Notice2022-10999
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
Primary source
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Published
May 23, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 99 (Monday, May 23, 2022)</title>
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[Federal Register Volume 87, Number 99 (Monday, May 23, 2022)]
[Notices]
[Pages 31241-31242]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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]
BILLING CODE P
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