The Centers for Medicare and Medicaid Services (CMS) published its final rule regarding the Medicare Advantage (MA) Risk Adjustment Data Validation (RADV) program in early February 2023. Among other matters, the final rule...more
The U.S. Department of Justice (DOJ) has reached a settlement with hospice company AseraCare, closing a 12-year-old saga that carries substantial implications for False Claims Act (FCA) enforcement in cases involving a...more
3/10/2020
/ Department of Justice (DOJ) ,
Evidence ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospice ,
Jury Instructions ,
Medical Necessity ,
Medicare ,
Motion For New Trial ,
Objective Falsity ,
Remand
The solicitor general filed an amicus brief in the U.S. Supreme Court last month supporting the relators’ opposition to certiorari in Gilead Sciences, Inc. v. United States ex rel. Campie, et al., No. 17-936. Yet the...more
12/19/2018
/ Amicus Briefs ,
Department of Justice (DOJ) ,
Discovery ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Gilead Sciences Inc v United States ex rel Campie ,
Manufacturers ,
Materiality ,
Misrepresentation ,
Motion to Dismiss ,
Petition for Writ of Certiorari ,
Pharmaceutical Industry ,
Prescription Drugs ,
Qui Tam ,
Reimbursements ,
Relators ,
Remand ,
Solicitor General
The U.S. District Court for the Southern District of New York recently held that the FDA may not constitutionally bring a misbranding action based on truthful and non-misleading off-label promotion of an FDA-approved drug,...more
9/23/2015
/ Amarin ,
Commercial Speech ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Misbranding ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs