TL;DR: Aetna, a CVS Health company, modified CPB 0873 governing temsirolimus (Torisel) coverage, effective October 11, 2025. Here's what billing teams need to know before the next claim goes out.
Aetna's updated temsirolimus coverage policy under CPB 0873 in the Aetna system defines exactly which oncology indications qualify for medical necessity approval — and which ones will get denied. The policy covers HCPCS code J9330 (temsirolimus injection, 1 mg) as the primary billable drug code, with administration billed under CPT codes 96409, 96413, 96414, 96415, 96416, and 96417. If your practice treats patients with renal cell carcinoma, mantle cell lymphoma, endometrial carcinoma, soft tissue sarcoma, or uterine sarcoma on Aetna plans, this policy directly controls your reimbursement.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Temsirolimus (Torisel) — CPB 0873 |
| Policy Code | CPB 0873 |
| Change Type | Modified |
| Effective Date | October 11, 2025 |
| Impact Level | High |
| Specialties Affected | Oncology, Hematology, Gynecologic Oncology, Urology |
| Key Action | Audit all active temsirolimus treatment plans against the approved indication list and confirm J9330 is coded with a covered ICD-10 before submitting |
Aetna Temsirolimus Coverage Criteria and Medical Necessity Requirements 2025
Aetna considers temsirolimus (Torisel or generic temsirolimus) medically necessary for a specific, closed list of indications. This is not a broad-use policy. Every claim must map to one of the covered diagnoses — or it will be denied.
Here are the five approved categories under this coverage policy:
1. Advanced Renal Cell Carcinoma
Temsirolimus is covered for treatment of advanced renal cell carcinoma. The policy does not restrict to a specific line of therapy for this indication. Pair J9330 with ICD-10 codes C64.1–C65.9.
2. Endometrial Carcinoma
Aetna covers temsirolimus as a single agent for subsequent-line treatment of locally advanced, recurrent, or metastatic endometrial carcinoma. "Subsequent treatment" is doing real work here — this is not a first-line indication. ICD-10 C54.1 applies for endometrial carcinoma specifically.
3. Soft Tissue Sarcoma — Two Distinct Paths
This is the most complex part of the policy. Aetna covers two different soft tissue sarcoma scenarios, and the billing setup differs between them.
| # | Covered Indication |
|---|---|
| 1 | Single-agent therapy for locally advanced unresectable or metastatic perivascular epithelioid cell tumor (PEComa), recurrent angiomyolipoma, or recurrent lymphangioleiomyomatosis. Bill J9330 alone. |
| 2 | Combination therapy for non-pleomorphic rhabdomyosarcoma, temsirolimus combined with cyclophosphamide and vinorelbine. You'll bill J9330 alongside cyclophosphamide (J9073, J9074, J9075, or J9076 depending on manufacturer) and vinorelbine (J9390). Your ICD-10 codes in the C49.x range cover soft tissue sarcoma sites. |
If you're billing the combination regimen, your charge capture needs all three drug codes, plus the appropriate administration codes under CPT 96413–96417 for the infusion components.
4. Relapsed or Refractory Mantle Cell Lymphoma
Temsirolimus is covered for relapsed or refractory mantle cell lymphoma. ICD-10 codes C83.10 through C83.19 apply for mantle cell lymphoma by nodal region. Confirm the patient has prior treatment documented — "relapsed or refractory" requires medical record support.
5. Advanced or Recurrent Uterine Sarcoma (PEComa)
Aetna covers temsirolimus as a single agent for subsequent treatment of advanced, recurrent/metastatic, or inoperable PEComa of uterine origin. This is distinct from the soft tissue sarcoma PEComa indication above — it's uterine-specific and uses ICD-10 codes in the C53–C55 range.
Continuation of Therapy
Aetna's continuation criteria are straightforward. Once a patient qualifies under an approved indication, Aetna will continue to cover temsirolimus as long as there's no unacceptable toxicity and no disease progression. Document both of these at each renewal. A claim denial at the continuation stage usually means the supporting documentation didn't address one of those two conditions.
Aetna Temsirolimus Exclusions and Non-Covered Indications
Aetna's position is direct: all indications not listed in the approved section are considered experimental, investigational, or unproven.
The ICD-10 code table attached to this policy includes diagnosis codes for conditions like hepatoblastoma (C22.2), pancreatic malignancies (C25.x), salivary gland tumors (C07, C08.x), oropharyngeal cancers (C10.x, C11.x), retinal malignancies (C69.20–C69.22), and thyroid cancer (C73). These appear in the policy's broader code set but are not listed as covered indications.
The real issue here is this: the presence of a diagnosis code in the policy's ICD-10 table does not mean Aetna covers temsirolimus for that diagnosis. Those codes appear in the policy's reference data, but they don't map to an approved indication. Submit a claim pairing J9330 with C73 (thyroid cancer) and you're looking at a denial.
If your oncologist is using temsirolimus off-label for one of these diagnoses, talk to your compliance officer before billing. The medical necessity standard under this coverage policy is explicit, and off-label use without supporting clinical evidence will not meet it.
Coverage Indications at a Glance
| Indication | Status | Relevant HCPCS/ICD-10 | Notes |
|---|---|---|---|
| Advanced renal cell carcinoma | Covered | J9330 / C64.1–C65.9 | No line-of-therapy restriction stated |
| Locally advanced, recurrent, or metastatic endometrial carcinoma | Covered | J9330 / C54.1 | Single agent only; subsequent-line treatment |
| Locally advanced unresectable/metastatic PEComa (soft tissue) | Covered | J9330 / C49.x | Single agent only |
| Recurrent angiomyolipoma | Covered | J9330 / C49.x | Single agent only |
| Recurrent lymphangioleiomyomatosis | Covered | J9330 / C49.x | Single agent only |
| Non-pleomorphic rhabdomyosarcoma | Covered | J9330 + J9073–J9076 + J9390 / C49.x | Combination with cyclophosphamide and vinorelbine |
| Relapsed or refractory mantle cell lymphoma | Covered | J9330 / C83.10–C83.19 | Prior treatment required; document relapse/refractory status |
| Advanced, recurrent/metastatic or inoperable uterine PEComa | Covered | J9330 / C53–C55 | Single agent; subsequent-line treatment |
| All other indications (thyroid, pancreatic, salivary gland, oropharyngeal, retinal, hepatoblastoma, etc.) | Experimental / Not Covered | — | No coverage under current CPB 0873 |
Aetna Temsirolimus Billing Guidelines and Action Items 2025
The effective date for this modified policy is October 11, 2025. Claims submitted on or after that date are subject to the updated criteria. Here's what your billing team should do now.
| # | Action Item |
|---|---|
| 1 | Audit all active temsirolimus treatment plans before October 11, 2025. Confirm each active patient explicitly maps to one of the five approved indications using the same language Aetna uses in CPB 0873. Vague clinical descriptions won't hold up. |
| 2 | Update your charge capture for the rhabdomyosarcoma combination regimen. If you treat non-pleomorphic rhabdomyosarcoma patients, your charge capture must include J9330 (temsirolimus), J9073/J9074/J9075/J9076 (cyclophosphamide — pick the right brand-specific code), and J9390 (vinorelbine). Missing any of these from the claim creates a partial billing problem and a reimbursement gap. |
| 3 | Train your coders on the PEComa distinction. The policy covers PEComa in two separate indication buckets — soft tissue (C49.x) and uterine (C53–C55). The clinical context determines which ICD-10 range you use. Mixing them up doesn't just risk a denial — it's a documentation accuracy issue. |
| 4 | Document "subsequent treatment" and "relapsed or refractory" status in the medical record before billing. Aetna's medical necessity criteria for endometrial carcinoma, uterine sarcoma, and mantle cell lymphoma all require evidence of prior treatment failure. If the notes don't support it, the claim won't survive a review. |
| 5 | Flag any off-label use immediately. If a physician is prescribing temsirolimus for a diagnosis outside the five covered categories, do not submit to Aetna without first consulting your compliance officer. The temsirolimus billing exposure on a denied specialty drug claim is significant. Get ahead of it. |
| 6 | Check continuation-of-therapy documentation at every visit. Aetna requires no evidence of unacceptable toxicity and no disease progression to continue coverage. Build these two checkpoints into your clinical documentation workflow now — don't wait for a denial to discover the gap. |
| 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 Temsirolimus Under CPB 0873
Covered HCPCS Codes (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| J9330 | HCPCS | Injection, temsirolimus, 1 mg (Torisel) |
Other HCPCS Codes Related to CPB 0873
These codes apply to the cyclophosphamide + vinorelbine combination regimen for rhabdomyosarcoma.
| Code | Type | Description |
|---|---|---|
| J9073 | HCPCS | Injection, cyclophosphamide (Ingenus), 5 mg |
| J9074 | HCPCS | Injection, cyclophosphamide (Sandoz), 5 mg |
| J9075 | HCPCS | Injection, cyclophosphamide, not otherwise specified, 5 mg |
| J9076 | HCPCS | Injection, cyclophosphamide (Baxter), 5 mg |
| J9390 | HCPCS | Injection, vinorelbine tartrate, 10 mg |
CPT Administration Codes
| Code | Type | Description |
|---|---|---|
| 96409 | CPT | Chemotherapy administration; intravenous, push technique, single or initial substance/drug |
| 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 |
| 96417 | CPT | Chemotherapy administration; intravenous infusion technique |
Key ICD-10-CM Diagnosis Codes
| Code | Description |
|---|---|
| C64.1–C65.9 | Malignant neoplasm of kidney and renal pelvis |
| C54.1 | Malignant neoplasm of endometrium |
| C53.0–C55 | Malignant neoplasm of uterus (uterine sarcoma/PEComa) |
| C49.0–C49.9 | Malignant neoplasm of connective and soft tissue |
| C83.10 | Mantle cell lymphoma, unspecified site |
| C83.11 | Mantle cell lymphoma, lymph nodes of head, face, and neck |
| C83.12 | Mantle cell lymphoma, intrathoracic lymph nodes |
| C83.13 | Mantle cell lymphoma, intra-abdominal lymph nodes |
| C83.14 | Mantle cell lymphoma, lymph nodes of axilla and upper limb |
| C57.0–C57.2 | Malignant neoplasm of fallopian tube |
| C07 | Malignant neoplasm of parotid gland |
| C08.0–C08.9 | Malignant neoplasm of other major salivary glands |
| C10.0–C10.9 | Malignant neoplasm of oropharynx |
| C11.0–C11.9 | Malignant neoplasm of nasopharynx |
| C22.2 | Hepatoblastoma |
| C25.0–C25.9 | Malignant neoplasm of pancreas |
| C69.20–C69.22 | Malignant neoplasm of retina |
| C73 | Malignant neoplasm of thyroid gland |
Note: C07, C08.x, C10.x, C11.x, C22.2, C25.x, C69.20–C69.22, and C73 appear in the policy's ICD-10 reference data but do not correspond to covered indications under CPB 0873. Billing J9330 against these codes will result in a claim denial under Aetna's medical necessity criteria.
Get the Full Picture for CPT 96413
Track this policy across versions, search 1,500+ policies by CPT code, and get real-time alerts when any payer changes coverage.