Health Law Regulatory & Compliance Competition
UM Carey Law Team (left to right):
3L John Glass, 3L Rebecca Hall, 1L Neha Patel, Virginia Rowthorn, managing director, Law & Health Care Program, Diane Hoffmann, director, Law & Health Care Program.
The 2nd Annual Health Law Regulatory and Compliance Competition will be held on Saturday, February 16, 2013, at the University of Maryland Francis King Carey School of Law.
The 2nd Annual Competition will focus on the life sciences industry, food and drug law, and compliance with fraud and abuse laws related to companies that manufacture products regulated by the Food and Drug Administration (FDA). Specifically, this year’s problem will challenge students to address several areas, including but not limited to:
- Issues relating to off-label marketing, advertising and promotion;
- Compliance with the Food, Drug & Cosmetic Act, applicable amendments, and FDA regulations and guidance;
- Enforcement and negotiation of Corporate Integrity Agreements (CIAs) with the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS);
- Kickbacks and other potentially improper arrangements between life science companies and healthcare stakeholders (e.g., hospitals, private practice, academic medical centers); and
- FDA application and regulatory approval requirements for drugs, medical devices, and dietary supplements
Sponsors
Detailed Description
The Health Law Regulatory and Compliance Competition requires teams of three (3) students to analyze a particular fact pattern using federal health regulations, rules, and agency documents, and to present a legal and policy solution and/or recommendations to a panel of regulatory and compliance attorneys. Participating students will be evaluated primarily on an oral presentation of issues identified in the fact pattern. Judges may also consider written notes submitted to the judges in the "competition template," which will be provided at the competition.
The fact pattern will be given out the day of the competition. Teams will have approximately 1.5 hours to review the fact pattern. The competition is open universe, therefore, teams will have access to the internet and may bring any additional materials with them. After their allotted times, teams will have approximately 15-20 minutes to present their recommendations and findings. Teams will present twice, to two separate judge panels. The competition will award the top three finalists. The winner will be announced at the competition during our commencement luncheon. The actions of teams and students will be governed by the Competition Rules.
The competition is open to teams from all ABA-accredited law schools and is appropriate for 2nd and 3rd year law students who have taken at least one health law course – preferably a survey course that touched on fraud and abuse issues and Food and Drug Law.
Given the broad range of health law issues, the Competition Steering Committee ("Committee") will craft a fact pattern based on different areas of health and regulatory compliance law each year. The Committee will post on the Competition website general areas and topics the fact pattern will cover each year so that students can prepare accordingly. In 2012, the Competition fact pattern included issues related to:
- Potential prosecution under the False Claims Act for off-label marketing and promotion surrounding various educational and promotional activities
- Compliance with the Health Insurance Portability and Accountability Act (HIPAA)
- Exclusion from the Centers for Medicare and Medicaid Services (CMS)
- Questionable billing practices that may implicate fraud and abuse laws and anti-kickback and Stark statutes
- Improper manufacturing and quality issues
More details about the 2nd Annual Health Law Regulatory and Compliance Competition will be posted here throughout the year, including a logistics information for the day of the competition, travel and lodging information, competition rules, and other resources.
If you would like more information about the Competition, have any questions, or would like to enter a team for the 2013 Competition, please email Abe Gitterman at MarylandCareyHealthCompetition@gmail.com or Virginia Rowthorn, Managing Director, Law & Health Care Program at vrowthorn@law.umaryland.edu.
Related Links
- Journal of Health Care Law & Policy
- Student Health Law Organization (SHLO)
- Legal Resource Center for Tobacco Regulation, Litigation and Advocacy
- The Maryland Healthcare Ethics Committee Network
- Center for Health & Homeland Security
- Center for Dispute Resolution (C-DRUM)
- Maryland Intellectual Property Legal Resource Center
- Conferences & Symposia
- Federal Regulation of Probiotics
- The Network for Public Health Law
UM | About This Site | Site Map | Contact Us
