[Federal Register Volume 90, Number 106 (Wednesday, June 4, 2025)]
[Notices]
[Pages 23687-23689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-10112]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10277, CMS-265-11 and CMS-10916]
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,
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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 August 4, 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
http://www.regulations.gov. 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: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.
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-10277--Medicare and Medicaid Programs: Conditions of Participation
for Hospices
CMS-265-11--Independent Renal Dialysis Facility Cost Report
CMS-10916--13th SOW QIN-QIO and AI/AN Advancing Healthcare Quality
through Technology (AHQT) Readiness Assessment
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 Collections
1. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Medicare and Medicaid Programs: Conditions of Participation
for Hospices; Use: Under the Medicare program, eligible beneficiaries
may receive covered services in a hospice, provided that certain
requirements are met by the hospice. Hospice care means a comprehensive
set of services identified and coordinated by an interdisciplinary
group to provide for the physical, psychosocial, spiritual and
emotional needs of a terminally ill patient and/or family members, as
delineated in a specific patient plan of care.
The information collection requirements (ICRs) described herein are
needed to implement the Medicare Conditions of Participation (CoPs) for
Medicare-participating hospices. The CoPs help assure an adequate level
of patient health and safety in participating hospices and help ensure
that Medicare hospice eligibility requirements are being met. CMS
originally published the Hospice Conditions of Participation on June 5,
2008 (hereinafter ``2008 Final Rule''). The regulations containing the
information collection requirements are located at 42 CFR part 418 of
the Code of Federal Regulations, Subparts B, C and D.
This is a reinstatement of the information collection request that
expired on March 31, 2024. The previous iteration of this OMB Control
Number: 0938-1067 (approved March 23, 2021) had an annual burden of
3,639,215 hours and annual costs of $273,001,454. For this requested
reinstatement, with changes, the total annual burden hours for industry
is 4,032,329 hours and the annual burden costs are $350,449,922. The
10.8% increase in hours is primarily due to the increase in the number
of hospices since the last iteration.
Since the last reinstatement was approved in March 2021, CMS
revised one of the hospice CoPs at 42 CFR 418.76 in the proposed rule,
Medicare Program: FY 2022 Hospice Wage Index and Payment Rate Update,
Hospice Conditions of Participation Updates, Hospice and Home Health
Quality Reporting Program Requirements published on April 14, 2021 (86
FR 19700). As CMS addressed in the final rule (CMS-1754-F) published on
August 4, 2021 (86 FR 42528), the comments received supported the
proposed revisions and did not require any changes to the original
burden estimates in this PRA package. This reinstatement incorporates
the policy changes made to Section 418.76 through this rule and updates
the associated burden estimates based on the original assumptions.
In November 2021, CMS required hospices to develop policies and
procedures as a CoP to ensure all staff were fully vaccinated and the
burden requirements were detailed in OMB Control Number: 0938-0266.
However, CMS removed this requirement and related burden for hospices
(and other facilities) in June 2023. Form Number: CMS-10277 (OMB
control number: 0938-1067); Frequency: Yearly; Affected Public: Private
sector (Business or other for-profit and Not-for-profit institutions);
Number of Respondents: 7,356; Total Annual Responses: 9,209,893; Total
Annual Hours: 4,032,329. (For policy questions regarding this
collection contact Claudia Molinar at 410-786-8445.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Independent Renal
Dialysis Facility Cost Report; Use: Under the authority of sections
1815(a) and 1833(e) of the Act, CMS requires that providers of services
participating in the Medicare program submit information to determine
costs for health care services rendered to Medicare beneficiaries. CMS
requires that providers follow reasonable cost principles under
1861(v)(1)(A) of the Act when completing the Medicare cost report
(MCR). Regulations at 42 CFR 413.20 and 413.24 require that providers
submit acceptable cost reports on an annual basis and maintain
sufficient financial records and statistical data, capable of
verification by qualified auditors.
ESRD facilities participating in the Medicare program submit these
cost reports annually to report cost and statistical data used by CMS
to
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determine reasonable costs incurred for furnishing dialysis services to
Medicare beneficiaries and to effect the year-end cost settlement for
Medicare bad debts. Form Number: CMS-265-11 (OMB control number: 0938-
0236); Frequency: Annually; Affected Public: Private Sector, Business
or other for-profits, State, Local, or Tribal Governments); Number of
Respondents: 7,329; Total Annual Responses: 7,329; Total Annual Hours:
483,714. (For questions regarding this collection contact Keplinger,
Jill C. at 410-786-4550.)
3. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection: 13th
SOW QIN-QIO and AI/AN Advancing Healthcare Quality through Technology
(AHQT) Readiness Assessment; Use: This is a new information collection
request. The Quality Improvement Network--Quality Improvement
Organization (QIN-QIO) program and American Indian/Alaska Native (AI/
AN) program assists providers/practices with high-quality, hands-on
quality improvement assistance toward meeting their needs, and the
healthcare quality and safety goals for beneficiaries. The purpose of
this new information collection within these programs is to assess the
readiness of participating nursing homes, hospitals, outpatient
clinical practices, and AIAN facilities to access, share, and use data
electronically for quality improvement and quality reporting. Use of
health information technology (HIT) is imperative to assess, monitor,
and improve healthcare quality, patient safety, and care coordination.
Many providers/practices continue to lack basic knowledge and
capacity to implement HIT to support data exchange between providers/
practices, payers, and patients, and to use data for improving quality
and outcomes. This ``digital divide'' creates burden for patients,
families, caregivers, providers/practices and increases costs and
administrative waste. This burden is disproportionate for underserved
populations. Advancing the use of technology and using interoperable
standards can reduce the overall cost and burden associated with data
collection and supports communication across the care continuum and is
an agency priority.
CMS has developed a 41-item Assessment of Health care Quality
Technical Readiness (AHQT) for use with participating providers/
practices under the QIN-QIO 13th SOW. Provider/practice burden
associated with the collection and reporting of quality measurement
data has historically been a pain point for the QIN-QIO and AI/AN
programs, especially in outpatient clinical practices and critical
access hospitals; this burden has been a barrier to both achievement of
quality improvement contract goals and proper evaluation of their
impact. The results of the assessment will be used to determine which
providers/practices may benefit from participation in a technical
assistance pilot specific during the QIN-QIO 13th SOW intended to
advance provider/practice capacity for engaging in quality improvement
and reporting activities facilitated by HIT. Form Number: CMS-10916
(OMB control number: 0938-NEW); Frequency: Occasionally; Affected
Public: Private Sector (Business or other for-profit and Not-for-profit
institutions); Number of Respondents: 53,000; Total Annual Responses:
10,600; Total Annual Hours: 10,600. (For policy questions regarding
this collection contact Geoffrey Berryman at 410-299-7390).
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-10112 Filed 6-3-25; 8:45 am]
BILLING CODE 4120-01-P