Rule2022-18541
Radiation Oncology (RO) Model
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 29, 2022
Effective
October 28, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
We are finalizing our proposal to delay the current start date of the RO Model to a date to be determined through future rulemaking, and to modify the definition of the model performance period to provide that the start and end dates of the model performance period for the RO Model will be established in future rulemaking.
Full Text
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<title>Federal Register, Volume 87 Issue 166 (Monday, August 29, 2022)</title>
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[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Rules and Regulations]
[Pages 52698-52704]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-18541]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 512
[CMS-5527-F2]
RIN 0938-AT89
Radiation Oncology (RO) Model
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Final rule.
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SUMMARY: We are finalizing our proposal to delay the current start date
of the RO Model to a date to be determined through future rulemaking,
and to modify the definition of the model performance period to provide
that the start and end dates of the model performance period for the RO
Model will be established in future rulemaking.
DATES: These regulations are effective on October 28, 2022.
FOR FURTHER INFORMATION CONTACT: Genevieve Kehoe,
<a href="/cdn-cgi/l/email-protection#164477727f77627f7978427e736477666f56757b65387e7e6538717960"><span class="__cf_email__" data-cfemail="227043464b43564b4d4c764a475043525b62414f510c4a4a510c454d54">[email protected]</span></a>, or 1-844-711-2664 Option 5, for questions
related to the Radiation Oncology Model.
SUPPLEMENTARY INFORMATION:
[[Page 52699]]
I. Background
We are committed to promoting higher quality of cancer care and
improving outcomes for Medicare beneficiaries while reducing costs. As
part of that effort, the Biden Administration has taken a number of
efforts to improve the care of Medicare cancer patients, most notably
with the President's cancer agenda and the Cancer Moonshot, as well as
the CMS Innovation Center's Oncology Care Model \1\ and Enhancing
Oncology Model,\2\ which focus on patients with cancer who receive
chemotherapy.
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\1\ <a href="https://innovation.cms.gov/innovation-models/oncology-care">https://innovation.cms.gov/innovation-models/oncology-care</a>.
\2\ <a href="https://innovation.cms.gov/innovation-models/enhancing-oncology-model">https://innovation.cms.gov/innovation-models/enhancing-oncology-model</a>.
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In December 2015, Congress passed the Patient Access and Medicare
Protection Act (Pub. L. 114-115), and section 3(b) of this legislation
required the Secretary of the Department of Health and Human Services
to submit to Congress a report, no later than 18 months after
enactment, on ``the development of an episodic alternative payment
model'' for payment under the Medicare program for radiation therapy
(RT) services. We released the 2017 Report to Congress: ``Episodic
Alternative Payment Model for Radiation Therapy Services,'' which laid
out the potential for reforming the way Medicare pays for radiation
oncology. Based on that work, using our authority under section 1115A
of the Social Security Act (the Act), we published a proposed rule,
titled ``Medicare Program; Specialty Care Models to Improve Quality of
Care and Reduce Expenditures'', which appeared in the Federal Register
on July 18, 2019 (84 FR 34478), and included a proposal for
implementing a mandatory model for radiation oncology services
(hereinafter referred to as the RO Model) (84 FR 34490 through 34535).
The RO Model was designed to test whether making site-neutral,
prospective, episode-based payments to hospital outpatient departments
(HOPDs), physician group practices (PGPs), and freestanding radiation
therapy centers for RT episodes of care would preserve or enhance the
quality of care furnished to Medicare beneficiaries while reducing or
maintaining Medicare program spending. More specifically, as described
in the final rule titled ``Medicare Program; Specialty Care Models to
Improve Quality of Care and Reduce Expenditures'' that appeared in the
September 29, 2020 Federal Register (85 FR 61115) (hereinafter referred
to as the ``Specialty Care Models final rule''), the RO Model was
designed to include prospective payments for certain RT services
furnished during a 90-day RO episode for included cancer types for
certain Medicare beneficiaries. The Model was designed to test the
cost-saving potential of prospective episode payments for certain RT
services furnished during an RO episode and whether shorter courses of
RT (that is, fewer doses, also known as fractions) will encourage more
efficient care delivery and incentivize higher value care.
In the Specialty Care Models final rule, we codified policies at 42
CFR part 512, subparts A and B, that included a finalized RO Model with
a model performance period that was to begin January 1, 2021, and end
December 31, 2025 (85 FR 61367). We finalized that each performance
year (PY) would be the 12-month period beginning on January 1 and
ending on December 31 of each calendar year (CY) during the model
performance period, and no new RO episodes may begin after October 3,
2025, in order for all RO episodes to end by December 31, 2025.
Due to the public health emergency for the Coronavirus disease 2019
(COVID-19) pandemic, we revised the RO Model's model performance period
at 42 CFR 512.205 to begin on July 1, 2021, and to end December 31,
2025, giving RO participants an additional 6 months to prepare for the
RO Model. We implemented the revised model period via interim final
regulations included in the final rule with comment period and interim
final rule with comment period that appeared in the December 29, 2020
Federal Register titled ``Medicare Program: Hospital Outpatient
Prospective Payment and Ambulatory Surgical Center Payment Systems and
Quality Reporting Programs; New Categories for Hospital Outpatient
Department Prior Authorization Process; Clinical Laboratory Fee
Schedule: Laboratory Date of Service Policy; Overall Hospital Quality
Star Rating Methodology; Physician-owned Hospitals; Notice of Closure
of Two Teaching Hospitals and Opportunity To Apply for Available Slots,
Radiation Oncology Model; and Reporting Requirements for Hospitals and
Critical Access Hospitals (CAHs) to Report COVID-19 Therapeutic
Inventory and Usage and to Report Acute Respiratory Illness During the
Public Health Emergency (PHE) for Coronavirus Disease 2019 (COVID-19)''
(85 FR 85866) (hereinafter referred to as ``CY 2021 OPPS/ASC IFC'').
Section 133 of the Consolidated Appropriations Act (CAA), 2021
(Pub. L. 116-260) (hereinafter referred to as ``CAA, 2021''), enacted
on December 27, 2020, included a provision that prohibited
implementation of the RO Model before January 1, 2022. This
congressional action superseded the start date of the model performance
period of July 1, 2021, established in the CY 2021 OPPS/ASC IFC. To
align the RO Model regulations with the requirements of the CAA, 2021,
we proposed to modify the definition of ``model performance period'' in
42 CFR 512.205 to provide for a 5-year model performance period
starting on January 1, 2022, unless the RO Model is prohibited by law
from starting on January 1, 2022, in which case the model performance
period would begin on the earliest date permitted by law that is
January 1, April 1, or July 1. We also proposed other modifications
both related to and unrelated to the timing of the RO Model in the
proposed rule that appeared in the August 4, 2021 Federal Register
titled ``Medicare Program: Hospital Outpatient Prospective Payment and
Ambulatory Surgical Center Payment Systems and Quality Reporting
Programs; Price Transparency of Hospital Standard Charges; Radiation
Oncology Model; Request for Information on Rural Emergency Hospitals''
(86 FR 42018). These provisions were finalized in a final rule with
comment period titled ``Medicare Program: Hospital Outpatient
Prospective Payment and Ambulatory Surgical Center Payment Systems and
Quality Reporting Programs; Price Transparency of Hospital Standard
Charges; Radiation Oncology Model'' that appeared in the November 16,
2021 Federal Register (86 FR 63458) (hereinafter referred to as the
``CY 2022 OPPS/ASC FC'').
On December 10, 2021, the Protecting Medicare and American Farmers
from Sequester Cuts Act (Pub. L. 117-71) was enacted, which included a
provision that prohibits implementation of the RO Model prior to
January 1, 2023. The CY 2022 OPPS/ASC FC specified that if the RO Model
was prohibited by law from beginning on January 1, 2022, the model
performance period would begin on the earliest date permitted by law
that is January 1, April 1, or July 1. As a result, under the current
definition for model performance period at 42 CFR 512.205, the RO Model
would start on January 1, 2023, because that date is the earliest date
permitted by law. However, given the multiple delays to date, and
because both CMS and RO participants must invest operational resources
in preparation for implementation of the RO Model, we have considered
how best to proceed under these circumstances.
[[Page 52700]]
In a proposed rule titled ``Radiation Oncology (RO) Model,'' which
appeared in the Federal Register on April 8, 2022 (87 FR 20800)
(hereinafter referred to as the ``April 2022 RO Model proposed rule''),
we proposed to delay the current start date of the RO Model to a date
to be determined through future rulemaking, and to modify the
definition of the model performance period at 42 CFR 512.205 to provide
that the start and end dates of the model performance period for the RO
Model will be established in future rulemaking.
We solicited public comment on our proposal and received
approximately 38 timely pieces of correspondence. We summarize and
respond to public comments in this final rule.
II. Provisions of the Finalized Regulations
A. Model Performance Period
As stated in the April 2022 RO Model proposed rule, we continue to
believe that the RO Model would address long-standing concerns related
to RT delivery and payment, including the lack of site neutrality for
payments, incentives that encourage volume of services over the value
of services, and coding and payment challenges (87 FR 20802). We
believe the RO Model would provide payment stability and promote high-
quality care for Medicare beneficiaries. We have heard that the RO
Model is valuable and needed in the radiation oncology space from some
interested parties and that some RT providers and RT suppliers selected
to be RO participants are dedicated to preparing for implementation of
the RO Model.
However, given that there have been two legislative delays of the
RO Model, the operational resources required of CMS and RO participants
to continue to prepare for the RO Model before it can be implemented,
and some interested parties' comments that they would not support the
RO Model unless specific changes were made, we proposed to delay the
start of the RO Model to a date to be determined through future
rulemaking and to modify the definition of model performance period at
42 CFR 512.205 to reflect this policy. We noted that we would plan to
propose the new start date no less than 6 months prior to that proposed
start date.
As noted previously, Congress has delayed the RO Model twice. There
is a substantial cost to continue funding preparation for
implementation of the RO Model in 2023. For example, funding is needed
for CMS to prepare for participant onboarding, claims systems changes,
and updates to the data used in the Model's design and participant-
specific payment amounts, among a number of other activities. The cost
of the operational funding needed to continue to prepare to implement
the RO Model takes resources away from the development of other
alternative payment models, particularly when it is not known whether
there may be further legislative delays to the start of the RO Model.
Additionally, those entities selected to be RO participants
continue to make good faith efforts to prepare to implement the RO
Model, which may involve financial, operational, and administrative
investment and resources. Given multiple delays and uncertainty about
the timing of the RO Model, delaying the RO Model indefinitely will
give RO participants the ability to pause their efforts to prepare for
implementation of the RO Model. In the April 2022 RO Model proposed
rule, we stated that we welcome additional dialogue with RO
participants and interested parties about Medicare payment for RT
services (87 FR 20802).
Further, RO participants and interested parties have requested
additional changes to the RO Model's payment methodology and to other
aspects of the RO Model design and participation requirements, such as
lower discounts while keeping the geographic scope of the Model the
same. As we have informed interested parties, if the discounts are
lowered below 3.5 percent for the professional component and 4.5
percent for the technical component, we would need to expand the
geographic scope of the RO Model to be larger than 30 percent of Core
Based Statistical Areas (CBSAs) (86 FR 63928 and 63929). If the
discount amounts are significantly smaller, all else equal, the
projected savings will be smaller, and therefore, the number of CBSAs
(and episodes) in the participant group may not be sufficient for CMS
to detect an effect of the RO Model with statistical confidence.
However, we believe that some interested parties will not support the
RO Model test moving forward with unchanged discounts and as noted
previously, these interested parties have also requested that we not
increase the geographic scope of the Model.
Thus, for these reasons, we proposed to delay the current start
date of the RO Model, and to establish the start and end dates for the
model through future rulemaking, which may also involve modifications
to the model design. We proposed to modify the definition of the model
performance period at 42 CFR 512.205 to reflect this proposed delay, by
removing the provision that the RO Model begins on January 1, 2022, and
ends on December 31, 2026, unless the RO Model is prohibited by law
from starting on January 1, 2022, in which case the model performance
period begins on the earliest date permitted by law that is January 1,
April 1, or July 1. We proposed to modify the definition of model
performance period to instead specify that CMS will establish the start
and end dates of the model performance period for the RO Model through
future rulemaking. Finally, in the April 2022 RO Model proposed rule,
we noted that if we do not finalize this proposal and instead proceed
with a start date of January 1, 2023, we do not plan to change the
CBSAs selected for participation before that start date (87 FR 20802).
The following is a summary of comments we received on the proposal
to delay the RO Model to a date to be determined through future
rulemaking in section II.A. of the April 2022 RO Model proposed rule
and our responses to these comments:
Comment: Many commenters supported the delay of the RO Model to a
date to be determined in future rulemaking. CMS received a couple
comments requesting a January 1, 2024 start date to allow for
additional time to prepare for the Model.
Response: We appreciate the support for the delay of the RO Model
to a date yet to be determined and that a couple commenters requested a
specific alternative future date for the RO Model to begin. We will
consider whether a January 1, 2024, start date or an alternative start
date would be feasible and whether such a date is likely to provide
enough time to address the current challenges associated with starting
the RO Model as we contemplate future rulemaking.
Comment: Some commenters requested that the RO Model as it is
currently designed be cancelled altogether. These commenters noted that
they believe that the Model as currently designed does not align with
the Biden Administration's Cancer Moonshot goal of increasing access to
innovative and appropriate cancer care. Specifically, commenters were
concerned the Model would impact equitable access to proton therapy and
future innovation in radiation oncology. Some commenters stated that
CMS should work with interested parties to redesign the Model with
respect to, for example, the discounts, mandatory participation,
billing requirements, quality and clinical reporting, included
modalities, and the Advanced Alternative Payment Model (APM) bonus.
[[Page 52701]]
Response: We appreciate these comments. However, we do not agree
with the comments that the RO Model should be cancelled. As noted
previously, we continue to believe that the RO Model will address long-
standing concerns related to delivery and payment of RT services and
benefit RT providers and RT suppliers as well as beneficiaries, because
of the RO Model's focus on financial predictability through
prospective, site-neutral, episode-based payment and care improvement
by linking payment to quality. The RO Model is designed to test an
innovative approach to payment and service delivery in the field of
radiation oncology. We welcome further dialogue with interested parties
and RO participants about the design of the RO Model.
Comment: A few commenters opposed the delay of the RO Model to a
date to be determined through future rulemaking. These commenters
stated that the RO Model has been delayed long enough and should begin
on January 1, 2023. A commenter noted its disappointment in the
continued delay of the RO Model and its frustration with the starting
and stopping of preparation efforts. The commenter provided support for
value-based, bundled payment for RT services to ensure payment
stability, and urged CMS to work with interested parties to make
necessary final refinements to the RO Model and implement it as soon as
possible. A commenter who requested that the RO Model start January 1,
2023 further stated that the only changes that should be considered
with a January 1, 2023 start are those related to changes in the
national base rates or the adjustment rates that would increase the
revenue to RO participants, because the commenter believed that the
cost of paying RO participants more would likely be less than the cost
of continued delays.
Response: Although we continue to believe that the RO Model will
address longstanding concerns related to delivery and payment of RT
services as described in more detail in the Specialty Care Models final
rule (85 FR 61347) and again in the CY 2022 OPPS/ASC FC (86 FR 63911
and 63912), such as the site-of-service payment differential that
exists under the OPPS and PFS as well as the incentives built into the
current fee-for-service payment system that promotes volume over the
value of services, Congress has delayed the RO Model twice, and it is
not known whether there may be further delays to the start of the RO
Model that are out of CMS's control. As noted previously, there is a
substantial cost to continue funding preparation for implementation of
the RO Model in 2023, and the cost of such funding takes resources away
from the development of other alternative payment models. A continued
cycle of starting and stopping preparation efforts may also involve
resources on the part of RO participants. Furthermore, as described in
the Specialty Care Models final rule (85 FR 61152) and in the CY 2022
OPPS/ASC FC (86 FR 63928 and 63929), in order to be able to detect an
impact of the Model, changes to RO Model payment methodology may
require changes to other aspects of the Model, such as increasing the
size of the Model. In light of the fact that it is unknown whether
there may be further delays to the RO Model that are out of CMS's
control, we believe that the best course of action is to delay the
implementation of the RO Model to a future date. While we appreciate
commenters' request to begin the RO Model as soon as possible on
January 1, 2023, we believe that the delay will provide us with the
opportunity for additional dialogue with RO participants and interested
parties about Medicare payment for RT services.
Comment: We received a few comments requesting that CMS provide
more than 6 months' notice in advance of the future RO Model start
date.
Response: We appreciate these comments. We want to emphasize that
we would plan to propose a new start date for the RO Model at least 6
months prior to that proposed start date, and the public would have an
opportunity to comment on the new proposed start date as part of the
rulemaking process. CMS is committed to the success of the RO Model and
providing RO participants sufficient time to prepare before the RO
Model begins. Should we receive comments indicating that a proposed
start date provides insufficient time to prepare, CMS will consider any
such comments in its decision of when to start the RO Model.
Comment: Many commenters provided feedback not directly related to
our proposal to delay the start date of the RO Model to a date to be
determined through future rulemaking. These comments concerned a range
of issues, including participation requirements and criteria, the
geographic size of the Model, included modalities, Advanced APM
incentive payment under the Quality Payment Program (QPP), and the
Model's pricing methodology (for example, the national base rates,
trend factor, case mix and historical experience adjustments, blend,
and discount rates). Commenters also provided feedback related to the
RO Model's potential impact on rural practices, health equity, and
health disparities, as well as the burden of collecting and reporting
the clinical data elements and the quality measures, and the burden of
the RO Model's billing requirements. Commenters also discussed patient
navigation tools, the beneficiary notification letter, and how the RO
Model does or does not align with the goals of the Biden
Administration's cancer agenda and the Cancer Moonshot.
Response: We appreciate these additional comments, which we may
further consider as we evaluate how best to proceed with the RO Model
going forward. As noted previously, we continue to welcome further
feedback and dialogue with interested parties and RO participants on
the design of the RO Model.
After considering public comments, we are finalizing our proposal
to delay the start of the RO Model to a date to be determined through
future rulemaking. Specifically, we are finalizing our proposed
revisions to the definition of model performance period at 42 CFR
512.205, to specify that model performance period means the 5
performance years (PYs) during which RO episodes initiate and
terminate, and that CMS will establish the start and end dates of the
model performance period for the RO Model through future rulemaking.
III. 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 CMS Innovation Center Models. Consequently, there is no
need for review by the Office of Management and Budget (OMB) under the
authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.).
IV. Regulatory Impact Analysis
A. Statement of Need
The purpose of this final rule is to delay the start of the RO
Model to a date yet to be determined, and to modify the definition of
model performance period at 42 CFR 512.205. Delaying the start of the
RO Model to a date yet to be determined does not change the statement
of need for the RO Model as described in the Specialty Care Models
final rule (85 FR 61347) and the CY 2021 OPPS/ASC IFC (85 FR 86296) and
again in the CY 2022 OPPS/ASC FC (86 FR 63458).
[[Page 52702]]
B. Overall Impact
We have examined the impact 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 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), and the
Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Section
3(f) of Executive Order 12866 defines a ``significant regulatory
action'' as an action that is likely to result in a rule: (1) having an
annual effect on the economy of $100 million or more in any 1 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.
A regulatory impact analysis (RIA) must be prepared for regulatory
actions with economically significant effects ($100 million or more in
any 1 year). Based on our estimates, OMB's Office of Information and
Regulatory Affairs has determined this rulemaking is ``economically
significant'' as measured by the $100 million threshold, and hence is
also a major rule under Subtitle E of the Small Business Regulatory
Enforcement Fairness Act of 1996 (also known as the Congressional
Review Act). Accordingly, we have prepared an RIA that to the best of
our ability presents the costs and benefits of the rulemaking.
C. Detailed Economic Analysis
Delaying the start of the RO Model to a later undetermined date and
modifying the regulatory text at 42 CFR 512.205 to reflect this means
that the annualized/monetarized estimates of costs and transfers policy
for the RO Model presented in the CY 2022 OPPS/ASC FC (86 FR 63986)
will not be realized at this time.
Similarly, the burden estimates related to implementation of the RO
Model presented in the Specialty Care Models final rule (85 FR 61358),
the CY 2021 OPPS/ASC IFC (85 FR 86297), and the CY 2022 OPPS/ASC FC (86
FR 63987) will not be realized at this time.
The regulatory impact analysis of the CY 2022 OPPS/ASC FC estimated
that on net the RO Model would reduce Medicare spending by $150 million
over the 5-year model performance period. This amount is the net
Medicare Part B impact that includes both Part B premium and Medicare
Advantage United States Per Capita Costs (MA USPCC) rate financing
interaction effects. This estimate excludes changes in beneficiary cost
sharing liability to the extent it is not a Federal outlay under the
policy. These potential impacts were estimated to occur beginning on
January 1, 2022, through December 31, 2026, in alignment with a January
1, 2022, model start. Table 1 summarizes the estimated impact of the RO
Model with a model performance period that would have begun January 1,
2022, and ended December 31, 2026. Table 2 provides additional
information about those expected impacts by year. However, because the
RO Model was not implemented on January 1, 2022, as contemplated in the
CY 2022 OPPS/ASC FC, such effects have yet not occurred.
Table 1--Estimates of Medicare Program Savings (Millions $) for Radiation Oncology Model
[Starting January 1, 2022]
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Year of model
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2022 2023 2024 2025 2026 Total*
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Net Impact to Medicare Program Spending................. -20 -30 -20 -40 -40 -150
Changes to Incurred FFS Spending........................ -20 -20 -20 -30 -30 -120
Changes to MA Capitation Payments....................... 0 -20 -20 -20 -30 -80
Part B Premium Revenue Offset........................... 0 10 10 10 10 50
Total APM Incentive Payments............................ 0 0 10 0 0 10
Episode Allowed Charges................................. 830 860 900 930 970 4,490
Episode Medicare Payment................................ 650 670 700 730 750 3,500
Total Number of Episodes................................ 53,300 54,900 56,400 58,000 59,600 282,200
Total Number of Beneficiaries........................... 51,900 53,500 54,900 56,500 58,100 250,200
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* Negative spending reflects a reduction in Medicare spending, while positive spending reflects an increase.
* Totals may not sum due to rounding and from beneficiaries that have cancer treatment spanning multiple years.
Table 2--Radiation Oncology Model Physician Group Practice (PGP) (Including Freestanding Radiation Therapy Centers) vs Hospital Outpatient Department
(HOPD) Allowed Charge Impacts 2022 to 2026 as Compared to Those Not Participating in the RO Model
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2022 to 2026
% Impact 2022 (%) 2023 (%) 2024 (%) 2025 (%) 2026 ($) (%)
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PGP (including freestanding radiation therapy centers).. 3.1 4.5 6.0 7.4 8.9 6.3
HOPD.................................................... -7.8 -8.8 -9.6 -10.6 -11.6 -9.9
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[[Page 52703]]
Nevertheless, and notwithstanding the RO Model delay, the analysis
uses a baseline in which the RO Model provisions of the CY 2022 OPPS/
ASC FC were effective on January 1, 2022, to calculate the monetized
estimates of the effects of this final rule. We maintain the analytical
approach described in the regulatory impact analysis of the CY 2022
OPPS/ASC FC, and, for the purposes of quantifying the effects of this
final rule, we assumed that the regulations at 42 CFR part 512, subpart
B, as amended by the CY 2022 OPPS/ASC FC were otherwise in full effect.
As we are finalizing the delay of the start of the RO Model to a date
yet to be determined, the estimated savings presented in Table 90 of
the CY 2022 OPPS/ASC FC will not occur at this time. We summarize this
result in Table 3 later in this section, which illustrates, inversely,
the net monetized estimates contained in Table 90 of the CY 2022 OPPS/
ASC FC. The period covered shown in Table 3 begins January 2022 in
alignment with Table 90 of the CY 2022 OPPS/ASC FC.
As required by OMB Circular A-4 (available at the Office of
Management and Budget website at: <a href="https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf">https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf</a>), we have prepared an
accounting statement in Table 3 showing the classification of the
impact associated with the provisions of this final rule.
Table 3--Accounting Statement: Estimated Impacts From CY 2022 TO CY 2026 as a Result of Provisions of This Final
Rule
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Units
Estimates -----------------------------------------------
Category (million) Discount rate Period
Year dollar (%) covered
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Transfers:
Annualized Monetized ($million/year)............ $27 2020 7 2022-2026
29 2020 3 2022-2026
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From Whom to Whom............................... From the Federal Government to healthcare providers.
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D. Regulatory Flexibility Act (RFA)
The RFA requires agencies to analyze options for regulatory relief
of small entities. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and small governmental
jurisdictions. Most hospitals and most other health care providers and
suppliers are small entities, either by nonprofit status or by having
revenues of less than $8 million to $41.5 million in any 1 year.
Individuals and states are not included in the definition of a small
entity. For details, see the Small Business Administration's ``Table of
Small Business Size Standards'' at <a href="https://www.sba.gov/document/support--table-size-standards">https://www.sba.gov/document/support--table-size-standards</a>.
As its measure of significant economic impact on a substantial
number of small entities, HHS uses a change in revenue of more than 3
to 5 percent. Because we are finalizing our proposal, the estimated
impact of the RO Model as described in the CY 2022 OPPS/ASC FC will not
occur. Instead, payment for submitted claims will be made under the
applicable Medicare payment methodology. As a result, the Secretary has
determined that this final rule will not have a significant impact on a
substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare an
RIA if a rule may have a significant impact on the operations of a
substantial number of small rural hospitals. This analysis must conform
to the provisions of section 604 of the RFA. For purposes of section
1102(b) of the Act, we define a small rural hospital as a hospital that
is located outside of a Metropolitan Statistical Area for Medicare
payment regulations and has fewer than 100 beds. We are not preparing
an analysis for section 1102(b) of the Act because we have determined,
and the Secretary certifies, that the RO Model will not have a
significant impact on the operations of a substantial number of small
rural hospitals.
We requested comments on our estimate of significantly affected
providers and suppliers and the magnitude of estimated effects for the
proposed rule. We did not receive any comments.
E. Unfunded Mandates Reform Act (UMRA)
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2022, that
threshold is approximately $165 million. This final rule does not
mandate any requirements for State, local, or tribal governments, or
for the private sector.
F. Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a 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 the RO Model is a Federal payment model impacting
Federal payments only and does not implicate local governments or state
law. Therefore, the requirements of Executive Order 13132 are not
applicable.
List of Subjects in 42 CFR Part 512
Administrative practice and procedure, Health facilities, Medicare,
Reporting and recordkeeping requirements.
For the reasons set forth in the preamble and under the authority
at 42 U.S.C. 1302, 1315a, and 1395hh, the Centers for Medicare &
Medicaid Services amends 42 CFR part 512 as set forth below:
PART 512--RADIATION ONCOLOGY MODEL AND END STAGE RENAL DISEASE
TREATMENT CHOICES MODEL
0
1. The authority citation for part 512 continues to read as follows:
Authority: 42 U.S.C. 1302, 1315a, and 1395hh.
[[Page 52704]]
0
2. Section 512.205 is amended by revising the definition of ``Model
performance period'' to read as follows:
Sec. 512.205 Definitions.
* * * * *
Model performance period means the 5 performance years (PYs) during
which RO episodes initiate and terminate. CMS will establish the start
and end dates of the model performance period for the RO Model through
future rulemaking.
* * * * *
Dated: August 24, 2022.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2022-18541 Filed 8-25-22; 4:15 pm]
BILLING CODE 4120-01-P
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