[Federal Register Volume 88, Number 172 (Thursday, September 7, 2023)]
[Notices]
[Pages 61595-61596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19323]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3437-FN]


Medicare and Medicaid Programs: Application From the 
Accreditation Commission for Health Care, Inc. 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 
Accreditation Commission for Health Care, Inc 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 on September 
22, 2023 through September 22, 2027.

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

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 that 
certain requirements are met. Section 1832(a)(2)(F)(i) of the Social 
Security Act (the Act) establishes distinct criteria for facilities 
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 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 a 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 entities 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 regulations at Sec.  488.5(e)(2)(i) require AOs to reapply 
for continued approval of its accreditation program every 6 years or 
sooner as determined by CMS.
    Accreditation Commission for Health Care's (ACHC's) current term of 
approval for its ASC accreditation program expires September 22, 2023.

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 April 3, 2023, we published a proposed notice in the Federal 
Register (88 FR 19645), announcing ACHC's request for continued 
approval of its Medicare ASC accreditation program. In the April 3, 
2023, 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 ACHC'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 ACHC'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 comparison of ACHC's Medicare ASC accreditation 
program standards to our current Medicare ASC conditions for coverage 
(CfCs).
    <bullet> A documentation review of ACHC's survey process to do the 
following:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and ACHC's ability to provide continuing surveyor 
training.
    ++ Compare ACHC's processes to those we require of state survey 
agencies, including periodic resurvey and the ability to investigate 
and respond appropriately to complaints against ACHC accredited ASCs.
    ++ Evaluate ACHC's procedures for monitoring accredited ASCs it has 
found to be out of compliance with ACHC's program requirements. (This 
pertains only to monitoring procedures when ACHC 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 ACHC's ability to report deficiencies to the surveyed 
ASCs and respond to the ASC's plans of correction in a timely manner.
    ++ Establish ACHC'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 ACHC's staff and other resources.
    ++ Confirm ACHC's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm ACHC's policies with respect to surveys being 
unannounced.

[[Page 61596]]

    ++ Confirm ACHC'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 ACHC'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 April 3, 
2023, proposed notice also solicited public comments regarding whether 
ACHC's requirements met or exceeded the Medicare CfCs for ASCs. We 
received two (2) timely pieces of correspondence.
    Comment: Two commenters expressed support for ACHC and their ASC 
accreditation program and encouraged CMS to approve them for continued 
recognition as a national AO for ASCs.
    Response: We appreciate the support from commenters and agree that 
ACHC should be approved for continued recognition as a national AO for 
ASCs that wish to participate in the Medicare or Medicaid programs.

V. Provisions of the Final Notice

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

    We compared ACHC's ASC accreditation requirements and survey 
process with the Medicare CfCs of part 416, and the survey and 
certification process requirements of parts 488 and 489. Our review and 
evaluation of ACHC's ASC accreditation application, which were 
conducted as described in section III of this notice, yielded the 
following areas where, as of the date of this notice, ACHC has 
completed revising its standards and certification processes in order 
to--
    <bullet> Meet the standard's requirements of all the following 
regulations:
    ++ Section 416.44(a), to address that an ASC ``must provide a 
functional and sanitary environment for the provision of surgical 
services.''
    ++ Section 416.44(b)(2), to address the requirements regarding Life 
Safety Code (LSC) waivers.
    ++ Section 416.45(a), to address the regulatory language for 
granting privileges in accordance with recommendations from qualified 
medical personnel.
    ++ Section 416.54(d)(2), to clarify the cycle of testing for the 
ASC's emergency preparedness plans.
    In addition to the standards review, CMS also reviewed ACHC's 
comparable survey processes, which were conducted as described in 
section III of this notice, and yielded the following areas where, as 
of the date of this notice, ACHC has completed revising its survey 
processes to demonstrate that it uses survey processes that are 
comparable to state survey agency processes by:
    ++ Revising the compliant policies and processes to align with the 
State Operations Manual, Chapter 5 guidance. In particular, ACHC's 
Administrative Review Offsite Investigation process to align with the 
triage process to track and trend for potential focus areas during the 
next onsite survey or complete an onsite complaint investigation.
    ++ Revising ACHC's ASC Accreditation Process policies to include 
the applicable sections of the Health Care Facilities Code (HCFC) 
National Fire Protection Agency (NFPA 99) in accordance with section 
416.44(c).
    ++ Ensuring that all ASC LSC surveyors have received comparable, 
adequate training or have sufficient experience to make them qualified 
to survey health care facilities to both the 2012 LSC and 2012 NFPA 99 
requirements.
    ++ Ensuring that each deficiency citation of the Medicare ASC CfCs 
is documented in such a way that is comparable to the state survey 
agencies conducting federal Medicare ASC surveys.
    ++ Ensuring that all findings of non-compliance, that crosswalk to 
a comparable Medicare CfC, is identified in the final survey report.
    ++ Providing guidance and instruction to surveyors on determining 
the appropriate level of citation for LSC deficiencies.

B. Term of Approval

    Based on our review and observations described in section III and 
section V of this notice, we approve ACHC as a national accreditation 
organization for ASCs that request participation in the Medicare 
program. The decision announced in this notice is effective September 
22, 2023, through September 22, 2027 (4 years). In accordance with 
Sec.  488.5(e)(2)(i) the term of the approval will not exceed 6 years.
    While ACHC has taken actions based on the findings annotated in 
section V.A, of this notice, (Differences Between ACHC's Standards and 
Requirements for Accreditation and Medicare Conditions and Survey 
Requirements) as authorized under Sec.  488.8, we will continue ongoing 
review of ACHC's ASC survey processes to ensure full implementation and 
sustained compliance. In keeping with CMS's initiative to increase AO 
oversight broadly and ensure that our requested revisions by ACHC are 
fully implemented, CMS expects more frequent review of ACHC's 
activities in the future.

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 Evell J. Barco Holland, who is the Federal 
Register Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

Evell J. Barco Holland,
Federal Register Liaison, Center for Medicare & Medicaid Services.
[FR Doc. 2023-19323 Filed 9-6-23; 8:45 am]
BILLING CODE 4120-01-P