Heather O'Shea handles civil litigation and regulatory and compliance matters involving the health care industry. For more than 20 years she has represented health care providers, pharmaceutical and device manufacturers, and other health care entities in matters involving fraud and abuse enforcement, including the False Claims Act (FCA), the Anti-Kickback Statute, Stark Law, and Medicare and Medicaid reimbursement. Heather represents clients on regulatory and compliance matters involving Medicare and Medicaid, fraud and abuse laws, reimbursement regulations, the Physician Payments Sunshine Act (Open Payments), clinical research compliance, and U.S. Food & Drug Administration (FDA) regulations. She has significant experience conducting internal investigations, representing clients in voluntary disclosures, and counseling clients on refunds to Medicare. Heather also has extensive experience advising clients on compliance program development, implementation, and conducting assessments of existing compliance programs.
Heather's recent representations include defending a medical device manufacturer in a successful motion to dismiss an FCA case premised on alleged invalidated unenforceable patents, obtaining dismissal of qui tam actions in Virginia and Georgia federal courts that alleged the submission of false clams due to purported violations of Medicaid billing requirements, and conducting an internal investigation for a manufacturer relating to compliance with the Anti-Kickback Statute in connection with discounting and sales and marketing practices. She also has represented multiple hospitals in FCA cases brought by the DOJ where the allegations focused on medical necessity.
Heather is a member of the American Health Lawyers Association, the American Bar Association, and the Illinois Association of Healthcare Attorneys.
Experience
Speaking Engagements
- February 23, 2017
U.S. Business Outlook in the New Administration Transition in the Legal Trenches: How Trump Appointees Could Shape the Judiciary and Influence Enforcement Priorities - December 8, 2016
The Attorney-Client Privilege and Work Product Doctrine: What In-House Counsel Need To Know - September 22, 2016
Emerging Enforcement Trends and Developments - May 14-15, 2015
2015 Health Care Labor & Employment Symposium - May 13, 2014
Employment Issues and Retaliation Claims: Strategies and Risk Management False Claims Act Institute - May 6, 2014
The Continuing Expansion of Health Care Enforcement by U.S. and International Authorities: Key Developments and Implications for the Future - December 11, 2013
FDLI Enforcement, Litigation and Compliance Conference - Legal Issues Keeping In-house Counsel Up at Night - April 9-10, 2013
Jones Day 2013 Chicago Health Care Conference - November 15, 2012
Latest Trends With The Corporate Whistleblower: What In-House Counsel and Corporate Compliance Officers Should Be Prepared For, North Shore Wine Tasting and CLE - March 28, 2012
Increased Scrutiny on Pharmaceutical and Medical Device R&D Activities: The Impact on Clinical Research Sites - March 28, 2012
Health Care 2012: Issues and Answers for a Complex Industry - March 28, 2012
Healthcare 2012: Issues & Answers For A Complex Industry - October 21, 2011
Stark: Mitigating Risks and Strategies in Response to the Self-Disclosure Protocol, 15th Annual Health Care Compliance Forum - October 21, 2011
Counsel and Executives in the Cross Hairs? 15th Annual Health Care Compliance Forum - October 19, 2011
Trends in Compliance and Government Enforcement, 15th Annual Health Care Compliance Forum - March 15, 2011
Counsel in the Cross Hairs? Lessons Learned From Recent Prosecutions, Health Care Compliance and Enforcement Forum - December 2, 2010
Handling Government Inquiries-Identifying and Managing Risks
- Loyola University Chicago (LL.M. in Health Law 1999); Loyola University New Orleans (J.D. 1995); Texas Christian University (B.S. 1992)
- Illinois, Texas, District of Columbia, and U.S. District Court for the Northern District of Illinois
- Extern, United States Attorney's Office, Criminal Division, Northern District of Texas, Fort Worth (Summer 1993)
Chambers USA (2014, 2015, 2017, 2018, 2019, and 2020)
The Best Lawyers in America (2016-2021)
Selected for Nightingale's Healthcare News 2007 List of Outstanding Hospital Lawyers