Notice2025-09496
Agency Information Collection Activities: Submission for OMB Review; 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
May 28, 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 101 (Wednesday, May 28, 2025)</title>
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[Federal Register Volume 90, Number 101 (Wednesday, May 28, 2025)]
[Notices]
[Pages 22490-22492]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-09496]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10798, CMS-R-235, CMS-359/CMS-360, and CMS-
10069]
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 June 27, 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
[[Page 22491]]
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 to a previously approved information collection; Title:
Application for Part B Immunosuppressive Drug Coverage (Part B-ID);
Use: Sections 226A, 1836(b) and 1837(n) of the Act provide the
statutory authority for this new, limited Medicare entitlement program.
It is stated in Sec. 407.1(a)(6) that, sections 1836(b) and 1837(n) of
the Act provide for coverage of immunosuppressive drugs as described in
section 1861(s)(2)(J) of the Act under Part B beginning on or after
January 1, 2023, for eligible individuals whose benefits under Medicare
Part A and eligibility to enroll in Part B on the basis of ESRD would
otherwise end with the 36th month after the month in which the
individual receives a kidney transplant by reason of section 226A(b)(2)
of the Act.
CMS-10798 provides the necessary information to determine
eligibility and to process the beneficiary's request for enrollment for
in Part B-ID coverage. This form is only used for enrollment by
beneficiaries whose Medicare entitlement based on ESRD would otherwise
end after a successful kidney transplant to continue enrollment under
Medicare Part B only for the coverage of immunosuppressive drugs who
already have Part A, but not Part B.
Form CMS-10798 is completed by the individual or is completed by an
SSA representative using information provided by the Medicare enrollee
during a telephone interview. The form is owned by CMS but not
completed by CMS staff. SSA processes Medicare enrollments on behalf of
CMS. Form Number: CMS-10798 (OMB control number: 0938-1428); Frequency:
Once; Affected Public: Individuals and Households, State, Local, or
Tribal Governments; Number of Respondents: 1,019; Total Annual
Responses: 1,019; Total Annual Hours: 173. (For policy questions
regarding this collection contact Tyrissa Woods at 410-786-0286 or
<a href="/cdn-cgi/l/email-protection#20745952495353410e574f4f445360434d530e4848530e474f56"><span class="__cf_email__" data-cfemail="e9bd909b809a9a88c79e86868d9aa98a849ac781819ac78e869f">[email protected]</span></a>.)
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Data Use
Agreement (DUA) Limited Data Set (LDS) Forms Research Identifiable
Files (FIF) Forms; Use: The Privacy Act of 1974, section 552a requires
the Centers for Medicare & Medicaid Services (CMS) to track all
disclosures of the agency's Personally Identifiable Information (PII).
CMS is also required by the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 and the Federal Information Security
Management Act (FISMA) of 2002 to properly protect all Protected Health
Information (PHI) data maintained by the agency and account for the
disclosure of PHI. When entities, such as academic, Federal or State
agency researchers or CMS contractors request CMS PII/PHI data, they
enter into a Data Use Agreement (DUA) with CMS. The DUA stipulates that
the recipient of CMS data must properly protect the data according to
all applicable data security standards and provide for its appropriate
destruction at the completion of the project/study or the expiration
date of the DUA.
CMS is permitted to disclose data files for approved research
purposes in compliance with 45 CFR 164.512(I). Researchers requesting
limited data set files (LDS) must, as part of the request process,
complete a research request packet that provides CMS with information
pertaining to the research study, including describing how the research
results/findings will be disseminated, as well as the data files being
requested. Should CMS approve the research request, the data requestor
enters into a Data Use Agreement (DUA). This data collection is
necessary to ensure that disclosures of data for research purposes
comply with Federal laws and regulations as well as CMS policy. Form
Number: CMS-R-235 (OMB control number 0938-0734); Frequency:
Occasionally; Affected Public: Private Sector--State, Local, or Tribal
Governments; and Business or other for-profits, Not-for-profits
institutions and Federal Government; Number of Respondents: 7,805;
Total Annual Responses: 7,805; Total Annual Hours: 4,234. (For policy
questions regarding this collection contact Rebecca Dorman at 410-786-
2095 or <a href="/cdn-cgi/l/email-protection#0e7c6b6c6b6d6d6f206a617c636f604e6d637d2066667d20696178"><span class="__cf_email__" data-cfemail="b4c6d1d6d1d7d7d59ad0dbc6d9d5daf4d7d9c79adcdcc79ad3dbc2">[email protected]</span></a>.)
3. Type of Information Collection Request: Reinstatement with
change of a previously approved information collection; Title of
Information Collection: Comprehensive Outpatient Rehabilitation
Facility (CORF) Certification and Survey Forms; Use: This information
collection is for the reinstatement of the CMS-359 and CMS-360 forms.
The purpose of these forms is described below. The form CMS-359 is an
application for health care providers that seek to participate in the
Medicare program as a Comprehensive Outpatient Rehabilitation Facility
(CORF). The form initiates the process for facilities to become
certified as a CORF and it provides the CMS Location and State Survey
Agency (SA) staff identifying information regarding the applicant that
is stored in the Automated Survey Processing Environment (ASPEN)
system.
The form CMS-360 is a survey tool used by the SAs to record
information in order to determine a provider's compliance with the CORF
Conditions of Participation (COPs) and to report this information to
the Federal Government. The form includes basic information on the COP
requirements, check boxes to indicate the level of compliance, and a
section for recording notes. CMS has the responsibility and authority
for certification decisions which are based on provider compliance with
the COPs and this form supports this process. Form Number: CMS-359/360
(OMB control number: 0938-0267); Frequency: Occasionally; Affected
Public: Private Sector (Business or other for-profits); Number of
Respondents: 179; Number of Responses: 31; Total Annual Hours: 241.
(For questions regarding this collection contact Caroline Gallaher
(410) 786-8705.)
4. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of
[[Page 22492]]
Information Collection: Rural Community Hospital Demonstration Program
Application; Use: CMS is requesting the information collection request
previously approved under OMB control number 0938-0880, the Medicare
Waiver Demonstration/Model Application, be reinstated. The approval
lapsed due to an administrative oversight.
The Centers for Medicare & Medicaid Services (CMS) has operated the
statutory Rural Community Hospital (RCH) Demonstration since 2004. The
authorizing statute instructed CMS to test cost-based payment for
Medicare inpatient services for rural hospitals with fewer than 51 beds
that are not eligible to be Critical Access Hospitals (CAH).
The RCH Demonstration Program was initially authorized by section
410A of the Medicare Modernization Act (MMA) of 2003. Following the
initial 5-year authorization, the demonstration has been extended 3
times, each time for an additional 5 years--first, by Sections 3123 and
10313 of the Affordable Care Act; then by section 15003 of the 21st
Century Cures Act; and by section 128 of the Consolidated
Appropriations Act of 2021. Currently, the demonstration has 20
participants out of a maximum of 30 hospitals, and it is scheduled to
end in 2028.
For previous authorizations, CMS has issued a Request for
Applications (RFA) to solicit applications for the demonstration
program. For the last solicitation, in 2017, CMS received 51
applications for 13 open spaces. CMS is planning on a new RFA to fill
the ten spaces that are currently open.
Per the RFA, applications are requested in identical format,
regardless of the specific goals and projects of the individual
applicants. The standardized application format is not controversial,
and it will reduce burden on applicants and reviewers. Responses are
strictly voluntary. The standard format will enable CMS to select
proposals that meet CMS objectives and show the best potential for
success.
The RFA will ask interested hospitals to provide a problem
statement, strategies for ongoing financial viability, goals for
participation in the demonstration, and plans for collaboration with
other providers in the area. Applications will be submitted in the
user-friendly format outlined in the Medicare Waiver Demonstration/
Model Application.
A panel of evaluators will be assembled and utilize a standardized
rubric to score the submitted proposals and identify hospitals with the
highest scores. Results will be used to guide the future of the
Medicare and Medicaid programs and to inform reform initiatives. Form
Number: CMS-10069 (OMB control number: 0938-0880); Frequency: Once;
Affected Public: Business or other for-profits and Not-for-profit
institutions; Number of Respondents: 30; Total Annual Responses: 30;
Total Annual Hours: 2,400. (For policy questions regarding this
collection contact Alexis Lilly at 410-786-3501).
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-09496 Filed 5-27-25; 8:45 am]
BILLING CODE 4120-01-P
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