Notice2023-05761
Medicare and Medicaid Programs: Application From the Accreditation Commission for Health Care, Inc. for Continued Approval of Its End-Stage Renal Disease (ESRD) 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
March 21, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This final notice announces our decision to approve the Accreditation Commission for Health Care, Inc for continued recognition as a national accrediting organization for end stage renal disease facilities that wish to participate in the Medicare or Medicaid programs.
Full Text
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<title>Federal Register, Volume 88 Issue 54 (Tuesday, March 21, 2023)</title>
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[Federal Register Volume 88, Number 54 (Tuesday, March 21, 2023)]
[Notices]
[Pages 16981-16983]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-05761]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3434-FN]
Medicare and Medicaid Programs: Application From the
Accreditation Commission for Health Care, Inc. for Continued Approval
of Its End-Stage Renal Disease (ESRD) Accreditation Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This final notice announces our decision to approve the
Accreditation Commission for Health Care, Inc for continued recognition
as a national accrediting organization for end stage renal disease
facilities that wish to participate in the Medicare or Medicaid
programs.
DATES: The decision announced in this final notice is applicable on
April 11, 2023 through April 10, 2029.
FOR FURTHER INFORMATION CONTACT:
Joy Webb, (410) 786-1667.
Caecilia Blondiaux, (410) 786-2190.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services from an end stage renal disease (ESRD) facility
provided certain requirements are met. Section 1881(b) of the Social
Security Act (the Act), establishes distinct criteria for facilities
seeking designation as an ESRD facility. 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 494 specify the
minimum conditions that an ESRD facility must meet to participate in
the Medicare program.
Generally, to enter into an agreement, an ESRD facility must first
be certified by a state survey agency (SA) as complying with the
conditions or requirements set forth in part 494 of our
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regulations. Thereafter, the ESRD facility 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 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 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 AOs to
reapply for continued approval of its accreditation program every 6
years or sooner, as determined by CMS.
ACHC's current term of approval for their ESRD facility
accreditation program expires April 11, 2023.
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 October 4, 2022, we published a proposed notice in the Federal
Register (87 FR 60171), announcing ACHC's request for continued
approval of its Medicare ESRD facility accreditation program. In the
October 4, 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 ACHC's Medicare ESRD facility
accreditation application in accordance with the criteria specified by
our regulations, which include, but are not limited to the following:
<bullet> A virtual onsite 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 ESRD surveyors; (4) ability to
investigate and respond appropriately to complaints against accredited
ESRD facilities; and (5) survey review and decision-making process for
accreditation.
<bullet> The comparison of ACHC's Medicare ESRD facility
accreditation program standards to our current Medicare ESRD facility
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 ESRD
facilities.
++ Evaluate ACHC's procedures for monitoring accredited ESRD
facilities 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
ESRD facilities and respond to the ESRD facilities' 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 October 4,
2022 proposed notice also solicited public comments regarding whether
ACHC's requirements met or exceeded the Medicare CoPs for ESRD
facilities. No comments were received in response to our proposed
notice.
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 ESRD facility accreditation requirements and
survey process with the Medicare CoPs of parts 494, and the survey and
certification process requirements of parts 488 and 489. Our review and
evaluation of ACHC's ESRD facility 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 of the following
regulations:
++ Section 494.30(b)(3)(x), to clarify and address the contingency
plans for staff who are not fully vaccinated for COVID-19.
++ Section 494.60(d)(1), to address dialysis facilities that do not
provide one or more exits to the outside must comply with Life Safety
Code (NFPA 101).
++ Section 494.60(d)(4), to clarify specific Life Safety Code
provisions that may be waived, only if the waiver will not adversely
affect the health and safety of the patients.
++ Section 494.60(d)(5), to clarify that no dialysis facility may
operate in a building adjacent to an industrial high hazard area.
In addition to the standards review, CMS also reviewed ACHC's
comparable survey processes, which were conducted as described in
section III. of this final notice, and yielded the
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following areas where, as of the date of this final notice, ACHC 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 the compliant policies and processes to align with the
State Operations Manual, Chapter 5 guidance. In particular, the
Administrative Review Offsite Investigation process to align with the
triage process to track and trend for potential focus areas during the
next onsite survey or complete an onsite complaint investigation.
++ Clarifying the quantifying data surrounding equipment and
maintenance logs, specifically the equipment review. The survey reports
or notes need to identify the number of logs reviewed, date or
timeframes.
++ Providing surveyor training on documentation reviews and the
process for verifying the completeness of the facility request.
++ Reinforcing and providing education to facility surveyors to
request Dialysis Facility Reports, the reports provide aggregate data
regarding laboratory values, demographic information, mortality rates,
hospitalizations, infections, etc., which may assist the surveyors
during the review of patient medical records.
++ Developing additional surveyor training for verifying all
elements required for the CMS emergency preparedness requirements.
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 ESRD facilities that request
participation in the Medicare program. The decision announced in this
final notice is effective April 11, 2023 through April 11, 2029 (6
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 ESRD survey substance and processes.
In keeping with CMS's initiative to increase AO oversight broadly, and
ensure that our requested revisions by ACHC are completed, 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: March 15, 2023.
Evell J. Barco Holland,
Federal Register Liaison, Center for Medicare & Medicaid Services.
[FR Doc. 2023-05761 Filed 3-20-23; 8:45 am]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on March 21, 2023.
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