[Federal Register Volume 85, Number 138 (Friday, July 17, 2020)]
[Notices]
[Pages 43582-43584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15599]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3391-FN]
Medicare and Medicaid Programs; Application From the Joint
Commission for Continued 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 (TJC) 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 notice is effective on July 15,
2020, through July 15, 2022.
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), establish
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. There is an
alternative; however, to surveys by SAs.
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 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 current term of approval for their hospital
accreditation program expires July 15, 2020.
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 18, 2020, we published a proposed notice in the Federal
Register (85 FR 8874), announcing TJC's request for continued approval
of its Medicare hospital accreditation program. In the February 18,
2020
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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 hospital accreditation application
in accordance with the criteria specified by our regulations, which
include, but are not limited to the following:
An onsite 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.
The comparison of TJC's Medicare hospital accreditation
program standards to our current Medicare hospital conditions of
participation (CoPs).
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 February
18, 2020 proposed notice also solicited public comments regarding
whether TJC's requirements met or exceeded the Medicare CoPs for
hospitals. No comments were received 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 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--
Meet the standard's requirements of all of the following
regulations:
++ Section 482.21(b)(2)(i), to incorporate language related to
using patient care data to monitor the effectiveness and safety of
services and quality of care.
++ Section 482.22(c)(5)(ii), to include comparable language, which
requires that the updated examination of the patient including any
changes in the patient's condition be completed and documented by a
physician (as defined in section 1861(r) of the Act), an
oromaxillofacial surgeon, or other qualified licensed individual in
accordance with State law and hospital policy.
++ Section 482.23(c)(6)(i)(A), to address patients' self-
administration of hospital-issued medications that may be allowed by a
hospital pursuant to a practitioner's order (specifically to
incorporate a comparable standard to ensure that a practitioner
responsible for the care of the patient has issued an order, consistent
with hospital policy, permitting such self-administration of
medications).
++ Section 482.26(d)(2), to address timeframes related to records
retention of accredited hospitals.
++ Section 482.41(c)(2), to include reference to the Healthcare
Facilities Code (HCFC) NFPA Health Care Facilities Code (NFPA 99) (2012
edition).
++ Section 482.57(b)(1), to incorporate language related to written
documentation requirements for personnel qualified to perform specific
respiratory care procedures and the amount of supervision required for
personnel to carry out such procedures.
++ Glossary adjustment to incorporate language to include the
caregiver or support person within the definition of family member.
In addition to the standards review, CMS also 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:
++ Providing additional clarity to the how TJC determines the size
and composition of the organization's survey teams for hospitals as
required under Sec. 488.5(a)(5) including Life Safety Code (LSC)
surveyors.
++ Modifying TJC's accreditation award letter to facilities to
remove the term ``lengthen'' to eliminate potential conflict as it
relates to survey cycle length not to exceed 36 months, as survey
cycles for deeming purposes do not exceed this timeframe.
++ Adding references to the 2012 edition of the (NFPA) Health Care
Facilities Code (NFPA 99) within its Accreditation Process and Surveyor
Activity Guide.
++ Providing clarification to its Surveyor Activity Guide
indicating that the 2012 edition of the NFPA Life Safety Code and NFPA
99 applies at hospital outpatient surgical departments, regardless of
the number of patients served.
++ Providing clarification to its Surveyor Activity Guide
indicating that surveys must consider all hospital provider-based
locations.
++ Requiring additional training for TJC's surveyors and adjusting
TJC's survey processes as they relate to off-site locations, to include
surveying for LSC and other Physical Environment standards.
++ Making adjustments to TJC's survey processes as they relate to
leading and probing questions during interviews.
++ Making adjustments to TJC's survey processes as they relate to
providing a setting, which promotes ease of sharing information with
surveyors during interviews, in
[[Page 43584]]
particular placing restrictions on interviewing staff in front of first
line supervisors.
++ Requiring additional training for surveyors and making
modifications instructing surveyors regarding the level of detail
provided to the facility during TJC's daily briefing, to ensure it does
not change the integrity of the survey process.
++ Requiring additional training for TJC's surveyors and adjusting
TJC's survey processes as they relate to in-depth review of medical
records.
++ Making modifications to TJC's survey processes as they relate to
the ``Governing Body'' Condition of Participation (Sec. 482.12).
Specifically:
-- Clarifications to TJC's governing body Tracer and Leadership
sessions, as they relate to discussion-based investigation techniques
and record reviews.
-- Determinations of deficiencies and TJC's preliminary decision making
processes, such as determining the severity of deficiencies, and TJC's
process for citing the governing body based on the deficiencies found
at a facility.
-- Citing the governing body for deficiencies within a facility's
physical environment based on the severity of deficiencies.
++ Clarifying timeframes for Plans of Corrections to be submitted
by the facility to TJC and TJC's performance of Evidence of Standard
Compliance (ESC) processes, as well as onsite follow up surveys as part
of TJC's ESC survey activities.
++ Modifying TJC's survey process related to providing each patient
in the sample a unique identifier in deficiency reports and for TJC
surveyors to have appropriate identifiable information on a separate
identifier list which can be provided to the facility upon exit.
++ Clarifying and providing additional training to surveyors
related to survey processes and procedures for review of credentialing
and human resources and or personnel file reviews.
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, 2020 through July 15, 2022 (2 years). In accordance
with Sec. 488.5(e)(2)(i) the term of the approval will not exceed 6
years. This shorter term of approval is based on our concerns related
to the comparability of TJC's survey processes to those of CMS, as well
as what CMS has observed of TJC's performance on the survey
observation. Some of these concerns stem from the level of detail TJC
provides in the daily briefings it provides to facilities, as well as
TJC's processes surrounding its staff interview practices.
Additionally, we are concerned about TJC's review of medical records
and surveying off-site locations, in particular for the Physical
Environment condition of participation. Based on these observations and
review of TJC's processes as discussed at section V.A. (Differences
Between TJC's Standards and Requirements for Accreditation and Medicare
Conditions and Survey Requirements), we remain concerned about the
thoroughness of review conducted within the facilities. While TJC has
taken action based on the findings annotated in section V.A., as
authorized under Sec. 488.8, we will continue ongoing review of TJC's
survey processes across all their approved accrediting programs to
ensure that all our recommended changes have been implemented. In
keeping with CMS's initiative to increase AO oversight, and ensure that
our requested revisions by TJC are complied with, CMS expects more
frequent review of TJC's activities to avoid any continued
inconsistencies.
VI. Collection of Information and Regulatory Impact Statement
This document does not impose information collection 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.). In accordance with the provisions of
Executive Order 12866, this regulation was not reviewed by the Office
of Management and Budget.
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Seema Verma, having reviewed and approved this document,
authorizes Evell J. Barco Holland, who is the Federal Register Liaison,
to electronically sign this document for purposes of publication in the
Federal Register.
Dated: July 15, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of Health and Human Services.
[FR Doc. 2020-15599 Filed 7-15-20; 4:15 pm]
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