In 2019, pharmaceutical company Pfizer requested an advisory opinion from HHS for its proposed cost-sharing assistance program that would allow eligible Medicare patients to be covered for out-of-pocket expenses for tafamidis, a drug used to treat a rare heart condition.
HHS later advised Pfizer that this program would violate the Federal Anti-Kickback Statute by inducing patients to buy the drug. The multinational company shot back with a request to review the decision, which the Supreme Court ultimately denied earlier this month.
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