Office of Inspector General
Department of Health and Human Services
Attention: OIG-11-N, Room 5246
330 Independence Avenue, SW
Washington, DC 20201

Dear Sir/Madam:

      The American Association for Clinical Chemistry (AACC) appreciates the opportunity to assist the Office of the Inspector General (OIG) by providing suggestions for future "safe harbor categories" and special fraud alerts. The Association believes this cooperation and dialogue between the OIG and the laboratory community is important to reducing allegations of fraud against many testing facilities. AACC offers the following comments for your consideration.

One area that we would like the OIG to address is continuing education. Specifically, we recommend that the OIG delineate under what circumstances manufacturers, commercial laboratories and other providers can sponsor or provide continuing education programs to health care facilities and practitioners. We are concerned that many educational opportunities may be foregone by practitioners who, at the request of the provider, may have to notify other local practitioners about the presentation (and request their attendance) to avoid the appearance of impropriety.

For example, a hospital recently requested a commercial laboratory to give a presentation regarding the various types of tests they perform, the strengths and weaknesses of those tests and the timeframe for performing them. The commercial laboratory agreed to the hospital’s request, but only on the condition that the other local practitioners be notified of the presentation and arrangements made for their attendance. The commercial laboratory made this request, because they were concerned that the OIG may consider a presentation to a single hospital as an inducement for Medicare referrals. We are concerned that this perception may hinder some facilities from seeking such educational opportunities, or providers from offering the service.

Similarly, manufacturers often provide promotional activities at professional meetings, which are important to educating scientists about new products and technologies. This information allows laboratorians to make more informed purchasing decisions, as well as learn about the strengths and weaknesses of various testing methods—data that can be useful to improving the quality of care and reducing health care costs. This activity should be safeguarded from potential charges of wrongdoing.

AACC suggests that OIG consider drafting a safe harbor, which explicitly delineates the circumstances under which manufacturers, commercial laboratories and health care providers can offer or provide such services without fear of fraud and abuse allegations. We believe that the benefits from these educational ventures far exceed the slight risk of providers using the services as an inducement for Medicare referrals or equipment purchases. We would be willing to assist you in this endeavor, if you decide it merits further attention.

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 industries 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, or if you have any questions about our comments, 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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