Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. Recently the U.S.Food and Drug Administration (FDA) issued an emergency use authorization for the investigational monoclonal antibody therapies which include Eli Lilly’s monoclonal antibody regimen, bamlanivimab and Regeneron’s product, casirivimab and imdevimab. These antibody therapies are used for the treatment of mild-to moderate COVID-19 in adults and paediatric patients with positive COVID-19 test results who are at high risk for progressing to severe COVID-19 and/or hospitalization.
CMS identified specific code(s) for each COVID-19 monoclonal antibody product and specific administration code(s) for Medicare payment:
Labeller name: Eli Lilly
Q0239 Injection, bamlanivimab-xxxx, 700 mg
M0239 Intravenous infusion, bamlanivimab-xxxx, includes infusion and post administration monitoring
Labeller name: Regeneron
Q0243 Injection, casirivimab and imdevimab, 2400 mg
M0243 intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring
Medicare Payment for Monoclonal COVID-19 Infusion:
Payment for infusion:
Medicare pays for the administration of monoclonal antibody products to treat COVID-19. The Medicare national average payment rate for the administration will be approximately $310 for the infusions of bamlanivimab and casirivimab and imdevimab (administered together). This payment rate is based on one hour of infusion and post-administration monitoring in the hospital outpatient setting.
Payment for Product:
Medicare will not pay for monoclonal antibody products that providers receive it for free. However if health care providers begin to purchase monoclonal antibody products, CMS anticipates setting the payment rate in the same manner it set the payment rates for COVID-19 vaccines through future notice and updates.
Billing for Monoclonal Antibody COVID-19 Infusion Administration:
Health care providers can bill for the administration of the COVID-19 monoclonal antibody infusion on a single claim for COVID-19 monoclonal antibody administration or submit claims on a roster bill, in accordance with the FDA EUA for each product.
When billing for monoclonal antibody administrations, CMS expects healthcare providers to maintain appropriate medical documentation that supports the medical necessity of the service. The documentation should also include the name of the practitioner who ordered or made the decision to administer the infusion, even in cases where claims for these services are submitted on roster bills.
When COVID-19 monoclonal antibody doses are provided by the government without charge, providers should only bill for the administration and should not include the COVID-19 monoclonal antibody codes on the claim.
Happy learning! Happy Coding!