A Return to United States ex rel. Zafirov and Vertex Pharmaceuticals

October 29, 2026  |  New York Law Journal

In the latest edition of his New York Law Journal healthcare enforcement column, Morvillo Abramowitz Grand Iason & Anello partner Rob Radick explores two recent appellate decisions that carry significant implications and will undoubtedly be the subject of further litigation. In United States ex rel. Zafirov v. Florida Medical Associates, LLC, the Eleventh Circuit rejected an Appointments Clause challenge to the False Claims Act’s qui tam provision but remanded for further consideration of two other constitutional lines of attack. In Vertex Pharmaceuticals Inc. v. U.S. Department of Health and Human Services, the D.C. Circuit upheld an advisory opinion in which HHS found that a proposed program involving the payment of funds for fertility treatments to offset the negative side effects of a gene-editing therapy would violate the Anti-Kickback Statute (AKS), but rejected HHS’s conclusion that the program violated the AKS’s civil counterpart, the Beneficiary Inducement Statute.

A Return to United States ex rel. Zafirov and Vertex Pharmaceuticals