Is remdesivir now approved by the FDA for outpatient use?
Yes. Coverage for remdesivir has been evolving and changing quickly over the past few weeks. Initially, CMS announced the creation of code J0248 (Injection, remdesivir, 1 mg) with an effective date of December 23, 2021. However, at the time the FDA had not yet updated its approval of VEKLURY to include outpatient usage. Meaning, although CMS had created a HCPCS code to report on outpatient claims, usage of the drug in the outpatient setting would have been considered “off-label usage.” On January 7, 2022, CMS issued an MLN Connects Special Edition noting that that due to the lack of a national coverage determination for administration in an outpatient setting, Medicare coverage for VEKLURY (remdesivir) in an outpatient environment would be left to MAC discretion.
Most recently, on January 21, 2022, the FDA expanded the emergency use authorization (EUA) for remdesivir to include the use for non-hospitalized patients with mild to moderate COVID-19 who are at high risk of their case becoming severe. Craneware will continue to monitor and update this site as information becomes available.
Resources:
CMS MLN Connects dated January 7, 2022
https://www.cms.gov/outreach-and-educationoutreachffsprovpartprogprovider-partnership-email-archive/2022-01-07-mlnc-se
EUA Fact Sheet for VEKLURY
https://www.gilead.com/-/media/files/pdfs/remdesivir/eua-fact-sheet-for-hcps.pdf