DOJ files false claims act complaint against Regeneron over drug pricing

The United States filed a complaint under the False Claims Act against Regeneron Pharmaceuticals. Regeneron manufactures and sells Eylea, an anti-vascular endothelial growth factor inhibitor approved by the Food and Drug Administration to treat, among other conditions, neovascular Age-Related Macular Degeneration, a prevalent, usually age-related condition that impairs vision. The complaint alleges that Regeneron fraudulently inflated Medicare reimbursement rates for Eylea by knowingly submitting false average sales price reports to the Centers for Medicare and Medicaid Services that excluded certain price concessions. In particular, the United States alleges that Regeneron knowingly failed to report price concessions in the form of credit card processing fees that Regeneron paid to specialty drug distributors to benefit its customers. According to the complaint, Regeneron paid these credit card fees so that distributors would accept credit cards for Eylea purchases while still charging a lower, cash price for the drug, and so that Regeneron’s customers – typically retina and ophthalmic practices – could receive credit card benefits for their purchases, such as “cash back” and other credit card rewards. “We will not permit pharmaceutical companies to flout price reporting requirements to maintain high drug prices,” said Principal Deputy Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department is committed to protecting federal health care programs from improper actions by drug companies or others that drive up the cost of those programs at the taxpayers’ expense.”