On Oct. 20, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued unfavorable Advisory Opinion 23-08 (AO 23-08), continuing its long-held position that the provision of value-added...more
In recent years, various federal agencies, including the Department of Health and Human Services Office of the Inspector General and the U.S. Food and Drug Administration (FDA), have increasingly scrutinized compounded...more
A Texas federal court recently denied a pharmaceutical supplier’s motion to dismiss claims brought by a whistleblower under the federal False Claims Act (FCA) alleging violations of the Anti-Kickback Statute (AKS) and...more