[Federal Register Volume 89, Number 138 (Thursday, July 18, 2024)]
[Notices]
[Pages 58380-58382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15816]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3456-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: Notice.

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SUMMARY: This 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 applicable September 1, 
2024, to September 1, 2030.

FOR FURTHER INFORMATION CONTACT: Caecilia Andrews (410) 786-2190.

SUPPLEMENTARY INFORMATION:

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

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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, 2024.

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.
    We note, TJC submitted the application for continued CMS-approval 
in advance; therefore the 210-days from the receipt of a complete 
application and our decision to approve has reset TJC's approval terms 
from December to September.

III. Provisions of the Proposed Notice

    On February 26, 2024, CMS published a proposed notice in the 
Federal Register (89 FR 14076), announcing TJC's request for continued 
approval of its Medicare ASC accreditation program. In the February 26, 
2024, 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 equivalency of TJC's standards for ASCs as compared 
with Medicare's Conditions for Coverage (CfCs) for ASCs.
     TJC's survey process to determine the following:
    ++ The composition of the survey team, surveyor qualifications, and 
the ability of the organization to provide continuing surveyor 
training.
    ++ The comparability of TJC's processes to those of State agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
    ++ TJC's processes and procedures for monitoring an ASC found out 
of compliance with TJC's program requirements. These monitoring 
procedures are used only when TJC identifies noncompliance. If 
noncompliance is identified through validation reviews or complaint 
surveys, the State survey agency monitors corrections as specified at 
Sec.  488.9(c)(1).
    ++ TJC's capacity to report deficiencies to the surveyed facilities 
and respond to the facility's plan of correction in a timely manner.
    ++ TJC's capacity to provide CMS with electronic data and reports 
necessary for the effective validation and assessment of the 
organization's survey process.
    ++ The adequacy of TJC's staff and other resources, and its 
financial viability.
    ++ TJC's capacity to adequately fund required surveys.
    ++ TJC's policies with respect to whether surveys are announced or 
unannounced, to ensure that surveys are unannounced.
    ++ 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.
    ++ 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 CMS 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 
26, 2024 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 416.42 to clarify that ASCs may only allow qualified 
physicians to perform surgery.
    ++ Section 416.44(b)(1) to ensure ASCs to meet the provisions 
applicable to Ambulatory Health Care Occupancies and address the Life 
Safety Code (LSC) Tentative Interim Amendments (TIAs), TIA 12-2, TIA 
12-3, and TIA 12-4 requirements.
    ++ Section 416.44(b)(2) to clarify within TJC's existing standard 
related to LSC waivers, that the timeframe for achieving compliance 
begins when the facility receives the survey report and in accordance 
with the timeframes in Sec.  488.28(d).
    ++ Section 416.44(c) to incorporate the requirement for ASCs to 
comply with Health Care Facilities Code (HCFC) NFPA 99, and Tentative 
Interim Amendments (TIAs), TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5 and 
TIA 12-6 and to revise TJC's introductory paragraph of the Statement of 
Condition Instructions to include HCFC deficiencies.
    ++ Section 416.50(e)(2) to clarify the standard to ensure if a 
patient is adjudged incompetent under applicable State laws by a court 
of proper jurisdiction, the rights of the patient are exercised by the 
person appointed under State law to act on the patient's behalf.

[[Page 58382]]

    ++ Section 416.50(e)(3) to clearly identify that if a State court 
has not deemed a patient incompetent, any legal representative or 
surrogate designated by the patient in accordance with State law may 
exercise the patient's rights to the extent allowed by State law.
    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:
    ++ Clarifying TJC's survey activity for Life Safety Code (LSC) 
related to the length of time required to complete an LSC/Health Care 
Facilities Code (HCFC) survey, as the survey activity will depend upon 
various circumstances (for example, age & condition, size of ASC/
building, construction type, number of stories, sprinkler system, 
essential electric system, etc.).
    ++ Updating TJC's survey procedures to ensure all areas of the LSC/
HCFC are surveyed and reflected in TJC's 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.
    ++ Clarifying that any LSC/HCFC waivers can only be granted by CMS, 
in accordance with Sec.  416.44(c)(2).
    ++ Providing additional surveyor training as it relates to scope, 
manner and degree of citations related to medication administration, 
physical environment, and Life Safety Code, in accordance with the 
State Operations Manual (SOM) Appendix L, Task 4.
    ++ Providing additional surveyor education comparable to CMS' 
Principles of Documentation, specifically to ensure records reviewed 
and reported on TJC's survey report to the facility are clear.
    ++ Revising TJC's process to ensure the appropriate sample of 
patient records is reviewed during surveys based on ASC case volume.

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 
September 1, 2024 through September 1, 2030. In accordance with Sec.  
488.5(e)(2)(i) the term of the approval will not exceed 6 years.

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

Vanessa Garcia,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2024-15816 Filed 7-17-24; 8:45 am]
BILLING CODE 4120-01-P