[Federal Register Volume 87, Number 191 (Tuesday, October 4, 2022)]
[Notices]
[Pages 60173-60175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

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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:
     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.
     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.
     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:
     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.
     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.
     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.
     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.
     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:
     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).
     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.
     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.
     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).
     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.
     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.
     Providing additional education to NDAC surveyors on 
interviewing patients and staff using open-ended questioning, in 
accordance with SOM Chapter 2, Section 2714.
     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