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AetnaCommercial · Prior Auth · Medical Policy · Hematology, Allergy & Immunology, Pediatrics +1 moreMedium impact

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

Act
immediately
Effective date
Not stated in the notice
Identified
Aug 27, 2026

Summary

Aetna has established a new clinical policy (CPB 1102) for Marnetegragene Autotemcel (Kresladi), a gene therapy for severe leukocyte adhesion deficiency-I (LAD-I) in pediatric patients ages 9 months to <10 years. This is a one-time, single-dose autologous stem cell therapy requiring mandatory precertification through National Medical Excellence (877-212-8811) and administration at an Aetna Institutes GCIT Designated Network. Billing teams must implement precertification workflows and ensure strict compliance with 16 specific approval criteria before claims can be submitted.

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What to do

immediately · 8 steps
01Billing team must establish a mandatory precertification workflow for all Kresladi (Marnetegragene Autotemcel) cases.
02Train all billing and authorization staff to contact National Medical Excellence at 877-212-8811 BEFORE any treatment initiation for precertification approval.
03Update 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.
04Create 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.
05Confirm provider qualifications (immunologist, hematologist, or LAD-I specialist) before authorizing treatment.
06Ensure services are delivered at an Aetna Institutes GCIT Designated Network facility.
07Coordinate 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).
08Claims submitted without documented precertification and missing approval criteria will be denied.

Codes mentioned

3820438205382063820738215382303823238240382438006980076820408224782248823108237482435825658294784100841328429584520840758415584450844608500285004850078502585027850498668986701867028670387389873908739188182881898872090935909979641396415D71.1

Original notice

Marnetegragene Autotemcel (Kresladi) (CPB 1102, reviewed 13-2026-07)
aetna.com · Always check the source before changing claims.
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Related policy hubs

Aetna policiesHematologyAllergy & ImmunologyPediatricsTransplant SurgeryCode 38204Code 38205Code 38206Code 38207Code 38215Code 38230Code 38232Code 38240Code 38243Code 80069Code 80076Code 82040Code 82247Code 82248Code 82310Code 82374Code 82435Code 82565Code 82947Code 84100Code 84132Code 84295Code 84520Code 84075Code 84155Code 84450Code 84460Code 85002Code 85004Code 85007Code 85025Code 85027Code 85049Code 86689Code 86701Code 86702Code 86703Code 87389Code 87390Code 87391Code 88182Code 88189Code 88720Code 90935Code 90997Code 96413Code 96415Code D71.1

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