In November 2020, The United States Department of Health and Human Services Office of Inspector General (OIG) issued a “Special Fraud Alert: Speaker Programs“. The Special Fraud Alert highlights the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by life sciences companies. It raises questions on the educational value of speaker programs, and stated programs are thus subject to scrutiny.
Got us all scratching our heads as to why we even needed another regulatory alert at this point, no?
Sarah DiFransesca, partner at Dinsmore & Shohl LLP then explained this in a recent webinar with qordata.
Why do we even have the Special Fraud Alert?
Numerous False Claims Act (FCA) settlements with OIG and DOJ involved allegations that pharmaceutical and medical device companies violated the Anti-Kickback Statute (AKS) by paying remuneration to HCPs for speaker programs with the intent of induce prescriptions of company products.
The OIG, therefore, considers that one purpose of the remuneration to the HCP speaker and attendees is to induce or reward referrals which is a violation of the AKS. Hence, the Special Fraud Alert addresses some of the allegations found in these cases and clearly lists the speaker program characteristics that could potentially be suspect under the Anti-Kickback Statute.
Better Safe than Sorry: What exactly about Speaker Programs could get you into trouble?
According to OIG’s Special Fraud Alert, the following speaker program characteristics can potentially be suspect under the Anti-Kickback Statute.
-
Sponsoring speaker programs where little or no substantive information is actually presented
-
Providing alcohol or meals exceeding the modest value
-
Holding programs at locations not conducive to the exchange of educational information
-
Sponsoring a large number of programs on the same (or substantially the same) topic or product
-
Significant time with no new medical/scientific information nor new FDA approval
-
Attending programs on the same (or substantially the same) topics more than once
-
Attendees include individuals without a legitimate business reason to attend the program
-
The company’s sales or marketing business units influence the selection of speakers or the company selects HCP speakers or attendees based on past or expected revenue
-
The company pays HCP speakers more than fair market value for the speaking service
How qordata can help you ensure compliance with Special Fraud Alert?
As a legal professional, we know this sounds like a whole lot of work for you.
Are you prepared for it?
The Special Fraud Alert for Speaker programs means you’ll have to look for more compliance risks, put more monitoring controls and be a lot more vigilant when it comes to your speaker events.
But why would you be working so hard when qordata’s Compliance Monitoring can do all of that for you?
Our Compliance monitoring solution caters to:
-
Live Monitoring (Speaker programs, Ride-alongs, Advisory Boards, etc)
-
Analytical Monitoring (Interactive dashboards to remediate issues or take corrective measures)
What’s in Compliance Monitoring for Monitoring Speaker Programs?
Compliance Monitoring can be instrumental in monitoring Speaker Programs, especially after the recent Special Fraud Alert. Here’s what we offer:
-
Custom checklists
-
Custom workflow
-
Scheduling Speaker events
-
Pre-Audit
-
Dashboards
-
History and Audit log
Reduce your compliance risks w.r.t Special Fraud Alert for Speaker Programs. Schedule and monitor your speaker events with Compliance Monitoring. For a detailed demo, contact us today!
Why qordata?
-
Dashboards with a comprehensive view of HCP engagements and activities.
-
Easy-to-use UI/UX (you won’t need extensive training sessions).
-
The software works for you, not the other way around.
-
High-cost effectiveness (you won’t have to fight for additional budgets).
Other relevant read:
