Synagis (palivizumab) prior authorization form coverage criteria
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Template and requirements for prior authorization of Synagis (palivizumab) for pediatric members of Sanford Health Plan; directs providers on information and documentation needed to request coverage (including clinical details for specific high-risk groups).
No material clinical or coverage changes in this revision.
Coverage criteria for Synagis (palivizumab)
General eligibility and submission
Coverage may be approved when the provider submits a completed, legible prior authorization form with required documentation showing the infant meets one of the high‑risk group criteria and therapy is requested within the RSV season; approvals cover up to 5 doses during the season.
Prior authorizations cannot be completed by phone; attach required clinical documentation to support the selected high-risk group.
Chronic Lung Disease (CLD) of prematurity
Preterm infants with chronic lung disease of prematurity
Provider must attach clinical documentation verifying oxygen requirement and any chronic therapies or pharmacy records.
Congenital Heart Disease (CHD)
Infants with hemodynamically significant congenital heart disease (CHD)
Attach a letter of medical necessity from a pediatric cardiologist and supporting documentation (medication lists, surgical plans).
Anatomic pulmonary / Neuromuscular disease
Children with anatomic pulmonary abnormalities or neuromuscular disease
Attach relevant clinical records or specialist notes describing the impairment in airway clearance.
Immunocompromised infants
Immunocompromised children
Attach laboratory data, treatment records, or specialist documentation demonstrating the immunocompromised state.
Cystic Fibrosis (CF)
Children with Cystic Fibrosis
Attach clinical documentation, pharmacy records, hospitalization records, imaging reports, or growth records as applicable.
The prior authorization form does not list any explicit clinical exclusions. The form includes a checkbox to request retroactive coverage for a previous claim or date of service and provides a field to record the applicable date of service, allowing providers to indicate that coverage is being sought after-the-fact.
The policy states that the Plan's decision will be based on the member's individual plan policy and the clinical documentation submitted. The form does not enumerate discrete "not medically necessary" conditions; determinations about medical necessity or exclusions will be made by Sanford Health Plan according to each member's plan rules and the supporting clinical information provided with the request.
Initial therapy requirements
Initial therapy
Initial therapy requests require full completion of the prior authorization form and submission of supporting documentation for the indicated high‑risk group.
If approved, coverage applies to up to 5 doses administered between November 15 and April 15; retroactive coverage must be indicated on the form with date of service.
Continuation therapy requirements
Continuation therapy
Continuation requests require documentation that therapy was previously started and justification for ongoing dosing.
Field present on form for continuation indication; attach supporting records to justify continued dosing within the season.
Billing and diagnosis codes
| HCPC (if applicable) | Field for provider to supply HCPCS code for medication/billing |
| PRIMARY DIAGNOSIS (ICD-10 CODE) | Primary diagnosis ICD-10 code field |
| SECONDARY DIAGNOSIS (ICD-10 CODE) | Secondary diagnosis ICD-10 code field |
Submission, documentation, and approval actions for providers
Submit completed PA form; approval covers up to 5 seasonal doses
Submit a fully completed and legible prior authorization form by fax to (701) 234-4568 or online through the provider portal; approvals, if granted, will cover up to 5 doses to be given between November 15 and April 15 of the season.
- Fax completed form to (701) 234-4568 or submit online at sanfordhealthplan.com/providerlogin.
- Approvals cover up to 5 doses given between November 15 and April 15.
Provide start date and rationale for continuation requests
For continuation requests, indicate “Continuation of therapy” on the form and provide the original therapy start date plus clinical rationale and supporting records to justify ongoing dosing.
- Check the “Continuation of therapy” box and enter the start date on the form.
- Attach supporting records and clinical rationale demonstrating need for continued therapy.
Attach clinical documentation, labs, pharmacy records, and letters of medical necessity
Attach all relevant clinical documentation to support the diagnosis and qualifying criteria for the infant’s risk group, including lab results, pharmacy records, and letters of medical necessity as applicable.
- Clinical records showing oxygen use, chronic therapies, or hospitalizations as required by the indicated risk group.
- Pharmacy records or medication lists for chronic corticosteroid/diuretic therapy or heart-failure medications.
- Letter of medical necessity from pediatric cardiologist when CHD criteria are claimed.
Do not submit PA requests by phone; ensure form is complete and legible
Prior authorizations cannot be completed by phone; all fields must be completed and legible—incomplete or illegible submissions may delay or prevent approval.
- All fields must be completed and legible for review.
- Prior authorizations cannot be completed over the phone.
Key patient data fields required on the form
Quantity limits and dosing
Site of care and administration notes
No site-of-care restriction specified
The form does not impose a site-of-care restriction; no specific site limitation is specified on the prior authorization form.
Step therapy and prior trial requirements
| Step | Form field / requirement | Details |
|---|---|---|
| New vs Continuation | ||
| Provider must indicate whether the requested therapy is 'New' or 'Continuation of therapy' (checkboxes on form). If continuation is selected, the form requires the original therapy start date. | ||
| Form collects this as a single-step selection only; no multi-step drug trial or step-failure series is specified on the form—providers simply mark New or Continuation and, for continuation, supply the start date. |
Background on Synagis (palivizumab)
Synagis (palivizumab) is an RSV prophylactic monoclonal antibody indicated to help prevent severe respiratory syncytial virus disease in certain high-risk pediatric populations. The form is structured to collect clinical information and documentation to assess eligibility for infants and children with conditions including chronic lung disease of prematurity (CLD), hemodynamically significant congenital heart disease (CHD), certain anatomic pulmonary or neuromuscular disorders, profound immunocompromise, and cystic fibrosis with complications so that the Plan can determine coverage for up to the authorized doses during the RSV season.
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