[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