By Alan M. Kirschenbaum –
Hyman, Phelps & McNamara, P.C. has updated the firm’s outline on the Application of the Health Care Fraud and Abuse Laws to the Marketing of Pharmaceuticals and Medical Devices. The outline, which was last updated in 2009, has been expanded to cover devices as well as drugs. It provides an overview of the Federal health care program antikickback law, the Federal False Claims Act, and other federal and state fraud and abuse laws and related laws, identifying noteworthy cases and OIG precedents that interpret these laws. The outline also discusses the major enforcement risk areas for which drug and device companies have been targeted in recent years, including the offer of free goods and services, bundled discounts, consulting fees, grants, post-marketing studies, inflation of reported prices, off-label promotion, and other areas, citing relevant OIG guidance and examples of enforcement actions and settlements in each area.