Notice2025-19284
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
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Published
October 2, 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 189 (Thursday, October 2, 2025)</title>
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[Federal Register Volume 90, Number 189 (Thursday, October 2, 2025)]
[Notices]
[Pages 47766-47767]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19284]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10506 and CMS-10846]
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 November 3, 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. 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 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).
[[Page 47767]]
<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.)
2. Type of Information Collection Request: Revision with of the
currently approved collection; Title: Medicare Part D Manufacturer
Discount Program; Use: Congress enacted the Inflation Reduction Act of
2022, Public Law 117-169 (IRA). Section 11201 of the IRA eliminates the
coverage gap phase of the Part D benefit. It also sunsets the coverage
gap discount program (CGDP) after December 31, 2024, and amends the
Social Security Act (the Act) to add section 1860D-14C, requiring the
Secretary to establish a new Medicare Part D manufacturer discount
program (MDP) beginning January 1, 2025. Under the MDP, participating
manufacturers are required to provide discounts on their ``applicable
drugs'' (brand drugs, biologics, and biosimilars) both in the initial
coverage phase and in the catastrophic coverage phase of the Part D
benefit.
Information in this collection is needed to set up agreements
between manufacturers and CMS. Under section 1860D-14C(a) of the Act,
such agreements are required for manufacturers in order to participate
in the MDP and, under section 1860D43(a) of the Act, for their
applicable drugs to be covered under Part D beginning in 2025. The
information collected from manufacturers in the Health Plan Management
System (HPMS) (Appendix A) is needed to create and execute MDP
agreements and to determine which manufacturers qualify as a specified
manufacturer or specified small manufacturer for phased-in discounts
under section 1860D-14C(g)(4) of the Act. Banking information collected
by the TPA from manufacturers and plan sponsors (Appendix B) is needed
to prepare invoices and process financial transactions (deposits and
payments) through the ACH. Form Number: CMS-10846 (OMB control number:
0938-1451); Frequency: Once; Affected Public: Private sector, Business
or other for-profits and not for profits institutions; Number of
Respondents: 40; Number of Responses: 40; Total Annual Hours: 320. (For
questions regarding this collection, contact Beckie Peyton at (410)
786-1572 or <a href="/cdn-cgi/l/email-protection#680a0d0b03010d46180d111c0706280b051b4600001b460f071e"><span class="__cf_email__" data-cfemail="395b5c5a52505c17495c404d5657795a544a1751514a175e564f">[email protected]</span></a>).
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-19284 Filed 10-1-25; 8:45 am]
BILLING CODE 4120-01-P
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