Patient Assistance Program (PAP)
Definition
Patient Assistance Programs (PAPs) are programs through which drug manufacturers provide free or deeply discounted medications to patients who meet financial need criteria. PAPs are a separate mechanism from the 340B program and serve patients who may not have insurance or who cannot afford their medications.
In the 340B context, PAPs create potential compliance complexity. If a covered entity uses 340B-purchased drugs for patients who are also enrolled in a manufacturer PAP, there is a risk of the manufacturer providing two forms of assistance on the same drug—which may raise compliance questions. Covered entities should have clear policies about how PAP medications interact with 340B drug dispensing.
Additionally, some manufacturers have used PAP enrollment as a condition of access to 340B pricing in contract pharmacy arrangements, which has been controversial and is part of the broader manufacturer restrictions debate.
Frequently Asked Questions
Why Patient Assistance Program (PAP) Matters
PAPs and the 340B program can interact in ways that create compliance complexity. Covered entities should have clear policies about how PAP medications are handled relative to 340B purchasing and dispensing to avoid unintended compliance issues.
How Virtue 340B Uses It
Virtue 340B helps covered entities develop policies for managing the intersection of PAP medications and 340B program operations.