[Federal Register Volume 90, Number 104 (Monday, June 2, 2025)]
[Notices]
[Pages 23337-23339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-09870]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3469-FN]
Medicare and Medicaid Programs; Application From The Joint
Commission for Continued Approval of its Hospice Accreditation Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice announces our decision to approve The Joint
Commission for continued recognition as a national accrediting
organization for hospices that wish to participate in the Medicare or
Medicaid programs.
DATES: The decision announced in this notice is applicable from June
18, 2025 through June 18, 2030.
FOR FURTHER INFORMATION CONTACT: Joann Fitzell, (410) 786-4280 or
Lillian Williams, (410) 786-8636.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services in a hospice, provided certain requirements are met by
the hospice. Section 1861(dd) of the Social Security Act (the Act)
establishes distinct criteria for facilities seeking designation as a
hospice. Regulations concerning provider agreements are at 42 CFR part
489, and those pertaining to activities relating to the survey and
certification of facilities are at 42 CFR part 488. The regulations at
42 CFR part 418 specify the conditions that a hospice must meet in
order to participate in the Medicare program, the scope of covered
services, and the conditions for Medicare payment for hospices.
Generally, to enter into an agreement, a hospice must first be
certified as complying with the conditions set forth in part 418 and
recommended to the Centers for Medicare & Medicaid (CMS) for
participation by a State survey agency. Thereafter, the hospice is
subject to periodic surveys by a State survey agency to determine
whether it continues to meet these conditions. However, there is an
alternative to certification surveys by State agencies. Accreditation
by a nationally recognized Medicare accreditation program approved by
CMS may substitute for both initial and ongoing State review.
Section 1865(a)(1) of the Act provides that, if the Secretary of
the Department of Health and Human Services (the Secretary) finds that
accreditation of a provider entity by an approved national accrediting
organization (AO) meets or exceeds all applicable Medicare conditions,
CMS may treat the provider entity as having met those conditions; that
is, we may ``deem'' the provider entity to be in compliance.
Accreditation by an AO is voluntary and is not required for Medicare
participation.
If an AO is recognized by the Secretary as having standards for
accreditation that meet or exceed Medicare requirements, any provider
entity accredited by the national AO's approved program may be deemed
to meet the Medicare conditions. A national AO applying for CMS
approval of its accreditation program under part 488, must provide CMS
with reasonable assurance that the accrediting organization requires
the accredited provider entities to meet requirements that are at least
as stringent as the Medicare conditions of participation (CoPs). Our
regulations concerning the approval of AOs are set forth at Sec.
488.5. Section 488.5(e)(2)(i) requires an AO to reapply for continued
approval of its Medicare accreditation program every 6 years or sooner
as determined by CMS. The Joint Commission's (TJC's) term of approval
as a recognized accreditation program for hospices expires June 18,
2025.
II. Application Approval Process
Section 1865(a)(3)(A) of the Act provides a statutory timetable to
ensure that our review of applications for CMS approval of an
accreditation program is conducted in a timely manner. The Act provides
us 210 days after the date of receipt of a complete application, with
any documentation necessary to make the determination, to complete our
survey activities and application process. Within 60 days after
receiving a complete application, we must publish a notice in the
Federal Register that identifies the national accrediting body making
the request, describes the request, and provides no less than a 30-day
public comment period. At the end of the 210-day period, we must
publish a notice in the Federal Register of our decision to approve or
deny the application.
III. Provisions of the Proposed Notice
On January 13, 2025 we published a proposed notice in the Federal
Register (90 FR 2706), announcing TJC's request for continued approval
of its Medicare hospice accreditation program. In the January 13, 2025
proposed notice, we detailed our evaluation criteria. Under section
1865(a)(2) of the Act and in our regulations at Sec. 488.5, we
conducted a review of TJC's Medicare hospice accreditation program
application in accordance with the criteria specified by our
regulations, which include, but are not limited to, the following:
A virtual administrative review of TJC's: (1) Corporate
policies; (2) financial and human resources available to accomplish the
proposed surveys; (3) procedures for training, monitoring, and
evaluation of its hospice surveyors; (4) ability to investigate and
respond appropriately to complaints against accredited hospices; and
(5) survey review and decision-making process for accreditation.
The comparison of TJC's Medicare hospice accreditation
program standards to our current Medicare hospice CoPs.
A documentation review of TJC's survey process to--
++ Determine the composition of the survey team, surveyor
qualifications, and TJC's ability to provide continuing surveyor
training.
++ Compare TJC's processes to those we require of State survey
agencies, including periodic resurvey and the
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ability to investigate and respond appropriately to complaints against
accredited hospices.
++ Evaluate TJC's procedures for monitoring hospices it has found
to be out of compliance with TJC's program requirements. (This pertains
only to monitoring procedures when TJC identifies noncompliance. If
noncompliance is identified by a State survey agency through a
validation survey, the State survey agency monitors corrections as
specified at Sec. 488.9(c)).
++ Assess TJC's ability to report deficiencies to the surveyed
hospice and respond to the hospice's plan of correction in a timely
manner.
++ Establish TJC's ability to provide CMS with electronic data and
reports necessary for effective validation and assessment of the
organization's survey process.
++ Determine the adequacy of TJC's staff and other resources.
++ Confirm TJC's ability to provide adequate funding for performing
required surveys.
++ Confirm TJC's policies with respect to surveys being
unannounced.
++ Confirm TJC's policies and procedures to avoid conflicts of
interest, including the appearance of conflicts of interest, involving
individuals who conduct surveys or participate in accreditation
decisions.
++ Obtain TJC's agreement to provide CMS with a copy of the most
current accreditation survey together with any other information
related to the survey as we may require, including corrective action
plans.
IV. Analysis of and Responses to Public Comments on the Proposed Notice
In accordance with section 1865(a)(3)(A) of the Act, the January
13, 2025 proposed notice also solicited public comments regarding
whether TJC's requirements met or exceeded the Medicare CoPs for
hospices. We received no comments in response to our proposed notice.
V. Provisions of the Final Notice
A. Differences Between TJC's Standards and Requirements for
Accreditation and Medicare Conditions and Survey Requirements
We compared TJC's hospice accreditation requirements and survey
process with the Medicare CoPs of part 418, and the survey and
certification process requirements of parts 488 and 489. Our review and
evaluation of TJC's hospice application, which were conducted as
described in section III of this notice, yielded the following areas
where, as of the date of this notice, TJC has completed revising its
standards and certification processes in order to meet the requirements
at:
Section 418.52(b)(4)(iii), to include reference to the
State survey agency.
Section 418.52(c)(5), to include reference to ``45 CFR
parts 160 and 164''.
Section 418.52(c)(6), to address the right of a patient to
be free of the misappropriation of the patient's property.
Section 418.54(e), to address the hospice's quality
assessment and performance improvement program.
Section 418.58(c)(1)(ii), to address the program activity
requirement to consider the incidence, prevalence, and severity of
problems in those areas.
Section 418.60(c), to address the requirement for
contracted providers, patients, family members, and other caregivers.
Section 418.66(a), to address the requirement that the
hospice must provide evidence to CMS that it has made a good faith
effort to hire a sufficient number of nurses to provide services.
Section 418.76(b)(3)(xiii), to address the requirement the
hospice is responsible for training hospice aids, as needed, for skills
not covered in the basic checklist, as described in paragraph
(b)(3)(ix) of this section.
Section 418.100(f)(1), to address the Medicare approval
requirement.
Section 418.102(a)(1)(ii), to address the requirement that
the contract must specify the physician who assumes the medical
director's responsibilities and obligations.
Section 418.104(e)(2), to address the requirement that if
a patient revokes the election of hospice care or is discharged from
hospice in accordance with Sec. 418.26, the hospice must forward to
the patient's attending physician a copy of the hospice discharge
summary, and the patient's clinical record, if requested.
Section 418.104(f), to address the requirement of making
the clinical record available in hardcopy or electronic form.
Section 418.110(c)(1), to address the hospice's
requirement to address real or potential threats to the health and
safety of patients, others, and property.
Section 418.110(c)(2)(i) through (c)(2)(iv), to address
the requirement for their associated procedures to control
``reliability and quality.''
Section 418.110(d)(3), to address that the provisions of
the adopted edition of the Life Safety Code do not apply in a State if
CMS finds that a fire and safety code imposed by State law adequately
protects patients in hospices.
Section 418.110(e)(2), to address the requirement for
Health Care Facilities Code waiver/equivalency requests.
Section 418.110(n), to address the requirement that
restraint or seclusion must be discontinued at the earliest possible
time.
Section 418.110(q), to include the National Fire
Protection Association (NFPA 99), Standards for Health Care Facilities
Code requirements.
Section 418.113(a), to address the requirement to update
the emergency preparedness plan every 2 years.
Section 418.113(c)(7), to address the requirement that the
emergency preparedness communication plan must include a means of
providing information about the hospice's inpatient occupancy, needs,
and its ability to provide assistance, to the authority having
jurisdiction, the Incident Command Center, or designee.
In addition to the standards review, we also reviewed TJC's
comparable survey processes, which were conducted as described in
section III. of this notice, and yielded the following areas where, as
of the date of this notice, TJC has completed revising its survey
processes to demonstrate that it uses survey processes that are
comparable to State survey agency processes by:
Revising TJC's surveyor guide to revise the current Life
Safety Code Building Assessment document to address both the Life
Safety Code and Health Care Facilities Code (HCFC) in accordance with
Sec. Sec. 418.110(d) and (e).
Revising TJC's surveyor guidance to be comparable with
Appendix I related to inpatient hospice care.
Ensuring that all Hospice Life Safety Code surveyors have
received instructions, procedures, or resources for conducting
inpatient hospice Life Safety Code/Health Care Facilities Code
certification surveys consistent with SOM Chapter 4, Section 4009C--
Training, Education, and Experience.
B. Term of Approval
Based on our review and observations described in section III. of
this notice, we approve TJC as a national accreditation organization
for hospices that request participation in the Medicare program,
effective June 18, 2025 through June 18, 2030. Due to the temporary
travel suspensions for non-critical or mission essential activities for
the Department of Health and Human Services (HHS) in early 2025, CMS
was unable to observe a hospice survey completed by TJC surveyors as
part of the application review process, which is typically one
component of the
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comparability evaluation. Therefore, we are providing TJC with a
shorter period of approval. Based on our discussions with TJC and the
information provided in its application, we are confident that TJC will
continue to ensure that its accredited hospices will continue to meet
or exceed the required standards. While TJC has taken actions based on
the findings noted in section IV. of this notice (Differences Between
TJC's Standards and Requirements for Accreditation and Medicare
Conditions and Survey Requirements), as authorized under Sec. 488.8,
we will continue ongoing review of TJC hospice survey processes and
will conduct a survey observation on a modified schedule until further
notice.
VI. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. Consequently, there is no need for review by the Office
of Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Mehmet Oz, having reviewed and approved this document,
authorizes Vanessa Garcia, who is the Federal Register Liaison, to
electronically sign this document for purposes of publication in the
Federal Register.
Vanessa Garcia,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2025-09870 Filed 5-30-25; 8:45 am]
BILLING CODE 4120-01-P