[Federal Register Volume 90, Number 240 (Wednesday, December 17, 2025)]
[Notices]
[Page 58566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-23116]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10834]
Agency Information Collection Activities: Submission for OMB
Review; 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 a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate 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 on the collection(s) of information must be received by
the OMB desk officer by January 16, 2026.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
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 Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(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 (44 U.S.C. 3506(c)(2)(A)) requires
federal agencies to publish a 30-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 that
summarizes the following proposed collection(s) of information for
public comment.
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Requirement for
Electronic Prescribing for Controlled Substances (EPCS) for a Covered
Part D Drug Under a Prescription Drug Plan or an MA-PD Plan; Use:
Section 2003 of the SUPPORT for Patients and Communities Act of 2018
requires that prescribing of a Schedule II, III, IV, and V controlled
substance under Medicare Part D be done electronically in accordance
with an electronic prescription drug program beginning January 1, 2021,
subject to any exceptions, which HHS may specify. In the calendar year
(CY) 2021 and 2022 Physician Fee Schedule (PFS) final rules, CMS
finalized the electronic prescribing for controlled substances (EPCS)
requirements and exceptions at 42 CFR 423.160(a)(5). Compliance for
prescribers not in long-term care facilities begins in CY 2023.
Compliance for prescribers in long-term care facilities begins in CY
2028.
EPCS requirements do not require prescribers or pharmacies to
submit additional data to CMS; however, CMS did finalize one exception
that requires data collection. The EPCS exception, at Sec.
423.160(a)(5)(iii), requires a prescriber to apply for a waiver if the
prescriber is unable to conduct EPCS due to circumstances beyond the
prescriber's control. This collection of information is necessary to
provide adequate and timely exception from the EPCS requirements if the
prescriber is unable to conduct EPCS due to circumstances beyond the
prescriber's control. Form Number: CMS-10834 (OMB control number: 0938-
1455); Frequency: Annually; Affected Public: Public sector (State,
Local or Tribal Governments), Private sector (Business or other for-
profits and Not-for-profit institutions); Number of Respondents: 306;
Total Annual Responses: 306; Total Annual Hours: 52. (For policy
questions regarding this collection contact Carrie Sena at 410-786-
8003.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-23116 Filed 12-16-25; 8:45 am]
BILLING CODE 4120-01-P