[Billing Code: 4120-01-P]

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.
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 [Insert date 30 days after date of publication in the
Federal Register].
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 Web site as soon as possible after they have been
received: http://www.regulations.gov. Follow the search instructions on that Web site 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 §§ 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 § 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 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 § 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 § 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: 6/26/2024 8:45 am; Publication Date: 6/27/2024]