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What HCPCS code should we use to report Regeneron’s “monoclonal antibody cocktail” of casirivimab and imdevimab?

On December 3, 2020, CMS announced the creation of new HCPCS code, Q0243, to report for Regeneron’s REGN-COV2 drug therapy; which is a combination product of casirivimab and imdevimab. CMS has also established a distinct HCPCS code to report for REGN-COV2’s administration, M0243. We provided the long descriptions for both HCPCS codes below for your convenience.

Q0243: Injection, casirivimab and imdevimab, 2400 mg

M0243: Intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring

Per the CMS COVID-19 Vaccines and Monoclonal Antibodies homepage, the effective dates for both HCPCS codes Q0243 and M0243 have been backdated to 11/21/2020 – the same date the FDA granted an Emergency Use Authorization (EUA) for REGN-COV2.

As noted in the CMS MLN article linked below, use of REGN-COV2 is reserved “for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive COVID-19 test results who are at high risk for progressing to severe COVID-19 and/or hospitalization”. Clinical leadership should review the FDA’s REGN-COV2 EUA fact sheet carefully for detailed instructions regarding limitations of use.

We would point out, it appears initial doses of REGN-COV2 will be provided to practitioners free of charge. It is important to note, providers cannot seek reimbursement for drugs provided at no-cost to your facility. If you do receive doses of REGN-COV2 free of charge, the drug itself (HCPCS Q0243) will need to be billed with a token charge of $1.01 or less on your claims.

CMS Special Edition MLN Connects, “CMS Takes Further Steps to Ensure Medicare Beneficiaries Have Wide Access to COVID-19 Antibody Treatment”:
https://www.cms.gov/files/document/2020-12-03-mlnc-se.pdf

CMS COVID-19 Vaccines and Monoclonal Antibodies homepage:
https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/covid-19-vaccines-and-monoclonal-antibodies

FDA “Fact Sheet for Health Care Providers: Emergency Use Authorization of Casirivimab and Imdevimab”:
https://www.fda.gov/media/143892/download