```

[Federal Register Volume 79, Number 138 (Friday, July 18, 2014)]
[Notices]
[Pages 42019-42021]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16735]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3287-FN]

Medicare and Medicaid Programs; Initial Approval of The 
Compliance Team's (TCT's) Rural Health Clinic (RHC) Accreditation 
Program

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Final notice.

-----------------------------------------------------------------------

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

DATES: This final notice is effective July 18, 2014 through July 18, 
2018.

FOR FURTHER INFORMATION CONTACT: Valarie Lazerowich, (410) 786-4750, 
Cindy Melanson, (410) 786-0310, or Patricia Chmielewski, (410) 786-
6899.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in a RHC provided certain requirements are met. 
Section 1861(aa) and 1905(l)(1) of the Social Security Act (the Act) 
establishes distinct criteria for facilities seeking designation as a 
RHC. The minimum requirements that a RHC must meet to participate in 
Medicare are set forth in regulation at 42 CFR part 491, subpart A. The 
conditions for Medicare payment for RHCs are set forth at 42 CFR 405, 
subpart X. Regulations

[[Page 42020]]

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.
    For an RHC to enter into a provider agreement with the Medicare 
program, the RHC must first be certified by a state survey agency as 
complying with the conditions or requirements set forth in section 
1861(aa) of the Act and 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. However, there is an alternative 
to surveys by state agencies. Certification by a nationally recognized 
accreditation program can substitute for ongoing state review.
    Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by an approved national accrediting 
organization (AO) that all applicable Medicare conditions are met or 
exceeded, we will deem those provider entities as having met the 
requirements. Accreditation by an AO is voluntary and is not required 
for Medicare participation.
    If an AO is recognized by the Secretary of the Department of Health 
and Human Services (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 have met the Medicare conditions. A national AO 
applying for approval of its accreditation program under part 488, 
subpart A, must provide us 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.  488.4 and Sec.  
488.8(d)(3).

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 February 24, 2014, we published a proposed notice in the Federal 
Register (79 FR 10162) announcing TCT's request for approval of its RHC 
accreditation program. In the proposed notice, we detailed our 
evaluation criteria. Under section 1865(a)(2) of the Act and in our 
regulations at Sec.  488.4 and Sec.  488.8, 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:
     An onsite administrative review of TCT's: (1) Corporate 
policies; (2) financial and human resources available to accomplish the 
proposed surveys; (3) procedures for training, monitoring, and 
evaluation of its surveyors; (4) ability to investigate and respond 
appropriately to complaints against accredited facilities; and, (5) 
survey review and decision-making process for accreditation.
     The comparison of TCT's accreditation requirements to our 
current Medicare RHC conditions for certification.
     A documentation review of TCT's survey process to 
determine the following:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and TCT's ability to provide initial and continuing 
surveyor training.
    ++ Compare TCT's processes to those of state survey agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
    ++ Evaluate TCT's procedures for monitoring RHCs out of compliance 
with TCT's program requirements. The monitoring procedures are used 
only when TCT identifies non-compliance. If non-compliance is 
identified by the state survey agency through validation surveys, the 
state survey agency monitors corrections as specified at Sec.  
488.7(d).
    ++ Assess TCT's ability to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    ++ Establish TCT's ability to provide us with electronic data and 
reports necessary for effective validation and assessment of the 
organization's survey process.
    ++ Determine the adequacy of TCT's staff and other resources.
    ++ Confirm TCT's ability to provide adequate funding for performing 
required surveys.
    ++ Confirm TCT's policies with respect to whether surveys are 
announced or unannounced.
    ++ Obtain 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 we may require, including corrective action 
plans.
    In accordance with section 1865(a)(3)(A) of the Act, the February 
24, 2014 proposed notice also solicited public comments regarding 
whether TCT's requirements met or exceeded the Medicare conditions for 
certification for RHCs. We received eight comments in response to our 
proposed notice. All of the comments received expressed unanimous 
support for TCT's RHC accreditation program.

IV. Provisions of the Final Notice

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

    We compared TCT's RHC requirements and survey process with the 
Medicare conditions for certification and survey process as outlined in 
the State Operations Manual (SOM). Our review and evaluation of TCT's 
RHC application, which were conducted as described in section III of 
this final notice, yielded the following:
     To meet the requirements at Sec.  491.2, TCT revised its 
standards to include the definition of ``Secretary'' and ``Rural 
Area.''
     To meet the requirements at Sec.  491.5(a)(3), TCT revised 
its standards to address the requirement that RHCs can be both 
permanent and mobile units.
     To meet the requirements at Sec.  491.5(d)(1)(i), TCT 
revised its standards to ensure the requirements related to designation 
of a shortage area included the ratio of primary care physicians 
practicing within the area to the resident population.
     To meet the requirements at Sec.  491.7(b)(2)-(3), TCT 
revised its crosswalk to include standards concerning the disclosure of 
the names and addresses of the person principally responsible for 
directing the operation of the clinic or center and the person 
responsible for medical direction.
     To meet the requirements at Sec.  491.8(a)(1), TCT revised 
its standards to address the requirement to have one or more physicians 
and one or more physician's assistants or nurse practitioners.
     To meet the requirements at Sec.  491.8(b)(1)(iii), TCT 
revised its standards address the role of the

[[Page 42021]]

physician in providing medical orders and medical care services to 
patients of the clinic or center.
     To meet the requirements at Sec.  491.9(b)(4), TCT revised 
its standards to address the requirement that patient care policies are 
reviewed at least annually, and as necessary by the clinic or center.
     To meet the requirements at Sec.  491.9(c)(2), TCT revised 
its standards to ensure laboratory services are provided in accordance 
with the requirements at 42 CFR Part 493 and Section 353 of the Public 
Health Service Act.
     To meet the requirements at Sec.  491.9(d)(1), TCT revised 
its standards to require the clinic or center have an agreement or 
arrangement with one or more providers or suppliers participating under 
Medicare or Medicaid to furnish other services to its patients.
     TCT developed an action plan to ensure compliance with its 
own policies regarding RHCs receiving the correct accreditation date on 
their notice of survey results.
     To meet the requirements at Sec.  488.4(a)(6), TCT revised 
its policies to ensure timeframes for investigation of complaints are 
comparable with the requirements in section 5075.9 of the State 
Operations Manual.
     To meet the requirements at Sec.  489.13(b), TCT revised 
its policies to clarify that the effective date of the agreement or 
approval is determined by the CMS Regional Office and may not be 
earlier than the latest of the dates of which CMS determines that all 
applicable federal requirements are met. TCT revised all Clinic Advisor 
On-Site Worksheets to include a descriptive title for the requirement 
of each worksheet for increased clarity.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we have determined that TCT's RHC accreditation 
program requirements meet or exceed our requirements. Therefore, we 
approve TCT as a national accreditation organization for RHCs that 
request participation in the Medicare program, effective July 18, 2014 
through July 18, 2018.

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.

    Dated: July 8, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2014-16735 Filed 7-17-14; 8:45 am]
BILLING CODE 4120-01-P
```