This is to notify you of the federal government's increased scrutiny regarding speaker programs and other arrangements with pharmaceutical and medical device companies that might constitute a violation of the federal anti-kickback statute (AKS), which could result in both civil and criminal penalties.

On November 16, 2020, the Department of Health and Human Service's Office of Inspector General (OIG) issued a special fraud alert on speaker programs by pharmaceutical and medical device companies. The full text of the alert can be found at the OIG website HERE.

This alert reflects longstanding and ongoing concerns of federal healthcare regulators about physicians and other healthcare professionals (HCP) being offered anything of value from drug and device companies. HCPs are a ripe source of potential business for these companies as they can refer or influence referrals to such companies' products. UW Medicine likewise shares these concerns, given that these speaker programs are often very lucrative for the HCPs and/or held at highly desirable locations (entertainment venues or recreational events). Regardless, any item(s) of value (irrespective of the fair market value), including food, meals, beverages, travel, services, supplies, equipment or pharmaceuticals, may influence professional judgment about business-related decisions impacting the work of UW Medicine.

The OIG and Department of Justice (DOJ) provide the following as examples of speaker program activities that create increased risk:

• Companies inviting HCPs to present at events where the educational value of the program appears low. Examples include events at expensive restaurants (typically, a dinner where free alcohol is served) or locations where entertainment or recreational activities are featured (wineries, sports stadiums, golf clubs, resort destinations, etc.);
• Companies inviting family and friends of speaking HCPs to also attend the event, when those other individuals have no legitimate business reason to attend;
• Companies selecting high-prescribing HCPs to speak favorably about the company's products at events in exchange for above fair-market value compensation; or
• HCPs who repeatedly speak at (or attend) industry-sponsored programs that are on the same or similar topic.

For School of Medicine faculty, activities highlighted in the alert are already prohibited or severely restricted by the Policy on Potential Financial Conflicts of Interest for Commercial and Non-Profit Entities. UW Medicine Compliance also has several related FAQs that touch on activities which may or may not be permitted for all UW Medicine healthcare providers, including Gifts, Food, and Meals from External Sources and Sponsored Travel. However, given the heightened OIG/DOJ scrutiny it is important that all HCP's are aware of these prohibitions/restrictions and follow them.

Please distribute this memo to your faculty and healthcare teams to help increase awareness about this issue. Contact UW Medicine Compliance at 206.543.3098 / comply@uw.edu if you have any questions. Also, for UW HCPs contemplating outside work for drug and device companies, such activities must be reviewed and approved in advance. Questions regarding the UW outside work process should be directed to the School of Medicine Dean's Office Business Unit at SoMOutsideWork@uw.edu. ​