Vedolizumab (Entyvio) — CPB 0885 | AETNA Coverage Update

Aetna modified CPB 0885 for vedolizumab (Entyvio), effective December 4, 2025. Here's what billing teams need to know.

Aetna, a CVS Health company, updated its vedolizumab coverage policy under CPB 0885 in Aetna's clinical policy bulletin system. The primary billing code for this drug is HCPCS J3380 (injection, vedolizumab, 1 mg), billed alongside infusion administration codes CPT 96365 or CPT 96413. This update clarifies medical necessity criteria across four covered indications and adds specific continuation-of-therapy standards your team needs to document before submitting claims.

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna, a CVS Health company
Policy	Vedolizumab (Entyvio) — CPB 0885
Policy Code	CPB 0885
Change Type	Modified
Effective Date	December 4, 2025
Impact Level	High
Specialties Affected	Gastroenterology, Hematology, Oncology
Key Action	Confirm prior authorization documentation matches updated continuation-of-therapy criteria before billing J3380 after December 4, 2025

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Aetna Vedolizumab Coverage Criteria and Medical Necessity Requirements 2025

The Aetna vedolizumab coverage policy under CPB 0885 covers four distinct indications. Each one has its own medical necessity criteria, and each has different prescriber requirements. Getting the wrong specialist listed on your prior authorization request is a fast path to a claim denial.

Aetna requires that vedolizumab be prescribed by or in consultation with a gastroenterologist for Crohn's disease (CD) and ulcerative colitis (UC). For immune checkpoint inhibitor-related toxicity, a gastroenterologist, hematologist, or oncologist qualifies. For acute graft versus host disease (aGVHD), only a hematologist or oncologist satisfies the prescriber requirement. Document the consulting specialist clearly in your precertification paperwork.

Precertification is mandatory. Call (866) 752-7021 or fax (888) 267-3277. You can also use Aetna's specialty pharmacy precertification forms for the Statement of Medical Necessity. Don't skip this step — vedolizumab is a high-cost biologic, and Aetna requires precertification for all participating providers and members in applicable plan designs.

Initial Approval: What Qualifies

For Crohn's disease and ulcerative colitis, the standard is moderately to severely active disease. That phrasing carries weight — mild disease doesn't qualify, and your documentation needs to show disease severity clearly.

For immune checkpoint inhibitor-related diarrhea or colitis (ICD-10 K52.1, K52.89, D89.9), the member must have had an inadequate response, intolerance, or contraindication to systemic corticosteroids or infliximab (J1745). That's a step-therapy requirement built into the medical necessity criteria. If you bill J3380 without evidence of a prior corticosteroid or infliximab trial documented in the record, expect a denial.

For acute graft versus host disease (D89.810–D89.813), Aetna requires either an inadequate response to systemic corticosteroids, or an intolerance or contraindication to corticosteroids. Only one of those two criteria needs to be met — not both.

Continuation of Therapy: The Details That Matter Most

This is where billing teams get tripped up, and it's where the CPB 0885 Aetna system update adds the most specificity.

For Crohn's disease, continuation is covered when the member achieves or maintains remission — or shows a positive clinical response. That response must come from improvement in at least one of the following from baseline: abdominal pain or tenderness, diarrhea, body weight, abdominal mass, hematocrit, mucosal appearance on endoscopy or imaging (including computed tomography enterography, magnetic resonance enterography, or intestinal ultrasound), or improvement on a disease activity scoring tool like the Crohn's Disease Activity Index (CDAI).

For ulcerative colitis, the same structure applies. Remission or positive clinical response supports continuation. The real-world documentation challenge is capturing that "improvement from baseline" language in your clinical notes before submitting continuation prior auth requests.

The site of care matters here too. Aetna's utilization management policy on site of care for specialty drug infusions applies to vedolizumab billing. If you're billing 96365 or 96413 for an infusion setting that doesn't match Aetna's preferred site of care, you may face a coverage issue that has nothing to do with the clinical criteria.

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Aetna Vedolizumab Exclusions and Non-Covered Indications

Aetna considers all indications for vedolizumab outside the four listed above as experimental, investigational, or unproven. There's no ambiguity in the policy language — if it's not CD, UC, immune checkpoint inhibitor-related toxicity, or aGVHD, it doesn't qualify.

CPT 80280 (vedolizumab drug assay, sometimes used for therapeutic drug monitoring) is listed in CPB 0885 as a code not covered for the indications listed in the bulletin. If your practice uses 80280 to monitor vedolizumab levels, understand that Aetna's coverage policy does not cover this code for these indications. Build that into your patient financial counseling before the infusion, not after.

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Coverage Indications at a Glance

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Aetna Vedolizumab Billing Guidelines and Action Items 2025

The effective date of December 4, 2025 is here. If your team hasn't reviewed workflows against CPB 0885, do it now.

Copy Action Items

If your practice bills vedolizumab across multiple indications — say, both inflammatory bowel disease and oncology-related colitis — and you're unsure how your specific payer mix interacts with this update, talk to your compliance officer before submitting continuation claims.

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CPT, HCPCS, and ICD-10 Codes for Vedolizumab Under CPB 0885

Covered HCPCS Code (When Selection Criteria Are Met)

Code	Type	Description Copy
J3380	HCPCS	Injection, vedolizumab, 1 mg

Not Covered CPT Code

Code	Type	Description	Reason Copy
80280	CPT	Vedolizumab (drug assay)	Not covered for indications listed in CPB 0885

Step-Therapy and Comparator HCPCS Codes Referenced in CPB 0885

These codes represent prior-line therapies or comparators referenced in the policy. They're relevant to your step-therapy documentation, not to the vedolizumab claim itself.

Key ICD-10-CM Diagnosis Codes

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