[Federal Register Volume 89, Number 85 (Wednesday, May 1, 2024)]
[Notices]
[Pages 35105-35107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09426]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3451-FN]


Medicare and Medicaid Programs: Application From the Joint 
Commission for Initial CMS-Approval of Its Rural Health Clinic (RHC) 
Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of 
Health and Human Services (HHS).

ACTION: Final notice.

-----------------------------------------------------------------------

SUMMARY: This final notice announces our decision to approve The Joint 
Commission (TJC) for initial recognition as a national accrediting 
organization (AO) for rural health clinics (RHCs) that wish to 
participate in the Medicare or Medicaid programs.

DATES: The decision announced in this notice is applicable June 1, 
2024, to June 1, 2028.

FOR FURTHER INFORMATION CONTACT: Caecilia Andrews (410) 786-2190.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in a rural health clinic (RHC) provided certain 
requirements are met by the RHC. Sections 1861(aa)(1) and (2) and 
1905(l)(1) of the Social Security Act (the Act), establish distinct 
criteria for facilities seeking designation as an RHC. 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, subpart A. The regulations at 42 CFR 
part 491, subpart A, specify the conditions that an RHC must meet to 
participate in the Medicare program. The scope of covered services and 
the conditions for Medicare payment for RHCs are set forth at 42 CFR 
part 405, subpart X.
    Generally, to enter into an agreement, an RHC must first be 
certified by a State survey agency as complying with the conditions or 
requirements set forth in part 491 of CMS regulations. Thereafter, the 
RHC is subject to regular surveys by a State survey agency to determine 
whether it continues to meet these requirements.
    However, there is an alternative to surveys by State survey 
agencies. Section 1865(a)(1) of the Act provides that, if a provider 
entity demonstrates through accreditation by an approved national 
accrediting organization (AO) that all applicable Medicare conditions 
are met or exceeded, we will deem those provider entities 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 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 would be deemed to meet the 
Medicare conditions. A national AO applying for CMS approval of their 
accreditation program under 42 CFR 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 Joint Commission (TJC) has requested initial approval by CMS 
for its RHC program. CMS has reviewed TJC's application as described 
later in this rule and is hereby announcing TJC's initial term of 
approval for a period of four years.

II. Approval of Deeming Organization

    Section 1865(a)(2) of the Act and our regulations at Sec.  488.5 
require that our findings concerning review and approval of a national 
accrediting organization's requirements consider, among other factors, 
the applying accrediting organization'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 us 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 identifying the national accrediting body making the request, 
describing the nature of the request, and providing 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.

III. Provisions of the Proposed Notice

    On December 7, 2023, CMS published a proposed notice in the Federal 
Register (88 FR 85290), announcing TJC's request for initial approval 
of its Medicare rural health clinic (RHC) accreditation program. In 
that proposed notice, we detailed our evaluation criteria.
    Under section 1865(a)(2) of the Act and in our regulations at Sec.  
488.5 and Sec.  488.8(h), we conducted a review of TJC's RHC 
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 
RHC surveyors; (4) ability to investigate and respond appropriately to 
complaints against accredited RHCs; 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 RHC deeming accreditation program, 
would meet or exceed 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 (SA), including periodic resurvey and the ability to 
investigate and respond appropriately to complaints against TJC-
accredited RHCs.
    ++ Evaluate TJC's procedures for monitoring an accredited RHC 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 Sec.  488.9(c)).
    ++ Assess TJC's ability to report deficiencies to the surveyed RHC 
and respond to the RHC'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

[[Page 35106]]

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 December 
7, 2023, proposed notice also solicited public comments regarding 
whether TJC's requirements met or exceeded the Medicare Conditions for 
Certification (CfCs) for RHCs. We did not receive any public comments.

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 RHC accreditation requirements and survey process 
with the Medicare conditions set forth at 42 CFR part 491, subpart A, 
the survey and certification process requirements of parts 488 and 489, 
and survey process as outlined in the State Operations Manual (SOM). 
Our review and evaluation of TJC's RHC application, which was 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 to--
     Meet the Medicare CfC requirements for all of the 
following regulations:
    ++ Section 491.2, to clarify the definition of a rural health 
clinic, specifically that a rural health clinic is not a rehabilitation 
agency or a facility primarily for the care and treatment for mental 
diseases, and also to include the definition of the Secretary.
    ++ Section 491.4, to explicitly reference that an RHC must be in 
compliance with applicable Federal, State and local laws and 
regulations.
    ++ Section 491.4(a) and 491.4(b), to specify that an RHC must be 
licensed pursuant to applicable State and local law and that staff are 
licensed, certified or registered in accordance with applicable State 
and local laws.
    ++ Section 491.10(a)(2), to include the term ``designated member of 
the professional staff,'' who are responsible for maintaining the 
records and for insuring that they are completely and accurately 
documented, readily accessible, and systematically organized.
    In addition to the standards review, CMS 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 to 
demonstrate that it uses survey processes that are comparable to State 
survey agency processes by:
    ++ Removing language suggesting survey activities could be 
completed virtually (as temporarily allowed during the COVID-19 Public 
Health Emergency (PHE)), since the conclusion of the PHE has occurred.
    ++ Clarifying that mid-level staffing waivers are only applicable 
to existing CMS-certified RHCs and that initial enrollment applications 
for CMS-certification must meet all staffing requirements at 42 CFR 
491.8, in accordance with the State Operations Manual (SOM), Appendix 
G, and SOM Chapter 2.
    ++ Clarifying, in accordance with SOM, Appendix G, Task 1, that 
TJC's survey composition includes a Registered Nurse.
    ++ Ensuring survey procedures align with SOM, Appendix G, 
Interpretive guidelines at Sec.  491.5(a)(3)(iii), which require that 
an RHC with additional locations must enroll each permanent unit 
separately, and each must independently and fully comply with the RHC 
CfCs.
    ++ To ensure survey processes align with SOM, Appendix G, Task 3-
Observation Methods, related to patient and staff identifiers.
    ++ Clarifying instructions related to the selection of active 
patient records consistent with SOM, Appendix G, Task 3.
    ++ Revise survey documentation, including the survey report and 
evidence of standard compliance, to include the RHC's name and address, 
not that of the health system to which it might belong, consistent with 
regulations at Sec.  413.65 and Sec.  491.5(a)(1).
    ++ To provide additional surveyor training related to the 
evaluation of emergency preparedness at Sec.  491.12, specifically 
related to review of the RHC's risk assessment to ensure that risk 
assessments account for the patient population served.
    ++ To provide a survey process for calculating the required time of 
mid-level staff based on the hours of operations to assess staffing in 
accordance with Sec.  491.8(a)(6), specifically to ensure a nurse 
practitioner, physician assistant, or certified nurse-midwife (CNM) is 
available to furnish patient care services at least 50 percent of the 
time the RHC operates, even when a physician is also present in the 
clinic.
    ++ To provide additional surveyor training related to staffing 
requirements, including physicians providing medical direction within 
the RHC, consistent with Sec.  491.8(b)(1).
    ++ To ensure surveyor guidance includes inspecting all areas within 
patient care rooms, comparable to SOM, Appendix G, to assess the RHC's 
physical plant and environment at Sec.  491.6.
    ++ To update TJC's survey procedures to be comparable to SOM, 
Appendix G, survey protocol for Sec.  491.9(a)(2) and Sec.  491.9(c)(1) 
to adequately assess that the RHC is primarily engaged in providing 
outpatient health services and the RHC staff furnishes those diagnostic 
and therapeutic services and supplies that are commonly furnished in a 
physician's office or at the entry point into the health care delivery 
system, which includes medical history, physical examination, 
assessment of health status, and treatment for a variety of medical 
conditions.
    ++ To reassess survey time and allocation of survey teams 
consistent with Sec.  488.5(a)(5) and Sec.  488.5(a)(6), especially for 
a new deeming program and initial surveys.

B. Term of Approval

    Based on our review and observations described in section III. and 
section V. of this final notice, we approve TJC as a national 
accreditation organization for RHCs that request participation in the 
Medicare program. The decision announced in this final notice is 
effective June 3, 2024, to June 3, 2028 (4 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. chapter 35).
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this 
document, authorizes Trenesha Fultz-Mimms, who is the Federal Register 
Liaison, to electronically sign this document for

[[Page 35107]]

purposes of publication in the Federal Register.

Trenesha Fultz-Mimms,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2024-09426 Filed 4-30-24; 8:45 am]
BILLING CODE 4120-01-P