[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]



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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).


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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