J3401, Beremagene geperpavec-svdt for topical administration, containing nominal 5 x
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Documentation demonstrating the therapy is supported by FDA-approved labeling or nationally recognized authoritative references/compendia or peer‑reviewed literature.
- For drug therapy, documentation of the proposed dose, frequency, and duration and citation of the authoritative source supporting those parameters (e.g., MCG, DrugDex, NCCN).
- Documentation that the prescribed use is cited as safe and effective in one or more standard medical reference compendia adopted by HHS or in peer‑reviewed medical literature.
- Prescription and clinical records supporting the medical necessity of the drug for the indicated use.
Key Coverage Criteria
- Covered when hospital outpatient facility infusion services for specialty medications and IVIG/SCIG therapy are considered medically necessary and the member meets the specific clinical criteria described in the policy.
- Vyjuvek is proven and medically necessary for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) who meet all of the following criteria: For initial therapy, all of the following: Diagnosis of DEB; submission of medical records confirming COL7A1 mutation; patient has at least one recurrent or chronic open wound with adequate granulation tissue, excellent vascularization, no active wound infection, and no history of squamous cell carcinoma; Vyjuvek prescribed by a der [...]
- Use of gene therapies to treat wounds in patients with dystrophic epidermolysis bullosa
- Requested therapy must be proven effective for the relevant diagnosis based on generally accepted standards of practice.
- For drug therapy, the proposed dose, frequency, and duration must be consistent with recommendations in at least one authoritative source (e.g., FDA labeling, major drug compendia, MCG, DrugDex, NCCN).
- Gene therapies for treatment of wounds in dystrophic epidermolysis bullosa.
10 Active Policies
UHC-POL-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care
UHC-POL-vyjuvek, Vyjuvek (Beramagene Geperpavec-Svdt)
RX501.164, Gene Therapies for Treatment of Wounds in Dystrophic Epidermolysis Bullosa
BCBSIL-RX501.164, Gene Therapies for Treatment of Wounds in Dystrophic Epidermolysis Bullosa
BCBSMT-RX501.164, Gene Therapies for Treatment of Wounds in Dystrophic Epidermolysis Bullosa
Related Codes
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