Health Care and Litigation Partner Author Chapter in Pharmaceutical and Medical Device Compliance Manual

In The News
September 19, 2019

Litigation & enforcement partner Colleen Conry (Washington, D.C.) co-authored a chapter in the Pharmaceutical and Medical Device Compliance Manual Second Edition titled “Thou Shalt Not Buy Business: The Implications of Anti-Kickback Statute on the Drug and Device Industry.” The book, published by the American Health Lawyers Association with Seton Hall Law School, includes guidance to develop compliance programs for the complex enforcement and business environment amid growing scrutiny from state, federal and international regulators.

The authors were assisted by health care associate Michael DiMaio (Boston) and life sciences regulatory & compliance associate Rebecca Williams (Washington, D.C.).

The book chapter addresses Anti-Kickback Act topics including the statute and its interpretations, permissible business arrangements, enforcement and penalties, legislative history and judicial interpretation, implementation of safe harbors, increasing punishments, statutory prohibitions, case law, compliance program guidance, and selected settlements of AKA allegations, among other matters.