Aetna modified CPB 0974 for ado-trastuzumab emtansine (Kadcyla), effective January 23, 2026. Here's what billing teams need to know now.
Aetna, a CVS Health company, updated CPB 0974 — its coverage policy for Kadcyla — on January 23, 2026. This policy governs Kadcyla billing across breast cancer, non-small cell lung cancer (NSCLC), and salivary gland tumor indications. The primary HCPCS code for this drug is J9354 (injection, ado-trastuzumab emtansine, 1 mg), administered under CPT 96413 and related infusion codes. If your oncology or infusion billing team handles Aetna commercial claims for any of these diagnoses, this update changes what you can get approved and paid for.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Ado-trastuzumab emtansine (Kadcyla) — CPB 0974 |
| Policy Code | CPB 0974 |
| Change Type | Modified |
| Effective Date | January 23, 2026 |
| Impact Level | High |
| Specialties Affected | Oncology, Hematology-Oncology, Infusion Therapy, Specialty Pharmacy |
| Key Action | Verify prior auth criteria match updated indications for NSCLC and salivary gland tumors before billing J9354 |
Aetna Kadcyla Coverage Criteria and Medical Necessity Requirements 2026
The CPB 0974 Aetna system governs precertification and medical necessity for Kadcyla across all Aetna commercial plans. Medicare members fall under a separate pathway — check Aetna's Part B criteria page for those cases.
Precertification is required for every Aetna commercial member receiving Kadcyla, regardless of indication. Call (866) 752-7021 or fax (888) 267-3277 to initiate prior authorization. You can also access SMN precertification forms through Aetna's Specialty Pharmacy Precertification portal. Don't skip this step — missing precertification is the fastest path to a claim denial on J9354.
Aetna's coverage policy also enforces a Site of Care Utilization Management Policy for Kadcyla. That means the location where infusion occurs — office, outpatient hospital, infusion center — is subject to review. If your team bills 96413 for a site Aetna deems avoidable, expect pushback. Confirm site-of-care compliance before scheduling infusions.
Breast Cancer Medical Necessity Criteria
Aetna covers Kadcyla for four distinct breast cancer scenarios. Each has its own conditions, and billing the wrong one is a straight denial.
Subsequent treatment: HER2-positive metastatic or recurrent breast cancer, or HER2-positive breast cancer with no response to preoperative systemic therapy. Use as a single agent.
First-line therapy: HER2-positive metastatic or recurrent breast cancer when taxane-based therapy is unsuitable. Can be billed as a single agent or in combination with pertuzumab (J9306). This is the only breast cancer indication where a combination regimen gets coverage.
Adjuvant treatment: HER2-positive breast cancer, single agent only, approved for up to 12 months total. Reauthorization stops at the 12-month cap — no exceptions.
Brain metastases: HER2-positive breast cancer, as a single agent or in combination with neratinib. Neratinib has no specific HCPCS code listed in this policy, so confirm billing instructions with your pharmacy team before submitting claims.
NSCLC Medical Necessity Criteria
This is the tightest set of criteria in the policy. All three conditions must be met simultaneously for coverage:
| # | Covered Indication |
|---|---|
| 1 | The disease is recurrent, advanced, or metastatic. |
| 2 | Kadcyla is used as a single agent. |
| 3 | The member has not progressed on a prior HER2-targeted drug. |
That third criterion is the one to watch. The policy cites Enhertu (fam-trastuzumab deruxtecan-nxki, J9358) as an example of a HER2-targeted drug that would trigger this criterion. Other HER2-targeted therapies may also apply — document the full treatment history and confirm with the prior auth reviewer. Don't assume clinical rationale will override it.
Salivary Gland Tumor Medical Necessity Criteria
Coverage here is straightforward: recurrent, unresectable, or metastatic HER2-positive salivary gland tumors, single agent only. Relevant ICD-10 codes include C07 (malignant neoplasm of parotid gland) and C08.0 through C08.9 (other major salivary gland malignancies). This is a narrower patient population, but the criteria are clean and the documentation requirements are manageable.
Aetna Kadcyla Exclusions and Non-Covered Indications
Aetna is direct: any indication not listed in Section I of CPB 0974 is considered experimental, investigational, or unproven. There is no gray area here.
This matters most for NSCLC cases where a patient has already progressed on a HER2-targeted therapy. Those claims won't get approved. Build a pre-auth screening step around that prior therapy question before the case ever reaches your billing team.
Combination regimens in breast cancer are also tightly controlled. Pertuzumab combination is only approved for first-line metastatic or recurrent breast cancer when taxane is unsuitable. Neratinib combination is only approved for brain metastases. Any other combination request — even if clinically reasonable — lands in experimental territory under this policy.
Coverage Indications at a Glance
| Indication | Status | Key HCPCS/ICD-10 | Notes |
|---|---|---|---|
| HER2+ metastatic/recurrent breast cancer — subsequent treatment | Covered | J9354 | Single agent only; prior auth required |
| HER2+ breast cancer, no response to preoperative therapy | Covered | J9354 | Single agent only; prior auth required |
| HER2+ metastatic/recurrent breast cancer — first-line, taxane unsuitable | Covered | J9354, J9306 (combo with pertuzumab) | Only covered combo regimen for breast cancer |
| Adjuvant HER2+ breast cancer | Covered (12-month cap) | J9354 | Single agent; reauth stops at 12 months total |
| Brain metastases in HER2+ breast cancer | Covered | J9354 + neratinib (no HCPCS listed) | Single agent or with neratinib; confirm neratinib billing separately |
| HER2-mutated recurrent/advanced/metastatic NSCLC | Covered | J9354 | Single agent; must not have progressed on a HER2-targeted drug (e.g., Enhertu, J9358) |
| HER2+ recurrent/unresectable/metastatic salivary gland tumor | Covered | J9354; C07, C08.x | Single agent only |
| Any other indication | Not Covered | — | Considered experimental/investigational by Aetna |
Aetna Kadcyla Billing Guidelines and Action Items 2026
The effective date on this policy is January 23, 2026. Any claim for Kadcyla billed to Aetna commercial plans after that date falls under these criteria. Here's what to do now.
| # | Action Item |
|---|---|
| 1 | Audit your open prior auth requests against the updated NSCLC criteria. If any pending NSCLC cases involve patients who previously received a HER2-targeted therapy — Enhertu (J9358) is one example, but others may also apply — those won't get approved. Pull those cases now, flag them for your oncologist, and don't bill J9354 until you have a compliant clinical rationale or a covered indication. Confirm the full treatment history with the prior auth reviewer before submitting. |
| 2 | Set a hard 12-month tracker for every adjuvant breast cancer case. Aetna will not approve reauthorization past 12 months total for adjuvant treatment. Build this into your authorization management system. If you're tracking manually, add a calendar alert at month 10 to assess where each patient stands. |
| 3 | Confirm site of care before scheduling infusions. The Site of Care Utilization Management Policy applies to all Kadcyla infusions under Aetna commercial plans. Before billing 96413 or 96365 for a new patient, verify the approved infusion site with Aetna. An unapproved site is a reimbursement problem you can't fix after the fact. |
| 4 | Verify ICD-10 codes against the updated covered indication list. For NSCLC, confirm you're using codes that reflect HER2 (ERBB2)-mutated recurrent, advanced, or metastatic disease. For salivary gland tumors, use C07 or the appropriate C08 subcategory. Mismatched diagnosis codes are a primary driver of claim denial on oncology drug claims. |
| 5 | Clarify neratinib billing before submitting brain metastasis claims. Neratinib has no listed HCPCS code in CPB 0974. If your team is billing a combination regimen of J9354 plus neratinib for brain metastases, confirm the correct billing code for neratinib with your specialty pharmacy and Aetna rep before submitting. An unrecognized or missing HCPCS code will hold up the claim. |
| 6 | Document combination regimen justification in the medical record. For first-line metastatic or recurrent breast cancer with pertuzumab (J9306), you need clear documentation that taxane-based therapy is unsuitable. "Unsuitable" needs clinical support in the chart — not just a checkbox. Aetna reviewers will look for this on reauthorization. |
| 7 | If your patient mix includes complex multi-indication cases, loop in your compliance officer. This policy has narrow criteria across three cancer types, and the interaction between covered and non-covered scenarios (especially for NSCLC and combination regimens) creates real exposure. Don't let a billing team make those calls alone. |
| 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 Ado-Trastuzumab Emtansine Under CPB 0974
HCPCS Codes — Covered When Criteria Are Met
| Code | Type | Description |
|---|---|---|
| J9354 | HCPCS | Injection, ado-trastuzumab emtansine, 1 mg |
| J9306 | HCPCS | Injection, pertuzumab, 1 mg |
| J9355 | HCPCS | Trastuzumab, 10 mg |
| J9358 | HCPCS | Injection, fam-trastuzumab deruxtecan-nxki (Enhertu), 1 mg |
Note: J9306 applies only to the first-line breast cancer combination regimen. J9358 (Enhertu) is referenced in the NSCLC exclusion criteria as an example of a HER2-targeted drug — prior use of a HER2-targeted therapy blocks coverage for Kadcyla in NSCLC. Other HER2-targeted drugs may also trigger this exclusion; confirm the full treatment history with the prior auth reviewer. Neratinib has no HCPCS code listed in this policy.
CPT Codes — Drug Administration (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| 96365 | CPT | IV infusion for therapy/prophylaxis/diagnosis, initial |
| 96366 | CPT | IV infusion, each additional hour |
| 96372 | CPT | Therapeutic/prophylactic/diagnostic injection, subcutaneous or intramuscular |
| 96401 | CPT | Chemotherapy administration |
| 96402 | CPT | Chemotherapy administration |
| 96403 | CPT | Chemotherapy administration |
| 96404 | CPT | Chemotherapy administration |
| 96405 | CPT | Chemotherapy administration |
| 96406 | CPT | Chemotherapy administration |
| 96407 | CPT | Chemotherapy administration |
| 96408 | CPT | Chemotherapy administration |
| 96409 | CPT | Chemotherapy administration |
| 96410 | CPT | Chemotherapy administration |
| 96411 | CPT | Chemotherapy administration |
| 96412 | CPT | Chemotherapy administration |
| 96413 | CPT | Chemotherapy administration |
| 96414 | CPT | Chemotherapy administration |
| 96415 | CPT | Chemotherapy administration |
| 96416 | CPT | Chemotherapy administration |
| 96417 | CPT | Chemotherapy administration |
| 96418 | CPT | Chemotherapy administration |
| 96419 | CPT | Chemotherapy administration |
| 96420 | CPT | Chemotherapy administration |
| 96421 | CPT | Chemotherapy administration |
| 96422 | CPT | Chemotherapy administration |
| 96423 | CPT | Chemotherapy administration |
| 96424 | CPT | Chemotherapy administration |
| 96425 | CPT | Chemotherapy administration |
| 96426 | CPT | Chemotherapy administration |
| 96427 | CPT | Chemotherapy administration |
| 96428 | CPT | Chemotherapy administration |
| 96429 | CPT | Chemotherapy administration |
| 96430 | CPT | Chemotherapy administration |
| 96431 | CPT | Chemotherapy administration |
| 96432 | CPT | Chemotherapy administration |
| 96433 | CPT | Chemotherapy administration |
| 96434 | CPT | Chemotherapy administration |
| 96435 | CPT | Chemotherapy administration |
| 96436 | CPT | Chemotherapy administration |
| 96437 | CPT | Chemotherapy administration |
| 96438 | CPT | Chemotherapy administration |
| 96439 | CPT | Chemotherapy administration |
| 96440 | CPT | Chemotherapy administration |
| 96441 | CPT | Chemotherapy administration |
| 96442 | CPT | Chemotherapy administration |
| 96443 | CPT | Chemotherapy administration |
| 96444 | CPT | Chemotherapy administration |
| 96445 | CPT | Chemotherapy administration |
| 96446 | CPT | Chemotherapy administration |
| 96447 | CPT | Chemotherapy administration |
| 96448 | CPT | Chemotherapy administration |
| 96449 | CPT | Chemotherapy administration |
| 96450 | CPT | Chemotherapy administration |
Key ICD-10-CM Diagnosis Codes
The codes listed here are a representative subset. The full CPB 0974 code set includes 141 ICD-10-CM codes. Reference the complete policy for the full list before submitting claims.
| Code | Description |
|---|---|
| C07 | Malignant neoplasm of parotid gland [HER2 positive] |
| C08.0 | Malignant neoplasm of other and unspecified major salivary glands [HER2 positive] |
| C08.1 | Malignant neoplasm of other and unspecified major salivary glands [HER2 positive] |
| C08.2 | Malignant neoplasm of other and unspecified major salivary glands [HER2 positive] |
| C08.3 | Malignant neoplasm of other and unspecified major salivary glands [HER2 positive] |
| C08.4 | Malignant neoplasm of other and unspecified major salivary glands [HER2 positive] |
| C08.5 | Malignant neoplasm of other and unspecified major salivary glands [HER2 positive] |
| C08.6 | Malignant neoplasm of other and unspecified major salivary glands [HER2 positive] |
| C08.7 | Malignant neoplasm of other and unspecified major salivary glands [HER2 positive] |
| C08.8 | Malignant neoplasm of other and unspecified major salivary glands [HER2 positive] |
| C08.9 | Malignant neoplasm of other and unspecified major salivary glands [HER2 positive] |
| C16.0–C16.9 | Malignant neoplasm of stomach (multiple subcategories) |
| C18.0–C18.1 | Malignant neoplasm of colon (subcategories) |
⚠️ Important: Stomach (C16.x) and colon (C18.x) codes are present in the CPB 0974 code set but do not correspond to any covered indication listed in this policy. Do not use these codes to support Kadcyla claims without explicit guidance from your compliance officer and Aetna.
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