[Federal Register Volume 89, Number 92 (Friday, May 10, 2024)]
[Notices]
[Pages 40493-40494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10250]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3455-FN]


Medicare and Medicaid Programs: Application From The Compliance 
Team (TCT) for Continued 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.

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SUMMARY: This final notice announces our decision to approve The 
Compliance Team (TCT) for continued 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 final notice is effective July 
17, 2024, to July 17, 2028.

FOR FURTHER INFORMATION CONTACT: 
    Joy Webb (410) 786-1667.
    Shonte Carter (410) 786-3532.

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 Compliance Team (TCT) has requested CMS approval for its RHC 
program. CMS has reviewed TCT's application as described in the 
following section and is hereby announcing TCT's 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 the 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 21, 2023, CMS published a proposed notice in the 
Federal Register (88 FR 88393), announcing TCT's request for 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 TCT'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 TCT'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 TCT's survey processes to confirm that a 
provider or supplier, under TCT's RHC deeming accreditation program, 
would meet or exceed the Medicare program requirements.
     A documentation review of TCT's survey process to do the 
following:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and TCT's ability to provide continuing surveyor 
training.
    ++ Compare TCT's processes to those we require of State survey 
agencies, including periodic resurvey and the ability to investigate 
and respond appropriately to complaints against TCT-accredited RHCs.
    ++ Evaluate TCT's procedures for monitoring an accredited RHC it 
has found to be out of compliance with TCT's program requirements. 
(This pertains only to monitoring procedures when TCT identifies non-
compliance. If a SA identifies non-compliance through a validation 
survey, the SA monitors corrections as specified at Sec.  488.9(c)).
    ++ Assess TCT's ability to report deficiencies to the surveyed RHC 
and respond to the RHC's plan of correction in a timely manner.
    ++ Establish TCT'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 TCT's staff and other resources.
    ++ Confirm TCT's ability to provide adequate funding for performing 
required surveys.
    ++ Confirm TCT's policies with respect to surveys being 
unannounced.
    ++ Confirm TCT'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.

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    ++ Obtain TCT'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 
21, 2023, proposed notice also solicited public comments regarding 
whether TCT's requirements met or exceeded the Medicare Conditions for 
Certification (CfCs) for RHCs. CMS did not receive any public comments.

V. Provisions of the Final Notice

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

    We compared TCT'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 TCT'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, TCT has completed 
revising its standards and certification processes in order to--
     Meet the Medicare CfC requirements for all of the 
following regulations:
    ++ Section 488.5(a)(4)(ii), to provide documentation demonstrating 
the comparability of the organization's survey process and surveyor 
guidance to those required for State survey agencies conducting federal 
Medicare surveys for the same provider or supplier type to ensure 
levels of triaging will not negatively impact patient care and 
outcomes.
    ++ Section 488.5(a)(12) to specify a triage process for responding 
to and investigating complaints against accredited facilities, 
including policies and procedures regarding referrals when applicable 
to appropriate licensing bodies and ombudsman programs.
    ++ Section 488.26(b) to ensure citation level of deficiencies are 
cited appropriately, by conducting additional review of standards and 
RHC Medicare CfCs, provide a process for ensuring a thorough 
understanding of manner and degree of deficiency, and surveyor 
training.
    ++ Section 491.5(a)(1) to explicitly demonstrate RHC is located in 
a rural area, through policies and procedures, ensure surveyor's 
documentation exhibits the RHC physical name and address where services 
are provided.
    ++ SOM Chapter 2, Section 2700A to establish a policy and procedure 
to protect the integrity and intent of unannounced surveys when surveys 
are conducted at multiple locations and in close proximity.
    ++ SOM Chapter 2, Section 2728B, is to clarify an acceptable plan 
of correction that includes the RHC completing the organizational plan 
of correction template and documentation implementing the plan for 
future compliance and monitoring.
    ++ SOM Chapter 5 Section 5075, to ensure the administrative review 
and offsite investigation that are generally not permitted is 
consistent with the compliant policies found in Chapter 5.
    ++ Provide a revised plan of correction policy comparable to 
Chapter 2 of the SOM.
    In addition to the standards review, CMS reviewed TCT'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, TCT has completed revising its survey processes in 
order to demonstrate that it uses survey processes that are comparable 
to state survey agency processes by:
    ++ Removing TCT's policies to allow patient and staff identifiers 
to be kept together. Such identifiers need to be kept separately from 
the surveyor's notes and findings to keep patients and staff private.
    ++ Revising language prohibiting Protected Health Information from 
being taken from the clinic. TCT language is inconsistent with CMS 
policy, which allows surveyors to photocopy documents needed to support 
deficient findings.
    ++ Clarifying TCT's policy that gives surveyors the discretion to 
conduct interviews privately. This policy is inconsistent with CMS 
policy governing private interviews with patients, staff, and visitors; 
it is a requirement and not discretionary unless the interviewee 
refuses.
    ++ Specifying TCT's policy to allow facilities to audio tape exit 
conferences, require facilities to provide two tapes and tape recorders 
and a recording of the meeting simultaneously, and then permitting the 
surveying team to select one of the tapes at the conclusion of the exit 
conference.

B. Term of Approval

    Based on our review and observations described in section III. and 
section V. of this final notice, we approve TCT as a national 
accreditation organization for RHCs that request participation in the 
Medicare program. The decision announced in this final notice is 
effective July 17, 2024, to July 17, 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 purposes of 
publication in the Federal Register.

Trenesha Fultz-Mimms,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2024-10250 Filed 5-9-24; 8:45 am]
BILLING CODE 4120-01-P