TL;DR: Aetna, a CVS Health company, modified CPB 1007 covering ciltacabtagene autoleucel (Carvykti), effective February 14, 2026. Billing teams need to verify all nine medical necessity criteria before submitting claims under HCPCS Q2056 and CAR-T procedure codes 38225–38228.
Aetna updated its Carvykti coverage policy under CPB 1007 Aetna system, tightening the criteria framework for this high-cost CAR-T therapy used in relapsed or refractory multiple myeloma. The policy governs HCPCS code Q2056 (ciltacabtagene autoleucel) alongside CPT codes 38225, 38226, 38227, and 38228 for the full CAR-T workflow—from T-cell harvesting through infusion. If your oncology or hematology billing team handles Carvykti cases, this policy warrants a close read before you submit another claim.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna |
| Policy | Ciltacabtagene Autoleucel (Carvykti) — CPB 1007 |
| Policy Code | CPB 1007 |
| Change Type | Modified |
| Effective Date | February 14, 2026 |
| Impact Level | High |
| Specialties Affected | Hematology, Oncology, Bone Marrow Transplant Programs, Infusion Centers |
| Key Action | Confirm all nine medical necessity criteria are documented before submitting Q2056 claims; contact NME at 877-212-8811 for precertification |
Aetna Ciltacabtagene Autoleucel Coverage Criteria and Medical Necessity Requirements 2026
Aetna's Carvykti coverage policy requires prior authorization through the National Medical Excellence (NME) program. Call 877-212-8811 before you schedule leukapheresis. This is not optional—precertification is required for all Aetna participating providers and members in applicable plan designs. If you skip this step, you own the denial.
The coverage policy designates Carvykti as a GCIT product—Gene-based, Cellular & Other Innovative Therapies. That designation means Aetna's dedicated GCIT team reviews these cases, not the standard medical review queue. Expect more scrutiny, longer turnaround times, and a higher documentation bar than you'd see on a typical oncology prior auth.
To establish medical necessity for Q2056, your clinical team must satisfy all nine criteria below. Every one of them must be met. Missing a single criterion means a denial.
The nine criteria for medical necessity:
| # | Covered Indication |
|---|---|
| 1 | The member is 18 years of age or older. |
| 2 | The diagnosis is relapsed or refractory multiple myeloma (ICD-10 C90.0 and related codes). |
| 3 | The member received at least one prior line of therapy that included at least one immunomodulatory agent. |
| 4 | That same prior therapy included at least one proteasome inhibitor. |
| 5 | The disease is lenalidomide-refractory. |
| 6 | The member has never received ciltacabtagene autoleucel or any other CAR-T therapy directed at any target. |
| 7 | The member's ECOG performance status is 0, 1, or 2. |
| 8 | The member has adequate and stable kidney, liver, pulmonary, and cardiac function. |
| 9 | The member has no known active or prior history of CNS involvement (including CNS multiple myeloma), no clinically significant active infection, no active graft-versus-host disease, and no active inflammatory disorder. |
Criteria nine bundles four separate exclusionary conditions into one line. Document each of those four conditions explicitly in your precertification request. Don't leave the GCIT reviewer to infer that the patient is free of CNS disease—state it directly in the clinical notes. Note that the CNS exclusion covers both active CNS involvement and prior history of CNS involvement. Both disqualify the member.
The lenalidomide-refractory requirement (criterion five) is worth flagging to your clinical documentation team now. The policy requires lenalidomide-refractory disease; ensure the oncologist's documentation explicitly states refractory status. The policy does not define the refractory window—work with your clinical team and reference FDA labeling or NCCN guidelines for documentation standards, but do not represent a specific timeframe as Aetna policy.
Carvykti billing under this coverage policy is a one-dose treatment. The policy explicitly states "one dose" in the medical necessity section. Continuation-of-therapy provisions refer back to dosage and administration guidance, not to repeated infusions.
Aetna Carvykti Exclusions and Non-Covered Indications
Aetna's position is direct: all other indications are experimental, investigational, or unproven. Carvykti has one covered indication under this policy—relapsed or refractory multiple myeloma in adults who meet all nine criteria above.
Any use outside that box—pediatric patients, earlier lines of therapy, solid tumors, other hematologic malignancies—will be denied as experimental. Don't submit Q2056 for off-label indications expecting to win on appeal. Aetna has locked this down firmly.
The CAR-T exclusivity requirement (criterion six) is also a hard wall. If your patient received any prior CAR-T therapy—idecabtagene vicleucel, lisocabtagene maraleucel, or any other product directed at any antigen—Carvykti is not covered. This isn't BCMA-specific. It's any CAR-T, any target, ever.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Relapsed or refractory multiple myeloma, age ≥18, lenalidomide-refractory, ≥1 prior line with IMiD + PI, CAR-T naïve, ECOG 0–2, adequate organ function, no known active or prior history of CNS involvement/active infection/GVHD/inflammatory disorder | Covered | Q2056, 38225–38228, 0537T–0540T, C90.0 | Prior auth required; contact NME 877-212-8811; one dose only |
| Any indication in members under age 18 | Not Covered / Experimental | — | Policy limits to adults 18+ |
| Prior CAR-T therapy recipients (any target) | Not Covered | — | Hard exclusion; no exceptions stated |
| Known active or prior history of CNS multiple myeloma or CNS involvement | Not Covered | — | Absolute contraindication in policy language; covers both active disease and prior history |
| Earlier lines of therapy without lenalidomide-refractory disease | Not Covered / Experimental | — | Must be lenalidomide-refractory |
| All other hematologic or solid tumor indications | Experimental/Investigational | — | Aetna explicitly designates all other uses as unproven |
Aetna Carvykti Billing Guidelines and Action Items 2026
The financial exposure on Carvykti claims is significant. Carvykti carries a list price well above $400,000 per infusion. A denial on Q2056 without a solid appeal strategy is not a recoverable situation for most practices. Get your process right before the effective date of February 14, 2026.
| # | Action Item |
|---|---|
| 1 | Audit your precertification workflow for CAR-T cases immediately. All Carvykti cases require precertification through NME at 877-212-8811, not through standard Aetna prior authorization channels. If your team has been routing these through your normal PA process, fix that today. |
| 2 | Build a checklist for all nine medical necessity criteria. Make it a required step before the clinical team submits the precertification request. Every criterion must be documentable from the chart at the time of submission. Don't wait for the GCIT reviewer to ask for it. |
| 3 | Train your documentation team on lenalidomide-refractory specificity. The policy requires lenalidomide-refractory disease; ensure the oncologist's documentation explicitly states refractory status. The policy does not define the refractory window—work with your clinical team and reference FDA labeling or NCCN guidelines for documentation standards. Loop in your medical director to confirm your documentation meets Aetna's refractory requirement. |
| 4 | Confirm CAR-T naïve status before submitting any claim. Query your EHR for prior CAR-T orders on every Carvykti candidate. This exclusion applies to any CAR-T product directed at any target—not just prior BCMA-directed therapies. One prior CAR-T infusion in the patient's history means denial. |
| 5 | Update your charge capture to include all relevant CAR-T workflow codes. Carvykti billing spans multiple CPT codes across the full treatment process: 38225 (T-cell harvesting), 38226 (preparation for transport), 38227 (receipt and preparation of CAR-T cells), and 38228 (CAR-T administration, autologous). You may also see the legacy Category III codes 0537T through 0540T on older encounters. Map these to the correct encounter types in your charge capture system. |
| 6 | Code the ECOG status and organ function assessments explicitly in the record. Aetna's GCIT team will look for this. ECOG performance status of 0, 1, or 2 must be documented. Organ function—kidney, liver, pulmonary, cardiac—needs recent lab and clinical documentation. Vague notes won't hold up. |
| 7 | For lymphodepletion chemotherapy, bill the correct infusion codes. Carvykti protocols include lymphodepleting chemotherapy before infusion. Bill that separately using CPT 96413 (initial infusion), 96414 (push technique), 96415 (each additional hour), 96416 (initiation of prolonged infusion), and 96417 (each additional sequential infusion). These are related codes under CPB 1007 and should be billed on the appropriate encounter. |
If you're not sure how the GCIT review process applies to your Carvykti volume, talk to your compliance officer before submitting new cases. The reimbursement stakes are too high to learn through denials.
| 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 Ciltacabtagene Autoleucel Under CPB 1007
HCPCS Codes — Covered When Selection Criteria Are Met
| Code | Type | Description |
|---|---|---|
| Q2056 | HCPCS | Ciltacabtagene autoleucel, up to 100 million autologous B-cell maturation antigen (BCMA)-directed CAR-T cells |
CPT and HCPCS Codes — Related to CPB 1007
These codes cover the full CAR-T workflow and associated therapies billed in connection with Carvykti treatment.
| Code | Type | Description |
|---|---|---|
| 38225 | CPT | CAR-T therapy; harvesting of blood-derived T lymphocytes for development of genetically modified CAR-T cells |
| 38226 | CPT | CAR-T therapy; preparation of blood-derived T lymphocytes for transportation (e.g., cryopreservation, storage) |
| 38227 | CPT | CAR-T therapy; receipt and preparation of CAR-T cells for administration |
| 38228 | CPT | CAR-T therapy; CAR-T cell administration, autologous |
| 0537T | CPT | CAR-T therapy; harvesting of blood-derived T lymphocytes (Category III) |
| 0538T | CPT | CAR-T therapy; preparation of blood-derived T lymphocytes (Category III) |
| 0539T | CPT | CAR-T therapy; receipt and preparation of CAR-T cells (Category III) |
| 0540T | CPT | CAR-T therapy; CAR-T cell administration, autologous (Category III) |
| 96413 | CPT | Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug |
| 96414 | CPT | Chemotherapy administration, intravenous infusion technique; push technique, each substance/drug |
| 96415 | CPT | Chemotherapy administration, intravenous infusion technique; each additional hour |
| 96416 | CPT | Chemotherapy administration, intravenous infusion technique; initiation of prolonged chemotherapy infusion (more than 8 hours) |
| 96417 | CPT | Chemotherapy administration, intravenous infusion technique; each additional sequential infusion |
| J9041 | HCPCS | Injection, bortezomib, 0.1 mg |
| J9044 | HCPCS | Injection, bortezomib, not otherwise specified, 0.1 mg |
| J9046 | HCPCS | Injection, bortezomib (Dr. Reddy's), not therapeutically equivalent to J9041, 0.1 mg |
| J9047 | HCPCS | Injection, carfilzomib, 1 mg |
| J9048 | HCPCS | Injection, bortezomib (Fresenius Kabi), not therapeutically equivalent to J9041, 0.1 mg |
| J9049 | HCPCS | Injection, bortezomib (Hospira), not therapeutically equivalent to J9041, 0.1 mg |
| J9051 | HCPCS | Injection, bortezomib (Maia), not therapeutically equivalent to J9041, 0.1 mg |
| J9145 | HCPCS | Injection, daratumumab, 10 mg |
Key ICD-10-CM Diagnosis Codes
| Code | Description |
|---|---|
| C90.0 | Multiple myeloma [relapsed or refractory] |
| C90.1 | Multiple myeloma [relapsed or refractory] |
| C90.10 | Plasma cell leukemia not having achieved remission |
| C90.2 | Multiple myeloma [relapsed or refractory] |
| C90.20 | Malignant solid tumors |
| C90.21 | Malignant solid tumors |
| C90.22 | Malignant solid tumors |
| C90.23 | Malignant solid tumors |
| C90.24 | Malignant solid tumors |
| C90.25 | Malignant solid tumors |
| C90.26 | Malignant solid tumors |
| C90.27 | Malignant solid tumors |
| C90.28 | Malignant solid tumors |
| C90.29 | Malignant solid tumors |
| C90.30 | Malignant solid tumors |
| C90.31 | Malignant solid tumors |
| C90.32 | Malignant solid tumors |
| C00.0–C88.91 | Malignant solid tumors (related range) |
| C96.0–D09.9 | Malignant solid tumors (related range) |
For the primary Carvykti indication, bill C90.0 (multiple myeloma [relapsed or refractory]) as listed in the source policy. Verify the correct code specificity with your clinical team and coding resources at each encounter.
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