[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)]
[Notices]
[Pages 38697-38699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16871]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3366-PN]


Medicare and Medicaid Programs: National Dialysis Accreditation 
Commission (NDAC) for Approval of its End Stage Renal Disease (ESRD) 
Facility Accreditation Program

AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS.

ACTION: Notice with request for comment.

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SUMMARY: This proposed notice acknowledges the receipt of an 
application from the National Dialysis Accreditation Commission (NDAC) 
for recognition as a national accrediting organization (AO) 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 September 6, 
2018.

ADDRESSES: In commenting, refer to file code CMS-3366-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-3366-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-3366-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: Tara Lemons, (410) 786-3030, Monda 
Shaver, (410) 786-3410, or Marie Vasbinder, (410) 786-8665.

[[Page 38698]]


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 the facility meets the requirements established by the 
Secretary of the Department of Health and Human Services (Secretary). 
Section 1881(b) of the Social Security Act (the Act) establishes 
distinct requirements for facilities seeking designation as an ESRD 
facility under Medicare. Regulations concerning provider agreements and 
supplier approval are at 42 CFR part 489 and those pertaining to 
activities relating to the survey, certification, and enforcement 
procedures of suppliers which include ESRD facilities are at 42 CFR 
part 488. The regulations at 42 CFR part 494 subparts A through D 
implement section 1881(b) of the Act, which specify the conditions that 
an ESRD facility must meet in order to participate in the Medicare 
program and the conditions for Medicare payment for ESRD facilities.
    Generally, to enter into a Medicare 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. Section 1865(a)(1) of 
the Act had historically prohibited dialysis facilities from 
participating in Medicare via a CMS-approved accreditation program; 
however, section 50403 of the Bipartisan Budget Act of 2018 amended 
section 1865(a) of the Act to include renal dialysis facilities as 
provider entities allowed to participate in Medicare through a CMS-
approved accreditation program. Accreditation by an AO is voluntary and 
is not required for Medicare participation.
    If an AO is recognized by 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 
may be deemed to meet the Medicare conditions. An 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.  488.5.

II. Provisions of the Proposed Notice

A. 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 an 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 proposed notice is to inform the public of 
National Dialysis Accreditation Commission's (NDAC) request for 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 ESRD facilities.
    This is the first application from a national accreditation body 
seeking approval of an accreditation program for ESRD facilities.

B. Evaluation of Deeming Authority Request

    NDAC submitted all the necessary materials to enable us to make a 
determination concerning its request for CMS-approval of its ESRD 
facility accreditation program. This application was determined to be 
complete on June 8, 2018. Under section 1865(a)(2) of the Act and our 
regulations at Sec.  488.5, our review and evaluation of NDAC will be 
conducted in accordance with, but not necessarily limited to, the 
following factors:
     The equivalency of NDAC's standards for ESRD facilities as 
compared with Medicare's CfCs for ESRD facilities.
     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 
found out of compliance with NDAC's program requirements. These 
monitoring procedures are used only when NDAC identifies noncompliance. 
If noncompliance is identified through validation reviews or complaint 
surveys, the State survey agency monitors corrections as specified at 
Sec.  488.9(c)(1).
    ++ 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 agreement to provide CMS with a copy of the most current 
accreditation survey together with any other information related to the 
survey as CMS may require (including corrective action plans).

[[Page 38699]]

III. 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. 3501 et seq.).

IV. 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.
    Upon completion of our evaluation, including evaluation of comments 
received as a result of this notice, we will publish a final notice in 
the Federal Register announcing the result of our evaluation.

    Dated: July 27, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-16871 Filed 8-6-18; 8:45 am]
 BILLING CODE 4120-01-P