CurrentBaylor Scott & White Health PlanPolicy 235

Palivizumab (Synagis) prophylaxis for RSV

Medical necessity and prior authorization criteria for palivizumab (Synagis) prophylaxis for prevention of serious RSV disease in infants and young children under Baylor Scott & White Health Plan; applies to all lines of business unless otherwise indicated.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyPalivizumab (Synagis) prophylaxis for RSV

Policy CodePolicy 235

Change TypeNo material change

Effective Date11/01/2025

Next Review Date09/08/2026

Key ActionObtain prior authorization for Synagis; ensure nirsevimab is not available or feasible before approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Up to 5Maximum doses per RSV season when criteria met

<24 monthsPrimary eligible age threshold

<12 monthsAlternate eligible age threshold

Prior authAdministrative requirement

Medical Necessity and Coverage Criteria

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Age-based groups: Two distinct age-based eligibility pathways are defined: members <24 months of age at start of RSV season, and members <12 months of age at start of RSV season.see children nodes

Members <24 months at start of RSV season: At least ONE of the following must be met:

If met, up to 5 doses until end of RSV season may be medically necessary.

<24 months criteria list

a: Active diagnosis of chronic lung disease (CLD) of prematurity (defined as born <31 6/7 weeks gestational age who require >21% oxygen for at least 28 days after birth) AND required treatment with one of the following therapies within the 6 months prior to RSV season: >21% supplemental oxygen OR chronic corticosteroid therapy OR diuretic therapy OR bronchodilator OR long-term ventilation.
b: Hemodynamically significant congenital heart disease, including patients who have undergone cardiac transplantation during the RSV season.
c: Cystic fibrosis with severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life OR persistent abnormalities on chest radiography or chest computed tomography when stable) OR weight for length <10th percentile on pediatric growth chart.
d: Immunocompromised: received or will receive solid organ transplant, hematopoietic stem cell transplant, or chemotherapy during the RSV season; or other condition causing profound immunocompromise (document ICD-10).

Members <12 months at start of RSV season: At least ONE of the following must be met:

If met, up to 5 doses until end of RSV season may be medically necessary.

<12 months criteria list

a: Premature infants without other indications: born at or before <28 6/7 weeks gestation.
b: Active diagnosis of chronic lung disease (CLD) of prematurity: born <31 6/7 weeks gestation who require >21% oxygen for at least the first 28 days after birth.
c: Severe congenital pulmonary abnormality or neuromuscular disorder that impairs ability to clear secretions from the upper airway due to ineffective cough.
d: Cystic fibrosis with clinical evidence of CLD and/or nutritional compromise (e.g., failure to thrive).
e:

Billing and Code Sets

Covered CPT CodesCPTCovered

90378

Respiratory syncytial virus, monoclonal antibody

Covered HCPCS CodesHCPCSCovered

S9562

Home injectable therapy, palivizumab, including administrative services, professional pharmacy services

ICD-10 codesICD-10

No codes listed

Gestational age thresholds

Primary gestational age cutoff<28 6/7 weeks (used for premature infant eligibility under <12 months pathway)

Alternate gestational age cutoff<31 6/7 weeks (used for CLD of prematurity definitions)

Application by age groupBoth thresholds are applied within age-based eligibility: <12 months pathway uses <28 6/7 weeks for premature infants; CLD definitions use <31 6/7 weeks.

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior authorization required for Synagis

Prior authorization is required for Synagis (palivizumab); members who meet the policy criteria may be eligible to receive Synagis during the RSV season. Use CPT 90378 and HCPCS S9562 when requesting authorization as applicable.

Prior authorization status: Required
Eligible members per policy may receive Synagis during RSV season
Referenced codes in policy: 90378 (CPT), S9562 (HCPCS)

Step Therapy

Approve Synagis only after nirsevimab considered

Synagis will only be approved if nirsevimab is NOT available or feasible to administer; follow the newer AAP or ACIP recommendations regarding palivizumab use.

Approval contingent on nirsevimab unavailability or infeasibility
Follow AAP/ACIP recommendations for palivizumab use

Documentation Required

Review member EOC/SPD before requesting authorization

Before submitting an authorization request, review the member's Evidence of Coverage (EOC) or Summary Plan Description (SPD) for benefit details and any plan-specific rules.

Check EOC or SPD for member-specific coverage limits and exclusions
For Medicare or Medicaid, confirm applicable NCD/LCD or state Medicaid procedures as noted in policy

Denial Risk

Denial risk: prior RSV hospitalization or prior nirsevimab

Coverage is not medically necessary for any member who has experienced a breakthrough RSV hospitalization during the current season or who has already received a dose of nirsevimab during the current season; requests in these situations risk denial.

Breakthrough RSV hospitalization during current season = not medically necessary
Receipt of nirsevimab during current season = not medically necessary

Key Clinical Definitions

CLD of prematurity — definition and criteria

DefinitionChronic lung disease (CLD) of prematurity: born <31 6/7 weeks gestational age who require >21% oxygen for at least 28 days after birth.

Treatment requirementAND required treatment within 6 months prior to RSV season with >21% supplemental oxygen or chronic corticosteroid therapy, diuretic therapy, bronchodilator, or long-term ventilation (for <24 months pathway).

Age pathway relevanceListed as an eligible condition for both <24 months and <12 months at start of RSV season criteria sets.

Premature infants — gestational age definition

DefinitionPremature infants (without other indications): born at or before <28 6/7 weeks gestation.

Age pathwayThis criterion applies to members <12 months of age at start of RSV season as one qualifying condition for Synagis eligibility.

Relation to other indicationsUsed when no other listed indications (e.g., CLD, congenital heart disease) are present but gestational age alone meets eligibility under the <12 months pathway.

Clinical Background

Palivizumab (Synagis) is a monoclonal antibody used to reduce serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in high-risk children. Institutional guidance from the American Academy of Pediatrics (AAP) and the Advisory Committee on Immunization Practices (ACIP) is followed; specifically, newer AAP or ACIP recommendations regarding palivizumab not listed in this policy will be followed for medical necessity determinations. When criteria are met, up to 5 doses may be medically necessary until the end of the RSV season.