Counseling companies in the life sciences industry involves assessment of client activities in relation to federal and state anti-kickback laws. Reed Smith's experience in this area is significant and diverse.
We help clients stay on top of fraud and abuse, anti-kickback, Stark and safe harbor laws, identifying the potential risks arising from marketing, sales and pricing programs. Our attorneys recommend compliance procedures, conduct training, and perform audits to prevent enforcement actions and penalties. We have obtained advisory opinions that help companies manage risk and structure business initiatives with a better understanding of federal enforcement intentions.
Reed Smith's attorneys stand by clients faced with civil and/or criminal investigations, helping to negotiate settlements and defend clients in government and qui tam (whistleblower) litigation, and to implement corporate integrity agreements.
When the need arises, we assist clients who are subject to civil and criminal investigations and actions brought by the Office of Inspector General and the Department of Justice for alleged violations of the anti-kickback laws, the federal False Claims Act and other statutes.