Irinotecan Liposome Injection (Onivyde) (CPB 0902, reviewed 2026-02-24)

By March 24, 2026: Billing team must implement prior authorization verification process for HCPCS code J9205 (Onivyde) on all Aetna commercial plans. REQUIREMENTS: (1) Before processing any J9205 claim, verify patient has ONE of the approved diagnoses (ampullary adenocarcinoma [C24.1] or pancreatic adenocarcinoma [C25.0-C25.9]); (2) Confirm treatment regimen matches policy criteria—document whether it is first-line NALIRIFOX, subsequent therapy after specific prior treatments (gemcitabine-based, fluoropyrimidine-based, or oxaliplatin-based without prior irinotecan), or recurrent/locally advanced disease; (3) Validate provider documentation includes patient ECOG performance status (0-1 for most indications, 0-1 or 2 for recurrent disease) and confirms adequate biliary drainage and nutritional intake; (4) Confirm serum bilirubin is within normal limits (no coverage for elevated bilirubin); (5) Update billing software and encounter templates to collect and flag these data elements; (6) Route all other indications (brain tumors, colon cancer, lung cancer, esophageal cancer, gastric cancer, biliary tract cancer, ovarian cancer, and others listed as experimental) to denial with reference to experimental status. RESPONSIBLE PARTIES: Billing team (prior auth verification), Providers (documentation on encounter forms), and coding staff (ICD-10 diagnosis code accuracy). CONSEQUENCES: Claims lacking required documentation or missing approved criteria will be denied. Claims for experimental indications will be denied automatically.