Notice2022-21415
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
October 4, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This notice announces our decision to approve the National Dialysis Accreditation Commission (NDAC) 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.
Full Text
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<title>Federal Register, Volume 87 Issue 191 (Tuesday, October 4, 2022)</title>
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[Federal Register Volume 87, Number 191 (Tuesday, October 4, 2022)]
[Notices]
[Pages 60173-60175]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-21415]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3428-FN]
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 & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice announces our decision to approve the National
Dialysis Accreditation Commission (NDAC) 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: This notice is applicable January 4, 2023 through January 4,
2029.
FOR FURTHER INFORMATION CONTACT: Caecilia Blondiaux, (410) 786-2190.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services from a hospital, provided certain requirements are
met. Section 1881(b) of the Social Security Act (the Act) establishes
statutory authority for the Secretary of the Department of Health and
Human Services (Secretary) to set criteria for facilities seeking
designation as a dialysis facility (also known as an ``end-stage renal
disease (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 for
coverage 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
[[Page 60174]]
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 CMS 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 requirements. 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 requirements. 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.
The National Dialysis Accreditation Commission's (NDAC's) current
term of approval for their ESRD facility accreditation program expires
January 4, 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 May 23 2022, we published a proposed notice in the Federal
Register (87 FR 31241), announcing NDAC's request for continued
approval of its Medicare ESRD facilities accreditation program. In that
proposed notice, we detailed our evaluation criteria. Under section
1865(a)(2) of the Act and in our regulations at Sec. 488.5 and Sec.
488.8(h), we conducted a review of NDAC's Medicare ESRD facilities
accreditation application in accordance with the criteria specified by
our regulations, which include, but are not limited to the following:
<bullet> An administrative review of NDAC'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 facility 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> A review of NDAC's survey processes to confirm that a
provider or supplier, under NDAC's ESRD facilities deeming
accreditation program, meets or exceeds the Medicare program
requirements.
<bullet> A documentation review of NDAC's survey process to do the
following:
++ Determine the composition of the survey team, surveyor
qualifications, and NDAC's ability to provide continuing surveyor
training.
++ Compare NDAC's processes to those we require of state survey
agencies, including periodic resurvey and the ability to investigate
and respond appropriately to complaints against NDAC accredited ESRD
facilities.
++ Evaluate NDAC's procedures for monitoring accredited ESRD
facilities it has found to be out of compliance with its program
requirements.
++ Assess NDAC's ability to report deficiencies to the surveyed
ESRD facilities and respond to the ESRD facilities plan of correction
in a timely manner.
++ Determine the adequacy of NDAC's staff and other resources.
++ Confirm NDAC's ability to provide adequate funding for
performing required surveys.
++ Confirm NDAC's policies with respect to surveys being
unannounced.
++ Confirm 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.
++ Obtain 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. Analysis of and Responses to Public Comments on the Proposed Notice
In accordance with section 1865(a)(3)(A) of the Act, the May 23,
2022 proposed notice also solicited public comments regarding whether
NDAC's requirements met or exceeded the Medicare conditions for
coverage for ESRD facilities. We received no comments.
V. Provisions of the Final Notice
A. Differences Between NDAC's Standards and Requirements for
Accreditation and Medicare Conditions and Survey Requirements
We compared NDAC's ESRD facilities accreditation requirements and
survey process with the Medicare conditions for coverage of parts 494,
and the survey and certification process requirements of parts 488 and
489. Our review and evaluation of NDAC's renewal application, which
were conducted as described in section III. of this final notice,
yielded the following areas where, as of the date of this notice, NDAC
has revised its standards and certification processes in order to-meet
our requirements at:
<bullet> Section 494.30(a)(2), to specify the requirement to
implement the guidelines as outlined in the Medicare regulations for
the prevention of IV catheter-related infections.
<bullet> Section 494.60(c)(2)(i), to include reference to the 2008
ASHRAE 170 ventilation design parameters or a reference to these design
parameters for ESRD facilities that are required to comply with the
2012 NFPA 99, as it relates to providing comfortable temperature within
the ESRD facility.
<bullet> Section 494.60(e), to provide specific language which
requires dialysis facilities that do not have one or more exits to
grade level from the patient treatment level to meet the 2012 Health
Care Facilities Code (NFPA 99), regardless of the number of patients
served.
<bullet> Section 494.62(c)(1)(iv), to incorporate other dialysis
facilities' contact information in the ESRD facility's emergency
preparedness program as part of its communication plans.
<bullet> Section 494.70(a)(17), to specify that patients may file
internal or external grievances, personally, anonymously or through a
representative of the patient's choosing.
In addition to the standards review, CMS reviewed NDAC's comparable
survey processes, which were conducted as described in section III. of
this final notice, and yielded the following areas where, as of the
date of this notice, NDAC has completed revising its survey processes
in order to demonstrate that it uses survey processes that are
comparable to state survey agency processes by:
<bullet> Developing a process on how NDAC will obtain the Dialysis
Facility Reports (DFRs) from its already-accredited
[[Page 60175]]
facilities in accordance with survey comparability at Sec.
488.5(a)(4)(ii).
<bullet> Revising NDAC's Life Safety Code Surveyor Responsibilities
section to include survey responsibilities and licensure requirements
to ensure the 2012 editions of the Life Safety Code (NFPA 101) and
Health Care Facilities Code (NFPA 99) are met.
<bullet> Updating NDAC's Surveyor Field Manual to include surveyor
process and worksheets for Life Safety Code and Health Care Facilities
Code surveyors and revise other associated documents as necessary.
<bullet> Revising NDAC's complaint policy to include prioritization
classifications for complaints and timeframes to investigate based on
the priority level in accordance with Sec. 488.5(a)(12).
<bullet> Revising NDAC's survey processes for Emergency
Preparedness to align with the CMS requirements. Specifically, to
ensure surveyors review ESRD facility plans to include primary and
alternate means for communicating as required by Sec. 494.62(c)(3) and
testing guidance in accordance with Sec. 494.62(d)(2), including
conducting after-action reviews after an actual emergency event.
<bullet> Clarifying that NDAC's policy for immediate jeopardy
includes: (1) a process for providing the template to the dialysis
facility; and (2) documentation of this information on the statement of
deficiencies, in accordance with Sec. 488.5(a)(4)(ii) and the State
Operations Manual (SOM), Appendix Q Section VI. Calling Immediate
Jeopardy.
<bullet> Providing additional education to NDAC surveyors on
interviewing patients and staff using open-ended questioning, in
accordance with SOM Chapter 2, Section 2714.
<bullet> Providing additional education and training to NDAC
surveyors on emergency preparedness interviews of patients, staff and
facility leadership to ensure the facility can demonstrate knowledge of
the emergency preparedness program, including its policies and
procedures, in accordance with the survey procedures in SOM Appendix Z.
B. Term of Approval
Based on our review and observations described in section III. and
section V. of this final notice, we approve NDAC as a national
accreditation organization for ESRD facilities that request
participation in the Medicare program. The decision announced in this
final notice is effective January 4, 2023 through January 4, 2029 (6
years). In accordance with Sec. 488.5(e)(2)(i) the term of the
approval will not exceed 6 years.
VI. Collection of Information and Regulatory Impact Statement
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 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. 2022-21415 Filed 10-3-22; 8:45 am]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on October 4, 2022.
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