Smith and Patel Quoted on DOJ’s FCA Enforcement Priorities in Health Care

Jacques noted that there has been uptick in enforcement activity related to Anti-Kickback Statute violations.

“There’s been a string of settlements relating to sham speaker programs, including a recent $200 million settlement with pharmaceutical manufacturer Gilead Sciences, Inc., which was allegedly hosting social gatherings for prescribers with little or no educational content under the guise of speaker programs,” he said. “In light of these settlements, it would be prudent for life-sciences companies to re-evaluate how they structure speaker programs, and likewise, healthcare providers should be evaluating their policies for attendance at such programs.”

Jacques noted that the DOJ is continuing to pursue more traditional kickback theories. “We’re seeing a number of settlements that involve allegations of lavish meals, resort trips, and extravagant gifts in exchange for prescriptions. Finally, we are seeing an uptick in FCA activity tied to drug-pricing practices, particularly where companies are alleged to have manipulated or failed to report pricing data that feeds into government reimbursement formulas,” he said, adding that, “All this signals that (the) DOJ is marrying classic (Anti-Kickback Statute) theories with the FCA’s potent remedies, and it is not hesitating to demand nine-figure resolutions where it believes the facts support them.”

Jacques emphasized that the Trump Administration has been steadfast in its intent to increase enforcement actions on fraud, waste, and abuse, and that the FCA is the most successful tool in the government’s toolbox for combating fraud on the government.

Nadia noted that the attorneys at the DOJ have indicated an increase in customs fraud enforcement, particularly in light of recent tariffs. She anticipates that the DOJ’s Civil Rights Fraud Initiative will increase the use of the FCA to check what the government views as illegal DEI activities.

“We cannot emphasize enough the importance of compliance,” she said. “Healthcare providers should develop and maintain a robust compliance program that includes clear policies and procedures addressing speaker programs, consulting arrangements, and interactions with the industry.”

Nadia said that although recent civil rights fraud enforcement has focused on universities, health care providers are not immune to such actions, noting thatproviders may want to review and update their policies to ensure compliance.

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