The clinical criteria used by NC Medicaid for the 2021-2022 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.
Extended Coverage Season
Normally a late fall/winter season, due to atypically high levels of circulating RSV, the Synagis coverage season will start Aug. 15, 2021, and last through March 31, 2022. Up to eight monthly doses can be covered. RSV activity will be closely monitored during the eight-month timeframe to determine if the season length should be adjusted.
- The June 2021 Centers for Disease Control and Prevention (CDC) health advisory notice to notify clinicians and caregivers about increased interseasonal RSV activity across parts of the Southern United States.
- The North Carolina Division of Public Health (DPH) Epidemiology sections has reported a substantial uptick in the number of RSV cases throughout the state at levels almost to the height of the typical RSV season.
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). Documentation of CLD must be submitted as defined to meet criteria approval, such as a newborn intensive care unit (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 a 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 the start of their second RSV season
- Cystic Fibrosis - with manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the 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 Limitations
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%.
Prior Approval Request
The Synagis® prior authorization (PA) request form for NC Medicaid Direct beneficiaries is found on the NCTracks pharmacy services page at: https://www.nctracks.nc.gov/content/public/providers/pharmacy/pa-drugs-criteria-new-format.html.
- 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
Effective this season, document-for-safety is discontinued for Synagis PA submission. PA requests for beneficiaries enrolled in a Standard Plan should be submitted in accordance with the plan’s procedures. Refer to the plan’s website or help desk for assistance.
- AmeriHealth Caritas North Carolina, Inc.
- Carolina Complete Health, Inc.
- Healthy Blue of North Carolina
- UnitedHealth Care of North Carolina, Inc
- WellCare Health Plan
Pharmacy Distributor Information
Use of a point of sale PA override code 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.
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.
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 coverage of Synagis outside of policy. 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.
Contact
Outpatient Pharmacy Services, 919-527-7658