Eliza L. Andonova
For over a decade, Eliza Andonova has counseled healthcare companies on the complex laws that regulate the healthcare industry. Eliza helps clients establish and continually improve their compliance programs so that they can focus on providing life-sustaining and life-improving treatments. When things don't go according to plan, Eliza helps companies determine how to respond. She conducts internal investigations and advises on corrective actions. This may include self-disclosure to appropriate government agencies, and when necessary, defending against enforcement actions.
Eliza's focus is on federal and state anti-kickback statutes, civil monetary penalties law, and false claims laws. She advises drug and device manufacturers and direct healthcare providers on such issues as discount and rebate arrangements, consultant and speaker arrangements, product support services, business courtesies and gifts, agreements with purchasers and vendors, charitable contributions, grants, and patient assistance programs. She also trains employees on legal and regulatory requirements and the dynamic enforcement landscape.
Eliza has advised a number of manufacturer clients in the negotiation and implementation of Corporate Integrity Agreements with the Office of Inspector General of the U.S. Department of Health and Human Services. In addition to her fraud and abuse work, Eliza has advised organ procurement organizations (OPOs) and transplant centers facing regulatory actions or sanctions.
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.
Areas of Focus
Counseled drug manufacturers on support programs and agreements, with purchasers and distributors in preparation for the launch of new products.
Advised a number of manufacturers on their patient assistance programs and relationships with independent charitable foundations.
Advised device manufacturer on the implementation of a Corporate Integrity Agreement.