Question:
Can hospitals bill for a new drug approved by the FDA but with no code assigned yet by CMS?
Answer:
Hospital outpatient departments may bill for new drugs and biologicals approved by the Food & Drug Administration (FDA) with code C9399. When this code appears on a claim, the outpatient code editor (OCE) suspends the claim for manual pricing by the Medicare contractor, which does so at 95 percent of the drug’s average wholesale price (AWP) using the Red Book™ or an equivalent recognized compendium, and processes the claim for payment. Hospitals discontinue billing HCPCS code C9399 and the national drug code (NDC) when CMS implements a HCPCS code, status indicator, and appropriate payment amount.