[Federal Register Volume 90, Number 148 (Tuesday, August 5, 2025)]
[Notices]
[Pages 37515-37516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-14828]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10495, CMS 855S and CMS-R-131]
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 6, 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
CMS-R-131 Advance Beneficiary Notice of Non-coverage
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.
[[Page 37516]]
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 the
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 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.)
3. Title of Information Collection: Advance Beneficiary Notice of
Non-coverage; Type of Information Collection Request: Revision of a
currently approved collection; Use: The use of the Advance Beneficiary
Notice of Non-coverage (ABN) is to inform Medicare beneficiaries of
their liability under specific conditions. This has been available
since the ``limitation on liability'' provisions in section 1879 of the
Social Security Act (the Act) were enacted in 1972 (P.L. 92-603). The
ABN, Form CMS-R-13 was designed to inform Medicare beneficiaries of
their potential financial liability.
ABNs are not given every time items and services are delivered.
Rather, ABNs are given only when a physician, provider, practitioner,
or supplier anticipates that Medicare will not provide payment in
specific cases. An ABN may be given, and the beneficiary may
subsequently choose not to receive the item or service. An ABN may also
be issued because of other applicable statutory requirements other than
Sec. 1862(a)(1) such as when a beneficiary wants to obtain an item
from a supplier who has not met Medicare supplier number requirements,
as listed in section 1834(j)(1) of the Act or when statutory
requirements for issuance specific to HHAs are applicable. Form Number:
CMS-R-131 (OMB control number: 0938-0566); Frequency: Yearly; Affected
Public: Private Sector, Business or other for profits, Not for profits
institutions; Number of Respondents: 1,723,755; Number of Responses:
331,715,277; Total Annual Hours: 38,701,221. (For questions regarding
this collection contact Jennifer McCormick at 410-786-2852 or
[email protected].)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-14828 Filed 8-4-25; 8:45 am]
BILLING CODE 4120-01-P