November 30, 2020

OIG Issues Special Fraud Alert, Takes Aim at Speaker Programs

November 16, 2020 — The US Department of Health and Human Services’ (HHS) Office of the Inspector General (OIG) has long expressed skepticism about the educational value of manufacturer speaker programs. Numerous investigations have involved allegations that companies organize and pay for these events with the intent of inducing health care professionals (HCPs) to prescribe or order companies’ products. Industry contends that these programs fit a legitimate educational need.

Today’s guidance again notifies speakers, attendees, and manufacturer-sponsors that those involved in such programs may be subject to increased scrutiny. At issue is manufacturers’ practice of providing anything of value—whether speaker fees or the meals over which programs are customarily provided—to an HCP who is in a position to influence the use of companies’ products. OIG appears to put both speakers and participants on notice of its concerns.

The guidance document mainly solidifies the agency’s prior statements on this topic but appears to go beyond it in some respects—for example, taking issue with programs hosted at restaurants, the involvement of marketing departments in speaker selection, and conducting ROI analysis in identifying participants.

OIG identifies a number of speaker program characteristics that may give rise to particular concern, including:

  • Content: Lack of substantive content and/or new medical or scientific information,
  • Alcohol and Meals: Availability of alcohol or meals exceeding modest value,
  • Venue: Location not conducive to exchange of educational information,
  • Volume: Large number of similar or the same programs,
  • Repetition: Repeat attendees for the same program content, and
  • Illegitimate Attendees: Including individuals who, based on their job responsibilities, don’t have a legitimate business reason for attending a program.

While the guidance leaves open the possibility for speaker programs to continue, manufacturers would be well-advised to conduct a holistic review of their existing policies and procedures to ensure sufficient controls. 

If you have questions regarding this alert or conducting speaker programs, please contact Razor Legal Solutions here.

This alert provides information as a service to clients and other friends of the firm for educational purposes only. It should not be construed or relied upon as legal advice, and it does not create an attorney-client relationship. © Razor Legal Solutions 2020