[Federal Register Volume 90, Number 34 (Friday, February 21, 2025)]
[Notices]
[Pages 10079-10080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-02914]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3466-FN]
Medicare and Medicaid Programs: Approval of Application From the
American Association for Accreditation of Ambulatory Surgery Facilities
dba QUAD A for Continued CMS-Approval of Its Outpatient Physical
Therapy (OPT) 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 from
the American Association for Accreditation of Ambulatory Surgery
Facilities dba QUAD A for continued recognition as a national
accrediting organization for Outpatient Physical Therapy programs that
wish to participate in the Medicare or Medicaid programs.
DATES: The decision announced in this notice is applicable April 4,
2025 to April 4, 2030.
FOR FURTHER INFORMATION CONTACT: Caecilia Andrews, (410) 786-2190.
SUPPLEMENTARY INFORMATION:
I. Background
A healthcare provider may enter into an agreement with Medicare to
participate in the program as a provider of outpatient physical therapy
(OPT) provided certain requirements are met. Section 1861(p)(4) of the
Social Security Act (the Act), establishes distinct criteria for
facilities seeking designation as an OPT. Regulations concerning
Medicare provider agreements in general are at 42 CFR part 489 and
those pertaining to the survey and certification for Medicare
participation of providers and certain types of suppliers are at part
488. The regulations at part 485, subpart H, specify the conditions
that a provider must meet to participate in the Medicare program as an
OPT.
Generally, to enter into an agreement, an OPT must first be
certified by a state survey agency (SA) as complying with the
conditions or requirements set forth in part 485 of our Medicare
regulations. Thereafter, the OPT 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.
The QUAD A's current term of approval for its OPT program expires
April 4, 2025.
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 October 17, 2024, we published a proposed notice in the Federal
Register (89 FR 8368), announcing QUAD A's request for continued
approval of its Medicare OPT accreditation program. In the 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 OPT accreditation application in accordance with
the criteria specified by our regulations, which include, but are not
limited to the following:
An administrative review of QUAD A's: (1) corporate
policies; (2) financial
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and human resources available to accomplish the proposed surveys; (3)
procedures for training, monitoring, and evaluation of its surveyors;
(4) ability to investigate and respond appropriately to complaints
against accredited facilities; and (5) survey review and decision-
making process for accreditation.
A comparison of QUAD A's accreditation to our current
Medicare OPT conditions of participation (CoPs).
A documentation review of QUAD A's survey process to:
++ Determine the composition of the survey team, surveyor
qualifications, and QUAD A's ability to provide continuing surveyor
training.
++ Compare QUAD A's processes to those of state survey agencies,
including survey frequency, and the ability to investigate and respond
appropriately to complaints against accredited facilities.
++ Evaluate QUAD A's procedures for monitoring OPTs out of
compliance with QUAD A's program requirements. The monitoring
procedures are used only when QUAD A identifies noncompliance. If
noncompliance is identified through validation reviews, the state
survey agency monitors corrections as specified at Sec. 488.7(d).
++ Assess QUAD A's ability to report deficiencies to the surveyed
facilities and respond to the facility's plan of correction in a timely
manner.
++ Establish QUAD A'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 staff and other resources.
++ Confirm QUAD A's ability to provide adequate funding for
performing required surveys.
++ 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.
++ Confirm QUAD A's policies with respect to whether surveys are
unannounced.
IV. Analysis of and Responses to Public Comments on the Proposed Notice
In accordance with section 1865(a)(3)(A) of the Act, the October
17, 2024 proposed notice also solicited public comments regarding
whether QUAD A's requirements met or exceeded the Medicare CoPs for
OPTs. We did not receive any comments.
V. Provisions of the Final Notice
A. Differences Between OPT's Standards and Requirements for
Accreditation and Medicare Conditions and Survey Requirements
We compared QUAD A's requirements and survey process with the
Medicare CoPs and survey process as outlined in the State Operations
Manual (SOM). Our review and evaluation of QUAD A's OPT application
were conducted as described in section III. of this notice and has
yielded the following areas where, as of the date of this notice, QUAD
A's has completed revising its standards and certification processes in
order to:
Meet the standard's requirements of all of the following
regulations:
++ Section 488.5(a)(4)(ii), to incorporate additional
clarifications on the types of surveys related to OPT organizations and
incorporate comparable guidance for surveyors, consistent with CMS
policy memorandums Admin Info-24-22 (which streamlined certification
processes for OPTs and other programs) as well as QSO-24-18 OPT (which
outlined OPT expectations for surveying extension locations).
++ Section 485.721(b) and State Operations Manual (SOM) Appendix E,
to provide additional clarification in its survey process to ensure
that clinical record reviews include primary and extension locations
and treatment provided by contracted employees, if applicable and
include all content as required by the regulation.
++ Section 485.709, to review survey findings and provide
additional policies or training to identify situations where governing
body citations at a condition level would be appropriate.
++ Sections 488.5(a)(4)(ii) and 488.28(d), to revise the
communication information provided to the provider to delineate more
clearly the process as it relates to potential termination as OPTs is
generally expected to be in compliance within 60 days of the
deficiencies, as comparable to the process of the State Survey
Agencies. Specifically, we requested QUAD A to clarify the impact for
Medicare participation versus QUAD A's accreditation program.
In addition to the standards review, we also reviewed QUAD A'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, 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:
Providing additional surveyor education to ensure, when
opportunities present during the course of the survey, that surveyors
conduct patient interviews, consistent with SOM Appendix E.
Revising survey processes to provide emphasis on staff
interviews and gearing those interviews to allow staff to demonstrate
knowledge of the applicable policies and procedures.
Revising the survey process and providing education to
surveyors to ensure equipment used by the OPT not only encompasses
elements of Sec. 485.723(b), but also includes an assessment of
whether the facility is complying with the manufacturer instructions
for use and guidance.
B. Term of Approval
Based on our review and observations described in section III. and
section V. of this notice, we approve QUAD A as a national AO for OPTs
that request participation in the Medicare program. The decision
announced in this final notice is effective April 4, 2025 through April
4, 2030 (5 years). 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 Acting Administrator of the Centers for Medicare & Medicaid
Services (CMS), Stephanie Carlton, 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. 2025-02914 Filed 2-20-25; 8:45 am]
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