Notice2022-09361
Medicare and Medicaid Programs; Approval of Application by The Joint Commission (TJC) for Continued CMS-Approval of its Hospital Accreditation Program
Primary source
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Published
May 2, 2022
Effective
July 15, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 84 (Monday, May 2, 2022)</title>
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[Federal Register Volume 87, Number 84 (Monday, May 2, 2022)]
[Notices]
[Pages 25642-25644]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.cms.gov/files/document/admin-info-22-02-all.pdf">https://www.cms.gov/files/document/admin-info-22-02-all.pdf</a>.
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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
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