2013 Health Law & Policy Summer Institute Course Descriptions
Day Courses (9 am - 5 pm)
June 17 - 18
Health Care Fraud and Compliance I: 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 Certificate from American University Washington College of Law. Academic credit requirement. Take home exam, due 3 weeks after the course ends.
Pharmaceuticals and the Law (D. Kracov ): 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. This is one of four courses focusing on Pharmaceutical Law that can be counted towards a Pharmaceutical Law Certificate from American University Washington College of Law. Academic credit requirement: Take home exam, due 3 weeks after the course ends.
June 19 - 20
Health Care Fraud and Compliance II: Health Care Corporate Compliance and Governance (A. Scielzo) Participants will explore 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. This is one of three courses focusing on Health Care Fraud and Compliance and can be counted towards a Health Care Fraud and Compliance Certificate from American University Washington College of Law. Academic credit requirement: Take home exam, due 3 weeks after the course ends.
Pharmaceutical Patent Protection and Enforcement (J. Grossman, J. Cubert, D. Doshi): Pharmaceutical patents are the economic cornerstone of the pharmaceutical and biotechnology industry. Financing the costly development timeline from R&D through pre-clinical testing to clinical development and approval requires access to scientific building-blocks as well as exclusivity for the developed product. This course analyzes the inevitable conflicts that arise between access and exclusivity, and how patent counsel guide their clients through a legal and regulatory maze to the promised land of a pharmaceutical, medical device, and biologics. This is one of four courses focusing on Pharmaceutical Law that can be counted towards a Pharmaceutical Law Certificate from American University Washington College of Law. Academic credit requirement: Take home exam, due 3 weeks after the course ends.
June 21 & 28
The Law and Ethics of End-of-Life Health Care (H. Gertner): As the US population ages, the need to address the many legal and ethical challenges raised by end-of-life health care continues to grow. This class will examine how the law reconciles competing ethical values and interests in controversies surrounding the delivery of medical care at the end of life.It will also explore how demographic trends, new technologies, and health reform are affecting the difficult substantive questions faced by lawyers, policymakers, and ethicists who work on end-of-life health care. Readings will include primary legal texts (case law, legislation, advisory opinions, etc.) as well as commentary from the legal, medical, and philosophical perspectives. Academic credit requirement: Take home exam, due 3 weeks after the course ends.
June 24 - 25
OIG Health Care Fraud and Compliance Workshop (T. Maida and M. Tinker): Taught by HHS officials in the Office of Counsel to the Inspector General, this course builds on the two fraud and compliance courses from the first week: Legal Issues in Health Care Fraud and Abuse and Health Care Corporate Compliance and Governance. This course will provide an in-depth examination of how the health care provider community interacts with the Department of Health and Human Services' Office of Inspector General (OIG) on issues of health care fraud and compliance. Class time will be a combination of lectures, group discussions, and participation in resolving hypotheticals based on real world scenarios involving health care fraud and compliance. Specifically, the course will address OIG's involvement in criminal investigations, FCA investigations, exclusion, Corporate Integrity Agreements and Self-Disclosure Protocol issues, OIG Audits, and OIG Evaluations. This is one of three courses focusing on Health Care Fraud and Compliance and can be counted towards a Health Care Fraud and Compliance Certificate from American University Washington College of Law. 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 Professor Scielzo's Health Care Fraud and Abuse course and/or Health Care Corporate Compliance and Governance before taking this course.
Public Health Litigation (M. Pierce): The past several decades have witnessed a proliferation of lawsuits with important public health implications, including suits against manufacturers of tobacco, asbestos, cars, guns, and certain types of food. Although distinct, these suits raise many common doctrinal, policy, and practical challenges and opportunities for litigators and public health advocates. This course will examine the value of using litigation to advance public health policy and will also consider recent trends that may pose barriers to public health litigation. The course will feature several prominent guest lecturers, including David Vladeck, former Director of the Federal Trade Commission's Bureau of Consumer Protection, and Stephen Gardner, Director of Litigation for the Center for Science in the Public Interest. Academic credit requirement: Take home exam, due 3 weeks after the course ends.
June 26 - 27
Reproductive Genetics, Reproductive Technologies and the Law (G. Javitt and S. Crockin):This course aims to introduce participants to the many ways in which the legal system has had an impact on, and is helping shape, the revolutionary scientific advances in the reproductive and genetic technologies, together with the ethical and societal concerns they raise. Since the birth of the world’s first IVF baby in 1978, emerging assisted reproductive technology ("ART") and genetic advances have continually challenged existing laws and spawned the need for new ones, all while making front page news.We will examine and analyze the underlying, competing, and evolving laws, policies, and tensions arising from ART and genetic technologies. The course will focus on: the impact on existing family, health, contract, and constitutional law; and the role and potential role of regulation and regulatory agencies in overseeing ART and genetic technologies. We will also briefly address the intersection with controversial laws and policies involving abortion, personhood, and embryonic stem cell research. Participants will come away from this course with an understanding of the legal aspects of the reproductive and genetic technologies and an ability to analyze the legal dimensions of both these current and emerging technologies. Academic credit requirement: Take home exam, due 3 weeks after the course ends.
Evening Courses (6 pm - 9:05 pm)
June 17 - 20
International Human Rights Law and Global Health (J. Vasquez & C. Leria): This course examines the relationship between human rights law and global health. Participants will explore the scope of the right to health and will consider how that right and other related rights can be used to protect and promote global health. We will pay special attention to the interpretation of the right to health by the Inter-American Commission and Court of Human Rights and the activities of the Pan American Health Organization in the region of the Americas. Academic credit requirement: 15 page paper, plus endnotes, due 3 weeks after the course ends.
June 24 - 27
The Law and Politics of Health Insurance Exchanges (C. Meneses): The Supreme Court’s health reform decision and the reelection of President Obama ensure that Health Insurance Exchanges will be implemented in all 50 states. These Exchanges are a central part of the Affordable Care Act’s health insurance coverage strategy and are expected to transform individual and small-group health insurance markets. 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. States that have opted to create their own exchanges or to partner with the federal government to create an exchange face numerous decisions about how to structure their Exchanges and health insurance markets. 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. Meanwhile, the fact that about half of the states have opted to default to the federal government’s Exchange raises serious implementation challenges for the federal government and questions about how it will structure the Exchanges in these states. This course will explore, discuss and analyze the legal and political opportunities and challenges surrounding the establishment and operation of Health Insurance Exchanges. Academic credit requirement: Paper, due 3 weeks after the course ends.