Beremagene Geperpavec-Svdt Biological Suspension Mixed with Excipient Gel for Topical Application (Vyjuvek™) HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines

Effective July 15, 2023, NC Medicaid covers beremagene geperpavec-svdt biological suspension mixed with excipient gel for topical application

Effective with date of service July 15, 2023, NC Medicaid Direct and NC Medicaid Managed Care cover beremagene geperpavec-svdt biological suspension mixed with excipient gel for topical application (Vyjuvek) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3590 - Unclassified biologics.

Strength/Package Size: Vyjuvek is a biological suspension, mixed into excipient gel, for topical application.  

  • Vyjuvek biological suspension is supplied as a 1.0 mL extractable volume in a single dose vial at a nominal concentration of 5×109 PFU/mL. 
  • The excipient gel is supplied as a 1.5 mL fill volume in a separate single use vial.  
  • Vyjuvek biological suspension (1 mL) is mixed into the excipient gel vial prior to administration as Vyjuvek gel.

Beremagene geperpavec-svdt biological suspension mixed with excipient gel for topical application is indicated for the treatment of wounds in patients six months of age and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

Recommended Dose: Vyjuvek gel is applied topically to wound(s) once a week.

Maximum Weekly Dose (plaque forming units; PFU):  

  • 6 months to < 3 years old: 1.6×109 [volume after mixing biological suspension with excipient gel = 0.8 mL]
  • ≥ 3 years old: 3.2×109 [volume after mixing biological suspension with excipient gel = 1.6 mL]

See full prescribing information for further detail. 

For Medicaid Billing

  • The ICD-10-CM diagnosis code required for billing is: Q81.2 - Epidermolysis bullosa dystrophica
  • Providers must bill with HCPCS code: J3590 - Unclassified biologics
  • One Medicaid unit of coverage is: 1 mL  
  • The maximum reimbursement rate per unit is: $10,476.00000  
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are: 82194-0501-01, 82194-0510-02 
  • The NDC units should be reported as "UN1"
  • For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update.
  • For additional information regarding NDC claim requirements related to the PADP, refer to the PADP Clinical Coverage Policy 1B, Attachment A, H.7 on NC Medicaid's website.
  • Providers shall bill their usual and customary charge for non-340B drugs.
  • PADP reimburses for drugs billed for Medicaid beneficiaries by 340B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340B drugs shall bill the cost that is their actual acquisition cost. Providers shall indicate that a drug was purchased under a 340B purchasing agreement by appending the "UD" modifier on the drug detail.
  • The fee schedule for the PADP is available on the NC Medicaid Fee Schedule & Covered Code portal.

ICD-10-CM Manual. American Medical Association, 2023 manual.

*Information current as of Sept. 26, 2023, and is not a substitute for professional judgment. For full prescribing information, please refer to current package insert or other appropriate sources prior to making clinical judgments.


NCTracks Call Center: 800-688-6696 

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