[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

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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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