Respiratory Syncytial Virus (RSV) Vaccines for Adults
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Defines medical necessity and coverage criteria for RSV vaccines (Abrysvo, Arexvy, mRESVIA) in adults and for Abrysvo in pregnancy, for CareFirst-managed benefits.
Policy updated to adopt FDA approvals for Abrysvo and mRESVIA in high-risk adults aged 18-74, and to remove mRESVIA from the experimental/investigational designation.
ACIP updated recommended age of adults at increased risk from 60-74 to 50-74, but the policy adheres to FDA-approved age ranges for certain vaccines.
Coverage Criteria for RSV Vaccines
Arexvy coverage
Covered when ALL of the following are met
CareFirst adopts ACIP/FDA age stratification for Arexvy as stated in policy guidelines
Abrysvo coverage (adults and pregnancy)
Covered when ALL of the following are met
CareFirst adopts FDA approvals for Abrysvo including high-risk adults 18-74
Prescribing information includes warning about potential preterm birth if given outside 32-36 weeks
mRESVIA coverage
Covered when ALL of the following are met
Policy adopts FDA approval extending use in high-risk adults age 18-74; CareFirst follows FDA approvals
Experimental / Investigational
Not covered (experimental/investigational) when ANY of the following apply
mRESVIA was removed from the experimental/investigational designation per the 2025 update; Abrysvo and Arexvy remain experimental/investigational for other unapproved indications
Abrysvo and Arexvy are considered experimental/investigational for any indication that does not meet the policy’s stated medical criteria and guidelines. CareFirst applies the BCBSA/TEC-derived assessment criteria: a technology must meet all required evidentiary and regulatory standards (including final U.S. regulatory approval and sufficient evidence of improved net health outcomes) to be considered medically necessary. Use of Abrysvo or Arexvy outside the policy guideline indications therefore does not meet those criteria and is not covered.
Vaccination with Abrysvo or Arexvy outside the established age groups or, for Abrysvo in pregnancy, outside the specified gestational window is considered not medically necessary because safety and effectiveness have not been established. The prescribing information and available trial data do not support use in younger adults excluded from clinical trials or in pregnant persons outside the 32 through 36 weeks gestational age window; therefore such administration will not be covered.
Billing and Coding
Provider Actions and Authorization
Prior authorization may be required
Some services, drugs, and places of service require prior authorization—providers must check the member's contract for benefits and submit preauthorization requests when required.
- Verify member-specific benefits and prior authorization requirements in the member contract before scheduling or administering RSV vaccines.
Step therapy
No step therapy requirements are specified in this policy for Abrysvo, Arexvy, or mRESVIA.
Preauthorization and submission
Submit preauthorization requests online at www.provider.carefirst.com or by calling CareFirst at 1-866-773-2884 (1-866-PRE-AUTH); always verify member contract provisions as they supersede policy criteria.
- Use the online portal (www.provider.carefirst.com) or phone (1-866-773-2884) for preauthorization submission.
- Confirm any contract-specific restrictions or exclusions before submitting, since member contract terms take precedence.
Denial risk for unapproved indications
Use of Abrysvo and Arexvy for indications outside the policy guidelines is considered experimental/investigational and may be denied.
- Vaccination outside the established age groups or pregnancy window where safety and efficacy have not been established is considered not medically necessary and may be denied.
Background
Respiratory syncytial virus (RSV) is an RNA virus that causes seasonal respiratory infections and can progress to serious lower respiratory tract disease such as bronchiolitis and pneumonia. Infants, older adults, and immunocompromised persons are at higher risk for severe disease; severe RSV may require hospitalization and supportive care including oxygen, intravenous fluids, or mechanical ventilation. Vaccination with licensed RSV vaccines (Arexvy, Abrysvo, and mRESVIA) is intended to reduce the incidence of RSV lower respiratory tract disease in older adults and selected high‑risk younger adults.
Definitions
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