[Federal Register Volume 89, Number 218 (Tuesday, November 12, 2024)]
[Notices]
[Pages 89014-89015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26124]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3459-FN]


Medicare and Medicaid Programs; Approval of Application by the 
American Association for Accreditation of Ambulatory Surgery 
Facilities, dba QUAD A, for Continued CMS-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 acknowledges the approval of an application by the 
American Association for Accreditation of Ambulatory Surgery 
Facilities, dba QUAD A, 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 27, 
2024, to November 27, 2029.

FOR FURTHER INFORMATION CONTACT: 
    Erin Imhoff, (410) 786-2337.
    Joy Webb, (410) 786-1667.

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.
    QUAD A's current term of approval for its ASC program expires 
November 27, 2024.

II. Application Approval Process

    Section 1865(a)(2) of the Act and our regulations at Sec.  488.5 
require that our findings concerning review and approval of an AO's 
requirements consider, among other factors, the applying AO's 
requirements for accreditation; survey procedures; resources for 
conducting required surveys; capacity to furnish information for use in 
enforcement activities; monitoring procedures for provider entities 
that were not in compliance with the conditions or requirements; and 
their ability to provide CMS with the necessary data for validation.
    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 13, 2024, we published a proposed notice in the Federal 
Register (89 FR 50330), announcing QUAD A's request for continued 
approval of its Medicare ASC accreditation program. In the June 13, 
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 QUAD A's Medicare ASC accreditation application 
in accordance with the criteria specified by our regulations, which 
include, but are not limited to the following:
    <bullet> An administrative review of QUAD A'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.
    <bullet> The equivalency of QUAD A's standards for ASCs as compared 
with Medicare's Conditions for Coverage (CfCs) for ASCs.
    <bullet> QUAD A'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 QUAD A's processes to those of State 
agencies, including survey frequency, and the ability to investigate 
and respond appropriately to complaints against accredited facilities.
    ++ QUAD A's processes and procedures for monitoring an ASC found 
out of compliance with QUAD A's program requirements. These monitoring 
procedures are used only when QUAD A 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).
    ++ QUAD A's capacity to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    ++ QUAD A'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 QUAD A's staff and other resources, and its 
financial viability.

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    ++ QUAD A's capacity to adequately fund required surveys.
    ++ QUAD A's policies with respect to whether surveys are announced 
or unannounced, to ensure that surveys are unannounced.
    ++ QUAD A'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.
    ++ QUAD A'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 June 13, 
2024 proposed notice also solicited public comments regarding whether 
QUAD A's requirements met or exceeded the Medicare CfCs for ASCs. No 
public comments were received in response to our proposed notice.

V. Provisions of the Final Notice

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

    We compared QUAD A'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 QUAD A'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, QUAD A has completed 
revising its standards and certification processes in order to do all 
of the following:
    <bullet> Meet the standard's requirements of all of the following 
regulations:
    ++ Section 416.40, to ensure that ASCs comply with state licensure 
requirements.
    ++ Section 416.44(b)(2), to clarify that an AO may recommend a 
waiver of specific provisions of the Life Safety Code (LSC), which 
would result in unreasonable hardship upon an ASC, but only if the 
waiver will not adversely affect the health and safety of the patients.
    We also reviewed QUAD A'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, QUAD 
A has completed revising its survey processes in order to demonstrate 
that it uses survey processes that are comparable to state survey 
agency processes by:
    ++ Updating QUAD A's survey procedures to ensure all areas of the 
Health Care Facilities Code (HCFC) are surveyed and reflected in QUAD 
A's policies and surveyor guides.
    ++ Providing clarification to QUAD A's survey scheduling policies 
to explain the number of LSC surveyors required for survey teams at 
small, medium, and large ASCs.
    ++ Revising QUAD A policy to ensure surveyor qualifications include 
experience with the LSC and HCFC.
    ++ Providing additional surveyor training to ensure that LSC 
deficiency citations contain a sufficient level of detail and 
quantifiable information comparable to what is required by the CMS 
Principles of Documentation in Chapter 9 of the State Operations 
Manual.
    ++ Providing a process to ensure that any findings on the ASC 
surveyor infection control worksheet are cited appropriately in the 
final survey report.
    ++ Providing a process to ensure the appropriate sample of patient 
records, including open and closed records, is reviewed during surveys 
based on the ASC's case volume.

B. Term of Approval

    Based on our review described in section III. and section V. of 
this final notice, we approve QUAD A as a national AO for ASCs that 
request participation in the Medicare program. The decision announced 
in this final notice is effective November 27, 2024 through November 
27, 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 purposes of 
publication in the Federal Register.

Vanessa Garcia,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2024-26124 Filed 11-8-24; 8:45 am]
BILLING CODE 4120-01-P