AMARILLO, TX – The False Claims Act (FCA) is a powerful tool used by the federal government to combat fraud, particularly in healthcare and defense contracting. Central to its enforcement is the qui tam mechanism, which allows private whistleblowers, also known as relators, to bring lawsuits on behalf of the United States and share in any recovery.
Courts have upheld the public-private enforcement partnership as constitutional for decades, citing its deep roots in legal tradition. But in recent years, several Supreme Court Justices have expressed skepticism, reigniting debate over whether qui tam relators improperly wield executive power without appointment under Article II of the Constitution.
That debate reached a critical juncture in United States ex rel. Zafirov v. Florida Medical Associates, LLC et al., (Zafirov) which is now before the Eleventh Circuit Court of Appeals. The case stems from a September 2024 decision by Judge Kathryn Kimball Mizelle of the Middle District of Florida, who became the first federal judge to hold that the FCA’s qui tam provisions are unconstitutional.
The District Court’s Groundbreaking Ruling
Relator Clarissa Zafirov alleged that her former employer, Florida Medical Associates, submitted hundreds of thousands of false claims to Medicare by misrepresenting diagnosis codes. When the government declined to intervene, Zafirov pursued the case independently under the FCA’s qui tam provisions. Judge Mizelle dismissed the suit, reasoning that the relators act as “officers of the United States” because they exercise significant authority pursuant to federal law and occupy a continuing position established by statute.
Under Article II’s Appointments Clause, such officers must be appointed by the President, courts of law, or department heads. Because the relators self-appoint by filing suit, Judge Mizelle concluded that the FCA’s framework violates the Constitution. She rejected arguments that historical practices, such as English bounty statutes or Civil War-era qui tam actions, could save the statute from this infirmity. Essentially, she concluded that FCA relators wield core executive power without constitutional appointment, making the qui tam provision unconstitutional and requiring dismissal.
Judge Mizelle also noted that it was not until the defendants moved for a judgment on the pleadings, arguing that the FCA’s qui tam provision violates Article II’s Appointments Clause, Take Care Clause, and Vesting Clause, that the government intervened solely to contest the defendants’ constitutional arguments. They otherwise allowed Zafirov to steer the litigation.
The Appeal to the Eleventh Circuit
The Eleventh Circuit heard oral arguments in December 2025 before Judges Robert J. Luck, Elizabeth L. Branch, and Senior Judge Federico A. Moreno. The panel probed two central questions:
Do relators exercise “significant authority” reserved for government officers?
Counsel debated whether the relator’s ability to initiate litigation, dictate investigative resources, and pursue appeals amounts to executive power. Defendants argued that this authority intrudes on the President’s duty to “take care that the laws be faithfully executed.”
Does historical precedent justify the FCA’s structure?
The government and relator emphasized that qui tam statutes have existed for centuries and form part of the constitutional backdrop. Defendants countered that tradition cannot override Article II’s text, primarily when relators act without executive oversight.
The bench was active, pressing both sides on the balance between constitutional theory and practical enforcement. Observers noted that the judges appeared concerned that relators could compel government investigations simply by filing suit under seal, a statutory requirement that obligates the Department of Justice to review allegations.
Broader Context and Supreme Court Signals
The Zafirov appeal arrives amid growing judicial skepticism. In U.S. ex rel. Polansky v. Executive Health Resources (2023), Justice Clarence Thomas dissented, calling qui tam a “constitutional Twilight Zone.” United States ex rel. Polansky v. Executive Health Resources, Inc., No. 21‑1052, slip op. at 7 (U.S. June 16, 2023). Justices Brett Kavanaugh and Amy Coney Barrett signaled agreement, suggesting the Court should revisit the issue in an appropriate case.
Historically, appellate courts have upheld the FCA’s constitutionality, rejecting challenges under Article II, separation of powers, and due process. Yet Judge Mizelle’s ruling in Zafirov broke from this consensus, emboldening defendants nationwide to raise constitutional defenses. Several district courts have declined to follow her reasoning, but the Eleventh Circuit’s decision will mark the first appellate test of this new wave of challenges.
Stakes for Enforcement and Whistleblowers
The implications are profound. The Department of Justice relies heavily on qui tam relators, particularly in healthcare fraud, where insider knowledge is essential. In fiscal year 2024, FCA recoveries exceeded $2.4 billion, with whistleblower cases comprising the majority. By mid-2025, recoveries had already reached nearly $3.8 billion.
If the Eleventh Circuit affirms Mizelle’s ruling, relators may be barred from pursuing cases independently, leaving enforcement solely to the government. This could reduce the volume of FCA litigation, as historically, qui tam filings outnumber government-initiated suits two to one. Alternatively, the DOJ might need to devote far greater resources to maintain enforcement levels.
For whistleblowers, the decision could eliminate financial incentives and diminish protections, potentially chilling fraud reporting. For defendants, it could provide a robust new defense against FCA liability.
The Path Forward
Regardless of the Eleventh Circuit’s outcome, the case is widely expected to reach the Supreme Court. With multiple Justices already signaling interest, Zafirov may provide the vehicle for a definitive ruling on the constitutionality of qui tam actions.
Until then, uncertainty looms. Compliance officers, healthcare providers, and contractors must prepare for potential shifts in FCA enforcement. Advocacy groups stress that weakening qui tam actions could undermine fraud detection, while business groups argue it would restore constitutional balance.
Zafirov pits centuries of legal tradition against modern constitutional scrutiny, testing whether private citizens may continue to wield executive power in the fight against fraud. The Eleventh Circuit’s decision will not only shape the future of whistleblower litigation, it may also set the stage for a Supreme Court showdown that could redefine the contours of public-private enforcement in American law.
While this area of law is still being determined, DME suppliers should remain wary and ensure they are complying with the rules and regulations. If a DME supplier is doing something it should not be doing, someone knows about it. Whistleblowers, whether employees, contractors, or other insiders, are incentivized under the False Claims Act to file qui tam lawsuits and often receive a percentage of the recovery. This environment makes suppliers particularly vulnerable: even minor documentation errors or billing discrepancies can be framed as fraud once a whistleblower brings them forward. For suppliers, the danger lies not only in intentional misconduct but also in the appearance of noncompliance, that whistleblowers can exploit to initiate investigations. Strengthening compliance programs, auditing contracts, and maintaining transparent documentation are therefore essential defenses against whistleblower-driven scrutiny.
Jeffrey S. Baird, Esq., is chairman of the Health Care Group at Brown & Fortunato, PC, a law firm based in Texas with a national healthcare practice. He represents pharmacies, infusion companies, HME companies, manufacturers, and other healthcare providers throughout the United States. Mr. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization and can be reached at (806) 345-6320 or [email protected].
Jacque K. Steelman, Esq., is a member of the Health Care Group at Brown & Fortunato, PC, a law firm with a national healthcare practice based in Texas. She represents pharmacies, infusion companies, HME companies, manufacturers, and other healthcare providers throughout the United States. Ms. Steelman can be reached at (972) 684-5789 or [email protected].
