Pharmaceutical and medical device companies’ financial relationships with physicians are a large and growing focus of OIG and DOJ enforcement activity. That makes it more important than ever to ensure that these arrangements can withstand critical examination. Determining fair market value (FMV) fees is difficult, and little practical guidance is available. Old ways of valuing professional services — surveys of historical data, opportunity cost, etc. — are no longer good enough. Finding a defensible way to value the specialized services physicians provide as speakers, advisory board members, clinical researchers, etc. is central — but not the whole answer to the FMV challenge.

Compliance concerns increasingly focus on consistency of practice across business and functional groups, ensuring transparency, and the broader framework for handling commercial relationships with providers. And going forward, the real challenge will not simply be how much you pay these providers, but the reason you hired them in the first place. Companies must ensure — and be able to demonstrate — that commercial and clinical engagements are based