CMS CAR T-Cell Therapy Coverage Policy Updated: What Billing Teams Need to Know (NCD 374)

CMS has issued a modification to National Coverage Determination (NCD) 374, governing Medicare coverage for Chimeric Antigen Receptor (CAR) T-cell therapy. For oncology billing teams and revenue cycle directors managing high-cost cell therapy claims, understanding exactly what CMS covers—and what it doesn't—is critical to preventing denials on treatments that can cost $400,000 or more per patient. Here's a complete breakdown of the updated policy requirements.

What CMS Covers Under NCD 374: CAR T-Cell Therapy Medicare Coverage

Under the Centers for Medicare & Medicaid Services' NCD 374, Medicare covers autologous CAR T-cell therapy for cancer treatment when two core requirements are met:

1. The therapy is administered at a healthcare facility enrolled in the FDA's Risk Evaluation and Mitigation Strategies (REMS) program
2. The therapy is used for a medically accepted indication — defined under Social Security Act section 1861(t)(2) as either an FDA-approved indication per the product label, or an off-label use supported by one or more CMS-approved compendia

This coverage framework has been in effect since August 7, 2019. The modification effective March 12, 2026, updates this policy record — billing teams should review their internal documentation to ensure it reflects the current version of NCD 374.

CAR T-cell therapy works by extracting a patient's own T-cells, genetically modifying them to express a chimeric antigen receptor (CAR) that targets specific proteins on cancer cell surfaces, and reinfusing them into the patient. Because this is autologous therapy — using the patient's own cells — the coverage framework is distinct from allogeneic cell therapies, which are not addressed under this NCD.

CMS CAR T-Cell Therapy Non-Covered Indications: What Gets Denied

CMS is equally explicit about what Medicare will not pay for under this NCD. Two categories of non-covered services apply effective August 7, 2019:

• Non-FDA-approved autologous CAR T-cell products — If the product itself has not received FDA approval, the claim will not be covered under NCD 374, regardless of the indication
• Any autologous CAR T-cell treatment that fails to meet the requirements in Section B — meaning administration outside of an FDA REMS-enrolled facility, or use for an indication that is neither FDA-approved nor supported in CMS-approved compendia

These two denial triggers are the most common sources of claim rejection for CAR T-cell services. Before submitting, billing teams must verify that the specific product (e.g., axicabtagene ciloleucel, tisagenlecleucel, lisocabtagene maraleucel) has FDA approval and that the documented clinical indication matches the approved label or compendia support. Denials based on non-coverage are difficult to appeal without this documentation locked down prior to treatment.

Clinical Trial Coverage for CAR T-Cell Therapy Under NCD 374

There is an important carve-out for research settings. CMS will cover routine costs in clinical trials that use CAR T-cell therapy as an investigational agent, provided the trial meets the requirements established under NCD 310.1 (Clinical Trials).

This matters for academic medical centers and NCI-designated cancer centers running Phase I, II, or III trials involving experimental CAR T constructs or novel targets. The routine costs of care — think lab work, imaging, standard supportive medications — are billable to Medicare even when the CAR T product itself is investigational and therefore non-covered. The investigational product costs would be covered by the trial sponsor or another funding mechanism, not Medicare.

Billing teams at trial sites need to carefully separate routine clinical care costs from investigational agent costs on every claim. Miscoding trial-related services can trigger both denials and compliance risk.

Benefit Category and Site-of-Service Considerations

CMS classifies CAR T-cell therapy under two benefit categories:

• Drugs and Biologicals
• Inpatient Hospital Services

This dual classification reflects the clinical reality of CAR T administration — patients typically require inpatient admission for monitoring due to the risk of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Revenue cycle teams should expect the majority of CAR T claims to route through inpatient billing under Medicare Part A, with the drug component billed separately according to applicable payment methodologies.

Outpatient administration does occur at some FDA REMS-enrolled facilities for specific products and patient populations. In those cases, the Part B drug billing pathway applies, and teams should confirm current pass-through or bundling status for the specific product under the Outpatient Prospective Payment System (OPPS).

Affected Codes

The policy document for NCD 374 does not list specific CPT or HCPCS codes within the NCD text itself. Applicable billing codes for CAR T-cell therapy products and associated services are addressed in the linked CMS Claims Processing Transmittals (including TN 10454, TN 10796, TN 10891, TN 11721, TN 11774, and TN 13432). Billing teams should reference those transmittals directly for product-specific HCPCS codes—CMS periodically assigns new Q-codes or J-codes as new CAR T products receive FDA approval.

No ICD-10-CM codes are specified within NCD 374 itself. Applicable diagnosis codes will correspond to the covered cancer indication (e.g., diffuse large B-cell lymphoma, B-cell acute lymphoblastic leukemia, multiple myeloma) and must align with the FDA-approved label or compendia-supported use for the specific product administered.

What Your Billing Team Should Do