Notice2025-18979
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
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Published
September 30, 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 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.
Full Text
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<title>Federal Register, Volume 90 Issue 187 (Tuesday, September 30, 2025)</title>
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[Federal Register Volume 90, Number 187 (Tuesday, September 30, 2025)]
[Notices]
[Pages 46895-46897]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18979]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10680, CMS-10844 and CMS-10506]
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 October 30, 2025.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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: <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 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. Title of Information Collection: Electronic Visit Verification
Compliance Survey; Type of Information Collection Request: Extension
without change of a currently approved collection; Use: The web-based
survey will allow states to self-report their progress in implementing
electronic visit verification (EVV) for personal care services (PCS)
and home health care services (HHCS), as required by section 1903(l) of
the Social Security Act. CMS will use the survey data to assess states'
compliance with section 1903(l) of the Act and levy Federal Medical
Assistance Percentage (FMAP) reductions where necessary as required by
section 1903(l) of the Act.
The survey will be disseminated to all 51 state Medicaid agencies
(including the District of Columbia) and the Medicaid agencies of five
US territories. States will be required to complete the survey in order
to demonstrate that they are complaint with section 1903(l) of the Act
by reporting on their EVV implementation status for PCS provided under
sections 1905(a)(24), 1915(c), 1915(i), 1915(j), 1915(k), and Section
1115 of the Act; and HHCS provided under section 1905(a)(7) of the Act
or under a demonstration project or waiver (e.g., section 1915(c) or
1115 of the Act).
The survey will be a live form, meaning states will have the
ability to update their section 1903(l) compliance status on a
continuous basis. As FMAP reductions are assigned quarterly per section
1903(l) of the Act, states who are not in compliance will be asked to
review their survey information on a quarterly basis to ensure it is
up-to-date and to update their survey responses as needed until they
come into compliance. Form Number: CMS-10680 (OMB control number: 0938-
1360); Frequency: On occasion; Affected Public: State, Local, or Tribal
Governments; Number of Respondents: 56; Number of Responses: 336; Total
Annual Hours: 504. (For questions regarding this collection contact
Ryan Shannahan at 410-786-0295.)
2. Type of Information Collection Request: Revision with of a
currently approved collection; Title of Information Collection:
Negotiation Program Drug Selection for Initial Price Applicability Year
2028 under Sections 11001 and 11002 of the Inflation Reduction Act
Information Collection Request; Use: Under the authority in sections
11001 and 11002 of the Inflation Reduction Act of 2022 (Pub. L. 117-
169), the Centers for Medicare & Medicaid Services (CMS) is
implementing the Medicare Drug Price Negotiation Program, codified in
sections 1191 through 1198 of the Social Security Act (the Act). The
information collection request forms for the Small Biotech Exception,
the Biosimilar Delay, and the Selection of Renegotiation-Eligible Drugs
for initial price applicability year 2028 must be submitted to CMS
before CMS establishes the selected drug list for initial price
applicability year 2028.
Small Biotech Exception: In accordance with section 1192(d)(2) of
the Act, the term ``negotiation-eligible drug'' excludes, with respect
to the initial price applicability years 2026, 2027, and 2028, a
qualifying single source drug that meets the requirements for the
exception for small biotech drugs (the ``Small Biotech Exception,'' or
``SBE''). This information is required in order for CMS to accurately
identify whether a given drug meets the criteria for the Small Biotech
Exception in
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accordance with section 1192(d)(2) of the Act. To ensure that drugs
payable under Part B and/or drugs covered under Part D that meet the
requirements for the SBE are excluded from the term ``negotiation-
eligible drug,'' a manufacturer that seeks the SBE for its drug payable
under Part B and/or covered under Part D (``Submitting Manufacturer'')
must submit information to CMS about the company and its products in
order for the drug to be considered for the exception. If the
Submitting Manufacturer seeks the SBE for a drug payable under Part B
and/or covered under Part D it acquired after December 31, 2021, the
Submitting Manufacturer must also submit information related to the
separate entity that had the Medicare Coverage Gap Discount Program
agreement for the drug on December 31, 2021 for drugs covered under
Part D and information related to the holder of the New Drug
Application(s) (NDA)(s) or Biologics License Applications(s) (BLA)(s)
as of December 31, 2021 for drugs payable under Part B. If the
Submitting Manufacturer was acquired by another entity after December
31, 2021, the Submitting Manufacturer must provide information
regarding that acquiring entity for CMS to assess whether the
acquisition triggers the limitation at section 1192(d)(2)(B)(ii) of the
Act.
Biosimilar Delay: In accordance with section 1192(f)(1)(B) of the
Act, the manufacturer of a biosimilar biological product (``Biosimilar
Manufacturer'' of a ``Biosimilar'') may submit a request, prior to the
selected drug publication date, for CMS' consideration to delay the
inclusion of a negotiation-eligible drug that includes the reference
product for the Biosimilar (such a negotiation-eligible drug is herein
referred to as a ``Reference Drug'') on the selected drug list for a
given initial price applicability year (the ``Biosimilar Delay''). This
information is required in order for CMS to accurately determine if a
drug meets the criteria for the Biosimilar Delay for initial price
applicability year 2028 in accordance with section 1192(f) of the Act.
To ensure that the delay of selection and negotiation of biologics is
only applied if there is a high likelihood that the Biosimilar will be
licensed and marketed, a Biosimilar Manufacturer that seeks the
Biosimilar Delay must submit information to CMS related to the
Biosimilar. This information includes identifying information for the
Biosimilar and the Reference Drug; the licensure status of the
Biosimilar; attestations that the Biosimilar Manufacturer is not the
same or treated as the same entity as the Reference Manufacturer, that
the Biosimilar Manufacturer and the Reference Manufacturer (who is the
manufacturer of the Reference Drug) have not entered into an agreement
that requires or incentivizes the Biosimilar Manufacturer to submit the
Biosimilar Delay, or directly or indirectly restricts the quantity of
the Biosimilar that may be sold in the United States over a specified
period of time; and documentation specified under section 1192(f)(3) of
the Act to demonstrate there is a high likelihood that the Biosimilar
will be licensed and marketed within two years of the statutorily-
defined selected drug publication date for initial price applicability
year 2028.
Selection of Renegotiation-Eligible Drugs: Section 1194(f) of the
Act establishes the requirements governing the identification of
renegotiation-eligible drugs and selection of drugs for renegotiation.
CMS will offer Primary Manufacturers \1\ the voluntary option to submit
information to CMS to inform CMS' determinations of which selected
drugs qualify as a renegotiation-eligible drug and may be selected for
renegotiation in accordance with section 1194(f)(3) of the Act.
Specifically, section 1194(f)(2)(D) of the Act instructs CMS to
identify whether a selected drug is eligible for renegotiation because
a new indication has been added to the selected drug and based on a
material change to any of the factors listed in section 1194(e) of the
Act. Form Number: CMS-10844 (OMB control number 0938-1443); Frequency:
Once; Affected Public: Private Sector, Business, and Not-for Profits;
Number of Respondents: 65; Number of Responses: 65; Total Annual Hours:
3,677.50. (For questions regarding this collection contact Elisabeth
Daniel at 667-290-8793.)
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\1\ To the extent that more than one entity meets the statutory
definition of manufacturer (specified in section 1193(a)(1) of the
Act) for a selected drug for purposes of initial price applicability
year 2028, CMS will designate the entity that holds the New Drug
Application(s) (NDA(s))/Biologics License Application(s) (BLA(s))
for the selected drug to be ``the manufacturer'' of the selected
drug (hereinafter the ``Primary Manufacturer'').
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3. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Conditions of Participation for Community Mental Health
Centers and Supporting Regulations; Use: The purpose of this package is
to request a re-instatement with change to the Office of Management and
Budget (OMB) of the collection of information requirements associated
with the conditions of participation (CoPs) that Community Mental
Health Centers (CMHCs) must meet to participate in the Medicare
program.
On October 29, 2013, we published CoPs, for CMHCs (78 FR 64630).
The CoPs included the following: Personnel qualifications (Sec.
485.904); Client Rights (Sec. 485.910); Admission, Initial Evaluation,
Comprehensive Assessment, and Discharge or Transfer of the Client
(Sec. 485.914); Treatment Team, Active Treatment Plan, and
Coordination of Services (Sec. 485.916); Quality Assessment and
Performance Improvement (Sec. 485.917); and Organization, Governance,
Administration of Services, and Partial Hospitalization Services (Sec.
485.918). We finalized emergency preparedness requirements for CMHCs
(Sec. 485.920) in the ``2016 Emergency Preparedness (EP) Final Rule''
published on September 16, 2016 (81 FR 63921). The information
collections associated with the EP CoPs requirements can be found under
OMB Control Number 0938-1325.
On September 30, 2019, we published final rule, ``Medicare and
Medicaid Programs; Regulatory Provisions to Promote Program Efficiency,
Transparency, and Burden Reduction; Fire Safety Requirements for
Certain Dialysis Facilities; Hospital and Critical Access Hospital
(CAH) Changes to Promote Innovation, Flexibility, and Improvement in
Patient Care,'' which revised the CMHC CoPs at Sec. 485.914 (84 FR
51829, 51752 through 51754).
We finalized revisions to the CMHC CoPs in the ``CY 2024 Hospital
Outpatient Prospective Payment and Ambulatory Surgical Center Payment
Systems Final Rule,'' published on November 22, 2023 (88 FR 81540,
82076 through 82079). This final rule revised the following conditions
of participation: Personnel qualifications (Sec. 485.904), Admission,
Initial Evaluation, Comprehensive Assessment, and Discharge or Transfer
of the Client (Sec. 485.914); Treatment Team, Person-Centered Active
Treatment Plan, and Coordination of Services (Sec. 485.916); and
Organization, Governance, Administration of Services, Partial
Hospitalization Services (Sec. 485.918).
Medicare Part B covers partial hospitalization (PHP) services and
intensive outpatient (IOP) services furnished by or under arrangements
made by the CMHC if they are provided by a CMHC as defined in 42 CFR
410.110. Section 4162 of the Omnibus Budget Reconciliation Act of 1990
(OBRA 1990) (Pub. L. 101-508) amended sections 1832(a)(2) and
1861(ff)(3) of the Act to allow CMHCs to provide PHP services.
Furthermore, the
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Consolidated Appropriations Act (CAA), 2023 (Pub. L. 117-238)
established in section 4124 coverage of IOP services in CMHCs. The
legislation extended Medicare coverage and payment of IOP services
furnished by a CMHC beginning January 1, 2024, adding to the existing
coverage and payment for PHP services in CMHCs. Section 4121 of the
CAA, 2023 also established a new Medicare benefit category for services
furnished and directly billed by Mental Health Counselors (MHCs) and
Marriage and Family Therapists (MFTs).
The services provided by CMHCs must be furnished by, or under
arrangement with a CMHC participating in the Medicare program. They
must include the following:
<bullet> Prescribed by a physician and furnished under the general
supervision of a physician.
<bullet> Subject to certification by a physician in accordance with
42 CFR 424.24(e)(1).
<bullet> Furnished under a treatment plan that meets the
requirements of 42 CFR 424.24(e)(2).
<bullet> Provides outpatient services, including specialized
outpatient services for children, elderly individuals, individuals with
serious mental illness, and residents of its mental health service area
who have been discharged from inpatient mental health facilities.
<bullet> Provides 24-hour-a-day emergency care services.
<bullet> Provides day treatment, partial hospitalization services
(PHP) or intensive outpatient services (IOP) other than an individual's
home or in an inpatient or residential setting, or psychosocial
rehabilitation services.
<bullet> Provides screening for clients being considered for
admission to State mental health facilities to determine the
appropriateness of such services unless otherwise directed by State
law.
<bullet> Meets applicable licensing or certification requirements
for CMHCs in the state in which it is located.
<bullet> Provides at least 40 percent of its services to
individuals who are not eligible for benefits under title XVIII of the
Act.
We collect information on several health and safety aspects, such
as Client rights (Sec. 485.910) active treatment plans (Sec.
485.916), Quality assessment and performance improvement (Sec.
485.917), and governance (Sec. 485.918).
The primary users of this information will be Federal and State
agency surveyors for determining through the survey process, whether a
CMHC qualifies for approval or re-approval under Medicare. CMS and its
contractors will use this information to review claims to determine
whether the patient is eligible for the PHP or IOP benefit and whether
the claim meets the criteria for coverage and Medicare payment. Lastly,
the information will be used by CMHCs to ensure their own compliance
with all requirements to assist in guiding their patient care and
quality programs. Form Number: CMS-10506 (OMB control number: 0938-
1245); Frequency: Occasionally; Affected Public: Private sector--
Business or other for-profits and Not-for-profit organizations; Number
of Respondents: 1,475; Total Annual Responses: 7,420; Total Annual
Hours: 1,434. (For policy questions regarding this collection contact
Claudia Molinar at 410-786-8445.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-18979 Filed 9-29-25; 8:45 am]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on September 30, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.