[Federal Register Volume 87, Number 99 (Monday, May 23, 2022)]
[Notices]
[Pages 31241-31242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10999]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3428-PN]


Medicare and Medicaid Programs: Application From the National 
Dialysis Accreditation Commission (NDAC) for Continued Approval of Its 
End Stage Renal Disease (ESRD) Facility Accreditation Program

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Notice with request for comment.

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SUMMARY: This notice acknowledges the receipt of an application from 
the National Dialysis Accreditation Commission 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: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on June 22, 2022.

ADDRESSES: In commenting, refer to file code CMS-3428-PN. Because of 
staff and resource limitations, we cannot accept comments by facsimile 
(FAX) transmission.
    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-3428-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-3428-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: Caecilia Blondiaux, (410) 786-2190.

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.

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 a Medicare-certified 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 
subparts A through D specify the conditions that an ESRD must meet in 
order to participate in the Medicare program, the scope of covered 
services, and the conditions for Medicare payment for ESRD facilities.
    Generally, to enter into an agreement, an ESRD facility must first 
be certified by a State survey agency as complying with the conditions 
or requirements set forth in part 494 subparts A through D of our 
Medicare regulations. Thereafter, the ESRD facility is subject to 
regular surveys by a State survey agency 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 may 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.  488.4 and 488.5. 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.
    The National Dialysis Accreditation Commission's (NDAC's) current 
term of approval for their ESRD facility accreditation program expires 
January 4, 2023.

II. Approval of Deeming Organizations

    Section 1865(a)(2) of the Act and regulations at Sec.  488.5 
require that our findings concerning review and approval of an AO's 
requirements consider, among other factors, the

[[Page 31242]]

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 NDAC's 
request for continued CMS-approval of its ESRD facility accreditation 
program. This notice also solicits public comment on whether NDAC's 
requirements meet or exceed the Medicare conditions for coverage (CfCs) 
for ESRDs.

III. Evaluation of Deeming Authority Request

    NDAC submitted all the necessary materials to enable us to make a 
determination concerning its request for continued CMS-approval of its 
ESRD facility accreditation program. This application was determined to 
be complete on March 14, 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 NDAC will be conducted in accordance with, but not 
necessarily limited to, the following factors:
    <bullet> The equivalency of NDAC's standards for ESRD facilities as 
compared with CMS' ESRD facility CfCs.
    <bullet> NDAC'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 NDAC's processes to those of state 
agencies, including survey frequency, and the ability to investigate 
and respond appropriately to complaints against accredited facilities.
    ++ NDAC's processes and procedures for monitoring an ESRD facility 
out of compliance with NDAC's program requirements. These monitoring 
procedures are used only when NDAC's identifies noncompliance. If 
noncompliance is identified through validation reviews or complaint 
surveys, the state agency (SA) monitors corrections as specified at 
Sec.  488.9.
    ++ NDAC's capacity to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    ++ NDAC'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 NDAC's staff and other resources, and its 
financial viability.
    ++ NDAC's capacity to adequately fund required surveys.
    ++ NDAC's policies with respect to whether surveys are announced or 
unannounced, to assure that surveys are unannounced.
    ++ NDAC'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.
    ++ NDAC'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 35).

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: May 18, 2022.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2022-10999 Filed 5-20-22; 8:45 am]
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