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The government must show a drugmaker’s allegedly unlawful inducements were the “but for” cause of a doctor writing a prescription and seeking reimbursement for a certain drug in order to establish False Claims Act liability predicated on a violation of the federal Anti-Kickback Statute, the 1st U.S. Circuit Court of Appeals has decided.
The case involves Medicare claims for Eylea, a prescription drug manufactured by Regeneron Pharmaceuticals that is used for treating neovascular age-related macular degeneration.
The government sued Regeneron alleging the drugmaker violated the AKS by engaging in a scheme to induce prescriptions of Eylea by covering copayments for some patients who received the drug. According to the government, Medicare claims filed by doctors who prescribed Eylea “resulted from” a violation of the AKS.
A 2010 amendment to the AKS provides that a claim for payment by a federal health care program that includes items or services resulting from a violation of the AKS constitutes a false or fraudulent claim for purposes of the FCA.
According to Regeneron, under the amendment, an AKS violation must be a “but-for” cause of a claim for payment to trigger FCA liability.
But the government contended that the “resulting from” language in the amendment called for a lower causation standard.
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