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