On November 16, 2020, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) issued a Special Fraud Alert: Speaker Programs, highlighting the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies.

For purposes of this Special Fraud Alert, the OIG defined speaker programs as company-sponsored events at which a physician or other health care professional makes a speech or presentation to other health care professionals about a drug or device product or a disease state on behalf of the company.  In the Special Fraud Alert, the OIG stated it is “skeptical about the educational value of such programs”, in which drug and device companies have reported paying nearly $2 billion to health care professionals for services in the last three years.  The OIG highlighted a list of suspect characteristics of these programs, which could demonstrate an intent to induce health care professionals to prescribe or order (or recommend) the companies’ products in violation of the Anti-Kickback Statute:

  • 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;
  • Health care professionals 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 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 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);
  • The company pays 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 health care professionals.

The OIG issued this alert during the COVID-19 pandemic, which many might consider puzzling given that the health crisis is “necessarily curtailing many in-person activities”.  But the OIG appears to be asking drug and device manufacturers to use this time to reassess their use of speaker programs because of the kickback risk they often present “and consider alternative less-risky means for conveying information.”  We also construe the Special Fraud Alert as a warning both to manufacturers and to participants in speaker programs that the OIG continues to be paying attention in this area.  The OIG does not issue Special Fraud Alerts frequently, and in past instances, they have sometimes preceded related enforcement activity.  We will not be surprised to see some significant enforcement action against speaker programs in the near future.  Providers should continue to monitor this issue for continuing developments.

For further questions regarding this or other fraud and abuse matters, please contact Mark Fitzgerald at Mark.Fitzgerald@PowersLaw.com, Christina Hughes at Christina.Hughes@PowersLaw.com, or Natalie Dobek at Natalie.Dobek@PowersLaw.com, or the Powers professional with whom you usually work.

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