HCPCS
J2267
1 mg = 1 unit
Phase 1
Identify what you're billing
Confirm IV induction vs SC maintenance pathway — same J-code, different benefit routing.
IV induction (J2267 medical) vs SC maintenance (J2267 or pharmacy) FDA label updated Jan 2025
One drug, two formulations — but unlike Skyrizi/Tremfya, the SC pen can bill medical under J2267 if office-administered.
Omvoh exists in two formulations that share one HCPCS code. The IV induction vial
(300 mg / 15 mL single-dose vial, 20 mg/mL) is used for the three-dose induction at weeks 0, 4, and 8.
The SC prefilled pen (100 mg / 1 mL single-dose) is used for maintenance starting week 12 —
each 200 mg maintenance dose is two pens. Both formulations are billed under J2267 when
administered in a provider setting, with units always equal to milligrams administered.
| Omvoh IV induction | Omvoh SC maintenance | |
|---|---|---|
| HCPCS | J2267 — 300 units/dose | J2267 if office-administered (200 units/dose); none if pharmacy benefit |
| Benefit pathway | Medical (buy-and-bill or specialty pharmacy white-bag) | Either medical or pharmacy — payer-specific |
| Indications | UC, Crohn's induction | UC, Crohn's maintenance from week 12 |
| Strength / form | 300 mg / 15 mL SDV (20 mg/mL) | 100 mg / 1 mL prefilled pen (2 pens per 200 mg dose) |
| Dose | 300 mg IV at weeks 0, 4, 8 | 200 mg SC every 4 weeks |
| Administration | IV infusion over ≥30 minutes | SC injection (provider or patient self-administered) |
| Admin CPT | 96365 + 96366 | 96372 if office-administered; none if patient self-administers |
| Prior auth | Medical drug PA | Pharmacy formulary PA OR medical drug PA — depends on plan routing |
The week-12 transition is the most common Omvoh billing failure. Practices complete the
third IV induction dose at week 8, the patient is responding well, and the maintenance script gets
sent to specialty pharmacy — but the pharmacy PA was never submitted in parallel with the medical
induction PA. The result: 4–6 week dosing gap, patient symptom flare, and the practice scrambling
to source the 100 mg pens through buy-and-bill instead. Confirm the maintenance pathway
(pharmacy vs medical) with the payer at the time of the induction PA, and submit both PAs in parallel.
Why Omvoh is different from Skyrizi/Tremfya for SC maintenance: The SC formulations of
Skyrizi (180 mg, 360 mg on-body injector) and Tremfya
(SC autoinjector) are designed exclusively for pharmacy-benefit self-administration. Omvoh's 100 mg
prefilled pen can be office-administered by a clinic nurse with 96372 + J2267 on a medical claim, OR
self-administered at home by the patient through specialty pharmacy on the pharmacy benefit. Payer
steering varies materially: confirm before billing.
Dosing & full regimen FDA label rev. Jan 2025 (Crohn's approval)
From the FDA prescribing information. Same induction-then-maintenance regimen for both UC and Crohn's disease.
IV induction (J2267 medical benefit)
| Visit | Week | Dose | Route | Vials/pens | Units billed |
|---|---|---|---|---|---|
| Induction 1 | Week 0 (baseline) | 300 mg | IV over ≥30 min | 1 × 300 mg / 15 mL SDV | 300 |
| Induction 2 | Week 4 | 300 mg | IV over ≥30 min | 1 × 300 mg / 15 mL SDV | 300 |
| Induction 3 | Week 8 | 300 mg | IV over ≥30 min | 1 × 300 mg / 15 mL SDV | 300 |
| Transition at week 12 to SC maintenance — pathway depends on payer. | |||||
| Maint 1 | Week 12 | 200 mg | SC (2 × 100 mg pens) | 2 pens | 200 (if medical) / pharmacy |
| Maint ongoing | q4w from week 12 | 200 mg | SC (2 × 100 mg pens) | 2 pens | 200 per dose / pharmacy |
Worked example — complete induction billing for a UC patient
# Three IV induction doses: weeks 0, 4, 8
Drug units per dose: 300 (J2267)
HCPCS: J2267 · Modifier: JZ · Vials: 1 × 300 mg / 15 mL
Admin: 96365 (30-min therapeutic IV, non-chemo)
ICD-10: K51.90 (UC, unspecified) or specific subtype
# Per-dose Medicare reimbursement (Q2 2026 ASP+6%)
300 units × $42.092 = $12,627.60 drug
+ 96365 admin payment (varies by MAC/locality)
# 3-dose induction total (drug only, Medicare ASP+6%)
Total drug units billed: 900 (3 × 300)
Total drug cost: ~$37,882.80 before sequestration
After ~2% sequestration: ~$37,125.14 actual paid
# SC maintenance per dose (if medical benefit)
200 units × $42.092 = $8,418.40 drug
+ 96372 admin payment (~$25 nationally)
Drug units per dose: 300 (J2267)
HCPCS: J2267 · Modifier: JZ · Vials: 1 × 300 mg / 15 mL
Admin: 96365 (30-min therapeutic IV, non-chemo)
ICD-10: K51.90 (UC, unspecified) or specific subtype
# Per-dose Medicare reimbursement (Q2 2026 ASP+6%)
300 units × $42.092 = $12,627.60 drug
+ 96365 admin payment (varies by MAC/locality)
# 3-dose induction total (drug only, Medicare ASP+6%)
Total drug units billed: 900 (3 × 300)
Total drug cost: ~$37,882.80 before sequestration
After ~2% sequestration: ~$37,125.14 actual paid
# SC maintenance per dose (if medical benefit)
200 units × $42.092 = $8,418.40 drug
+ 96372 admin payment (~$25 nationally)
Vial waste — rare
The 300 mg IV induction dose is delivered with exactly one 300 mg single-dose vial; the 200 mg SC maintenance dose uses exactly two 100 mg prefilled pens. Standard administration produces zero waste — JZ applies to virtually every Omvoh claim. JW would only apply if an infusion was stopped mid-administration (e.g., hypersensitivity reaction), in which case the discarded portion is reported on a separate line.
Premedication
Not required. Mirikizumab is a non-chemotherapy anti-IL-23p19 monoclonal antibody. No routine pre-infusion methylprednisolone or antihistamine is required per the FDA label. Standard biologic safety: TB screening before initiation, monitor for hypersensitivity during and after infusion, hepatic transaminases at baseline.
NDC reference Lilly NDC family verified May 2026
| NDC (10/11-digit) | Strength | Package Size | Units/Vial | Use |
|---|---|---|---|---|
0002-7544-01 / 00002-7544-01 |
300 mg / 15 mL | Single-dose vial (20 mg/mL) | 300 units (1 mg = 1 unit) | IV induction for UC & Crohn's |
0002-7629-11 / 00002-7629-11 |
100 mg / 1 mL | Carton of 2 single-dose prefilled pens | 100 units per pen (200 units per maintenance dose) | SC maintenance from week 12 |
0002-7693-11 (representative) |
100 mg / 1 mL | Single-pen carton (where dispensed individually) | 100 units per pen | Specialty pharmacy SC maintenance dispense |
Use the IV vial NDC on infusion claims; use the SC pen NDC on office-administered SC claims.
Submitting the SC pen NDC on a 96365/96366 IV admin line, or the IV vial NDC on a 96372 SC admin line,
will trigger NDC-vs-HCPCS mismatch denials at most payers. The HCPCS (J2267) is the same; the NDC must
match the formulation actually administered.
Lilly labeler code 0002. All Omvoh NDCs begin with the Lilly labeler prefix
0002 (10-digit) or 00002 (11-digit). Verify the exact 11-digit NDC at the
time of dispensing — carton-vs-vial NDC suffixes differ and DailyMed maintains the current
authoritative list.
Phase 2
Code the claim
Non-chemo therapeutic IV codes (96365/96366) for induction; 96372 for SC maintenance in-office.
Administration codes CPT verified May 2026
Omvoh is a non-chemotherapy biologic. Use therapeutic IV codes (96365/96366) for induction and 96372 for SC maintenance in a provider setting.
| Code | Description | When to use |
|---|---|---|
96365 |
Intravenous infusion, for therapy/diagnosis; initial, up to 1 hour | Primary code for Omvoh IV induction. The minimum-30-minute infusion fits comfortably within the 1-hour window. |
96366 |
Intravenous infusion, for therapy/diagnosis; each additional hour | Add only when infusion extends beyond 60 minutes (some protocols use 60-minute administration). Typical 30-minute infusions use 96365 alone. |
96372 |
Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular | Use for SC maintenance administered in the provider's office (medical-benefit pathway). One unit per encounter regardless of pen count. |
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour | NOT appropriate. Omvoh is a non-chemo IL-23p19 biologic, not an anti-neoplastic agent. |
96415 |
Chemotherapy administration, IV infusion; each additional hour | NOT appropriate. Same reason as 96413. |
Common error: billing 96413/96415 instead of 96365/96366. Practices that habitually use
chemo admin codes for oncology biologics (nivolumab J9299, pembrolizumab J9271) sometimes default to
96413 for Omvoh. This is incorrect — Omvoh is a non-chemo IL-23p19 inhibitor for IBD and falls under
therapeutic IV codes 96365/96366. Submitting 96413 will trigger payer denial or post-pay recoupment.
SC maintenance in-office is straightforward 96372 + J2267. When the patient receives
the SC maintenance dose in the provider's office under the medical benefit, bill 96372 (single unit)
plus J2267 with 200 units for the 200 mg dose. If the patient self-administers at home from a specialty
pharmacy script, there is no medical claim — the drug is paid via the pharmacy benefit and no admin
code applies.
Modifiers CMS verified May 2026
JZ — required on virtually every Omvoh medical claim
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. Omvoh IV induction uses a 300 mg / 15 mL single-dose vial for a fixed 300 mg dose — one vial in, full vial used, zero waste. The SC prefilled pen is also a single-dose container; the 200 mg maintenance dose uses both pens fully. JZ applies to virtually every Omvoh claim under either pathway.
JW — rare for Omvoh
JW reports the discarded portion of a single-dose vial. Because both the IV vial (300 mg) and SC pen (100 mg) are sized precisely to the labeled dose, partial-vial waste is uncommon. JW would only apply if a partial vial is discarded (e.g., infusion stopped mid-dose due to reaction). One of JZ or JW must be on every J2267 claim per CMS's July 2023 single-dose container policy.
Modifier 25 — same-day E/M
Use modifier 25 on the E/M code when a significant, separately identifiable evaluation and management service is performed on the same day as the infusion (e.g., GI clinic visit immediately before induction infusion for active flare assessment). Routine pre-infusion clinical assessment is bundled into the infusion admin code.
SC pen on prefilled-pen claim — JZ default
When the 100 mg prefilled pens are office-administered (medical benefit), JZ remains the default because two pens deliver the full 200 mg dose with no waste. If a pen is dropped, contaminated, or otherwise unusable, document the wastage and bill JW on a separate line for the discarded amount.
340B modifiers (JG, TB)
For 340B-acquired Omvoh, follow your MAC's current 340B modifier policy. Lilly Patient One does not provide 340B-specific billing instructions; defer to local MAC guidance.
ICD-10-CM — ulcerative colitis and Crohn's disease FY2026 verified May 2026
J2267 is appropriate for moderately-to-severely active UC and Crohn's. Use the most specific code supported by encounter documentation.
| ICD-10 | Description | Notes |
|---|---|---|
| Ulcerative colitis — K51.x family (FDA approval Oct 2023) | ||
K51.00 / K51.011–K51.019 | Ulcerative (chronic) pancolitis, w/o or w/ complications | Extensive colitis; common UC presentation for biologic-refractory disease |
K51.20 / K51.211–K51.219 | Ulcerative (chronic) proctitis | Limited distal disease |
K51.30 / K51.311–K51.319 | Ulcerative (chronic) rectosigmoiditis | |
K51.40 / K51.411–K51.419 | Inflammatory polyps of colon | |
K51.50 / K51.511–K51.519 | Left-sided colitis | |
K51.80 / K51.811–K51.819 | Other ulcerative colitis | |
K51.90 / K51.911–K51.919 | Ulcerative colitis, unspecified | Use only when extent is not documented |
| Crohn's disease — K50.x family (FDA approval Jan 2025) | ||
K50.00 / K50.011–K50.019 | Crohn's disease of small intestine, w/o or w/ complications | Most common when ileum is the primary site |
K50.10 / K50.111–K50.119 | Crohn's disease of large intestine | Colonic Crohn's |
K50.80 / K50.811–K50.819 | Crohn's of both small and large intestine | Ileocolonic disease |
K50.90 / K50.911–K50.919 | Crohn's disease, unspecified site | Use only when site is not documented |
Plaque psoriasis (L40.x) and psoriatic arthritis (M07.x) are NOT valid ICD-10s for J2267.
Omvoh is approved only for adult moderately-to-severely active UC and Crohn's disease. A J2267 claim
with a psoriasis or PsA diagnosis will deny — those indications use other IL-23p19 inhibitors
(Skyrizi, Tremfya SC formulations) on the pharmacy benefit. Do not confuse Omvoh's IBD-only label
with Skyrizi's broader psoriasis/PsA/IBD approvals.
Site of care & place of service Verified May 2026
UnitedHealthcare, Aetna, and most major BCBS plans run site-of-care UM for IBD biologic infusions. With only 3 IV induction infusions per patient (and the dose then transitioning to SC), the site-of-care pressure on Omvoh is concentrated entirely in the induction phase. Once SC maintenance begins, site-of-care concerns disappear (whether the SC dose is office-administered or self-administered).
| Setting | POS | Claim form | Payer steering |
|---|---|---|---|
| Physician GI office | 11 | CMS-1500 / 837P | Preferred by commercial UM (IV induction + SC maintenance) |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Preferred by commercial UM for IV induction |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Disfavored after first dose by some plans |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored |
| Patient home (SC) | 12 | none (pharmacy benefit) OR CMS-1500 with home admin | Common for SC maintenance via specialty pharmacy self-injection |
Once SC maintenance starts at week 12, the site-of-care debate ends. If the payer
routes SC to the pharmacy benefit, the patient self-administers at home with no medical claim. If
the payer keeps SC on the medical benefit, the dose is typically office-administered (POS 11) with
no facility-fee dispute. Either way, the chronic infusion-suite chair time goes away — a structural
advantage Omvoh shares with Skyrizi, Tremfya, and Stelara over chronic-IV biologics like
Remicade and Entyvio IV.
Claim form field mapping Lilly 2025 guide
From Lilly Omvoh provider billing reference materials and standard CMS-1500 conventions.
IV induction claim (CMS-1500)
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 00002-7544-01 + ML + 15 (mL of IV vial used) |
| HCPCS J2267 + JZ (or JW if waste) | 24D (drug line) | Mark JZ on virtually every Omvoh IV claim |
| Drug units | 24G | 300 (per IV induction dose) |
| CPT 96365 (admin line) | 24D (admin line) | Add 96366 if infusion exceeds 60 minutes |
| ICD-10 | 21 | K51.x (UC) or K50.x (Crohn's) — never L40.x or M07.x |
| PA number | 23 | Required by all major commercial payers |
SC maintenance claim (medical-benefit office admin)
| Information | CMS-1500 box | Notes |
|---|---|---|
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 00002-7629-11 + ML + 2 (mL across both pens) |
| HCPCS J2267 + JZ | 24D (drug line) | Same J-code as IV; units reflect mg |
| Drug units | 24G | 200 (per SC maintenance dose) |
| CPT 96372 (admin line) | 24D (admin line) | Single unit; SC injection |
| ICD-10 | 21 | Same K51.x or K50.x as induction |
Phase 3
Get paid
Step therapy from anti-TNF is the norm. Document IBD severity (Mayo / CDAI) explicitly.
Payer policy snapshot + step therapy Reviewed May 2026
All major commercial payers require prior authorization for J2267 with documented IBD severity, prior biologic history, and step-therapy compliance.
| Payer | PA? | Step therapy | SC maintenance routing |
|---|---|---|---|
| UnitedHealthcare Medical Drug Coverage Policy |
Yes | Required: prior anti-TNF (Humira or Remicade) trial AND/OR anti-integrin (Entyvio) trial — or contraindication | Typically pharmacy benefit (OptumRx) |
| Aetna CPB Omvoh (mirikizumab-mrkz) |
Yes | Required: trial/failure of at least one preferred anti-TNF or anti-integrin; documentation of moderately-to-severely active disease | Pharmacy benefit preferred; medical-benefit office admin allowed with PA |
| BCBS plans Vary by plan |
Yes | Generally aligned with AGA / ACG IBD guidelines + prior biologic step therapy | Plan-specific; often pharmacy for SC |
| Cigna / Evernorth | Yes | Step from anti-TNF; some plans also require Stelara trial before IL-23-selective | Accredo specialty pharmacy for SC maintenance |
| Medicare (LCD) MAC LCDs for biologics |
Generally no PA | None imposed by Medicare; FDA on-label IBD induction/maintenance with appropriate dx | Medical benefit Part B if office-administered; Part D if home self-admin |
Typical commercial step-therapy chain
Most commercial payers require documentation that the patient has failed, is intolerant of, or has a contraindication to:
- At least one anti-TNF (Humira / adalimumab biosimilars or Remicade / infliximab biosimilars)
- And/or anti-integrin (Entyvio / vedolizumab)
- And/or another biologic (Stelara, Skyrizi, Tremfya) depending on plan
JAK inhibitors (tofacitinib / Xeljanz, upadacitinib / Rinvoq) are sometimes accepted as step-therapy alternatives in UC. Verify per-plan formulary tier and prior-step requirements before submitting PA.
Document moderately-to-severely active IBD in the PA. Submit Mayo Score (UC) or
Crohn's Disease Activity Index (CDAI) / Simple Endoscopic Score for Crohn's Disease (SES-CD), plus
relevant labs (CRP, fecal calprotectin) and endoscopy/histology findings. PA reviewers cite
"insufficient documentation of moderately-to-severely active disease" as a frequent denial reason
for IL-23-selective agents.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J2267
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions · Next update: July 1, 2026 (Q3)
ASP + 6%
$42.092
per mg / per unit
300 mg IV induction dose
$12,627.60
300 units × ASP+6%
3-dose induction total
$37,882.80
weeks 0, 4, 8 (drug only)
Annual budget impact: 3 IV induction doses + ~13 SC maintenance doses per year =
~$37,883 induction + ~$109,439 maintenance (if medical benefit) = ~$147,322/year drug-only at
Q2 2026 ASP+6%. After ~2% sequestration: ~$144,376 actual paid. When SC maintenance routes to
the pharmacy benefit, only induction (~$37,883) hits the Part B / commercial medical line; SC drug spend
moves to the pharmacy line item.
Coverage
No NCD specific to mirikizumab. Coverage falls under MAC LCDs for biologics + the generic Part B drug-coverage framework. All MACs cover J2267 for FDA-approved on-label moderately-to-severely active UC and Crohn's disease with appropriate ICD-10 documentation.
Code history
- J2267 — "Injection, mirikizumab-mrkz, 1 mg" — permanent code; pre-permanent-code period used unclassified
J3490/J3590 - ASP trajectory: payment limit drifted modestly downward across 2025 from initial post-launch levels into the low $40s/mg, with Q2 2026 at $42.092/mg (current). Quarterly fluctuation is normal under CMS ASP+6% methodology.
Patient assistance — Lilly Patient One Lilly verified May 2026
- Phone: 1-866-472-8663 (1-866-4-PATIENT) — benefits investigation, prior authorization assistance, copay enrollment, appeal support
- Omvoh Savings Card: commercial copay support — eligible commercially-insured patients pay as little as $5 per dose with annual maximum benefit (excludes Medicare, Medicaid, federal-program patients). Verify current terms at omvoh.com.
- Lilly Cares Foundation Patient Assistance Program: free product for uninsured / underinsured patients meeting income requirements (typically ≤500% FPL; verify current threshold). Administered as a 501(c)(3) separate from Lilly's commercial copay support.
- Foundations: for Medicare patients (ineligible for the manufacturer copay card), refer to Patient Advocate Foundation, HealthWell Foundation, and IBD-specific funds — verify open IBD funds quarterly.
- Web: omvoh.com · lillypatientone.com · lillycares.com
Need to model what a specific patient will actually pay across the 3-dose IV induction course plus
~13 SC maintenance doses after copay assistance, deductible, coinsurance, and OOP max?
Run a CareCost Estimate — J2267 pre-loaded.
Phase 4
Fix problems
Wrong admin code, IV/SC pathway confusion, and missing step-therapy documentation are the top three.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Wrong admin code (96413/96415 instead of 96365/96366) | Chemo admin reflex applied to non-chemo biologic | Resubmit with 96365 (and 96366 if >60 min). Omvoh is non-chemo; chemo admin codes are inappropriate. |
| SC pen NDC on IV induction claim (or vice versa) | Wrong NDC paired with wrong admin code | Match the NDC to the actual formulation administered: 00002-7544-01 (IV vial) with 96365; 00002-7629-11 (SC pen) with 96372. |
| Pharmacy vs medical benefit routing dispute | SC maintenance script sent to wrong benefit pathway | Verify payer's preferred maintenance pathway at induction PA time. If payer requires pharmacy benefit, route to specialty pharmacy; if medical, bill J2267 + 96372 in office. |
| Step therapy not documented | PA submitted without prior anti-TNF / anti-integrin trial documentation | Submit prior biologic history (drug, duration, response, reason for discontinuation) with PA. |
| Wrong ICD-10 (L40.x or M07.x) | Psoriasis or PsA dx submitted — not approved indications | Omvoh is approved only for adult moderately-to-severely active UC (K51.x) and Crohn's (K50.x). PsO/PsA use other agents (Skyrizi SC, Tremfya SC, Cosentyx). |
| JZ missing | Single-dose vial/pen claim without JZ | Resubmit with JZ. Required since 7/1/2023 on every J-code claim with no discarded drug. |
| SC maintenance gap at week 12 | Pharmacy PA for SC maintenance not in place by week 12 | Submit pharmacy PA in parallel with medical PA for IV induction. Don't wait until week 8. |
| Site of care (HOPD) | HOPD administration on a commercial plan with site-of-care UM | Move to office (POS 11) or AIC (POS 49), or submit medical necessity letter if HOPD required. |
| Insufficient severity documentation | Mayo Score / CDAI / labs / endoscopy not in PA | Submit objective severity measures + endoscopy/histology + relevant labs (CRP, fecal calprotectin). |
| Crohn's PA submitted before payer updated 2025 policy | Some plans were slow to add Crohn's coverage after Jan 2025 FDA approval | Cite FDA approval date (Jan 15, 2025), VIVID-1 trial, and current payer policy revision in appeal; most policies updated through 2025. |
Frequently asked questions
What is the HCPCS code for Omvoh?
Omvoh is billed under HCPCS J2267 — "Injection, mirikizumab-mrkz, 1 mg." Each
milligram equals one billable unit. The 300 mg IV induction dose is billed as 300 units; the 200 mg
SC maintenance dose, when administered in a provider setting under the medical benefit, is billed as
200 units. The same J-code covers both the IV induction vial and the SC prefilled pens.
How does Omvoh compare to Skyrizi and Tremfya?
All three are anti-IL-23p19 selective monoclonal antibodies approved for IBD with IV-induction-then-SC
regimens, but the billing nuances differ. Skyrizi (J2327):
600 mg IV at wk 0/4/8, then SC maintenance is exclusively pharmacy benefit (180 mg or 360 mg q8w).
Tremfya (J1628): 200 mg IV at wk 0/4/8, then SC maintenance
is pharmacy benefit (100 mg q8w). Omvoh (J2267): 300 mg IV at wk 0/4/8, then 200 mg SC
q4w — SC can be pharmacy or office-administered medical (the only one of the three with that flexibility).
How do I bill IV induction vs SC maintenance for Omvoh?
IV induction (300 mg, weeks 0/4/8): J2267 with 300 units + 96365 (add 96366 if >60 min) on the medical benefit. SC maintenance (200 mg q4w): if office-administered under medical benefit, J2267 with 200 units + 96372; if specialty-pharmacy self-administered under pharmacy benefit, no medical claim. Verify the maintenance pathway with the payer at induction PA time and submit both PAs in parallel.
What's the difference between Omvoh and Stelara?
Mechanism: Omvoh selectively blocks IL-23 by binding the p19 subunit. Stelara
(ustekinumab) blocks both IL-12 and IL-23 by binding the shared p40 subunit. Codes:
Omvoh is J2267; Stelara IV induction is J3358 and SC maintenance is
J3357. Positioning: Most payers position IL-23-selective agents (Omvoh,
Skyrizi, Tremfya) after an anti-TNF and sometimes after a Stelara trial. The IL-23-selective mechanism
is differentiated and supported by direct head-to-head trial data in some IBD populations.
Is Omvoh covered for both UC and Crohn's?
Yes. FDA approved Omvoh for moderately-to-severely active ulcerative colitis on October 26, 2023 (based on LUCENT-1 and LUCENT-2 phase 3 trials), and for moderately-to-severely active Crohn's disease on January 15, 2025 (based on the VIVID-1 phase 3 trial). Same J2267 code, same induction-then-maintenance regimen. Use K51.x ICD-10 codes for UC claims and K50.x for Crohn's.
Does Omvoh require step therapy from an anti-TNF first?
Most commercial payers require documented failure, intolerance, or contraindication to at least one preferred anti-TNF (Humira / adalimumab biosimilars or Remicade / infliximab biosimilars) before approving Omvoh. Some payers also accept prior anti-integrin (Entyvio) or another biologic (Stelara, Skyrizi, Tremfya) as a step. Medicare LCDs typically do not impose step therapy.
Is Omvoh approved for pediatric patients?
No. As of the current FDA label, Omvoh is approved for adults (18 years and older) only. Safety and effectiveness in pediatric patients have not been established. Pediatric IBD continues to rely primarily on anti-TNF agents and ustekinumab where age-appropriate.
When was Omvoh approved for Crohn's disease?
The FDA approved Omvoh for Crohn's disease on January 15, 2025, based on the VIVID-1 phase 3 trial. This expanded the original UC approval (October 26, 2023) into the broader IBD space. Same dosing regimen (300 mg IV at weeks 0/4/8 → 200 mg SC q4w) and same J2267 code apply to both indications — the only billing change is the K50.x ICD-10 family instead of K51.x.
What is the Medicare reimbursement for J2267?
For Q2 2026, the Medicare Part B payment limit for J2267 is $42.092 per mg (ASP + 6%). The 300 mg IV induction dose reimburses at approximately $12,627.60 per infusion. Three induction doses total approximately $37,882.80. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%. ASP is updated quarterly by CMS.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- Eli Lilly — Omvoh (mirikizumab-mrkz) Prescribing Information
- DailyMed — OMVOH (mirikizumab-mrkz)
- FDA — Omvoh approval for ulcerative colitis (October 26, 2023)
- Lilly press releases — UC approval (Oct 2023) and Crohn's approval (Jan 15, 2025)
- D'Haens et al. — LUCENT-1 and LUCENT-2: mirikizumab in moderately-to-severely active UC (NEJM)
- CMS — Medicare Part B Drug ASP Pricing File
- CMS HCPCS Level II — J2267 reference
- UnitedHealthcare — Mirikizumab Medical Drug Coverage Policy
- Aetna CPB — Omvoh (mirikizumab-mrkz)
- AGA — Clinical Practice Guidelines for IBD biologic therapy
- ACG — Clinical Guidelines for ulcerative colitis and Crohn's disease in adults
- FDA National Drug Code Directory
- Lilly Patient One — HCP & patient support resources
About this page
We maintain this page as a living reference. Medicare ASP pricing is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files. Coding and policy content is reviewed at least quarterly and updated whenever a source document changes.
Found an error? Email hello@carecostestimate.com.
Refresh cadence
| Element | Cadence | How it's refreshed |
|---|---|---|
| Medicare ASP pricing | Quarterly | Auto-bound to CareCost ASP layer; updates on CMS file release. |
| Payer policies (UHC, Aetna, BCBS, Cigna) | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules | Annual | Reviewed against CMS HCPCS quarterly files and AMA CPT releases. |
| NDC, dosing, FDA label, indication list | Event-driven | Tied to Lilly document version + FDA label revision date. Omvoh label expanded with Crohn's approval Jan 2025. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS, Lilly,
and payer documents — all linked above). Final review by the CareCost editorial team is in
progress. Until that review is complete, treat this as a draft reference and verify each cited source
for high-stakes claims.
Change log
- — Initial publication. ASP data: Q2 2026 ($42.092/mg). Manufacturer source: Lilly 2025 Omvoh provider materials and Lilly Patient One. FDA label: incorporates 2025 Crohn's approval. Indications covered: ulcerative colitis (Oct 2023) and Crohn's disease (Jan 2025). Dual-pathway billing pattern (IV induction medical + SC maintenance pharmacy-or-medical) documented in IV-vs-SC section and claim-form mapping.
Methodology
Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File. Payer policies are read directly from each payer's published medical/pharmacy policy documents. Indication list and dosing are verified against the current FDA label revision. We do not paraphrase from billing-software vendor blogs.