[Federal Register Volume 74, Number 185 (Friday, September 25, 2009)]
[Notices]
[Pages 48974-48976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22956]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2487-FN]


Medicare and Medicaid Programs; Application by the American 
Osteopathic Association for Continued Deeming Authority for Ambulatory 
Surgical Centers

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

ACTION: Final notice.

-----------------------------------------------------------------------

SUMMARY: This final notice announces our decision to approve the 
American Osteopathic Association (AOA) for continued recognition as a 
national accreditation program for ambulatory surgical centers (ASCs) 
seeking to participate in the Medicare or Medicaid programs.

DATES: Effective Date: This final notice is effective on October 23, 
2009 through October 23, 2013.

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. Sections 1832(a)(2)(F)(i) of the Social 
Security Act (the Act) establishes distinct criteria for facilities 
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

[[Page 48975]]

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 as having 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 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 we determine.

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 that a 30-day public 
comment period. At the end of the 210-day period, we must publish an 
approval or denial of the application.

III. Provisions of the Proposed Notice

    On May 26, 2009, we published a proposed notice (74 FR 24857) 
announcing the American Osteopathic Association's (AOA) request for re-
approval as a deeming organization for ASCs. In the proposed notice, we 
detailed our evaluation criteria. Under section 1865(a)(2) of the Act 
and our regulations at Sec.  488.4 (Application and reapplication 
procedures for accreditation organizations), we conducted a review of 
the AOA application in accordance with the criteria specified by our 
regulation, which include, but are not limited to the following:
     An onsite administrative review of AOA'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;
     A comparison of AOA's ASC accreditation standards to our 
current Medicare ASC conditions for coverage; and
     A documentation review of AOA's survey processes to:
    [cir] Determine the composition of the survey team, surveyor 
qualifications, and the ability of AOA to provide continuing surveyor 
training;
    [cir] Compare AOA's processes to those of State survey agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities;
    [cir] Evaluate AOA's procedures for monitoring providers or 
suppliers found to be out of compliance with AOA's program 
requirements. The monitoring procedures are used only when AOA 
identifies noncompliance. If noncompliance is identified through 
validation reviews, the State survey agency monitors corrections as 
specified at Sec.  488.7(d);
    [cir] Assess AOA's ability to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner;
    [cir] Establish AOA's ability to provide us with electronic data 
and reports necessary for effective validation and assessment of AOA's 
survey process;
    [cir] Determine the adequacy of staff and other resources;
    [cir] Review AOA's ability to provide adequate funding for 
performing required surveys;
    [cir] Confirm AOA's policies with respect to whether surveys are 
announced or unannounced; and
    [cir] Obtain AOA's agreement to provide us 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 26, 
2009 proposed notice (74 FR 24857) also solicited public comments 
regarding whether AOA's requirements met or exceeded the Medicare 
conditions for coverage (CfC) for ASCs. We received no public comments 
in response to our proposed notice.

IV. Provisions of the Final Notice

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

    We compared the AOA's ASCs accreditation requirements and survey 
process with the Medicare CfCs and survey process as outlined in the 
State Operations Manual (SOM). Our review and evaluation of the AOA's 
deeming application, which were conducted as described in section III 
of this final notice, yielded the following:
     AOA modified its policies related to the accreditation 
effective date in accordance with the requirements at Sec.  489.13;
     AOA modified its policies regarding timeframes for sending 
and receiving a plan of correction (PoC) in accordance with section 
2728 of the SOM;
     AOA revised its policies to include timeframes for 
investigation of complaints in accordance with the requirements at 
section 5075.9 of the SOM;
     AOA developed and implemented internal monitoring 
procedures to ensure its surveyors are trained and qualified to meet 
the requirements at Sec.  488.4(a)(4);
     AOA developed an action plan to ensure that deemed status 
survey files are complete, accurate, and consistent with the 
requirements at Sec.  488.6(a);
     AOA developed and conducted surveyor training on the 
documentation of deficiencies to ensure that all cited deficiencies 
contain a regulatory reference, a clear and detailed description of the 
deficient practice, and relevant finding;
     AOA developed a policy to ensure that facilities with 
condition level non-compliance on a recertification survey submit an 
acceptable PoC, and receive a follow-up onsite focused survey, in order 
to meet the requirements at Sec.  488.20(b) and Sec.  488.28(a);
     AOA revised its policies and developed an internal 
tracking tool to

[[Page 48976]]

ensure that facilities with condition level non-compliance on an 
initial survey receive an onsite follow-up full survey, in order to 
meet the requirements at section 2005A2 of the SOM;
     AOA developed and incorporated measures to improve the 
accuracy and consistency of data submissions to CMS in order to meet 
the requirements at Sec.  488.4(b);
     AOA revised its policies on blackout dates to meet the 
requirements at 2700A of the SOM;
     AOA revised its accreditation decision letters to ensure 
that they are accurate and contain all the required elements for our 
Regional Office to render a decision regarding the deemed status of an 
accredited ASC;
     AOA revised and updated its surveyor team handbook to 
include references to its ASC deeming program;
     AOA extended its onsite survey time allotted for review of 
the CfCs from 1 day to 2 days in order to meet the requirements at 
Sec.  488.26; and
     AOA removed all references to mandatory consultative 
services from its policies to avoid potential conflict of interest 
issue.
    To verify AOA's continued compliance with the provisions of this 
final notice, we will conduct a follow-up corporate onsite visit within 
1 year of the date of publication of this notice.

B. Term of Approval

    Based on the review and observations described in section III of 
this final notice, we have determined that the AOA's requirements for 
ASCs meet or exceed our requirements. Therefore, we approve AOA as a 
national accreditation organization for ASCs that request participation 
in the Medicare program, effective October 23, 2009 through October 23, 
2013.

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: September 10, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E9-22956 Filed 9-24-09; 8:45 am]
BILLING CODE 4120-01-P