TL;DR: The Centers for Medicare & Medicaid Services modified NCD 374 governing CAR T-cell therapy coverage policy, with a policy record update effective January 9, 2026. Here's what billing teams need to know before submitting claims.
CMS CAR T-cell therapy coverage policy under NCD 374 Medicare has been in place since August 7, 2019 — and the core coverage rules haven't changed. What has changed is the policy record itself, flagged as a modification on January 9, 2026. This policy does not list specific CPT or HCPCS codes in the current data. Your billing team needs to confirm code-level guidance through the associated Medicare Claims Processing transmittals (TN 10454, TN 10796, TN 10891, TN 11721, TN 11774, and TN 13432) linked directly in the NCD.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | CMS (Centers for Medicare & Medicaid Services) |
| Policy | Chimeric Antigen Receptor (CAR) T-cell Therapy |
| Policy Code | NCD 374 |
| Change Type | Modified |
| Effective Date | January 9, 2026 (policy record update; clinical coverage rules effective August 7, 2019) |
| Impact Level | Medium — high financial exposure per case; any documentation gap creates significant claim denial risk |
| Specialties Affected | Oncology, Hematology, Inpatient Hospital Billing, Infusion/Biologic Billing |
| Key Action | Confirm your facility is enrolled in FDA REMS and that every CAR T claim ties to an FDA-approved indication or CMS-approved compendium use before submission |
CMS CAR T-Cell Therapy Coverage Criteria and Medical Necessity Requirements 2026
The core medical necessity rule under NCD 374 is straightforward. CMS covers autologous CAR T-cell therapy when three conditions are all met at the same time.
First, the treatment must be autologous — meaning the T-cells come from the patient being treated. Second, the healthcare facility administering the therapy must be enrolled in the FDA's Risk Evaluation and Mitigation Strategies (REMS) program. Third, the use must be a medically accepted indication under Social Security Act Section 1861(t)(2).
That third condition is where most claim denial risk lives. "Medically accepted indication" under NCD 374 means one of two things: the therapy is used for an FDA-approved indication as written on the product label, or the therapy has FDA approval and the off-label use is supported by at least one CMS-approved compendia. That second path — off-label, compendium-supported use — is legitimate under this coverage policy, but your documentation has to show it explicitly.
CAR T-cell therapy billing carries some of the highest per-claim dollar exposure in oncology. A single course of treatment can run $400,000 or more before facility and professional fees. One missing documentation element — no REMS enrollment confirmation, no compendium citation for an off-label use — and you're looking at a full denial on a claim that size.
Whether CMS requires prior authorization for CAR T-cell therapy under NCD 374 is not addressed in this policy document. However, given the cost and complexity, check with your Medicare Administrative Contractor (MAC) for any local prior authorization or prior auth requirements layered on top of this NCD. Some MACs have issued Local Coverage Determinations (LCDs) that add conditions beyond what NCD 374 states.
CMS CAR T-Cell Therapy Exclusions and Non-Covered Indications
CMS draws a hard line on two things under NCD 374.
Non-FDA-approved CAR T-cells are not covered, full stop. If the product hasn't cleared FDA approval, Medicare will not reimburse it — regardless of clinical evidence, trial data, or physician judgment. There's no pathway to coverage for unapproved products under this NCD.
Any use that doesn't meet Section B's requirements is non-covered. That means if your facility isn't enrolled in FDA REMS, the claim is non-covered. If the indication isn't FDA-approved and isn't in a CMS-approved compendium, the claim is non-covered. Missing either of those boxes doesn't create a gray area — it creates a denial.
The investigational use carve-out is real but narrow. Routine costs in clinical trials using CAR T-cell therapy as an investigational agent are covered — but only when the trial meets the requirements in NCD 310.1. If your facility is running or participating in CAR T trials, your billing guidelines for those cases follow NCD 310.1, not NCD 374's standard coverage rules. Make sure your billing team knows which path applies to each case before submission.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Autologous CAR T-cell therapy for cancer — FDA-approved indication, facility enrolled in FDA REMS | Covered | Not specified in NCD 374 data; confirm with MAC transmittals | Must match the FDA-approved product label exactly |
| Autologous CAR T-cell therapy for cancer — off-label use, FDA-approved product, use supported in CMS-approved compendia, facility enrolled in REMS | Covered | Not specified in NCD 374 data | Compendium citation must be in the medical record |
| Non-FDA-approved autologous CAR T-cells | Not Covered | N/A | No pathway to coverage under NCD 374 |
| Autologous CAR T-cell therapy — facility NOT enrolled in FDA REMS | Not Covered | N/A | REMS enrollment is a hard requirement |
| CAR T-cell therapy used as investigational agent in a qualifying clinical trial | Covered (routine costs only) | Governed by NCD 310.1 | Trial must meet NCD 310.1 requirements |
CMS CAR T-Cell Therapy Billing Guidelines and Action Items 2026
The January 9, 2026 effective date for this policy record update is a good forcing function to audit your CAR T claims process now. Here's what to do.
| # | Action Item |
|---|---|
| 1 | Confirm your facility's FDA REMS enrollment status today. REMS enrollment is a binary coverage requirement. If your facility isn't enrolled, no CAR T claim will pay under Medicare — period. Pull the enrollment confirmation and keep it accessible for your billing team and auditors. |
| 2 | Check every CAR T case against the FDA-approved label or a CMS-approved compendium before billing. For on-label use, document the specific indication from the product label in the medical record. For compendium-supported off-label use, identify which CMS-approved compendium supports that use and cite it explicitly in the documentation. |
| 3 | Pull the Medicare Claims Processing transmittals tied to NCD 374. The policy record references TN 10454, TN 10796, TN 10891, TN 11721, TN 11774, and TN 13432. These transmittals contain the code-level billing instructions that NCD 374 itself doesn't spell out. Your charge capture setup needs to reflect those instructions. |
| 4 | Check with your MAC for any LCDs or prior authorization requirements layered on top of NCD 374. CMS sets the national floor. Your MAC can add local requirements above it. Contact your MAC's provider relations team or check their website for CAR T-specific guidance before the next claim cycle. |
| 5 | Separate your clinical trial CAR T cases from standard CAR T cases in your billing workflow. Clinical trial cases follow NCD 310.1, not NCD 374's standard path. If your team is billing trial cases under the standard NCD 374 rules, you may be over-documenting in some areas and under-documenting in others. |
| 6 | Flag CAR T denials for immediate review — don't let them age. Given the dollar amounts involved, a denied CAR T claim sitting in a queue for 30 days is a cash flow problem. Build a denial escalation path specifically for CAR T cases. If your denial rate for CAR T is above zero and you can't immediately identify why each denial happened, talk to your compliance officer before the next billing cycle. |
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
CPT, HCPCS, and ICD-10 Codes for CAR T-Cell Therapy Under NCD 374
The NCD 374 policy data does not list specific CPT, HCPCS, or ICD-10 codes. This is not unusual for a CMS NCD — code-level billing instructions live in the associated Medicare Claims Processing transmittals rather than the NCD document itself.
Where to Find the Applicable Codes
Review these transmittals directly from CMS for the billing codes and instructions tied to CAR T-cell therapy:
| Transmittal | Type | Link |
|---|---|---|
| TN 10454 | Medicare Claims Processing | Via CMS.gov |
| TN 10796 | Medicare Claims Processing | Via CMS.gov |
| TN 10891 | Medicare Claims Processing | Via CMS.gov |
| TN 11721 | Medicare Claims Processing | Via CMS.gov |
| TN 11774 | Medicare Claims Processing | Via CMS.gov |
| TN 13432 | Medicare Claims Processing | Via CMS.gov |
Do not rely on internal charge masters or third-party code lists alone for CAR T-cell therapy billing. Go directly to these transmittals to confirm the codes your MAC expects on a compliant claim. If your billing system vendor has pre-loaded codes for CAR T, cross-check those codes against the transmittals before submitting.
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