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Could the Road to an AKS Violation Be Paved with Good Intentions? Pfizer Asks SCOTUS

FDA Law Blog

In its petition filed earlier this month, Pfizer challenges HHS’s interpretation of the AKS as “staggeringly overbroad,” contrary to the congressional intent behind the AKS, and a threat to “almost any activity that facilitates patient access to federally funded healthcare.” Background.

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Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law Blog

The Court instead concluded that the term, as used in the AKS, is “more accurately understood as a voluntary, intentional violation of a known legal duty…the mens rea element goes no further” (internal quotations omitted).

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