Health Reform Connect

In an Advisory Opinion issued on November 23, 2011, the Office of Inspector General ("OIG") stated that an arrangement involving a laboratory company and a physician's office could implicate the Anti-Kickback Statute ("AKS"), as it would not meet the requirements of any safe harbor.  Specifically, the proposed arrangement would involve the laboratory company setting up an allergy testing lab on the physician's behalf, and on an exclusive basis with the physician.  Under this arrangement, the laboratory company would provide the personnel working in the lab, and the physician would bill Federal health care and other third party payor programs for the lab services, and would then pay the laboratory company sixty percent (60%) of the physician's gross collections for the lab services.  The OIG stated that because the compensation to be paid to the laboratory would not be fixed in advance of entering into the arrangement, the arrangement would not qualify under any AKS safe harbor.

The OIG voiced additional concern over potentially improper and abusive marketing activities that may occur under the arrangement in that the laboratory company would have access to the physician's patients' information, and would thereby have the opportunity to encourage the physician to order medically unnecessary tests.  The OIG stated that this would be considered suspect marketing activity.

For more information on this article or the OIG Advisory Opinion, please contact Leigh Ann O'Neill at 317-238-6346.