Notice2024-25009
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
October 28, 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 208 (Monday, October 28, 2024)</title>
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[Federal Register Volume 89, Number 208 (Monday, October 28, 2024)]
[Notices]
[Pages 85538-85539]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-25009]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10912]
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 December 27, 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:
[[Page 85539]]
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-10912 Medicare Transaction Facilitator for 2026 and 2027 under
Sections 11001 and 11002 of the Inflation Reduction Act (IRA)
Information Collection Request
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: New Collection; Title of
Information Collection: Medicare Transaction Facilitator for 2026 and
2027 under Sections 11001 and 11002 of the Inflation Reduction Act
(IRA) 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 (``selected drugs''). In accordance with section 1193(a) of
the Act, any Primary Manufacturer of a selected drug that continues to
participate in the Negotiation Program and reaches agreement upon an
MFP must provide access to the MFP to MFP-eligible individuals, defined
in section 1191(c)(2)(A) of the Act, and to pharmacies, mail order
services, other dispensing entities, providers and suppliers with
respect to such MFP-eligible individuals who are dispensed that
selected drug during a price applicability period. The purpose of this
information collection request (ICR) is for CMS to collect information
from manufacturers of drugs covered under Part D selected for
negotiation under the Inflation Reduction Act for the initial price
applicability years 2026 and 2027 and the dispensing entities that
dispense the selected drugs to MFP-eligible individuals. To facilitate
the effectuation of the MFP, CMS will engage a Medicare Transaction
Facilitator (``MTF''). The MTF system will be composed of two modules:
the MTF Data Module (MTF DM), and the MTF Payment Module (MTF PM).
Medicare Transaction Facilitator Data Elements: The MTF system will
be composed of two modules: the MTF Data Module (MTF DM), and the MTF
Payment Module (MTF PM). Primary Manufacturers participating in the
Negotiation Program are required to participate in the MTF DM. Further,
CMS intends to propose in future rulemaking to require Part D plan
sponsors to include in their pharmacy agreements provisions requiring
dispensing entities to participate in the MTF DM for purposes of data
exchange. As such, for the purposes of this ICR, CMS assumes full
participation in the MTF DM by affected Primary Manufacturers and
dispensing entities. Meanwhile, participation in the MTF PM, for use in
passing through payment from the Primary Manufacturer to dispensing
entities, will be optional for Primary Manufacturers; as a result,
dispensing entities may receive fund transfers from the MTF PM, or via
an alternative process established by a Primary Manufacturer. As
discussed in section 40.4 of the Medicare Drug Price Negotiation
Program: Final Guidance, Implementation of Sections 1191-1198 of the
Social Security Act for Initial Price Applicability Year 2027 and
Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and
2027 (``final guidance''), CMS will engage the MTF DM to facilitate the
exchange of certain claim-level data elements and payment elements for
selected drugs. The data exchange component of the MTF will involve
both the transmission of certain claim-level data elements to the
Primary Manufacturer and receipt of claim-level payment elements from
the Primary Manufacturer. Both Primary Manufacturers and dispensing
entities will need to provide certain information at the onset of their
enrollment in the MTF DM system to facilitate effectuation of the MFP
via refunds from Primary Manufacturers. Both Primary Manufacturers and
dispensing entities will be able to submit complaints and disputes
through their participation in the MTF DM. Primary Manufacturers will
also submit information to fulfill their requirement to provide an MFP
Effectuation Plan and transmit recurring data submissions reflecting
their payment elements, as described in the final guidance. Given these
information collection requirements, this ICR includes the following
forms: (A) Drug Price Negotiation Program MTF DM Dispensing Entity and
Third-Party Support Enrollment Form; (B) Drug Price Negotiation Program
MTF DM Primary Manufacturer Maximum Fair Price (MFP) Effectuation Plan
Form; (C) Drug Price Negotiation Program MTF DM Primary Manufacturer
Payment Elements Form; and (D) Drug Price Negotiation Program Complaint
and Dispute Intake Form. Form Number: CMS-10912 (OMB control number:
0938-New); Frequency: Once and Daily; Affected Public: Private sector,
Business or other for-profit, and individuals; Number of Respondents:
85,853; Total Annual Responses: 93,120; Total Annual Hours: 821,560.
(For policy questions regarding this collection contact Brennan Folsom
at 667-414-0014.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-25009 Filed 10-25-24; 8:45 am]
BILLING CODE 4120-01-P
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