[Federal Register Volume 77, Number 189 (Friday, September 28, 2012)]
[Notices]
[Pages 59616-59618]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23996]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3264-FN]


Medicare and Medicaid Programs; Approval of the American 
Osteopathic Association/Healthcare Facilities Accreditation Program 
(AOA/HFAP) Application for Continuing CMS-Approval of Its Ambulatory 
Surgical Center (ASC) 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 
American Osteopathic Healthcare Facilities Accreditation Program (AOA/
HFAP) 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 final notice is effective October 23, 2013 
through October 23, 2017.

FOR FURTHER INFORMATION CONTACT:
    Barbara Easterling (410) 786-0482.
    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 ASC provided certain health, safety, and other 
requirements are met. Section 1832(a)(2)(F)(i) of the Act permits the 
Secretary to establish distinct criteria for facilities seeking 
designation as an ASC. 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. Regulations pertaining to activities 
relating to the survey and certification of facilities are at 42 CFR 
part 488.
    Generally, in order 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. 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. In accordance with the 
requirements at 416.26, an ASC may be deemed to meet conditions for 
coverage if it is accredited by a national accrediting body.
    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 
488.4 and 488.8. The regulations at 488.8(d)(3) require accrediting 
organizations to reapply for continued approval of its accreditation 
program

[[Page 59617]]

every 6 years or sooner as determined by CMS.
    AOA/HFAP's current term of approval for their ASC accreditation 
program expires October 23, 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 210 days after the date of receipt of a complete application, with 
any documentation necessary to make the determination, 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 May 25, 2012, we published a proposed notice in the Federal 
Register (77 FR 31361) announcing AOA/HFAP'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 488.4 and 488.8, we conducted a review of 
AOA/HFAP'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 AOA/HFAP'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 AOA/HFAP's accreditation to our current 
Medicare ASC conditions for coverage.
     A documentation review of AOA/HFAP's survey process for 
the following:
    + Determine the composition of the survey team, surveyor 
qualifications, and AOA/HFAP's ability to provide continuing surveyor 
training.
    + Compare AOA/HFAP'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 AOA/HFAP's procedures for monitoring ASC's found to be 
out of compliance with AOA/HFAP's program requirements. The monitoring 
procedures are used only when AOA/HFAP identifies noncompliance. If 
noncompliance is identified through validation reviews, the State 
survey agency monitors corrections as specified at 488.7(d).
    + Assess AOA/HFAP's ability to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    + Establish AOA/HFAP'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 AOA/HFAP's ability to provide adequate funding for 
performing required surveys.
    + Confirm AOA/HFAP's policies with respect to whether surveys are 
announced or unannounced.
    + Obtain AOA/HFAP'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 May 25, 
2012 proposed notice also solicited public comments regarding whether 
AOA/HFAP's requirements met or exceeded the Medicare conditions for 
coverage for ASCs. We received one comment in response to our proposed 
notice. The commenter expressed support for AOA/HFAP's ASC 
accreditation program.

IV. Provisions of the Final Notice

A. Differences Between AOA/HFAP's Standards and Requirements for 
Accreditation and Medicare's Conditions and Survey Requirements

    We compared AOA/HFAP'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 AOA/
HFAP's ASC application, which were conducted as described in section 
III of this final notice, yielded the following:
     To meet the requirements at 416.44(b)(1), AOA/HFAP revised 
its standards to include thresholds for new and existing Life Safety 
Code (LSC) requirements. In addition, AOA/HFAP revised its standards to 
ensure all waivers for LSC deficiencies are reviewed and approved by 
the CMS Regional Office.
     To meet the requirement at 416.44(b)(4), AOA/HFAP revised 
its standards to ensure all ASCs are in compliance with the emergency 
lighting requirements.
     To meet the requirement at 416.50, AOA/HFAP revised its 
crosswalk to include the patient rights condition for coverage 
requirements.
     To meet the requirements at 488.4, AOA/HFAP revised its 
policies to ensure the survey process requirements for ASCs is 
accurate, clear and complete.
     To meet the requirements at 488.8, AOA/HFAP modified its 
policies and procedures to ensure all complaints are appropriately 
triaged, and investigated.
     To meet the requirements at section 2728 of the SOM, AOA/
HFAP modified its policies to ensure all accepted plans of correction 
include the citation cited, the procedure implementing the plan, and 
the monitoring procedure.
     To meet the requirements of 2728B, AOA/HFAP revised its 
policies to ensure all plans of correction contain the procedure for 
implementing the plan and the monitoring procedure to ensure cited 
deficiencies remain corrected and in compliance with the regulatory 
requirements.
     AOA/HFAP also made extensive organization-wide changes to 
their internal processes in response to an 18 month accreditation 
program review that was concluded in July 2012. AOA/HFAP demonstrated 
compliance with our requirements across their organization and 
accreditation programs.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we have determined that AOA/HFAP's requirements for 
ASCs meet or exceed our requirements. Therefore, we approve AOA/HFAP as 
a national accreditation organization for ASCs that request 
participation in the Medicare program, effective October 23, 2013 
through October 23, 2017.

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; No. 93.773 Medicare--ASC Insurance Program; and 
No. 93.774,

[[Page 59618]]

Medicare--Supplementary Medical Insurance Program)

    Dated: September 25, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-23996 Filed 9-27-12; 8:45 am]
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