[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Notices]
[Pages 65676-65677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27592]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3362-FN]


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

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

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve the 
Accreditation Association for Ambulatory Health Care, Inc. for 
continued recognition as a national accrediting organization for 
ambulatory surgical centers that wish to participate in the Medicare or 
Medicaid programs.

DATES: Applicable Date: December 20, 2018 through December 20, 2024.

FOR FURTHER INFORMATION CONTACT: Lillian Williams, (410) 786-8636, 
Monda Shaver, (410) 786-3410, or Renee Henry, (410) 786-7828.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in an Ambulatory Surgical Center (ASC) provided 
certain requirements are met. Sections 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 as complying with the conditions set forth in part 416 and 
recommended to the Centers for Medicare & Medicaid Services (CMS) for 
participation by a state survey agency. Thereafter, the ASC is subject 
to periodic surveys by a state survey agency to determine whether it 
continues to meet these conditions. However, there is an alternative to 
certification surveys by state agencies. Accreditation by a nationally 
recognized Medicare accreditation program approved by CMS may 
substitute for both initial and ongoing state review.
    Section 1865(a)(1) of the Act provides that, if the Secretary of 
the Department of Health and Human Services finds that accreditation of 
a provider entity by an approved national accrediting organization 
meets or exceeds all applicable Medicare conditions or requirements, we 
may deem the provider entity as having met those conditions or 
requirements. Accreditation by an accrediting organization is voluntary 
and is not required for Medicare participation.
    A national accrediting organization applying for approval of its 
Medicare accreditation program under part 488, subpart A, must provide 
CMS with reasonable assurance that the accrediting organization 
requires its accredited provider entities to meet requirements that are 
at least as stringent as the Medicare conditions. Our regulations 
concerning the approval of accrediting organizations are set forth at 
Sec.  488.4.

II. Application Approval Process

    Section 1865(a)(3)(A) of the Act 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 a notice of approval or denial of the 
application.

III. Provisions of the Proposed Notice

    On July 26, 2018, we published a proposed notice entitled 
``Application from the Accreditation Association for Ambulatory Health 
Care, Inc. (AAAHC) for Continued Approval of its Ambulatory Surgical 
Center Accreditation Program'' in the Federal Register (83 FR 35486) 
announcing AAAHC's request for continued approval of its Medicare ASC 
accreditation program. In the proposed notice, we detailed our 
evaluation criteria. Under section 1865(a)(2) of the Act and in our 
regulations at Sec.  488.5, we conducted a review of AAAHC's Medicare 
ASC accreditation renewal application in accordance with the criteria 
specified by our regulations, which include, but are not limited to the 
following:
     An onsite administrative review of AAAHC's: (1) Corporate 
policies; (2) financial and human resources available to accomplish the 
proposed surveys; (3) procedures for training, monitoring, and 
evaluation of its ASC surveyors; (4) ability to investigate and respond 
appropriately to complaints against accredited ASCs; and, (5) survey 
review and decision-making process for accreditation.
     The comparison of AAAHC's Medicare ASC accreditation 
program standards to our current Medicare ASC conditions for coverage 
(CfCs).
     A documentation review of AAAHC's survey process to:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and AAAHC's ability to provide continuing surveyor 
training.
    ++ Compare AAAHC's processes to those we require of state survey 
agencies, including periodic resurvey and the ability to investigate 
and respond appropriately to complaints against accredited ASCs.
    ++ Evaluate AAAHC's procedures for monitoring ASCs it has found to 
be out of compliance with AAAHC's program requirements. (This pertains 
only to monitoring procedures when AAAHC identifies non-compliance. If 
noncompliance is identified by a state survey agency through a 
validation survey, the state survey agency monitors corrections as 
specified at Sec.  488.9(c).)
    ++ Assess AAAHC's ability to report deficiencies to the surveyed 
ASC and respond to the ASCs plan of correction in a timely manner.

[[Page 65677]]

    ++ Establish AAAHC's ability to provide CMS with electronic data 
and reports necessary for effective validation and assessment of the 
organization's survey process.
    ++ Determine the adequacy of AAAHC's staff and other resources.
    ++ Confirm AAAHC's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm AAAHC's policies with respect to surveys being 
unannounced.
    ++ Obtain 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 we may require, including corrective action 
plans.
    In accordance with section 1865(a)(3)(A) of the Act, the July 26, 
2018 proposed notice also solicited public comments regarding whether 
AAAHC's requirements met or exceeded the Medicare CfCs for ASCs. We 
received no comments in response to our proposed notice.

IV. Provisions of the Final Notice

A. Differences Between AAAHC's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements

    We compared AAAHC's ASC accreditation program requirements and 
survey process with the Medicare CfCs at part 416, and the survey and 
certification process requirements of parts 488 and 489. Our review and 
evaluation of AAAHC's ASC application, which were conducted as 
described in section III of this final notice, yielded the following 
areas where, as of the date of this notice, AAAHC has revised its 
standards and certification processes in order to meet the requirements 
at:
     Sec.  416.44(b)(1), to ensure its standards appropriately 
reference Life Safety Code requirements;
     Sec.  416.44(c), to ensure its standards appropriately 
reference Life Safety Code requirements;
     Sec.  416.44(c)(1)(iv), to ensure its standards 
appropriately reference Life Safety Code requirements;
     Sec.  488.5(a)(4)(ii), to ensure comparability of AAAHC's 
survey process and surveyor guidance to those required for state survey 
agencies conducting federal Medicare surveys for the same provider or 
supplier type;
     Sec.  488.5(a)(4)(iv), to ensure all identified areas of 
non-compliance are clearly documented and cited appropriately in the 
final survey report.
     Sec.  488.5(a)(7) through (9), to ensure its surveyors are 
appropriately qualified, trained and maintain competence during 
extended periods of time without conducting a survey;
     Sec.  488.5(a)(11)(ii), to ensure accurate survey findings 
are reported to CMS;
     Sec.  488.5(a)(12), to ensure complaints are triaged 
appropriately and surveyed within the required timeframes;
     Sec.  488.18(a), to ensure that the findings are 
documented and written within the principles of documentation.
     Sec.  488.26(b), to ensure deficiencies are cited at the 
appropriate level based on manner and degree of findings; and
     Sec.  488.28(d), to ensure that its policies for 
correction of deficiencies in ASCs is comparable to CMS requirements, 
requiring that deficiencies normally must be corrected within 60 days.
     Sec.  489.13(c), to ensure that all accreditation 
requirements have been met before granting accreditation and making a 
recommendation for participation or continued participation in the 
Medicare program comparable to CMS requirements, requiring that 
deficiencies normally must be corrected within 60 days.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we approve AAAHC as a national accreditation 
organization for ASCs that request participation in the Medicare 
program, effective December 20, 2018 through December 20, 2024.

V. 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.).

    Dated: December 14, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-27592 Filed 12-20-18; 8:45 am]
BILLING CODE 4120-01-P