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Does Remdesivir have an assigned HCPCS code? Should we report Remdesivir using HCPCS code C9399?

There is currently no HCPCS code for Remdesivir. Assuming all pass-through and other program coverage requirements are met, CMS will typically establish either a temporary or permanent HCPCS code for a new drug product once the product is approved by the Food and Drug Administration (FDA). While Remdesivir has been granted emergency use authorization by the FDA, this is not the same as full FDA approval. Currently, Remdesivir is not approved by the FDA for any clinical indication, COVID-19 or otherwise.

We would not advise reporting Remdesivir using HCPCS code C9399. Per the CMS Claims Processing Manual Chapter 17 Section 90.2:

“HCPCS code C9399, Unclassified drug or biological, is for new drugs and biologicals that are approved by FDA on or after January 1, 2004, for which a specific HCPCS code has not been assigned.”

As discussed above, Remdesivir has not yet been approved by the FDA, therefore does not meet the CMS requirements for reporting under HCPCS code C9399.

Remdesivir is still currently reserved for critically ill COVID-19 patients, meaning this drug is likely to be administered in the inpatient setting. Drug HCPCS codes are generally not reported on inpatient claim types with the exception of hemophilia clotting factors. Therefore, from a chargemaster maintenance perspective, we would advise creating your Remdesivir charge using revenue code 25X with no HCPCS code attached – as this is how the charge will display on the final inpatient claim.

Gilead Emergency Access for Remdesivir homepage:
https://www.gilead.com/purpose/advancing-global-health/covid-19/emergency-access-to-remdesivir-outside-of-clinical-trials

CMS Claims Processing Manual Chapter 17:
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdf