FDLI's Food and Drug Law and Regulation

Authors: Gail L. Daubert Joseph W. Metro

Gail Daubert, Joe Metro and Gordon Schatz wrote “Reimbursement, Fraud and Abuse,” a chapter in the third edition of FDLI’s Food and Drug Law and Regulation. The chapter provides an overview of reimbursement and fraud and abuse issues as they pertain to manufacturers of medical devices, pharmaceuticals and biologics. There are several different types of health insurance programs, with payors ranging from government entities, private nonprofit insurers, commercial insurers and managed care organizations. As a result, there is often great variance in policies relating to reimbursement and fraud and abuse. Gail, Joe and Gordon’s chapter focuses primarily on two key governmental payors, Medicare and Medicaid, that commonly influence the actions and regulations of other payors.