Government Pushes New Legal Strategy in Regeneron False Claims Act Case

Federal prosecutors are pressing forward with a novel approach in their False Claims Act (FCA) case against Regeneron Pharmaceuticals, potentially lowering the bar for establishing liability in healthcare fraud litigation. The case, centered on alleged Anti-Kickback Statute (AKS) violations, continues to evolve in the United States District Court for the District of Massachusetts.

The Department of Justice filed a summary judgment motion in October 2025 that reveals a significant shift in its legal strategy following a First Circuit ruling earlier this year. The government is attempting to circumvent the need to prove direct “but-for” causation between alleged kickbacks and Medicare claims for Regeneron’s macular degeneration drug Eylea.

At the heart of the government’s allegations is the claim that Regeneron illegally subsidized Medicare patient copayments by making substantial donations to the Chronic Disease Fund (CDF), a foundation providing copay assistance. Prosecutors argue these donations were strategically designed to steer patients toward Eylea instead of lower-cost alternatives, violating the Anti-Kickback Statute.

The case has drawn significant attention within the healthcare and pharmaceutical industries, as it could redefine enforcement standards for patient assistance programs and financial relationships between drugmakers and third-party foundations.

In its motion, the DOJ asks the court to rule that every Medicare Part B claim for Eylea submitted between 2013 and 2014 contained either an express or implied certification of compliance with the AKS. The government points to Medicare’s CMS-1500 paper claims, electronic EDI Enrollment Forms, and provider enrollment agreements, all of which require adherence to federal law.

The government’s new approach follows a notable First Circuit decision in the case earlier this year. While the appellate court had held that FCA plaintiffs must prove “actual causality” in cases based directly on AKS violations, it also recognized that claims under false certification theories operate on a “separate track” that may not require the same causation standard.

DOJ’s current strategy leverages this distinction, arguing that it needs to show only that Regeneron’s contributions to the CDF were a “substantial factor” in causing the claims to be submitted, rather than the sole reason. This broader “proximate cause” approach could significantly ease the government’s burden of proof.

Healthcare compliance experts are closely monitoring the case, as it represents a potential watershed moment in FCA enforcement. If successful, the government’s arguments could establish that companies face liability when their conduct foreseeably leads to false claims, even without direct causal links to each claim.

“This case represents a significant evolution in how the government approaches FCA cases based on kickback allegations,” said Jennifer Roberts, a healthcare compliance attorney not involved in the litigation. “If the court accepts this theory, we’ll see a much wider net for potential liability throughout the healthcare industry.”

While the government may face a lower bar for establishing liability under this approach, it will still need to prove a causal connection between the alleged misrepresentations and any financial losses to recover damages. This “proximate cause” standard requires showing both causation in fact and legal causation—establishing that the defendant’s conduct was a substantial factor in bringing about the injury, and that such injury was foreseeable.

The government’s brief also emphasizes the materiality of AKS compliance, arguing that adherence to anti-kickback provisions is central to Medicare’s payment decisions. Drawing on Supreme Court precedent and the history of FCA enforcement for kickback-related violations, prosecutors contend that noncompliance with AKS is material as a matter of law.

Regeneron has defended its actions, maintaining that its donations to CDF were lawful charitable contributions that did not influence prescribing patterns. The company argues its drug pricing followed industry standards and guidance.

The implications for the healthcare industry could be far-reaching. If the court adopts the government’s position, pharmaceutical manufacturers, healthcare providers, and other entities involved with federal health programs will need to ensure that all business practices can withstand heightened scrutiny, particularly regarding patient assistance programs and third-party foundation relationships.

The case underscores the critical importance of robust documentation, clear compliance protocols, and vigilant oversight of all certifications made in connection with federal healthcare programs. As one industry observer noted, “This isn’t just about Regeneron—it’s about establishing new boundaries for the entire healthcare ecosystem.”