[Federal Register Volume 77, Number 228 (Tuesday, November 27, 2012)]
[Notices]
[Pages 70783-70785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-28728]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3265-FN]


Medicare and Medicaid Programs; Approval of the Accreditation 
Association for Ambulatory Health Care (AAAHC) Application for 
Continuing CMS Approval of Its Ambulatory Surgical Center Accreditation 
Program

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Final notice.

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

DATES: Effective Date: This notice is effective December 20, 2012 
through December 20, 2018.

FOR FURTHER INFORMATION CONTACT: Lillian Williams, (410) 786-8636. 
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) requires ASCs to meet

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health, safety, and other standards specified by the Secretary. 
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 part 416. Thereafter, the ASC is subject to 
regular surveys by a State survey agency to determine whether it 
continues to meet these requirements. However, there is an alternative 
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, CMS will deem those provider entities as having met the 
Medicare 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, a 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 
accrediting organizations to reapply for continued approval of its 
accreditation program every 6 years or sooner as determined by CMS.
    The Ambulatory Health Care's (AAAHC) current term of approval for 
their ASC accreditation program expires on December 20, 2012.

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 June 22, 2012, we published a proposed notice in the Federal 
Register (77 FR 37678) entitled, ``Application from the Accreditation 
Association for Ambulatory Health Care for Continued Approval of Its 
Ambulatory Surgical Centers Accreditation Program'' announcing the 
AAAHC's request for continued approval of its ASC accreditation 
program.
    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 AAAHC'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 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 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 AAAHC's accreditation to CMS's current 
Medicare ASC conditions for coverage.
     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 of State survey agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
    + Evaluate AAAHC's procedures for monitoring ASC's found to be out 
of compliance with AAAHC's program requirements. The monitoring 
procedures are used only when AAAHC identifies noncompliance. If 
noncompliance is identified through validation reviews, the State 
survey agency monitors corrections as specified at Sec.  488.7(d).
    + Assess AAAHC's ability to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    + 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 staff and other resources.
    + Confirm AAAHC's ability to provide adequate funding for 
performing required surveys.
    + Confirm AAAHC's policies with respect to whether surveys are 
announced or 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 June 22, 
2012 proposed notice also solicited public comments regarding whether 
AAAHC's requirements met or 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 AAAHC's Standards and Requirements for 
Accreditation and Medicare's Conditions and Survey Requirements

    We compared AAAHC's ASC requirements and survey process with the 
Medicare conditions for certification and survey process as outlined in 
the State Operations Manual (SOM). Our review and evaluation of AAAHC'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(a), AAAHC revised 
its standards to address all contracts.
     To meet the requirements at Sec.  416.41(c)(1), AAAHC 
revised its standards to address ``the emergency care of patients.''
     To meet the requirements at Sec.  416.44, AAAHC revised 
its standards to address the Life Safety Code (LSC) survey and created 
a policy to ensure all ASCs receive a complete and comprehensive LSC 
survey.
     To meet the requirements at Sec.  416.47(a), AAAHC revised 
its standards to address the use of patients records.
     To meet the requirements at Sec.  416.47(b), AAAHC revised 
its standards to address the requirement that every record must be 
accurate, legible, and promptly completed.
     To meet the requirements at Sec.  416.50(b)(1)(ii), AAAHC 
revised its standards to ensure patients have the right to ``voice 
grievances regarding treatment or care that is (or fails to be) 
provided.''
     To meet the requirements at Sec.  488.4(a)(5), AAAHC 
modified its policies to improve the accuracy and consistency of data 
submissions to CMS.
     To meet the requirements at Sec.  488.4(a)(6), AAAHC 
modified its

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policies to ensure that all compliant investigations are conducted in 
accordance with the requirements in the SOM, chapter 5.
     To meet the requirements at Sec.  488.28(a) and Section 
2726 of the SOM, AAAHC amended its policies to require a Plan of 
Correction (PoC) for all deficiencies cited.
     To meet the requirements at section 2728A of the SOM, 
AAAHC modified its policies to include all of the required elements in 
an acceptable PoC.
     To meet the requirements at 2728B of the SOM, AAAHC 
modified its policies regarding timeframes for requesting PoCs.
     To meet the requirements at section 2728B of the SOM, 
AAAHC modified its policies to ensure that accepted PoCs contain all 
elements specified in the SOM.
     To meet the Medicare requirements at section 3012 of the 
SOM related to focused and follow-up surveys, AAAHC amended its 
policies to include the 45-day response timeframe.
     To meet the requirements at Appendix L of the SOM-- 
Sampling for Initial Surveys, Recertification Surveys, or 
Representative Sample Validation Surveys, AAAHC revised its policies to 
ensure surveyors review at least the required minimum number of medical 
records during a survey.
     To meet the requirements at Appendix L of the SOM-- Use of 
the Infection Control Tool, AAAHC revised its survey protocol to ensure 
consistency, completeness and proper implementation of the Infection 
Control Tool.
     To verify AAAHC's continued compliance with the provisions 
of the LSC, CMS will conduct a follow-up survey observation within 1 
year of the date of publication of this final notice.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we have determined that AAAHC's requirements for 
ASCs meet or exceed our requirements. Therefore, we approve AAAHC as a 
national accreditation organization for ASCs that request participation 
in the Medicare program, effective December 20, 2012 through December 
20, 2018.

V. Collection of Information Requirements

    This document does not impose any 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).

(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. 2012-28728 Filed 11-23-12; 8:45 am]
BILLING CODE 4120-01-P