Amanda Kutz concentrates her practice on transactional work and regulatory compliance matters in the firm’s Health Care practice, providing legal and strategic advice to health care providers on mergers and acquisitions, joint ventures, physician contracting matters and assisting with licensing issues throughout the change of ownership process. Amanda has extensive experience in handling compliance matters arising under the Medicare and Medicaid programs, state licensing programs, HIPAA, the Anti-Kickback Statute, the Stark Law, the False Claims Act, EMTALA and matters involving the FDA and Public Health Service Act. 

Amanda represents health care providers before professional licensing boards, medical staff hearings, insurance panel credentialing appeals and throughout the certificate of need process. She also works with medical societies and health care industry groups doing collaborative research with health care systems to improve best practices and patient care and organized one of the first federally-certified Patient Safety Organizations in the country.

Amanda regularly advises biotech companies, organ procurement organizations and tissue banks on transactional matters, including joint ventures, distributorships, product development agreements, supply arrangements and consulting arrangements. Amanda has particular experience negotiating clinical trial agreements and advising on labeling and advertising claims, off-label promotion and sales and marketing practices that meet FDA, OIG and AdvaMed Ethics Code compliance guidelines.

Professional and Community Memberships

• American Bar Association
• American Health Lawyers' Association
• Healthcare Business Women's Association, Mid-Atlantic Chapter
• Virginia State Bar

Recognitions

• Phi Beta Kappa
• The College of William and Mary School of Law, Benjamin Rush Health Law Scholar
• William and Mary Law Review, Notes Editor
• William and Mary Bill of Rights Journal

Publications

• Charting a New Course: Practical Considerations for Implementing an Electronic Medical Record System, 12 Richmond Journal of Law and the Public Interest 101 (2009)
• Creating a Statutory Pathway for FDA Approval of Generic Biotech Drugs, Life Sciences, a Publication of the American Health Lawyers Association Life Sciences, Vol..1 Issue 1 (2007)
• Finding a Home for Orphan Drugs in the 21st Century, Second Prize, Epstein Becker Health Law Writing Competition (2005)
• A Jury of One’s Peers: Virginia’s Restoration of Rights Process and Its Adverse Effect on the African American Community, 46 William and Mary Law Review 2016 (2005)

Presentations

• FDA Basics and the Drug Approval Process (2009)
• EMTALA Compliance Training Seminar (2008)
• The Federal Stark Law: What Every Corporate Attorney Should Know (2007)