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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 CMS3372IFC.
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:
CMS3372IFC, P.O. Box 8013, Baltimore, MD 212448013.
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: CMS3372IFC, Mail Stop C42605, 7500 Security Boulevard, Baltimore, MD 212441850.
For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Linda Gousis at 410 7862281 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 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 1862a1A 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 M2114 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 agencys 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 M2114. 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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