[Federal Register Volume 88, Number 54 (Tuesday, March 21, 2023)]
[Notices]
[Pages 16981-16983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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.
     The comparison of ACHC's Medicare ESRD facility 
accreditation program standards to our current Medicare ESRD facility 
conditions of participation (CoPs).
     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--
     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

[[Page 16983]]

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]
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