Lunsotogene Parvec-cwha (Otarmeni) (CPB 1103)

Billing and precertification teams must implement the following requirements: (1) Establish precertification process for Otarmeni by contacting Aetna GCIT at (866) 752-7021 or fax (888) 267-3277 for all applicable plan members prior to administration; (2) Verify treatment will occur at an Aetna Institutes GCIT Designated Network facility, as gene therapy administration at non-designated facilities will not be covered; (3) Update billing systems to require Statement of Medical Necessity (SMN) precertification forms (available at Specialty Pharmacy Precertification) before claim submission; (4) Train providers and clinical staff that Otarmeni is limited to one dose per ear per lifetime and cannot be administered if patient has received prior cochlear implant in that ear or previous gene therapy; (5) Ensure supporting documentation includes genetic testing confirming biallelic OTOF variants, audiological measurements (ABR showing ≥90 dB HL), otoacoustic emissions or cochlear microphonics confirmation, and imaging (CT or MRI) ruling out surgical contraindications. Claims lacking precertification or submitted for non-designated facilities will be denied.