[Federal Register Volume 90, Number 157 (Monday, August 18, 2025)]
[Notices]
[Pages 40073-40074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-15616]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10495 and CMS-855S]


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 October 17, 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 
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-10495 Data Collection and Submission for Open Payments
CMS-855S Medicare Enrollment Application: Durable Medical Equipment, 
Prosthetics, Orthotics, and Supplies (DMEPOS) 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: Extension of a currently 
approved collection; Title of Information Collection: Registration, 
Attestation, Dispute Resolution and Correction, Assumptions Document 
and Data Retention Requirements for Open Payments; Use: The Patient 
Protection and Affordable Care Act was enacted on March 23, 2010 (Pub. 
L. 111-148). This statute amended section 1128 of the Social Security 
Act (the Act) by adding a new subsection G that requires applicable 
manufacturers of drugs, devices, biologics, or medical supplies covered 
under title XVIII of the Act (Medicare) or a State plan under title XIX 
(Medicaid) or XXI of the Act (the Children's Health Insurance Program, 
or CHIP) to report annually to the Secretary certain payments or other 
transfers of value to physicians and teaching hospitals. Section 1128G 
of the Act also requires applicable manufacturers and applicable group 
purchasing organizations (GPOs) to report certain information regarding 
the ownership or investment interests held by physicians or the 
immediate family members of physicians in such entities, as well as any 
payments provided to such physicians. The submitted information 
facilitates various aspects of the program. The information collected 
through the registration process is used by CMS to validate 
registration for applicable manufacturers, applicable GPOs, covered 
recipients, and physician owners or investors that are registering for 
Open Payments. Details collected during the dispute resolution and 
correction process allows CMS to notify applicable manufacturers and 
applicable GPOs that a covered recipient or physician owner or investor 
is initiating a dispute regarding data submitted about them and allow 
CMS to relay the nature of the dispute. The assumptions documents 
submitted by applicable manufacturers or applicable GPOs assist CMS in 
providing guidance (for example, determining form and nature of payment 
categories, calculating the value of a payment, determining the date of 
payment, and reporting the terms of an ownership or investment 
interest). Form Number: CMS-10495 (OMB control number: 0938-1237); 
Frequency: Annually; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 1,788; Total Annual Responses: 
1,788; Total Annual Hours: 1,950,948. For policy questions regarding 
this collection contact Kathleen Ott at 410-786-4246.
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare 
Enrollment Application--Durable Medical Equipment, Prosthetics, 
Orthotics and Supplies (DMEPOS) Suppliers; Use: The primary function of 
the Form CMS-855S Medicare enrollment application for suppliers of 
durable medical equipment, prosthetics, orthotics, and supplies 
(DMEPOS) is to gather information from the supplier that tells us who 
the supplier is, whether the supplier meets certain qualifications to 
be a Medicare DMEPOS supplier, where the supplier practices or renders 
services, and other information

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necessary to establish correct claims payments. Form Number: CMS-855S 
(OMB control number: 0938-1056); Frequency: Yearly; Affected Public: 
Private Sector, Business or other for-profits and Not-for-profit 
institutions; Number of Respondents: 32,790; Total Annual Responses: 
32,790; Total Annual Hours: 67,886. (For policy questions regarding 
this collection contact Frank Whelan at 410-786-1302.)

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-15616 Filed 8-15-25; 8:45 am]
BILLING CODE 4120-01-P