CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Chimeric Antigen Receptor (CAR) T‑cell therapy for cancer — BlueCHiP for Medicare

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.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyChimeric Antigen Receptor (CAR) T‑cell therapy for cancer — BlueCHiP for Medicare

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAug 7, 2019

Next Review DateN/A

Key ActionSubmit CAR T-cell therapy claims to CMS with the required procedure and drug codes for authorization and reimbursement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

08/07/2019policy effective date for CMS coverage

CMS NCDcoverage basis

2019-2020temporary payment years

6 codesrequired codes

Coverage Criteria for CAR T‑cell Therapy

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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

Required claim codes for CAR T-cell therapymixed

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

Billing Rule

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

Step therapy — No step therapy requirements specified

No step therapy requirements are specified for CAR T‑cell therapy in this policy.

Billing Rule

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

Denial Risk

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

Autologous CAR T-cell therapy — definition

MechanismGenetic modification confers a CAR that enhances T-cell recognition and binding to specific tumor antigens, improving anti-tumor activity.

Administration setting requirementMust be administered at healthcare facilities enrolled in the FDA Risk Evaluation and Mitigation Strategies (REMS) program as required by CMS.

Indication requirementsCovered when used for a medically accepted indication as defined in Social Security Act section 1861(t)(2): either an FDA-approved label indication or an FDA-approved product used for a compendia-supported non-labeled use.