Procedures for Prior Authorization of Palivizumab (Synagis®) for Respiratory Syncytial Virus Season 2022/2023 Coverage season starts Oct. 1, 2022.
The clinical criteria used by NC Medicaid for the 2022/2023 Respiratory Syncytial Virus (RSV) season are consistent with guidance published by the American Academy of Pediatrics (AAP): 2021 – 2024 Report of the Committee on Infectious Diseases, 32nd Edition. This guidance for Synagis use among infants and children at increased risk of hospitalization for RSV infection is available online by subscription. Providers are encouraged to review the AAP guidance.
The coverage season is Oct. 1, 2022, through March 31, 2023. Coverage for a maximum of five doses within the six-month timeframe is allowed. Request for coverage of a sixth dose will be evaluated under EPSDT.
Request for Coverage Outside of Policy for NC Medicaid Direct Enrollees
To request coverage for a sixth dose or outside of the specified six month time period, please submit an EPSDT coverage request using the Non-Covered State Medicaid Plan Services Request Form for Recipients under 21 Years of Age.
PA Request for Coverage During the Season for NC Medicaid Direct Enrollees
Providers should submit PA requests for coverage of Synagis beginning Sept. 21, 2022.
The Synagis PA request form for NC Medicaid Direct beneficiaries is found on the NCTracks pharmacy services page. Submit PA requests by fax to NCTracks at 855-710–1969.
Call the NCTracks Pharmacy PA Call Center at 866-246-8505 for assistance with submitting a PA request. Document-for-safety is discontinued for Synagis PA submission.
Coverage Requests and Claims Processing for Managed Care Plan Enrollees
Synagis PA and EPSDT requests for beneficiaries enrolled in a Managed Care Standard Plan should be submitted in accordance with the Plan’s procedures. Refer to the plan’s website or contact their help desk for assistance with the Synagis PA form, EPSDT form and applicable dates. Pharmacy providers should refer to communications from the PHPs for Synagis claim submission guidance.
- AmeriHealth Caritas North Carolina, Inc.
- Carolina Complete Health, Inc.
- Healthy Blue of North Carolina
- UnitedHealth Care of North Carolina, Inc
- WellCare Health Plan
Guidelines for Evidenced-Based Synagis Prophylaxis
- Infants younger than 12 months at start of their FIRST RSV season with a diagnosis of:
- Prematurity - born before 29 weeks 0 days gestation
- Infants in their FIRST RSV season 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), [must submit documentation of CLD as defined to meet criteria approval, e.g. NICU discharge summary].
- 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.
- Cystic Fibrosis with clinical evidence of CLD and/or nutritional compromise
- Note: Infants in their FIRST RSV season with cyanotic heart disease may receive prophylaxis with cardiologist recommendation. Documentation of cardiologist recommendation required.
- Infants less than 24 months of age in their SECOND RSV season with a diagnosis of:
- 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
- Cystic Fibrosis - with manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in first year or abnormalities on chest radiography or chest computed tomography that persist when stable) or weight-for-length less than 10th percentile.
- Infants in their FIRST or SECOND RSV Season:
- With profound immunocompromise during the RSV season
- Undergoing cardiac transplantation during the RSV season
Coverage of Synagis for CLD, profound immunocompromise, cardiac transplantation and cystic fibrosis will terminate when the beneficiary exceeds 24 months of age.
If any infant or young child receiving monthly palivizumab prophylaxis experiences a breakthrough RSV hospitalization, coverage of Synagis should be discontinued due to the extremely low likelihood of a second same season hospitalization <0.5%.
Pharmacy Information for NC Medicaid Direct Claims Submission
Synagis claims processing will begin on Sept. 27, 2022, to allow sufficient time for pharmacies to provide Synagis for administration starting on Oct. 1, 2022. POS claims should not be submitted by the pharmacy prior to the first billable date of service for the season.
Payment of a Synagis claim with a date of service before Sept. 27, 2022, and after March 31, 2023, is not allowed. Use of a point of sale PA override code is not allowed.
Submit POS claims for EPSDT approved Synagis coverage according to approved time period.
Pharmacy providers should always calculate and indicate an accurate days supply when submitting claims. 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.
NCTracks Call Center: 800-688-6696