Aetna Updated CPB 0917 for Durvalumab (Imfinzi) — What Billing Teams Need to Know in 2025
TL;DR: Aetna, a CVS Health company, modified CPB 0917 covering durvalumab (Imfinzi) billing, effective December 6, 2025. This update expands the covered indications across multiple oncology specialties and tightens the biomarker-based eligibility criteria that determine whether J9173 claims will pass precertification review.
This coverage policy governs HCPCS J9173 (injection, durvalumab, 10 mg) across a wide range of cancers — from NSCLC and SCLC to biliary tract, cervical, and head and neck cancers. If your oncology or hematology billing team submits claims under J9173 and bills administration through CPT codes 96413–96417, this update requires your immediate attention. The criteria are detailed, mutation-specific, and easy to get wrong under time pressure.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Durvalumab (Imfinzi) — CPB 0917 |
| Policy Code | CPB 0917 |
| Change Type | Modified |
| Effective Date | December 6, 2025 |
| Impact Level | High |
| Specialties Affected | Medical oncology, thoracic oncology, GI oncology, gynecologic oncology, head and neck oncology |
| Key Action | Audit all pending and future J9173 precertification requests against the updated biomarker exclusion and combination therapy criteria before submitting |
Aetna Durvalumab Coverage Criteria and Medical Necessity Requirements 2025
The Aetna durvalumab coverage policy under CPB 0917 in the Aetna system requires precertification for every member in an applicable plan design. There are no exceptions. Call (866) 752-7021 or fax (888) 267-3277 to initiate precertification. For Statement of Medical Necessity forms, use the Specialty Pharmacy Precertification portal.
The site of care utilization management policy also applies. Where a member receives the infusion matters — Aetna's drug infusion site-of-care policy governs this separately from CPB 0917 itself.
Non-Small Cell Lung Cancer (NSCLC)
This is the most complex section of the policy. There are three distinct NSCLC pathways, and each one has its own biomarker and combination therapy requirements.
Unresectable Stage II or III NSCLC: Aetna considers durvalumab medically necessary as a single agent when the tumor tests negative for EGFR exon 19 deletion and exon 21 L858R mutations and the member completed concurrent platinum-based chemotherapy and radiation without disease progression. CPT 81235 (EGFR gene analysis) is listed in this policy — that test result is a hard gate. No negative EGFR result, no approval.
Recurrent, Advanced, or Metastatic NSCLC: The member must be negative for EGFR exon 19 deletion, exon 21 L858R mutations, and ALK, RET, and ROS1 rearrangements. Durvalumab is covered here in combination with tremelimumab-actl (J9347) and platinum-based chemotherapy, or as maintenance therapy — either as a single agent or combined with pemetrexed (J9304 or J9305).
Resectable NSCLC: Covered as neoadjuvant treatment combined with platinum-containing chemotherapy, then continued as adjuvant single-agent therapy post-surgery. Same biomarker exclusions apply: negative EGFR, ALK, RET, and ROS1.
The real issue with the NSCLC section is how many prior authorization requests will fail because the biomarker documentation wasn't pulled into the clinical record before submission. Make CPT 81235 results a required field in your precertification workflow.
Small Cell Lung Cancer (SCLC)
Two pathways here. For extensive-stage SCLC, durvalumab is covered as first-line treatment in combination with etoposide (J9181) and carboplatin (J9045) or cisplatin (J9060), followed by single-agent maintenance. For limited-stage SCLC, it's covered as adjuvant consolidation — single agent — when the member did not progress on systemic therapy with concurrent radiation.
Biliary Tract Cancer
Covered in combination with cisplatin or carboplatin and gemcitabine (J9196, J9198, or J9201) for locally advanced, unresectable, or metastatic biliary tract cancer. This includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer. Also covered for disease recurrence after surgery and adjuvant therapy.
Cervical Cancer
Covered for persistent, recurrent, or metastatic small cell neuroendocrine carcinoma of the cervix (NECC) in combination with etoposide and cisplatin or carboplatin, continued as single-agent maintenance.
Aetna Durvalumab Exclusions and Non-Covered Indications
Aetna's exclusion here is short but absolute. Members who experienced disease progression while on any PD-1 or PD-L1 inhibitor therapy are not eligible for durvalumab. Full stop.
This matters operationally because durvalumab itself is a PD-L1 inhibitor. A member who progressed on pembrolizumab (J9271), nivolumab (J9299), atezolizumab (J9022), avelumab (J9023), or cemiplimab-rwlc (J9119) — all listed in the policy — will be denied. Those codes appear in the policy precisely because Aetna expects prior therapy history to be documented and reviewed before approval.
If your clinical team is considering durvalumab for a patient who already failed a checkpoint inhibitor, this is a denial waiting to happen. Flag it before it goes to precertification.
Coverage Indications at a Glance
| Indication | Status | Key Codes | Notes |
|---|---|---|---|
| Unresectable Stage II/III NSCLC (post chemoradiation, no progression) | Covered | J9173, CPT 81235 | Single agent only; EGFR exon 19/21 negative required |
| Recurrent/advanced/metastatic NSCLC | Covered | J9173, J9347, J9304, J9305 | Must be negative for EGFR, ALK, RET, ROS1; combo with tremelimumab + chemo or maintenance |
| Resectable NSCLC (neoadjuvant + adjuvant) | Covered | J9173, CPT 81235 | Neoadjuvant with platinum chemo; adjuvant as single agent; EGFR/ALK/RET/ROS1 negative |
| Extensive-stage SCLC (first-line) | Covered | J9173, J9181, J9045, J9060 | Combo with etoposide + carboplatin or cisplatin; followed by single-agent maintenance |
| Limited-stage SCLC (adjuvant consolidation) | Covered | J9173 | Single agent; no disease progression after chemoradiation |
| Biliary tract cancer (locally advanced, unresectable, metastatic) | Covered | J9173, J9045, J9060, J9196, J9198, J9201 | Combo with cisplatin or carboplatin + gemcitabine; includes recurrence after surgery/adjuvant therapy |
| Cervical cancer — NECC | Covered | J9173, J9181, J9045, J9060 | Combo with etoposide + cisplatin or carboplatin; continued as single-agent maintenance |
| Disease progression on PD-1/PD-L1 inhibitor | Not Covered | J9173 | Absolute exclusion; prior checkpoint inhibitor failure disqualifies |
Aetna Durvalumab Billing Guidelines and Action Items 2025
The effective date of December 6, 2025 is already past. If you haven't reviewed your J9173 workflows against this updated coverage policy, do it today.
| # | Action Item |
|---|---|
| 1 | Audit all active J9173 precertifications against the updated criteria. Check biomarker documentation (CPT 81235 results) for every NSCLC case. If EGFR status isn't in the file, get it before the next submission. |
| 2 | Build biomarker exclusion screening into your precertification intake form. The policy requires negative EGFR, ALK, RET, and ROS1 results for multiple NSCLC indications. Make this a hard-stop checklist item, not an afterthought. |
| 3 | Screen prior PD-1/PD-L1 therapy history before every durvalumab request. A prior auth submission for a patient who progressed on pembrolizumab or nivolumab will be denied. Pull the oncology treatment history before you submit — not after you get the denial. |
| 4 | Confirm combination regimen codes are accurate on each claim. Durvalumab billing for most indications requires co-administration with specific agents. Make sure J9347, J9181, J9045, J9060, J9304, or J9305 — whichever apply — are on the claim with the correct units and administration codes (CPT 96413–96417). |
| 5 | Verify site of care before scheduling infusions. Aetna's site-of-care utilization management policy runs parallel to CPB 0917. A claim can be medically necessary under CPB 0917 and still get denied for the wrong infusion setting. Check the site-of-care policy before scheduling. |
| 6 | Document disease stage and progression status explicitly in your medical necessity letters. Vague clinical language causes denials. "Unresectable stage III NSCLC, no progression following concurrent chemoradiation, EGFR exon 19 and 21 negative" is what the reviewer needs to see. |
| 7 | If your billing mix includes multi-indication oncology practices, loop in your compliance officer. The criteria differ meaningfully by indication. A SCLC claim and an NSCLC claim for the same drug have completely different documentation requirements. A compliance review before December 31, 2025 is worth the time. |
| 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 Durvalumab Under CPB 0917
Covered HCPCS Code (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| J9173 | HCPCS | Injection, durvalumab, 10 mg |
CPT Codes Referenced in the Policy
| Code | Type | Description |
|---|---|---|
| 81235 | CPT | EGFR (epidermal growth factor receptor) gene analysis, common variants |
| 96413 | CPT | Chemotherapy administration; intravenous infusion technique, up to 1 hour |
| 96414 | CPT | Chemotherapy administration; intravenous infusion technique, each additional hour |
| 96415 | CPT | Chemotherapy administration; intravenous infusion technique, each additional hour |
| 96416 | CPT | Chemotherapy administration; intravenous infusion technique, initiation of prolonged infusion |
| 96417 | CPT | Chemotherapy administration; intravenous infusion technique, each additional sequential infusion |
Key ICD-10-CM Diagnosis Codes
The policy includes 351 ICD-10-CM codes. The table below shows the top-level groupings confirmed in the policy data. Work with your oncology coders to map the full list from the source policy.
| Code Range | Description |
|---|---|
| C00.0–C00.9 | Squamous cell carcinoma of head and neck (lip) |
| C01 | Squamous cell carcinoma of head and neck (base of tongue) |
| C02.0–C02.9 | Squamous cell carcinoma of head and neck (tongue, other) |
| C03.0–C03.9 | Squamous cell carcinoma of head and neck (gum) |
| C05.0–C05.1 | Squamous cell carcinoma of head and neck (palate) |
| C06.0–C06.9 | Squamous cell carcinoma of head and neck (mouth, other) |
| C09.0–C09.9 | Squamous cell carcinoma of head and neck (tonsil) |
| C10.3 | Squamous cell carcinoma of head and neck (posterior pharyngeal wall) |
| C11.0–C11.3 | Squamous cell carcinoma of head and neck (nasopharynx) |
Access the full 351-code ICD-10 list through the source policy at PayerPolicy CPB 0917.
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