Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”; Delay of Effective Date; Public Comment Period, 14542-14545 [2021-05490]
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State Implementation Plan, which is
incorporated by reference in accordance
with the requirements of 1 CFR part 51.
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Reviews
Under the CAA, the Administrator is
required to approve a SIP submission
that complies with the provisions of the
Act and applicable Federal regulations.
42 U.S.C. 7410(k); 40 CFR 52.02(a).
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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 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
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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
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• Does not contain any unfunded
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affect small governments, as described
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implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
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• Is not a significant regulatory action
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The SIP is not approved to apply on
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tribe has demonstrated that a tribe has
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country, the rule does not have tribal
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implications and will not impose
substantial direct costs on tribal
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List of Subjects in 40 CFR Part 52
Environmental protection, Air
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reference, Reporting and recordkeeping
requirements, Volatile organic
compounds.
Dated: March 10, 2021.
Edward H. Chu,
Acting Regional Administrator, Region 7.
For the reasons stated in the
preamble, the EPA amends 40 CFR part
52 as set forth below:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
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Subpart AA—Missouri
§ 52.1320
[Amended]
2. In § 52.1320, the table in paragraph
(c) is amended by removing the entry
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2-Air Quality Standards and Air
Pollution Control Regulations for the
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■
[FR Doc. 2021–05403 Filed 3–16–21; 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–IFC]
RIN 0938–AT88
Medicare Program; Medicare Coverage
of Innovative Technology (MCIT) and
Definition of ‘‘Reasonable and
Necessary’’; Delay of Effective Date;
Public Comment Period
Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION: Interim final rule; delayed
effective date; request for comments.
AGENCY:
Consistent with the
memorandum of January 20, 2021, from
the Assistant to the President and Chief
of Staff, titled ‘‘Regulatory Freeze
Pending Review,’’ this document delays
the effective date of the final rule titled,
‘‘Medicare Program; Medicare Coverage
of Innovative Technology (MCIT) and
Definition of ’Reasonable and
Necessary’ ’’ published in the Federal
Register on January 14, 2021, for 60
days. We are providing a 30-day public
comment period to allow interested
parties to provide comments about
issues of fact, law, and policy raised by
the rule and this information could be
considered by the agency in
determining whether further actions are
appropriate, which could include
whether to revise or rescind.
DATES:
Effective date: As of March 12, 2021,
the effective date of the final rule
amending 42 CFR part 405 published at
86 FR 2987 on January 14, 2021, is
delayed by this interim final rule until
May 15, 2021.
Comment period: To be assured
consideration, comments on the January
14, 2021 final rule and ‘‘Medicare
Program; Medicare Coverage of
Innovative Technology (MCIT) and
Definition of ‘‘Reasonable and
SUMMARY:
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Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Rules and Regulations
Necessary’’ ’’ and this interim action
must be received at one of the addresses
provided below, by April 16, 2021.
ADDRESSES: In commenting, please refer
to file code CMS–3372–IFC.
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 https://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–IFC, 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–IFC,
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:
Linda Gousis at (410) 786–2281 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: https://
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
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
In the January 14, 2021 Federal
Register, we published a final rule titled
‘‘Medicare Program; Medicare Coverage
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of Innovative Technology (MCIT) and
Definition of ‘‘Reasonable and
Necessary’’ ’’ (86 FR 2987). The January
2021 final rule established a Medicare
coverage pathway to provide Medicare
beneficiaries nationwide with faster
access to new, innovative medical
devices designated as breakthrough by
the Food and Drug Administration
(FDA). The MCIT pathway will 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. This
January 2021 final rule also
implemented 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.
II. Provisions of the Interim Final Rule
With Comment Period (IFC)
A. Purpose of This Action
On January 20, 2021, the Assistant to
the President and Chief of Staff issued
a memorandum titled ‘‘Regulatory
Freeze Pending Review’’ (‘‘Regulatory
Freeze Memorandum’’) which, along
with the guidance on implementation of
the memorandum issued by the Office
of Management and Budget (OMB) in
Memorandum M–21–14 dated January
20, 2021, directs agencies to consider
delaying the effective date of rules
published in the Federal Register that
have not yet become effective,
consistent with applicable law, for the
purpose of reviewing any questions of
fact, law, and policy the rules may raise.
The OMB memorandum directed that
the decision to delay should include
consideration of whether—
• The rulemaking process was
procedurally adequate;
• The rule reflected proper
consideration of all relevant facts;
• The rule reflected due
consideration of the agency’s statutory
or other legal obligations;
• The rule is based on a reasonable
judgment about the legally relevant
policy considerations;
• The rulemaking process was open
and transparent;
• Objections to the rule were
adequately considered, including
whether interested parties had fair
opportunities to present contrary facts
and arguments;
• Interested parties had the benefit of
access to the facts, data, or other
analyses on which the agency relied;
and
• The final rule found adequate
support in the rulemaking record.
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After considering this guidance, we
determined that a 60-day delay is
appropriate to ensure that: (1) The
rulemaking process was procedurally
adequate; (2) the agency properly
considered all relevant facts; (3) the
agency considered statutory or other
legal obligations; (4) the agency had
reasonable judgment about the legally
relevant policy considerations; and (5)
the agency 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, we are delaying the effective
date of the January 2021 MCIT final rule
and inviting 30 days of public
comments subsequent to promulgation
of this document consistent with the
Regulatory Freeze Memorandum and
OMB Memorandum M–21–14. Further,
we appreciate the strong public interest
in our rulemaking, and we are
especially interested in public
comments on each of the five decision
criteria noted previously with respect to
the January 2021 MCIT final rule.
Accordingly, this document delays
the effective date of the January 2021
MCIT final rule as specified in the DATES
section and opens a 30-day comment
period on the facts, law, and policy
underlying the rule.
B. Potential Concerns and Invitation for
Public Comment
1. Operational Issues
The MCIT pathway would address
uncertainty in Medicare coverage for
newly FDA market-authorized
breakthrough devices. While the rule
would eliminate coverage uncertainty
early after FDA market authorization
and automates coverage ‘‘so that
innovative products are brought to
market faster,’’ the rule did not directly
address operational issues, such as how
the agency would establish coding and
payment levels for particular devices,
which are both central to prompt market
access. CMS cannot be certain of the
precise timing of FDA market
authorizations and the exact indication
for use of the devices until they become
market authorized. However, in order to
fully operationalize Medicare coverage
for a particular breakthrough device,
CMS must make other decisions before
it can properly pay claims. Among those
are whether the device falls within a
Medicare benefit category under Part A
(Hospital Insurance Benefits) or Part B
(Supplementary Medical Insurance
Program). These determinations are
often called benefit category
determinations or BCDs. In addition, we
often must take into account the setting
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where the device is furnished, whether
there is an existing payment
methodology that applies to the
particular breakthrough device
(including, for example, whether a
device would be paid under a bundled
payment system or is separately
payable). We must also determine
whether there is an appropriate billing
code for the device in order to support
electronic claims filing and efficient
claims processing.
We recognize that some public
comments on the September 1, 2020
MCIT proposed rule, especially from
manufacturers, supported our initiating
MCIT only after coverage, coding, and
payment had been established. We
underestimated the operational
challenges highlighted by these
comments. We seek comment on how
CMS should resolve the operational
issues, such as benefit category
determinations, coding, and payment
levels.
2. Overlapping Rules
CMS separately proposed a Benefit
Category and Payment Determination
process in the November 4, 2020
proposed rule titled ‘‘Benefit Category
and Payment Determinations for DME,
Prosthetic Devices, Orthotics and
Prosthetics, Therapeutic Shoes and
Inserts, Surgical Dressings, or Splints,
Casts, and Other Devices Used for
Reductions of Fractures and
Dislocations’’ (DMEPOS) (85 FR 70358).
(The comment period for the November
2020 proposed rule closed on January 4,
2021.) This proposed rule outlined a
process to establish a BCD for Durable
Medical Equipment (DME). The
proposed rule has not been finalized.
Because of the publication sequences of
the MCIT public comment period
ending on November 2, 2020 and the
DMEPOS proposed rule being published
2 days after the MCIT comment period
closed, it may not have allowed
stakeholders to adequately comment on
the integration of the two policies.
While we recognize the proposed rule
was specifically considering DMEPOS,
and not all breakthrough devices fall
within these categories, that rule may
serve as a model for resolving similar
operational issues that could expedite
and facilitate Medicare payment. While
CMS has not completed its public
comment review of the DMEPOS
payment rule, there are comments
requesting that CMS align its processes.
We seek comment on whether
commenters would have raised
additional concerns if there had been an
opportunity to comment on the
DMEPOS payment and MCIT rules at
the same time.
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3. New Information: Breakthrough
Device Volume
The regulatory impact analysis (RIA)
published as part of the MCIT final rule
was based on the expectation that the
FDA breakthrough device program
would initially apply to a relatively
small number of devices based on the
low number of breakthrough devices
that had become market authorized.
Using this information, we assumed this
number would remain in a relatively
steady state for the first few years and
included this assumption in the RIA.
The MCIT proposed rule stated that 2 to
5 devices would likely fall within the
MCIT coverage pathway initially and
would remain fairly consistent in the
short term, and increase gradually
thereafter. At that time, the publicly
available FDA count of breakthrough
device designations was from the end of
fiscal year 2018, when there were 97
FDA-designated breakthrough devices.
New data, publicly reported by the FDA
on February16, 2021 (https://
www.fda.gov/news-events/fda-voices/
reflections-record-year-novel-deviceinnovation-despite-covid-19challenges), indicated that more than
400 devices have been designated as
breakthrough. We recognize that not all
of those devices will be marketauthorized, and we cannot know the
precise timing of those market
authorizations. Recent public data
suggests a larger number of marketauthorized breakthrough devices may be
eligible for MCIT. The public may not
have had an opportunity to consider
this aspect of potential growth. We seek
comment on whether the assumption
about the potential volume of FDA
breakthrough devices was flawed such
that the public did not have a
meaningful opportunity to comment on
the proposed rule.
4. Medicare Patient Benefit/Protection
and Other Issues
Further, after the close of the MCIT
public comment period, some experts
raised questions in published articles
about how breakthrough technology
may work—in older patients and the
evidence basis for Medicare coverage of
these technologies (Bach. New York
Times, December 1, 2020; https://
www.nytimes.com/2020/12/01/opinion/
trump-medicare-medicaid.html; Eroding
Progress on Evidence and Outcomes:
CMS’s New Proposed Pathway for
Medical Device Coverage. Neumann and
Chambers. Health Affairs, December 2,
2020 and Medicare’s New DeviceCoverage Pathway—Breakthrough or
Breakdown. Rathi, Johnston, Ross and
Dhruva. New England Journal of
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Medicine, March 10, 2021). CMS is
aware that Medicare patients often have
different clinical profiles and
considerations due to the complexity of
their medical conditions and multiple
treatments compared to other age
groups. Because Medicare patients
usually have more than one comorbidity and are likely being treated
for more than one condition, CMS has
historically reviewed clinical evidence
showing that the devices have been
studied in the Medicare population or
that outcomes are generalizable to the
Medicare population. The various
treatments may interact with each other,
potentially affecting overall patient
benefits.
Some public commenters challenged
CMS’ premise that the MCIT coverage
could result in improved care for
Medicare beneficiaries absent specific
evidence that the MCIT eligible devices
benefit the Medicare population. In
response to the public comments, the
MCIT final rule gives CMS authority to
remove a breakthrough device from the
MCIT pathway where a medical device
safety communication or warning letter
is issued by the FDA, or if the FDA
revokes market authorization for a
device. We seek comment on whether
the revisions in the MCIT final rule
adequately addressed the public’s
concern of clinical benefit to the
Medicare population.
5. Public Request for a More Detailed
Proposal
Public commenters on the proposed
rule requested that we not finalize the
rule because of a potential lack of clarity
on the ‘‘reasonable and necessary’’
definition, which is the statutory
standard for covering MCIT
breakthrough devices after the coverage
pathway ends and most items and
services that fall under the Medicare
fee-for-service program. These
commenters stated that CMS did not
include sufficient detail in the proposed
rule about the impact of commercial
insurance coverage and, therefore,
suggested that they could not
adequately or meaningfully comment.
Further, some commenters suggested
that the agency should publish another
proposed rule with significantly more
detail. We seek comment on whether
the public had adequate opportunity to
comment on the proposed rule. We are
also soliciting comment on whether
CMS adequately responded to
objections to the proposed rule,
including whether interested parties
had fair opportunities to present
contrary facts and arguments that may
help to improve the final rule.
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6. Adequacy of Rulemaking Process
Lastly, OMB Memorandum M–21–14
requires agencies to consider, among
other things, whether the rulemaking
process was procedurally adequate and
whether interested parties had a fair
opportunity to present contrary facts
and arguments. We are soliciting
comment on the following:
• Whether there are any other
procedural issues pertaining to the
January 2021 MCIT rulemaking process.
• If there are other procedural issues,
what are those issues and what should
CMS do to remedy those issues?
• Should the January 2021 MCIT final
rule be amended, rescinded, or further
delayed pending review by the CMS or
allowed to go into effect?
III. Waiver of Proposed Rulemaking
and the 60-Day Public Comment
Periods
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). Unless there is a
statutory exception, section 1871(b)(1)
of the Act generally requires the
Secretary of the Department of Health
and Human Services (the Secretary) to
provide for notice of a proposed rule in
the Federal Register and provide a
period of not less than 60 days for
public comment before establishing or
changing a substantive legal standard
regarding the matters enumerated by the
statute. Similarly, under 5 U.S.C. 553(b)
of the APA, the agency is required to
publish a notice of proposed rulemaking
in the Federal Register before a
substantive rule takes effect. Section
553(d) of the APA and section
1871(e)(1)(B)(i) of the Act usually
require a 30-day delay in effective date
after issuance or publication of a rule,
subject to exceptions. Sections 553(b)(B)
and 553(d)(3) of the APA provide for
exceptions from the advance notice and
comment requirement and the delay in
effective date requirements. Sections
1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the
Act also provide exceptions from the
notice and 60-day comment period and
the 30-day delay in effective date.
Section 553(b)(B) of the APA and
section 1871(b)(2)(C) of the Act
expressly authorize an agency to
dispense with notice and comment
rulemaking for good cause if the agency
makes a finding that notice and
comment procedures are impracticable,
unnecessary, or contrary to the public
interest.
We find that notice and comment
rulemaking is impracticable,
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unnecessary, and contrary to the public
interest with respect to the relatively
short delay in the effective date of the
final MCIT rule announced by this
action. The final rule was published in
the Federal Register on January 14,
2021. Even if the MCIT final rule were
to go into effect on March 15, 2021,
CMS would be unable to operationalize
the program by that date. Because the
agency is required to make other
decisions, such as benefit category
determinations, whether there is an
existing payment methodology and
whether there is an existing code or
establishing code for the MCIT eligible
breakthrough device, it would be
impracticable to operationalize the
MCIT rule on the March 15, 2021
effective date. These operational
practicalities leave CMS incapable of
implementing the MCIT program on
March 15, 2021. Additionally, the
higher than anticipated volume of
devices receiving FDA breakthrough
device designation exponentially
complicates the operational concerns
that we have identified. Further, public
comments highlighted the importance of
the agency having the ability to not only
cover an FDA-designated breakthrough
device expeditiously, but also to be able
to have coding and payment levels
established at the same time.
It would be impracticable to provide
the normal 60-day comment period for
such a brief delay in the effective date
because the rule would be effective
before the public comments could be
meaningfully considered. Given the
March 15, 2021 effective date for the
MCIT final rule, there is not sufficient
time to adequately consider advance
public comment on this delay and it
would interfere with the public’s
interest in the orderly promulgation and
implementation of regulations. We find
good cause for dispensing with advance
public comment because it is
impracticable to provide a meaningful
opportunity to comment before
extending the effective date of the MCIT
rule.
The White House memorandum also
recommends that, for rules postponed
for further review, agencies consider
opening a 30-day comment period to
allow interested parties to provide
comments about issues of fact, law, and
policy raised by those rules, and
consider any requests for
reconsideration involving such rules.
Consistent with this guidance, we are
requesting public comments on these
topics, as well as the specific questions
posed previously. After reviewing
comments received in response to this
notice, we may determine there is a
need to postpone the effective date
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14545
further to allow additional time to
consider issues of fact, law, and policy
or to reconsider the January 2021 MCIT
final rule.
IV. Summary
This rule delays the effective date of
January 2021 MCIT final rule to May 15,
2021 for further review of the of fact,
law, and policy raised by the rule. This
rule also invites 30 days of public
comment and requests interested parties
to provide comments about issues of
fact, law, and policy raised by the
January 14, 2021 final rule so that CMS
can consider any requests for
reconsideration involving the rule. We
also invite additional public comments
on whether the rule should be amended,
rescinded, delayed pending further
review, or allowed to go into effect.
For the reasons stated previously, we
find that there is good cause under 5
U.S.C. 553(b)(B) and (d)(3) to publish
this action without prior notice and
comment, and for this action to become
effective immediately upon publication
in the Federal Register.
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.
Norris Cochran,
Acting Secretary, Department of Health and
Human Services.
[FR Doc. 2021–05490 Filed 3–12–21; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 64
[Docket ID FEMA–2021–0003; Internal
Agency Docket No. FEMA–8671]
Suspension of Community Eligibility
Federal Emergency
Management Agency, DHS.
ACTION: Final rule.
AGENCY:
This rule identifies
communities where the sale of flood
insurance has been authorized under
the National Flood Insurance Program
(NFIP) that are scheduled for
suspension on the effective dates listed
within this rule because of
noncompliance with the floodplain
management requirements of the
program. If the Federal Emergency
SUMMARY:
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]]>Agencies
[Federal Register Volume 86, Number 50 (Wednesday, March 17, 2021)]
[Rules and Regulations]
[Pages 14542-14545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05490]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 405
[CMS-3372-IFC]
RIN 0938-AT88
Medicare Program; Medicare Coverage of Innovative Technology
(MCIT) and Definition of ``Reasonable and Necessary''; Delay of
Effective Date; Public Comment Period
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Interim final rule; delayed effective date; request for
comments.
-----------------------------------------------------------------------
SUMMARY: Consistent with the memorandum of January 20, 2021, from the
Assistant to the President and Chief of Staff, titled ``Regulatory
Freeze Pending Review,'' this document delays the effective date of the
final rule titled, ``Medicare Program; Medicare Coverage of Innovative
Technology (MCIT) and Definition of 'Reasonable and Necessary' ''
published in the Federal Register on January 14, 2021, for 60 days. We
are providing a 30-day public comment period to allow interested
parties to provide comments about issues of fact, law, and policy
raised by the rule and this information could be considered by the
agency in determining whether further actions are appropriate, which
could include whether to revise or rescind.
DATES:
Effective date: As of March 12, 2021, the effective date of the
final rule amending 42 CFR part 405 published at 86 FR 2987 on January
14, 2021, is delayed by this interim final rule until May 15, 2021.
Comment period: To be assured consideration, comments on the
January 14, 2021 final rule and ``Medicare Program; Medicare Coverage
of Innovative Technology (MCIT) and Definition of ``Reasonable and
[[Page 14543]]
Necessary'' '' and this interim action must be received at one of the
addresses provided below, by April 16, 2021.
ADDRESSES: In commenting, please refer to file code CMS-3372-IFC.
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 https://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-IFC, 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-IFC, 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: Linda Gousis at (410) 786-2281 or
[email protected].
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: https://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 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
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).
The January 2021 final rule established a Medicare coverage pathway to
provide Medicare beneficiaries nationwide with faster access to new,
innovative medical devices designated as breakthrough by the Food and
Drug Administration (FDA). The MCIT pathway will 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.
This January 2021 final rule also implemented 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.
II. Provisions of the Interim Final Rule With Comment Period (IFC)
A. Purpose of This Action
On January 20, 2021, the Assistant to the President and Chief of
Staff issued a memorandum titled ``Regulatory Freeze Pending Review''
(``Regulatory Freeze Memorandum'') which, along with the guidance on
implementation of the memorandum issued by the Office of Management and
Budget (OMB) in Memorandum M-21-14 dated January 20, 2021, directs
agencies to consider delaying the effective date of rules published in
the Federal Register that have not yet become effective, consistent
with applicable law, for the purpose of reviewing any questions of
fact, law, and policy the rules may raise.
The OMB memorandum directed that the decision to delay should
include consideration of whether--
The rulemaking process was procedurally adequate;
The rule reflected proper consideration of all relevant
facts;
The rule reflected due consideration of the agency's
statutory or other legal obligations;
The rule is based on a reasonable judgment about the
legally relevant policy considerations;
The rulemaking process was open and transparent;
Objections to the rule were adequately considered,
including whether interested parties had fair opportunities to present
contrary facts and arguments;
Interested parties had the benefit of access to the facts,
data, or other analyses on which the agency relied; and
The final rule found adequate support in the rulemaking
record.
After considering this guidance, we determined that a 60-day delay
is appropriate to ensure that: (1) The rulemaking process was
procedurally adequate; (2) the agency properly considered all relevant
facts; (3) the agency considered statutory or other legal obligations;
(4) the agency had reasonable judgment about the legally relevant
policy considerations; and (5) the agency 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, we are delaying the effective date of the January
2021 MCIT final rule and inviting 30 days of public comments subsequent
to promulgation of this document consistent with the Regulatory Freeze
Memorandum and OMB Memorandum M-21-14. Further, we appreciate the
strong public interest in our rulemaking, and we are especially
interested in public comments on each of the five decision criteria
noted previously with respect to the January 2021 MCIT final rule.
Accordingly, this document delays the effective date of the January
2021 MCIT final rule as specified in the DATES section and opens a 30-
day comment period on the facts, law, and policy underlying the rule.
B. Potential Concerns and Invitation for Public Comment
1. Operational Issues
The MCIT pathway would address uncertainty in Medicare coverage for
newly FDA market-authorized breakthrough devices. While the rule would
eliminate coverage uncertainty early after FDA market authorization and
automates coverage ``so that innovative products are brought to market
faster,'' the rule did not directly address operational issues, such as
how the agency would establish coding and payment levels for particular
devices, which are both central to prompt market access. CMS cannot be
certain of the precise timing of FDA market authorizations and the
exact indication for use of the devices until they become market
authorized. However, in order to fully operationalize Medicare coverage
for a particular breakthrough device, CMS must make other decisions
before it can properly pay claims. Among those are whether the device
falls within a Medicare benefit category under Part A (Hospital
Insurance Benefits) or Part B (Supplementary Medical Insurance
Program). These determinations are often called benefit category
determinations or BCDs. In addition, we often must take into account
the setting
[[Page 14544]]
where the device is furnished, whether there is an existing payment
methodology that applies to the particular breakthrough device
(including, for example, whether a device would be paid under a bundled
payment system or is separately payable). We must also determine
whether there is an appropriate billing code for the device in order to
support electronic claims filing and efficient claims processing.
We recognize that some public comments on the September 1, 2020
MCIT proposed rule, especially from manufacturers, supported our
initiating MCIT only after coverage, coding, and payment had been
established. We underestimated the operational challenges highlighted
by these comments. We seek comment on how CMS should resolve the
operational issues, such as benefit category determinations, coding,
and payment levels.
2. Overlapping Rules
CMS separately proposed a Benefit Category and Payment
Determination process in the November 4, 2020 proposed rule titled
``Benefit Category and Payment Determinations for DME, Prosthetic
Devices, Orthotics and Prosthetics, Therapeutic Shoes and Inserts,
Surgical Dressings, or Splints, Casts, and Other Devices Used for
Reductions of Fractures and Dislocations'' (DMEPOS) (85 FR 70358). (The
comment period for the November 2020 proposed rule closed on January 4,
2021.) This proposed rule outlined a process to establish a BCD for
Durable Medical Equipment (DME). The proposed rule has not been
finalized. Because of the publication sequences of the MCIT public
comment period ending on November 2, 2020 and the DMEPOS proposed rule
being published 2 days after the MCIT comment period closed, it may not
have allowed stakeholders to adequately comment on the integration of
the two policies. While we recognize the proposed rule was specifically
considering DMEPOS, and not all breakthrough devices fall within these
categories, that rule may serve as a model for resolving similar
operational issues that could expedite and facilitate Medicare payment.
While CMS has not completed its public comment review of the DMEPOS
payment rule, there are comments requesting that CMS align its
processes. We seek comment on whether commenters would have raised
additional concerns if there had been an opportunity to comment on the
DMEPOS payment and MCIT rules at the same time.
3. New Information: Breakthrough Device Volume
The regulatory impact analysis (RIA) published as part of the MCIT
final rule was based on the expectation that the FDA breakthrough
device program would initially apply to a relatively small number of
devices based on the low number of breakthrough devices that had become
market authorized. Using this information, we assumed this number would
remain in a relatively steady state for the first few years and
included this assumption in the RIA. The MCIT proposed rule stated that
2 to 5 devices would likely fall within the MCIT coverage pathway
initially and would remain fairly consistent in the short term, and
increase gradually thereafter. At that time, the publicly available FDA
count of breakthrough device designations was from the end of fiscal
year 2018, when there were 97 FDA-designated breakthrough devices. New
data, publicly reported by the FDA on February16, 2021 (https://www.fda.gov/news-events/fda-voices/reflections-record-year-novel-device-innovation-despite-covid-19-challenges), indicated that more
than 400 devices have been designated as breakthrough. We recognize
that not all of those devices will be market-authorized, and we cannot
know the precise timing of those market authorizations. Recent public
data suggests a larger number of market-authorized breakthrough devices
may be eligible for MCIT. The public may not have had an opportunity to
consider this aspect of potential growth. We seek comment on whether
the assumption about the potential volume of FDA breakthrough devices
was flawed such that the public did not have a meaningful opportunity
to comment on the proposed rule.
4. Medicare Patient Benefit/Protection and Other Issues
Further, after the close of the MCIT public comment period, some
experts raised questions in published articles about how breakthrough
technology may work--in older patients and the evidence basis for
Medicare coverage of these technologies (Bach. New York Times, December
1, 2020; https://www.nytimes.com/2020/12/01/opinion/trump-medicare-medicaid.html; Eroding Progress on Evidence and Outcomes: CMS's New
Proposed Pathway for Medical Device Coverage. Neumann and Chambers.
Health Affairs, December 2, 2020 and Medicare's New Device-Coverage
Pathway--Breakthrough or Breakdown. Rathi, Johnston, Ross and Dhruva.
New England Journal of Medicine, March 10, 2021). CMS is aware that
Medicare patients often have different clinical profiles and
considerations due to the complexity of their medical conditions and
multiple treatments compared to other age groups. Because Medicare
patients usually have more than one co-morbidity and are likely being
treated for more than one condition, CMS has historically reviewed
clinical evidence showing that the devices have been studied in the
Medicare population or that outcomes are generalizable to the Medicare
population. The various treatments may interact with each other,
potentially affecting overall patient benefits.
Some public commenters challenged CMS' premise that the MCIT
coverage could result in improved care for Medicare beneficiaries
absent specific evidence that the MCIT eligible devices benefit the
Medicare population. In response to the public comments, the MCIT final
rule gives CMS authority to remove a breakthrough device from the MCIT
pathway where a medical device safety communication or warning letter
is issued by the FDA, or if the FDA revokes market authorization for a
device. We seek comment on whether the revisions in the MCIT final rule
adequately addressed the public's concern of clinical benefit to the
Medicare population.
5. Public Request for a More Detailed Proposal
Public commenters on the proposed rule requested that we not
finalize the rule because of a potential lack of clarity on the
``reasonable and necessary'' definition, which is the statutory
standard for covering MCIT breakthrough devices after the coverage
pathway ends and most items and services that fall under the Medicare
fee-for-service program. These commenters stated that CMS did not
include sufficient detail in the proposed rule about the impact of
commercial insurance coverage and, therefore, suggested that they could
not adequately or meaningfully comment. Further, some commenters
suggested that the agency should publish another proposed rule with
significantly more detail. We seek comment on whether the public had
adequate opportunity to comment on the proposed rule. We are also
soliciting comment on whether CMS adequately responded to objections to
the proposed rule, including whether interested parties had fair
opportunities to present contrary facts and arguments that may help to
improve the final rule.
[[Page 14545]]
6. Adequacy of Rulemaking Process
Lastly, OMB Memorandum M-21-14 requires agencies to consider, among
other things, whether the rulemaking process was procedurally adequate
and whether interested parties had a fair opportunity to present
contrary facts and arguments. We are soliciting comment on the
following:
Whether there are any other procedural issues pertaining
to the January 2021 MCIT rulemaking process.
If there are other procedural issues, what are those
issues and what should CMS do to remedy those issues?
Should the January 2021 MCIT final rule be amended,
rescinded, or further delayed pending review by the CMS or allowed to
go into effect?
III. Waiver of Proposed Rulemaking and the 60-Day Public Comment
Periods
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). Unless there is a statutory
exception, section 1871(b)(1) of the Act generally requires the
Secretary of the Department of Health and Human Services (the
Secretary) to provide for notice of a proposed rule in the Federal
Register and provide a period of not less than 60 days for public
comment before establishing or changing a substantive legal standard
regarding the matters enumerated by the statute. Similarly, under 5
U.S.C. 553(b) of the APA, the agency is required to publish a notice of
proposed rulemaking in the Federal Register before a substantive rule
takes effect. Section 553(d) of the APA and section 1871(e)(1)(B)(i) of
the Act usually require a 30-day delay in effective date after issuance
or publication of a rule, subject to exceptions. Sections 553(b)(B) and
553(d)(3) of the APA provide for exceptions from the advance notice and
comment requirement and the delay in effective date requirements.
Sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act also provide
exceptions from the notice and 60-day comment period and the 30-day
delay in effective date. Section 553(b)(B) of the APA and section
1871(b)(2)(C) of the Act expressly authorize an agency to dispense with
notice and comment rulemaking for good cause if the agency makes a
finding that notice and comment procedures are impracticable,
unnecessary, or contrary to the public interest.
We find that notice and comment rulemaking is impracticable,
unnecessary, and contrary to the public interest with respect to the
relatively short delay in the effective date of the final MCIT rule
announced by this action. The final rule was published in the Federal
Register on January 14, 2021. Even if the MCIT final rule were to go
into effect on March 15, 2021, CMS would be unable to operationalize
the program by that date. Because the agency is required to make other
decisions, such as benefit category determinations, whether there is an
existing payment methodology and whether there is an existing code or
establishing code for the MCIT eligible breakthrough device, it would
be impracticable to operationalize the MCIT rule on the March 15, 2021
effective date. These operational practicalities leave CMS incapable of
implementing the MCIT program on March 15, 2021. Additionally, the
higher than anticipated volume of devices receiving FDA breakthrough
device designation exponentially complicates the operational concerns
that we have identified. Further, public comments highlighted the
importance of the agency having the ability to not only cover an FDA-
designated breakthrough device expeditiously, but also to be able to
have coding and payment levels established at the same time.
It would be impracticable to provide the normal 60-day comment
period for such a brief delay in the effective date because the rule
would be effective before the public comments could be meaningfully
considered. Given the March 15, 2021 effective date for the MCIT final
rule, there is not sufficient time to adequately consider advance
public comment on this delay and it would interfere with the public's
interest in the orderly promulgation and implementation of regulations.
We find good cause for dispensing with advance public comment because
it is impracticable to provide a meaningful opportunity to comment
before extending the effective date of the MCIT rule.
The White House memorandum also recommends that, for rules
postponed for further review, agencies consider opening a 30-day
comment period to allow interested parties to provide comments about
issues of fact, law, and policy raised by those rules, and consider any
requests for reconsideration involving such rules. Consistent with this
guidance, we are requesting public comments on these topics, as well as
the specific questions posed previously. After reviewing comments
received in response to this notice, we may determine there is a need
to postpone the effective date further to allow additional time to
consider issues of fact, law, and policy or to reconsider the January
2021 MCIT final rule.
IV. Summary
This rule delays the effective date of January 2021 MCIT final rule
to May 15, 2021 for further review of the of fact, law, and policy
raised by the rule. This rule also invites 30 days of public comment
and requests interested parties to provide comments about issues of
fact, law, and policy raised by the January 14, 2021 final rule so that
CMS can consider any requests for reconsideration involving the rule.
We also invite additional public comments on whether the rule should be
amended, rescinded, delayed pending further review, or allowed to go
into effect.
For the reasons stated previously, we find that there is good cause
under 5 U.S.C. 553(b)(B) and (d)(3) to publish this action without
prior notice and comment, and for this action to become effective
immediately upon publication in the Federal Register.
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.
Norris Cochran,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2021-05490 Filed 3-12-21; 4:15 pm]
BILLING CODE 4120-01-P
