Federal appeals court rules Pfizer plan to cover heart medication copays violates US law News
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Federal appeals court rules Pfizer plan to cover heart medication copays violates US law

The US Court of Appeals for the Second Circuit Monday rejected an appeal from Pfizer Inc. after the Department of Health and Human Services (DHHS) said that Pfizer’s plan to cover patients’ copays for its heart failure medications violated US law. The medications cost an estimated $13,000 per year, with many patients who need them unable to afford the price.

To help patient’s afford the medications, Pfizer created the Direct Copay Assistance Program. The program guaranteed that Pfizer would cover part of the co-pay for the medications, with the rest of the cost covered by Medicare or Medicaid. However, the DHHS’s Inspector General prevented the program from being implemented. The Inspector General said that the program would violate the federal Anti-Kickback Statute (AKS), a law meant to prevent fraud and abuse in connection with Medicare and Medicaid. A district court in New York upheld the DHHS’s interpretation of the AKS.

The 2nd Circuit Court of Appeals unanimously affirmed the district court’s decision. The Court stated that Pfizer’s plan to cover patient co-pays would violate the AKS, writing:

…to violate the AKS, one must intend to induce the purchase of a federally reimbursable healthcare product. [Pfizer’s attempt to help patients cover co-pays] is specifically designed to induce Medicare beneficiaries to purchase Pfizer’s tafamidis, a federally reimbursable drug. As such, the Direct Program falls squarely within the AKS’s prohibitions.

While Medicare and Medicaid can help low-income patients cover the cost of the medication, many patients will not qualify and will be left to cover the entire cost without assistance.