Does J3401 require prior authorization?

Yes, J3401 requires prior authorization (high confidence). At least one active policy explicitly requires prior authorization.

What is the Medicare reimbursement rate for J3401?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

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`J3401`, Beremagene geperpavec-svdt for topical administration, containing nominal 5 x

HCPCS/CPT

Prior Authorization

Prior Auth Required

At least one active policy explicitly requires prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

Prior authorization required by HealthPartners Pharmacy Administration.
Medical chart documentation required for wound criteria.

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 [...]
Beremagene geperpavec-svdt (Vyjuvek) is medically necessary for adults and children with dystrophic epidermolysis bullosa who (1) have COL7A1 mutations and clinical DEB manifestations (e.g., chronic wounds, blistering, ulcerations, scarring) and (2) have no active infection or history of squamous cell carcinoma in the treated wound(s).
Beremagene geperpavec-svdt (Vyjuvek™) may be considered medically necessary for adult and pediatric individuals if they meet criteria 1 through 2: 1) Diagnosis of dystrophic epidermolysis bullosa with COL7A1 mutation and corresponding clinical manifestations (chronic wounds, blistering, ulcers, scarring). 2) No active infection or history of squamous cell carcinoma in the targeted wound(s).
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 COL7A1 mutation; at least one recurrent or chronic open wound with adequate granulation tissue, excellent vascularization, no active wound infection, no SCC history; prescribed by a dermatologist with DEB expertise; not used with Filsuvez on same wound; no pl [...]
No prior treatment with the requested medication or any gene therapy product.

20 Active Policies

FLORIDA_BLUE-FLBLUE-VYJUVEK-BEREMAGENE-GEPERPAVEC-FDC22BB66D, Vyjuvek (beremagene geperpavec)

BCBSKS-VYJUVEK-DCE2CBEFEE, Vyjuvek

BCBSLA-00864-D8EEEC175D, 00864 beremagene geperpavec-svdt (Vyjuvek)

MGBHP-VYJUVEK-67D5EDAFB8, Vyjuvek

BCBSM-2175290-41D3C2C48E, VYJUVEK (BEREMAGENE GEPERPAVEC)

HEALTHPARTNERS-CC-ENTRY-267698, Gene therapy for dystrophic epidermolysis bullosa (Vyjuvek, Zevaskyn)

MULTI

POINT32HEALTH-MDMNG-14281, Vyjuvek (Beramagene Geperpavec-Svdt)

MULTI

POINT32HEALTH-MDMNG-14291, Vyjuvek (Beramagene Geperpavec-Svdt)

MULTI

BCBSNE-X-216-5C1C455482, VYJUVEK (PREAUTHORIZATION REQUIRED)

HEALTHNET_OR-HNOR-BEREMAGENE-GEPERPAVEC-SVDT-VYJUVEK-CP-PHAR-592-832CC43A43, Beremagene Geperpavec-svdt (Vyjuvek); CP.PHAR.592

MODA-VYJUVEK-3BD4504526, Vyjuvek (beremagene geperpavec-svdt)

IBX-COMMERCIAL-08-02-10B-68E3EE12E8, Beremagene Geperpavec (Vyjuvek)

UHC-COMM-MD-VYJUVEK-BERAMAGENE-GEPERPAVEC-SVDT-COMMU-6E80156747, Vyjuvek (Beramagene Geperpavec-Svdt) – Community Plan Medical Benefit Drug Policy

UHC-EXCH-MD-VYJUVEK-BERAMAGENE-GEPERPAVEC-SVDT-INDIV-BCF610BA83, Vyjuvek (Beramagene Geperpavec-Svdt) – Individual Exchange Medical Benefit Drug Policy

UHC-POL-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care

SUREST-POL-SUREST-vyjuvek, Vyjuvek (Beramagene Geperpavec-Svdt)

UHC-POL-vyjuvek, Vyjuvek (Beramagene Geperpavec-Svdt)

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

BCBSNM-RX501.164, Gene Therapies for Treatment of Wounds in Dystrophic Epidermolysis Bullosa

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J3401, Beremagene geperpavec-svdt for topical administration, containing nominal 5 x

HCPCS/CPT

Prior Authorization

Prior Auth Required

At least one active policy explicitly requires prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

Prior authorization required by HealthPartners Pharmacy Administration.
Medical chart documentation required for wound criteria.

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 [...]
Beremagene geperpavec-svdt (Vyjuvek) is medically necessary for adults and children with dystrophic epidermolysis bullosa who (1) have COL7A1 mutations and clinical DEB manifestations (e.g., chronic wounds, blistering, ulcerations, scarring) and (2) have no active infection or history of squamous cell carcinoma in the treated wound(s).
Beremagene geperpavec-svdt (Vyjuvek™) may be considered medically necessary for adult and pediatric individuals if they meet criteria 1 through 2: 1) Diagnosis of dystrophic epidermolysis bullosa with COL7A1 mutation and corresponding clinical manifestations (chronic wounds, blistering, ulcers, scarring). 2) No active infection or history of squamous cell carcinoma in the targeted wound(s).
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 COL7A1 mutation; at least one recurrent or chronic open wound with adequate granulation tissue, excellent vascularization, no active wound infection, no SCC history; prescribed by a dermatologist with DEB expertise; not used with Filsuvez on same wound; no pl [...]
No prior treatment with the requested medication or any gene therapy product.