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U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy.
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On November 9, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy, bamlanivimab (Eli Lilly), 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.
On November 21, 2020, the FDA issued an EUA for the investigational monoclonal antibody therapy, casirivimab and imdevimab (Regeneron), administered together, 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 COVID19 and/or hospitalization.
HOW TO REPORT MONOCLONAL ANTIBODY THERAPY
CMS created the new codes in response to the U.S. Food and Drug Administration (FDA) issuing an emergency use authorization (EUA) for the new therapy on Nov. 9. The two drugs are administered together, and the therapy is reported with the following new HCPCS Level II codes:
| Code | Descriptor | Payment |
|---|---|---|
| Q0243 | Injection, casirivimab and imdevimab, 2400 mg | $0.010 |
| M0243 | Intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring | $309.600 |
| Q0239 | Injection, bamlanivimab, 700 mg | $0.010 |
| M0239 | intravenous infusion, bamlanivimab, includes infusion and post administration monitoring | $309.600 |
PAYMENT FOR PRODUCT
Medicare will not provide payment for the COVID-19 monoclonal antibody products that health care providers receive for free, as will be the case upon the product’s initial availability in response to the COVID-19 PHE. If health care providers begin to purchase these monoclonal antibody products, CMS anticipates setting the payment rate in the same way we set the payment rate for COVID-19 vaccines. For example, Medicare will pay 95% of AWP for COVID-19 vaccines furnished in the physician office setting, and pay hospital outpatient departments at reasonable cost for COVID-19 vaccines.
Providers can bill under Medicare Part B for the administration of this infusion therapy on a single claim or submit multiple claims on a roster bill. CMS warns, however, that the requirements for administration of this therapy are “considerably more complex” and may not lend themselves to roster billing.
Providers should make sure to document the steps they took to meet the terms of the FDA’s EUA. CMS also wants to see the name of the practitioner who ordered or made the decision to administer the infusion to each patient, even if using roster billing.
There is no cost-sharing for COVID-19-related services and supplies: Copayments/coinsurance and deductibles do not apply for Medicare patients.
Author: Tonoya Ahmed
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