Exclusive: AbbVie sues to narrow drug discount patient definition
Add Axios as your preferred source to
see more of our stories on Google.
Illustration: Shoshana Gordon/Axios
Humira and Botox maker AbbVie is suing the Trump administration to get a clearer definition of who counts as an eligible patient in the government's discount drug program.
Why it matters: While it might seem like an arcane debate, drugmakers say an overly broad definition allows hospitals and other providers to bilk them for more discounted medications than they're due.
- AbbVie's complaint is the latest twist in an ongoing fight between the drug industry and hospitals over the federal 340B program, which is designed to provide discounted drugs to safety-net providers but has been mired in litigation and finger-pointing.
Safety-net providers in the 340B program can only claim discounts on medicines dispensed to their own patients.
- But the law that created 340B more than three decades ago didn't define criteria including how long the provider had to serve the patient to claim a discount.
- The Health Resources and Services Administration said in 1996 that patients must have an "established relationship" with the provider in question.
Where it stands: AbbVie's lawsuit filed in U.S. District Court for the District of Columbia on Wednesday says that definition is "overly inclusive, capturing individuals who may have had only a cursory encounter with the covered entity a long time ago."
- That is not in line with Congress's intentions for the program, the complaint argues.
- AbbVie says eligible patients should be limited to those prescribed medicine as a direct result of care received at the provider within the last 12 months.
- The provider seeking the drug discount should be actively managing the care for any condition meriting the patient's medication, AbbVie says.
Between the lines: The lawsuit comes as 340B providers, pharmaceutical companies and policymakers battle in court over other issues, like whether providers can access their discounts at certain pharmacies. The providers say the program is critical to taking care of underserved patients.
What they're saying: AbbVie's goal is to "establish this clear, sensible patient definition to get at what we see as the proliferation of abuse in the 340B program," said Jeffrey Colvin, the company's vice president of legal strategy.
- "We think this is sort of the key issue at the crux of the program that needs to be addressed."
The intrigue: A federal court previously sided with providers and ruled for a broad patient definition in a 2023 case surrounding the attempted removal of a health center from the program. AbbVie's Colvin said that decision doesn't apply here.
What we're watching: GOP lawmakers in the House of Representatives introduced a bill last year that would codify its own 340B patient definition, among other program changes.
