CAR-T Therapy "Notification" (PDF) Opens in a New Tab.
Defines notification/coverage criteria and documentation requirements for multiple FDA-approved autologous CAR-T cellular therapies (listed products) for specified hematologic malignancies, dosing limits, lymphodepletion regimens, and one-course-per-lifetime duration. Includes HCPCS/Q-codes, related CPT and revenue code mapping, and distribution note.
Added Gene/Cellular Therapy distribution channel management language according to benefit booklet for clarity.
Added new indication for Breyanzi for relapsed or refractory marginal zone lymphoma (MZL) for adults after at least 2 prior lines of systemic therapy.
Added HCPCS code Q2058 for Aucatzyl (effective 7/1/2025) and removed certain miscellaneous codes.
Added C9301 to dosing reference table effective 4/1/2025; C9399 termed 3/31/2025.
Added newly approved Aucatzyl and updated indications for Breyanzi, Tecartus, and other minor adjustments (January 2025v2).
Added supporting CPT codes 38225-38228 replacing temporary T-codes effective 1/1/2025.
For Abecma and Carvykti, indications and prior-line requirements were expanded per updated FDA labels in April 2024v2.
Multiple product indications were added across 2022-2024 (Carvykti, Tecartus ALL indication, Yescarta expanded indication, Breyanzi additions).
Removed criteria requiring no active infection including hepatitis B, hepatitis C, and HIV (June 2021).
Removed specific weight dosing within Yescarta criteria per updated FDA label, and added requirement of documentation of planned dose (June 2021).