Rule2021-27452
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 17, 2021
Effective
December 20, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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."
Full Text
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<title>Federal Register, Volume 86 Issue 240 (Friday, December 17, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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]
BILLING CODE P
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</html>Indexed from Federal Register on December 17, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.