A heated clash over a U.S. government drug discount program has intensified after a federal agency appealed several recent court rulings that questioned its approach to enforcing a decades-old initiative. At the same time, AbbVie became the latest in a growing number of companies to restrict its discounts, adding to the disarray over a program that provides a safety net to low-income patients.
In a series of filings made last week, the U.S. Department of Health and Human Services appealed decisions issued in different federal courts that, in varying degrees, raised concerns about the agency’s authority to administer its interpretation of the 340B Drug Discount Program. Some of the rulings, though, also chastised drug makers for taking unilateral steps to withhold discounts.
The 340B program requires drug makers to offer discounts that are typically estimated to be 25% to 50% — but could be much higher — on all outpatient drugs to hospitals and clinics that serve low-income populations. There are approximately 12,400 so-called covered entities, including 2,500 hospitals, participating in the program, a number that has grown substantially in recent years.
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