[Federal Register Volume 87, Number 84 (Monday, May 2, 2022)]
[Notices]
[Pages 25642-25644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09361]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3420-FN]


Medicare and Medicaid Programs; Approval of Application by The 
Joint Commission (TJC) for Continued CMS-Approval of its Hospital 
Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve The Joint 
Commission for continued 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, 2022 through July 15, 2025.

FOR FURTHER INFORMATION CONTACT: Caecilia Blondiaux, (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 a 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. Our regulations 
concerning the approval of AOs are set forth at Sec. Sec.  488.4, 488.5 
and Sec.  488.5(e)(2)(i). The regulations at Sec.  488.5(e)(2)(i) 
require AOs 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, 2022.

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 December 10, 2021, we published a proposed notice in the Federal 
Register (86 FR 70500), 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 application 
in accordance with the criteria specified by our regulations, which 
include, but are not limited to the following:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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 
hospitals and respond to the hospitals 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 December 
10, 2021 proposed notice also solicited public comments regarding 
whether

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TJC's requirements met or exceeded the Medicare conditions for 
participation (CoPs) for hospitals. We received one comment.
    The commenter inquired about CMS activities related to AO 
oversight. Specifically, the commenter stated that there continues to 
be discrepancies between AO and CMS standards and processes. The 
commenter stated it would be extremely helpful if the AOs and CMS could 
be consistent in interpretation and surveillance.
    CMS' review requires AO standards to meet or exceed those of the 
Medicare CoPs and for AOs to have comparable survey processes. The 
December 2021 proposed notice described CMS' process and oversight 
activities in Section III. Evaluation of Deeming Authority Request, 
which highlighted the evaluation CMS conducts before granting deeming 
authority to an AO. In Section V. of this final notice, CMS is 
highlighting areas which were identified to have discrepancies or lack 
of clarity within TJC's standards and survey processes. We note that 
TJC corrected these discrepancies before the renewing their deeming 
authority for CMS-approved hospital accreditation program.

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 parts 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. of this final 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--
    <bullet> Meet the standard's requirements of all of the following 
regulations:
    ++ Section 482.12(c)(4)(i), to clarify that the governing body 
ensures that a doctor of medicine or osteopathy is responsible for the 
care of the patient. Specifically, that the applicability of the 
standard reflects both Medicare and Medicaid patients.
    ++ Section 482.12(d)(3), to explicitly state that the facility's 
overall institutional plan must provide for capital expenditures for at 
least a 3-year period.
    ++ Section 482.12(d)(4), to provide specifics as outlined within 
the standards, to include specifics, such as that the facility's 
overall institutional plan must include and identify in detail the 
objective of, and the anticipated sources of financing for, each 
anticipated capital expenditure in excess of $600,000 (or a lesser 
amount that is established, in accordance with section 1122(g)(1) of 
the Act, by the State in which the hospital is located).
    ++ Sections 482.12(d)(4)(i) through 482.12(d)(4)(iii), to provide 
specifics as outlined within the standard, to include acquisition of 
land; improvement of land, buildings, and equipment; or, the 
replacement, modernization, and expansion of buildings and equipment.
    ++ Section 482.13(d)(2), to specify that the patient has the right 
to receive his or her medical records based on oral or written request 
and comparable language that that the hospital must not frustrate the 
legitimate efforts of individuals to gain access to their own medical 
records.
    ++ Section 482.23(c)(6)(i)(A), to remove terminology of 
``independent'' practitioners consistent with the regulation.
    ++ Section 482.41(b)(5), to include language that requires the 
hospital fire control plan to contain provisions for cooperating with 
firefighting authorities.
    ++ Section 482.41(d)(2), to include specifically, the requirement 
for supplies to be maintained to ensure and acceptable level of safety 
and quality.
    ++ Section 482.41(d)(3), to provide clarifications that the 
physical environment must be based on the complexity of the facility 
and services offered.
    ++ Section 482.41(e), to provide comparable standards which 
incorporate by reference the National Fire Protection Association 
(NFPA) standards.
    In addition to the standards review, CMS reviewed TJC's comparable 
survey processes, which were conducted as described in section III. of 
this final notice, and yielded the following areas where, as of the 
date of this notice, TJC has completed revising its survey processes in 
order to demonstrate that it uses survey processes that are comparable 
to state survey agency processes by:
    ++ Removing language suggesting a timeframe for completion of 
certain survey activities. In particular, revising the survey process 
to avoid imposing a time restriction, which could potentially suggest 
that a full assessment of all life safety and environment of care 
standards may not be conducted if timeframe exceeds.
    ++ Revising TJC's survey processes to include surveyor review to 
determine that a path of egress is well lit, including outside the 
building as required by NFPA 101-2012, 7.8.1.1.
    ++ Developing survey procedures to incorporate that on any Medicare 
hospital survey, contracted patient care activities or patient services 
(such as dietary services, treatment services, and diagnostic services) 
located on hospital campuses or hospital provider-based locations 
should be surveyed as part of the hospital for compliance with the 
CoPs.
    ++ Emphasizing in TJC's policy and procedures that only CMS may 
approve temporary closures of deemed facilities. Specifically, TJC 
closely aligned their organizational policies with CMS' guidance 
provided in Administrative Memorandum 22-02-ALL,\1\ which provided 
guidance related to temporary closures and cessation of business 
situations.
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    \1\ Administrative Memorandum 22-02-ALL (December 23, 2021). 
Transitioning Certification Functions for Changes of Ownership, 
Administrative Changes, and Initial Enrollment Performed by the CMS 
Survey and Operations Group https://www.cms.gov/files/document/admin-info-22-02-all.pdf.
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    ++ Providing additional training to surveyors related the 
appropriate level of citations for Governing Body and Nursing Services 
when deficiencies are found in a hospital.
    ++ Clarifying the complaint processes during the public health 
emergency and ensuring that all survey activities continue to be 
unannounced.

B. Term of Approval

    Based on our review and observations described in section III. and 
section 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, 2022 through July 15, 2025 (3 years). In accordance 
with Sec.  488.5(e)(2)(i) the term of the approval will not exceed 6 
years. Due to travel restrictions and the reprioritization of survey 
activities brought on by the 2019 Novel Coronavirus Disease (COVID-19) 
Public Health Emergency (PHE), CMS was unable to observe a hospital 
survey completed by TJC surveyors as part of the application review 
process, which is one component of the 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 
deemed hospitals will continue to meet or exceed Medicare standards. 
While TJC has taken actions based on the findings annotated in section 
V.A., of this final

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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's 
hospital survey. In keeping with CMS's initiative to increase AO 
oversight broadly, and ensure that our requested revisions by TJC are 
completed, CMS expects more frequent review of TJC's activities in the 
future.

VI. Collection of Information

    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), Chiquita Brooks-LaSure, having reviewed and approved this 
document, authorizes Lynette Wilson, who is the Federal Register 
Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

    Dated: April 27, 2022.
Lynette Wilson,
Federal Register Liaison, Center for Medicare & Medicaid Services.
[FR Doc. 2022-09361 Filed 4-29-22; 8:45 am]
BILLING CODE 4120-01-P