Lifileucel (Amtagvi) — CPB 1056 | AETNA Coverage Update

Aetna modified CPB 1056 for lifileucel (Amtagvi), effective September 26, 2025. Here's what billing teams need to do.

Aetna, a CVS Health company, updated its lifileucel (Amtagvi) coverage policy under CPB 1056 Aetna system on September 26, 2025. This change affects billing for advanced unresectable or metastatic melanoma treatment across commercial plans. If your team bills for cell therapy infusion using CPT 96413, 96414, or 96415, or if you're working with HCPCS J9271 or J9299 alongside this therapy, this policy requires your immediate attention.

Quick-Reference Table

Aetna Lifileucel Coverage Criteria and Medical Necessity Requirements 2025

The Aetna lifileucel (Amtagvi) coverage policy applies to commercial medical plans only. For Medicare criteria, Aetna directs providers to its separate Medicare Part B step-therapy requirements — CPB 1056 does not govern those claims.

Precertification is mandatory. Every Aetna participating provider and member in an applicable plan must get prior authorization before lifileucel is administered. Contact National Medical Excellence (NME) at 877-212-8811 to initiate precertification. Don't assume your standard oncology prior auth workflow applies here — NME is a separate pathway, and using the wrong channel will cost you time.

The medical necessity threshold for this therapy is high by design. Lifileucel is a tumor-infiltrating lymphocyte (TIL) cell therapy — a one-time, patient-specific infusion manufactured from the patient's own tumor tissue. The pre-treatment workup is extensive and directly tied to reimbursement. That workup includes pulmonary function testing (CPT 94150 for vital capacity, CPT 94375 for respiratory flow volume loop, CPT 94618 for 6-minute walk test, and CPT 94726 for plethysmography), renal function panel (CPT 80069), and BRAF gene analysis (CPT 81210). These aren't optional add-ons — they're clinical prerequisites that support medical necessity documentation for the cell therapy itself.

Pembrolizumab (J9271) and nivolumab (J9299) appear in the code set because checkpoint inhibitor failure is likely part of the prior treatment pathway. Whether Aetna considers prior checkpoint inhibitor therapy a coverage requirement, your documentation supporting medical necessity must show the patient's treatment history clearly.

Aetna Lifileucel Site-of-Care Requirements and GCIT Network 2025

This is the part of the Aetna lifileucel coverage policy that will catch billing teams off guard. Unless a member's health plan has specifically opted out of the requirement, lifileucel must be administered at an Aetna Institutes® Gene Based, Cellular and Other Innovative Therapy (GCIT®) Network facility.

This is not a soft preference. If your facility isn't designated as a GCIT network site and the member's plan hasn't waived the requirement, the claim will not be covered. A claim denial here isn't recoverable after the fact — you can't retroactively change where the infusion happened.

Check the Aetna Institutes® GCIT Designated Networks list before scheduling any patient for lifileucel. The list is available through Aetna's drug infusion site-of-care policy page. Build this verification step into your prior auth workflow at NME, not as a separate afterthought.

The "unless the plan has elected not to require" language is intentionally vague. If you're not certain whether a specific member's plan has waived the GCIT requirement, call NME at 877-212-8811 and get a clear answer in writing before the infusion date.

Coverage Indications at a Glance

Aetna Lifileucel Billing Guidelines and Action Items 2025

1. Route all precertification requests through NME — not standard prior auth channels.
Call 877-212-8811. This is the only pathway Aetna accepts for lifileucel precertification. Build NME's contact directly into your oncology scheduling workflow. Any case involving lifileucel billing should trigger this step before anything else.

2. Verify GCIT network status for your facility before September 26, 2025 is in your rearview.
If you haven't already confirmed your facility's designation, do it now. The effective date has passed. If your facility isn't listed, you need a plan — either refer out or confirm the specific member's plan has waived the requirement. Get that confirmation in writing.

3. Attach pre-treatment workup codes to the prior auth request with supporting documentation.
CPT 80069, 81210, 94150, 94375, 94618, and 94726 are part of the clinical record that establishes medical necessity. Don't bill them in isolation — they should appear in the patient's chart as documented prerequisites supporting the lifileucel treatment decision.

4. Confirm ICD-10 specificity on every claim.
The covered diagnosis codes span C43.0 through C43.9 for cutaneous melanoma and C69.30 through C69.42 for uveal/ocular melanoma. Use the most specific code for the site. Unspecified codes (C43.9) leave room for denial on specificity grounds when more precise codes are available.

5. Bill lymphodepleting chemotherapy infusion correctly before the lifileucel infusion.
Lifileucel protocols require lymphodepleting chemotherapy before the cell infusion. Use CPT 96413 for the initial infusion hour, 96414 for each additional sequential drug, and 96415 for each additional hour. These codes need to be linked to the same care episode in your documentation.

6. Don't apply CPB 1056 to Medicare patients.
If a patient is Medicare-enrolled, Aetna's Medicare Part B step-therapy criteria govern coverage — not this CPB. Using CPB 1056 criteria for a Medicare claim is the wrong framework. Check the patient's coverage type before pulling from this policy.

7. Flag BRAF mutation status in the chart.
CPT 81210 (BRAF gene analysis) is in the code set. This matters for treatment pathway documentation, especially when pembrolizumab (J9271) or nivolumab (J9299) are part of the prior treatment history. BRAF status affects whether targeted therapy was indicated before lifileucel.

If you're unsure how this policy applies to your specific plan mix or patient population, loop in your compliance officer before submitting. Cell and gene therapy claims carry high dollar exposure, and a denied claim here isn't a simple rebill.

CPT, HCPCS, and ICD-10 Codes for Lifileucel (Amtagvi) Under CPB 1056

CPT Codes

HCPCS Codes

Key ICD-10-CM Diagnosis Codes