[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)]
[Notices]
[Pages 57822-57824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24356]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3322-PN]


Medicare and Medicaid Programs: Application From the American 
Association for Accreditation of Ambulatory Surgery Facilities for 
Continued Approval of Its Rural Health 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 American Association for Accreditation of 
Ambulatory Surgery Facilities (AAAASF) for continued recognition as a 
national accrediting organization for Rural Health Clinics (RHCs). 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. on October 26, 2015.

ADDRESSES: In commenting, please refer to file code CMS-3322-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-3322-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-3322-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.)

[[Page 57823]]

    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: Cindy Melanson, (410) 786-0310; 
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-3322-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) 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. The regulations at 
42 CFR part 491, subpart A, specify the minimum conditions that an RHC 
must meet to participate in the Medicare program.
    Generally, to enter into an agreement, an RHC must first be 
certified by a State survey agency as complying with the conditions or 
requirements set forth in part 491, subpart A of our Medicare 
regulations. Thereafter, the RHC is subject to regular surveys by a 
State survey agency to determine whether it continues to meet these 
requirements.
    Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by a Centers for Medicare & Medicaid 
Services (CMS) approved national accrediting organization that all 
applicable Medicare conditions are met or exceeded, we may 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 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 may 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 CMS 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 and re-approval of accrediting organizations are set forth at 
Sec.  488.5. The regulations at Sec.  488.5(i) require accrediting 
organizations to reapply for continued approval of its accreditation 
program every 6 years or sooner as determined by CMS.
    American Association for Accreditation of Ambulatory Surgery 
Facilities (AAAASF's) current term of approval for their RHC 
accreditation program expires March 23, 2016.

II. Approval of Deeming Organizations

    Section 1865(a)(2) of the Act and our regulations at 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 CMS 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 
AAAASF's request for continued approval of its RHC accreditation 
program. This notice also solicits public comment on whether AAAASF's 
requirements meet or exceed the Medicare conditions for certification 
for RHCs.

 III. Evaluation of Deeming Authority Request

    AAAASF 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 July 31, 2015. Under section 1865(a)(2) of the Act and our 
regulations at Sec.  488.5 (Application and re-application procedures 
for national accrediting organizations), our review and evaluation of 
AAAASF will be conducted in accordance with, but not necessarily 
limited to, the following factors:
     The equivalency of AAAASF's standards for RHCs as compared 
with Medicare's RHC conditions for certification.
     AAAASF'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 AAAASF's processes to those of State 
agencies, including survey frequency, and the ability to investigate 
and respond appropriately to complaints against accredited facilities.
    ++ AAAASF's processes and procedures for monitoring a RHC found out 
of compliance with AAAASF's program requirements. These monitoring 
procedures are used only when AAAASF identifies noncompliance. If 
noncompliance is

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identified through validation reviews or complaint surveys, the State 
survey agency monitors corrections as specified at Sec.  488.9(c).
    ++ AAAASF's capacity to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    ++ AAAASF'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 AAAASF's staff and other resources, and its 
financial viability.
    ++ AAAASF's capacity to adequately fund required surveys.
    ++ AAAASF's policies with respect to whether surveys are announced 
or unannounced, to assure that surveys are unannounced.
    ++ AAAASF'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: September 16, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-24356 Filed 9-24-15; 8:45 am]
 BILLING CODE 4120-01-P