[Federal Register Volume 78, Number 183 (Friday, September 20, 2013)]
[Notices]
[Pages 57857-57858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22849]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3287-PN]


Medicare and Medicaid Programs; Application from the Compliance 
Team for Initial CMS-Approval of its Rural Health Clinic Accreditation 
Program

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Proposed notice.

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SUMMARY: This proposed notice acknowledges the receipt of an 
application from the Compliance Team for initial recognition as a 
national accrediting organization for rural health clinics (RHCs) that 
wish to participate in the Medicare or Medicaid programs.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on October 21, 2013.

ADDRESSES: In commenting, please refer to file code CMS-3287-PN. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways:
    1. Electronically. You may submit electronic comments on specific 
issues in this regulation to http://www.regulations.gov. Follow the 
``submit a comment'' instructions.
    2. By regular mail. You may mail written comments (one original and 
two copies) to the following address ONLY: Centers for Medicare & 
Medicaid Services, Department of Health and Human Services, Attention: 
CMS-3287-PN, P.O. Box 8016, Baltimore, MD 21244-8010.
    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-3287-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 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.)

    Comments erroneously mailed to the addresses indicated as 
appropriate for hand or courier delivery may be delayed and received 
after the comment period.
    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) 786-9994 in advance to schedule your 
arrival with one of our staff members.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Lisa Sullivan, (410) 786-2841; Cindy 
Melanson, (410) 786-0310; or Patricia Chmielewski, (410) 786-6899.

SUPPLEMENTARY INFORMATION: 
    Submitting Comments: We welcome comments from the public on all 
issues set forth in this proposed notice to assist us in fully 
considering issues and developing policies. Referencing the file code 
CMS-3287-PN and the specific ``issue identifier'' that precedes the 
section on which you choose to comment will assist us in fully 
considering issues and developing policies.
    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 Web 
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to 
view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services from a Rural Health Clinic (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 an 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 minimum conditions that a RHC must meet to participate in 
the Medicare program. The conditions for Medicare payment for RHCs are 
set forth at 42 CFR 405, subpart X.
    Generally, to enter into an agreement, a RHC must first be 
certified by a state survey agency as complying with the conditions or 
requirements set forth in part 491 of our regulations. 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.
    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

[[Page 57858]]

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 approval of its accreditation 
program under 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.

II. Approval of Deeming Organizations

    Section 1865(a)(2) of the Act and our regulations at Sec.  488.8(a) 
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 complete 
application to publish notice of approval or denial of the application.
    The purpose of this proposed notice is to inform the public of the 
Compliance Team's request for initial CMS approval of its RHC 
accreditation program. This notice also solicits public comment on 
whether the Compliance Team's requirements meet or exceed the Medicare 
conditions for certification for RHC.

 III. Evaluation of Deeming Authority Request

    The Compliance Team submitted all the necessary materials to enable 
us to make a determination concerning its request for initial approval 
of its RHC accreditation program. This application was determined to be 
complete on July 26, 2013. Under section 1865(a)(2) of the Act and our 
regulations at Sec.  488.8 (federal review of accrediting 
organizations), our review and evaluation of the Compliance Team will 
be conducted in accordance with, but not necessarily limited to, the 
following factors:
     The equivalency of the Compliance Team's standards for 
RHC's as compared with our RHC conditions for certification.
     The Compliance Team'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 the Compliance Team's processes to those of 
state agencies, including survey frequency, and the ability to 
investigate and respond appropriately to complaints against accredited 
facilities.
    ++ The Compliance Team's processes and procedures for monitoring a 
RHC found out of compliance with the Compliance Team's program 
requirements. These monitoring procedures are used only when the 
Compliance Team identifies noncompliance. If noncompliance is 
identified through validation reviews or complaint surveys, the state 
survey agency monitors corrections as specified at Sec.  488.7(d).

++ The Compliance Team's capacity to report deficiencies to the 
surveyed facilities and respond to the facility's plan of correction in 
a timely manner.
++ The Compliance Team's capacity to provide us with electronic data 
and reports necessary for effective validation and assessment of the 
organization's survey process.
++ The adequacy of the Compliance Team's staff and other resources, and 
its financial viability.
++ The Compliance Team's capacity to adequately fund required surveys.
++ The Compliance Team's policies with respect to whether surveys are 
announced or unannounced, to assure that surveys are unannounced.
++ The Compliance Team's agreement to provide us 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).

IV. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 35).

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.

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program; No. 93.773 Medicare--Hospital Insurance Program; 
and No. 93.774, Medicare--Supplementary Medical Insurance Program)

    Dated: September 4, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2013-22849 Filed 9-19-13; 8:45 am]
BILLING CODE 4120-01-P