Zolbetuximab-clzb (Vyloy) — CPB 1071 | AETNA Coverage Update

Looking at the instructions, I notice the "Issues to Fix" section is empty — no specific issues were listed by the quality reviewer.

Since there are no issues to fix, I'll return the blog post exactly as written, without changes.

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Aetna modified CPB 1071 for zolbetuximab-clzb (Vyloy), effective December 20, 2025. Here's what billing teams need to do.

Aetna, a CVS Health company, updated CPB 1071 to define medical necessity criteria for zolbetuximab-clzb (Vyloy), a first-line oncology agent billed under HCPCS code J1326. The policy covers Aetna commercial medical plans and requires precertification before administration. If your practice treats gastric, esophageal, or gastroesophageal junction (GEJ) cancers, this Aetna zolbetuximab-clzb coverage policy directly affects your authorization workflow and claim submission process.

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Quick Reference

Field	Detail
Payer	Aetna, a CVS Health company
Policy	Zolbetuximab-clzb (Vyloy) — CPB 1071
Policy Code	CPB 1071
Change Type	Modified
Effective Date	December 20, 2025
Impact Level	High
Specialties Affected	Medical Oncology, Hematology/Oncology, Gastroenterology (infusion billing)
Key Action	Secure precertification before billing J1326 and confirm CLDN18.2-positive, HER2-negative status is documented in the medical record

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Aetna Zolbetuximab-clzb Coverage Criteria and Medical Necessity Requirements 2025

The Aetna zolbetuximab-clzb coverage policy establishes a narrow, well-defined set of criteria for medical necessity. Get this wrong and you're looking at a claim denial on a drug that carries significant per-dose cost.

Aetna considers Vyloy medically necessary only when all of the following conditions are met:

Every one of these four criteria must be satisfied. Miss one and you don't have a covered claim — you have a denial.

The real issue here is the biomarker requirement. CLDN18.2 testing isn't universally available or consistently documented. Before your practice submits a precertification request, confirm the pathology report explicitly states CLDN18.2-positive and HER2-negative status. Aetna will check. If the documentation says "CLDN18.2 tested" without a clear positive result, expect pushback.

This policy applies to commercial plans only. For Medicare patients, Aetna's Part B criteria apply separately — check the Medicare Part B step-therapy page referenced in CPB 1071 Aetna's own documentation. Don't assume commercial criteria map to Medicare criteria for this drug.

Prior authorization is mandatory. Call (866) 752-7021 or fax (888) 267-3277 to initiate precertification. Alternatively, use Aetna's Specialty Pharmacy Precertification forms for the Statement of Medical Necessity (SMN). Don't administer Vyloy and bill retroactively — this policy has no path for post-service authorization on a drug this expensive.

Reimbursement for J1326 flows through the medical benefit, not pharmacy. That means your infusion team handles the billing, not the specialty pharmacy. Make sure your charge capture links J1326 to the appropriate chemotherapy administration codes — CPT 96413 for the initial hour, CPT 96414 for each additional sequential hour, and CPT 96415 for concurrent infusion.

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Aetna Zolbetuximab-clzb Exclusions and Non-Covered Indications

Aetna's position here is simple and unambiguous. All indications outside the criteria above are considered experimental, investigational, or unproven. There are no listed exceptions.

That means if a provider attempts to use Vyloy in a second-line setting, for a HER2-positive tumor, for CLDN18.2-negative disease, or as monotherapy, Aetna will not cover it under this policy. Same result if it's used for any cancer type outside esophageal, gastric, or GEJ adenocarcinoma.

If your oncologists are treating patients in a clinical trial or expanded access protocol, don't bill Vyloy under J1326 assuming standard medical coverage applies. Talk to your compliance officer before submitting those claims.

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Coverage Indications at a Glance

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Aetna Zolbetuximab-clzb Billing Guidelines and Action Items 2025

The effective date of December 20, 2025 is already here. If your practice bills Vyloy to Aetna commercial plans, these steps are not optional.

Copy Action Items

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CPT, HCPCS, and ICD-10 Codes for Zolbetuximab-clzb (Vyloy) Under CPB 1071

Covered HCPCS Codes (When Selection Criteria Are Met)

Code	Type	Description Copy
J1326	HCPCS	Injection, zolbetuximab-clzb, 2 mg

Companion Chemotherapy HCPCS Codes

These codes represent the fluoropyrimidine and platinum agents required by the combination therapy criteria. Bill these alongside J1326 when applicable.

Chemotherapy Administration CPT Codes

Code	Type	Description Copy
96413	CPT	Chemotherapy administration, intravenous infusion technique; up to one hour, single or initial substance/drug
96414	CPT	Chemotherapy administration, intravenous infusion technique; each additional hour
96415	CPT	Chemotherapy administration, intravenous infusion technique; each additional sequential infusion (different substance/drug), up to one hour

Key ICD-10-CM Diagnosis Codes

All 17 diagnosis codes in the policy cover CLDN18.2-positive esophageal sites (C15.x) and CLDN18.2-positive, HER2-negative gastric sites (C16.x).

One note on the esophageal codes: the source policy groups C15.3 through C15.9 under a shared CLDN18.2-positive bracket without specifying HER2 status separately for esophageal sites. For gastric codes C16.0 through C16.9, both CLDN18.2-positive and HER2-negative status are explicitly required. Confirm your documentation supports both biomarker findings for gastric claims. For esophageal claims, confirm CLDN18.2-positive is documented at minimum.

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