Notice2025-11324
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
June 20, 2025
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
<html>
<head>
<title>Federal Register, Volume 90 Issue 117 (Friday, June 20, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 117 (Friday, June 20, 2025)]
[Notices]
[Pages 26301-26302]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11324]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10501, CMS-10846 and CMS-10578]
Agency Information Collection Activities: Proposed Collection;
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' 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 August 19, 2025.
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-10501 Healthcare Fraud Prevention Partnership (HFPP): Data Sharing
and Information Exchange
CMS-10846 Medicare Part D Manufacturer Discount Program
CMS-10578 Emergency Preparedness Requirements for Medicare and Medicaid
Providers Participating Providers and Suppliers
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 currently
approved collection; Title: Healthcare Fraud Prevention Partnership
(HFPP) Data Sharing and Information Exchange; Use: Section 1128C(a)(2)
of the Social Security Act (42 U.S.C. 1320a-7c(a)(2)) authorizes the
Secretary and the Attorney General to consult, and arrange for the
sharing of data with, representatives of health plans for purposes of
establishing a Fraud and Abuse Control Program as specified in Section
1128(C)(a)(1) of the Social Security Act. The result of this authority
has been the establishment of the HFPP. The HFPP was officially
established by a Charter in the fall of 2012 and signed by HHS
Secretary Sibelius and U.S. Attorney General Holder. In December 2020,
President Trump signed into law H.R.133--Consolidated Appropriations
Act, 2021, which amended Section 1128C(a) of the Social Security Act
(42 U.S.C. 1320a-7c(a)) providing explicit statutory authority for the
Healthcare Fraud Prevention Partnership including the potential
expansion of the public-private partnership analyses.
Data sharing within the HFPP primarily focuses on conducting
studies for the purpose of combatting fraud, waste, and abuse. These
studies are intended to target specific vulnerabilities within the
payment systems in both the public and private healthcare sectors. The
HFPP and its committees design and develop studies in coordination with
the TTP. The core function of the TTP is to manage and execute the HFPP
studies within the HFPP. Form Number: CMS-10501 (OMB control number:
0938-1251); Frequency: Occasionally; Affected Public: Private sector
(Business or other for-profits); Number of Respondents: 28; Number of
Responses: 28; Total Annual Hours: 120. (For questions regarding this
collection, contact Maricruz Bonfante at (410-786-5086).
[[Page 26302]]
2. Type of Information Collection Request: Revision with change of
the currently approved collection; Title: Medicare Part D Manufacturer
Discount Program; Use: Congress enacted the Inflation Reduction Act of
2022, Public Law 117-169 (IRA). Section 11201 of the IRA eliminates the
coverage gap phase of the Part D benefit. It also sunsets the coverage
gap discount program (CGDP) after December 31, 2024, and amends the
Social Security Act (the Act) to add section 1860D-14C, requiring the
Secretary to establish a new Medicare Part D manufacturer discount
program (MDP) beginning January 1, 2025. Under the MDP, participating
manufacturers are required to provide discounts on their ``applicable
drugs'' (brand drugs, biologics, and biosimilars) both in the initial
coverage phase and in the catastrophic coverage phase of the Part D
benefit.
Information in this collection is needed to set up agreements
between manufacturers and CMS. Under section 1860D-14C(a) of the Act,
such agreements are required for manufacturers in order to participate
in the MDP and, under section 1860D43(a) of the Act, for their
applicable drugs to be covered under Part D beginning in 2025. The
information collected from manufacturers in the Health Plan Management
System (HPMS) (Appendix A) is needed to create and execute MDP
agreements and to determine which manufacturers qualify as a specified
manufacturer or specified small manufacturer for phased-in discounts
under section 1860D-14C(g)(4) of the Act. Banking information collected
by the TPA from manufacturers and plan sponsors (Appendix B) is needed
to prepare invoices and process financial transactions (deposits and
payments) through the ACH. Form Number: CMS-10846 (OMB control number:
0938-1451); Frequency: Once; Affected Public: Private sector, Business
or other for-profits and Not-for-profits institutions; Number of
Respondents: 200; Number of Responses: 200; Total Annual Hours: 320.
(For questions regarding this collection, contact Maricruz Bonfante at
(410-786-5086).
3. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Emergency Preparedness Requirements for Medicare and
Medicaid Providers Participating Providers and Suppliers; Use: This is
a reinstatement of the information collection request that expired on
January 31, 2023. The previous iteration of this OMB Control Number:
0938-1325 had a burden of 1,260,474 annual hours. For this requested
reinstatement, with changes, the total annual burden hours for industry
is 1,251,158 hours and the annual burden costs are $401,106,506.
Emergency Preparedness information collections were established as
a result of the Omnibus final rule ``Medicare and Medicaid Programs;
Emergency Preparedness Requirements for Medicare and Medicaid
Participating Providers and Suppliers,'' 81 FR 63860 (September 16,
2016) (hereinafter ``2016 Final Rule''). This information collection
request captures the burden necessary for existing providers and
suppliers to maintain their emergency preparedness collection of
information requirements. This request also captures the burden to
develop and implement the emergency preparedness requirements for newly
approved Medicare and Medicaid providers and suppliers, also referred
to as facilities.
This information collection (``IC'') is an ``Omnibus'' request. The
emergency preparedness Conditions of Participation (CoPs) apply to the
19 Medicare and Medicaid providers that are listed in the next section.
However, for reasons discussed below, this information collection
request captures the burden for 17 of the affected Medicare and
Medicaid providers and suppliers.
This is a departure, as we normally submit information collection
requests (``ICRs'') by provider and supplier type. For example, the
collection of information(s) stemming from the Conditions of
Participation for the ``Hospital'' provider type are under OMB Control
Number: 0938-0328. The collection of information(s) stemming from the
Conditions of Participations for the ``Hospice'' provider type are
under OMB Control Number: 0938-1067, etc. We make this exception for
continuity and simplicity. We continue to cross reference this
emergency preparedness IC in each provider type's individual
information collection request.
In response to past terrorist attacks, natural disasters, and the
subsequent national need to refine the nation's strategy to handle
emergency situations, there continues to be a coordinated effort across
Federal agencies to establish a foundation for development and
expansion of emergency preparedness systems.
This reinstatement includes a new facility type, Rural Emergency
Hospitals (REHs), which was created in 2021, after the prior
reinstatement for this package had been approved in 2020. Congress
introduced the designation Rural Emergency Hospitals (REHs) as part of
the Consolidated Appropriations Act of 2021 (Pub. L. 116-260), which is
codified at 42 United States Code Sec. 1395x(kkk)(1) or Section
1861(kkk)(1) of the Social Security Act. REHs are subject to the
Emergency Preparedness CoPs per 42 CFR 485.542 and are similar to the
Critical Access Hospital (CAH's) Emergency Preparedness CoPs. Form
Number: CMS-10578 (OMB control number 0938-1325); Frequency: Annually;
Affected Public: Private Sector: Business or other for-profits and Not-
for-profits institutions; Number of Respondents: 60,712; Total Annual
Responses: 80,915; Total Annual Hours: 1,251,158. (For policy questions
regarding this collection contact Claudia Molinar at 410-786-8445.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-11324 Filed 6-18-25; 8:45 am]
BILLING CODE 4120-01-P
</pre></body>
</html>Indexed from Federal Register on June 20, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.