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Pemivibart (Pemgarda) for Pre-Exposure Prophylaxis for Coronavirus Disease 2019 (COVID-19) for Medicare Advantage Members (Retroactively Effective to 03/22/2024)


Purpose

The purpose of this document is to communicate the Company's coverage position for pemivibart (Pemgarda) for pre-exposure prophylaxis for Coronavirus disease 2019 (COVID-19) for Medicare Advantage members.  Coverage for pre-exposure prophylaxis for Coronavirus disease 2019 (COVID-19) for Medicare Advantage ​members​ is retroactively effective to March 22, 2024.

Background

On March 22, 2024, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the investigational IV monoclonal antibody pemivibart (Pemgarda) for pre-exposure prophylaxis of COVID-19 in persons ≥ 12 years old (weight ≥40 kg) who are moderately to severely immunocompromised and are unlikely to respond adequately to COVID- 19 vaccination. Pemivibart (Pemgarda) is the only treatment currently authorized in the United States for pre-exposure prophylaxis of COVID-19.  Pemivibart (Pemgarda) is not authorized for use as a treatment for COVID-19 or for the prevention of COVID-19 in someone who has been exposed to a person already infected with COVID-19. 

Pemivibart (Pemgarda) is a human immunoglobulin G​ (IgG1) monoclonal antibody that targets the spike protein receptor binding domain, inhibiting the attachment of the SARS-CoV-2 virus to human ACE2 receptors. Pemivibart (Pemgarda) is derived from adintrevimab, an investigational antibody that was effective against the Delta variant of SARS-CoV-2, but not against circulating Omicron variants. Unlike adintrevimab, the parent mAB of pemivibart (Pemgarda), pemivibart (Pemgarda) has activity against the currently dominant JN.1 Omicron lineage of SARS-CoV-2. Future variants of the SARS-CoV-2 virus may emerge that are not neutralized by this pemivibart (Pemgarda), indicating that it may not be useful in preventing COVID-19 caused by other variants. Pemivibart (Pemgarda) was developed with an immunobridging approach to determine whether it may be effective for pre-exposure prophylaxis of COVID-19. Immunobridging is based on the serum neutralization titer efficacy relationships identified with other neutralizing human monoclonal antibodies against SARS-CoV-2.

The initial dosage of pemivibart (Pemgarda) for emergency use in adults and adolescents (12 years of age and older weighing at least 40 kg) is 4500 mg administered as a single intravenous infusion. Any repeat dosing would be an additional 4500 mg administered as a single intravenous infusion approximately every 3 months, as needed. 

Pre-exposure prophylaxis use of pemivibart (Pemgarda) is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. Individuals for whom COVID-19 vaccination is recommended, including individuals with moderate-to-severe immune compromise who may derive benefit from COVID-19 vaccination, should receive COVID-19 vaccination. In individuals who have recently received a COVID-19 vaccine, pemivibart (Pemgarda)​ should be administered at least 2 weeks after vaccination.

Coverage Statement

Pemivibart (Pemgarda)

IV infusion of pemivibart (Pemgarda) is covered for pre-exposure prophylaxis of COVID-19 in persons ≥ 12 years old (weight ≥40 kg) when the following criteria are met: 
  • Individual is not currently infected with SARS-CoV-2 and does not have a known recent exposure to an individual infected with SARS-CoV-2; and 
  • Individual is moderately to severely immunocompromised due to a medical condition or receipt of immunosuppressive medications or treatments and is unlikely to mount an adequate immune response to COVID-19 vaccination.

Pemivibart (Pemgarda) is not covered under any other indications, including but not limited to, the following: 

  • Treatment of COVID-19, or
  • Post-exposure prophylaxis of COVID-19 in individuals who have been exposed to someone infected with SARS-CoV-2.

References

Carranza V. Am I eligible for pemgarda? Plus, 6 other FAQs about this preventive COVID-19 medication. May 02, 2024.  Available at: https://www.goodrx.com/pemgarda/monoclonal-antibodies-for-covid. Accessed June 27, 2024.

Centers for Medicare & Medicaid Services (CMS). COVID-19 monoclonal antibodies.  Page last modified 04/09/2024. Available at: https://www.cms.gov/monoclonal.  Accessed June 26, 2024.

Centers for Medicare & Medicaid Services (CMS). 2024 Healthcare common procedure coding system (HCPCS). Available at: https://www.cms.gov/medicare/coding-billing/healthcare-common-procedure-system/quarterly-update. Accessed June 26, 2024.

Centers for Medicare & Medicaid Services (CMS). Hospital Outpatient Prospective Payment System: MM13632.
May 31, 2024. Available at: https://www.cms.gov/files/document/mm13632-hospital-outpatient-prospective-payment-system-july-2024-update.pdf.​ Accessed July 30, 2024. 

Pemgarda (pemivibart) injection for intravenous use. Billing and coding information. April 2024. Available at: https://www.pemgarda.com/wp-content/uploads/2024/05/INV_Billing-Coding-Guide_051424.pdf. Accessed on June 26, 2024.

US Food and Drug Administration (FDA). Fact sheet for healthcare providers: Emergency use authorization of Pemgarda (Pemivibart). [FDA Web site]. Revised May 2024. Available at: https://www.fda.gov/media/177067/download. Accessed June 25, 2024.

US Food and Drug Administration (FDA). Invivyd, Inc – Pemgarda. Emergency Use Authorization 122 letter.  [FDA Web site]. April 3, 2024.  Available at: https://www.fda.gov/media/177068/download. Accessed June 25, 2024. 

Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.


The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates. 

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.​


CPT Procedure Code Number(s)


N/A


ICD - 10 Procedure Code Number(s)


N/A


ICD - 10 Diagnosis Code Number(s)


Report the most appropriate diagnosis code in support of covered criteria as listed in the NewsFlash​

HCPCS Level II Code Number(s)


M0224 Intravenous infusion, pemivibart, for the pre-exposure prophylaxis only, for certain adults and adolescents (12 years of age and older weighing at least 40 kg) with no known SARS-CoV-2 exposure, who either have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments, includes infusion and post administration monitoring


Q0224 Injection, pemivibart, for the pre-exposure prophylaxis only, for certain adults and adolescents (12 years of age and older weighing at least 40 kg) with no known SARS-CoV-2 exposure, and who either have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments, and are unlikely to mount an adequate immune response to COVID-19 vaccination, 4500 mg​


Revenue Code Number(s)


​N/A


Modifiers 

N/A​​

08/12/2024