CommercialPrior AuthMedium impact
Emapalumab-lzsg (Gamifant) (CPB 0948, reviewed 2025-12-08)
Aetna·Hematology, Pediatrics, Rheumatology +3 more·Medical Policy
Effective date
Dec 8, 2025
We identified it
Aug 13, 2026
Summary
Aetna has updated its clinical policy for Emapalumab-lzsg (Gamifant) to establish coverage criteria for treatment of primary hemophagocytic lymphohistiocytosis (HLH) and macrophage activation syndrome (MAS) in Still's disease. Billing teams must implement prior authorization requirements and ensure proper TB screening documentation before claims can be processed. This is a new or significantly revised policy (reviewed 2025-12-08) affecting a specialty injectable medication with specific patient eligibility and pre-treatment requirements.
Action Required
By 2025-12-15: Billing and clinical teams must implement the following: (1) Establish prior authorization process for CPT/HCPCS codes J9210, 96365, and 96366 requiring documentation of: refractory/recurrent/progressive HLH disease or intolerance to conventional therapy, confirmed primary HLH diagnosis (genetic testing or 5+ clinical signs), exclusion of secondary HLH causes, and completed TB screening (PPD or interferon-gamma release assay with prophylactic TB treatment if positive); (2) For MAS in Still's disease cases, require documentation of confirmed/suspected sJIA or AOSD, active MAS diagnosis, inadequate response/intolerance to high-dose IV glucocorticoids, and exclusion of primary HLH/active infections/malignancy; (3) Update EMR/billing software to flag claims requiring TB screening documentation (codes 86480, 86481, 86580) before approving J9210 claims; (4) Add pre-authorization checklist to encounter forms reminding providers to document all eligibility criteria before treatment initiation; (5) Train front-desk and billing staff that claims lacking required documentation or prior authorization will be denied. Contact Aetna for prior authorization before patient treatment begins.