In short

J3401 is the HCPCS Level II code for beremagene geperpavec-svdt for topical administration, containing nominal 5 x 10^9 pfu/ml vector genomes, per 0.1 ml. CMS assigns NDCs for Vyjuvek to it. One billing unit is 0.1 ml. The Medicare Part B payment limit is $1,029.469 per unit (October 1, 2026 through December 31, 2026).

Code

CMS HCPCS file
HCPCS codeJ3401
Billing unit0.1 ml
Descriptor
Beremagene geperpavec-svdt for topical administration, containing nominal 5 x 10^9 pfu/ml vector genomes, per 0.1 ml
Short descriptor
Vyjuvek 5x10^9pfu/ml, 0.1 ml
Code set
HCPCS Level II, maintained by CMS
Effective
Jan 1, 2024

The billing unit is read from the descriptor. Confirm it against the CMS file before billing.

Medicare Part B payment limit

CMS ASP file
Payment limit per unit$1,029.469
Per0.1 ml
Coinsurance20%

Effective October 1, 2026 through December 31, 2026. Payment allowance limits subject to the ASP methodology are based on 2Q26 ASP data. A payment limit is not a coverage decision; the Medicare contractor decides coverage. CMS ASP pricing files

Units and claim line

Enter the dose to get the units and the NDC line for the CMS-1500 and the 837P.

Enter the units to build the claim line.

NDCs billed under J3401

CMS’s ASP NDC–HCPCS crosswalk (effective October 1, 2026 through December 31, 2026) assigns 1 NDC to J3401 for Vyjuvek. Billing units per package are CMS’s figures for this code’s unit.

NDCs assigned to J3401 in the CMS ASP crosswalk
DrugNDC (11-digit)LabelerPackageBilling units per package
Vyjuvek82194-0510-02Krystal Biotech, Inc.125

J3401: common questions

Is J3401 a CPT code?
No. J3401 is a HCPCS Level II code, maintained by CMS, that identifies the drug supplied. CPT codes are five-digit numbers from the AMA that describe services. Giving the drug, for example an injection or infusion, is usually reported with a separate CPT administration code. CPT codes for drug administration.
What NDCs are billed under J3401?
CMS's ASP crosswalk for October 1, 2026 through December 31, 2026 lists 1 NDC under J3401, for Vyjuvek. The table on this page shows each one with its billing units per package.
What is the Medicare payment limit for J3401?
$1,029.469 per 0.1 ml, effective October 1, 2026 through December 31, 2026, from CMS's Part B drug payment limit file. Multiply by the units billed for the allowed amount before deductible and coinsurance. It is not a coverage decision.
What is one billing unit of J3401?
One unit of J3401 is 0.1 ml, as stated in the code's descriptor. Units to report = dose given ÷ 0.1 ml. J-code billing units.

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