[Federal Register Volume 80, Number 233 (Friday, December 4, 2015)]
[Notices]
[Pages 75866-75867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30316]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3329-PN]


Medicare and Medicaid Programs: Application From the Institute 
for Medical Quality for Initial 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 Institute for Medical Quality (IMQ) for 
recognition as a national accrediting organization (NAO) for Ambulatory 
Surgical Centers (ASCs) 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 January 4, 2016.

ADDRESSES: In commenting, please refer to file code CMS-3329-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-3329-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-3329-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 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: Cindy Melanson, (410) 786-0310. 
Patricia Chmielewski, (410) 786-6899. Marie Vasbinder, (410) 786-8665.

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

[[Page 75867]]

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 (NAO) that 
all applicable Medicare conditions are met or exceeded, we may deem 
those provider entities as having met the requirements. Accreditation 
by an NAO is voluntary and is not required for Medicare participation.
    If an NAO 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. A NAO applying for approval of its 
accreditation program under part 488, subpart A, must provide CMS with 
reasonable assurance that the NAO requires the accredited provider 
entities to meet requirements that are at least as stringent as the 
Medicare conditions. Our regulations concerning the approval of NAOs 
are set forth at Sec.  488.5.

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 NAO's 
requirements consider, among other factors, the applying NAO'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 the 
Institute for Medical Quality (IMQ's) request for initial CMS-approval 
of its ASC accreditation program. This notice also solicits public 
comment on whether IMQ's requirements meet or exceed the Medicare 
conditions for coverage (CfCs) for ASCs.

III. Evaluation of a NAO's Accreditation Program

    IMQ submitted all the necessary materials to enable us to make a 
determination concerning its request for initial CMS-approval of its 
ASC accreditation program. This application was determined to be 
complete on October 8, 2015. Under Section 1865(a)(2) of the Act and 
our regulations at Sec.  488.5, our review and evaluation of IMQ will 
be conducted in accordance with, but not necessarily limited to, the 
following factors:
     The equivalency of IMQ's standards for ASCs as compared 
with Medicare's CfCsf or ASCs.
     IMQ'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 IMQ's processes to those of State agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
    ++ IMQ's processes and procedures for monitoring an ASC found out 
of compliance with IMQ's program requirements. These monitoring 
procedures are used only when IMQ 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).
    ++ IMQ's capacity to report deficiencies to the surveyed facilities 
and respond to the facility's plan of correction in a timely manner.
    ++ IMQ'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 IMQ's staff and other resources, and its 
financial viability.
    ++ IMQ's capacity to adequately fund required surveys.
    ++ IMQ's policies with respect to whether surveys are announced or 
unannounced, to assure that surveys are unannounced.
    ++ IMQ'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: November 18, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-30316 Filed 12-3-15; 8:45 am]
BILLING CODE 4120-01-P