[Federal Register Volume 84, Number 24 (Tuesday, February 5, 2019)]
[Notices]
[Pages 1737-1739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01103]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3366-FN]


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

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

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve 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: The approval announced in this notice is effective January 4, 
2019 through January 4, 2023.

FOR FURTHER INFORMATION CONTACT: Renee Henry, (410) 786-7828, Monda 
Shaver, (410) 786-3410 or Joann Fitzell (410) 786-4280.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in 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 (the 
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 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.
    For an ESRD facility to enter into a provider agreement with the 
Medicare program, an ESRD facility must first be certified by a State 
survey agency as complying with the conditions or requirements set 
forth in section 1881(b) of the Act and our regulations at part 494 
subparts A through D. Subsequently, the ESRD facility is subject to 
ongoing review by a State survey agency to determine whether it 
continues to meet the Medicare requirements. However, there is an 
alternative to State compliance surveys. Certification by a nationally 
recognized accreditation program can substitute for ongoing State 
review.
    Section 1865(a)(1) of the Act provides that, if the Secretary finds 
that accreditation of a provider entity by an approved national 
accrediting organization (AO) meets or exceeds all applicable Medicare 
conditions, we may treat the provider entity as having met those 
conditions, that is, we may ``deem'' the provider entity to be in 
compliance. Accreditation by an AO is voluntary and is not required for 
Medicare participation.
    Section 1865(a)(1) of the Act had historically excluded dialysis 
facilities from participating in Medicare via a Centers for Medicare & 
Medicaid Services (CMS)-approved accreditation program; however, 
section 50404 of the Bipartisan Budget Act of 2018 (Pub. L. 115-123) 
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.
    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. Application Approval Process

    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 
that were not in compliance with the conditions or requirements; and 
their 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.

III. Provisions of the Proposed Notice

    On August 7, 2018, we published a proposed notice in the Federal 
Register announcing National Dialysis Accreditation Commission's 
(NDAC's) request for approval of its Medicare ESRD facility 
accreditation program (83 FR 38697). In the proposed notice, we 
detailed our evaluation criteria. Under section 1865(a)(2) of the Act 
and in our regulations at Sec.  488.5, we conducted a review of NDAC's 
Medicare ESRD Facility accreditation application in accordance with the 
criteria specified by our regulations, which include, but are not 
limited to, the following:
     An onsite 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 hospital 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 comparison of NDAC's Medicare accreditation program 
standards to our current Medicare ESRD facility Conditions for Coverage 
(CfCs).
     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 re-survey and the ability to investigate 
and respond appropriately to complaints against accredited ESRD 
Facilities.
    ++ Evaluate NDAC's procedures for monitoring ESRD Facilities it has 
found to be out of compliance with NDAC's program requirements. (This 
pertains only to monitoring procedures when NDAC identifies non-
compliance. If non-compliance is identified by a State survey agency 
through a validation survey, the State survey agency monitors 
corrections as specified at Sec.  488.9(c)(1).
    ++ Assess NDAC's ability to report deficiencies to the surveyed 
facilities

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and respond to the facility's plan of correction in a timely manner.
    ++ Establish NDAC's ability to provide CMS with electronic data and 
reports necessary for effective validation and assessment of the 
organization's survey process.
    ++ 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.
    ++ 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.
    In accordance with section 1865(a)(3)(A) of the Act, the August 7, 
2018, proposed notice also solicited public comments regarding whether 
NDAC's requirements met or exceeded the Medicare CfCs for ESRD 
facilities. Six comments were submitted. Of these comments, four were 
in full support of approving NDAC as a new AO for ESRD Facilities. They 
welcomed the additional support this would provide the industry in 
certifying facilities. CMS thanks them for their support. One commenter 
voiced support of allowing accreditation of ESRD facilities, but 
expressed concern that continuing to allow State Survey Agencies to 
conduct surveys when accreditation is allowed would cause confusion for 
facilities. CMS thanks the commenter for their submission; however, the 
law allows an ESRD facility to be surveyed by a State Survey Agency or 
an accrediting organization. Accreditation by an AO is a voluntary 
choice made by the ESRD facility. In addition, this process of allowing 
certification either through accreditation by an AO or through a survey 
performed by a State Survey Agency has been well established in other 
programs and does not, to our knowledge, present any confusion to 
providers. One commenter encouraged CMS to continue to recognize the 
value of home-only programs. Another commenter expressed concern with 
NDAC's ability to provide sufficient national coverage with limited 
staffing available to travel and respond to certification needs and 
complaints. This commenter also expressed concern over Conflict of 
Interest related to NDAC conducting mock surveys in the past for some 
facilities, which may be potential clients. In its application, NDAC 
addressed staffing requirements adequately to support national 
expansion. With respect to conflict of interest concerns, we believe 
that NDAC addressed these concerns adequately in their application and 
will conduct unbiased surveys. Firewalls and policies surrounding 
conflicts of interest are in line with other approved AO programs.

IV. 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 facility accreditation requirements and 
survey process with the Medicare CfCs at part 494, and the survey and 
certification process requirements of parts 488 and 489. NDAC's 
standards and standards crosswalk were also examined to ensure that the 
appropriate CMS regulations would be included in citations as 
appropriate. Our review and evaluation of NDAC's ESRD facility 
application, which was 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 the following standards and certification 
processes:
     Section 494.30(a)(1)(i), to ensure that its interpretive 
guidance accurately reflects the appropriate CMS standard.
     Section 494.40(a), to ensure that appropriate maximum 
allowable limits for microbial and endotoxin counts are comparable to 
CMS requirements and to clarify that bacteria counts can be tested via 
outside lab or dip test.
     Section 494.60(d)(4)(ii), to correct its related standards 
crosswalk to accurately reflect the CMS standards references and the 
2012 edition of the Life Safety Code.
     Section 494.70(a)(14), to clarify language that each 
facility must develop and implement an internal grievance process.
     Section 494.70(a)(16), to clarify language that each 
facility must inform patients that they can file a grievance.
     Section 494.70(d), to accurately reflect current CMS 
regulations and references.
     Section 494.90(b)(1)(i), to ensure that allowing an 
Advanced Practice Registered Nurse or Physician Assistant to conduct 
patient assessments and plans of care does not eliminate the physician 
from participation in the interdisciplinary team and team discussions.
     Section 494.170(b)(3), to ensure that ESRD facilities must 
also meet this CMS requirement for home care patients who receive 
supplies and equipment from a durable medical equipment supplier.
     Section 494.180(b)(1), to ensure that State-specific 
staffing requirements that are more stringent than CMS requirements 
will be cited at as the appropriate CMS standard.
     Section 494.180(c)(1), to ensure that State-specific 
Medical-staff requirements that are more stringent than CMS 
requirements will be cited at the appropriate CMS standard.
     NDAC revised its policies and procedures to ensure that 
its documentation demonstrates that the organization's survey reports 
identify, for each finding of noncompliance with accreditation 
standards, the appropriate comparable Medicare CfCs.
     NDAC revised its policies and procedures to ensure that 
all observations of non-compliance are noted on the final deficiency 
report and to require that an acceptable plan of correction must be 
submitted by the ESRD facility.
     NDAC revised its policies, procedures and surveyor 
worksheets to ensure that survey documentation is consistently and 
accurately completed.
     NDAC updated its policies and procedures to ensure that 
the effective date of full accreditation does not precede the receipt 
date of an acceptable plan of correction.
     NDAC revised its policy to include language that would 
specifically restrict the accreditation time period to no more than 36 
months.
     NDAC revised its policies and procedures to review and 
assess surveyor documentation on survey reports to ensure that all 
findings noted on the surveyor worksheets are clearly and accurately 
reflected in the final survey (deficiency) report and that these 
findings are quantifiable where appropriate.
     NDAC revised its policies and procedures to ensure that a 
survey report is generated for each survey, irrespective of 
deficiencies found on a follow-up survey.
     NDAC revised its policies and procedures to ensure that a 
follow-up survey conducted for the purposes of ``clearing'' a previous 
observation of non-compliance at the condition level, assesses 
compliance with the entire condition that was previously cited.
     NDAC revised its policies and procedures to include 
``denial'' of accreditation when condition-level non-compliance is 
found on an initial survey.
     NDAC revised its policy related to conducting follow-up 
surveys to clarify that the follow-up survey for condition-level non-
compliance must take place within 45 calendar days from the survey end 
date for which the condition-level finding was originally made.

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B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we have determined that NDAC's ESRD facility 
accreditation program requirements meet or exceed our requirements, and 
its survey processes are also comparable. Therefore, we approve NDAC as 
a national accreditation organization for ESRD facilities that request 
participation in the Medicare program, effective January 4, 2019 
through January 4, 2023.

V. 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.).

    Dated: January 2, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-01103 Filed 2-4-19; 8:45 am]
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