Treatment of Coronavirus Disease 2019 (COVID-19)

POLICY NUMBER

L.2.01.431

Actemra (tocilizumab)

Olumiant (baricitinib)

Veklury (remdesivir)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

In late 2019, a novel coronavirus, now designated SARS-CoV-2, was identified as the cause of an outbreak of acute respiratory illness in Wuhan, China. The World Health Organization (WHO) designated the disease COVID-19 (coronavirus disease 2019). In January 2020, the WHO declared a public health emergency as epidemics grew in many countries all over the world. The public health emergency declaration for COVID-19 is scheduled to expire on May 11, 2023.

Throughout the course of the pandemic, multiple treatment options were developed. Some treatments were granted full U.S. Food and Drug Administration (FDA) approval while others received Emergency Use Authorization (EUA). An EUA is a mechanism to facilitate the availability and use of medical countermeasures during public health emergencies, such as the COVID-19 pandemic. Under an EUA, the FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life- threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.

FDA-Approved COVID-19 Treatments

ActemraActemra (tocilizumab) intravenous infusion is indicated for the treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

OlumiantOlumiant (baricitinib) tablet is indicated for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.

VekluryVeklury (remdesivir) intravenous infusion is indicated for the treatment of COVID-19 in adult and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, who are:

• Hospitalized, or

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

POLICY

Medically Necessary COVID-19 Treatment

Hospitalized Individuals

Actemra (tocilizumab) is considered medically necessary for the treatment of COVID-19 in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. This is included within the hospital DRG.

Olumiant (baricitinib) is considered medically necessary for the treatment of COVID-19 in hospitalized adult patients requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. This is included within the hospital DRG.

Veklury (remdesivir) is considered medically necessary for the treatment of COVID-19 in hospitalized adult and pediatric patients weighing at least 40 kilograms (about 88 pounds) up to a maximum of 10 days. This is included within the hospital DRG.

Veklury (remdesivir) is considered medically necessary for the treatment of COVID-19 in hospitalized pediatric patients 28 days of age and older and weighing 3 kilograms (about 7 pounds) to less than 40 kilograms up to a maximum of 10 days. This is included within the hospital DRG.

Non-Hospitalized Individuals

Veklury (remdesivir) administration is considered medically necessary for the treatment of COVID-19 in pediatric patients 28 days of age and older and weighing 3 kilograms (about 7 pounds) to less than 40 kilograms with positive results 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, up to a maximum of 3 days.

Veklury (remdesivir) is considered medically necessary for the treatment of COVID-19 in adult and pediatric patients weighing at least 40 kilograms (about 88 pounds) with positive results 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, up to a maximum of 3 days.

Not Medically Necessary COVID-19 Treatment

All other drugs, therapeutic agents, and/or combinations that have not been approved by the FDA, including any authorized under an EUA, are considered investigational, including but not limited to:

• Bamlanivimab in combination with etesevimab

• Bebtelovimab

• Chloroquine

• COVID-19 convalescent plasma

• Evusheld (tixagevimab co-packaged with cilgavimab)

• Favipiravir

• Hydroxychloroquine

• Lagevrio

• Mefloquine

• Olumiant (baricitinib) in combination with Veklury (remdesivir)

• Other IL-6 pathway inhibitors (sarilumab, siltuximab)

• Pemgarda (pemivibart)

• Protease Inhibitors (lopinavir-ritonavir)

• REGEN-COV (casirivimab and imdevimab)

• Sotrovimab

• Veklury (remdesivir) for pediatric patients less than 28 days old and not weighing at least 3 kilograms

COVID-19 drugs, therapeutic agents, and/or combinations paid for and dispersed by the Federal Government are not eligible for reimbursement.

POLICY EXCEPTIONS

Federal Employee Program (FEP) Members: All injections and other treatments for COVID-19 (both FDA-approved and authorized under an EUA) will pay at regular medical benefits.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; andB. appropriate with regard to standards of good medical practice; andC. not solely for the convenience of the Member, his or her Provider; andD. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

Criteria for High Risk of Progressing to Severe COVID-19 and/or Hospitalization:

Patients who are high risk for progressing to severe COVID-19 and/or hospitalization include those who are 12 years of age and older weighing at least 40 kg with positive results of direct SARS-Co-2 testing within 10 days of symptom onset who meet any of the criteria below:

• Older age (for example, age ≥65 years of age)

• Obesity or being overweight (for example, BMI >25 kg/m2, or if age 12-17, have BMI ≥85th percentile for their age and gender)

• Pregnancy

• Chronic kidney disease

• Diabetes

• Immunosuppressive disease or immunosuppressive treatment

• Cardiovascular disease (including congenital heart disease) or hypertension

• Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma, interstitial lung disease, cystic fibrosis, and pulmonary hypertension)

• Sickle cell disease

• Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)

• Having a medical-related technological dependence [for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)]

• Other medical conditions or factors (such as race and ethnicity) that may place individuals at an increased risk for progression to more severe disease.

POLICY HISTORY

05/08/2020: New policy added.

10/22/2020: Policy description updated regarding Veklury (remdesivir), hydroxychloroquine, and chloroquine. Policy section updated to add that intravenous administration of Veklury (remdesivir) is considered medically necessary in the inpatient hospital setting for the treatment of COVID-19 in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) up to a maximum of 10 days. All other drugs and therapeutics are considered investigational, including Veklury (remdesivir) for the treatment of COVID-19 not requiring inpatient hospitalization. Policy Guidelines updated to define medically necessary. Sources updated. Code Reference section updated to add ICD-10 procedure codes XW033E5 and XW043E5 as medically necessary.

01/19/2021: Policy description and policy statement updated regarding COVID-19 treatments authorized under an Emergency Use Authorization (EUA). Added policy statement to list drugs and therapeutic agents considered medically appropriate when administered in accordance with the terms of the EUA granted by the FDA. Policy Guidelines updated to list high-risk criteria for patients progressing to severe COVID-19 and/or hospitalization. Sources updated. Code Reference section updated to add HCPCS codes M0239, M0243, and ICD-10 procedure codes XW033F6, XW033G6, XW043F6, XW043G6, XW0DXM6, XW0G7M6, and XW0H7M6.

02/26/2021: Policy description and policy statement updated to list bamlanivimab in combination with etesevimab as a COVID-19 treatment authorized under emergency use authorization. Code Reference section updated to add HCPCS code M0245.

04/21/2021: Policy description and policy statement updated to note that on 04/16/2021, the FDA revoked the EUA for bamlanivimab when administered alone. Sources updated. Due to revocation, Code Reference section updated to add ICD-10 procedure codes XW13325 and XW14325 and to remove XW033F6 and XW043F6. Also removed HCPCS code M0239.

08/02/2021: Policy description and policy statement updated to list sotrovimab and Actemra (tocilizumab) as COVID-19 treatments authorized under emergency use authorization. Code Reference section updated to add procedure code M0247, M0249, M0250, XW033H5 and XW043H5.

08/20/2021: Policy description and policy statement updated to list REGEN-COV (casirivimab and imdevimab) as post-exposure prophylaxis COVID-19 treatment authorized under emergency use authorization. High risk criteria updated in the Policy Guidelines. Code Reference section updated to add HCPCS codes M0244, M0246, and M0248.

09/01/2021: Code Reference section updated to add HCPCS codes M0240 and M0241.

01/24/2022: Policy statement updated to list Evusheld and Veklury (remdesivir) as COVID-19 treatments authorized under emergency use authorization. Also updated to state that the EUAs for bamlanivimab in combination with etesevimab and REGEN-COV (casirivimab and imdevimab) have been revoked by the FDA as of 01/24/2022. Code Reference section updated to add M0220 and M0221. Removed procedure codes M0240, M0241, M0243, M0244, M0245, M0246, XW033G6, XW043G6.

02/10/2022: Policy updated to add expanded FDA approval for Veklury (remdesivir) administration in the outpatient setting. Code Reference section updated to add HCPCS J0248.

03/31/2022: Policy statement updated to list bebtelovimab as a COVID-19 treatment authorized under emergency use  authorization. Code Reference section updated to add HCPCS codes C9507, M0222, M0223, and new ICD-10 procedure codes XW023X7 and XW023Y7.

03/23/2023: Policy description and policy statement updated regarding FDA approved treatments for COVID-19. Removed list of treatment authorized and revoked under an EUA added link to list on the FDA Web site. Removed procedure codes M0220, M0221, M0222, M0223, M0247, M0248, and XW023X7.

05/01/2023: Policy title changed from "Prevention and Treatment of Coronavirus Disease 2019 (COVID-19)" to "Treatment of Coronavirus Disease 2019 (COVID-19)." Policy description and statement updated regarding the following FDA-approved COVID-19 treatments: Actemra, Olumiant, and Veklury. Revised the list of investigational drugs and added statement that COVID-19 drugs paid for and dispersed by the Federal Government are not eligible for reimbursement. Policy Exception added for FEP members. Policy Guidelines updated to remove statement regarding monoclonal antibodies. Sources updated. Code Reference section updated to add ICD-10 diagnosis code U07.1, remove HCPCS codes C9507, M0249, M0250, and remove ICD-10 procedure codes XW023Y7, XW13325, and XW14325. Effective 05/12/2023.

02/14/2024: Policy reviewed; no changes.

04/25/2024: Policy section updated to add Pemgarda (pemivibart) as investigational. Code Reference section updated to add new HCPCS codes M0224 and Q0224 to the Not Medically Necessary Codes table.

03/13/2025: Policy reviewed; no changes.

SOURCE(S)

1. Actemra prescribing information. Genentech, Inc. December 2022. Last accessed March 2023.

2. Olumiant prescribing information. Eli Lilly and Company. June 2022. Last accessed March 2023.

3. Veklury prescribing information. Gilead Sciences, Inc. January 2022. Last accessed March 2023.

4. U.S. Food and Drug Administration: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covid19euas

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

Not Medically Necessary Codes

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