Michael M. Gaba is a partner in the Washington, D.C. office of Holland & Knight where he is the federal policy leader of the firm’s national Healthcare & Life Sciences Team. His regulatory and legislative life sciences practice includes counseling and representing medical device and biotech companies before the Food and Drug Administration, the Centers for Medicare and Medicaid Services, and the U.S. Congress. More specifically, Mr. Gaba works on a range of issues related to healthcare reform, with an emphasis on HHS integration, the FDA Amendments Act, post-market surveillance and enforcement, with a particular focus on combination product approval and labeling, as well as coverage, coding, and reimbursement for these sophisticated products.
Mr. Gaba also represents national not-for-profit organizations before the legislative branch and the National Institutes of Health on healthcare policy and funding matters.
Mr. Gaba writes extensively and lectures on a range of healthcare issues, including comparative effectiveness, interagency coordination and its impact in the post-market context, defending FDA enforcement actions, as well as on coverage, coding, and reimbursement strategies for medical device manufacturers.
Mr. Gaba worked on Capitol Hill in the personal offices of Congressman Robert Garcia (D-NY) and Senator Bill Bradley (D-NJ), and on the Labor and Human Resources Committee for Senator Edward Kennedy (D-MA).