Marnetegragene Autotemcel (Kresladi) (CPB 1102, reviewed 13-2026-07)

Immediately: Billing team must establish a mandatory precertification workflow for all Kresladi (Marnetegragene Autotemcel) cases. (1) Train all billing and authorization staff to contact National Medical Excellence at 877-212-8811 BEFORE any treatment initiation for precertification approval. (2) Update billing software and/or authorization system with a block rule that prevents claim submission for CPT codes 38204-38215, 38230, 38232, 38240-38243, and 96413-96415 without documented precertification approval in member file. (3) Create or update authorization forms to confirm all 16 approval criteria have been met: age 9 months-<10 years, confirmed ITGB2 biallelic variants, CD18 expression thresholds, prior significant infection or family history, HSCT candidate status without HLA-matched sibling donor, negative HIV-1/2 and HTLV-1/2 serology, appropriate monitoring plan, no hepatic/renal/pulmonary dysfunction, no active malignancy, no persistent infections, LEUKAPHERESIS/bone marrow harvest candidacy confirmed, no significant medical conditions (poorly controlled diabetes/hypertension/cardiac arrhythmia/CHF/recent arterial thromboembolism within 6 months), and no prior gene therapy. (4) Confirm provider qualifications (immunologist, hematologist, or LAD-I specialist) before authorizing treatment. (5) Ensure services are delivered at an Aetna Institutes GCIT Designated Network facility. (6) Coordinate collection of all supporting diagnostic documentation (flow cytometry results showing CD18/CD11a/CD11b expression percentages, genetic testing confirming ITGB2 variants, infection history, serology results, hepatic/renal/pulmonary function panels). Claims submitted without documented precertification and missing approval criteria will be denied.