Aetna modified CPB 0917 for durvalumab (Imfinzi), effective December 6, 2025. Here's what billing teams need to do.
Aetna, a CVS Health company, updated its durvalumab (Imfinzi) coverage policy under CPB 0917 on December 6, 2025. This policy governs reimbursement for J9173 (injection, durvalumab, 10 mg) across a wide range of oncology indications—from lung cancer to biliary tract cancer to head and neck squamous cell carcinoma. If your practice bills J9173 alongside chemotherapy administration codes 96413 through 96417, this update affects your prior authorization workflow and medical necessity documentation immediately.
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, hematology/oncology, thoracic surgery, hepatobiliary surgery, head and neck surgery |
| Key Action | Audit all active durvalumab prior authorizations against updated indication-level criteria before billing J9173 on or after December 6, 2025 |
Aetna Durvalumab Coverage Criteria and Medical Necessity Requirements 2025
The Aetna durvalumab coverage policy under CPB 0917 is one of the more layered oncology policies you'll see. The indication list is long, and the biomarker requirements are specific. Getting this wrong means claim denial—and with a drug that costs well over $10,000 per infusion cycle, the financial exposure is real.
Precertification is required for all Aetna participating providers and members in applicable plan designs. Call (866) 752-7021 or fax (888) 267-3277 to initiate prior authorization. You can also access Statement of Medical Necessity forms at Aetna's Specialty Pharmacy Precertification portal.
Aetna also applies a Site of Care Utilization Management policy to durvalumab. Before you bill 96413 for the infusion, confirm that the site of service meets Aetna's requirements under their Drug Infusion Site of Care policy. This is separate from the clinical coverage criteria—and a denial on site of service grounds is just as costly as a denial on medical necessity grounds.
Non-Small Cell Lung Cancer (NSCLC)
Aetna covers durvalumab for NSCLC under three distinct clinical scenarios. Each has its own biomarker and treatment context requirements.
Unresectable Stage II or III NSCLC: The member must have disease that has not progressed following concurrent platinum-based chemoradiation. The tumor must be negative for EGFR exon 19 deletion and exon 21 L858R mutations—verified by CPT 81235. Durvalumab is covered as a single agent only in this setting.
Recurrent, Advanced, or Metastatic NSCLC: The tumor must be negative for EGFR exon 19 deletion, exon 21 L858R mutations, and ALK, RET, and ROS1 rearrangements. Coverage applies when durvalumab is used in combination with tremelimumab-actl (J9347) and platinum-based chemotherapy, or as maintenance therapy—either as a single agent or in combination with pemetrexed (J9304 or J9305).
Resectable NSCLC: Coverage requires neoadjuvant treatment combined with platinum-containing chemotherapy, followed by adjuvant single-agent durvalumab after surgery. The same biomarker exclusions apply: negative for EGFR exon 19 deletion, exon 21 L858R mutations, ALK, RET, and ROS1 rearrangements.
The pattern here is clear—EGFR-mutated NSCLC is excluded across all three NSCLC indications. Make sure your team pulls the molecular testing results before submitting any prior auth for lung cancer patients.
Small Cell Lung Cancer (SCLC)
The SCLC coverage criteria in CPB 0917 are newer and worth close attention. Aetna covers durvalumab in three SCLC scenarios:
| # | Covered Indication |
|---|---|
| 1 | First-line treatment of extensive-stage SCLC in combination with etoposide (J9181) and carboplatin (J9045) or cisplatin (J9060), followed by single-agent maintenance |
| 2 | Adjuvant consolidation for limited-stage SCLC as a single agent, when the member did not progress after systemic therapy with concurrent radiation |
| 3 | Subsequent therapy for progression or relapse, in combination with etoposide and carboplatin or cisplatin, followed by single-agent maintenance |
The adjuvant consolidation indication for limited-stage SCLC is the one to flag. It's a narrower population with a specific treatment history requirement. Document the prior systemic therapy and radiation course clearly in your prior auth submission.
Biliary Tract Cancer
Aetna covers durvalumab for biliary tract cancer in combination with cisplatin (J9060) or carboplatin (J9045) and gemcitabine (J9201, J9196, J9198, or J9184). This applies to locally advanced, unresectable, gross residual (R2) disease, and metastatic biliary tract cancer. The policy also covers adjuvant treatment in this setting and covers resectable locoregionally advanced gallbladder cancer when combined with cisplatin or carboplatin and gemcitabine.
These are meaningful expansions relative to earlier Imfinzi policies. If your practice treats biliary tract cancers, audit your charge capture for J9173 now.
Aetna Durvalumab Exclusions and Non-Covered Indications
The primary exclusion under CPB 0917 is straightforward: Aetna does not cover durvalumab for members who experienced disease progression while on PD-1 or PD-L1 inhibitor therapy.
This exclusion matters because durvalumab itself is a PD-L1 inhibitor. A patient who progressed on pembrolizumab (J9271), nivolumab (J9299), atezolizumab (J9022), avelumab (J9023), or cemiplimab (J9119) is not eligible for Imfinzi under this policy. The inclusion of those codes in the CPB is directly relevant here—they're the agents that create ineligibility.
Document prior immunotherapy exposure in every prior auth submission. A claim denial because of undisclosed prior PD-L1 progression is hard to appeal and harder to explain to the oncologist.
EGFR-mutated NSCLC is functionally excluded from all NSCLC indications. Aetna will not approve durvalumab for a patient with EGFR exon 19 deletion or exon 21 L858R mutation in the lung cancer setting. The CPT 81235 result needs to be in the chart and referenced in the auth request.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Unresectable Stage II/III NSCLC (post chemoradiation, EGFR-negative) | Covered | J9173, 81235 | Single agent only; prior auth required |
| Recurrent/advanced/metastatic NSCLC (EGFR/ALK/RET/ROS1-negative) | Covered | J9173, J9347, J9304, J9305 | Combo with tremelimumab + chemo, or maintenance; prior auth required |
| Resectable NSCLC, neoadjuvant + adjuvant (EGFR/ALK/RET/ROS1-negative) | Covered | J9173 | Must include surgical intent; prior auth required |
| Extensive-stage SCLC, first-line | Covered | J9173, J9181, J9045, J9060 | Combination with etoposide + carboplatin or cisplatin; prior auth required |
| Limited-stage SCLC, adjuvant consolidation | Covered | J9173 | No prior disease progression after chemoradiation; prior auth required |
| SCLC, subsequent therapy (progression/relapse) | Covered | J9173, J9181, J9045, J9060 | Combination + maintenance; prior auth required |
| Locally advanced/unresectable/metastatic biliary tract cancer | Covered | J9173, J9060, J9045, J9201 | Combination with cisplatin or carboplatin + gemcitabine; prior auth required |
| Adjuvant biliary tract cancer | Covered | J9173, J9060, J9045, J9201 | Combination with cisplatin or carboplatin + gemcitabine; prior auth required |
| Resectable locoregionally advanced gallbladder cancer | Covered | J9173, J9060, J9045, J9201 | Combination with cisplatin or carboplatin + gemcitabine; prior auth required |
| NSCLC with EGFR exon 19 deletion or exon 21 L858R mutation | Not Covered | 81235 | Excluded across all NSCLC indications |
| Disease progression on prior PD-1 or PD-L1 inhibitor | Not Covered | J9271, J9299, J9022, J9023, J9119 | Hard exclusion; document prior IO exposure |
Aetna Durvalumab Billing Guidelines and Action Items 2025
These are not general suggestions. The effective date is December 6, 2025—if you bill J9173 for Aetna members and haven't done these things, do them now.
| # | Action Item |
|---|---|
| 1 | Audit all active durvalumab prior authorizations for affected indications. Pull every open auth for J9173 and check it against the updated criteria in CPB 0917. Pay particular attention to SCLC authorizations—the limited-stage consolidation indication and the subsequent-therapy indication are the most likely to have documentation gaps. |
| 2 | Verify EGFR and biomarker testing documentation for every NSCLC case. CPT 81235 results must be in the medical record before you submit a prior auth for any NSCLC indication. An approval without documented EGFR-negative status will be a problem on audit. |
| 3 | Check prior immunotherapy exposure for every new durvalumab request. Before submitting any prior auth for J9173, confirm the member has no documented disease progression on a PD-1 or PD-L1 inhibitor. Review the chart for prior use of pembrolizumab (J9271), nivolumab (J9299), atezolizumab (J9022), avelumab (J9023), or cemiplimab (J9119). |
| 4 | Confirm site of service compliance before billing 96413 through 96417. Aetna's Site of Care Utilization Management policy applies to durvalumab infusions. A claim denial on site of service is separate from medical necessity and not always correctable on appeal. Confirm the infusion setting meets Aetna's requirements before scheduling. |
| 5 | Update your charge capture to link J9173 with the correct combination agents. Many of the covered indications require specific combinations—tremelimumab (J9347) for certain NSCLC scenarios, etoposide (J9181) plus carboplatin (J9045) or cisplatin (J9060) for SCLC, gemcitabine variants (J9201, J9196, J9198, J9184) for biliary tract cancer. Your charge capture should flag J9173 claims that don't include the expected combination agent codes. |
| 6 | Review biliary tract cancer claims if you added this indication recently. The coverage for adjuvant biliary tract cancer and resectable gallbladder cancer may represent new territory for some practices. If your billing team wasn't tracking these indications under CPB 0917, run a lookback and confirm any recently billed claims are correctly supported. |
If you're unsure how this policy applies to your specific patient mix or payer contract, talk to your compliance officer before December 6, 2025.
| 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 Codes (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| J9173 | HCPCS | Injection, durvalumab, 10 mg |
Other HCPCS Codes Related to CPB 0917
These codes appear in the policy as related agents—combination therapies, comparators, and agents that may create ineligibility.
| Code | Type | Description |
|---|---|---|
| J0640 | HCPCS | Injection, leucovorin calcium, per 50 mg |
| J9022 | HCPCS | Injection, atezolizumab, 10 mg |
| J9023 | HCPCS | Injection, avelumab, 10 mg |
| J9045 | HCPCS | Injection, carboplatin, 50 mg |
| J9060 | HCPCS | Injection, cisplatin, powder or solution, 10 mg |
| J9119 | HCPCS | Injection, cemiplimab-rwlc, 1 mg |
| J9171 | HCPCS | Injection, docetaxel, 1 mg |
| J9172 | HCPCS | Injection, docetaxel (Ingenus), not therapeutically equivalent to J9171, 1 mg |
| J9181 | HCPCS | Injection, etoposide, 10 mg |
| J9184 | HCPCS | Injection, gemcitabine hydrochloride (Avyxa), 200 mg |
| J9190 | HCPCS | Injection, fluorouracil, 500 mg |
| J9196 | HCPCS | Injection, gemcitabine hydrochloride (Accord), not therapeutically equivalent to J9201, 200 mg |
| J9198 | HCPCS | Injection, gemcitabine hydrochloride (Infugem), 100 mg |
| J9201 | HCPCS | Injection, gemcitabine hydrochloride, not otherwise specified, 200 mg |
| J9263 | HCPCS | Injection, oxaliplatin, 0.5 mg |
| J9271 | HCPCS | Injection, pembrolizumab, 1 mg |
| J9299 | HCPCS | Injection, nivolumab, 1 mg |
| J9304 | HCPCS | Injection, pemetrexed (Pemfexy), 10 mg |
| J9305 | HCPCS | Injection, pemetrexed, not otherwise specified, 10 mg |
| J9347 | HCPCS | Injection, tremelimumab-actl, 1 mg |
CPT Codes Related to CPB 0917
| 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 1 hour |
| 96414 | CPT | Chemotherapy administration; intravenous infusion, each additional hour |
| 96415 | CPT | Chemotherapy administration; intravenous infusion, each additional hour |
| 96416 | CPT | Chemotherapy administration; intravenous infusion, initiation of prolonged infusion |
| 96417 | CPT | Chemotherapy administration; intravenous infusion, each additional sequential infusion |
Key ICD-10-CM Diagnosis Codes
The full policy includes 351 ICD-10-CM codes. The table below shows a representative sample of the primary diagnosis categories. Your billing team should pull the complete code list from CPB 0917 directly for claim-level code selection.
| Code | 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) |
With 351 ICD-10-CM codes in scope, don't rely on memory or prior claim templates. Pull the full list from the Aetna CPB 0917 source document and validate diagnosis codes at the claim level.
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