Larry Vernaglia

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.

This course focuses on the highly regulated industry of health care, but with attention to the law applicable to hospitals and health systems. The course will review Federal and State statutes, regulations, as well as case law relevant to hospital organization, responsibilities and liability, credentialing, fraud and abuse laws and compliance oversight. The course is intended to develop competencies in understanding health care and health care insurance laws and regulations as they pertain to hospitals, developing familiarity with the reimbursement (particularly Medicare & Medicaid), regulatory compliance and enforcement issues facing hospital counsel. In addition, it is expected that students will demonstrate legal analysis and reasoning, problem-solving and communications skills required for work in a hospital/health care setting. Through understanding core health care law principles, students will learn the foundational legal, structural and business aspects of the modern hospital complex. Understanding how hospitals fit into the broader health care environment of payors, physicians, patients, regulators and other health care providers, law students will be able to appreciate the challenging dynamics affecting the health care system and the role of the hospital, often at the hub of activity, both in terms of current practice, but also health care delivery system reform. After completing the class, students will have been exposed to the key health care-related legal issues facing hospitals that hospital counsel and other health care lawyers need to know. Additionally, recognition of these stressors will be important training for lawyers in other disciplines interacting with hospitals, such as labor and employment law, intellectual property, antitrust, criminal defense, environmental, corporate, employee benefits, tax, etc. Course materials include a case book, primary source documentation, and guest lectures from in-house and outside counsel representing hospitals.