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
1Cutaneous 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
2Chronic graft-versus-host disease (GVHD) — as add-on therapy with systemic corticosteroids after no response to first-line treatment
3Neuroblastoma — per CPB 0895 criteria for dinutuximab (Unituxin)
+ 1 more indications

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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):

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
+ 6 more indications

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This policy is now in effect (since 2025-12-11). Verify your claims match the updated criteria above.

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 more action items

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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.


Sample Version Diff Line-by-line changes
Previous VersionCurrent Version
Coverage is considered experimental and investigational for all indicationsCoverage is considered medically necessary when specific criteria are met
Prior authorization is not requiredPrior authorization is required for initial treatment
Documentation must include clinical historyDocumentation must include clinical history
+ 1 more action items

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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)
+ 17 more codes

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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
+ 17 more codes

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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.


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