Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”
| Published date | 15 September 2021 |
| Citation | 86 FR 51326 |
| Record Number | 2021-20016 |
| Section | Proposed rules |
| Court | Centers For Medicare & Medicaid Services |
51326
Federal Register / Vol. 86, No. 176 / Wednesday, September 15, 2021 / Proposed Rules
107(d)(3)(E) are actions that affect the
status of a geographical area and do not
impose any additional regulatory
requirements on sources beyond those
imposed by state law. A redesignation to
attainment does not in and of itself
create any new requirements, but rather
results in the applicability of
requirements contained in the CAA for
areas that have been redesignated to
attainment. Moreover, the Administrator
is required to approve a SIP submission
that complies with the provisions of the
CAA and applicable Federal regulations.
42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions,
EPA’s role is to approve state choices,
provided that they meet the criteria of
the CAA. Accordingly, this action
merely approves state law as meeting
Federal requirements and does not
impose additional requirements beyond
those already imposed by state law. For
that reason, this action:
•Is not a ‘‘significant regulatory
action’’ subject to review by the Office
of Management and Budget under
Executive Orders 12866 (58 FR 51735,
October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011);
•Does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.);
•Is certified as not having a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act (5
U.S.C. 601 et seq.);
•Does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
•Does not have federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
•Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
•Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
•Is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the CAA; and
•Does not provide EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
In addition, this proposed action does
not apply on any Indian reservation
land or in any other area where EPA or
an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of
Indian country, this rulemaking does
not have tribal implications as specified
by Executive Order 13175 (65 FR 67249,
November 9, 2000), because
redesignation is an action that affects
the status of a geographical area and
does not impose any new regulatory
requirements on tribes, impact any
existing sources of air pollution on
tribal lands, nor impair the maintenance
of ozone national ambient air quality
standards in tribal lands.
List of Subjects
40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Lead, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and
recordkeeping requirements, Sulfur
oxides, Volatile organic compounds.
40 CFR Part 81
Environmental protection, Air
pollution control, National parks,
Wilderness areas.
Authority: 42 U.S.C. 7401 et seq.
Dated: September 8, 2021.
Michelle L. Pirzadeh,
Acting Regional Administrator, Region 10.
[FR Doc. 2021–19801 Filed 9–14–21; 8:45 am]
BILLING CODE 6560–50–P
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.
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 http://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY:
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: CMS–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 MCIT@
cms.hhs.gov.
SUPPLEMENTARY INFORMATION
: Inspection
of Public Comments: All comments
received before the close of the
comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following
website as soon as possible after they
have been received: http://
www.regulations.gov. Follow the search
instructions on that website to view
public comments. CMS will not post on
Regulations.gov 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
VerDate Sep<11>2014 17:03 Sep 14, 2021 Jkt 253001 PO 00000 Frm 00048 Fmt 4702 Sfmt 4702 E:\FR\FM\15SEP1.SGM 15SEP1
khammond on DSKJM1Z7X2PROD with PROPOSALS
51327
Federal Register / Vol. 86, No. 176 / Wednesday, September 15, 2021 / Proposed Rules
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—
•The rulemaking process was
procedurally adequate;
•We properly considered all relevant
facts;
•We considered statutory or other
legal obligations;
•We had reasonable judgment about
the legally relevant policy
considerations; and
•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
VerDate Sep<11>2014 17:03 Sep 14, 2021 Jkt 253001 PO 00000 Frm 00049 Fmt 4702 Sfmt 4702 E:\FR\FM\15SEP1.SGM 15SEP1
khammond on DSKJM1Z7X2PROD with PROPOSALS
51328
Federal Register / Vol. 86, No. 176 / Wednesday, September 15, 2021 / Proposed Rules
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 Rodrı
´guez-Man
˜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, https://doi.org/10.1093/
gerona/gly110.
2
CMS, Guidance for the Public, Industry, and
CMS Staff Coverage with Evidence Development,
available at https://www.cms.gov/medicare-
coverage-database/details/medicare-coverage-
document-details.aspx?MCDId=27.
3
Food and Drug Administration, Breakthrough
Devices Program Guidance for Industry and Food
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.
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).
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
VerDate Sep<11>2014 17:03 Sep 14, 2021 Jkt 253001 PO 00000 Frm 00050 Fmt 4702 Sfmt 4702 E:\FR\FM\15SEP1.SGM 15SEP1
khammond on DSKJM1Z7X2PROD with PROPOSALS
51329
Federal Register / Vol. 86, No. 176 / Wednesday, September 15, 2021 / Proposed Rules
and Drug Administration Staff, 9, available at:
https://www.fda.gov/media/108135/download.
4
86 FR 2988 (January 14, 2021) available at
https://www.govinfo.gov/content/pkg/FR-2021-01-
14/pdf/2021-00707.pdf.
5
CMS, Medicare Program Integrity Manual,
Chapter 13, 13.5.4, available at https://
www.cms.gov/regulations-and-guidance/guidance/
manuals/downloads/pim83c13.pdf.
6
Rathi et al.
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.
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.
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.
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.
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.
VerDate Sep<11>2014 17:03 Sep 14, 2021 Jkt 253001 PO 00000 Frm 00051 Fmt 4702 Sfmt 4702 E:\FR\FM\15SEP1.SGM 15SEP1
khammond on DSKJM1Z7X2PROD with PROPOSALS
51330
Federal Register / Vol. 86, No. 176 / Wednesday, September 15, 2021 / Proposed Rules
7
Breakthrough Devices Program Guidance for
Industry and Food and Drug Administration Staff,
available at https://www.fda.gov/media/108135/
download.
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:
•It represents a breakthrough
technology.
•No approved or cleared alternatives
exist.
•It offers significant advantages over
existing approved or cleared
alternatives.
•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
VerDate Sep<11>2014 17:03 Sep 14, 2021 Jkt 253001 PO 00000 Frm 00052 Fmt 4702 Sfmt 4702 E:\FR\FM\15SEP1.SGM 15SEP1
khammond on DSKJM1Z7X2PROD with PROPOSALS
51331
Federal Register / Vol. 86, No. 176 / Wednesday, September 15, 2021 / Proposed Rules
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.
VerDate Sep<11>2014 17:03 Sep 14, 2021 Jkt 253001 PO 00000 Frm 00053 Fmt 4702 Sfmt 4702 E:\FR\FM\15SEP1.SGM 15SEP1
khammond on DSKJM1Z7X2PROD with PROPOSALS
51332
Federal Register / Vol. 86, No. 176 / Wednesday, September 15, 2021 / Proposed Rules
8
FY 2020 Hospital Inpatient Prospective Payment
System (IPPS) Proposed Rule (84 FR 19640 and
19641) (May 3, 2019) available at https://
www.govinfo.gov/content/pkg/FR-2019-05-03/pdf/
2019-08330.pdf (accessed October 17, 2019).
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.
T
ABLE
1—I
LLUSTRATED
I
MPACT FOR THE
M
EDICARE
P
ROGRAM BY
D
EFINITION OF
R
EASONABLE AND
N
ECESSARY
Estimated change in Medicare costs for the
alternatives considered for the MCIT/R&N final rule Commercial insurer coverage as sole
determinant No change
(not codifying a
definition) Codified definition
Coverage Determinations (NCDs and
LCDs). $0 $51–880 million .................................. $3.4+ billion.
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 × 2,322 × 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 × 6,500
patients × 2 = $ 291.5 million). For
subsequent years, we increased the
number of anticipated devices in the
VerDate Sep<11>2014 17:03 Sep 14, 2021 Jkt 253001 PO 00000 Frm 00054 Fmt 4702 Sfmt 4702 E:\FR\FM\15SEP1.SGM 15SEP1
khammond on DSKJM1Z7X2PROD with PROPOSALS
51333
Federal Register / Vol. 86, No. 176 / Wednesday, September 15, 2021 / Proposed Rules
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 https://www.whitehouse.gov/
sites/whitehouse.gov/files/omb/circulars/A94/
a094.pdf—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.
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.
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.
T
ABLE
2—I
LLUSTRATED
I
MPACT ON THE
M
EDICARE
P
ROGRAM BY
MCIT C
OVERAGE
P
ATHWAY
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
VerDate Sep<11>2014 17:03 Sep 14, 2021 Jkt 253001 PO 00000 Frm 00055 Fmt 4702 Sfmt 4702 E:\FR\FM\15SEP1.SGM 15SEP1
khammond on DSKJM1Z7X2PROD with PROPOSALS
51334
Federal Register / Vol. 86, No. 176 / Wednesday, September 15, 2021 / Proposed Rules
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
■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).
§ 405.201 [Amended]
■2. Section 405.201(b) is amended by
removing the definition for ‘‘Reasonable
and necessary’’.
VerDate Sep<11>2014 17:03 Sep 14, 2021 Jkt 253001 PO 00000 Frm 00056 Fmt 4702 Sfmt 4702 E:\FR\FM\15SEP1.SGM 15SEP1
khammond on DSKJM1Z7X2PROD with PROPOSALS
51335
Federal Register / Vol. 86, No. 176 / Wednesday, September 15, 2021 / Proposed Rules
Subpart F—[Removed and Reserved]
■3. Remove and reserve subpart F,
consisting of §§ 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
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Parts 1, 2, 27
[WT Docket No. 19–348; DA 21–1024; FRS
44893]
Wireless Telecommunications Bureau
Seeks Comment on the Selection
Process for and Operation of the
Reimbursement Clearinghouse for the
3.45 GHz Band
AGENCY
: Federal Communications
Commission.
ACTION
: Proposed rule.
SUMMARY
: In this document, the
Wireless Telecommunications Bureau
(the Bureau) seeks comment on the
appropriate industry stakeholders to
form a search committee to select a
Reimbursement Clearinghouse
(Clearinghouse) to oversee the
reimbursement of relocation expenses
for certain secondary non-federal
radiolocation licensees in the 3.45–3.55
GHz band (3.45 GHz band). The Bureau
also seeks comment on other issues
related to the Clearinghouse search
committee process.
DATES
: Interested parties may file
comments on or before September 30,
2021; and reply comments on or before
October 12, 2021.
ADDRESSES
: You may submit comments,
identified by WT Docket No. 19–348, by
any of the following methods:
•Electronic Filers: Comments may be
filed electronically using the internet by
accessing the ECFS: http://apps.fcc.gov/
ecfs/ in docket number WT Docket No.
19–348. See Electronic Filing of
Documents in Rulemaking Proceedings,
63 FR 24121 (1998).
•Paper Filers: Parties who choose to
file by paper must file an original and
one copy of each filing.
•Filings in response to this Public
Notice may be sent by hand or
messenger delivery, by commercial
overnight courier, or by first-class or
overnight U.S. Postal Service mail. All
filings must be addressed to the
Commission’s Secretary, Office of the
Secretary, Federal Communications
Commission.
•Commercial overnight mail (other
than U.S. Postal Service Express Mail
and Priority Mail) must be sent to 9050
Junction Drive, Annapolis Junction, MD
20701. U.S. Postal Service first-class,
Express, and Priority mail must be
addressed to 45 L Street NE,
Washington, DC 20554.
•Until further notice, the
Commission no longer accepts any hand
or messenger delivered filings. This is a
temporary measure taken to help protect
the health and safety of individuals, and
to mitigate the transmission of COVID–
19. See FCC Announces Closure of FCC
Headquarters Open Window and
Change in Hand-Delivery Policy, Public
Notice, DA 20–304 (March 19, 2020).
https://www.fcc.gov/document/fcc-
closes-headquarters-open-window-and-
changes-hand-delivery-policy.
FOR FURTHER INFORMATION CONTACT
:
Joyce Jones, Wireless
Telecommunications Bureau, Mobility
Division, (202) 418–1327 or
joyce.jones@fcc.gov. For information
regarding the PRA information
collection requirements, contact Cathy
Williams, Office of Managing Director,
at 202–418–2918 or Cathy.Williams@
fcc.gov.
SUPPLEMENTARY INFORMATION
: This is a
summary of a Public Notice in WT
Docket No. 19–348, DA 21–1024,
released August 20, 2021. The full text
of the Public Notice is available for
public inspection at the following
internet address: https://www.fcc.gov/
document/345-ghz-clearinghouse-
search-committee-public-notice.
Alternative formats are available for
people with disabilities (Braille, large
print, electronic files, audio format), by
sending an email to FCC504@fcc.gov or
calling the Consumer and Governmental
Affairs Bureau at 202–418–0530 (voice)
or 202–418–0432 (TTY). Pursuant to
§§ 1.415 and 1.419 of the Commission’s
rules, 47 CFR 1.415, 1.419, interested
parties may file comments on or before
the dates indicated on the first page of
this document.
Ex Parte Rules
This proceeding shall continue to be
treated as a ‘‘permit-but-disclose’’
proceeding in accordance with the
Commission’s ex parte rules (47 CFR
1.1200). Persons making ex parte
presentations must file a copy of any
written presentation or a memorandum
summarizing any oral presentation
within two business days after the
presentation (unless a different deadline
applicable to the Sunshine period
applies). Persons making oral ex parte
presentations are reminded that
memoranda summarizing the
presentation must (1) list all persons
attending or otherwise participating in
the meeting at which the ex parte
presentation was made, and (2)
summarize all data presented and
arguments made during the
presentation. If the presentation
consisted in whole or in part of the
presentation of data or arguments
already reflected in the presenter’s
written comments, memoranda or other
filings in the proceeding, the presenter
may provide citations to such data or
arguments in his or her prior comments,
memoranda, or other filings (specifying
the relevant page and/or paragraph
numbers where such data or arguments
can be found) in lieu of summarizing
them in the memorandum. Documents
shown or given to Commission staff
during ex parte meetings are deemed to
be written ex parte presentations and
must be filed consistent with rule
1.1206(b). In proceedings governed by
rule 1.49(f) or for which the
Commission has made available a
method of electronic filing, written ex
parte presentations and memoranda
summarizing oral ex parte
presentations, and all attachments
thereto, must be filed through the
electronic comment filing system
available for that proceeding, and must
be filed in their native format (e.g., .doc,
.xml, .ppt, searchable .pdf). Participants
in this proceeding should familiarize
themselves with the Commission’s ex
parte rules.
Supplemental Initial Regulatory
Flexibility Analysis
As required by the Regulatory
Flexibility Act of 1980 (RFA), the
Bureau has prepared a Supplemental
Initial Regulatory Flexibility Analysis
(IRFA) of the possible significant
economic impact on small entities of the
policies and requirements proposed in
the Public Notice. It requests written
public comment on the Supplemental
IRFA contained in the Public Notice.
Comments must be filed in accordance
with the same deadlines as comments
filed in response to the Public Notice as
set forth on the first page of this
document and have a separate and
distinct heading designating them as
responses to the Supplemental IRFA.
The Commission’s Consumer and
Governmental Affairs Bureau, Reference
Information Center, will send a copy of
the Public Notice, including the
Supplemental IRFA, to the Chief
Counsel for Advocacy of the Small
Business Administration.
Paperwork Reduction Act Analysis
This document contains proposed
information collection requirements.
VerDate Sep<11>2014 17:03 Sep 14, 2021 Jkt 253001 PO 00000 Frm 00057 Fmt 4702 Sfmt 4702 E:\FR\FM\15SEP1.SGM 15SEP1
khammond on DSKJM1Z7X2PROD with PROPOSALS
