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 |
|---|---|
| 1 | Moderately to severely active ulcerative colitis (K51.00–K51.919) |
| 2 | Moderately 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 |
|---|---|
| 1 | Remission; or |
| 2 | A 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 |
| Moderately to severely active Crohn's disease — continuation | Covered (new as of March 5, 2026) | J2267, K50.00–K50.919 | Must show remission or improvement in any baseline marker |
| All other indications | Not Covered | — | Classified as experimental, investigational, or unproven |
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 | Build a TB screening checklist into your Omvoh onboarding workflow. New biologic users need a documented negative TB test (CPT 86580, 86480, or 86481) within 12 months of starting therapy. If the patient had a positive screen, document the chest X-ray (CPT 71045–71048) and any follow-up workup. Latent TB requires treatment before you start the drug. |
| 5 | Set up renewal reminders with continuation criteria documentation requirements. For both UC and CD, auth renewals need evidence of remission or clinical response. The policy lists specific markers — stool frequency, CRP, fecal calprotectin, CDAI score, mucosal appearance, and others. Make sure your clinical team knows which data points to capture and document at each visit. |
| 6 | Audit any Omvoh claims submitted between FDA approval for CD and March 5, 2026. If your team submitted J2267 with K50.xx codes before the effective date of this policy change, those likely denied. Review that claim inventory. If Aetna has now confirmed coverage, resubmit with updated authorization and proper documentation. |
| 7 | Check plan-level coverage for members on self-funded plans. This CPB applies to commercial medical plans. Self-funded employers can carve out specific drugs or indications. Confirm coverage at the plan level before starting therapy for any new Crohn's disease patient. |
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.
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
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 |
| 96368 | CPT | IV infusion, concurrent infusion |
| 96372 | CPT | Therapeutic/prophylactic/diagnostic injection; subcutaneous or intramuscular |
| 96401 | CPT | Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic |
| 96413 | CPT | Chemotherapy administration, IV infusion technique; up to 1 hour |
| 96414 | CPT | Chemotherapy administration, IV infusion technique; each additional hour |
| 96415 | CPT | Chemotherapy administration, IV infusion technique; each additional sequential infusion |
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) |
| 87116 | CPT | Culture, tubercle or other acid-fast bacilli (e.g., TB, AFB, mycobacterial), any source, with isolation |
| 87556 | CPT | Infectious agent detection by nucleic acid; Mycobacterium tuberculosis, amplified probe technique |
| 87798 | CPT | Infectious agent detection by nucleic acid, NOS; amplified probe technique |
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 |
| 71048 | CPT | Radiologic examination, chest; 4 or more views |
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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