Procedures for Prior Authorization of Synagis® (palivizumab) for Respiratory Syncytial Virus Season 2020/2021

Tuesday, September 15, 2020

The clinical criteria used by NC Medicaid for the 2020/2021 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, 2020 through March 31, 2021. Providers are encouraged to review the AAP guidance prior to the start of the RSV season. 

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 Requests

During the Synagis® coverage period, submit all prior approval (PA) requests electronically to https://www.documentforsafety.org/pub/. 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 Congenital Heart Disease (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. 27, 2020. Payment of a Synagis® claim with a date of service before Oct. 27, 2020, and after March 31, 2021, 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. Submit POS claims for Synagis® doses with multiple vial strengths as a single compound-drug claim. Synagis® doses that require multiple vial strengths that are submitted as separate individual claims are 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 or charlene.sampson@dhhs.nc.gov to facilitate submission of a PA request for Synagis®. More information about the Synagis® program is available at  https://www.documentforsafety.org/pub/

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 Early and Periodic Screening, Diagnostic and Treatment Form (EPSDT) coverage is found on Medicaid’s Health Check and EPSDT web page.  

Technical Support

Technical support is available Monday to Friday from 8 a.m. to 5 p.m. by calling toll free 1-833-682-2333 or local 919-600-7590. Technical support can assist with provider registration, username and password issues, beneficiary searches and other registry functions. 

Contact

NC Medicaid Pharmacy Program, 919-527-7658