Respiratory Syncytial Virus (RSV) - Synagis (palivizumab) prior authorization
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This document is a prior authorization/prescription form governing requests for Synagis (palivizumab) for prevention of severe RSV in pediatric patients; it affects prescribing providers, specialty pharmacies, and prior authorization reviewers for Arizona Complete Health members.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Eligibility criteria (form-based clinical indications)
Covered when documentation demonstrates relevant high-risk conditions and age/gestational criteria appropriate for Synagis prophylaxis.
High-risk condition met
- Hemodynamically significant congenital heart disease (CHD): Diagnosis of hemodynamically significant congenital heart disease and patient is < 12 months of age at the start of the RSV season; AND one or more of: moderate–severe pulmonary hypertension, cyanotic heart disease (if consulted with a pediatric cardiologist), receiving medications to control congestive heart failure, and requires cardiac surgical procedures.
Chronic lung disease (CLD) of prematurity
- If < 12 months at start of RSV season: Diagnosis of CLD and patient is less than 12 months of age at the start of the RSV season.
- If 12 to <24 months at start of RSV season: Diagnosis of CLD and patient is between 12 and less than 24 months of age at the start of the RSV season AND receiving one or more of: supplemental oxygen (provide date last received), chronic corticosteroid therapy (provide date last received), or diuretic therapy (provide date last received).
- Cystic fibrosis (CF): Diagnosis of cystic fibrosis with criteria by age at start of RSV season: if < 12 months — clinical evidence of chronic lung disease or nutritional compromise (explain); if 12 to <24 months — manifestations of severe lung disease (hospitalization for pulmonary exacerbation in first year of life or persistent radiographic/CT abnormalities) or weight for length <10th percentile.
- Conditions impairing airway clearance: Congenital or neuromuscular conditions that impair the ability to clear secretions from the upper airway because of ineffective cough, AND patient is less than 12 months of age at the start of the RSV season.
- Prior severe RSV disease: Hospitalization for RSV infection this season (supporting documentation required).
- Other risk factors: Other medical history and/or risk factors documented on the form (provide details in supporting documentation).
For Chronic Lung Disease (CLD) of prematurity, the form provides a specific clinical definition and explicit exclusions. CLD is defined as infants born <32 weeks, 0 days gestation who required supplemental oxygen >21% for at least the first 28 days of life. The form also states that CLD is NOT defined as asthma, croup, recurrent upper respiratory infections, chronic bronchitis, bronchiolitis, or a history of prior RSV infection, and requires submission of supporting documentation such as gestational age, birth weight, current weight, NICU stay/discharge summary (if applicable), and evidence of oxygen or other therapies when indicated.
The form does not use an explicit phrase like “not medically necessary” to deny coverage. Instead, medical necessity is established by completion of the form’s criteria and submission of required supporting documentation. Missing or incomplete documentation (for example, gestational age, NICU discharge summary, dates of prior Synagis doses, or evidence supporting a listed high‑risk condition) is identified as a reason a request may not meet the form’s requirements and could lead to denial.
Diagnosis, Dosing, and Coding Details
| ICD-9/ICD-10 | Primary Diagnosis (checkbox list includes Congenital Heart Disease; Chronic respiratory disease arising in the perinatal period; Congenital abnormality of respiratory system; Cystic Fibrosis; gestational age options including <24 weeks, 24 weeks, 25-26 weeks, 27-28 weeks, 29-30 weeks, 31-32 weeks, 33-34 weeks, 35-36 weeks, 37+ weeks; Other) |
Provider Requirements and Authorization Steps
Prior authorization and separate home health/injection training authorization required
Prior authorization is required for Synagis administration. A separate authorization is required for injection training/home health visits coordinated through the specialty pharmacy; providers should call the number on the form to obtain that authorization.
- Prior authorization required for Synagis administration
- Separate authorization required for injection training/home health visit; call (888) 788-4408
No step therapy required
The form does not specify any step therapy requirements for Synagis; no prior medication trials are listed as prerequisites on the authorization form.
Required supporting clinical documentation
Submit all requested supporting clinical documentation with the prior authorization, including gestational age, birth and current weights with dates, NICU stay/discharge summary if applicable, dates of prior Synagis doses, and clinical evidence relevant to the indicated high‑risk condition.
- Patient's gestational age (weeks and days)
- Birth weight and current weight with date recorded
- NICU stay indication and NICU discharge summary (if applicable); date(s) of first Synagis dose if given in NICU
- Dates of prior Synagis doses / last date received
- Evidence of hospitalization for RSV this season
- Documentation supporting diagnosis (eg, CLD definition and treatment dates, CHD details and need for surgery, cystic fibrosis severity indicators, neuromuscular or congenital conditions impairing secretion clearance)
Denial risk if required documentation is missing
Failure to provide the required supporting clinical documentation listed on the form may result in denial of the prior authorization request.
- Missing gestational age, weights, NICU discharge summary, dates of prior Synagis doses, or evidence supporting CLD/CHD/CF/neuromuscular conditions increases risk of denial
Key Definitions
Background and Rationale
Palivizumab (Synagis) is a monoclonal antibody given as monthly intramuscular injections to help prevent severe RSV disease in high‑risk infants. The form frames eligibility around age and specific high‑risk conditions — including prematurity/gestational age, chronic lung disease of prematurity as defined above, hemodynamically significant congenital heart disease, cystic fibrosis with severe lung disease manifestations, neuromuscular or airway clearance impairment, and prior hospitalization for RSV. Providers must document gestational age, birth weight, current weight and dates of relevant treatments or hospitalizations; dosing instructions on the prescription section list Synagis at 15 mg/kg IM one time per month.
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