The U.S. 2nd Court of Appeals recently revisited a whistleblower lawsuit against Novartis, a Swiss pharmaceutical company, creating a new development in the enforcement of the Anti-Kickback Statute, Policy & Medicine reported Jan. 8.
Here are five things to know about the case and the wider implications:
1. In this caseSteven Camburn, a whistleblower, brought allegations against Novartis, claiming the company used its speaker programs to conceal kickbacks to physicians.
2. Mr. Camburn further alleged that Novartis organized peer-to-peer speaker events that Novartis utilized to market one of its pharmaceutical products. He claims that these events often had few or no legitimate attendees, were social in nature and speakers were sometimes paid for events that were cancelled, all designed to "unduly influence physicians' prescribing habits," according to the report.
3. The court's holding of the "at-least-one-purpose" rule states that "in relator-initiated actions, a defendant violates the AKS when at least one (rather than the primary or sole) purpose of the remuneration she provides is to induce purchase of a federally reimbursable healthcare product."
4. This differs from other interpretations that require that the inducement be the primary or sole purpose of the remuneration but, as the Court notes, the ruling is in line with seven other courts.
5. The broader implication for healthcare, particularly for pharmaceutical companies, is that healthcare companies must exercise more caution and compliance in their speaker program operations, ensuring the legitimacy of educational events with proper attendance. Any compensation must be commensurate with the services provided.