2024-15816. Medicare and Medicaid Programs: Application From The Joint Commission for Continued Approval of Its Ambulatory Surgical Center (ASC) Accreditation Program

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Department of Health and Human Services

Centers for Medicare & Medicaid Services

1. [CMS-3456-FN]

AGENCY:

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

ACTION:

Notice.

SUMMARY:

This notice announces our decision to approve The Joint Commission 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 September 1, 2024, to September 1, 2030.

FOR FURTHER INFORMATION CONTACT:

Caecilia Andrews [phone].

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 § 488.5.

The Joint Commission's (TJC's) current term of approval for its ASC program expires December 20, 2024.

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.

We note, TJC submitted the application for continued CMS-approval in advance; therefore the 210-days from the receipt of a complete application and our decision to approve has reset TJC's approval terms from December to September.

III. Provisions of the Proposed Notice

On February 26, 2024, CMS published a proposed notice in the Federal Register (89 FR 14076), announcing TJC's request for continued approval of its Medicare ASC accreditation program. In the February 26, 2024, 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 TJC's Medicare ASC accreditation application in accordance with the criteria specified by our regulations, which include, but are not limited to the following:

• An administrative review of TJC'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.
• The equivalency of TJC's standards for ASCs as compared with Medicare's Conditions for Coverage (CfCs) for ASCs.
• TJC'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 TJC's processes to those of State agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities.

++ TJC's processes and procedures for monitoring an ASC found out of compliance with TJC's program requirements. These monitoring procedures are used only when TJC 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).

++ TJC's capacity to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner.

++ TJC'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 TJC's staff and other resources, and its financial viability.

++ TJC's capacity to adequately fund required surveys.

++ TJC's policies with respect to whether surveys are announced or unannounced, to ensure that surveys are unannounced.

++ TJC'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.

++ TJC'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. Analysis of and Responses to Public Comments on the Proposed Notice

In accordance with section 1865(a)(3)(A) of the Act, the February 26, 2024 proposed notice also solicited public comments regarding whether TJC's requirements met or exceeded the Medicare CfCs for ASCs. No comments were received in response to our proposed notice.

V. Provisions of the Final Notice

A. Differences Between TJC's Standards and Requirements for Accreditation and Medicare Conditions and Survey Requirements

We compared TJC'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 TJC'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, TJC has completed revising its standards and certification processes in order to do all of the following:

• Meet the standard's requirements of all of the following regulations:

++ Section 416.42 to clarify that ASCs may only allow qualified physicians to perform surgery.

++ Section 416.44(b)(1) to ensure ASCs to meet the provisions applicable to Ambulatory Health Care Occupancies and address the Life Safety Code (LSC) Tentative Interim Amendments (TIAs), TIA 12-2, TIA 12-3, and TIA 12-4 requirements.

++ Section 416.44(b)(2) to clarify within TJC's existing standard related to LSC waivers, that the timeframe for achieving compliance begins when the facility receives the survey report and in accordance with the timeframes in § 488.28(d).

++ Section 416.44(c) to incorporate the requirement for ASCs to comply with Health Care Facilities Code (HCFC) NFPA 99, and Tentative Interim Amendments (TIAs), TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5 and TIA 12-6 and to revise TJC's introductory paragraph of the Statement of Condition Instructions to include HCFC deficiencies.

++ Section 416.50(e)(2) to clarify the standard to ensure if a patient is adjudged incompetent under applicable State laws by a court of proper jurisdiction, the rights of the patient are exercised by the person appointed under State law to act on the patient's behalf.

++ Section 416.50(e)(3) to clearly identify that if a State court has not deemed a patient incompetent, any legal representative or surrogate designated by the patient in accordance with State law may exercise the patient's rights to the extent allowed by State law.

CMS also reviewed TJC'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, TJC has completed revising its survey processes in order to demonstrate that it uses survey processes that are comparable to state survey agency processes by:

++ Clarifying TJC's survey activity for Life Safety Code (LSC) related to the length of time required to complete an LSC/Health Care Facilities Code (HCFC) survey, as the survey activity will depend upon various circumstances (for example, age & condition, size of ASC/building, construction type, number of stories, sprinkler system, essential electric system, etc.).

++ Updating TJC's survey procedures to ensure all areas of the LSC/HCFC are surveyed and reflected in TJC's Surveyor Activity Guide.

++ Providing clarification to its Surveyor Activity Guide indicating that the 2012 edition of the NFPA Life Safety Code and NFPA 99 applies to ASCs.

++ Clarifying that any LSC/HCFC waivers can only be granted by CMS, in accordance with § 416.44(c)(2).

++ Providing additional surveyor training as it relates to scope, manner and degree of citations related to medication administration, physical environment, and Life Safety Code, in accordance with the State Operations Manual (SOM) Appendix L, Task 4.

++ Providing additional surveyor education comparable to CMS' Principles of Documentation, specifically to ensure records reviewed and reported on TJC's survey report to the facility are clear.

++ Revising TJC's process to ensure the appropriate sample of patient records is reviewed during surveys based on ASC case volume.

B. Term of Approval

Based on our review described in section III. and section V. of this final notice, we approve TJC as a national accreditation organization for ASCs that request participation in the Medicare program. The decision announced in this final notice is effective September 1, 2024 through September 1, 2030. In accordance with § 488.5(e)(2)(i) the term of the approval will not exceed 6 years.

VI. Collection of Information and Regulatory Impact Statement

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.