Yervoy (ipilimumab) — HCPCS J9228

Dosing & unit math FDA label Mar 2026

From FDA prescribing information, label revised March 2026 (BLA 125377).

Adult dosing — regimen drives everything

• Melanoma adjuvant or 1L monotherapy (advanced): 3 mg/kg IV q3w × 4 doses
• Melanoma + Opdivo (1L unresectable/metastatic): ipi 3 mg/kg + nivo 1 mg/kg q3w × 4 doses, then Opdivo monotherapy
• RCC + Opdivo (intermediate/poor risk, 1L): ipi 1 mg/kg + nivo 3 mg/kg q3w × 4 doses, then Opdivo monotherapy
• MSI-H/dMMR CRC + Opdivo: ipi 1 mg/kg + nivo 3 mg/kg q3w × 4 doses, then Opdivo monotherapy
• HCC + Opdivo (2L+ post-sorafenib): ipi 3 mg/kg + nivo 1 mg/kg q3w × 4 doses, then Opdivo monotherapy
• NSCLC + Opdivo + chemo (1L): ipi 1 mg/kg q6w + nivo 360 mg q3w + 2 cycles chemo, then ipi/nivo continued q6w/q3w
• Mesothelioma + Opdivo (1L unresectable): ipi 1 mg/kg q6w + nivo 360 mg q3w, up to 2 years
• Esophageal SCC + Opdivo: ipi 3 mg/kg q3w + nivo 3 mg/kg q2w, up to 2 years

Pediatric (≥12 years)

• Melanoma adjuvant: 3 mg/kg IV q3w × 4 doses (same as adult)
• No other pediatric indications
• Bill the actual mg administered (not rounded)
• Pediatric patients will produce partial-vial waste — JW modifier applies (see Modifiers)

Worked example — melanoma + Opdivo combo, 80 kg patient (induction phase)

Worked example — RCC + Opdivo combo, 80 kg patient (low ipi, high nivo)

No premedication routinely required

Like Opdivo and other immune checkpoint inhibitors, Yervoy does NOT require pre-infusion methylprednisolone or antihistamine. Manage infusion reactions per FDA label if they occur. Premedication is NOT a substitute for irAE monitoring.

Regimen table by indication FDA label Mar 2026

One row per FDA-approved regimen. Verify the regimen on the order before calculating units.

NDC reference FDA NDC Directory verified May 2026

Administration codes CPT verified May 2026

Ipilimumab is billed as chemotherapy administration despite being immunotherapy.

Combo with Opdivo — same-day admin coding CPT verified May 2026

Sequential infusion coding applies. Bill both drugs and both admin codes.

Yervoy + Opdivo is the dominant Yervoy regimen. When both are given on the same day, bill BOTH drugs (each with its own modifier and ICD-10) and BOTH administration codes (sequential infusion logic).

Worked example — melanoma + Opdivo combo, 80 kg patient (Dose 1)

Modifiers CMS verified May 2026

JW — report partial-vial waste (common with Yervoy)

Yervoy uses single-dose vials and weight-based dosing — partial-vial waste is the norm, not the exception. JW reports the discarded portion of a single-dose vial on a separate claim line. Example: 80 kg patient at 3 mg/kg = 240 mg required; pull from one 200 mg vial + one 50 mg vial = 250 mg in vials, discard 10 mg → bill JW with 10 units of waste. Document the discarded amount in the chart with the wasted volume in mL.

JZ — required when there is no waste

Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. For Yervoy this is rarer than for Opdivo (because of weight-based dosing) but still occurs — e.g., a patient weighing exactly 100 kg on the 1 mg/kg combo regimen requires 100 mg which is exactly two 50 mg vials. One of JZ or JW must be on every J9228 claim.

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. Routine pre-infusion clinical assessment (vitals, lab review, irAE screening) is bundled into the admin code — modifier 25 requires distinct E/M work beyond the infusion-day routine.

340B modifiers (JG, TB)

For 340B-acquired Yervoy, follow your MAC's current 340B modifier policy. BMS's billing guide does not provide 340B-specific instructions. Yervoy is high-cost and a frequent 340B-program drug for eligible covered entities.

ICD-10-CM by indication FY2026 verified May 2026

Use the most specific code supported by encounter documentation. Biomarker tags critical for several indications.

Site of care & place of service Verified May 2026

UnitedHealthcare, Aetna, and most major BCBS plans run aggressive site-of-care UM for immune checkpoint inhibitors. Aetna CPB 0892 explicitly steers ICIs out of HOPD after the first 3 months unless on combo chemo or active toxicity management. Yervoy + Opdivo combo is sometimes given a longer HOPD pass during induction (4 doses) due to higher irAE risk — verify per payer.

Claim form field mapping BMS Access Support 2026

From BMS Access Support HCP coding & coverage page.

Payer policy snapshot + biomarker requirements Reviewed May 2026

All major payers require concurrent PA on Yervoy + Opdivo for combo regimens. Biomarker testing in hand before submission.

Biomarker test billing (separate from drug claim)

Step therapy

Generally NOT required for FDA-labeled 1L indications (melanoma, RCC, MSI-H/dMMR CRC, HCC + Opdivo, NSCLC + Opdivo + chemo). Some payers require prior therapy failure before specific indications (e.g., HCC after sorafenib). Verify per-payer.

Concurrent PA requirement

For combo Yervoy + Opdivo regimens, most major payers require a single PA that authorizes BOTH drugs at the regimen-specific doses. Submitting separate PAs for ipi and nivo can cause rejection or delay. Submit one combo PA listing the indication, biomarker results, both HCPCS codes (J9228 + J9299), both doses, and the schedule.

Medicare reimbursement CMS Q2 2026 (live)

Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.

Coverage

No NCD specific to ipilimumab. Coverage falls under MAC LCDs for biologics + the generic drug-coverage framework. All MACs cover J9228 for FDA-approved on-label indications with appropriate ICD-10 and biomarker documentation. Combo regimens require both drugs covered concurrently.

Code history

• J9228 — permanent code, effective January 1, 2013 (initial FDA approval was March 2011; pre-permanent-code period used unclassified J3490 / J9999)
• Yervoy is the most expensive checkpoint inhibitor per mg by a wide margin — ~5-6× the per-mg cost of Opdivo (J9299) and Keytruda (J9271)

Patient assistance — BMS Access Support BMS verified May 2026

• BMS Access Support: 1-800-861-0048 / bmsaccesssupport.com — benefits investigation, prior authorization assistance, appeal support (same program supports Yervoy and Opdivo together)
• Yervoy Co-Pay Assistance Program: commercial copay support; eligible commercially-insured patients pay $0 copay, up to ~$25,000/year (excludes Medicare, Medicaid, federal program patients)
• BMS Patient Assistance Foundation: free product for uninsured / underinsured patients meeting income requirements (administered through the BMS Patient Assistance Program, Inc., a 501(c)(3))
• Foundations: for Medicare patients, refer to PAN Foundation, HealthWell Foundation, CancerCare Co-Payment Assistance — verify open oncology funds quarterly (melanoma, RCC, CRC, HCC, NSCLC funds open and close throughout the year)
• Combo regimen assistance: BMS Access Support coordinates copay and PAP support across BOTH Yervoy and Opdivo on combo regimens — one application covers both
• Web: bmsaccesssupport.com/yervoy

Safety & irAE management FDA label Mar 2026

Yervoy carries the highest immune-related adverse event rate of any approved checkpoint inhibitor. No formal Boxed Warning — treat W&P like one.

Major irAE categories (from FDA label)

• Pneumonitis — can be fatal. Hold/discontinue per grade. CT chest at first sign of dyspnea/cough.
• Colitis — Yervoy diarrhea/colitis can be fatal. Bowel perforation reported. Aggressive management with IV methylprednisolone; infliximab if steroid-refractory.
• Hepatitis — LFTs every dose. Hold for grade 2; discontinue for grade 3-4.
• Endocrinopathies — Yervoy is the leading drug-induced cause of hypophysitis. Also: hypothyroidism, hyperthyroidism, T1DM (often presents as DKA), adrenal insufficiency. Check TSH, AM cortisol, glucose before each dose.
• Dermatologic — Stevens-Johnson syndrome, TEN, DRESS reported. Hold for grade 3, permanent discontinue for grade 4.
• Neurologic — encephalitis, meningitis, Guillain-Barré, myasthenia gravis. New neuro symptoms warrant immediate workup.
• Ocular — uveitis, episcleritis. Refer to ophthalmology promptly.
• Infusion reactions — uncommon but reported. Slow rate or interrupt for mild/moderate; permanent discontinue for severe.
• Embryo-fetal toxicity — document contraception counseling for patients of reproductive potential.

Pre-dose monitoring labs (typical protocol)

• Before EVERY dose: CBC, CMP (incl. LFTs and creatinine), TSH
• Before EVERY dose during ipi/nivo combo induction: AM cortisol, glucose
• Baseline + as clinically indicated: troponin (rare but reported myocarditis), amylase/lipase, ACTH

Billing implications of irAE management

• Monitoring labs are billable separately under their own CPT codes (CBC 85025, CMP 80053, TSH 84443, etc.) and are NOT bundled into the infusion code.
• irAE-related ED visits, IV steroids, and admissions are billable encounters — document the link to the prior Yervoy/Opdivo dose for medical necessity.
• Steroid taper for grade 2+ colitis or pneumonitis often delays/halts subsequent Yervoy doses — reconfirm PA on resumption.

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Yervoy?

Yervoy (ipilimumab) is billed under HCPCS J9228 — "Injection, ipilimumab, 1 mg." Each milligram equals one billable unit. This is the most common biller error: J9228 is 1 mg per unit (NOT 10 mg per unit), despite ipilimumab's 5 mg/mL concentrate format. A 240 mg dose for an 80 kg patient on 3 mg/kg dosing is billed as 240 units of J9228, not 24 units.

How many units do I bill for a Yervoy dose?

Total units = total mg administered. Yervoy is weight-based, so units vary by patient: 80 kg patient at 3 mg/kg = 240 mg = 240 units; 80 kg patient at 1 mg/kg = 80 mg = 80 units. Verify the regimen first (1 mg/kg in RCC + Opdivo and MSI-H/dMMR CRC + Opdivo; 3 mg/kg in melanoma mono + most other combos). Round to the nearest mg per FDA label.

What administration CPT do I use for Yervoy?

CPT 96413 — "Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug." Standard infusion is 30 minutes (90 min for some combos). Despite being immunotherapy, Yervoy is billed as chemo admin per AMA classification. For combo with Opdivo: bill 96413 for the first drug and 96417 ("each additional sequential infusion, up to 1 hr") for the second drug. Do NOT bill 96365.

Do I bill JZ or JW for Yervoy?

Bill JW when partial-vial waste occurs (most weight-based doses). Bill JZ when the vial combination yields zero waste (e.g., 100 mg dose = 2×50 mg vials). One of JZ or JW must be on every J9228 claim per CMS's July 2023 single-dose container policy. JW reports the discarded mg on a separate claim line — wasted drug is reimbursable but must be reported.

What is the Medicare reimbursement for J9228?

For Q2 2026, the Medicare Part B payment limit for J9228 is $187.166 per mg (ASP + 6%) — by far the most expensive checkpoint inhibitor per mg. An 80 kg patient at 3 mg/kg (240 mg) reimburses at approximately $44,919.84 per dose; the same patient at 1 mg/kg combo dose (80 mg) reimburses at approximately $14,973.28 per dose. A 4-dose melanoma adjuvant course at 3 mg/kg is approximately $179,679 in drug spend. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.

How is Yervoy billed when given with Opdivo on the same day?

Bill BOTH drugs (J9228 + J9299, each with their own units, modifiers, and ICD-10) AND BOTH administration codes: 96413 once for the first drug infused (typically Yervoy first) and 96417 once for the second sequential drug. Do not duplicate 96413. Submit a single combo PA covering both drugs. Confirm the regimen-specific dose ratio: low ipi (1 mg/kg) for RCC and CRC, high ipi (3 mg/kg) for melanoma, HCC, mesothelioma, and esophageal. Reversing the doses is a top denial driver.

What indications does Yervoy have?

FDA-approved for: melanoma (adjuvant + advanced/metastatic, adult + pediatric ≥12), advanced RCC (intermediate/poor risk, with Opdivo), MSI-H/dMMR colorectal cancer (with Opdivo), hepatocellular carcinoma (HCC, with Opdivo), NSCLC (1L PD-L1+, with Opdivo + chemo), unresectable malignant pleural mesothelioma (with Opdivo), and esophageal squamous cell carcinoma (with Opdivo or chemo). Almost every indication other than melanoma monotherapy is COMBO with Opdivo. Verify the regimen and dose schedule (1 vs 3 mg/kg, q3w vs q6w) by indication before billing.

Why does Yervoy have such high toxicity?

Yervoy blocks CTLA-4, which is upstream of PD-1 in the T-cell activation cascade. This produces broader, deeper, and earlier T-cell activation than PD-1 inhibitors like Opdivo or Keytruda — and a correspondingly higher rate of immune-related adverse events. Severe colitis (sometimes fatal), hypophysitis (Yervoy is the leading drug-induced cause), pneumonitis, hepatitis, T1DM, adrenal insufficiency, and severe dermatologic reactions are all elevated. When combined with Opdivo (dual checkpoint blockade), grade 3-4 irAE rates can exceed 50%. Counsel patients aggressively, monitor labs (LFTs, TSH, AM cortisol, glucose) before each dose, and have a colitis/pneumonitis management plan ready.

Source documents

1. BMS Access Support — Yervoy Codes & Coverage HCP page
   Manufacturer billing reference, 2026
2. DailyMed — YERVOY (ipilimumab) Prescribing Information
   FDA-approved label, revised March 2026 (BLA 125377)
3. FDA Yervoy label PDF (most recent revision)
4. BMS press releases — Yervoy + Opdivo combo indication updates
5. CMS — Medicare Part B Drug ASP Pricing File
   Q2 2026 quarterly file, effective April 1 – June 30, 2026
6. SEER CanMED — HCPCS J9228 reference
7. UnitedHealthcare — Oncology Medication Clinical Coverage Policy
8. Aetna CPB 0892 — Immune Checkpoint Inhibitors (covers Yervoy + Opdivo + Opdualag)
9. BMS Access Support — Yervoy & Opdivo combined access program
10. NCCN Clinical Practice Guidelines in Oncology (Melanoma, RCC, CRC, HCC, NSCLC)
    NCCN-recommended Yervoy + Opdivo combo regimens
11. FDA National Drug Code Directory

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

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Change log

• May 2, 2026 — Initial publication. ASP data: Q2 2026. Manufacturer source: BMS Access Support 2026. FDA label: Mar 2026 revision (BLA 125377). 7+ regimens documented including melanoma mono/adjuvant + 6 Opdivo combos. irAE safety section emphasized.

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 schedules are verified against the current FDA label revision and NCCN guidelines. We do not paraphrase from billing-software vendor blogs.