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Proposed Rule2026-22812

Medicare and Medicaid Programs; Cutting Administrative Requirements for Excellence in Patient Care

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Published

November 10, 2026

Issuing agencies

Health and Human Services DepartmentCenters for Medicare & Medicaid Services

Abstract

This proposed rule would reform Medicare and Medicaid regulations deemed obsolete or excessively burdensome on healthcare providers and suppliers, with the objective of reducing costs, enhancing flexibility in delivering innovative care, and streamlining existing regulations. This reform seeks to enable healthcare professionals to devote more resources to improving patient care by eliminating or minimizing requirements that impede quality patient care or that divert resources away from furnishing high quality patient care.

Full Text

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<title>Federal Register, Volume 91 Issue 216 (Tuesday, November 10, 2026)</title>
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[Federal Register Volume 91, Number 216 (Tuesday, November 10, 2026)]
[Proposed Rules]
[Pages 72634-72767]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-22812]

[[Page 72633]]

Vol. 91

Tuesday,

No. 216

November 10, 2026

Part II

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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42 CFR Parts 403, 416, et al.

Medicare and Medicaid Programs; Cutting Administrative Requirements for
Excellence in Patient Care); Proposed Rule

Federal Register / Vol. 91, No. 216 / Tuesday, November 10, 2026 /
Proposed Rules

[[Page 72634]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 403, 416, 418, 438, 442, 460, 482, 483, 485, and 494

[CMS-3484-P]
RIN 0938-AW04

Medicare and Medicaid Programs; Cutting Administrative
Requirements for Excellence in Patient Care

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).

ACTION: Proposed rule.

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SUMMARY: This proposed rule would reform Medicare and Medicaid
regulations deemed obsolete or excessively burdensome on healthcare
providers and suppliers, with the objective of reducing costs,
enhancing flexibility in delivering innovative care, and streamlining
existing regulations. This reform seeks to enable healthcare
professionals to devote more resources to improving patient care by
eliminating or minimizing requirements that impede quality patient care
or that divert resources away from furnishing high quality patient
care.

DATES: To be assured consideration, comments must be received at one of
the addresses provided below, by January 11, 2027.

ADDRESSES: In commenting, please refer to file code CMS-3484-P.
Comments, including mass comment submissions, must be submitted in one
of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to <a href="https://www.regulations.gov/docket/CMS-2026-3631">https://www.regulations.gov/docket/CMS-2026-3631</a>. Follow
the ``Submit a comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-3484-P, P.O. Box 8010,
Baltimore, MD 21244-8010.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-3484-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the ``SUPPLEMENTARY INFORMATION'' section.

FOR FURTHER INFORMATION CONTACT: CMS Health and Safety Inquiries, 410-
786-6633, <a href="/cdn-cgi/l/email-protection#38705d59544c5059565c6b595e5d4c417156494d514a515d4b785b554b1650504b165f574e">[email&#160;protected]</a>, for further information
related to the following: Ongoing and public health emergency (PHE)
respiratory illness data reporting for hospitals, critical access
hospitals, long-term care facilities and rural emergency hospitals;
obstetrical services quality assessment and performance improvement,
all staff trainings, and critical access hospital co-location; long-
term care facility staff COVID-19 vaccination education and Ombudsman
notice; intermediate care facility for individuals with intellectual
disabilities staff vaccination education; and Life Safety Code, Health
Care Facilities Code, and Emergency and Standby Powers Systems Code.
<a href="/cdn-cgi/l/email-protection#266265717443564954524f484166454b55084e4e5508414950">[email&#160;protected]</a>, for further information related to Medicaid
institutional payment transparency reporting.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments
received before the close of the comment period are available for
viewing by the public, including any personally identifiable or
confidential business information that is included in a comment. We
post all comments received before the close of the comment period on
the following website as soon as possible after they have been
received: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the search instructions
on that website to view public comments. CMS will not post on
<a href="http://Regulations.gov">Regulations.gov</a> public comments that make threats to individuals or
institutions or suggest that the commenter will take actions to harm an
individual. CMS continues to encourage individuals not to submit
duplicative comments. We will post acceptable comments from multiple
unique commenters even if the content is identical or nearly identical
to other comments.
Plain Language Summary: In accordance with 5 U.S.C. 553(b)(4), a
plain language summary of this proposed rule may be found at <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.

I. Background

A. Executive Summary

The Centers for Medicare & Medicaid Services (CMS) is committed to
incorporating and integrating ongoing retrospective review of
regulations to achieve a more streamlined and effective regulatory
framework. CMS routinely reviews its regulations to identify
opportunities to strengthen the patient health and safety requirements
by revising the Conditions of Participation (CoPs), Conditions for
Coverage (CfCs), Conditions for Certification, and Requirements for
Participation, (collectively referred to as CoPs).
We conducted a comprehensive review of the CoPs for all 21 provider
and supplier types with the objectives of improving the quality of
existing regulations consistent with statutory requirements;
streamlining procedural solutions; maximizing net benefits (including
benefits that are difficult to quantify); and reducing costs and other
burdens on facilities to comply with regulations. We identified
obsolete and burdensome regulations that could be eliminated or
reformed to enhance the effectiveness of facility operations and reduce
unnecessary burden or other costs, with a particular focus on freeing
up resources that health care providers could otherwise use to improve
patient health and safety. We have also identified unnecessary and
burdensome reporting requirements that can be eliminated to improve the
efficiency of the Medicaid program.
Relationship of This Rulemaking to Future Reforms: We are committed
to working with, and welcome suggestions for future rulemaking from,
interested parties to identify other reforms to the CoPs that would
improve patient health and safety while reducing unnecessary burden on
health care facilities and entities or improve flexibility in meeting
the Federal requirements.

B. Summary of Major Provisions

We propose to reduce regulatory burden on providers and suppliers
by modifying, removing, or streamlining current regulations that we now
believe are excessively burdensome. We note that the appropriate term
for the individual receiving care and/or services differs depending
upon the facility type, such as hospital ``patients'' and Intermediate
Care Facilities for Individuals with Intellectual Disabilities (ICFs/
IID) ``clients.'' When discussing each individual provider or supplier
type, we use the appropriate term; however, when discussing all or
multiple provider or supplier types we will use the general term
``patient.'' Similarly, despite the different terms used for specific
entities (such as campus, center, clinic, facility, organization, or
program), when we are discussing all or multiple entities, we will use
the general term ``facility.''

[[Page 72635]]

1. Hospitals
For hospitals, we propose to remove the recently finalized staff
training requirements for transfer protocols, emergency services
readiness, and obstetrics (OB) care, as well as OB-specific quality
assessment and performance improvement (QAPI) requirements. We are also
proposing policies that address informed consent requirements and
policies and procedures that aim to support families' ability to
request collection of birth tissues, including for cultural, religious,
or personal reasons in hospitals.
2. Long Term Care (LTC) Facilities
For LTC facilities, we propose to revise the facility assessment
requirement by removing the requirement for the active involvement of
representatives of direct care staff in conducting the LTC facility
assessment. We also propose to revise the infection control requirement
to remove the ongoing (weekly) acute respiratory illness data reporting
requirements and amend the reporting requirements during a Public
Health Emergency (PHE) to include the data elements originally
specified in the ongoing data reporting section. We are also proposing
to remove requirements related to educating staff about COVID-19
vaccine and its benefits and risks, offering it to them, and
documenting these actions.
Additionally, we propose to revise the physical environment
requirements to exempt existing facilities from the room occupancy and
bathroom facility standards when there is a change of ownership (CHOW)
for the facility or a lapse in and restoration of a facility's
certification. We also propose to remove the requirement for LTC
facilities to provide Ombudsman notice of resident transfers related to
emergent care and solicit public comment regarding additional changes
to the Ombudsman notice. Finally, we solicit public comment on the role
of physician assistants and nurse practitioners in delivering resident
care.
3. Intermediate Care Facilities for Individuals With Intellectual
Disabilities (ICFs/IID)
For ICFs/IID, we propose to remove requirements related to
educating staff about the COVID-19 vaccine and its benefits and risks
and offering it to them.
4. Rural Emergency Hospitals (REHs)
For REHs, we propose to remove expired COVID-19 requirements
related to ongoing data reporting and staff vaccination regulations. We
propose to remove the data reporting requirement during a PHE to reduce
burden. We also propose to update the emergency preparedness
requirement to revise the point of contact that REHs may use to obtain
copies of standards that are incorporated by reference and to correct
an inaccurate cross-reference.
5. Critical Access Hospitals (CAHs)
For CAHs, we propose revising the regulation to clarify current CMS
policy that CAH distance eligibility determinations are based on
proximity to hospitals that provide acute inpatient care services,
including other CAHs, rather than hospitals that provide only specialty
services, such as psychiatric hospitals, long-term care hospitals
(LTCHs), or rehabilitation hospitals. We also propose adding a
requirement that implements section 241 of the Consolidated
Appropriations Act, 2026 (Pub. L. 119-75), that revised the application
of the statutory distance requirement in specified circumstances as set
forth in the law. In addition, we propose to remove recently finalized
staff training requirements for emergency services readiness, and
obstetrical (OB) care, as well as OB-specific quality assessment and
improvement (QAPI) requirements. We are also proposing policies that
address informed consent requirements and policies and procedures that
aim to support families' ability to request collection of birth
tissues, including for cultural, religious, or personal reasons in
CAHs.
6. Life Safety Code (LSC) and Health Care Facilities Code (HCFC)
Updates for All Applicable Providers and Suppliers
We propose to update the National Fire Protection Association
(NFPA) LSC and HCFC editions that are incorporated into the regulations
for religious nonmedical health care institutions (RNHCIs), ambulatory
surgical centers (ASCs), inpatient hospices, programs of all-inclusive
care for the elderly (PACE), hospitals, LTC facilities, ICFs/IID, REHs,
CAHs, and dialysis facilities. The LSC and HCFC are nationally
recognized fire and building safety standards published by the NFPA. We
propose to adopt the most recent (2024) editions of the LSC and HCFC,
with limited exceptions.
7. Emergency and Standby Power Sources
For hospitals, CAHs, REHs, and LTC facilities that are required to
have emergency and standby power systems, we propose to update the
current requirements to allow the use of additional sources of
emergency power. We also propose to adopt the 2022 edition of the
Standard for Emergency and Standby Power Systems (ESPS), which
establishes safety and performance requirements for emergencies and
standby power systems.
8. Outside Window or Door Requirement Updates
For RNHCIs, inpatient hospices, hospitals, CAHs, and LTC
facilities, we propose to remove the requirement for windows and doors
in every patient sleeping area and a 36-inch windowsill requirement for
buildings constructed after July 5, 2016, and defer to the egress
requirements within the health care occupancy chapters of the LSC.
Additionally, for hospitals and CAHs, we also propose to remove the 60-
inch windowsill requirement for special nursing care areas in new
occupancies. We propose to remove a similar requirement for ICFs/IID
related to windows in client bedrooms that are below the level of the
ground outside and defer to the window requirements for resident board
and care occupancies within the LSC.
9. Life Safety Code and Health Care Facility Code Waiver Authority
We propose to codify our authority to waive certain LSC and HCFC
provisions in the regulatory text applicable to each affected provider
type. We would permit facilities to comply with specific provisions of
a newer edition of the LSC or HCFC, subsequent to CMS review. We would
permit this exception after we have determined that the provision
provides an equal or superior means of ensuring patient safety as
compared to the provisions of the code edition currently adopted in
regulation at that time.
10. Transplant Programs Request for Information (RFI)
CMS' policy on organ transplantation is to increase the number of
transplants available to patients on the organ transplant waiting
lists. Achieving this goal requires a sufficient number of transplant
programs to provide lifesaving surgeries. There are currently over 250
Medicare-approved programs providing organ transplantation services.
However, programs seeking initial Medicare approval report challenges
in meeting the initial requirements for Medicare certification. We are
soliciting public comments on how to reduce potential barriers for new
transplant programs seeking Medicare certified transplant programs.

[[Page 72636]]

11. Supervision of Anesthesia Services RFI
We are soliciting public comments related to Medicare's physician
supervision requirement for certified registered nurse anesthetists
(CRNAs) administering anesthesia services in hospitals, CAHs, REHs, and
ASCs. Under current policy, anesthesia must be administered only by
qualified practitioners. When a CRNA administers anesthesia, a
physician, such as the operating practitioner or an anesthesiologist,
must be immediately available to provide supervision. Since 2001, CMS
has allowed a State's Governor to request an exemption from this
requirement, permitting CRNAs to practice independently where
consistent with State law. CMS is now requesting public input on this
policy, including whether it should be retained, revised, or otherwise
modified.
12. Reducing Reporting Burden for Hospital and CAH Respiratory Illness
and Infectious Disease Data RFI
We are soliciting public comments on ways to reduce the reporting
burden associated with respiratory illness and infectious disease data
reporting requirements for hospitals, including CAHs (collectively
referred to as ``hospitals'' for purposes of this RFI). Following the
COVID-19 response, the health care community identified a need for
standardized data elements and digital data collection approaches to
ease this burden, particularly given the risk of overlapping or
duplicative requirements across agencies for smaller or resource-
constrained facilities. CMS, in partnership with CDC, has worked to
reduce this burden through the development of data standards, adoption
of interoperability modernization activities, and use of a single
reporting system, the National Healthcare Safety Network (NHSN), which
currently offers flexible reporting options such as Comma-Separated
Values (CSV) import, Application Programming Interface (APIs), and Fast
Healthcare Interoperability Resources (FHIR)-based approaches. Building
on these efforts, CMS is requesting public comment on how to further
support hospitals' adoption of data and interoperability capabilities
to reduce burden through greater automation and digital data
collection.
13. Medicaid Institutional Payment Transparency
We propose to rescind requirements for States to report annually,
at the facility level, on the percentage of Medicaid payments for
nursing facility services that is spent on compensation for direct care
workers, the percentage of Medicaid payments for nursing facility
services that is spent on compensation for support staff, and the
percentage of Medicaid payments for ICF/IID services that is spent on
compensation for support staff. We also solicit public comment on
approaches to address direct care worker shortages and strengthen the
direct care workforce in nursing facilities and ICFs/IID.

C. Statutory and Regulatory Background

The Social Security Act (the Act) sets forth definitions for the
types of providers and suppliers that may participate in Medicare and
Medicaid, the requirements that each must meet to be eligible for
Medicare and Medicaid participation, and the Secretary's authority to
establish other requirements as necessary to protect the health and
safety of patients. The following list identifies the statutory and
regulatory citations for the providers and suppliers for which we are
proposing to revise or remove regulations in this rule:
<bullet> Religious Nonmedical Health Care Institutions (RNHCIs)--
section 1821 of the Act and 42 CFR 403.700 through 403.770.
<bullet> Ambulatory Surgical Centers (ASCs)--section
1832(a)(2)(F)(i) of the Act and 42 CFR 416.
<bullet> Hospices--section 1861(dd)(1) of the Act and 42 CFR 418.
<bullet> Programs of All-Inclusive Care for the Elderly (PACE)--
sections 1894, 1905(a), and 1934 of the Act and 42 CFR 460.
<bullet> Hospitals--section 1861(e)(9) of the Act and 42 CFR 482.
<bullet> Long Term Care (LTC) Facilities--Skilled Nursing
Facilities (SNFs)--under section 1819 of the Act, Nursing Facilities
(NFs)--under section 1919 of the Act, 42 CFR 483.1 through 483.315, 42
CFR 438.72, and 42 CFR 442.43.
<bullet> Intermediate Care Facilities for Individuals with
Intellectual Disabilities (ICF/IID)--section 1905(d) of the Act, 42 CFR
483.400 through 483.480, and 42 CFR 442.43.
<bullet> Rural Emergency Hospitals (REHs)--sections 1861(kkk) of
the Act and 42 CFR 485.500 through 485.546.
<bullet> Critical Access Hospitals (CAHs)--sections 1820 and
1861(mm) of the Act and 42 CFR 485.601 through 485.649.
<bullet> Dialysis Facilities--sections 1881(b), 1881(c), 1881(f)(7)
of the Act and 42 CFR 494.
In addition, Title XIX of the Act established the Medicaid program
as a joint Federal and State program to provide medical assistance to
eligible individuals. Section 1902(a)(30)(A) of the Act requires State
Medicaid programs to ensure that payments to providers are consistent
with efficiency, economy, and quality of care and are sufficient to
enlist enough providers so that care and services are available to
beneficiaries at least to the extent as to the general population in
the same geographic area. Section 1902(a)(6) of the Act requires State
Medicaid agencies to make reports, in such form and containing such
information, as the Secretary may from time to time require. To comply
with provisions as the Secretary may from time to time find necessary
to assure the correctness and verification of such reports, section
1932(c) of the Act lays out quality assurance standards with which
States must comply when delivering Medicaid services through managed
care organizations (MCOs). Section 1902(a)(4) of the Act provides
authority to specify ``methods of administration'' that are ``necessary
for proper and efficient'' administration of the State plan.
CMS previously published four final rules 1 2 3 4 that
removed or revised unnecessary, obsolete, or excessively burdensome
regulations for these health care providers and suppliers, resulting in
significant annual Medicare and Medicaid savings. These rules also
enhanced health care professionals' ability to focus on improving
patient care by eliminating or reducing requirements that hindered
quality or diverted resources away from delivering high-quality care.
The 2019 final rule produced an estimated savings of $800 million
annually.\5\ Among other things, in the 2019 final rule, we scaled back
the emergency preparedness requirements across providers; revised

[[Page 72637]]

the hospital and CAH CoPs for infection control, swing beds, and
documentation; simplified hospice requirements for medications; and
added flexibility to the home health CoPs for home health aide
competency evaluations.
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\1\ ``Medicare and Medicaid Program; Regulatory Provisions to
Promote Program Efficiency, Transparency, and Burden Reduction,''
published May 16, 2012. 77 FR 29002.
\2\ ``Medicare and Medicaid Programs; Reform of Hospital and
Critical Access Hospital Conditions of Participation,'' published
May 16, 2012. 77 FR 29034.
\3\ ``Medicare and Medicaid Programs; Regulatory Provisions to
Promote Program Efficiency, Transparency, and Burden Reduction; Part
II,'' published May 12, 2014. 79 FR 27106.
\4\ ``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,'' published September
30, 2019. 84 FR 51732.
\5\ ``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,'' published September
30, 2019. 84 FR 51732.
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This proposed rule is a continuation of our efforts to reduce
regulatory burden and is in accordance with recent Executive Order
(E.O.) 14192 ``Unleashing Prosperity Through Deregulation'' \6\ and
E.O. 14219: ``Ensuring Lawful Governance and Implementing the
President's `Department of Government Efficiency' Deregulatory
Initiative.'' \7\
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\6\ 90 FR 9065.
\7\ 90 FR 10583.
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This proposed rule is also related to the RFI ``Unleashing
Prosperity Through Deregulation of the Medicare Program Request for
Information,'' that CMS released in April 2025 (henceforth referred to
as the 2025 deregulatory RFI).\8\ The RFI sought public feedback on
approaches and opportunities to streamline regulations and reduce
administrative burdens on providers, suppliers and beneficiaries. CMS
reviewed the 937 timely submissions and considered the comments and
suggestions. Additionally, we have conducted our own review and
evaluation of current practices. This included an analysis of
regulations released by the prior Administration and long-standing
requirements, meetings with external interested parties, and
collaboration with other CMS interested parties to identify
opportunities to improve patient care by reducing unnecessary provider
compliance burden through deregulation.
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\8\ ``Medicare Regulatory Relief [verbar] CMS.'' <a href="http://Cms.gov">Cms.gov</a>, 2025,
<a href="https://www.cms.gov/files/document/unleashing-prosperity-through-deregulation-medicare-program-request-information.pdf">https://www.cms.gov/files/document/unleashing-prosperity-through-deregulation-medicare-program-request-information.pdf</a>. Accessed
September 2025.
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In 2024, we finalized Medicaid institutional payment transparency
reporting requirements in the ``Minimum Staffing Standards for Long-
Term Care (LTC) Facilities and Medicaid Institutional Payment
Transparency Reporting'' final rule (2024 Minimum Staffing final rule;
CMS 3442-F) \9\ to promote public transparency around States' statutory
obligation under section 1902(a)(30)(A) of the Act and around the
quality requirements in section 1932(c) of the Act for services
furnished through MCOs and prepaid inpatient health plans (PIHPs) \10\
under our authority under section 1902(a)(4) of the Act.
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\9\ <a href="https://www.federalregister.gov/documents/2024/05/10/2024-08273/medicare-and-medicaid-programs-minimum-staffing-standards-for-long-term-care-facilities-and-medicaid#h-32">https://www.federalregister.gov/documents/2024/05/10/2024-08273/medicare-and-medicaid-programs-minimum-staffing-standards-for-long-term-care-facilities-and-medicaid#h-32</a>.
\10\ Throughout this section, the use of the term ``managed care
plan'' means MCOs and PIHPs.
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To support the implementation of the Medicaid institutional payment
transparency reporting requirements, we engaged with States, providers,
and other interested parties to provide training and technical
assistance and address questions. Based on the public input received
through this engagement and our internal deliberations as we developed
guidance and technical specifications, we have a better understanding
of the complexity and challenges of implementing certain components of
the requirements we finalized. This understanding has led us to propose
to deregulate some of the provisions from that 2024 final rule.

D. Summary of Costs and Benefits

1. Overall Impact
This proposed rule would create savings and reduce burden in many
areas. Several of the proposed changes would create measurable monetary
savings for providers and suppliers, while others would create less
quantifiable savings of time and administrative burden. We estimate an
average annual savings of approximately $320 million.
2. Section-By-Section Economic Impact Estimates
Hospitals: We expect average annual savings of $123.2 million and
$1.23 billion over 10 years for hospitals.
Long Term Care Facilities (LTC): We expect average annual savings
of $142.6 million and $1.426 billion over 10 years for LTC facilities.
Critical Access Hospitals (CAHs): We expect an average annual
savings of $16.6 million and $166 million over 10 years for CAHs.
Intermediate Care Facilities for Individuals with Intellectual
Disabilities (ICFs/IID): We expect an average annual savings of $6.6
million and $66 million over 10 years for ICFs/IID.
Rural Emergency Hospitals (REHs): This proposed rule would not
result in any costs or savings for REHs.
Life Safety Code (LSC) and Health Care Facilities Code (HCFC)
Updates: We expect an average annual cost of approximately $112,000,
and $1,120,000--over 10 years that would be offset by unquantified
flexibility savings.
Emergency and Standby Power Sources: These proposals would not
result in costs but would provide providers with increased flexibility.
Outside Window or Door Requirement Updates: These proposals would
not result in any costs but would provide providers with increased
flexibility for building construction.
Medicaid Institutional Payment Transparency Reporting: We expect an
average annual savings of approximately $68,760, and $687,600 over 10
years for the Federal Government. We expect an average annual savings
of approximately $68,760 and $687,600 over 10 years for States. We
expect an average annual savings of $30.4 million and $304.1 million
over 10 years for providers.

E. Severability

We are clarifying and emphasizing our intent that if any provision
of this proposed rule, if finalized, is held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, or stayed pending further action, it shall be severable
from the remainder of the final rule, and from rules and regulations
currently in effect, and not affect the remainder thereof or the
application of the provision to other persons not similarly situated or
to other, dissimilar circumstances. If any provision is held to be
invalid or unenforceable, the remaining provisions which could function
independently should take effect and be given the maximum effect
permitted by law. In this rule, we propose several provisions that are
intended to and will operate independently of each other, even if each
serves the same general purpose or policy goal. Where a provision is
necessarily dependent on another, the context generally makes that
clear.

II. Provisions of the Proposed Regulations

A. Hospitals

Hospitals provide a range of services to treat patients with acute
care needs, which may include emergency medicine, surgery, labor and
delivery, cardiac care, oncology, among a wide variety of other
services. Hospitals also administer general and specialty care that
cannot safely be provided in other settings, under the supervision of
physicians and licensed practitioners. They may operate as independent
institutions or as part of a larger health care system or learning
institution. As of January 2026, there are around 4,700 Medicare-
certified hospitals.\11\
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\11\ Centers for Medicare & Medicaid Services. Quality,
Certification and Oversight Reports (QCOR), Hospital provider
reports, Active Provider and Supplier Counts Report, FY 2025.
Accessed January 30, 2026. <a href="https://qcor.cms.gov/main.jsp">https://qcor.cms.gov/main.jsp</a>.
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Under sections 1866 and 1902 of the Act, hospitals seeking to
participate in

[[Page 72638]]

the Medicare or Medicaid program, respectively, or both, must enter
into an agreement with the Secretary or the State Medicaid agency, as
appropriate. Hospitals (all hospitals to which the requirements of 42
CFR part 482 apply, including short-term acute care hospitals, long
term care hospitals (LTCHs), rehabilitation hospitals, psychiatric
hospitals, cancer hospitals, and children's hospitals), seeking to be
Medicare and Medicaid providers of services must be certified as
meeting Federal participation requirements. Our CoPs set out at 42 CFR
part 482 establish the patient health and safety protections
established by the Secretary for hospitals (except for critical access
hospitals (CAHs)). The specific statutory authority for hospitals is
set forth in section 1861(e) of the Act. In addition to specific terms
of that subsection, the hospital provision at section 1861(e)(9) of the
Act authorizes the Secretary to issue any additional regulations deemed
necessary to protect the health and safety of those receiving services
in the hospital.
In accordance with section 1864 of the Act, State surveyors assess
hospital compliance with the conditions as part of the process of
determining whether a hospital qualifies for a provider agreement under
Medicare. However, under section 1865 of the Act, hospitals can elect
to be reviewed instead by private accrediting organizations approved by
CMS as having standards that meet or exceed the applicable Medicare
standards and survey procedures comparable to those CMS requires for
State survey agencies.
1. Proposal To Remove OB QAPI Requirements (Sec. 482.21(b) and (e))
In November 2024, as part of the final rule, ``Medicare and
Medicaid Programs: Hospital Outpatient Prospective Payment and
Ambulatory Surgical Center Payment Systems; Quality Reporting Programs,
Including the Hospital Inpatient Quality Reporting Program; Health and
Safety Standards for Obstetrical Services in Hospitals and Critical
Access Hospitals; Prior Authorization; Requests for Information;
Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four
Walls Exceptions; Individuals Currently or Formerly in Custody of Penal
Authorities; Revision to Medicare Special Enrollment Period for
Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On
Payment for High-Cost Drugs Provided by Indian Health Service and
Tribal Facilities'' (henceforth referred as CY 2025 OPPS/ASC final
rule) \12\ CMS finalized new CoPs for hospitals that offer obstetrical
(OB) services. Prior to the CY 2025 OPPS/ASC final rule, CMS had not
established CoPs specifically for OB services. Rather those services
fell within the scope of broader CoPs applicable to hospitals,
including the QAPI requirements. Separate from the CoPs, CMS also
addressed maternal health through sub-regulatory
guidance,13 14 hospital quality measures, and initiatives
such as the Birthing-Friendly Hospital designation.
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\12\ 89 FR 93912.
\13\ Centers for Medicare and Medicaid Services. State
Operations Manual Appendix A -Survey Protocol, Regulations and
Interpretive Guidelines for Hospitals Transmittals for Appendix A.
2024, <a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_a_hospitals.pdf">https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_a_hospitals.pdf</a>. Accessed 31 July 2026.
\14\ Center for Clinical Standards and Quality. ``QSO-22-05-
Hospitals (ADVISORY).'' Centers for Medicare & Medicaid Services, 7
Dec. 2021, <a href="https://www.cms.gov/files/document/qso-22-05-hospitals.pdf">https://www.cms.gov/files/document/qso-22-05-hospitals.pdf</a>.
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In the CY 2025 OPPS/ASC final rule,\15\ we finalized additional
QAPI requirements for hospitals that offer OB services (Sec.
482.21(b)(4) and (e)), revisions to the discharge planning CoP for all
hospitals related to transfer protocols (Sec. 482.43(c)), revisions to
the CoP related to emergency services readiness for hospitals that
provide emergency services (Sec. 482.55(c)(3)), as well as baseline
standards for the organization, staffing, and delivery of OB care,
including staff training on evidence-based maternal health practices
(Sec. 482.59). In this section we discuss the proposed changes to the
hospital QAPI requirements. Revisions to the discharge planning CoP,
emergency services CoP, and obstetrical services CoP, are discussed in
sections II.A.2., II.A.3., and II.A.4. of this proposed rule,
respectively.
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\15\ 89 FR 93912.
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On January 25, 2003, we published the Medicare and Medicaid
Programs; Hospital Conditions of Participation: Quality Assessment and
Performance Improvement final rule,\16\ which codified provisions in
the hospital CoPs, requiring hospitals to develop, implement, and
maintain a QAPI program (Sec. 482.21). The hospital QAPI program CoP
requires hospitals to implement an ongoing hospital-wide, data-driven
system to improve quality of care, patient safety, and improved health
outcomes. Hospitals must use data to identify and prioritize
improvement areas (Sec. 482.21(b)), sustain measurable improvements
(Sec. 482.21(c)), conduct performance improvement projects (Sec.
482.21(d)), and demonstrate leadership oversight over the program and
that the program reflects the complexity of the facility's organization
and services (Sec. 482.21(e)). On September 30, 2019, CMS published
the ``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'' final rule,\17\ which finalized a new
standard at Sec. 482.21(f), to allow a hospital that is part of a
hospital system to elect to have a unified and integrated QAPI program
for all of its member hospitals. This rule also expanded the program
data requirements at Sec. 482.21(b), to require that the hospital QAPI
program incorporate quality indicator data submitted to or received
from quality reporting and quality performance programs. In the CY 2025
OPPS/ASC final rule,\18\ we finalized additional QAPI requirements for
hospitals that offer OB services (89 FR 94593). Specifically, effective
January 1, 2027, the facility at a minimum, will be required to: (1)
analyze data and quality indicators by diverse subpopulation as
determined by the facility; (2) measure, analyze, and track outcomes
and disparities in processes of care, services, and outcomes among OB
patients; (3) analyze and prioritize patient health outcomes and
disparities, develop and implement actions to improve patient health
outcomes and disparities, measure results, and track performance to
ensure improvements are sustained when disparities exist among OB
patients; and (4) conduct at least one measurable performance
improvement project that focuses on improving health outcomes and
maternal health disparities, annually. Additionally, hospitals that
offer OB services are required to have their OB leadership participate
in the facility's QAPI program (Sec. 482.21(e)(1)) and, where a state,
local, or tribal maternal mortality review committee (MMRC) exists, the
facility must have a process for incorporating publicly available MMRC
data and recommendations into its QAPI program (Sec. 482.21(e)(2)).
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\16\ 68 FR 3437.
\17\ 84 FR 51776.
\18\ 89 FR 94484.
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This proposal to remove OB QAPI requirements at Sec. 482.21(b)(4)
and (e) would promote efficiency and reduce waste, consistent with the
E.O. 14219 and E.O. 14192. As part of regulatory reviews conducted in
response to these E.O.s, CMS received input through the

[[Page 72639]]

2025 deregulatory RFI \19\ from interested parties. Commenters,
including physician organizations, medical associations, and rural
health advocates, specifically raised concerns about the OB QAPI
requirements at Sec. 482.21(b)(4) and (e) as well as the broader OB
services CoPs (Sec. 482.59) finalized in the CY 2025 OPPS/ASC final
rule. Commenters indicated that these requirements were overly
burdensome and costly, particularly for small and rural hospitals, and
expressed concern that compliance costs could contribute to the closure
of labor and delivery units, which would worsen access to maternity
care and potentially exacerbate maternal health disparities.
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\19\ ``Medicare Regulatory Relief [verbar] CMS.'' <a href="http://Cms.gov">Cms.gov</a>, 2025,
<a href="https://www.cms.gov/files/document/unleashing-prosperity-through-deregulation-medicare-program-request-information.pdf">https://www.cms.gov/files/document/unleashing-prosperity-through-deregulation-medicare-program-request-information.pdf</a> Accessed
September 2025.
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While we originally disagreed with these types of comments in the
CY 2025 OPPS/ASC final rule, we have since refined our understanding of
the issues that hospitals are facing in diverting resources away from
direct patient care to comply with administrative standards. Upon
further consideration, including input received through the 2025
deregulatory RFI and the policy priorities reflected in E.O. 14219 and
E.O. 14192, CMS has reassessed the burden imposed by the OB-specific
QAPI requirements and the quality improvement those requirements would
achieve, beyond what was previously already required under the
existing, broadly applicable QAPI CoPs at Sec. 482.21. In particular,
CMS now finds that the existing QAPI CoPs, which require hospitals to
maintain an effective, ongoing, facility-wide, data-driven program that
measures, analyzes, and tracks quality indicators, including adverse
patient events, across all services provides a sufficient foundation
for quality oversight of OB care, without the need for OB-specific
requirements. In consideration of the above, CMS is proposing to remove
the OB QAPI requirements at Sec. 482.21(b)(4) and (e) for hospitals
that offer OB services. Hospitals would continue to be required to
comply with the remaining QAPI requirements at Sec. 482.21, including
with respect to OB services.
CMS also recognizes the compliance costs associated with the OB
QAPI requirements, estimated in the CY 2025 OPPS/ASC final rule,\20\
are $187,985,440 and 1,110,900 hours of staff time over a ten-year
period, or approximately $18,798,544 and 111 staff hours annually. This
burden may pose a disproportionate burden on small and rural hospitals,
potentially contributing to the closure of labor and delivery units and
thereby worsening access to maternity care in underserved communities.
Hospitals may have begun taking steps toward compliance with the OB
QAPI requirements finalized in the CY 2025 OPPS/ASC final rule, which
are not effective until January 1, 2027. CMS has considered these
efforts toward achieving compliance and, given that the requirements
have not yet taken effect, expects the disruption to hospitals from
this proposed change in position to be limited. Although it is unlikely
that this proposed rule will be finalized before January 1, 2027, we
would request our surveyors that conduct surveys after that date to
focus on those CoPs that are not potentially subject to imminent
revision. CMS recognizes and affirms the importance of high-quality OB-
focused QAPI programs in improving maternal health outcomes and
reducing maternal mortality and morbidity. While we are proposing to
remove the OB-specific requirements at Sec. 482.21(b) and (e), we
strongly encourage hospitals that offer OB services to prioritize
maternal health as part of their existing QAPI programs. Furthermore,
nothing in these proposals prohibits hospitals from establishing and
maintaining policies and procedures that go beyond the minimum
standards set forth in the CoPs. Hospitals are encouraged to exercise
this flexibility to ensure they are meeting the unique needs of their
patient populations.
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\20\ 89 FR 94577.
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Furthermore, HHS has several existing quality initiatives related
to maternal health, including CMS' ``Birthing-Friendly'' designation
and state-based National Perinatal Quality Collaboratives (PQCs)
supported by the Centers for Disease Control (CDC) and Prevention. The
Birthing-Friendly Hospital Designation (hereinafter referred to as
``the Designation''), was created to identify hospitals that
demonstrate the delivery of high-quality maternal care and a commitment
to improving maternal health outcomes (87 FR 49284 through 49290).\21\
The Designation serves as a quality-driven mechanism to incentivize
hospitals to adopt and sustain evidence-based maternal health
practices, and is one of several tools CMS is leveraging to advance
maternal health outcomes. CMS intends to explore, in future rulemaking,
opportunities to expand the Designation and similar quality-based
programs as a primary vehicle for reducing maternal mortality and
morbidity, and we invite public comment on how such programs could be
structured or expanded to address maternal health disparities. CMS is
also actively refining the Designation program, including through a
recent Request for Information (RFI) in the proposed rule titled,
Medicare Program; Hospital Inpatient Prospective Payment Systems for
Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective
Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates;
Requirements for Quality Programs; and Other Policy Changes (91 FR
19597, April 14, 2026),\22\ which sought public input on updates to
designation criteria, alignment with other Federal and state maternal
health quality initiatives, and strategies to increase hospital
participation, particularly among rural and safety-net hospitals.
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\21\ 87 FR 48780.
\22\ 91 FR 19312.
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While the Designation operates at the hospital level, state-based
PQCs complement this effort by advancing standardized best practices at
the state and regional level, serving as another tool for advancing
maternal health. As of March 2026, there are 52 state- and territory-
based PQCs,\23\ of which 36 are funded by the CDC.\24\ Through Federal
grants and cooperative agreements with the CDC and/or funding and
support from state and local governments, PQCs have achieved notable
improvements in maternal health and safety, including in severe
pregnancy complications.\25\ For example, the Illinois Perinatal
Quality Collaborative launched the Severe Maternal Hypertension
Initiative helped raise timely treatment rates for sever hypertension
from 41 percent to 87 percent within 2 years.\26\ Together, this
regulatory approach ensures flexibility and reduces burden while
maintaining strong support for maternal and infant health.
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\23\ ``National Network of Perinatal Quality Collaboratives.''
The National Institute for Children's Health Quality, National
Institute for Children's Health Quality, <a href="https://nichq.org/projects/national-network-of-perinatal-quality-collaboratives/">https://nichq.org/projects/national-network-of-perinatal-quality-collaboratives/</a>. Accessed 30
March 2026.
\24\ ``State Perinatal Quality Collaboratives.'' Centers for
Disease Control and Prevention, 15 May 2024, <a href="https://www.cdc.gov/maternal-infant-health/pqc/state-pqcs.html">https://www.cdc.gov/maternal-infant-health/pqc/state-pqcs.html</a>. Accessed 24 September
2025.
\25\ ``Perinatal Quality Collaboratives.'' Centers for Disease
Control and Prevention, 15 May 2024, <a href="https://www.cdc.gov/maternal-infant-health/pqc/index.html">https://www.cdc.gov/maternal-infant-health/pqc/index.html</a>. Accessed 24 September 2025.
\26\ Centers for Disease Control and Prevention. ``PQC Impacts:
Reducing Pregnancy Complications From High Blood Pressure.''
Maternal Infant Health, 20 May 2024, <a href="https://www.cdc.gov/maternal-infant-health/pqc/success-stories-illinois.html">https://www.cdc.gov/maternal-infant-health/pqc/success-stories-illinois.html</a>.
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CMS acknowledges that U.S. maternal mortality remains elevated
relative to peer nations and that the majority of

[[Page 72640]]

pregnancy-related deaths are considered preventable. According to data
from MMRCs in 45 states, 85.7 percent of pregnancy-related deaths
occurring in 2022 were preventable, with clinical skill and quality of
care, lack of continuity of care, and knowledge identified as the most
common contributing factors.\27\ MMRC prevention recommendations were
directed at the provider level (32.2 percent), facility level (18.6
percent), and system level (38.0 percent),\28\ underscoring the
importance of facility-level responsiveness to MMRC findings.
Comprehensive strategies for improving maternal health quality, such as
engaging with State PQCs, utilizing AIM resources, and seeking the CMS
Birthing-Friendly designation, can significantly enhance outcomes in
maternal health. CMS encourages hospitals that offer OB services to
incorporate maternal health quality improvement activities, including
review of publicly available MMRC data and recommendations where
available, into their existing QAPI programs under Sec. 482.41.
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\27\ CDC. ``Pregnancy-Related Deaths: Data from Maternal
Mortality Review Committees.'' Maternal Mortality Prevention, 28
Aug. 2025, <a href="http://www.cdc.gov/maternal-mortality/php/data-research/mmrc/index.html?cove-tab=4">www.cdc.gov/maternal-mortality/php/data-research/mmrc/index.html?cove-tab=4</a>. Accessed 28 May 2026.
\28\ ``Pregnancy-Related Deaths: Data from Maternal Mortality
Review Committees.'' Maternal Mortality Prevention, 28 Aug. 2025,
<a href="http://www.cdc.gov/maternal-mortality/php/data-research/mmrc/index.html?cove-tab=5">www.cdc.gov/maternal-mortality/php/data-research/mmrc/index.html?cove-tab=5</a>. Accessed 28 May 2026.
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2. Proposal To Remove Transfer Protocol Staff Training (Sec.
482.43(c))
The hospital discharge planning requirements at Sec. 482.43,
``Discharge planning,'' were originally published on December 13,
1994,\29\ including the requirement that hospitals must maintain a
written discharge planning process for all patients that supports safe,
timely transitions from hospital care. This includes early
identification of patients at risk of adverse outcomes and timely
discharge planning evaluations by qualified personnel to assess post-
hospital care needs, service availability, and the patient's capacity
for self-care or appropriateness of the discharge setting (Sec.
482.43). When needed, hospitals must document and communicate
evaluation results, develop and implement discharge plans, reassess
plans as patient needs change, ensure appropriate transfer or referral,
and regularly review their discharge planning process.
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\29\ 59 FR 64142.
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In the September 30, 2019 final rule, ``Medicare and Medicaid
Programs; Revisions to Requirements for Discharge Planning for
Hospitals, Critical Access Hospitals, and Home Health Agencies, and
Hospital and Critical Access Hospital Changes to Promote Innovation,
Flexibility, and Improvement in Patient Care,'' \30\ CMS established
additional discharge planning requirements requiring hospitals to
assist patients and their caregivers in selecting post-acute care
providers by sharing relevant quality and resource use data that are
relevant to the patient's goals of care and treatment preferences, and
to document this sharing of information in the medical record (Sec.
482.43(a)(8)).
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\30\ 84 FR 51836.
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The discharge planning CoP was last updated in the CY 2025 OPPS/ASC
final rule. Effective July 1, 2025, all hospitals must have written
policies and procedures for transferring patients under their care
(Sec. 482.43(c)). This requirement is inclusive of hospital
inpatients, such as transfers from the emergency department to
inpatient admission, transfers between inpatient units in the same
hospital, as well as transfers between inpatient units at different
hospitals. In addition, hospitals are required to provide annual
training to the relevant staff (as determined by the facility)
regarding the hospital policies and procedures for transferring
patients under its care.
In the CY 2025 OPPS/ASC final rule, CMS specifically agreed with
commenters that supported inclusion on annual training on transfer
protocols in the hospital CoPs to promote consistency in transfer
processes and ensure that transfers are conducted safely by minimizing
errors.\31\ In light of additional public comments received through the
2025 deregulatory RFI \32\ and the issuance of E.O. 14192 and E.O.
14219, CMS is now reconsidering that position. CMS received comments on
the 2025 deregulatory RFI stating that transfer protocols are already
built into existing regulations, and that the additional formal annual
staff training requirement is unnecessarily prescriptive, as staff
engage with transfer processes routinely as part of daily clinical
operations and maintain familiarity through regular practice, including
through electronic health record systems that facilitate unit-to-unit
and facility-to-facility transfer processes. CMS agrees that a
separate, prescriptive annual training requirement is not necessary to
ensure staff familiarity with transfer policies and procedures. CMS
also recognizes that the broader existing regulatory requirements,
including Emergency Medical Treatment and Labor Act (EMTALA)
requirements for emergency department transfers, the existing discharge
planning CoP requirements (Sec. 482.43), and accrediting organization
(AO) standards collectively support staff competency in transfer
processes without the need for a separate annual training requirement.
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\31\ 89 FR 94481.
\32\ ``Medicare Regulatory Relief [verbar] CMS.'' <a href="http://Cms.gov">Cms.gov</a>, 2025,
<a href="https://www.cms.gov/files/document/unleashing-prosperity-through-deregulation-medicare-program-request-information.pdf">https://www.cms.gov/files/document/unleashing-prosperity-through-deregulation-medicare-program-request-information.pdf</a>. Accessed
September 2025.
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CMS acknowledges that hospitals were required to undertake
compliance efforts, including conducting initial annual training
sessions and documenting staff completion in personnel records, since
the July 1, 2025, effective date of Sec. 482.43(c). However, CMS has
determined that the ongoing annual compliance burden of maintaining and
documenting a separate staff training requirement on transfer protocols
outweighs the benefit of retaining this requirement, given that the
written policies and procedures requirement remains in place and the
existing operational and regulatory requirements support staff
knowledge of transfer protocols.
Specifically, the compliance costs associated with the emergency
services readiness staff training requirements, estimated in the CY
2025 OPPS/ASC final rule,\33\ are more than $862 million and 5.1
million hours of staff time over a ten-year period, or approximately
$86 million and 505,213 staff hours annually.
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\33\ 89 FR 94481.
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Removing the annual transfer protocol staff training requirement
may allow clinicians to spend more time with patients and prioritize
high-quality patient care, while maintaining flexibility in how
hospitals ensure staff familiarity with transfer policies and reduce
regulatory compliance burden. As patient transfers require coordinated
clinical decision-making across settings and levels of care,
maintaining written transfer policies support consistent transfer
decision-making, including critical or infrequent situations. Removing
this annual training requirement would not prevent hospitals, states or
AOs from independently establishing and enforcing facility policies
requiring annual training.
3. Proposal To Remove Emergency Services Readiness Staff Training
(Sec. 482.55(c))
In the CY 2025 OPPS/ASC final rule,\34\ CMS finalized emergency
services readiness staff training

[[Page 72641]]

requirements for hospitals (89 FR 94592). As of July 1, 2025, Sec.
482.55(c)(3) requires hospitals to train applicable staff annually on
the protocols and provisions implemented pursuant to the emergency
services readiness requirements at Sec. 482.55(c). Specifically, in
accordance with the complexity and scope of services offered by the
facility, the hospital must have adequate provisions and protocols to
meet the emergency needs of patients. These protocols must be
consistent with nationally recognized and evidence-based guidelines for
the care of patients with emergency conditions, including but not
limited to patients with OB emergencies, complications, and immediate
post-delivery care. The hospital's governing body is responsible for
identifying and documenting which staff must complete training on
emergency services readiness protocols and procedures. Additionally,
the hospital must document in their personnel records that the training
was successfully completed and demonstrate staff knowledge on emergency
services readiness topics. Further, the hospital must use findings from
their QAPI programs to inform staff training needs and any additions,
revisions, or updates to training topics on an ongoing basis.
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\34\ 89 FR 93912.
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In the CY 2025 OPPS/ASC final rule, CMS disagreed with commenters
who contended that the emergency services readiness staff training
requirements at Sec. 485.618(e)(2) were duplicative of existing CoPs
(89 FR 94472). CMS is now reconsidering that position in light of
public comments we received through the 2025 deregulatory RFI \35\ and
E.O. 14219 and E.O. 14192, which direct agencies to reduce regulatory
burdens. Commenters stated that this requirement is duplicative, as
most hospitals have internal standards and protocols to ensure
compliance with nationally accepted guidelines for emergency care and
readiness including OB emergencies, complications, immediate post-
delivery care, and other patient health and safety events. Other
commenters noted that the emergency services readiness requirements at
Sec. 482.55(c) will impose large burdens on hospitals and health care
professionals, particularly for small and rural hospitals with limited
staffing and financial resources. CMS agrees that the combination of
existing CoP requirements (including those for QAPI under Sec.
482.21), EMTALA requirements, AO accreditation standards, specialty
board certification requirements, and nationally recognized clinical
resources ensure staff competency in emergency services readiness
without the need for a separate, prescriptive annual training
requirement. This determination is further supported by the role of
state licensing boards, which require clinicians to meet continuing
education and competency standards for licensure renewal, as well as
private-sector patient safety organizations that advance national
clinical readiness and safety practices.
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\35\ ``Medicare Regulatory Relief [verbar] CMS.'' <a href="http://Cms.gov">Cms.gov</a>, 2025,
<a href="https://www.cms.gov/files/document/unleashing-prosperity-through-deregulation-medicare-program-request-information.pdf">https://www.cms.gov/files/document/unleashing-prosperity-through-deregulation-medicare-program-request-information.pdf</a>. Accessed
September 2025.
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CMS acknowledges that hospitals were required to undertake
compliance efforts since the July 1, 2025, effective date, however, CMS
has determined that the ongoing annual compliance burden outweighs the
incremental benefit of retaining this requirement given the robust
existing structure of other applicable regulations, AO standards, board
certifications, EMTALA requirements, and QAPI requirements.
Specifically, the compliance costs associated with the emergency
services readiness staff training requirements, estimated in the CY
2025 OPPS/ASC final rule \36\ at $1.73 billion and 16.4 million hours
of staff time over a 10-year period, or approximately $173 million and
1.6 million hours annually.
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\36\ 89 FR 94545 to 94546.
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The financial pressures facing rural hospitals further underscore
the need for this reconsideration. Rural hospitals are experiencing
significant and worsening financial challenges that threaten patient
access to care, including emergency services. According to the North
Carolina Rural Health Research Program's financial distress index, a
model that assesses rural hospital vulnerability across financial
performance, government reimbursement, organizational traits, and
market characteristics,\37\ there are currently 86 rural hospitals in
the highest financial risk category and an additional 329 are in the
mid-highest risk category.\38\ For rural hospitals already experiencing
financial strain, the recurring annual cost associated with
implementing, documenting, and maintaining separate staff training
requirements is an additional burden, further worsening existing
financial constraints. The financial challenges rural hospitals face
may impact access to care as shown by expanding ambulance and health
care deserts,\39\ and the absence of hospital-based obstetric services
in 60 percent of rural counties.\40\ The compounding financial and
operational challenges rural hospitals experience highlight the
disproportionate burden of retaining a requirement that CMS has
determined is duplicative of similar regulations, AO accreditation
standards, specialty board certifications, and EMTALA requirements.
Therefore, removing this staff training requirement may allow
clinicians to spend more time with patients and prioritize providing
high-quality patient care, while maintaining flexibility in how
hospitals ensure staff competency and reducing regulatory compliance
expenditures.
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\37\ Malone, Tyler L, et al. ``An Updated Model of Rural
Hospital Financial Distress.'' The Journal of Rural Health, vol. 41,
no. 2, 3 Oct. 2024, <a href="http://onlinelibrary.wiley.com/doi/full/10.1111/jrh.12882">onlinelibrary.wiley.com/doi/full/10.1111/jrh.12882</a>, <a href="https://doi.org/10.1111/jrh.12882">https://doi.org/10.1111/jrh.12882</a>. Accessed 27 May 2026.
\38\ Malone, Tyler, et al. ``Rural Hospital Financial Distress:
Relative Risk in 2025.'' North Carolina Rural Health Research
Program, Nov. 2025, <a href="http://www.ruralhealthresearch.org/publications/1742">www.ruralhealthresearch.org/publications/1742</a>.
Accessed 28 May 2026.
\39\ Jonk, Y., Milkowski, C., Croll, Z., & Pearson, K. (2023).
Ambulance Deserts: Geographic Disparities in the Provision of
Ambulance Services [Chartbook]. University of Southern Maine, Muskie
School, Maine Rural Health Research Center.
\40\ Interrante JD, O'Hanlon K, Kozhimannil KB. Availability of
Hospital-Based Obstetric Services in the United States by County,
2010-2023: A State-by-State Report. University of Minnesota Rural
Health Research Center. January 2026. <a href="https://rhrc.umn.edu/publication/availability-of-hospital-based-obstetric-services-in-the-united-states-by-county-2010-2023-a-state-by-state-report/">https://rhrc.umn.edu/publication/availability-of-hospital-based-obstetric-services-in-the-united-states-by-county-2010-2023-a-state-by-state-report/</a>.
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Existing requirements for hospitals that provide emergency
services, located at Sec. 482.55, require hospitals to meet each
patient's emergency care needs in accordance with acceptable standards
of practice through appropriate oversight, integration, and staffing.
Hospitals must also have adequate provisions and protocols to meet the
emergency needs of patients. Further, hospitals may incorporate
emergency services readiness and staff competency activities into their
QAPI programs under Sec. 482.21, which require hospitals to evaluate
and improve the quality of all services furnished, including emergency
and OB services. Considering the duplicative nature of these
requirements, and in alignment with both E.O. 14192 and E.O. 14219, we
are proposing to remove the emergency services readiness staff training
requirement at Sec. 482.55(c)(3). This change would streamline
regulatory requirements while preserving patient safety, allowing
clinicians to spend more time delivering high-quality care to patients.
In meeting the existing emergency services CoP requirements at
Sec. 482.55, hospitals commonly rely on AO standards, voluntary
certification programs, and nationally recognized clinical resources
that include staff training and competency expectations

[[Page 72642]]

related to emergency services readiness. AOs have staff training
requirements pertaining to emergency services readiness for patients
with critical illnesses. For example, The Joint Commission (TJC) offers
facility certification programs in managing critical illnesses, such as
heart attacks and stroke, through its comprehensive heart attack and
stroke centers programs in collaboration with the American Heart
Association and American Stroke Association.
Additionally, professional health care societies offer facility
credentialing opportunities and free resources to improve emergency
services readiness. For example, the American College of Emergency
Physicians (ACEP) offers a geriatric emergency department (ED)
accreditation program, with the aim of promoting best clinical
practices for older adults, coordinating care more efficiently, and
reducing the cost of care.\41\ ACEP also offers an ED accreditation
program to establish transparency and improve patient care through the
implementation of evidence-based policies and practices.\42\ EDs also
have access to free educational resources such as the American College
of Obstetricians and Gynecologists' (ACOG's) toolkit for OB emergencies
in non-obstetric settings and the Alliance for Innovation on Maternal
Health (AIM) Obstetric Emergency Readiness Kit, including guidance for
rural facilities, to improve their obstetrical
readiness.43 44 CMS also recognizes that risk-appropriate
care, a strategy to ensure that pregnant women and infants receive the
right care in the right place at the right time, is an important
framework for rural hospitals, including those without dedicated OB
services.\45\ Under this approach, healthy patients can safely deliver
in their communities, while complex pregnancies are delivered in
hospitals with the personnel and resources to support higher risk
conditions. Having formal transfer policies and protocols in place
beyond individual hospital systems is foundational to providing risk-
appropriate care. Hospitals, including those without dedicated OB
services, may find it beneficial to ensure that providers have the
skills necessary to stabilize and transport, or potentially deliver, a
high-risk pregnancy, and are encouraged to explore the range of
training resources available to support obstetric emergency
preparedness in non-obstetric settings. Similarly, the National
Pediatric Readiness Project, developed in partnership with ACEP, the
Emergency Nurses Association (ENA), and the American Academy of
Pediatrics, empowers EDs nationwide to improve their ``pediatric
readiness'' or capability to care for acutely ill and injured children
through free assessment and toolkit resources.\46\
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\41\ ``Accreditation Programs.'' American College of Emergency
Physicians, <a href="http://www.acep.org/patient-care/accreditation-programs">www.acep.org/patient-care/accreditation-programs</a>.
Accessed 4 February 2026.
\42\ ``Accreditation Programs.'' American College of Emergency
Physicians, <a href="http://www.acep.org/patient-care/accreditation-programs">www.acep.org/patient-care/accreditation-programs</a>.
Accessed 4 February 2026.
\43\ ``Obstetric Emergencies in Nonobstetric Settings.''
<a href="http://www.acog.org">www.acog.org</a>, <a href="http://www.acog.org/programs/obstetric-emergencies-in-nonobstetric-settings">www.acog.org/programs/obstetric-emergencies-in-nonobstetric-settings</a>. Accessed 4 February 2026.
\44\ ``AIM [verbar] Alliance for Innovation on Maternal
Health.'' <a href="http://Saferbirth.org">Saferbirth.org</a>, <a href="http://saferbirth.org/">saferbirth.org/</a>. Accessed 4 February 2026.
\45\ CDC. ``CDC Levels of Care Assessment Tool (CDC
LOCATe[supreg]).'' Maternal Mortality Prevention, 13 Feb. 2026,
<a href="http://www.cdc.gov/maternal-infant-health/php/cdc-locate/index.html#cdc_toolkit_main_purpose-risk-appropriate-care">www.cdc.gov/maternal-infant-health/php/cdc-locate/index.html#cdc_toolkit_main_purpose-risk-appropriate-care</a>. Accessed
28 May 2026.
\46\ ``National Pediatric Readiness Project.'' Emergency Medical
Services for Children Innovation and Improvement Center (EIIC),
emscimprovement.center/domains/pediatric-readiness-project/.
Accessed 4 February 2026.
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In addition, hospitals commonly rely on existing specialty board
certification and continuing education requirements to ensure that
emergency services staff are qualified and prepared to deliver care in
accordance with acceptable standards of practice, consistent with Sec.
482.55. Notably, specialty board certification is a key component of
physician education and required by a majority of hospital-based
employers. For example, physicians can pursue board certification in
emergency medicine from organizations such as the American Board of
Emergency Medicine (ABEM) or the Board of Certification in Emergency
Medicine (BCEM).\47\ Emergency Medicine board certification requires
physicians to demonstrate and maintain knowledge of key emergency
topics, including OB emergencies.\48\ ACEP also offers Continuing
Medical Education (CME) in best practice updates for managing common
and critical emergency conditions through conferences, online modules,
and seminars and requires its members to earn 150 CME hours every 3
years.49 50 The Board of Certification of Emergency Nursing
offers nurses credentialling as a certified emergency nurse (CEN),
while the ENA offers nurses continuing education courses in managing
critical patients, including pediatrics, obstetrics, geriatrics, and
trauma.\51\
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\47\ ``Emergency Medicine Board Certification [verbar] ABPS.''
American Board of Physician Specialties, 7 October 2025,
<a href="http://www.abpsus.org/specializations/emergency-medicine">www.abpsus.org/specializations/emergency-medicine</a>. Accessed 4
February 2026.
\48\ ``Continuing Medical Education.'' American College of
Emergency Physicians, <a href="http://www.acep.org/education/cme">www.acep.org/education/cme</a>. Accessed 4
February 2026.
\49\ ``ACEP26--Chicago, Illinois--October 5-8, 2026.'' <a href="http://Acep.org">Acep.org</a>,
ACEP's Scientific Assembly, 2026, <a href="http://www.acep.org/sa">www.acep.org/sa</a>. Accessed 4
February 2026.
\50\ ``Continuing Medical Education.'' American College of
Emergency Physicians, <a href="http://www.acep.org/education/cme">www.acep.org/education/cme</a>. Accessed 4
February 2026.
\51\ ``CEN--Certified Emergency Nurse Specialization.'' Board of
Certification for Emergency Nursing, <a href="http://bcen.org/cen">bcen.org/cen</a>. Accessed 4
February 2026.
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The extensive nature of these resources and the nature of hospital
expectations for clinician training would continue to drive
improvements in clinician training in the absence of the emergency
services staff training requirements that we propose to remove from the
hospital regulations.
4. Proposal To Remove OB Services Staff Training (Sec. 482.59(c))
In the CY 2025 OPPS/ASC final rule,\52\ we finalized OB services
staff training requirements for hospitals. Effective January 1, 2027,
section Sec. 482.59(c) requires hospitals to ``develop policies and
procedures to ensure that relevant staff are trained on select topics
for improving the delivery of maternal care.'' The training topics must
reflect the scope and complexity of the services offered within the
facility, including facility-identified, evidence-based best practices
and protocols. Hospitals will also be required to use findings from
their QAPI programs to inform staff training needs and any additions to
the training topics on an ongoing basis and provide relevant new staff
with initial training. In addition, the governing body will be required
to identify and document which staff must complete an initial training
and subsequent biennial (every 2 years) training. Additionally, the
hospital must document in the staff personnel records that the training
was successfully completed and must be able to demonstrate staff
knowledge on the aforementioned topics.
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\52\ 89 FR 93912.
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As part of the regulatory review conducted in response to the E.O
14219 and E.O. 14192, we solicited and received interested parties
input through the 2025 deregulatory RFI.\53\ Commenters expressed
several concerns about the OB services CoP staff training requirements
at Sec. 482.59(c). Several commenters requested that rural hospitals
be exempt from the new OB services and QAPI requirements, noting that
REHs, a provider type with its own unique care model and standards, are
exempt and that small, rural hospitals require flexibility given their
unique operational constraints. Commenters

[[Page 72643]]

also raised concerns about the requirement that the governing body
identify and document which staff must complete training on maternal
care protocols, suggesting that decisions regarding the frequency,
content, and scope of staff training are more appropriately made at the
facility leadership level and that prescriptive training requirements
take staff away from direct patient care while increasing the cost of
care. More broadly, commenters expressed concern that the staff
training requirements, as currently designed, are highly unlikely to
reduce maternal mortality or morbidity while significantly increasing
administrative burden, and that they risk exacerbating access to care
challenges, particularly in rural and underserved areas, by
contributing to hospitals reducing or discontinuing OB services.
Several commenters also noted that the requirements are duplicative of
standards hospitals are already held to under existing requirements,
including EMTALA, AO standards, and existing staff training and quality
monitoring requirements.
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\53\ ``Medicare Regulatory Relief [verbar] CMS.'' <a href="http://Cms.gov">Cms.gov</a>, 2025,
<a href="https://www.cms.gov/files/document/unleashing-prosperity-through-deregulation-medicare-program-request-information.pdf">https://www.cms.gov/files/document/unleashing-prosperity-through-deregulation-medicare-program-request-information.pdf</a>. Accessed
September 2025.
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CMS previously considered similar concerns in the CY 2025 OPPS/ASC
final rule (89 FR 94480 to 94483). At that time, we concluded that the
patient safety benefits of the staff training requirements outweighed
the operational and financial burdens on hospitals, and that existing
AO standards and CME requirements did not fully substitute for the
specific, QAPI-informed, facility-level training we were establishing.
We reviewed both of those conclusions in accordance with the
deregulatory directives set forth in E.O. 14219 and E.O. 14192, and the
additional input received through the 2025 deregulatory RFI to reassess
the relative costs and benefits of the requirement. Upon further
review, and consistent with concerns raised by commenters through the
2025 deregulatory RFI and the CY 2025 OPPS/ASC final rule, we find that
the staff time and administrative costs associated with Sec.
482.59(c), when added to existing financial and workforce pressures,
could affect some hospitals' decisions to continue providing OB
services at their current level, particularly in areas with limited
access to maternity care. We further find that existing AO
accreditation standards, board certification requirements, and
voluntary professional society training opportunities together provide
a robust and sufficient foundation for ensuring staff competency in OB
care, such that the incremental benefit of the additional CoP
requirement does not justify its associated burden. Specifically, the
compliance costs associated with the OB services staff training
requirement for hospitals, estimated in the CY 2025 OPPS/ASC final
rule,\54\ are $242 million and 1.8 million hours of staff time over a
10-year period, translating to approximately $24.2 million and 176,600
staff hours annually. Due to these concerns, and to reduce unnecessary
regulatory burden while preserving patient safety, we are proposing to
remove the OB services staff training requirement at Sec. 482.59(c).
We also note that, since this requirement does not take effect until
January 1, 2027, hospitals are not yet required to comply and are
unlikely to have made significant investments or actions in preparation
for meeting this requirement. To the extent that any hospitals have
already begun investing resources in implementing these requirements in
anticipation of the effective date, we acknowledge those efforts and
note that the training infrastructure developed may continue to serve
facilities under existing AO standards and voluntary initiatives. As
noted previously, although it is unlikely that this proposed rule will
be finalized before January 1, 2027, we would request that our
surveyors conducting surveys after that date focus on those CoPs that
are not potentially subject to imminent revision. CMS recognizes and
affirms the critical importance of high-quality, evidence-based OB
staff training programs in improving maternal health outcomes and
reducing maternal mortality and morbidity. While we are proposing to
remove the requirement at Sec. 482.59(c) we strongly encourage
hospitals to continue investing in these activities. Hospitals have the
flexibility to exceed the health and safety standards set forth by CMS
by establishing additional policies and procedures as needed to address
the specific needs of their patients.
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\54\ 89 FR 94542 to 94543.
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If the proposed changes are finalized, hospitals that provide OB
services would still need to continue to meet all applicable CoPs
related to the organization of services, staffing, delivery of care,
and emergency preparedness to ensure safe, high-quality care for
pregnant, birthing, and postpartum patients. In meeting these ongoing
requirements, hospitals accredited by a CMS-approved accrediting
organization would continue to comply with the standards of their AO,
which may include staff competency and readiness to safely care for
pregnant and postpartum patients. AOs have staff training requirements
pertaining to maternal health. For example, TJC requires facilities to
provide role-specific education to all staff and providers who treat
pregnant and postpartum patients on their OB hemorrhage procedure
(Standard PC.06.01.01 EP 4) and to develop written, evidence-based
procedures for managing pregnant and postpartum patients with severe
hypertension/preeclampsia procedures (Standard PC.06.03.01 EP 3). Under
TJC standards, this education must occur at orientation, whenever there
are changes to the processes or procedures, or at least every 2 years
(Standard PC.06.01.01 EP 4, Standard PC.06.03.01 EP 3). Facilities must
also conduct drills at least annually to determine system issues,
followed by a team debrief (Standard OC.06.01.01 EP 5).\55\
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\55\ ``Comprehensive Accreditation Manual for Hospitals.'' The
Joint Commission, 1 July 2025, <a href="https://acrobat.adobe.com/id/urn:aaid:sc:VA6C2:843eea61-ae7f-4a8f-b413-fb52d44317b7">https://acrobat.adobe.com/id/urn:aaid:sc:VA6C2:843eea61-ae7f-4a8f-b413-fb52d44317b7</a>. Accessed 4
February 2026.
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Hospitals accredited by TJC may voluntarily seek assessment and
confirmation of their maternal care capabilities through TJC's
``Maternal Levels of Care Verification'' program, developed in
collaboration with ACOG.\56\ The program evaluates whether a facility
has the expertise, equipment, and resources necessary to provide risk-
appropriate care. It also helps hospitals identify and address
capability gaps, clarify which patients they are equipped to manage and
when transfer is appropriate, and strengthen collaborative
relationships with other facilities, supporting broader efforts to
reduce maternal mortality and severe maternal morbidity.\57\
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\56\ ``Maternal Levels of Care Verification.''
<a href="http://www.jointcommission.org">www.jointcommission.org</a>, <a href="http://www.jointcommission.org/what-we-offer/verification/maternal-levels-of-care-verification/">www.jointcommission.org/what-we-offer/verification/maternal-levels-of-care-verification/</a>. Accessed 4
February 2026.
\57\ ``Maternal Levels of Care Verification.''
<a href="http://www.jointcommission.org">www.jointcommission.org</a>, <a href="http://www.jointcommission.org/what-we-offer/verification/maternal-levels-of-care-verification/">www.jointcommission.org/what-we-offer/verification/maternal-levels-of-care-verification/</a>. Accessed 4
February 2026.
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Additionally, hospital clinicians may choose to pursue and maintain
board certification to demonstrate their expertise and commitment to
their specialty and evidence-based medicine. Medical specialty board
certification is a key component of physician education and required by
a majority of hospital-based employers. Although certification requires
an investment of time and resources, this process may enhance
physicians' employment opportunities, professional standing, and
increase patient trust. Hospitals may also support board certification
as part of their credentialing and quality improvement

[[Page 72644]]

activities, as it can assist in verifying physician qualifications,
meeting accreditation standards, and promoting high-quality patient
care.
In addition to AO standards and board certification, several
professional health care societies offer training opportunities related
to improving management of OB emergencies to protect the health of
mothers. For example, ACOG's ``Emergencies in Clinical Obstetrics''
course covers a variety of OB emergencies including breech vaginal
delivery, shoulder dystocia, postpartum hemorrhage, and teamwork and
communication.\58\ Further, ACOG provides CME for physicians and health
care professionals practicing obstetrics and gynecology through
eModules, conferences, simulations, courses, and webinars.\59\ The
American Academy of Family Physicians' (AAFP) ``Advanced Life Support
in Obstetrics (ALSO) Program'' equips the entire pregnancy care team
with skills to effectively manage OB emergencies and positively impact
maternal outcomes.\60\
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\58\ ``Emergencies in Clinical Obstetrics.'' <a href="http://www.acog.org">www.acog.org</a>,
<a href="http://www.acog.org/education-and-events/simulations/eco">www.acog.org/education-and-events/simulations/eco</a>. Accessed 4
February 2026.
\59\ ``Continuing Medical Education Program.'' <a href="http://www.acog.org">www.acog.org</a>,
<a href="http://www.acog.org/education-and-events/cme-program">www.acog.org/education-and-events/cme-program</a>. Accessed 4 February
2026.
\60\ ``Advanced Life Support in Obstetrics (ALSO) Program.''
<a href="http://Aafp.org">Aafp.org</a>, 2020, <a href="http://www.aafp.org/cme/programs/also.html">www.aafp.org/cme/programs/also.html</a>. Accessed 4
February 2026.
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Patient advocacy groups and nursing associations also offer
maternal health educational opportunities. March of Dimes offers
several educational programs that include continuing nursing education
(CNE) and CME in maternal health and provide peer-reviewed and
clinically relevant content.\61\ Additionally, the American Nurses
Association supports professional development by offering resources and
opportunities for nurses to enhance their skills and knowledge in
various nursing specialties, including obstetrics.62 63 64
The Association of Women's Health, Obstetric, and Neonatal Nurses
(AWHONN) offers the ``Obstetric Patient Safety: OB Emergencies
Workshop'' to disseminate best practices to help clinicians identify,
assess, and manage the care for patients with OB emergencies.\65\ We
believe that this robust set of external resources and standards can be
used by hospitals to comply with the existing CoPs related to the
organization of services, staffing, delivery of care, and emergency
preparedness to ensure safe, high-quality care for pregnant, birthing,
and postpartum patients in the absence of the specific OB services
staff training requirement that we are proposing to remove.
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\61\ ``Continuing Education Courses.'' <a href="http://Marchofdimes.org">Marchofdimes.org</a>, 2024,
<a href="http://www.marchofdimes.org/our-work/health-professionals/continuing-education-courses">www.marchofdimes.org/our-work/health-professionals/continuing-education-courses</a>. Accessed 4 February 2026.
\62\ American Nurses Association. ``About ANA.'' American Nurses
Association, 2025, <a href="http://www.nursingworld.org/ana/about-ana/">www.nursingworld.org/ana/about-ana/</a>. Accessed 4
February 2026.
\63\ American Nurses Association. ``About ANA.'' American Nurses
Association, 2025, <a href="http://www.nursingworld.org/ana/about-ana/">www.nursingworld.org/ana/about-ana/</a>. Accessed 4
February 2026.
\64\ ``Continuing Education for Nurses (CE) [verbar] ANA
Enterprise.'' American Nurses Association, 2024,
<a href="http://www.nursingworld.org/continuing-education/">www.nursingworld.org/continuing-education/</a>. Accessed 4 February
2026.
\65\ ``Getting Started with OPS.'' Association of Women's
Health, Obstetric and Neonatal Nurses, <a href="http://www.awhonn.org/education/hospital-products/ops/getting-started-with-ops/www.awhonn.org/education/hospital-products/ops/getting-started-with-ops/">www.awhonn.org/education/hospital-products/ops/getting-started-with-ops/www.awhonn.org/education/hospital-products/ops/getting-started-with-ops/</a>. Accessed
4 February 2026.
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We invite the public to comment on these proposals, and on any
alternatives to our approach. Also, we are interested in any
suggestions to improve existing requirements, within our statutory
authority, where they make providing quality care difficult or less
effective. Additionally, we seek comments on whether and how such
training and quality improvement initiatives could be more effectively
advanced through the Birthing-Friendly hospital designation program or
similar voluntary, incentive-based frameworks, rather than through the
CoPs. The most useful comments will be those that include data or
evidence to support the position, offer suggestions to amend specific
sections of the existing regulations, or offer particular additions.
5. Patients' Rights for Birth Tissue Collection in Hospitals (Proposed
Sec. 482.59(c))
a. Background on Birth Tissues Uses
Birth tissues are solely generated as a direct result of pregnancy,
labor, and delivery and may be discarded, retained by the patient,
stored, donated, banked for potential future medical use, and/or
transferred to a third party for research or commercial purposes. These
tissues can include umbilical cord blood, umbilical cord tissue,
umbilical veins, placenta, amniotic membrane, chorionic membrane,
amniotic fluid, and Wharton's jelly.\66\ Currently, the vast majority
of birth tissue--approximately 96 percent--is disposed of following
delivery.\67\ If intended for future medical purposes, such tissue must
be collected promptly and handled in a manner designed to minimize
contamination.\68\ For our analysis, it is helpful to separate our
discussion of the collection of cord blood from consideration of other
birth tissues.
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\66\ The gelatinous connective tissue that protects vessels
within the umbilical cord.
\67\ <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC3477280/">https://pmc.ncbi.nlm.nih.gov/articles/PMC3477280/</a>.
\68\ <a href="https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/03/umbilical-cord-blood-banking">https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/03/umbilical-cord-blood-banking</a>.
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Cord blood is the most commonly collected birth tissue for future
medical use (approximately 110,000 collections annually, or about 3
percent of births, with 75 to 80 percent stored in private banks).\69\
It is also the most researched and regulated birth tissue, at both the
federal and state level. Cord blood is unique in that families can
pursue either public or private cord banking. Public cord blood banking
has an established role in hematopoietic stem cell transplantation for
certain malignant, hematologic, immunologic, and metabolic
disorders.\70\ Public cord banking is free to the family as part of a
national transplant registry. HRSA oversees the C.W. Bill Young Cell
Transplantation Program and the National Cord Blood Inventory.\71\
These programs were established under the Stem Cell Therapeutic and
Research Acts to expand donor and cord blood availability to fund and
coordinate the collection, banking, and distribution of cord blood
units to increase access for transplantation and research.\72\ Yet only
approximately 180 facilities participate in public cord banks
nationwide due to costs associated with collection, processing, and
storage.\73\ Conversely, private cord banks allow families to retain
exclusive access to their stored cord blood for potential future
personal or family use with collection and storage costs paid out of
pocket by the family, which can total several thousand dollars
initially, followed by annual storage costs of several hundred
dollars.74 75 76
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\69\ <a href="https://www.consumeraffairs.com/health/cord-blood-banking-statistics.html">https://www.consumeraffairs.com/health/cord-blood-banking-statistics.html</a>.
\70\ <a href="https://publications.aap.org/pediatrics/article/140/5/e20172695/37866/Cord-Blood-Banking-for-Potential-Future">https://publications.aap.org/pediatrics/article/140/5/e20172695/37866/Cord-Blood-Banking-for-Potential-Future</a>.
\71\ Health Resources and Services Administration, Donation and
Transplantation Statistics, Blood Stem Cell, <a href="https://bloodstemcell.hrsa.gov/data/donation-and-transplantation-statistics">https://bloodstemcell.hrsa.gov/data/donation-and-transplantation-statistics</a>
(last visited June 2026).
\72\ <a href="https://bloodstemcell.hrsa.gov/about/legislation">https://bloodstemcell.hrsa.gov/about/legislation</a>.
\73\ <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC3477280/">https://pmc.ncbi.nlm.nih.gov/articles/PMC3477280/</a>.
\74\ <a href="https://publications.aap.org/pediatrics/article/140/5/e20172695/37866/Cord-Blood-Banking-for-Potential-Future">https://publications.aap.org/pediatrics/article/140/5/e20172695/37866/Cord-Blood-Banking-for-Potential-Future</a>.
\75\ <a href="https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/03/umbilical-cord-blood-banking">https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/03/umbilical-cord-blood-banking</a>.
\76\ <a href="https://www.cordbloodbanking.com/banking/cost/">https://www.cordbloodbanking.com/banking/cost/</a>.
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Professional organizations have emphasized the importance of
accurate information, informed consent, and

[[Page 72645]]

conflict-of-interest disclosure in cord blood banking. ACOG states that
public cord blood banking is the recommended method of obtaining cord
blood for transplantation, immune therapies, or other medically
validated indications and that routine private cord blood banking is
not supported by available evidence and that ``there is no current
evidence to support the use of an autologous umbilical cord blood
sample in regenerative medicine.'' \77\ The American Academy of
Pediatrics has similarly noted that public cord blood banking is highly
regulated, while private banking may be costly and rarely used for
treatment, and has recommended ethical and operational standards
addressing informed consent, financial disclosures, and conflicts of
interest.\78\ The American Medical Association (AMA) Code of Medical
Ethics states that physicians who provide OB care should be prepared to
inform pregnant women of options regarding cord blood donation or
storage and potential uses, and should obtain informed consent before
the onset of labor whenever feasible when participating in
collection.\79\
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\77\ American College of Obstetricians and Gynecologists,
Committee Opinion No. 771, Umbilical Cord Blood Banking (Mar. 2019),
<a href="https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/03/umbilical-cord-blood-banking">https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/03/umbilical-cord-blood-banking</a>.
\78\ William T. Shearer et al., Cord Blood Banking for Potential
Future Transplantation, 140 Pediatrics e20172695 (2017), <a href="https://publications.aap.org/pediatrics/article/140/5/e20172695/37866/Cord-Blood-Banking-for-Potential-Future">https://publications.aap.org/pediatrics/article/140/5/e20172695/37866/Cord-Blood-Banking-for-Potential-Future</a>.
\79\ American Medical Association, Code of Medical Ethics
Opinion 6.1.5, Umbilical Cord Blood Banking, <a href="https://code-medical-ethics.ama-assn.org/ethics-opinions/umbilical-cord-blood-banking">https://code-medical-ethics.ama-assn.org/ethics-opinions/umbilical-cord-blood-banking</a>.
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Data on collection rates of other birth tissue (non-cord blood) for
future medical uses are limited due to a lack of standardized national
data. Parent's Guide to Cord Blood, a patient advocacy group, estimates
approximately 100,000 placentas are collected by birth tissue
procurement organizations (BTPOs) each year and distributed to research
and/or commercial entities.\80\ Unlike cord blood, there is no public
banking infrastructure for other birth tissues. The Food and Drug
Administration (FDA) regulates such tissues either under section 361 of
the Public Health Service (PHS) Act and 21 CFR part 1271 \81\ or under
Section 351 of the PHS Act and relevant sections of the Federal Food,
Drug and Cosmetic Act.\82\ These tissues are often marketed to the
public in a misleading manner and without following applicable
statutory and/or regulatory requirements.\83\
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\80\ <a href="https://parentsguidecordblood.org/en/news/its-morning-your-c-section-and-someone-wants-you-donate-your-placenta">https://parentsguidecordblood.org/en/news/its-morning-your-c-section-and-someone-wants-you-donate-your-placenta</a>.
\81\ 21 CFR part 1271, includes requirements related to
collection, processing, storage, and distribution of certain tissues
HCT/Ps (including placenta, amniotic membrane, and cord tissue).
\82\ Section 361 of the Public Health Service Act, 42 U.S.C.
264; Section 351 of the Public Health Service Act, 42 U.S.C. 262; 21
CFR part 1271; Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301
et seq.
\83\ Food and Drug Administration, Consumer Alert on
Regenerative Medicine Products Including Stem Cells and Exosomes,
<a href="https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes">https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes</a>.
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Regenerative medicine products derived from human cells or tissues,
including stem cells, umbilical cord blood, amniotic tissue, and
related products that meet all of the criteria in 21 CFR 1271.10(a) are
subject only to regulation under section 361 of the PHS Act and the
regulations in 21 CFR part 1271. If such a product does not meet all
the criteria set out in 21 CFR 1271.10(a), and the establishment that
manufactures the HCT/P does not qualify for any of the exceptions
listed in 21 CFR 1271.15, the HCT/P will be regulated under section 351
of the PHS Act and/or the FD&C Act, and applicable regulations,
including 21 CFR part 1271, and FDA approval will generally be
required.\84\ Specifically, the FDA issues warning letters to companies
regarding the marketing of unapproved biological products and regarding
manufacturing and quality system deficiencies. Additionally, FDA has
stated that unapproved regenerative medicine therapies can pose serious
safety risks. Adverse events associated with the use of unapproved
regenerative medicine products have included bacterial infections,
blindness, tumor formation, inflammatory reactions, and other
harms.85 86 87 These regulations, company communications,
and public safety communications provide additional context regarding
FDA's oversight of regenerative medicine products, including birth
tissues, and the potential risks associated with products that do not
comply with applicable statutory and regulatory requirements.
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\84\ <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimal">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimal</a>.
\85\ <a href="https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/patient-and-consumer-warning-about-potential-serious-risks-harm-following-use-unapproved-products">https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/patient-and-consumer-warning-about-potential-serious-risks-harm-following-use-unapproved-products</a>.
\86\ Food and Drug Administration, Important Patient and
Consumer Information About Regenerative Medicine Therapies (June 3,
2021), <a href="https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies">https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies</a>.
\87\ <a href="https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-products">https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-products</a>.
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Investigative reporting has also described commercialization of
birth tissues and the potential for donations made in connection with
childbirth to enter supply chains for unapproved or unproven products.
In a 2019 investigation, The New Yorker and ProPublica reported that
some patients who donated birth tissue understood the donation to be
for a beneficial purpose, but did not recall the details of the
donation process, and described a broader market for birth tissue
products used in unproven commercial uses, often without families'
awareness.88 89
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\88\ Caroline Chen, The Birth-Tissue Profiteers, The New Yorker
and ProPublica (May 7, 2019), <a href="https://www.newyorker.com/news/news-desk/the-birth-tissue-profiteers">https://www.newyorker.com/news/news-desk/the-birth-tissue-profiteers</a>.
\89\ Mathilde Cohen, The Law of Placenta, 31 Yale Journal of Law
and Feminism 337 (2020).
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National data on the number of placentas or other birth tissues
released to or taken home by families each year is not available. The
limited available evidence consists primarily of small surveys of
hospital/pathology practices and non-national studies of placentophagy
or community birth populations.90 91 92 We are aware that
mothers and families may have significant cultural, religious,
spiritual, or personal interests in birth tissues, especially the
placenta and umbilical cord.\93\ Although birth tissues are often
treated as medical waste within healthcare settings, scholarly
literature describes numerous traditions and cultural practices, in the
United States and internationally, involving the retention, burial,
preservation, or other uses of birth tissue following childbirth.\94\
Scholars have further observed that patient preferences regarding the
disposition of birth tissues are not always reflected in institutional
policies or informed consent practices, and that families may face
inconsistent policies or practices when seeking to retain their
placentas and other birth tissues.95 96 One limited survey
in 2013

[[Page 72646]]

found that 61 percent of hospitals allow for placenta release to
families, and most hospitals had an interdisciplinary policy supporting
it.\97\
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\90\ <a href="https://journals.sagepub.com/doi/10.2350/13-05-1338-OA.1">https://journals.sagepub.com/doi/10.2350/13-05-1338-OA.1</a>.
\91\ <a href="https://pubmed.ncbi.nlm.nih.gov/29722066/">https://pubmed.ncbi.nlm.nih.gov/29722066/</a>.
\92\ Although Cohen's analysis draws on international case
studies, including examples from Brazil, CMS cites the article
because it addresses ethical, legal, and commercial issues
associated with birth tissue procurement and use that have received
comparatively limited attention in the U.S. literature.
\93\ Mathilde Cohen, The Law of Placenta, 31 Yale Journal of Law
and Feminism 337 (2020).
\94\ Mathilde Cohen, The Law of Placenta, 31 Yale Journal of Law
and Feminism 337 (2020).
\95\ Mathilde Cohen, The Law of Placenta, 31 Yale Journal of Law
and Feminism 337 (2020).
\96\ <a href="https://parentsguidecordblood.org/en/news/your-placenta-rights-under-us-state-laws">https://parentsguidecordblood.org/en/news/your-placenta-rights-under-us-state-laws</a>.
\97\ <a href="https://journals.sagepub.com/doi/10.2350/13-05-1338-OA.1">https://journals.sagepub.com/doi/10.2350/13-05-1338-OA.1</a>.
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b. Need for New Hospital Standards
As discussed in section II. A. of this proposed rule, section
1861(e)(9) of the Act authorizes the Secretary to establish additional
requirements necessary for the health and safety of patients served by
Medicare-participating hospitals. Existing hospital CoPs establish the
framework for protecting patient rights, promoting informed decision-
making, and ensuring accurate medical and clinical record
documentation. Together, the requirements safeguard patient health and
safety and promote quality care for all patients in Medicare- and
Medicaid-participating hospitals. Specifically, patient rights CoPs for
hospitals at Sec. 482.13(a) and (b) provide that patients or their
representatives have the right to make informed decisions regarding
their care, including being informed of their health status, being
involved in care planning and treatment, and being able to request or
refuse treatment. The hospital medical records CoP at Sec.
482.24(c)(4)(v) requires the medical record to contain properly
executed informed consent forms for procedures and treatments specified
by the medical staff, or by Federal or State law if applicable.
However, there are no existing CoPs related specifically to the
collection of birth tissues.
We note that this differs from the regulatory framework applicable
to organs and tissues collected for transplantation. For example, Sec.
482.45 establishes specific requirements for organ, tissue, and eye
procurement, including requirements related to hospitals' agreements
with organ procurement organizations, tissue banks, and eye banks and
policies governing the donation process. Of note, hospitals are not
required to have a relationship with birth tissue procurement
organizations or birth tissue banks. Organs and tissues collected for
transplantation are therefore subject to an established regulatory
framework and associated donation and consent process. The existing
hospital CoPs do not establish comparable requirements specifically
addressing the collection and disposition of birth tissues following a
live birth, including circumstances in which tissues may be retained by
the patient or collected, donated, transferred, stores, or used for
purposes other than transplantation.
We believe that decisions involving the collection, storage,
donation, banking, transfer, release, or discarding of birth tissues
may implicate important patient interests and rights and therefore
warrant additional transparency and informed decision-making
protections. Unlike many other biological materials generated during
the course of medical care, birth tissues may have unique cultural,
religious, personal, or familial significance to patients and their
families.\98\ At the same time, birth tissues may also have medical,
research, or other uses that can involve their collection or transfer
to entities outside of the hospital. These characteristics distinguish
birth tissues from both biological materials routinely discarded in the
course of medical care and organs and tissues collected through
established transplantation and donation processes. Therefore, families
giving birth at hospitals may reasonably wish to understand whether
such tissues will be discarded, available for them to retain, used for
research purposes, transferred to third parties, stored for future use,
or otherwise utilized in commercial activities.
---------------------------------------------------------------------------

\98\ Mathilde Cohen, The Law of Placenta, 31 Yale Journal of Law
and Feminism 337 (2020).
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Moreover, because of the concerns discussed previously about
inappropriate clinical use and profiteering, transparency is
particularly important when a hospital participates in a program or
arrangement through which birth tissues may be donated, transferred,
banked, stored, or used by a third party and/or for commercial
purposes. We believe that patients have the right to the information
necessary to make an informed decision about consenting to these uses
of their personal birth tissues and biological materials.
CMS understands that many hospitals may already have policies
around informed consent and allow patients to request retention or
release of birth tissues, subject to State law, infection prevention
and control requirements, and clinical circumstances.\99\ However,
practices may vary, and patients may not know whether, when, or how to
make such a request. Some hospitals may rely on general consent forms
or medical waste policies that do not clearly inform patients about
possible collection, transfer, storage, donation, commercial use, or
other disposition of birth tissues. Variation in these processes can
create uncertainty for patients, staff, and hospitals.
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\99\ <a href="https://journals.sagepub.com/doi/10.2350/13-05-1338-OA.1">https://journals.sagepub.com/doi/10.2350/13-05-1338-OA.1</a>.
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We believe that establishing new requirements to address these
variations would strike the appropriate balance between improving
transparency, creating consistent patient expectations and ensuring
that no hospital is compelled to collect, bank, donate, or release
tissues in circumstances that would be unsafe, unlawful, or
inconsistent with clinical care.
c. Proposed Scope and Definition of Birth Tissues (Sec. 482.59(c))
Mothers who give birth in hospitals that furnish OB services should
have baseline protections regarding informed decision-making,
documentation, and safe handling of their birth tissues when the
hospital engages in birth tissue collection, storage, donation,
banking, transfer, or release. To advance this goal, we propose to add
new standards at Sec. 482.59(c). As noted earlier in this section, we
are proposing to remove the current requirements at Sec. 482.59(c) and
replace them with new standards that build on the CoPs for obstetrical
services. These new standards address informed consent for birth tissue
collection and patient requests for retention or release of birth
tissues.
We propose to add a new standard to the OB Services CoP at Sec.
482.59(c), titled ``Birth tissue collection.'' Facilities that furnish
obstetrical services vary widely in their involvement with birth
tissues. For example, some hospitals are deeply involved in birth
tissue activities, including operating or sponsoring public cord blood
donation programs, contracting with third-party collection or tissue
procurement entities, or facilitating private banking arrangements.
Others have more limited involvement, such as occasionally receiving
requests to retain or release birth tissues to the patient for
cultural, religious, or personal uses or to a private third-party for
personal future medical uses, research, or donation, even where no
formal relationship exists between the hospital and the third party. To
account for this variation, the proposed standard would apply to only
those hospitals that furnish obstetrical services and participate in
one or more activities related to birth tissues including collection,
storage, donation, banking, transfer, or release to patient. For
purposes of this standard, we interpret participation to include
hospital-sponsored, hospital-operated, or hospital-facilitated
activities, that is, any instance in which the hospital's personnel,
premises, policies, or processes are used in connection with the
collection, packaging, storage, transfer, banking, donation, or release

[[Page 72647]]

birth tissues. Facilities that do not engage in any of these activities
would not be subject to the proposed standard.
Furthermore at Sec. 482.59(c), we propose to define ``birth
tissues'' to capture the materials most commonly associated with live
childbirth that may be collected, retained, stored, donated, banked,
transferred, or released for personal, clinical, research, and/or
commercial purposes. For purposes of this proposed rule, birth tissue
is limited to tissue or biological material obtained in connection with
labor and delivery resulting in a live birth. This proposal does not
apply to tissue or biological material obtained in other clinical
circumstances. Specifically, we propose to define ``birth tissue'' as
``human cells, tissues, and cellular and tissue-based products obtained
during or immediately following labor and delivery, (including
cesarean-section delivery), such as umbilical cord blood, umbilical
cord tissue, placenta, amniotic membrane, amniotic fluid,\100\ and
other tissues or biological materials associated with live
childbirth.'' This definition is intended to avoid gaps in patient
protections that could arise if the rule addressed only one category of
birth tissue, such as cord blood, while other tissues were collected,
transferred, released, or disposed of under less transparent processes.
This definition is also intended to be flexible enough to accommodate
changes in collection practices and terminology over time. NIH has
issued policy describing additional requirements related to research
uses of such tissue.\101\ Importantly, our definition is not intended
to conflict with or alter FDA definitions or classifications of human
cells, tissues, and cellular or tissue-based products (HCT/Ps) under
FDA authorities or other similar FDA terminology, which remain
controlling for purposes of FDA regulation.\102\ Similarly, CMS'
definition of birth tissues is not intended to conflict with or alter
NIH's definitions or policies as it relates to this or similar topics.
Lastly, we note that nothing in this proposal limits or impairs a
family's ability to receive their stillborn child for the purposes of
holding, mourning, or making funeral arrangements. Such activities are
regulated under state and local law, and hospital specific
policies.\103\ Furthermore, such scenarios are beyond the scope of this
regulation, which applies only to live births.
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\100\ CMS acknowledges that the inclusion of amniotic fluid
within ``birth tissues'' definition differs from FDA's definition of
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/
P). Namely, that amniotic fluid is not an HCT/P for FDA regulatory
purposes. See 21 CFR 1271.3(d)(3). See also FDA's July 2020 guidance
entitled ``Regulatory Considerations for Human Cells, Tissues, and
Cellular and Tissue-Based Products: Minimal Manipulation and
Homologous Use'' (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimal">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimal</a>), on page 15
states ``Secreted body fluids (e.g. amniotic fluid) are generally
not considered HCT/Ps'' per the definition of HCT/P in 21 CFR
1271.3(d). However, CMS for its regulatory purposes includes
amniotic fluid within its definition of ``birth tissue'' based on
current practices regarding collection of such material and the CMS
definition is not intended to incorporate FDA's definition in 1271.
\101\ <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4.1.15_human_fetal_tissue_research.htm">https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4.1.15_human_fetal_tissue_research.htm</a>.
\102\ FDA regulations define human cells, tissues, or cellular
or tissue-based products (HCT/Ps) as articles containing or
consisting of human cells or tissues that are intended for
implantation, transplantation, infusion, or transfer into a human
recipient. See 21 CFR 1271.3(d). FDA does not define or use the term
``birth tissue'' in 21 CFR part 1271, its 2007 Donor Eligibility
Guidance (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/eligibility-determination-donors-human-cells-tissues-and-cellular-and-tissue-based-products">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/eligibility-determination-donors-human-cells-tissues-and-cellular-and-tissue-based-products</a>), or its Minimal
Manipulation/Homologous Use guidance (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimal">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimal</a>). In January 2025, FDA issued draft guidance
entitled ``Recommendations for Determining Eligibility of Donors of
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/
Ps)'' (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-determining-eligibility-donors-human-cells-tissues-and-cellular-and-tissue-based">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-determining-eligibility-donors-human-cells-tissues-and-cellular-and-tissue-based</a>). This document
uses the term ``gestational cells or tissues.'' Differences may
exist between FDA's definitions of HCT/Ps and ``gestational cells or
tissues'' and CMS' definition of ``birth tissues,'' as CMS is not
intending to incorporate FDA's definition into this rulemaking. CMS
chose to define and use the term ``birth tissue'' because it is
already familiar to tissue establishments and to hospitals that
contract with them. Since this proposed CoP would regulate facility-
patient interactions, as well as facility policies, documentation,
and processes related to informed decision-making and the safe
release of birth tissues, CMS chose terminology that is familiar to
the affected industry.
\103\ <a href="https://stacks.cdc.gov/view/cdc/80634/cdc_80634_DS1.pdf">https://stacks.cdc.gov/view/cdc/80634/cdc_80634_DS1.pdf</a>.
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d. Proposals for Informed Consent (Sec. 482.59(c)(1))
At proposed Sec. 482.59(c)(1), we would require that the hospital
ensure that it obtains informed consent from the patient or the
patient's representative prior to the collection, storage, donation,
transfer, banking, or release to patients of birth tissues, consistent
with the hospital's scope of services and role in those activities. The
consent must be documented consistent with the medical records
requirements at Sec. 482.24(c)(4)(v).
Consistent with the phrase ``scope of services and role in those
activities'' in proposed Sec. 482.59(c)(1), the obligations under this
proposal would be tailored to the specific activities in which the
hospital participates. The proposal would not require hospitals to
offer new services, to purchase or provide new equipment, or initiate
or sponsor a collection program, private banking arrangement, or other
birth tissue collection program. Rather, it would require only that
when a hospital furnishes obstetrical services and participates in a
covered birth tissue activity, the hospital maintains appropriate
consent, documentation, policies, procedures, and safe handling
processes commensurate with its scope of services and role in that
activity. For example, a hospital that operates a public cord blood
collection program would be expected to ensure that its consent process
includes the information and disclosures applicable to public donation.
In contrast, a hospital that does not participate in a public cord
blood collection program and is only collecting birth tissue in
response to an individual mother's request for release of a placenta
for personal or cultural reasons would be expected to document the
request and release decision consistent with its policies and provide
safe handling instructions.
We propose that the informed consent process include, as
applicable, six categories of information: (1) a description of the
birth tissues to be collected; (2) the intended use, including
commercial and research uses, of the birth tissues; (3) disclosure of
any third-party involvement and conflicts of interest; (4) information
regarding risks, limitations, and infection prevention and quality
control considerations; (5) notice that a patient's refusal to provide
informed consent will not affect access to care or treatment; (6) and
any other information required under applicable Federal or State law.
These elements establish a baseline and are not intended to prescribe a
single consent form or process for all hospitals or activities. For
example for relevant research purposes, HHS' Federal Policy for the
Protection of Human Subjects (also known as the Common Rule; codified
at 45 CFR part 46 (Authority: 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C.
300v-1(b)) 104 105 may also apply, such as Institutional
Review Board (IRB) review, additional informed consent requirements,
and specific protections for pregnant women, fetuses, and neonates
(subparts B and D), inclusive of certain birth tissues such as the

[[Page 72648]]

placenta.\106\ CMS acknowledges the importance of research related to
birth tissues 107 108 and views this proposal as in
alignment with the Common Rule and not as a replacement for such
standards. This proposed rule would therefore defer to Common Rule
standards related to exempted or waived research activities.
Additionally, facilities retain the flexibility to adapt their consent
processes to reflect their specific scope of services and patient needs
in alignment with local, state, and federal law and regulations. Birth
tissues may move through complex supply chains and may have research,
clinical, manufacturing, or commercial value. We propose at Sec.
482.59(c)(1)(i) and (ii) requirements for disclosure to ensure that
patients and families fully understand how collected tissues may be
transferred to a third party, processed into a product, sold, used in
research, banked for future use, or discarded if quality criteria are
not met. Patients must be informed if a hospital and/or third party
will be financially compensated for the procurement, facilitation,
transfer, end use or other activity regarding collected tissues.
Providing this information supports patient autonomy and empowers the
patient to make a decision that reflects the patient's values and
preferences.
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\104\ <a href="https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html">https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html</a>.
\105\ <a href="https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html">https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html</a>.
\106\ <a href="https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-B/section-46.206">https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-B/section-46.206</a>.
\107\ <a href="https://www.nichd.nih.gov/sites/default/files/inline-files/STILLBIRTH_WG_REPORT_03152023.pdf">https://www.nichd.nih.gov/sites/default/files/inline-files/STILLBIRTH_WG_REPORT_03152023.pdf</a>.
\108\ https://pubmed.ncbi.nlm.nih.gov/36180175/'' <a href="https://pubmed.ncbi.nlm.nih.gov/36180175">https://pubmed.ncbi.nlm.nih.gov/36180175</a>.
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We propose at Sec. 482.59(c)(1)(iii) to require disclosure of
(both not-for-profit and for-profit) third-party involvement and
conflicts of interest. ACOG and AMA both recognize the importance of
conflict-of-interest disclosure in cord blood banking.\109\ Disclosure
is particularly important when a hospital, practitioner, or other staff
member has a financial, contractual, ownership, employment, research,
or other business relationship with a third party that could reasonably
be viewed as influencing the presentation of delivery options to the
patient (such as recommending a cesarean-section over a vaginal
delivery) or when such a relationship could result in profit from the
processing and sale of birth materials). Patients must receive
sufficient information to understand third-party involvement and
potential conflicts when they are making decisions about birth tissues
from their deliveries. The components of the informed consent as
required at proposed Sec. 482.59(c)(1)(i) through (vi) are consistent
with general informed consent principles and with professional guidance
that emphasizes disclosure of financial interests.\110\
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\109\ American College of Obstetricians and Gynecologists,
Committee Opinion No. 771, Umbilical Cord Blood Banking (Mar. 2019),
<a href="https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/03/umbilical-cord-blood-banking">https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/03/umbilical-cord-blood-banking</a>; American Medical
Association, Code of Medical Ethics Opinion 6.1.5, Umbilical Cord
Blood Banking, <a href="https://code-medical-ethics.ama-assn.org/ethics-opinions/umbilical-cord-blood-banking">https://code-medical-ethics.ama-assn.org/ethics-opinions/umbilical-cord-blood-banking</a>.
\110\ American College of Obstetricians and Gynecologists,
Committee Opinion No. 771, Umbilical Cord Blood Banking (Mar. 2019),
<a href="https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/03/umbilical-cord-blood-banking">https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/03/umbilical-cord-blood-banking</a>.
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We propose at Sec. 482.59(c)(1)(iv) to require information
regarding risks, limitations, infection prevention, and quality control
considerations. Depending on the activity, relevant information could
include the possibility that collection may not be feasible because of
maternal or neonatal clinical circumstances, that a specimen may fail
to meet volume or quality criteria, that stored birth tissues may not
be clinically useful in the future, or that releasing tissue for
personal handling may involve infection prevention and storage
considerations.
We also propose at Sec. 482.59(c)(1)(v) that the patient be
informed that refusal to provide informed consent will not affect
access to care or treatment. Patients in labor or experiencing
obstetrical emergencies may be vulnerable to time pressure or perceived
pressure from clinicians, hospital staff, or third parties. Equally,
the patient's decision to request collection or release of birth
tissues does not obligate the hospital to provide services that are
unsafe, unavailable, or inconsistent with State law or hospital policy.
This is consistent with patient exercise of rights at Sec.
482.13(b)(2).
We recognize that timing of consent in the labor and delivery
context can be challenging. As previously discussed, the proposed
requirements apply to birth tissue obtained during or immediately
following labor and delivery resulting in live birth. The timing of the
informed consent process does not alter the scope of tissues subject to
this proposal. Prenatal education and consent are preferable when
feasible, especially for planned donation or banking arrangements, but
patients may present without prior knowledge of their options or make
key requests at admission or after delivery. Under these proposals,
hospitals retain flexibility to design processes that are consistent
with clinical practice, patient needs, State law, and the hospital's
role provided that consent is obtained before the applicable birth
tissue activity occurs whenever possible, and that collection or
release activities does not interfere with clinical care (for example,
pathologic examination of the placenta). Patient safety takes
precedence in high-acuity or emergent circumstances.
Finally, we also recognize that, in some circumstances, a patient
may independently arrange with a third-party tissue bank, private bank,
courier, or other entity and may ask the hospital solely to accommodate
collection or release. In such cases, the hospital is not expected to
become an expert in the third party's products, business practices,
marketing claims, or downstream uses. The hospital should have a
process, consistent with its policies, to document the patient's
request; confirm, as appropriate to the hospital's role, that the
patient has provided authorization or evidence of the applicable third-
party consent; and document the actions taken by the hospital to
accommodate, accommodate subject to reasonable conditions, delay, or
deny the request based on clinical circumstances, infection prevention,
and legal requirements. This approach supports patient choice while
ensuring that the hospital's obligations remain proportional to the
hospital's actual role and involvement. We note that FDA regulates
human cells, tissues, and cellular and tissue-based products, including
birth tissues.
e. Policies and Procedures for Cultural, Religious, or Personal Uses
(Sec. 482.59(c)(2))
At Sec. 482.59(c)(2), we propose to require the hospital to have
written policies and procedures that permit patients to request
retention or release of birth tissues for cultural, religious, or
personal reasons, consistent with State law and the hospital's
infection prevention and control program requirements under Sec.
482.42. Such policies and procedures would not require patients to
provide justification or documentation for their respective cultural,
religious, or personal reasons. We propose this requirement because
patient requests for retention or release may arise in routine
deliveries, scheduled cesarean deliveries, emergent deliveries, or
other clinical contexts, and families and staff need clear procedures
for safe, consistent collection and release of birth tissues.
The proposed policies and procedures would address four core
topics. First, policies must address processes for patient requests for
retention or release of birth tissues. We expect hospitals to specify
how and when a patient or representative may make a request, who

[[Page 72649]]

is responsible for receiving and documenting the request, what forms or
authorizations must be completed, and how the hospital will communicate
decisions regarding release to the patient. Hospitals should design
processes that are easily understandable and accessible for their
patient population and align with clinical operations.
Second, the policies and procedures must address safe handling,
packaging, storage, and release practices of birth tissues. For
example, we expect hospitals to identify the personnel responsible for
handling birth tissues, provide appropriate containers or packaging as
needed in alignment with safe handling, clearly label each tissue
container or package as appropriate, accommodate tissue storage pending
release as requested by the patient, establish chain-of-custody or
handoff processes where needed, and implement protocols for
circumstances requiring consultation with infection prevention
personnel, pathology, risk management, or clinical leadership. These
procedures should reflect the type of tissue, the intended use, the
clinical circumstances, and the hospital's infection prevention and
control program. Third, we propose that policies and procedures must
address circumstances under which retention or release may be limited
or denied, including infection prevention and control concerns,
biohazard risks, certain clinical conditions, emergency cases, or other
applicable legal requirements, as discussed below.
<bullet> Infection Prevention and Control Concerns and Biohazard Risks
Suspected or confirmed infection, contamination, or other biohazard
concerns may create unacceptable risks that warrant limiting or denying
retention or release. Occupational Safety and Health Administration
(OSHA) classifies human blood, certain body fluids, and unfixed human
tissues and organs as potentially infectious materials.\111\ Because
placental and related birth tissues may contain blood and other
biological material, hospitals would need to implement handling and
packaging procedures to protect patients, staff, and others from
potential exposure to bloodborne pathogens (for example, HIV, hepatitis
B, hepatitis C, or other infectious agents).\112\ Hospitals must have
processes to address safe handling, packaging, storage, and release
when patients request retention or release of birth tissues. Hospitals
should also identify circumstances in which release may be limited or
denied due to infection prevention and control concerns consistent with
the hospital's infection prevention and control program under Sec.
482.42.
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\111\ OSHA Bloodborne Pathogens Standard, 29 CFR 1910.1030.
<a href="https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1030">https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1030</a>.
\112\ <a href="https://www.cdc.gov/pregnancy-hiv-std-tb-hepatitis/php/screening/index.html">https://www.cdc.gov/pregnancy-hiv-std-tb-hepatitis/php/screening/index.html</a>.
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<bullet> Certain Clinical Conditions
Retention or release may also be limited when tissue is needed for
pathology review or other clinically appropriate diagnostic evaluation.
Placental pathology may assist in the evaluation of adverse maternal,
fetal, or neonatal outcomes, including fetal growth restriction,
stillbirth,\113\ infection, congenital abnormalities, preterm birth,
placental insufficiency, maternal hypertensive disorders, or other
complications of pregnancy and delivery. Hospitals should identify in
their policies the clinical circumstances under which retention for
diagnostic purposes would take precedence over patient's requests for
release. To the extent possible, patient requests should take
precedence over circumstances under which hospitals may want to retain
the placenta or other birth tissues for elective evaluation, research,
or other purposes. Unless there are circumstances such as infection
prevention concerns or a need for the hospital to retain the birth
tissue for appropriate diagnostic evaluation, the patient's autonomy
over their biological materials related to delivery should be
prioritized.
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\113\ <a href="https://www.acog.org/clinical/clinical-guidance/obstetric-care-consensus/articles/2020/03/management-of-stillbirth">https://www.acog.org/clinical/clinical-guidance/obstetric-care-consensus/articles/2020/03/management-of-stillbirth</a>.
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<bullet> Emergency Cases
Patient safety takes precedence in all emergency circumstances in
which staff cannot safely collect, process, or release birth tissues
due to emergent patient care needs. Collection, storage, donation,
banking, transfer, or release activities of birth tissues should not
delay emergency care, interfere with the clinical management of labor
and delivery, or alter medically appropriate obstetric or neonatal
practice.114 115 A hospital would not be expected to delay
necessary clinical intervention to complete a birth tissue consent
process or collection activity, and failure to collect birth tissue due
to emergent clinical circumstances would not, by itself, constitute
noncompliance. To the extent necessary, such consents may be obtained
following resolution of the emergency and stabilization of the
patient's condition.
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\114\ American College of Obstetricians and Gynecologists,
Committee Opinion No. 771, Umbilical Cord Blood Banking (Mar. 2019),
<a href="https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/03/umbilical-cord-blood-banking">https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/03/umbilical-cord-blood-banking</a>.
\115\ American Medical Association, Code of Medical Ethics
Opinion 6.1.5, Umbilical Cord Blood Banking, <a href="https://code-medical-ethics.ama-assn.org/ethics-opinions/umbilical-cord-blood-banking">https://code-medical-ethics.ama-assn.org/ethics-opinions/umbilical-cord-blood-banking</a>.
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<bullet> Other Applicable Legal Requirements
Retention, testing, handling, or disposition of birth tissue may
also be limited or governed by applicable Federal, State, Tribal,
territorial, or local law (See discussion of relevant State laws in
section II.A.5. of this proposed rule.) By defining these criteria in
advance, hospitals provide patients and staff with clear expectations
and transparent and consistent processes. These proposed requirements
are intended to complement, not interfere with, a hospital's existing
authority to retain birth tissues when clinically appropriate or
otherwise required by law.
Fourth, at Sec. 482.59(c)(2)(i)(D), we propose that the policies
and procedures must address staff education regarding the hospital's
procedures for responding to patient requests. This education is
intended to be focused and practical. Staff who may receive or respond
to requests to know how to identify the applicable policy, document the
request, process the request safely and within their scope of services,
and provide safe handling instructions when tissue is released.
Lastly, we propose at Sec. 482.59(c)(2)(ii) that the hospital
provide patients who request retention or release of birth tissues with
instructions for safe handling, transport, storage, and disposition of
the tissues, as applicable. These instructions should be
understandable, practical, and tailored to the birth tissue and release
context. For example, instructions might address the need to maintain
tissue in a leak-proof container, avoid exposure to other patients or
staff, refrigerate or otherwise store tissue as directed, use
appropriate personal protective measures, or comply with applicable
local disposition requirements. The proposed requirement would not
require hospitals to supervise the patient's use after release, but it
does require the hospital to provide instructions that support safe
decision-making at the point of release.
In summary, these proposed requirements are intended to operate
alongside, not in place of, other existing Federal and State
authorities. FDA regulates human cells, tissue and cellular and tissue-
based products (HCT/Ps) either under Section 361 of the Public Health
Service Act and 21

[[Page 72650]]

CFR part 1271 or under Section 351 of the PHS Act and relevant sections
of the Federal Food, Drug, and Cosmetic (FD&C) Act and applicable
regulations. FDA has issued guidance on minimal manipulation and
homologous use and has stated that HCT/Ps that do not meet the criteria
to be regulated solely under section 361 of the Public Health Service
Act and 21 CFR part 1271 are regulated as drugs, devices, and/or
biological products.\116\ FDA also has taken compliance and enforcement
actions addressing unapproved HCT/Ps, including products derived from
birth tissues.
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\116\ Food and Drug Administration, Regulatory Considerations
for Human Cells, Tissues, and Cellular and Tissue-Based Products:
Minimal Manipulation and Homologous Use; Guidance for Industry and
Food and Drug Administration Staff (July 2020), <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimal">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimal</a>.
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The proposed CoPs at Sec. 482.59(c) occupies a narrower and
distinct role, regulating the facility-patient interaction, facility
policies, documentation, and processes for informed decision-making and
safe release in Medicare and Medicaid participating hospitals. Nothing
in this proposal determines whether any product is lawfully marketed or
subject to FDA premarket review. Rather the purpose of the CoPs is to
protect patient health and safety and to ensure that quality care is
furnished to all patients in Medicare-participating hospitals. In
accordance with section 1864 of the Act, State surveyors assess
hospital compliance with the conditions as part of the process of
determining whether a hospital qualifies for a provider agreement under
Medicare. Alternatively, under section 1865 of the Act, hospitals can
elect to be reviewed instead by private accrediting organizations
approved by CMS as having standards that meet or exceed the applicable
Medicare standards and survey procedures comparable to those CMS
requires for State survey agencies. Examples of survey and enforcement
activities include review of facility policies and procedures, auditing
of patient medical records, and interviewing facility leadership and
staff.
We invite public comment on proposed Sec. 482.59(c), including the
scope of hospitals and activities to which the standard should apply;
the proposed definition of birth tissues; the proposed informed consent
standard; and the proposed policies and procedures for cultural,
religious, or personal uses.

B. Long-Term Care Facilities

LTC facilities, meaning SNFs and NFs, are institutions or distinct
parts of an institution that are primarily engaged in providing skilled
nursing care and related services to patients that require medical or
nursing care or rehabilitation services due to an injury, disability,
or illness. As of January 2026, there are around 15,000 LTC facilities
caring for about 1.25 million residents daily.\117\ LTC facilities
seeking to be Medicare and Medicaid providers of services must be
certified as meeting Federal participation requirements set forth at 42
CFR part 483 (hereafter, ``LTC requirements''), which set out the
resident health and safety protections established by the Secretary.
The specific statutory authority for LTC facilities is set forth in
section 1819 and 1919 of the Act. Sections 1819(d)(4)(B) and
1919(d)(4)(B) of the Act explicitly authorize the Secretary to issue
any regulations he deems necessary to protect the health and safety of
residents of LTC facilities. Under sections 1866 and 1902 of the Act,
LTC facilities seeking to participate in the Medicare or Medicaid
program, respectively, or both, must enter into an agreement with the
Secretary or the State Medicaid agency, as appropriate.
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\117\ Centers for Medicare & Medicaid Services. Quality,
Certification and Oversight Reports (QCOR), Nursing home provider
reports, Active Provider and Supplier Counts Report, FY 2025.
Accessed February 2, 2026. <a href="https://qcor.cms.gov/main.jsp">https://qcor.cms.gov/main.jsp</a>.
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1. Proposal To Amend Transfer Notice to Ombudsman (Sec. 483.15(c))
In 2016 CMS finalized revised requirements that LTC facilities must
meet to participate in the Medicare and Medicaid programs.\118\ This
comprehensive update of the regulations focused on quality of
healthcare furnished through Federal programs, patient safety and
reducing procedural burdens on providers. Among other things, this 2016
final rule emphasized the importance of protection to residents from
being inappropriately transferred or discharged, providing residents
with access to an advocate who can inform them of their options and
rights, and ensuring that the Office of the State LTC Ombudsman is
aware of facility activities related to transfers and discharges.
Specifically, as a part of ensuring resident rights at Sec. 483.15(c),
we require LTC facilities to provide notice to the resident and the
resident's representative(s) before transfer or discharges. The
facility must also send a copy of the notice to a representative of the
Office of the State Long-Term Care Ombudsman.
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\118\ 81 FR 68688.
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In accordance with the January 30, 2017, E.O. ``Reducing Regulation
and Controlling Regulatory Costs'' (E.O. 13771), on July 18, 2019, we
published a proposed rule entitled, ``Requirements for LTC Facilities:
Provisions to Promote Efficiency and Transparency.'' \119\ In that rule
we proposed changes to Sec. 483.15 related to admission, transfer, and
discharge rights. Specifically, we proposed to revise the requirement
for facilities to send transfer and discharge notices to the State LTC
ombudsman to apply only to ``involuntary transfers and discharges.'' In
response to the proposed rule, we received comments from a wide range
of individual health care professionals, various healthcare
associations, LTC facilities, organizations representing providers of
LTC and senior service, LTC Ombudsmen, advocacy groups for LTC
consumers, and LTC consumers and their family representatives. Many
commenters supported the proposed change to remove Ombudsman
notifications for hospitalizations where the facility has every
intention of accepting the resident back following the hospitalization.
However, some commenters suggested that this should be addressed in the
sub-regulatory guidance, rather than through regulatory revisions.
Furthermore, these commenters indicated that the use of the terms
``involuntary'' or ``facility-initiated'' in the regulations is
confusing and suggest that a notice would not be required unless a
resident actively objects to the transfer or discharge. Due to
circumstances surrounding the COVID-19 pandemic and the rapidly
evolving needs and concerns of the LTC community at that time, we did
not finalize the proposal to restrict Ombudsman notices to involuntary
transfers and discharges only.
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\119\ 84 FR 34737.
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While the original intent of this requirement as finalized in the
2016 rule was to enable Ombudsman officials to intervene in cases of
inappropriate resident discharges, the volume of paperwork related to
notice for every transfer of care and discharge has prevented Ombudsman
officials from effectively focusing their efforts on inappropriate
discharges, thereby negating the purpose of the regulation. In an
emergent care situation, the urgency of the transfer of a resident to
an acute care hospital for emergent care must be the primary focus of
LTC facility staff, with a notice of transfer provided to the resident
and resident's representative(s) as soon as practicable

[[Page 72651]]

before the transfer in accordance with the requirements set forth at
Sec. 483.15(c)(4)(ii)(D). Copies of notices for emergency transfers
must be sent to the Ombudsman, however the practicalities of
implementing this requirement have led to the permitted practice of
submitting a monthly list of residents who experienced a transfer to
receive emergency care. This current practice does not meet the
original intent of the regulations to prevent residents from being
inappropriately transferred or discharged, as a transfer for emergency
care services is inherently appropriate, nor does the practice as
implemented lend itself to actionable efforts on the part of the
Ombudsman officials.
We are aware that Ombudsman offices have expressed concerns about
the issue of large numbers of notices and the difficulties of sorting
notices in a timely manner so that problematic notices can be
identified and acted upon. Responses to the 2025 deregulatory RFI \120\
indicate that transfer and discharge notice requirements create
administrative burden for nursing homes, particularly during emergent
resident hospital transfers. Commenters indicated that while these
notices may be necessary for planned discharges, they are excessive and
are low priority for urgent hospital visits. Commenters recommend
eliminating transfer notices for emergent care and eliminating the
requirement to send a copy of the notice to the Ombudsman to reduce
administrative burden and confusion for the families.
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\120\ ``Medicare Regulatory Relief [verbar] CMS.'' <a href="http://Cms.gov">Cms.gov</a>,
2025, <a href="https://www.cms.gov/files/document/unleashing-prosperity-through-deregulation-medicare-program-request-information.pdf">https://www.cms.gov/files/document/unleashing-prosperity-through-deregulation-medicare-program-request-information.pdf</a>.
Accessed September 2025.
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In light of the public comments and the misalignment between our
original regulatory goals and the way in which LTC facilities and
Ombudsman offices have complied with the regulations, we propose to
modify the requirement at Sec. 483.15(c)(3)(i) for LTC facilities to
provide Ombudsman notice of resident transfers, except for transfers
related to emergent care, as a way to focus Ombudsman official efforts
on the reduction of inappropriate transfers and discharges and to
alleviate the burdens of sending and processing these notices for both
LTC facilities and Ombudsman officials.
The transfer and discharge facility requirements at Sec. 483.15(c)
would continue to require that the facility must permit each resident
to remain in the facility and not transfer or discharge the resident
from the facility unless certain circumstances are present. The
circumstances center around the resident's welfare, whether the
resident has improved sufficiently that the resident no longer needs
the services provided by the facility, safety of individuals in the
facility is endangered due to the clinical or behavioral status of the
resident, payment issues and/or the facility ceases to operate. In
addition, the resident has the right to appeal a transfer or discharge.
The robust nature of the facility requirements around transfer and
discharge, specifically the timing of the notice at least 30 days
before the resident is transferred or discharged, would continue to
assure that residents receive appropriate protection in the transfer
and discharge process. The requirements would also continue to require
that if the information in the notice changes prior to affecting the
transfer or discharge, the facility must update the recipients of the
notice as soon as practicable once the updated information becomes
available. We invite comments on how to reduce burden while supporting
sharing the most current, updated information related to transfer and
discharge notices.
2. Proposal To Amend Facility Assessment Requirement (Sec. 483.71)
In May 2024 CMS finalized changes to the LTC facility
requirements.\121\ Among other things, these changes moved the existing
facility assessment requirements from Sec. 483.70(e) to their own
requirement at Sec. 483.71. As part of this revision, CMS expanded the
facility assessment requirements to require the active involvement of
certain categories of staff and others in the facility assessment
process. One of those new categories is direct care staff, including
but not limited to, RNs, LPNs/LVNs, NAs, and representatives of the
direct care staff, if applicable. Most commenters at the time of the
proposed rule supported the inclusion of direct care staff; however,
some commenters opposed including third party representatives of direct
care staff, such as union representatives.
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\121\ 89 FR 40876.
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Commenters contended that inclusion of representatives of direct
care staff would be inappropriate since the facility assessment is an
operational document for the facility. They also suggested that the
inclusion of third parties, especially union representatives, could be
disruptive, divisive, and render the facility assessment ineffective.
In addition, commenters raised concerns that third parties, especially
union representatives, would be primarily concerned about the well-
being of the workers they represent instead of the quality of
residents' care. CMS acknowledged these counter arguments to the
proposal but subsequently finalized the provision, and we have
continued to review and reevaluate all aspects of the facility
assessment regulation. Upon review of these changes, conducted in light
of recent E.O. 14192 ``Unleashing Prosperity Through Deregulation''
\122\ and E.O. 14219 ``Ensuring Lawful Governance and Implementing the
President's `Department of Government Efficiency' Deregulatory
Initiative,'' \123\ CMS identified the provision related to ensuring
the active involvement of representatives of direct care staff as being
operationally and logistically burdensome without direct benefits to
resident care. LTC facilities do not have any authority over the
actions or inactions of direct care staff representatives; therefore,
requiring LTC facilities to be responsible for assuring their active
involvement in the facility assessment process is impracticable. We
have determined that holding LTC facilities responsible for the actions
of those that do not have employment or contractual obligations with
the facility is not an appropriate requirement for LTC facility
regulations. As such, we propose to remove this provision from the
requirements. We would retain the remainder of the facility assessment
requirements without change.
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\122\ 90 FR 9065.
\123\ 90 FR 10583.
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The facility assessment is a foundational element of the LTC
requirements, providing the basis for ensuring residents receive safe
and appropriate care. LTC facilities are required to conduct and
document a facility-wide assessment to determine what resources are
necessary to competently care for their residents during both day-to-
day operations and emergencies, including an evaluation of the resident
population and the resources needed to serve them. The facility
assessment informs several key areas of LTC facility operations,
including nursing services (Sec. 483.35), food and nutrition services
(Sec. 483.60), quality assurance and performance improvement (Sec.
483.75), infection control (Sec. 483.80), and training (Sec. 483.95).
We recognize that LTC facilities serve a uniquely vulnerable population
with complex, chronic, and often rapidly changing care needs. Unlike
other provider types, LTC facilities serve as the permanent residence
for their residents, requiring a level of individualized, continuous
care planning that necessitates a structured,

[[Page 72652]]

facility-wide assessment. The facility assessment requirement reflects
this distinct care environment and is intended to ensure that
facilities have the resources, staffing, and systems in place to meet
the needs of their specific resident population.
Although we are proposing to remove the prescriptive requirement
regarding the inclusion of representatives of direct care staff in the
facility assessment, we encourage LTC facilities to consider the input
of any individuals the facility deems appropriate as part of a
comprehensive and meaningful facility assessment. We recognize the
facility assessment as an essential tool for effective LTC facility
planning. While we remain committed to ensuring that facility
assessments are comprehensive and meaningful, we also acknowledge the
administrative burden this process may place on LTC facilities.
Therefore, we invite public comments on approaches to streamline and
reduce burden associated with the facility assessment process, without
compromising its integrity or effectiveness. Specifically, we seek
input on the following:
<bullet> What process improvements or best practices have LTC
facilities found effective in conducting facility assessments
efficiently?
<bullet> Are there existing or emerging technological tools that
could assist LTC facilities in completing this process more
efficiently?
<bullet> How can CMS support facilities in leveraging these tools
while maintaining the quality and comprehensiveness of the assessment?
3. Infection Control (Sec. 483.80(d) and (g))
The COVID-19 Public Health Emergency (PHE) placed unprecedented
strain on the Nation's healthcare system, particularly LTC facilities,
which faced severe staffing shortages and limited access to personal
protective equipment (PPE) and critical supplies. Protecting LTC
residents under these conditions required enhanced visibility into the
spread and impact of infectious diseases within these settings. To
address this need, CMS published a series of interim final rules with
comment period (IFCs) and subsequent final rules during and after the
PHE to establish and refine data reporting, testing, vaccination, and
infection control requirements for LTC facilities. The data informed
coordination of operations and were especially important to anticipate
and prepare for surge conditions.
Beginning on May 8, 2020, CMS issued an IFC \124\ revising
infection prevention and control requirements to better respond to
COVID-19, including electronic reporting of confirmed and suspected
COVID-19 cases to the Centers for Disease and Control and Prevention
and notification requirements for residents and their representatives.
These reporting requirements enabled CMS and CDC to identify national
epidemiological trends in LTC facilities. On September 2, 2020, CMS
issued a second IFC \125\ establishing COVID-19 testing requirements
for LTC facilities, including documentation and response protocols
following positive test results. On May 13, 2021, CMS issued an
additional IFC \126\ further revising infection control requirements by
requiring LTC facilities and ICFs-IID to provide education about COVID-
19 vaccines and to offer vaccination to residents, clients, and staff,
as well as to report resident and staff vaccination status to CDC.
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\124\ 85 FR 27550.
\125\ 85 FR 54820.
\126\ 86 FR 26306.
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To ensure continuity of critical data collection beyond the end of
the PHE, CMS finalized the COVID-19 reporting requirements from the May
2020 and May 2021 IFCs in a November 9, 2021 final rule.\127\ This rule
modified and streamlined reporting requirements, reduced reporting
frequency, and required LTC facilities to continue reporting
standardized COVID-19 data elements through December 31, 2024, with
ongoing reporting of vaccination status without a sunset date. On June
5, 2023, CMS issued a final rule \128\ removing expired COVID-19
testing requirements, withdrawing the COVID-19 staff vaccination
mandate issued in an earlier IFC, ``Medicare and Medicaid Programs;
Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule''
dated November 5, 2021 (hereafter ``Staff Vaccination IFC''),\129\ and
finalizing requirements for LTC facilities and ICFs-IID to continue
providing vaccine education and offering COVID-19 vaccinations to
residents, clients, and staff. Together, these actions reflect CMS'
evolving regulatory approach to monitoring and mitigating the impact of
COVID-19 in LTC settings while reducing unnecessary burden as
conditions changed following the PHE.
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\127\ 86 FR 62240.
\128\ 88 FR 36485.
\129\ 86 FR 61555.
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In November 2024, CMS finalized the current iteration of these
requirements, as part of the ``Medicare Program; Calendar Year (CY)
2025 Home Health Prospective Payment System (HH PPS) Rate Update; HH
Quality Reporting Program Requirements; HH Value-Based Purchasing
Expanded Model Requirements; Home Intravenous Immune Globulin (IVIG)
Items and Services Rate Update; and Other Medicare Policies''
(henceforth referred to as CY 2025 HH PPS final rule) \130\ which
included ongoing respiratory illness data reporting requirements as
well as requirements for reporting during a Secretary-declared PHE (89
FR 88459). These requirements further reduced compliance burden when
compared to the data reporting that was required during the PHE.
Specifically, we decreased the scope of data categories required to be
reported (including, total deaths and COVID-19 deaths among patients
and staff, ventilator capacity, access to COVID-19 testing, and staff
vaccination status).
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\130\ 89 FR 88354.
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In the CY 2025 HH PPS final rule, CMS finalized requirements at
Sec. 483.80(g) for LTC facilities to report respiratory illness data
on an ongoing basis as well as additional reporting requirements during
a declared national, State, or local PHE (89 FR 88458). We revised the
requirements related to LTC facility infection prevention and control
and antibiotic stewardship program to extend a modified form of the
COVID-19 and influenza reporting requirements that included data for
RSV and reduced the frequency of reporting compared to prior rules.
Specifically, we required LTC facilities to report a facility census as
well as information on acute respiratory illnesses (including
influenza, COVID-19, and RSV), related to resident vaccination status,
confirmed resident cases, and hospitalized residents in a standardized
format and frequency specified by the Secretary, through the CDC's NHSN
on an ongoing basis (Sec. 483.80(g)(1)(i) (89 FR 88485). We also
established that during a declared Federal, State, or local PHE, the
Secretary could require LTC facilities to report additional or modified
data elements relevant to an acute infectious illness, up to a
frequency of daily reporting, without going through additional notice
and comment rulemaking. We also established that during a declared PHE
the Secretary may require LTC facilities to report supply inventory
shortages, staffing shortages, relevant medical countermeasures and
therapeutic inventories usage, and relevant confirmed infections for
staff (Sec. 483.80(g)(2)).

[[Page 72653]]

a. Proposal To Remove Staff Covid-19 Vaccine Educate, Offer and
Documentation Requirements (Sec. 483.80(d))
During the COVID-19 PHE, CMS, in consultation with the CDC, issued
an evolving series of requirements to address emerging concerns. As
part of the response, CMS required LTC facilities to educate and offer
COVID-19 vaccination to staff. On May 13, 2021, CMS published an
IFC,\131\ which revised the health and safety requirements that LTC
facilities must meet to participate in the Medicare and Medicaid
programs. The IFC established requirements at Sec. 483.80(d)(3),
requiring that LTC facilities provide COVID-19 vaccination education to
staff, and offer COVID-19 vaccines to staff, and document these
activities, referred to as the ``educate and offer'' provisions. The
IFC also established similar requirements related to educating and
offering COVID-19 vaccinations to residents. On June 5, 2023, CMS
finalized the educate and offer provisions. Specifically, LTC
facilities are required to develop and implement policies and
procedures to ensure that all of the requirements set forth within that
section are followed. For residents and staff members, the facility
maintains documentation related to COVID-19 vaccination that includes,
at a minimum, that residents and staff were provided education
regarding the benefits and potential risks associated with COVID-19
vaccines; were offered a COVID-19 vaccine or information on obtaining a
COVID-19 vaccine; and the COVID-19 vaccine status of residents and
staff and related information as indicated by the CDC's NHSN. These
educate and offer provisions, supported quality measures that included
healthcare providers that were adopted in the 2024 SNF Prospective
Payment System rule.\132\
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\131\ 86 FR 61555.
\132\ 88 FR 53200.
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Similar to the requirement that LTC facilities must educate their
staffs about the COVID-19 vaccine and offer it to them, issued on
November 5, 2021, we issued the Staff Vaccination IFC.\133\ This IFC
revised the requirements that most Medicare- and Medicaid-certified
providers and suppliers were required to meet to participate in the
Medicare and Medicaid programs to include requirements regarding
development and implementation of policies and procedures to ensure
COVID-19 vaccination of staff. At that time evidence continued to
demonstrate that unvaccinated healthcare staff presented risks to
patient safety across healthcare settings, and that too few healthcare
staff were getting vaccinated. While the requirements established by
the staff vaccination IFC were necessary to protect the health and
safety of residents at that time, circumstances of the COVID-19
pandemic evolved with the eventual lifting of the PHE. On June 5, 2023,
we issued a final rule \134\ that ultimately withdrew the requirements
regarding development and implementation of policies and procedures to
ensure COVID-19 vaccination of staff, noting that declining infection
rates, deaths, and decreasing severity of disease were important
reasons for withdrawing the healthcare staff COVID-19 vaccination
provisions.
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\133\ 86 FR 61555.
\134\ 88 FR 36485.
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We find the same reasoning to be true when examining the necessity
and appropriateness of the requirement that LTC facilities must educate
staff about the COVID-19 vaccine, offer it to them, and document these
actions. During the COVID-19 PHE, there was value in these requirements
as we sought to protect vulnerable residents from the risks of
infection with the COVID-19 virus through reduced transmission from
facility staff members. We expect that, if finalized, eliminating the
staff COVID-19 education requirements found at Sec. 483.80(d)(3),
would free up resources that LTC facilities could use to implement best
practices for infection control and prevention.
We would retain the COVID-19 educate and offer requirements
applicable to LTC facility residents currently codified at Sec.
483.80(d)(3). This is consistent with the resident-specific
immunization requirements at Sec. 483.80(d) that are specific to
influenza and pneumococcal immunizations that also apply to just
residents and not staff.
To further streamline and simplify the documentation requirements
for residents regarding COVID-19 immunization, we are proposing to
align the regulatory text with the influenza and pneumococcal
immunization requirements at Sec. 483.80(d)(1) and (d)(2).
Specifically, we are proposing to revise the language at Sec.
483.80(d)(3). While the current requirement includes documentation in
the resident's medical record of each individual dose of the COVID-19
vaccine, the proposed changes would consolidate documentation into two
concise elements: education and immunization status. The proposed
regulatory text for COVID-19 immunizations at 483.80(d)(3) would follow
the sequence for influenza and pneumococcal immunizations at Sec.
483.80(d)(1) and (d)(2). The regulation sequence starts with education
regarding the benefits and potential side effects of immunization,
offering the option to refuse immunization, and documentation
requirements that fall into two categories, education provided and
whether the resident received the immunization. This streamlined
regulatory text should be familiar to providers. We are also proposing
to remove the requirements at Sec. 483.80(d)(3) for education
regarding multi-dose vaccine series. We are proposing at Sec.
483.80(d)(3)(i) to require education of vaccine requirements to be more
flexible, as vaccines formulations can change over time. We are also
proposing to revise the documentation requirements for immunization
status to include that the resident was either immunized or not
immunized. If the resident is not immunized, documentation would be
required to indicate if this was due to medical contraindication or
refusal.
Research demonstrates that LTC facility residents are highly
susceptible to COVID-19 infection because of their age, comorbidities,
and frailty.\135\ Vaccination of residents in LTC facilities against
respiratory diseases including influenza, pneumococcal disease, and
COVID-19 is a simple, inexpensive, and effective means to reduce the
burden of infection in this segment of the population.\136\ In fall
2024 COVID-19 vaccination coverage among LTC facility residents, as
reported to NHSN, was lower than coverage of community dwelling older
adults, while influenza vaccination coverage among LTC facility
residents was similar to that of the general adult population aged 65
years and older.\137\ While LTC facility residents faced increased
risks from these infections, their vaccination rates for RSV and COVID-
19 lagged behind their community dwelling counterparts. This
vaccination gap may reflect vaccination barriers in LTC facilities that
have real consequences for resident health and safety. During each week
of October 2024, approximately 5,500 LTC facility residents received a
diagnosis of

[[Page 72654]]

COVID-19 and 360 were hospitalized after having received a positive
COVID-19 test result.\138\ During the 2023 to 2024 respiratory virus
season, approximately one in six adults hospitalized with COVID-19 was
a LTC facility resident, and their peak weekly hospitalization rate was
approximately eight times the peak weekly rate of all U.S. adults aged
70 years and older.\139\ CMS continues to believe that LTC residents
have the right to be informed and exercise their right to self-
determination by making informed decisions about the care they receive,
and that LTC facilities should be required to facilitate informed
decision making among residents and their representatives. Residents
and their representatives would continue to have the right to refuse
all offered vaccines. Additionally, LTC facilities would continue to be
required to document information regarding the education and offering
of the vaccine to each resident.
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\135\ Nursing homes used unproven COVID measures and didn't use
vaccines, antivirals enough, review finds. CIDRAP.
\136\ Gerontology (2024) 70 (3): 241-247. <a href="https://doi.org/10.1159/000534998">https://doi.org/10.1159/000534998</a>.
\137\ Reses HE, Segovia G, Dubendris H, et al. Coverage with
Influenza, Respiratory Syncytial Virus, and COVID-19 Vaccines Among
Nursing Home Residents--National Healthcare Safety Network, United
States, November 2024. MMWR Morb Mortal Wkly Rep 2024;73:1052-1057.
DOI: <a href="http://dx.doi.org/10.15585/mmwr.mm7346a2">http://dx.doi.org/10.15585/mmwr.mm7346a2</a>.
\138\ Reses HE, Segovia G, Dubendris H, et al. Coverage with
Influenza, Respiratory Syncytial Virus, and COVID-19 Vaccines Among
Nursing Home Residents--National Healthcare Safety Network, United
States, November 2024. MMWR Morb Mortal Wkly Rep 2024;73:1052-1057.
DOI:
\139\ Reses HE, Segovia G, Dubendris H, et al. Coverage with
Influenza, Respiratory Syncytial Virus, and COVID-19 Vaccines Among
Nursing Home Residents--National Healthcare Safety Network, United
States, November 2024. MMWR Morb Mortal Wkly Rep 2024;73:1052-1057.
DOI:
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We note that while we are proposing to eliminate the staff COVID-19
educate and offer requirements, adherence to proper infection control
guidelines, including current CMS infection control requirements,
continues to be an effective strategy to prevent COVID-19 cases and
deaths. For example, one study found that in nursing homes with higher
adherence to CDC infection prevention guidelines, including hand
hygiene, disinfection, PPE use, and screenings for symptoms and
elevated temperature, there were lower incidences of COVID-19 vis-
[agrave]-vis nursing homes with lower adherence.\140\ A broader
literature review found an association between proper mask use and
proper donning of PPE and a lower prevalence of COVID-19
infections.\141\ Another literature review centered on influenza in LTC
facilities and the need for robust infection prevention and control
practices to minimize outbreaks. Prevention and control of influenza in
LTC facilities requires a multifaceted approach that includes infection
prevention and control policies, strong managerial leadership, outbreak
planning and a well-trained workforce.\142\ Leading organizations,
including the Society for Healthcare Epidemiology of America (SHEA) and
the Association for Professional in Infection Control and Epidemiology
(APIC) have also recently released updated guidelines for best
practices related to infection prevention and control policies in
nursing homes that are an important source of information to help
providers protect vulnerable residents.\143\ CMS recognizes these
guidelines recommend that staff should receive recommended vaccinations
or have documented evidence of immunity against vaccine-preventable
diseases. Also, the guidelines recommend that LTC facilities should
identify and implement multimodal interventions to increase vaccine
acceptance by LTC facility staff.
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\140\ Telford, Carson T et al. ``COVID-19 Infection Prevention
and Control Adherence in Long-Term Care Facilities, Atlanta,
Georgia.'' Journal of the American Geriatrics Society vol. 69,3
(2021): 581-586. doi:10.1111/jgs.17001.
\141\ Henriques, H.R., Sousa, D., Faria, J. et al. Learning from
the covid-19 outbreaks in long-term care facilities: a systematic
review. BMC Geriatr 23, 618 (2023). <a href="https://doi.org/10.1186/s12877-023-04319-w">https://doi.org/10.1186/s12877-023-04319-w</a>.
\142\ Lansbury LE, Brown CS, Nguyen-Van-Tam JS. Influenza in
long-term care facilities. Influenza Other Respir Viruses. 2017
Sep;11(5):356-366. doi: 10.1111/irv.12464. Epub 2017 Jul 26. PMID:
28691237; PMCID: PMC5596516.
\143\ Mody L, Advani SD, Ashraf MS, et al. Multisociety guidance
for infection prevention and control in nursing homes. Infection
Control & Hospital Epidemiology. 2025;46(11):1069-1096. doi:10.1017/
ice.2025.10252.
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We expect that eliminating the staff COVID-19 education
requirements would help LTC facilities realign resource allocation to
implement best practices for infection control and prevention. LTC
facility residents are at risk for becoming infected with and
experiencing complications from respiratory viruses, protecting
residents against respiratory illness by continuing to educate and
offer them vaccinations coupled with supporting their rights for
informed choices will promote quality of life.
b. Proposal To Remove Ongoing Data Reporting Requirements (Sec.
483.80(g))
As part of regulatory review conducted in response to E.O. 14219
and E.O. 14192, CMS solicited and received interested parties' input
through the 2025 deregulatory RFI.\144\ Some comments focused on the
ongoing acute respiratory illness data reporting requirement.
Commenters stated that this provision is duplicative of State and local
requirements, noting that these requirements--including reporting
clusters of respiratory symptoms and confirmed cases to local public
health agencies as required under infection control regulations, as
well as data reported through the CMS Minimum Data Set (MDS)--already
impose excessive burden on facilities through time consumed in, data
collection, verification, and submission. Moreover, the reporting
creates technical challenges operating reporting software. While we
received comments noting similar concerns during the CY 2025 HH PPS
final rule comment period, such concerns are common when implementing
new regulations and at that time we believed that facilities could
overcome these challenges and the data would be used to protect the
health and safety of residents. Since the implementation of this final
rule, facilities have reported continuing to struggle with data
reporting to the extent that they are unable to comply.
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\144\ ``Medicare Regulatory Relief [verbar] CMS.'' <a href="http://Cms.gov">Cms.gov</a>,
2025, <a href="https://www.cms.gov/files/document/unleashing-prosperity-through-deregulation-medicare-program-request-information.pdf">https://www.cms.gov/files/document/unleashing-prosperity-through-deregulation-medicare-program-request-information.pdf</a>.
Accessed September 2025.
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Furthermore, based on feedback on the 2025 deregulatory RFI from
providers and interested parties, we have come to understand that
current expenditures related to ongoing data reporting are likely
diverting staff from direct resident care.
Most notably, CMS estimates that maintaining the current reporting
requirement would impose approximately $61 million in average annual
costs and require over 600,000 average annual staff hours. We have not
identified corresponding improvements in resident health or safety that
would justify this burden. In brief, the ongoing cost and
administrative burden to LTC facilities outweigh any demonstrated
benefit.
The burden of data reporting includes labor costs associated with
developing policies and procedures to report the required information,
as well as costs associated with gathering, reviewing, and organizing
the data used to compile the reported information. At this time, CMS
does not believe that the benefits of ongoing data reporting outweigh
the costs of complying with these requirements, and interested parties
have requested removal of the existing requirements.
Given these considerations, CMS proposes to remove the ongoing
reporting requirements currently found at Sec. 483.80(g)(1) while
retaining the authority to require specific reporting during a future
Secretary declared PHE. This approach does not impose new costs, as PHE
reporting requirements are already established in regulation.
Preserving the Secretary's authority ensures the ability to require
targeted reporting for emerging infectious diseases without additional
rulemaking.

[[Page 72655]]

Infection prevention and control is a primary goal and
responsibility of facilities in their normal day-to-day operations.
While we propose to remove both the requirements for educating staff
about the COVID-19 vaccine and offering it to them and the requirements
for ongoing data reporting related to respiratory illnesses from the
LTC infection prevention and control requirements, the remaining
infection control requirements would continue to remain in effect.
Sections 1819(d)(3) and 1919(d)(3) the Act explicitly require LTC
facilities to develop and maintain an infection control program that is
designed, constructed, equipped, and maintained in a manner to protect
the health and safety of residents, personnel, and the general public.
Existing requirements for LTC facilities at Sec. 483.80 require
facilities to establish and maintain an infection prevention and
control program designed to provide a safe, sanitary, and comfortable
environment and to help prevent the development and transmission of
communicable diseases and infections. This program must include, among
other things, an antibiotic stewardship program with antibiotic use
protocols and a system to monitor antibiotic use and at least one
designated infection preventionist, who is responsible for the
facility's infection prevention and control programs. Specifically, the
infection control officer(s) are required to develop a system for
identifying, reporting, investigating, and controlling infections and
communicable diseases of residents and personnel. Furthermore, Sec.
483.71 requires that LTC facilities conduct and document a facility-
wide assessment to determine what resources are necessary to care for
its residents competently during both day-to-day operations (including
nights and weekends) and emergencies. This includes determining the
infection prevention and control needs in their facility. In addition,
issues identified in the all-facilities' infection prevention and
control programs must be addressed in facility-wide QAPI programs
(Sec. 483.75). All of these requirements would remain in place if CMS
were to finalize the proposed removal of the ongoing data reporting
requirement to ensure patient health and safety. As such, we believe
that there would be adequate minimum infection prevention and control
practices in the absence of the ongoing respiratory illness data
reporting requirements and staff COVID-19 vaccination requirements.
In addition to complying with the robust LTC facility requirements,
facilities may have other measures in place to address infectious
disease outbreaks in response to State and local governments laws. For
example, some States may have regulations for communicating information
to local public health agencies. We believe that these ongoing
requirements provide the necessary protection for residents from
infections within the LTC environment. We understand that data from
healthcare providers remain a key driver to identify and respond to
resident needs and public health threats.
The CDC has continued to refine data collection and promote
electronic data collection directly from electronic health records,
like fast healthcare interoperability resources (FHIR) enabled data
reporting from hospitals. These activities help to reduce voluntary
reporting burden and build a foundation for conducting surveillance in
all clinical settings that may incentivize LTC facilities to
voluntarily report data. We encourage LTC facilities to continue
submitting data to the NHSN on an ongoing basis to contribute to
greater public health efforts.
We also remind LTC facilities that, while we are proposing to
remove the ongoing acute respiratory illness data reporting, we are
proposing to retain the requirements for facilities to report specified
acute infectious illness data during a declared PHE, in the
standardized format and frequency specified by the Secretary, as
currently required at Sec. 483.80(g)(2). During the comment period for
the CY 2025 PPS/HH final rule, healthcare facilities and interested
parties noted that the value of data reporting during a PHE outweighed
the administrative burden. During a PHE, insight into facility capacity
helps to ensure capabilities are available to meet patient needs with
quality care through enhanced planning, technical assistance, resource
allocation, and coordination. Retaining the current PHE data reporting
requirements enables facilities to maintain a functional reporting
capacity. This data can be used to inform and guide response efforts at
the local, State, and Federal levels to protect residents and their
communities, including resource allocation and load balancing within
and across facilities during emergencies when system capacity is most
critical.
We propose to modify the current regulations for acute infectious
illness data reporting during a PHE for LTC facilities because some of
the necessary data elements are listed within the ongoing data
reporting section that we propose to remove. All of the elements that
we propose to include in the data reporting requirements during a PHE
are already required by the current regulations for ongoing reporting
and would provide a response-ready foundation for LTC facilities and
the broader health system.
The proposed regulatory revisions would retain the Secretary's
authority to require reporting during a declared PHE, without naming
the yet-unknown infectious disease pathogen(s), while reducing the
overall burden on facilities. This approach provides CMS with the
flexibility to respond to a broad range of future public health threats
without the need for additional rulemaking, while imposing reporting
obligations for only those circumstances necessary to protect patient
health and safety. Specifically, we propose to retain requirements that
LTC facilities must report (1) facility census (currently Sec.
483.80(g)(1)(ii)(A)); (2) confirmed, resident cases (currently Sec.
483.80(g)(1)(ii)(C)); (3) hospitalized residents with confirmed cases
(currently Sec. 483.80(g)(1)(ii)(D)); (4) confirmed infections for
staff (currently Sec. 483.80 (g)(2)(i)); (5) supply inventory
shortages (currently Sec. 483.80 (g)(2)(ii)); (6) staffing shortages
(currently Sec. 483.80 (g)(2)(iii)); and (7) medical countermeasures
and therapeutic inventories (currently Sec. 483.80 (g)(2)(iv)) during
a PHE. We are proposing to rescind the reporting of resident
vaccination status (currently Sec. 483.80(g)(1)(ii)(B)).
To facilitate LTC facility compliance with the proposed data
reporting requirements during a PHE, the Secretary would provide clear,
standardized definitions for any data to be reported, as well as
instructions for the effective reporting date. HHS would provide
notification to LTC facility to activate PHE reporting and indicate the
frequency and required elements based on the specific circumstances at
the time. We expect that we would use existing communication mechanism,
such a Quality Safety and Oversight (QSO) Memorandum, that is readily
available to the public, nationally accessible, and familiar to
interested parties, to ensure clarity and access to necessary
information.
We invite public comment on these proposals, and on any
alternatives to our approach. Also, we are interested in any
suggestions to improve existing requirements, within our statutory
authority, where they make providing quality care difficult or less
effective. The most useful comments will be those that include data or
evidence to support the position, offer suggestions to amend specific
sections of the existing regulations, or offer particular additions. We
also request comments on how to reduce burden related to capturing

[[Page 72656]]

information related to supply inventory shortages, staffing shortages,
and medical countermeasures and therapeutic inventories.
4. Revisions to Existing LTC Facilities' Resident Room Occupancy and
Bathroom Facility Requirements Sec. 483.90(e)(1)(i) and (f)
LTC facilities newly certified after November 28, 2016, must meet
the current resident occupancy and bathroom facility standards--
specifically, the requirements to accommodate no more than two
residents per bedroom and to provide each resident room with its own
bathroom equipped with a commode and sink. These requirements can
create significant barriers for new providers seeking to take over
operations and re-open a facility, as large-scale renovations--
particularly for older buildings--may be required to comply with these
standards. Such renovations may create significant financial
challenges, potentially deterring new providers from re-opening
facilities, particularly in areas that already have limited access to
long-term care services. To address these concerns and reduce barriers
related to the certification of new providers, we propose to amend
resident room occupancy (proposed to be redesignated as Sec.
483.90(d)(1)(i)) and bathroom facility standards (proposed to be
redesignated as Sec. 483.90(e)), both of which set standards for
``newly certified'' facilities. We propose to remove the term ``newly
certified ``from the resident room occupancy and bathroom facility
standards, thereby eliminating certification status as the trigger for
compliance with the requirements to accommodate no more than two
residents per bedroom and to provide each resident room with its own
bathroom equipped with a commode and sink.
Specifically, we propose that for facilities that receive approval
of building construction and reconstruction plans by the State and
local authorities after November 28, 2016, each bedroom must
accommodate no more than two residents per room. We also propose that
for facilities that receive approval of building construction plans by
the State and local authorities after November 28, 2016, each resident
room must be provided with its own bathroom with at least a commode and
sink.
This change would exempt existing facilities from being required to
meet the current room occupancy (no more than two residents per room)
and bathroom standards (commode and sink per room) because the facility
changed ownership or experienced a gap in operations. Even with this
exemption, LTC facilities must still comply with the CoPs, which are
intended to protect the health and safety of residents and ensure that
high-quality care is provided to all residents. LTC facilities must
also comply with Title III of the Americans with Disabilities Act
(ADA), which prohibits discrimination based on disability in public
accommodations and commercial facilities, and requires businesses and
non-profit service providers to ensure equal access to their goods,
services, and facilities. In addition, sections 1819(b)(1)(A) and
1919(b)(1)(A) of the Act explicitly require Medicare and Medicaid LTC
facilities to care for their residents in a manner and environment that
promotes the maintenance or enhancement of the safety and quality of
life of each resident. We invite public comment on these proposals, and
on any alternatives to our approach as well as the risks and potential
unintended consequences.
5. Additional LTC Comment Solicitation
We are seeking public comments related to information regarding
resident preferences on sending discharge notice to the State Ombudsman
office, specifically when the discharge is initiated by the resident or
resident's representative. Second, we are seeking information regarding
expanding the scope of practice of physician assistants and nurse
practitioners providing care in SNFs, especially as it pertains to
performing visits currently required to be made by a physician.
a. Ombudsman Notice of Discharge Opt Out
The current requirement at Sec. 483.15(c)(3)(i) requires that LTC
facilities provide a notice of transfer or discharge prior to
transferring or discharging a resident. Facilities must notify the
resident and the resident representative(s), in writing and in a
language and manner they understand, of the transfer or discharge and
the reasons for the move. Facilities are also required to send a copy
of this notice to a representative of the Office of the State Long-Term
Care Ombudsman. The regulation specifies both the timing of the notice
and the required content.
As part of safeguarding resident rights, LTC facilities must notify
the State Ombudsman office of all resident discharges and transfers. As
previously discussed, several interested parties have indicated that
this requirement results in a significant volume of paperwork for
facilities to generate and distribute, as well as a substantial
administrative workload for Ombudsman offices to receive and review
these notices. Based on recent input from interested parties, we are
seeking comments on whether residents should be permitted to opt out of
having their discharge notice sent to the Ombudsman, and the facility
must document the resident's preference in the medical record. We
believe that residents and resident representatives that initiate a
transfer or discharge may not need or want review of their decisions by
Ombudsman officials. This option could increase resident self-
determination and privacy, decrease paperwork for LTC facilities, and
reduce the number of notices received by Ombudsman offices, while
maintaining existing notice requirements for residents and their
representatives. In consideration of this idea, we request public
comments on the following questions:
<bullet> What types of communications occur between LTC facilities
and the Ombudsman office for discharges and how is the notice process
currently managed?
<bullet> What types of training or guidance would LTC facility
staff need to properly explain the opt-out option to residents and
resident representatives?
<bullet> How would LTC facilities document for surveyors to verify
that a discharge was initiated by a resident or the resident's
representative?
<bullet> Are there any unintended consequences to opting out of
discharge notices being sent to the Ombudsman? For example, how would
LTC facilities ensure that residents understand their rights in
relation to notifying the Ombudsman office of their discharge prior to
opting out of having a notice sent?
b. Comment Solicitation on Expanding the Scope of Practice of Physician
Assistants and Nurse Practitioners
According to the U.S. Census Bureau,\145\ the number of Americans
over 65 is expected to nearly double, jumping from 54 million in 2019
to 95 million by 2060. With an aging population, we expect an
increasing demand for skilled nursing care, and we are aware of
concerns regarding access to skilled nursing care and long wait times
for admission to LTC facilities. Nearly every nursing home and assisted
living community in the United State are facing workforce
shortages.\146\ The

[[Page 72657]]

number of board-certified geriatricians in the US fell from 10,270 in
2000 to 7,413 in 2022; \147\ this drop has been further exacerbated by
recruitment and retention challenges for specialists involved in
geriatrics--the geriatricians, nurses, and home health aides-- which
face considerable excess demand relative to supply.\148\
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\145\ <a href="https://www.census.gov/topics/population/older-aging.html">https://www.census.gov/topics/population/older-aging.html</a>.
\146\ State of the

[…truncated; see source link]

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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.