Changes to the Definition of Therapeutic Substance

Page last updated: 03 March 2010

The Government has amended the Health Insurance (General Medical Services Table) Regulations (the Regulations) with effect from 1 March 2010 to remove the definition of ‘therapeutic substance’ from those Regulations.

Prior to this amendment, services by medical practitioners involving the administration of therapeutic substances only attracted Medicare benefits if those substances had been registered by the Therapeutic Goods Administration (TGA) for the clinical indication for which they had been assessed.

The change affects all Medicare Benefits Schedule (MBS) items referring to therapeutic substances. The Government expects that, as part of this process for any off-label drug use, appropriate consent will be obtained from patients.