J0248 Established as Medi-Cal Benefit for Remdesivir to Treat COVID-19

March 3, 2022

Effective for dates of service on or after December 23, 2021, the Centers for Medicare & Medicaid Services (CMS) has created HCPCS code J0248 (injection, remdesivir, 1 mg) for billing remdesivir (Veklury) when administered in an outpatient setting.

On January 21, 2022, the U.S. Food and Drug Administration (FDA) has expanded the approved indication for Veklury to include its use in

  • non-hospitalized adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms).

Additionally, the FDA revised the Emergency Use Authorization (EUA) for Veklury to include treatment of:

  • non-hospitalized pediatric patients weighing 3.5 kilograms to less than 40 kilograms or pediatric patients less than 12 years of age weighing at least 3.5 kilograms.

Individuals listed above must also have positive results of direct SARS-CoV-2 viral testing, mild-to moderate COVID-19, and be at high risk of progression to severe COVID-19, including hospitalization or death.

These patients can now receive treatments outside of a traditional inpatient hospital setting, including skilled nursing facilities, home healthcare setting and outpatient facilities such as infusion centers.

Providers may submit claims billed with code J0248 on or after May 1, 2022.

An Erroneous Payment Correction (EPC) will be implemented for affected claims billed with HCPCS code J0248 for dates of service on or after December 23, 2021.

Provider manual updates reflecting these changes will be released in a future Medi-Cal Update.