Host Jonathan Porter welcomes back to the show Husch Blackwell attorney Abe Souza to discuss False Claims Act (FCA) enforcement in the pharmacy context. Pharmacies face multiple pressures, from disruptive online enterprises that threaten brick-and-mortar profitability to heightened regulatory vigilance concerning opioids. As pharmacies contemplate how to tweak business models to operate more profitably, the risk of violating FCA provisions is something that compliance programs must consider carefully.

Our discussion kicks off with DOJ’s focus on opioids and its use of the FCA to accomplish its policy ends. As Abe explains, the FCA’s civil penalty model is sometimes preferred by prosecutors due to its clarity and its ability to generate civil penalties large enough to punish violators and deter future violations. Jonathan and Abe then explore two recent litigations involving FCA allegations against pharmacies to draw out some practical takeaways for pharmacy operations.

The conversation then pivots to consider fraudulent claims uncovered by the government, particularly concerning drugs that are, contrary to the claims filed, not dispensed. Government investigators have grown adept at using inventory records and supply chain analysis to reveal potential false claims, providing a relatively easy and scalable enforcement model for U.S. Attorneys to use in FCA cases.

To conclude, Jonathan and Abe discuss the hazards of aggressive marketing campaigns involving high-reimbursement drugs and discuss a recent criminal enforcement against a Kentucky pharmacist involving medicated pads, highlighting some practical tips for pharmacy operators to consider.

Jonathan Porter | Full Biography

Jonathan focuses on white collar criminal defense, federal investigations brought under the False Claims Act, and litigation against the government and whistleblowers, where he uses his experience as a former federal prosecutor to guide clients in sensitive and enterprise-threatening litigation. At the Department of Justice, Jonathan earned a reputation as a top white-collar prosecutor and trial lawyer and was a key member of multiple international healthcare fraud takedowns and high-profile financial crime prosecution teams. He serves as a vice chair of the American Health Law Association’s Fraud and Abuse Practice Group and teaches white collar crime as an adjunct professor of law at Mercer University School of Law.

Abe Souza | Full Biography

Abe regularly represents clients embroiled in internal and government investigations, as well as in government enforcement actions. Abe also represents clients in complex business disputes and commercial litigation matters, including those involving antitrust and class action claims. Prior to joining Husch Blackwell, Abe served for nearly five years as an Assistant U.S. Attorney in the Northern District of Illinois where he worked directly with FBI agents and other investigators and served as a first-chair trial lawyer. Abe began his legal career as a law clerk for the Honorable Joan Humphrey Lefkow of the U.S. District Court for the Northern District of Illinois.