Physician advisory boards are used to provide medical products companies with real-time, expert insight and feedback on clinical and marketing issues to inform business decision making. Such insights can be critical to understanding the clinical landscape and marketplace, identifying unmet needs, and building the value case for products in development. Unfortunately, engagement of physicians by medical products companies to serve on advisory boards, in consulting and speaking roles have also come under increasing scrutiny by regulatory enforcement agencies concerned about conflicts of interest.

Prompted by a limited number of high profile cases, regulatory enforcement agencies have made it a priority to ensure that physicians who are so engaged are not just receiving covert payment for using or influencing the purchase of a company’s products. Backing up word with deed, OIG enforcement of anti-kickback statutes has set new records over the past 18 months. To compound the challenge, the specific actions expected by enforcement agencies evolve with each new settlement.