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###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

          - [CMS-2487-FN]

# 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                           ( print 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 § 488.4 and § 488.8(d)(3). The regulations at § 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 § 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:

○ Determine the composition of the survey team, surveyor qualifications, and the ability of AOA to provide continuing surveyor training;

○ 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;

○ 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 § 488.7(d);

○ Assess AOA's ability to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner;

○ Establish AOA's ability to provide us with electronic data and reports necessary for effective validation and assessment of AOA's survey process;

○ Determine the adequacy of staff and other resources;

○ Review AOA's ability to provide adequate funding for performing required surveys;

○ Confirm AOA's policies with respect to whether surveys are announced or unannounced; and

○ 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 § 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 § 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 § 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 § 488.20(b) and § 488.28(a);
    - AOA revised its policies and developed an internal tracking tool to       ( print 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 § 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 § 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