Medicare and Medicaid Programs; Application From The Joint Commission for Continued CMS Approval of its Hospital Accreditation Program

I. Background

Under the Medicare program, eligible beneficiaries may receive covered services from a hospital, provided certain requirements are met. Section 1861(e) of the Social Security Act (the Act) establishes distinct criteria for facilities seeking designation as a hospital. 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 482 specify the minimum conditions that a hospital must meet to participate in the Medicare program.

Generally, to enter into an agreement, a hospital must first be certified by a state survey agency (SA) as complying with the conditions or requirements set forth in part 482 of our regulations. Thereafter, the hospital 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 requirements are met or exceeded, we will deem those provider entities as having met such 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 (the Secretary) as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program would be deemed to meet the Medicare requirements. A national 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 requirements. ( printed page 26588) Our regulations concerning the approval of AOs are set forth at §§ 488.4, 488.5 and 488.5(e)(2)(i). The regulations at § 488.5(e)(2)(i) require an AO to reapply for continued approval of its accreditation program every 6 years or sooner, as determined by CMS.

The Joint Commission's (TJC's) current term of approval for their hospital accreditation program expires July 15, 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 February 11, 2025, we published a proposed notice in the Federal Register (90 FR 9341), announcing TJC's request for continued approval of its Medicare hospital accreditation program. In that proposed notice, we detailed our evaluation criteria. Under Section 1865(a)(2) of the Act and in our regulations at § 488.5 and § 488.8(h), we conducted a review of TJC's Medicare hospital accreditation program 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 hospital surveyors; (4) ability to investigate and respond appropriately to complaints against accredited hospitals; and (5) survey review and decision-making process for accreditation.
• A review of TJC's survey processes to confirm that a provider or supplier, under TJC's hospital deeming accreditation program, meets or exceeds the Medicare program requirements.
• A documentation review of TJC's survey process to do the following:

++ Determine the composition of the survey team, surveyor qualifications, and TJC's ability to provide continuing surveyor training.

++ Compare TJC's processes to those we require of state survey agencies, including periodic resurvey and the ability to investigate and respond appropriately to complaints against TJC-accredited hospitals.

++ Evaluate TJC's procedures for monitoring accredited hospitals it has found to be out of compliance with TJC's program requirements. (This pertains only to monitoring procedures when TJC identifies non-compliance. If noncompliance is identified by a SA through a validation survey, the SA monitors corrections as specified at § 488.9(c)).

++ Assess TJC's ability to report deficiencies to the surveyed hospital and respond to the hospital's plan of correction in a timely manner.

++ Establish TJC'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 TJC's staff and other resources.

++ Confirm TJC's ability to provide adequate funding for performing required surveys.

++ Confirm TJC's policies with respect to surveys being unannounced.

++ Confirm 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.

++ Obtain 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 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 February 11, 2025, proposed notice also solicited public comments regarding whether TJC's requirements met or exceeded the Medicare conditions of participate (CoPs) for hospitals. We received several comments.

Comment: Two commenters believed the application should be approved. One of the commenters stated that the processes in place by TJC ensure frequent in-person surveys and assist the organizations being surveyed, while making online resources available. Another commenter was in support of approval and noted their belief that TJC's requirements meet or exceed the Medicare CoPs for hospitals. This commenter noted having experienced surveys by TJC of their facility and that TJC's survey process is an effective means of ensuring that the facility is a safe place for patients to be treated. The commenter suggested one area of improvement would be to increase survey frequency and believed that more frequent surveys would better establish everyday readiness for facilities.

Response: We appreciate the commenters' support of TJC as a CMS-approved AO for hospitals. CMS requires AOs to conduct surveys at least every 36 months in accordance with § 488.5(a)(4)(i). We note that AOs have the discretion to require and perform surveys more frequently than every 36 months.

Comment: CMS received another comment of support for TJC's continued recognition of its hospital accreditation program and suggested that TJC's accreditation process helps in maintaining high hospital standards. While in support of TJC's continued approval, the commenter suggests that there should be more transparency in its survey process and stronger safeguards to prevent conflicts of interest.

Response: We appreciate the commenter's general support and agree that further transparency in survey processes is instrumental in ensuring comparability between the AO processes and those of CMS. We also agree that AOs must prevent conflicts of interests. As part of CMS' review of AOs for continued recognition, and in accordance with § 488.5(a)(10), CMS reviews AOs' 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.

Comment: One commenter raised concern related to TJC's standard at EC.02.03.03 EP 1, which requires one hour between fire drills. The commenter stated that the National Fire Protection Association (NFPA) Code 101-2012: 18/19:7.1.7 does not require a 1-hour variance, but that there should be varied conditions. The commenter encouraged CMS to address this inconsistency and ensure TJC surveyors are educated on the NFPA Code.

Response: We appreciate the commenter's concern related to variance for fire drills. As discussed within the proposed notice (90 FR 9341) and our outlined evaluation criteria in section III. “Provisions of the Proposed Notice”, CMS reviewed TJC standards to ensure that standards meet or exceed the Medicare CoPs. CMS also reviewed ( printed page 26589) TJC's survey processes for comparability to those of the SAs. As part of this final notice announcing our approval of TJC for continued deeming authority for hospitals, we note that TJC has met these requirements. TJC may exceed the CMS baseline health and safety standards.

Comment: One commenter suggested TJC has enacted several fire/life safety requirements that are not included in the prescriptive requirements of NFPA 101, 2012 edition, as adopted by CMS. The commenter provided three examples. The first example noted that TJC standard LS.02.01.30 EP 3, related to requirements for existing hazardous area protection, requires hospitals to ensure doors to rooms containing flammable or combustible materials are provided with positive latching hardware and that roller latches are prohibited on such doors. The commenter stated that there is no such requirement in NFPA 101 for protection of hazardous areas in NFPA 101 Sections 18/19.3.2.1 or 8.7. The second example noted that TJC's standard at LS.02.01.30 EP13 requires a hospital to prove that positive latching hardware is not an available option provided by the manufacturer to eliminate the positive latching requirement from powered corridor doors, which is inconsistent with NFPA 101 Section 18.3.6.3.7. The third example was related to TJC's standard at LS.02.01.10 EP 9, which requires that doors in “fire-rated smoke barriers” must have a rating of “Forty-five minutes in one-hour barriers—Twenty minutes in thirty-minute barriers.” The commenter states that the requirements of NFPA 101 Section 18/19.3.7.6 for health care occupancy do not require any fire ratings for these doors. The commenter suggested that these standards cause undue hardship on facilities and require extra costs to remediate “deficient” items that are not required by code at the time of building construction nor required retroactively. The commenter requested that CMS provide additional guidance to TJC to limit the AO's ability to create standards above the codes and the standards adopted by CMS in federal law.

Response: We appreciate the commenter's concern that these standards may cause undue hardship on facilities and require extra costs to remediate. As discussed within the Proposed Notice (90 FR 9341) and our outlined evaluation criteria in section III. “Provisions of the Proposed Notice”, CMS reviewed TJC standards to ensure that standards meet or exceed the Medicare CoPs. CMS also reviewed TJC's survey processes for comparability to those of the SAs. As part of this final notice announcing our approval of TJC for continued deeming authority for hospitals, we note that TJC has met these requirements. TJC may exceed the CMS baseline health and safety standards.

Comment: CMS received one comment related to TJC's requirement for Life Safety Drawings for Ambulatory Surgical Centers (ASCs) as part of its Hospital Accreditation Program (HAP) guidance. The commenter stated that TJC's requirements include identification, sizing, and type of patient use of suites. The commenter stated that the NFPA 101, 2012, chapters 20 and 21 do not dictate additional considerations for suites and their sizing as seen in chapters 18 and 19. The commenter suggested that this requirement has led to confusion as to the acceptable use and sizing of suites in ambulatory settings by TJC surveyors. The commenter suggested that TJC and/or CMS should clarify the additional requirements for suite limitations in Ambulatory occupancies that are not currently found in NFPA 101.

Response: We appreciate the commenter's concern. As discussed within the Public Notice (90 FR 9341) and our outlined evaluation criteria in section III. “Provisions of the Proposed Notice”, CMS reviewed TJC standards to ensure that its standards meet or exceed the Medicare CoPs. CMS also reviewed TJC's survey processes for comparability to those of the SAs. As part of this final notice announcing our approval of TJC for continued deeming authority for hospitals, we note that TJC has met these requirements. TJC's standards may exceed CMS' baseline health and safety standards.

Comment: One commenter requested that CMS leverage its authority under §§ 488.4 and 488.5 to require TJC remove its “time-defined criteria” for inspection, testing, and maintenance (ITM) intervals. Specifically, the commenter stated that TJC's survey process under its Comprehensive Accreditation Manual for Hospitals (CAMH), Environment of Care (EC) Chapter, and TJC's revised 2025 standard requiring ITM activities are not mandated by the CoPs under 42 CFR part 482, by the State Operations Manual, nor by the NFPA 101 and 99 (2012) codes that are federally adopted.

Response: We appreciate the commenter's concern regarding TJC's “time-defined criteria” for inspection, testing, and maintenance intervals. As noted within the public notice (90 FR 9341) and our outlined evaluation criteria in section III. “Provisions of the Proposed Notice”, CMS reviewed TJC standards to ensure that its standards meet or exceed the Medicare CoPs. CMS also reviewed TJC's survey processes for comparability to those of the SAs. As part of this final notice announcing our approval of TJC for continued deeming authority for hospitals, we note that TJC has met these requirements. However, TJC may exceed CMS' baseline health and safety standards.

Comment: One commenter suggested that TJC's survey process ignores the Food and Drug Administration (FDA) clearance requirements for specific sterile barrier systems. The commenter suggested that TJC's surveyors provide subjective guidance to facilities, which poses a patient safety issue. The commenter suggests that TJC has not been adhering to the stated FDA clearances and its guidance contradicts the principles of the sterilization process. The commenter also stated that incorrect deficiency citations result in revisit surveys, adding a significant financial cost to the provider. The commenter requests that CMS direct TJC to follow FDA regulatory clearance requirements and if there are potential deficiencies, TJC should be consulting the sterile barrier system's manufacturer instructions.

Response: We appreciate the commenter's concerns. TJC is required to develop standards that are comparable to or exceed the CMS CoPs, including § 482.51(b) Standard: Delivery of Service: “Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care.” While this specific standard requires policies to be developed for sterilization and other practices, and for those policies to be consistent with national standards of practice, it does not require a specific national standard set by a recognized national organization or by another federal agency such as the FDA. Upon review of the hospital accreditation application provided by TJC, CMS determined that their standards for surgical services met or exceeded our requirements. Additionally, there was no indication in the survey process documents that a surveyor providing subjective information was considered a fundamental part of the survey process.

Comment: One commenter stated that CMS should leverage its regulatory authority under § 488.5 to require TJC to revise several key areas of its accreditation standards to ensure TJC's standards meet or exceed the requirements established by CMS and federally adopted codes, as outlined in Section 1865(a)(1) of the Social Security ( printed page 26590) Act. The commenter stated that TJC's Comprehensive Accreditation Manual for Hospitals (CAMH) creates a false sense of safety and security for hospitals by oversimplifying compliance requirements, specifically in the Environment of Care (EC) and Life Safety (LS) chapters. The commenter also stated concern related to inconsistency among TJC's Life Safety Code (LSC) surveyors, suggesting that its surveyors lack foundational knowledge of NFPA codes, frequently leading to misinterpretations and improper citations during surveys. Finally, the commenter also raised concerns related to TJC and Joint Commission Resources (JCR), stating TJC has issued training materials and interpretations through paid subscriptions developed by its for-profit arm, JCR.

Response: We appreciate the commenter's concerns. As outlined in section III. “Provisions of the Proposed Notice”, CMS conducts a rigorous review of the AO's ability to meet or exceed CMS requirements and to have comparable survey processes to those of the SAs. During our review of TJC's standards, we noted that all standards and the requested CMS revisions to the standards have been reviewed and have met CMS' baseline health and safety standards contained in the CoPs. Additionally, part of our review process includes a review of the education and experience requirements that surveyors must meet (§ 488.5(a)(7)); a review for comparability (§ 488.5(a)(4)); and a review of 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 (§ 488.5(a)(10)). As discussed in section V. “Provisions of the final notice”, TJC has revised its standards and survey processes based on our findings through this application review.

Comment: One commenter stated that TJC does not accurately provide surveys to all healthcare organizations it is surveying. The commenter stated that each TJC surveyor uses their own judgment and interpretations of codes and policies. They stated further that, over the last five years, TJC's survey approach has shifted from an educational one to one that is punitive.

Response: While it is not clear to us what the commenter means when they state that TJC does not “accurately provide” surveys to the healthcare facilities it is surveying, CMS reviewed TJC's survey processes related to the frequency of surveys performed as well as its agreement to re-survey every accredited provider or supplier, through unannounced surveys, no later than 36 months after the prior accreditation effective date, consistent with the CMS requirements at § 488.5(a)(4)(i). Additionally, CMS reviewed and approved TJC's survey processes to ensure comparability to those of the SAs. We also reviewed TJC's surveyor education and performed an onsite observation of TJC's surveyors during a hospital survey. We did not observe TJC's surveyors as taking what would be possibly considered a ”punitive” approach to the survey. We recommend that the commenter address any specific concerns related to what they believe is TJC's “punitive” survey approach with the AO directly.

Comment: One commenter requested CMS oversight of medical device representatives in surgical settings and raised concerns related to CMS' lack of oversight for non-hospital employees, specifically Medical Device Representatives (MDRs), who might directly impact surgical safety and infection control. The commenter suggested there is a regulatory gap between the oversight of MDRs and the overall CMS hospital safety and infection control requirements.

Response: We appreciate the commenter's concerns. However, this comment is outside the scope of this final 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 hospital accreditation requirements and survey process with the Medicare CoPs of part 482, and the survey and certification process requirements of parts 488 and 489. Our review and evaluation of TJC's hospital application, which were conducted as described in section III. “Provisions of the Proposed Notice”, yielded the following areas where, as of the date of this final notice, TJC has completed revising its survey processes to demonstrate that it uses survey processes that are comparable to state survey agency processes by:

• Providing additional Life Safety Code (LSC) surveyor guidance and training materials to require the determination and confirmation of building construction, and to perform a complete inspection of all smoke and fire barriers and dampers in ducts that penetrate smoke and fire barriers, comparable to the requirements in State Operations Manual (SOM), Appendix I, Task 4—Information Gathering.
• Revising the survey processes and offsite materials prior to surveys, consistent with SOM Appendix A, Task 1—Offsite Preparation, to ensure locations associated with the hospital's healthcare system fall under the CMS Certification Number (CCN) for the hospital and not another CMS-certified provider type.
• Revising TJC's survey procedures for LSC building assessment and any other applicable documents to require the LSC surveys be conducted by LSC Surveyors, or Clinical Surveyors who meet TJC's LSC Surveyor qualifications and training, at all locations included in a CMS certification survey, consistent with SOM Chapter 2, Section 2706—SA Survey Team Composition and SOM Chapter 4, Section 4009C—Education, Training, and Experience.
• Revising the survey process to ensure hospital outpatient surgical departments are surveyed for compliance with the 2012 LSC Ambulatory Health Care Occupancies chapters, regardless of the number of patients served, in accordance with § 482.41(b)(1)(i).
• Revising the survey process to ensure all inpatient locations of the hospital are included in the survey, not just representative samples, consistent with SOM Appendix A, Introduction, Task 3—Information Gathering/Investigation, General Procedures, Survey Locations.
• Reviewing its current policies and procedures related to leadership citations and engage in a process to review whether a citation of the Governing Body is warranted based on the nature of the deficiencies and determine the level of deficiency to ensure the appropriate level of enforcement. This is comparable to SOM Appendix A—Task 4—Preliminary Decision Making and Analysis of Findings—Determining the Severity of Deficiencies.

B. Term of Approval

Based on our review and observations described in sections III. and V. of this final notice, we approve TJC as a national accreditation organization for hospitals that request participation in the Medicare program. The decision announced in this final notice is effective July 15, 2025, through July 15, 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 and Regulatory Impact Statement

This document does not impose information collection requirements, that is, reporting, recordkeeping or ( printed page 26591) 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 CMS, Mehmet Oz, having reviewed and approved this document, authorizes Chyana Woodyard, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register .