Friday’s (August 28, 2015) released guidance from HRSA in the Federal Register had a number of points of clarification which would make 340B compliance clearer and therefore easier, but a handful of “guidance” points actually sound like big changes.

Discharge Prescriptions: Part C(5) proposes that a patient must be classified as an outpatient at the time a drug is prescribed, and that such a determination must be made based on insurance billing. On the face of it, this eliminates discharge medications from eligibility. Or does it mean that hospitals will change their policies to re-categorize patients before giving prescriptions clearly intended for outpatient use?

Referrals: OPA has clearly walked back their guidance on this, changing from yes if the “loop” is closed to “nope”: prescriptions written by doctors not at the 340B entity are not eligible.

Fewer Eligible Prescribers: the former “…or other arrangements” has been removed and replaced with “such that the covered entity may bill for services on behalf of the provider”. This might be OPA’s attempt to clarify that hospital privileges don’t grant a doctor 340B status, but it might be an onerous standard that could eliminate doctors otherwise reasonably considered eligible.

We have until October 27 to comment on the proposed guidance.