Aetna modified CPB 0024 for aldesleukin (Proleukin), effective December 11, 2025. Here's what billing teams need to know before submitting claims.
Aetna, a CVS Health company, updated its aldesleukin coverage policy under CPB 0024 Aetna system to add a new covered indication tied to Amtagvi (lifileucel), an FDA-approved tumor-infiltrating lymphocyte therapy. The primary billing code affected is J9015 (injection, aldesleukin, per single use vial), administered via intravenous infusion codes 96413–96417. If your oncology billing team handles metastatic melanoma cases, this change directly affects your claim submission process.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna |
| Policy | Aldesleukin (Proleukin) — CPB 0024 |
| Policy Code | CPB 0024 |
| Change Type | Modified |
| Effective Date | December 11, 2025 |
| Impact Level | High |
| Specialties Affected | Oncology, Hematology/Oncology, Pediatric Oncology, Transplant Medicine |
| Key Action | Update workflows to capture Amtagvi sequencing for metastatic melanoma claims using J9015 before billing aldesleukin post-Amtagvi infusion |
Aetna Aldesleukin Coverage Criteria and Medical Necessity Requirements 2025
The core of this coverage policy change is a new sub-indication under metastatic cutaneous melanoma. Aetna now covers aldesleukin intravenous administration for up to six doses following Amtagvi (lifileucel) infusion, for unresectable or metastatic cutaneous melanoma. This is a meaningful expansion — and it comes with a specific dose ceiling you need to document.
Before this update, melanoma coverage under CPB 0024 was limited to high-dose single-agent subsequent therapy for metastatic or unresectable disease. That criterion still stands. The new Amtagvi-sequencing indication runs alongside it, not in place of it. You now have two distinct pathways for melanoma coverage under this policy.
For initial approval, Aetna considers aldesleukin intravenous medically necessary for four conditions:
| # | Covered Indication |
|---|---|
| 1 | Cutaneous melanoma — either as high-dose single-agent subsequent therapy for metastatic or unresectable disease, or for up to six doses following Amtagvi infusion for unresectable or metastatic disease |
| 2 | Chronic graft-versus-host disease (GVHD) — as add-on therapy with systemic corticosteroids after no response to first-line treatment |
| 3 | Neuroblastoma — per CPB 0895 criteria for dinutuximab (Unituxin) |
| 4 | Metastatic renal cell carcinoma |
The Amtagvi sequencing criterion is the change that drove this update. Amtagvi does not yet have a dedicated HCPCS code. The policy groups a cluster of corticosteroid HCPCS codes (J0702, J1020, J1030, J1040, J1094, J1100, J1700, J1710, J1720, J2650, J2920, J2930, J3300, J3301, J3302, J3303, J7509, J7510, J7512, J8540) under an "Amtagvi – no specific code" designation, indicating no dedicated Amtagvi billing code exists within this policy. The clinical role of these codes in the Amtagvi context is not defined in the policy text. That's notable for billing: if your team needs to document the Amtagvi infusion that precedes aldesleukin, there is no specific Amtagvi code to anchor the claim sequence. Work with your billing consultant to establish consistent documentation practices before the effective date of December 11, 2025.
Prior authorization workflows for specialty oncology drugs are common with Aetna — confirm PA requirements directly with Aetna for each patient case, as CPB 0024 does not specify PA requirements within the policy text. Given the new sequencing requirement — aldesleukin after Amtagvi — expect reviewers to look for documentation confirming Amtagvi was administered before the aldesleukin course. Build that into your auth requests now.
Aetna Aldesleukin Continuation of Therapy Requirements 2025
Continuation criteria differ by indication, and these details drive claim denials at the second and third courses of therapy. Know these before you bill.
For renal cell carcinoma and cutaneous melanoma (single-agent subsequent treatment):
- Evaluate the member for response approximately four weeks after completing a course
- Evaluate again immediately before the next treatment course begins
- Only continue if there is some tumor shrinkage after the last course
- Retreatment must not be contraindicated
- Separate each treatment course by at least seven weeks from the date of hospital discharge
These are Aetna's exact criteria. "Some tumor shrinkage" is the standard — not complete response, not stable disease. Document partial response specifically. A claim for a second course without documented tumor shrinkage will not survive a medical necessity review.
For chronic GVHD: Continuation requires symptom improvement and no unacceptable toxicity. Straightforward — but your notes need to capture both elements explicitly.
For neuroblastoma: Continuation is covered when there is no evidence of unacceptable toxicity or disease progression on the current regimen.
Aetna Aldesleukin Exclusions and Non-Covered Indications
Aetna considers all indications for aldesleukin outside the four listed above as experimental, investigational, or unproven. That's a broad exclusion. Any off-label use — bladder cancer, colorectal cancer, HIV, or other immune-modulating applications — will not meet medical necessity under this coverage policy.
Two HCPCS codes appear on the "not covered" list regardless of selection criteria: J0480 (basiliximab, 20 mg) and J7513 (daclizumab, parenteral, 25 mg). These are IL-2 receptor antagonists sometimes used in combination protocols or GVHD management. Aetna is drawing a clear line — those drugs don't get coverage under CPB 0024, even when aldesleukin itself is approved.
Subcutaneous and intramuscular chemotherapy administration codes 96401 and 96402 are also explicitly not covered for the indications listed in this policy. Aldesleukin must be administered intravenously to meet these criteria. If you see a claim for subcutaneous aldesleukin administration under this policy, it will deny.
Coverage Indications at a Glance
| Indication | Status | Key Code(s) | Notes |
|---|---|---|---|
| Cutaneous melanoma — high-dose single-agent subsequent therapy, metastatic or unresectable | Covered | J9015, 96413–96417 | Must meet continuation criteria for 2nd+ courses |
| Cutaneous melanoma — post-Amtagvi infusion, up to 6 doses | Covered (NEW) | J9015, 96413–96417 | No specific Amtagvi HCPCS code; document Amtagvi infusion in clinical notes |
| Chronic graft-versus-host disease (GVHD) — add-on after no response to first-line | Covered | J9015, 96413–96417 | Must use with systemic corticosteroids; continuation requires symptom improvement |
| Neuroblastoma | Covered | J9015, 96413–96417 | See CPB 0895 for dinutuximab criteria |
| Metastatic renal cell carcinoma | Covered | J9015, 96413–96417 | Strict 7-week rest period between courses; tumor shrinkage required to continue |
| All other indications (off-label, investigational) | Not Covered | — | Considered experimental/investigational/unproven |
| Basiliximab (J0480) | Not Covered | J0480 | Explicitly excluded under CPB 0024 |
| Daclizumab (J7513) | Not Covered | J7513 | Explicitly excluded under CPB 0024 |
| Subcutaneous/IM administration (96401, 96402) | Not Covered | 96401, 96402 | IV route required; these codes denied for listed indications |
Aetna Aldesleukin Billing Guidelines and Action Items 2025
| # | Action Item |
|---|---|
| 1 | Update your prior authorization templates before December 11, 2025. Add a field specifically for Amtagvi administration date and confirmation. Confirm PA requirements directly with Aetna for each patient case, as CPB 0024 does not specify PA requirements within the policy text. For the new melanoma indication, reviewers will need to see that Amtagvi was given before aldesleukin. If your auth request doesn't capture this, you'll get delays or denials. |
| 2 | Confirm IV route documentation on every aldesleukin claim. CPT codes 96413, 96414, 96415, 96416, and 96417 are your covered administration codes. Codes 96401 and 96402 (subcutaneous or intramuscular) are explicitly not covered under this policy. Check your charge capture to make sure the correct route is coded every time. |
| 3 | Build a response evaluation checkpoint into your melanoma and renal cell carcinoma workflows. Continuation approval requires documented tumor response approximately four weeks after each course. If your oncology coordinators aren't scheduling that evaluation and documenting it explicitly in the chart, your second-course claims are vulnerable. Set a calendar trigger — it's a simple fix that prevents a predictable claim denial. |
| 4 | Flag the seven-week rest period for renal cell carcinoma and melanoma retreatment. Aetna requires at least seven weeks between courses, measured from the date of hospital discharge. If your billing team submits a prior auth for retreatment before that window closes, expect a denial. Build a date-check into your scheduling workflow tied to discharge date. |
| 5 | Document "some tumor shrinkage" precisely in your clinical notes. Vague language like "tolerated well" or "patient stable" won't satisfy Aetna's continuation criteria. Notes should state specifically that tumor shrinkage was observed on post-treatment imaging. This is the phrase Aetna's policy uses — match it in your documentation. |
| 6 | Do not bill J0480 or J7513 under this policy. Those codes are explicitly excluded under CPB 0024. If basiliximab or daclizumab is used in the treatment regimen, do not bundle them into an aldesleukin claim. Separate billing routes apply, and your compliance officer should confirm how those are handled under Aetna's other applicable policies. |
| 7 | Review ICD-10 coding for Amtagvi-sequenced melanoma claims. The full ICD-10-CM code set under this policy spans 660 codes. For metastatic cutaneous melanoma, confirm ICD-10 code selection with your coding team against the complete code list in CPB 0024 — specific applicable codes are not enumerated in the policy summary available to billing teams and must be verified against the full policy document. The six-dose limit for post-Amtagvi aldesleukin requires dose-counting documentation — track this at the patient level, not just at the claim level. |
If your team handles a high volume of melanoma or renal cell carcinoma cases billed to Aetna, run an audit of your current aldesleukin claims before December 11, 2025. Compare your documentation practices against the continuation criteria above. If anything is unclear about how this applies to your patient mix, talk to your compliance officer before the effective date.
| 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 Aldesleukin (Proleukin) Under CPB 0024
Covered HCPCS Code (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| J9015 | HCPCS | Injection, aldesleukin, per single use vial |
CPT Codes — Not Covered for Indications Listed in CPB 0024
| Code | Type | Description |
|---|---|---|
| 96401 | CPT | Chemotherapy administration, subcutaneous or intramuscular |
| 96402 | CPT | Chemotherapy administration, subcutaneous or intramuscular |
CPT Codes — Other Codes Related to CPB 0024
| Code | Type | Description |
|---|---|---|
| 96365 | CPT | Intravenous infusion, for therapy, prophylaxis, or diagnosis |
| 96366 | CPT | Intravenous infusion, for therapy, prophylaxis, or diagnosis (additional hour) |
| 96367 | CPT | Intravenous infusion, for therapy, prophylaxis, or diagnosis (additional sequential) |
| 96368 | CPT | Intravenous infusion, for therapy, prophylaxis, or diagnosis (concurrent) |
| 96369 | CPT | Subcutaneous infusion, for therapy, prophylaxis, or diagnosis |
| 96370 | CPT | Subcutaneous infusion, for therapy, prophylaxis, or diagnosis (additional hour) |
| 96371 | CPT | Subcutaneous infusion, for therapy, prophylaxis, or diagnosis (additional pump) |
| 96374 | CPT | Therapeutic, prophylactic, or diagnostic injection (IV push, single) |
| 96375 | CPT | Therapeutic, prophylactic, or diagnostic injection (IV push, each additional) |
| 96376 | CPT | Therapeutic, prophylactic, or diagnostic injection (IV push, facility) |
| 96379 | CPT | Unlisted therapeutic, prophylactic, or diagnostic intravenous or intra-arterial injection or infusion |
| 96405 | CPT | Chemotherapy administration; intralesional, up to and including 7 lesions |
| 96406 | CPT | Chemotherapy administration; intralesional, more than 7 lesions |
| 96409 | CPT | Chemotherapy administration; intravenous, push technique, single or initial substance/drug |
| +96411 | CPT | Chemotherapy administration; intravenous, push technique, each additional substance/drug |
| 96413 | CPT | Chemotherapy administration; intravenous infusion technique, up to 1 hour |
| 96414 | CPT | Chemotherapy administration; intravenous infusion technique, each additional hour |
| 96415 | CPT | Chemotherapy administration; intravenous infusion technique, each additional hour (infusion) |
| 96416 | CPT | Chemotherapy administration; intravenous infusion technique, initiation of prolonged infusion |
| 96417 | CPT | Chemotherapy administration; intravenous infusion technique, each additional sequential infusion |
HCPCS Codes — Not Covered Under CPB 0024
| Code | Type | Description |
|---|---|---|
| J0480 | HCPCS | Injection, basiliximab, 20 mg |
| J7513 | HCPCS | Daclizumab, parenteral, 25 mg |
HCPCS Codes — Amtagvi-Related (No Specific Amtagvi Code)
| Code | Type | Description |
|---|---|---|
| J0702 | HCPCS | Injection, betamethasone acetate 3 mg and betamethasone sodium phosphate 3 mg |
| J1020 | HCPCS | Injection, methylprednisolone acetate, 20 mg |
| J1030 | HCPCS | Injection, methylprednisolone acetate, 40 mg |
| J1040 | HCPCS | Injection, methylprednisolone acetate, 80 mg |
| J1094 | HCPCS | Injection, dexamethasone acetate, 1 mg |
| J1100 | HCPCS | Injection, dexamethasone sodium phosphate, 1 mg |
| J1700 | HCPCS | Injection, hydrocortisone acetate, up to 25 mg |
| J1710 | HCPCS | Injection, hydrocortisone sodium phosphate, up to 50 mg |
| J1720 | HCPCS | Injection, hydrocortisone sodium succinate, up to 100 mg |
| J2650 | HCPCS | Injection, prednisolone acetate, up to 1 ml |
| J2920 | HCPCS | Injection, methylprednisolone sodium succinate, up to 40 mg |
| J2930 | HCPCS | Injection, methylprednisolone sodium succinate, up to 125 mg |
| J3300 | HCPCS | Injection, triamcinolone acetonide, preservative free, 1 mg |
| J3301 | HCPCS | Injection, triamcinolone acetonide, not otherwise specified, 10 mg |
| J3302 | HCPCS | Injection, triamcinolone diacetate, per 5 mg |
| J3303 | HCPCS | Injection, triamcinolone hexacetonide, per 5 mg |
| J7509 | HCPCS | Methylprednisolone, oral, per 4 mg |
| J7510 | HCPCS | Prednisolone, oral, per 5 mg |
| J7512 | HCPCS | Prednisone, immediate release or delayed release, oral, 1 mg |
| J8540 | HCPCS | Dexamethasone, oral, 0.25 mg |
The policy groups these codes under an "Amtagvi – no specific code" designation, indicating no dedicated Amtagvi billing code exists within this policy. The clinical role of these codes in the Amtagvi context is not defined in the policy text.
Key ICD-10-CM Diagnosis Codes
The full ICD-10-CM code set spans 660 codes. Verify specific applicable codes against the full policy document at CPB 0024 on PayerPolicy. The presence of infectious disease codes (A00.0–B99.9) in the code set reflects contraindication documentation — active infections are a basis for denying aldesleukin therapy, not a covered indication.
Get the Full Picture
Track this policy across versions, search 1,500+ policies by CPT code, and get real-time alerts when any payer changes coverage.