COVID-19 Treatment and Cost Share Guidance

As of Jan. 27, 2023, there is only 1 monoclonal antibody treatment option authorized for use:

• Actemra (Tocilizumab) – post-diagnosis only for adults who meet the treatment criteria

On Jan. 26, 2023, the FDA announced that Evusheld (tixagevimab + cilgavimab) is not currently authorized for use. Claims for Evusheld will be denied for date of service Jan. 27, 2023 or later.

Please review the FDA’s COVID-19 site for the latest information on FDA-authorized and approved COVID-19 treatments. 

Prior authorization

Prior authorization is not required for administration of these monoclonal antibodies, given the potential benefit of outpatient therapeutic intervention in high-risk patients with early mild to moderate COVID-19. Typical processes and member benefits, including those related to clinical trial participation, if applicable, will apply for outpatient visits.

Member coverage and cost share

For Individual Exchange, Individual and Group Market health plans, the investigational monoclonal antibody treatment will be considered a covered benefit during the national public health emergency period ending on May 11, 2023. Patients should meet the emergency use authorization (EUA) criteria for FDA-authorized monoclonal antibody treatment in an outpatient setting.

UnitedHealthcare waived cost sharing for the administration (intravenous infusion) of monoclonal antibody treatments for in-network providers in outpatient settings through March 31, 2021.

Out-of-network coverage and cost share is adjudicated according to a member’s health plan.

For Medicare Advantage health plans, the CMS Medicare Administrative Contractor will reimburse claims for Medicare beneficiaries with no cost share (copayment, coinsurance or deductible) through 2021. Effective Jan. 1, 2022, UnitedHealthcare will reimburse claims for Medicare beneficiaries with no cost share (copayment, coinsurance or deductible). 

For Medicaid health plans, Medicaid state-specific requirements may apply. For Medicaid and other state-specific regulations, please refer to your state-specific website or your state’s UnitedHealthcare Community Plan website, if applicable.

Resources

For more information on administration, high-risk patients and treatment availability, please review the following resources:

• To find monoclonal antibody treatment in your area, use the National Infusion Center Association locator.
• CMS Monoclonal Antibody COVID-19 Infusion
  

For pre-exposure prophylaxis (prevention) of COVID-19, the FDA has granted emergency use authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab and administered together). It is a long-acting monoclonal antibody combination therapy. Unlike sotrovimab and bebtelovimab, Evusheld is not used for treatment of COVID-19. 

Evusheld has been authorized for use in in certain adults and pediatric individuals (ages 12 years and older, weighing at least 40 kg) who: 

• Are not currently infected with COVID-19, and 
• Who have not recently been exposed to an individual infected with COVID-19 (post-exposure prevention). 

The authorization also requires that individuals have one of the following:

• Moderate to severely compromised immune systems due to a medical condition or due to taking immunosuppressive medications or treatments, and who may not be able to mount an adequate immune response to COVID-19 vaccination OR
• A history of severe adverse reaction(s) to a COVID-19 vaccine and/or component(s) of those vaccines, leading to a recommendation that the individual not be vaccinated according to the approved or authorized schedule

Pre-exposure prevention with Evusheld is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.

Oral therapies

In late December 2021, two new oral therapies (Paxlovid and Molnupiravir) received an emergency use authorization (EUA) to treat mild-moderate COVID-19. Individuals appropriate for treatment are those with a positive COVID-19 viral test result and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Paxlovid is authorized for adults and children 12 years of age and older weighing at least 40kg. Molnupiravir is only authorized for adults for whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate. Both therapies should only be prescribed by physicians, advanced practice registered nurses and physician assistants that are licensed or authorized under state law to prescribe drugs in the anti-infective class.

The federal government has purchased initial supplies of these oral therapies and there will not be a cost for the drug treatment. We will pay a professional fee to dispensing pharmacies. 

Infusion therapy

On April 28, 2022, the FDA expanded  the approval of Veklury (remdesivir) to include pediatric patients who:

• Are at least 28 days and weigh at least 3 kg, and
• Who have a positive COVID-19 viral test 

On Jan. 21, 2022, the Food and Drug Administration (FDA) expanded the approved and authorized indications for Veklury (remdesivir) to be used in non-hospitalized adults and pediatric patients with a positive COVID-19 viral test. Coverage for outpatient administration of Veklury is effective as of Dec. 23, 2021.

As outlined above, remdesivir is approved for adults and pediatric patients who are:

• Hospitalized, or
• Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death

Since remdesivir can only be administered by an authorized healthcare professional, either in a hospitalized or outpatient setting, it’s not part of the PDL or formulary. Coverage via pharmacy benefits may be permitted by exception where required by state and/or federal regulations (e.g., Part D may cover if a caregiver is unable to procure the medication and instead secures the medication subsequent to the issuance of a prescription).

Individual and Group Market, Individual and Family Plans and Medicaid

Monoclonal antibody treatment: Health care professionals should only bill for the administration. Do not include the monoclonal antibody product codes on the claim when the product is provided for free. Implementation for self-funded customers may vary.

Medicare

Effective Jan. 1, 2022, charges for monoclonal antibody infusion and antiviral treatments, including administration charges, should be submitted to UnitedHealthcare following the standard claims process. Any claims for Medicare beneficiaries that are submitted to the MAC during this timeframe will be denied, and health care professionals will be directed to submit the claims to UnitedHealthcare.

Please use our COVID-19 Billing Guide when billing for COVID-19 treatment.

For more information, visit the Center for Medicare & Medicaid Services (CMS) Monoclonal Antibody COVID-19 Infusion page.

Treatment coverage may vary by health plan. Please review each section below for details. Some service or facility exclusions may apply. Implementation for self-funded customers may vary. We will adjudicate benefits in accordance with the member’s health plan.

Medicare Advantage

For Medicare health plans, administration claims for FDA-authorized or approved COVID-19 monoclonal antibody or antiviral treatments for Medicare beneficiaries will be reimbursed with no cost share (copayment, coinsurance or deductible) through the national public health emergency.

Reimbursement and cost share waivers are limited to monoclonal antibody and antiviral treatments that are FDA-authorized or approved at the time of treatment.

Individual Exchange, Individual and Group Market fully insured health plans

No cost share waivers are currently in effect. Coverage and cost sharing is adjudicated in accordance with the member’s health plan.

Please see our summary of COVID-19 temporary program provisions for information about the cost share waivers that have previously been in effect.

Medicaid

Waiver of cost share is subject to state requirements. Please refer to your state’s COVID-19-specific website for more information.

Please review the COVID-19 Billing Guide for details on billing codes.

Medicare Advantage, Individual Exchange, Individual and Group Market fully insured health plans

No cost share waivers are currently in effect. Coverage and cost sharing is adjudicated in accordance with the member’s health plan.

Medicaid

Coverage and waiver of cost share is subject to state requirements. Please refer to your state’s COVID-19-specific website for more information.