RSV prophylaxis (palivizumab) for high-risk infants and children
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Guideline governing coverage and prior authorization for palivizumab (Synagis) prophylaxis against respiratory syncytial virus (RSV) for high-risk infants and children enrolled in Hawaii Medicaid QUEST Integration and Medicaid FFS during the 2018-2019 RSV season.
No material clinical or coverage changes in this revision.
Coverage Criteria for Palivizumab (RSV Prophylaxis)
Eligibility criteria
Covered when ANY of the following age-based criteria are met at the start of the RSV season
Infants and children with heart disease are addressed in the eligibility and exclusion criteria. Hemodynamically insignificant heart disease (examples include secundum atrial septal defect, small ventricular septal defect, mild coarctation, and patent ductus arteriosus) is not covered for palivizumab prophylaxis. By contrast, hemodynamically significant congenital heart disease that requires ongoing medical management (including persistent pulmonary hypertension requiring medical management) is part of the covered indications for infants <12 months at the start of the RSV season. Cardiac lesions that have been adequately corrected by surgery are excluded unless the patient continues to require medication or supplemental oxygen for the cardiac condition. Mild cardiomyopathy that does not require medical therapy is also excluded.
Palivizumab is for prevention, not treatment. It is not covered for patients with an active RSV infection or a documented RSV infection during the current RSV season; therapy should be discontinued in infected patients. Providers should therefore withhold or stop doses when RSV infection is present or confirmed during the season.
Provider Actions, Authorization, and Documentation
Prior authorization required
Prior authorization is required for palivizumab and must be obtained from the member's Medicaid QI health plan (AlohaCare, HMSA, Kaiser Permanente, 'Ohana Health Plan, UnitedHealthcare Community Plan) or, for Koan SHOTT transplant patients, from Xerox. Requests must be faxed on the Standardized Prior Authorization (PA) Form to 1-888-335-8474.
Authorized dosing schedule (28–35 day intervals)
Authorization covers palivizumab doses administered during the RSV season at intervals of 28–35 days between September 1, 2018 and March 31, 2019.
Required referral documentation for clinic-administered doses
Referrals to Kapi'olani Medical Center for clinic-administered Synagis must include patient identifiers and supporting medical information.
- Patient name and date of birth
- Gestational age at birth
- Current diagnosis and a current progress note
- The patient's discharge summary may be used as the referral document
- If not the patient's current provider, notify the Neonatology Office at 808-983-8670
Coverage exclusions — patients not meeting high‑risk criteria
Palivizumab is not covered for patients who do not meet the listed high‑risk criteria, including those with hemodynamically insignificant heart disease or with active/documented RSV infection during the current season.
- Examples of hemodynamically insignificant heart disease: secundum ASD, small VSD, mild coarctation, PDA
- Therapy should be discontinued for patients with active RSV infection during the current season
Clinical Definitions
Background
Palivizumab (Synagis®) is a humanized monoclonal antibody approved by the Food and Drug Administration for RSV prophylaxis in high‑risk infants and children. Hawaii Medicaid follows the FDA indication and aligns coverage with national AAP guidance, applying those recommendations with local RSV season dates. The approved intramuscular dosage is 15 mg/kg, and the 2018–2019 Hawaii coverage period runs from September 1, 2018 through March 31, 2019.
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