[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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