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Federal Register / Vol. 86, No. 94 / Tuesday, May 18, 2021 / Rules and Regulations B. March 17, 2021 Interim Final Rule IFC

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid Services 42 CFR Part 405
CMS3372F2
RIN 0938AT88

Medicare Program; Medicare Coverage of Innovative Technology MCIT and Definition of Reasonable and Necessary; Delay of Effective Date Centers for Medicare &
Medicaid Services CMS, Department of Health and Human Services HHS.
ACTION: Final rule.
AGENCY:

This final rule 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 January 14, 2021 Federal Register.
DATES: As of May 14, 2021, the effective date of the final rule amending 42 CFR
part 405, published at 86 FR 2987, January 14, 2021, and delayed at 86 FR
14542, March 17, 2021, is further delayed until December 15, 2021.
FOR FURTHER INFORMATION CONTACT: Lori Ashby at 4107866322 or MCIT@
cms.hhs.gov.
SUMMARY:

SUPPLEMENTARY INFORMATION:

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I. Background
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 M2114 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: 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, in an interim final rule that took effect on March 12, 2021, and appeared 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.

A. Introduction
C. Review of Public Comments on the Delay of the MCIT/R&N 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 MCIT/R&N final rule. 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. Under the final rule as currently written, 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 1862a1A of the Social Security Act the Act for items and services that are furnished under Medicare Parts A and B.

We received approximately 215
timely pieces of correspondence in response to the interim final rule delaying the effective date of the MCIT/
R&N final rule.
In this section of this final rule, we summarize our response to comments on the delay of the MCIT/R&N final rule. To the extent applicable, we intend to also consider these comments for future rulemaking.
Comment: Some manufacturers, in particular those with FDA designated breakthrough devices that have been market authorized, as well as the industry groups representing them commented that the MCIT/R&N final rule should be implemented without further delay. Although they acknowledged certain operational issues remain, specifically coding and payment for applicable devices and/or the services in which they are used, these commenters suggested those issues could be overcome by adapting existing processes such as inpatient new technology add on payment NTAP and
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outpatient hospital transitional passthrough payment to determine coding and payment, at least when these devices are used in the hospital setting.
These commenters also expressed that they believe patient safety provisions in the final rule are sufficient to protect beneficiaries.
Other manufacturers that have FDA
breakthrough designated devices but generally have yet to receive market authorization were supportive of a MCIT policy that would be more comprehensive and that includes specified guidance and expedited processes for benefit category determination, coding, and payment.
These manufacturers support a delay of the MCIT/R&N final rule to the extent that such a delay would lead to a more comprehensive policy than the one that would be effective in May 2021.
Response: The current MCIT/R&N
final rule solely relates to coverage of certain devices under Medicare; it does not establish a benefit category determination BCD, medical coding, nor payment rates for any devices.
While we recognize that some commenters support a different policy that would address benefit category determinations, coding, and payment, in addition to coverage, the MCIT/R&N
final rule was not designed to address factors beyond Medicare coverage.
Further, while the rule eliminates coverage uncertainty early after FDA
market authorization for those devices with a clear benefit category, the rule did not directly address the operational issues, such as how the agency would establish coding and payment.
Comment: Several individual physicians and members of the public submitted comments supporting implementation of the MCIT/R&N final rule given the promise of breakthrough devices for their specialties or disease states of concern: Chronic obstructive pulmonary disease COPD, prostate care, heart failure, stroke, opioid use disorder, oncology, and sleep disorders.
On the other hand, some commenters suggested that the final MCIT/R&N rule provided automatic coverage for breakthrough devices without adequate evidentiary support.
Response: We are aware that breakthrough devices span numerous clinical specialties. We note that MCIT
would be one of several coverage pathways that is, claim-by-claim adjudication, local coverage, National Coverage Determination NCD for breakthrough devices. 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
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