[Federal Register Volume 89, Number 124 (Thursday, June 27, 2024)]
[Notices]
[Pages 53626-53627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14137]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3461-PN]


Medicare and Medicaid Programs: Application by the Accreditation 
Association for Ambulatory Health Care for Continued CMS-Approval of 
Ambulatory Surgical Center Accreditation Program

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

ACTION: Proposed notice.

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SUMMARY: This proposed notice announces the receipt of an application 
from the Accreditation Association for Ambulatory Health Care for 
continued recognition as a national accrediting organization for 
Ambulatory Surgical Centers that wish to participate in the Medicare or 
Medicaid programs.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on July 29, 2024.

ADDRESSES: In commenting, refer to file code CMS-3461-PN. Because of 
staff and resource limitations, we cannot accept comments by facsimile 
(FAX) transmission.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-3461-PN, P.O. Box 8010, 
Baltimore, MD 21244-8010.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-3461-PN, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

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

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following 
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to 
view public comments. CMS will not post on Regulations.gov public 
comments that make threats to individuals or institutions or suggest 
that the commenter will take actions to harm an individual. CMS 
continues to encourage individuals not to submit duplicative comments. 
We will post acceptable comments from multiple unique commenters even 
if the content is identical or nearly identical to other comments.

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. Sec.  488.4 and 488.5.
    The Accreditation Association for Ambulatory Health Care's 
(AAAHC's) current term of approval for its ASC program expires December 
20, 2024.

II. Approval of Deeming Organization

    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

[[Page 53627]]

accreditation; survey procedures; resources for conducting required 
surveys; capacity to furnish information for use in enforcement 
activities; monitoring procedures for provider entities found not in 
compliance with the conditions or requirements; and ability to provide 
CMS with the necessary data for validation.
    Section 1865(a)(3)(A) of the Act further requires that we publish, 
within 60 days of receipt of an organization's complete application, a 
notice that identifies the national accrediting body making the 
request, describes the nature of the request, and provides at least a 
30-day public comment period. We have 210 days from the receipt of a 
complete application to publish notice of approval or denial of the 
application.
    The purpose of this proposed notice is to inform the public of 
AAAHC's request for continued CMS-approval of its ASC accreditation 
program. This notice also solicits public comment on whether AAAHC's 
requirements meet or exceed the Medicare conditions for coverage (CfCs) 
for ASCs.

III. Evaluation of Deeming Authority Request

    AAAHC submitted all the necessary materials to enable us to make a 
determination concerning its request for continued CMS-approval of its 
ASC accreditation program. This application was determined to be 
complete on May 24, 2024. Under section 1865(a)(2) of the Act and Sec.  
488.5, our review and evaluation of AAAHC will be conducted in 
accordance with, but not necessarily limited to, the following factors:
     The equivalency of AAAHC's standards for ASCs as compared 
with Medicare's 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's 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. 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.).

V. Response to Public Comments

    Because of the large number of public comments, we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.
    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 Service.
[FR Doc. 2024-14137 Filed 6-26-24; 8:45 am]
BILLING CODE 4120-01-P