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Mens Rea

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

FDA Law Blog

NOVEMBER 6, 2022

Now, after an unfavorable HHS Office of the Inspector General (OIG) advisory opinion and two defeats in court, Pfizer has appealed the Second Circuit’s decision to the Supreme Court. If SCOTUS takes up this case, it could have significant and far-reaching implications across the healthcare fraud and abuse landscape. Background.

Mens Rea

Mens Rea Statute Healthcare Manufacturing

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

FDA Law Blog

AUGUST 4, 2022

That court granted summary judgment to the government on the APA claim and rejected Pfizer’s narrower reading of the AKS, which would require an element of “corrupt” intent to impose AKS liability. Similarly, the Court drew on the plain meaning of “willfully” to reject Pfizer’s argument that the term suggests “an element of corruption.”

Statute

Statute Mens Rea Manufacturing Court

Paralegal Brief

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

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

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