[Federal Register Volume 83, Number 121 (Friday, June 22, 2018)]
[Notices]
[Pages 29118-29120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13436]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3351-FN]


Medicare and Medicaid Programs; Application by The Compliance 
Team for Continued CMS Approval of Its Rural Health Clinic 
Accreditation Program

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

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve The 
Compliance Team (TCT) for continued recognition as a national 
accrediting organization for Rural Health Clinics (RHCs) that wish to 
participate in the Medicare or Medicaid programs.

DATES: Applicable Date: This notice is effective July 18, 2018 through 
July 18, 2024.

FOR FURTHER INFORMATION CONTACT: 
    Christina Mister-Ward, (410) 786-2441.
    Monda Shaver, (410) 786-3410.
    Marie Vasbinder, 410-786-8665.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in a rural health clinic (RHC) provided certain 
requirements are met by the RHC. Section 1861(aa) and 1905(l)(1) of the 
Social Security Act (the Act), establish distinct criteria for 
facilities seeking designation as a RHC. 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, subpart A. The regulations at 42 CFR part 491, 
subpart A specify the conditions that a RHC must meet to participate in 
the Medicare program. The scope of covered services and the conditions 
for Medicare payment for RHCs are set forth at 42 CFR part 405, subpart 
X.
    Generally, to enter into a provider agreement with the Medicare 
program, a RHC must first be certified by a state survey agency as 
complying with the

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conditions or requirements set forth in 42 CFR part 491. Thereafter, 
the RHC is subject to regular surveys by a state survey agency to 
determine whether it continues to meet these requirements.
    There is an alternative, however, to surveys by state agencies. 
Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by an approved national accrediting 
organization that all applicable Medicare conditions are met or 
exceeded, we will deem those provider entities as having met the 
requirements. Accreditation by an accrediting organization is voluntary 
and is not required for Medicare participation.
    If an accrediting organization 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 would be deemed to meet the 
Medicare conditions. A national accrediting organization applying for 
CMS approval of its accreditation program under 42 CFR part 488, 
subpart A, must provide us with reasonable assurance that the 
accrediting organization requires the accredited provider entities to 
meet requirements that are at least as stringent as the Medicare 
conditions. Our regulations concerning the approval of accrediting 
organizations are set forth at Sec.  488.5. Section 488.5(e)(2)(i) 
requires an accrediting organization to reapply for continued approval 
of its accreditation program every 6 years or as determined by CMS. The 
Compliance Team's (TCT's) current term of approval for its RHC 
accreditation program expires July 18, 2018.

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

    In the January 23, 2018 Federal Register (83 FR 3152), we published 
a notice announcing TCT's request for continued approval of its RHC 
accreditation program. In the proposed notice, we detailed our 
evaluation criteria. Under section 1865(a)(2) of the Act and Sec.  
488.5, we conducted a review of TCT's application in accordance with 
the criteria specified by our regulations, which include, but are not 
limited to the following:
     The equivalency of TCT's standards for RHCs as compared 
with CMS's RHC conditions for certification.
     TCT'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 TCT's processes to those of state agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
    ++ TCT's processes and procedures for monitoring a RHC determined 
to be out of compliance with TCT's program requirements. These 
monitoring procedures are used only when TCT 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).
    ++ TCT's capacity to report deficiencies to the surveyed facilities 
and respond to the facility's plan of correction in a timely manner.
    ++ TCT'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 TCT's staff and other resources, and its 
financial viability.
    ++ TCT's capacity to adequately fund required surveys.
    ++ TCT's policies with respect to whether surveys are announced or 
unannounced, to assure that surveys are unannounced.
    ++ TCT'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).

IV. Analysis of and Responses to Public Comments on the Proposed Notice 
With Comment Period

    In accordance with section 1865(a)(3)(A) of the Act, the January 
23, 2018 proposed notice also solicited public comments regarding 
whether TCT's requirements met or exceeded the Medicare Condition for 
Certification (CfC) for RHCs. We received one comment in response to 
our proposed notice. The comment received expressed support for TCT's 
RHC accreditation program.

V. Provisions of the Final Notice

Conditions and Survey Requirements

    We compared TCT's RCH accreditation requirements and survey process 
with the Medicare CfCs at 42 CFR part 491, the survey and certification 
process requirements of parts 488 and 489 and survey process as 
outlined in the State Operations Manual (SOM). TCT's standards 
crosswalk was also examined to ensure that the appropriate CMS 
regulations would be included in citations as appropriate. Our review 
and evaluation of TCT's RHC 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, TCT has revised its 
standards and certification processes so that its processes are 
comparable to CMS requirements:
     Section 491.2(1), to update its standard for nurse 
practitioner and accompanying crosswalk to remove the duplicative 
language ``by the currently certified''.
     Section 491.4, to address staff licensure compliance in 
its surveyor guidance.
     Sections 491.7(a)(2) through (b)(3), to correct its 
crosswalk to reflect the correct standard reference ADM 4.0.1.
     Section 491.8(a)(3), to update its standard to address the 
regulatory requirement that at least one physician assistant or nurse 
practitioner be employed by the clinic.
     Sections 491.8(c)(1)(i) and 491.9(b)(2), to correct the 
standard language to clarify the required membership of the group of 
professional personnel responsible for policy development and 
implementation.
     Section 491.8(c)(2)(i), to correct erroneously cited CMS 
regulatory references.
     Section 491.9(b)(4), to update its standard language to 
clarify the required membership of the group of professional personnel 
responsible for policy review annually.
     Section 491.10(a)(1), to update its standards and 
crosswalk to explicitly require the RHC to maintain a clinical record 
system in addition to maintaining the record system in accordance with 
written policies and procedures.

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     Section 491.12(c)(3)(i), to update its standard to include 
reference to RHC ``staff'' and to delete reference to ``FQHC.''
     Section 491.12(d)(1)(iv), to update surveyor guidance to 
include specific examples of acceptable methods for documenting the 
evaluation of the effectiveness of RHC staff training, and the 
demonstration of RHC staff knowledge and competency.
     To clearly include frequency of monitoring on-going 
compliance as a required element for acceptable plan of corrections.
     To clarify its Administrative Policy regarding removal and 
denial of accreditation.
     To ensure each deficiency is cited at the appropriate 
level according to the scope and severity of the finding.
     To ensure all provider-submitted plans of correction 
address all non-compliant practices identified on survey.
     To address the inaccurate reporting of facility and survey 
data to CMS.
     To provide evidence ensuring staff were educated on its 
policy related required personal file documents to be located on site 
at the RHC.
     To provide evidence ensuring staff are educated on its 
policy related to deficiencies that are corrected onsite.
     To identify patient medical records while protecting the 
patient's identity during the survey event.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we have determined that TCT's rural health clinic 
requirements meet or exceed our requirements, and its survey processes 
are comparable to ours. Therefore, we approve TCT as a national 
accreditation organization for hospitals that request participation in 
the Medicare program, effective July 18, 2018 through July 18, 2024.

VI. 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: June 11, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-13436 Filed 6-21-18; 8:45 am]
 BILLING CODE 4120-01-P