[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)]
[Notices]
[Pages 3152-3154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01178]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3351-PN]


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: Proposed notice with request for comment.

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SUMMARY: This proposed notice acknowledges the receipt of an 
application from The Compliance Team

[[Page 3153]]

(TCT) for continued recognition as a national accrediting organization 
for rural health clinics (RHCs) that wish to participate in the 
Medicare or Medicaid programs. The statute requires that within 60 days 
of receipt of an organization's complete application, the Centers for 
Medicare & Medicaid Services (CMS) publish a notice that identifies the 
national accrediting body making the request, describes the nature of 
the request, and provides at least a 30-day public comment period.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. February 22, 2018.

ADDRESSES: In commenting, refer to file code CMS-3351-PN. Because of 
staff and resource limitations, we cannot accept comments by facsimile 
(FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-3351-PN, P.O. Box 8016, 
Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-3351-PN, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or 
courier) your written comments ONLY to the following addresses:
    a. For delivery in Washington, DC--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Room 445-G, Hubert 
H. Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201.
    (Because access to the interior of the Hubert H. Humphrey Building 
is not readily available to persons without Federal government 
identification, commenters are encouraged to leave their comments in 
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing 
by stamping in and retaining an extra copy of the comments being 
filed.)
    b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
call telephone number (410) 786-7195 in advance to schedule your 
arrival with one of our staff members.
    Comments erroneously mailed to the addresses indicated as 
appropriate for hand or courier delivery may be delayed and received 
after the comment period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: 
    Christina Mister-Ward, (410) 786-2441.
    Monda Shaver, (410) 786-3410.
    Patricia Chmielewski, (410) 786-6899.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments 
received before the close of the comment period are available for 
viewing by the public, including any personally identifiable or 
confidential business information that is included in a comment. We 
post all comments received before the close of the comment period on 
the following website as soon as possible after they have been 
received: http://www.regulations.gov. Follow the search instructions on 
that website to view public comments.

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 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 (TCT) current term of approval for its RHC 
accreditation program expires July 18, 2018.

II. Approval of Accreditation Organizations

    Section 1865(a)(2) of the Act and Sec.  488.5 require that our 
findings concerning review and approval of a national accrediting 
organization's requirements consider, among other factors, the applying 
accrediting organization'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 found not in compliance with the 
conditions or requirements; and ability to provide us 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

[[Page 3154]]

complete application to publish notice of approval or denial of the 
application.
    The purpose of this proposed notice is to inform the public of 
TCT's request for continued CMS approval of its RHC accreditation 
program. This notice also solicits public comment on whether TCT's 
requirements meet or exceed the Medicare conditions for certification 
for RHCs.

III. Evaluation of Accreditation Organization Request

    TCT submitted all the necessary materials to enable us to make a 
determination concerning its request for continued approval of its RHC 
accreditation program. This application was determined to be complete 
on November 24, 2017. Under section 1865(a)(2) of the Act and Sec.  
488.5 (Application and re-application procedures for national 
accrediting organizations), our review and evaluation of TCT will be 
conducted in accordance with, but not necessarily limited to, the 
following factors:
     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. 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.).

V. Response to Public Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.
    Upon completion of our evaluation, including evaluation of comments 
received as a result of this notice, we will publish a final notice in 
the Federal Register announcing the result of our evaluation.

    Dated: January 12, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-01178 Filed 1-22-18; 8:45 am]
 BILLING CODE 4120-01-P