Aetna modified CPB 1048 for mirikizumab-mrkz (Omvoh), effective March 5, 2026. Here's what billing teams need to know.

Aetna, a CVS Health company, updated Clinical Policy Bulletin 1048 to add Crohn's disease as a covered indication for mirikizumab-mrkz (Omvoh), alongside the existing ulcerative colitis coverage. If your team bills J2267 (injection, mirikizumab-mrkz, 1 mg) or infusion codes 96365–96368 for Aetna members, this coverage policy expansion changes your prior authorization workflow starting now. The policy covers ICD-10 ranges K50.00–K50.919 (Crohn's disease) and K51.00–K51.919 (ulcerative colitis).


Quick-Reference Table

Field Detail
Payer Aetna, a CVS Health company
Policy Mirikizumab-mrkz (Omvoh) — CPB 1048
Policy Code CPB 1048
Change Type Modified
Effective Date March 5, 2026
Impact Level High
Specialties Affected Gastroenterology, infusion centers, specialty pharmacy billing
Key Action Update prior auth workflows and charge capture to include Crohn's disease (K50.xx) as a covered indication under J2267

Aetna Mirikizumab-mrkz (Omvoh) Coverage Criteria and Medical Necessity Requirements 2026

The Aetna Omvoh coverage policy now covers two indications: moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease. Both require precertification before you bill J2267 or any associated infusion code.

Call (866) 752-7021 or fax (888) 267-3277 to initiate prior authorization. You can also submit a Statement of Medical Necessity form through Aetna's Specialty Pharmacy Precertification portal.

Prescriber requirement: Mirikizumab-mrkz must be prescribed by or in consultation with a gastroenterologist. A prescription from a primary care physician alone won't satisfy medical necessity under CPB 1048 Aetna. Get that consult note in the chart before submitting your auth request.

Initial Approval Criteria

Aetna considers Omvoh medically necessary for:

#Covered Indication
1Moderately to severely active ulcerative colitis (K51.00–K51.919)
2Moderately to severely active Crohn's disease (K50.00–K50.919)

All other indications are classified as experimental, investigational, or unproven. That's a hard denial if you bill outside these two diagnoses.

Continuation of Therapy Criteria — Ulcerative Colitis

To continue coverage for UC, the member must achieve or maintain one of the following:

#Covered Indication
1Remission; or
2A positive clinical response shown by low disease activity or improvement in any of these from baseline: stool frequency, rectal bleeding, urgency of defecation, C-reactive protein (CRP), fecal calprotectin (FC), mucosal appearance on endoscopy/CTE/MRE/intestinal ultrasound, or improvement on a disease activity scoring tool (e.g., UCEIS, Mayo score)

The "any of the following" standard is member-friendly. One measurable improvement from baseline qualifies. Document it clearly in the auth renewal request.

Continuation of Therapy Criteria — Crohn's Disease

For CD continuation, the member must achieve or maintain remission or show a positive clinical response with improvement in any of these from baseline: abdominal pain or tenderness, diarrhea, body weight, abdominal mass, hematocrit, mucosal appearance on endoscopy/CTE/MRE/intestinal ultrasound, or improvement on a disease activity scoring tool (e.g., CDAI score).

The same flexible "any of the following" standard applies here. Body weight and hematocrit are included — that's a lower bar than some biologics require for CD continuation. Providers who document these markers routinely will have a smoother reimbursement path than those relying solely on endoscopy.

TB Screening Requirement

Members who are new to biologic or targeted synthetic drugs must have a documented negative TB test within 12 months of starting Omvoh. Acceptable tests include a tuberculin skin test (CPT 86580), an interferon-gamma release assay (CPT 86480 or 86481), or relevant culture/nucleic acid testing.

If TB screening is positive, the member needs further workup — chest X-ray (CPT 71045–71048) and additional testing — before Omvoh can be started. Active TB is an absolute contraindication. Latent TB requires treatment before initiation.

This TB documentation requirement is standard across IL-23 inhibitors and most biologics. If your team already has a checklist for ustekinumab or risankizumab, apply the same process here.


Aetna Omvoh Exclusions and Non-Covered Indications

Any indication outside moderately to severely active UC or moderately to severely active CD is experimental, investigational, or unproven under CPB 1048. Aetna draws a hard line here.

If you're seeing off-label use for conditions like indeterminate colitis, microscopic colitis, or other IBD-adjacent diagnoses, do not bill J2267 expecting coverage. Those claims will deny. Talk to your compliance officer before submitting if the diagnosis doesn't map clearly to K50.xx or K51.xx.


Coverage Indications at a Glance

Indication Status Relevant Codes Notes
Moderately to severely active ulcerative colitis — initial therapy Covered J2267, K51.00–K51.919 Prior auth required; gastroenterologist prescriber required
Moderately to severely active ulcerative colitis — continuation Covered J2267, K51.00–K51.919 Must show remission or improvement in any baseline marker
Moderately to severely active Crohn's disease — initial therapy Covered (new as of March 5, 2026) J2267, K50.00–K50.919 Prior auth required; gastroenterologist prescriber required; TB screen required
+ 2 more indications

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This policy is now in effect (since 2026-03-05). Verify your claims match the updated criteria above.

Aetna Omvoh Billing Guidelines and Action Items 2026

The Crohn's disease addition is the real news in this update. If your practice treats IBD patients on Omvoh — or is considering Omvoh for CD — these are your action items.

#Action Item
1

Update your charge capture for J2267 to include K50.xx diagnosis codes. The effective date is March 5, 2026. If your billing system only had K51.xx mapped to J2267 for Aetna, fix that now. Claims with K50.xx diagnoses submitted before this date would have denied. Claims submitted after March 5 with proper documentation should process.

2

Verify prior auth is in place before the first Crohn's disease infusion. Precertification is required for all Aetna participating providers on applicable plan designs. Call (866) 752-7021. Don't assume a UC auth transfers to a CD indication — it won't.

3

Confirm the prescribing gastroenterologist is documented in the chart. Aetna requires the medication be prescribed by or in consultation with a gastroenterologist. A consult note or co-signature satisfies this. A PCP-only order does not. Missing this detail is a fast path to a claim denial.

+ 4 more action items

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If your practice is new to Omvoh billing and you have significant CD volume, loop in your billing consultant before the first claim goes out. The prior auth requirements and continuation criteria are specific enough that a clean process upfront saves a lot of rework.


Sample Version Diff Line-by-line changes
Previous VersionCurrent Version
Coverage is considered experimental and investigational for all indicationsCoverage is considered medically necessary when specific criteria are met
Prior authorization is not requiredPrior authorization is required for initial treatment
Documentation must include clinical historyDocumentation must include clinical history
+ 1 more action items

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CPT, HCPCS, and ICD-10 Codes for Mirikizumab-mrkz (Omvoh) Under CPB 1048

Covered HCPCS Code (When Selection Criteria Are Met)

Code Type Description
J2267 HCPCS Injection, mirikizumab-mrkz, 1 mg

Administration and Infusion CPT Codes

Code Type Description
96365 CPT IV infusion, therapy/prophylaxis/diagnosis — initial, up to 1 hour
96366 CPT IV infusion, therapy/prophylaxis/diagnosis — each additional hour
96367 CPT IV infusion, additional sequential infusion, up to 1 hour
+ 6 more codes

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TB Screening CPT Codes (Required at Initiation for Biologic-Naïve Members)

Code Type Description
86480 CPT TB test, cell-mediated immunity; gamma interferon antigen response measurement
86481 CPT TB test; enumeration of gamma interferon-producing T-cells in cell suspension
86580 CPT Skin test; tuberculosis, intradermal (Mantoux)
+ 3 more codes

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Chest Imaging CPT Codes (Required if TB Screen Is Positive)

Code Type Description
71045 CPT Radiologic examination, chest; single view
71046 CPT Radiologic examination, chest; 2 views
71047 CPT Radiologic examination, chest; 3 views
+ 1 more codes

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Key ICD-10-CM Diagnosis Codes

Code Range Description
K50.00–K50.919 Crohn's disease [regional enteritis] — covered as of March 5, 2026
K51.00–K51.919 Ulcerative colitis, moderately to severely active

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