[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Rules and Regulations]
[Pages 71582-71583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27452]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 447

[CMS-2482-CN]
RIN 0938-AT82


Medicaid Program; Delay of Effective Date for Provision Relating 
to Manufacturer Reporting of Multiple Best Prices Connected to a Value 
Based Purchasing Arrangement; Delay of Inclusion of Territories in 
Definition of States and United States; Correction

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

ACTION: Final rule; correction.

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SUMMARY: This document corrects technical errors in the final rule that 
appeared in the November 19, 2021 Federal Register entitled, ``Medicaid 
Program; Delay of Effective Date for Provision Relating to Manufacturer 
Reporting of Multiple Best Prices Connected to a Value Based Purchasing 
Arrangement; Delay of Inclusion of Territories in Definition of States 
and United States.''

DATES: Effective December 20, 2021.

FOR FURTHER INFORMATION CONTACT: Christine Hinds, (410) 786-4578.

SUPPLEMENTARY INFORMATION:

I. Background

    In FR Doc. 2021-25009 (86 FR 64819), the final rule entitled, 
``Medicaid Program; Delay of Effective Date for Provision Relating to 
Manufacturer Reporting of Multiple Best Prices Connected to a Value 
Based Purchasing Arrangement; Delay of Inclusion of Territories in 
Definition of States and United States'' there were technical errors 
that are identified and corrected in this correcting document. These 
corrections are applicable as of December 16, 2021.

II. Summary of Errors

A. Summary of Errors in the Preamble

    On page 64819 of the Medicaid Program; Delay of Effective Date for 
Provision Relating to Manufacturer Reporting of Multiple Best Prices 
Connected to a Value Based Purchasing Arrangement; Delay of Inclusion 
of Territories in Definition of States and United States final rule, we 
inadvertently omitted the delayed effective date of the revised 
definition of ``Best price'' at Sec.  447.505(a), which was previously 
published in the December

[[Page 71583]]

31, 2020 Federal Register (85 FR 87000) in instruction 10.a.

B. Summary of Errors in the Regulatory Text

    On page 64825, we inadvertently included amendatory instruction 3.

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. In 
addition, section 553(d) of the APA mandates a 30-day delay in 
effective date after issuance or publication of a substantive 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. 
Section 553(b)(B) of the APA authorizes 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. 
Similarly, section 553(d)(3) of the APA allows the agency to avoid the 
30-day delay in effective date where good cause is found and the agency 
includes in the rule a statement of the finding and the reasons for it. 
In our view, this correcting document does not constitute a rulemaking 
that would be subject to these requirements.
    This document merely corrects technical errors in the Medicaid 
Program; Delay of Effective Date for Provision Relating to Manufacturer 
Reporting of Multiple Best Prices Connected to a Value Based Purchasing 
Arrangement; Delay of Inclusion of Territories in Definition of States 
and United States final rule. The corrections contained in this 
document are consistent with, and do not make substantive changes to, 
the policies that were proposed, subject to notice and comment 
procedures, and adopted in the Medicaid Program; Delay of Effective 
Date for Provision Relating to Manufacturer Reporting of Multiple Best 
Prices Connected to a Value Based Purchasing Arrangement; Delay of 
Inclusion of Territories in Definition of States and United States 
final rule. As a result, the corrections made through this correcting 
document are intended to resolve inadvertent errors so that the 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 
Medicaid Program; Delay of Effective Date for Provision Relating to 
Manufacturer Reporting of Multiple Best Prices Connected to a Value 
Based Purchasing Arrangement; Delay of Inclusion of Territories in 
Definition of States and United States 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 effective date 
for the policies that we previously proposed, received public comment 
on, and subsequently finalized in the final rule. For these reasons, we 
believe there is good cause to waive the requirements for notice and 
comment and delay in effective date.

IV. Correction of Errors

    In FR Doc. 2021-25009 (86 FR 64819), make the following 
corrections:

A. Correction of Errors in the Preamble

    On page 64819 in the second column, correct the DATES section to 
read:

DATES: This rule is effective December 20, 2021. As of December 20, 
2021, the effective date of amendatory instruction 10.a. of the final 
rule published December 31, 2020 at 85 FR 87000 of January 1, 2022 is 
delayed until July 1, 2022.

B. Correction of Errors in the Regulatory Text


Sec.  447.505  [Corrected]

0
On page 64825, remove instruction 3.

Karuna Seshasai,
Executive Secretary to the Department, Department of Health and Human 
Services.
[FR Doc. 2021-27452 Filed 12-16-21; 8:45 am]
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