Notice2024-14582
Agency Information Collection Activities: Proposed Collection; Comment Request
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
July 2, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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 information technology to minimize the information collection burden.
Full Text
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<title>Federal Register, Volume 89 Issue 127 (Tuesday, July 2, 2024)</title>
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[Federal Register Volume 89, Number 127 (Tuesday, July 2, 2024)]
[Notices]
[Pages 54824-54825]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-14582]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10849 and CMS-10516]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
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SUMMARY: 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
information technology to minimize the information collection burden.
DATES: Comments must be received by September 3, 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
<a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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: __, 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: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</a>.
FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION:
Contents
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-10849--Negotiation Data Elements and Drug Price Negotiation Process
for Initial Price Applicability Year 2027 under Sections 11001 and
11002 of the Inflation Reduction Act Information Collection Request
CMS-10516--Program Integrity: Exchange, Premium Stabilization
[[Page 54825]]
Programs, and Market Standards; Amendments to the HHS Notice of Benefit
and Payment Parameters for 2014; Final Rule II
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 concerning each
proposed collection of information, including each proposed extension
or reinstatement of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, CMS is publishing this notice.
Information Collections
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Negotiation Data
Elements and Drug Price Negotiation Process for Initial Price
Applicability Year 2027 under Sections 11001 and 11002 of the Inflation
Reduction Act Information Collection Request; 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, 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 second year of the Negotiation Program, the
Secretary of Health and Human Services (the ``Secretary'') will select
up to 15 high expenditure, single source drugs covered under Part D for
negotiation.
Negotiation Data Elements: The statute requires that CMS consider
certain data from Primary Manufacturers as part of the negotiation
process. To the extent that more than one entity meets the statutory
definition of manufacturer (specified in section 1193(a)(1) of the Act)
for a selected drug for purposes of initial price applicability year
2027, CMS will designate the entity that holds the New Drug
Application(s) (NDA(s))/Biologics License Application(s) (BLA(s)) for
the selected drug to be ``the manufacturer'' of the selected drug
(hereinafter the ``Primary Manufacturer''). The Primary Manufacturer's
data submissions include non-FAMP and related data for selected drugs
for the purpose of establishing a ceiling price, as outlined in section
1193(a)(4)(A) of the Act, and the negotiation factors outlined in
section 1194(e)(1) of the Act for the purpose of formulating offers and
counteroffers process pursuant to section 1193(a)(4)(B) of the Act.
Some of these data are held by the Primary Manufacturer and are not
currently available to CMS. Data described in sections 1194(e)(1) and
1193(a)(4) of the Act must be submitted by the Primary Manufacturer.
Section 1194(e)(2) of the Act requires CMS to consider certain data
on selected drugs and their alternative treatments. 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
section 1194(e)(2) of the Act. Manufacturers may optionally submit this
information as part of their Negotiation Data Elements Information
Collection Request Form. The public may also optionally submit evidence
about the selected drugs and their alternative treatments.
Drug Price Negotiation Process: Any MFPs that are negotiated for
these selected drugs will apply beginning in initial price
applicability year 2027. For initial price applicability year 2027, the
negotiation period begins on the earlier of the date that the Primary
Manufacturer enters into a Medicare Drug Price Negotiation Program
Agreement or February 28, 2025.
Section 1194(b)(2)(C) of the Act provides that if the Primary
Manufacturer does not accept CMS' written initial offer, the Primary
Manufacturer may submit an optional written counteroffer no later than
30 days after the date of receipt of CMS' written initial offer. If the
Primary Manufacturer chooses to develop and submit a written
counteroffer to CMS' written initial offer during the drug price
negotiation process for initial price applicability year 2027, the
Primary Manufacturer must submit the Counteroffer Form. CMS is also
considering expanded use of the Counteroffer Form within the drug price
negotiation process. Form Number: CMS-10849 (OMB control number: 0938-
1452); Frequency: Once; Affected Public: Private Sector, Business or
other for-profits; Number of Respondents: 340; Number of Responses:
340; Total Annual Hours: 16,264. (For policy questions regarding this
collection contact Elisabeth Daniel at 667-290-8793.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Program
Integrity: Exchange, Premium Stabilization Programs, and Market
Standards; Amendments to the HHS Notice of Benefit and Payment
Parameters for 2014; Final Rule II; Use: On March 23, 2010, the Patient
Protection and Affordable Care Act (PPACA; Pub. L. 111-148) was signed
into law and on March 30, 2010, the Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111-152) was signed into law. The
two laws implement various health insurance policies. On June 19, 2013,
the Department of Health and Human Services (HHS) published proposed
rule CMS-9957-P: Program Integrity: Exchanges, SHOP, Premium
Stabilization Programs, and Market Standards (78 FR 37302) (Program
Integrity Proposed Rule) which, among other things, contained third
party disclosure requirements and data collections that supported the
oversight of premium stabilization programs, State Exchanges, and
qualified health plan (QHP) issuers in Federally-facilitated Exchanges
(FFEs). Parts of the proposed rule were finalized as Patient Protection
and Affordable Care Act; Program Integrity: Exchange, Premium
Stabilization Programs, and Market Standards; Amendments to the HHS
Notice of Benefit and Payment Parameters for 2014; Final Rule (Program
Integrity Final Rule II), 78 FR 25326 (October 24, 2013). This ICR
relates to a portion of the information collection request (ICR)
requirements set forth in the final rule. Form Number: CMS-10516 (OMB
control number: 0938-1277); Frequency: Annually; Affected Public:
Private Sector, State, Local, or Tribal Governments; Business or other
for-profits, and Not-for Profits; Number of Respondents: 457; Number of
Responses: 457; Total Annual Hours: 42,771. (For questions regarding
this collection, contact Andrea Honig at (301) 492-4147.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-14582 Filed 7-1-24; 8:45 am]
BILLING CODE 4120-01-P
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