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Etuvetidigene Autotemcel (Waskyra) (CPB 1097)

Aetna·Hematology, Allergy & Immunology, Pediatrics +1 more·Medical Policy
Effective date
Not stated
We identified it
Sep 30, 2026
Days to comply
—

Summary

Aetna has issued a new Clinical Policy Bulletin (CPB 1097) establishing coverage criteria for Etuvetidigene Autotemcel (Waskyra), a gene therapy for Wiskott-Aldrich syndrome. This is a one-time autologous gene therapy requiring precertification through National Medical Excellence (NME) and administration at designated Aetna Institutes GCIT Network facilities. Billing teams must implement precertification workflows and ensure providers meet strict patient eligibility criteria before treatment.

Action Required

Action needed
IMMEDIATELY: (1) Billing team must establish precertification requirement for all Waskyra administrations by contacting National Medical Excellence (NME) at 877-212-8811 before patient treatment. Update billing system to flag CPT codes 38225-38228, 38206-38207, 36511, and 88184-88187 with mandatory precertification requirement. (2) Providers must verify patient eligibility against all criteria in CPB 1097 before scheduling: patient age ≥6 months, confirmed WAS gene mutation with abnormal WASP expression or severe clinical phenotype (Zhu score ≥3), no HLA-identical sibling donor available, negative HIV/Hepatitis C status, and no contraindicated conditions (active TB, malignancy, end-organ dysfunction, etc.). (3) Verify treatment will occur at Aetna Institutes GCIT Designated Network facility; non-network administration may result in claim denial. (4) Update encounter documentation templates to require provider confirmation of all 13 eligibility criteria and treatment plan sign-off by immunologist, hematologist, or WAS specialist. (5) Create internal checklist for billing staff to verify: precertification approval obtained, provider specialty documented, network facility confirmed, and ICD-10 code D82.0 correctly linked before claim submission. Failure to obtain precertification will result in claim denials. Claims submitted for ineligible patients or non-network facilities will be denied.

Affected Billing Codes

38205
38206
38207
38209
38210
38212
38213
38214
38215
36511
38225
38226
38227
38228
38241
88184
88185
88187
96365
96366
96367
96368
S2150
D82.0