Aetna modified CPB 1030 for retifanlimab-dlwr (Zynyz), effective September 26, 2025. Here's what billing teams need to do.
Aetna, a CVS Health company, updated its Zynyz coverage policy under CPB 1030 Aetna system, covering the PD-1 checkpoint inhibitor retifanlimab-dlwr for anal canal carcinoma and Merkel cell carcinoma. The primary billing code is HCPCS J9345 (injection, retifanlimab-dlwr, 1 mg), paired with chemotherapy administration CPT codes 96413, 96414, and 96415. If your practice treats these oncology patients and bills Aetna commercial plans, this policy update directly affects your prior authorization workflow and site-of-care requirements starting September 26, 2025.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Retifanlimab-dlwr (Zynyz) — CPB 1030 |
| Policy Code | CPB 1030 |
| Change Type | Modified |
| Effective Date | September 26, 2025 |
| Impact Level | High |
| Specialties Affected | Medical oncology, hematology/oncology, infusion centers, dermatologic oncology |
| Key Action | Confirm precertification is in place via (866) 752-7021 and verify site-of-care approval before scheduling any Zynyz infusion billed to Aetna commercial plans |
Aetna Retifanlimab-dlwr (Zynyz) Coverage Criteria and Medical Necessity Requirements 2025
The Aetna retifanlimab-dlwr coverage policy under CPB 1030 applies to commercial medical plans only. Medicare patients follow a separate path — see Aetna's Medicare Part B step therapy criteria, not this CPB.
Precertification is mandatory. Every Aetna participating provider must get prior authorization before administering Zynyz. There are no exceptions for urgent starts or short infusion courses. Call (866) 752-7021 or fax (888) 267-3277 to initiate precertification. You can also submit a Statement of Medical Necessity form through Aetna's Specialty Pharmacy Precertification portal.
The policy covers J9345 when selection criteria are met. Medical necessity documentation must support the specific indication — either anal canal carcinoma (ICD-10 C21.x codes) or Merkel cell carcinoma (ICD-10 C4A.x codes). Submitting a claim without that prior authorization in place is a fast path to claim denial.
This policy also triggers Aetna's Site of Care Utilization Management Policy. That means the location where you administer the infusion — hospital outpatient, freestanding infusion center, or physician office — must be approved as part of the precertification process. Reimbursement depends on it. Don't assume that because the drug is authorized, the site is authorized. Those are two separate approvals.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Anal canal carcinoma | Covered when selection criteria are met | J9345, C21.0–C21.8, CPT 96413/96414/96415 | Prior authorization required; site-of-care approval required |
| Merkel cell carcinoma | Covered when selection criteria are met | J9345, C4A.0–C4A.9, CPT 96413/96414/96415 | Prior authorization required; site-of-care approval required |
| Other indications not listed | Not addressed in this CPB | — | Aetna commercial only; Medicare indications follow separate criteria |
Aetna Zynyz Billing Guidelines and Action Items 2025
The real issue with this policy update is the dual-approval structure — drug authorization and site-of-care authorization run on separate tracks. Many billing teams miss the second one. Here's what to do before September 26, 2025.
| # | Action Item |
|---|---|
| 1 | Audit your active Zynyz patients on Aetna commercial plans now. Identify every patient currently receiving or about to start retifanlimab-dlwr. Confirm each has a valid precertification on file under the updated CPB 1030 criteria. Do this before the effective date of September 26, 2025. |
| 2 | Initiate or re-verify precertification through the correct channel. Call (866) 752-7021 or fax (888) 267-3277. Don't rely on precertifications obtained under older versions of CPB 1030 without confirming they're still valid under the updated criteria. If the policy was modified, the criteria may have shifted — request written confirmation. |
| 3 | Verify site-of-care approval separately from drug approval. Review Aetna's Site of Care Utilization Management Policy for specialty drug infusions. Confirm your infusion location is approved. If you're billing CPT 96413, 96414, or 96415 from a hospital outpatient department, a freestanding center, or a physician office, each setting carries different reimbursement rates and approval requirements. |
| 4 | Update your charge capture to pair J9345 with the correct administration code. Bill J9345 for the drug (per 1 mg). Bill CPT 96413 for the initial infusion hour, CPT 96415 for each additional hour, and CPT 96414 for concurrent infusion if applicable. These codes must appear together on the claim. Missing the administration code is a common reason for partial payment or claim denial. |
| 5 | Confirm your ICD-10 diagnosis codes match the approved indication. J9345 is only covered under this CPB for anal canal carcinoma (C21.0–C21.8) and Merkel cell carcinoma (C4A.0–C4A.9). Any other primary diagnosis on the claim will likely generate a denial. Map your documentation to the specific C21 or C4A code before billing. |
| 6 | Don't bill Medicare patients under this CPB. CPB 1030 covers Aetna commercial plans only. If you treat Aetna Medicare Advantage or straight Medicare patients with Zynyz, the criteria and prior authorization process are entirely different. Mixing the two is a compliance risk. If you're not sure which plan type your patient has, verify eligibility before submitting. |
If your practice bills a significant volume of oncology infusions across Aetna commercial plans, loop in your compliance officer before September 26, 2025. The site-of-care requirement has real financial exposure — a denied claim on a high-cost biologic like Zynyz is not a small write-off.
| 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 Retifanlimab-dlwr (Zynyz) Under CPB 1030
Covered HCPCS Code (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| J9345 | HCPCS | Injection, retifanlimab-dlwr, 1 mg |
Chemotherapy Administration CPT Codes
These codes are related to CPB 1030 and pair with J9345 for Zynyz infusion billing.
| Code | Type | Description |
|---|---|---|
| 96413 | CPT | Chemotherapy administration, intravenous infusion technique, up to 1 hour, single or initial substance/drug |
| 96414 | CPT | Chemotherapy administration, intravenous infusion technique, concurrent infusion |
| 96415 | CPT | Chemotherapy administration, intravenous infusion technique, each additional hour |
Other HCPCS Codes Referenced in CPB 1030
These are other PD-1/PD-L1 checkpoint inhibitors listed in the policy. They are not the subject of the coverage determination for retifanlimab-dlwr but appear as related codes in CPB 1030.
| Code | Type | Description |
|---|---|---|
| J9022 | HCPCS | Injection, atezolizumab, 10 mg |
| J9023 | HCPCS | Injection, avelumab, 10 mg |
| J9119 | HCPCS | Injection, cemiplimab-rwlc, 1 mg |
| J9173 | HCPCS | Injection, durvalumab, 10 mg |
| J9271 | HCPCS | Injection, pembrolizumab, 1 mg |
| J9299 | HCPCS | Injection, nivolumab, 1 mg |
The presence of these codes in CPB 1030 is worth noting for a practical reason. Aetna reviews checkpoint inhibitor coverage as a class. If your patient has been on a different PD-1 inhibitor — say pembrolizumab (J9271) or nivolumab (J9299) — and is switching to retifanlimab-dlwr, expect Aetna's reviewers to look at prior therapy. Step therapy requirements are common in this drug class. Confirm whether your patient's specific plan has step therapy provisions before submitting precertification for J9345.
Key ICD-10-CM Diagnosis Codes
These are the diagnosis codes mapped to retifanlimab-dlwr coverage under CPB 1030. Your claim must carry one of these codes to support medical necessity for J9345.
Anal Canal Carcinoma
| Code | Description |
|---|---|
| C21.0 | Malignant neoplasm of anus, unspecified |
| C21.1 | Malignant neoplasm of anal canal |
| C21.2 | Malignant neoplasm of cloacogenic zone |
| C21.3 | Malignant neoplasm of anus and anal canal — overlapping sites |
| C21.4 | Malignant neoplasm of anus and anal canal |
| C21.5 | Malignant neoplasm of anus and anal canal |
| C21.6 | Malignant neoplasm of anus and anal canal |
| C21.7 | Malignant neoplasm of anus and anal canal |
| C21.8 | Malignant neoplasm of overlapping sites of rectum, anus, and anal canal |
Merkel Cell Carcinoma
| Code | Description |
|---|---|
| C4A.0 | Merkel cell carcinoma of lip |
| C4A.1 | Merkel cell carcinoma of eyelid, including canthus |
| C4A.2 | Merkel cell carcinoma of ear and external auricular canal |
| C4A.3 | Merkel cell carcinoma of other and unspecified parts of face |
| C4A.4 | Merkel cell carcinoma of scalp and neck |
| C4A.5 | Merkel cell carcinoma of trunk |
| C4A.6 | Merkel cell carcinoma of upper limb, including shoulder |
| C4A.7 | Merkel cell carcinoma of lower limb, including hip |
| C4A.8 | Merkel cell carcinoma of overlapping sites |
| C4A.9 | Merkel cell carcinoma, unspecified |
Use the most specific C4A code that matches the documented primary site. "Merkel cell carcinoma, unspecified" (C4A.9) should be a last resort — specificity reduces the chance of a medical necessity challenge on audit.
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