Gavel & Pestle Podcast host –Darshan Kulkarni, PharmD, MS, Esq – provides insight on Off-Label indication and illegal promotion of drugs. What you don’t know can get you thrown in jail or millions in fines.
Providing Coverage for Off-label Prescriptions
While off-label promotion is the purview of the Justice department, certain off-label prescribing is for all intents and purposes sanctioned by behemoth entities such as Medicare, and guided by national compendia. In 1993, a portion of the Omnibus Reconciliation Act legally required Medicare to cover an off-label use of a cancer drug if it is in the drug compendia, or is supported by peer-reviewed articles in certain journals outlined by Medicare.
References: BioWorld Perspectives