Physicians and other healthcare providers (HCPs) are often invited to participate in speaker programs that include presentations on pharmaceutical products, medical devices, and healthcare initiatives.  These are frequently company-sponsored events where an HCP may be paid an honorarium and remuneration for costs including mileage and meals.  These arrangements are not per se inappropriate under the federal Anti-Kickback Statute (AKS) and False Claims Act (FCA).  However, the Office of Inspector General (OIG) and Department of Justice (DOJ) have signaled an increasing skepticism about these programs.

In the last several years, the government has investigated and resolved numerous fraud cases involving allegations that payments offered in connection with speaker programs violated the AKS, resulting in billions of dollars in fines.  For example, in July 2022, Biogen Inc., a global biotechnology company, agreed to pay $900 million to resolve alleged violations of the AKS and FCA relating to allegations that Biogen provided illegal kickbacks to loyal prescribers of its products, including through remuneration tied to sham speaker programs.  In June 2019, Insys Therapeutics agreed to a $225 million settlement related to allegations that it paid illegal kickbacks through a sham speaker program series.

The Office of Inspector General has identified suspect characteristics of speaker programs through a special fraud alert.  These include the following:

  • The company sponsors speaker programs where little or no substantive information is actually presented.
  • Alcohol is available or a meal exceeding modest value is provided to the attendees of the program (the concern is heightened when the alcohol is free).
  • The program is held at a location that is not conducive to the exchange of educational information (e.g., restaurants or entertainment or sports venues).
  • The company sponsors a large number of programs on the same or substantially the same topic or product, especially in situations involving no recent substantive change in relevant information.
  • There has been a significant period of time with no new medical or scientific information nor a new FDA-approved or cleared indication for the product; HCPs attend programs on the same or substantially the same topics more than once (as either a repeat attendee or as an attendee after being a speaker on the same or substantially the same topic).
  • Attendees include individuals who don’t have a legitimate business reason to attend the program, including, for example, friends, significant others, or family members of the speaker or HCP attendee; employees or medical professionals who are members of the speaker’s own medical practice; staff of facilities for which the speaker is a medical director; and other individuals with no use for the information.
  • The company’s sales or marketing business units influence the selection of speakers or the company selects HCP speakers or attendees based on past or expected revenue that the speakers or attendees have or will generate by prescribing or ordering the company’s product(s) (e.g., a return on investment analysis is considered in identifying participants).
  • The company pays HCP speakers more than fair market value for the speaking service or pays compensation that takes into account the volume or value of past business generated or potential future business generated by the HCPs.

This is not an exhaustive list.  The presence or absence of any one factor is not determinative of liability.  Experienced counsel can assist physicians and HCPs who have questions about these investigations and potential liability.

Matthew P. Massey is a Partner in the White Collar, Government Investigations, and Special Matters Group.  He is a former Assistant U.S. Attorney with the U.S. Attorney’s Office for the District of Columbia.  He represents businesses and individuals in high stakes matters including federal criminal defense and white collar crimes.