[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Notices]
[Pages 15037-15038]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04935]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers CMS-10834]


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 (the 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 May 9, 2023.

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: 

[[Page 15038]]

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-10834 Requirement for Electronic Prescribing for Controlled 
Substances (EPCS) for a Covered Part D Drug Under a Prescription Drug 
Plan or an MA-PD Plan

    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 Collection

    1. Type of Information Collection Request: New collection (Request 
for a new OMB control number); 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 2025.
    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)(iv), 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-
NEW); Frequency: Annually; Affected Public: Private Sector (Business or 
other for-profits, Not-for-Profit Institutions), and Public sector 
(State, Local or Tribal Governments); Number of Respondents: 100; Total 
Annual Responses: 100; Total Annual Hours: 17. (For policy questions 
regarding this collection contact Mei Zhang at (410) 786-7837).

    Dated: March 7, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-04935 Filed 3-9-23; 8:45 am]
BILLING CODE 4120-01-P