Can an eligible facility have pharmaceutical transaction(s) reclassified, after the fact, assuming it was purchased, then used for 340B eligible patients?
The OPA does not authorize or prohibit the use of a credit/rebill, or similar process, to re-characterize a transaction after the fact. If this process is used, a recommendation for an informed consent by all involved, including the manufacturer, be obtained. Any process used must be in compliance with Federal, State, and local law and all processes should be transparent with a clear audit trail that fully reflects the actual timing and facts underlying a transaction. The covered entity retains responsibility in ensuring full compliance and integrity of their use of the 340B program.
