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###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

          - [CMS-3461-FN]

# AGENCY:

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

# ACTION:

Notice.

# 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 § 488.5.

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