[Federal Register Volume 90, Number 118 (Monday, June 23, 2025)]
[Notices]
[Pages 26587-26591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-11451]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3468-FN]
Medicare and Medicaid Programs; Application From The Joint
Commission for Continued CMS Approval of its Hospital Accreditation
Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This final notice announces our decision to approve The Joint
Commission for continued CMS-recognition as a national accrediting
organization for hospitals that wish to participate in the Medicare or
Medicaid programs.
DATES: The decision announced in this final notice is effective July
15, 2025, through July 15, 2030.
FOR FURTHER INFORMATION CONTACT: Caecilia Andrews, (410) 786-2190.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services from a hospital, provided certain requirements are
met. Section 1861(e) of the Social Security Act (the Act) establishes
distinct criteria for facilities seeking designation as a hospital.
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
482 specify the minimum conditions that a hospital must meet to
participate in the Medicare program.
Generally, to enter into an agreement, a hospital must first be
certified by a state survey agency (SA) as complying with the
conditions or requirements set forth in part 482 of our regulations.
Thereafter, the hospital is subject to regular surveys by an SA to
determine whether it continues to meet these requirements.
Section 1865(a)(1) of the Act provides that, if a provider entity
demonstrates through accreditation by a Centers for Medicare & Medicaid
Services (CMS)-approved national accrediting organization (AO) that all
applicable Medicare requirements are met or exceeded, we will deem
those provider entities as having met such requirements. Accreditation
by an AO is voluntary and is not required for Medicare participation.
If an AO is recognized by the Secretary of the Department of Health
and Human Services (the Secretary) as having standards for
accreditation that meet or exceed Medicare requirements, any provider
entity accredited by the national accrediting body's approved program
would be deemed to meet the Medicare requirements. A national AO
applying for approval of its accreditation program under part 488,
subpart A, must provide CMS with reasonable assurance that the AO
requires the accredited provider entities to meet requirements that are
at least as stringent as the Medicare requirements.
[[Page 26588]]
Our regulations concerning the approval of AOs are set forth at
Sec. Sec. 488.4, 488.5 and 488.5(e)(2)(i). The regulations at Sec.
488.5(e)(2)(i) require an AO to reapply for continued approval of its
accreditation program every 6 years or sooner, as determined by CMS.
The Joint Commission's (TJC's) current term of approval for their
hospital accreditation program expires July 15, 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 approving or denying the
application.
III. Provisions of the Proposed Notice
On February 11, 2025, we published a proposed notice in the Federal
Register (90 FR 9341), announcing TJC's request for continued approval
of its Medicare hospital accreditation program. In that proposed
notice, we detailed our evaluation criteria. Under Section 1865(a)(2)
of the Act and in our regulations at Sec. 488.5 and Sec. 488.8(h), we
conducted a review of TJC's Medicare hospital accreditation program
application in accordance with the criteria specified by our
regulations, which include, but are not limited to, the following:
An 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
hospital surveyors; (4) ability to investigate and respond
appropriately to complaints against accredited hospitals; and (5)
survey review and decision-making process for accreditation.
A review of TJC's survey processes to confirm that a
provider or supplier, under TJC's hospital deeming accreditation
program, meets or exceeds the Medicare program requirements.
A documentation review of TJC's survey process to do the
following:
++ 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 ability to investigate
and respond appropriately to complaints against TJC-accredited
hospitals.
++ Evaluate TJC's procedures for monitoring accredited hospitals it
has found to be out of compliance with TJC's program requirements.
(This pertains only to monitoring procedures when TJC identifies non-
compliance. If noncompliance is identified by a SA through a validation
survey, the SA monitors corrections as specified at Sec. 488.9(c)).
++ Assess TJC's ability to report deficiencies to the surveyed
hospital and respond to the hospital'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 February
11, 2025, proposed notice also solicited public comments regarding
whether TJC's requirements met or exceeded the Medicare conditions of
participate (CoPs) for hospitals. We received several comments.
Comment: Two commenters believed the application should be
approved. One of the commenters stated that the processes in place by
TJC ensure frequent in-person surveys and assist the organizations
being surveyed, while making online resources available. Another
commenter was in support of approval and noted their belief that TJC's
requirements meet or exceed the Medicare CoPs for hospitals. This
commenter noted having experienced surveys by TJC of their facility and
that TJC's survey process is an effective means of ensuring that the
facility is a safe place for patients to be treated. The commenter
suggested one area of improvement would be to increase survey frequency
and believed that more frequent surveys would better establish everyday
readiness for facilities.
Response: We appreciate the commenters' support of TJC as a CMS-
approved AO for hospitals. CMS requires AOs to conduct surveys at least
every 36 months in accordance with Sec. 488.5(a)(4)(i). We note that
AOs have the discretion to require and perform surveys more frequently
than every 36 months.
Comment: CMS received another comment of support for TJC's
continued recognition of its hospital accreditation program and
suggested that TJC's accreditation process helps in maintaining high
hospital standards. While in support of TJC's continued approval, the
commenter suggests that there should be more transparency in its survey
process and stronger safeguards to prevent conflicts of interest.
Response: We appreciate the commenter's general support and agree
that further transparency in survey processes is instrumental in
ensuring comparability between the AO processes and those of CMS. We
also agree that AOs must prevent conflicts of interests. As part of
CMS' review of AOs for continued recognition, and in accordance with
Sec. 488.5(a)(10), CMS reviews AOs' 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.
Comment: One commenter raised concern related to TJC's standard at
EC.02.03.03 EP 1, which requires one hour between fire drills. The
commenter stated that the National Fire Protection Association (NFPA)
Code 101-2012: 18/19:7.1.7 does not require a 1-hour variance, but that
there should be varied conditions. The commenter encouraged CMS to
address this inconsistency and ensure TJC surveyors are educated on the
NFPA Code.
Response: We appreciate the commenter's concern related to variance
for fire drills. As discussed within the proposed notice (90 FR 9341)
and our outlined evaluation criteria in section III. ``Provisions of
the Proposed Notice'', CMS reviewed TJC standards to ensure that
standards meet or exceed the Medicare CoPs. CMS also reviewed
[[Page 26589]]
TJC's survey processes for comparability to those of the SAs. As part
of this final notice announcing our approval of TJC for continued
deeming authority for hospitals, we note that TJC has met these
requirements. TJC may exceed the CMS baseline health and safety
standards.
Comment: One commenter suggested TJC has enacted several fire/life
safety requirements that are not included in the prescriptive
requirements of NFPA 101, 2012 edition, as adopted by CMS. The
commenter provided three examples. The first example noted that TJC
standard LS.02.01.30 EP 3, related to requirements for existing
hazardous area protection, requires hospitals to ensure doors to rooms
containing flammable or combustible materials are provided with
positive latching hardware and that roller latches are prohibited on
such doors. The commenter stated that there is no such requirement in
NFPA 101 for protection of hazardous areas in NFPA 101 Sections 18/
19.3.2.1 or 8.7. The second example noted that TJC's standard at
LS.02.01.30 EP13 requires a hospital to prove that positive latching
hardware is not an available option provided by the manufacturer to
eliminate the positive latching requirement from powered corridor
doors, which is inconsistent with NFPA 101 Section 18.3.6.3.7. The
third example was related to TJC's standard at LS.02.01.10 EP 9, which
requires that doors in ``fire-rated smoke barriers'' must have a rating
of ``Forty-five minutes in one-hour barriers--Twenty minutes in thirty-
minute barriers.'' The commenter states that the requirements of NFPA
101 Section 18/19.3.7.6 for health care occupancy do not require any
fire ratings for these doors. The commenter suggested that these
standards cause undue hardship on facilities and require extra costs to
remediate ``deficient'' items that are not required by code at the time
of building construction nor required retroactively. The commenter
requested that CMS provide additional guidance to TJC to limit the AO's
ability to create standards above the codes and the standards adopted
by CMS in federal law.
Response: We appreciate the commenter's concern that these
standards may cause undue hardship on facilities and require extra
costs to remediate. As discussed within the Proposed Notice (90 FR
9341) and our outlined evaluation criteria in section III. ``Provisions
of the Proposed Notice'', CMS reviewed TJC standards to ensure that
standards meet or exceed the Medicare CoPs. CMS also reviewed TJC's
survey processes for comparability to those of the SAs. As part of this
final notice announcing our approval of TJC for continued deeming
authority for hospitals, we note that TJC has met these requirements.
TJC may exceed the CMS baseline health and safety standards.
Comment: CMS received one comment related to TJC's requirement for
Life Safety Drawings for Ambulatory Surgical Centers (ASCs) as part of
its Hospital Accreditation Program (HAP) guidance. The commenter stated
that TJC's requirements include identification, sizing, and type of
patient use of suites. The commenter stated that the NFPA 101, 2012,
chapters 20 and 21 do not dictate additional considerations for suites
and their sizing as seen in chapters 18 and 19. The commenter suggested
that this requirement has led to confusion as to the acceptable use and
sizing of suites in ambulatory settings by TJC surveyors. The commenter
suggested that TJC and/or CMS should clarify the additional
requirements for suite limitations in Ambulatory occupancies that are
not currently found in NFPA 101.
Response: We appreciate the commenter's concern. As discussed
within the Public Notice (90 FR 9341) and our outlined evaluation
criteria in section III. ``Provisions of the Proposed Notice'', CMS
reviewed TJC standards to ensure that its standards meet or exceed the
Medicare CoPs. CMS also reviewed TJC's survey processes for
comparability to those of the SAs. As part of this final notice
announcing our approval of TJC for continued deeming authority for
hospitals, we note that TJC has met these requirements. TJC's standards
may exceed CMS' baseline health and safety standards.
Comment: One commenter requested that CMS leverage its authority
under Sec. Sec. 488.4 and 488.5 to require TJC remove its ``time-
defined criteria'' for inspection, testing, and maintenance (ITM)
intervals. Specifically, the commenter stated that TJC's survey process
under its Comprehensive Accreditation Manual for Hospitals (CAMH),
Environment of Care (EC) Chapter, and TJC's revised 2025 standard
requiring ITM activities are not mandated by the CoPs under 42 CFR part
482, by the State Operations Manual, nor by the NFPA 101 and 99 (2012)
codes that are federally adopted.
Response: We appreciate the commenter's concern regarding TJC's
``time-defined criteria'' for inspection, testing, and maintenance
intervals. As noted within the public notice (90 FR 9341) and our
outlined evaluation criteria in section III. ``Provisions of the
Proposed Notice'', CMS reviewed TJC standards to ensure that its
standards meet or exceed the Medicare CoPs. CMS also reviewed TJC's
survey processes for comparability to those of the SAs. As part of this
final notice announcing our approval of TJC for continued deeming
authority for hospitals, we note that TJC has met these requirements.
However, TJC may exceed CMS' baseline health and safety standards.
Comment: One commenter suggested that TJC's survey process ignores
the Food and Drug Administration (FDA) clearance requirements for
specific sterile barrier systems. The commenter suggested that TJC's
surveyors provide subjective guidance to facilities, which poses a
patient safety issue. The commenter suggests that TJC has not been
adhering to the stated FDA clearances and its guidance contradicts the
principles of the sterilization process. The commenter also stated that
incorrect deficiency citations result in revisit surveys, adding a
significant financial cost to the provider. The commenter requests that
CMS direct TJC to follow FDA regulatory clearance requirements and if
there are potential deficiencies, TJC should be consulting the sterile
barrier system's manufacturer instructions.
Response: We appreciate the commenter's concerns. TJC is required
to develop standards that are comparable to or exceed the CMS CoPs,
including Sec. 482.51(b) Standard: Delivery of Service: ``Surgical
services must be consistent with needs and resources. Policies
governing surgical care must be designed to assure the achievement and
maintenance of high standards of medical practice and patient care.''
While this specific standard requires policies to be developed for
sterilization and other practices, and for those policies to be
consistent with national standards of practice, it does not require a
specific national standard set by a recognized national organization or
by another federal agency such as the FDA. Upon review of the hospital
accreditation application provided by TJC, CMS determined that their
standards for surgical services met or exceeded our requirements.
Additionally, there was no indication in the survey process documents
that a surveyor providing subjective information was considered a
fundamental part of the survey process.
Comment: One commenter stated that CMS should leverage its
regulatory authority under Sec. 488.5 to require TJC to revise several
key areas of its accreditation standards to ensure TJC's standards meet
or exceed the requirements established by CMS and federally adopted
codes, as outlined in Section 1865(a)(1) of the Social Security
[[Page 26590]]
Act. The commenter stated that TJC's Comprehensive Accreditation Manual
for Hospitals (CAMH) creates a false sense of safety and security for
hospitals by oversimplifying compliance requirements, specifically in
the Environment of Care (EC) and Life Safety (LS) chapters. The
commenter also stated concern related to inconsistency among TJC's Life
Safety Code (LSC) surveyors, suggesting that its surveyors lack
foundational knowledge of NFPA codes, frequently leading to
misinterpretations and improper citations during surveys. Finally, the
commenter also raised concerns related to TJC and Joint Commission
Resources (JCR), stating TJC has issued training materials and
interpretations through paid subscriptions developed by its for-profit
arm, JCR.
Response: We appreciate the commenter's concerns. As outlined in
section III. ``Provisions of the Proposed Notice'', CMS conducts a
rigorous review of the AO's ability to meet or exceed CMS requirements
and to have comparable survey processes to those of the SAs. During our
review of TJC's standards, we noted that all standards and the
requested CMS revisions to the standards have been reviewed and have
met CMS' baseline health and safety standards contained in the CoPs.
Additionally, part of our review process includes a review of the
education and experience requirements that surveyors must meet (Sec.
488.5(a)(7)); a review for comparability (Sec. 488.5(a)(4)); and a
review of 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 (Sec. 488.5(a)(10)). As discussed in section V. ``Provisions
of the final notice'', TJC has revised its standards and survey
processes based on our findings through this application review.
Comment: One commenter stated that TJC does not accurately provide
surveys to all healthcare organizations it is surveying. The commenter
stated that each TJC surveyor uses their own judgment and
interpretations of codes and policies. They stated further that, over
the last five years, TJC's survey approach has shifted from an
educational one to one that is punitive.
Response: While it is not clear to us what the commenter means when
they state that TJC does not ``accurately provide'' surveys to the
healthcare facilities it is surveying, CMS reviewed TJC's survey
processes related to the frequency of surveys performed as well as its
agreement to re-survey every accredited provider or supplier, through
unannounced surveys, no later than 36 months after the prior
accreditation effective date, consistent with the CMS requirements at
Sec. 488.5(a)(4)(i). Additionally, CMS reviewed and approved TJC's
survey processes to ensure comparability to those of the SAs. We also
reviewed TJC's surveyor education and performed an onsite observation
of TJC's surveyors during a hospital survey. We did not observe TJC's
surveyors as taking what would be possibly considered a ''punitive''
approach to the survey. We recommend that the commenter address any
specific concerns related to what they believe is TJC's ``punitive''
survey approach with the AO directly.
Comment: One commenter requested CMS oversight of medical device
representatives in surgical settings and raised concerns related to
CMS' lack of oversight for non-hospital employees, specifically Medical
Device Representatives (MDRs), who might directly impact surgical
safety and infection control. The commenter suggested there is a
regulatory gap between the oversight of MDRs and the overall CMS
hospital safety and infection control requirements.
Response: We appreciate the commenter's concerns. However, this
comment is outside the scope of this final 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 hospital accreditation requirements and survey
process with the Medicare CoPs of part 482, and the survey and
certification process requirements of parts 488 and 489. Our review and
evaluation of TJC's hospital application, which were conducted as
described in section III. ``Provisions of the Proposed Notice'',
yielded the following areas where, as of the date of this final notice,
TJC has completed revising its survey processes to demonstrate that it
uses survey processes that are comparable to state survey agency
processes by:
Providing additional Life Safety Code (LSC) surveyor
guidance and training materials to require the determination and
confirmation of building construction, and to perform a complete
inspection of all smoke and fire barriers and dampers in ducts that
penetrate smoke and fire barriers, comparable to the requirements in
State Operations Manual (SOM), Appendix I, Task 4--Information
Gathering.
Revising the survey processes and offsite materials prior
to surveys, consistent with SOM Appendix A, Task 1--Offsite
Preparation, to ensure locations associated with the hospital's
healthcare system fall under the CMS Certification Number (CCN) for the
hospital and not another CMS-certified provider type.
Revising TJC's survey procedures for LSC building
assessment and any other applicable documents to require the LSC
surveys be conducted by LSC Surveyors, or Clinical Surveyors who meet
TJC's LSC Surveyor qualifications and training, at all locations
included in a CMS certification survey, consistent with SOM Chapter 2,
Section 2706--SA Survey Team Composition and SOM Chapter 4, Section
4009C--Education, Training, and Experience.
Revising the survey process to ensure hospital outpatient
surgical departments are surveyed for compliance with the 2012 LSC
Ambulatory Health Care Occupancies chapters, regardless of the number
of patients served, in accordance with Sec. 482.41(b)(1)(i).
Revising the survey process to ensure all inpatient
locations of the hospital are included in the survey, not just
representative samples, consistent with SOM Appendix A, Introduction,
Task 3--Information Gathering/Investigation, General Procedures, Survey
Locations.
Reviewing its current policies and procedures related to
leadership citations and engage in a process to review whether a
citation of the Governing Body is warranted based on the nature of the
deficiencies and determine the level of deficiency to ensure the
appropriate level of enforcement. This is comparable to SOM Appendix
A--Task 4--Preliminary Decision Making and Analysis of Findings--
Determining the Severity of Deficiencies.
B. Term of Approval
Based on our review and observations described in sections III. and
V. of this final notice, we approve TJC as a national accreditation
organization for hospitals that request participation in the Medicare
program. The decision announced in this final notice is effective July
15, 2025, through July 15, 2030 (5 years). In accordance with Sec.
488.5(e)(2)(i), the term of the approval will not exceed 6 years.
VI. Collection of Information and Regulatory Impact Statement
This document does not impose information collection requirements,
that is, reporting, recordkeeping or
[[Page 26591]]
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 CMS, Mehmet Oz, having reviewed and approved
this document, authorizes Chyana Woodyard, who is the Federal Register
Liaison, to electronically sign this document for purposes of
publication in the Federal Register.
Chyana Woodyard,
Federal Register Liaison, Center for Medicare & Medicaid Services.
[FR Doc. 2025-11451 Filed 6-20-25; 8:45 am]
BILLING CODE 4120-01-P