Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

          - [CMS-3466-PN]

# AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

# ACTION:

Notice with request for comment.

# SUMMARY:

This notice acknowledges the receipt 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 providers 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 November 18, 2024.

# ADDRESSES:

In commenting, refer to file code CMS-3466-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                         *https://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-3466-PN, P.O. Box 8010, Baltimore, MD 21244-8010.                              ( print page 83690)    

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-3466-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:

 Caecilia Andrews, (410) 786-2190. Joy Webb, (410) 786-1667.

# 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:                     *http://www.regulations.gov.*                     Follow the search instructions on that website 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

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. 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 QUAD A's request for continued CMS-approval of its OPT accreditation program. This notice also solicits public comment on whether QUAD A's requirements meet or exceed the Medicare conditions for participation (CoPs) for OPTs.

## III. Evaluation of Deeming Authority Request

QUAD A submitted all the necessary materials to enable us to make a determination concerning its request for continued CMS-approval of its OPT accreditation program. This application was determined to be complete on September 9, 2024. Under section 1865(a)(2) of the Act and § 488.5, our review and evaluation of QUAD A will be conducted in accordance with, but not necessarily limited to, the following factors:
    - The equivalency of QUAD A's standards for OPTs as compared with Medicare's CoPs for OPTs.
    - 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 OPT 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 § 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.

++ 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.                          ( print page 83691)    

++ 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 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 Services.

[FR Doc. 2024-23930 Filed 10-16-24; 8:45 am]

BILLING CODE 4120-01-P