Health Care Corporate Compliance

Health care organizations of all types (hospitals and health systems, medical device and pharmaceutical companies, health plans, and other health care providers) must develop and maintain an effective corporate compliance and ethics program. Boards of Directors are judged on whether or not they have taken steps, directly and through management, to implement such programs. This is necessary both as a core management tool and to demonstrate a commitment to good governance and compliance in order to take advantage of penalty reductions under U.S. Sentencing Guidelines, including the Sentencing Commission’s June 2020 revisions. “Such compliance and ethics program shall be reasonably designed, implemented, and enforced so that the program is generally effective in preventing and detecting criminal conduct.” But how do you design such a program? How does legal counsel assist the company in building and operating one? What distinguishes the “legal function” from the “compliance function.” Lawyers working in health care businesses need to be able to answer these questions to advice the board and management. This course focuses on the fundamentals required to develop and maintain an effective health care corporate compliance program. Students will study the seven elements of a successful compliance program in practical detail and will learn best practices for compliance programs. Specifically, this will include learning how best to design and implement compliance oversight and committees, practicing policy drafting, and exploring the most effective ways to educate and train in compliance. This will also include developing an excellent understanding of audit, investigation, and corrective action skills and strategies. GRADING NOTICE: This class does not offer the CR/NC/H option.