AbbVie has filed a lawsuit challenging federal guidance on how “patient” is defined under the 340B program, according to an April 8 press release.
The company said the current definition, based on guidance issued in 1996, allows covered entities to claim discounts for prescriptions tied to minimal or unrelated patient interactions, including care delivered far from the qualifying facility.
AbbVie argued the interpretation has created loopholes that enable duplicate discounts and allow 340B savings to be used as discretionary revenue rather than tied to direct patient benefit.
The lawsuit seeks to establish a clearer definition requiring prescriptions to be connected to care provided at the facility, with providers actively managing treatment and having seen the patient within the past 12 months.
AbbVie said the proposed changes would not affect access to discounted medicines for eligible patients or revenue for providers using the program in good faith.
The filing comes amid a wave of legal disputes for AbbVie over the 340B program. For instance, in February a federal judge dismissed AbbVie’s challenge to Tennessee’s Hospital Protection Act, ruling the state law does not conflict with federal 340B requirements.
Meanwhile, the Justice Department filed a brief backing AbbVie in a separate appeal of Colorado’s 340B contract pharmacy law, arguing the state statute is preempted by federal law. Similar laws have been enacted in more than 20 states, fueling ongoing litigation between drugmakers and states over the scope of the program.
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