May 25, 2012—The Office of Pharmacy Affairs (OPA) posted two new policy releases on its Web site yesterday. The first is an update to OPA’s non-discrimination policy requiring drug manufacturers to treat 340B providers the same as non-340B providers when manufacturers develop alternate allocation systems for drugs in short supply. OPA had issued a policy release on its non-discrimination policy last November. It appears that OPA has revised its policy to make it recommended that manufacturers submit allocation plans to OPA before implementing them as opposed to mandatory, which the November release required.
The second policy release addresses 340B covered entity eligibility as it relates to accountable care organizations (ACOs). The new ACO policy release makes it clear that a 340B provider’s participation in an ACO does not automatically make all patients of the ACO eligible for 340B.
The Monitor will report on these developments in greater depth shortly.