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 do.

Aetna, a CVS Health company, updated Clinical Policy Bulletin 0885 governing vedolizumab (Entyvio) coverage for commercial medical plans. The policy covers four approved indications — Crohn's disease, ulcerative colitis, immune checkpoint inhibitor-related toxicity, and acute graft versus host disease — and requires precertification for all participating providers. The primary billing code is HCPCS J3380 (injection, vedolizumab, 1 mg), with infusion administration billed under CPT 96365 or 96413. If you bill Entyvio for Aetna commercial members, this update affects your prior authorization workflow, continuation criteria documentation, and site-of-care requirements.

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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 precertification is active for all Entyvio claims and verify site-of-care compliance before submitting

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Aetna Vedolizumab Coverage Criteria and Medical Necessity Requirements 2025

The Aetna vedolizumab coverage policy under CPB 0885 applies to commercial plans only. Medicare members follow a separate path — check Aetna's Medicare Part B criteria page for those requirements.

Precertification is mandatory. Call (866) 752-7021 or fax (888) 267-3277. If you skip this step, you're looking at a claim denial before the clinical review even starts. Pull Statement of Medical Necessity forms from Aetna's Specialty Pharmacy Precertification portal.

Site of care also requires separate utilization management review. Aetna's Site of Care policy for specialty drug infusions applies here. That means an infusion center billing under CPT 96365 or 96413 needs to satisfy both the drug-level prior authorization and the site-level review. Don't treat these as the same approval.

Prescriber Specialty Requirements

Aetna restricts who can prescribe vedolizumab based on indication:

#	Covered Indication Copy
1	Crohn's disease and ulcerative colitis: Must be prescribed by or in consultation with a gastroenterologist
2	Immune checkpoint inhibitor-related toxicity: Gastroenterologist, hematologist, or oncologist
3	Acute graft versus host disease: Hematologist or oncologist

If the prescribing provider doesn't match the indication, expect a prior authorization denial. Flag this in your intake workflow before submitting the precertification request.

Initial Approval: What Aetna Considers Medically Necessary

Aetna considers vedolizumab medically necessary for four indications. The medical necessity bar for each is different, so read them separately.

Crohn's disease (ICD-10 K50.00–K50.919): Moderately to severely active CD. No step therapy requirement listed for initial approval — the severity threshold is the key gate.

Ulcerative colitis (ICD-10 K51.00–K51.919): Moderately to severely active UC. Same pattern as CD. Fulminant UC with hospitalization maps to K55.11–K55.27 in this policy.

Immune checkpoint inhibitor-related toxicity (ICD-10 D89.9, K52.1, K52.89): Aetna requires documented inadequate response, intolerance, or contraindication to systemic corticosteroids or infliximab (J1745). This is a step therapy requirement. You need that step therapy failure documented before the PA will clear.

Acute graft versus host disease (ICD-10 D89.810–D89.813): Requires either inadequate response to systemic corticosteroids, or intolerance/contraindication to corticosteroids. One of those two criteria must be met.

Continuation of Therapy Criteria

Continuation approval is where a lot of claims stall. Aetna sets different continuation standards for CD versus UC.

For Crohn's disease, continuation is approved when the member achieves or maintains remission, OR shows positive clinical response. That response can be evidenced by improvement in any of the following from baseline: abdominal pain or tenderness, diarrhea, body weight, abdominal mass, hematocrit, mucosal appearance on endoscopy or imaging (CTE, MRE, or intestinal ultrasound), or improvement on a disease activity scoring tool like the CDAI.

That's a wide net — improvement in any one of those markers qualifies. Document all of them at every visit. You want as many data points as possible when the renewal hits.

For ulcerative colitis, the continuation standard mirrors this structure: remission or positive clinical response evidenced by low disease activity.

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Aetna Vedolizumab Exclusions and Non-Covered Indications

Aetna considers all indications not listed above as experimental, investigational, or unproven. There's no gray area here — if it's not one of the four approved indications, the answer is no.

CPT 80280 (vedolizumab drug level/monitoring test) is explicitly listed as not covered for indications in the CPB. If your gastroenterology team orders 80280 for therapeutic drug monitoring, don't bill it expecting Aetna reimbursement under this policy. It won't clear.

The collagenous colitis code K52.831 appears in the ICD-10 list, which signals Aetna has considered it — but the primary approved diagnoses are CD, UC, immune checkpoint inhibitor toxicity, and acute GVHD. If you're billing vedolizumab for collagenous colitis, verify with your compliance officer before the effective date of December 4, 2025, whether that falls under an approved indication or gets flagged as experimental.

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Coverage Indications at a Glance

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Aetna Vedolizumab Billing Guidelines and Action Items 2025

This is where the rubber meets the road. The CPB 0885 Aetna system update effective December 4, 2025 requires action across several workflows. Work through these before claims start dropping under the revised policy.

Copy Action Items

If you have patients with complex presentations — GVHD with concurrent UC, or checkpoint inhibitor colitis after prior biologic failure — loop in your compliance officer before the December 4, 2025 effective date. The indication boundaries matter for PA approval, and a wrong diagnosis code on the PA request can delay treatment.

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

Covered HCPCS Codes (When Selection Criteria Are Met)

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

Not Covered Under CPB 0885

Code	Type	Description	Reason Copy
80280	CPT	Vedolizumab (drug level/monitoring)	Not covered for indications listed in the CPB

Related Imaging CPT Codes

Step Therapy and Comparator HCPCS Codes

These codes represent therapies Aetna references as prior step requirements or clinical comparators within the CPB.

Key ICD-10-CM Diagnosis Codes

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