January 23, 2020 –
Compliance and medical affairs teams who manage events must consider more than just the amount being paid to HCPs and other external advisors. While the hourly rate is a vital consideration, it is worth stepping back and assessing the engagement(s) as a whole. Groups should make sure that their focus is not so granular as to miss the forest for the trees.
A recent whistleblower case revealed the willingness of courts to crack down on companies who are perceived to abuse speaker programs as a way to reward high-prescribing HCPs. In this case compliance teams need to make sure that groups in their organization understand the need to justify not only the event, but the specific speaker being employed. If a proposed event fails either of those two tests, it should not be run.
Even if the speakers had been paid at a true fair market value rate for their time, the fact that the speakers were allegedly being engaged as a result of their prescription numbers runs directly afoul of the false claims act. Courts have historically been very open to arguments that engagements with manufacturers can directly influence prescription volume.
If the regulations alone aren’t enough to keep teams in line, it might be worth reminding speaker bureaus that qui tam lawsuits can provide up to 30% of the settlement reward to the whistleblower. This is more than enough incentive for someone inside the organization who knows something is wrong to step in.
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ABOUT THE AUTHOR
Jacob Presson is the manager of FMV Services at Cutting Edge Information. In this role, he delivers premier FMV data to life sciences companies to ensure compliant HCP engagements. As an experienced analyst, Mr. Presson believes that robust data is the best tool for informed decision making. He is a graduate of N.C. State University.