CAR T-cell therapy (autologous) — Coverage and CMS claims submission
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Coverage and payment guidelines for CAR T-cell therapy for Medicare Advantage members; describes CMS coverage, coding, and submission requirements for providers and facilities.
No material clinical or coverage changes in this revision.
Coverage Criteria (CMS NCD)
Nationally Covered Indications
Coverage decisions per CMS NCD:
Effective for services performed on or after 08/07/2019.
Nationally Non-Covered
Non-covered when ALL of the following are met:
Effective for services performed on or after 08/07/2019.
Clinical Trials
Clinical trial coverage:
Effective for services performed on or after 08/07/2019.
Autologous CAR T-cell treatment is non-covered when the requirements in the Nationally Covered Indications are not met. Specifically, the policy follows the CMS determination that the use of non-FDA-approved autologous T‑cells expressing at least one CAR is non‑covered, and autologous treatment for cancer with T‑cells expressing at least one CAR is non‑covered whenever the conditions outlined for covered use (such as REMS‑enrolled facility administration and FDA‑approved product/indication or compendia support) are not satisfied. Effective date: 08/07/2019.
Coding and Procedure Codes
| 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 |
| KX | Modifier acknowledging service is submitted by or performed in an FDA REMS approved facility |
| LU | Modifier informing the Medicare Administrative Contractor that the service is fractionated |
Provider Actions and Claim Submission
Claims and code submission to CMS
To ensure reimbursement for this service, providers must submit claims for chimeric antigen receptor (CAR) T-cell therapy for cancer procedures to CMS for authorization and reimbursement. Include the CAR T procedure HCPCS codes below and applicable modifiers when submitting claims.
- 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
- Modifiers: KX — acknowledges service is being submitted by or performed in an FDA REMS‑approved facility
- Modifier: LU — informs the Medicare Administrative Contractor that the service is fractionated
Claims submission requirement
Providers must submit claims for CAR T-cell therapy procedures to CMS for authorization/reimbursement and include the CAR T procedure HCPCS codes listed. Failure to submit appropriate codes and modifiers may result in denial or delayed payment.
Non‑covered therapies
The use of non–FDA‑approved autologous CAR T‑cell therapies (and any CAR T use that does not meet the national coverage requirements) is non‑covered and may be denied. Providers should confirm that the product is FDA‑approved and used per the FDA label or supported by a CMS‑approved compendium and that the administering facility is enrolled in the FDA REMS program prior to billing.
Provider actions
Provider operational note: ensure facility REMS enrollment documentation and supporting clinical records (FDA label or CMS‑approved compendia references) are available on request. When submitting claims for Medicare Advantage members, include the CAR T HCPCS codes and applicable KX and LU modifiers as indicated.
Background
Chimeric Antigen Receptor (CAR) T‑cell therapy is an autologous cellular immunotherapy in which a patient’s own T cells are genetically modified to express a CAR that targets cancer cells. Coverage policy aligns with the CMS national determination: FDA‑approved CAR T products and uses supported by CMS‑approved compendia may be covered when administered in FDA REMS‑enrolled facilities; investigational or non‑FDA‑approved autologous CAR T products are not covered under the NCD. Effective date for the CMS determination is 08/07/2019.
Definitions
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