One-fifth of the U.S. economy centers around health care industry sectors. This seminar examines criminal, civil and administrative tools used by federal and state enforcement authorities to police the U.S. healthcare system. We will focus on cases brought under federal and state False Claims Acts (FCA), the Anti-Kickback Statue (AKS), Stark laws, Federal Food Drug and Cosmetic Act (FDCA), and Foreign Corrupt Practices Act (FCPA). The seminar provides a survey of the enforcement activities of the U.S. Department of Justice (DOJ), the Office of Inspector General at Department of Health and Human Services (OIG), and state Medicaid Fraud Control Units (MFCUs) in matters against pharmaceutical and medical device manufacturing companies, physicians, hospitals, clinical practices, nursing homes, laboratories, and others. The seminar materials thoroughly cover the statues, safe-harbors, and regulations that govern the health care industry. We will also discuss risk mitigation strategies and compliance program best practices across industry sectors to provide insight into the impact enforcement has on (1) clinical decision-making, (2) costs to providers, payers, and patients, (3) patient safety, and (4) quality of care. In an effort to maintain a broad perspective with the diverse and frequently changing legal landscape in the area, in addition to the case book, materials discussed and presented in this course draw from news reports, trade publications, and U.S. government agency materials.
The class requires a paper of approximately 20-25 pages in length.