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Food Drug Law J. 2010;65(1):141-57, iii.

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

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Management Consulting Firm, New York, NY, USA.


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.

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