AbbVie Files Landmark Lawsuit to Narrow 340B 'Patient' Definition — Directly Targeting FQHC Contract Pharmacy Arrangements
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 takeaways
- 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
Primary source
HFMA / Fierce Pharma / 340B ReportSource packet
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FQHC Talent. (2026, April 9). AbbVie Files Landmark Lawsuit to Narrow 340B 'Patient' Definition — Directly Targeting FQHC Contract Pharmacy Arrangements. Primary source: HFMA / Fierce Pharma / 340B Report. Retrieved July 28, 2026, from https://www.fqhctalent.com/intel/abbvie-340b-patient-definition-lawsuit
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