Notice2024-09426
Medicare and Medicaid Programs: Application From the Joint Commission for Initial CMS-Approval of Its Rural Health Clinic (RHC) Accreditation Program
Primary source
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Published
May 1, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 85 (Wednesday, May 1, 2024)</title>
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[Federal Register Volume 89, Number 85 (Wednesday, May 1, 2024)]
[Notices]
[Pages 35105-35107]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-09426]
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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.
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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:
<bullet> 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.
<bullet> 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.
<bullet> 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
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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--
<bullet> 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
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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
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</html>Indexed from Federal Register on May 1, 2024.
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