Drug Manufacturer AbbVie Sues HRSA Over the 340B Patient Definition

4/17/2026 – Drug Manufacturer AbbVie Sues HRSA Over the 340B Patient Definition

Last week, the drug manufacturer AbbVie filed a federal lawsuit challenging HRSA’s long-standing definition of a 340B patient. The lawsuit specifically challenges HRSA’s 1996 Guidance, which defines who qualifies as a “patient” of a covered entity for purposes of receiving 340B-discounted prescriptions.

Background

In 2024, AbbVie identified what it alleges to be “concerning purchase trends” from two covered entities, a hospital and an FQHC. AbbVie reported that the FQHC saw 340B purchases of AbbVie Immunology Products (e.g., Humira, Skyrizi, and Rinvoq) increase by over 119% in a year, with 71% of purchases dispensed through out-of-state pharmacies. AbbVie also noted that prescribers at the FQHC ranked among the top in the nation for prescribing Skyrizi and Humira. Similarly, AbbVie identified that the hospital’s purchasing volume in the first three quarters of 2024 was 35% higher than in all of 2023 combined. AbbVie further noted that there was “an unusual and atypical increase in 340B purchases of three Immunology Products (Humira, Skyrizi, and Rinvoq)” at the hospital. As a result, AbbVie requested permission from HRSA to audit the FQHC and hospital, explaining to the agency that the company was concerned about potential diversion of 340B-priced drugs. HRSA denied AbbVie’s audit requests due to the “‘concern[]’ that the audit workplan reflect[ed] AbbVie’s own patient interpretation and [did] not follow the HRSA 1996 patient guidelines.”

Lawsuit

On April 8, 2026, AbbVie filed a lawsuit in the U.S. District Court of the District of Columbia challenging HRSA’s definition of a “patient.”[^[1]] AbbVie asks that a judge allow the company to audit covered entities using its own, more restrictive, definition of a “patient” rather than use HRSA’s definition, which has been in effect for nearly three decades. AbbVie argues that HRSA’s current interpretation of the term “patient” “facilitates widespread 340B program abuse” naming the hospital and the FQHC as potential culprits of said abuse. AbbVie’s own “best reading” of the term “patient,” dramatically narrows the scope of eligible individuals and includes the following:

“Legitimate Healthcare Service from Covered Entity: The individual receives an outpatient healthcare service from a covered entity site that is registered and listed in the 340B Office of Pharmacy Affairs Information System (OPAIS) database— HRSA’s database for 340B participant registration—and that service meets all of the following requirements:

- Direct Connection Between Prescription and Care from Covered Entity: The covered outpatient drug is prescribed as a direct result of the healthcare encounter by a healthcare professional who is acting pursuant to an employment or contractual agreement under which the healthcare professional provides services at the covered entity site;
- Substantive Medical Care: The healthcare encounter is sufficient to allow the healthcare professional to meet clinical practice standards for diagnosing and treating the condition for which the covered outpatient drug is prescribed;
- Timely Care Relationship: The healthcare service takes place no more than 12 months prior to the dispensing or administration of the covered outpatient drug; and
- Compliant with Funding: For covered entities other than Disproportionate Share Hospitals, the healthcare service is consistent with the services for which grant funding or federally qualified health center look-alike status has been provided to the entity.

Direct Oversight. The healthcare professional who provides the service described above has direct oversight of the individual’s care, which means that:

- Prescriber Oversees Condition for which 340B Priced Drug Is Prescribed: The healthcare professional is personally responsible for diagnosing and directly managing the patient’s condition for which the covered outpatient drug is prescribed as part of a provider-patient relationship that is sufficient to meet clinical practice standards for diagnosing and treating the condition for which the covered outpatient drug is prescribed; and
- Covered Entity Manages Patient’s Care: The covered entity maintains primary responsibility for care for the patient’s condition for which the covered outpatient drug is prescribed.”

Final Notes

Regarding patient eligibility, the 340B statute merely states that a covered entity “shall not resell or otherwise transfer [a 340B] drug to a person who is not a patient of the entity.” Given the lack of details in the 340B law about patient eligibility, we believe HRSA’s broad 1996 patient guidelines are far more consistent with the statute and congressional intent than AbbVie’s highly prescriptive and prohibitive definition of patient. HRSA’s guidance gives covered entities the flexibility they need to “stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.”[^[2]] AbbVie’s narrow patient definition would deprive covered entities of the ability to provide 340B prescriptions to individuals that entities consider to be their patients.

Please contact Powers’ drug pricing team, or your lead Powers attorney, if you have any questions.

^[1] Complaint, AbbVie Inc., v, Kennedy, No. 1 :26-cv-01190 (D.D.C filed Apr. 8, 2026).

²H.R. Rep. No. 102-384, pt. 2, at 12 (1992); Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Patient and Entity Eligibility, 61 Fed. Reg. 55,156, 55,157-158 (Oct. 24, 1996), https://www.hrsa.gov/sites/default/files/hrsa/opa/patient-entity-eligibility-10-24-96.pdf.