[Federal Register Volume 87, Number 191 (Tuesday, October 4, 2022)]
[Notices]
[Pages 60171-60172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21417]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3434-PN]


Medicare and Medicaid Programs: Application From the 
Accreditation Commission for Health Care (ACHC) for Continued Approval 
of its End-Stage Renal Disease (ESRD) Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice with request for comment.

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SUMMARY: This notice acknowledges the receipt of an application from 
the Accreditation Commission for Health Care (ACHC) for continued 
recognition as a national accrediting organization for end-stage renal 
disease (ESRD) facilities that wish to participate in the Medicare or 
Medicaid programs.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on November 3, 2022.

ADDRESSES: In commenting, please refer to file code CMS-3434-PN.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-3434-PN, P.O. Box 8010, 
Baltimore, MD 21244-8010.

    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-3434-PN, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Joy Webb, (410) 786-1667 or Jennifer 
Milby, (410) 786-8828.

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following 
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to 
view public comments. CMS will not post on Regulations.gov public 
comments that make threats to individuals or institutions or suggest 
that the individual will take actions to harm the individual. CMS 
continues to encourage individuals not to submit duplicative comments. 
We will post acceptable comments from multiple unique commenters even 
if the content is identical or nearly identical to other comments.

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services from an end-stage renal disease (ESRD) facility (also 
known as a ``dialysis facility'') provided certain requirements are 
met. Section 1881(b) of the Social Security Act (the Act), establish 
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 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 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 AOs to 
reapply for continued approval of its accreditation program every 6 
years or sooner as determined by CMS.

[[Page 60172]]

    The Accreditation Commission for Health Care's (ACHC's) current 
term of approval for their ESRD facility accreditation program expires 
April 11, 2023.

II. Approval of Deeming Organizations

    Section 1865(a)(2) of the Act and our regulations at Sec.  488.5 
require that our findings concerning review and approval of a national 
AO's requirements consider, among other factors, the applying AO's 
requirements for accreditation; survey procedures; resources for 
conducting required surveys; capacity to furnish information for use in 
enforcement activities; monitoring procedures for provider entities 
found not in compliance with the conditions or requirements; and 
ability to provide CMS with the necessary data for validation.
    Section 1865(a)(3)(A) of the Act further requires that we publish, 
within 60 days of receipt of an organization's complete application, a 
notice identifying the national accrediting body making the request, 
describing the nature of the request, and providing at least a 30-day 
public comment period. We have 210 days from the receipt of a complete 
application to publish notice of approval or denial of the application.
    The purpose of this notice is to inform the public of the ACHC's 
request for continued approval of its ESRD facility accreditation 
program. This notice also solicits public comment on whether the ACHC 
requirements meet or exceed the Medicare conditions for coverage (CfCs) 
for ESRD facilities.

III. Evaluation of Deeming Authority Request

    The ACHC submitted all the necessary materials to enable us to make 
a determination concerning its request for continued approval of its 
ESRD facility accreditation program. This application was determined to 
be complete on August 26, 2022. Under section 1865(a)(2) of the Act and 
our regulations at Sec.  488.5 (Application and re-application 
procedures for national accrediting organizations), our review and 
evaluation of the ACHC will be conducted in accordance with, but not 
necessarily limited to, the following factors:
     The equivalency of the ACHC's standards for ESRD 
facilities as compared with Medicare's ESRD facility CfCs.
     The ACHC's survey process to determine the following:
    ++ The composition of the survey team, surveyor qualifications, and 
the ability of the organization to provide continuing surveyor 
training.
    ++ The comparability of the ACHC's processes to those of state 
agencies, including survey frequency, and the ability to investigate 
and respond appropriately to complaints against accredited facilities.
    ++ The ACHC's processes and procedures for monitoring an ESRD 
facility found out of compliance with the ACHC program requirements. 
These monitoring procedures are used only when the ACHC identifies 
noncompliance. If noncompliance is identified through validation 
reviews or complaint surveys, the SA monitors corrections as specified 
at Sec.  488.9.
    ++ The ACHC's capacity to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    ++ The ACHC's capacity to provide CMS with electronic data and 
reports necessary for effective validation and assessment of the 
organization's survey process.
    ++ The adequacy of the ACHC's staff and other resources, and its 
financial viability.
    ++ The ACHC's capacity to adequately fund required surveys.
    ++ The ACHC's policies with respect to whether surveys are 
announced or unannounced, to assure that surveys are unannounced.
    ++ The 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.
    ++ The 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. 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. chapter 3501 et seq.).

V. Response to Public Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this 
document, authorizes Lynette Wilson, who is the Federal Register 
Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

    Dated: September 28, 2022.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2022-21417 Filed 10-3-22; 8:45 am]
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