Medicare AdvantageCoverageMedium impact
Waskyra (etuvetidigene autotemcel) - Medicare Advantage (New)
Humana·Hematology, Oncology, Pediatrics +2 more·Medicare Advantage
Effective date
Sep 1, 2026
We identified it
Sep 2, 2026
Summary
Humana Medicare Advantage has introduced a new coverage policy for Waskyra (etuvetidigene autotemcel), an autologous gene therapy for pediatric and adult patients with Wiskott-Aldrich Syndrome (WAS) who lack suitable HLA-matched donors. Coverage requires medical director review and strict criteria compliance, with specific exclusions for patients who are pregnant, breastfeeding, or unwilling to use contraception.
Action Required
By September 1, 2026: (1) Billing team must add new HCPCS code J3386 (etuvetidigene autotemcel injection) to billing system and establish it as a new-to-plan coverage code. (2) Update prior authorization workflows to require mandatory medical director review through the Corporate Transplant Department (1-866-421-5663, transplant@humana.com, fax 502-508-9300) before billing any Waskyra claims. (3) Create billing checklist ensuring all four coverage criteria are documented: WAS diagnosis with WAS gene mutation confirmed, patient age ≥6 months, HSCT clinical appropriateness, and absence of suitable HLA-matched related donor. (4) Implement claim edits to deny coverage if patient is pregnant, breastfeeding, or declined contraception (per coverage limitations). (5) Train billing and prior auth staff on the requirement to verify genetic testing documentation and transplant eligibility assessment before submission. (6) Update encounter templates and referral forms to capture pregnancy/reproductive planning status. Failure to route claims through Corporate Transplant Department will result in denials; claims missing required clinical documentation will be rejected.