2012 Health Law and Policy Institute


Course Descriptions & Schedules

Week 1: June 18 – 21

Monday – Tuesday (6/18 – 19), Day course

Health Care Fraud and Abuse (A. Scielzo): This course examines 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. The course features the following guest lecturers, who bring substantial law firm and government expertise on fraud and abuse: John Boese, Carrie Valiant, Jason Christ, Stuart Silverman, and Johanna Michaels Kriesel. Academic credit requirement: Take home exam, due 3 weeks after the course ends. 8:30 am - 5 pm.

Wednesday – Thursday (6/20 – 21), Day course

Health Care Corporate Compliance and Governance (A. Scielzo): This course will discuss the importance of corporate compliance for health care organizations, and provide an overview of the compliance landscape. Lectures will use current compliance failures as a teaching tool, and will delve into the specific elements of an effective compliance program. 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 and overlap. The teaching strategies for this course will include readings, lectures, group discussions and mock client hypotheticals. Academic credit requirement: Take home exam, due 3 weeks after the course ends. 9 am - 5 pm.

Reproductive Technologies and the Law (S. Crockin): This course will examine and analyze the underlying, competing, and evolving laws, policies, and 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. Disputes and issues involving the ARTs frequently involve—and challenge—existing family, health, contract, and constitutional law, and also intersect with controversial law and policies involving abortion, personhood, and stem cell research. Students will come away from this course with an understanding of the legal aspects of the ARTs and an ability to analyze the legal dimensions of both current and emerging reproductive technologies. Academic credit requirement: Take home exam, due 3 weeks after the course ends. 9 am - 5 pm.

Monday – Thursday (6/18 – 21), Evening Course

The Law and Politics of Health Insurance Exchanges (C. Meneses): Health Insurance Exchanges are a central part of the Affordable Care Act’s health insurance coverage strategy, and a number of states have enacted legislation, or have pending legislation, that establishes a state Exchange. State Exchanges offer consumers and small businesses a transparent market in which to shop for affordable health insurance.  The Exchanges will also determine individuals’ eligibility for insurance affordability programs such as Medicaid, the Child Health Insurance Program (CHIP), and advance premium tax credits and cost-sharing reductions. Each state faces numerous decisions in structuring an Exchange and health insurance markets. State legislators and policymakers must take a comprehensive look at the how the ACA will affect health insurance coverage. They must weigh the impact different policy options will have on access to care; insurance premiums; medical care; and costs to individuals, employers, and state. This course will explore, discuss and analyze the policies surrounding the establishment and operation of the Exchange, using Maryland as a case study. Academic credit requirement: Paper, due 3 weeks after the course ends. 6 pm - 9:10 pm.

Week 2: June 25 – 28

Monday – Tuesday (6/25 – 26), Day courses:

Intellectual Property Law and the US Health Care System (J. Grossman, J. Cubert, D. Doshi): This course provides significant exposure to the many relationships between U.S. patent, trademark, and copyright laws and health care, including: introduction to trademark law; issues concerning trademarks and pharmaceuticals; Introduction to patent law; introduction to Hatch-Waxman; drug development pipeline and IP counseling; reverse payments and health care reform; patenting life forms; introduction to copyright law; copyright and medical coding- who owns CPT?; copyright issues and medical imaging; copyright and medical technology - databases, software; Introduction to the international IP protection schemes; IP issues concerning medical devices; and the interplay in health care between privacy and IP-- data privacy, genetics, and biotechnology. Academic credit requirement: Take home exam, due 3 weeks after the course ends. 8:30 am - 5 pm.

Bioethics and the Law (H. Gertner): This class will examine how the legal policy systems reconcile 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. Academic credit requirement: Take home exam, due 3 weeks after the course ends.

Wednesday – Thursday (6/27 – 28), Day courses:

Genetics and the Law (G. Javitt): Genetics and the Law is intended to introduce students to the many ways in which the legal system, construed broadly, is influenced by and influences the science of genetics. This course also aims to introduce students to the ethical and societal concerns raised by new genetic technologies and how the law addresses these issues or may do so in the future. Academic credit requirement: Take home exam, due 3 weeks after the course ends. 9:00 am - 5 pm.

Pharmaceuticals and the Law (M. Ruggiero): As government increasingly determines the environment for how drugs are developed and delivered to patients, it is critical for biopharmaceutical manufacturers to engage in the policy realm to promote patient access to appropriate care and to preserve medical innovation. This course will provide an introduction to the range of legal and policy issues relevant to the pharmaceutical industry, including: 1) the regulatory regime governing drug development, approval, and promotion; 2) the 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) intellectual property protections for biopharmaceuticals, including patents and data exclusivity; and 6) product liability and biopharmaceuticals. Academic credit requirement: Take home exam, due 3 weeks after the course ends.

Monday – Thursday (6/25– 28), Evening Course:

International Human Rights Law and Global Health (J. Vasquez & C. Leria): This course introduces students to the substance and theory of human rights law through a focus on public health. Exploring the linkage between human rights, international public health policy, and international law, the course examines the right to health vis-á-vis other human rights, as framed by international treaties and covenants. Classroom discussions will examine how human rights law can be an important tool in addressing current global health challenges, such as improving mental health systems and reducing the incidence of HIV/AIDS. Academic credit requirement: 15 page paper, plus endnotes, due 3 weeks after the course ends. 6 pm - 9:10 pm.

* Day courses will generally run from 8:30 am to 5 pm Monday - Tuesday or Wednesday - Thursday with coordinated lunch breaks that feature panel discussions and networking opportunities.

** Evening courses will run from 6 pm to 9:10 pm Monday - Thursday of each week.