Amanda L. Kutz

Amanda concentrates her practice on transactional work and regulatory compliance matters in the firm’s Health Care and Business Practice Groups. Amanda has extensive experience advising health care clients on compliance matters arising under the Medicare and Medicaid programs, state licensing programs, HIPAA, and fraud and abuse laws.

Amanda has an active administrative practice, representing health care clients before professional licensing boards, medical staff hearings and throughout the Certificate of Public Need process. She also works with 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 regularly advises health care and biotechnology companies on transactional matters, including mergers and acquisitions, joint ventures, distributorships, and consulting arrangements. Amanda has particular experience negotiating clinical trial agreements and advising on sales and marketing practices that meet FDA, OIG and AdvaMed Ethics Code compliance guidelines.

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

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 Women Attorneys Association
• Legal Information Network for Cancer (LINC), pro bono attorney
• Central Virginia Legal Aid Society, pro bono

Publications and Presentations

• 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