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[Federal Register Volume 77, Number 227 (Monday, November 26, 2012)]
[Notices]
[Pages 70446-70447]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28640]

[[Page 70446]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3262-FN]

Medicare and Medicaid Programs; Approval of the American 
Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) 
for Continuing CMS Approval of Its Ambulatory Surgical Center 
Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Final notice.

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SUMMARY: This notice announces our decision to approve the American 
Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) 
for continued recognition as a national accrediting organization for 
ambulatory surgical centers (ASCs) that wish to participate in the 
Medicare or Medicaid programs.

DATES: Effective Date: This final notice is effective November 27, 2012 
through November 27, 2018.

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 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 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 42 CFR part 416. Thereafter, the ASC is 
subject to regular surveys by a State survey agency to determine 
whether it continues to meet these 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 accrediting 
organization that all applicable Medicare conditions are met or 
exceeded, we will deem those provider entities as having met the 
requirements. Accreditation by an accrediting organization is voluntary 
and is not required for Medicare participation.
    If an accrediting organization is recognized by the Secretary as 
having standards for accreditation that meet or exceed Medicare 
requirements, any provider entity accredited by the national 
accrediting body's approved program would be deemed to meet the 
Medicare conditions. A national accrediting organization applying for 
approval of its accreditation program under part 488, subpart A, must 
provide us with reasonable assurance that the accrediting organization 
requires the 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 and Sec.  488.8(d)(3). The regulations at Sec.  488.8(d)(3) 
require an accrediting organization to reapply for continued approval 
of its accreditation program every 6 years or sooner as determined by 
CMS.
    American Association for Accreditation of Ambulatory Surgery 
Facilities (AAAASFs) current term of approval for their ASC 
accreditation program expires November 27, 2012.

II. Application Approval Process

    Section 1865(a)(3)(A) of the Act provides a statutory timetable to 
ensure that our review of applications for CMS approval of an 
accreditation program is conducted in a timely manner. The Act provides 
us with 210 days from receipt of a complete application, with any 
documentation necessary, to make the determination and to complete our 
survey activities and application process. Within 60 days after 
receiving a complete application, we must publish a notice in the 
Federal Register that identifies the national accrediting 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 a notice in the Federal Register approving or denying the 
application.

III. Provisions of the Proposed Notice

    On June 22, 2012, we published a proposed notice in the Federal 
Register (77 FR 37678) announcing AAAASF's request for continued 
approval of its 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.  488.4 and Sec.  488.8, we conducted a 
review of AAAASF's application in accordance with the criteria 
specified by our regulations, which include, but are not limited to the 
following:
     An onsite administrative review of AAAASF's--(1) corporate 
policies; (2) financial and human resources available to accomplish the 
proposed surveys; (3) procedures for training, monitoring, and 
evaluation of its surveyors; (4) ability to investigate and respond 
appropriately to complaints against accredited facilities; and (5) 
survey review and decision-making process for accreditation.
     The comparison of AAAASF's accreditation to CMS's current 
Medicare ASC conditions for coverage.
     A documentation review of AAAASF's survey process to--
    + Determine the composition of the survey team, surveyor 
qualifications, and AAAASF's ability to provide continuing surveyor 
training.
    + Compare AAAASF's processes to those of State survey agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
    + Evaluate AAAASF's procedures for monitoring ASCs found to be out 
of compliance with AAAASF's program requirements. The monitoring 
procedures are used only when AAAASF identifies noncompliance. If 
noncompliance is identified through validation reviews, the State 
survey agency monitors corrections as specified at Sec.  488.7(d).
    + Assess AAAASF's ability to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    + Establish AAAASF'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 staff and other resources.
    + Confirm AAAASF's ability to provide adequate funding for 
performing required surveys.
    + Confirm AAAASF's policies with respect to whether surveys are 
announced or unannounced.
    + Obtain AAAASF'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 June 22, 
2012 proposed notice also solicited public comments regarding whether 
AAAASF's requirements met or

[[Page 70447]]

exceeded the Medicare conditions for coverage for ASCs. We received no 
public comments in response to our proposed notice.

IV. Provisions of the Final Notice

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

    We compared AAAASF's ASC requirements and survey process with the 
Medicare conditions for coverage and survey process as outlined in the 
State Operations Manual (SOM). Our review and evaluation of AAAASF's 
ASC application, which were conducted as described in section III of 
this final notice, yielded the following:
     To meet the requirements at Sec.  416.41(b)(2), AAAASF 
revised its standards to ensure the ASC's transfer agreement is with a 
local, Medicare-participating hospital that meets the requirements for 
emergency services.
     To meet the requirements at Sec.  416.44(a)(2), AAAASF 
revised its standards to address the requirement that ``the ASC must 
have a separate recovery room and waiting area.''
     AAAASF revised its crosswalk to ensure that all regulatory 
references are correct for the following citations: Sec.  416.42(a)(2), 
Sec.  416.42(c)(2), Sec.  416.44(c)(3), Sec.  416.50(c)(1), Sec.  
416.50(e), and Sec.  416.50(g).
     To meet the requirements at Sec.  488.4(a)(4), AAAASF 
modified its policies to ensure all personnel files are accurate and 
complete.
     To meet the requirements at Sec.  488.4(a)(5), AAAASF 
modified its policies to improve the accuracy and consistency of data 
submissions to CMS.
     To meet the requirements at Sec.  488.4(a)(6), AAAASF 
modified its policies to ensure all compliant investigations are 
conducted in accordance with the requirements in chapter Five of the 
SOM.
     To meet the requirements at Sec.  488.6(a), AAAASF revised 
its policies and procedures to ensure deemed status survey files are 
complete and accurate.
     To meet the requirements at Sec.  488.12, AAAASF modified 
its policies to ensure all pertinent survey information, including all 
surveys conducted, is included in the final accreditation decision 
letters.
     To meet the medical record requirements at Appendix L of 
the SOM, AAAASF revised its policies to ensure surveyors review the 
required number of medical records during a survey.
     To meet the requirements at Section 2728 of the SOM, 
AAAASF modified its policies regarding timeframes for sending and 
receiving a plan of correction.
     To meet the requirements at Section 3012 of the SOM, 
AAAASF modified its policies to ensure follow-up, focused surveys for 
condition level noncompliance are conducted timely.
     To meet the requirements at Section 2700A of the SOM, 
AAAASF modified its policies to ensure all surveys are conducted 
unannounced.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we have determined that AAAASF's requirements for 
ASCs meet or exceed our requirements. Therefore, we approve AAAASF as a 
national accreditation organization for ASCs that request participation 
in the Medicare program, effective November 27, 2012 through November 
27, 2018.

V. Collection of Information Requirements

    This document does not impose any information reporting, 
recordkeeping or third-party disclosure 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).

    Authority: Section 1865 of the Social Security Act (42 U.S.C. 
1395bb).

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

    Dated: November 20, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-28640 Filed 11-23-12; 8:45 am]
BILLING CODE 4120-01-P
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