COVID-19 Monoclonal Antibody Treatments

Frequently Asked Questions

I’m interested in providing monoclonal antibodies at my office. Is there a tool to help me estimate staffing needs and scheduling?

HHS in conjunction with John Hopkins university create a calculator to help potential sites identify staffing needs. https://www.phe.gov/Preparedness/Pages/mabcalctool.aspx

Has the expiration date on the products in my inventory been extended?

The best source of information regarding extension of expiration dating is:

Please contact the manufacturer of your product if you have lot specific questions or are unable to find the information needed on the phe.gov webpage.

Patient Eligibility Criteria for Monoclonal Antibodies

Effective 2/14/2022, the Oral Antiviral and Monoclonal Antibody Screening Score (OMASS) tool will no longer be utilized in New Mexico. The tool is being phased out as current COVID-19 therapeutics inventory exceeds demand.

Providers should determine patient eligibility by reviewing each medication’s individual FDA Emergency Use Authorization. The documents can be found on the FDA’s Emergency Use Authorization Drugs and Non-Vaccine Biological Products webpage.

The state has provided a quick reference guide and treatment decision aid to assist providers in appropriate treatment selection. The state strongly recommends prioritization of Tier 1 & 2 COVID-19 therapeutics for patients at high risk of severe COVID-19 disease.

Directory of Monoclonal Antibody Sites

Setting Up Your Facility to Provide Monoclonal Antibody Treatments

    1. Review the Health and Human Services checklist for Administering Monoclonal Antibody Treatments For COVID-19 in Your Facility and the U.S. Government’s Monoclonal Antibody Therapeutics Playbook for your site’s readiness.

*At this time, due to very limited supplies, only hospitals and pharmacies servicing nursing facilities are eligible for allocations. We encourage providers to register. Once supply increases, all registered providers will have access to monoclonal antibodies.

Once supply increases, all registered providers will have access to monoclonal antibodies.

Monoclonal Antibody Provider Required Reporting

Reporting of Monoclonal Antibody Inventory and Utilization

  • All sites are required to report their inventory and utilization weekly on Wednesday. The data impacts the states allocation from the federal government. The data is also used to ensure equitable allocation between facilities.
    • Non-hospital sites shall report monoclonal antibody inventories to both the federal government (utilizing their HHS Protect account) AND the state (utilizing ReadyOp Form). Reporting is conducted weekly on Wednesday from 8am to 12pm. Please note submissions before or after this time frame are not captured.
    • Hospitals shall report monoclonal antibody inventories to both the federal government and to the state utilizing their EMResource account. Reporting is conducted weekly on Wednesday and must be completed by noon.

Reporting Adverse Events

Reporting of serious adverse events and medication errors is required by the FDA.

 Report serious adverse events to FDA MedWatch: https://www.fda.gov/media/76299/download

Monoclonal Antibody Distribution

Monoclonal antibodies are currently under allocation. The federal government allocates a portion of the available supply to each state and is currently done on a weekly cycle.

https://www.phe.gov/emergency/events/COVID19/therapeutics/distribution/Pages/data-tables.aspx

New Mexico Department of Health allocates product to participating facilities based on their reported utilization and inventory. Shipments are received by facilities once weekly.

Administration of Monoclonal Antibodies

Monoclonal antibodies must be administered in accordance with their current Emergency Use Authorizations (EUAs):

Billing of Monoclonal Antibodies

Weekly HHS Office Hours

New information regarding these therapeutics, administration and their distribution is provided weekly by the federal government. If you are interested in joining, please email COVID19Therapeutics@hhs.gov to request Zoom links.

 The Biweekly calls take place on Tuesdays (2:00 – 3:00PM ET) and Thursdays (2:00 – 3:00PM ET)

Additional Resources

Health and Human Services (HHS) has numerous toolkits with information ranging from administration resources, clinical evidence summaries, patient education resources, COVID-19 variant proportion data, and frequently asked questions to payment resources. These tools are available through the HHS Public Health Emergency webpage:

https://www.phe.gov/emergency/events/COVID19/therapeutics/Pages/default.aspx

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