Notice2025-18216
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
September 19, 2025
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 (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 90 Issue 180 (Friday, September 19, 2025)</title>
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[Federal Register Volume 90, Number 180 (Friday, September 19, 2025)]
[Notices]
[Pages 45214-45215]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18216]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10595, CMS-10834 and CMS-10511]
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 November 18, 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
<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:
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-10595--QHP Issuers Data Collection for Notices for Plan or Display
Errors Special Enrollment Periods
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
CMS-10511--Medicare Coverage of Items and Services in FDA
Investigational Device Exemption Clinical Studies
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
[[Page 45215]]
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 without change
of a currently approved collection; Title of Information Collection:
QHP Issuers Data Collection for Notices for Plan or Display Errors
Special Enrollment Periods; Use: The Patient Protection and Affordable
Care Act (Pub. L. 111-148) and Health Care and Education Reconciliation
Act of 2010 (Pub. L. 111-152), collectively referred to as the PPACA,
established new competitive private health insurance markets called
Marketplaces, or Exchanges, which gave millions of Americans and small
businesses access to qualified health plans (QHPs), including stand-
alone dental plans (SADPs)--private health and dental insurance plans
that have been certified as meeting certain standards.
In the final rule, the Patient Protection and Affordable Care Act;
HHS Notice of Benefit and Payment Parameters for 2017 (CMS-9937-F), we
finalized 45 CFR 156.1256, which requires QHP issuers, in the case of a
material plan or benefit display error included in 45 CFR
155.420(d)(12), to notify their enrollees of the error and the
enrollees' eligibility for a special enrollment period (SEP) within 30
calendar days after the issuer is informed by an Federally-facilitated
Exchange (FFE) that the error is corrected, if directed to do so by the
FFE. This requirement provides notification to QHP enrollees of errors
that may have impacted their QHP selection and enrollment and any
associated monthly or annual costs, as well as the availability of an
SEP under Sec. 155.420(d)(12) for the enrollee to select a different
QHP, if desired.
The original approved information collection request (ICR) (OMB #:
0938-1301) titled Third Party Payment of QHP Premiums and Additional
Notices for QHP Issuers Data Collection was approved on 9/13/2016. The
ICR was approved with change on 1/3/2020 and most recently approved on
03/01/2023. This ICR serves as the formal request for an extension
without change of a currently approved clearance. Form Number: CMS-
10595 (OMB control number 0938-1301); Frequency: Annually; Affected
Public: Private Sector (business or other for-profits, not-for-profit
institutions) Number of Respondents: 394; Number of Responses: 394;
Total Annual Hours: 152.50. (For questions regarding this collection,
contact Emily Martin at 301-492-4423).
2. 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.)
3. Type of Information Collection Request: Extension of a currently
approved information collection; Title of Information Collection:
Medicare Coverage of Items and Services in FDA Investigational Device
Exemption Clinical Studies; Use: Section 1862(m) of the Social Security
Act (and regulations at 42 CFR Subpart B (sections 405.201-405.215)
allows for payment of the routine costs of care furnished to Medicare
beneficiaries in a Category A investigational device exemption (IDE)
study and authorizes the Secretary to establish criteria to ensure that
Category A IDE trials conform to appropriate scientific and ethical
standards. Medicare does not cover the Category A device itself because
Category A (Experimental) devices do not satisfy the statutory
requirement that Medicare pay for devices determined to be reasonable
and necessary. Medicare may cover Category B (Non-experimental)
devices, and associated routine costs of care, if they are considered
reasonable and necessary and if all other applicable Medicare coverage
requirements are met.
Under the current centralized review process, interested parties
(such as study sponsors) that wish to seek Medicare coverage related to
Category A or B IDE studies have a centralized point of contact for
submission, review and determination of Medicare coverage IDE study
requests. In order for CMS (or its designated entity) to determine if
the Medicare coverage criteria are met, as described in our
regulations, CMS (or its designated entity) must review documents
submitted by interested parties or study sponsors. Such information
submitted will be a FDA IDE approval letter, IDE study protocol, IRB
approval letter, National Clinical Trials (NCT) number, and Supporting
materials as needed. Form Number: CMS-10511 (OMB control number: 0938-
1250); Frequency: Yearly; Affected Public: Private Sector (Business or
other for-profits, Not-for-Profit Institutions); Number of Respondents:
118 Total Annual Responses: 118; Total Annual Hours: 236. (For policy
questions regarding this collection contact Xiufen Sui at 410-786-
3136.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-18216 Filed 9-18-25; 8:45 am]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on September 19, 2025.
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