Notice2023-04935
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
March 10, 2023
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 (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.
Full Text
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<title>Federal Register, Volume 88 Issue 47 (Friday, March 10, 2023)</title>
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[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Notices]
[Pages 15037-15038]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<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:
[[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
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