Health care compliance is a significant concern for organizations. Recent changes to the False Claims Act and other government enforcement mechanisms have increased risks of noncompliance. At the same time, the rules with which entities must comply are increasingly complex and new regulatory requirements are emerging in the areas of quality of care, waste, privacy, data management, and health care reform. As a result, compliance is emerging as a fundamental part of organizational governance.
Under the Federal Sentencing Guidelines, an effective compliance program must prevent and detect criminal behavior as well as encourage ethical conduct and a commitment to compliance with the law. It must provide relevant and enforceable policies, deliver effective education, utilize reliable risk assessment tools, and it must demonstrate that it can identify and correct problems quickly. The senior compliance officer is the face of the organization in investigations, and a good compliance program can significantly lower enforcement risk when problems arise. Accordingly, lawyers need to understand both the law and its application in the compliance landscape to be especially valuable to clients.
This course will give students a real world understanding of what compliance is like today. We will evaluate current issues in the provider and pharmaceutical industries against relevant laws, regulations, and regulatory guidance. We will look at the requirements of an effective compliance program, and we will examine issues in investigations and litigation arising from compliance failures.