2014 Health Law & Policy Summer Institute Course Descriptions
Day Courses (9 am - 5 pm)
June 16 - 17
Pharmaceuticals & the Law (D. Kracov & M. Ruggiero): As the government increasingly determines virtually every aspect of how drugs are developed and delivered to patients, it is important to understand the complex framework governing pharmaceutical innovation and patient access to new therapies. This course will provide an introduction to the range of legal and policy issues relevant to the biopharmaceutical industry, including: 1) the regulation of drug and biologic development, approval, and promotion; 2) laws and regulations governing access to biopharmaceuticals and other types of care under large government healthcare programs; 3) fraud and abuse laws and regulations and "transparency" policy trends, including disclosure of and restrictions on interactions with healthcare providers; 4) "healthcare reform" policy trends, including cost containment, expanding coverage for the uninsured, and improving the quality of healthcare; 5) statutory intellectual property protections for biopharmaceuticals, including patent-related processes and various exclusivities; and 6) the interplay between biopharmaceutical regulation and product liability. This is one of three courses focusing that can be counted towards a Pharmaceutical Law Series Certificate of Completion. Academic credit requirement: Take home exam, due 3 weeks after the course ends.
June 18 - 19
Bioethics & the Law (H. Gertner): This class will examine how the US legal system reconciles competing values and interests in controversies surrounding the practice of medicine. Case law, legislation, advisory policies, and institutional policies will be examined, as well as selected commentary from the legal, medical, and philosophical perspectives. Substantive topics may include:ethical issues at the beginning of life, including abortion, maternal-fetal conflicts, and embryo disposition, the definition of death, the right to refuse treatment, medical decisions regarding treatment for incompetent patients (including children), physician assisted suicide, organ transplantation, and research involving human subjects. This is one of three courses that can be counted towards a Bioethics & the Law Series Certificate of Completion. Academic credit requirement: Take home exam, due 3 weeks after the course ends.
June 23 - 24
Health Care Fraud & Compliance I: Legal Issues in Health Care Fraud and Abuse (A. Scielzo): Participants will examine fraud and abuse in the delivery of health care through discussions of the criminal and civil laws and regulations that combat various forms of health care fraud. The course includes a False Claims Act "Boot Camp" as well as discussion of Stark Law and Anti-Kickback Statute issues, health care anti-fraud enforcement efforts under both Medicare and Medicaid, sanctions, and compliance. The teaching strategies for this course will include readings, guest lectures, group discussions, and mock client hypotheticals. This is one of three courses focusing on Health Care Fraud and Compliance and can be counted towards a Health Care Fraud and Compliance Series Certificate of Completion. Academic credit requirement. Take home exam, due 3 weeks after the course ends.
The Law & Ethics of Assisted Reproductive Technologies (S. Crockin): This course will examine and analyze the underlying, competing, and evolving laws, policies, and ethical tensions arising from the assisted reproductive technologies (ARTs). Over the past thirty years, since the birth of the world’s first IVF baby, these ongoing medical advances have challenged existing laws and spawned the need for new ones, all while continuing to make front page news. The growing involvement of third-party participants—including sperm and egg donors and gestational surrogates—and rapidly expanding use of the ARTs by single patients and same-sex couples, adds to these challenges. Disputes and issues involving the ARTs frequently involve—and challenge—existing family, health, contract, and constitutional law, and also intersect with controversial laws and policies involving abortion, personhood, and embryonic cell research. Students will come away from this course with an understanding of the legal and ethical aspects of the ARTs and an ability to analyze the legal and ethical dimensions of both current and emerging reproductive technologies. This is one of 3 courses focusing on Bioethics and can be counted towards a Bioethics and the Law Certificate of Completion from American University Washington College of Law. Academic credit requirement: Take home exam, due 3 weeks after the course ends. This is one of three courses that can be counted towards a Bioethics & the Law Series Certificate of Completion Academic credit requirement: Take home exame, due 3 weeks after the course ends .
June 25 - 26
Health Care Fraud & Compliance II: Health Care Corporate Compliance and Governance (A. Scielzo) Participants will explore the importance of corporate compliance for health care organizations, review the current health care compliance landscape, and become familiar with key compliance guidance and principles. Lectures will use current compliance failures as a teaching tool, and will delve into the specific elements of an effective compliance program. A discussion of effective HIPAA compliance will be used as a case example. With regards to corporate governance, the course will provide an overview of fiduciary duties, with emphasis on the specific challenges faced in the health care industry. The course will conclude with a discussion of how effective health care corporate compliance and governance intersect. The teaching strategies for this course will include readings, lectures, and group discussions. This is one of three courses focusing on Health Care Fraud and Compliance and can be counted towards a Health Care Fraud and Compliance Series Certificate of Completion. Academic credit requirement: Take home exam, due 3 weeks after the course ends.
The Law & Ethics of Human Subjects Research (L. Odwazny) Research involving humans as research subjects incurs special ethical and legal responsibilities – some are voluntary, and some are mandated by law. Largely in response to notable and horrific scandals, frameworks for ethical protections for the conduct of human subjects research developed in the 20th century, and the field of research ethics has been burgeoning for the past 50 years with a vast increase in bioethical commentary. The U.S. legal system for regulating the conduct of human subjects research developed concurrently, culminating in 1991 with the current Federal regulatory structure. The U.S. Federal system of regulating human subjects research is based on ethical principles and sets the minimum legally allowable standards for the conduct of Federally funded human subjects research -- and continues to be a contentious and hotly debated regulatory scheme. This course is designed to encourage an understanding of the interrelationship of law and ethics in the protection of human subjects in research: to this end, the course will provide the historical context for the development of the discipline of research ethics; an overview of the U.S. and international codes of research ethics, with a focus on the substance and operation of current U.S. law; and a case-based exploration of controversial issues at the intersection of law and ethics. This course can be counted either towards a Pharmaceutical Law Series Certificate or a Health Care Fraud and Compliance Series Certificate. Academic credit requirement: Paper due 3 weeks after the course ends.
June 27 - 28
Health Care Fraud & Compliance III: In-House Health Care Practicum (T. Rao): . This is an advanced health law course teaching students to step into the role of an in-house health care attorney. Students will focus on practical skills using hypotheticals and specifically focusing on counsel involvement in government investigations and disclosure of privilege, identifying over-payments, and self-disclosures. The key takeaway of the course is for students to gain practical knowledge and a foundation to spot issues in order to marry health law regulations with the operations of health care organizations. This course will provide enough perspective that it will aid students who are looking to interview and obtain a position working in house, government, or at a firm working with health care clients. This is one of three courses focusing on Health Care Fraud and Compliance and can be counted towards a Health Care Fraud and Compliance Series Certificate of Completion. Academic credit requirement: Take home exam, due 3 weeks after the course ends.
Prerequisites: Law students must first have taken a health care fraud and abuse course or a health care compliance course in order to take this course. Non-credit participants who have no experience in health care fraud and abuse or compliance are encouraged to take Health Care Fraud and Compliance I & II before taking this course.
June 16 - 21 (6:00 - 9:00 pm, Monday - Thursday and 9:00 am to 12:00 pm Saturday, June 21)
Health Care Economics & the Law (N. Bath): This course will examine how the Affordable Care Act and related health reform legislation attempts to slow rising health care costs. Slowing health care costs is one of the greatest domestic challenges of this century. Health care spending continues to outpace economic growth and is expected to account for 20% of the US economy by 2021. (By comparison, in 2010, other OECD countries spent on average about 9.5% of their GDP on health care.) Therefore, anyone who works on health care policy must understand the major economic theories upon which our current health care laws are based. This course will examine the extent to which current laws incorporate these theories and how these theories are applied to two discrete areas of health care reform: 1) health insurance coverage (both public and private) and 2) provider payment. We will discuss competing schools of thought in both of these areas of health reform, focusing in particular on the role economic arguments play (implicitly or explicitly) in major public policy debates. We will also discuss the changing role of economic analysis in the political process – particularly with regard to the Congressional Budget Office, as well as how economics impacts health care jurisprudence in these two areas. This is one of two courses that can be counted toward a Health Care Economics and the Law Course Series Certificate of Completion. Academic credit requirement: TBD.
June 23 - 26 (6:00 - 9:15 pm)
Current Antitrust Topics in the Evolving Healthcare Marketplace (M. Botti): This course will address 3 broad topics (1) key antitrust legal issues applicable to healthcare matters; (2) significant areas of healthcare commercial activity in which antitrust issues have arisen; and (3) the interaction between healthcare policy decisions and antitrust enforcement. We will approach each of these issues by looking at recent enforcement, litigation, or policy matters that illustrate the principles. For example, a recent proposed acquisition in Idaho of a physician group by a large hospital group resulted in a decision exploring the interface between the reform goals of the Affordable Care Act and the traditional concerns of the antitrust laws for mergers creating market power. That decision and similar developments will provide material for the course, which will look as well at issues involving private and public healthcare financing, pharmaceuticals, and other issues involving hospitals and physicians. This is one of two courses that can be counted toward a Health Care Economics and the Law Course Series Certificate of Completion. Academic credit requirement: TBD.
June 14 - July 25
Epidemiology & the Law (M. Pierce): Epidemiology is the study of the determinants and distribution of disease, injury, and other health-related states within and across populations. Epidemiology informs and intersects with health law in a variety of ways. Among other things, epidemiology can be used to determine causation in personal injury suits; safety and effectiveness in drug trials; and, at the broadest level, the impact that our laws have on our health and well-being. A basic understanding of epidemiology can help attorneys and policymakers more effectively assess empirical research and determine when and how to consult with epidemiological experts. The goal of this course is to provide participants with a basic understanding of epidemiology by introducing them to fundamental epidemiological and statistical concepts and examining how these concepts can be applied to health law policy, practice, and theory. Participants should leave this course with a better understanding of how to leverage epidemiology to achieve their legal and policy goals. Academic credit requirement: Two exercises and a take home exam, due 2 weeks after the course ends.
In-class sessions for Epidemiology and the Law meet at the following times: