[Federal Register Volume 75, Number 161 (Friday, August 20, 2010)]
[Notices]
[Pages 51464-51465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19888]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2476-FN2]


Medicare and Medicaid Programs; Approval of the American 
Association for Accreditation of Ambulatory Surgery Facilities for 
Continued Deeming Authority for Ambulatory Surgical Centers

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

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve without 
condition the American Association for Accreditation of Ambulatory 
Surgery Facilities' (AAAASF) request for continued recognition as a 
national accreditation program for ambulatory surgical centers (ASC) 
seeking to participate in the Medicare or Medicaid programs.

DATES: Effective Date: This final notice is effective on November 27, 
2009 through November 27, 2012.

FOR FURTHER INFORMATION CONTACT:
Cindy Melanson (410) 786-0310.
Patricia Chmielewski (410) 786-6899.

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. Section 1832(a)(2)(F)(i) of the Social 
Security Act (the Act) establishes distinct criteria for a facility 
seeking designation as an ASC. Under this authority, the minimum 
requirements that an ASC must meet to participate in Medicare are set 
forth in regulations at 42 CFR part 416, which determine the basis and 
scope of ASC covered services, and the conditions for Medicare payment 
for facility services. 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.
    Generally, to enter into an agreement, an ASC must first be 
certified by a State survey agency as complying with conditions or 
requirements set forth in part 416 of our regulations. Then, the ASC is 
subject to regular surveys by a State survey agency to determine 
whether it continues to meet those requirements. There is an 
alternative, however, to surveys by State agencies.
    Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by an approved national 
accreditation organization that all applicable Medicare conditions are 
met or exceeded, we may ``deem'' those provider entities to have met 
the requirements. Accreditation by an accreditation organization is 
voluntary and is not required for Medicare participation.
    If an accreditation organization is recognized by the Secretary as 
having standards for accreditation that meet or exceed Medicare 
requirements, a provider entity accredited by the national accrediting 
body's approved program may be deemed to meet the Medicare conditions. 
A national accreditation organization applying for approval of deeming 
authority under part 488, subpart A, must provide us with reasonable 
assurance that the accreditation organization requires the accredited 
provider entities to meet requirements that are at least as stringent 
as the Medicare conditions. Our regulations concerning re-approval of 
accrediting organizations are set forth at section Sec.  488.4 and 
Sec.  488.8(d)(3). The regulations at Sec.  488.8(d)(3) require 
accreditation organizations to reapply for continued approval of 
deeming authority every 6 years, or sooner as determined by CMS. The 
regulation at Sec.  488.8(f)(3)(i) provides CMS the authority to grant 
conditional approval of an accreditation organization's deeming 
authority, with a probationary period of up to 180 days, if the 
accreditation organization has not adopted comparable standards during 
the reapplication process.
    We received a complete application from AAAASF for continued 
recognition as a national accreditation organization for ASCs on March 
31, 2009. In accordance with the requirements at Sec.  488.4 and Sec.  
488.8(d)(3), we published a proposed notice on June 26, 2009 (74 FR 
30587) and a final notice on November 27, 2009 (74 FR 62330). This 
final notice provides CMS' final determination in response to the 
conditional approval with a 180-day probationary period granted to the 
American Association for Accreditation of Ambulatory Surgery Facilities 
on November 27, 2009.

II. Deeming Applications Approval Process

    Section 1865(a)(3)(A) of the Act provides a statutory timetable to 
ensure that our review of deeming applications is conducted in a timely 
manner. The Act provides us with 210 calendar days after the date of 
receipt of an application to complete our survey activities and 
application review process. Within 60 days of receiving a completed 
application, we must publish a notice in the Federal Register that 
identifies the national accreditation body making the request, 
describes the request, and provides no less than a 30-day public 
comment period. At the end of the 210-day period, we must publish an 
approval or denial of the application. In accordance with Sec.  
488.8(f)(2), if CMS determines following the deeming authority review 
that the organization has failed to adopt requirements comparable to 
CMS requirements, the accreditation organization may be given a 
conditional approval of its deeming authority for a probationary period 
of up to 180 days to adopt comparable requirements. Within 60 days 
after the end of this period, we must make a final determination as to 
whether or not the AAAASF's accreditation program for ASCs is 
comparable to CMS requirements and issue an appropriate notice that 
includes our reasons for our determination.

III. Provisions of the November 27, 2009 Final Notice

    Our review of AAAASF's renewal application for ASC deeming 
authority revealed that AAAASF had on-going, serious, widespread areas 
of non-compliance. Specifically, AAAASF's inability to provide accurate 
and timely data on deemed providers; lack of complete and accurate 
deemed facility survey files; and, inadequate surveyor training and 
evaluation program. Due to the significant number of areas of 
noncompliance identified during the review of AAAASF's renewal 
application for deeming authority, we conditionally approved AAAASF's 
ASC accreditation program for 3 years with a 180 day probationary 
period. Under section 1865(a)(2) of the Act and our regulations at 
Sec.  488.4 and Sec.  488.8, we conducted a comparability review of

[[Page 51465]]

AAAASF's ASC accreditation program to determine compliance with the 
Medicare requirements for ASCs at 42 CFR part 416.

IV. Provisions of the Final Notice

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

    During the 180 day probationary period, we conducted a comparison 
of AAAASF's accreditation requirements for ASCs to our current Medicare 
conditions for coverage (CfCs) as outlined in the State Operations 
Manual (SOM). We also conducted a corporate onsite visit and survey 
observation to validate proper application of the requirements. Our 
review and evaluations of AAAASF's deeming application yielded the 
following:
     AAAASF's survey files were complete, accurate, and 
consistent with the requirements at Sec.  488.6(a).
     AAAASF's data submissions are accurate, complete and 
timely in accordance with the requirements at Sec.  488.4(b).
     AAAASF revised it accreditation decision letters to ensure 
they are accurate and contain all of the elements necessary for the 
Regional Office to render a decision regarding the deemed status of an 
accredited ASC.
     AAAASF revised its policies to require its surveyors to 
use the surveyor tools thus ensuring accurate and complete survey 
files.
     AAAASF developed surveyors tools to include a medical 
record review sheet, personnel review sheet, and policy review to 
assist surveyors with accurate, and complete documentation.
     To meet the Medicare requirements related to unannounced 
surveys at 2700A of the SOM, AAAASF modified its policies related to 
the survey window in which organizations could receive an accreditation 
survey for deemed status.
     To meet the survey process requirements in Appendix L of 
the SOM, AAAASF developed a policy outlining the minimum number of 
medical records that must be reviewed during a certification survey.
     To meet the requirements at SOM 2200F, AAAASF revised its 
policies and procedures to ensure documentation of deficiencies 
contains a regulatory reference, a clear and detailed description of 
the deficient practice, and relevant finding.
     To meet the requirements at 2728 of the SOM, AAAASF 
modified its policies regarding timeframes for sending and receiving a 
plan of correction (PoC) for life safety code surveys.
     To ensure its surveyors were adequately trained, AAAASF 
developed a website where surveyors could access a resource library of 
training webinars, interpretative guidelines, principles of 
documentation, standards, surveyor handbook, survey forms and other 
materials to assist surveyors in the field.

B. Term of Approval

    Based on the review and observations, we have determined that 
AAAASF's accreditation program for ASCs meets or exceeds our 
requirements. Therefore, we approve, without condition, AAAASF as a 
national accreditation organization for ASCs that request participation 
in the Medicare program, effective November 27, 2009 through November 
27, 2012. Under Sec.  488.4(f)(4), notice was given to AAAASF on 
November 27, 2009 (74 FR 62330) and this final notice, although not 
required by our regulations, is being published as a public service for 
informational purposes.

V. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 35).

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program) (Catalog of Federal Domestic Assistance Program 
No. 93.773, Medicare--Hospital Insurance; and Program No. 93.774, 
Medicare--Supplementary Medical Insurance Program).

    Dated: August 5, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-19888 Filed 8-19-10; 8:45 am]
BILLING CODE 4120-01-P