Procedures for Prior Authorization of Synagis® (palivizumab) for Respiratory Syncytial Virus Season 2019-2020

Tuesday, October 1, 2019

The clinical criteria used by NC Medicaid for the 2019-2020 Respiratory Syncytial Virus (RSV) season are consistent with guidance published by the American Academy of Pediatrics (AAP): 2018 – 2021 Report of the Committee on Infectious Diseases, 31st Edition. This guidance for Synagis use among infants and children at increased risk of hospitalization for RSV infection is available online by subscription. The coverage season is Nov. 1, 2019, through March 31, 2020. Providers are encouraged to review the AAP guidance prior to the start of the RSV season.

On Feb. 1, 2020, NC Medicaid will transition some populations from fee-for-service to managed care statewide.  Coverage of Synagis will transition to the Medicaid Managed Care Prepaid Health Plan (PHP) selected by or assigned to the beneficiary. Beginning Feb. 1, 2020, providers will only use the web-based process to submit a prior authorization request for coverage of Synagis or complete a dose request to obtain the medication for beneficiaries with traditional Medicaid fee-for-service (now known as Medicaid Direct) coverage.     

Guidelines for Evidenced-Based Synagis Prophylaxis

  • Infants younger than 12 months at start of season with a diagnosis of:
    • Prematurity - born before 29 weeks 0 days gestation
      • Infants in their first year of life with a diagnosis of:
        • Chronic Lung Disease (CLD) of prematurity (defined as birth at less than 32 weeks 0 days gestation and requiring greater than 21 percent oxygen for at least 28 days after birth),
        • Hemodynamically significant acyanotic heart disease, receiving medication to control congestive heart failure, and will require cardiac surgical procedures
        • Moderate to severe pulmonary hypertension,
        • Neuromuscular disease or pulmonary abnormality that impairs the ability to clear secretions from the upper airway because of ineffective cough.

          Note: Infants in the first year of life with cyanotic heart disease may receive prophylaxis with cardiologist recommendation.

  • Infants less than 24 months of age with a diagnosis of:
    • Profound immunocompromise during RSV season
    • CLD of prematurity (see above definition) and continue to require medical support (supplemental oxygen, chronic corticosteroid or diuretic therapy) during the six-month period before start of second RSV season
    • Cardiac transplantation during RSV season

Prior Approval Request

During the Synagis coverage period, submit all prior approval (PA) requests electronically to The web-based program will process PA information in accordance with the guidelines for use. A PA request can be automatically approved based on the information submitted. The program allows a provider to self-monitor the status of a request. Up to five doses can be approved for coverage.

Coverage of Synagis for CHD, neuromuscular disease or congenital anomaly that impairs ability to clear respiratory secretions from the upper airway will terminate when the beneficiary exceeds 12 months of age. Coverage of Synagis for CLD, profound immunocompromise or cardiac transplantation will terminate when the beneficiary exceeds 24 months of age.

Dose Authorization

Each Synagis dose will be individually authorized to promote efficient product distribution. Providers must submit a “next dose request” to obtain an authorization for each dose. Providers should ensure the previously obtained supply of Synagis is administered before submitting a next dose request. Providers will fax each single-dose authorization to the pharmacy distributor of choice.

If an infant received one or more Synagis doses prior to hospital discharge, the provider should indicate, as part of the request, the most recent date a dose was administered. The number of doses administered by the provider should be adjusted accordingly. If any infant or young child receiving monthly palivizumab prophylaxis experiences a breakthrough RSV hospitalization, coverage of Synagis will be discontinued.

Pharmacy Distributor Information

Single-dose vial specific authorizations, not to exceed the maximum number of doses approved for the beneficiary, will be issued by NC Medicaid. It is important for the Synagis distributor to have the appropriate single-dose authorization on hand and a paid point of sale (POS) claim prior to shipping Synagis. An individual dose authorization is required for each paid Synagis claim. The drug quantity submitted on the claim must not exceed the quantity indicated on the authorization. Payment for a Synagis claim will be denied if a dose request was not done by the provider. Use of a point of sale PA override code is not allowed.

Synagis claims processing will begin on Oct. 29, 2019, to allow sufficient time for pharmacies to provide Synagis by Nov. 1, 2019. Payment of a Synagis claim with a date of service before Oct. 29, 2019, and after March 31, 2020, is not allowed. POS claims should not be submitted by the pharmacy distributor prior to the first billable date of service for the season.

Pharmacy providers should always indicate an accurate days’ supply when submitting claims to NC Medicaid. Claims for Synagis doses that include multiple vial strengths must be submitted as a single compound-drug claim. Synagis doses that require multiple vial strengths that are submitted as separate individual claims will be subject to recoupment. Physicians and pharmacy providers are subject to audits of beneficiary records by NC Medicaid. Maintain Synagis dose authorizations in accordance with required recordkeeping time frames.

Provider Information

Providers without internet access should contact the Medicaid outpatient pharmacy Synagis lead at (919) 527-7658 to facilitate submission of a PA request for Synagis. More information about the Synagis program is available at

Submitting a Request to Exceed Policy

The provider should use the Non-Covered State Medicaid Plan Services Request Form for Recipients under 21 Years of Age to request Synagis doses exceeding policy or for coverage outside the defined coverage period. Fax the form to 919-715-1255.  The form is available on the NCTracks Prior Approval web page. Information about EPSDT coverage is found on Medicaid’s Health Check and EPSDT web page

Technical Support

Technical support is available Monday - Friday from 8 a.m. to 5 p.m. by calling toll free (833) 682-2333 or local: (919) 600-7590. Technical support can assist with provider registration, user name and password issues, beneficiary searches and other registry functions.

GDIT, (800) 688-6696