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[Federal Register Volume 89, Number 239 (Thursday, December 12, 2024)]
[Notices]
[Pages 100498-100500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29152]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3461-FN]

Medicare and Medicaid Programs; Approval of Application by the 
Accreditation Association for Ambulatory Healthcare for Continued CMS-
Approval of Its Ambulatory Surgical Center Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

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SUMMARY: This notice acknowledges the approval of an application by the 
Accreditation Association for Ambulatory Healthcare 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 November 20, 
2024 through November 20, 2029.

FOR FURTHER INFORMATION CONTACT: 
    Joy Webb, (410) 786-1667.
    Joann Fitzell, (410) 786-4280.

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 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 Accreditation Association for Ambulatory Healthcare's (AAAHC's) 
current term of approval for its ASC program expires December 20, 2024.

[[Page 100499]]

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 June 27, 2024, we published a proposed notice in the Federal 
Register (89 FR 53626 through 53627), announcing AAAHC's request for 
continued approval of its Medicare ASC accreditation program. In the 
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 AAAHC's Medicare ASC accreditation renewal 
application in accordance with the criteria specified by our 
regulations, which include, but are not limited to, the following:
     An administrative review of AAAHC: (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 AAAHC's standards for ASCs as compared 
with Medicare's Conditions for Coverage (CfCs) for ASCs.
     AAAHC'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 AAAHC's processes to those of State 
agencies, including survey frequency, and the ability to investigate 
and respond appropriately to complaints against accredited facilities.
    ++ AAAHC's processes and procedures for monitoring an ASC found out 
of compliance with AAAHC's program requirements. These monitoring 
procedures are used only when AAAHC 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).
    ++ AAAHC's capacity to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    ++ AAAHC'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 AAAHC staff and other resources, and its 
financial viability.
    ++ AAAHC's capacity to adequately fund required surveys.
    ++ AAAHC's policies with respect to whether surveys are announced 
or unannounced, to ensure that surveys are unannounced.
    ++ AAAHC'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.
    ++ AAAHC'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 Response to Public Comments on the Proposed Notice

    In accordance with section 1865(a)(3)(A) of the Act, the June 27, 
2024 proposed notice also solicited public comments regarding whether 
AAAHC's requirements met or exceeded the Medicare CfCs for ASCs. We did 
not receive any public comments.

V. Provisions of the Final Notice

A. Differences Between AAAHC's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements

    We compared AAAHC's ASC accreditation program requirements and 
survey process with the Medicare CfCs at 42 CFR part 416, and the 
survey and certification process requirements of parts 488 and 489. Our 
review and evaluation of AAAHC'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, AAAHC has 
completed revising its standards and survey processes in order to do 
all of the following:
     Section 488.5(a)(7), to ensure the ASC Life Safety Code 
(LSC) surveyors meet the minimum qualifications, competencies, and 
experience. Additionally, provide mentor training to future LSC site 
visitor trainees and retain evaluation records in the LSC site visitor 
training records.
     Section 488.5(a)(4)(vii), to add the Health Care 
Facilities Code timeframes on waivers allowance.
     Section 488.26(b), to clarify surveyor training, specific 
to manner and degree, including consideration of the risk of occupants 
associated with system deficiencies.
     Principle of Documentation, Exhibit 7A, to ensure that all 
Plans of Correction contain identifiers and survey reports are 
comparable to CMS' standards.
     Infection Control Surveyor Worksheet, Exhibit 351, to 
ensure that the Infection Control Worksheets are completed thoroughly 
to assess compliance with infection control breaches by gathering 
complete information.
     State Operations Manual Appendix L, to address the sample 
selection of files reviewed to include open and closed record review.

B. Term of Approval

    Based on our review and observations described in Sections III. and 
V. of this final notice, we approve AAAHC as a national accreditation 
organization for ASCs that request participation in the Medicare 
program, effective December 20, 2024 through December 20, 2029. In 
accordance with Sec.  488.5(e)(2)(i), the term of the approval will not 
exceed 6 years.

VI. Collection of Information Requirements

    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

[[Page 100500]]

purposes of publication in the Federal Register.

Vanessa Garcia,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2024-29152 Filed 12-11-24; 8:45 am]
BILLING CODE 4120-01-P
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