On September 30, 2024, a federal district court judge held that the qui tam provisions of the False Claims Act (FCA) violate the Appointments Clause of Article II of the Constitution.  U.S. ex rel. Zafirov v. Fla. Med. Assocs., LLC, C.A. No. 8:19-cv-01236-KKM, 2024 U.S. Dist. LEXIS 176626 (M.D. Fla. Sept. 30, 2024) (“Zafirov”).  While Zafirov’s holding is novel, the constitutional issue raised in that decision is not.

In the past year, DOJ obtained some of its largest recoveries in cases where violations of the Stark Law, which bars physicians from profiting from self-referrals for certain services payable by Medicare or Medicaid, served as a predicate offense for FCA claims. These included cases against Community Health Network, Covenant Healthcare System, Cardiac Imaging, and Steward Health entities.

Several case dispositions from this past year, both criminal and civil, reaffirm DOJ’s policy of ensuring individual accountability in resolving allegations of wrongdoing and underscore the importance of considering that issue in the resolution of any FCA case.

In 2023, the Supreme Court and the US Courts of Appeals published a number of significant decisions involving FCA issues with implications for health care and life science entities, including a deepening circuit split on the causation standard applicable to FCA cases based on theories under the Anti-Kickback Statute.

Despite the DOJ Criminal Division’s January 2023 revisions to its Corporate Enforcement Policy defining the criteria for declining to prosecute a criminal case, based on the two case examples from this past year, it is unclear how often the DOJ will actually put that policy into practice and decline or defer prosecution.

After growing significantly over the last decade, private equity health care deal activity nevertheless remained robust last year, with an estimated deal volume of about $29 billion in North America.

A recent Massachusetts Federal District Court decision adds to divergent opinions deciding an important health care enforcement question: what causation standard applies to a False Claims Act (FCA) case based on a violation of the Anti-Kickback Statute (AKS)? The AKS states that a claim that includes items or services “resulting from” a violation of the AKS constitutes a “false or fraudulent claim” under the FCA. 42 U.S.C. § 1320a-7b(g). On September 27, 2023, Chief Judge Saylor of the District of Massachusetts issued a decision in United States v. Regeneron Pharmaceuticals, Inc., C.A No. 20-11217-FDS, which adopted a “but-for” standard of causation applicable to the AKS’s “resulting from” language.

Mintz’s Health Care Enforcement Defense Practice regularly provides a comprehensive examination of health care fraud enforcement trends in its new EnforceMintz newsletter. The inaugural issue delved into False Claims Act cases and enforcement activity related to telemedicine, Medicare Advantage, opioids, kickbacks, and more.

Individuals and entities in the opioid supply chain continue to be a top enforcement priority for the Department of Justice (DOJ) and other enforcement agencies, and we expect this trend will continue in 2023. Federal enforcement efforts this past year were a mixed bag: DOJ suffered a significant setback at the Supreme Court, devoted new resources to curb opioid-related criminal conduct by individuals, and further expanded its civil enforcement toolkit to limit opioid overprescribing by pharmacies and pharmacists. DOJ’s civil enforcement efforts will continue unabated in 2023 as well, as evidenced by the government’s newest lawsuit against a major distributor filed in the final days of 2022. Additionally, state governments and private plaintiffs procured massive civil settlements in the national opioid litigation involving three major pharmacies in 2022.