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Entyvio (J3380): Medicare coverage & FDA-indicated diagnoses

Entyvio (vedolizumab) · Medicare Part B (physician-administered) · 10 FDA-indicated ICD-10 codes

Medicare pays for Entyvio (J3380) under Part B per medical necessity. There is no drug-specific Medicare LCD, so the 10 ICD-10 codes below are the FDA-approved indications — the labeled uses Medicare generally pays for — grouped by condition. Coverage is judged by your MAC. Page reviewed Aug 23, 2026.

Page reviewed Aug 23, 2026 · from FDA-approved labeling (Drugs@FDA) — no drug-specific Medicare LCD

Quick answer

Medicare benefit
Part B (physician-administered)
FDA-indicated diagnoses
10 ICD-10 codes
Governing policy
FDA indications (no LCD)
Contractor (MAC)
Per medical necessity
Source
FDA labeling
Page reviewed
Aug 23, 2026
HCPCS codes covered:
J3380
No drug-specific Medicare coverage article exists for Entyvio. Coverage is decided per medical necessity by your MAC. The FDA-approved indications below are the labeled uses Medicare generally pays for; an off-label use may be covered if supported by an approved compendium. Find your MAC by state →

What Medicare pays for Entyvio (2026 Q3)

Once a claim carries a covered diagnosis, Medicare Part B reimburses the drug at the ASP + 6% payment limit. Current allowed amounts per billing unit:

HCPCSDescriptionPer unitAllowed (ASP + 6%)
J3380Inj vedolizumab iv 1 mg1 mg$21.622

Source: CMS ASP Drug Pricing File, 2026 Q3. Payment = ASP + 6% per unit; multiply by units billed (watch JZ/JW wastage). Your patient's share is typically 20% after the deductible. Estimate the full cost & patient out-of-pocket →

Entyvio is a physician-administered biologic billed under Medicare Part B (not the Part D pharmacy benefit). Under Part B, Medicare pays the practice for the drug (HCPCS J3380) plus its administration — but only when the claim's diagnosis (ICD-10) code supports medical necessity. Each MAC publishes the specific covered diagnoses in a Billing & Coding Article; a claim with a diagnosis outside that list is typically denied as not medically necessary (CO-50).

Covered ICD-10 diagnoses for Entyvio

The 10 FDA-approved indications for J3380, grouped by condition — filter to find a code.

Ulcerative Colitis — 6 diagnoses (applies to J3380)

Diseases of the digestive system (6)

ICD-10Covered diagnosis
K51.00Ulcerative (chronic) pancolitis without complications
K51.20Ulcerative (chronic) proctitis without complications
K51.30Ulcerative (chronic) rectosigmoiditis without complications
K51.50Left sided colitis without complications
K51.80Other ulcerative colitis without complications
K51.90Ulcerative colitis, unspecified, without complications

Crohn's Disease — 4 diagnoses (applies to J3380)

Diseases of the digestive system (4)

ICD-10Covered diagnosis
K50.00Crohn's disease of small intestine without complications
K50.10Crohn's disease of large intestine without complications
K50.80Crohn's disease of both small and large intestine, without complications
K50.90Crohn's disease, unspecified, without complications

What commercial payers require for Entyvio

Medicare Part B is only half the answer — most Entyvio claims are adjudicated by a commercial plan with its own medical policy. Below is what 30 commercial payers publish for Entyvio, read from each payer's own policy document. 28 of 30 that state a position require prior authorization, and 17 run a site-of-care program that can push the infusion out of the hospital outpatient setting.

PayerPrior authPreferred product firstSite of careIndications namedPolicy date
Aetna policy ↗Required—Separate site of care policy applies; specific restrictions defined in referenced UM policy; Utilization Management Policy on Site of Care for Specialty Drug Infusions22026-06-30
Anthem / Elevance policy ↗Required——22023-12-01
Arkansas BCBS policy ↗Required—A separate Site of Care / Site of Service Review policy (policy #2018030) applies to this pharmacologic/biologic medication.22026-02-26
BCBS Federal Employee Program policy ↗Required——22026-01-01
BCBS Kansas policy ↗Not required—Site-of-care program applies2—
BCBS Louisiana policy ↗Not required——22025-08-01
BCBS Massachusetts policy ↗Required——22024-10-01
BCBS Michigan policy ↗Required—Site-of-care program applies22026-07-01
BCBS Minnesota policy ↗Required——22026-03-03
BCBS Mississippi policy ↗Required——22025-08-01
BCBS Nebraska policy ↗Required——22025-11-05
BCBS South Carolina policy ↗Required—Site-of-care program applies22026-04-01
BCBS Tennessee policy ↗Required——22026-04-30
Blue Shield of California policy ↗Required—Preferred site-of-service program may apply (PPO, Direct Contract HMO, and when applicable ASO, Shared Advantage, HMO non-direct): infusions directed to home, physician office, or an independent (non-hospital) infusion center. Hospital outpatient facility administration requires meeting listed criteria.22026-02-01
Capital BlueCross policy ↗Required——22025-03-04
CareFirst BCBS policy ↗Required—A hospital-outpatient site-of-care program applies. Hospital outpatient infusion of vedolizumab is medically necessary only when general Section II criteria OR vedolizumab-specific criteria are met: first two infusions permitted to determine tolerance; pediatric patients under 21; or moderate infusion reactions not responding to standard interventions. Otherwise members are steered to lower-cost sites (office/ambulatory infusion center/home).2—
Centene / Ambetter policy ↗Required——2—
Cigna policy ↗Required—Site-of-care program applies22026-05-15
Excellus BCBS policy ↗Required——22026-06-23
Florida Blue policy ↗Required—Hospital-affiliated outpatient site of care requirements may apply; refer to 09-J3000-46 Site of Care Policy for Select Non-Oncology Medications22026-07-01
HCSC (IL/TX/OK/NM/MT) policy ↗Required—Site-of-care program applies22026-06-15
Highmark BCBS policy ↗Required—Considered medically necessary for individuals 18 and older when administered in a physician's office not affiliated with a hospital, non-hospital-affiliated specialized infusion centers, or in the home. Hospital outpatient administration is medically necessary only when specific medical-instability criteria are met; otherwise not medically necessary when an approved site of care is a viable option.22020-12-07
HMSA (BCBS Hawaii) policy ↗Required——22025-08-01
Horizon BCBS NJ policy ↗Required—Site of administration for infusion and injectable prescription medications is governed by a separate Horizon policy (Policy #142). Note: for Medicare Advantage this site-of-administration requirement does not apply.22020-07-23
Independence Blue Cross policy ↗Required—The Company reserves the right to reimburse only services furnished in the most appropriate and cost-effective setting appropriate to the member's medical needs and condition, steering infusion to lower-cost sites of care.22024-09-09
Kaiser Permanente WA policy ↗Required—Must be administered in a non-hospital setting (see Site of Care: Infusion Therapy and Clinic Administered Medicines policy for criteria, reauthorization, and new-start exceptions). Home-infused medications covered in-network only through Kaiser Permanente Specialty Home Infusion; no out-of-network home-infusion benefit.22024-12-01
Premera Blue Cross policy ↗Required—Entyvio (vedolizumab) IV is subject to site of service review (age 13+). Preferred medically necessary sites are physician's office, infusion center, and home infusion; hospital-based outpatient setting is not medically necessary unless the policy's site-of-service criteria are met. Does not apply to Alaska fully-insured members.22026-06-01
Regence BCBS policy ↗Required—Site of care administration requirements apply to Entyvio as a provider-administered therapy (refer to Medication Policy Manual, Site of Care Review, dru408), steering infusion to approved lower-cost sites.22026-04-01
UnitedHealthcare policy ↗Required—Provider Administered Drugs Site of Care policy applies22025-07-01
Wellmark BCBS policy ↗Required——22025-06-06

What Entyvio payers put in writing

Quoted from the medical policies linked above — 24 distinct requirements across 30 payers. These are the sentences an appeal has to answer.

Clinical prerequisites — what must be true before they pay

Prior authorization

Quantity and frequency limits

Dosing rules

Read from each payer's published medical policy between 2026-08-03 and 2026-08-13. Every requirement above is quoted from the policy it links to. Commercial policy changes without notice — confirm before you bill.

How to bill Entyvio

Put a medically necessary, FDA-indicated diagnosis from the list above on the claim line with J3380. Matching codes, units and JZ/JW wastage →

Which policy governs Entyvio

No drug-specific LCD or Article — see the note at the top of this page. Find your MAC → What an LCD, an Article and an NCD each govern →

If a claim for Entyvio is denied

With no drug-specific Article, the usual cause is a diagnosis the MAC does not accept as medically necessary for J3380, or an off-label use with no compendium support. The five denial patterns and how to fix each →

Frequently asked questions

Is Entyvio covered by Medicare?
Yes. Entyvio (J3380) is covered under Medicare Part B as a physician-administered drug when billed for a medically necessary indication. There is no drug-specific Local Coverage Determination (LCD) for it, so coverage is determined per medical necessity by your MAC; the FDA-approved indications below are the starting point.
What diagnoses are covered for Entyvio (J3380)?
Medicare publishes no drug-specific covered-diagnosis list for J3380. The 10 ICD-10 codes here are the FDA-approved indications; an off-label use needs approved-compendium support (DrugDex, NCCN) to be payable.
Which Medicare policy covers Entyvio?
No drug-specific LCD or Billing & Coding Article exists for Entyvio. It's covered under the general Medicare Part B drug benefit per medical necessity, as judged by your Medicare Administrative Contractor (MAC).
Why was my Entyvio claim denied as not medically necessary?
The most common cause is a diagnosis the MAC doesn't consider medically necessary for J3380. Bill a covered/FDA-approved indication from the list below, document medical necessity, and confirm any local guidance with your MAC.

Related references

Entyvio billing & units guideJ-code, NDC, units, JZ/JW wastage Medicare coverage hubCovered diagnoses for more drugs Estimate patient costReimbursement & patient out-of-pocket Avastin coverage458 covered ICD-10 codesInfliximab coverage406 covered ICD-10 codesBotox (Botulinum Toxin) coverage313 covered ICD-10 codes

Covered is only half the answer.

You know the diagnosis is payable. Now quote the patient before the visit and catch underpayments: get Entyvio's exact Medicare allowed amount, your payer's rate vs. ASP+6%, and the patient's out-of-pocket — in about 30 seconds, free.

Estimate Entyvio cost & patient owe →

Source & verification

Source
FDA-approved indications (Drugs@FDA labeling) mapped to ICD-10-CM. No drug-specific Medicare LCD/Article exists for Entyvio — Part B coverage is determined per medical necessity by your MAC.
Primary sources
DailyMed — Entyvio prescribing information · CMS Part B Drug ASP Pricing File — the quarterly payment limit quoted above · CMS Medicare Coverage Database — searched for “Entyvio”; no drug-specific NCD, LCD or Billing & Coding Article exists, which is why the FDA-indicated codes above are the working list
Page last reviewed by CareCost
Aug 23, 2026 (coverage data retrieved 2026-08-26; we re-verify against CMS quarterly).
Code licensing
ICD-10-CM codes are public domain (CMS/CDC). CPT® codes are AMA-copyrighted and are intentionally not listed here — see the administration-code reference for those.
Not advice
This is general billing reference, not legal or billing advice. Always verify against the LCD/Article that applies to your MAC and patient.
How we build this
Compiled programmatically from the CMS Coverage API under a founder-led methodology maintained by Erin Rose (Founder), and reviewed against the source article with a practitioner-correction loop. See our methodology and editorial policy.
Spotted an error?
Email editorial@carecostestimate.com.