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

On July 10, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule (“Proposed Rule”) in which it outlined proposed amendments to the suspension provisions and deadlines for reporting and returning Medicare Part A and Part B overpayments, and stated that it is continuing its review and evaluation of previously proposed changes to existing overpayment regulations.Continue Reading CMS Proposes to Amend Overpayment Rule-Questions Remain Regarding How the Rule Will be Implemented Should CMS Adopt the False Claims Act’s “Reckless Disregard or Deliberate Ignorance” Standard

Yesterday, the Supreme Court issued a unanimous decision holding that the scienter element of the False Claims Act (“FCA”) is met if a defendant subjectively knew his or her claims were false and submitted them anyway. See United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway. The Court’s ruling was narrow and avoided the more challenging—and common—issues raised during oral argument (which we previously discussed here).Continue Reading Supreme Court Clarifies that Subjective (Not Objective) Knowledge of Falsity of Claim Dictates False Claims Act Liability

Companies regularly are required to interpret ambiguous and vague regulatory provisions. Today, the United States Supreme Court heard oral arguments in a pair of consolidated cases to determine whether a defendant’s subjective interpretation of an ambiguous regulation is relevant to determining the knowledge (or scienter) element of the False Claims Act or, as the Seventh Circuit held in the case below, that once a defendant can articulate an objectively reasonable interpretation its contemporaneously held subjective belief is irrelevant to the knowledge inquiry. The issue is a significant one for both the government and relators on one side, and potential defendants on the other, as False Claims Act (FCA) liability imposes treble damages and penalties exceeding $20,000 per claim as well as relators’ attorneys’ fees and costs.Continue Reading Supreme Court Hears Arguments on False Claims Act Scienter Standard

Arguments were heard in the case of United States ex rel. Polansky v. Executive Health Resources, Inc., No. 21-1052 to determine whether and on what statutory grounds, the government, after initially declining to intervene, may subsequently intervene and dismiss a qui-tam False Claims Act (“FCA”) suit. The Court’s decision will resolve a dispute regarding the balance of power between an individual whistleblower and the Department of Justice (“DOJ”).Continue Reading SCOTUS to Decide Whether the Government has the Authority to Dismiss an FCA Suit After Initially Declining to Intervene and, if so, on What Grounds

The Centers for Medicare and Medicaid Services (“CMS”) has issued a proposed rule which would amend the existing regulations for reporting and returning identified overpayments (the “Proposed Rule”). Specifically, with respect to the meaning of “identification” of overpayment, CMS proposes to eliminate the “reasonable diligence” (or traditional negligence) standard and replace it with the False Claims Act’s (“FCA’s”) standard of “knowing” and “knowingly” (i.e., reckless disregard or deliberate ignorance of a potential overpayment).Continue Reading CMS Proposes to Amend Overpayment Rule, Remove Potential Overpayment and False Claims Act Liability for Mere Negligence