[Federal Register Volume 82, Number 112 (Tuesday, June 13, 2017)]
[Notices]
[Pages 27067-27068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12193]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3343-PN]


Medicare and Medicaid Programs: Application From the American 
Osteopathic Association/Healthcare Facilities Accreditation Program 
(AOA-HFAP) for Continued CMS Approval of Its Ambulatory Surgical Center 
Accreditation Program

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Notice with request for comment.

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SUMMARY: This proposed notice acknowledges the receipt of an 
application from the American Osteopathic Association/Healthcare 
Facilities Accreditation Program (AOA-HFAP) for continued recognition 
as a national accrediting organization for Ambulatory Surgical Centers 
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 July 13, 2017.

ADDRESSES: In commenting, please refer to file code CMS-3343-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-3343-PN, P.O. Box 8010, 
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-3343-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) 786-9994 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: Monda Shaver, (410) 786-0310, Erin 
McCoy, (410) 786-2337, or 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 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 an Ambulatory Surgical Center (ASC) provided 
certain requirements are met. Section 1832(a)(2)(F)(i) of the Social 
Security Act (the Act) establishes distinct criteria for facilities 
seeking designation as an ASC. 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 416 specify the conditions 
that an ASC must meet in order to participate in the Medicare program, 
the scope of covered services, and the conditions for Medicare payment 
for ASCs.
    Generally, to enter into an agreement, an ASC must first be 
certified by a State survey agency as complying with the conditions or 
requirements set forth in part 416 of our Medicare regulations. 
Thereafter, the ASC 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 (AO) that all 
applicable Medicare conditions are met or exceeded, we may 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 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. An AO applying for approval of its accreditation 
program under part 488, subpart A, must provide CMS with reasonable 
assurance that the AO requires the accredited provider

[[Page 27068]]

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.  488.5.

II. CMS Approval of Accreditation Organizations

    Section 1865(a)(2) of the Act and our regulations at Sec.  488.5 
require that our findings concerning review and approval of an AO's 
requirements consider, among other factors, the applying AO'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 notice of proposed recognition is to inform the 
public of the American Osteopathic Association/Healthcare Facilities 
Accreditation Program's (AOA-HFAP's) request for continued CMS approval 
of its ASC accreditation program. This notice also solicits public 
comment on whether AOA-HFAP's requirements meet or exceed the Medicare 
conditions for coverage (CfCs) for ASCs.

III. Evaluation of an AO's Accreditation Program

    AOA-HFAP submitted all the necessary materials to enable us to make 
a determination concerning its request for continued CMS approval of 
its ASC accreditation program. This application was determined to be 
complete on April 14, 2017. Under section 1865(a)(2) of the Act and our 
regulations at Sec.  488.5, our review and evaluation of AOA-HFAP will 
be conducted in accordance with, but not necessarily limited to, the 
following factors:
     The equivalency of AOA-HFAP's standards for ASCs as 
compared with Medicare's CfCs for ASCs.
     AOA-HFAP'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 AOA-HFAP's processes to those of State 
agencies, including survey frequency, and the ability to investigate 
and respond appropriately to complaints against accredited facilities.
    ++ AOA-HFAP's processes and procedures for monitoring an ASC found 
out of compliance with AOA-HFAP's program requirements. These 
monitoring procedures are used only when AOA-HFAP 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)(1).
    ++ AOA-HFAP's capacity to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    ++ AOA-HFAP'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 AOA-HFAP's staff and other resources, and its 
financial viability.
    ++ AOA-HFAP's capacity to adequately fund required surveys.
    ++ AOA-HFAP's policies with respect to whether surveys are 
announced or unannounced, to assure that surveys are unannounced.
    ++ AOA-HFAP'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).
    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.

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.

    Dated: June 7, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2017-12193 Filed 6-12-17; 8:45 am]
 BILLING CODE 4120-01-P