For over 15 years, Eliza Andonova has counseled health care companies on the complex laws that regulate their industry.
Eliza helps drug and device manufacturers navigate the complex health care fraud and abuse prohibitions related to their relationships with prescribers, payers, pharmacies, purchasers, or patients. She works with manufacturers to evaluate risk and identify mitigation strategies for their most important commercialization offerings so they can provide broad access to life-sustaining and life-improving treatments.
Eliza focuses on compliance with federal and state anti-kickback statutes, false claims laws, as well as transparency laws and marketing regulations. She advises manufacturers on the structure and implementation of patient support programs, product support services like reimbursement support or nurse educators, and charitable donations. She counsels clients on discount and rebate arrangements, agreements with purchasers and vendors, and the implementation and continued improvement of compliance programs.
When things don't go according to plan, Eliza helps companies determine how to respond. She conducts internal investigations and advises on corrective actions like self-disclosure to appropriate government agencies and, when necessary, defending against enforcement actions.
Eliza has advised many manufacturers in negotiating and implementing Corporate Integrity Agreements with the Office of Inspector General of the U.S. Department of Health and Human Services. She also helps manufacturers and direct health care providers continually improve their compliance programs by conducting compliance program assessments, advising on the implementation of compliance policies, and training employees on the legal and regulatory requirements and dynamic enforcement landscape.
After law school, Eliza served as a law clerk to the Honorable James H. Michael, Jr. of the U.S. District Court for the Western District of Virginia.
Counseled drug manufacturers on patient support programs and agreements with purchasers, pharmacies, and distributors in preparation for the launch of new products.
Regularly advises manufacturers on their patient assistance programs and relationships with independent charitable foundations.
Negotiated and advised manufacturers and direct providers on the implementation of Corporate Integrity Agreements.
Advised manufacturers on design and implementation of product support programs, including sponsored testing programs.
Regularly works with clients to assess compliance programs, implement and update policies and training, and establish risk assessment programs.
- J.D., Cornell Law School, cum laude, 2002
- B.A., Franklin & Marshall College, cum laude, 1999
- District of Columbia
- U.S. District Court, District of Columbia
- U.S. Court of Appeals, First Circuit
- Member, American Health Lawyers' Association