[Federal Register Volume 88, Number 159 (Friday, August 18, 2023)]
[Notices]
[Pages 56631-56633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17745]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3440-FN]


Medicare and Medicaid Programs: Application From the Joint 
Commission for Continued CMS Approval of Its Critical Access Hospital 
Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

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ACTION: Notice.

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SUMMARY: This notice announces our decision to approve the Joint 
Commission for continued recognition as a national accrediting 
organization for critical access hospitals that wish to participate in 
the Medicare or Medicaid programs.

DATES: The decision announced in this notice is applicable November 21, 
2023 to November 21, 2027.

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

SUPPLEMENTARY INFORMATION: 

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in a critical access hospital (CAH), provided that the 
facility meets certain requirements. Sections 1820(c)(2)(B), 1820(e) 
and 1861(mm)(1) of the Social Security Act (the Act) establish distinct 
criteria for facilities seeking designation as a CAH. 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. Our regulations at 42 CFR part 485, 
subpart F specify the conditions of participation (CoPs) that a CAH 
must meet to participate in the Medicare program, the scope of covered 
services, and the conditions for Medicare payment for CAHs. The 
regulations at 42 CFR 485.647 specify that a CAH's psychiatric or 
rehabilitation distinct part unit (DPU), if any, must meet the hospital 
requirements specified in subparts A, B, C, and D of part 482 in order 
for the CAH DPU to participate in the Medicare program.
    Prior to becoming a CAH, to enter into an agreement, a CAH must 
first be certified by a state survey agency as a hospital complying 
with the conditions of participation at 42 CFR part 482. It then can 
convert to a CAH by complying with the conditions or requirements at 
part 485, subpart F. Thereafter, the CAH 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 agencies. Certification by a nationally recognized accreditation 
program can substitute for ongoing state review.
    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 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 requirements.
    Our regulations concerning the approval of AOs are at Sec. Sec.  
488.4 and 488.5. The regulations at Sec.  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. This notice is to announce our 
continued approval of TJC's CAH accreditation program for a period of 4 
years.

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 March 3, 2023, we published a proposed notice in the Federal 
Register (88 FR 13446), announcing TJC's request for continued approval 
of its Medicare critical hospital accreditation program. In the 
proposed notice, we detailed our evaluation criteria. Under section 
1865(a)(2) of the Act and in our regulations at Sec.  488.5, we 
conducted a review of TJC's Medicare CAH accreditation 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 
surveyors; (4) ability to investigate and respond appropriately to 
complaints against accredited facilities; and (5) survey review and 
decision-making process for accreditation.
     A comparison of TJC's accreditation to our current 
Medicare CAH CoPs.
     A documentation review of TJC's survey process to:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and TJC's ability to provide continuing surveyor 
training.
    ++ Compare TJC's processes to those of state survey agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
    ++ Evaluate TJC's procedures for monitoring CAHs out of compliance 
with TJC's program requirements. The monitoring procedures are used 
only when TJC identifies noncompliance. If noncompliance is identified 
through validation reviews, the state survey agency monitors 
corrections as specified at Sec.  488.7(d).
    ++ Assess TJC's ability to report deficiencies to the surveyed 
facilities and respond to the facility'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 staff and other resources.
    ++ Confirm TJC's ability to provide adequate funding for performing 
required surveys.
    ++ Confirm TJC's policies with respect to whether surveys are 
unannounced.
    ++ 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 March 3, 
2023 proposed notice also solicited public comments regarding whether 
TJC's requirements met or exceeded the Medicare CoPs for CAHs. We 
received two comments in response to our proposed notice.
    One commenter expressed concerns related to oversight of hospitals 
and the healthcare industry as a whole, and in particular, beliefs of 
corruption within

[[Page 56633]]

the system and concerns related to the COVID-19 public health emergency 
response. Another commenter stated the commenter would like Medicare to 
cover acupuncturists in CAHs and other facilities.
    While we appreciate the commenters' concerns, these comments are 
outside of the scope of this notice. We remain committed to improving 
the quality and safety of patients in all healthcare settings and 
providing oversight of all AOs.

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 CAH requirements and survey process with the 
Medicare CoPs and survey process as outlined in the State Operations 
Manual (SOM). Our review and evaluation of TJC's CAH application were 
conducted as described in section III of this notice and yielded the 
following areas where, as of the date of this notice, TJC's has 
completed revising its standards and certification processes in order 
to:
     Meet the standard's requirements for all of the following 
regulations:
    ++ Section 485.604(a)(2), to clarify the requirements for education 
including a master's or doctoral level degree in a defined clinical 
area of nursing from an accredited educational institution.
    ++ Section 485.616(c)(4)(iv), to specify the requirement of an 
internal review of the distant-site physician's or practitioner's 
performance of the privileges at the CAH whose patients are receiving 
the telemedicine services.
    ++ Section 485.623(b)(1), to specify that all essential mechanical, 
electrical and patient care equipment is maintained in safe operating 
condition.
    ++ Section 485.635(b)(3), to include reference to State law within 
the standard for radiology services.
    In addition to the standards review, CMS also reviewed TJC's 
comparable survey processes, which were conducted as described in 
section III of this notice, and yielded the following areas where, as 
of the date of this notice, TJC has completed revising its survey 
processes, in order to demonstrate that it uses survey processes that 
are comparable to state survey agency processes by:
     Revising TJC's surveyor guide to ensure a comprehensive 
review of environmental safety and life safety requirements are 
performed.
     Revising TJC's surveyor guide and survey processes to 
ensure compliance with the Medicare-conditions are assessed at each 
provider-based location where care is provided per CAH Appendix W of 
the SOM.
     Providing training and education to surveyors related to 
the use of open-ended questions during staff interviews to elicit 
information, consistent with chapter 2, section 2714 of the SOM.
     Revising the survey instructions and providing education 
to surveyors to conduct patient interviews. In accordance with CAH 
Appendix W-Task 3--Information Gathering/Investigation of the SOM, 
surveyors must observe the actual provision of care and services to 
patients and conduct patient interviews throughout the course of the 
survey.
     Review and assess TJC's surveyor time and resource 
allocations of the number of surveyors on site consistent with Sec.  
488.5(a)(5), Sec.  488.5(a)(6) and Sec.  488.5(a)(9) to ensure 
sufficient time is allotted to conduct all required survey activities.
     Provide additional training and education to surveyors on 
procedures related to investigation of ``immediate jeopardy'' 
situations in accordance with appendix Q-section VI of the SOM.
     Review and revise TJC's complaint investigation process, 
specifically to ensure the complainant (when not anonymous), receives 
an acknowledgement letter and closure letter, as outlined within 
chapter 5, sections 5010.2 and 5080.1 of the SOM.
     Review TJC's elements of performance and survey deficiency 
findings to ensure any deficiencies are appropriately correlated or 
matched with a Medicare condition, when appropriate, in accordance with 
Sec.  488.5(a)(4)(ii).

B. Term of Approval

    Based on our review and observations described in section III and 
section V of this notice, we approve TJC as a national AO for CAHs that 
request participation in the Medicare program. The decision announced 
in this final notice is effective November 21, 2023 through November 
21, 2027 (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. 3501 et seq.).
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this 
document, authorizes Vanessa Garcia who is the Federal Register 
Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

Vanessa Garcia,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-17745 Filed 8-17-23; 8:45 am]
BILLING CODE 4120-01-P