WASHINGTON (Reuters) - The U.S. Supreme Court on Monday turned away Pfizer Inc's bid to revive its plan to cover out-of-pocket expenses of Medicare patients for drugs costing $225,000 a year to treat a rare heart condition after federal officials found that the drugmaker's arrangement could amount to illegal kickbacks.
The justices took up Pfizer's appeal of a lower court's ruling that agreed with the government's view that the company's proposal to directly cover cost-sharing co-payments required of patients to use its Vyndaqel and Vyndamax drugs could violate a federal law called the Anti-Kickback Statute.
The law targets fraud and abuse, such as bribery, in federal healthcare programs including Medicare, which provides coverage for the elderly and disabled. Pfizer contends the government's interpretation of the law was blocking access to critical medical care.
New York-based Pfizer's medication, also known as tafamidis, treats a rare heart condition known as transthyretin amyloid cardiomyopathy that can lead to progressive heart failure. An estimated 100,000 to 150,000 Americans, mostly elderly, have the condition.
Sales of the treatment totaled $2.02 billion in 2021. A February 2020 study found tafamidis to be the most expensive cardiovascular drug launched in the United States.
Given the drug's high price, patients would need to bear yearly co-payments of roughly $13,000, with Medicare covering the rest. Pfizer's proposal sought to assist "middle-income" patients who do not qualify for low-income co-pay support but might still be deterred by its cost.
The U.S. Department of Health and Human Services' Office of Inspector General in 2020 concluded that the proposal could violate the kickback law by inducing patients to buy Pfizer's drug while leaving taxpayers to bear the costs.
Pfizer sued the department to challenge its determination. The Manhattan-based 2nd U.S. Court of Appeals last July ruled in favor of the government, rejecting Pfizer's argument that a subsidy program would violate the anti-kickback law only if it were administered with corrupt intent.
Pfizer had told the Supreme Court that the government has impermissibly transformed an anti-corruption statute into a cost-saving tool, and that Congress did not intend "to criminalize a sick patient's acceptance of co-pay assistance to afford critical medical care."
(Reporting by Andrew Chung in Washington; Editing by Will Dunham)
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