Beremagene Geperpavec-svdt (Vyjuvek) — CPB 1033 | AETNA Coverage Update

Aetna modified CPB 1033 for beremagene geperpavec-svdt (Vyjuvek), effective January 5, 2026. Here's what billing teams need to know.

Aetna, a CVS Health company, updated its Vyjuvek coverage policy under CPB 1033 Aetna system — the clinical policy bulletin governing beremagene geperpavec-svdt for dystrophic epidermolysis bullosa (DEB) wound treatment. The policy now operates under Aetna's GCIT (Gene-based, Cellular & Other Innovative Therapies) review program, with HCPCS code J3401 as the primary billing code. If your team bills J3401 for Vyjuvek, this policy sets the complete prior authorization and medical necessity framework you need before claims go out.

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna
Policy	Beremagene Geperpavec-svdt (Vyjuvek) — CPB 1033
Policy Code	CPB 1033
Change Type	Modified
Effective Date	January 5, 2026
Impact Level	High
Specialties Affected	Dermatology, Wound Care
Key Action	Confirm prior authorization is submitted through Aetna's GCIT team before administering Vyjuvek, using HCPCS J3401

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Aetna Vyjuvek Coverage Criteria and Medical Necessity Requirements 2026

This is a high-bar policy. Aetna won't pay for Vyjuvek unless every criterion on a multi-part checklist is satisfied. Miss one, and you're looking at a claim denial.

The Aetna Vyjuvek coverage policy requires prior authorization for all participating providers and members in applicable plan designs. Call (866) 752-7021 or fax (888) 267-3277 to initiate precertification. This is a GCIT product, which means it goes to Aetna's specialized GCIT team — not standard utilization management.

Vyjuvek Vyjuvek billing starts with prescriber requirements. The medication must be prescribed by — or in consultation with — a dermatologist or wound care specialist. A primary care physician writing this script without specialist involvement will get denied.

Medical Necessity: What Aetna Actually Requires

Aetna considers beremagene geperpavec-svdt medically necessary for DEB wound treatment when all of the following are met:

Patient-level criteria:

#	Covered Indication Copy
1	Clinical manifestations of disease: extensive skin blistering, skin erosions, or scarring
2	Genetic test confirming a mutation in the COL7A1 gene
3	One or more open wounds designated as target wounds

Wound-level criteria (all must be met for each target wound):

#	Covered Indication Copy
1	Wound is clear in appearance and shows no signs of infection
2	Wound has adequate granulation tissue and vascularization
3	No history of squamous cell carcinoma in the specific wound(s) receiving treatment

Administration criteria:

#	Covered Indication Copy
1	Vyjuvek will be administered once weekly by a healthcare professional, the member, or a caregiver — either in a clinical setting or at home
2	Vyjuvek will not be applied to wounds that are currently healed

The COL7A1 genetic testing requirement is the one that trips up teams most often. You need that documentation in the chart before you submit prior authorization. No genetic test results, no authorization. This isn't a soft recommendation — it's a hard stop.

The squamous cell carcinoma exclusion is wound-specific, not patient-specific. A patient with a history of skin SCC coded under Z85.828 isn't automatically ineligible. The question is whether the specific wound being treated has that history. Document this clearly in the precert submission.

Prior authorization reimbursement for Vyjuvek hinges entirely on how complete your documentation is. Aetna's GCIT team reviews these closely. Send incomplete records and expect delays or denials, not approval requests.

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Aetna Vyjuvek Exclusions and Non-Covered Indications

Aetna's position here is direct: any indication not explicitly listed above is experimental, investigational, or unproven. Full stop.

That means Vyjuvek for EB subtypes other than DEB — such as simplex or junctional — won't clear medical necessity review. The policy is specific to dystrophic epidermolysis bullosa with a confirmed COL7A1 mutation. Recessive or dominant DEB aren't differentiated in the coverage criteria, but the genetic confirmation requirement effectively anchors coverage to COL7A1-related disease.

Applying Vyjuvek to currently healed wounds is also non-covered. This sounds obvious, but it matters for weekly administration protocols. If a target wound closes between treatment visits, that wound is no longer eligible for reimbursement under this coverage policy. Document wound status at each visit.

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Coverage Indications at a Glance

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Aetna Vyjuvek Billing Guidelines and Action Items 2026

These are the steps your billing and authorization teams need to execute. Don't wait — the effective date is January 5, 2026.

Copy Action Items

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CPT, HCPCS, and ICD-10 Codes for Beremagene Geperpavec-svdt Under CPB 1033

Covered HCPCS Codes (When Selection Criteria Are Met)

Code	Type	Description Copy
J3401	HCPCS	Beremagene geperpavec-svdt for topical administration, containing nominal 5 x 10^9 pfu/ml vector gen

Key ICD-10-CM Diagnosis Codes

Code	Description	Notes Copy
Q81.2	Epidermolysis bullosa dystrophica	Primary diagnosis for DEB — required for coverage
Open wound codes (numerous)	Open wounds (various sites)	Must code the specific treatment wound site; use the appropriate open wound ICD-10 code for the anatomical location
Z85.828	Personal history of other malignant neoplasm of skin [squamous cell carcinoma]	Include when relevant; document that SCC history does not involve the target wound(s)

A note on the open wound codes: Aetna lists multiple open wound ICD-10 codes as applicable — the specific code depends on the anatomical site being treated. Work with your clinical team to code the correct wound location. Don't use an unspecified wound code when a more specific one applies. Specificity matters here because the policy requires documentation of wound characteristics, and your ICD-10 selection should reflect the clinical record.

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