Notice2024-26124
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
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
November 12, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 218 (Tuesday, November 12, 2024)</title>
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[Federal Register Volume 89, Number 218 (Tuesday, November 12, 2024)]
[Notices]
[Pages 89014-89015]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
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