Aetna modified CPB 0892 covering nivolumab products (Opdivo, Opdivo Qvantig, and Opdualag), effective October 19, 2025. Billing teams managing oncology claims need to review prior authorization workflows and documentation requirements before submitting claims under J9289, J9298, and J9299.
This update from Aetna, a CVS Health company, expands and clarifies the Aetna nivolumab coverage policy across a wide range of cancer indications—from melanoma and non-small cell lung cancer to rare tumors like ampullary adenocarcinoma and anaplastic thyroid carcinoma. CPB 0892 Aetna governs all three formulations across commercial plans, and the indication list is long enough that claims teams need a structured approach to get it right.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Nivolumab Products (Opdivo, Opdivo Qvantig, and Opdualag) |
| Policy Code | CPB 0892 |
| Change Type | Modified |
| Effective Date | October 19, 2025 |
| Impact Level | High |
| Specialties Affected | Medical Oncology, Hematology/Oncology, Infusion Centers, Radiation Oncology (support), Gastroenterology (GI oncology) |
| Key Action | Verify prior authorization is in place for all three nivolumab formulations before billing J9289, J9298, or J9299 on or after October 19, 2025 |
Aetna Nivolumab Coverage Criteria and Medical Necessity Requirements 2025
Precertification is required. Full stop. Before you bill J9299 (nivolumab, 1 mg), J9289 (nivolumab and hyaluronidase-nvhy, 2 mg), or J9298 (nivolumab and relatlimab-rmbw, 3 mg/1 mg), you need prior authorization in place. Call (866) 752-7021 or fax (888) 267-3277 to start the process.
The real issue with this coverage policy is the volume and specificity of the criteria. Aetna doesn't just say "cancer—approved." Each indication has its own set of conditions: tumor biomarkers, prior treatment history, combination partners, and sometimes the specific disease stage. Medical necessity is not a blanket determination here. It's indication-specific.
The biomarker requirements are where denials will happen. Several indications require tumor mutation burden-high (TMB-H) status—defined as ≥10 mutations per megabase (mut/Mb)—or microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) status. If your documentation doesn't confirm the biomarker, the claim won't survive review. Test results need to be in the record before you submit.
Aetna also applies a Site of Care Utilization Management Policy to all three formulations. This means where the infusion happens matters for reimbursement. Review the Site of Care policy before scheduling infusions at a higher-cost setting—Aetna will use it.
The approved indications span more than 30 tumor types. Here's a structured look at what the policy covers.
Aetna Nivolumab Exclusions and Non-Covered Indications
Aetna has a clear rule on PD-1/PD-L1 progression: if a member already progressed on a PD-1 or PD-L1 inhibitor, they are generally not eligible for nivolumab. There are three exceptions to this rule.
First, metastatic or unresectable melanoma. Second, metastatic or unresectable small bowel adenocarcinoma treated in combination with ipilimumab after progression on single-agent checkpoint inhibitor therapy. Third, hepatocellular carcinoma following progression on atezolizumab plus bevacizumab (J9022 + J9035).
Outside those three carve-outs, prior checkpoint inhibitor progression is a hard stop. If your clinical team is proposing nivolumab for a patient who progressed on pembrolizumab (J9271) or another PD-1/PD-L1 agent, document which exception applies—or expect a denial.
Coverage Indications at a Glance
This table covers the indications included in the policy summary. The full policy lists more than 30 tumor types. Consult the complete CPB 0892 document for indications not listed here.
| Indication | Status | Formulation | Key Criteria |
|---|---|---|---|
| Ampullary adenocarcinoma (progressive/metastatic) | Covered | Opdivo + ipilimumab | MSI-H or dMMR required |
| Anal carcinoma (metastatic) | Covered | Opdivo single agent | Subsequent-line treatment |
| Anaplastic thyroid carcinoma (stage IVC) | Covered | Opdivo single agent | Stage IVC only |
| Biliary tract cancers — subsequent treatment | Covered | Opdivo + ipilimumab | TMB-H required for some presentations |
| Biliary tract cancers — neoadjuvant (resectable gallbladder) | Covered | Opdivo + ipilimumab | TMB-H required; no jaundice at presentation |
| Bone cancer (unresectable/metastatic) | Covered | Opdivo + ipilimumab | TMB-H ≥10 mut/Mb; prior treatment required |
| CNS brain metastases — melanoma | Covered | Opdivo single agent or + ipilimumab | Melanoma primary |
| CNS brain metastases — other tumors | Covered | Opdivo single agent | Per policy criteria |
| Hepatocellular carcinoma (post atezolizumab + bevacizumab) | Covered | Opdivo (exception to PD-1 progression rule) | Must have progressed on atezo + bev |
| Small bowel adenocarcinoma (metastatic/unresectable) | Covered | Opdivo + ipilimumab | Post–single agent checkpoint inhibitor; exception to PD-1 rule |
| Prior PD-1/PD-L1 progression (most indications) | Not Covered | All formulations | Does not meet exception criteria |
| Indications without required biomarker documentation | Not Covered | All formulations | Missing TMB-H, MSI-H, or dMMR testing |
Note: Opdivo Qvantig (J9289) and Opdualag (J9298) have their own indication-specific criteria within CPB 0892. The full policy document lists all approved uses for each formulation separately. If you're billing J9298 for Opdualag, confirm the indication is approved specifically for that formulation—not just for nivolumab broadly.
Aetna Nivolumab Billing Guidelines and Action Items 2025
| # | Action Item |
|---|---|
| 1 | Confirm prior authorization before every claim. All three formulations—Opdivo (J9299), Opdivo Qvantig (J9289), and Opdualag (J9298)—require precertification on all Aetna commercial plans. Claims submitted without an active auth will deny. Call (866) 752-7021 or fax the SMN form before the October 19, 2025 effective date if you have pending cases. |
| 2 | Pull biomarker results into the chart before submitting. Indications requiring TMB-H, MSI-H, or dMMR status need documented lab results in the record. If pathology hasn't confirmed the biomarker, the prior auth request will stall and the claim will follow. This is the most predictable source of claim denial under this policy. |
| 3 | Check the Site of Care policy for every infusion order. Aetna's utilization management policy applies here. If you're billing CPT 96413–96417 for chemotherapy infusion or 96365–96368 for non-chemotherapy infusion, the site of service is under review. Infusions scheduled at a hospital outpatient department when an office or alternative site is available may be redirected or denied. |
| 4 | Verify the exception criteria for any patient with prior PD-1/PD-L1 exposure. If a patient progressed on pembrolizumab (J9271), cemiplimab (J9119), durvalumab (J9173), or another checkpoint inhibitor, document which of the three exceptions applies before billing. Melanoma, small bowel adenocarcinoma post–checkpoint progression, or HCC post–atezolizumab/bevacizumab are the only covered scenarios. |
| 5 | Audit your ICD-10 codes against the approved indication list. CPB 0892 maps to 565 ICD-10-CM codes. If your diagnosis code doesn't align with an approved indication, the claim won't clear. Run a crosswalk between your primary diagnosis codes and the approved indications in the policy before submitting. This is especially relevant for rare tumor types where the ICD-10 code range is narrow. |
| 6 | For combination regimens, document each agent separately. When billing nivolumab plus ipilimumab (J9228), both agents need their own coverage justification. Ipilimumab has its own coverage criteria under this policy. A precertification for nivolumab doesn't automatically cover ipilimumab or any co-administered agents like carboplatin (J9045), cisplatin (J9060), or gemcitabine (J9201). |
| 7 | Flag Opdualag cases for extra review. Opdualag (J9298, nivolumab and relatlimab-rmbw) is the newest formulation in this policy. It has a narrower approved indication set than Opdivo. If your team is billing J9298, confirm the specific indication is covered under CPB 0892 for that formulation—not just for nivolumab generally. If you're unsure, talk to your compliance officer before the October 19 effective date. |
| 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 Nivolumab Under CPB 0892
HCPCS Codes — Covered When Selection Criteria Are Met
| Code | Description |
|---|---|
| J9289 | Injection, nivolumab and hyaluronidase-nvhy, 2 mg (Opdivo Qvantig) |
| J9298 | Injection, nivolumab and relatlimab-rmbw, 3 mg/1 mg (Opdualag) |
| J9299 | Injection, nivolumab, 1 mg (Opdivo) |
HCPCS Codes — Not Covered Under CPB 0892 (Referenced as Non-Covered Comparators/Combinations)
These codes appear in the policy but are not covered as substitutes or alternatives to nivolumab products. Several are referenced as comparators or co-administration agents with their own coverage requirements.
| Code | Description |
|---|---|
| C9257 | Injection, bevacizumab, 0.25 mg |
| J3263 | Injection, toripalimab-tpzi, 1 mg |
| J8520 | Capecitabine, oral, 150 mg |
| J8521 | Capecitabine, oral, 500 mg |
| J9000 | Injection, doxorubicin hydrochloride, 10 mg |
| J9022 | Injection, atezolizumab, 10 mg |
| J9023 | Injection, avelumab, 10 mg |
| J9024 | Injection, atezolizumab, 5 mg and hyaluronidase-tqjs |
| J9035 | Injection, bevacizumab, 10 mg |
| J9042 | Injection, brentuximab vedotin, 1 mg |
| J9045 | Injection, carboplatin, 50 mg |
| J9055 | Injection, cetuximab, 10 mg |
| J9060 | Injection, cisplatin, powder or solution, 10 mg |
| J9119 | Injection, cemiplimab-rwlc, 1 mg |
| J9130 | Dacarbazine, 100 mg |
| J9173 | Injection, durvalumab, 10 mg |
| J9181 | Injection, etoposide, 10 mg |
| J9190 | Injection, fluorouracil, 500 mg |
| J9196 | Injection, gemcitabine hydrochloride (accord), 200 mg |
| J9200 | Injection, floxuridine, 500 mg |
| J9201 | Injection, gemcitabine hydrochloride, not otherwise specified, 200 mg |
| J9206 | Injection, irinotecan, 20 mg |
| J9208 | Injection, ifosfamide, 1 gram |
| J9228 | Injection, ipilimumab, 1 mg |
| J9263 | Injection, oxaliplatin, 0.5 mg |
| J9271 | Injection, pembrolizumab, 1 mg |
| J9272 | Injection, dostarlimab-gxly, 10 mg |
| J9275 | Injection, cosibelimab-ipdl, 2 mg |
| J9329 | Injection, tislelizumab-jsgr, 1 mg |
| J9345 | Injection, retifanlimab-dlwr, 1 mg |
| J9347 | Injection, tremelimumab-actl, 1 mg |
| J9360 | Injection, vinblastine sulfate, 1 mg |
| Q5107 | Injection, bevacizumab-awwb biosimilar (Mvasi), 10 mg |
CPT Codes — Infusion Administration
These codes support billing for the infusion administration of nivolumab products.
| Code | Description |
|---|---|
| 96365 | IV infusion, therapy/prophylaxis/diagnosis — initial, up to 1 hour |
| 96366 | IV infusion, therapy/prophylaxis/diagnosis — each additional hour |
| 96367 | IV infusion, additional sequential drug, up to 1 hour |
| 96368 | IV infusion, concurrent drug infusion |
| 96413 | Chemotherapy administration, IV infusion — initial, up to 1 hour |
| 96414 | Chemotherapy administration, IV infusion — each additional hour |
| 96415 | Chemotherapy administration, IV infusion — each additional hour (continuation) |
| 96416 | Chemotherapy administration, IV infusion — initiation of prolonged infusion (>8 hours) |
| 96417 | Chemotherapy administration, IV infusion — each additional sequential infusion |
CPT Codes — Esophageal Surgery (NSCLC-Related)
These codes appear in the policy in connection with NSCLC biomarker testing criteria. They are listed in the billing guidelines context for esophageal resection procedures tied to nivolumab adjuvant indications.
| Code | Description |
|---|---|
| 43107 | Total or near esophagectomy, without thoracotomy; with pharyngogastrostomy or cervical esophagogastrostomy |
| 43108 | Total or near esophagectomy, without thoracotomy; with colon interposition or small intestine reconstruction |
| 43112 | Total or near esophagectomy, with thoracotomy; with pharyngogastrostomy or cervical esophagogastrostomy |
| 43113 | Total or near esophagectomy, with thoracotomy; with colon interposition or small intestine reconstruction |
| 43116 | Partial esophagectomy, cervical, with free intestinal graft |
| 43117 | Partial esophagectomy, distal two-thirds, with thoracotomy and separate abdominal incision |
| 43118 | Partial esophagectomy with colon interposition or small intestine reconstruction |
| 43121 | Partial esophagectomy, distal two-thirds, with thoracotomy only |
| 43122 | Partial esophagectomy, thoracoabdominal or abdominal approach |
| 43123 | Partial esophagectomy with colon interposition or small intestine reconstruction (thoracoabdominal) |
| 43124 | Total or partial esophagectomy, without reconstruction, with cervical esophagostomy |
| 43286 | Esophagectomy, total or near total, laparoscopic mobilization of abdominal and mediastinal esophagus |
| 43287 | Esophagectomy, distal two-thirds, laparoscopic mobilization |
| 43288 | Esophagectomy, total or near total, thoracoscopic mobilization |
CPT Codes — Molecular and Genetic Testing
These codes appear in the policy for biomarker testing requirements supporting nivolumab eligibility in NSCLC and other solid tumors.
| Code | Description |
|---|---|
| 81210 | BRAF (B-Raf proto-oncogene) gene analysis, V600 variants |
| 81235 | EGFR gene analysis, common variants |
Key ICD-10-CM Diagnosis Codes
CPB 0892 maps to 565 ICD-10-CM codes. The full list covers malignant neoplasms across nearly every body system. Below is the range included in the policy data. Your billing team should run a complete crosswalk against the full code list in the policy before submitting.
| Code Range | Description |
|---|---|
| C00.0–C06.9 | Malignant neoplasms of lip, tongue, gum, floor of mouth, palate, and other/unspecified parts of mouth |
The full ICD-10 code set under CPB 0892 extends across 565 codes covering cancers of the head and neck, thorax, GI tract, genitourinary system, skin, lymphatic system, and more. Access the complete list at the CPB 0892 policy source.
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