether an RT provider or RT supplier must participate in the Model
will avoid potential RT provider or RT supplier burden by avoiding an
additional requirement that they submit claims using more detailed
geographic information. If finalized as proposed, CMS would provide a
look-up tool that includes all five-digit ZIP Codes linked to CBSAs
selected in accordance with our proposed selection policy described in
this proposed rule. This tool would be located on the RO Model website.
Using CBSAs to identify RO participants would enable CMS to analyze
groups of RT providers and RT suppliers in areas selected to
participate in the Model and compare them to groups of RT providers and
RT suppliers not participating in the Model. To the extent that CBSAs
act like or represent markets, these group analyses would allow CMS to
observe potential group level, market-like effects. We have found group
level effects important as context for understanding the results of
other models tested under section 1115A of the Act. For example,
stakeholders questioned whether a model changed the overall volume of
services related to the specific model in a given area. We would not be
able to address this issue for the RO Model without using a geographic
area as the unit of analysis.
With respect to selecting CBSAs under the Model, we propose to use
a stratified sample design based on the observed ranges of episode
counts in CBSAs using claims data from calendar years 2015-2017. We
would then randomize the CBSAs within each stratum into participant and
comparison groups until the targeted number of RO episodes within each
group of CBSAs needed for a robust \28\ test of the Model is reached.
The primary purpose of the evaluation is to estimate the impact of the
Model across all participating organizations. Larger sample sizes
decrease the chances that the evaluation would produce mistakes, that
is show `no effect' when an effect is actually present (like an
instance when a smoke detector fails to sound an alarm even though
smoke is actually present) or show `an effect' when no effect is
actually present (like an instance when a smoke detector is sounding an
alarm that suggests smoke is detected when actually no smoke is
present). Given that we plan to sample 40 percent of all eligible RO
episodes in eligible CBSAs nationwide (as defined in section III.C.5 of
this proposed rule), we believe we should be sufficiently powered (that
is, the sample size and the expected size of the effect of the Model
are both large enough at a given significance level) to confidently
show the impact of the Model. The comparison group would consist of RT
providers and RT suppliers from randomized CBSAs within the same strata
as the selected RO participants from the participant group, resulting
in a comparison group of an approximately equal number of CBSAs and
episodes as in the participant group that would allow for the effects
of the RO Model to be evaluated. Strata will be divided into five
quintiles based on the total number of episodes within a given CBSA.
The stratification would limit uneven RT provider and RT supplier and
episode numbers within the participant and comparison groups of CBSAs
that can result from a simple random sample. If a CBSA is randomly
assigned to the participant group, then the RT providers and RT
suppliers who furnish RT services in that CBSA would be RO
participants. If the CBSA is randomly assigned to the comparison group,
then the providers and suppliers who furnish RT services in that CBSA
would not be RO participants, but the claims they generate and the
episodes constructed from those claims would be used as part of the RO
Model's evaluation.
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\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.
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After determining the sampling framework, we conducted the
necessary power calculations (statistical tests to determine the
minimum sample size of the participant and comparison groups in the
Model, designed in order to produce robust and reliable results) using
Medicare FFS claims from January 1, 2015 through December 31, 2017, to
construct episodes and then identify a sufficient sample size so that
results would be precise and reliable. We determined that 40 percent of
eligible episodes (as defined in section III.C.5 of this proposed rule)
in eligible CBSAs nationally would allow for a rigorous test of the RO
Model that would produce evaluation results that we can be confident
are accurately reflecting what actually occurred in the Model test, and
that this size would limit the number of episodes expected in the
participant group to no more than is needed for a robust statistical
test of the projected impacts of the Model.
Using randomly selected stratified CBSAs would ensure that the
participant and comparison groups of CBSAs would each contain
approximately 40 percent of all eligible episodes nationally. The
comparison group of CBSAs would be used to evaluate the impact of the
RO Model on spending, quality, and utilization. The CBSAs would be
randomly selected and those CBSAs and the ZIP Codes selected for
participation would be published on the RO Model website once the final
rule is displayed.
4. Proposed Beneficiary Population
We propose that a Medicare FFS beneficiary be included in the RO
Model if the beneficiary:
Receives included RT services in a five-digit ZIP Code
linked to a selected CBSA from a RO participant during the model
performance period for a cancer type that meets the criteria for
inclusion in the RO Model; and
At the time that the initial treatment planning service of
the episode is furnished by a RO participant, the beneficiary:
++ Is eligible for Medicare Part A and enrolled in Medicare Part B;
and
++ Has traditional Medicare FFS as his or her primary payer.
In addition, we propose to exclude from the RO Model any
beneficiary who, at the time that the initial treatment planning
service of the episode is furnished by a RO participant:
Is Enrolled in any Medicare managed care organization,
including but not limited to Medicare Advantage plans;
Is Enrolled in a PACE plan;
Is not in a Medicare hospice benefit period; or
Is covered under United Mine Workers.
Because the RO Model would evaluate RT services furnished to
beneficiaries who have been diagnosed with one of the cancer types
identified as satisfying our proposed criteria for inclusion in the
Model, as discussed in section III.C.5.a, we believe it would be
necessary to include only beneficiaries who have at least one of the
identified cancer types and who also receive RT services from RO
participants. Further, a key objective of the RO Model would be to
evaluate if and/or how RT service delivery changes in either the HOPD
or freestanding radiation therapy center setting as a result of a
change in payment systems from that of FFS under OPPS or PFS,
respectively, to that of prospectively determined bundled rates for an
episode of RT services as described in section III.C.6.c. We propose
these criteria in order to limit RT provider and RT supplier
participation in the RO Model to beneficiaries whose RT providers and
RT suppliers would otherwise be paid by way of traditional FFS payments
for the identified cancer types. We believe that these eligibility
criteria for RO
[[Page 34497]]
beneficiaries are necessary in order to properly evaluate this change
with minimal intervening effects.
We propose that a beneficiary who meets all of these criteria, and
who does not trigger any of the beneficiary exclusion criteria, would
be called a ``RO beneficiary''. We propose to codify the terms ``RO
beneficiary,'' ``RT provider,'' and ``RT supplier'' at Sec. 512.205.
In addition, we propose to include in the RO Model any beneficiary
participating in a clinical trial for RT services for which Medicare
pays routine costs, provided that such beneficiary meets all of the
proposed beneficiary inclusion criteria. We would consider routine
costs of a clinical trial to be all items and services that are
otherwise generally available to Medicare beneficiaries (that is, there
exists a benefit category, it is not statutorily excluded, and there is
not a national non-coverage decision) that are provided in either the
experimental or the control arms of a clinical trial.\29\ 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.
---------------------------------------------------------------------------
\29\ The current Medicare policy on routine cost in clinical
trials is described in Routine Costs in Clinical Trials 100-3
section 310.1.
---------------------------------------------------------------------------
The RO Model's proposed design would not allow RO beneficiaries to
``opt out'' of the Model's pricing methodology. A beneficiary who is
included in the RO Model pursuant to the previously proposed criteria
would have his or her RT services paid for under the Model's pricing
methodology and would be responsible for the coinsurance amount as
described in section III.C.6.i. Beneficiaries do have the right to
choose to receive RT services in a geographic area not included in the
RO Model.
If a RO beneficiary stops meeting any of the proposed eligibility
criteria or triggers any of the exclusion criteria (see section
III.C.4. of this proposed rule) before the TC of an episode initiates,
then the episode would be an incomplete episode as described in section
III.C.6.a. of this proposed rule Payments to RO participants will be
retrospectively adjusted to account for incomplete episodes during the
annual reconciliation process, as described in section III.C.11. of
this proposed rule.
If traditional Medicare stops being an RO beneficiary's primary
payer after the TC of the episode has been initiated, then regardless
of whether the beneficiary's course of RT treatment was completed, the
90-day period would be considered an incomplete episode and, the RO
participant would receive only the first installment of the episode
payment. In the event that a beneficiary dies or enters hospice during
an episode, then the RO participant would receive both installments of
the episode payment, regardless of whether the RO beneficiary's course
of RT has ended (see section III.C.7. of this proposed rule).
We are proposing these beneficiary eligibility criteria for
purposes of determining beneficiary inclusion in and exclusion from the
Model.
5. Proposed RO Model Episodes
In this proposed RO Model, Medicare would pay RO participants a
site-neutral, episode-based payment amount for all specified RT
services furnished to a RO beneficiary during a 90-day episode. In this
section, we first explain our proposal to include criteria to add or
remove cancer types under the Model and their relevant diagnoses codes
in the Model as well as the RT services and modalities that would be
covered and not covered in an episode payment for treatment of those
cancer types. We then explain our proposal for testing a 90-day episode
and propose the conditions that must be met to trigger an episode.
a. Proposed Included Cancer Types
We propose the following criteria for purposes of including cancer
types under the RO Model. The cancer type--
Is commonly treated with radiation; and
Has associated current ICD-10 codes that have demonstrated
pricing stability.
We further propose to codify these criteria for included cancer
types at Sec. 512.230(a) of our regulation.
We propose the following criteria for purposes of removing cancer
types under the RO Model.
RT is no longer appropriate to treat a cancer type per
nationally recognized, evidence-based clinical treatment guidelines;
CMS discovers a >=10 percent (>=10%) error in established
national baseline rates; or
The Secretary determines a cancer type not to be suitable
for inclusion in the Model.
We further propose to codify these criteria for removing cancer
types at Sec. 512.230(b) of our regulation.
We identified 17 cancer types in Table 1 that meet our proposed
criteria. These 17 cancer types are commonly treated with RT and
Medicare claims data was sufficiently reliable to calculate prices for
prospective episode payments that accurately reflect the average
resource utilization for an episode. These cancer types are made up of
specific ICD-9 and ICD-10 diagnosis codes. For example, as shown in
Table 1, there are cancer types for ``breast cancer'' and ``prostate
cancer,'' which are categorical terms that represent a grouping of ICD-
9 and ICD-10 codes affiliated with those conditions. To identify these
cancer types and their relevant diagnosis codes to include in the
Model, we identified cancers that are treated with RT.
Using the list of cancer types and relevant diagnosis codes, we
analyzed the interquartile ranges of the episode prices across
diagnosis codes within each cancer type to determine pricing stability.
We chose to exclude benign neoplasms and those cancers that are rarely
treated with radiation because there were not enough episodes for
reliable pricing and they were too variable to pool.
During our review of skin cancer episodes, we discovered that
Current Procedural Terminology[supreg] (CPT[supreg]) 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[supreg] code 0394T to
report high dose rate (HDR) electronic skin brachytherapy and 0395T to
report HDR electronic interstitial or intracavitary treatments) in
2016. Local coverage determinations (LCDs) that provide information
about whether or not a particular item or service is covered were
created and subsequently changed during this time period. Our analysis
suggested that the volume and pricing of these services dropped
significantly between 2015 and 2016, with pricing decreasing more than
50 percent. As a result, we did not believe that we could price
episodes for skin cancers that accurately reflect the average resource
utilization for an episode. Thus, skin cancer was excluded.
We are proposing that the RO Model's included cancer types would
include those that are commonly treated with RT and that can be
accurately priced for prospective episode payments. An up-to-date list
of cancer types would be kept on the RO Model website.
We propose to define the term ``included cancer types'' to mean the
[[Page 34498]]
cancer types determined by the criteria set forth in Sec. 512.230,
which are included in the RO Model test.
[GRAPHIC] [TIFF OMITTED] TP18JY19.000
We would maintain the list of ICD-10 codes for included cancer
types under the RO Model on the RO Model website. Any addition or
removal of these proposed cancer types would be communicated via the RO
Model website and written correspondence to RO participants. We would
notify RO participants of any changes to the diagnosis codes for the
included cancer types per the CMS standard process for announcing
coding changes and update the list on the RO Model website no later
than 30 days prior to each PY.
We invite public comments on our proposal.
b. Episode Length and Trigger
(1) Proposed Episode Length
We are proposing that the length of an episode under the RO Model
be 90 days. Based on the analysis of Medicare claims data between
January 1, 2014 and December 30, 2015, approximately 99 percent of
beneficiaries receiving RT completed their course of radiation within
90 days of their initial treatment planning service. Day 1 would be the
date of service that a Professional participant or Dual participant
furnishes the initial treatment planning service (included in the PC),
provided that a Technical participant or Dual participant furnishes an
RT delivery service (included in the TC) within 28 days of the
treatment planning service. In other words, the relevant 90-day period
would be considered an episode only if a Technical participant or Dual
participant furnishes the TC to an RO beneficiary within 28 days of
when a Professional participant or Dual participant furnishes the PC to
such RO beneficiary. When those circumstances
[[Page 34499]]
occur, the ``start'' of the episode would be the date of service that
the initial treatment planning service was rendered. If, however, a
Technical participant or Dual participant does not furnish the TC to an
RO beneficiary within the 28-day period, then no episode will have
occurred and any payment would be made to the RO participant in
accordance with our incomplete episode policy. We refer readers to
sections III.C.5.b and III.C.6.a for an overview of our proposed
episode trigger and incomplete episode policies, respectively.
To better understand the standard length of a course of RT, we
analyzed Medicare claims for beneficiaries who received any RT services
between January 1, 2014 and December 30, 2015. Preliminary analysis
showed that average Medicare spending for radiation treatment tends to
drop significantly 9 to 11 weeks following the initial RT service for
most diagnoses, including prostate, breast, lung, and head and neck
cancers. Furthermore, based on this data, approximately 99 percent of
beneficiaries receiving RT completed their course of radiation within
90 days of their initial treatment planning service. We intend to make
a summary-level, de-identified file titled the ``RT Expenditures by
Time'' available on the RO Model's website that supports our findings
in this preliminary analysis.
Based on our analysis, for the purpose of establishing the national
base rates for the PC and TC of each episode for each cancer type,
episodes were triggered by the occurrence of a treatment planning
service followed by a radiation treatment delivery service within 28
days of the treatment planning service (HCPCS codes 77261-77263). In
addition, for the purpose of establishing the national base rates in
section III.C.6.c, the episodes lasted for 89 days starting from the
day after the initial treatment planning service in order to create a
full 90-day episode.
Based on these analyses, we are proposing a 90 day episode
duration.
(2) Proposed Episode Trigger
Because we only want to include episodes in which beneficiaries
actually receive RT services, we propose that an episode would be
triggered only if both of the following conditions are met: (1) There
is an initial treatment planning service (that is, submission of
treatment planning HCPCS codes 77261-77263, all of which would be
included in the PC) furnished by a Professional participant or a Dual
participant; and (2) at least one radiation treatment delivery service
(as listed in Table 2: List of RO Model Bundled HCPCS) is furnished by
a Technical participant or a Dual participant within the following 28
days. The PC is attributed to the RT supplier of the initial radiation
treatment planning service. The TC is attributed to the RT provider or
RT supplier of the initial radiation treatment delivery service. As we
previously explained, an episode that is triggered would end 89 days
after the date of the initial treatment planning service, creating a 90
day episode. If, however, a beneficiary receives an initial treatment
planning service but does not receive RT treatment from a Technical
participant or Dual participant within 28 days, then the requirements
for triggering an episode would not be met, and no RO episode will have
occurred, and the proposed incomplete episode policy would take effect.
In those cases where the TC of an episode is not furnished by a
Dual participant (that is, when the same RO participant does not
furnish both the PC and the TC of an episode), the Professional
participant would provide the Technical participant with a signed
radiation prescription and the final treatment plan, all of which is
usually done electronically. This will inform the Technical participant
of when the episode began.
(3) Proposed Policy for Multiple Episodes and the Clean Period
Given our findings that 99 percent of Medicare FFS beneficiaries
complete treatment within 90 days of the initial treatment planning
service, and to minimize any potential incentive for a RO participant
to extend a treatment course beyond the 90-day episode in order to
trigger a new episode, we propose that another episode may not be
triggered until at least 28 days after the previous episode has ended.
This is because, while a missed week of treatment is not uncommon, a
break from RT services for more four weeks (or 28 days) generally
signals the start of a new course of treatment.\30\ We refer to the 28-
day period after an episode has ended, during which time a RO
participant would bill for medically necessary RT services furnished to
a RO beneficiary in accordance with Medicare FFS billing rules, as the
``clean period.'' We propose to codify the term ``clean period'' at
Sec. 512.205 of our regulations.
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\30\ CMS was advised by radiation oncologists consulting on the
design of the Model that four weeks signals the start of a new
course of treatment.
---------------------------------------------------------------------------
If clinically appropriate, a RO participant may initiate another
episode for the same beneficiary after the 28-day clean period has
ended. During the clean period, a RO participant would be required to
bill for RT services for the beneficiary in accordance with FFS billing
rules. The Innovation Center would monitor the extent to which services
are furnished outside of 90-day episodes, including during clean
periods, and for the number of RO beneficiaries who receive RT in
multiple episodes.
We invite public comment on our proposal.
c. Proposed Included RT Services
We propose that the RO Model would include most RT services
furnished in HOPDs and freestanding radiation therapy centers. Services
furnished within an episode of RT usually follow a standard, clearly
defined process of care and generally include a treatment consultation,
treatment planning, technical preparation and special services
(simulation), treatment delivery, and treatment management, which are
also categorical terms used to generally describe RT services. The
subcomponents of RT services have been described in the following
manner: \31\
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\31\ American Society for Radiation Oncology (ASTRO). Basics of
RO Coding. https://www.astro.org/Basics-of-Coding.aspx.
---------------------------------------------------------------------------
Consultation: A consultation is an evaluation and management (E&M)
service, which typically consists of a medical exam, obtaining a
problem-focused medical history, and decision making about the
patient's condition/care.
Treatment planning: Treatment planning tasks include determining a
patient's disease-bearing areas, identifying the type and method of
radiation treatment delivery, specifying areas to be treated, and
selecting radiation therapy treatment techniques. Treatment planning
often includes simulation (the process of defining relevant normal and
abnormal target anatomy and obtaining the images and data needed to
develop the optimal radiation treatment process). Treatment planning
may involve marking the area to be treated on the patient's skin,
aligning the patient with localization lasers, and/or designing
immobilization devices for precise patient positioning.
Technical preparation and special services: Technical preparation
and special services include radiation dose planning, medical radiation
physics, dosimetry, treatment devices, and special services. More
specifically, these services also involve building treatment devices to
refine treatment delivery and mathematically determining the dose
[[Page 34500]]
and duration of radiation therapy. Radiation oncologists frequently
work with dosimetrists and medical physicists to perform these
services.
Radiation treatment delivery services: Radiation treatment is
usually furnished via a form of external beam radiation therapy or
brachytherapy, and includes multiple modalities. Although treatment
generally occurs daily, the care team and patient determine the
specific timing and amount of treatment. The treating physician must
verify and document the accuracy of treatment delivery as related to
the initial treatment planning and setup procedure.
Treatment management: Radiation treatment management typically
includes review of port films, review and changes to dosimetry, dose
delivery, treatment parameters, review of patient's setup, patient
examination, and follow-up care.
Our claims analysis revealed that beneficiaries received a varying
number of consultations from different physicians prior to the
treatment planning visit, which determines the prescribed course of
radiation therapy, including modality and number of treatments to be
delivered. We are proposing to include treatment planning, technical
preparation and special services, treatment delivery, and treatment
management as the RT services in an episode paid for by CMS, and we
propose to codify this at Sec. 512.235. E&M services are furnished by
a wide range of physician specialists (for example, primary care,
general oncology, others) whereas the other radiation services are
typically only furnished by radiation oncologists and their team. This
is reflected in the HCPCS code set used to bill for these services. In
our review of claims data, many different types of specialists furnish
E&M services. It is common for multiple entities to bill for treatment
consultations (E&M services) for the same beneficiary, whereas
typically only a single entity bills for RT services for a beneficiary
when we limited the services considered to treatment planning,
technical preparation and special services, treatment delivery, and
treatment management. When consultations and visits were included for
an analysis of professional RT services during 2014-2016, only 18
percent of episodes involved billing by a single entity (TIN or CCN) as
opposed to 94 percent of episodes when consultations and visits were
excluded. When consultations and visits were included for an analysis
of technical RT services during 2014-2016, 78 percent of episodes
involved billing by a single entity (TIN or CCN) as opposed to 94
percent of episodes when consultations and visits were excluded. The
difference in percentages is due to the fact that patients see a wide
variety of doctors during the course of cancer treatment, which will
often involve visits and consultations.
We are not proposing to include E&M services as part of the episode
payment. RO participants would continue to bill E&M services under
Medicare FFS.
We would also exclude low volume RT services from the RO Model.
These include certain brachytherapy surgical procedures, neutron beam
therapy, hyperthermia treatment, and radiopharmaceuticals. We are
excluding these services from the Model because they are not offered in
sufficient amounts for purposes of evaluation.
Given that physicians sometimes contract with others to supply and
administer brachytherapy radioactive sources (or radioisotopes), we
considered omitting these services from the episode payment. After
considering either including or excluding brachytherapy radioelements
from the RO Model, we are proposing to include brachytherapy
radioactive elements, rather than omit these services, from the
episodes because they are generally furnished in HOPDs and the
hospitals are usually the purchasers of the brachytherapy radioactive
elements. When not furnished in HOPDs, these services are furnished in
ASCs, which we are proposing to exclude from the Model. We invite
public comments on our proposal, including comments on the proposed
inclusion of brachytherapy radioactive sources in the episodes.
The RO Model payments would replace current FFS payments only for
the included RT services furnished during an episode. For the included
modalities, proposed in section III.C.5.d of this proposed rule, the RO
Model episode would include HCPCS codes related to radiation oncology
treatment. Please see section III.C.7 for our proposed billing
guidelines. We have compiled a list of HCPCS codes that represent
treatment planning, technical preparation and special services,
treatment delivery, and treatment management for the included
modalities. RT services included on this list are referred to as ``RO
Model Bundled HCPCS'' when they are provided during a RO Model episode
since payment for these services is bundled into the RO episode
payment. Thus, we propose to codify at Sec. 512.270 that these RT
services would not be paid separately during an episode. We may add,
remove, or revise any of the bundled HCPCS codes included in the RO
Model. We would notify participants of any changes to the HCPCS codes
per the CMS annual Level 2 HCPCS code file. We would maintain a list of
the HCPCS codes included in the RO Model on the RO Model website.
BILLING CODE P
[[Page 34501]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.001
[[Page 34502]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.002
BILLING CODE C
d. Proposed Included Modalities
We propose 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 are
proposing to include all of these modalities because they are the most
commonly used to treat the 17 included 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.
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.\32\ Higher
payment rates for services involving certain treatment modalities may
encourage use of those modalities over others.\33\
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\32\ 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.
\33\ Ibid.
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Medicare payment for RT has 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.\34\ 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,\35\
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
[[Page 34503]]
increase in PBT, we can monitor changes in the utilization of treatment
modalities during the course of the Model. The aforementioned increase
in PBT volume may depend on a variety of factors.
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\34\ 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.
\35\ 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.
---------------------------------------------------------------------------
The RO Model's episode payment is 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
groups together different modalities for specific cancer types, often
with variable costs, into a single payment that reflects average
treatment costs. The Model would include an historical experience
adjustment which would account for RO participant's historical care
patterns, including a RO participant's historical use of more expensive
modalities, and certain factors that are beyond a provider's control.
We believe that applying the same payment for the most commonly used RT
modalities would allow physicians to pick the highest-value modalities.
Given the goals of the RO Model as well as the proposed payment
design, we believe it is important to treat all modalities equally.
With respect to PBT, 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.\36\ 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.\37\ 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 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 invite
public comment our proposal to include PBT in the RO Model.
---------------------------------------------------------------------------
\36\ 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.
\37\ http://medpac.gov/docs/default-source/reports/jun18_ch10_medpacreport_sec.pdf.
---------------------------------------------------------------------------
We are considering excluding PBT from the included modalities in
instances where a 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 invite 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.
6. Proposed Pricing Methodology
a. Overview
The proposed pricing methodology describes 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. We propose 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 a
RO beneficiary during an episode, which is calculated as set forth in
proposed Sec. 512.255. We further propose to codify this term,
``participant-specific professional episode payment,'' at Sec. 512.205
of our regulations.
We propose 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 a RO beneficiary during an episode, which is calculated as
set forth in proposed Sec. 512.255. We further propose to codify this
term, ``participant-specific technical episode payment,'' at Sec.
512.205 of our regulations.
There are eight primary steps to the proposed pricing methodology.
In the first step, we would 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. The calculation of these rates would 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. 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
exclude those episodes that do not meet the criteria described in
section III.C.5 of this proposed rule. From those episodes, we would
then calculate the amount CMS paid on average to providers 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 would be
fixed throughout the model performance period.
In the second step, we would 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 OPPS and PFS. We propose 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 propose to codify the term
``trend factor'' at Sec. 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, 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 the national base rates with a
trend factor would 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 would 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 providers' historical care patterns and certain factors that are
beyond a provider's control, which vary systematically among providers
and suppliers so as to
[[Page 34504]]
warrant adjustment in payment. 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 would 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 would 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.
The efficiency factor measures if a 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 would further adjust payment by applying a
discount factor. The discount factor, the set percentage by which CMS
reduces an episode payment amount, after the trend factor and
adjustments have been applied, but before standard CMS adjustments
including the geographic practice cost index (GPCI), sequestration, and
beneficiary cost-sharing, would reserve savings for Medicare and reduce
beneficiary cost-sharing. We propose to codify the term ``discount
factor'' at Sec. 512.205.
In the fifth step, we would 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, which we
discuss further in section III.C.11. We propose to define the term
``duplicate RT service'' to mean any included RT service (as identified
at Sec. 512.235) 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 after the episode. We propose to codify ``duplicate
RT service'' at Sec. 512.205. 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 a RO beneficiary within 28 days following a
Professional participant or the Dual participant furnishing an RT
treatment planning service to that RO beneficiary; or (2) traditional
Medicare stops being the primary payer at any point during the relevant
90-day period the RO beneficiary; or (3) a RO beneficiary stops meeting
the beneficiary population criteria under Sec. 512.215(a) or triggers
the beneficiary exclusion criteria under Sec. 512.215(b) before the
technical component of an episode initiates.
We would also 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 would 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 would apply geographic adjustments to
payments. In the seventh and final eighth step, we would 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 payment amounts
for the provision of the PC and TC of each included cancer type in the
Model. We would 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 is a pricing example for an episode of lung
cancer. We provide 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 intend to provide 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.
b. Proposal To Construct Episodes Using Medicare FFS Claims and
Calculate Episode Payment
We would 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 described in section III.C.3.d. We
would exclude those episodes that do not meet the criteria described in
section III.C.5 of this proposed 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 described in
section III.C.5.b. We would 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 would
neither Winsorize nor cap payment amounts nor adjust for outliers in
this step.
So that all payment amounts are in 2017 dollars, we would 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 would 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.
Conversion of 2015 and 2016 payment amounts to 2017 dollars would
be done differently, depending on which step of the pricing methodology
is being calculated. For instance, episode payments for episodes used
to calculate national base rates and case mix
[[Page 34505]]
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.
c. Proposed National Base Rates
We propose 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 proposed included cancer types. We
further propose to codify this term at Sec. 512.205 of our
regulations.
The following episodes would be excluded 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 (see Table 1);
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 proposed in section III.C.4.
We are proposing 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 are proposing 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 this section exclude episodes that are in
accordance with proposals set forth in section III.C.5.
(1) Proposed National Base Rate Calculation Methodology
When calculating the national base rates, we would only use
episodes that meet the following criteria: (1) Episodes initiated in
2015-2017; (2) episodes attributed to a HOPD; and (3) during an
episode, the majority of technical services were provided in a HOPD
(that is, more technical services were provided in a HOPD than in a
freestanding radiation therapy center). 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 that the PFS payment amounts
for services involving capital equipment.
CMS would publish the national base rates and 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.
Our proposed national base rates for the model performance period
based on the criteria set forth for cancer type inclusion are
summarized in Table 3.
BILLING CODE P
[[Page 34506]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.004
BILLING CODE C
d. Proposal To Apply Trend Factors to National Base Rates
We would next apply a trend factor to the 34 different national
base rates in Table 3. 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.
We propose that 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.
---------------------------------------------------------------------------
\38\ The final HCPCS codes specific to the RO Model would be
published in the CY2020 Level 2 HCPCS code file.
---------------------------------------------------------------------------
For the PC of each included cancer type and the TC of each included
cancer type, we would calculate a ratio of: (a) Volume-weighted FFS
payment rates for
[[Page 34507]]
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
would be FFS rates from 2017.
To calculate the numerator, we would multiply: (a) The average
number of times each HCPCS code (relevant to the component and the
cancer type for which the trend factor would be applied) was furnished
for the most recent calendar year with complete data \39\ by (b) the
corresponding FFS payment rate (as paid under OPPS or PFS) for the
upcoming performance year.
---------------------------------------------------------------------------
\39\ 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.
---------------------------------------------------------------------------
To calculate the denominator, we would multiply: (a) The average
number of times each HCPCS code (relevant to the component and the
cancer type for which the trend factor would be applying) 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)[hairsp]/[hairsp](2017 volume * 2017 corresponding
FFS rates as paid under OPPS or PFS)
We would 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 34 trended national base rates.
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 propose 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.\40\
---------------------------------------------------------------------------
\40\ 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.
---------------------------------------------------------------------------
We propose to use this trend factor methodology as part of the RO
Model's pricing methodology.
e. Proposal To Adjust for Case Mix and Historical Experience
After applying the proposed trend factor in section III.C.6.d, we
propose to adjust the 34 trended national base rates to account for
each RO participant's historical experience and case mix history.
(1) Proposed Case Mix Adjustments
The cost of care can vary according to many factors that are beyond
a provider's control, and the presence of certain factors, otherwise
referred to here as case mix variables, may vary systematically among
providers and warrant adjustment in payment. For this reason, we
propose to apply a RO participant-specific case mix adjustment for the
PC and the TC that would be applied to the trended national base rates.
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 propose 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 is 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 would 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 would determine a
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. 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 would then determine a 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 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 a RO participant to
determine a single expected payment for the PC or the TC. The
difference between a RO participant's predicted payment and a 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. Mathematically this would be expressed as follows:
Case mix adjustment = (Predicted payment-Expected payment)[hairsp]/
[hairsp]Expected payment
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 a RO participant's
case mix adjustments take into account more recent changes in the case
mix of their beneficiary population. For example, we would use data
from 2015-2017 for PY1, data from 2016-2018 for PY2, data from 2017-
2019 for PY3, etc.
(2) Proposed Historical Experience Adjustments and Efficiency Factor
To determine historical experience adjustments for a RO participant
we would use episodes attributed to the RO
[[Page 34508]]
participant that initiated during 2015-2017. We would 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 would use
episodes as described in section III.C.6.b (that is, all episodes
nationally), except we would 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 would not vary by
cancer type.
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 would then be divided by (c) the summed expected payments used in
the case mix adjustment calculations. We would repeat these same
calculations for the historical experience adjustment for the TC.
Mathematically, for episodes attributed to the RO participant, this
would be expressed as:
Historical experience adjustment = (Winsorized payments-Predicted
payments)[hairsp]/[hairsp]Expected payments
Based on our proposed calculation, if a 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 a 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 would use an
efficiency factor. Efficiency factor means the weight that a 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, 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.
(3) Proposal To Apply the Adjustments
To apply the case mix adjustment, the historical experience
adjustment, and the efficiency factor as described in section III.C.6.e
to the trended national base rates detailed in Step 2, for the PC we
would 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. Mathematically this would be expressed as:
Combined Adjustment = (Historical experience adjustment * Efficiency
factor) + Case mix adjustment + 1.0
The combined adjustment would then be multiplied by the
corresponding trended national base rate from Step 2 for each cancer
type. We would repeat these calculations for the corresponding case mix
adjustment, historical experience adjustment, and efficiency factor 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.
We propose to use these case mix adjustments, historical experience
adjustments, and efficiency factors to calculate the adjustments under
the RO Model's pricing methodology.
(4) Proposal for HOPD or Freestanding Radiation Therapy Center With
Fewer Than Sixty Episodes During 2015-2017 Period
Under this proposed rule, if a HOPD or freestanding radiation
therapy center (identified by a CCN or TIN) furnishes RT services
during the model performance period within a selected CBSA and is
required to participate in the Model because it meets eligibility
requirements, but has 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 continues to have fewer than sixty episodes attributed
to it during the 2016-2018 period, then 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 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 would 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 would 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.
[[Page 34509]]
(5) Proposal To 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 are proposing 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. If the new TIN or CCN begins
to furnish RT services within a selected CBSA, then it must participate
in the Model. We are proposing 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.
The RO Model requires 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 proposed at Sec. 512.180(c), except
that under the RO Model, RO participants must also provide a
notification regarding a new clinical relationship that may or may
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 proposed policy regarding change in legal business name and change
in control provisions, we refer readers to discussion in section II.L
and proposed regulations at Sec. 512.180(b) and (c).
f. Proposal To Apply a Discount Factor
After applying participant-specific adjustments under section
III.C.6.e to the trended national base rates, we would next deduct a
percentage discount from those amounts for each performance year. The
discount factor would not vary by cancer type. The discount factor for
the PC would be 4 percent. The discount factor for the TC would be 5
percent. We are proposing the 4 and 5 percent discounts based on
discounts in other models tested under section 1115A and private payer
models. We believe these figures for the discount factor, four and 5
percent for the PC and TC, respectively, strike an appropriate balance
in creating savings for Medicare while not creating substantial
financial burden on RO participants with respect to reduction in
payment.
We propose to apply these discount factors to the RO participant-
adjusted and trended payment amounts for each of the RO Model's
performance years.
g. Proposal To Apply Withholds
We propose to withhold a percentage of the total episode payments,
that is the payment amounts 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 outline our proposals for three
withhold policies in this section of this proposed rule.
(1) Proposed Incorrect Payment Withhold
We propose 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 described in section III.C.6.a; and (2)
incomplete episodes as described in section III.C.6.a of this proposed
rule.
We are proposing 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 a RO
participant's cash flow. We believe that a 2 percent incorrect payment
withhold would set aside sufficient funds to capture a RO participant's
duplicate RT services and incomplete episodes during the reconciliation
process. We anticipate that duplicate RT services requiring
reconciliation will be uncommon, and that few overpayments for such
services would therefore be subject to our proposed 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 would use the annual reconciliation process described in section
III.C.11 to determine whether a RO participant is eligible to receive
back the full 2 percent withhold amount, a portion of it, or must repay
funds to CMS. We propose to define the term ``repayment amount'' to
mean the amount owed by a RO participant to CMS, as reflected on a
reconciliation report. We propose to codify the term ``repayment
amount'' at Sec. 512.205 of our regulations. In addition, we propose
to define the term ``reconciliation report'' to mean the annual report
issued by CMS to a RO participant for each performance year, which
specifies the RO participant's reconciliation payment amount or
repayment amount. We further propose to codify the term
``reconciliation report'' at Sec. 512.205.
(2) Proposed Quality Withhold
We propose 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
propose to define the term ``AQS'' to mean the numeric score calculated
for each RO participant based on its performance on, and reporting of,
proposed quality measures and clinical data, as described in section
III.C.8.f, which is used to determine the amount of a RO participant's
quality reconciliation payment amount. We further propose to codify
this term at Sec. 512.205 of our regulations. The annual
reconciliation process described in section III.C.11 would determine
how much of the 2 percent withhold a Professional participant or Dual
participant would receive back.
(3) Proposed Patient Experience Withhold
We would withhold 1 percent 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. 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[supreg] Cancer Care Survey) Cancer Care Survey for
Radiation Therapy as described in section III.C.8.b. of this proposed
rule.
[[Page 34510]]
Like the incorrect payment and quality withholds, the annual
reconciliation process described in section III.C.11. of this proposed
rule would determine how much of the 1 percent withhold a participant
would receive back.
We propose the incorrect payment withhold, the quality withhold,
and the patient experience withhold be included in the RO Model's
pricing methodology.
h. Proposal To Adjust for Geography
Geographic adjustments are standard Medicare adjustments that occur
in the claims system. Even though the Model would establish a common
payment amount for the same RT services regardless of where they are
furnished, payment would still be processed through the current claims
systems, with adjustments as discussed in section III.C.7, for OPPS and
PFS. 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 would adjust the
trended national base rates that have been adjusted for each RO
participant's case mix, historical experience and after which the
discount rate 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. 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 would 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 a 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 episodes under the Model would have different
RO Model-specific RVU shares, but these shares would not vary by cancer
type. Table 4 provides the proposed relative weight of each for the PCs
and TCs of the RO Model-specific RVUs share.
Table 4--RVU Shares
------------------------------------------------------------------------
Professional component Technical component
------------------------------------------------------------------------
Work PE MP Work PE MP
------------------------------------------------------------------------
0.66 0.30 0.04 0.00 0.99 0.01
------------------------------------------------------------------------
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 propose to apply the OPPS Pricer as is automatically applied
under OPPS outside of the Model. We propose 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.
i. Proposal To Apply Coinsurance
We propose to calculate the coinsurance amount for a RO beneficiary
after applying, as appropriate, the proposed 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). This policy would remain the same under the RO
Model. RO beneficiaries would 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.
We believe that maintaining the 20 percent coinsurance payment will
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.
We note 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 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 episode. In other
words, the proposed withhold and discount factors would, on average, be
expected to reduce the total amount RO beneficiaries or secondary
insurers would owe RO participants. In addition, 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 likewise be higher than it would otherwise be for a
single RT service visit. For RO beneficiaries who do not have a
secondary insurer, 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, we would 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 trended national base rates that
concern the TC after the case
[[Page 34511]]
mix and historical experience adjustments, discount factor, applicable
withholds, and geographic adjustment have been applied.
We invite 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 proposed case mix and historical experience
adjustments, withholds, discount factors, and geographic adjustments
have been applied.
j. Example of Participant-Specific Professional Episode Payment and
Participant-Specific Technical Episode Payment for an Episode Involving
Lung Cancer in PY1
Table 5 details the participant-specific professional episode
payment paid by CMS to a single TIN for the furnishing of RT
professional services to RO beneficiary for an episode of lung cancer.
The participant-specific professional episode payment in this example
does not include any withhold amount that the RO participant would be
eligible to receive back or repayment if more money is needed beyond
the withhold amount from the RO participant.
BILLING CODE P
[GRAPHIC] [TIFF OMITTED] TP18JY19.005
Table 6 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 a RO beneficiary for an episode of lung cancer.
The sequence and naming conventions of steps (n)-(r) in Table 6 may
vary under the OPPS.
[[Page 34512]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.006
BILLING CODE C
We invite public comment on our proposed pricing methodology.
7. Proposed Professional and Technical Billing and Payment
Similar to how many procedure codes have professional and technical
components as identified in the CMS National Physician Fee Schedule
Relative Value File, all 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. We believe that the
best design for a prospective episode payment system for RT services is
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 reduces the likelihood that the limit on
beneficiary liability for copayment for a procedure provided in a HOPD
(as described in section 1833(t)(8)(C)(i) of the Act) is met.
Accordingly, we propose to 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 propose to 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
would make changes to the current Medicare payment systems using the
standard Medicare Fee for Service operations policy related Change
Requests (CRs).
Our proposed design for testing a prospective episode payment model
(that is, the RO Model) for RT services requires making prospective
episode payments for all RT services included in an episode, as
proposed in section III.C.5.c, instead of using Medicare FFS payments
for services provided during an episode. Local coverage determinations
(LCDs), which provide information about the reasonable and necessary
conditions of coverage
[[Page 34513]]
allowed, would still apply to all RT services provided in an episode.
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 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.
Payment for the PC would be made through the PFS and would only be paid
to physicians (as identified by their respective TINs).
Under our proposed billing policy, a Professional participant or
Dual participant that furnishes the PC of the episode must bill one of
the new RO Model-specific HCPCS codes and SOE modifier. This would
indicate within the claims systems that an episode has started. Upon
submission of a claim with a RO Model-specific HCPCS codes and 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 must bill the same RO
Model-specific HCPCS code that initiated the episode with a modifier
indicating the end of an episode (EOE) after the end of the 90-day
episode. This would indicate that the episode has ended. Upon
submission of a claim with a RO Model-specific HCPCS codes and EOE
modifier 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 must bill a new
model-specific HCPCS code with a SOE modifier. 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 model-specific HCPCS code with a SOE modifier. We
would pay the second half of the payment for the TC of the episode
after the end of the episode. The Technical participant or Dual
participant must bill the same RO Model-specific HCPCS code with an EOE
modifier that initiated the episode. This would indicate that the
episode has ended.
Similar to the way PCs are billed, we would develop a new HCPCS
codes (and any modifiers) for the TC of each of the included cancer
types. 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. 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.
The TC of the episode would begin on or after the date that the PC
of the episode is initiated and 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. This is because the treatment
planning service and the actual RT treatment do not always occur on the
same day.
RO participants would be required to submit encounter data (no-pay)
claims that include all RT services identified on the RO Model Bundled
HCPCS list (Table 2) as services are furnished and would otherwise be
billed under the Medicare FFS systems. We will monitor trends in
utilization of RT services during the Model. These claims will not be
paid because the bundled payments cover RT services provided during the
episode. The encounter data would be used for evaluation and model
monitoring, specifically trending utilization of RT services, and other
CMS research.
If a RO participant provides clinically appropriate RT services
during the 28 days after an episode ends, then the RO participant must
bill Medicare FFS for those RT services. A new episode may not be
initiated during the 28 days after an episode ends. As we explain in
section III.C.5.b.(3). of this proposed rule, we refer to this 28 day
period as the ``clean period.''
In the event that a RO beneficiary changes RT provider or RT
supplier after the SOE claim has been paid, 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. This
would occur during the annual reconciliation process described in
section III.C.11. of this proposed rule. The subsequent provider or
supplier (whether or not they are a RO participant) would bill FFS for
furnished RT services.
Similarly, in the event that a beneficiary dies, enters hospice, 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 (also
referred to as an incomplete episode), during the annual reconciliation
process 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, 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 enters hospice after both PC and TC
of the episode have been initiated, the RO participant(s) may bill EOE
claims and be paid the second half of the episode payment amounts
regardless of whether treatment was completed. This is because death
and hospice are included in the case mix adjuster.
There may be instances where new providers and suppliers begin
furnishing RT services in a CBSA selected to participate in the RO
Model. These new providers and suppliers would be RO participants and
would have to be identified as such in the claims systems. When a claim
is submitted with a RO Model-specific HCPCS code for a site of service
that is located within one of the randomly selected CBSAs as identified
by the service location's ZIP Code, but the CCN or TIN is not yet
identified as a RO participant in the claims systems, 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, they will be identified in the claims system and will 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
there is sufficient data to calculate those adjustments as described in
the pricing methodology section III.C.6. of this proposed rule.
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 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-
[[Page 34514]]
specific webinars, and the RO Model website.
8. Quality
The quality measures we propose in this proposed rule, along with
the proposed clinical data elements in section III.C.8.e, would be
scored according to the methodology proposed in section III.C.8.f to
calculate the Aggregate Quality Score (AQS). The AQS would be applied
to the quality withhold described in section III.C.6.g.(2). of this
proposed rule to calculate the quality reconciliation payment amount
due to a Professional participant or Dual participant as specified in
section III.C.11. of this proposed rule. Results from selected patient
experience measures based on the CAHPS[supreg] 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 this proposed rule.
a. Proposed Measure Selection
We propose to adopt the following set of quality measures for the
RO Model in order to assess the quality of care provided during
episodes. We would begin requiring annual quality measure data
submission by Professional participants and Dual participants in March
of 2021 for episodes starting and ending inPY1, Quality measures will
continue requiring annual data submissions thereafter through the
remainder of the model performance period as described in section
III.C.8.c. of this proposed rule These quality measures would be used
to determine a RO participant's AQS, proposed in section III.C.8.f. of
this proposed rule, and subsequent quality reconciliation amount,
described in section III.C.11. of this proposed rule. Based on the
considerations set forth in this rule, we propose the following
measures for the RO Model beginning in PY1 and continuing thereafter:
Oncology: Medical and Radiation--Plan of Care for Pain--NQF
\41\ #0383; CMS Quality ID #144
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\41\ National Quality Forum.
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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 are proposing to adopt these quality measures for the RO Model
for two reasons. First, the Model is designed to preserve or enhance
quality of care, and quality measures would allow us to quantify the
impact of the Model on quality of care, RT services and processes,
outcomes, patient satisfaction, and organizational structures and
systems. Second, as discussed in section III.C.9 of this proposed rule,
we intend for the RO Model to qualify as an Advanced APM, and also meet
the criteria to be a MIPS APM. As stated previously, we believe the
proposed quality measures would satisfy the quality measure-related
requirements for both an Advanced APM and a MIPS APM. We believe that
the following proposed measures meet the requirements of 42 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. These measures are already
adopted in MIPS, and we believe the other proposed measure is evidence
based, reliable, and valid. We note, however, that we have not proposed
an outcome measure for the RO Model. Under 42 CFR 414.1415(b)(3), the
quality measures upon which an Advanced APM bases payment to
participants for covered professional services under the terms of the
APM must include at least one additional measure that is an outcome
measure unless CMS determines that there are no available or applicable
outcome measures included in the MIPS final quality measures list for
the Advanced APM's first QP Performance Period. Because we have
determined there are currently no outcome measures available or
applicable for the RO Model, this requirement does not apply to the RO
Model. However, if a relevant outcome measure becomes available, we
would consider it for inclusion in the RO Model's measure set if deemed
appropriate.
We believe our proposed use of quality measures as described in our
proposed AQS scoring methodology in section III.C.8.f. of this proposed
rule would meet the quality measure and cost/utilization requirement
for a MIPS APM under section 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 participants and Dual participants would be
familiar with the measures used in the Model. Lastly, we considered
cross-cutting measures that would allow comparisons of quality across
episode payment models and other CMS model tests.
While 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
scoring on quality performance, we intend to adjust the measure set in
future PYs by adding new measures or removing measures if we determine
those adjustments to be appropriate at the time. Prior to adding or
removing measures we would use notice and comment rulemaking.
Table 7 includes the four proposed RO Model quality measures and
CAHPS[supreg] Cancer Care Survey, the level at which measures would be
reported, and the measures' status as pay-for-reporting or pay-for-
performance, as described in section III.C.8.b. of this proposed rule.
The table also includes the RO Model clinical data elements collection,
proposed in section III.C.8.e. of this proposed rule.
[[Page 34515]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.007
b. Proposed RO Model Measures and CAHPS[supreg] Cancer Care Survey for
Radiation Therapy
In this section, we describe more fully the proposed quality
measures that we propose to use in the RO Model for purposes of
designing a model that could qualify as an Advanced APM and a MIPS APM,
and for measuring quality of care. We describe each measure and our
reasons for its proposed selection in this proposed rule. We also
describe the CAHPS[supreg] Cancer Care Survey for Radiation Therapy and
our proposal to administer the survey as part of the Model.
We selected these proposed 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 that we are proposing are currently NQF-endorsed \42\
process measures approved for MIPS.\43\ The three NQF-endorsed measures
approved for MIPS (Plan of Care for Pain; Screening for Depression and
Follow-Up Plan; and Advance Care Plan) will be applied as pay-for-
performance, given that baseline performance data exists.\44\ The
fourth measure in the RO Model (Treatment Summary Communication) will
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.f.(1). of this proposed rule. All four measures are clinically
appropriate for RT. We selected these measures 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
are also proposing the CAHPS[supreg] Cancer Care Survey to collect
information that we believe is appropriate and specific to a patient's
experience during an RT episode. We believe these measures and the
CAHPS[supreg] Cancer Care Survey \45\ would allow the RO Model to
develop an aggregate quality score (AQS) in our pay-for-performance
methodology (described in section III.C.8.f.) that incorporates
performance measurement with a focus on clinical care and patient
experience.
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\42\ NQF endorsement summaries: http://www.qualityforum.org/News_And_Resources/Endorsement_Summaries/Endorsement_Summaries.aspx.
\43\ See the CY 2018 QPP final rule (82 FR 53568).
\44\ Baseline performance is based on the entirety of data
submitted to meet MIPS data reporting requirements for these
measures and are not specific to radiation oncology performance.
\45\ As discussed in section III.C.8.b(5) and III.C.8.f, the
CAHPS[supreg] Cancer Care Survey would be administered beginning in
April 1, 2020, and we would seek to include measures in the
aggregate quality score beginning inPY3.
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(1) Proposed Oncology: Medical and Radiation--Plan of Care for Pain
(NQF #0383; CMS Quality ID #144)
We propose to adopt the Oncology: Medical and Radiation--Plan of
Care for Pain measure in the RO Model. The Oncology: Medical and
Radiation--Plan of Care for Pain 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.'' \46\ 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.\47\ Proper pain
[[Page 34516]]
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.
---------------------------------------------------------------------------
\46\ 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.
\47\ 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/.
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We believe this measure is appropriate for inclusion in the RO
Model because it is specific to a RT episode of care. It considers the
quality of care of medical and radiation oncology and is NQF endorsed.
The RO Model would adopt the measure according to the most recent
version of the specifications, which is under review at NQF in Fall
2019. The current measure version is 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). 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 we believed that it was necessary to remove the measure from the RO
Model, then we would propose to do so through notice and comment
rulemaking.
This measure is currently undergoing triennial review for NQF
endorsement, and while we expect changes to the measure specifications,
we do not believe these changes would change the fundamental basis of
the measure, nor do we believe they would impact the measure's
appropriateness for inclusion in the RO Model. NQF endorsement is a
factor in our decision to propose the Medical and Radiation--Plan of
Care for Pain measure, but it is not the only factor, so if the measure
were to lose its NQF endorsement, we may choose to retain it so long as
we believe it continues to support CMS and HHS policy goals. Therefore,
we propose to adopt the Plan of Care for Pain measure with the
associated specifications available beginning in PY1. This measure will
be a pay-for-performance measure and scored in accordance with our
proposed methodology in section III.C.8.f.
As discussed further in section III.C.8.c, we would require
Professional participants and Dual participants to report quality
measure data to the RO Model-specific data collection system in the
manner consistent with that submission portal and the measure
specification. The current version of the Plan of Care for Pain measure
specification states the data would 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
proposed rule.
For the RO Model, we propose to use the registry specifications for
this measure. Detailed measure specifications may be found at: https://qpp.cms.gov/docs/QPP_quality_measure_specifications/Claims-Registry-Measures/2018_Measure_144_Registry.pdf.
(2) Proposed Preventive Care and Screening: Screening for Depression
and Follow-Up Plan (NQF #0418; CMS Quality ID #134)
We propose to adopt the Preventive Care and Screening: Screening
for Depression and Follow-Up Plan measure in the RO Model. The
Preventive Care and Screening: Screening for Depression and Follow-Up
Plan measure 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.'' \48\ We believe this clinical topic is
appropriate for a RT episode of care even though it is not specific to
RT. While this measure is drafted for consideration of general mental
health, it can also be applied to RT. 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, we believe inclusion of this
measure is desirable to screen and treat the potential mental health
effects of RT. 49 50 51 52 53 54 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. 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 use
in other CMS programs. If we were to remove the measure, we would use
notice and comment in rulemaking. This measure would be a pay-for-
performance measure beginning in PY1 and scored in accordance with our
proposed methodology in section III.C.8.f.
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\48\ 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.
\49\ Siu AL, and the US Preventive Services Task Force USPSTF.
Screening for Depression in Adults: US Preventive Services Task
Force Recommendation Statement. JAMA. 2016;315(4):380-387.
doi:10.1001/jama.2015.18392.
\50\ 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. doi:10.1371/journal.pone.0027181.
\51\ Li, M., Kennedy, E.B., Byrne, N., G[eacute]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. doi:10.1200/
jop.2016.011072.
\52\ Pinquart, M., & Duberstein, P.R. (2010). Depression and
cancer mortality: A meta-analysis. Psychological Medicine, 40(11),
1797-1810. doi:10.1017/s0033291709992285.
\53\ Massie, M.J. (2004). Prevalence of Depression in Patients
With Cancer. Journal of the National Cancer Institute Monographs,
2004(32), 57-71. doi:10.1093/jncimonographs/lgh014.
\54\ 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.
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As discussed further in section III.C.8.c, we would require
Professional participants and Dual participants to report quality
measure data to the RO Model-specific data collection system in the
manner consistent with that submission portal and the measure
specification. The current version of the Preventive Care and
Screening: Screening for Depression and Follow-Up Plan measure
specification states the data would 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 proposed rule.
For the RO Model, we propose to use the registry specifications for
this measure. Detailed measure specifications may be found at: https://qpp.cms.gov/docs/QPP_quality_measure_specifications/Claims-Registry-Measures/2018_Measure_134_Registry.pdf.
[[Page 34517]]
(3) Proposed Advance Care Plan (NQF #0326; CMS Quality ID #047)
We propose to adopt the Advance Care Plan measure in the RO Model.
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 is a
cross-cutting measure across all specialties and a variety of settings,
but we believe that it 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 and has been collected for OCM
(beginning in 2018 as OCM-24) and MIPS (beginning in CY2018 as CMS
#047), making its data collection processes reasonably well
established. 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 use in other CMS programs and initiatives. If we
believed it was necessary to remove the measure from the Model, we
would propose to do so through notice and comment rulemaking. This
measure would be a pay-for-performance measure beginning in PY1 and
scored in accordance with our proposed methodology in section
III.C.8.f.
As discussed further in section III.C.8.c, we would require
Professional participants and Dual participants to report quality
measure data the RO Model-specific data collection system in the manner
consistent with that submission portal and the measure specification.
The current version of the Advance Care Plan measure specification
states the data would 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 proposed rule.
For the RO Model, we propose to use the registry specifications for
this measure. Detailed measure specifications may be found at: https://qpp.cms.gov/docs/QPP_quality_measure_specifications/Claims-Registry-Measures/2018_Measure_047_Registry.pdf.
(4) Proposed Treatment Summary Communication--Radiation Oncology
We propose to adopt the Treatment Summary Communication--Radiation
Oncology measure in the RO Model. 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.'' \55\ We believe this measure is appropriate for
inclusion in the RO Model because it is specific to a RT episode of
care. This measure assesses care coordination and communication between
providers during transitions of cancer care treatment and recovery.
While this measure is not NQF endorsed, 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 propose to
include the measure as we believe it to be valid and relevant to the RO
Model's goals. This measure will be the one pay-for reporting measure
included in the calculation of the AQS until a benchmark is established
that would enable it to be pay-for-performance, which is expected to be
beginning in PY3.
---------------------------------------------------------------------------
\55\ 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.
---------------------------------------------------------------------------
As discussed further in section III.C.8.c, we would require
Professional participants and Dual participants to report quality
measure data to the RO Model-specific data collection system in the
manner consistent with that submission portal and the measure
specification. The current version of the Treatment Summary
Communication measure specification states the data would 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 proposed rule.
For the RO Model, we propose to use the registry specifications for
this measure. Detailed measure specifications may be found at: http://www.qualityforum.org/QPS/0381.
(5) Proposed CAHPS[supreg] Cancer Care Survey for Radiation Therapy
We propose to have a CMS-approved contractor administer the
CAHPS[supreg] Cancer Care Survey for Radiation Therapy (``CAHPS[supreg]
Cancer Care survey'') beginning April 1, 2020 and ending in 2025 to
account for episodes that were completed in the last quarter of 2024.
We are proposing the CAHPS[supreg] cancer care survey for inclusion in
the Model as it is appropriate and specific to patient experience of
care within a RT episode. Variations of the CAHPS[supreg] 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[supreg] survey have been used within the PCHQR
Program, Hospital OQR Program, MIPS, OCM, and others, making
considerations regarding data collection reasonably well established.
In future rulemaking, we plan to propose a set of patient
experience measures based on the CAHPS[supreg] Cancer Care survey,
which would be included in the AQS as pay-for-performance measures
beginning in PY 3.
The CAHPS[supreg] 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 invite public comment on our proposal to administer the
CAHPS[supreg] Cancer Care Survey for Radiation Therapy for purposes of
testing the RO Model.
c. Proposed Form, Manner, and Timing for Quality Measure Data Reporting
We propose the following data collection processes for the four
proposed quality measures described in section III.C.8.b.(1) through
(4). of this proposed rule beginning in PY1.
First, we propose to require Professional participants and Dual
[[Page 34518]]
participants to report aggregated quality measure data, instead of
beneficiary-level quality measure data. These data will be used to
calculate the participants' quality performance as discussed in section
III.C.8.f.(1). of this proposed rule and subsequent quality
reconciliation payments on an annual basis.
Second, we propose to require that data be reported for all
applicable patients (for example, not just Medicare beneficiaries or
beneficiaries with radiation episodes under the Model) based on the
numerator and denominator specifications for each measure. 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
reporting portal in the form, manner and at the time consistent with
the RO Model requirements.
Similar to the approach taken for the Quality Payment Program,\56\
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.
---------------------------------------------------------------------------
\56\ 42 CFR 414.1380(b)(1)(iii).
---------------------------------------------------------------------------
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 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 propose 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 measure submission
portal. 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 would submit quality
measure data for the time period noted in the measure specification.
Thus, if a measure is calculated on an annual CY basis, participants
would not adjust the reporting period to reflect the model time period.
We anticipate this adherence to the measure specifications used in MIPS
would reduce measure reporting burden for RO participants. In the event
that the model implementation begins on April 1, 2020, the calendar
year submission would remain; this would allow RO participants to use
their MIPS data submission to meet the RO Model requirements. We
believe that any segmentation to reflect only the RO Model time period
in PY1 would be inconsistent with the measure, and add substantial
reporting burden to RO participants. RO participants would submit data
based on the individual measure specifications as previously discussed,
unless otherwise announced by CMS. 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 would determine that Professional participants and Dual
participants successfully collected and submitted quality measure data
if the data are accepted in the RO Model portal by the reporting
deadline of March 31 after the PY. 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.
As discussed in section III.C.8.f, the CAHPS[supreg] 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 that RO
participants would have the opportunity to become more familiar with
the CAHPS[supreg] Cancer Care survey process and ask any questions.
d. Proposed Maintenance of Technical Specifications for Quality
Measures
As part of its regular maintenance process for NQF-endorsed
performance measures, the NQF requires measure stewards to submit
annual measure maintenance updates and undergo maintenance of
endorsement review every 3 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 would confirm
existing or minor specification changes with NQF on an annual basis.
NQF solicits information from measure stewards for annual reviews, and
it reviews measures for continued endorsement in a specific three-year
cycle. We note that NQF's annual or triennial maintenance processes for
endorsed measures may result in the NQF requiring updates to the
measures. Additionally, the Model includes measures that are not NQF-
endorsed, but we anticipate that they will similarly require non-
substantive technical updates to remain current.
e. Proposed Clinical Data Collection
In addition to collecting quality measure data, we also propose
under Sec. 512.275(c) 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 discuss more fully in sections III.C.8.f(1) and section
III.C.14, respectively.
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 proposed 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. We would determine
the specific data elements and reporting standards prior to the start
of the Model and would communicate them on the Model website.
In addition, we would provide education, outreach, and technical
assistance. We believe this information
[[Page 34519]]
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. 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 may also use it to begin developing
and testing new radiation oncology-specific quality measures during the
Model.
To facilitate data collection, we plan to share the proposed
clinical data elements and reporting standards with EHR vendors and the
radiation oncology specialty societies prior to the start of the Model.
Our goal would be 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 and reduce the
additional reporting burden on providers and may increase the quality
of reporting. Providers 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 a model-
specific data collection system. We would create a template for RO
participants to complete with the specified clinical data elements,
provide a secure 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 are also proposing to establish reporting standards. We propose
that all Professional participants and Dual participants must submit
clinical data information biannually, in July and January, each PY for
RO beneficiaries with the applicable cancer types that completed their
90-day episode within the previous six months. This would be in
addition to the quality measure data as described in section III.C.8.c.
We are specifically interested in feedback on the five cancer types
where we propose to collect clinical data, which data elements should
be captured for the five cancer types, and potential barriers to
collecting data of this type.
We invite comments on our proposal to collect clinical data.
f. Proposal To Connect Performance on Quality Measures to Payment
(1) Proposed Calculation for the Aggregate Quality Score
The AQS would be based on each Professional participant's and Dual
participant's: (1) Performance on the set of proposed evidenced-based
quality measures in sections III.C.8.b(1), (2), and (3) of this
proposed rule compared to those measures' quality performance
benchmarks; (2) reporting of data for the proposed pay-for-reporting
measures (those without established performance benchmarks) in section
III.C.8.b.(4) of this proposed rule; and (3) reporting of clinical data
elements on applicable RO beneficiaries proposed in section III.C.8.e.
of this proposed 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 proposed in section III.C.8.b.\57\ 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.
---------------------------------------------------------------------------
\57\ 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.
---------------------------------------------------------------------------
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 propose 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 when
data is submitted for >=95% of applicable RO beneficiaries)
Quality measures would be scored as pay-for-performance or pay-for-
reporting, depending on whether established benchmarks exists, as
proposed in section III.C.8. 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. The
measures proposed as pay-for-performance for PY1 are selected 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.\58\ For example, when a Professional participant's 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 would provide credit to the
Professional participant or Dual participant for reporting the required
data for the measure. We intend to 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.
---------------------------------------------------------------------------
\58\ The benchmarks are published annually at this CMS site:
https://qpp.cms.gov/about/resource-library.
---------------------------------------------------------------------------
As stated earlier in this rule, measures may be scored as pay-for-
reporting (instead of pay-for-performance). Professional participants
and Dual participants that report the 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 proposed in section III.C.8.b(4), the Treatment
Summary Communication measure would 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 propose to weight all four of
our proposed quality measures (those deemed pay-for-performance as well
as pay-for-reporting) equally and aggregate
[[Page 34520]]
them as half of the AQS. To accomplish that aggregation as half of the
AQS, we would award up to 10 points for each measure, then recalibrate
Professional participants' or Dual participants' measure scores to a
denominator of 50 points. CAHPS[supreg] Cancer Care Survey for
Radiation Therapy results discussed in section III.C.8.b(5) would be
added into the AQS beginning in PY3 and we would propose the specific
weights of the selected measures from the CAHPS[supreg] survey in
future rulemaking. We would also propose specific weights for
additional 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 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 on a given
measure.
For example, a Professional participant or Dual participant might
have sufficient cases to report numerical data on three 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 would 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, it
would receive 0 out of 10 for that measure in the quality portion of
the AQS, and the denominator would remain at 40 points, which would
then be recalibrated to 50 points. For example, if the same
Professional participant or Dual participant scored 20 points out of 40
possible points, it would be equivalent to 25 points after
recalibrating the denominator to 50 points ((20/40) * 50 = 25).
Our assessment of whether the Professional participant 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 data elements to us as requested,
which we discuss in section III.C.8.c. 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 propose to 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. 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.
To calculate the AQS, we propose to sum each Professional
participant's 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 rule. Table 8 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 P
[[Page 34521]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.008
Table 9 details the AQS calculation for a Professional participant
or Dual participant that did not meet the reporting requirements for
the clinical data elements and the pay-for-reporting measure.
[GRAPHIC] [TIFF OMITTED] TP18JY19.009
[[Page 34522]]
BILLING CODE 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 invite public comment on the proposed calculation for the AQS
methodology.
(2) Proposal To Apply the AQS to the Quality Withhold
We propose the following method to apply the AQS to the amount of
the quality withhold that could be earned back by a RO participant. 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,\59\ the example AQS of
88.3 would result in a quality reconciliation payment amount of $43.64
($2,465.68 * 1.77% = $43.64).\60\
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\59\ This number refers to the result in line (j) in Table 5.
\60\ This number is prior to the geographic adjustment and
sequestration being applied.
---------------------------------------------------------------------------
We would continue to weight measures equally in PY1 through PY5
unless we determine that the Model needs to emphasize specific clinical
transformation priorities or add new measures. Any updates to the
scoring methodology in future PYs would 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, 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.
We invite public comments on our proposal to apply the AQS to the
amount of the quality withhold proposed in section III.C.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)
We anticipate that the RO Model would be both an Advanced APM and a
MIPS APM. For purposes of the Quality Payment Program, we propose that
the RO participant, specifically either a Dual participant or a
Professional participant, would be the APM Entity.
We propose to establish an ``individual practitioner list'' under
the RO Model, created by CMS and sent to Dual participants and
Professional participants to review, revise, certify, and return to CMS
so that CMS may make QP determinations for the APM incentive payment
amount and to identify any MIPS eligible clinicians who would be scored
for MIPS based on their participation in this MIPS APM. If finalized as
proposed, the individual practitioner list would serve as the
Participation List as defined in the regulation at section 414.1305 for
the Model. We propose to codify the term ``individual practitioner
list'' for purposes of the RO Model in Sec. 512.205 of our
regulations.
The individuals included on the individual practitioner list would
include physician radiation oncologists that are eligible clinicians
participating in the RO Model with either a Dual participant or a
Professional participant as described in section III.C.5.a of this
proposed 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, MIPS eligible clinicians who are identified on the
participation list for the performance period of an APM Entity
participating in a MIPS APM are scored for MIPS using the APM scoring
standard as provided in our regulation at 42 CFR 414.1370. Only
Professional participant physicians and Dual participant physicians
included on the individual practitioner list would be considered
eligible clinicians.
We propose that prior to the start of each PY, we would create and
provide each Dual participant and Professional participant with an
individual practitioner list. 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, CMS would create and
provide the new Dual participant or Professional participant with an
individual practitioner list.
In order to certify the list, an individual with the authority to
legally bind the RO participant must certify the accuracy,
completeness, and truthfulness of the list. 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. 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 are not proposing 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. We
propose that 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, 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 will 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 is effective on the date of
the notice. The notice must be submitted in a form and manner specified
by CMS.
In order to remove an individual practitioner from the list, the RO
participant must notify CMS within 15 days if 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 will 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 removal, the removal is effective on the date of the notice. The
notice must be submitted in a form and manner specified by CMS.
Further, we propose that the RO participant must ensure that the
individuals included on the individual practitioner list maintain
compliance with the regulation at Sec. 424.516, including notifying
CMS of any
[[Page 34523]]
reportable changes in status or information. The certified individual
practitioner list would be used for purposes related to QP
determinations as specified in 42 CFR part 414 subpart O. We further
propose that if the Dual participant or Professional participant does
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. We propose to codify these
provisions relating to the individual practitioner list at Sec.
512.217.
In order to be an Advanced APM, the RO Model must meet the criteria
specified in our regulation at 42 CFR 414.1415. 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
hospitals are the APM Entities, each hospital, 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 propose 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 propose 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 solicit public comments on this proposal.
Second, to be an Advanced APM, 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 discuss the RO Model's proposed quality measure set in section
III.C.8.b. We intend to use the results of the following proposed
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.: (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 propose 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. Specifically, we
believe that these measures would meet the criteria under 42 CFR
414.1415(b).
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. There
currently are no such outcome measures available or applicable for the
RO Model's first QP Performance Period. If a relevant outcome measure
becomes available, we would consider it for inclusion in the RO Model's
measure set if deemed appropriate.
Third, 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. We expect that the RO
Model would 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.
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.''
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, we propose that the APM Entities would be at risk
for all costs associated with RT services as defined in section
III.C.5.c 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
aforementioned 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 is responsible
under the APM exceed expected expenditures, the RO participant is
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 a 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, we anticipate that the proposed RO Model would meet
the criteria to be a MIPS APM under the Quality Payment Program
starting in PY1 if the implementation date is finalized as January 1,
2020 or PY2 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). Pursuant to Sec. 414.1370(a), MIPS eligible clinicians
who are identified on a participation list for the performance period
of an APM
[[Page 34524]]
Entity participating in a MIPS APM are scored under MIPS using the APM
scoring standard. We propose to use the same individual practitioner
list developed as previously proposed, to identify the relevant
eligible clinicians for purposes of making QP determinations and
applying the APM scoring standard under the Quality Payment Program.
We note 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 described in section II.F and
III.C.14. Under our proposed 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, 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 invite public comment on these proposals.
10. Proposed Medicare Program Waivers
We believe it would be necessary to waive certain requirements of
title XVIII of the Act solely for purposes of carrying out the testing
of the RO Model under section 1115A(b) of the Act. Each of the waivers,
which we discuss 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.
a. Proposed Waiver of Hospital Outpatient Quality Reporting (OQR)
Program Payment Adjustment
We believe that it is 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 this proposed rule, we are proposing 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 or 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 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, will continue to be paid under the OPPS and subject to the 2.0
percentage point reduction under the Hospital OQR Program when
applicable. We believe this waiver is 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 episode
is designed to be as similar as possible, irrespective of whether the
RO participant is an HOPD or a freestanding radiation therapy center.
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. If the
requirement to apply the Hospital OQR Program payment
[[Page 34525]]
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. We believe 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 believe 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 are proposing 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 seek
comment on our proposal to waive application of the Hospital OQR
Program 2.0 percentage 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.
b. Proposed Waiver of the Requirement To Apply the MIPS Payment
Adjustment Factors to Certain RO Model Payments
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 propose 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 (as identified in Table 2)
because we believe 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 episode is
designed to be as similar as possible, irrespective of whether the RO
participant is an HOPD or a freestanding radiation therapy center.
Applying the MIPS payment adjustment factors would undermine our goal
of site-neutral payments under the RO Model.
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. We believe 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. We believe that without this
waiver, model participants may be incentivized to change their behavior
and steer beneficiaries towards freestanding radiation therapy centers
if they expect the MIPS payment adjustment factors would be positive,
and away from freestanding radiation therapy centers if they expect the
MIPS payment adjustment factors would be negative.
RO participants that bill for services under the professional RO
Model-specific HCPCS codes would 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. We believe subjecting a RO participant to
payment consequences under 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, we believe
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.
c. Proposed Waiver of Requirement To Include Technical Component
Payments in Calculation of the APM Incentive Payment Amount
We believe that it is necessary for purposes of testing the RO
Model to 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 42
CFR 414.1450(b). The regulation at 42 CFR 414.1450(b) establishes the
APM Incentive Payment Amount; 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 would
bill the
[[Page 34526]]
Model-specific HCPCS codes that are relevant to their RO participant
type.
We believe this waiver is 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 would 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, Dual 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.
We believe this would prejudice the model testing of site neutral
payments as well as potentially interfere 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 believe 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.
d. Proposed General Payment Waivers
We believe 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 propose 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 would be necessary because otherwise the proposed
RO Model payments would 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 proposed participant-
specific technical episode payment would be set by the OPPS (we note
that the waiver of OPPS payment would 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 propose 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 described in section III.C.6) is
effective at reducing program expenditures while preserving or
enhancing the quality of care. Specifically, as proposed, the RO Model
would test whether adjusting the current fee-for-service payments for
RT services to a prospective episode-based payment model would
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.
e. Proposed Waiver of Appeals Requirements
We believe that it is 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 propose to implement this waiver so
that RO participants may utilize the proposed timely error and
reconsideration request process specific to the RO Model as proposed in
section III.C.12 of this proposed rule to review potential RO Model
reconciliation errors. We would note 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 propose to implement this waiver because the proposed pricing
methodology for the RO Model is unique and as such we have developed
and proposed a separate timely error notice and reconsideration request
process that RO participants would use in lieu of the claims appeals
process under section 1869 of the Act.
In section III.C.12 of this proposal, we propose a process for RO
participants to contest the calculation of their reconciliation payment
amounts, the calculation of their reconciliation recoupment amounts,
and the calculation of their AQS. Reconciliation payment amount means a
payment made by CMS to a RO participant as determined in accordance
with Sec. 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 note, in the specific
circumstance wherein a provider acts on behalf of the beneficiary in a
claims appeal, section 1869 applies. We only propose to waive the right
of RO participants to avail themselves of the claims appeals process
under section 1869 to the extent otherwise applicable.
[[Page 34527]]
f. Proposed Waiver of Amendments Made by Section 603 of the Bipartisan
Budget Act of 2015
We believe that it is 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 propose 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 III.C.7. In addition, we would not apply the PFS relativity adjuster
to the RO Model payment and would instead pay them in the same manner
as other RO Model participants because the RO Model pricing
methodology's design as described in Section III.C.6.c 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. We believe this waiver is 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 invite public comments on our proposed payment waivers.
11. Proposed Reconciliation Process
We propose to conduct an annual reconciliation for each RO
participant after each PY to reconcile payments due to the RO
participant with payments owed to CMS due to the withhold policies
discussed in section III.C.6.g. The annual reconciliation would occur
in August following a PY in order to allow time for claims run-out,
data collection, reporting, and calculating results.\61\ For example,
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 believe
that an annual reconciliation is appropriate because incomplete
episodes and duplicate RT services as described in section III.C.6.a
may result in additional payment owed to a RO participant or owed to
CMS for RT services furnished to a RO beneficiary in those cases.
---------------------------------------------------------------------------
\61\ Claims run-out is the period of time that CMS allows for
the timely submission of claims by providers and suppliers before
reconciliation.
---------------------------------------------------------------------------
a. Proposed True-Up Process
We propose to conduct an annual true-up of reconciliation for each
PY, which would mean 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 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, and reducing potential confusion
for RO participants. We would follow the same process each performance
year. We would true-up the PY1 reconciliation approximately one year
after the initial reconciliation proposed in Sec. 512.285.section
III.C.11. As a result, we would conduct a true-up of PY1 in August
2022, a true-up of PY2 in August 2023, and so forth.
We invite public comments on our proposed true-up process.
b. Proposed Reconciliation Amount Calculation
To calculate a reconciliation payment amount either owed to a RO
participant by CMS or a reconciliation repayment amount owed by CMS to
a RO participant, we propose the following process:
Calculate the incorrect payment reconciliation amount: 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 episodes furnished during that PY by
that RO participant). This would determine the amount owed to CMS by
the RO participant based on total payments made to the RO participant
for incomplete episodes and duplicate RT services for a given PY, if
applicable. A 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: If the RO participant is a Professional
participant, then we would add the Professional participant's
incomplete episode reconciliation 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: If the RO
participant is a Technical participant then the Technical participant's
reconciliation amount would be equal to the incomplete episode
reconciliation amount. There would be no further additions or
subtractions.
For Technical participants in PY3, PY4, and PY5: We would
add the Technical participant's incomplete episode reconciliation
amount to the patient experience reconciliation amount, proposed 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[supreg] Cancer Care Radiation Therapy Survey.
For Dual participants in PY1 and PY2: We would add the
Dual participant's incorrect payment reconciliation 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
[[Page 34528]]
maximum withhold amount as described in section III.C.8.f(2).
For Dual participants in PY3, PY4, and PY5: We would
add the Dual participant's incorrect payment reconciliation 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.
We invite public comment on our proposal on calculating
reconciliation amounts.
Table 10 represents an example reconciliation for a Professional
participant. The numbers listed in the table are illustrative only. In
this example, the incorrect payment withhold amount for this
Professional participant is $6,000 or 2 percent of $300,000 (the total
payments for this participant after the trend factor, adjustments, and
discount factor have been applied). The Professional participant owes
CMS $3,000 for duplicate payments due to claims submitted on behalf of
beneficiaries who received RT services by another provider or supplier
during their episode. Lastly, the Professional participant owes CMS
$1,500 for cases of incomplete episodes whereby the PC of the episode
was billed and due to death or other reason, the TC was not billed by
the time of reconciliation. 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 the
participant from CMS for the incorrect payment reconciliation amount
(a). This amount is then added to the quality reconciliation amount
(b). The quality withhold amount for this participant is also $6,000 or
2 percent of $300,000. This participant's performance on the AQS
entitles 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 payment of $6,600 total
reconciliation payment (c) is due to the participant from CMS for that
performance year. We note that this example does not include the
geographic adjustment or the 2 percent adjustment for sequestration.
[GRAPHIC] [TIFF OMITTED] TP18JY19.026
12. Proposed Timely Error Notice and Reconsideration Request Processes
We believe it is 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 (proposed in section III.C.11), or
AQS (proposed in section III.C.8.f(1)) as reflected on a RO
reconciliation report that has not been deemed final. Therefore, we are
proposing 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 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 propose to 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 is 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 will 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,
[[Page 34529]]
we propose a two-level process for RO participants to request
reconsideration of determinations related to calculation of their
reconciliation payment, recoupment amount, or AQS under the RO Model.
We propose the first level to be a timely error notice process and the
second level to be reconsideration review process, as subsequently
discussed. The processes proposed here are based on the processes
implemented under certain current models being tested by the Innovation
Center.
We propose that only RO participants may utilize either the first
or second level of the reconsideration process, unless otherwise stated
in other sections of this proposed subpart. We believe that only RO
participants should be able to utilize the proposed process because
non-participants will not receive calculation of a reconciliation
payment amount, repayment amount, or AQS, and will generally have
access to the section 1869 claims appeals processes to appeal the
payments they receive under the Medicare program.
1. Timely Error Notice
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 propose that the first
level of the proposed reconsideration process would be a timely error
notice. Specifically, we are proposing that 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 proposed part. The RO participant shall have 30 days from
the date the RO reconciliation report is issued to provide their timely
error notice. This would be subject to the limitations on
administrative and judicial review as previously described.
Specifically, a 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 proposed Sec. 512.290. We propose 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 propose that CMS 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 propose to codify this timely error notice policy at
Sec. 512.290(a).
2. Reconsideration Review
We propose that the second level of the proposed reconsideration
process would permit RO participants to dispute CMS's 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 propose that the CMS reconsideration official
would 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. We are proposing that, to be considered, 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.
We propose the reconsideration review request would be submitted in a
form and manner specified by CMS.
As there would not otherwise be a timely error notice response for
the reconsideration official to review, we are proposing that in order
to access the reconsideration review process, a 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, repayment,
recoupment amount, or AQS, we propose the reconsideration review
process would not be available to the RO participant with regard 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.
If the RO participant did timely submit a timely error notice and
the RO participant is dissatisfied with CMS's 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 propose that the reconsideration review request must
provide a detailed explanation of the basis for the dispute and include
supporting documentation for the RO participant's assertion that CMS or
its representatives did not accurately calculate the reconciliation
payment amount, repayment, recoupment amount, or AQS in accordance with
the terms of the RO Model.
We propose that 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. 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 is the final step of the Innovation Center
administrative dispute resolution process, we propose that the
determination made by the CMS reconsideration official would be final
and binding. This proposed reconsideration review process is consistent
with other resolution processes used throughout the agency. We propose
to codify this reconsideration review process at Sec. 512.290(b).
We invite public comment on these proposed provisions regarding the
proposed timely error notice and reconsideration review processes.
13. Proposed Data Sharing
CMS has experience with a range of efforts designed to improve care
coordination and the quality of care,
[[Page 34530]]
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 previously
described, 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 proposed model, including the model
participant's participation in the proposed model, which could then
also be used to inform the public and other model participants
regarding the impact of the proposed model on both program spending and
the quality of care.
a. Data Privacy Compliance
In proposed Sec. 512.275(a), we propose that, as a condition of
their receipt of patient-identifiable data from CMS for purposes of the
RO Model, RO participants must 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 agreement entered into
by the RO participant and CMS as a condition of the RO participant
receiving such data. These laws include, without limitation, the
standards for the privacy of individually identifiable health
information and the security standards for the protection of electronic
protected health information under the regulations promulgated under
the Health Insurance Portability and Accountability Act of 1996 (HIPAA)
and the Health Information Technology for Economic and Clinical Health
Act (HITECH). Additionally, we are proposing that RO participants would
be required to contractually bind all downstream recipients of CMS data
to comply with all laws pertaining to any patient-identifiable data
requested from CMS and the terms of any agreement that the RO
participant enters into with CMS as a condition of receiving the data
under the RO Model, as a condition of the downstream recipient's
receipt of the data from the RO participant and their maintenance
thereof. We believe requiring RO participants to bind their downstream
recipients in writing to comply with applicable law and requirements is
necessary to protect the individually identifiable health information
data that may be shared with RO participants by CMS for care redesign
and care coordination purposes.
b. RO Participant Public Release of Patient De-Identified Information
We are not proposing to restrict RO participants' ability to
publicly release patient de-identified information that references the
RO participant's participation in the RO Model. Information that RO
participants may publicly release about their participation in the RO
Model may include, but is not limited to, 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 that have been de-
identified in accordance with HIPAA requirements in 45 CFR 164.514(b).
In order to ensure external stakeholders understand that information
the RO participant releases represents their own content and opinion,
and does not reflect the input or opinions of CMS, we propose 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 propose to utilize the same
disclaimer for public release of information by the RO participant that
we propose to codify at Sec. 512.120(c)(2) for purposes of descriptive
model materials and activities: ``The statements contained in this
document are solely those of the authors and do not necessarily reflect
the views or policies of the Centers for Medicare & Medicaid Services
(CMS). The authors assume responsibility for the accuracy and
completeness of the information contained in this document.'' We are
proposing to require the use of this disclaimer so that the public, and
RO beneficiaries in particular, are not misled into believing that RO
participants are speaking on behalf of the agency.
c. Proposed Data Submitted by RO Participants
In addition to the quality measures and clinical data described in
section III.C.8, we propose 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 a HOPD. We
would require RO participants to supply and/or confirm the NPIs for the
physicians who bill for RT services using the applicable TINs. 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 propose 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 propose to do this through annual web-based
surveys. The data requested for use under the RO Model will be used to
better understand participants' office activities, benchmarks, and
track participant compliance.
d. Proposed Data Provided to RO Participants
Thirty (30) days prior to the start of each PY, we propose to
provide RO participants with updated participant-specific professional
episode payment and technical episode payment amounts (for example,
episode price files) 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 and 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 recoupment amount, as
applicable. To seek such care coordination and quality improvement data
RO participants should use a Participant Data Request and Attestation
(DRA) form, which will be available on the RO Model website. 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 further propose 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 shall not disseminate individually identifiable
original or derived information from the files specified in the Model
DRA to
[[Page 34531]]
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, the RO participant
would be required to make ``reasonable efforts to limit'' the
information to the ``minimum necessary'' as defined by 45 CFR 164.500
through 164.534 to accomplish the intended purpose of the use,
disclosure or request. The RO participant would be required to further
limit its disclosure of such information to what is permitted by
applicable law, including the regulations promulgated under the HIPAA
and 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. We propose that 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 invite public comment on our proposals related to data sharing
for the RO Model.
f. Access To Share Beneficiary Identifiable Data
As discussed earlier in this proposed 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 would 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,
would 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 would 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/circulars_default) 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). 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 would be strictly prohibited. Further, the RO participant
would be required to agree that the data specified in the DRA would not
be physically moved, transmitted, or disclosed in any way from or by
the site of the Data Custodian indicated in the 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 destroy all data in
its possession as agreed upon under the DRA.
14. Proposed Monitoring and Compliance
If finalized, the general provisions relating to monitoring and
compliance proposed 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
Sec. 512.130, comply with the government's the right to audit,
inspect, investigate, and evaluate any documents or other evidence
regarding implementation of the RO Model under Sec. 512.135(a), and to
retain and provide the government with access to records in accordance
with Sec. Sec. 512.135(b) and (c). Additionally, CMS would conduct
model monitoring activities with respect to the RO Model in accordance
with Sec. 512.150(b). We believe that the general provisions relating
to monitoring and compliance are 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 beneficiaries from potential harms that may result from the
activities of a RO participant.
Consistent with Sec. 512.150(b), we anticipate 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; monitoring quality
outcomes; site visits; monitoring quality outcomes and clinical data,
if applicable; and tracking patient complaints and appeals. We
anticipate using the most recent claims data available to track
utilization as described in section III.C.7, and beneficiary outcomes
under the Model. More specifically, we may track utilization of certain
types of treatments,
[[Page 34532]]
beneficiary hospitalization and emergency department use, and
fractionation (numbers of treatments) against historical treatment
patterns for each participant. We believe this type of monitoring is
important because as RO participants transition from receiving FFS
payment to receiving new (episode-based) payment, we want 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 may 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. This work may involve
pairing clinical data with claims data to identify specific issues by
cancer type.
a. Proposed Monitoring for Utilization/Costs and Quality of Care
We would monitor RO participants for compliance with RO Model
requirements. We anticipate 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 randomly selected CBSA). We anticipate
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 intend
to monitor patient and provider/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, RO participants would
report data on program activities and beneficiaries consistent with the
data collection policies proposed in section III.C.8. These data would
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 would 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
participants to detect issues with 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.
We invite public comment on our proposal.
b. Proposed Monitoring for Model Compliance
As explained in section III.C.9, we propose to require all
participants to annually attest in a form and manner specified by CMS
that they would use CEHRT throughout such PY in a manner sufficient to
meet the requirements as set forth in 42 CFR 414.1415(a)(1)(i). In
addition, we further propose that each Technical participant and Dual
participant would 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
intervals throughout the Model upon advanced written notice to the RO
participants. We propose to codify these RO Model requirements at Sec.
512.220(a)(3). We note that CMS may monitor the accuracy of such
attestations and that false attestations would be punishable under
applicable federal law.
In addition, we would monitor for compliance with the other RO
Model requirements listed in this section through site visits and
medical record audits conducted in accordance with Sec. 512.150. We
propose to codify at Sec. 512.220(a)(2) to require 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
document 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.
We invite public comment on this proposal.
c. Proposed Performance Feedback
We propose to provide detailed and actionable information regarding
RO participant performance related to the RO Model. We intend to
leverage the clinical data to be collected through the model-specific
data collection system, 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 believe these reports can drive important
conversations and support quality improvement progress. The design of
and frequency that these reports would be provided to participants
would be determined in conjunction with the RO Model implementation and
monitoring contractor.
We invite public comment on our proposal.
d. Proposed Remedial Action for Non-Compliance
We refer readers to section II.J of this proposed rule for our
proposals regarding remedial and administrative action.
15. Beneficiary Protections
We propose to require Professional participants and Dual
participants to notify RO beneficiaries that the RO participant is
participating in this RO Model by providing written notice to each RO
beneficiary during the RO beneficiary's initial treatment planning
[[Page 34533]]
session. We intend 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 a RO beneficiary's right to refuse having
his or her data shared under Sec. 512.225(a)(2). Beneficiaries who do
not wish to have their data shared 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
beneficiary notifies the RO participant.
We believe it would 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. We propose that the required RO Model beneficiary notice be
exempt from the requirement at Sec. 512.120(c)(2) and in section
II.D.3 of this part, which requires that the model participant include
a disclaimer statement on all descriptive model materials and
activities 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.'' We believe that such
statement should not apply to the proposed RO Model beneficiary notice,
because RO participants would be required to use standardized language
developed by CMS. We propose these policies at Sec. 512.225(c).
If beneficiaries have any questions or concern with their
physicians, we encourage 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://qioprogram.org/beneficiary-and-family-centered-care-national-coordinating-center).
We invite public comment on the proposed beneficiary protections.
16. Proposed Evaluation
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.
Our evaluation would focus primarily on understanding how
successful the Model is in achieving improved quality and reduced
expenditures as evidenced by 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 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, 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.
In addition to assessing the impact of the Model in achieving
improved quality and reduced Medicare expenditures, the evaluation is
likely to address questions that include (but would 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 CMMI models or CMS/non-CMS
initiatives and how could they impact the evaluation findings?
CMS anticipates that the evaluation would include a difference-in-
differences \62\ or similar analytic approach to estimate model
effects. 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 eligibility, and other factors. Data to control
for patient differences would be obtained primarily from claims and
patient surveys.
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\62\ 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.
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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
selected CBSA geographic areas, as discussed in section III.C.3.d,
would 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 refer readers to section II.E of this proposed rule for our
proposed policy on RO participant cooperation with the RO Model's
evaluation and monitoring policies. We invite public comment on our
proposed approach related to the evaluation of the RO Model.
17. Termination of the RO Model
The proposed general provisions relating to termination of the
Model by CMS proposed in section II.J of this rule would apply to the
RO Model.
18. Potential Overlap With Other Models Tested Under Section 1115A
Authority and CMS Programs
a. Overview
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. We believe that the RO
Model would be compatible with other CMS models and
[[Page 34534]]
programs that also provide health care entities with opportunities to
improve care and reduce spending. We expect that there would be
situations where a Medicare beneficiary in a 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 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.
Currently, 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 section 1115A
of the Act or the Medicare Shared Savings Program (Shared Savings
Program) under section 1899 of the Act. If, in the future, we determine
that such adjustments are necessary, we would propose overlap policies
for the RO Model through notice and comment rulemaking.
b. Accountable Care Organizations (ACOs)
We believe there would be potential overlap between the proposed 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.\63\ We believe 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 believe
overlap could likely occur in two instances: (1) The same provider or
supplier participates in both a Medicare 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.
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\63\ The statutory limitation under Sec. 1899(b)(4)(A) 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.
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While shared savings payments made under an ACO initiative have the
potential to overlap with discounts and withholds in the RO Model, it
is difficult to determine the level of potential overlap at this time.
It is also difficult to determine how many aligned ACO beneficiaries
would require RT services or if those beneficiaries would seek care
from a RO participant. Given that the RO Model is expected to reduce
Medicare spending in aggregate, we anticipate that in most cases
payments under the RO Model would be less than what Medicare would have
paid outside the Model. It is possible, however, 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 expect overall payments for RT services to be lower than they
would be absent the Model, we want to ensure that a significant
proportion of the RO Model discounts, which represent Medicare savings,
would not be paid out as shared savings.
Due to these factors, we intend 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
these calculations that might be necessary due to the overlap with the
RO Model would be made using the applicable ACO initiative procedures.
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 expect
that there would 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 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).
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 proposed in section III.C.7, the RO Model would 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
only includes 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. 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
[[Page 34535]]
included in the OCM episode. In addition, to account for the savings
generated by the RO Model discount and withhold amounts, 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
propose 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, again based on the number of days of overlap
with the OCM episode. 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 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 believe a process to allocate exact
amounts paid to the participants with different reconciliation
timelines between the two models would be operationally complex.
We intend to continue to review the potential overlap with OCM if
the RO Model is finalized as proposed, including whether there are
implications for OCM's prediction model for setting risk-adjusted
target episode prices, which include receipt of RT services. 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.
d. Bundled Payments for Care Improvement (BPCI) Advanced
BPCI Advanced is testing a new iteration of bundled payments for 37
clinical episodes (33 inpatient and 4 outpatient).\64\ BPCI Advanced 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 BPCI
Advanced, a beneficiary in a RO episode could be treated by a provider
or supplier that is participating in BPCI Advanced for one of the 37
clinical episodes included in BPCI Advanced. Since prospective episode
payments made under the RO Model would not be affected by BPCI
Advanced, BPCI Advanced would determine whether to account for RO Model
overlap in its reconciliation calculations, and CMS would provide
further information to BPCI Advanced participants through an amendment
to their participation agreement.
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\64\ 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.
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19. Decision Not To Include a Hardship Exemption
We do not believe that a hardship exemption for RO participants
under the Model is necessary, since in 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 proposed efficiency factor in section
III.C.6.e(2) is 0.90 for all RO participants. Accordingly, we are not
proposing such an exemption in this proposed rule, and will not include
such an exemption in the final rule in this rulemaking.
However, to the extent any stakeholders disagree with our
assessment, we welcome 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. We intend to use any input we
receive on this issue to consider whether a hardship exemption might be
appropriate in subsequent rulemaking for a future PY.
IV. End-Stage Renal Disease (ESRD) Treatment Choices Model
A. Introduction
The proposed End-Stage Renal Disease (ESRD) Treatment Choices (ETC)
Model, referred to in this section IV of the proposed rule as ``the
Model,'' would test whether adjusting the current Medicare fee-for-
service (FFS) payments for dialysis services would 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 and kidney-pancreas 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.\65\ In the proposed ETC
Model, CMS would adjust Medicare payments under the ESRD Prospective
Payment System (PPS) to ESRD facilities and payments under the Medicare
Physician Fee Schedule (PFS) to Managing Clinicians paid the ESRD
Monthly Capitation Payment (MCP) selected for participation in the
Model. The payment adjustments would include an upward adjustment on
home dialysis and home dialysis-related claims with claim through dates
during the initial three years of the ETC Model, that is, between
January 1, 2020 and December 31, 2022. In addition, we would make an
upward or downward performance adjustment on all dialysis claims and
dialysis-related claims with claim through dates between July 1, 2021
and June 30, 2026, depending on the rates of home dialysis utilization
and kidney and kidney-pancreas transplantation among the beneficiaries
attributed to these participating ESRD facilities and Managing
Clinicians. The ETC Model would test whether such payment adjustments
can reduce total program expenditures and improve or maintain quality
of care for Medicare beneficiaries with ESRD.
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\65\ 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.
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B. Background
1. Rationale for the Proposed ESRD Treatment Choices Model
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
[[Page 34536]]
beneficiaries have accounted for about 1 percent of the Medicare
population and accounted for approximately 7 percent of total Medicare
spending.\66\ 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.67 68
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\66\ Kirchoff SM. Medicare Coverage of End-Stage Renal Disease
(ESRD). Congressional Research Service. August 16, 2018. p. 1.
\67\ 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.
\68\ 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.
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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 proposed ETC Model would 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.
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.\69\ Among HD cases, 98.0 percent used in-center HD, and 2.0
percent used home hemodialysis (HHD).\70\ PD is rarely conducted within
a facility. In section IV.B.2 of this proposed 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. In proposing the ETC Model, we aim to test
whether new payment incentives would lead to greater rates of home
dialysis (both PD and HHD) and kidney transplantation. 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.
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\69\ 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.
\70\ 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.
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a. Home Dialysis
There are two general types of dialysis: HD, in which an artificial
filter outside of the body is used to clean the blood; 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 proposed ETC Model, 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.71 72
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\71\ 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.
\72\ 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.
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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.\73\ 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 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.\74\
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\73\ Blagg CR. A Brief History of Home Hemodialysis. Annals in
Renal Replacement Therapy. 1996; 3: 99-105.
\74\ Unites States Government Accountability Office. End Stage
Renal Disease: Medicare Payment Refinements Could Promote Increased
Use of Home Dialysis (GAO-16-125). October 2015.
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Additionally, 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).\75\
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\75\ United States Renal Data System, Annual Data Report, 2018.
Volume 2, Chapter 11: International Comparisons. Figure F11.12.
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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.
[[Page 34537]]
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
notes 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.\76\
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\76\ 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
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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 CKD
beneficiaries, built-up capacity at ESRD facilities, and a lack of
infrastructure to support home dialysis.\77\ (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.\78\ 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 chronic kidney disease (CKD) stages III to V enrolled in a North
American cohort study showed that as many as 85 percent were medically
eligible for PD.\79\ 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.\80\ 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.\81\ Another study reported 42 percent of patients preferring PD
when the option was presented to them.\82\
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\77\ 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.
\78\ 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.
\79\ 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.
\80\ 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.
\81\ 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.
\82\ Maaroufi A, Fafin C, Mougel S, Favre G, Seitz-Polski P,
Jeribi A, Vido S, Dewismi C, Albano L, Esnault V, Moranne O. Patient
preferences regarding choice of end-stage renal disease treatment
options. American Journal of Nephrology. 2013; 37(4): 359-369. doi:
1159/000348822.
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Recent studies show substantial support among nephrologists and
patients for dialysis treatment at home.83 84 85 86 87 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.
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\83\ Rivara MB, Mehrotra R. The Changing Landscape of Home
Dialysis in the United States. Current Opinion in Nephrology and
Hypertension.2014; 23(6):586-591.doi:10.1097/MNH0000000000000066.
\84\ Mehrotra R, Chiu YW, Kalantar-Zadeh K, Bargman J, Vonesh E.
Similar Outcomes With Hemodialysis and Peritoneal Dialysis in
Patients With End-Stage Renal Disease. Archives of Internal
Medicine. 2011; 171(2): 110-118. Doi:10.1001/archinternmed.2010.352.
\85\ Ghaffari et al. 2013.
\86\ Ledebo I, Ronco C. The best dialysis therapy? Results from
an international survey among nephrology professionals. Nephrology
Dialysis Transplantation.2008;6:403-408.doi:10.1093/ndtplus/sfn148.
\87\ Schiller B, Neitzer A, Doss S. Perceptions about renal
replacement therapy among nephrology professionals. Nephrology News
& Issues. September 2010; 36-44.
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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.88 89 90 91 92 (Most studies on the comparative
cost and effectiveness of different dialysis modalities assess PD
versus HD. 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, 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.\93\ Despite selection bias
present in existing research, we expect 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, if finalized.
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\88\ Walker R, Marshall MR, Morton RL, McFarlane P, Howard K.
The cost-effectiveness of contemporary home haemodialysis modalities
compared with facility haemodialysis: A systematic review of full
economic evaluations. Nephrology. 2014; 19: 459-470 doi: 10.1111/
nep.12269.
\89\ Walker R, Howard K, Morton R. Home hemodialysis: A
comprehensive review of patient-centered and economic
considerations. ClinicoEconomics and Outcomes Research. 2017; 9:
149-161.
\90\ Howard K, Salkeld G, White S, McDonald S, Chadban S, Craig
J, Cass A. The cost effectiveness of increasing kidney
transplantation and home-based dialysis. Nephrology. 2009; 14: 123-
132 doi: 10.1111/j.1440-1797.2008.01073.x.
\91\ Quinn R, Ravani P, Zhang X, Garg A, Blake P, Austin P,
Zacharias JM, Johnson JF, Padeya S, Verreli M, Oliver M. Impact of
Modality Choice on Rates of Hospitalization in Patients Eligible for
Both Peritoneal Dialysis and Hemodialysis. Peritoneal Dialysis
International. 2014; 34(1): 41-48 doi: 10.3447/pdi.2012.00257.
\92\ Sinnakirouchenan R, Holley, J. Peritoneal Dialysis Versus
Hemodialysis: Risks, Benefits, and Access Issues. Advances in
Chronic Kidney Disease. 2011; 18(6): 428-432. doi: 10.1053/
j.ackd.2011.09.001.
\93\ United States Renal Data System, Annual Data Report, 2018.
Volume 2, Chapter 1: Incidence, Prevalence, Patient Characteristics,
and Treatment Modalities. Table 1.
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In addition, current research on patients in the U.S. and Canada
indicates similar, or better, patient survival outcomes for PD compared
to HD.94 95 96 (As previously noted, most
[[Page 34538]]
research on the comparative effectiveness of different dialysis
modalities compares PD to HD, but 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.\97\ Therefore, 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, 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.98 99 100 101 102 103 104 Patient
benefits of HHD and PD also can include better quality of life and
greater independence.105 106 107 As described in greater
detail throughout this section IV of this proposed rule, one of the
aims of the proposed ETC Model is to test whether new payment
incentives would lead to greater rates of home dialysis.
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\94\ Wong B, Ravani P, Oliver MJ, Holroyd-Leduc J, Venturato L,
Garg AX, Quinn RR. Comparison of Patient Survival Between
Hemodialysis and Peritoneal Dialysis Among Patients Eligible for
Both Modalities. American Journal of Kidney Diseases. 2018; 71(3)
344-351. doi:10.1053/j.ajkd.2017.08.028.
\95\ Kumar VA, Sidell MA, Jones JP, Vonesh EF. Survival of
propensity matched incident peritoneal and hemodialysis patients in
a United States health care system. Kidney International. 2014; 86:
1016-1022. doi:10.1038/ki.2014.224.
\96\ Mehrotra et al. 2011.
\97\ United States Renal Data System. Annual Data Report, 2018.
Volume 2, Chapter 5: Mortality. Figure 5.1. Mortality rates were
adjusted for age, sex, race, ethnicity, primary diagnosis and
vintage.
\98\ Li KP, Chow KM. Peritoneal Dialysis--First Policy Made
Successful: Perspectives and Actions. American Journal of Kidney
Diseases. 2013; 62(5): 993-1005. doi: http://dx/doi.org/10.1053/j.ajkd.2013.03.038.
\99\ Yeates K, Zhu N, Vonesh E, Trpeski L, Blake P, Fenton S.
Hemodialysis and peritoneal dialysis are associated with similar
outcomes for end-stage renal disease treatment in Canada. Nephrology
Dialysis Transplantation. 2012; 27(9): 3568-3575. doi: https://doi.org/10.1093/ndt/gfr/674.
\100\ Chiu YW, Jiwakanon S, Lukowsky L, Duong U, Kalantar-Zadeh,
Mehrotra R. An Update on the Comparisons of Mortality Outcomes of
Hemodialysis and Peritoneal Dialysis Patients. Seminars in
Nephrology. 2011; 31(2): 152-158. Doi:10.1016/
j.semnephrol.2011.01.004.
\101\ Mehrotra et al. 2011.
\102\ Sinnakirouchenan R, Holley JL. 2011.
\103\ Quinn RR, Hux JE, Oliver MJ, Austin, PC, Tonelli M,
Laupacis A. Selection Bias Explains Apparent Differential Mortality
between Dialysis Modalities. Journal of the American Society of
Nephrology. 2011; 22(8) 1534-1542. doi: 10.1681/ASN.2010121232.
\104\ Weinhandl ED, Foley RN, Gilbertson DT, Arneson TJ, Snyder
JJ, Collins AJ. Propensity-Matched Mortality Comparison of Incident
Hemodialysis and Peritoneal Dialysis Patients. Journal of the
American Society of Nephrology. 2010; 21(3): 499-506. doi: 10.1681/
ASN.2009060635: 10.1681/ASN.2009060635.
\105\ Ghaffari et al. 2013.
\106\ Rivara and Mehrotra. 2014.
\107\ Juergensen E, Wuerth D, Finkelstein SH et al.,
Hemodialysis and Peritoneal Dialysis: Patients' Assessments of Their
Satisfaction with Therapy and the Impact of the Therapy on their
Lies. Clinical Journal of American Society of Nephrology. 2006;
1(6): 1191-1196. DOI: https://doi.org/10.2215/CJN.01220406.
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b. Kidney Transplants
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-pancreas transplant may come from a living
or deceased donor, the pancreas can only come from a deceased donor.
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.
A systematic review of studies worldwide finds significantly lower
mortality and risk of cardiovascular events associated with kidney
transplantation compared with maintenance dialysis.\108\ Additionally,
this review finds that beneficiaries who receive transplants experience
a better quality of life than treatment with chronic dialysis.\109\
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\108\ 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.
\109\ Tonelli, M. et al. 2011.
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Per-beneficiary-per-year Medicare expenditures for beneficiaries
receiving kidney or kidney-pancreas transplants are often substantially
lower than for those on dialysis.\110\ 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.\111\
Among transplant recipients, there are a lower rates of
hospitalizations, emergency department visits, and readmissions.\112\
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.
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\110\ United States Renal Data System. Annual Data Report, 2018.
Volume 2. Chapter 9: Healthcare expenditures for Persons with ESRD.
Figure F9.8.
\111\ 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.
\112\ 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.
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Notwithstanding these outcomes, 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.\113\ 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.\114\ 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, there are other likely contributing
causes, such as differences in health care systems, the infrastructure
supporting transplantation, and cultural factors.\115\
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\113\ 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.
\114\ United States Renal Data System. Annual Data Report, 2018.
Volume 2. Chapter 11. International Comparisons. Figure 11.16.
\115\ United States Renal Data System. Annual Data Report, 2018:
Volume 2. Chapter 11. International Comparisons. https://www.usrds.org/2018/view/v2_11.aspx.
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The main barrier to kidney transplant is the supply of available
organs. Medicare is undertaking regulatory efforts to increase organ
supply, discussed in section IV.B.3.a of this proposed rule. Further,
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
[[Page 34539]]
that potentially viable organs are discarded.\116\ We anticipate that
Managing Clinicians and ESRD facilities selected for participation in
the proposed ETC Model would address these areas of improvement through
various strategies in order to improve their rates of transplantation.
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.\117\
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\116\ 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.
\117\ 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.
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After increasing during the 1990s, the volume of simultaneous
pancreas and kidney transplants has either remained stable or declined
slightly since the early 2000s. 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.\118\
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\118\ 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.
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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 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 throughout this section IV of
this proposed rule, one of the aims of the proposed ETC Model is to
test whether new payment incentives would lead to greater rates of
kidney transplantation.
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
propose 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 propose 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. 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 propose
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. One or both of the payment
adjustments under the proposed 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.
2. The Medicare ESRD Program
In this section, 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 Social
Security Act (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,
[[Page 34540]]
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.
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).
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
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 type or amount of medically necessary
care, and a transitional drug add-on payment adjustment (TDAPA). 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.
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).
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 may 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
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
[[Page 34541]]
same regardless of the number of in-person visits.\119\
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\119\ Medicare Claims Processing Manual, Chapter 8, 140; https://www.cms.gov/Regulations-and-Guidance/Manuals/Downloads/clm104.c08.pdf.
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(3) The Kidney Disease Education Benefit
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. 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.\120\ 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. 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. Also, a provider
of services located in a rural area is eligible as a ``qualified
person'' to provide the service. 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.
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\120\United States Government Accountability Office 2015.
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c. Impacts of Medicare Payment Rules on Home Dialysis
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).
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.\121\
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.
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\121\ United States Government Accountability Office, 2015.
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Although this increase was generally concurrent with the phase-in
of the ESRD PPS, the GAO report identified factors that might undermine
incentives 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.\122\
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\122\ United States Government Accountability Office, 2015.
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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.\123\
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\123\ United States Government Accountability Office, 2015.
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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.\124\
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\124\ United States Government Accountability Office. 2015.
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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. The proposed ETC Model is
consistent with several different recent actions to support the goal of
modality choice for ESRD beneficiaries, which are described in this
proposed rule.
a. Regulatory Efforts
On September 20, 2018, CMS 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). The proposed rule would, among other
things, remove the requirements at 42 CFR 482.82 that currently require
transplant centers to submit clinical experience, outcomes, and other
data in order to obtain Medicare re-approval. CMS proposed to remove
these requirements in order to address unintended consequences of
existing 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
[[Page 34542]]
penalized for outcomes that are non-compliant with Sec. 482.82.
According to the proposed rule, transplant programs have avoided using
these kidneys for fear of non-compliance with the Conditions of
Participation for transplant centers in hospitals (Sec. Sec. 482.80
and 482.82) and potential Medicare termination of the program, despite
evidence to the contrary that the use of these kidneys would not pose a
problem for transplant recipients. Although CMS proposed to remove
certain requirements at Sec. 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. CMS stated that the agency will continue to monitor and
assess outcomes, after initial Medicare approval. (83 FR 47706)
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. 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). 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. 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 year 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.\125\ Although the evaluation results available
for the CEC Model thus far are limited, based on these 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.
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\125\ Marrufo G, et al. Comprehensive End-Stage Renal Disease
Care (CEC) Model: Performance Year 1 Annual Evaluation Report. CMS
Innovation Center. November 2017; innovation.cms.gov/Files/reports/cec-annrpt-py1.pdf.
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On July 10, 2019, CMS announced four voluntary kidney models: The
Kidney Care First (KCF) Model, and three Comprehensive Kidney Care
Contracting (CKCC) Models. These models build on the existing CEC
Model, and include 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. We view the KCF Model and the CKCC Models as
complementary to the proposed ETC Model, as both models would
incentivize a greater focus on kidney transplants. We propose that ESRD
facilities and Managing Clinicians may participate in both the ETC
Model and either the KCF Model or one of the CKCC Models, as discussed
in section IV.C.6. of this proposed rule.
C. Provisions of the Proposed Regulation
1. Proposal To Implement the ETC Model
In this section IV of the proposed rule, we propose our policies
for the ETC Model, including model-specific definitions and the general
framework for implementation of the ETC Model. The proposed payment
adjustments are 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 acknowledge 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 recognize 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.
As previously described, 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. If the ETC Model were to begin April 1, 2020, all
intervals within the currently proposed timelines, 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 3 months
later. We seek comment on the alternative start date, April 1, 2020,
and the subsequent three month adjustment to all ETC Model dates,
including the implementation of the HDPA and PPA.
We are also including 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 propose to codify the definitions and policies of the ETC Model
at subpart C of part 512 of 42 CFR (proposed Sec. Sec. 512.300 through
512.397).
[[Page 34543]]
We discuss the proposed definitions in section IV.C.2 of this proposed
rule and each of the proposed regulatory provisions under the
applicable subject area later. Section II of this proposed rule
proposes that the general provisions proposed to be codified at
Sec. Sec. 512.100 through 512.180 would apply to both the proposed ETC
Model and the proposed RO Model described in section III of this
proposed rule.
2. Definitions
We propose at Sec. 512.310 to define certain terms for the ETC
Model. We describe these proposed definitions in context throughout
this section IV of this proposed rule. We seek comment on the proposed
definitions as a part of our seeking comment on the proposed policies
for the ETC Model. If finalized, the definitions proposed in section II
of this proposed rule also would apply to the ETC Model.
3. ETC Participants
a. Mandatory Participation
We propose to require all Managing Clinicians and all ESRD
facilities located in selected geographic areas to participate in the
ETC Model. We propose to define ``selected geographic area(s)'' as
those Hospital Referral Regions (HRRs) selected by CMS, as described in
section IV.C.3.b of this proposed 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 section IV.C.3.b of the
proposed rule.
For purposes of the ETC Model, we propose to define ``ESRD
facility'' as defined in 42 CFR 413.171. Under Sec. 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 Sec. 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 propose 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, 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 propose 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. 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,
analyses of claims data revealed that a variety of clinician specialty
types manage ESRD beneficiaries and bill the MCP, including non-
physician practitioners. We 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.
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 the KCF Model, and the CKCC Models, 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, 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. 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 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.
Second, 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 greater
detail elsewhere in this section IV of the proposed rule, we propose 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 propose 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 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. 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.
We invite public comments on our proposal for mandatory
participation, as well as our proposal to select ETC Participants based
on their location in a selected geographic area.
b. Selected Geographic Areas
We propose 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 believe that geographic
areas would 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 section IV.C.11 of
this proposed rule. Specifically, by using geographic areas as the unit
for randomized selection, we would be able to study the impact of the
Model on program costs and quality of care, both
[[Page 34544]]
overall and between ESRD facilities and Managing Clinicians selected
for participation in the proposed 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 aim
to include in the Model approximately 50 percent of adult ESRD
beneficiaries. To achieve this goal, we propose 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, if finalized); 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, we believe a broad
geographic distribution of participants would be necessary to
effectively test the impact of the proposed payment adjustments.
We propose 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 propose 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 believe there would be a sufficient
number of HRRs to support random selection and improve statistical
power of the proposed Model's evaluation. 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) forecasts an average increase of 1.5 percentage
points per year. With a current home dialysis rate of 8.6 percent,\126\
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,\127\ 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. 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.
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\126\ 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.
\127\ United States Renal Data System, Annual Data Report, 2018.
Volume 2. Chapter 6: Transplantation. https://www.usrds.org/2018/view/v2_06.aspx.
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We considered using Core Based Statistical Areas (CBSAs) or
Metropolitan Statistical Areas (MSAs) as the geographic unit of
selection. However, 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.
We also considered using counties or states as the geographic unit
of selection. However, 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 model test 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. 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. In the
alternative, we would consider using CBSAs as the geographic unit of
selection, and assigning rural counties not included in CBSAs to the
nearest CBSA, as this approach would use an existing methodology
already used by CMS to denote regions (CBSAs, which are used, among
other things, in determining the wage index adjustments to Medicare
inpatient prospective payment system rates to account for variation in
hospital wages and wage-related costs related to location), while also
making sure that a random selection of providers and suppliers located
in rural areas are included as participants in the ETC Model.
We propose 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://www.census.gov/geo/reference/gtc/gtc_census_divreg.html. 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 propose that the U.S. Territories, as that term is proposed to
be defined in section II of this proposed rule, would be excluded from
selection, as HRRs are not constructed to include these areas.
[[Page 34545]]
In addition, outside of the randomization, we propose 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. 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. We believe that adding
Maryland-based ESRD facilities and Managing Clinicians as participants
in the proposed ETC Model would assist the state of Maryland and
hospitals located in that state to meet the Medicare TCOC targets
established under the Maryland TCOC Model.
We propose that all HRRs that are not selected geographic areas
would be referred to as ``comparison geographic area(s).'' We propose
that comparison geographic areas would be used for the purposes of
constructing performance benchmarks (as discussed in section IV.C.5.d
of this proposed rule), and for the Model evaluation (as discussed in
section IV.C.11 of this proposed rule).
We invite public comments on our proposal to use HRRs as the
geographic unit of selection, with regional stratification, and to
exclude U.S. Territories from the selected geographic areas. We invite
comment on our alternative consideration to use CBSAs as the geographic
unit of selection, and assign rural counties not included in CBSAs to
the nearest CBSA. We also invite comment on the inclusion of all HRRs
for which at least 20 percent of the component zip codes are located in
Maryland, separate from the randomization, as well as whether HRRs that
include areas included in the Pennsylvania Rural Health Model, the
Vermont All-Payer ACO Model, or future state-based models tested under
section 1115A of the Act should also be selected geographic areas for
purposes of the ETC Model.
c. Participant Selection for the ETC Model
We propose to define ``ETC Participant'' as an ESRD facility or
Managing Clinician that is required to participate in the ETC Model in
accordance with proposed Sec. 512.325(a), which describes the
selection of model participants based on their location within a
selected geographic area, as previously described. In addition, we note
that the proposed definition of ``model participant,'' as defined in
section II of this proposed rule, would include an ETC Participant.
(1) ESRD Facilities
We propose that all Medicare-certified ESRD facilities located in a
selected geographic area would be required to participate in the ETC
Model. We propose 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.
We invite public comment on this proposal for identifying where
ESRD facilities are located for purposes of selecting ESRD facilities
for participation in the ETC Model.
(2) Managing Clinicians
We propose that all Medicare-enrolled Managing Clinicians located
in a selected geographic area would be required to participate in the
ETC Model. We propose to identify 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 would use the practice location through which the Managing
Clinician bills the plurality of his or her MCP claims. We considered
using the zip code of the mailing address listed in PECOS. However, 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.
We invite public comment on this proposal for identifying where
Managing Clinicians are located for purposes of selecting Managing
Clinicians for participation in the ETC Model.
4. Home Dialysis Payment Adjustment
We propose 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
2020-CY 2022). 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 section
IV.C.5 of this proposed rule, which would begin in mid-CY 2021 and
increase in magnitude over the duration of the Model; as such we
propose 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 propose 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 proposed Sec. 512.345 (Payments Subject to the Clinician
HDPA) and Sec. 512.350 (Schedule of Home Dialysis Payment
Adjustments). We propose to define the ``Facility HDPA'' as 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 proposed Sec. 512.340 (Payments
Subject to the Facility HDPA) and Sec. 512.350 (Schedule of Home
Dialysis Payment Adjustments). We propose to define the ``HDPA'' as
either the Facility HDPA or the Clinician HDPA. 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 propose to implement a
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 proposed rule.
a. Payments Subject to the HDPA
We propose that the HDPA would apply to all ETC Participants for
those payments described in sections IV.C.4.b and IV.C.4.c of this
proposed rule, according to the proposed schedule described in section
IV.C.4.d of this proposed rule. We solicit comment on the proposal to
apply the HDPA with
[[Page 34546]]
respect to all ETC Participants, without exceptions.
We also propose that the HDPA would apply to claims where Medicare
is the secondary payer for coverage under section 1862(b)(1)(C) of the
Act. 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 propose 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. 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 seek comment on the proposal to apply the HDPA to Medicare
as secondary payer claims.
b. Facility HDPA
For ESRD facilities that are ETC Participants, we propose to adjust
Medicare payments under the ESRD PPS for home dialysis services by the
HDPA according to the proposed schedule described in section IV.C.4.d
of this proposed rule. As noted previously, under the ESRD PPS, a
single per treatment payment is made to an ESRD facility for all renal
dialysis services and 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. The current
formula for determining the final ESRD PPS per treatment payment amount
is 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
Under our proposal, we would 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 propose to define
the ``Adjusted ESRD 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. The proposed formula for determining the
final ESRD PPS per treatment payment amount with the Facility HDPA
would be as follows:
[GRAPHIC] [TIFF OMITTED] TP18JY19.010
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 seek comment on our proposed
definition of the 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.
We propose in Sec. 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
section IV.C.4.d of this proposed rule, where the beneficiary is age 18
or older during the entire month of the claim. 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.
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. Taken together, we believe these condition codes capture home
dialysis services furnished by ESRD facilities, and therefore are the
codes we propose to use to identify those payments subject to the
Facility HDPA. We seek comment on this proposed provision.
As further described in section IV.C.7.a of this proposed rule, we
also propose 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.
c. Clinician HDPA
For Managing Clinicians that are ETC Participants, we propose to
adjust the MCP by the Clinician HDPA when billed for home dialysis
services. We propose 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,
[[Page 34547]]
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 proposed ETC Model.
We propose in Sec. 512.345 to adjust the amount otherwise paid
under Part B with respect to MCP claims on claim lines with CPT[supreg]
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 through
date during a CY subject to adjustment, as described in section
IV.C.4.d of this proposed rule, where the beneficiary is age 18 or
older for the entire month of the claim. CPT[supreg] code 90965 is for
ESRD related services for home dialysis per full month for patients 12-
19 years of age. CPT[supreg] 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 propose to
use to identify those payments subject to the HDPA. As noted
previously, we propose 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. We seek comment on this proposed provision.
d. HDPA Schedule and Magnitude
We propose in new Sec. 512.350 that the magnitude of the HDPA
would decrease over the CYs 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. 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. 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. 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 propose the payment adjustment schedule in Table 11:
Table 11--Proposed HDPA Schedule
------------------------------------------------------------------------
CY CY CY
2020 2021 2022
------------------------------------------------------------------------
Magnitude of Payment Adjustment................. +3% +2% +1%
------------------------------------------------------------------------
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 seek input from the public about the proposed
magnitude and duration of the proposed HDPA.
5. Performance Payment Adjustment
We propose 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 section IV.C.5.d of this proposed rule. We propose 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
proposed Sec. 512.370(d) (Modality Performance Score), which is used
to determine the amount of the ETC Participant's PPA, as described in
proposed Sec. 512.380 (PPA Amounts and Schedule). We seek comment on
the composition of the MPS, particularly the inclusion of the
transplant rate in the MPS.
There would be two types of PPAs: The Clinician PPA and the
Facility PPA. We propose 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
proposed Sec. 512.375(b) (Payments Subject to Adjustment) and proposed
Sec. 512.380 (PPA Amounts and Schedule). We propose 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 proposed Sec.
512.375(a) (Payments Subject to Adjustment) and proposed Sec. 512.380
(PPA Amounts and Schedule). We propose to define the ``PPA'' as either
the Facility PPA or the Clinician PPA.
a. Annual Schedule of Performance Assessment and PPA
We propose to assess ETC Participant performance on the home
dialysis rate and the transplant rate, described in sections IV.C.5.c.1
and IV.C.5.c.2 respectively, of this proposed rule, and to make
corresponding payment adjustments according to the proposed schedule
described later. We propose in Sec. 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 propose 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 propose in Sec. 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 propose to define ``Performance Payment Adjustment Period (PPA
Period)'' as the 6-month period during which a PPA is applied in
accordance with proposed Sec. 512.380 (PPA Amounts and Schedule). Each
MY included in the ETC Model and its corresponding PPA Period would be
specified in proposed Sec. 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. 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 MY 2, there would be a 6-month
period of overlap between a MY and the previous MY. For example, MY 1
would begin January 1, 2020, and would run through December 31, 2020;
and MY 2 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
[[Page 34548]]
conclusion of the MY. For example, MY 1, which would end December 31,
2020, would correspond to PPA Period 1, which would begin July 1, 2021,
and end December 31, 2021.
In Table 12, we propose the following schedule of MYs and PPA
Periods:
[GRAPHIC] [TIFF OMITTED] TP18JY19.011
We invite public comment on the proposed schedule of MYs and
corresponding PPA Periods.
b. Beneficiary Population and Attribution
We propose 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 propose 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. 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 propose to attribute pre-emptive transplant beneficiaries
to Managing Clinicians for purposes of calculating the transplant rate,
specifically. We propose to define a ``pre-emptive transplant
beneficiary'' as a Medicare beneficiary who received a kidney or
kidney-pancreas transplant prior to beginning dialysis. 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. 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. 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 are proposing to limit the definition of pre-
emptive transplant beneficiary to include Medicare beneficiaries only.
We propose to attribute ESRD Beneficiaries, and pre-emptive
transplant beneficiaries where applicable, to ETC Participants for each
month of each MY, and we further propose that such attribution would be
made after the end of each MY. We considered attributing beneficiaries
to participating ESRD facilities and Managing Clinicians for the entire
MY; however, we believe monthly attribution would more accurately
capture the care relationship between beneficiaries and their ESRD
providers and suppliers. As ETC Participant behavior and care
relationships with beneficiaries may change as a result of the ETC
Model, 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. A pre-emptive transplant beneficiary may
be attributed to only one Managing Clinician during a MY, regardless of
the number of months for which the beneficiary is attributed to the
Managing Clinician.
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. In this case, we 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 believe that prospective attribution would not work
well for the particular design of this Model. In particular, 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. 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
invite public comment on the proposal to attribute beneficiaries on a
monthly basis after the end of the relevant MY.
[[Page 34549]]
We propose to provide ETC Participants lists of their attributed
beneficiaries after attribution has occurred, after the end of the MY.
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, 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.
(1) Beneficiary Exclusions
We propose to exclude certain categories of beneficiaries from
attribution to ETC Participants, consistent with other CMS models and
programs. Specifically, we are proposing 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 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 dialysis for acute kidney injury (AKI) only,
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.
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 could not ascertain a consensus in the literature that
supported any specific age cut-off. We also considered excluding
beneficiaries with housing insecurity from attribution for the purposes
of calculating the home dialysis rate, but could not find an objective
way to measure housing instability.
We invite public comment on the proposed exclusions from
beneficiary attribution under the ETC Model, including criteria
according to which dementia should be assessed, as well as any others,
for example, physical or functional limitations, on the basis of which
beneficiaries should be excluded from attribution. We also seek
comments as to whether we should exclude beneficiaries over a specific
age threshold, and whether there is an objective measure we could use
for housing insecurity.
(2) Attribution Services
(a) Attribution to ESRD Facilities
We propose 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 propose 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. 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 propose that the ESRD Beneficiary would be
attributed to the ESRD facility at which the beneficiary received the
earliest dialysis treatment that month.
We propose 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 alternative, we considered 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. We do, 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. We note that this proposed policy is consistent with the
CEC Model.
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.
Additionally, we considered including a minimum duration that an ESRD
[[Page 34550]]
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 proposed Model.
We propose 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.
We seek comment on the proposed methodology for attributing ESRD
Beneficiaries to ESRD facilities and the alternatives considered, as
well as our proposal not to attribute pre-emptive transplant
beneficiaries to ESRD facilities.
(b) Attribution to Managing Clinicians
We propose 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.\128\
Therefore, 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 propose that, for purposes of ESRD Beneficiary attribution
to Managing Clinicians, we would include MCP claims with CPT[supreg]
codes 90957, 90958, 90959, 90960, 90961, 90962, 90965, or 90966.
CPT[supreg] 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[supreg] 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). Taken
together, these are all the CPT[supreg] 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.
---------------------------------------------------------------------------
\128\ Medicare Claims Processing Manual, Chapter 8; https://www.cms.gov/Regulations-and-Guidance/Manuals/Downloads/clm104.c08.pdf.
---------------------------------------------------------------------------
Additionally, for the transplant rate for Managing Clinicians, we
would also attribute pre-emptive transplant beneficiaries to Managing
Clinicians. Because pre-emptive transplant beneficiaries have not
started dialysis at the time of their transplant, we would not be able
to attribute them to Managing Clinicians based on MCP claims, as we
would for ESRD Beneficiaries. Rather, we propose that pre-emptive
transplant beneficiaries would be attributed to a Managing Clinician
based on the Managing Clinician with whom the beneficiary had the most
claims 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. 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.
We seek comment on the proposed methodology for attributing ESRD
Beneficiaries and pre-emptive transplant beneficiaries to Managing
Clinicians and the alternatives considered.
c. Performance Measurement
We propose 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. 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, CMS also proposes 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. 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, we
believe basing the rates on claims data, supplemented with Medicare
administrative data about beneficiary enrollment and transplant
registry data about transplant occurrences, would 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 solicit 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.
(1) Home Dialysis Rate
We propose 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 Sec. 512.365(b) (Home Dialysis
Rate). We propose to construct the home dialysis rate for ETC
Participants that are ESRD facilities as described in section
IV.C.5.c.1.a of this proposed rule and for ETC Participants who are
Managing Clinicians as described in section IV.C.5.c.1.b of this
proposed rule.
We solicit comment on our proposed methodology for assessing home
dialysis rates for ESRD facilities and Managing Clinicians that are ETC
Participants, as well as alternative methodologies for assessing home
dialysis rates. We describe later our proposed plan for risk adjusting
and reliability adjusting these rates.
(a) Home Dialysis Rate for ESRD Facilities
Under our proposal, the denominator of the home dialysis rate for
ESRD facilities would be the total dialysis treatment beneficiary years
for
[[Page 34551]]
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 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 propose 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. 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. 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.
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,
these modalities lack clear definitions in the literature and delivery
of care for these modalities is billed through the same codes as in-
center hemodialysis, making it impossible for CMS to identify the
relevant claims. We seek comment on the identification and inclusion of
these particular beneficiaries in the numerator of the home dialysis
rate calculation for ESRD facilities.
(b) Home Dialysis Rate for Managing Clinicians
We propose 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 would
identify maintenance dialysis months based on claims, specifically
claims with CPT[supreg] codes 90957, 90958, 90959, 90960, 90961, 90962,
90965, or 90966. CPT[supreg] 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[supreg]
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.
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[supreg] codes 90965 or 90966.
CPT[supreg] code 90965 is for ESRD related services for home dialysis
per full month for patients 12-19 years of age. CPT[supreg] 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.
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,
these modalities lack clear definitions in the literature and delivery
of care for these modalities is billed through the same codes as in-
center hemodialysis, making it impossible for CMS to identify the
relevant claims. We seek comment on the identification and inclusion of
these particular beneficiaries in the numerator of the home dialysis
rate calculation for Managing Clinicians.
(2) Transplant Rate
We propose 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 Sec.
512.365(c) (Transplant Rate). We propose to construct the transplant
rate for ETC Participants that are ESRD facilities as described in
section IV.C.5.c.(2)(a) of this proposed rule, and for ETC Participants
who are Managing Clinicians as described in section IV.C.5.c.(2)(b) of
this proposed rule.
For purposes of constructing the transplant rate, we propose two
transplant rate-specific beneficiary exclusions. Specifically, we
propose 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 skilled nursing facility (SNF) at any
point during the month. We propose these additional exclusions to
recognize that, while these beneficiaries can be candidates for home
dialysis, they are generally not considered candidates for
transplantation. These exclusions would be similar to the exclusions
used in the Percentage of Prevalent Patients Waitlisted (PPPW) measure
that has been adopted by ESRD QIP. We seek comment on the proposal to
exclude from the transplant rate beneficiaries aged 75 or older and
beneficiaries in
[[Page 34552]]
SNFs. The transplant rate calculations would also exclude beneficiaries
who elected hospice, as we are proposing 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.
We considered using rates of transplant waitlisting rather than the
actual transplant rate. However, for the ETC Model, we propose to test
the effectiveness of the Model's incentives on outcomes, rather than on
processes. 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 acknowledge 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 believe that ESRD
facilities and Managing Clinicians are well positioned to assist
beneficiaries through the transplant process, and we want to
incentivize this focus. Transplant waitlist measures also 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
solicit 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 solicit comment on an
alternative transplant waitlist measure that would also capture living
donation.
We propose using one year of data, from an MY, to construct the
transplant rate to align with the construction of the home dialysis
rate. However, 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, 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 section IV.C.5.c.(4) of this
proposed 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 solicit feedback on our proposal to construct the transplant
rate using only one year of data, from the MY.
Also, we solicit comment on our proposed methodology for assessing
transplant rates and alternative methodologies considered for assessing
transplant rates. We discuss later in this rule our proposed plan for
risk adjusting and reliability adjusting these rates.
(a) Transplant Rate for ESRD Facilities
For ESRD facilities, we propose 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. 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 propose 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, 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 propose 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.
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, 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. 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. We solicit comment on the
inclusion of transplants in the numerator after the year of the
transplant.
(b) Transplant Rate for Managing Clinicians
Whereas ESRD facilities provide care to beneficiaries only once
they have
[[Page 34553]]
begun dialysis, Managing Clinicians provide care for beneficiaries
before they begin dialysis. Therefore, we propose 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. 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 seek comment on
the proposed inclusion of pre-emptive transplants in both the numerator
and the denominator for the Managing Clinician transplant rate
calculation.
We propose 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[supreg] codes 90957,
90958, 90959, 90960, 90961, 90962, 90965, or 90966. CPT[supreg] codes
90957, 90958, 90959, 90960, 90961, and 90962 are for ESRD related
services 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[supreg] 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 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.
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. We recognize 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, we
believe 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 propose 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 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, 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
propose 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 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.
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, we believe 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
proposed 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.
We solicit comment on the inclusion of transplants in the numerator
after the year of the transplant.
(3) Risk Adjustment
In order to account for underlying variation in the population of
beneficiaries attributed to participating ESRD facilities and Managing
Clinicians, we propose that CMS would risk adjust both the home
dialysis rate and the transplant rate.
For the home dialysis rate, we propose to use the most recent final
risk score for the beneficiary, calculated using the CMS-HCC
(Hierarchical
[[Page 34554]]
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. 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 are proposing 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. The CMS-HCC risk adjustment models were developed for the
Medicare Advantage program and uses 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.\129\ There are
various CMS-HCC Models used in the Medicare Advantage program, all of
which are developed using cost and diagnoses from claims data from the
Medicare FFS program, including models specific to calculating risk
scores for enrollees with ESRD. Under the CMS-HCC Models, the risk
factors--meaning the demographic factors and conditions (as represented
by HCCs)--have a coefficient that represents the amount of risk
projected to be associated with and is unique to the condition or
demographic status. A relative factor is created for each demographic
and condition variable by dividing the coefficient by the average
annual cost of a FFS beneficiary predicted by the model in a
denominator year. For payment, CMS calculates a risk score for each
enrollee by adding the relative factors of an enrollee's demographics
and health status (that is, HCCs). CMS then multiplies the resulting
risk score (after some adjustments are applied) by the monthly
capitation amount to pay the Medicare Advantage plan risk adjustment.
CMS has developed a separate CMS-HCC ESRD Model for beneficiaries who
are on dialysis, who have received kidney transplants, or who are in
post-graft status.
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\129\ CMS. Report to Congress: Risk adjustment in Medicare
Advantage. December 2018; cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/RTC-Dec2018.pdf.
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We propose 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. 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 Advantage program.\130\ 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.
---------------------------------------------------------------------------
\130\ 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/MedicareAdvtgSpecRateStats/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/MedicareAdvtgSpecRateStats/Downloads/Announcement2020.pdf.
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For MY 1 (January 1, 2020 through December 31, 2020), which
corresponds to PPA Period 1 (July 1, 2021 through December 31, 2021),
we are proposing in section IV.C.5.g of this proposed rule that CMS
would notify ETC Participants of their PPA no later than June 1, 2021.
The calculation of the PPA and component risk-adjusted home dialysis
rate would occur in May 2021. As the final risk scores for payment year
2020 would not be calculated for purposes of the Medicare Advantage
program until 2021, we are proposing that CMS would use the final risk
scores calculated by CMS for 2019, which will happen in 2020 using the
CMS-HCC ESRD Dialysis Model adopted for risk adjustment of payments for
payment year 2019 to risk adjust the home dialysis rates for MY 1/PPA
Period 1. CMS adopted and announced the specific CMS-HCC ESRD Dialysis
Model used for payments for 2019 in the CY 2019 Rate Announcement
issued in April 2018.\131\ We are further proposing that CMS would use
the final risk scores calculated by CMS in 2021, using the CMS-HCC ESRD
Dialysis Model adopted for risk adjustment of payments for 2020, to
risk adjust the home dialysis rates for MY 2 (July 1, 2020 through June
30, 2021)/PPA Period 2 (January 1, 2022 through June 30, 2022). CMS
adopted and announced the specific CMS-HCC ESRD Dialysis Model used for
payments for 2020 in the CY 2020 Rate Announcement issued on April 1,
2019.\132\
---------------------------------------------------------------------------
\131\ For the CY2019 Advance Notice and Rate Announcement,
specifying the CMS-HCC ESRD Dialysis Model used for payment in 2019,
see: https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Announcements-and-Documents.html.
\132\ (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/MedicareAdvtgSpecRateStats/Downloads/Announcement2020.pdf.
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We believe that using risk scores developed using the CMS-HCC ESRD
Dialysis Model to risk adjust the ETC Model home dialysis rate is
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. Moreover, use of the final risk scores as we are
proposing means that the ETC Model would follow the same methodology
and use 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 Sec.
422.308(c)(1) and (2)(ii), so those risk factors would be used in risk
adjustment for the ETC Model; 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. However, for the ETC Model, there would not be a frailty
adjustment (for example, outlined in Sec. 422.308(c)(4)) that is used
in the Medicare Advantage program for certain special needs plans.
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 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. However, we believe that the HCC system
for risk adjustment currently in use in the Medicare Advantage program
would be sufficient for the purposes of this Model, without
[[Page 34555]]
the effort required to develop a new methodology.
We propose that the risk-adjustment methodologies for the home
dialysis rate and transplant rate would be applied independently. We
considered using the same risk adjustment strategy for both rates,
however, we recognize 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. Further, even in the Medicare Advantage program, a
different CMS-HCC Model is used for beneficiaries who have received a
transplant. We believe that the benefit of separate risk adjustment
methodologies outweighs the additional complexity.
For the proposed ETC Model transplant rate, 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. 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 propose 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,
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
proposed ETC Model would exclude beneficiaries under 18 from the
attribution methodology used for purposes of calculating the transplant
rates, we propose 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).
We 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.
We 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 their suitability for receiving a transplant.
We solicit comment on the proposed risk adjustment methodologies
and the alternatives considered.
(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 propose to employ a reliability
adjustment. Under this approach, we propose 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 propose 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 section IV.C.5.d of
this proposed 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. 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. 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. However, we believe this approach
balances the need for individualized performance assessment and
incentives with the importance of reliably assessing the performance of
each ETC Participant.
For Managing Clinicians, we propose that the performance on these
measures would first be 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 propose 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 propose 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 propose 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 propose
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
[[Page 34556]]
which the group practice is located (for group practices) or the
Managing Clinician's HRR (for solo practitioners).
For ESRD facilities, we propose that the individual unit would be
the ESRD facility. We propose to define a subsidiary ESRD facility as
an ESRD facility owned in whole or in part by another legal entity. We
propose this definition in recognition of the structure of the dialysis
market, as described in this rule. We propose 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 seek 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.
We acknowledge 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 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. We believe 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. 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, we
concluded 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. We seek public comment on our proposal to address this
facet of the provision of home dialysis in the larger dialysis market
through the reliability adjustment as well as the alternatives
considered.
d. Benchmarking and Scoring
We propose calculating two types of benchmarks for rates of home
dialysis and transplants against which to assess ETC Participant
performance in MY 1 and MY 2 (both of which begin in CY 2020). 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 propose 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 propose to refer to this period of
time as the ``benchmark year.'' We propose using data from ESRD
facilities and Managing Clinicians located in comparison geographic
areas to construct these benchmarks. As an alternative, we 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. We propose 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 intend to establish the
benchmarking methodology for future MYs through subsequent rulemaking.
Our intent in future MYs is to increase achievement benchmarks
among ETC Participants above the rates observed in comparison
geographic areas. By MY 9 and MY 10, in order to receive the maximum
achievement score, we are 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 seek 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 propose 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 propose
that an ETC Participant cannot 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. This policy would be consistent with
other CMS programs and initiatives employing similar improvement
scoring methodologies, including the CEC Model.
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, 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 seek 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 MY
1 and MY 2 achievement scores and improvement scores on the home
dialysis rate and transplant rate.
[[Page 34557]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.012
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 propose the
following formula for determining the MPS:
[GRAPHIC] [TIFF OMITTED] TP18JY19.013
We propose 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. 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 recognize 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 are proposing that the home dialysis rate component take a
greater weight than the transplant rate component of the MPS. We
request comment on the proposed MPS calculation.
e. Performance Payment Adjustments
We propose that CMS would make upwards and downwards adjustments to
payments for claims for dialysis and dialysis-related services,
described in IV.C.5.e of this proposed rule, submitted by each ETC
Participant with a claim through date during the applicable PPA period
based on the ETC Participant's PPA. We propose 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 proposed
PPAs are designed to be comparable to the MIPS payment adjustment
factors for MIPS eligible clinicians, as described in sections
IV.C.5.e.(1) and IV.C.5.e.(2) of this proposed rule. Specifically, the
proposed PPAs are 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). The PPAs proposed for the ETC Model
are also designed to increase over time and to be asymmetrical--with
larger negative adjustments than positive adjustments--in order to
create stronger financial incentives.
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 are proposing 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. We believe
that the proposed exclusion of ESRD facilities that fall below the low-
volume threshold described in section
[[Page 34558]]
IV.C.5.f.(1) of this proposed 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.
(1) Facility PPA
For ESRD facilities that are ETC Participants, as described in
proposed Sec. 512.325(a) (Selected Participants), we propose 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 Sec.
512.355(c) (Measurement Years and Performance Payment Adjustment
Periods). 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 propose
to apply the Facility PPA to claims where Medicare is the secondary
payer. We see comment on this proposal.
The formula for determining the final ESRD PPS per treatment
payment amount with the Facility PPA would be as follows:
[GRAPHIC] [TIFF OMITTED] TP18JY19.014
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:
[GRAPHIC] [TIFF OMITTED] TP18JY19.015
Table 14 depicts the proposed amounts and schedule for the Facility
PPA over the ETC Model's PPA periods, which we propose to codify in
proposed Sec. 512.380.
[GRAPHIC] [TIFF OMITTED] TP18JY19.016
As also described in section IV.C.7.a of this proposed rule, we
further propose 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.
(2) Clinician PPA
For Managing Clinicians that are ETC Participants, as described in
proposed Sec. 512.325(a) (Selected Participants), we propose to adjust
payments for
[[Page 34559]]
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[supreg] 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 Sec. 512.355(c) (Measurement Years and Performance Payment
Adjustment Periods). CPT[supreg] 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[supreg]
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 propose to apply the Clinician PPA to
claims where Medicare is the secondary payer. We seek comment on this
proposal.
Table 15 depicts the proposed amounts and schedule for the
Clinician PPA over the ETC Model's PPA periods, which we propose to
codify in proposed Sec. 512.380.
[GRAPHIC] [TIFF OMITTED] TP18JY19.017
We propose 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.
We seek comment on our PPA proposals, including the proposed
magnitude of and schedule for these proposed payment adjustments for
both ESRD facilities and Managing Clinicians participating in the ETC
Model.
f. Low-Volume Threshold Exclusions for the PPA
(1) ESRD Facilities
We propose 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 at IV.C.5.b, 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 months from multiple beneficiaries. We are
proposing 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. We 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 invite public comment on this 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.
(2) Managing Clinicians
We propose excluding ETC Participants that are Managing Clinicians
who fall below a specified low-volume threshold during an MY 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. 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 propose 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 considered using 11 beneficiary-years as the low-
volume exclusion for Managing Clinicians, to mirror the proposed
exclusion for ESRD facilities. However, we recognize 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 propose 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 alternative, we considered establishing
the low-volume
[[Page 34560]]
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 invite 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.
g. Notification
Per the PPA schedule, we propose 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 three 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 propose to notify
ETC Participants of their attributed beneficiaries, MPSs and
corresponding PPAs. We propose notification of ETC Participants no
later than one month before the start of the PPA Period in which the
PPA would go into effect. We believe this notification period balances
the need for sufficient claims run-out to ensure accuracy, as well as
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 propose to conduct notifications in a form and manner determined
by CMS.
h. Targeted Review
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 believe to have occurred in the calculation of the MPS.
Therefore, we are proposing 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 note 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 Medicare Administrative Contractor.
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 propose 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 there
to have occurred an error 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. 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 proposed Sec. 512.170.
To request a targeted review, 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 propose 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 propose that we will 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
propose 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, it would be required
to 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 conducted 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. Decisions based on the
targeted review process would be final, and there would be no further
review or appeal.
We considered compressing the duration of the targeted review
process such that it could be completed before the PPA period in which
the MPS in question sets the PPA. However, 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.
We invite public comment on these proposed provisions regarding the
proposed targeted review process.
6. Overlap With Other Innovation Center Models and CMS Programs
The ETC Model would overlap with several other CMS programs and
models, and we seek 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 propose 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 are proposing that the
Facility HDPA and the Facility PPA would adjust the Adjusted ESRD PPS
per Treatment Base Rate, as previously discussed at section IV.C.4.b of
this proposed 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
[[Page 34561]]
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 propose 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 is designed to
ensure that the MIPS payment adjustment factors will still have a
significant weight for Managing Clinicians.
Kidney Care First Model (KCF) and the Comprehensive Kidney
Care Contracting (CKCC) Model--The KCF and CKCC Modela are optional
Innovation Center models for nephrologists, dialysis facilities,
transplant providers, and other providers and suppliers that are
focused on beneficiaries with CKD and beneficiaries with ESRD. The KCF
and CKCC Models will run from January 1, 2020, through December 31,
2025, and will have five years of financial accountability overlap with
the ETC Model beginning January 1, 2021. We propose that the types of
entities eligible to participate in these models -KCF practices and
Kidney Contracting Entities (KCEs)--would be permitted to participate
in either the KCF or one of the CKCC Models within regions where the
ETC Model would be in effect. Not allowing these entities to
participate as KCF practices or KCEs within the ETC Model's selected
geographic areas would limit participation in the KCF and CKCC Models,
and could prevent a sufficient number of KCF practices or KCEs from
participating in the KCF and KCCC Models, such that these models would
not have sufficient participation to be evaluated. CMS believes it is
important to test both models in order to evaluate payment incentives
inside and outside the coordinated care context. The ETC Model would
allow for a broader scope of test due to its mandatory nature across
half the country, while the KCF and CKCC Model will test the effects on
outcomes of higher levels of risk for a self-selected group of
participants. Payment adjustments under the ETC Model would be counted
as expenditures for purposes of the KCF and CKCC Models. Both models
would include explicit incentives for participants when beneficiaries
receive kidney transplants; and 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 under the KCF and
CKCC Models. 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.\133\ As a result, CMS believes it would be
appropriate to test incentives in both the ETC Model and the KCF and
CKCC Models simultaneously to assess their effects on the transplant
rate.
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\133\ 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.
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Comprehensive ESRD Care (CEC) Model--The CEC Model is a
voluntary Innovation Center model for ESRD dialysis facilities,
nephrologists, and other providers and suppliers that focuses on
beneficiaries with ESRD. The CEC Model will end on December 31, 2020,
and therefore, would overlap for one year with the proposed ETC Model.
We propose that ETC Participants could be selected from regions where
there are participants in the CEC Model. Given the national
distribution of CEC ESCOs, 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 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. 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 ETC Model's selected
geographic areas, which we believe would negatively impact the CEC
Model test by requiring termination of several ESCOs, 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 Medicare APMs--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 propose that any increase or
decrease in program expenditures that are 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
Shared Savings Program, CMS considers ``individually beneficiary
identifiable final payments made under a demonstration, pilot, or time
limited program'' (see, for example, Sec. 426.610(a)(6)(ii)(B)). We
believe that this existing policy sufficiently addresses overlaps that
would arise between the Medicare Shared Savings Program and the
proposed ETC Model. CMS would review any 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 seek public input on our proposed overlap policies.
We invite public comments on our proposals to account for overlaps
with other CMS programs and models.
7. Medicare Program Waivers
We believe it is 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 propose 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.
a. Medicare Payment Waivers
In order to make the proposed payment adjustments under the ETC
Model, namely the HDPA and PPA discussed in sections IV.C.4 and IV.C.5
[[Page 34562]]
of this proposed rule, respectively, 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 would 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 would 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
propose 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 propose
that beneficiary cost sharing be unaffected 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 run counter to the intent of
the Model.
Therefore we would 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 seek comment on our proposed waivers of
Medicare payment requirements related to the HDPA and PPA and
beneficiary cost sharing.
b. Waiver of Select KDE Benefit Requirements
We believe 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. CMS believes 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 propose 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(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.\134\ We propose 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 need not 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). 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 do not believe it is necessary for testing the Model. Moreover, ESRD
facilities are already required to educate beneficiaries about their
treatment modality options in the ESRD facility conditions for coverage
at Sec. 494.70(a)(7); and to develop and implement a plan of care that
addresses the patient's modality of care, at Sec. 494.90(a)(7).
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\134\ United States Government Accountability Office. 2015.
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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). We understand this
prevents many beneficiaries in Stage V of CKD from receiving the
benefits of KDE before starting dialysis or pursuing a transplant. We
hypothesize 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. \135\ We propose 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.
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\135\ United States Government Accountability Office. 2015.
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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 are proposing 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 propose 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
propose 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.
[[Page 34563]]
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 propose 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.
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 were necessary for purposes of testing
the Model.
We seek comment on our proposals to waive select requirements of
the KDE benefit for purposes of testing the ETC Model and alternatives
considered.
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, no
fraud and abuse waivers are being issued for this Model. Thus,
notwithstanding any other provision of this proposed regulation, all
ETC Participants must comply with all applicable laws and regulations.
9. Beneficiary Protections
As we discuss in section IV.C.4.b, we propose 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 section II.B.2.a.(8) of this proposed 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 propose to prohibit ETC Participants from
offering or paying any remuneration to influence a beneficiary's choice
of renal replacement modality, unless such remuneration complies with
all applicable law. We believe 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, 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. 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 previously in sections IV.C.4.c and
IV.C.5.e.(2) of this proposed rule, we are proposing 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 section IV.C.7.a. of this
proposed rule, we intend to use our waiver authority under section
1115A(d)(1) of the Act to issue certain payment waivers, in accordance
with, which beneficiaries would be held harmless from any model-
specific payment adjustments made to Medicare payments under this
Model.
In proposed Sec. 512.330(a), we would require ETC Participants 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 and kidney transplants and who to
contact if they have questions or concerns. We are proposing this
notification to further non-speculative government interests including
transparency and beneficiary freedom of choice. So as not to be unduly
burdensome, 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 patients, 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).
All other ETC Participant
[[Page 34564]]
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
section II.D.3 of this proposed rule.
We invite public comment on the proposed beneficiary protections
for the ETC Model.
10. Monitoring
a. Monitoring Activities
If finalized, the general provisions relating to monitoring
proposed in section II.I of this rule would apply to ETC Participants,
including but not limited to cooperating with the model monitoring
activities per the proposed Sec. 512.150, granting the government the
right to audit per the proposed Sec. 512.135(a), and retaining and
providing access to records per Sec. 512.135(c) and Sec. 512.135(b),
respectively. CMS would conduct the model monitoring activities in
accordance with the proposed Sec. 512.150. We believe that we must
closely monitor the implementation and outcomes of the ETC Model
throughout its duration. 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 Sec. 512.150, we propose 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 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.
We recognize 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. Therefore, to avoid inappropriate use
of home dialysis, as described in section IV.C.5.c.(3) of this proposed
rule, we propose to use risk adjustment to account for factors related
to good candidacy for home dialysis. As described in section
IV.C.5.b.(1) of this proposed rule, we also propose to exclude from
beneficiary attribution certain categories of beneficiaries not well
suited to home dialysis, including beneficiaries with a diagnosis of
dementia. We are proposing 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, CMS would
monitor for inappropriate encouragement or recommendations for home
dialysis through the proposed monitoring activities. Instances of
inappropriate home dialysis may show up in increased 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
propose to review a sample of medical records for indicators that a
beneficiary was not suited for home dialysis. Through patient surveys
and interviews, CMS would look for instances of coercion on beneficiary
choice of modality against beneficiary wishes. If such instances of
coercion were found, we would take one or more remedial action(s) as
described at proposed Sec. 512.160 against the ETC Participant and
refer the case to CMS for further investigation and/or remedial action.
Additionally, 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 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 would be examining 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
the proposed Sec. 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.
We welcome 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 would 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.
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 believe beneficiary and/or care partner feedback would
be a tremendous asset to help CMS determine and resolve any issues
directly affecting beneficiaries.
[[Page 34565]]
In addition, we are seeking comment on how the proposed 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.
We invite public comment on our proposed monitoring plan for the
ETC Model.
b. Quality Measures
In addition to the monitoring activities discussed previously, we
propose 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.
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.\136\ 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. Though 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. 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.
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\136\ 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.
---------------------------------------------------------------------------
We considered including the In-Center Hemodialysis (ICH)
CAHPS[supreg] survey to monitor beneficiary perceptions of 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 are not
proposing to use this measure for purposes of the ETC Model.
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. 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 propose that the SHR and SMR measures would not be tied to
payment under the ETC Model. However, 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 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. 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 invite public comment on the proposed quality measures and
whether their proposed use would enable CMS to sufficiently monitor for
adverse events for ESRD beneficiaries, in combination with the
monitoring activities previously described. We also invite other
suggestions as to measures that would support monitoring beneficiary
health and safety under the model, while minimizing provider burden.
We also invite public comment on the proposal not to tie quality
measurement to the payment adjustments in the ETC Model.
Additionally, as described in section IV.C.6 of this proposed rule,
we propose 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. 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 do not
propose to waive any of these requirements for purposes of testing the
ETC Model.
11. Evaluation
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 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
[[Page 34566]]
evaluation contractor to perform this evaluation. As specified in
section II.E of this rule, all ETC Participants will be required to
cooperate with the evaluation.
Research questions addressed in the evaluation would include, but
would 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
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 propose 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. 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.
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.
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 attributed using
the same claims-based beneficiary attribution methods we propose to use
for purposes of calculating the MPS.
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 KCF Model, and the CKCC Models. 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,
KCF, or CKCC Models.
We invite public comment on our proposed approach related to the
evaluation of the proposed ETC Model.
12. Learning System
In conjunction with the proposed ETC Model, CMS intends to 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, organ procurement organizations (OPOs), and large
donor hospitals. 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 believe that the 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.
13. Remedial Action
The remedial actions outlined in the general provisions in proposed
Sec. 512.160, if finalized, 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 proposed Sec. 512.160(a) (Grounds for
Remedial Action), CMS may take one or more of the remedial actions
listed under proposed Sec. 512.160(b).
14. Termination of the ETC Model
If finalized, the general provisions relating to termination of the
Model by CMS proposed in section II.J of this proposed 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 proposed Sec. 512.170, termination of the Model under
section 1115A(b)(3)(B) of the Act would not be subject to
administrative or judicial review.
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 proposed rule
need not be reviewed by the Office of Management and Budget. However,
we have summarized the anticipated information collection requirements
in section VII.C.4 of the Regulatory Impact Analysis.
[[Page 34567]]
VI. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this proposed
rule, and, when we proceed with a subsequent document, we will respond
to the comments in the preamble to that document.
VII. Regulatory Impact Analysis
We have examined the impact of this proposed rule as required by
Executive Order 12866 and other laws and Executive Orders, requiring
economic analysis of the effects of proposed 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 hence 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 proposed rule.
A. Statement of Need
1. Need for Proposed Radiation Oncology (RO) Model
Radiotherapy (RT) services represent a promising area of health
care for payment and service delivery reform. First, RT services can be
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 MPFS and increased coding complexity and administrative
burden. As part of the RO Model's design, CMS would also 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 would
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 proposed rule,
RO participants would be required to collect and submit data on quality
measures, clinical data, and patient experience throughout the course
of the RO Model, beginning January 1, 2020, with the final data
submission ending in 2025.
2. Need for Proposed 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 quality of care and quality
of life 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 improvement in
quality of care for beneficiaries and reduced expenditures under the
ETC Model inasmuch as the Model would create incentives for
beneficiaries, along with their families and caregivers, to choose the
optimal kidney replacement modality.
In section IV.B of this proposed 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 would 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 proposed
rule, ETC Participants would receive adjusted payments and would 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 Proposed RO Model and ETC Model
As detailed in Table 16A, we estimate a net impact of $260 million
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, we estimate a net impact of $250 million 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, we estimate 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 expect that the ETC Model would cost an additional $15
million, resulting from increases in education and training costs.
Therefore, the net impact to Medicare spending is estimated to be $169
million in savings as a result of the ETC Model.
We solicit comment on the assumptions and analysis presented
throughout this regulatory impact section.
B. Overall Impact
We have examined the impacts of this 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
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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, this proposed rule
triggers these criteria.
C. Anticipated Effects
1. Scale of the Model
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 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 enough
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, we determined the sample size
necessary for a minimum estimated savings impact of three percent.
While a savings higher than three 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
three percent level, then we would increase the risk of missing an
opportunity to detect the actual savings produced by the Model or of
concluding there are savings when there are not savings.
The RO Model as proposed would include 40 percent of radiation
oncology episodes in eligible geographic areas, as defined in this
proposed rule. In a simulation, we randomly selected CBSAs and found
that there would be 616 physician group practices (PGPs) (325 being
freestanding radiation therapy centers) and 541 hospital outpatient
departments furnishing RT services in those simulated selected CBSAs.
Among the simulated selected PGPs, 173 furnish RT services in both
freestanding radiation therapy centers and HOPDs. 285 PGPs furnish RT
services only in HOPDs, and 158 PGPs furnish RT services only in
freestanding radiation therapy services. These providers and suppliers
furnished 39.7 percent of radiation oncology episodes nationally, based
on data from 2015 to 2017. If finalized as proposed with the Model
starting in January 2020, thee RO Model would have a 5-year performance
period and include an estimated 364,000 episodes, 322,000
beneficiaries, and $5.4 billion in total episode spending of allowed
charges (inclusive of beneficiary cost-sharing). See Table 16A for an
annual breakdown. If finalized as proposed, with an April 1, 2020 start
date, the RO Model would have a 5-year performance period and include
an estimated 346,000 episodes, 307,000 beneficiaries, and $5.1 billion
in total episode spending of allowed charges (inclusive of beneficiary
cost-sharing). See Table 16B for an annual breakdown.
b. End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model
The ETC Model as proposed would include approximately 50 percent of
ESRD Beneficiaries, through the ESRD facilities and Managing Clinicians
selected for participation in the Model. The Innovation Center would
randomly select 50 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, would be required to participate in the Model. There
are currently 7,097 ESRD facilities and 7,283 Managing Clinicians
enrolled in Medicare, distributed across 306 HRRs and providing care
for 432,436 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 would apply the payment adjustments described in section
IV. of this proposed rule to claims with claim through dates between
January 1, 2020 through June 30, 2026, and over that time period, would
include an estimated 3,548 ESRD facilities, 3,642 Managing Clinicians,
216,218 beneficiaries, and $169 million in net Medicare savings. See
Table 17 for an annual breakdown.
c. Aggregate Effects on the Market
There may be spillover effects in the non-Medicare market, or even
in the Medicare market in other areas as a result of these models, if
finalized. 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 it is unclear 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 welcome comments on this assumption and evidence on how
this rulemaking, if finalized, would impact non-Medicare payers and
patients.
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
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service basis to both PGPs (including freestanding radiation therapy
centers) and HOPDs through the PFS and the OPPS, respectively. The
proposed RO Model would 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,
2020 and December 31, 2024.
The proposed RO Model would test differences in payment from
traditional FFS Medicare by paying model participants two equal lump-
sum payments, once at the start of the episode and again at the end,
for episodes of care. Episodes would be defined as all Medicare items
and services described in proposed Sec. 512.235 that are furnished to
a beneficiary described in proposed Sec. 512.215 during the period of
time that begins with episode initiation defined in proposed Sec.
512.245 and ends 89 days after the start date of the episode. Once an
episode is initiated, RO participants would 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 episode.
For each participating entity, the participant-specific
professional payment and participant-specific technical episode payment
amounts would be determined as described in detail in section III.C.6.
of this proposed rule.
The RO Model would not be a total cost of care model. RO
participants would 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 proposed criteria for inclusion in the RO
Model and associated FFS procedure codes are included in section
III.C.5. of this proposed rule.
(2) Data and Methods
A stochastic simulation was created to estimate the financial
impacts of the proposed RO Model relative to baseline expenditures. The
simulation relied upon statistical assumptions derived from
retrospectively constructed RT episodes between 2015 and 2017. This
information was reviewed and determined to be reasonable for the
estimates.
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
2018 Medicare Trustees Report and applied to simulated episode
payments. In addition, current relative value units under the PFS and
relative payment weights under the OPPS are assumed to be fixed at the
simulated levels found in the 2015 through 2017 ARC episode data.
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 2024 under the Medicare Access
and CHIP Reauthorization Act of 2015. OPPS conversion factors are
assumed to be updated at the Hospital Market Basket less Multifactor
Productivity in our simulation. We forecast that net OPPS updates would
outpace the PFS by 3.0 percent on average annually between 2019 and
2024.
(3) Medicare Estimate
Table 16 summarizes the estimated impact of the proposed RO Model.
We estimate that on net the Medicare program would save $260 million
($250 million with an April 1 start date) over the 5 performance years
(2020 through 2024) with final data submission of clinical data
elements and quality measures in 2025 to account for episodes ending in
2024. 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.
We project that 82 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 2019 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 CY2017 provider billing
patterns.
As proposed, the APM incentive payment would apply only to the
professional episode payment amounts and not the technical episode
payment amounts. We also assume HOPD line item cap as described in
section 1833(t)(8)(C)(i) of the Act will continue to be applied as is
done under current law.
Complete information regarding the data sources and underlying
methodology for withhold reconciliation were not available at the time
of this forecast. In the case of the incomplete payment withhold, we
assume 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. In Table 16, negative spending
reflects a reduction in Medicare spending, while positive spending
reflects an increase. No APM incentive payments would be paid based on
participation in the RO Model in 2020 and 2021, due to the two-year lag
between the QP performance and payment periods.
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[GRAPHIC] [TIFF OMITTED] TP18JY19.018
[GRAPHIC] [TIFF OMITTED] TP18JY19.019
A key assumption underlying the above 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 model, then we estimate Medicare would only
reduce net outlays by $50 million ($40 million with an April 1 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 start date) for the projection period. Please
note that although V&I growth from 2014 through 2017 fell within this
1.0 percent range and did not exhibit a secular trend, actual
experience may differ.
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 proposed
ETC Model would be a mandatory payment model designed to test payment
adjustments to certain dialysis and dialysis-related payments, as
discussed in section IV. of this proposed rule, for ESRD facilities and
to the MCP for Managing Clinicians from January 1, 2020 to June 30,
2026.
Under the proposed ETC Model, there would be two payment
adjustments designed to increase rates of home dialysis and kidney and
kidney-pancreas transplants through financial incentives. The HDPA
would be an upward payment adjustment on certain home dialysis and home
dialysis-related claims, as described in proposed Sec. 512.340 and
Sec. 512.350 for ESRD facilities and Sec. 512.345 and Sec. 512.350
for Managing Clinicians, during the initial 3 years of the ETC Model.
The PPA would be an upward or downward payment adjustment on
certain dialysis and dialysis-related claims submitted by ETC
participants, as described in proposed Sec. 512.375(a) and Sec.
512.380 for ESRD facilities and Sec. 512.375(b) and Sec. 512.380 for
Managing Clinicians, that would apply to claims with claim through
dates beginning on July 1, 2021 and increase in magnitude over the
duration of the Model. CMS would assess each ETC Participant's home
dialysis rate, as described in proposed Sec. 512.365(b), and
transplant rate, as described in proposed Sec. 512.365(c), for each
Measurement Year. The ETC Participant's home dialysis rate and
transplant rate would be risk adjusted and reliability adjusted, as
described in proposed Sec. 512.365(d) and proposed Sec. 512.365(e),
respectively. The ETC Participant would receive a Modality Performance
Score (MPS)
[[Page 34571]]
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 proposed Sec.
512.370(d). In MY 1 and MY 2, the achievement scores would be
calculated in relation to a set of benchmarks based on the historical
rates of home dialysis and kidney transplants among ESRD facilities and
Managing Clinicians located in comparison geographic areas. We intend
to increase these benchmarks over time through subsequent notice and
comment rulemaking, as discussed in section IV.C.5.d. of this proposed
rule. The improvement score would 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 would determine the magnitude of its
PPA during the corresponding 6-month PPA Period, which would begin 6
months after the end of the MY. An ETC Participant's MPS would be
updated on a rolling basis every 6 months.
The ETC Model would not be a total cost of care model. ETC
participants would still bill FFS Medicare, and items and services not
subject to the ETC Model's payment adjustments would continue to be
paid as they would be 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
and transplant claims reported during 2016 and 2017, the most recent
years with complete data available. Both datasets and the proposed
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, or with 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.
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 proposed exclusion in proposed Sec. 512.385(a), ESRD facilities
with less than 132 total attributed beneficiary months during a given
MY were excluded.
The Managing Clinicians' data were aggregated to the group TIN,
individual TIN, or NPI (in order of availability) level for
beneficiaries on home dialysis and were constructed using outpatient
claims with CPT[supreg] codes 90965 and 90966. Beneficiaries receiving
in-center dialysis were defined by outpatient claims with CPT[supreg]
codes 90957, 90958, 90959, 90960, 90961, and 90962. A low-volume
exclusion was applied 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 transplant data for ESRD facilities and Managing Clinicians
were obtained from Medicare inpatient claims with MS-DRGs 008 and 652;
and claims with ICD-10 procedure codes 0TY00Z0, 0TY00Z1, 0TY00Z2,
0TY10Z0, 0TY10Z1, and 0TY10Z2.\137\ The beneficiary attribution
eligibility criteria in proposed Sec. 512.360(b) and low-volume
exclusions in proposed Sec. 512.385 were applied to the transplant
data in the ESRD facilities and Managing Clinicians datasets. In
addition, the transplant data were further restricted by excluding
beneficiaries during any months in which they were 75 years of age or
older or for any months in which they were in a skilled nursing
facility.
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\137\ SRTR data was not used in this analysis, as it was not
available at the time the analysis was conducted. While this
omission adds some small amount of uncertainty to the analysis, we
do not believe that this lack of data compromises the validity of
the analysis, as the number of kidney and kidney-pancreas
transplants not identifiable through claims data is very small.
---------------------------------------------------------------------------
The home dialysis score and transplant score for the PPA were
calculated using the following methodology for the ESRD facilities and
Managing Clinicians. A reliability adjustment was applied to the home
dialysis (transplant) rate to account for the small numbers of
beneficiaries attributed to individual ETC Participants and 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 section
IV.C.5.d of this proposed rule. Four credibility tiers of total member
months (that is, 400, 600, 800, and 1,000) were constructed with
corresponding HRR weights of 80, 60, 40, and 20 percent. ETC
Participant behavior for each year was simulated by adjusting the ETC
Participant's baseline home dialysis (or transplant) rate for a
simulated statistical fluctuation and then summing with the assumed
increase in home dialysis (or transplant) rate multiplied by a randomly
generated improvement scalar. The achievement and improvement scores
were assigned by comparing the participant's simulated home dialysis
(or transplant) rate for the MY to the percentile distribution of home
dialysis (or transplant) rates in the prior year. Last, the MPS was
calculated using the maximum of each achievement or improvement score.
The home dialysis score constituted two-thirds of the MPS, and the
transplant score one-third of the MPS.
The HDPA calculation required a simplified methodology, with home
dialysis and home dialysis-related payments adjusted by 3, 2, and 1
percent during 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[supreg] 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.
(3) Medicare Estimate--Assume Rolling Benchmark
Table 17 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
[[Page 34572]]
participation in the ETC Model. We estimate the Medicare program would
save a net total of 185 million dollars from the PPA and HDPA between
January 1, 2020 and June 30, 2026, less 15 million in increased
training and education expenditures. Therefore, the net impact to
Medicare spending is estimated to be 169 million dollars in savings. In
Table 17, 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 CMS is proposing
that the payment adjustments under the ETC Model would 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 ESRD facility PPA; a reduction in Medicare
spending of 220 million dollars over the period from January 1, 2020
through June 30, 2026. In comparison, the net effect of the Managing
Clinician PPA was only 8 million dollars in Medicare savings. This
estimate was based on an empirical study of historical home dialysis
utilization and transplant rates for FFS beneficiaries that CMS
virtually assigned to dialysis facilities and to nephrology practices
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 proposed payment policy
assuming providers respond by marginally increasing their share of
patients utilizing home dialysis. Random variables were used to vary
the effectiveness that individual providers 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 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), respectively. KDE 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
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 would
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.
Individual ESRD facilities 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 would result in home dialysis ultimately
representing approximately 19 percent of overall maintenance dialysis
in selected geographic areas by 2026. 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 the section
VII.C.2.b.(4). of the proposed rule. However, as part of the
sensitivity analysis for the savings calculations for the model, we lay
out different savings scenarios if the incentives ETC Model were to
cause an increase in living donation and if the learning system
described in section IV.C.12 of this proposed 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.
[[Page 34573]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.020
(a) Sensitivity Analysis: Medicare Estimate--Assume Fixed Benchmark
An alternative model specification was analyzed where benchmarks
remain fixed at baseline year 0 over time (results available upon
request). Both the fixed and rolling benchmark assumptions projected
about 19 million dollars in increased overall HDPA Medicare payments to
ESRD facilities and Managing Clinicians in 2020. We project about 1
million dollars in additional HD training add-on payments. This would
represent about 20 million dollars in increased Medicare expenditures
in 2020 overall. Both specifications of the benchmark also projected
the net impact of approximately 1 million dollars in increased Medicare
expenditures in 2021.
The two scenarios diverge after 2021, with large differences
observed in overall net PPA and HDPA savings/losses. Table 17
illustrates that when benchmarks are rolled forward, using the
methodology described in section VII.C.2.b.(3), the overall savings in
PPA net and HDPA increase each year during the 2022-2026 period. In
contrast, when benchmark targets are fixed, in 2022 the overall PPA net
and HDPA savings increase to 16 million dollars, followed by overall
losses in years 2022-2026 of 0, 35, 89, and 62 million dollars,
respectively. The fixed benchmark would 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, 2020 through June
30, 2026, with the fixed benchmark, was 189 million dollars in losses,
compared to a total of 185 million dollars in savings with the rolling
benchmark method. The net impact on Medicare spending for the PPA and
HDPA using the fixed benchmark method is 203 million dollars in losses.
(b) Sensitivity Analysis: Medicare Savings Estimate--Results for the
10th and 90th Percentiles
Returning to the methodology used for the Medicare estimate with a
rolling benchmark, 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 17. Since the
impact on Medicare spending for the proposed 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 264 and 112 million dollars in savings (compared to 185
million dollars in savings in Table 17).
(4) Effects on Kidney Transplantation
Kidney transplantation is considered the optimal treatment for most
ESRD beneficiaries. However, while the proposed PPA includes a one-
third weight on the ESRD facilities' or Managing Clinician's kidney
transplant rate, we decided to be conservative and did not include an
assumption that the overall number of kidney transplants will increase.
The number of ESRD patients on the kidney transplant wait list 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 donated kidneys. The United States Renal Data
System \138\ reported 20,161 kidney transplants in 2016 compared to an
ESRD transplant waiting list of over 80,000. Living donor kidney
[[Page 34574]]
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.
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\138\ United States Renal Data System. 2018. ``ADR Reference
Table E6 Renal Transplants by Donor Type.''
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The PPA's transplant incentive would likely increase the share of
ESRD Beneficiaries who join the transplant wait list but is unlikely to
impact the donation 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 would not impact payment to transplant centers the ETC Model would
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 live
kidney donations for which significant Medicare program savings could
be realized. For example, 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).139 140 The ETC Model as proposed does not include a
proposal 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.\141\ 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
\142\ 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.
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\139\ 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.
\140\ 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.
\141\ Public Law 108-216 (section 377 of the Public Health
Service (PHS) Act, 42 U.S.C. 274f).
\142\ OPTN & SRTR 2017 Annual Report. Section KI Kidney
Transplants. https://www.srtr.org/reports-tools/srtroptn-annual-data-report/.
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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.\143\ 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.
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\143\ Axelrod DA, Schnitzler MA, Xiao H, et al. 2018. ``An
Economic Assessment of Contemporary Kidney Transplant Practice.''
American Journal of Transplantation 18: 1168-1176.
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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 would help reduce the number of beneficiaries under the
age of 65 who would 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 would 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 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
would 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 500 new transplants mainly
from relatives of recipients, would produce approximately $68 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.\144\
Similar to the estimate above 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.
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\144\ OPTN & SRTR 2017 Annual Report. Section KI Kidney
Transplants. https://www.srtr.org/reports-tools/srtroptn-annual-data-report/.
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First, we assumed 50 percent of newly harvested deceased-donor
kidneys would 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 would be for
[[Page 34575]]
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 would 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 would 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 would 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 would reduce long run program spending by
$143 million. Costs for this effort include a learning and diffusion
investment of $25 million over the model testing period and a potential
increase in PPA adjustments to clinician and facility payments of
approximately $30 million. The projected increase in transplantation is
estimated to produce a net savings of $88 million--a net return on
investment of approximately 1.6.
(5) 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.\145\ 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-center hemodialysis, and/or not be provided to
caregivers.
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\145\ 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.
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The proposed ETC Model would 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 growth rate to increase from 2.2 in
2020 to 3.2 in 2026. 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 (2020) was set to 2 percent,
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 during 2021 to 2026. 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 growth 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 would 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. This results in a projected doubling of the costs
attributed to the KDE benefit to approximately one million dollars in
2026.
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 dollars.
3. Effects on Medicare Beneficiaries
a. Radiation Oncology Model
We anticipate that the RO Model would benefit or have a negligible
impact on the cost to beneficiaries receiving RT services. 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 would remain the same under the RO
Model. More specifically, beneficiaries would be responsible for 20
percent of each of the PC and TC episode payments made under the RO
Model. Since we are proposing 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 would
decrease. Thus, beneficiary cost-sharing, on average, would 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 would continue
under the RO Model.
In addition, we note that, because episode payment amounts under
the RO Model would include payments for RT services that would likely
be provided over multiple visits, individual beneficiary coinsurance
payments would likewise be higher than they would otherwise be for an
individual RT service visit. We would encourage RO participants to
collect coinsurance for services furnished under the RO Model in
multiple installments.
b. ESRD Treatment Choices Model
We anticipate that the ETC Model would 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 would remain the same under the ETC Model. However, the
Model would apply the Clinician PPA and the Clinician HDPA to the
amount otherwise paid by Part B to ensure beneficiaries are held
harmless from any effect on cost sharing. Additionally, Medicare FFS
beneficiaries are generally responsible for 20 percent of the allowed
charge for Part B ESRD PPS services furnished by an ESRD facility. This
policy would remain the same under the ETC Model. However, CMS proposes
to waive
[[Page 34576]]
certain requirements of title XVIII of the Act as necessary to test the
Facility PPA and Facility HDPA proposed under the Model and proposes
that beneficiaries would be held harmless from any effect of these
payment adjustments on cost sharing.
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; \146\ as well
as better overall, physical, and psychological health
147 148 in comparison to other dialysis options.
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\146\ D[aogon]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.
\147\ 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
\148\ 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.
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4. Effects on RO and ETC Participants
RO participants will be given instructions on how to bill for
patients, using RO Model-specific HCPCS codes. We expect it would take
medical coding staff approximately 0.72 hours [(((~36 pages * 300
words/per page)/250 words per minute)/60 minutes) = 0.72] \149\ to read
and learn the payment methodology and billing sections of the rule. In
addition, we would add one hour to review the relevant MLN Matters
publication, 1 hour to read the RO Model billing guide, and one hour to
attend the billing guidance webinar, for a total of 3.72 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.\150\ The
total cost of learning the billing system for the RO Model thus is
$144.34 per participant, or approximately $167,000 in total (1,157
expected participants x $144.34/participant = $167,000 total).
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\149\ https://aspe.hhs.gov/system/files/pdf/242926/HHS_RIAGuidance.pdf.
\150\ 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. https://www.bls.gov/ooh/Healthcare/Medical-records-and-health-information-technicians.htm.
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The ETC Model would not alter the way ETC Participants bill
Medicare. Therefore, we believe that there would be no additional
burden for ETC Participants related to billing practices.
We believe the burden for audits and record retention do not
diverge from existing provider requirements in the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 (HIPAA)
administrative simplification rules (45 CFR 164.316(b)(2)), which
require a covered entity, such as a physician billing Medicare, to
retain required documentation for six years from the date of its
creation or the date when it last was in effect, whichever is later.
While the HIPAA Privacy Rule does not include medical record retention
requirements, it does require that covered entities apply appropriate
administrative, technical, and physical safeguards to protect the
privacy of medical records and other protected health information (PHI)
for whatever period such information is maintained by a covered entity,
including through disposal. The Privacy Rule is available at 45 CFR
164.530(c). In addition, CMS requires records of providers submitting
cost reports to be retained in their original or legally reproduced
form for a period of at least 5 years after the closure of the cost
report. This requirement is available at 42 CFR 482.24(b)(1). Given
these existing requirements, we do not believe that the audit or record
retention requirement in the RO Model or the ETC Model will create an
additional burden or impact on participants.
Similarly, monitoring and compliance requirements for the RO Model
and the ETC Model would not diverge from general monitoring
requirements for Medicare Part B providers. We believe that the
requirements in this section do not add additional burden or impose
regulatory impact on participants.
The model evaluation for both the RO Model and the ETC Model would
likely 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 would 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 would also apply to RO Model
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 $388.00 per entity
per year. Since we estimate approximately 1,157 RO Model participants,
then total burden estimate for collecting and reporting quality
measures and clinical data would be approximately $449,000.
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 proposed rule that is provided for Small Businesses
would also apply to RO Model participants and ETC participants that are
not considered small entities. The burden estimate for reading and
interpreting this proposed rule may be equal to or less than that for
small businesses. We estimated that cost of reading the rule for RO
participants would be approximately $466.89 per entity with a total
cost of approximately $1,354,000 (2,900 eligible entities x $466.89/
participant). In sum, we estimate that reading the RO Model rule,
learning the RO billing system, and submitting quality measures and
clinical data to the RO Model would cost approximately $1,000 per RO
participant, and collectively cost approximately $1,156,000 across the
1,157 RO participants, and an additional $814,000 for those RO
providers who read the rule, but are not ultimately selected as RO
participants, for a total cost $1,970,000. Similarly, we base our
estimate for the cost of reading the proposed rule for ETC participants
on the same cost per participant as used for the RO Model, that is,
$466.89 per entity. We assume that all ESRD facilities and managing
clinicians will read the rule, even though only a subset of each
category would 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
[[Page 34577]]
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, the Secretary has considered small entities and has determined
and certifies that this proposed rule will not have a significant
economic impact on a substantial number of small entities.
a. Radiation Oncology Model
This proposed 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 $11 million to $38.5 million in any 1
year, depending on the type of provider; the $38.5 million per year
threshold is for hospitals, whereas the $11 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 proposed rule is
likely to have ``significant'' impacts on small entities.\151\
Throughout the rule we describe how the proposed changes to a
prospective episode payment may affect PGPs and HOPDs.
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\151\ 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).
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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.\152\ PGPs and
HOPDs also serve patients with other coverage, for example, through
Medicare or commercial insurance. We believe 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 revenue for RT services,
we expect that the anticipated average impact of revenue based solely
on Medicare FFS payments to be less than 1 percent. Therefore, we have
determined that this proposed rule would not have a greater than 5
percent impact on total revenues on a substantial number of small
entities. We estimate the administrative costs of adjusting to and
complying with the quality measure and clinical data element reporting
requirements proposed in the RO Model for small entities to be
approximately $388.00 per entity per year. To estimate the costs per
small entity, we assume that a Medical Records & Health Information
Technician with an Hourly salary (from BLS) plus 100 percent fringe
benefits would cost $38.80/hour \153\ and would report the information
on quality measures and clinical data elements. We would expect
submission of the 4 quality data measures to take approximately 8 hours
and would require submission once a year, ($38.80 x 8.0 hours x 1
submission) = $310.40. We would expect the submission of clinical data
elements to take up to an hour, but occur twice a year, that is.
($38.80 x 1 hour x 2 submission) = $77.60. The burden costs per small
entity associated with measure and data reporting proposals should be
small because three of the four measures proposed 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.
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\152\ This figure comes from the 2018 Medicare Trustees Report,
Table IV.V1, p151 from the footnote that has the A and B share.
\153\ https://www.bls.gov/ooh/Healthcare/Medical-records-and-health-information-technicians.htm.
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We further estimate the administrative cost of reading and
interpreting this proposed rule per small entity at approximately
$446.89. We expect that a medical health service manager reading 250
per minutes could review the rule in approximately 4.66 hours
[(approximately 233 pages * 300 words/per page)/250 words per minute)
\154\/60 minutes)]. We estimate 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.\155\ Assuming an average
reading speed for pages relevant to the RO Model, we estimate that it
would take approximately 4.66 hours for the staff to review half of
this proposed rule. For each provider that reviews the rule, the
estimated cost based on the expected time and salary of the person
reviewing the rule ($446.89 = ($95.90 * 4.66 hrs).
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\154\ https://aspe.hhs.gov/system/files/pdf/242926/HHS_RIAGuidance.pdf.
\155\ 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.
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We welcome public comments on our estimates and analysis of the
impact of the proposed rule on those small entities.
b. ESRD Treatment Choices Model
The proposed rule includes as model participants: (1) Managing
Clinicians; and (2) ESRD facilities. We assume for the purposes of the
regulatory impact analysis that the great majority of Managing
Clinicians would be small entities and that the greater majority of
ESRD facilities would not be small entities. Throughout the rule we
describe how the proposed adjustments to certain payments for 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-standardshttp://www.sba.gov/content/small-businesssize-standards). The great majority of ESRD facilities are not small
entities as they are owned in whole or in part of 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 proposed PPA in the ETC Model, which includes both
positive and negative adjustments on payments for dialysis services,
would exclude ESRD facilities with fewer than 132 attributed
beneficiary-months during the relevant year and the Managing Clinicians
with the lowest volume of claims for the MCP using a percentile based
exclusion threshold.
For the remaining small entities that are above the exclusion
threshold and randomly selected for participation, the
[[Page 34578]]
design of the ETC Model would incorporate a risk adjustment and a
reliability adjustment to allow for the calculation of home dialysis
rates and transplant rates for both small entities and larger entities
that may be owned in whole or in part by another company.
The risk adjustment would account for the underlying variation in
the patient population of individual ESRD facilities and Managing
Clinicians. The risk adjustment for the home dialysis rate would be
based on 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, as described in section IV.C.5.b.(3) of the proposed
rule. The transplant rate is proposed to be risk adjusted by age, as
described in section IV.C.5.b.(3) of the proposed rule.
The reliability adjustment would create a weighted average between
the individual ETC Participant's home dialysis rate and transplant rate
and the aggregate home dialysis rate and transplant rate of the ETC
Participants aggregation group, 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. The reliability
adjustment allows for comparable performance rates for ESRD facilities
and Managing Clinicians across the size spectrum.
Taken together, the proposed low volume threshold exclusions, risk
adjustments, and reliability adjustments previously described, with the
fact that the ETC Model would affect Medicare payment only for select
services furnished to Medicare FFS beneficiaries, we have determined
that this proposed rule would not have a greater than 5 percent impact
on a substantial number of small entities.
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 603 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
proposed RO Model and ETC Model would not have a significant impact on
the operations of a substantial number of small rural hospitals.
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 one year of $100 million in 1995
dollars, updated annually for inflation. In 2019, that is approximately
$154 million. This proposed 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
proposed rule, if finalized as proposed, 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 proposed rule, we have identified our proposed
policies and alternatives that we have considered, and provided
information as to the likely effects of these alternatives and the
rationale for each of the proposed policies. We solicit and welcome
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 proposed rule contains a proposed model specific to radiation
oncology. It provides descriptions of the requirements that we propose
to waive, identifies the proposed payment methodology to be tested, and
presents rationales for our decisions and, where relevant, alternatives
that were considered. We carefully considered the alternatives to this
proposed 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 proposed rule also contains a proposed model specific to ESRD.
It provides descriptions of the requirements that we propose to waive,
identifies the performance metrics and payment adjustments to be
tested, and presents rationales for our decisions, and where relevant,
alternatives that were considered. We carefully considered the
alternatives to this proposed 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 half 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 welcome comments on our proposals and the alternatives we have
identified.
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 18 and 19, we have prepared an accounting statement showing the
classification of transfers, benefits, and costs associated with the
provisions in this proposed 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 proposed rule, we estimate that
the financial impact of the Radiation Oncology Model and ESRD Treatment
Choices Model proposed here would be net federal savings of $429
million ($419 million with an April 1 start date) over a 5 year
performance period (2020 through 2024).
In accordance with the provisions of Executive Order 12866, this
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.
0
For the reasons set forth in the preamble and under the authority at 42
U.S.C. 1302, 1315(a), and 1395hh, the Centers for Medicare & Medicaid
Services proposed to amend 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 Episodes Being Tested
512.230 Criteria for determining cancer types.
512.235 Included RT services.
512.240 Included modalities.
512.245 Scope of 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
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.
[[Page 34580]]
Performance Payment Adjustment
512.355 Schedule of performance assessment and performance payment
adjustment.
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, 1315(a), and 1395hh.
Subpart A--General Provisions Related to Innovation Center Models
Sec. 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 Sec.
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.
Sec. 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 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.
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 pursuant to
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'' defined under section
1861(u) of the Act and codified in the definition of ``provider'' at
Sec. 400.202 of this chapter.
Supplier means a supplier as defined in section 1861(d) of the Act
and codified at Sec. 400.202 of this chapter.
US 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.
Sec. 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. Notwithstanding the foregoing, 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
[[Page 34581]]
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 ``at-risk beneficiary'' as defined at
Sec. 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 Sec. 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 would
take 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.
Sec. 512.130 Cooperation in model evaluation and monitoring.
The model participant and its downstream participants must comply
with the requirements of Sec. 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 Sec. 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.
Sec. 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 six 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 pursuant to 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.
Sec. 512.140 Rights in data and intellectual property.
(a) CMS may use any data obtained under Sec. Sec. 512.130,
512.135, and 512.150 to evaluate and monitor the Innovation Center
model and may 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 to be disseminated may include 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.
(b) Notwithstanding any other provision of this part, all data that
has been confirmed by CMS to be proprietary trade secret information
and technology of the model participant or its downstream participants
will not be released by CMS or its designee(s) 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 will be subject to review
and confirmation by CMS prior to CMS' acting upon such assertions.
Sec. 512.150 Monitoring and compliance.
(a) Compliance with laws. The model participant and each of its
downstream
[[Page 34582]]
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 and
each of its downstream participants with the terms of the Innovation
Center model including this subpart. Such monitoring activities may
include, without limitation--
(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 Sec. 512.150(c);
(vi) Monitoring quality outcomes and clinical data, if applicable;
and
(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 Sec. 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) To the extent practicable, CMS or its designee will provide the
model participant or downstream participant with no less than 15 days
advance notice of any site visit. To the extent practicable, CMS will
attempt to accommodate a request for particular dates in scheduling
site visits. However, the model participant or downstream participant
may not request a date that is more than 60 days after the date of the
initial site visit notice from CMS.
(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) Notwithstanding the foregoing, 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) Right to correct. If CMS discovers that it has made or received
an incorrect model-specific payment under the terms of the Innovation
Center model, CMS may make payment to, or demand payment from, the
model participant.
(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
statutes, rules, or regulations administered by the Federal Government.
Sec. 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.
Sec. 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 will provide
written notice to the model participant specifying the grounds for
model termination and the effective date of such termination.
Sec. 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.
[[Page 34583]]
(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 assessment by CMS of the quality of care furnished by the
model participant.
(3) The attribution of model beneficiaries to the model participant
by CMS, 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.
Sec. 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 60 days before 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. 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. If CMS determines,
in accordance with Sec. 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 Sec. 512.160(b).
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
Sec. 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 participants.
(2) Episodes being tested under the RO Model.
(3) Methodology for pricing and quality performance.
(4) Payments and billing under the RO Model.
(5) The Model as an Advanced APM and MIPS APM under the Quality
Payment Program.
(6) Program waivers issued for RO participant use.
(7) Data reporting requirements.
(8) Payment reconciliation and appeals processes.
(c) Applicability. 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.
Sec. 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,
proposed quality measures and clinical data. The AQS is used to
determine the amount of a RO participant's quality reconciliation
payment amount.
Clean period means the 28-day period after an episode has ended,
during which time a 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 a
participant-specific professional episode payment or a participant-
specific technical episode payment 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. The discount
factor does not vary by cancer type. The discount factor for the
professional component is 4 percent; the discount factor for the
technical component is 5 percent.
Dual participant means a RO participant that furnishes for both the
professional component and technical component of RT services of an
episode through a freestanding radiation therapy center, identified by
a single TIN.
Duplicate RT service means any included RT service that is
furnished to a single RO beneficiary by a RT provider or RT supplier
that did not initiate the PC or TC of that RO beneficiary during the
episode.
[[Page 34584]]
Episode means the 90-day period that, as set forth in Sec.
512.245, begins on the date of service that an individual practitioner
under a professional participant or a dual participant furnishes an
initial RT treatment planning service to a 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.
HOPD means hospital outpatient department.
Included cancer types means the cancer types determined by the
criteria set forth in Sec. 512.230, which are included in the RO Model
test.
Included RT services means the RT services identified at Sec.
512.235, which are included in the RO Model test.
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 a RO beneficiary within 28 days following a
Professional participant or the Dual participant furnishing an 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) A RO beneficiary stops meeting the beneficiary population
criteria under Sec. 512.215(a) or triggers the beneficiary exclusion
criteria under Sec. 512.215(b) before the technical component of an
episode initiates.
Individual practitioner means a Medicare-enrolled physician
(identified by an NPI) who furnishes RT services to Medicare FFS
beneficiaries, and have reassigned their billing rights to the TIN of a
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 Sec. 512.217. The individual practitioner list is used
for the RO Model as a Participation List as defined in Sec. 414.1305
of this chapter.
Model performance period means, the date the RO Model begins
through December 31, 2024, the last date during which episodes under
the Model must be completed. No new episodes may begin after October 3,
2024 in order for all episodes to be completed by December 31, 2024.
National base rate means the total payment amount for the relevant
component of an episode, before application of the trend factor,
discount factor, adjustments, and applicable withholds, for each of the
proposed included cancer types.
NPI means National Provider Identifier.
Participant-specific professional episode payment means a payment,
which is calculated by CMS as set forth in Sec. 512.255 and which is
paid by CMS to a Professional participant or Dual participant as set
forth in Sec. 512.265, for the provision of the professional component
to a RO beneficiary during an episode.
Participant-specific technical episode payment means a payment,
which is calculated by CMS as set forth in Sec. 512.255 and which is
paid by CMS to a Technical participant or Dual participant in
accordance with Sec. 512.265, for the provision of the technical
component to a RO beneficiary during an 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.
Professional component (PC) means the included RT services that may
only be furnished by a physician.
Professional participant means a RO participant that is a Medicare-
enrolled PGP identified by a single TIN that furnishes only the PC of
an episode.
Radiotherapy (RT) services are the treatment planning, technical
preparation, special services (such as simulation), treatment delivery,
and treatment management services associated with cancer treatment that
use high doses of radiation to kill cancer cells and shrink tumors.
Reconciliation payment means a payment made by CMS to a RO
participant, as determined in accordance with Sec. 512.285.
Repayment amount means the amount owed by a RO participant to CMS,
as determined in accordance with Sec. 512.260.
RO beneficiary means a Medicare FFS beneficiary who meets all of
the beneficiary inclusion criteria at Sec. 512.215(a) and who does not
trigger any of the beneficiary exclusion criteria at Sec. 512.215(b).
Reconciliation report means the annual report issued by CMS to a RO
participant for each performance year, which specifies the RO
participant's reconciliation payment amount or repayment amount.
RO participant means a Medicare-enrolled PGP, freestanding
radiation therapy center, or HOPD that participates in the RO Model
pursuant to Sec. 512.210. A RO participant may be a Dual participant,
Professional participant, or Technical participant.
RT provider means a Medicare-enrolled HOPD that furnishes RT
services in a 5-digit ZIP Code linked to a selected CBSA.
RT supplier means a Medicare-enrolled PGP or freestanding radiation
therapy center that furnishes RT services in a 5-digit ZIP Code linked
to a selected CBSA.
Selected CBSA means a CBSA that has been randomly-selected by CMS
under Sec. 512.210(c).
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 a RO participant that is a Medicare-
enrolled HOPD or freestanding radiation therapy center, identified by a
single CMS Certification Number (CCN) or TIN, which furnishes only for
the TC of an episode.
TIN stands for 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 means the process to calculate additional payments or
repayments for incomplete episodes and duplicate RT services that are
identified after claims run-out.
RO Model Participation
Sec. 512.210 RO participants and geographic areas.
(a) RO participants. (1) Unless otherwise specified in paragraph
(b) of this section, any Medicare-enrolled PGP, freestanding radiation
therapy center, or HOPD that furnishes included RT services in a 5-
digit ZIP Code linked to a selected CBSA to a RO beneficiary for an
episode that begins on or after January 1, 2020, and ends on or before
December 31, 2024, must participate in the RO Model.
(b) Participant exclusions. A PGP, freestanding radiation therapy
center, or HOPD will be 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
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(5) Participates in or is identified by CMS as eligible to
participate the Pennsylvania Rural Health Model.
(c) Selected CBSAs. CMS randomly selects CBSAs to identify RT
providers and RT suppliers to participate in the Model through a
stratified sample design, allowing for participant and comparison
groups to contain approximately 40 percent of all episodes in eligible
geographic areas (CBSAs).
Sec. 512.215 Beneficiary population.
(a) Beneficiary inclusion criteria. (1) Except as provided in
paragraph (b) of this section, a beneficiary is included in the RO
Model if the beneficiary:
(i) Receives included RT services in a 5-digit ZIP Code linked to a
selected CBSA from a RO participant during the model performance period
for a cancer type that meets the criteria for inclusion in the RO
Model; and
(ii) At the time that the initial treatment planning service of an
episode is furnished by an RO participant, the beneficiary--
(A) Is eligible for Medicare Part A and enrolled in Medicare Part
B; and
(B) Has traditional FFS Medicare as his or her primary payer.
(2) Any RO beneficiary enrolled in a clinical trial for RT services
for which Medicare pays routine costs will be included in the RO Model
provided that the beneficiary satisfies all of the beneficiary
inclusion criteria in paragraph (a)(1) of this section.
(b) Beneficiary exclusion criteria. A beneficiary is excluded from
the RO Model if, at the initial treatment planning service the
beneficiary is--
(1) Enrolled in any Medicare managed care organization, including
but not limited to Medicare Advantage plans;
(2) Enrolled in a PACE plan;
(3) Is in a Medicare hospice benefit period; or
(4) Covered under United Mine Workers.
(c) Changes during an episode. (1) If a RO beneficiary stops
meeting any of the proposed eligibility criteria before the TC of the
episode has been initiated, then the episode is classified as an
incomplete episode. Payments to RO participants will be retrospectively
adjusted to account for incomplete episodes during the annual
reconciliation process.
(2) 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 is considered an incomplete episode and, the RO
participant may receive only the first installment of the episode
payment. In the event that a RO beneficiary dies or enters hospice
during an episode, then the RO participant may receive both
installments of the episode payment regardless of whether the RO
beneficiary's course of RT has ended.
Sec. 512.217 Identification of individual practitioners.
(a) General. Prior to the start of each performance year, CMS will
create and provide 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 such individual practitioner list, the RO participant must
review and certify the individual practitioner list 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 such
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.
(d) Changes to the individual practitioner list--(1) Additions. (i)
A RO participant must notify CMS of an addition to its individual
practitioner list within 15 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, the
addition of an individual practitioner to the RO participant's
individual practitioner list is effective on the date specified in the
notice furnished to CMS, but no earlier than 15 days before the date of
the notice. If the RO participant fails to submit timely notice to CMS,
the addition of an individual practitioner to the individual
practitioner list is effective on the date of the notice.
(2) Removals. (i) A RO participant must notify CMS no later than 15
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, but not earlier than 15 days
before the date of the notice. If the RO participant fails to submit a
timely notice of the removal, the removal is effective on the date of
the notice.
(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 Sec. 424.516 of this chapter.
Sec. 512.220 RO participant compliance with RO Model requirements.
(a) RO participant-specific requirements. (1) RO participants are
required to meet the Model requirements to qualify for the APM
Incentive Payment, as applicable.
(2) Each Professional participant and Dual participant must ensure
its individual practitioners--
(i) 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) 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) Assess each RO beneficiary's tumor, node, and metastasis
(TNM) cancer stage for the CMS-specified cancer diagnoses;
(iv) Assess the RO beneficiary's performance status as a
quantitative measure determined by the physician;
(v) Send a treatment summary to each RO beneficiary's referring
physician within 3 months of the end of treatment to coordinate care;
(vi) Discuss with each RO beneficiary prior to treatment delivery
his or her inclusion in, and cost-sharing responsibilities under, the
RO Model; and
(vii) Perform and document Peer Review (audit and feedback on
treatment plans) for 50 percent of new patients in PY1, for 55 percent
of new
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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.
(3) 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 in a radiation oncology-specific AHRQ-
listed patient safety organization (PSO) (per their PSO Provider
Service Agreement).
(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
Sec. 414.1415(a)(1)(i) of this chapter. Before each performance year,
each RO participant must certify in the form and manner and by a
deadline specified by CMS that it will use CEHRT throughout such
performance year in a manner sufficient to meet the requirements set
forth in Sec. 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 Sec. 414.1415(a)(1)(i) of this
chapter.
Sec. 512.225 Beneficiary notification.
(a) General. Professional participants and Dual participants must
notify each RO beneficiary to whom it furnishes included RT services
that--
(1) The RO participant is participating in the RO Model;
(2) The RO beneficiary has the opportunity to decline claims data
sharing for care coordination and quality improvement purposes. If a RO
beneficiary declines claims data sharing for care coordination and
quality improvement purposes 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; and
(3) Information regarding RO beneficiary 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 a 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 Sec. 512.120(c). The requirement
described in Sec. 512.120(c)(2) shall not apply to the standardized
written notice described in paragraph (b) of this section.
Scope of Episodes Being Tested
Sec. 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 will remove 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
baseline rates; or
(3) The Secretary determines a cancer type not to be suitable for
inclusion in the Model.
(c) ICD-10 codes for included cancer types. CMS displays on the RO
Model website no later than 30 days prior to each performance year the
ICD-10 diagnosis codes associated with each included cancer type.
Sec. 512.235 Included RT services.
(a) Only the following RT services furnished using an included
modality identified at Sec. 512.240 for an included cancer type are
included RT services that are paid for by CMS under Sec. 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 will be subject to Medicare FFS payment rules.
Sec. 512.240 Included modalities.
The modalities included in the RO Model are 3-dimensional conformal
RT (3DCRT), intensity-modulated RT (IMRT), image-guided RT (IGRT),
stereotactic radiosurgery (SRS), stereotactic body RT (SBRT),
intraoperative radiotherapy (IORT), proton beam therapy (PBT), and
brachytherapy.
Sec. 512.245 Scope of episodes.
(a) General. Any episode that begins on or after January 1, 2020,
and ends on or before December 31, 2024, will be part of the RO Model
test and subject to the rules under this part.
(b) Death or election of hospice benefit. An episode may be
included in, and paid for under, the RO Model even if the RO
beneficiary dies or enters hospice during the episode. In accordance
with Sec. 512.215(c), the RO participant may receive both installments
of the episode payment under such circumstances, regardless of whether
the RO beneficiary enters hospice before the relevant course of RT
treatment has ended.
(c) Clean periods. An episode must not be initiated for the same RO
beneficiary during a clean period.
Pricing Methodology
Sec. 512.250 Determination of national base rates.
CMS determines a national base rate for the PC and TC for each
included cancer type. 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. We exclude those episodes that do not
meet the criteria described in Sec. 512.245. From those episodes, we
then calculate the amount CMS paid on average to providers for the PC
and TC for each of the included cancer types in the HOPD setting,
creating the Model's national base rates.
Sec. 512.255 Determination of participant-specific professional
episode payment and participant-specific technical episode payment
amounts.
Before the start of each performance year CMS calculates the
amounts for participant-specific professional episode payment amounts
and participant-specific technical episode payment amounts for each
included cancer type using the following:
(a) Trend factors. 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.
(b) Case mix adjustment. CMS establishes and applies case mix
adjustments to the trended national base rates for the PC and TC of
each included cancer type. These adjustments reflect 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.
(c) Historical experience adjustment. CMS establishes and applies
historical experience adjustments to the national
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base rates after the trend factor and case mix adjustment have been
applied. The historical experience adjustments reflect each RO
participant's actual historical experience.
(d) Efficiency factor. The professional historical experience
adjustment and technical historical experience adjustment for each RO
participant are weighted by an efficiency factor. The RO participants
with a professional historical experience adjustment or technical
historical experience adjustment with a value equal to or less zero
have a different CMS policy factor than those RO participants with a
professional or technical historical experience adjustment of more than
zero.
(e) Changes in business structure. RO participants must notify CMS
in writing of a merger, acquisition, or other new clinical or business
relationship, at least 90 days before the effective date of the change.
CMS updates case mix and historical experience adjustments pursuant 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.
(f) HOPD or freestanding radiation therapy center with fewer than
60 episodes during 2015-2017. If a HOPD, or freestanding radiation
therapy center (identified by a CCN or TIN) meets eligibility
requirements and begins to provide RT services within a selected CBSA,
but has fewer than 60 episodes from 2015 to 2017 to calculate case mix
and historical experience adjustments, then its participant-specific
professional episode payment amount and participant-specific technical
episode payment amount are 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 through 2017 period continues to have
fewer than 60 episodes attributed to it during the 2016 through 2018
period, then 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 through
2018 period, then 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 to PY5, we will reevaluate those same RO
participants as we did in PY2 to determine the number of episodes in
the rolling 3-year period used in the case mix adjustment for that
performance year. RO participants that continue to have fewer than 60
attributed episodes in the rolling 3-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.
(g) Discount factor. CMS deducts a percentage discount from the
trended national base rates after the case mix and historical
experience adjustments have been applied. The discount factor for the
PC is 4 percent. The discount factor for TC is 5 percent.
(h) Incorrect payment withhold. CMS withholds from each RO
participant 2 percent from each episode payment, after the trend
factor, adjustments, and discount factor have been applied, in order to
account for duplicate RT services and incomplete episodes. CMS
determines during the annual reconciliation process set forth at Sec.
512.285 whether a RO participant is eligible to receive a portion or
all of the withheld amount or whether any payment is owed to CMS.
(i) Quality withhold. CMS withholds 2 percent for the PC to the
applicable trended national base rates after the case mix and
historical experience adjustments and discount factors are applied to
comply with the Advanced APM criteria codified in Sec. 414.1415(b)(1)
of this chapter which requires an Advanced APM to include quality
measure results as a factor when determining payment to participants
under the terms of the APM. RO participants may earn back this
withhold, in part or in full, based on their AQS.
(j) Patient experience withhold. CMS withholds one percent of the
technical episode payment amounts starting in 2022 (PY3) to account for
patient experience in the RO Model, which is based on the patient-
reported Consumer Assessment of Healthcare Providers and
Systems[supreg] (CAHPS[supreg]) Cancer Care Radiation Therapy survey.
RO participants may earn back this withhold, in part or in full, based
on their results from the CAHPS[supreg] Cancer Care Radiation Therapy
survey.
(k) Geographic adjustment. CMS further adjusts the trended national
base rates that have been adjusted for each RO participant's case mix,
historical experience, and after which the discount rate 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.
(l) Coinsurance. RO participants may collect beneficiary
coinsurance payments in multiple installments via a payment plan.
Billing and Payment
Sec. 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 shall bill a RO Model-specific HCPCS code and a
start-of-episode modifier to indicate that the treatment planning
service has been furnished and that an episode has been initiated.
(2) Dual participants and Technical participants shall bill a RO
model-specific HCPCS code and start-of-episode modifier to indicate
that a treatment delivery service was furnished.
(3) RO participant shall bill the same RO Model-specific HCPCS code
that initiated the episode and an end-of-episode modifier to indicate
that the episode has ended.
(c) Billing for RT services performed during a clean period. A RO
participant shall bill for any medically necessary RT services
furnished to a RO beneficiary during a clean period pursuant to
existing FFS billing processes in the OPPS and PFS.
Sec. 512.265 Payment.
(a) Payment for episodes. CMS pays a RO participant for all
included RT services furnished to a RO beneficiary during an episode as
follows--
(1) CMS pays a Professional participant a participant-specific
professional episode payment for the professional component furnished
to a RO beneficiary during an episode.
(2) CMS pays a Technical participant a participant-specific
technical episode payment for the technical component furnished to a RO
beneficiary during an 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
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component furnished to a RO beneficiary during an episode.
(b) Payment installments. CMS makes each of the payments described
in paragraph (a) of this section in two equal installments, as
follows--
(1) CMS pays one-half of a participant-specific professional
episode and/or one-half of the participant-specific technical episode
payment after the RO participant bills a RO Model-specific HCPCS code
with a start-of-episode modifier.
(2) CMS pays the remaining half of a participant-specific
professional episode and/or one-half of the participant-specific
technical episode payment after the RO participant bills a RO Model-
specific HCPCS code with an end-of-episode modifier.
Sec. 512.270 Treatment of add-on payments under existing Medicare
payment systems.
CMS does not make separate Medicare FFS payments to RO participants
for any included RT services that are furnished to a RO beneficiary
during an episode. A RO participant may receive Medicare FFS payment
for items and services furnished to a RO beneficiary during an episode,
provided that any such other item or service is not an included RT
service.
Data Reporting
Sec. 512.275 Quality measures, clinical data, and reporting.
(a) Data privacy compliance. The RO participant must comply with
all applicable laws pertaining to any patient-identifiable data
requested from CMS under the terms of the Innovation Center model, as
well as the terms of any agreement entered into by the RO participant
with CMS as a condition of receiving that data. These laws include
without limitation the standards for the privacy of individually
identifiable health information and the security standards for the
protection of electronic protected health information under the
regulations promulgated under the Health Insurance Portability and
Accountability Act of 1996 (HIPAA) and the Health Information
Technology for Economic and Clinical Health Act (HITECH). The RO
participant must bind all downstream recipients of such data in a
signed writing to comply with all applicable laws pertaining to
patient-identifiable data provided by CMS, as well as the terms of any
agreement entered into by the RO participant with CMS as a condition of
receiving that data, as a condition of a downstream recipient's receipt
of the data from the RO participant and the maintenance thereof.
(b) Participant public release of patient de-identified
information. The RO participant must include the disclaimer codified at
Sec. 512.120(c)(2) on the first page of any publicly-released
document, the content 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) Professional and Dual participants. Professional participants
and Dual participants must report selected quality measures on all
patients and clinical data elements, such as cancer stage, disease
involvement, 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
Sec. 512.280 RO Model Medicare program waivers.
(a) General. The Secretary shall 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 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) under section
1848(q)(6)(E) of the Act and Sec. 414.1405(e) of this chapter 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.
(d) APM Incentive Payment. CMS waives the requirements of Sec.
414.1450(b) 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 Sec.
414.1450(b)(1).
(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) 1869 claims appeals procedures.
Reconciliation
Sec. 512.285 Reconciliation process.
(a) General. CMS uses the reconciliation process described in
paragraph (b) of this section after the end of each performance year to
identify any reconciliation payment amount owed to a RO participant or
any repayment amount owed by a RO participant to CMS.
(b) Annual reconciliation. CMS conducts an annual reconciliation
for each RO participant in August following each performance year.
(1) Reconciliation report. CMS issues each RO participant a
reconciliation report for each performance year. Each reconciliation
report contains the following:
(i) The determination as to whether the RO participant is eligible
for a reconciliation payment or must make a repayment to CMS.
(ii) The RO participant's reconciliation payment amount or
repayment amount for the relevant performance year, as calculated by
CMS.
(2) Reconciliation payments. If a RO reconciliation report
indicates that a RO participant has earned a reconciliation payment,
then CMS must issue such payment to the RO participant in the amount
specified in the reconciliation report as soon as administratively
possible after the reconciliation report is deemed final. The RO
participant is not permitted to collect any beneficiary cost-sharing
with respect to any reconciliation payment received.
(3) Repayment amounts. If a final reconciliation report indicates
that CMS is owed a repayment amount, then the RO participant must make
a payment to CMS in the repayment amount 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
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otherwise owed by CMS to the RO participant, including Medicare
payments for items and services unrelated to the RO Model.
Sec. 512.290 Timely error notice and reconsideration review process.
(a) Timely error notice. Subject to the limitations on review in
Sec. 512.170, if the RO participant identifies a suspected error in
the calculation of their reconciliation payment or repayment amount or
AQS for which a determination has not yet been deemed to be final under
the terms of the RO reconciliation report, the RO participant may
provide written notice of the suspected calculation error to CMS, in a
form and manner and by a date and time specified by CMS.
(1) Unless the RO participant provides such notice, the
reconciliation payment or repayment amount determination made under
Sec. 512.285(b)(1) is deemed final 30 days after it is issued.
(2) If CMS receives a timely notice of a suspected calculation
error, then CMS will respond 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.
(4) The 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
paragraph (b) of this section.
(b) Reconsideration review. (1) If the RO participant is
dissatisfied with CMS's response to the timely error notice, then the
RO participant may request a reconsideration review of CMS's response
within 10 days of the issue date of CMS' response in a form and manner
specified by CMS.
(2) The reconsideration review request must provide a detailed
explanation of the basis for the dispute and 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) 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 final.
(4) CMS designates a reconsideration official, who is a designee of
CMS, who is authorized to receive such requests and who was not
involved in the responding to the RO participant's timely error notice.
The CMS 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:
(i) The issues in dispute;
(ii) The briefing schedule; and
(iii) The review procedures.
(5) 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
Sec. 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.
Sec. 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 Sec. 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, and transitional drug add-on payment adjustment (TDAPA)
amount.
Benchmark year means the 12-month period that begins 18 months
prior to the start of a given measurement year (MY) from which data is
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 Sec. Sec. 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
Sec. Sec. 512.375(b) and 512.380.
Comparison geographic area(s) means those HRRs that are not
selected geographic areas.
ESRD Beneficiary means a beneficiary receiving dialysis or other
services for end-stage renal disease, up to and including the month in
which the beneficiary receives a kidney or kidney-pancreas transplant.
ESRD facility means an ESRD facility as specified in Sec. 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 Sec.
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 Sec. Sec. 512.340 and 512.350.
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 Sec. Sec. 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 Sec. 512.365(b).
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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/.
Managing clinician means a Medicare-enrolled physician or non-
physician practitioner 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 Sec. 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
Sec. 512.370(d), which is used to determine the amount of the ETC
Participant's PPA, as described in Sec. 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 Sec. 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 pursuant to Sec. 512.380.
Pre-emptive transplant beneficiary means a beneficiary who received
a kidney or kidney-pancreas transplant prior to beginning dialysis.
Selected geographic area(s) are those HRRs selected by CMS pursuant
to Sec. 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 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 Sec. 512.365(c).
ESRD Treatment Choices Model Scope and Participants
Sec. 512.320 Duration.
CMS will apply the payment adjustments described in this subpart
under the ETC Model to claims with claim through dates beginning
January 1, 2020, and ending June 30, 2026.
Sec. 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 a random sample of 50 percent of HRRs,
stratified by Census-defined regions (Northeast, South, Midwest, and
West), as well as all HRRs for which at least 20 percent of the
component zip codes are located in Maryland. CMS excludes all U.S.
Territories from the selected geographic areas.
Sec. 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.
(b) Applicability of general Innovation Center model provisions.
The requirement described in Sec. 512.120(c) 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 Sec. 512.110 must meet the
requirements described in Sec. 512.120(c).
Home Dialysis Payment Adjustment
Sec. 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, 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
calendar year (CY) subject to adjustment as described in Sec. 512.350
and the beneficiary is 18 years of age or older during the entire month
of the claim.
Sec. 512.345 Payments subject to the clinician HDPA.
CMS adjusts the amount otherwise paid under 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 through date during a CY subject to
adjustment as described in Sec. 512.350 and the beneficiary is 18
years of age or older during the entire month of the claim.
Sec. 512.350 Schedule of home dialysis payment adjustments.
CMS adjusts the payments specified in Sec. 512.340 by the Facility
HDPA and adjusts the payments specified in Sec. 512.345 by the
Clinician HDPA, according to the following schedule:
(a) CY 2020: +3 percent
(b) CY 2021: +2 percent
(c) CY 2022: +1 percent
Performance Payment Adjustment
Sec. 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, 2020, and the final MY ends on June
30, 2025.
(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, 2021,
and the final PPA Period ends on June 30, 2026.
(c) Measurement Years and Performance Payment Adjustment Periods.
MYs and PPA Periods follow the schedule in Table 1 to Sec. 512.355(c):
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Sec. 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 transplant
beneficiaries to a Managing Clinician for one or more months during a
MY based on the pre-emptive transplant beneficiary's receipt of
services specified in paragraph (c)(2) of this section during that
month, for the purpose of assessing the Managing Clinician's
performance on the transplant rate during that MY. CMS attributes ESRD
Beneficiaries and pre-emptive transplant beneficiaries to the ETC
Participant for each month during a MY 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 transplant beneficiary to no more than one
Managing Clinician for a given MY.
(b) Exclusions from attribution. CMS does not attribute an ESRD
Beneficiary or a pre-emptive transplant beneficiary to an ETC
Participant for a month if, at any point during the month, the ESRD
Beneficiary or the pre-emptive transplant 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;
(5) Has elected hospice;
(6) Is receiving dialysis for acute kidney injury (AKI) only; or
(7) Has a diagnosis of dementia.
(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 have received renal
dialysis services, other than renal dialysis services for AKI, during
the month from the ESRD facility. 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, as identified by
claims with Type of Bill 072X, with claim through dates during the
month. 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. CMS
does not attribute pre-emptive transplant beneficiaries to ESRD
facilities.
(2) Managing clinician beneficiary attribution. An ESRD Beneficiary
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 through dates
during the month. A pre-emptive transplant beneficiary is attributed to
the Managing Clinician with whom the beneficiary 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.
Sec. 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
transplant beneficiaries attributed to the ETC Participant under Sec.
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) ESRD facilities. 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.
The numerator is the total number of home dialysis treatment
beneficiary years for attributed beneficiaries during the MY. 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, 75, 76, or 80.
Information used to calculate the ESRD facility home
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dialysis rate includes Medicare claims data and Medicare administrative
data. The ESRD facility home dialysis rate is risk adjusted, as
described in paragraph (d)(1) of this section, and reliability
adjusted, as described in paragraph (e)(1) of this section.
(2) Managing clinicians. 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. The numerator is
the total number of home dialysis treatment beneficiary years for
attributed ESRD Beneficiaries during the MY. 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. Information used to calculate the Managing
Clinician home dialysis rate includes Medicare claims data and Medicare
administrative data. The Managing Clinician home dialysis rate is risk
adjusted, as described in paragraph (d)(1) of this section, and
reliability adjusted, as described in paragraph (e)(2) of this section.
(c) Transplant rate. CMS calculates the transplant rate for ETC
Participants as follows.
(1) ESRD facilities. 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 or were in a skilled nursing facility at any
point during the month. The numerator is the total number of attributed
ESRD Beneficiaries who received a kidney transplant or a kidney-
pancreas transplant at any time during the MY. Kidney transplants and
kidney-pancreas transplants are identified using claims with MS-DRG 008
or 652; claims with ICD-10 procedure codes 0TY00Z0, 0TY00Z1, 0TY00Z2,
0TY10Z0, 0TY10Z1, or 0TY10Z2; and information about transplants from
the SRTR Database and Medicare administrative data to identify any
transplants among attributed beneficiaries that are not identified
through claims. The ESRD facility transplant rate is risk adjusted, as
described in paragraph (d)(2) of this section, and reliability
adjusted, as described in paragraph (e)(1) of this section.
(2) Managing clinicians. The denominator is 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 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 or were in a
skilled nursing facility during the month. Beneficiary years for pre-
emptive transplant beneficiaries included in the denominator are
composed of those months during which a pre-emptive transplant
beneficiary is attributed to a Managing Clinician, from the beginning
of the MY up to and including the month of the transplant. The
numerator is the total 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. ESRD Beneficiaries who received a
kidney transplant or a kidney-pancreas transplant are identified using
claims with MS-DRG 008 or 652; claims with ICD-10 procedure codes
0TY00Z0, 0TY00Z1, 0TY00Z2, 0TY10Z0, 0TY10Z1, or 0TY10Z2; and
information about transplants from the SRTR Database to identify any
transplants among attributed beneficiaries that are not identified
through claims. The Managing Clinician transplant rate is risk
adjusted, as described in paragraph (d)(2) of this section, and
reliability adjusted, as described in paragraph (e)(2) of this section.
(d) Risk adjustment. CMS risk adjusts the home dialysis rate using
the methodology described in paragraph (d)(1) of this section and risk
adjusts the transplant rate using the methodology described in
paragraph (d)(2) of this section.
(1) The home dialysis rate for Managing Clinicians and ESRD
facilities is risk adjusted using the most recent final risk score for
the beneficiary available at the time of the calculation of the home
dialysis rate, calculated using the CMS-HCC (Hierarchical Condition
Category) ESRD Dialysis Model used for risk adjusting payment in the
Medicare Advantage program.
(2) The transplant rate is risk adjusted by 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. The transplant rate is 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.
(e) Reliability adjustment. (1) ESRD facilities. An ERSD facility's
home dialysis rate and transplant rate are each reliability adjusted
such that the ESRD facility's adjusted rate is the weighted average of
the ESRD facility's rate and the rate of all ESRD facilities in the
ESRD facility's aggregation group, weighted based on the reliability of
the ESRD facility's rate. 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. The aggregation group for an ESRD facility that is not a
subsidiary ESRD facility includes all ESRD facilities located in the
HRR in which the ESRD facility is located, with the exception of
subsidiary ESRD facilities.
(2) Managing clinicians. A Managing clinician's home dialysis rate
and transplant rate are each reliability adjusted such that the
Managing clinician's adjusted rate is the weighted average of the
Managing clinician's rate and the rate of all Managing clinicians in
the Managing clinician's aggregation group, based on the reliability of
the Managing clinician's rate. Home dialysis
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rates and transplant rates are first grouped at the practice group
level, as identified by practice TIN, for Managing clinicians who are
in a group practice, and at the individual NPI level for Managing
clinician who are solo practitioners. Performance is then aggregated to
the aggregation group level. The aggregation group for Managing
clinicians in a group practice is all Managing clinicians within the
HRR in which the group practice is located. The aggregation group for
Managing clinicians who are solo practitioners is all Managing
clinicians within the HRR in which the Managing clinician is located.
Sec. 512.370 Benchmarking and scoring.
(a) General. CMS assesses the home dialysis rate and transplant
rate for each ETC Participant against the applicable benchmarks to
calculate an achievement score, as described in paragraph (b) of this
section. CMS assesses the home dialysis rate and transplant rate for
each ETC Participant against the applicable benchmarks to calculate an
improvement score, as described in paragraph (c) of this section. 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. The ETC Participant's MPS determines the
ETC Participant's PPA, as described in Sec. 512.380.
(b) Achievement scoring. CMS assesses ETC Participant performance
on the home dialysis rate and transplant rate against benchmarks
constructed based on the home dialysis rate and transplant rate among
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 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 x (Higher of home dialysis rate
achievement or improvement score) + (Higher of transplant rate
achievement or improvement score)
Sec. 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 18 years of age or older during the
entire month of the claim, on claims with claim through dates during
the applicable PPA Period as described in Sec. 512.355(c).
(b) Clinician PPA. CMS adjusts the amount otherwise paid under 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 18 years of age or older during the
entire month of the claim, on claims with claim through dates during
the applicable PPA Period as described in Sec. 512.355(c).
Sec. 512.380 PPA amounts and schedules.
CMS adjusts the payments described in Sec. 512.375 based on the
ETC Participant's MPS calculated as described in Sec. 512.370(d)
according to the amounts and schedules in Tables 1 and 2 to Sec.
512.380.
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Sec. 512.385 PPA exclusions.
(a) ESRD facilities. CMS excludes an ESRD facility that has fewer
than 11 attributed beneficiary-years during a MY from the applicability
of the Facility PPA for the corresponding PPA Period.
(b) Managing Clinicians. CMS excludes a Managing Clinician who
falls below the low-volume threshold described in this paragraph during
a MY from the applicability of the Clinician PPA for the corresponding
PPA Period. The low-volume threshold is set at the bottom 5 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.
Sec. 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 60 days 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
payment that arises from the application of an incorrect PPA during the
next PPA period that begins after the notification of the ETC
Participant.
(5) Decisions based on targeted review are final, and there is no
further review or appeal.
Quality Monitoring
Sec. 512.395 Quality measures.
CMS collects data on the two quality measures below 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
Sec. 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.
(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) Kidney Disease Education (KDE) benefit waivers. CMS waives the
following requirements of title XVIII of the Act solely for purposes of
testing the ETC Model:
(1) CMS waives the requirement that only doctors, physician
assistants, nurse practitioners, and clinical nurse specialists can
furnish KDE services under section 1861(ggg)(2)(A)(i) of the Act and
Sec. 410.48(c)(2)(i) of this chapter 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;
(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 Sec. 410.48(b)(1) of this chapter to
permit beneficiaries diagnosed with CKD Stage V or within the first 6
months of receiving a diagnosis of ESRD to receive the KDE benefit;
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(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 Sec. 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 Sec. 410.48(d)(5)(iii) of this chapter, provided
that such outcomes assessment is performed within one month of the
final KDE session by qualified staff.
Dated: July 2, 2019.
Seema Verma,
Administrator, Centers for Medicare and Medicaid Services.
Dated: July 9, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-14902 Filed 7-10-19; 4:45 pm]
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