Kusserow on Compliance: OIG cautions pharmaceutical and medical device companies over speaker programs

The HHS OIG published a Special Fraud Alert cautioning pharmaceutical and medical device companies against conducting speaker programs given the “inherent risks” of implicating the Anti-Kickback Statute and False Claims Act. The OIG cited numerous enforcement actions related to speaker program arrangements, as well as Sunshine Act payment records reflecting significant payments for such programs in recent years. The OIG called for companies to assess the need for re-starting in-person speaker programs that have been paused during the COVID-19 pandemic. The Fraud Alert outlines “suspect” characteristics of a speaker program that may provoke an enforcement action, including the following:

  • Selected high-prescribing persons to be speakers and rewarded them with lucrative fees.
  • There is little or no substantive information presented at the program.
  • Alcohol is available or a meal exceeding “modest value” is provided to program attendees.
  • Held speaker programs at entertainment venues not conducive to educational presentation.
  • Company sponsors many programs on the same or substantially the same topic or product, especially if there has been no recent substantive change in relevant information.
  • Programs conducted where there has been a “significant period of time” with no new medical or scientific information nor new-FDA approval of a product or indication.
  • Programs where the attendees have attended other programs on the same or substantially the same topics more than once.
  • Attendees include individuals who do not have a legitimate business reason to attend the program, such as friends, significant others, family members, practice employees, and others with no use for the information.
  • Sales representatives or marketing personnel involved in the selection of speakers or the company selects HCP speakers or attendees based on past or potential revenue generated by prescriptions (e.g., a return on investment analysis).
  • Payment to HCP speakers exceeds fair market value for the speaking service or compensation takes into account the volume of business generated by the HCPs.
  • Conditioned speaker remuneration on sales targets (e.g., required speaker HCPs to write a minimum number of prescriptions in order to receive the speaker honoraria).

 

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on LinkedIn.

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Copyright © 2020 Strategic Management Services, LLC. Published with permission.