Inflation Reduction Act (IRA) Revised Program Guidance, 42723 [2023-14097]
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lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 126 / Monday, July 3, 2023 / Notices
Elements under Sections 11001 and
11002 of the Inflation Reduction Act;
Use: Under the authority in sections
11001 and 11002 of the Inflation
Reduction Act of 2022 (Pub. L. 117–
169), the Centers for Medicare &
Medicaid Services (CMS) is
implementing the Medicare Drug Price
Negotiation Program (the ‘‘Negotiation
Program’’), codified in sections 1191
through 1198 of the Social Security Act
(‘‘the Act’’). The Act establishes the
Negotiation Program to negotiate
maximum fair prices (‘‘MFPs’’), defined
at 1191(c)(3) of the Act, for certain high
expenditure, single source selected
drugs covered under Medicare Part B
and Part D. For the first year of the
Negotiation Program, the Secretary of
Health and Human Services (the
‘‘Secretary’’) will select 10 Part D high
expenditure, single source drugs for
negotiation.
The statute requires that CMS
consider certain data from Primary
Manufacturers as part of the negotiation
process. These data include the data
required to calculate non-FAMP for
selected drugs for the purpose of
establishing a ceiling price, as outlined
in section 1193(a)(4)(A), and the
negotiation factors outlined in section
1194(e)(1) for the purpose of
formulating offers and counteroffers
process pursuant to section
1193(a)(4)(B). Some of these data are
held by the Primary Manufacturer and
are not currently available to CMS. Data
described in section 1194(e)(1) and
1193(a)(4) must be submitted by the
Primary Manufacturer.
Section 1194(e)(2) requires CMS to
consider certain data on alternative
treatments to the selected drug. Because
the statute does not specify where these
data come from, CMS will allow for
optional submission from Primary
Manufacturers and the public. CMS will
additionally review existing literature,
conduct internal analyses, and consult
subject matter and clinical experts on
the factors listed in 1194(e)(2) to ensure
consideration of such factors.
Manufacturers may optionally submit
this information as part of their
Negotiation Data Elements Information
Collection Request Form. The public
may optionally submit evidence about
alternative treatments. Form Number:
CMS–10847 (OMB control number:
0938–NEW); Frequency: Occasionally;
Affected Public: Individuals and
Households, Private Sector (Business or
other for-profits and Not-for-profit
institutions); Number of Respondents:
3,300; Total Annual Responses: 3,000;
Total Annual Hours: 17,000. (For policy
questions regarding this collection
VerDate Sep<11>2014
17:10 Jun 30, 2023
Jkt 259001
contact Lara Strawbridge at 410–786–
6880.)
Dated: June 29, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–14176 Filed 6–30–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1800–N]
Inflation Reduction Act (IRA) Revised
Program Guidance
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
the availability of CMS’ revised
guidance for the Medicare Drug Price
Negotiation Program for the
implementation of the Inflation
Reduction Act. CMS will be releasing
additional Inflation Reduction Actrelated guidance; all can be viewed on
the dedicated Inflation Reduction Act
section of the CMS website.
ADDRESSES: Inquiries related to the
revised guidance should be sent to
IRARebateandNegotiation@cms.hhs.gov
with the relevant subject line,
‘‘Medicare Drug Price Negotiation
Program Guidance.’’
SUPPLEMENTARY INFORMATION: The
Inflation Reduction Act was signed into
law on August 16, 2022. Sections 11001
and 11002 of the Inflation Reduction
Act (IRA) (Pub. L. 117–169), signed into
law on August 16, 2022, 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 (hereafter ‘‘the Act’’) as
added by sections 11001 and 11002 of
the Inflation Reduction Act.
To obtain copies of the revised
guidance and the responses to
comments from the initial guidance, as
well as other Inflation Reduction Actrelated documents, please access the
CMS Inflation Reduction Act website by
copying and pasting the following web
address into your web browser: https://
SUMMARY:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
42723
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: June 28, 2023.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2023–14097 Filed 6–30–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2440]
Cardiovascular and Renal Drugs
Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Cardiovascular and Renal
Drugs Advisory Committee. The general
function of the committee is to provide
advice and recommendations to FDA on
regulatory issues. The meeting will be
open to the public. FDA is establishing
a docket for public comment on this
document.
SUMMARY:
The meeting will be held on
September 13, 2023, from 9 a.m. to 4
p.m. Eastern Time.
ADDRESSES: All meeting participants
will be heard, viewed, captioned, and
recorded for this advisory committee
meeting via an online teleconferencing
and/or video conferencing platform.
Answers to commonly asked
questions about FDA advisory
committee meetings may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
DATES:
E:\FR\FM\03JYN1.SGM
03JYN1
]]>Agencies
[Federal Register Volume 88, Number 126 (Monday, July 3, 2023)]
[Notices]
[Page 42723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14097]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1800-N]
Inflation Reduction Act (IRA) Revised Program Guidance
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing the availability of CMS' revised guidance for the Medicare
Drug Price Negotiation Program for the implementation of the Inflation
Reduction Act. CMS will be releasing additional Inflation Reduction
Act-related guidance; all can be viewed on the dedicated Inflation
Reduction Act section of the CMS website.
ADDRESSES: Inquiries related to the revised guidance should be sent to
[email protected] with the relevant subject line,
``Medicare Drug Price Negotiation Program Guidance.''
SUPPLEMENTARY INFORMATION: The Inflation Reduction Act was signed into
law on August 16, 2022. Sections 11001 and 11002 of the Inflation
Reduction Act (IRA) (Pub. L. 117-169), signed into law on August 16,
2022, 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 (hereafter ``the
Act'') as added by sections 11001 and 11002 of the Inflation Reduction
Act.
To obtain copies of the revised guidance and the responses to
comments from the initial guidance, as well as 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: June 28, 2023.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-14097 Filed 6-30-23; 8:45 am]
BILLING CODE 4120-01-P
