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.
Management Consulting Firm, New York, NY, USA.
Fred
F
Eaton
Jaimee
J
Reid
D032781:Codes of Ethics / Q000331:legislation & jurisprudence; D003132:Commerce / Q000191:economics* / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000191:economics* / Q000331:legislation & jurisprudence; D004864:Equipment and Supplies / Q000191:economics*; D005607:Fraud / Q000191:economics* / Q000331:legislation & jurisprudence*; D006801:Humans; D007400:Interprofessional Relations; D008389:Marketing of Health Services / Q000191:economics / Q000331:legislation & jurisprudence; D010820:Physicians / Q000191:economics* / Q000331:legislation & jurisprudence; D012017:Referral and Consultation; D014481:United States; D014486:United States Food and Drug Administration