Zopapogene Imadenovec-drba (Papzimeos) (CPB 1090, reviewed 2026-06-19)

REQUIREMENTS: Immediately (policy effective 2026-06-19): (1) Billing team must update billing system to require MANDATORY precertification for CPT 96372 and HCPCS J3404 for all Aetna commercial plan members before claim submission. Add precertification contact information (phone: 866-752-7021; fax: 888-267-3277) to precertification procedures. (2) Front desk and precertification staff must verify that providers are otolaryngologists or RRP specialists before accepting referrals. (3) Implement claim validation checklist in billing system to ensure all required criteria are present before claim submission: confirmed HPV serotype 6 or 11, documentation of 3+ debulking procedures in prior 12 months, negative HBV/HCV serology, no prior Papzimeos doses (limit one 4-dose course lifetime), and attestation of minimal residual disease maintenance protocol. (4) Billing team must reject and return to provider any claims for J3404 lacking complete documentation of these criteria or from non-qualifying specialists. (5) Update internal coding guidelines to link ICD-10 codes B97.7 and D14.1 specifically to Papzimeos claims requiring precertification. (6) Providers must submit Statement of Medical Necessity (SMN) forms per Specialty Pharmacy Precertification process. Claims submitted without precertification approval will be denied. This is a rare, specialty therapy with strict utilization controls.