90 FR 34 pgs. 10079-10080 - 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
Type: NOTICEVolume: 90Number: 34Pages: 10079 - 10080
Pages: 10079, 10080Docket number: [CMS-3466-FN]
FR document: [FR Doc. 2025-02914 Filed 2-20-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Medicare & Medicaid Services
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid 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.
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 §?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 §?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:
[top] • An administrative review of QUAD A's: (1) corporate policies; (2) financial
• 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 §?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 §?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 §?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]
BILLING CODE 4120-01-P