Aetna modified CPB 1078 for datopotamab deruxtecan-dlnk (Datroway), effective March 5, 2026. Here's what billing teams need to act on now.
Aetna updated its Datroway coverage policy under CPB 1078 to add NSCLC as a covered indication alongside breast cancer. The policy governs HCPCS code J9011 (datopotamab deruxtecan-dlnk, 1 mg) and administration codes CPT 96413 and 96415. If your oncology or infusion billing team handles Aetna commercial claims for either of these tumor types, this change directly affects your prior authorization workflow and charge capture.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna |
| Policy | Datopotamab Deruxtecan-dlnk (Datroway) — CPB 1078 |
| Policy Code | CPB 1078 |
| Change Type | Modified |
| Effective Date | March 5, 2026 |
| Impact Level | High |
| Specialties Affected | Medical Oncology, Hematology/Oncology, Infusion Centers |
| Key Action | Update prior auth criteria templates for both breast cancer and NSCLC; confirm EGFR mutation documentation is in the chart before submitting J9011 claims |
Aetna Datroway Coverage Criteria and Medical Necessity Requirements 2026
Aetna's Datroway coverage policy under CPB 1078 now covers two indications: hormone receptor-positive (HR+), HER2-negative metastatic breast cancer and EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer. Both indications require prior authorization. Call (866) 752-7021 or fax (888) 267-3277 to start the precertification process.
Breast Cancer Criteria
For breast cancer, Aetna considers Datroway medically necessary when all three of these conditions are met:
| # | Covered Indication |
|---|---|
| 1 | The disease is unresectable or metastatic. |
| 2 | The cancer cells are hormone receptor positive and HER2-negative. |
| 3 | The member has received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. |
All three boxes must be checked. A patient who is HR+/HER2- but hasn't yet failed both endocrine therapy and chemotherapy won't meet medical necessity under this policy. Document treatment history in detail before you submit.
NSCLC Criteria
For non-small cell lung cancer, all three of these conditions must be met:
| # | Covered Indication |
|---|---|
| 1 | The disease is locally advanced or metastatic. |
| 2 | The tumor is EGFR mutation positive. |
| 3 | The member has received prior EGFR-directed therapy (Aetna gives osimertinib as an example) and platinum-based chemotherapy. |
The EGFR mutation requirement is the one most likely to generate a claim denial. If your oncologist ordered molecular testing and the results aren't in the precertification package, Aetna will reject it. Pull the EGFR testing results and include them upfront.
Continuation of Therapy
Reauthorization is available when there is no evidence of unacceptable toxicity or disease progression on the current regimen. This is standard language, but document it explicitly at each reauthorization interval. Vague clinical notes don't hold up in appeals.
Site of Care
Aetna's Site of Care Utilization Management Policy applies to Datroway infusions. This means Aetna may require infusion at a lower-cost site before approving a hospital outpatient setting. Check the site-of-care policy before you schedule the first infusion. Reimbursement rates and approval outcomes vary by site, and getting this wrong adds weeks to treatment start.
What This Coverage Policy Does Not Cover
Aetna considers all other indications for Datroway experimental, investigational, or unproven. This is a hard line. There are only two covered indications in this coverage policy: HR+/HER2- metastatic breast cancer and EGFR-positive NSCLC. Any off-label use — triple-negative breast cancer, other lung cancer subtypes, other solid tumors — will not be approved under CPB 1078 for commercial members.
Aetna Datroway Exclusions and Non-Covered Indications
The exclusion language here is broad by design. Aetna draws a bright line: if the indication isn't breast cancer meeting all three criteria or NSCLC meeting all three criteria, it's experimental.
This matters for oncology practices treating patients with HER2-low or TROP2-expressing tumors in other cancer types. Datroway is a TROP2-directed antibody-drug conjugate, and there is clinical interest in its use beyond these two approved indications. Under this policy, those uses won't get covered for Aetna commercial members. Don't waste time on a precertification request for an off-label indication — it won't pass.
If you believe a member has a compelling off-label case, loop in your compliance officer and billing consultant before submitting. A denial on an off-label claim can complicate appeals and flag the account for closer scrutiny.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| HR+/HER2- unresectable or metastatic breast cancer (post endocrine therapy + chemo) | Covered | J9011, CPT 96413, 96415 | Prior auth required; all three criteria must be met |
| EGFR mutation-positive locally advanced or metastatic NSCLC (post EGFR-directed therapy + platinum chemo) | Covered | J9011, CPT 96413, 96415 | Prior auth required; EGFR mutation documentation required |
| All other indications (off-label tumor types, other mutations, earlier-line use outside criteria) | Not Covered — Experimental/Investigational | J9011 | No coverage under CPB 1078 for commercial plans |
| Continuation of therapy (either covered indication) | Covered | J9011, CPT 96413, 96415 | Reauthorization requires no evidence of progression or unacceptable toxicity |
Aetna Datroway Billing Guidelines and Action Items 2026
The effective date is March 5, 2026. If you're already billing Datroway for breast cancer patients, verify that existing authorizations reflect the updated policy structure. For NSCLC patients, you're starting from scratch — no prior template exists in most practices.
Here are the specific steps your billing team needs to take:
| # | Action Item |
|---|---|
| 1 | Update your prior authorization templates immediately. You need separate templates for breast cancer and NSCLC. Each has three distinct criteria. A single generic oncology PA template will miss required fields and cause denials. |
| 2 | Add an EGFR mutation documentation checkpoint to your NSCLC workflow. Before any Datroway PA goes out for an NSCLC patient, confirm the EGFR mutation test result is on file and included in the submission. No result, no approval. |
| 3 | Verify treatment history documentation for breast cancer cases. Aetna requires prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease — not just any prior treatment. Document the specific agents, lines of therapy, and progression dates. |
| 4 | Confirm site of care before scheduling infusions. Aetna's site-of-care policy applies here. If you're billing from a hospital outpatient department, check whether Aetna requires a lower-cost site first. Getting denied at the site-of-care level delays treatment and burns staff time on appeals. |
| 5 | Set up your charge capture for J9011 alongside CPT 96413 and 96415. Bill J9011 per milligram of datopotamab deruxtecan-dlnk administered. Pair it with 96413 for the first hour of IV infusion and 96415 for each additional hour. These are the only administration codes listed in CPB 1078. |
| 6 | Build a reauthorization trigger in your scheduling system. Continuation of therapy requires reauthorization. Document no progression and no unacceptable toxicity at each interval. Don't let reauth lapse — a gap in authorization creates a billing gap. |
| 7 | Do not submit J9011 for off-label indications on Aetna commercial plans. The policy is explicit. Any indication outside the two covered indications is experimental. If your team sees a claim drafted for an NSCLC patient without EGFR mutation documentation or a breast cancer patient who hasn't failed prior therapy, stop it before it goes out. |
If your practice manages a high volume of oncology infusion billing across multiple payers, talk to your compliance officer before the effective date of March 5, 2026. The NSCLC indication in particular requires biomarker-level documentation that not every practice has built into its standard workflow.
| 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 Datroway Under CPB 1078
Covered HCPCS Code (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| J9011 | HCPCS | Injection, datopotamab deruxtecan-dlnk, 1 mg |
Administration CPT Codes (Related to CPB 1078)
| Code | Type | Description |
|---|---|---|
| 96413 | CPT | Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug |
| 96415 | CPT | Chemotherapy administration, IV infusion; each additional hour (list in addition to code for primary procedure) |
Key ICD-10-CM Diagnosis Codes
Aetna lists 84 ICD-10-CM codes across two cancer categories. Use the breast cancer codes for HR+/HER2- claims and the lung codes for EGFR-positive NSCLC claims. Confirm laterality and site specificity before billing — Aetna's code list is highly granular.
Lung Cancer (NSCLC) — C34.x Series (Representative Sample)
| Code | Description |
|---|---|
| C34.10 | Malignant neoplasm of bronchus and lung |
| C34.11 | Malignant neoplasm of bronchus and lung |
| C34.12 | Malignant neoplasm of bronchus and lung |
The full C34 range in this policy runs through C34.86, with 80 lung cancer codes in total. See CPB 1078 for the complete 84-code ICD-10-CM list, including all lung and breast cancer diagnosis codes.
A note on Datroway billing with these codes: the ICD-10 code alone won't carry the claim. Aetna requires the clinical criteria — HR+ status, HER2-negative status, prior therapy history for breast cancer, and EGFR mutation status plus prior therapy for NSCLC — to be documented in the medical record and reflected in the PA. The diagnosis code gets the claim in the door. The clinical documentation gets it paid.
Get the Full Picture for CPT 96413
Track this policy across versions, search 1,500+ policies by CPT code, and get real-time alerts when any payer changes coverage.