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Has CMS created a HCPCS code for remdesivir when used in the outpatient setting?

Yes. On January 7, 2022, CMS announced, through the MLN Connects Special Edition linked below, the creation of HCPCS J0248 for remdesivir (VEKLURY) when used in the outpatient setting. Per CMS, HCPCS J0248 will be retroactively effective back to December 23, 2021. We have provided the short and long descriptors for HCPCS J0248 below for your convenience.

Long descriptor: Injection, remdesivir, 1 mg

Short descriptor: Inj, remdesivir, 1 mg

It is extremely important to note that the FDA has NOT updated its Emergency Use Authorization for VEKLURY. VEKLURY is still only approved by the FDA for use in hospitalized patients. Meaning, if VEKLURY is administered in the outpatient setting, this will be considered “off-label” use by Medicare and other payers.

Within the MLN Connects Special Edition, CMS states it will be up to the individual MACs to review and determine when VEKLURY will be considered medically necessary, and therefore covered, on outpatient claims.

We would encourage all providers to begin conversations with their payers to determine when VEKLURY will and will not be covered on an outpatient basis.

CMS MLN Connects Special Edition, January 7, 2022, COVID-19: New HCPCS Code for Remdesivir Antiviral Medication:
https://www.cms.gov/outreach-and-educationoutreachffsprovpartprogprovider-partnership-email-archive/2022-01-07-mlnc-se

VEKLURY (Remdesivir) full prescribing information:
https://www.gilead.com/-/media/files/pdfs/medicines/COVID-19/veklury/veklury_pi.pdf

NIH COVID-19 Treatment Guidelines, Remdesivir:
https://www.covid19treatmentguidelines.nih.gov/therapies/antiviral-therapy/remdesivir/

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