Chimeric Antigen Receptor (CAR) T‑cell therapy for cancer — BlueCHiP for Medicare
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Coverage and payment guidelines for CAR T‑cell therapy for BlueCHiP for Medicare members, including CMS reimbursement rules and required claim coding; intended for providers submitting claims for Medicare beneficiaries.
No material clinical or coverage changes in this revision.
Coverage Criteria for CAR T‑cell Therapy
The policy specifies that the use of non‑FDA‑approved autologous T‑cells expressing at least one chimeric antigen receptor (CAR) is non‑covered. In addition, autologous CAR T‑cell treatment for cancer is non‑covered when the CMS National Coverage Determination (Section A) coverage requirements are not met.
Medical criteria are not applicable in this document; no separate medical necessity criteria beyond the CMS National Coverage Determination conditions are specified.
Required Claim Codes and Coding Guidance
| 0537T | Chimeric antigen receptor T-cell (CAR-T) therapy; harvesting of blood-derived T lymphocytes for development of genetically modified autologous CAR-T cells, per day |
| 0538T | Chimeric antigen receptor T-cell (CAR-T) therapy; preparation of blood-derived T lymphocytes for transportation (eg, cryopreservation, storage) |
| 0539T | Chimeric antigen receptor T-cell (CAR-T) therapy; receipt and preparation of CAR-T cells for administration |
| 0540T | Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous |
| Q2042 | Tisagenlecleucel, up to 600 million CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
| Q2041 | Axicabtagene Ciloleucel, up to 200 Million Autologous Anti-CD19 CAR T Cells, Including Leukapheresis And Dose Preparation Procedures, Per Infusion |
Provider Actions, Billing and Claim Submission
Submit CAR T‑cell therapy claims to CMS
Effective for services rendered in 2019 and 2020, Centers for Medicare & Medicaid Services (CMS) requires that providers submit claims for chimeric antigen receptor (CAR) T‑cell therapy for cancer procedures to CMS for authorization/reimbursement. Include the required HCPCS/CPT and Q‑codes on CMS claims as listed below.
- Submit CAR T‑cell therapy claims to CMS for authorization/reimbursement
- Include required procedure and product codes on CMS claims (see coding callout)
Step therapy — No step therapy requirements specified
No step therapy requirements are specified for CAR T‑cell therapy in this policy.
Claims submission and coding — include specified HCPCS/CPT and Q‑codes on CMS claims
In addition to the CAR T‑cell therapy HCPCS code(s), providers must include the following codes on CMS claims processing to support authorization and reimbursement.
- 0537T — Harvesting of blood‑derived T lymphocytes for development of genetically modified autologous CAR‑T cells, per day
- 0538T — Preparation of blood‑derived T lymphocytes for transportation (eg, cryopreservation, storage)
- 0539T — Receipt and preparation of CAR‑T cells for administration
- 0540T — CAR‑T cell administration, autologous
- Q2042 — Tisagenlecleucel, up to 600 million CAR‑positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose
- Q2041 — Axicabtagene Ciloleucel, up to 200 million autologous anti‑CD19 CAR T cells, including leukapheresis and dose preparation procedures, per infusion
Non‑covered uses — non‑FDA‑approved autologous CAR T‑cells or when CMS coverage conditions not met
The use of non‑FDA‑approved autologous T‑cells expressing at least one CAR is not covered. Autologous CAR T‑cell treatment for cancer is non‑covered when the CMS coverage conditions and the requirements described in this policy are not met.
Background
Chimeric antigen receptor (CAR) T‑cell therapy is an immunotherapy in which a patient’s T cells are genetically modified to express one or more CAR molecules that target specific tumor antigens. These genetically engineered T cells are expanded and reinfused to produce an anti‑tumor immune response and are used for certain hematologic malignancies and other cancers. Administration must occur at facilities meeting required program enrollment (for example, those enrolled in the FDA REMS program as stated in the CMS decision).
Definitions
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