Aetna modified CPB 0900 for talimogene laherparepvec (Imlygic), effective September 26, 2025. Here's what billing teams need to know.
Aetna, a CVS Health company, updated Clinical Policy Bulletin 0900 covering J9325 (injection, talimogene laherparepvec, per 1 million plaque forming units) along with CPT codes 11900 and 11901 for intralesional injection. This Aetna talimogene laherparepvec coverage policy also flags three checkpoint inhibitors—ipilimumab (J9228), pembrolizumab (J9271), and nivolumab (J9299)—as not covered when billed in combination with Imlygic. If your oncology billing team handles melanoma or other solid tumor cases, this update affects your charge capture and prior authorization workflow now.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Talimogene Laherparepvec (Imlygic) |
| Policy Code | CPB 0900 |
| Change Type | Modified |
| Effective Date | September 26, 2025 |
| Impact Level | High |
| Specialties Affected | Oncology, Surgical Oncology, Dermatology, Hematology/Oncology |
| Key Action | Verify precertification is in place before billing J9325; do not bill J9228, J9271, or J9299 in combination with Imlygic on Aetna commercial claims |
Aetna Talimogene Laherparepvec Coverage Criteria and Medical Necessity Requirements 2025
The core structure of this coverage policy is straightforward: Imlygic is covered when selection criteria are met, and precertification is required without exception. There is no pathway around the prior authorization requirement for Aetna commercial plans.
Precertification calls go to (866) 752-7021. You can fax at (888) 267-3277. If you need a Statement of Medical Necessity form, pull it from Aetna's Specialty Pharmacy Precertification page before scheduling treatment.
The policy explicitly limits its scope to commercial medical plans. For Medicare Advantage or Part B members, Aetna directs providers to its separate Medicare Part B criteria. Do not assume this CPB 0900 Aetna policy governs Medicare-covered patients—it does not.
Medical necessity documentation must support the indication. The ICD-10 codes listed in this policy span malignant melanoma (C43.0–C43.9), a wide range of other malignant neoplasms, neuroendocrine tumors (C7A.0–C7A.8), and organ transplant recipients with cutaneous squamous cell carcinoma (C44.92 paired with Z94.x transplant status codes). Your documentation needs to match the covered indication exactly. A claim with the wrong ICD-10 pairing—even for a diagnosis that seems clinically similar—will deny.
The real issue with talimogene laherparepvec billing is that the drug (J9325) and the administration codes (11900, 11901, and chemotherapy administration codes 96401, 96405, 96406) must all align under a single authorization. Missing one piece creates a gap that triggers a claim denial on either the drug or the procedure.
Aetna Imlygic Exclusions and Non-Covered Indications
This is the section that will cost teams money if they miss it. Aetna explicitly excludes Imlygic in combination with three major checkpoint inhibitors:
| # | Excluded Procedure |
|---|---|
| 1 | J9228 — Ipilimumab (Yervoy): not covered in combination with Imlygic |
| 2 | J9271 — Pembrolizumab (Keytruda): not covered in combination with Imlygic |
| 3 | J9299 — Nivolumab (Opdivo): not covered in combination with Imlygic |
This is a hard exclusion. These aren't covered-with-criteria codes. Aetna has placed them in the "not covered for indications listed in the CPB" group. If your oncologist is running a combination regimen that pairs Imlygic with any of these agents, Aetna commercial will not reimburse the combination under this policy.
The combination exclusion reflects the current clinical evidence picture—combination trials have produced mixed results, and Aetna is drawing a firm line here. The practical problem for billing teams: these combinations do happen in practice, especially in academic or trial-adjacent settings. Flag this for your clinical and prior auth teams before claims go out.
Cemiplimab-rwlc (J9119) appears in the policy as a related code but is not placed in the covered or excluded groups. It sits in the "other HCPCS codes related to the CPB" category. Treat that as a warning—its coverage status for combination use is unresolved in this policy. Talk to your compliance officer before billing J9119 alongside J9325 on Aetna commercial claims.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Malignant melanoma (intralesional injection) | Covered when criteria met | J9325, 11900, 11901, C43.0–C43.9 | Precertification required |
| Other malignant neoplasms (broad range) | Covered when criteria met | J9325, C00.0–C96.9 range | Must meet medical necessity criteria; precertification required |
| Neuroendocrine tumors | Covered when criteria met | J9325, C7A.0–C7A.8 | Precertification required |
| Organ transplant recipients with cutaneous SCC | Covered when criteria met | J9325, C44.92 + Z94.x | Requires both C44.92 and appropriate Z94 transplant status code |
| Imlygic + Ipilimumab combination | Not covered | J9228 | Combination excluded under CPB 0900 |
| Imlygic + Pembrolizumab combination | Not covered | J9271 | Combination excluded under CPB 0900 |
| Imlygic + Nivolumab combination | Not covered | J9299 | Combination excluded under CPB 0900 |
| Cemiplimab-rwlc (J9119) in combination | Status unresolved | J9119 | Listed as related code only; not assigned covered or excluded status |
Aetna Talimogene Laherparepvec Billing Guidelines and Action Items 2025
| # | Action Item |
|---|---|
| 1 | Initiate precertification before the first treatment date. This is not optional under Aetna commercial plans. Call (866) 752-7021 or fax (888) 267-3277. No precertification means no reimbursement—Aetna is explicit about this requirement for all participating providers and members in applicable plan designs. |
| 2 | Pull the correct SMN form from Aetna's Specialty Pharmacy Precertification portal before September 26, 2025. Use the updated form that reflects the modified CPB 0900 criteria. Using an outdated form slows the authorization and can result in a denial based on incomplete documentation. |
| 3 | Update your charge capture to bill J9325 per 1 million plaque forming units. Dose units matter for accurate reimbursement. Undercoding the units is a common error with per-unit HCPCS codes—audit your charge entry workflow now. |
| 4 | Pair J9325 with the correct administration code based on lesion count. Use CPT 11900 for up to and including seven lesions. Use CPT 11901 for more than seven lesions. Both are covered when selection criteria are met. Get this wrong and you're looking at a claim denial on the procedure side even if the drug auth is clean. |
| 5 | Block J9228, J9271, and J9299 from being co-billed with J9325 on Aetna commercial claims. Build a charge capture edit or claim scrubbing rule before the September 26, 2025 effective date. These combinations are not covered under this coverage policy, and a clean claim today becomes a denial and potential takebacks issue tomorrow. |
| 6 | Verify ICD-10 pairing for transplant recipients. If your patient has cutaneous squamous cell carcinoma (C44.92) and is an organ transplant recipient, you need the corresponding Z94.x transplant status code on the claim. The Z94 codes run from Z94.0 through Z94.9. Missing the secondary diagnosis code removes the clinical justification for coverage. |
| 7 | Confirm whether your Aetna member is on a commercial plan before using CPB 0900 criteria. If the patient is Medicare or Medicare Advantage, this bulletin does not apply. Using the wrong criteria set to build a prior auth request wastes time and produces a denial. Check the plan type first. |
If your team handles a high volume of oncology claims with checkpoint inhibitor combinations, loop in your compliance officer now. The combination exclusions in this policy create real exposure for practices running Imlygic alongside pembrolizumab or nivolumab off-label.
| 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 Talimogene Laherparepvec Under CPB 0900
Covered CPT Codes (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| 11900 | CPT | Injection, intralesional; up to and including 7 lesions |
| 11901 | CPT | More than 7 lesions |
Other CPT Codes Related to CPB 0900
| Code | Type | Description |
|---|---|---|
| 96401 | CPT | Chemotherapy administration, subcutaneous, intramuscular or intralesional |
| 96405 | CPT | Chemotherapy administration, subcutaneous, intramuscular or intralesional |
| 96406 | CPT | Chemotherapy administration, subcutaneous, intramuscular or intralesional |
Covered HCPCS Codes (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| J9325 | HCPCS | Injection, talimogene laherparepvec, per 1 million plaque forming units |
Not Covered HCPCS Codes (Combination with Imlygic)
| Code | Type | Description | Reason |
|---|---|---|---|
| J9228 | HCPCS | Injection, ipilimumab, 1 mg | Not covered in combination with Imlygic under CPB 0900 |
| J9271 | HCPCS | Injection, pembrolizumab, 1 mg | Not covered in combination with Imlygic under CPB 0900 |
| J9299 | HCPCS | Injection, nivolumab, 1 mg | Not covered in combination with Imlygic under CPB 0900 |
Other HCPCS Codes Related to CPB 0900
| Code | Type | Description |
|---|---|---|
| J9119 | HCPCS | Injection, cemiplimab-rwlc, 1 mg |
Key ICD-10-CM Diagnosis Codes
| Code | Description |
|---|---|
| C43.0–C43.9 | Malignant melanoma of skin (all anatomic sites) |
| C44.92 | Squamous cell carcinoma of skin, unspecified (organ transplant recipients) |
| C7A.0–C7A.8 | Malignant neuroendocrine tumors |
| C00.0–C43.9 | Malignant neoplasms (broad range) |
| C44.00–C76.8 | Malignant neoplasms (broad range) |
| C80.0–C96.9 | Malignant neoplasms (broad range) |
| Z94.0 | Kidney transplant status |
| Z94.1 | Heart transplant status |
| Z94.2 | Lung transplant status |
| Z94.3 | Heart and lungs transplant status |
| Z94.4 | Liver transplant status |
| Z94.5 | Skin transplant status |
| Z94.6 | Bone transplant status |
| Z94.7 | Corneal transplant status |
| Z94.8 | Other transplanted organ and tissue status |
| Z94.9 | Transplanted organ and tissue status, unspecified |
Get the Full Picture for CPT 11900
Track this policy across versions, search 1,500+ policies by CPT code, and get real-time alerts when any payer changes coverage.