[Federal Register Volume 84, Number 69 (Wednesday, April 10, 2019)]
[Notices]
[Pages 14381-14383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07135]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3371-FN]


Medicare and Medicaid Programs: Approval of an Application From 
Accreditation Commission for Health Care, Inc. 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 approval of the Accreditation 
Commission for Health Care, Inc. (ACHC) 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 final notice is effective April 
11, 2019 through April 11, 2023.

FOR FURTHER INFORMATION CONTACT: Tara Lemons, (410) 786-3030, 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.

[[Page 14382]]

    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 November 2, 2018, we published a proposed notice in the Federal 
Register announcing Accreditation Commission for Health Care, Inc.'s 
(ACHC's) request for approval of its Medicare ESRD facility 
accreditation program (83 FR 55172). 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 ACHC'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 ACHC'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 ACHC's Medicare accreditation program 
standards to our current Medicare ESRD facility Conditions for Coverage 
(CfCs).
     A documentation review of ACHC's survey process to do the 
following:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and ACHC's ability to provide continuing surveyor 
training.
    ++ Compare ACHC'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 ACHC's procedures for monitoring ESRD Facilities it has 
found to be out of compliance with ACHC's program requirements. This 
pertains only to monitoring procedures when ACHC 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 ACHC's ability to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    ++ Establish ACHC'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 ACHC's staff and other resources.
    ++ Confirm ACHC's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm ACHC's policies with respect to surveys being 
unannounced.
    ++ Obtain ACHC'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 November 
2, 2018, proposed notice also solicited public comments regarding 
whether ACHC's requirements met or exceeded the Medicare CfCs for ESRD 
facilities. No comments were received.

IV. Provisions of the Final Notice

A. Differences Between ACHC's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements

    We compared ACHC'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. ACHC'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 ACHC'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, ACHC has revised the following standards and certification 
processes:
     Section 494.30(a)(3)-(4), to ensure that its interpretive 
guidance includes HBV-specific procedures.
     Section 494.90(a)(7)(ii)(C), to ensure that its standard 
includes the full CMS regulatory reference.
     Section 494.100(c)(1)(iii), to ensure that its standard 
includes the full CMS regulatory reference.
     Section 494.100(c)(2), to ensure that its standards 
address requirements to ensure patient privacy.
     Section 494.110, to ensure that its standards address the 
complexity of the facility's organization.
     Section 494.120(c)(1)(iii), to correct the CMS reference 
noted in its standard.
     Section 494.170(c), to accurately reflect the federal 
requirements for retaining records when state statutes are less 
restrictive, and to ensure that its standard includes the full CMS 
regulatory reference.
     ACHC revised its policies, procedures and surveyor 
worksheets to ensure that survey documentation is consistently and 
accurately completed; contains sufficient detail; and provides 
quantifiable information when appropriate.
     ACHC revised its policies and procedures to clearly 
delineate the criteria for determining the size and composition of its 
survey teams.
     ACHC revised its policies and procedures to ensure all 
deemed surveys remain unannounced.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we have determined that ACHC's

[[Page 14383]]

ESRD facility accreditation program requirements meet or exceed our 
requirements, and its survey processes are also comparable. Therefore, 
we approve ACHC as a national accreditation organization for ESRD 
facilities that request participation in the Medicare program, 
effective April 11, 2019 through April 11, 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: April 5, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-07135 Filed 4-9-19; 8:45 am]
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