Amanda L. Kutz

Amanda concentrates her practice on regulatory compliance matters and transactional work in the firm’s Health Care Law and Business Law Practice Groups.  Amanda’s practice includes representation of life sciences companies, tissue banks and organ procurement organizations, physicians and physician groups, hospitals and health care systems, individual health care providers, pharmacies, and long-term care providers.

Amanda has extensive experience advising clients on compliance matters arising under the Medicare and Medicaid programs, federal and state licensing programs, HIPAA, the Anti-Kickback Statute and the “Stark” law.  Additionally, Amanda regularly represents clients in transactional matters, including mergers and acquisitions, joint ventures, distributorships, product development and supply agreements, consulting arrangements and change of ownership (CHOW) requirements. Amanda has particular experience negotiating clinical trial agreements and advising on sales and marketing practices that meet FDA, OIG and AdvaMed Code of Ethics compliance guidelines.

Amanda has an active administrative practice, representing health care clients before professional licensing boards, medical staff matters, and throughout the Certificate of Public Need (COPN) process. She also works with various medical societies and health care industry groups to improve best practices and organized one of the first federally-certified Patient Safety Organizations in the country. Amanda previously served in the Office of General Counsel at the U.S. Government Accountability Office (GAO).

Recognitions

• Virginia Business, “Legal Elite,” Legislative/Regulatory/Administrative, 2010, Health Law, 2011
• Virginia Super Lawyers, Rising Star in Health Care, 2010, 2012

Professional and Community Involvement

• American Bar Association, Administrative Law Section and Health Law Section
• American Health Lawyers Association
• Virginia State Bar: Past Chair, Health Law Section, Board of Governors
• Virginia Bar Association, Health Law Section
• Virginia Women Attorneys Association
• Legal Information Network for Cancer (LINC), pro bono counsel

Publications and Presentations

• FDA to Monitor ClinicalTrials.gov Compliance, American Health Lawyers Association, 2012
• Practice Safe Social Networking: Friending, Linking, and Tweeting Your Way to Success, Virginia Bar Association Annual Meeting, 2012
• Spotlight on Pharmaceutical Safety and Liability Issues, Q1 Productions Pharmaceutical Compliance Conference, 2010
• Clinical Trials and Tribulations, VBA Healthcare Practitioner's Roundtable, 2010
• Nuts and Bolts of Healthcare Reform, 2010
• FDA Basics and the Drug Approval Process, 2009
• Charting a New Course: Practical Considerations for Implementing an Electronic Medical Record System, Richmond Journal of Law and the Public Interest, 2009
• Creating a Statutory Pathway for FDA Approval of Generic Biotech Drugs, Life Sciences, a Publication of the American Health Lawyers Association, Vol.1 Issue 1, 2007