ENTYVIO J Code: J3380
Injection, vedolizumab, intravenous, 1 mg
Q4 2026 Medicare Payment Limit for J3380, effective October 1, 2026: $20.949 per HCPCS billing unit, down 3.1% from $21.622. From CMS's final file.
Drug & Product Overview
About ENTYVIO
Entyvio is a medication aligned to the HCPCS J Code: J3380 for billing, pricing, and reimbursement purposes in the United States. Classified under Immunology, it is administered via the intravenous route and manufactured by Takeda Pharmaceuticals.
According to CMS Drug Use Information: This medication is used to treat certain bowel disorders (ulcerative colitis, Crohn's disease). In these conditions, the body's defense system (immune system) attacks healthy tissues in the gut, causing symptoms such as abdominal pain, blood in the stool, and diarrhea. Vedolizumab belongs to a class of drugs known as monoclonal antibodies. It works by blocking the actions of a certain natural substance (integrin) in the body. This helps to decrease swelling (inflammation) in the gut, which lessens symptoms and may slow or stop damage from these bowel disorders.
Disclaimer: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional.
NDC Code Information
Based on publicly available CMS files. The list of NDCs below is not exhaustive.
| NDC Code | Drug | Manufacturer | Billing Units / Pkg | Package Size |
|---|---|---|---|---|
| 64764-0300-20 | Entyvio | Takeda Pharmaceuticals America, Inc. | 300 | 300 MG / 5 ML |
ENTYVIO Pricing & Reimbursement
National median reimbursement across major commercial payers.
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Real-world claims performance from FocalPoint, OnPoint Oncology's reimbursement analytics platform, with claims data accrued at the clearing house level.
Explore J3380 claims analytics on FocalPoint →
ENTYVIO CPT Administration Codes
The below list of CPT codes is intended for informational purposes only and may not be exhaustive. CPT® codes and descriptions are copyright American Medical Association (AMA). All rights reserved.
| CPT Code | Description |
|---|---|
| 96365 | Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour |
| 96366 | Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hour (List separately in addition to code for primary procedure) |
| 96372 Login for More | Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); intramuscular Login for More |
CMS has identified Entyvio (J3380) as a HCPCS code with single-dose containers. Therefore, the JW/JZ wastage modifiers could be required for billing purposes. Wastage billing guide →
ENTYVIO Medically Unlikely Edits (MUE)
The most billing units of J3380 Medicare will pay for one patient in one day, as published by CMS. 1 unit = 1 mg.
MAI 3 · Date of Service Edit: Clinical. Per-day limit based on clinical expectations; excess units are denied but may be appealed with documentation of medical necessity. See all MUE limits →
ENTYVIO Clinical Information
Indications and drug classification.
This list of indications is not exhaustive and may be subject to errors. The information on BuyandBill.com is intended for informational purposes only and should not be used for medical advice.
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Frequently Asked Questions
Is there an available Entyvio billing and coding guide?
Are there any available Entyvio patient assistance programs?
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Does billing ENTYVIO require JZ/JW wastage modifiers?
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