[Federal Register Volume 86, Number 20 (Tuesday, February 2, 2021)]
[Rules and Regulations]
[Page 7814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02180]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 486

[CMS-3380-F2]
RIN 0938-AU02


Medicare and Medicaid Programs; Organ Procurement Organizations 
Conditions for Coverage: Revisions to the Outcome Measure Requirements 
for Organ Procurement Organizations; Public Comment Period; Delay of 
Effective Date

AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and 
Human Services (HHS).

ACTION: Final rule; public comment period; delay of effective date.

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SUMMARY: In accordance with the memorandum of January 20, 2021, from 
the Assistant to the President and Chief of Staff, entitled 
``Regulatory Freeze Pending Review,'' this action temporarily delays 
for 60 days the effective date of part of the final rule entitled, 
``Medicare and Medicaid Programs; Organ Procurement Organizations 
Conditions for Coverage: Revisions to the Outcome Measure Requirements 
for Organ Procurement Organizations; Final rule'' published in the 
Federal Register on December 2, 2020. We are also providing an 
additional 30-day public comment period.

DATES: The February 1, 2021, effective date of the rule amending 42 CFR 
part 486, published at 85 FR 77898 on December 2, 2020, is delayed to 
March 30, 2021.
    Comment date: To be assured consideration, comments must be 
received at one of the addresses provided below, by March 4, 2021.

ADDRESSES: In commenting, please refer to file code CMS-3380-F2.
    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-3380-F2, P.O. Box 8010, 
Baltimore, MD 21244-8010.
    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-3380-F2, 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: Diane Corning, (410) 786-8486; Jesse 
Roach, (410) 786-1000; Kristin Shifflett, (410) 786-4133; CAPT James 
Cowher, (410) 786-1948; or Alpha-Banu Wilson, (410) 786-8687.

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

    The January 20, 2021 memorandum from the Assistant to the President 
and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' 
instructed Federal agencies to delay the effective date of rules 
published in the Federal Register, but which have not yet taken effect, 
for a period of 60 days. On December 2, 2020, we published a final rule 
in the Federal Register entitled ``Medicare and Medicaid Programs; 
Organ Procurement Organizations Conditions for Coverage: Revisions to 
the Outcome Measure Requirements for Organ Procurement Organizations; 
Final rule'' (85 FR 77898). The December 2020 final rule revises the 
Organ Procurement Organizations Conditions for Coverage to increase 
donation rates and organ transplantation rates by replacing the current 
outcome measures with new transparent, reliable, and objective outcome 
measures and increasing competition for open donation service areas. 
The effective date of that rule, except for amendment number 3, which 
would have been February 1, 2021, is now March 30, 2021. We are also 
providing a 30-day public comment period. The 60-day delay in effective 
date is necessary to give Department officials the opportunity for 
further review of the issues of fact, law, and policy raised by this 
rule. In addition, this action provides a comment period on the 
policies set out in the December 2, 2020 final rule to allow interested 
parties to provide comments about issues of fact, law and policy raised 
by the rule.

II. 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.

Norris Cochran,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2021-02180 Filed 1-29-21; 11:15 am]
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