Notice2023-06778
Medicare and Medicaid Programs: Application From the Accreditation Commission for Health Care for Continued Approval of its Ambulatory Surgical Center (ASC) Accreditation Program
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 3, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This proposed notice acknowledges the receipt of an application from the Accreditation Commission for Health Care for continued recognition as a national accrediting organization for Ambulatory Surgical Centers that wish to participate in the Medicare or Medicaid programs.
Full Text
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<title>Federal Register, Volume 88 Issue 63 (Monday, April 3, 2023)</title>
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[Federal Register Volume 88, Number 63 (Monday, April 3, 2023)]
[Notices]
[Pages 19645-19646]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-06778]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3437-PN]
Medicare and Medicaid Programs: Application From the
Accreditation Commission for Health Care for Continued Approval of its
Ambulatory Surgical Center (ASC) Accreditation Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice with request for comment.
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SUMMARY: This proposed notice acknowledges the receipt of an
application from the Accreditation Commission for 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, by May 3, 2023.
ADDRESSES: In commenting, refer to file code CMS-3437-PN.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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-3437-PN, P.O. Box 8016,
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-3437-PN, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
[Submission of comments on paperwork requirements. You may submit
comments on this document's paperwork requirements by following the
instructions at the end of the ``Collection of Information
Requirements'' section in this document.]
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Joy Webb, (410) 786-1667.
Erin Imhoff, (410) 786-2337.
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: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the search instructions on
that website to view public comments. CMS will not post on
<a href="http://Regulations.gov">Regulations.gov</a> public comments that make threats to individuals or
institutions or suggest that the individual will take actions to harm
the 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 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 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 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. 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 a national
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 identifying the national accrediting body making the request,
describing the nature of the request, and providing at least a 30-day
public comment period. We have 210 days from the receipt of a
[[Page 19646]]
complete application to publish notice of approval or denial of the
application.
The purpose of this proposed notice is to inform the public of
ACHC's request for continued approval of its ASC accreditation program.
This notice also solicits public comment on whether ACHC's requirements
meet or exceed the Medicare conditions for coverage (CfCs) for ASCs.
III. Evaluation of Deeming Authority Request
ACHC submitted all the necessary materials to enable us to make a
determination concerning its request for continued approval of its ASC
accreditation program. This application was determined to be complete
on February 24, 2023. Under section 1865(a)(2) of the Act and our
regulations at Sec. 488.5 (Application and re-application procedures
for national accrediting organizations), our review and evaluation of
ACHC will be conducted in accordance with, but not necessarily limited
to, the following factors:
<bullet> The equivalency of ACHC's standards for ASCs as compared
with Medicare's ASC CfCs.
<bullet> ACHC'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 ACHC's processes to those of state
agencies, including survey frequency, and the ability to investigate
and respond appropriately to complaints against accredited facilities.
++ ACHC's processes and procedures for monitoring an ASC found out
of compliance with ACHC program requirements. These monitoring
procedures are used only when ACHC identifies noncompliance. If
noncompliance is identified through validation reviews or complaint
surveys, the SA monitors corrections as specified at Sec. 488.9.
++ ACHC's capacity to report deficiencies to the surveyed
facilities and respond to the facility's plan of correction in a timely
manner.
++ ACHC's capacity to provide CMS with electronic data and reports
necessary for effective validation and assessment of the organization's
survey process.
++ The adequacy of ACHC's staff and other resources, and its
financial viability.
++ ACHC's capacity to adequately fund required surveys.
++ ACHC's policies with respect to whether surveys are announced or
unannounced, to assure that surveys are unannounced.
++ 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.
++ 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. 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 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 Evell J. Barco Holland, who is the Federal
Register Liaison, to electronically sign this document for purposes of
publication in the Federal Register.
Dated: March 28, 2023.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-06778 Filed 3-31-23; 8:45 am]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on April 3, 2023.
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