Monoclonal-Antibody-Treatment-Information-for-Providers-and-Facilities Monoclonal Antibody Treatment Information for Providers and Facilities

Monoclonal Antibody Treatment Information for Providers and Facilities

What are monoclonal antibodies, and what is their role in treating COVID-19?

Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful antigens such as viruses. Monoclonal antibodies to treat COVID-19 are directed against the spike protein of SARS-COV2, designed to block the virus' attachment and entry into human cells.

The monoclonal antibody products that have received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) and that are available in California are:

Given the sustained increase in variants resistant to bamlanivimab alone, and availability of alternative authorized monoclonal antibodies, the U.S. government has stopped the distribution of bamlanivimab alone. In March 2021, CDPH stopped recommending bamlanivimab monotherapy, and on April 16, 2021, the FDA revoked the EUA for bamlanivimab monotherapy. (1)

This recommendation and restriction only apply to the administration of bamlanivimab monotherapy. The other two authorized monoclonal antibody combinations for treatment of mild to moderate COVID-19 – bamlanivimab plus etesevimab and casirivimab plus imdevimab – continue to be available for direct ordering from the federal government.

Who is a candidate for monoclonal antibody treatment?

The treatment should be administered as soon as possible after positive results of direct SARS-CoV2 viral testing AND within 10 days of symptom onset.

Only high-risk groups with mild to moderate COVID-19 have been authorized for treatment at this time. Specifically people who:

  • Are > 65 years old, OR
  • Have chronic kidney disease, OR
  • Have diabetes, OR
  • Have a BMI > 35, OR
  • Have immunosuppressive disease, OR
  • Are currently receiving immunosuppressive treatment, OR
  • Are > 55 years old AND have:
    • Cardiovascular disease, OR
    • Hypertension, OR
    • COPD or other chronic respiratory disease, OR
  • Are 12-17 years old AND have:
    • BMI > 85th Percentile for their age and gender based on CDC growth charts, OR
    • Sickle cell disease, OR
    • Congenital or acquired heart disease, OR
    • Neurodevelopmental disorders, for example, cerebral palsy, OR
    • A medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR
    • Asthma, reactive airway or other chronic respiratory disease that requires daily medication for control

Please review the respective EUA fact sheets for bamlanivimab/etesevimab and casirivimab/imdevimab for more information.

Can a patient who is asymptomatic receive this treatment? 

No, the Emergency Use Authorizations (EUAs) for monoclonal antibody treatments are for the treatment of 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.

Monoclonal antibody treatments are not authorized for use in patients who are hospitalized due to COVID-19 OR who require oxygen therapy due to COVID-19 OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related morbidity.

Can a patient without positive results from direct SARS-CoV-2 viral testing receive this treatment?

No, the Emergency Use Authorizations (EUAs) for monoclonal antibody treatments are for the treatment of 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.

Monoclonal antibody treatments are not authorized for use in patients who are hospitalized due to COVID-19 OR who require oxygen therapy due to COVID-19 OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related morbidity.

Can a patient who is hospitalized due to COVID-19 receive this treatment?

No, the Emergency Use Authorizations (EUAs) for monoclonal antibody treatments are for the treatment of 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.

Monoclonal antibody treatments are not authorized for use in patients who are hospitalized due to COVID-19 OR who require oxygen therapy due to COVID-19 OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related morbidity.

Can a patient requiring oxygen therapy due to COVID-19 receive this treatment?

No, the Emergency Use Authorizations (EUAs) for monoclonal antibody treatments are for the treatment of 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.

Monoclonal antibody treatments are not authorized for use in patients who are hospitalized due to COVID-19 OR who require oxygen therapy due to COVID-19 OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related morbidity.

What types of settings can administer monoclonal treatment?

This treatment should only be administered in settings where health care providers have immediate access to medications to treat severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system, if necessary. Required elements for administering monoclonal treatment can be found in the respective EUA fact sheets for bamlanivimab/etesevimab and casirivimab/imdevimab.


Given the limitations to using existing acute care hospital infrastructure during surges, California Department of Public Health (CDPH) encourages the use of these products in non-hospital outpatient settings (e.g., skilled nursing facilities, community clinics/FQHCs, state hospitals, jails, and other congregate/outpatient settings that have the clinical capacity to use). 

My patient qualifies for monoclonal antibody treatment. What should I do next?

Appropriate candidates should be referred to the nearest facility accepting patients for monoclonal antibody treatment. To find a location near you, there are two locator tools:

How will my facility be reimbursed for the cost of administering the medication?

The cost of these products remains free, paid for by the federal government. The administration cost is billed through the usual claiming process, based on each patient's health care coverage.

For Medi-Cal, the following reimbursement codes for services rendered for monoclonal antibody infusions may be used for billing:

Medi-Cal Reimbursement Codes for Monoclonal Antibody Administration

M0243

  • Intravenous infusion, casirivimab and imdevimab, includes infusion and post administration monitoring
  • Effective date of 11/21/20
  • Maximum allowable rate of $309.60

M0245

  • Intravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring
  • Effective date of 2/9/2021
  • With a maximum allowable rate of $309.60

For more information, please see: Medi-Cal NewsFlash: Reimbursement of COVID-19 Vaccine and Monoclonal Antibody Administration for Medical Providers

For Medicare, the following reimbursement codes for services rendered for monoclonal antibody infusions may be used for billing:

Medicare Reimbursement Codes for Monoclonal Antibody Administration

M0243

  • Intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring

M0245

  • Intravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring

For more information regarding Medicare coding and billing for monoclonal antibody infusions, please see: Monoclonal Antibody COVID-19 Infusion | CMS

My facility can operationalize monoclonal antibody treatment. How can we obtain product?

All treatment sites must now order these monoclonal antibody products directly from AmerisourceBergen Corporation (ABC). The products remain free of charge to requesting sites. Treatment sites should review the direct ordering process guide and place orders directly with ABC at this site.

  • The products available for direct ordering include bamlanivimab plus etesevimab, casirivimab plus imdevimab, and etesevimab.
  • Note that etesevimab is only authorized for use in combination with bamlanivimab but can be ordered by itself to be combined with any bamlanivimab stock a facility already has on-hand.

Should you have any questions or concerns regarding the direct order process for COVID-19 monoclonal antibodies, you may contact the U.S Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (HHS/ASPR) at COVID19Therapeutics@hhs.gov or ABC at C19therapies@amerisourcebergen.com.

My facility is interested in using these treatments. Are there resources available to assist in operationalizing monoclonal antibody infusions?

For facilities and healthcare providers interested in setting up infusions for high-risk patients with COVID-19, ASPR has many resources available. This includes free digital content that your facility can use on social media platforms to help educate providers and patients. HHS has also provided a Combat Covid webpage as a resource for your patients. 

Additionally, if trying to set up a standalone Monoclonal Antibody Infusion Center, please see Monoclonal Antibody Infusion Center Model

HHS/ASPR also has a call center for questions and information related to monoclonal antibodies. Please share broadly with your networks of patients and providers.

  • English: 1-877-332-6585
  • Spanish:1-877-366-0310

Finally, particularly hard-hit local jurisdictions can submit resource requests through CalOES for additional supplies and/or staffing. These requests can then be escalated to the appropriate state and federal authorities whereby they can assist with additional resources, if available.

Additional resources:

 


Originally Published March 9, 2021