[Federal Register Volume 88, Number 171 (Wednesday, September 6, 2023)]
[Notices]
[Pages 60949-60951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19195]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3438-FN]


Medicare and Medicaid Programs: Application From the 
Accreditation Commission for Healthcare (ACHC) for Continued CMS-
Approval of Its Hospital Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

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SUMMARY: This notice announces our decision to approve the 
Accreditation Commission for Healthcare (ACHC) for continued 
recognition as a national accrediting organization for hospitals that 
wish to participate in the Medicare or Medicaid programs.

DATES: The decision announced in this notice is applicable on September 
25, 2023 through September 25, 2027.

FOR FURTHER INFORMATION CONTACT: Danielle Adams, (410) 786-8818; or 
Lillian Williams, (410) 786-8636.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services from a hospital provided that certain requirements are 
met. Section 1861(e) of the Social Security Act (the Act) establishes 
distinct criteria for facilities seeking designation as a hospital. 
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 
482 specify the minimum conditions that a hospital must meet to 
participate in the Medicare program.
    Generally, to enter into an agreement, a hospital must first be 
certified by a state survey agency (SA) as complying with the 
conditions or requirements set forth in 42 CFR part 482 of our 
regulations. Thereafter, the hospital is subject to regular surveys by 
a SA to determine whether it continues to meet these requirements.
    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 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 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 conditions. 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 conditions.
    Our regulations concerning the approval of AOs are set forth at 
Sec. Sec.  488.4, 488.5 and 488.5(e)(2)(i). 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.
    The Accreditation Commission for Healthcare's (ACHC) current term 
of approval for their hospital accreditation program expires September 
25, 2023.

II. Application Approval Process

    Section 1865(a)(3)(A) of the Act provides a statutory timetable to 
ensure

[[Page 60950]]

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 April 14, 2023, we published a proposed notice in the Federal 
Register (88 FR 23088), announcing ACHC's request for continued 
approval of its Medicare hospital accreditation program. In the April 
14, 2023 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 ACHC's Medicare hospital accreditation 
application in accordance with the criteria specified by our 
regulations, which include, but are not limited to the following:
    <bullet> An administrative review of ACHC's: (1) corporate 
policies; (2) financial and human resources available to accomplish the 
proposed surveys; (3) procedures for training, monitoring, and 
evaluation of its hospital surveyors; (4) ability to investigate and 
respond appropriately to complaints against accredited hospital; and 
(5) survey review and decision-making process for accreditation.
    <bullet> The comparison of ACHC's Medicare hospital accreditation 
program standards to our current Medicare hospital conditions of 
participation (CoPs).
    <bullet> A documentation review of ACHC's survey process to do the 
following:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and ACHC's ability to provide continuing surveyor 
training.
    ++ Compare ACHC's processes to those we require of state survey 
agencies, including periodic resurvey and the ability to investigate 
and respond appropriately to complaints against ACHC accredited 
hospitals.
    ++ Evaluate ACHC's procedures for monitoring accredited hospitals 
it has found to be out of compliance with ACHC's program requirements. 
(This pertains only to monitoring procedures when ACHC 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 ACHC's ability to report deficiencies to the surveyed 
hospitals and respond to the hospitals plans of correction in a timely 
manner.
    ++ Establish ACHC'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 ACHC's staff and other resources.
    ++ Confirm ACHC's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm ACHC's policies with respect to surveys being 
unannounced.
    ++ Confirm ACHC'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.
    ++ Obtain ACHC'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 April 14, 
2023, proposed notice also solicited public comments regarding whether 
ACHC's requirements met or exceeded the Medicare CoPs for hospitals. We 
received one comment in response to our proposed notice.
    The commenter expressed concern about hospital accreditation 
programs overall and the responsibility of patient safety in hospitals. 
The comment was not specific to ACHC.
    We appreciate this comment and the concern for patient safety and 
quality of care. We continue to prioritize patient safety and our 
responsibility for oversight of AOs. As described in Section III, 
``Provisions of the Proposed Notice'' of this final notice, we take 
various steps when considering to approve or not approve a national AO. 
Each AO wishing to be recognized by Medicare as a national AO must go 
through a rigorous process for CMS approval. We remain steadfast in our 
commitment to keeping the public informed of our evaluation process for 
AOs seeking approval from CMS.

V. Provisions of the Final Notice

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

    We compared ACHC's hospital accreditation requirements and survey 
process with the Medicare CoPs of 42 CFR part 482, and the survey and 
certification process requirements of parts 488 and 489. Our review and 
evaluation of ACHC's hospital accreditation application, which were 
conducted as described in section III. of this final notice, yielded 
the following areas where, as of the date of this final notice, ACHC 
has completed revising its standards and certification processes in 
order to--
    <bullet> Meet the standard's requirements of all the following 
regulations:
    ++ Section 482.22(c)(5)(iii), to fully address the requirement that 
an assessment of the patient (in lieu of the requirements of paragraphs 
(c)(5)(i) and (ii) of this section) be completed and documented after 
registration, but prior to surgery or a procedure requiring anesthesia 
services, when the patient is receiving specific outpatient surgical or 
procedural services and when the medical staff has chosen to develop 
and maintain a policy that identifies, in accordance with the 
requirements at paragraph (c)(5)(v) of this section, specific patients 
as not requiring a comprehensive medical history and physical 
examination, or any update to it, prior to specific outpatient surgical 
or procedural services. The assessment must be completed and documented 
by a physician (as defined in section 1861(r) of the Act), an oral and 
maxillofacial surgeon, or other qualified licensed individual in 
accordance with State law and hospital policy.
    ++ Section 482.22(c)(5)(iv), to fully address the requirement that 
the medical staff develop and maintain a policy that identifies those 
patients for whom the assessment requirements of paragraph (c)(5)(iii) 
of this section would apply. The provisions of paragraphs (c)(5)(iii), 
(iv), and (v) of this section do not apply to a medical staff that 
chooses to maintain a policy that adheres to the requirements of 
paragraphs of (c)(5)(i) and (ii) of this section for all patients.
    ++ Section 482.22(c)(5)(v), to fully address the requirement that 
the medical staff, if it chooses to develop and maintain a policy for 
the identification of specific patients to whom the assessment 
requirements in paragraph (c)(5)(iii) of this section would apply, must 
demonstrate evidence that the policy applies only to

[[Page 60951]]

those patients receiving specific outpatient surgical or procedural 
services as well as evidence that the policy is based on.
    ++ Section 482.41(b)(2), to address the requirements regarding Life 
Safety Code (LSC) waivers.
    ++ Section 482.41(b)(7), to address the requirements regarding 
alcohol-based hand rub (ABHR) dispensers.
    In addition to the standards review, CMS also reviewed ACHC'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 final notice, ACHC has completed revising its 
survey processes to demonstrate that it uses survey processes that are 
comparable to state survey agency processes by:
    <bullet> Revising the complaint response policies and processes to 
align with the State Operations Manual, Chapter 5 guidance. ACHC 
revised its Administrative Review Offsite Investigation process to 
align with CMS' triage process to track and trend for potential focus 
areas during the next onsite survey or complete an onsite complaint 
investigation.
    <bullet> Revising ACHC's hospital accreditation process policies to 
include the applicable sections of the Health Care Facilities Code 
National Fire Protection Agency (NFPA 99) in accordance with section 
482.41(c).
    <bullet> Ensuring that all hospital LSC surveyors have received 
comparable and adequate training or have sufficient experience to make 
them qualified to survey health care facilities for compliance with 
both the 2012 LSC and 2012 NFPA 99 requirements.
    <bullet> Providing guidance and instruction to surveyors on 
determining the appropriate level of citation for LSC deficiencies.

B. Term of Approval

    Based on our review and observations described in section III. and 
section V. of this final notice, we approve ACHC as a national 
accreditation organization for hospitals that request participation in 
the Medicare program. The decision announced in this final notice is 
effective September 25, 2023, through September 25, 2027 (4 years). In 
accordance with Sec.  488.5(e)(2)(i) the term of the approval will not 
exceed 6 years.
    While ACHC has taken actions based on the findings annotated in 
section V.A., of this final notice, (Differences Between ACHC's 
Standards and Requirements for Accreditation and Medicare Conditions 
and Survey Requirements) as authorized under Sec.  488.8, we will 
continue ongoing review of ACHC's hospital processes to ensure full 
implementation and sustained compliance. In keeping with CMS's 
initiative to increase AO oversight broadly and ensure that our 
requested revisions by ACHC are fully implemented, CMS expects more 
frequent review of ACHC's activities in the future.

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: August 31, 2023.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-19195 Filed 9-5-23; 8:45 am]
BILLING CODE 4120-01-P