04/15/2026
A new 340B lawsuit could reshape the definition of a “patient.”
In AbbVie v. HRSA, AbbVie challenges HRSA’s patient definition as too broad and directly leading to "widespread 340B program abuse". This directly opposes the 2023 Genesis decision, where the court rejected HRSA’s interpretation as too narrow , setting the groundwork for revisiting some entities more restrictive use of patient defintion policies.
This sets up a high-stakes legal battle on a core statutory question: who qualifies as a 340B patient?
If successful, the case could introduce stricter eligibility standards, including tighter links between care and prescriptions, time-limited patient status, and increased manufacturer audits and documentation expectations.
The outcome may significantly impact 340B patient eligibility rules including referral-based prescribing.
Read the full article below for a detailed analysis of the case and its potential implications:
Put on your seatbelt. The 340B space is about to get even more interesting. The newly filed AbbVie lawsuit against HRSA presents the inverse legal argument advanced in Genesis HealthCare Inc. Both cases center on the same statutory question, who qualifies as a patient under the 340B sta
