January 26, 2011—The Office of Pharmacy Affairs (OPA) has published guidance on its Web site that appears to modify its position on the use of 340B-purchased drugs for discharge prescriptions.
Hospitals enrolled in 340B say that OPA technical assistance contractors have been telling them that, per OPA policy, 340B drugs may not be used for patients whose only connection with the hospital’s outpatient pharmacy is that they were discharged from an inpatient setting. Hospitals say this effectively prohibits them from filling discharge prescriptions with 340B drugs for patients who did not receive outpatient care either immediately prior to or following a hospital admission.
Letter to OPA
Safety Net Hospitals for Pharmaceutical Access (SNHPA), which represents more than 600 340B hospitals, argued in a recent letter to OPA that the agency’s guidance conflicted both with longstanding OPA policy and the Centers for Medicare and Medicaid Services’ (CMS) treatment of discharge prescriptions as rebatable for purposes of the Medicaid drug rebate program. OPA’s policy created an undue burden on hospitals, SNHPA said, and appeared to circumvent proper administrative procedure by partially implementing OPA’s proposed but never finalized 2007 patient definition guidelines.
The recent clarification, published Jan. 21 in the form of an answer to a “frequently asked question” (FAQ), differs from the prior version in that it no longer contains the latter’s denial of 340B eligibility to “patients whose only connection to the hospital is the receipt of inpatient care.”
SNHPA officials say they believe the change properly shifts the standard away from the type of care a patient receives and focuses it instead on how the drugs are used.
Patient Definition in Flux
OPA cautions in its FAQ that “if an entity uses 340B drugs, it should be able to explain why the entity is responsible for the use of the drugs on an outpatient basis and have auditable records that demonstrate compliance with 340B requirements.”
OPA also says that “eligible entities have the responsibility to ensure that drugs purchased under 340B be limited to outpatient use and provided to patients who meet the requirements of the current patient definition.” This sentence in the FAQ includes a hyperlink to the current 1996 patient definition. On the same day that OPA published the FAQ, it also began the formal process of replacing the definition of patient (see related story.)