TL;DR: Aetna modified CPB 0995 for amivantamab-vmjw (Rybrevant), effective September 26, 2025. Billing teams need to confirm prior authorization is in place and that HCPCS J9061 claims are supported by EGFR mutation documentation before submitting.
Aetna, a CVS Health company, updated its amivantamab-vmjw coverage policy under CPB 0995 Aetna system, effective September 26, 2025. This bispecific antibody targets EGFR and MET mutations and is used primarily in non-small cell lung cancer (NSCLC). The core codes in play are HCPCS J9061 (amivantamab-vmjw, 2 mg per unit), CPT 81235 for EGFR gene analysis, and chemotherapy administration codes 96413–96417. If your practice bills oncology or infusion services for Aetna commercial members, this policy change belongs on your radar now.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Amivantamab-vmjw (Rybrevant) — CPB 0995 |
| Policy Code | CPB 0995 |
| Change Type | Modified |
| Effective Date | September 26, 2025 |
| Impact Level | High |
| Specialties Affected | Medical oncology, hematology/oncology, infusion centers, pulmonology |
| Key Action | Confirm precertification for all J9061 claims and verify EGFR molecular testing (CPT 81235) is documented before the effective date |
Aetna Amivantamab-vmjw Coverage Criteria and Medical Necessity Requirements 2025
The Aetna amivantamab-vmjw coverage policy under CPB 0995 applies to commercial medical plan members only. Medicare criteria live separately — see Aetna's Medicare Part B step therapy page for those guidelines. Do not apply commercial CPB 0995 criteria to Medicare Advantage claims.
Precertification is required for every Aetna participating provider and member in applicable plan designs. No exceptions. You call (866) 752-7021 or fax (888) 267-3277 to initiate prior authorization. Statement of Medical Necessity (SMN) forms are available through Aetna's Specialty Pharmacy Precertification portal.
The medical necessity foundation for J9061 claims rests on confirmed EGFR mutation status. CPT 81235 — EGFR gene analysis for common variants in non-small cell lung cancer — is the molecular testing code tied to this drug's coverage logic. If you're submitting J9061 without documented EGFR mutation results in the medical record, expect a claim denial. That's not a guess; it's how Aetna's oncology medical necessity criteria consistently work for targeted therapies.
The ICD-10 code set supporting this policy is heavy on NSCLC (C34.x series, 112 codes total across the policy). Aetna also includes esophageal malignancies (C15.x) and gastric malignancies (C16.x) in the covered diagnosis set — worth knowing if your oncology practice treats upper GI cancers alongside thoracic cases. Map your diagnosis codes precisely. Submitting a C34.10 when the chart supports C34.11 won't cause a denial by itself, but sloppy ICD-10 specificity invites additional documentation requests.
Reimbursement for amivantamab-vmjw billing flows through the infusion administration codes alongside J9061. CPT 96413 covers the initial hour of chemotherapy infusion. CPT 96414 covers each additional sequential hour of a different drug. CPT 96415 covers additional hours of the same drug. CPT 96416 covers initiation of a prolonged infusion (more than eight hours) requiring a pump. CPT 96417 covers each additional sequential drug infusion over 15 minutes. Your charge capture needs to reflect the actual infusion sequence — Aetna's coverage policy does not give you latitude to default to a single code.
Aetna Amivantamab-vmjw Exclusions and Non-Covered Indications
The policy data flags a specific subset of HCPCS codes under a separate coverage group label tied to lazertinib, osimertinib (Tagrisso), and combination regimens. Codes J9045 (carboplatin), J9060 (cisplatin), J9263 (oxaliplatin), and the full pemetrexed family (J9294, J9296, J9297, J9305, J9314, J9322, J9323, J9324) fall under that group label — "no specific criteria met" is the language in the policy data.
The real issue here: these platinum and pemetrexed codes represent the chemotherapy backbone used in combination regimens with amivantamab. Aetna separates them from J9061 in the coverage groupings. This does not mean they are universally denied, but it does mean they do not automatically ride J9061's coverage approval. If your practice bills combination regimens, verify that the precertification request covers the full regimen — not just the amivantamab component.
Osimertinib (Tagrisso) and lazertinib claims for Aetna commercial members are governed by a different policy framework. Do not assume CPB 0995 approval covers those agents. Billing them together under one auth without confirming scope is how you generate a split claim denial three months later.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| NSCLC with EGFR mutation (commercial members) | Covered when criteria met | J9061, CPT 81235, C34.x, 96413–96417 | Prior authorization required; EGFR mutation documentation required |
| Esophageal malignancy | Covered when criteria met | J9061, C15.x | Verify plan design includes this indication |
| Gastric malignancy | Covered when criteria met | J9061, C16.x | Verify plan design includes this indication |
| Amivantamab + platinum/pemetrexed combination regimen | No specific criteria listed; verify separately | J9045, J9060, J9263, J9294–J9324 | Auth must explicitly cover combination agents; do not assume ride-along coverage |
| Lazertinib or osimertinib (Tagrisso) | Not covered under CPB 0995 | — | Governed by separate Aetna policy; do not bill under this auth |
| Medicare members | Not applicable | — | Use Aetna Medicare Part B step therapy criteria instead |
Aetna Amivantamab-vmjw Billing Guidelines and Action Items 2025
| # | Action Item |
|---|---|
| 1 | Submit precertification before September 26, 2025 for any pending cases. Call (866) 752-7021 or fax (888) 267-3277. For members already on therapy, confirm that existing auths remain valid under the modified policy. Do not assume a standing auth covers the updated criteria. |
| 2 | Pull CPT 81235 documentation for every J9061 claim. EGFR gene analysis results must be in the chart. If the molecular test was done at an outside lab, get the report into your record before the claim goes out. Missing documentation is the most common driver of medical necessity denials on targeted oncology agents. |
| 3 | Audit your infusion charge capture for 96413–96417. These codes need to reflect actual infusion time and sequence, not a default. If your practice bills a single 96413 for every amivantamab infusion, review the actual administration records. Under-billing and over-billing both create problems — under-billing leaves money on the table, over-billing generates post-payment audits. |
| 4 | Verify precertification scope covers combination agents. If you're billing J9061 alongside pemetrexed (J9294, J9296, J9297, J9305, J9314, J9322, or J9323), carboplatin (J9045), or cisplatin (J9060), confirm your auth explicitly includes those codes. The policy separates them from J9061 coverage. One auth does not automatically cover all agents in a combination regimen. |
| 5 | Separate commercial and Medicare member workflows. CPB 0995 governs commercial members only. Medicare members follow a different pathway — Aetna's Medicare Part B step therapy criteria. If your billing team processes both in the same queue, add a flag at charge entry to route them correctly. A commercial-criteria precertification applied to a Medicare claim is a denial waiting to happen. |
| 6 | Pull and save SMN forms from Aetna's Specialty Pharmacy Precertification portal. These forms document the clinical justification Aetna requires. Keep them in the patient file tied to the service dates. If Aetna requests post-service documentation, you want these immediately accessible — not buried in a portal you'll need to re-access under a deadline. |
| 7 | If your payer mix is heavy Aetna commercial oncology, loop in your compliance officer before the September 26 effective date. The combination regimen coverage ambiguity in this policy — specifically the separation of J9061 from the platinum and pemetrexed codes — is the kind of gray area that generates audit exposure. Your compliance officer should review your precertification and billing workflows for combination cases specifically. |
| 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 Amivantamab-vmjw Under CPB 0995
Covered HCPCS Code (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| J9061 | HCPCS | Injection, amivantamab-vmjw, 2 mg |
HCPCS Codes — Combination Regimen Agents (No Specific Criteria Listed)
| Code | Type | Description |
|---|---|---|
| J9045 | HCPCS | Injection, carboplatin, 50 mg |
| J9060 | HCPCS | Injection, cisplatin, powder or solution, 10 mg |
| J9263 | HCPCS | Injection, oxaliplatin, 0.5 mg |
| J9294 | HCPCS | Injection, pemetrexed (Hospira), not therapeutically equivalent to J9305, 10 mg |
| J9296 | HCPCS | Injection, pemetrexed (Accord), not therapeutically equivalent to J9305, 10 mg |
| J9297 | HCPCS | Injection, pemetrexed (Sandoz), not therapeutically equivalent to J9305, 10 mg |
| J9305 | HCPCS | Injection, pemetrexed, not otherwise specified, 10 mg |
| J9314 | HCPCS | Injection, pemetrexed (Teva), not therapeutically equivalent to J9305, 10 mg |
| J9322 | HCPCS | Injection, pemetrexed (Bluepoint), not therapeutically equivalent to J9305, 10 mg |
| J9323 | HCPCS | Injection, pemetrexed ditromethamine, 10 mg |
| J9324 | HCPCS | Injection, pemetrexed (Pemrydi RTU), 10 mg |
CPT Codes Related to CPB 0995
| Code | Type | Description |
|---|---|---|
| 81235 | CPT | EGFR gene analysis, common variants (e.g., non-small cell lung cancer) |
| 96413 | CPT | Chemotherapy administration, intravenous infusion technique — up to one hour, single or initial substance/drug |
| 96414 | CPT | Chemotherapy administration — each additional sequential infusion of a different substance/drug, up to one hour |
| 96415 | CPT | Chemotherapy administration — each additional hour |
| 96416 | CPT | Chemotherapy administration — initiation of prolonged chemotherapy infusion (more than eight hours), requiring use of a portable or implantable pump |
| 96417 | CPT | Chemotherapy administration — each additional sequential infusion of a new substance/drug, up to 15 minutes |
Key ICD-10-CM Diagnosis Codes
| Code | Description |
|---|---|
| C15.3 | Malignant neoplasm of esophagus |
| C15.4 | Malignant neoplasm of esophagus |
| C15.5 | Malignant neoplasm of esophagus |
| C15.6 | Malignant neoplasm of esophagus |
| C15.7 | Malignant neoplasm of esophagus |
| C15.8 | Malignant neoplasm of esophagus |
| C15.9 | Malignant neoplasm of esophagus |
| C16.0 | Malignant neoplasm of stomach |
| C16.1 | Malignant neoplasm of stomach |
| C16.2 | Malignant neoplasm of stomach |
| C16.3 | Malignant neoplasm of stomach |
| C16.4 | Malignant neoplasm of stomach |
| C16.5 | Malignant neoplasm of stomach |
| C16.6 | Malignant neoplasm of stomach |
| C16.7 | Malignant neoplasm of stomach |
| C16.8 | Malignant neoplasm of stomach |
| C16.9 | Malignant neoplasm of stomach |
| C34.0 | Malignant neoplasm of bronchus and lung (NSCLC) |
| C34.1 | Malignant neoplasm of bronchus and lung (NSCLC) |
| C34.10 | Malignant neoplasm of upper lobe, bronchus or lung, unspecified side |
| C34.11 | Malignant neoplasm of upper lobe, right bronchus or lung |
| C34.12 | Malignant neoplasm of upper lobe, left bronchus or lung |
| C34.13 | Malignant neoplasm of upper lobe, bilateral |
| C34.14–C34.19 | Malignant neoplasm of upper lobe, bronchus or lung (additional specificity codes) |
| C34.2 | Malignant neoplasm of middle lobe, bronchus or lung |
| C34.20–C34.29 | Malignant neoplasm of middle lobe variants |
| C34.3 | Malignant neoplasm of lower lobe, bronchus or lung |
| C34.30–C34.39 | Malignant neoplasm of lower lobe variants |
| C34.4 | Malignant neoplasm of bronchus and lung (other part) |
| C34.40–C34.49 | Other part of bronchus and lung variants |
The full ICD-10-CM list contains 112 codes. The C34.x series covers the complete NSCLC laterality and lobe specificity set. Use the most specific code supported by the medical record.
Get the Full Picture for CPT 81235
Track this policy across versions, search 1,500+ policies by CPT code, and get real-time alerts when any payer changes coverage.