Proposed Rule2021-20016
Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”
Primary source
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Published
September 15, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This proposed rule would repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of ``Reasonable and Necessary'' final rule, which was published on January 14, 2021, and would be effective on December 15, 2021. We are providing a public comment period to allow interested parties to provide comments about the proposed repeal, our intent to conduct future rulemaking to explore an expedited coverage pathway that provides access to innovative beneficial technologies and the reasonable and necessary definition.
Full Text
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<title>Federal Register, Volume 86 Issue 176 (Wednesday, September 15, 2021)</title>
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[Federal Register Volume 86, Number 176 (Wednesday, September 15, 2021)]
[Proposed Rules]
[Pages 51326-51335]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-20016]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 405
[CMS-3372-P2]
RIN 0938-AT88
Medicare Program; Medicare Coverage of Innovative Technology
(MCIT) and Definition of ``Reasonable and Necessary''
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Proposed rule.
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SUMMARY: This proposed rule would repeal the Medicare Coverage of
Innovative Technology (MCIT) and Definition of ``Reasonable and
Necessary'' final rule, which was published on January 14, 2021, and
would be effective on December 15, 2021. We are providing a public
comment period to allow interested parties to provide comments about
the proposed repeal, our intent to conduct future rulemaking to explore
an expedited coverage pathway that provides access to innovative
beneficial technologies and the reasonable and necessary definition.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, by October 15, 2021.
ADDRESSES: In commenting, please refer to file code CMS-3372-P2.
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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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-3372-P2, P.O. Box 8013, Baltimore, MD
21244-8013.
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-3372-P2, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Lori Ashby, (410)-786-6322 or
<a href="/cdn-cgi/l/email-protection#4a0709031e0a29273964222239642d253c"><span class="__cf_email__" data-cfemail="ace1efe5f8eccfc1df82c4c4df82cbc3da">[email protected]</span></a>.
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: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the search instructions on
that website to view public comments. CMS will not post on
<a href="http://Regulations.gov">Regulations.gov</a> public comments that make threats to individuals or
institutions or suggest that the individual will take actions to harm
the individual. CMS continues to encourage
[[Page 51327]]
individuals not to submit duplicative comments. We will post acceptable
comments from multiple unique commenters even if the content is
identical or nearly identical to other comments.
I. Background
A. January 14, 2021 Final Rule
In the January 14, 2021 Federal Register, we published a final rule
titled ``Medicare Program; Medicare Coverage of Innovative Technology
(MCIT) and Definition of `Reasonable and Necessary' (86 FR 2987)
(hereinafter referred to as the ``MCIT/R&N final rule''). The MCIT/R&N
final rule established a Medicare coverage pathway to provide Medicare
beneficiaries nationwide with faster access to recently market
authorized medical devices designated as breakthrough by the Food and
Drug Administration (FDA). Under the final rule, MCIT would result in 4
years of national Medicare coverage starting on the date of FDA market
authorization or a manufacturer chosen date within 2 years thereafter.
The MCIT/R&N final rule would also implement regulatory standards to be
used in making reasonable and necessary determinations under section
1862(a)(1)(A) of the Social Security Act (the Act) for items and
services that are furnished under Medicare Parts A and B.
B. March 2021 Interim Final Rule (IFC) and May 2021 Final Rule To Delay
Effective Date
In response to the January 20, 2021 memorandum from the Assistant
to the President and Chief of Staff titled ``Regulatory Freeze Pending
Review'' (``Regulatory Freeze Memorandum'') (86 FR 7424, January 28,
2021) and guidance on implementation of the memorandum issued by the
Office of Management and Budget (OMB) in Memorandum M-21-14 dated
January 20, 2021, we determined that a 60-day delay of the effective
date of the MCIT/R&N final rule was appropriate to ensure that--
<bullet> The rulemaking process was procedurally adequate;
<bullet> We properly considered all relevant facts;
<bullet> We considered statutory or other legal obligations;
<bullet> We had reasonable judgment about the legally relevant
policy considerations; and
<bullet> We adequately considered public comments objecting to
certain elements of the rule, including whether interested parties had
fair opportunities to present contrary facts and arguments.
Therefore, in an interim final rule with comment period that went
on display at the Federal Register and took effect on March 12, 2021
(hereinafter referred to as the ``March 2021 IFC''), and was published
in the March 17, 2021 Federal Register (86 FR 14542), we--(1) delayed
the MCIT/R&N final rule effective date until May 15, 2021 (that is, 60
days after the original effective date of March 15, 2021); and (2)
opened a 30-day public comment period on the facts, law, and policy
underlying the MCIT/R&N final rule.
Many commenters on the March 2021 IFC supported further delaying
the MCIT/R&N final rule. Based upon the public comments, we did not
believe that it was in the best interest of Medicare beneficiaries for
the MCIT/R&N final rule to become effective on May 15, 2021. Therefore,
in a final rule that went on display at the Federal Register and took
effect on May 14, 2021 (hereinafter referred to as the ``May 2021 final
rule''), and was published in the May 18, 2021 Federal Register (86 FR
26849), we summarized the comments on the March 2021 IFC and further
delayed the MCIT/R&N final rule effective date until December 15, 2021.
We explained that the additional delay would provide us an opportunity
to address all of the issues raised by stakeholders, especially those
related to Medicare patient protections and evidence criteria. We
announced that during the delay, we would determine appropriate next
steps that are in the best interest of all Medicare stakeholders, and
beneficiaries in particular.
II. Provisions of Proposed Regulations
We propose to repeal the MCIT/R&N final rule. Our rationale for our
proposal as well as our requests for comments on this proposed rule are
explained in the following section.
A. Proposed Repeal of Medicare Coverage of Innovative Technology Policy
CMS developed MCIT in part due to concerns that delays and
uncertainty in Medicare coverage slowed innovation and impaired
beneficiary access to important new technologies, specifically those
designated as breakthrough devices by FDA. In response to these
concerns, the rule provided 4 years of expedited coverage to FDA market
authorized Breakthrough Devices on the first day of FDA market
authorization or a select date up to 2 years after the market
authorization date as requested by the device manufacturer. While the
final rule did not require manufacturers to develop additional
scientific evidence supporting the use of the Breakthrough Devices in
the Medicare population, manufacturers were aware that, upon conclusion
of MCIT coverage, the existing coverage pathways would be available
(that is, reasonable and necessary determinations would be made via
claim-by-claim adjudication, local coverage determinations (LCDs), and
national coverage determinations (NCDs), which include the coverage
with evidence development pathway). The NCD and LCD development
processes include reviews of publicly available clinical evidence to
determine whether or not the items or services are reasonable and
necessary and would be covered by Medicare.
We believe that the finalized MCIT/R&N rule is not in the best
interest of Medicare beneficiaries because the rule may provide
coverage without adequate evidence that the Breakthrough Device would
be a reasonable and necessary treatment for the Medicare patients that
have the particular disease or condition that the device is intended to
treat or diagnose. While the rule tried to address stakeholder concerns
about accelerating coverage of new devices, significant concerns
persist about the availability of clinical evidence on Breakthrough
Devices when used in the Medicare population as well as the benefit or
risks of these devices with respect to use in the Medicare population
upon receipt of coverage. Based on the comments received throughout the
development of the MCIT pathway, we do not believe that the final rule
as currently drafted, is the best way to achieve the goals of MCIT as
outlined in the MCIT/R&N final rule, in particular, to more precisely
meet the needs Medicare beneficiaries and other stakeholders in a
timely fashion. We believe that there are other ways to achieve our
stated goals. This may include better utilizing existing pathways or
conducting future rulemaking.
As noted in the May 2021 final rule, our prior policies permitted
the Medicare program to deny coverage for particular devices if we
learned that a particular device may be harmful to Medicare
beneficiaries. Specifically, Medicare Administrative Contractors (MACs)
could have denied claims under certain circumstances (86 FR 26851, May
18, 2021). Under the MCIT/R&N final rule, this case-specific
flexibility would have been removed. While we could remove coverage
through the NCD process, we would only be able to expeditiously remove
a Breakthrough Device from the MCIT coverage pathway for limited
reasons, such as if FDA issued a safety communication or warning letter
regarding the
[[Page 51328]]
Breakthrough Device, or removed the marketing authorization for a
device. We believe that this limitation on our authority is
impracticable as it may lead to preventable harm to Medicare
beneficiaries and it impedes Medicare's ability to make case-by-case
determinations regarding whether a device is reasonable and necessary
based on clinical evidence.
Further, while the finalized MCIT policy in the MCIT/R&N final rule
would have provided expedited Medicare coverage following market
authorization for breakthrough designated devices, there is currently
no FDA requirement that Medicare beneficiaries must be included in
clinical studies needed for market-authorization. Because the MCIT/R&N
final rule did not require data concerning Medicare beneficiaries,
there is the potential that Medicare would cover devices, even in the
absence of data demonstrating that the device is reasonable and
necessary for Medicare patients will benefit from the device.
Additionally, several medical device manufacturers suggested that, for
inclusion in MCIT, FDA pivotal studies should require inclusion of
sufficient numbers of Medicare beneficiaries (86 FR 26851, May 18,
2021).
Certain proponents of accelerated Medicare coverage have argued
that FDA's determination that a product meets applicable safety and
effectiveness standards for marketing authorization should be
sufficient to support Medicare coverage of Breakthrough Devices.
However, after further consideration of all public comments, we no
longer agree that the FDA safety and effectiveness standards alone are
sufficient to support open-ended Medicare coverage. FDA and CMS act
under different statutes that have different goals and the standard for
coverage (that is, a determination that a device is reasonable and
necessary for the diagnosis or treatment of illness or injury or to
improve the functioning of a malformed body member) is not synonymous
with standards for safety and efficacy standards for marketing
authorization for the broader population. Among other things, FDA
conducts premarket review of certain devices to evaluate their safety
and effectiveness and determines if they meet the applicable standard
to be marketed in the United States. In doing so, FDA relies on
scientific and medical evidence that does not necessarily include
patients from the Medicare population. In general, under the Medicare
statute, CMS is charged with determining whether items and services are
reasonable and necessary to diagnose or treat an illness or injury or
to improve the functioning of a malformed body member. One
consideration for CMS in making national coverage determinations under
the reasonable and necessary statute is whether the item/service
improves health outcomes for Medicare beneficiaries. It is important to
determine whether Medicare beneficiaries' health outcomes are improved
because these individuals are often older, with multiple
comorbidities,\1\ and are often underrepresented or not represented in
many clinical studies.
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\1\ Davide L Vetrano, MD, Katie Palmer, Ph.D., Alessandra
Marengoni, MD, Ph.D., Emanuele Marzetti, MD, Ph.D., Fabrizia
Lattanzio, MD, Ph.D., Regina Roller-Wirnsberger, MD, MME, Luz Lopez
Samaniego, Ph.D., Leocadio Rodr[iacute]guez-Ma[ntilde]as, MD, Ph.D.,
Roberto Bernabei, MD, Graziano Onder, MD, Ph.D., Frailty and
Multimorbidity: A Systematic Review and Meta-analysis, The Journals
of Gerontology: Series A, Volume 74, Issue 5, May 2019, Pages 659-
666, <a href="https://doi.org/10.1093/gerona/gly110">https://doi.org/10.1093/gerona/gly110</a>.
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1. Evidence Development and Patient Safety
The Medicare national coverage determination process includes a
robust review of available clinical evidence and focuses on the
Medicare population to make reasonable and necessary determinations. In
contrast, the MCIT pathway would establish an expedited 4-year coverage
pathway for all Breakthrough Devices that fall under a Medicare benefit
category without a specific requirement that the device must
demonstrate it is reasonable and necessary for the Medicare population.
In general, Medicare patients have more comorbidities and often require
additional and higher acuity clinical treatments which may impact the
outcomes differently than the patients generally enrolled in early
clinical trials. These considerations are often not addressed in the
early device development process.
When we issued the MCIT/R&N final rule on January 14, 2021, we
responded to commenters who suggested that CMS should take a different
approach. Some commenters suggested that we should require
manufacturers to provide data about Medicare outcomes before providing
coverage as reasonable and necessary. Other commenters suggested that
we provide incentives to manufacturers to include Medicare
beneficiaries in clinical studies, similar to CMS's Coverage with
Evidence Development (CED) paradigm, before coverage under section
1862(a)(1)(A) of the Act was allowed (86 FR 2990, January 14, 2021).\2\
In response to the March 2021 IFC, additional commenters supported
evidence development as part of the requirements to participate in the
MCIT pathway. Some commenters noted that some clinical trials that were
conducted to support market authorization through the Breakthrough
Devices pathway lack data on patients older than 65, patients with
disabilities, and patients with end stage renal disease (ESRD). They
asserted that the absence of this clinical information poses some
uncertainty about whether FDA's determination of safety and efficacy
could be generalized to the Medicare population (86 FR 26850 and 26851,
May 18, 2021). CMS acknowledges that after further consideration of
public comments, we have changed our position on this issue. In
response to commenters' concerns about expedited coverage without
adequate evidentiary support, CMS agrees that guaranteeing coverage for
all Breakthrough Devices receiving market authorization for any
Medicare patient could be problematic if there is no evidence
demonstrating a health benefit or addressing the additional risks for
Medicare beneficiaries (86 FR 26850 and 26851, May 18, 2021). We noted
that a Breakthrough Device may only be beneficial in a subset of the
Medicare population or when used only by clinicians within a certain
specialty to ensure benefit. Without additional clinical evidence on
the device's clinical utility for the Medicare population or
appropriate providers, it is challenging to determine appropriate
Medicare coverage of newly market-authorized Breakthrough Devices (86
FR 26850 and 26851, May 18, 2021).
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\2\ CMS, Guidance for the Public, Industry, and CMS Staff
Coverage with Evidence Development, available at <a href="https://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=27">https://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=27</a>.
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We recognize that the breakthrough designation may be granted by
FDA before sufficient clinical evidence is available to prove there is
a health benefit for Medicare patients. FDA has explained in guidance
that because decisions on requests for breakthrough designation will be
made prior to marketing authorization, FDA considers whether there is a
``reasonable expectation that a device could provide for more effective
treatment or diagnosis relative to the current standard of care (SOC)
in the U.S'' for purposes of the designation. This reasonable
expectation can be ``supported by literature or preliminary data
(bench, animal, or clinical)''.\3\ Without sufficient
[[Page 51329]]
evidence developed to show the device improves health outcomes for
Medicare beneficiaries, it may be challenging for the Medicare program
to determine the health benefit of these devices for Medicare
beneficiaries. Public comments expressed concern about how the Medicare
population is often excluded from clinical trials due to age and health
status.
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\3\ Food and Drug Administration, Breakthrough Devices Program
Guidance for Industry and Food and Drug Administration Staff, 9,
available at: <a href="https://www.fda.gov/media/108135/download">https://www.fda.gov/media/108135/download</a>.
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Previously, in the MCIT/R&N final rule, we noted that ``device
coverage under the MCIT pathway is reasonable and necessary for a
duration of time under section 1862(a)(1)(A) of the Act because the
device has met the very unique criteria of the FDA Breakthrough Devices
Program'' (86 FR 2988, January 14, 2021).\4\ Through further
consideration of the breakthrough designation process, we have changed
our position on this issue and determined that Breakthrough Device
designation is not, by itself, sufficient for expedited Medicare
coverage purposes. Rather, as explained previously, we understand that
FDA may grant a device breakthrough designation when the device has
shown a ``reasonable expectation'' of providing more effective
treatment or diagnosis of a life-threatening or irreversibly
debilitating disease or condition relative to the current U.S. SOC and
that it meets the other criterion for designation in section 515B(b)(2)
of the Federal Food, Drug, and Cosmetic Act (FD&C) Act (21 U.S.C. 360e-
3(b)(2)). In turn, we now do not believe it is in the best interest of
Medicare beneficiaries to base expedited, multiyear, broad national
coverage through section 1862(a)(1)(A) of the Act on this designation
alone.
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\4\ 86 FR 2988 (January 14, 2021) available at <a href="https://www.govinfo.gov/content/pkg/FR-2021-01-14/pdf/2021-00707.pdf">https://www.govinfo.gov/content/pkg/FR-2021-01-14/pdf/2021-00707.pdf</a>.
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Clinical studies that are conducted in order to gain market
authorization for FDA Breakthrough Devices may not always include
information on patients with similar demographics and characteristics
of the Medicare population. Additionally, there may be devices
designated as breakthrough that do not have adequate data on the
effectiveness of the device for the Medicare population. Without
requiring any evidence specific to the Medicare patients, there may not
be any evidence to demonstrate whether the device is beneficial or not
after the conclusion of MCIT coverage after 4 years. Without such
evidence, it is possible that Medicare would be covering and paying for
devices that may have little or no Medicare relevant clinical evidence
to assist physicians and patients in making potentially life-saving
treatment decisions. Evidence-based coverage policy is essential to our
objective of improving health outcomes while delivering greater value.
Supportive clinical evidence that ensures a device is both safe and
effective and reasonable and necessary in the Medicare population is
crucial in order to grant coverage for a device under section
1862(a)(1)(A) of the Act. Such evidence is used to determine whether a
new technology meets the appropriateness criteria of the longstanding
Medicare Program Integrity Manual Chapter 13 definition of reasonable
and necessary.\5\ We believe that it is important to require
manufacturers participating in an innovative coverage pathway, such as
MCIT, to produce evidence that demonstrates the health benefit of the
device and the related services for patients with demographics similar
to that of the Medicare population.
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\5\ CMS, Medicare Program Integrity Manual, Chapter 13, 13.5.4,
available at <a href="https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/pim83c13.pdf">https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/pim83c13.pdf</a>.
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In response to the March 2021 IFC, some commenters cited evidence
that FDA-mandated postmarket studies are not reliably completed (less
than 20 percent of required studies are completed within 3 to 5 years
after market authorization),\6\ and asserted that evidence
demonstrating a device's health benefit in Medicare beneficiaries is
essential. Commenters also recommended that CMS outline in guidance
documents the types of evidence that would be acceptable for
applications for national or local coverage determinations once the
MCIT pathway's 4 years had expired, such as real-world data or
randomized, controlled trials (86 FR 26851, May 18, 2021). By
voluntarily developing this evidence during the time a device is
covered under the MCIT pathway, the manufacturer could have the
evidence base needed for one of the other coverage pathways after the
MCIT pathway ends. However, the MCIT/R&N final rule did not require
manufacturers of Breakthrough Devices to develop evidence as part of
their participation requirements under MCIT. In the May 2021 final
rule, we noted that numerous commenters, including physicians with
experience in clinical research and medical specialty societies, sought
modifications to the MCIT/R&N final rule regarding evidence
development, including the addition of real-world evidence
requirements.
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\6\ Rathi et al.
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As was noted by commenters in response to the March 2021 IFC that
delayed the MCIT/R&N final rule until December 15, 2021, early and
unrestricted adoption of devices may have consequences that may not be
easy to reverse. CMS expects physicians to consider the available
evidence and assess the care needs of each patient when considering the
best treatment options. However, by guaranteeing coverage of devices
based solely on breakthrough status and FDA marketing authorization,
rather than also taking into account whether the device provides an
effective, reasonable and necessary treatment for Medicare patients,
there may be an incentive for physicians to use a device that has
coverage under the MCIT pathway rather than a device that is not
covered under the MCIT pathway but is nonetheless covered under an
existing coverage pathway and that may be more beneficial to patients.
This early adoption by physicians could potentially lead to these
devices being prematurely viewed as the standard of care, which could
adversely impact beneficiaries if there is another item or service
available to treat the patient that has an evidence-base to suggest
that it may lead to better health outcomes. We believe that providers'
clinical treatment decisions should take the individual needs of the
patient into account; therefore, we seek to avoid the appearance of
incentivizing the use of MCIT-covered devices when an alternative item
or service may be more appropriate.
While the MCIT/R&N final rule may provide beneficiaries and
manufacturers an assurance of national Medicare coverage, evidence
development under MCIT as previously finalized is voluntary and there
was no requirement that manufacturers conduct studies to generate
evidence to demonstrate clinical benefit to Medicare patients. We
acknowledge that we no longer believe that voluntary evidence
development is in the best interests of Medicare beneficiaries as we
believe such evidence is key to determining the best treatments for
Medicare patients to ensure that the benefits of treatments outweigh
the potential harms. For devices that lack evidence that is
generalizable to the Medicare population, we believe it is important
for evidence to be developed and some public commenters suggested that
we establish the coverage criteria (for example, provider experience,
site of service, availability of supporting services) to ensure
delivery of high-quality, evidence-based care.
[[Page 51330]]
While we are proposing to repeal the MCIT/R&N final rule, this
action would not prohibit coverage of Breakthrough Devices. As we noted
in the May 2021 final rule, even without the MCIT/R&N final rule in
effect, a review of claims data showed that Breakthrough Devices have
received and are receiving Medicare coverage when medically necessary.
Many of the eligible Breakthrough Devices are coverable and payable
through existing mechanisms. Some Breakthrough Devices may be addressed
by an existing LCD or NCD. New items and services can also be
adjudicated on a claim-by-claim basis and be covered and paid under the
applicable Medicare payment system if the MAC determines them to be
reasonable and necessary for specific patients upon a more
individualized MAC assessment. The MACs take into account a
beneficiary's particular clinical circumstances to determine whether a
beneficiary may benefit from the device. CMS acknowledges, among other
factors, that MCIT was developed in response to stakeholder concerns
about time lags and coverage uncertainty for devices subject to claim-
by-claim coverage determinations.
2. Limitations of the MCIT Pathway
The MCIT/R&N final rule limited MCIT only to Breakthrough Devices
that are designated as part of FDA's Breakthrough Devices Program. In
accordance with section 515B of the FD&C (21 U.S.C. 360e-3), FDA's
Breakthrough Devices Program is for certain medical devices and device-
led combination products, and can include lab tests.\7\ To be granted a
Breakthrough Device designation under the Breakthrough Devices Program,
medical devices and device-led combination products must meet two
criteria. The first criterion is that the device provides for more
effective treatment or diagnosis of life-threatening or irreversibly
debilitating human disease or conditions. The second criterion is that
the device must satisfy one of the following elements:
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\7\ Breakthrough Devices Program Guidance for Industry and Food
and Drug Administration Staff, available at <a href="https://www.fda.gov/media/108135/download">https://www.fda.gov/media/108135/download</a>.
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<bullet> It represents a breakthrough technology.
<bullet> No approved or cleared alternatives exist.
<bullet> It offers significant advantages over existing approved or
cleared alternatives.
<bullet> Device availability is in the best interest of patients
(for more information see 21 U.S.C. 360e-3(b)(2)).
We acknowledge that some stakeholders, and device manufacturers in
particular, supported MCIT and the concept of faster coverage.
Some commenters to the September 2020 MCIT/R&N proposed rule
expressed concern that the MCIT pathway could give specific
technologies an unfair advantage that would be unavailable to
subsequent market entrants, thereby decreasing innovation and market
competition (86 FR 2998). Commenters submitted a variety of alternative
approaches to covering second-to-market and non-breakthrough designated
new technology to remedy this unintended consequence. Some commenters
supported that CMS cover iterative refinements of the same Breakthrough
Device for the duration of the original device's MCIT term. Other
commenters suggested coverage under the MCIT pathway for subsequent
similar breakthrough and non-breakthrough designated devices of the
same type and indication for the balance of the first device's MCIT
term. Yet other commenters proposed that new market entrants that are
very similar to a Breakthrough Device should each receive the full 4
years of MCIT coverage, not tied to the timeline of the original
product. Commenters also suggested policies related to coverage options
for second-to-market or subsequent technologies of the same type, even
for the same indication or subsequent-to-market non-breakthrough
designated technologies that fall under the same class or category as
the predicate breakthrough technology and approved for the same
indication.
CMS acknowledges that we have changed our policy position on this
issue after further consideration of public comments. We agree with
commenters that there are many drawbacks to limiting coverage through
the MCIT pathway only to those devices that are part of the
Breakthrough Devices Program. As noted previously, the potential
incentives created by offering immediate coverage of Breakthrough
Devices may disincentivize development of innovative technologies that
do not meet the criteria for the Breakthrough Devices Program, such as
some non-breakthrough-designated second-to-market devices and
subsequent technologies of the same type. Additionally, we now believe
a more flexible coverage pathway that leverages existing statutory
authorities may be better able to provide faster coverage of new
technologies to Medicare beneficiaries while prioritizing patient
health and outcomes. CMS invites public comment on our proposal to
repeal the MCIT coverage pathway of the MCIT/R&N final rule for the
reasons previously described.
3. Future Coverage Policy Rulemaking
While we are proposing to repeal the MCIT/R&N final rule as it is
currently written, we are considering future policies and potential
rulemaking to provide improved access to innovative and beneficial
technologies. We are committed to exploring other policy options and
statutory authorities for coverage that better suit the needs of
Medicare beneficiaries and other stakeholders when the items or
services are supported by adequate evidence.
B. Definition of ``Reasonable and Necessary''
In general, section 1862(a)(1)(A) of the Act permits Medicare
payment under Part A or Part B for items or services that are
reasonable and necessary for the diagnosis or treatment of illness or
injury or to improve the functioning of a malformed body member. The
definition of ``reasonable and necessary'' in the MCIT/R&N final rule
mirrored the longstanding CMS Program Integrity Manual's definition of
``reasonable and necessary'' with a modification to the appropriateness
factor to specify when and how (upon publication of guidance) we would
utilize commercial insurer coverage policies.
Expanding the reasonable and necessary definition to systematically
consider commercial insurer coverage presents implementation and
appeals process challenges that would likely persist. In the preamble
to the MCIT/R&N final rule, we stated our intention to gather
additional public input on the methodology by which commercial
insurers' policies are determined to be relevant to the reasonable and
necessary appropriateness criteria in response to commenters concerns
that the commercial insurer appropriateness criteria was vague. We
stated that not later than 12 months after the effective date of the
MCIT/R&N final rule (that is, December 15, 2021), we would publish for
public comment, a draft methodology for determining when commercial
insurers' policies could be considered to meet the reasonable and
necessary definition appropriateness criteria for coverage of an item
or service. Comments received in response to the March 2021 IFC
expressed concern about how the commercial insurer policy provision
would be implemented. Commenters also expressed concerns that the R&N
definition included in the MCIT/R&N
[[Page 51331]]
final rule, and more specifically the commercial insurance aspects of
the definition, will remove existing flexibilities and potentially
impact CMS' ability to ensure equitable health care access for all
Medicare beneficiaries. Additionally, commenters suggested that the
reasonable and necessary definition should be included in a separate
rule as MCIT because R&N are independent and distinct provisions with
different implications for Medicare policy. In light of our proposal to
repeal the R&N definition, including the commercial insurance aspects
of the MCIT/R&N final rule, we will not be issuing subregulatory
guidance by March 15, 2022 on consideration of commercial insurer
coverage polices when there is insufficient evidence to make a national
or local coverage determination.
While we are proposing to fully repeal the MCIT/R&N final rule as
it is currently written, we invite comments on the R&N aspect of our
proposal. In lieu of fully repealing the R&N rule, should the final
rule instead merely repeal the commercial insurance aspects of the
rule? If CMS does consider future rulemaking to include defining
reasonable and necessary, what criteria should CMS consider as part of
the reasonable and necessary definition? For example, should CMS
maintain the codification of the definition of ``Reasonable and
Necessary'' as found in the Chapter 13 of the CMS Program Integrity
Manual (PIM) or consider different criteria?
C. Effect of Proposed Repeal
If the MCIT/R&N final rule is repealed as proposed, the revisions
to part 405 of Title 42 of the Code of Federal Regulations would not
occur and the text would remain unchanged. Specifically, a definition
of ``reasonable and necessary'' would not be included among the terms
defined at 42 CFR 405.201(b) and the guidance that the rule would have
required (subregulatory guidance on the topic of utilization of
commercial insurer polies) would not be introduced. Additionally,
Subpart F, which wholly consisted of Medicare Coverage of Innovative
Technology, would not be added, and Subpart F would remain reserved for
other purposes.
III. Regulatory Impact Statement
This proposed rule would repeal the MCIT pathway and codification
of the definition of ``reasonable and necessary.'' Because the January
2021 final rule effective date was delayed until December 15, 2021, the
MCIT coverage pathway and definition of ``reasonable and necessary''
have not been implemented, and no payments for items and services could
have been made in relation to these provisions since they have not
taken effect. In the January 2021 final rule, we included a robust
regulatory impact analysis of these provisions. Because the final rule
has not gone into effect, and this proposal would repeal the
provisions, there has not been an impact from these provisions nor
would there be an impact, relative to current coverage practice, upon
repeal; however, effects would be non-negligible relative to the future
trajectory without this proposed repeal.
In the MCIT/R&N final rule, we examined the impact of the final
rule as required by Executive Order 12866 on Regulatory Planning and
Review (September 30, 1993), Executive Order 13563 on Improving
Regulation and Regulatory Review (January 18, 2011), the Regulatory
Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section
1102(b) of the Social Security Act, section 202 of the Unfunded
Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive
Order 13132 on Federalism (August 4, 1999), the Congressional Review
Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation
and Controlling Regulatory Costs (January 30, 2017).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
regulatory impact analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year).
The MCIT/R&N 2021 final rule reached the economic threshold and thus
was considered a major rule. Because this proposed rule would
completely repeal the provisions, this proposed rule also reaches the
economic threshold and its finalization is anticipated to be a major
rule.
A. MCIT Pathway
CMS considered alternatives to repealing the MCIT pathway and the
definition of reasonable and necessary, such as maintaining the
provisions of the MCIT/R&N final rule and further delaying the
effective date. For the reasons described in detail in section II. of
this proposed rule such as patient safety and need for further public
engagement, we chose to propose to repeal the provisions. We note that
further delay of the MCIT/R&N final rule would not alter the patient
safety concerns inherent in the MCIT pathway.
As described in the MCIT/R&N final rule, the impacts of the MCIT
pathway and defining ``reasonable and necessary'' were hard to quantify
without knowing the specific Breakthrough Devices that would seek MCIT
and other items and services that would be included in future NCDs and
LCDs and the criteria that CMS will use for determining which
commercial insurers will be considered.
B. ``Reasonable and Necessary'' Definition
In order to demonstrate the potential impact on Medicare spending
for the definition of ``reasonable and necessary'' in the MCIT/R&N
final rule we developed scenarios that illustrated the impact of
implementing the two alternatives considered (no change/not codifying a
definition and codifying a definition). One of the options was making
no change, that is not codifying the definition of ``reasonable and
necessary'' in regulations. The impact for no change was $0, thus, we
reflect that value in Table 1 as repealing the MCIT/R&N final rule
would have the same impact. The number of NCDs and LCDs finalized in a
given year can vary and the cost of items and services within the
coverage decisions varies. Further, while we reviewed coverage of items
and services, we did not take into account unique Medicare rules
regarding which type of providers/clinicians may furnish certain
services, place of service requirements, or payment rules. Our analysis
was based on whether Medicare covered or non-covered an item or service
and whether we could find coverage for that item or service by any
commercial insurer. Lastly, this impact analysis was based on the
numbers of NCDs and LCDs finalized in 2020 (see Table 1).
In 2020, CMS and the MACs finalized 3 NCDs and 31 LCDs (This number
represents new LCDs in 2020 and made publicly available via the
Medicare Coverage Database. If more than one MAC jurisdiction issued an
LCD on the same item or service with the same coverage decision, only 1
of the LCDs was included in the count.)
Of the NCDs finalized in 2020, all 3 resulted in expanded national
Medicare coverage. Because none of those NCDs resulted in non-coverage,
we did not evaluate whether commercial insurers would have covered the
item or service. Therefore, based on 2020 data for NCDs only, the
impact would be $0.
[[Page 51332]]
Of the 31 LCDs, 27 provided Medicare positive coverage and 4
resulted in non-coverage. For those items and services non-covered we
identified 3 of those items and services were covered in at least 1
commercial insurer policy. For these non-covered items and services we
established that the possible range of the cumulative cost of covering
them could be from $0 to $3.4 billion for a single year (based on price
and approximate Medicare beneficiary utilization). Because our analysis
looked for any commercial insurer that covered the item or service, the
cost may be less when utilizing commercial insurer polices that
represent a majority of covered lives. In addition, even if a
commercial insurer covers an item or service, the final rule did not
require automatic Medicare coverage. Therefore, not all items and
services that are non-covered by Medicare but covered by commercial
insurance would be presumed covered under the MCIT/R&N final rule.
Rather, commercial insurer coverage would have been a factor that CMS
would have taken into account as part of the body of evidence in
determining coverage through the NCD and LCDs processes. Because not
all commercial insurer positive coverage will necessarily translate to
Medicare coverage and because CMS was to define which types of
commercial insurers (based on majority of covered lives) would be
relevant, we believe that commercial insurer coverage impact is likely
much smaller, closer to 15 to 25 percent of $3.4 billion, that is, $51
to $880 million.
Table 1--Illustrated Impact for the Medicare Program by Definition of Reasonable and Necessary
----------------------------------------------------------------------------------------------------------------
Estimated change in Medicare costs for the
alternatives considered for the MCIT/R&N final
rule Commercial insurer
--------------------------------------------------- coverage as sole
No change (not determinant
codifying a definition) Codified definition
----------------------------------------------------------------------------------------------------------------
Coverage Determinations (NCDs and $0 $51-880 million........ $3.4+ billion.
LCDs).
----------------------------------------------------------------------------------------------------------------
C. MCIT Pathway
In the MCIT/R&N final rule specifically for MCIT, we considered
regulatory alternatives to combine Medicare coverage with clinical
evidence development under section 1862(a)(1)(E) of the Act, to take no
regulatory action, or to adjust the duration of the MCIT pathway. The
impact of implementing the MCIT pathway was difficult to determine
without knowing the specific Breakthrough Devices that would be
covered. In addition, many of these devices would be eligible for
coverage in the absence of the rule, such as through a local or
national coverage determination, so the impact for certain items may be
the acceleration of coverage by just a few months. Furthermore, some of
these devices would be covered immediately if the MACs decide to pay
for them, which would result in no impact on Medicare spending for
devices approved under this pathway. However, it is possible that some
of these Breakthrough Devices would not otherwise be eligible for
coverage in the absence of the rule. Because it was not known how these
new technologies would otherwise come to market and be reimbursed, it
was not possible to develop a point estimate of the impact. In general,
we believed the MCIT coverage pathway would range in impact from having
no impact on Medicare spending, to a temporary cost for innovations
that are adopted under an accelerated basis.
The decision to enter the MCIT pathway would have been voluntary
for the manufacturer. Because manufacturers typically join the Medicare
coverage pathway that is most financially beneficial to them, this
could result in selection against the existing program coverage
pathways (to what degree is unknown at this point). In addition, the
past trend of new technology costing more than existing technology
could lead to a higher cost for Medicare if this trend continued for
technologies enrolling in the MCIT pathway. Nevertheless, new
technology may also mitigate ongoing chronic health issues or improve
efficiency of services thereby reducing some costs for Medicare.
To demonstrate the potential impact on Medicare spending, for the
MCIT/R&N final rule the CMS Office of the Actuary (OACT) developed
three hypothetical scenarios that illustrate the impact of implementing
the MCIT pathway. Scenarios two and three assumed that the device would
not have been eligible for coverage in the absence of the proposed rule
(see Table 2). The illustration used the new devices that applied for a
NTAP in FY 2020 as a proxy for the new devices that would utilize the
MCIT pathway. The submitted cost and anticipated utilization for these
devices was published in the Federal Register.\8\ In addition, we
assumed that two manufacturers would elect to utilize the MCIT pathway
in the first year, three manufacturers in the second year, four
manufacturers in the third year, and five manufacturers in the fourth
year each year for all three scenarios. This assumption is based on the
number of medical devices that received FY 2020 NTAP and were non-
covered in at least one MAC jurisdiction by LCDs and related articles
and our impression from the FDA that the number of devices granted
breakthrough status is increasing. For the first scenario, the no-cost
scenario, we assumed that all the devices would be eligible for
coverage in the absence of MCIT. If the devices received coverage and
payment nationally and at the same time then there would be no
additional cost under this pathway. For the second scenario, the low-
cost scenario, we assumed that the new technologies would have the
average costs ($2,044) and utilization (2,322 patients) of similar
technologies included in the FY 2020 NTAP application cycle. Therefore,
to estimate the first year of MCIT, we multiplied the add-on payment
for a new device by the anticipated utilization for a new device by the
number of anticipated devices in the pathway ($2,044 x 2,322 x 2 = $
9.5 million). For the third scenario, the high-cost scenario, we
assumed the new technologies would receive the maximum add-on payment
from the FY2020 NTAP application cycle ($22,425) and the highest
utilization of a device (6,500 patients). Therefore, to estimate for
the first year of MCIT, we estimated similarly ($22,425 x 6,500
patients x 2 = $ 291.5 million). For subsequent years, we increased the
number of anticipated devices in the
[[Page 51333]]
pathway by three, four, and five in the last two scenarios until
2024.\9\ In addition to not taking into account inflation, the
illustration does not reflect any offsets for the costs of these
technologies that would be utilized through existing authorities nor
the cost of other treatments (except as noted). It is not possible to
explicitly quantify these offsetting costs but they could substantially
reduce or eliminate the net program cost. However, by assuming that
only two to five manufacturers would elect MCIT coverage, we implicitly
assumed that, while more manufacturers could potentially elect coverage
under MCIT, the majority of devices would have been covered under a
different coverage pathway. Therefore, a substantial portion of the
offsetting costs are implicitly reflected.
---------------------------------------------------------------------------
\8\ FY 2020 Hospital Inpatient Prospective Payment System (IPPS)
Proposed Rule (84 FR 19640 and 19641) (May 3, 2019) available at
<a href="https://www.govinfo.gov/content/pkg/FR-2019-05-03/pdf/2019-08330.pdf">https://www.govinfo.gov/content/pkg/FR-2019-05-03/pdf/2019-08330.pdf</a>
(accessed October 17, 2019).
\9\ An indirect cost of the proposed rule would be increased
distortions in the labor markets taxed to support the Medicare Trust
Fund. Such distortions are sometimes referred to as marginal excess
tax burden (METB), and Circular A-94--OMB's guidance on cost-benefit
analysis of federal programs, available at <a href="https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A94/a094.pdf">https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A94/a094.pdf</a>--suggests that METB may be valued at roughly 25 percent of
the estimated transfer attributed to a policy change; the Circular
goes on to direct the inclusion of estimated METB change in
supplementary analyses. If secondary costs--such as increased
marginal excess tax burden is, in the case of this final rule--are
included in regulatory impact analyses, then secondary benefits must
be as well, in order to avoid inappropriately skewing the net
benefits results, and including METB only in supplementary analyses
provides some acknowledgement of this potential imbalance.
---------------------------------------------------------------------------
Based on this analysis, there was a range of potential impacts of
MCIT as shown in Table 2. The difference between the three estimates
demonstrates how sensitive the impact is to the cost and utilization of
these unknown devices.
Because MCIT has not yet been implemented, we lack evidence with
which to update the earlier estimates, so Table 2, only differs from
the analogous table accompanying the MCIT/R&N final rule in terms of
the sign (that is, the direction) on the estimates and a shifting of
the time horizon by one year so as to avoid stating this proposed rule
would have effects in the nearly-ended FY 2021.
Table 2--Illustrated Impact on the Medicare Program by MCIT Coverage Pathway
----------------------------------------------------------------------------------------------------------------
Costs (in millions)
---------------------------------------------------------------
FY 2022 FY 2023 FY 2024 FY 2025
----------------------------------------------------------------------------------------------------------------
No-cost Scenario................................ $0 $0 $0 $0
Low-cost Scenario............................... -9.5 -23.7 -42.7 -66.4
High-cost Scenario.............................. -291.5 -728.8 -1,311.9 -2,040.7
----------------------------------------------------------------------------------------------------------------
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. Some hospitals and other providers and suppliers are
small entities, either by nonprofit status or by having revenues of
less than $7.5 million to $38.5 million in any 1 year. Individuals and
States are not included in the definition of a small entity. For the
MCIT/R&N final rule, we reviewed the Small Business Administration's
Table of Small Business Size Standards Matched to North American
Industry Classification System (NAICS) Codes to determine the NAICS
U.S. industry titles and size standards in millions of dollars and/or
number of employees that apply to small businesses that could be
impacted by this rule. We determined that small businesses potentially
impacted by that rule include surgical and medical instrument
manufacturers (NAICS code 339112, dollars not provided/1,000
employees), Offices of Physicians (except Mental Health Specialists)
(NAICS code 621111, $12 million/employees not provided), and
Freestanding Ambulatory Surgical and Emergency Centers (NAICS code
621493, $16.5 million/employees not provided). Because the impact of
this proposed rule would be no change in current coverage policy, we
determined that small businesses identified would not be impacted by
this proposed rule. Given the nature of the breakthrough devices market
authorized thus far and the timely notification of the MCIT/R&N final
rule's delay of effective date, we do not anticipate that small
businesses would have made investment decisions or experienced a loss
of anticipated positive reimbursement as a result of the MCIT/R&N final
rule. Because MCIT has not gone into effect, and we are proposing to
repeal the rule, payments have not occurred nor would they occur under
MCIT; therefore, the impact of this proposed rule is neither an
increase nor decrease in revenue for providers. We are not preparing a
further analysis for the RFA because we have determined, and the
Secretary of the Department of Health and Human Services (the
Secretary) certifies, that the proposed rule and this subsequent final
rule will not have a significant negative economic impact on a
substantial number of small entities because small entities are not
being asked to undertake additional effort or take on additional costs
outside of the ordinary course of business.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis 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 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
proposed rule and the final rule would not have a significant impact on
the operations of a substantial number of small rural hospitals because
small rural hospitals are not being asked to undertake additional
effort or take on additional costs outside of the ordinary course of
business. Obtaining Breakthrough Devices for patients is at the
discretion of providers. We are not requiring the purchase and use of
Breakthrough Devices. Providers should continue to work with their
patients to choose the best treatment. For small rural hospitals that
provide Breakthrough Devices to their patients, this proposed rule
would not change the way they are currently covered through the
Medicare program.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2021, that
threshold was
[[Page 51334]]
approximately $158 million. This proposed rule would have no
consequential effect on State, local, or tribal governments or on the
private sector.
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. Since this final rule does not impose any costs on State
or local governments, the requirements of Executive Order 13132 are not
applicable.
In accordance with the provisions of Executive Order 12866, this
final rule was reviewed by the Office of Management and Budget.
IV. Waiver of the 60-Day Public Comment Period
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite public comment prior to a rule taking
effect in accordance with section 1871 of the Act and section 553(b) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b). Section
1871(a)(2) of the Act provides, in relevant part, that no rule,
requirement, or other statement of policy that establishes or changes a
substantive legal standard governing the scope of benefits, the payment
for services, or the eligibility of individuals, entities, or
organizations to furnish or receive services or benefits under Medicare
shall take effect unless it is promulgated through notice and comment
rulemaking. Unless there is a statutory exception, section 1871(b)(1)
of the Act generally requires the Secretary to provide a period of not
less than 60 days for public comment. Similarly, under 5 U.S.C. 553(b),
the agency is required to publish a notice of proposed rulemaking in
the Federal Register before a substantive rule takes effect.
However, section 1871(b)(2) of the Act, permits exceptions to the
60-day time period, including in situations where there would be good
cause under 5 U.S.C. 553(b). Section 553(b) of the APA permits no
public comment period when the agency, for good cause, finds the notice
and public procedure are impracticable, unnecessary, or contrary to the
public interest. We find good cause to reduce the public comment period
to 30 days with respect to the proposed repeal of the MCIT/R&N final
rule that would otherwise become effective on December 15, 2021. If we
were to provide the full 60-day public comment period on this proposed
rule, there would not be adequate opportunity to meaningfully consider
public comments before a final action was needed. In addition, we have
already provided two opportunities for public comments relating to the
subject matter of this rule earlier this year in connection with the
delay of the effective date. Although repealing a final rule is
different than delaying the effective date, the familiarity with the
subject matter reduces the time the public needs to formulate comments
on this proposed rule. Based on the prior comment periods, we are aware
that some public commenters opposed to the MCIT/R&N final rule are
likely to support repeal, while other commenters were in favor of
implementing that rule. The 30-day public comment period will provide
another opportunity to submit views on the proposed repeal, as well as
suggestions for future rulemaking. Under these specific circumstances,
we find that a 60-day comment period is unnecessary and a 30-day public
comment period will provide a sufficient opportunity for the public to
fully participate in this rulemaking and that there is good cause to
reduce the time period to 30 days.
We also find good cause to provide for a 30-day public comment
period in light of the potential for harm to Medicare beneficiaries
should this proposed repeal rule not be finalized before the effective
date of the MCIT/R&N final rule. If we did not finalize this rule by
the effective date, there would be confusion and uncertainty among
beneficiaries and their treating clinicians of coverage if the proposed
repeal rule became effective and then rescinded at a later date. To
avoid confusion and uncertainty this rule must be finalized no later
than December 15, 2021. In order for the repeal rule to be finalized by
the current MCIT effective date of December 15, 2021, CMS would require
30 days for public comment once the proposed rule is posted, an
additional 30 days for CMS to review the comments, draft and post the
repeal final rule, and an additional 30-day notice before the repeal
final rule becomes effective.
As noted previously, the MCIT/R&N final rule did not have
sufficient patient protections. While the MCIT/R&N rule attempted to
address concerns about accelerating coverage of new devices,
significant concerns persist about the availability of clinical
evidence on the devices when used in the Medicare population, including
the benefit or risks of these devices with respect to use in the
Medicare population. For example, there is no requirement that the
studies for FDA market-approval include Medicare patients. Medicare
patients have different clinical profiles and considerations due to the
complexity of their medical conditions and concomitant treatments
compared to other age groups. Further, the MCIT/R&N final rule takes
away tools that CMS has to deny coverage when it becomes apparent that
a particular device can be harmful to the Medicare population. To
remove a device from Medicare coverage under MCIT/R&N final rule, FDA
must issue a safety communication, warning letter, or remove the device
from the market. Therefore, if CMS observes a trend of higher risk or
harm with a device in the Medicare population, CMS authority to
expeditiously deny, limit to the appropriate patient population or
withdraw coverage is limited.
For all the aforementioned reasons, we find good cause to waive the
60-day comment period and provide a 30-day comment period for this
proposed rule.
V. 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 preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &
Medicaid Services, approved this document on September 10, 2021.
List of Subjects in 42 CFR Part 405
Administrative practice and procedure, Diseases, Health facilities,
Health professions, Medical devices, Medicare, Reporting and
recordkeeping requirements, Rural areas, X-rays.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR part 405 as set forth
below:
PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
0
1. The authority for part 405 continues to read as follows:
Authority: 42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x,
1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k).
Sec. 405.201 [Amended]
0
2. Section 405.201(b) is amended by removing the definition for
``Reasonable and necessary''.
[[Page 51335]]
Subpart F--[Removed and Reserved]
0
3. Remove and reserve subpart F, consisting of Sec. Sec. 405.601
through 405.607.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-20016 Filed 9-13-21; 4:15 pm]
BILLING CODE 4120-01-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.