CurrentUnitedHealthcarePolicy N/A

RSV prophylaxis (palivizumab/Synagis) prior authorization for pediatric beneficiaries

Forms and clinical criteria for prior authorization of RSV prophylaxis (Synagis) for infants and children under 24 months in North Carolina Medicaid; used by prescribing providers to request coverage based on gestational age, chronic lung disease, congenital heart disease, immunocompromise, cystic fibrosis, and transplant status.

Policy Summary

PayerUnitedHealthcare

PolicyRSV prophylaxis (palivizumab/Synagis) prior authorization for pediatric beneficiaries

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescribers must complete the NC Medicaid prior approval request form sections including beneficiary, prescriber, drug and clinical criteria to obtain prior authorization for Synagis.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

24 monthsage limit

<29w0dpremature cutoff

<32w0dCLD gestational age

21% ≥28doxygen requirement

Coverage criteria and policy scope

Policy Summary

PayerUnitedHealthcare

PolicyRSV prophylaxis (palivizumab/Synagis) prior authorization for pediatric beneficiaries

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescribers must complete the NC Medicaid prior approval request form sections including beneficiary, prescriber, drug and clinical criteria to obtain prior authorization for Synagis.

SourceLink

On This Page

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Coverage criteria by age and RSV season

Covered when ALL relevant section-specific criteria are met for the beneficiary's age and RSV season status.

Infants younger than 12 months in their first RSV season: Was the beneficiary born premature before 29 weeks 0 days of gestation?<29w0d gestation

Birth estimated gestational age (EGA) must be provided (weeks and days); check YES if applicable

Infants <24 months in FIRST RSV season with qualifying diagnoses

Options (first season): Hemodynamically significant acyanotic CHD receiving medication to control congestive heart failure and pending cardiac surgery
Options (first season): Moderate to severe pulmonary hypertension
Options (first season): Neuromuscular disease or pulmonary abnormality impairing ability to clear secretions (ineffective cough)
Options (first season): Cyanotic heart disease with cardiologist recommendation (documentation required)
Options (first season): Cystic fibrosis with clinical evidence of chronic lung disease (CLD) and/or nutritional compromise
Options (first season): Profoundly immunocompromised during RSV season
Options (first season): Undergoing cardiac transplantation during RSV season
Options (first season): Chronic Lung Disease (CLD) of prematurity defined as birth at less than 32 weeks 0 days gestation AND requiring >21% oxygen for at least the first 28 days after birth

Infants <24 months in SECOND RSV season with qualifying diagnoses

Options (second season): Profoundly immunocompromised during RSV season
Options (second season): Cardiac transplantation during RSV season
Options (second season): Cystic fibrosis with severe lung disease (previous hospitalization for pulmonary exacerbation in first year or persistent radiographic abnormalities) OR weight-for-length <10th percentile
Options (second season): CLD of prematurity and continued need for medical support during the six-month period before the start of the second RSV season (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen)

Age limit: Beneficiary must be less than 24 months of age for the FIRST or SECOND season criteria to apply

Requests that do not meet the policy’s defined clinical criteria, requests for coverage outside the specified coverage period, or requests where the patient received certain other RSV interventions require a different form and may be treated as exceptions. Specifically, if Beyfortus was administered during the current season or if maternal Abrysvo vaccine was given during pregnancy, the provider must use the Non-Covered State Medicaid Plan Services Request Form rather than this prior authorization form.

When submitting an exception or any request outside the policy, include the same core clinical information but be aware that such requests are handled under the non-covered/exception process and may be denied if they do not meet the alternate-review criteria.

Key clinical thresholds and coding-relevant values

inv-03: Prematurity cutoff — born before 29 weeks 0 days gestation

Prematurity cutoffBorn before 29 weeks 0 days gestation (Birth EGA must be provided on form)

Data to recordBirth estimated gestational age (weeks and days) must be entered on the prior authorization form

Applicable criteriaUsed for infants younger than 12 months in their first RSV season to determine eligibility

inv-04: CLD gestational age threshold — birth < 32 weeks 0 days

CLD gestational age thresholdBirth at less than 32 weeks 0 days gestation

ContextPart of the definition for Chronic Lung Disease (CLD) of prematurity used to determine eligibility

DocumentationSubmit NICU discharge summary or equivalent to support CLD diagnosis when cited on form

inv-05: Oxygen requirement for CLD definition — >21% oxygen for >=28 days

Oxygen requirement>21% oxygen for at least the first 28 days after birth

Role in CLD definitionCombined with gestational age (<32w0d) to define Chronic Lung Disease of prematurity

Evidence to submitDocumentation (e.g., NICU discharge summary) showing oxygen requirement duration should be provided

What prescribers must do and documentation to submit

Prior Authorization

Prior authorization form completion

Prescribers must complete the NC Medicaid prior approval request form. Use the Non-Covered State Medicaid Plan Services Request Form to request coverage that falls outside standard policy criteria.

Use the Non-Covered State Medicaid Plan Services Request Form for: requests outside policy criteria; coverage outside the defined coverage period; when Beyfortus (nirsevimab) was administered during the current season; when maternal Abrysvo was administered during pregnancy.

Denial Risk

Non-standard requests and alternate form

Prior authorization may be denied or require use of the Non-Covered State Medicaid Plan Services Request Form for non-standard requests. If a request does not meet the policy criteria or seeks coverage outside the defined season or eligibility, submit the alternate form and supporting justification.

Non-standard requests (out-of-policy criteria, coverage outside the defined season) may be denied without use of the alternate Non-Covered State Medicaid Plan Services Request Form.
If Beyfortus was given this season or maternal Abrysvo was given during pregnancy, use the alternate form to request coverage; otherwise the request may be denied.

Documentation Required

Required supporting documentation

Include documentation that supports the clinical criteria applicable to the beneficiary. Submit medical records that verify diagnoses, gestational age, and treatments.

NICU discharge summary or equivalent documentation to support CLD of prematurity.
Cardiology recommendation/documentation when coverage is requested for cyanotic heart disease or other cardiac indications.
Evidence of current treatments for CLD (e.g., chronic corticosteroid therapy, diuretic therapy, supplemental oxygen) if requesting coverage in a second RSV season.
Documentation of profound immunocompromise, cardiac transplantation timing, or other listed high-risk conditions.

Step Therapy

Sequencing / prior exposure constraints

Sequencing and prior-exposure constraints affect approval. Prior administration of specific RSV-prevention products can change coverage eligibility and may require the alternate request form and additional justification.

If Beyfortus (nirsevimab) was administered during the current season, submit the Non-Covered State Medicaid Plan Services Request Form to request Synagis (palivizumab) outside standard policy criteria.
If maternal Abrysvo was administered during pregnancy, use the Non-Covered State Medicaid Plan Services Request Form to request infant passive immunoprophylaxis outside policy criteria.
Document prior product administration (dates and product name) when seeking coverage after prior-season or in-season exposure to other RSV prophylaxis agents.

Policy context and intended use

This prior authorization form is intended to document the clinical information needed to assess eligibility for RSV prophylaxis (palivizumab/Synagis) in infants and young children. The form distinguishes whether the beneficiary is in their first or second RSV season and collects diagnosis and clinical details used to apply the age- and season-specific coverage criteria.

Prescribers must complete the NC Medicaid prior approval request form sections identifying the beneficiary and prescriber, the drug (name, strength, quantity and length of therapy), and the clinical criteria that support medical necessity. If the request is outside policy criteria or involves prior receipt of Beyfortus or maternal Abrysvo, use the Non-Covered State Medicaid Plan Services Request Form as noted.

Key definitions used in criteria

inv-11: CLD of prematurity — definition (birth <32w and >21% O2 requirement details)

DefinitionChronic Lung Disease (CLD) of prematurity: birth at less than 32 weeks 0 days gestation AND requiring greater than 21% oxygen for at least the first 28 days after birth

Documentation requiredPlease submit documentation of CLD as defined (e.g., NICU discharge summary) to meet criteria approval

Use in criteria setsListed as a qualifying diagnosis for infants <24 months in the FIRST RSV season (and considered for second season if ongoing medical support documented)

inv-12: RSV season status — first vs second season indicator required on form

Form requirementThe prior authorization form requires indicating whether the beneficiary is in their first RSV season or second RSV season

Location on formClinical Information section presents checkboxes: first RSV season / second RSV season

Effect on eligibilityCoverage criteria and which diagnoses qualify depend on whether it is the beneficiary's first or second RSV season