Bio: David Gee has 25 years of experience advising clinical and molecular diagnostic laboratories nationwide, including 12 years of experience as in-house counsel for three of the nation’s largest clinical labs. Gee’s responsibilities include counseling labs and other healthcare clients on a wide range of matters, including compliance with fraud and abuse laws, Medicare and Medicaid reimbursement, HIPAA compliance and preparedness, CLIA certification and compliance, business operations and transactions, corporate governance, managed care contracting, patient rights, and quality assurance.
Graduating magna cum laude from Brigham Young University, J. Reuben Clark Law School, where he was articles editor of the Law review and a member of the Order of the Coif, Gee formerly served as a law clerk for Associate Chief Justice I. Daniel Stewart of the Utah Supreme Court. He is a member of the Washington and California Bar Associations. He regularly speaks and writes on legal and regulatory issues facing the clinical laboratory industry.
Gee has advised many laboratory clients concerning the FDA’s evolving stance on regulation of Laboratory Developed Tests (LDTs), including the FDA’s most recent Draft Guidance and Framework for Regulatory Oversight, and how these proposed new requirements will likely affect their laboratory operations.