[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Rules and Regulations]
[Pages 9471-9472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02985]
[[Page 9471]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 400, 410, 414, 415, 423, 424, and 425
[CMS-1734-F2]
RIN 0938-AU10, 0938-AU31, 0938-AU32, and 0938-AU33
Medicare Program; CY 2021 Payment Policies Under the Physician
Fee Schedule and Other Changes to Part B Payment Policies; Medicare
Shared Savings Program Requirements; Medicaid Promoting
Interoperability Program Requirements for Eligible Professionals;
Quality Payment Program; Coverage of Opioid Use Disorder Services
Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid
Treatment Programs; Electronic Prescribing for Controlled Substances
for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and
Management Services; Hospital IQR Program; Establish New Code
Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model
Emergency Policy; Coding and Payment for Virtual Check-In Services
Interim Final Rule Policy; Coding and Payment for Personal Protective
Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in
Response to the Public Health Emergency (PHE) for COVID-19; and
Finalization of Certain Provisions From the March 31st, May 8th and
September 2nd Interim Final Rules in Response to the PHE for COVID-19;
Correcting Amendment
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule and interim final rule; correcting amendment.
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SUMMARY: This document corrects a typographical error in the final rule
that appeared in the December 28, 2020 Federal Register (hereinafter
referred to as the CY 2021 PFS final rule). The effective date was
January 1, 2021.
DATES: Effective date: This correcting amendment is effective February
16, 2021.
Applicability date: The correction indicated in this document is
applicable beginning January 1, 2021.
FOR FURTHER INFORMATION CONTACT: Cynthia Lambert Lawson, (410) 786-
1366, Gaysha Brooks, (410) 786-9649, or Annette Brewer, (410) 786-6580.
SUPPLEMENTARY INFORMATION:
I. Background
In FR Doc. 2020-26815 of December 28, 2020, the CY 2021 PFS final
rule (85 FR 84472), there was a typographical error that is identified
and corrected in the regulation text of this correcting amendment. The
correction is applicable as of January 1, 2021.
II. Summary of Error in the Regulations Text
On page 85033 of the CY 2021 PFS final rule, we made a
typographical error in amendatory instruction 24b for the regulation
text of Sec. 414.1400(b)(2) introductory text. In this amendatory
instruction, we inadvertently noted that we were revising paragraph
(b)(2) introductory text instead of adding it. Accordingly, we are
revising amendatory instruction 24b to accurately reflect the addition
of paragraph (b)(2) introductory text.
III. Waiver of Proposed Rulemaking and Delay in Effective Date
Under 5 U.S.C. 553(b) of the Administrative Procedure Act (the
APA), the agency is required to publish a notice of the proposed rule
in the Federal Register before the provisions of a rule take effect.
Similarly, section 1871(b)(1) of the Social Security Act (the Act)
requires the Secretary to provide for notice of the proposed rule in
the Federal Register and provide a period of not less than 60 days for
public comment. In addition, section 553(d) of the APA and section
1871(e)(1)(B)(i) of the Act mandate a 30-day delay in effective date
after issuance or publication of a rule. Sections 553(b)(B) and
553(d)(3) of the APA provide for exceptions from the APA notice and
comment, and delay in effective date requirements; in cases in which
these exceptions apply, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of
the Act provide exceptions from the notice and 60-day comment period
and delay in effective date requirements of the Act as well. Section
553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an
agency to dispense with normal notice and comment rulemaking procedures
for good cause if the agency makes a finding that the notice and
comment process is impracticable, unnecessary, or contrary to the
public interest, and includes a statement of the finding and the
reasons for it in the rule. In addition, section 553(d)(3) of the APA
and section 1871(e)(1)(B)(ii) allow the agency to avoid the 30-day
delay in effective date where such delay is contrary to the public
interest and the agency includes in the rule a statement of the finding
and the reasons for it.
In our view, this correcting amendment does not constitute a
rulemaking that would be subject to these requirements. This document
merely corrects a typographical error in the CY 2021 PFS final rule.
The correction contained in this document is consistent with, and does
not make substantive changes to, the policies and payment methodologies
that were proposed, subject to notice and comment procedures, and
adopted in the CY 2021 PFS final rule. As a result, the correction made
through this correcting amendment is intended to resolve a
typographical error so that the CY 2021 PFS final rule accurately
reflects the policies adopted in the final rule. Even if this were a
rulemaking to which the notice and comment and delayed effective date
requirements applied, we find that there is good cause to waive such
requirements. Undertaking further notice and comment procedures to
incorporate the corrections in this document into the CY 2021 PFS final
rule or delaying the effective date of the corrections would be
contrary to the public interest because it is in the public interest to
ensure that the rule accurately reflects our policies as of the date
they take effect. Further, such procedures would be unnecessary because
we are not making any substantive revisions to the final rule, but
rather, we are simply correcting the Federal Register document to
reflect the policies that we previously proposed, received public
comment on, and subsequently finalized in the CY 2021 PFS final rule.
For these reasons, we believe there is good cause to waive the
requirements for notice and comment and delay in effective date.
List of Subjects in 42 CFR Part 414
Administrative practice and procedure, Biologics, Diseases, Drugs,
Health facilities, Health professions, Medicare, Reporting and
recordkeeping requirements.
Accordingly, 42 CFR chapter IV is corrected by making the following
correcting amendments to part 414:
PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
0
1. The authority citation for part 414 continues to read as follows:
Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).
[[Page 9472]]
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2. Amend Sec. 414.1400 by revising the heading of paragraph (b)(2) and
adding paragraph (b)(2) introductory text to read as follows:
Sec. 414.1400 Third party intermediaries.
* * * * *
(b) * * *
(2) QCDR conditions for approval. In addition to the other
requirements in this section, the criteria for an entity to be approved
as a QCDR include the following:
* * * * *
Dated: February 9, 2021.
Wilma M. Robinson,
Deputy Executive Secretary to the Department, Department of Health and
Human Services.
[FR Doc. 2021-02985 Filed 2-12-21; 8:45 am]
BILLING CODE 4120-01-P