Mirror, mirror on the wall--evaluating Fair Market Value for manufacturer-physician consulting arrangements

Pharmaceutical and medical device manufacturers contract with thousands of physicians each year, and struggle to comply with the Fair Market Value requirements of the Anti-Kickback Statute's "personal services" safe harbor. Consultant arrangements between physicians and manufactures have come under increasing scrutiny by regulators. In 2007, the five leading Hip & Knee manufacturers entered into settlement agreements related to their contract practices with physician consultants. Government sources do not provide guidance for calculating Fair Market Value; however, this article recommends four principles to use when evaluating Fair Market Value methodologies.