Notice2024-10250
Medicare and Medicaid Programs: Application From The Compliance Team (TCT) for Continued Approval of Its Rural Health Clinic (RHC) Accreditation Program
Primary source
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Published
May 10, 2024
Effective
July 17, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 92 (Friday, May 10, 2024)</title>
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[Federal Register Volume 89, Number 92 (Friday, May 10, 2024)]
[Notices]
[Pages 40493-40494]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-10250]
[[Page 40493]]
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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:
<bullet> 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.
<bullet> 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.
<bullet> 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.
[[Page 40494]]
++ 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--
<bullet> 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
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</html>Indexed from Federal Register on May 10, 2024.
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