AbbVie Files Landmark Lawsuit to Narrow 340B 'Patient' Definition, Directly Targeting FQHC Contract Pharmacy Arrangements
Issue
AbbVie sued HRSA to challenge the 30-year-old 340B patient definition, proposing a four-part test requiring direct care connection, clinical encounter, active care management, and 12-month recency. AbbVie flagged Barrio Comprehensive Family Health Care Center (TX FQHC) — 340B purchases of Humira/Skyrizi/Rinvoq up 119% (2021-2022), 71% dispensed through out-of-state pharmacies.
If successful, this would dramatically shrink FQHC 340B eligibility for contract pharmacy and telehealth prescribing. Post-Chevron (Loper Bright) makes this challenge viable for the first time.
Key points
- First-ever manufacturer lawsuit challenging HRSA's 340B patient definition
- Four-part test proposed: direct care, clinical encounter, active management, 12-month recency
- Post-Chevron (Loper Bright) makes HRSA guidance vulnerable to legal challenge
Sources for this story
HFMA / Fierce Pharma / 340B ReportSources for your board packet
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Part of
- 340B drug pricing
AbbVie v. HRSA and the patient definition
FQHC Talent. (2026, April 9). AbbVie Files Landmark Lawsuit to Narrow 340B 'Patient' Definition, Directly Targeting FQHC Contract Pharmacy Arrangements. Source: HFMA / Fierce Pharma / 340B Report. Retrieved October 6, 2026, from https://www.fqhctalent.com/intel/abbvie-340b-patient-definition-lawsuit
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