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The purpose of this bulletin is to inform providers that DMAS fee-for-service (FFS) and all contracted managed care organizations (MCOs) will ensure coverage of the following for full benefit Medicaid and FAMIS members: 1) a COVID-19 antibody product (bebtelovimab), and 2) convalescent plasma for outpatient use in select patients. These are consistent with recent Federal Drug Administration’s (FDA) Emergency Use Authorizations (EUAs) and associated amendments, in accordance with Section 6008(b)(4) of the Families First Coronavirus Response Act. For further information on COVID-19 monoclonal antibody product and vaccine administration coverage, please reference previous DMAS memos here: https://www.virginiamedicaid.dmas.virginia.gov/wps/portal/MedicaidMemostoProviders.

Coverage of COVID-19 Antibody Product (Bebtelovimab)

In light of the FDA’s amended EUA authorizing the COVID-19 antibody product listed below for treatment of individuals with COVID-19, the following antibody product and administration codes will be covered for FFS and MCO members with dates of service on and after the date of the FDA EUA (2/11/2022), and when Requirements for Reimbursement of Antibody Products are met (treatment has received FDA EUA or approval, AND patients meets the conditions of the FDA EUA or approval as of the date services are delivered), as outlined in the “Updates to Coverage of COVID-19 Testing & Antibody Treatment” memo dated 4/23/21. The most recent criteria for approved and authorized COVID-19 treatments can be found here: https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs. FFS reimbursement rates are available for reference via the DMAS fee file. MCOs can be reached at the contacts listed at the end of this memo for MCO-specific reimbursement rates. Prior authorization is not required for either FFS or MCO members. 

• Q0222*: Injection, Bebtelovimab, 175mg
• M0222: Intravenous infusion, Bebtelovimab, includes infusion and post administration monitoring

*The Centers for Medicare and Medicaid Services (CMS) anticipates that, at this time, providers will not incur a cost for COVID-19 monoclonal antibody products. Providers should not bill for a COVID-19 monoclonal antibody product if they received it for free.

Coverage of Convalescent Plasma for Outpatient Use

In light of the FDA’s amended EUA authorizing the outpatient use of the treatment listed below for certain individuals with COVID-19 infection, the following billing codes will be covered for FFS and MCO members with dates of service on and after the date of the FDA EUA amendment (12/28/2021), and when the Requirements for Reimbursement of Convalescent Plasma outlined below are met. FFS reimbursement rates are available for reference via the DMAS fee file. MCOs can be reached at the contacts listed at the end of this memo for MCO-specific reimbursement rates:

• C9507: Fresh frozen plasma, high titer COVID-19 convalescent, frozen within 8 hours of collection, each unit

Requirements for Reimbursement of Convalescent Plasma

Medical documentation for FFS and MCO members must demonstrate that the following requirements are met:

• treatment has an active FDA Emergency Use Authorization (EUA) or FDA approval as of the date the treatment is administered, AND
• patient meets the disease severity and risk of progression standards identified by the  Infectious Diseases Society of America (IDSA) as appropriate for outpatient treatment with convalescent plasma for COVID-19, AND
• patient meets the immune status requirements outlined in the Limitations of Authorized Use or FDA approval, AND
• the patient is not eligible for, or does not have access to, other FDA authorized or approved treatment options for COVID-19, AND
• the collection, testing and administration of high-titer COVID-19 convalescent plasma is in compliance with FDA guidance

FFS claims submitted on or after the coverage dates listed above, which were initially denied on the grounds of non-coverage and which providers feel would now meet updated coverage criteria, may be resubmitted to DMAS FFS. Service authorization will not be required or enforced for FFS or MCO members.

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