Master of Laws in Health Law and Policy Curriculum

This course is an overview of the two most important government-funded healthcare programs. The course begins with a review of the history, purposes, expectations, and evolution of Medicare/ Medicaid legislation and then emphasizes recent changes, including the new prescription drug benefit under Medicare. Students will become familiar with issues important in the legal representation of patients, hospitals, doctors, and other providers under these laws. Special attention is given to the lawyer’s role regarding fraud and abuse statutes. The legal mechanisms of cost containment and utilization control within these programs are examined. The class explores policy issues and compares these programs to other federally funded healthcare programs. The requirements of the course can be met either by taking the final exam or by writing an erudite paper.

This course explores contemporary problems involving law, medicine, and ethics. The rights of patients, the responsibilities of physicians, and the interests of society are examined in the contexts of medical treatment, death and dying, abortion, the new reproductive technologies, genetics, research on human subjects, and organ transplants.

This course will explore the influence of law and regulation in the United States and other jurisdictions on the pharmaceutical and biotechnology industry. The central focus will be the pathway of the discovery, development, and commercialization of new medicines and the effect of various stakeholders, legal disciplines, governmental structures, and globalization on that pathway. Students will learn the lawyer’s role in negotiating agreements, resolving disputes, making policy, and otherwise building consensus in this complex setting. Topics include the history of food and drug and related law, the evaluation of drug safety and efficacy, market exclusivity and market protection, and the roles of the FDA and other U.S. and non-U.S. government agencies. Students will have the option of taking the final examination or writing a paper.

Passage of the Affordable Care Act has, in many ways, encouraged healthcare payers and providers to partner, merge, or acquire their way to establishing economies of scale. This course will explore several of the most prevalent commercial business transactions in the healthcare industry today. After studying the structure, purpose, and best practice approaches to identifying the right business transaction for an organization, students will explore the case law, statutes, and regulations applicable to healthcare transactions. With an emphasis on building a sustainable business combination, students will walk through the fundamental elements of a negotiated acquisition process: due diligence; preliminary negotiations and agreements; transaction structure; final negotiations; definitive agreements; and post-closing relationships. By the end of the course, students will be familiar with all phases of the healthcare partnership/merger/acquisition process and be able to apply core partnership principles to every transaction.

Public Health Law, Policy, and Ethics will focus on the application of law to public health and on the ethical and policy parameters of that application. During most of its history, the United States has struggled to improve population health without compromising the health of individuals. This course addresses legal and policy responses to issues such as mandatory vaccination, addiction, obesity, hunger, genetic testing, environmental pollution, epidemics, bioterrorism, natural disasters, and limitations on access to health care, among other issues. Students will consider how best to shape public health policy, the role of law in implementing policy, and the ethical implications of efforts by lawmakers to improve population health.

This course covers the fundamentals of statutory interpretation through the lens of a particular statute, the Americans with Disabilities Act of 1990, as amended. The course introduces students to the basics of statutory interpretation, then asks students to apply what they have learned in doctrinal context. Students will be exposed to the various mechanisms by and forums in which statutes are analyzed and interpreted, and the evidence used in the process, including but not limited to legislative history, agency interpretation, judicial decisions, and administrative regulations. Although the course is not designed as a doctrinal course in disability law, students should come away from the offering with a solid grasp of its fundamentals, as well as an understanding of the subject matter at hand.

Lawyers representing healthcare providers, whether the provider is an individual healthcare practitioner, a group, a single institution, or a large healthcare system, must deal with different areas of law to address the diverse issues that apply. This course is intended to acquaint students with the wide variety of federal and state legal and regulatory issues which healthcare attorneys encounter in their day-to-day practice. Specific examples of federal and state laws and regulations will serve as a framework to demonstrate the impact on healthcare providers. A paper is required.

Healthcare compliance covers a vast legal landscape, and this course is intended as a general exploration of the major sources of law applicable to health lawyers, government agencies, health care providers, research institutions, researchers, inventors and developers. This course is a practical application of the intersection of the areas students have already studied at this point in the program, from administrative agency law to ethics and policy, and the business of healthcare; it is not intended to focus on any one topic, such as Medicare and Medicaid. However, since health data privacy and security issues are pervasive across all areas of health law, particular attention will be paid to HIPAA and HITECH, and how they intersect with: human subjects research regulations under the Common Rule; electronic medical records and personal health records; and regulation of mobile medical devices, mobile medical apps and mobile health apps. Other areas that will briefly be explored include the European Data Privacy Directive and its various amendments; the death of Safe Harbor; PIPEDA and PHIPA; and certain state regulations, using New York State and California as models. The course will also explore how to create and foster a culture of compliance within any health-related organization. Statutes, rules, and regulations will be analyzed through lecture and practical exercises, which will include drafting sample internal policies, memos, and proposing gap-filling legislation or regulations.

The capstone course, to be taken in the final semester of the program, will focus on the application of substantive knowledge and skills gained during previous courses. The first few weeks of the course will focus on summarizing and reinforcing the concepts learned in previous courses. Then, the focus of the course will shift to identifying problems encountered in the healthcare system, in particular the intersection of previously covered topics, such as health care regulation, bioethics, insurance, and healthcare transactions, and formulating potential solutions to such problems. In order to do so, students will be asked to not only consider information from previously taken courses, but also to use research and critical-thinking skills to expand their knowledge of the healthcare system and the legal process in order to solidify their working knowledge of health law and legal institutions.

The course will generally be structured using major legal institutions within the United States for guidance, such as the functions of legislative, executive, and judicial institutions, as well as the roles of state and federal governments in the healthcare system. However, the information to be covered in the capstone course will focus on practical issues faced while working in the healthcare system, including current events, and the skills necessary to resolve such issues. In addition, students will be required to complete a final project, in the form of a research paper, which must identify at least two or more issues encountered in the health law program and offer a potential solution to such issues. The objective of the final project is for students to draw upon their knowledge of the healthcare system and legal institutions through independent research to offer a reasoned and well-supported solution to the issues selected by each student.