Aetna modified CPB 0903 for trabectedin (Yondelis), effective January 15, 2026. Here's what billing teams need to do.
Aetna, a CVS Health company, updated its trabectedin (Yondelis) coverage policy under CPB 0903, effective January 15, 2026. This policy governs medical necessity for J9352 (trabectedin injection, 0.1 mg) across a specific set of sarcoma diagnoses, and it now spells out line-of-therapy and combination-regimen requirements in more detail than the previous version. If your oncology billing team submits J9352 claims for Aetna commercial members, this update changes what documentation you need to support authorization and avoid claim denial.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Trabectedin (Yondelis) — CPB 0903 |
| Policy Code | CPB 0903 |
| Change Type | Modified |
| Effective Date | January 15, 2026 |
| Impact Level | High |
| Specialties Affected | Medical Oncology, Hematology/Oncology, Gynecologic Oncology, Revenue Cycle |
| Key Action | Audit J9352 prior authorization requests to confirm the correct line of therapy, sarcoma subtype, and combination-agent documentation before submitting claims after January 15, 2026 |
Aetna Trabectedin Coverage Criteria and Medical Necessity Requirements 2026
The updated Aetna trabectedin coverage policy draws hard lines around two main diagnostic categories: uterine sarcoma and soft tissue sarcoma. Coverage is not automatic within those categories. Aetna requires you to document the specific subtype, the line of therapy, and whether trabectedin is being used as a single agent or in combination with doxorubicin (J9000).
Uterine sarcoma — leiomyosarcoma
For leiomyosarcoma of the uterus, Aetna covers trabectedin under two scenarios. First, as first-line therapy in combination with doxorubicin — or as second-line or later if not used previously. Second, as a single agent for second-line or subsequent therapy.
The "or if not used previously" language in the first scenario matters. It gives your clinical team some flexibility if a patient skipped trabectedin plus doxorubicin up front. Document why it wasn't used first-line, and make that documentation available for prior authorization.
Soft tissue sarcoma — multiple subtypes, multiple rules
This is where the policy gets complex, and where most billing teams will hit trouble without a checklist.
Aetna breaks soft tissue sarcoma into four anatomic and histologic groupings, each with its own criteria:
| # | Covered Indication |
|---|---|
| 1 | Extremity/body wall, head/neck sarcoma — four separate coverage pathways exist here, including single-agent palliative care for advanced/metastatic disease, combination with doxorubicin for leiomyosarcoma, and single-agent use for myxoid liposarcoma in primary, neoadjuvant, or adjuvant settings. |
| 2 | Retroperitoneal/intra-abdominal sarcoma — Aetna covers single-agent trabectedin as palliative therapy, as adjuvant/neoadjuvant therapy for myxoid liposarcoma, and in combination with doxorubicin for leiomyosarcoma across multiple treatment lines. The policy notes that combination use with doxorubicin in later lines should factor in the patient's lifetime total doxorubicin dose — document this in your prior auth submission. |
| 3 | Advanced/metastatic pleomorphic rhabdomyosarcoma — single-agent palliative use as a subsequent line of therapy. |
| 4 | Three additional rare subtypes — solitary fibrous tumor, dedifferentiated liposarcoma, and epithelioid hemangioendothelioma each have single-agent coverage. Dedifferentiated liposarcoma coverage applies with or without concurrent well-differentiated liposarcoma. |
For all of these, as a general best practice for prior authorization submissions under complex sarcoma policies, document the specific subtype, the treatment line, and the proposed regimen. Thorough documentation supports medical necessity review and reduces the risk of denial.
Continuation of therapy
Aetna covers continued trabectedin billing when there is no evidence of unacceptable toxicity or disease progression. Build this criterion into your continuation authorization requests. A clinical note showing response or stable disease — with no documented toxicity requiring discontinuation — is the minimum standard.
Aetna Trabectedin Exclusions and Non-Covered Indications
Aetna states plainly that all indications not listed in the coverage criteria are experimental, investigational, or unproven. This is a closed list.
The real exposure here is off-label use for tumor types not named in the policy. Trabectedin has been studied in ovarian cancer, breast cancer, and other solid tumors. Aetna does not cover those uses under this policy. If your practice sees requests for trabectedin outside the listed sarcoma subtypes, expect denial.
Talk to your compliance officer before billing J9352 for any diagnosis outside the ICD-10 codes Aetna has listed under CPB 0903. General guidance on off-label appeals processes is outside the scope of this policy — your compliance officer or billing consultant can advise on your options.
Coverage Indications at a Glance
| Indication | Status | Relevant HCPCS Code | Notes |
|---|---|---|---|
| Uterine leiomyosarcoma — first-line, trabectedin + doxorubicin | Covered | J9352, J9000 | Or second-line if not used previously; document prior treatment history |
| Uterine leiomyosarcoma — second-line or later, single agent | Covered | J9352 | Document prior line(s) of therapy |
| Extremity/body wall/head/neck sarcoma — single agent, palliative, subsequent lines | Covered | J9352 | Advanced/metastatic with disseminated metastases required |
| Extremity/body wall/head/neck sarcoma — trabectedin + doxorubicin, palliative LMS | Covered | J9352, J9000 | Subsequent lines; document lifetime doxorubicin dose |
| Extremity/body wall/head/neck — single agent, myxoid liposarcoma (primary/neoadjuvant/adjuvant) | Covered | J9352 | Any treatment setting |
| Extremity/body wall/head/neck — first-line, trabectedin + doxorubicin, unresectable/metastatic LMS | Covered | J9352, J9000 | Unresectable or advanced/metastatic required |
| Retroperitoneal/intra-abdominal sarcoma — single agent palliative | Covered | J9352 | Unresectable/progressive after initial therapy, or stage IV with disseminated metastases |
| Retroperitoneal/intra-abdominal — single agent, myxoid liposarcoma (adjuvant/neoadjuvant) | Covered | J9352 | Document surgical context |
| Retroperitoneal/intra-abdominal — trabectedin + doxorubicin, LMS (first-line or progressive) | Covered | J9352, J9000 | Document lifetime doxorubicin dose for subsequent-line use |
| Advanced/metastatic pleomorphic rhabdomyosarcoma — single agent palliative | Covered | J9352 | Subsequent line only |
| Solitary fibrous tumor — single agent palliative | Covered | J9352 | — |
| Dedifferentiated liposarcoma — single agent | Covered | J9352 | With or without concurrent well-differentiated liposarcoma |
| Epithelioid hemangioendothelioma — single agent | Covered | J9352 | — |
| All other indications (e.g., ovarian cancer, breast cancer, other solid tumors) | Not Covered — Experimental/Investigational | — | Outside covered indications; consult your compliance officer |
Aetna Trabectedin Billing Guidelines and Action Items 2026
| # | Action Item |
|---|---|
| 1 | Update your prior authorization templates before January 15, 2026. As a general best practice for complex sarcoma policies, each authorization request for J9352 should specify the sarcoma subtype, the anatomic location, the line of therapy, and the proposed regimen (single agent vs. combination). Thorough documentation supports medical necessity review under this policy. |
| 2 | Document lifetime doxorubicin dose for every combination regimen. When billing J9352 alongside J9000 (doxorubicin) or Q2049/Q2050 (liposomal doxorubicin formulations) in later lines, Aetna explicitly flags cumulative dose as a consideration. Your clinical documentation must show this was reviewed. Missing it is an easy denial trigger. |
| 3 | Verify ICD-10-CM codes against the covered list before claim submission. This policy includes a long list of covered diagnosis codes. Cross-check every J9352 claim against Aetna's covered ICD-10 list. Submitting with a diagnosis code outside the covered set — even for a related tumor type — will result in claim denial. |
| 4 | Separate your CPT infusion codes correctly. Trabectedin administration bills under CPT 96413, 96414, 96415, or 96416 — all described in the policy as chemotherapy administration, intravenous infusion technique. For general guidance on sequencing these codes based on infusion duration and technique, refer to AMA CPT coding guidelines or consult your billing consultant. That guidance is not derived from this policy. |
| 5 | Build a continuation authorization checklist. Aetna covers continued trabectedin billing only when there is no evidence of disease progression or unacceptable toxicity. Your continuation auth requests need a clinical summary showing response or stable disease plus a toxicity review. Create a standard template your nursing or clinical team fills out at each cycle. |
| 6 | Flag dedifferentiated liposarcoma cases with co-occurring well-differentiated disease. Aetna's policy specifically calls out this combination. When both diagnoses appear in the chart, include both ICD-10 codes on the claim and reference them in the prior auth. This is one of the few policies that explicitly addresses this co-occurrence. |
| 7 | If your practice treats a high volume of rare sarcoma subtypes, talk to your compliance officer or billing consultant before the January 15, 2026 effective date. The line-of-therapy requirements across the retroperitoneal and extremity sarcoma subcategories are detailed enough that a pre-implementation audit is worth the time. |
| 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 Trabectedin Under CPB 0903
Covered CPT Codes — Chemotherapy Administration (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| 96413 | CPT | Chemotherapy administration, intravenous infusion technique |
| 96414 | CPT | Chemotherapy administration, intravenous infusion technique |
| 96415 | CPT | Chemotherapy administration, intravenous infusion technique |
| 96416 | CPT | Chemotherapy administration, intravenous infusion technique |
Covered HCPCS Codes (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| J9352 | HCPCS | Injection, trabectedin, 0.1 mg |
Other HCPCS Codes Related to CPB 0903
| Code | Type | Description |
|---|---|---|
| J9000 | HCPCS | Injection, doxorubicin hydrochloride, 10 mg |
| J9206 | HCPCS | Injection, irinotecan, 20 mg |
| Q2049 | HCPCS | Injection, doxorubicin hydrochloride, liposomal, imported Lipodox, 10 mg |
| Q2050 | HCPCS | Injection, doxorubicin hydrochloride, liposomal, not otherwise specified, 10 mg |
Note: J9206 (irinotecan) appears in the source policy as a related code but is not referenced in the coverage criteria as a combination agent with trabectedin. Do not infer a combination use relationship from its inclusion here.
Key ICD-10-CM Diagnosis Codes
The full covered diagnosis list for CPB 0903 includes 514 ICD-10-CM codes. The table below reflects the diagnostic categories represented in the policy data. Verify the complete list against the Aetna CPB 0903 source document before claim submission.
| Code Range | Description |
|---|---|
| C18.0–C19 | Malignant neoplasm of colon and rectum |
| C22.1 | Intrahepatic bile duct carcinoma (cholangiocarcinoma) |
| C24.0–C24.9 | Malignant neoplasm of other and unspecified parts of biliary tract (biliary tract carcinoma) |
| C25.0–C25.9 | Malignant neoplasm of pancreas |
| C34.0–C34.49 | Malignant neoplasm of bronchus and lung (including non-small cell lung cancer) |
The full ICD-10-CM list for this policy includes 514 codes spanning multiple cancer categories. Access the complete code set at the Aetna CPB 0903 source document. Do not bill J9352 with a diagnosis code outside the covered list.
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