[Federal Register Volume 88, Number 98 (Monday, May 22, 2023)]
[Notices]
[Pages 32770-32772]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10824]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3435-FN]


Medicare and Medicaid Programs: Application From the Center for 
Improvement in Healthcare Quality for Initial CMS-Approval of Its 
Critical Access Hospital Accreditation Program

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

ACTION: Notice.

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SUMMARY: This notice announces our decision to approve the Center for 
Improvement in Healthcare Quality for initial recognition as a national 
accrediting organization for critical access hospitals that wish to 
participate in the Medicare or Medicaid programs.

[[Page 32771]]


DATES: The decision announced in this notice is applicable June 1, 2023 
to June 1, 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 certain 
requirements are met. Sections 1820(c)(2)(B), 1820(e) and 1861(mm)(1) 
of the Social Security Act (the Act) establishes 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. The 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 and selected provisions of 42 
CFR part 412 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 or requirements at part 482, then can convert to a 
CAH by complying with the conditions or requirements at part 485, 
subpart F. 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 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 
initial approval of the Center for Improvement in Healthcare Quality's 
(CIHQ's) CAH accreditation program. CIHQ's CAH deeming authority will 
be reviewed for continued approval in accordance with the regulations 
at Sec. Sec.  488.4 and 488.5 after this initial term of approval.

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 December 7, 2022, we published a proposed notice in the Federal 
Register (87 FR 75049), announcing CIHQ's request for initial approval 
of its Medicare critical hospital accreditation program. In the 
December 2022 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 CIHQ's Medicare CAH accreditation 
application in accordance with the criteria specified by our 
regulations, which include, but are not limited to the following:
     A virtual administrative review of CIHQ'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 CIHQ's accreditation to our current 
Medicare CAH CoPs.
     A documentation review of CIHQ's survey process to:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and CIHQ's ability to provide continuing surveyor 
training.
    ++ Compare CIHQ'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 CIHQ's procedures for monitoring CAH out of compliance 
with CIHQ's program requirements. The monitoring procedures are used 
only when CIHQ identifies noncompliance. If noncompliance is identified 
through validation reviews, the state survey agency monitors 
corrections as specified at Sec.  488.7(d).
    ++ Assess CIHQ's ability to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    ++ Establish CIHQ'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 CIHQ's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm CIHQ's policies with respect to whether surveys are 
announced or unannounced.
    ++ Obtain CIHQ'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, 2022 proposed notice also solicited public comments regarding 
whether CIHQ's requirements met or exceeded the Medicare CoPs for CAHs. 
We received one comment, which was out of the scope of the proposed 
notice.

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V. Provisions of the Final Notice

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

    We compared CIHQ'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 CIHQ's CAH application were 
conducted as described in section III of this notice and has yielded 
the following areas where, as of the date of this notice, CIHQ's has 
completed revising its standards and certification processes in order 
to--
     Meet the standard's requirements of all of the following 
regulations:
    ++ Section 485.604(a)(2), to clarify the requirements for clinical 
nurse specialists' 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 a distant-site physician's or practitioner's 
performance under privileges at the CAH whose patients are receiving 
the telemedicine services from the physician or practitioner.
    ++ Section 485.623(b)(1), to ensure that all essential mechanical, 
electrical and patient care equipment is maintained in safe operating 
condition.
    ++ Section 485.623(c)(1)(i), to align CIHQ's comparable standards 
with the Life Safety Code (LSC) (National Fire Protection Association 
(NFPA) 101 and Tentative Interim Amendments (TIAs): TIA 12-1, TIA 12-2, 
TIA 12-3, and TIA 12-4).
    ++ Section 485.627(a), to include additional clarification or 
specific language on ``determining, implementing and monitoring 
policies governing the CAH's total operation''.
    ++ Section 485.635(b)(3), to include reference to state law within 
its standard for radiology services.
    ++ Section 485.638(a)(4)(iv), to specify the qualifications of who 
may make entries into the medical record, which must be dated, and 
signed by the individual who made the entry.
    ++ Section 485.639(a), to further expand on the qualifications on 
the practitioners who are allowed to perform surgery for CAH patients, 
in accordance with its approved policies and procedures, and with state 
scope of practice laws.
    In addition to the standards review, CMS also reviewed CIHQ'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, CIHQ 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 CIHQ's surveyor guide to ensure a comprehensive 
review of environmental safety and life safety requirements are 
performed.
     Clarifying CIHQ's policies to align with the SOM Appendix 
A-Hospitals, Survey Protocol, Task 3, Survey Locations, and Appendix W-
CAHs Entrance Activities, to include that all hospital departments and 
services at the primary hospital campus and remote locations, satellite 
locations, inpatient care locations, out-patient surgery locations, 
complex out-patient care locations, and a select sample of each type of 
other services provided at additional provider based locations, 
including contracted patient care activities or patient services will 
be surveyed. These facility types may have occupancy classifications 
other than healthcare or ambulatory occupancies, as determined by the 
LSC.
     Updating CIHQ's position summaries and description to 
include that the LSC surveyor's responsibilities is comprised of an 
assessment of both the LSC and Health Care Facilities Code.

B. Term of Approval

    Based on our review and observations described in sections III and 
V of this notice, we approve CIHQ as a national AO for CAHs that 
request participation in the Medicare program. The decision announced 
in this notice is effective June 1, 2023 through June 1, 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 Evell J. Barco Holland, who is the Federal 
Register Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

    Dated: May 17, 2023.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-10824 Filed 5-19-23; 8:45 am]
BILLING CODE 4120-01-P