Heather M. O'Shea
Heather O'Shea handles civil litigation and regulatory and compliance matters involving the health care industry. 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 Sunshine Act, clinical research compliance, and 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 representations include defending a national diagnostic services provider in multiple state Attorney General FCA cases, representing a community medical center in an OIG "unilateral monitoring" review, and advising multiple manufacturers on compliance with the Anti-Kickback Statute, sales, and marketing practices and with the Sunshine Act (Open Payments). She also represented The Christ Hospital in a novel FCA case in which the Department of Justice alleged that the manner the hospital staffed its reading panel for noninterventional cardiology tests violated the Anti-Kickback Statute. She also has represented multiple hospitals in FCA cases brought by the DOJ where the allegations focused on medical necessity.