Sally Richardson
Director, Center for Medicaid & State Operations
Health Care Financing Administration
7500 Security Boulevard, Room C-4-25-02
Baltimore, Maryland 21244-1850

Dear Ms. Richardson:

The Health Care Financing Administration (HCFA) is conducting demonstration projects in Florida and New Jersey to determine whether CLIA inspectors’ responsibilities should be expanded to include reviewing laboratory billing, medical necessity and other integrity-related practices. These additional duties would be financed by the Office of the Inspector General (OIG), which would use the data to identify laboratories committing fraud. Although the American Association for Clinical Chemistry (AACC) is sympathetic to the intent of the project—to combat sloppy or illegal billing practices—we are concerned that this approach, if adopted, could undermine the integrity of the CLIA program.

One of the strengths of the CLIA program is the cooperative spirit that exists between HCFA and the laboratory community. Many laboratories, by HCFA’s own admission, are very willing to work with the agency to improve the quality and accuracy of their testing, because of the informative nature of the inspection. Similarly, HCFA has frequently stated, and practiced, its intention to use the survey process as an educational opportunity/experience for assisting laboratories. Therefore, we are concerned that this relationship may be damaged by requiring surveyors to perform auditing functions for the OIG.

We are also concerned that such overlapping duties may result in the CLIA program subsidizing OIG activities. For example, CLIA survey fees may be used to pay for the HCFA inspector to travel to and from the site—saving the OIG the travel costs associated with an inspection. The CLIA program is a self-funding program enacted by Congress to ensure the quality and accuracy of laboratory testing. Any diversion of these funds would likely result in additional increases in laboratory fees (HCFA recently significantly increased laboratory certification fees across-the-board) and potentially involve HCFA in costly, unnecessary legal proceedings.

Further, we do not believe it is appropriate for a CLIA surveyor to perform auditing functions. The technical skills necessary for conducting a CLIA inspection, such as knowledge of medical instrumentation, good laboratory practices and laboratory sciences are not the same skills required of a financial auditor, who must be familiar with accounting techniques and Medicare billing and coding requirements. AACC strongly urges you to keep these functions separate and let each agency do what it does best.

Finally, we request that HCFA make available the studies that support its contention that there is a correlation between fraudulent billing practices and the quality of laboratory testing. We are not aware of any studies that demonstrate such a linkage. AACC strongly encourages HCFA to reject any efforts to involve the agency in fraud and abuse investigations—those duties are the responsibility of the OIG and should remain so.

By way of background, AACC is the principal association of clinical chemists--professional laboratory scientists--including MDs, PhDs and medical technologists. Clinical chemists develop and use chemical concepts, procedures, techniques and instrumentation in health-related investigations. The AACC represents clinical chemists working in hospitals, independent laboratories and the diagnostics industry nationwide. The AACC's objectives are to further the public interest and educational activities and help maintain high professional standards.

If we may be of any assistance on this matter, please call me at (717) 531-8316 or Vince Stine, Manager, Government Affairs at (202) 835-8721.




Laurence M. Demers, PhD, DABCC

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