Coalition’s Protection From Anti-Kickback Laws Denied by Federal Judge

Brushing aside a pharmaceutical coalition’s First Amendment claims and upholding a 2023 advisory opinion, a federal judge has rejected a plan for a proposed cancer-drug price relief program, ruling that it runs afoul of the Anti Kick-Back Statute (AKS).

The Pharmaceutical Coalition for Patient Access (PCPA) also lost on its claims against HHS, with U.S. District Judge Roderick C. Young stating in his opinion Wednesday for the Eastern District of Virginia that “The Court finds that PCPA cannot show that the Agency erred, let alone that the Agency acted arbitrarily, capriciously, or not in accordance with law.”  

PCPA had been pressing to implement a Medicare Part D patient assistance program in which enrollees would pay $35 per month for branded oncology drugs (or $10 per month for generic products) plus 10 to 25 percent of their Medicare Part D co-insurance obligation, and PCPA would cover the rest of the enrollee’s cost. 

Read Judge Young’s ruling here.

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