Georgia Fee-For-Service Medicaid Synagis (palivizumab) Policy for RSV Season 2014-2015
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Defines Georgia Medicaid Fee-For-Service coverage, limits, and prior authorization process for Synagis (palivizumab) prophylaxis for high-risk infants and children during the 2014-2015 RSV season.
No material clinical or coverage changes in this revision.
Coverage Criteria for Palivizumab (Synagis)
Eligibility and dosing limits
Covered when ALL of the following are met for specified high‑risk groups, with a maximum number of monthly doses determined by month of first dose and adjusted if an in‑hospital dose was administered.
Eligible risk groups
- Preterm infants <29 weeks' gestation who are <12 months of age at time of first injection.
- Preterm infants <32 weeks' gestation with chronic lung disease (CLD) of prematurity who required >21% oxygen therapy during the first 28 days of life and are <12 months of age at time of first injection; CLD patients may be eligible in the 2nd year of life (up to <24 months) if they continued to require medical support within the 6‑month period before the RSV season.
- Infants <12 months of age with hemodynamically significant congenital heart disease (CHD) who are acyanotic receiving medication to control congestive heart failure and will require cardiac surgery, or who have moderate to severe pulmonary hypertension, or who have cyanotic heart defects where the decision for prophylaxis was made in consultation with a pediatric cardiologist.
- Infants <12 months of age with a pulmonary abnormality or neuromuscular disease that impairs the ability to clear secretions from the upper airways.
- Children <24 months of age who are profoundly immunocompromised.
Timing and dose‑count rules
- High‑risk infants discharged from hospital in February should receive a February and a March dose; February in‑hospital dose should be given 48–72 hours prior to discharge.
- High‑risk infants discharged from hospital in March should receive a March dose; March in‑hospital dose should be given 48–72 hours prior to discharge.
- High‑risk infants born during the RSV season should receive a dose in the hospital 48–72 hours prior to discharge.
Dosing will not be allowed for infants with active infection or history of infection during the current season.
This policy is based on the 2014 American Academy of Pediatrics (AAP) and 2014–2015 Georgia Chapter AAP (GAAAP) recommendations, which conclude that palivizumab provides only a limited clinical benefit. Consequently, the policy does not support expanding indications beyond the specific high-risk groups listed in this document.
Provider Actions and Prior Authorization
Prior authorization required for Palivizumab (Synagis)
Palivizumab (Synagis) requires prior authorization through Georgia Medicaid. Pharmacy Services prior authorizations must be faxed to Catamaran; Physician Services prior authorizations are submitted via the MMIS portal.
Step therapy
No step therapy is described in this policy for Synagis prior authorization.
Prior authorization submission instructions
For Georgia Medicaid FFS members, submit Synagis prior authorization requests to Pharmacy Services by faxing the Synagis PA Request Form to Catamaran at 1-888-491-9742; the Synagis PA Request Form is located on the GDCH prior authorization web page. For Physician Services prior authorizations, submit via the MMIS portal at https://www.mmis.georgia.gov.
- Fax number for Pharmacy Services (Catamaran): 1-888-491-9742
- Form: Synagis® PA Request Form (available at http://dch.georgia.gov/prior-authorizationprocess-and-criteria)
- Physician Services PA submission: https://www.mmis.georgia.gov
Required supportive clinical documentation
Supporting clinical documentation must be provided with the prior authorization to demonstrate eligibility and to account for any inpatient doses.
- Gestational age (e.g., <29 weeks or <32 weeks as applicable)
- History of chronic lung disease (CLD) and oxygen requirement (>21% oxygen during first 28 days of life) or ongoing medical support within 6 months for second-year CLD eligibility
- Hemodynamically significant congenital heart disease (CHD) status and any cardiologist consultation as applicable
- Dates of any prior inpatient-administered Synagis doses (hospital-administered doses subtract from maximum outpatient doses)
Denial risk: who may submit requests
Requests may be denied if submitted by anyone other than prescribers; stamped or copied physician signatures will not be accepted.
- Only prescribers are allowed to submit requests for Synagis®.
- Stamped or copied physician signatures will not be accepted.
Denial risk: season window enforcement
Prior authorization requests filed outside the policy season window (October 1, 2014 through March 3, 2015) may be denied unless an approved exception applies for specified discharge scenarios extending dosing through March 31.
- Standard season window: October 1, 2014–March 3, 2015.
- Exceptions: dosing past March 3 through March 31 is allowed for high‑risk infants discharged in February or March who did not receive an in‑hospital March dose.
Key Definitions
Background and Guideline Basis
The Georgia Department of Community Health aligns this Synagis (palivizumab) policy with the 2014 AAP and 2014–2015 GAAAP guidance noting the seasonality of RSV and the limited clinical benefit of prophylaxis. AAP/GAAAP support up to five monthly doses to maintain protective serum concentrations for more than 24 weeks; the policy applies those recommendations to define eligible high-risk groups and dosing limits for the 2014–2015 RSV season.
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