Billing and coding for ENTYVIO

One of the most common reasons for prior authorization denial is the inclusion of an incorrect billing code. It is important to be accurate with coding for the product, administration, and associated procedures. Here are the most common codes to use when submitting documentation to your patient’s health plan.

The following coding information is intended as general information only. Please refer to your patient's payer's policies for specific billing guidance.

ENTYVIO Coding Guide

ENTYVIO	64764-300-20*	300 mg single-dose vial in individual carton
ENTYVIO	64764-108-21	108 mg single-dose prefilled pen in individual carton

*Proper billing may require code conversion to 11-digit format: 64764-0300-20.

J3380	ENTYVIO
J3380	Injection, vedolizumab, intravenous, 1 mg

96365	IV Infusion, up to 1 hour
96413^†	Chemotherapy, IV Infusion, up to 1 hour
96372	Therapeutic, prophylactic, or diagnostic injection; subcutaneous injection or intramuscular

^†Certain Medicare contractors do not allow the use of procedure code 96413 (Chemotherapy, intravenous (IV) Infusion, up to 1 hour) for administration of ENTYVIO. As applicable, healthcare provider should consult the Medicare contractor to determine which code is most appropriate, or call EntyvioConnect for assistance at 1-855-ENTYVIO.

Ulcerative colitis

K51.00	Ulcerative (chronic) pancolitis without complications
K51.20	Ulcerative (chronic) proctitis without complications
K51.30	Ulcerative (chronic) rectosigmoiditis without complications
K51.50	Left sided colitis without complications
K51.80	Other ulcerative colitis without complications
K51.90	Ulcerative colitis, unspecified, without complications

Crohn’s disease

K50.00	Crohn’s disease of small intestine without complications
K50.10	Crohn’s disease of large intestine without complications
K50.80	Crohn’s disease of both small and large intestine without complications
K50.90	Crohn’s disease, unspecified, without complications

ICD-10-CM=International Classification of Diseases, Tenth Revision, Clinical Modification

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The content on this page has been written and reviewed by Takeda.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.

WARNINGS AND PRECAUTIONS

Infusion-Related and Hypersensitivity Reactions: Infusion-related reactions and hypersensitivity reactions, including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate, have been reported. These reactions may occur with the first or subsequent infusions and may vary in their time of onset from during infusion or up to several hours post-infusion. If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
Infections: ENTYVIO increases the risk for developing infections. Serious infections in clinical trials included anal abscess, sepsis (some fatal), tuberculosis (TB), salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. Postmarketing reports include systemic bacterial, fungal, viral, and parasitic opportunistic infections.
Do not start ENTYVIO in patients with a clinically important active infection until resolved or adequately treated. In patients with chronic infection or history of recurrent infection, consider risks and benefits prior to ENTYVIO. Instruct patients to seek medical advice if signs or symptoms of acute or chronic infection occur. If a serious infection develops or does not respond to therapy, monitor closely and do not administer ENTYVIO until resolved.
Tuberculosis: Consider evaluating for TB prior to ENTYVIO. Do not administer ENTYVIO to patients with active TB. Before starting ENTYVIO, treat latent TB and consider anti-TB therapy in patients with a history of TB if adequate course of treatment cannot be confirmed. Monitor for active TB during and after ENTYVIO.
Progressive Multifocal Leukoencephalopathy (PML): PML, a rare and often fatal opportunistic infection of the central nervous system (CNS), has been reported with systemic immunosuppressants, including another integrin receptor antagonist. PML typically only occurs in patients who are immunocompromised. One case of PML in an ENTYVIO-treated patient with multiple contributory factors has been reported. Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms that may include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. If PML is suspected, withhold dosing with ENTYVIO and refer to neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
Liver Injury: There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury.
Immunizations: Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non-live vaccines and may receive live vaccines if the benefits outweigh the risks.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥3% and ≥1% higher than placebo) were: nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, pain in extremities, and injection site reactions with subcutaneous administration.

DRUG INTERACTIONS

Because of the potential for increased risk of PML and other infections, avoid the concomitant use of ENTYVIO with natalizumab products and with TNF blockers. Upon initiation or discontinuation of ENTYVIO in patients treated with CYP450 substrates, monitor drug concentrations or other therapeutic parameters, and adjust the dosage of the CYP substrate as needed.

INDICATIONS

ENTYVIO is indicated in adults for the treatment of:

moderately to severely active ulcerative colitis (UC)
moderately to severely active Crohn's disease (CD)

DOSAGE FORMS & STRENGTHS

ENTYVIO Intravenous (IV) Infusion: 300 mg vedolizumab
ENTYVIO Subcutaneous (SC) Injection: 108 mg vedolizumab

Please click for Full Prescribing Information.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.

WARNINGS AND PRECAUTIONS

Infusion-Related and Hypersensitivity Reactions: Infusion-related reactions and hypersensitivity reactions, including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate, have been reported. These reactions may occur with the first or subsequent infusions and may vary in their time of onset from during infusion or up to several hours post-infusion. If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
Infections: ENTYVIO increases the risk for developing infections. Serious infections in clinical trials included anal abscess, sepsis (some fatal), tuberculosis (TB), salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. Postmarketing reports include systemic bacterial, fungal, viral, and parasitic opportunistic infections.
Do not start ENTYVIO in patients with a clinically important active infection until resolved or adequately treated. In patients with chronic infection or history of recurrent infection, consider risks and benefits prior to ENTYVIO. Instruct patients to seek medical advice if signs or symptoms of acute or chronic infection occur. If a serious infection develops or does not respond to therapy, monitor closely and do not administer ENTYVIO until resolved.
Tuberculosis: Consider evaluating for TB prior to ENTYVIO. Do not administer ENTYVIO to patients with active TB. Before starting ENTYVIO, treat latent TB and consider anti-TB therapy in patients with a history of TB if adequate course of treatment cannot be confirmed. Monitor for active TB during and after ENTYVIO.
Progressive Multifocal Leukoencephalopathy (PML): PML, a rare and often fatal opportunistic infection of the central nervous system (CNS), has been reported with systemic immunosuppressants, including another integrin receptor antagonist. PML typically only occurs in patients who are immunocompromised. One case of PML in an ENTYVIO-treated patient with multiple contributory factors has been reported. Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms that may include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. If PML is suspected, withhold dosing with ENTYVIO and refer to neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
Liver Injury: There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury.
Immunizations: Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non-live vaccines and may receive live vaccines if the benefits outweigh the risks.

ADVERSE REACTIONS

DRUG INTERACTIONS

INDICATIONS

ENTYVIO is indicated in adults for the treatment of:

moderately to severely active ulcerative colitis (UC)
moderately to severely active Crohn's disease (CD)

DOSAGE FORMS & STRENGTHS

ENTYVIO Intravenous (IV) Infusion: 300 mg vedolizumab
ENTYVIO Subcutaneous (SC) Injection: 108 mg vedolizumab

Please click for Full Prescribing Information.

References:

ENTYVIO (vedolizumab) prescribing information. Takeda Pharmaceuticals.
HCPCS.codes. Accessed March 16, 2026. https://hcpcs.codes/j-codes/J3380/
CMS.gov. Accessed March 16, 2026. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices-Items/CMS-1715-5
CMS.gov. Accessed March 16, 2026. https://www.cms.gov/icd10m/version37-fullcode-cms/fullcode_cms/P0167.html

ENTYVIO billing and coding guide

Billing and coding for ENTYVIO

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ENTYVIO billing and coding guide

Billing and coding for ENTYVIO

NDC1

Product code (J code)2

Potential hospital outpatient procedural codes (CPT code)3

Diagnosis codes (ICD-10-CM)4

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Hear expert perspectives on ENTYVIO

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