[Federal Register Volume 85, Number 204 (Wednesday, October 21, 2020)]
[Notices]
[Pages 66989-66990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23230]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3397-FN]


Medicare and Medicaid Programs; Application From The Joint 
Commission for Continued Approval of Its Ambulatory Surgical Center 
(ASC) 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 Ambulatory Surgical Centers that wish to participate 
in the Medicare or Medicaid programs.

DATES: The decision announced in this notice is effective on December 
20, 2020 through December 20, 2024.
    Joy Webb (410) 786-1667.
    Erin Imhoff (410) 786-2337.

I. Background

    Ambulatory Surgical Centers (ASCs) are distinct entities that 
operate exclusively for the purpose of furnishing outpatient surgical 
services to patients. Under the Medicare program, eligible 
beneficiaries may receive covered services from an ASC provided certain 
requirements are met. Section 1832(a)(2)(F)(i) of the Social Security 
Act (the Act) establishes distinct criteria for a facility seeking 
designation as an ASC. 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 416 specify the conditions that an ASC must 
meet in order to participate in the Medicare program, the scope of 
covered services, and the conditions for Medicare payment for ASCs.
    Generally, to enter into an agreement, an ASC must first be 
certified by a State survey agency (SA) as complying with the 
conditions or requirements set forth in part 416 of our Medicare 
regulations. Thereafter, the ASC 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 conditions are met or exceeded, we may deem that 
provider entity as having met the 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 as having standards for accreditation that meet or 
exceed Medicare requirements, any provider entity accredited by the 
national accrediting body's approved program may be deemed to meet the 
Medicare conditions. The 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 conditions. 
Our regulations concerning the approval of AOs are set forth at Sec.  
488.5.
    The Joint Commission's (TJC's) current term of approval for its ASC 
program expires December 20, 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 May 26, 2020 we published a proposed notice in the Federal 
Register (85 FR 31511), announcing TJC's request for continued approval 
of its Medicare ASC accreditation program. In the May 26, 2020 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 ASC accreditation 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 
ASC surveyors; (4) ability to investigate and respond appropriately to 
complaints against accredited ASCs; and (5) survey review and decision-
making process for accreditation.
     The comparison of TJC's Medicare ASC accreditation program 
standards to our current Medicare ASC conditions for coverage (CfCs).
     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 ASCs.
    ++ Evaluate TJC's procedures for monitoring accredited ASCs 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 ASCs 
and respond to the ASCs' plans 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.

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IV. Analysis of and Responses to Public Comments on the Proposed Notice

    In accordance with section 1865(a)(3)(A) of the Act, the May 26, 
2020 proposed notice also solicited public comments regarding whether 
TJC's requirements met or exceeded the Medicare CfCs for ASCs. 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 ASC accreditation requirements and survey process 
with the Medicare CfCs of parts 416, and the survey and certification 
process requirements of parts 488 and 489. Our review and evaluation of 
TJC's ASC 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 do all of the following:
     Meet the standard's requirements of all of the following 
regulations:
    ++ Section 416.2, to include the regulatory definition of an ASC as 
a comparable TJC standard instead of a glossary definition.
    ++ Section 416.43(c)(2), to address the broad requirement under the 
quality improvement program to track adverse patient events.
    ++ Section 416.44(c), to include reference to the Health Care 
Facilities Code (HCFC) of the National Fire Protection Association 
(NFPA) 99 (2012 edition).
    ++ Section 416.45(a), to include adequate review of credential and 
personnel files during survey activity.
    ++ Section 416.48(a), to include policies regarding the 
administration of drugs be in accordance with acceptable standards of 
practice.
    ++ Section 416.50(a), to provide the correct regulatory citation 
reference to the CMS standard, ``Condition for Coverage--Patient 
Rights; Notice of Rights.''
    ++ Section 488.5(a)(4)(iv), to include the requirement that all 
comparable Medicare CfC citations be included in the findings sections 
of TJC's survey reports.
    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:
    ++ 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 HCFC of the NFPA 99 (2012 edition). 
(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 to ASCs, regardless of the number of patients served.
    ++ Clarifying the process for TJC's performance of on-site Evidence 
of Standard Compliance (ESC) processes, including what it means to 
provide coaching and guidance as part of TJC's ESC survey activities.

B. Term of Approval

    Based on our review described in section III. and section V. of 
this final notice, we approve TJC as a national accreditation 
organization for ASCs that request participation in the Medicare 
program. The decision announced in this final notice is effective 
December 20, 2020 through December 20, 2024. 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 an ASC 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 accredited 
ASCs 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 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 
ASC survey processes and will conduct a survey observation once the 
COVID-19 PHE has expired. 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 and Regulatory Impact Statement

    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), Seema Verma, 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: October 8, 2020.
Lynette Wilson,
Federal Register Liaison, Department of Health and Human Services.
[FR Doc. 2020-23230 Filed 10-20-20; 8:45 am]
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