340B Program Integrity Policy Update

Amgen supports the 340B program’s mission to strengthen access to medicines for people who are uninsured and underinsured. However, government reports and academic research have found that oversight gaps and rapid growth have raised concerns about program integrity, including duplicate discounts and use of 340B medicines for ineligible patients which are prohibited under federal law.

To help address these challenges, beginning June 1, 2026, Amgen will request submission of routine, claims-level data for all Amgen medicines from all 340B pharmacy and medical dispenses. Effective the same date, covered entities with an in-house pharmacy capable of dispensing 340B drugs to patients may no longer use contract pharmacy arrangements. Covered entities without an in-house pharmacy may designate a single contract pharmacy location.

Beginning November 15, 2026, Amgen will also request submission of standard healthcare visit and service claims data associated with all 340B pharmacy and medical dispenses of Amgen medicines. The anonymized data include standard information collected during a provider interaction. For example, the data may help determine whether the visit took place in an eligible 340B setting, if accurate billing and diagnosis codes were used and that the date of service aligns with when the medication was dispensed.

Our goal is to advance 340B program integrity, help patients access the care they need and support the providers who serve them. These measures are intended to improve transparency and address concerns related to duplicate discounts, diversion, fraud and misuse, while minimizing administrative burden on hospitals and clinics by relying on standard data already collected through existing workflows.

Amgen remains committed to working with the Administration, Congress and stakeholders to ensure that the 340B program operates as intended and delivers meaningful value to patients and the broader healthcare system.