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

CourtCenters For Medicare & Medicaid Services
Citation86 FR 71582
Publication Date17 December 2021
Record Number2021-27452
Federal Register, Volume 86 Issue 240 (Friday, December 17, 2021)
[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]
                =======================================================================
                -----------------------------------------------------------------------
                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.
                -----------------------------------------------------------------------
                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
                

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT