Pfizer Appeals Anti-Kickback Decision to the Supreme Court

Pfizer is appealing a decision by the Second U.S. Circuit Court of Appeals in August that its proposed copay assistance program for its $225,000-a-year heart treatment, tafamidis, would violate the federal anti-kickback statute (AKS).

In its appeal to the Supreme Court, Pfizer stated that it manufactures the only FDA-approved drug for a rare, and fatal cardiac condition, transthyretin amyloid cardiomyopathy, and that it “seeks to provide financial assistance to needy Medicare patients to help them access this breakthrough treatment.”

Pfizer’s plan was to grant patients $13,000 a year to cover all Medicare copays for the drug, while Medicare would have to pay the rest of the cost. Before launching the program, the company asked the HHS Office of the Inspector General (OIG) for a regulatory opinion on whether its assistance program would be legal.

In its response, the OIG called the proposal “highly suspect” as “one purpose of the [proposed program] — perhaps the primary purpose — would be to induce Medicare beneficiaries to purchase [Pfizer’s] federally reimbursable Medications.”

In its appeal to the Supreme Court, Pfizer contends that its copay program is not designed to influence a recipient’s medical decision-making.