False Claims Act

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The ABA’s 2026 False Claims Act Mock Trial Institute, held in New Orleans this year and sold out, once again offered a bevy of lessons, information, and insight. As always, the FCA Mock Trial Institute provided a valuable opportunity for members of the government, relator, and defense bars to network and talk cheerfully outside the occasionally adverse litigation atmosphere. Sheppard Mullin was again well represented among faculty and attendees by five attorneys from its experienced FCA team and hosted a well attended Thursday evening reception at Compare Lapin.Continue Reading Notes From The ABA’s 2026 False Claims Act Mock Trial Institute

Today, the Eleventh Circuit heard oral argument in United States ex rel. Zafirov v. Florida Medical Associates, LLC, a case addressing the constitutionality of qui tam relators that has drawn national attention. At stake is the future of qui tam whistleblower actions under the FCA—a statutory scheme that has, for decades, empowered private individuals to bring fraud claims on behalf of the federal government.Continue Reading Eleventh Circuit Hears Oral Arguments in High-Profile Challenge to Constitutionality of The False Claim Act’s Qui Tam Provision

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.Continue Reading Regeneron, the False Claims Act, and a New Era in Government Enforcement

The inexorable expansion of the False Claims Act (“FCA”) to cover virtually all types of cybersecurity breaches and violations – to include allegedly poor practices and failure to fully adhere to security controls – continues. At one time, an organization might have thought that it was unlikely to face a potential FCA investigation and litigation relating to its cybersecurity practices. That day is long past. Two recent FCA settlements illustrate the expansion: one is the first cybersecurity FCA settlement relating to healthcare Quality System Regulations (“QSR”) and the other involves the first settlement with a defense contractor that also pulls in its private equity owner.Continue Reading The Expanding Scope of FCA-Cybersecurity Liability

On July 9, 2025, the U.S. Department of Justice (“DOJ”) announced it sent more than 20 subpoenas to physicians and clinics involved in providing gender-affirming care to minors, and that the subpoenas related to investigations into healthcare fraud, false statements and other misconduct.[i] DOJ’s recent announcement, combined with the other actions described below, signal the government’s interest in pursuing action against providers that bill federal healthcare programs for gender-affirming care for minors, including puberty blockers, hormone therapy and surgeries. Specifically, these actions strongly suggest that the government will investigate not only criminal claims but also civil claims under the False Claims Act[ii] (“FCA”) against gender-affirming care providers that bill federal healthcare programs for services provided to minors, relying on bases related to miscoding/misbilling, lack of informed consent and lack of medical necessity. The FCA provides for treble damages and penalties of up to $28,619 per claim. We discuss each of these theories below and what providers can do to reduce potential exposure under these theories.Continue Reading Potential False Claims Act Liability for Providers of Gender-Affirming Care for Minors

On July 2, 2025, the Departments of Justice and Health & Human Services announced a joint working group aimed at “strengthening their ongoing collaboration to advance priority enforcement areas” under the False Claims Act (FCA) – described in the announcement as “one of the government’s most effective and successful tools” for fighting fraud. In Fiscal Year 2024, the Department of Justice recovered more than $2.9 billion through settlements and judgments under the FCA, with $1.6 billion (57%) coming from healthcare-related matters.Continue Reading DOJ and HHS Announce Joint False Claims Act Working Group and Enforcement Priorities

At the end of May, the Department of Justice (DOJ) announced the formation of a Civil Rights Fraud Initiative to “utilize the False Claims Act to investigate and, as appropriate, pursue claims against any recipient of federal funds that knowingly violates federal civil rights laws.” In connection with the Initiative, we will see DOJ’s False Claims Act practitioners in the Civil Division and the U.S. Attorneys’ Offices pairing with DOJ’s Civil Rights Division to “identify and root out instances in which recipients of federal funds fail to uphold their basic obligations under federal civil rights laws.”Continue Reading DOJ Civil Rights Fraud Initiative Will Use the False Claims Act to Target Antisemitism and DEI Programs

Earlier this month, the Eleventh Circuit (the “Court”) issued a decision in a False Claims Act (“FCA”) case against a medical supplier that offers welcome clarity for companies facing whistleblower allegations. In Vargas ex rel. Alvarez v. Lincare, Inc., 2025 U.S. App. LEXIS 9084 (11th Cir.), the Court emphasized high pleading requirements FCA plaintiffs must satisfy to survive a motion to dismiss. Specifically, the court held that it is not enough to allege a general scheme; the FCA plaintiff must also plead, with detail, how the scheme caused the actual submission of false claims to the government. The decision is especially significant in the healthcare context with respect to Anti-Kickback Statute (“AKS”) based FCA cases. The court made clear that the plaintiff must do more than include conclusory allegations that one purpose of the payment was to induce referrals—it must include details as to the defendant’s intent.Continue Reading Inferential Leaps and Conclusory Kickback Allegations Remain Verboten in False Claims Act Complaints

The litigator’s adage “it’s easy to plead, it’s hard to prove” once again came true in the long-running False Claims Act (FCA) case targeting Medicare Advantage (“MA”) plans operated by UnitedHealth (United). Eight years after the complaint was filed, a Special Master recommended granting United’s motion for summary judgment. U.S. ex rel. Poehling v. UnitedHealth Group, Inc., 2025 U.S. Dist. LEXIS 40921 (CD CA). Both the litigation and the Special Master’s report contain valuable insights for all FCA defendants, and especially for those matters involving allegations related to diagnosis coding.Continue Reading Proving Fraud is and Should Be Hard: Lessons from a Recent Medicare Advantage False Claims Act Decision

A federal district court in the Middle District of Florida issued a decision on Sept. 30th that threatens the federal government’s continued reliance on the False Claims Act (“FCA”) as the most powerful weapon in the Department of Justice’s enforcement arsenal. U.S. District Judge Kathryn Kimball Mizelle threw out a case against a group of Medicare Advantage organizations and providers on the grounds that an individual whistleblower suing on behalf of the federal government under the FCA, often called a “relator” in a “qui tam” lawsuit, violates the U.S. Constitution’s “appointments clause.” The Court concluded that relators, who are acting on behalf of the federal government, must be considered officers of the government and appointed in a manner consistent with Constitutional requirements. See U.S. ex rel Zafirov v. Florida Medical Associates, LLC, No. 8:19-cv-1236, 2024 U.S. Dist. LEXIS 176626, ECF No. 346 (M.D. Fl. Sept. 30, 2024).Continue Reading FCA Whistleblowers – No More?

In the high-stakes realm of False Claims Act (FCA) litigation, per-claim penalties can reach daunting levels that dwarf even treble damages. A recent ruling from the Eighth Circuit Court of Appeals provides valuable guidance on the limits of penalties under the Constitution’s Excessive Fines Clause (Clause). In Grant ex rel. United States v. Zorn, the Eighth Circuit applies the Clause in FCA litigation to identify when a penalty for purely economic loss offenses might be considered excessive. Specifically, the Court held that:Continue Reading There Are Limits! Reining In FCA Penalties Pursuant to the Excessive Fines Clause