HCPCS Code J3380: Injection, Vedolizumab, Intravenous, 1 mg

Explore HCPCS Code J3380 for vedolizumab injection administered intravenously. Includes billing, documentation, and related code guidance.

Use Code

## **What is this vedolizumab injection?** HCPCS code J3380 represents the injection of vedolizumab, intravenous, 1 mg, a treatment commonly used for ulcerative colitis and Crohn’s disease. This FDA-approved drug falls under drugs administered by injection and is maintained by CMS as a specific code for injection vedolizumab. Unlike a subcutaneous injection (SC injection) or subcutaneous formulation, J3380 is strictly defined as an IV infusion service. Providers use this code when reporting the administration and dosage of vedolizumab for patients requiring therapeutic treatment. J3380 is listed with a fee schedule status code E (excluded from the physician fee schedule by regulation), meaning it remains reported but not reimbursed under the standard Medicare Physician Fee Schedule. Instead, coverage may depend on the payer, setting, and related diagnosis codes.

## **Documentation requirements** When billing HCPCS code J3380 (injection, vedolizumab, intravenous, 1 mg), healthcare providers must ensure thorough documentation to support coverage and reimbursement: - **Medical necessity and diagnosis**: Clearly document FDA-approved indications, ulcerative colitis or Crohn’s disease, including the patient’s treatment history and failure of conventional therapies (e.g., corticosteroids or immunomodulators) (Blue Cross Blue Shield of Michigan, n.d.). - **Administration details**: Note the exact dose (in mg) administered, date of service, and service setting. Link this to the correct code, J3380, for each 1 mg given (Innovus Healthcare Solutions, 2014). - **Chart documentation**: Patient-specific documentation (chart notes, progress reports, or infusion records) is essential to support claims - **Billing unit validation**: Bill one unit for each 1 mg of vedolizumab administered. For example, a 300 mg dose must be billed as 300 units of J3380 - **Regulatory guidance**: Refer to CMS’s HCPCS Application Summary for dosage descriptors, billing conventions, and any coding decisions affecting J3380

## **Billing requirements** When billing for HCPCS code J3380 for injection (vedolizumab, 1 mg), providers must document the diagnostic injection or therapeutic use as supported by the patient’s clinical condition. Report the exact number of units administered to reflect the correct dose. Always verify payer rules, as some require prior authorization or specific site-of-service documentation. Use J3380 for injection vedolizumab consistently across claims to ensure accurate reimbursement. Incorrect reporting of dosage or failure to link the appropriate ICD-10-CM diagnosis may result in claim denials.

## **Other relevant codes** - **J3358**: Ustekinumab, for intravenous injection, 1 mg - **J3357**: Ustekinumab, for subcutaneous injection, 1 mg - **J1745**: Injection, infliximab, excludes biosimilar, 10 mg

## **References** Blue Cross Blue Shield of Michigan (n.d.). Entyvio ® (Vedolizumab). Retrieved September 2, 2025, from https://www.bcbsm.com/amslibs/content/dam/public/mpr/mprsearch/pdf/2181826.pdf Innovus Healthcare Solutions (2014, May 20). Entyvio. https://innovushealthcaresolutions.com/entyvio