Federal enforcement of the False Claims Act (FCA) against healthcare and pharmaceutical companies—especially based on alleged Anti-Kickback Statute (AKS) violations—continues to change, with the Regeneron Pharmaceuticals case at the forefront of recent developments. Recall that in Regeneron, the government alleges that the pharmaceutical company is illegally subsidizing copayments for Medicare beneficiaries by making large donations to third party foundations offering copay assistance to strategically steer patients to its high-cost specialty drug, Eylea, instead of lower-cost alternatives, resulting in alleged FCA liability based on an AKS violation. After the First Circuit held that a FCA plaintiff in an AKS-based FCA case must prove “actual causality, which in ordinary course takes the form of but-for causation,” United States v. Regeneron Pharms., Inc., 128 F.4th 324, 330 (1st Cir. 2025), the government is trying—again—to avoid having to prove a causal link between the alleged AKS violation and damages (i.e., financial harm to a government program). The government’s recent summary judgment brief in the United States District Court for the District of Massachusetts provides a detailed look at both its evolving legal theory and the practical compliance lessons for pharmaceutical manufacturers, providers, and health systems.
The Government’s Summary Judgment Motion: Key Arguments
In its October 2025 summary judgment brief, the DOJ seeks to resolve several legal issues...
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