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Has CMS established new HCPCS codes for the newly approved COVID-19 treatment, Bamlanivimab?

Yes. On November 9, 2020, the FDA issued an emergency use authorization for Bamlanivimab to treat mild-to-moderate cases of COVID-19 in patients who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab is the first COVID-19 treatment approved for use in the outpatient setting.

In response to the approval, on November 10, 2020, CMS announced it would be establishing two new HCPCS codes to be reported for Bamlanivimab and its administration. We have provided the long descriptions for the new HCPCS codes below for your convenience.

Q0239: Injection, bamlanivimab-xxxx, 700 mg

M0239: Intravenous infusion, bamlanivimab-xxxx, includes infusion and post administration monitoring

Although not explicitly stated in the CMS announcement, it is our interpretation that both HCPCS codes will have an effective date of November 9, 2020 – the date the FDA EUA was approved for Bamlanivimab.

Within their announcement, CMS states the reimbursement rate for the administration code, M0239, will be $309.60. CMS states Bamlanivimab will likely initially be provided to healthcare professionals free of charge. CMS reminds providers that they cannot seek reimbursement for treatments, COVID related or otherwise, that the provider receives at no-cost. No-cost items are allowed to be billed with token charges of $1.01 or less if required for your billing system or if a charge is needed to bypass claims edits. CMS states that once providers begin to purchase doses of Bamlanivimab at cost, the reimbursement rate will be set at 95% of the AWP or reasonable cost, depending on the setting of where the drug is administered.

CMS Monoclonal Antibody COVID-19 Infusion Program Instruction:
https://www.cms.gov/files/document/covid-medicare-monoclonal-antibody-infusion-program-instruction.pdf