[Federal Register Volume 89, Number 127 (Tuesday, July 2, 2024)]
[Notices]
[Pages 54824-54825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 
http://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: __, 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/PRA-Listing.

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