Knowledge Base Article

Q:

MMP’s November 11, 2020 COVID-19 Updates article included the November 9th FDA announcement where they had issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy Bamlanivimab. How should our hospital code and bill for providing this drug?

A:

As a reminder from the November 11th article, Bamlanivimab is not authorized for patients already hospitalized due to COVID-19. Instead, it is to be given in an outpatient setting and  “is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.”

November 10, 2020: CMS Posts Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction

CMS posted the document Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction on the CMS Current Emergencies Coronavirus Disease 2019 webpage in the Billing & Coding section. CMS notes that during the public health emergency (PHE), Medicare will cover and pay for these infusions the same way it covers and pays for COVID-19 vaccines (when furnished consistent with the EUA). The following Coding and Billing Guidance is excerpted from the CMS Infusion Program Instruction.

Coding for Monoclonal Antibody COVID-19 Infusion

CMS identified specific code(s) for the monoclonal antibody product and specific administration code(s) for Medicare payment:

Eli Lilly and Company's Antibody Bamlanivimab (LY-CoV555), EUA effective November 9, 2020

Q0239:

• Long descriptor: Injection, bamlanivimab-xxxx, 700 mg
• Short descriptor: bamlanivimab-xxxx

M0239:

• Long Descriptor: intravenous infusion, bamlanivimab-xxxx, includes infusion and post administration monitoring
• Short Descriptor: bamlanivimab-xxxx infusion

Billing for Monoclonal Antibody COVID-19 Infusion Administration

Health care providers can bill for the administration of the 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.

• The EUA for COVID-19 monoclonal antibody treatment bamlanivimab contains specific requirements for administration that are considerably more complex than for other services that are billed using roster billing. CMS expects that health care providers will maintain appropriate medical documentation that supports the medical necessity of the service. This includes documentation that supports that the terms of the EUA are met, including that it is being used for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) for a patient that is at high risk for progressing to severe COVID-19 and/or hospitalization. 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. Health care providers should not include the monoclonal antibody codes on the claim when the product is provided for free.

Health care providers who participate in a Medicare Advantage Plan should submit claims for bamlanivimab administration to Original Medicare for all patients enrolled in Medicare Advantage in 2020 and 2021.