News & Views

When Physician Speaking Engagements Break the Law

Every day across the country, some physicians receive large speakers’ honoraria checks from pharmaceutical and medical device companies. These funds compensate the physicians for speaking at so-called “educational programs,” which, if proper, are intended to educate other healthcare providers, inter alia, about the latest and greatest science underlying particular drugs and devices. However, when these CME programs are nothing more than sham events intended to bribe physicians, the federal Anti-Kickback Statute and the False Claims Act are violated, potentially triggering liability for both the speaker and the manufacturer. Indications of this may include:

  • The events lack educational value to the attendees and are nothing more than social events.
  • Few or no company-approved PowerPoint slides are presented at the events.
  • The events are held at venues that are not conducive to an education program (e.g., in sports bars, on fishing trips, at restaurants without private meeting areas).
  • The manufacturer touts internal analyses showing that its speaker programs have a high return on investment in terms of additional prescriptions for its drugs written by the doctors who participate in the program, both as speakers and attendees.
  • Physicians receive compensation to attend training events on the drugs, notwithstanding that many of them are not used as speakers.
  • Prescription writing records for physician-speakers reveal a significant correlation in prescriptions and payments.
  • The manufacturer creates incentives for sales representatives to use speaker programs as kickbacks without sufficient controls to prevent kickbacks from occurring.
  • Speakers are nominated by sales representatives, who pick doctors who have the highest prescription writing potential.
  • Speakers are approved without regard to merit.
  • Sales representatives have a periodic budget for speaker programs, which they are pressured to spend.
  • Sales representatives not only select the speaker, but also the venue, the topic of the program, and the date for the program.
  • The manufacturer places no limit on the number of programs a doctor can attend or how often a doctor can attend the same program.
  • There are no system controls to prevent a sales rep from arranging for the same doctors to take turns speaking and attending each other’s programs repeatedly.
  • Physician-speakers are paid to speak even when no one is in attendance except for members of the speakers’ own medical practices.
  • Sales representatives are able to easily sidestep supposed per-attendee spending limits placed on events held at restaurants.
  • Sales representatives spend lavishly on food and alcohol for attendees and speakers.
  • The manufacturer does not require that a restaurant have a quiet atmosphere or even a private room to be an acceptable venue for speaker programs.
  • There is no prohibition against holding programs at restaurants that are high-end for the particular community in which they are located.
  • There are few checks on whether the sales representatives are reporting truthfully on who attends speaker programs.
  • The manufacturer does not require signatures on attendance sheets at speaker events.
  • The manufacturer threatens to remove physician-speakers from the speakers’ bureau if they decrease their prescription volumes.
  • High-prescribing physician-speakers are permitted to speak at events even when they lack basic communication skills and knowledge.

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