[Federal Register Volume 83, Number 144 (Thursday, July 26, 2018)]
[Notices]
[Pages 35486-35488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15951]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3362-PN]


Medicare and Medicaid Programs: Application From the 
Accreditation Association for Ambulatory Health Care, Inc. (AAAHC) for 
Continued Approval of Its Ambulatory Surgical Center Accreditation 
Program

AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS.

ACTION: Notice with request for comment.

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SUMMARY: This proposed notice acknowledges the receipt of an 
application from the Accreditation Association for Ambulatory Health 
Care, Inc. (AAAHC) for continued recognition as a national accrediting 
organization (AO) 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 August 27, 2018.

ADDRESSES: In commenting, refer to file code CMS-3362-PN. Because of 
staff and resource limitations, we cannot accept comments by facsimile 
(FAX) transmission.
    Comments, including mass comment submissions, must be submitted in 
one of the following three 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:

[[Page 35487]]

CMS-3362-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-3362-PN, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Erin McCoy, (410) 786-2337, Monda 
Shaver, (410) 786-3410, or 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 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 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 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.
    The Accreditation Association for Ambulatory Health Care, Inc.'s 
(AAAHC's) current term of approval for its ASC program expires December 
20, 2018.

II. Provisions of the Proposed Notice

A. 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 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 proposed notice is to inform the public of 
AAAHC's request for continued CMS-approval of its ASC accreditation 
program. This notice also solicits public comment on whether AAAHC's 
requirements meet or exceed the Medicare conditions for coverage (CfCs) 
for ASCs.

B. Evaluation of Deeming Authority Request

    AAAHC 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 May 24, 2018. Under section 1865(a)(2) of the Act and our 
regulations at Sec.  488.5, our review and evaluation of AAAHC will be 
conducted in accordance with, but not necessarily limited to, the 
following factors:
    <bullet> The equivalency of AAAHC's standards for ASCs as compared 
with Medicare's CfCs for ASCs.
    <bullet> AAAHC'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 AAAHC's processes to those of State 
agencies, including survey frequency, and the ability to investigate 
and respond appropriately to complaints against accredited facilities.
    ++ AAAHC's processes and procedures for monitoring an ASC found out 
of compliance with AAAHC's program requirements. These monitoring 
procedures are used only when AAAHC 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).
    ++ AAAHC's capacity to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    ++ AAAHC'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 AAAHC's staff and other resources, and its 
financial viability.
    ++ AAAHC's capacity to adequately fund required surveys.
    ++ AAAHC's policies with respect to whether surveys are announced 
or unannounced, to assure that surveys are unannounced.
    ++ AAAHC'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).

[[Page 35488]]

C. Notice Upon Completion of Evaluation

    Upon completion of our evaluation, including evaluation of public 
comments received as a result of this notice, we will publish a final 
notice in the Federal Register announcing the result of our evaluation.

III. 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.).

IV. 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: July 20, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-15951 Filed 7-23-18; 4:15 pm]
BILLING CODE 4120-01-P