Edmonds v. Levine
United States District Court for the Southern District of Florida
417 F.Supp.2d 1323 (2006)

- Written by Mary Phelan D'Isa, JD
Facts
Jack Edmonds, Susan Weschke, and Gaylord Payne (plaintiffs), Florida Medicaid recipients, were denied reimbursement for the prescription drug Neurontin or its generic equivalent, gabapentin, that was prescribed for them for off-label uses that their physicians determined were medically necessary to treat their conditions. The uses for which the recipients’ physicians prescribed Neurontin were recognized in the compendia listed in congressionally recognized compendia. The recipients challenged the Florida Medicaid policy that limited off-label reimbursement for Neurontin to uses that could be substantiated as being safe and effective by double-blind, placebo-controlled, randomized clinical trials. The recipients, who were seeking prospective injunctive relief, alleged that the state policy impermissibly superimposes an effectiveness criterion on federal Food and Drug Administration (FDA) regulations that defined medically accepted indication to include any use that is either approved by the FDA or supported by one or more citations in any congressionally recognized compendia. The state alleged that its interpretation of the FDA regulations is entitled to substantial deference and because Neurontin had not been shown to have any curative effect on any of the uses for which the state denied reimbursement and because there were alternative covered drugs that had been proven safe and effective in treating the recipients’ conditions, the state was denying Medicaid benefits to which the recipients were legally entitled.
Rule of Law
Issue
Holding and Reasoning (Klein, J.)
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