Notice2023-19195
Medicare and Medicaid Programs: Application From the Accreditation Commission for Healthcare (ACHC) for Continued CMS-Approval of Its Hospital Accreditation Program
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 6, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 171 (Wednesday, September 6, 2023)</title>
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[Federal Register Volume 88, Number 171 (Wednesday, September 6, 2023)]
[Notices]
[Pages 60949-60951]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
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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
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</html>Indexed from Federal Register on September 6, 2023.
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