​Bebtelovimab

Important Information About Bebtelovimab

Bebtelovimab has received Emergency Use Authorization (EUA) allowing healthcare providers to administer bebtelovimab for outpatient treatment of mild to moderate COVID-19 in adults and children age 12 years and older, who are at high risk for progressing to severe COVID-19 and/or hospitalization and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.

Emergency Use Authorization of Bebtelovimab

On Feb. 11, 2022, Eli Lilly and Company received an EUA from the U.S. Food and Drug Administration (FDA) for its COVID-19 monoclonal antibody therapeutic bebtelovimab. Bebtelovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.

Ordering Bebtelovimab

Lilly has established an ordering process for purchase of bebtelovimab with their distributor, AmerisourceBergen, that opens the week of August 15 (see the HHS update Bebtelovimab Commercial Transition for information on the final allocations of US government supplied bebtelovimab). Additional information on the ordering process for commercial bebtelovimab is included below and will be distributed to all sites of care that have previously ordered the product. A maximum order limit of 270 doses per week per provider site will be imposed. There will be no minimum order quantity. Exceptions for weekly dose quantities beyond 270 will be evaluated on a case-by-case basis. Please note that to limit the potential for overstocking, no returns will be accepted for bebtelovimab.

To ensure your site has immediate access to purchase bebtelovimab, please see the ordering guidance below:

Existing AmerisourceBergen Accounts:

AmerisourceBergen will sell bebtelovimab to licensed and approved customers such as hospitals, infusion centers, long term care facilities, clinics, etc. However, retail pharmacies will be excluded.

For any questions regarding product access, please contact c19therapies@amerisourcebergen.com

Sites Without an AmerisourceBergen Account:

To purchase bebtelovimab, your site must have a fully-vetted commercial account with AmerisourceBergen. To initiate the account creation process, please contact AmerisourceBergen at the following email address: asdaccountsetup@amerisourcebergen.com.

If you have any questions regarding the commercial purchase of bebtelovimab, please contact AmerisourceBergen at c19therapies@amerisourcebergen.com.

HPOP Reporting for Bebtelovimab

To maintain visibility on access to bebtelovimab and to keep the therapeutic locator up to date for the US population, reporting of ordering and utilization of commercially purchased product is desired. Details about how to report commercially purchased product inventory and administrations are still in development and will be shared when available.

Note that reporting inventory and administration of all US government-procured and distributed supply of bebtelovimab remains a requirement until all US government-procured bebtelovimab is consumed (a provider site's inventory is depleted). Please continue to log into your HPOP account to report twice each week, at minimum.

Payment and Cost Sharing

US Government-Procured Supply

Note that for government-procured supply, providers should only bill for the administration of the drug and should not include the monoclonal antibody product codes on these claims. If a site received the product for free, and internal systems require a product code to bill for the administration, sites should enter $0.01 for the billed amount.

Commercially-Procured Supply

For bebtelovimab product purchased commercially, sites should continue to use HCPCS codes:

• Q0222: Injection, 175 mg for the product
• M0222: Intravenous injection, includes injection and post administration monitoring
• M0223: Intravenous injection, includes injection and post administration monitoring in the home or residence; this includes a beneficiary’s home that has been made provider-based to the hospital during the covid-19 public health emergency

1. Providers shouldn't bill for the product if they received it for free through the USG-purchased inventory.
2. Payment rate effective for dates of service on or after August 15, 2022. Providers should only bill Medicare for commercially-purchased products.
3. These rates will be geographically adjusted for many providers. For providers and suppliers with payments that are geographically adjusted by the methodology used by the Medicare Physician Fee Schedule (MPFS), files with the geographically adjusted payment rates for monoclonal antibody administration are included in the “Additional Resources” section below. Certain settings utilize other payment methodologies, such as payment based on reasonable costs.

No cost sharing (no copayment/coinsurance or deductible) for monoclonal antibody therapies to treat COVID-19 for people with Medicare fee-for-service and Medicare Advantage beneficiaries will be required for the duration of the calendar year in which the COVID-19 public health emergency ends.

For more information, please visit the following CMS sites:

• COVID-19 Monoclonal Antibodies
• COVID-19 Vaccine and Monoclonal Antibodies ASP webpage

Medicaid will pay for the cost of the bebtelovimab and its administration without the requirement for cost sharing through the last day of the first calendar quarter that begins one year after the last day of the Public Health Emergency. Under the American Rescue Plan Act of 2021 (ARP), state Medicaid programs cannot charge cost sharing on drugs to treat COVID-19 through the last day of the first calendar quarter that begins one year after the day that the PHE ends.

Bebtelovimab FDA EUA Resources

• Letter of Authorization
• Fact Sheet for Health Care Providers
• Fact Sheet for Patients and Caregivers (English)
• Fact Sheet for Patients and Caregivers (Spanish)
• FDA Frequently Asked Question on the EUA for Bebtelovimab