Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program Draft Guidance; Comment Request, 37229 [2024-09750]

Download as PDF Federal Register / Vol. 89, No. 88 / Monday, May 6, 2024 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–1800–NC3] Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program Draft Guidance; Comment Request Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ draft guidance for the second cycle of the Medicare Drug Price Negotiation Program and manufacturer effectuation of the maximum fair price for 2026 and 2027 for the implementation of the Inflation Reduction Act. This and other Inflation Reduction Act-related guidance can be viewed on the dedicated Inflation Reduction Act section of the CMS website at https://www.cms.gov/ inflation-reduction-act-and-medicare/. DATES: Comments must be received by July 2, 2024. ADDRESSES: Written comments should be sent to IRARebateandNegotiation@ cms.hhs.gov with the relevant subject line, ‘‘Medicare Drug Price Negotiation Program Draft Guidance.’’ FOR FURTHER INFORMATION CONTACT: Elizabeth Daniel, Elizabeth.daniel@ cms.hhs.gov or (667) 290–8793. SUPPLEMENTARY INFORMATION: The Inflation Reduction Act (IRA) (Pub. L. 117–169) was signed into law on August 16, 2022. Sections 11001 and 11002 of the IRA established the Medicare Drug Price Negotiation Program (hereafter the ‘‘Negotiation Program’’) to negotiate maximum fair prices (MFPs) for certain high expenditure, single source drugs and biological products. The requirements for this program are described in sections 1191 through 1198 of the Social Security Act as added by sections 11001 and 11002 of the IRA. The draft guidance describes how CMS intends to implement the Negotiation Program for Initial Price Applicability Year (IPAY) 2027 (January 1, 2027 to December 31, 2027), and specifies the requirements for manufacturer effectuation of the MFPs for 2026 and 2027. To obtain copies of the Negotiation Program draft guidance and other Inflation Reduction Act-related documents, please access the CMS Inflation Reduction Act website by ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:02 May 03, 2024 Jkt 262001 copying and pasting the following web address into your web browser: https:// www.cms.gov/inflation-reduction-actand-medicare. If interested in receiving CMS Inflation Reduction Act updates by email, individuals may sign up for CMS Inflation Reduction Act’s email updates at https://www.cms.gov/About-CMS/ Agency-Information/Aboutwebsite/ EmailUpdates. The Administrator of the Centers for Medicare & Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Evell J. Barco Holland, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Dated: April 30, 2024. Evell J. Barco Holland, Federal Register Liaison, Centers for Medicare & Medicaid Services. [FR Doc. 2024–09750 Filed 5–3–24; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10054] Agency Information Collection Activities: Proposed Collection; Comment Request 37229 information technology to minimize the information collection burden. DATES: Comments must be received by July 5, 2024. ADDRESSES: When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number: ll, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser: https://www.cms.gov/ Regulations-and-Guidance/Legislation/ PaperworkReductionActof1995/PRAListing. FOR FURTHER INFORMATION CONTACT: Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. Contents The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection’s supporting statement and associated materials (see ADDRESSES). CMS–10054 New Technology Services for Ambulatory Payment Classifications under the Outpatient Prospective Payment System Under the PRA (44 U.S.C. 3501– 3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires Federal agencies to publish a 60-day notice in the Federal Register AGENCY: SUMMARY: PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 William N. Parham at (410) 786–4669. SUPPLEMENTARY INFORMATION: E:\FR\FM\06MYN1.SGM 06MYN1

Agencies

[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[Notices]
[Page 37229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09750]



[[Page 37229]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1800-NC3]


Inflation Reduction Act (IRA) Medicare Drug Price Negotiation 
Program Draft Guidance; Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' draft 
guidance for the second cycle of the Medicare Drug Price Negotiation 
Program and manufacturer effectuation of the maximum fair price for 
2026 and 2027 for the implementation of the Inflation Reduction Act. 
This and other Inflation Reduction Act-related guidance can be viewed 
on the dedicated Inflation Reduction Act section of the CMS website at 
https://www.cms.gov/inflation-reduction-act-and-medicare/.

DATES: Comments must be received by July 2, 2024.

ADDRESSES: Written comments should be sent to 
[email protected] with the relevant subject line, 
``Medicare Drug Price Negotiation Program Draft Guidance.''

FOR FURTHER INFORMATION CONTACT: Elizabeth Daniel, 
[email protected] or (667) 290-8793.

SUPPLEMENTARY INFORMATION: The Inflation Reduction Act (IRA) (Pub. L. 
117-169) was signed into law on August 16, 2022. Sections 11001 and 
11002 of the IRA established the Medicare Drug Price Negotiation 
Program (hereafter the ``Negotiation Program'') to negotiate maximum 
fair prices (MFPs) for certain high expenditure, single source drugs 
and biological products. The requirements for this program are 
described in sections 1191 through 1198 of the Social Security Act as 
added by sections 11001 and 11002 of the IRA. The draft guidance 
describes how CMS intends to implement the Negotiation Program for 
Initial Price Applicability Year (IPAY) 2027 (January 1, 2027 to 
December 31, 2027), and specifies the requirements for manufacturer 
effectuation of the MFPs for 2026 and 2027.
    To obtain copies of the Negotiation Program draft guidance and 
other Inflation Reduction Act-related documents, please access the CMS 
Inflation Reduction Act website by copying and pasting the following 
web address into your web browser: https://www.cms.gov/inflation-reduction-act-and-medicare. If interested in receiving CMS Inflation 
Reduction Act updates by email, individuals may sign up for CMS 
Inflation Reduction Act's email updates at https://www.cms.gov/About-CMS/Agency-Information/Aboutwebsite/EmailUpdates.
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this 
document, authorizes Evell J. Barco Holland, who is the Federal 
Register Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

    Dated: April 30, 2024.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2024-09750 Filed 5-3-24; 8:45 am]
BILLING CODE 4120-01-P

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