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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 (tocilizumab) for hospitalized adults and pediatric patients, 2) expanded access to a COVID-19 antibody product (sotrovimab) for members at least 12 years of age, 3) expanded access to a COVID-19 antibody product (balanivimab/etesevimab) for 0-12 year-old members, 3), a COVID-19 antibody product (casirivimab and imdevimab) for post-exposure prevention, 4) a COVID-19 antibody product for pre-exposure prevention (tixagevimab/cilgavimab), 4) a COVID-19 antiviral treatment (remdesivir) for outpatient use, and 5) updated Pfizer-BioNTech COVID-19 vaccine eligibility. 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 (Tocilizumab)

In light of the FDA’s EUA authorizing of the COVID-19 treatment listed below for treatment of members at least 2 years of age, the following product and administration codes will be covered for corresponding FFS and MCO members with dates of service on and after the date of the FDA EUA (6/24/21), 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. 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.

• Q0249: Injection, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal
• M0249: Intravenous infusion, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ecmo) only, includes infusion and post administration monitoring, first dose
• M0250: Intravenous infusion, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ecmo) only, includes infusion and post administration monitoring, second dose

Expanded Coverage of COVID-19 Antibody Product (sotrovimab)

In light of the FDA’s amended EUA authorizing the COVID-19 antibody product listed below for treatment of members at least 12 years of age and weighing at least 40kg, the following antibody product and administration codes will be covered for corresponding FFS and MCO members with dates of service on and after the date of the FDA EUA (5/26/21), 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. 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.

• Q0247*: Injection, sotrovimab, 500 mg
• M0247: Intravenous infusion, sotrovimab, 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.

Expanded Coverage of COVID-19 Antibody Product (balanivimab/etesevimab) for 0-12 Year-old Members

In light of the FDA amended EUA authorizing the COVID-19 antibody product listed below for treatment or post-exposure prophylaxis of members 0-12 years of age, the following antibody product and administration codes will be covered for corresponding FFS and MCO members with dates of service on and after the date of the FDA EUA amendment (12/3/2021), and when Requirements for Reimbursement of Antibody Products are met (treatment has received FDA EUA or approval, AND patients meets the conditions of 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. This builds on existing coverage outlined in the memo referenced above. 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.

• Q0245*: Injection, bamlanivimab and etesevimab, 2100 mg
• M0245: Intravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring

* 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 COVID-19 Antibody Product (casirivimab and imdevimab) for Post-Exposure Prevention

In light of the FDA’s EUA authorizing the COVID-19 antibody product listed below for post-exposure prophylaxis of members at least 12 years of age and 40 kg, the following antibody product and administration codes will be covered for corresponding FFS and MCO members with dates of service on and after the date of the FDA EUA (7/30/21), and when Requirements for Reimbursement of Antibody Products are met (treatment has received FDA EUA or approval, AND patients meets the conditions of 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. 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.

• Q0240*: Injection, casirivimab and imdevimab, 600 mg
• M0240: Intravenous infusion or subcutaneous injection, casirivimab and imdevimab includes infusion or injection, and post administration monitoring, subsequent repeat doses

* 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 COVID-19 Antibody Product (tixagevimab/cilgavimab) for Pre-exposure Prevention

In light of the FDA’s recent EUA of the COVID-19 antibody product listed below for pre-exposure prevention, coverage for the following antibody product and administration codes is being added for FFS and MCO members with dates of service on and after the date of the FDA EUA (12/8/2021) and when Requirements for Reimbursement of Antibody Products are met (treatment has received FDA EUA or approval, AND patients meets the conditions of 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. 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.

• Q0220*: Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), 300 mg
• M0220: Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), includes injection and post administration monitoring

* 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 COVID-19 Antiviral Product (Remdesivir) for Outpatient Use

In light of the FDA’s amended approval and EUA for the COVID-19 antiviral infusion product listed below for treatment of patients weighing 3.5 kg and above, the following antiviral infusion product code will be covered for corresponding FFS and MCO members with dates of service on and after the date of the expanded FDA approval and EUA (1/21/22), and when Requirements for Reimbursement of Remdesivir for Outpatient Use are met (see below). 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.

• J0248: Injection, Remdesivir, 1 mg

The following administration billing codes are currently covered, and may be appropriate to submit in conjunction with the COVID-19 antiviral product for outpatient use covered above, when Requirements for Reimbursement of Remdesivir for Outpatient Use (see below) are met:

• 96365: Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour
• 96366 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hour (List separately in addition to code for primary procedure

Requirements for Reimbursement of Remdesivir for Outpatient Use

The antiviral infusion product code, and associated administration billing codes, outlined above, will be reimbursed by FFS and all MCOs under the following conditions:

• Treatment has an FDA Emergency Use Authorization (EUA) or FDA approval at the time the treatment is administered, AND
• Patient meets the conditions of FDA EUA or approval at the time the treatment is administered. At the time of this memo’s publication, these include patients with a positive result of direct SARS-CoV-2 viral testing, who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.

Pfizer-BioNTech COVID-19 Vaccine Eligibility Updates

The FDA amended its EUA authorizing administration of a booster dose of the Pfizer-BioNTech COVID-19 vaccine to members 16-17 years of age (as of 12/9/2021) and to members 12-15 years of age (as of 1/3/2022). Additionally, the amendment dated 1/3/2022 authorizes the booster dose when administered at least five months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine (as of 1/3/2022); prior to this amendment, a booster dose was authorized when administered at least six months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine. Claims for the following COVID-19 vaccine product and administration codes will be covered for FFS and MCO members when in accordance with FDA EUA authorizations and with dates of service on and after the FDA EUA amendment dates referenced above. This builds on existing coverage outlined in prior memos. FFS reimbursement rates are available for reference via the DMAS fee file. Managed Care Organizations (MCOs) can be reached at the contacts listed at the end of this memo for MCO-specific reimbursement rates.  

• 91300: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted, for intramuscular use
• 0004A: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; booster dose

Additionally, in light of the FDA’s amended EUA authorizing administration of a third dose of the Pfizer-BioNTech COVID-19 vaccine to certain immunocompromised members 5-11 years of age (1/3/2022), the following COVID-19 vaccine product and administration codes will be covered for corresponding fee for service (FFS) and MCO members with dates of service on and after the FDA EUA amendment dates referenced above. FFS reimbursement rates are available for reference via the DMAS fee file. Managed Care Organizations (MCOs) can be reached at the contacts listed at the end of this memo for MCO-specific reimbursement rates.

91307: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation, for intramuscular use
0073A: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; third dose

Additionally, in light of the FDA’s amended EUA authorizing administration of a third dose of the Pfizer-BioNTech COVID-19 vaccine to certain immunocompromised members 5-11 years of age (1/3/2022), the following COVID-19 vaccine product and administration codes will be covered for corresponding fee for service (FFS) and MCO members with dates of service on and after the FDA EUA amendment dates referenced above. FFS reimbursement rates are available for reference via the DMAS fee file. Managed Care Organizations (MCOs) can be reached at the contacts listed at the end of this memo for MCO-specific reimbursement rates.

• 91307: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation, for intramuscular use
• 0073A: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; third dose

Prior authorization for the dose or administration of 3rd COVID-19 vaccination is not required for either FFS or MCO members.

Pharmacy providers should use Submission Clarification Code = 7 (medically necessary) to indicate the administration of a booster dose of COVID-19 vaccine for eligible FFS Members. Basis of Cost Determination ‘15’ (free product or no associated cost) and Professional Service Code ‘MA’ (Medication Administered) still apply. Any questions on FFS pharmacy claims processing may be directed to the Magellan pharmacy call center 7 days a week 24 hours per day at 800-932-6648. Any questions on MCO pharmacy claims processing may be directed to managed care points of contact summarized below.

Claims submitted on or after the coverage dates of all codes outlined in this memo, which were initially denied on the grounds of non-coverage, will be reprocessed by DMAS FFS and all managed care plans without requiring resubmission of claims.

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