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Has CMS established new HCPCS codes for the combined COVID-19 monoclonal antibody therapy of Bamlanivimab and Etesevimab?

On February 18, 2021, CMS announced the creation of new HCPCS code, Q0245, to report for Eli Lily’s combined COVID-19 drug therapy product of Bamlanivimab and Etesevimab. CMS has also established a distinct HCPCS code to report for the product’s administration, M0245. We have provided the long descriptions for both HCPCS codes below for your convenience.
Q0245: Injection, bamlanivimab and etesevimab, 2100 mg

M0245: Intravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring

Per the CMS COVID-19 Vaccines and Monoclonal Antibodies homepage, the effective dates for both HCPCS codes Q0245 and M0245 have been backdated to 2/9/2021 – the same date the FDA issued its Emergency Use Authorization (EUA).

Per the FDA’s Emergency Use Authorization, the combined therapy of Bamlanivimab and Etesevimab is appropriate for “treating mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization”. Clinical leadership should review the FDA’s Eli Lily EUA fact sheet carefully for detailed instructions regarding limitations of use.

As with other COVID-19 antibody treatments, providers will likely receive initial doses of Bamlanivimab and Etesevimab at no-cost. Per the CMS COVID-19 Vaccines and Monoclonal Antibodies homepage, providers should not submit charges for the product itself (Q0245 in this instance) if it is received for free.

Resources Referenced in this Q&A:

CMS MLN Connects, 2021-02-18, “CMS Takes Further Steps to Ensure Medicare Beneficiaries Have Wide Access to COVID-19 Antibody Treatment”:
https://www.cms.gov/outreach-and-educationoutreachffsprovpartprogprovider-partnership-email-archive/2021-02-18-mlnc#_Toc64450217

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 (EUA) of Bamlanivimab and Etesevimab:
https://www.fda.gov/media/145802/download