COVID-19 has significantly impacted in-person HCP engagements in the life sciences industry. Many of these have been understood as temporary, to be resumed once the pandemic subsides.

In a newly published OIG Special Fraud Alert, the regulatory body is reaffirming their stance that in-person speaker events must be regulated and follow strict compliance guidelines. With this guidance, manufacturers should take this as a signal that there is heightened focus on this popular activity. Now is the time to review speaker bureau and speaker program activity to ensure that any gaps in existing controls are addressed.

IQVIA has been helping life sciences companies stay compliant for over 20 years. IQVIA stands alone in the industry with a dedicated practice tasked to constantly monitor, inform, and ultimately support our customers in their compliance needs related to HCP engagements, including live speaker programs.

IQVIA is the only partner that can provide full end to end HCP engagement management, reducing risk, and identifying compliance risk—while delivering meaningful and effective HCP engagements. IQVIA additionally provides the industry’s leading engagement management and transparency reporting software, along with the largest meeting services organization in the world.

IQVIA Global Compliance Consulting supports life sciences manufacturers, establishing a comprehensive compliance program with appropriate controls across governance, policies, processes, and operation monitoring. Specifically, around Speaker Programs, IQVIA supports the analysis of Speaker Bureau size, developing standards around annual planning, needs assessment and business justification. IQVIA helps life sciences organizations strengthen internal auditing and monitoring processes across various business functions, providing boots on the ground for in-person and virtual event monitoring, as well as data and transactional analysis.

IQVIA’s HCP Engagement Management solutions address many risk factors outlined in the OIG statement. Our out-of-the-box offerings enable embedded compliance, and business rules preconfigured to meet industry best practices and compliance guidelines.

The Chief Counsel to OIG, Gregory Demske, has alluded to the regulatory body’s increased concern over speaker programs in his remarks at the recent 21st Virtual Pharmaceutical and Medical Device Ethics and Compliance Congress.

• Significant passage of time with no new medical or scientific information nor a new FDA-approved or cleared indication for the speaker program with limited or no substantive information presented;
• Sponsoring 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;
• Speaker program meals exceeding modest value and availability of alcohol – with greater concern if alcohol is free;
• Speaker program venues that are not conducive to educational discussions;
• HCP repeat attendance on the same or substantially the same topics, or a speaker’s attendance to a program that he or she has spoken on substantially the same topic;
• Attendees with no legitimate business reasons to attend the speaker program, including:
  • Speaker’s or HCP attendee’s friends, significant others, family members
  • Employees of HCPs of the speaker’s own medical practice
  • Staff members for which the speaker is a medical director
  • Any individuals with no use for the educational information;
• Commercial business units (sales and marketing) having influence over the selection of speakers or any selection criteria of speakers or attendees based on past or expected revenue that the HCPs had or will generate by prescribing or ordering the manufacturer’s products;
• HCP speakers compensated for more than Fair Market Value for their speaking services, or a compensation scheme that takes into account the volume or value of past or potential future business generated by individuals.

This Special Fraud Alert, the first of its type in the past six years, demonstrates the OIG’s spotlight on this topic and the regulatory body’s call to action to rethink current industry speaker program practices. Furthermore, OIG warns that all parties that participate in speaker programs are subject to scrutiny, further illustrating the skepticism of intent across all key players in current speaker program practices.

For more information on how IQVIA Commercial Compliance can help you navigate the current compliance landscape, visit our website or email us here.