On August 12, 2022, the Department of Justice ("DOJ") filed its Amended Intervenor Complaint (the "Intervenor Complaint"), intervening in a qui tam action originally filed in 2014 by two nephrologists who referred patients to Fresenius Vascular Care d/b/a Azura Vascular Care ("Azura") clinics, Dr. John Pepe and Dr. Richard Sherman ("Relators"). The Relators filed their Fourth Amended Complaint ("Amended Complaint")1 against Fresenius Medical Care North America ("FMCNA"), Azura, and several other FMCNAaffiliated entities on August 7, 2020, alleging violations of the Federal False Claims Act ("FCA") and the Federal Anti-Kickback Statute ("AKS").2 The U.S. District Court for the Eastern District of New York unsealed the action on May 9, 2022. FMCNA is one of the two largest dialysis providers in the United States, operating over 2,500 dialysis units nationwide and treating over 200,000 dialysis patients annually. Azura operates more than 60 vascular care facilities across the country.
In the Intervenor Complaint, the DOJ alleges that Azura: (i) repeatedly performed and billed Medicare, Medicaid, and other government health care programs for medically unnecessary vascular access procedures, and (ii) falsified referrals to make it appear that patients' nephrologists referred the patients for these unnecessary procedures. On April 18, 2022, the Department of Justice ("DOJ") elected to intervene in the FCA claims but declined to intervene in the AKS claims. The AKS claims have...
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