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 See more +
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. See less -
