Michele R. Goodman

Michele Goodman represents clients throughout the health care and life sciences industries, providing regulatory and compliance counseling and advising on significant transactions, including M&A and biomedical research arrangements. She also advises clients subject to fraud and abuse investigations, enforcement actions, and government audits. Michele has represented pharmaceutical and medical and dental device manufacturers and distributors, hospitals, health systems, academic medical centers, clinical laboratories, home health care agencies, pharmacies, and ambulance providers.

Michele has experience assessing and developing compliance programs, conducting internal investigations, and advising clients on a variety of matters involving research compliance, Medicare and Medicaid reimbursement, and federal and state fraud and abuse and transparency laws, including the False Claims Act, the Anti-Kickback Statute, and the Physician Payments Sunshine Act (Open Payments). Her recent experience includes advising a health system on the development of a translational research program, and advising life sciences industry clients on strategic acquisitions of new product and service lines. Michele also has experience negotiating clinical trial agreements on behalf of sponsors, institutions, and investigators. [1]