Opdualag (nivolumab + relatlimab-rmbw) — HCPCS J9298

Opdualag (J9298) vs. Opdivo IV (J9299) vs. Opdivo Qvantig (J9289) CMS HCPCS verified May 2026

Three Bristol Myers Squibb nivolumab-containing products with three permanent J-codes. Picking the wrong code is the most common Opdualag billing error.

BMS markets three nivolumab-family products on the medical benefit, each with its own permanent HCPCS code, its own BLA, its own NDC inventory, and its own dosing schedule. Opdualag (J9298) is a fixed-dose combination with the first-in-class LAG-3 inhibitor relatlimab — it is NOT the same drug as Opdivo IV monotherapy (J9299) and it is NOT the SC formulation of Opdivo (J9289). Same nivolumab base, three distinct billing pathways.

Dosing & unit math FDA label Mar 2022 (current)

From FDA prescribing information, BLA 761234.

Adult and pediatric (≥12 years) — fixed flat dose

• 480 mg nivolumab + 160 mg relatlimab IV every 4 weeks — only FDA-approved schedule
• Not weight-based; the same flat dose is used across all approved patients (adult and pediatric ≥12)
• Continue until disease progression or unacceptable toxicity
• Vial supplies the combo at 12 mg nivo + 4 mg rela per mL (240 mg + 80 mg per 20 mL vial)
• Standard dose = exactly two single-dose vials — zero waste

Pediatric <12 years

• Not approved. Opdualag is not labeled below age 12. Do not bill J9298 for patients under 12.

Unit math — standard 480/160 mg q4w dose

Why q4w only

Opdualag was developed and approved with the q4w fixed-dose interval studied in RELATIVITY-047. q2w and q3w schedules are not FDA-labeled. Do not switch the dosing interval to mirror Opdivo q2w — payers will deny off-schedule claims and the fixed-dose combo vial is not designed to be split.

No premedication routinely required

Standard immune checkpoint inhibitor combo — no routine pre-infusion methylprednisolone or antihistamine. Have an irAE management plan ready (Opdualag has a broader irAE spectrum than nivolumab monotherapy due to LAG-3 blockade).

NDC reference FDA NDC Directory verified May 2026

Administration codes CPT verified May 2026

Opdualag is billed as chemotherapy administration despite being immunotherapy — same convention as Opdivo and Yervoy.

Modifiers CMS verified May 2026

JZ — required on virtually every adult Opdualag claim

Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. The Opdualag fixed-dose 480/160 mg dose draws two complete 240/80 mg single-dose vials with zero waste. JZ applies to virtually every Opdualag claim.

JW — rare; preformulated combo means waste is unusual

JW reports the discarded portion of a single-dose vial. For Opdualag, partial-vial waste is uncommon because the fixed flat dose maps exactly to two vials. JW would only apply in unusual scenarios (e.g., a documented dose reduction where the physician orders less than the full second vial). In those cases, bill the administered units under J9298-JZ on one line and the discarded units under J9298-JW on a separate line. One of JZ or JW must be on every J9298 claim per CMS policy.

Worked example — standard 480 mg nivo + 160 mg rela q4w dose

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., irAE management visit, dose-decision visit). Routine pre-infusion clinical assessment is bundled.

340B modifiers (JG, TB)

For 340B-acquired Opdualag, follow your MAC's current 340B modifier policy. BMS's billing guide does not provide 340B-specific instructions for J9298.

ICD-10-CM — melanoma FY2026 verified May 2026

Opdualag is approved for unresectable or metastatic melanoma only. Code to the most specific site, laterality, and metastasis status supported by documentation.

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 (which covers Opdivo, Yervoy, and Opdualag together) explicitly steers ICIs out of HOPD after the first 3 months unless on combo chemo or active irAE management. The Opdualag q4w schedule (only 13 doses per year) makes office and AIC administration especially attractive after the first cycle.

Claim form field mapping BMS 2026

From BMS Access Support HCP coding & coverage guidance for Opdualag.

Payer policy snapshot Reviewed May 2026

Opdualag is generally covered as Category 1 NCCN-preferred 1L therapy for unresectable / metastatic melanoma. PA criteria focus on stage, line of therapy, and ECOG status — not biomarkers.

Step therapy

Generally NOT required for 1L unresectable / metastatic melanoma. Some plans require documentation of why Opdivo monotherapy or Opdivo+Yervoy was not preferred — Opdualag is favored for patients with comorbidities, older age, or where the elevated irAE burden of Y-NIVO is undesirable. Plans rarely force Opdivo mono first when dual blockade is clinically warranted.

Switching from Opdivo monotherapy

Most payers will not approve Opdualag as a switch from prior PD-1 monotherapy for the same melanoma course unless there is documented progression and an off-label exception is granted. RELATIVITY-047 enrolled treatment-naive patients only; the FDA label doesn't restrict to 1L explicitly, but PA criteria generally do.

Medicare reimbursement CMS Q2 2026 (live)

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

Coverage

No NCD specific to Opdualag or relatlimab. Coverage falls under MAC LCDs for biologics + the general Part B drug-coverage framework. All MACs cover J9298 for FDA-approved 1L unresectable/metastatic melanoma with appropriate ICD-10 documentation (C43.x family) and unresectable/metastatic substantiation in the record.

Code history

• J9298 — permanent code, effective April 1, 2023 (FDA approval was March 18, 2022; pre-permanent-code period used unclassified C9097 and J3490)
• Descriptor: "Injection, nivolumab 3 mg and relatlimab 1 mg"

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 serves Opdivo and Yervoy as well)
• Opdualag Co-Pay Assistance Program: commercial copay support; eligible commercially-insured patients pay as little as $0 per dose (excludes Medicare, Medicaid, TRICARE, and other federal program patients)
• BMS Patient Assistance Foundation: free product for uninsured / underinsured patients meeting income requirements (administered through BMS Patient Assistance Program, Inc., a 501(c)(3)); covers Opdualag, Opdivo, and Yervoy
• Foundations (for Medicare patients): PAN Foundation, HealthWell Foundation, CancerCare Co-Payment Assistance Foundation — verify open melanoma funds quarterly; funds open and close based on donor capacity
• Web: bmsaccesssupport.com/opdualag

Common denials & how to fix them

Frequently asked questions

Opdualag vs Opdivo — which J-code do I bill?

Opdualag is HCPCS J9298 — "Injection, nivolumab 3 mg and relatlimab 1 mg." This is DIFFERENT from Opdivo IV (J9299, nivolumab 1 mg monotherapy) and Opdivo Qvantig (J9289, nivolumab + hyaluronidase SC). Same nivolumab base, but Opdualag is a fixed-dose combo with the first-in-class LAG-3 inhibitor relatlimab. Billing as J9299 will deny — Opdivo monotherapy is not the same product and the dose math will not reconcile against an Opdualag fixed-dose order. One unit of J9298 = the fixed 3:1 ratio (3 mg nivo + 1 mg rela). A standard 480/160 mg q4w dose bills as 160 units of J9298, not as separate nivo and rela lines.

How many units do I bill for a 480/160 mg Opdualag dose?

Bill 160 units of J9298 per standard adult or pediatric (≥12) dose. The HCPCS descriptor "Inj nivol relatlimab 3mg/1mg" defines one billable unit as the 3:1 fixed ratio (3 mg nivolumab + 1 mg relatlimab = 4 mg combo). A 480 mg nivo + 160 mg rela flat dose contains 160 of those combo units. The dose is preformulated in 240/80 mg single-dose vials; two full vials yield the standard dose with zero waste — bill JZ.

What administration CPT do I use for Opdualag?

CPT 96413 — "Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug." Standard Opdualag infusion is 30 minutes IV, fitting within the 1-hour 96413 window. Despite being immunotherapy, complex monoclonal antibody combos bill under chemo administration codes per AMA classification. Add 96415 only if documented infusion runs past 60 minutes. Do NOT bill 96365 (therapeutic IV).

Do I bill JZ or JW for Opdualag?

Bill JZ on virtually every adult Opdualag claim. The standard 480/160 mg dose draws two complete 240/80 mg single-dose vials with zero waste — JZ is required since 7/1/2023 on every single-dose container claim with no discarded drug. JW would only apply in unusual dose-reduction scenarios. One of JZ or JW must be on every J9298 claim line.

Is LAG-3 biomarker testing required before Opdualag?

No. There is no companion diagnostic and no required biomarker test for Opdualag. RELATIVITY-047 enrolled across the LAG-3 expression spectrum and benefit was seen regardless of LAG-3 status, so the FDA label does not gate access on a biomarker. Document unresectable or metastatic melanoma stage, treatment-naive status, and ECOG performance instead.

Opdualag vs the Opdivo + Yervoy combo — when do payers steer toward Opdualag?

Opdualag and Opdivo+Yervoy (Y-NIVO) are the two FDA-supported dual-checkpoint regimens for 1L unresectable or metastatic melanoma. Opdualag is positioned as the lower-toxicity option: grade 3-4 treatment-related adverse event rate ~21% in RELATIVITY-047 vs ~55% with Y-NIVO in CheckMate 067. Opdivo+Yervoy retains an edge on long-term OS data in select populations, but Opdualag is favored for older patients, patients with comorbidities, and patients where irAE management capacity is limited. NCCN lists both as Category 1 for 1L unresectable/metastatic melanoma. Payer PA criteria typically accept either.

Can a patient on Opdivo monotherapy switch to Opdualag mid-treatment?

Generally no. Opdualag is approved for unresectable or metastatic melanoma without specifying line, but RELATIVITY-047 enrolled treatment-naive patients only and most payer PA criteria restrict Opdualag to 1L. Patients who have already received PD-1 monotherapy for melanoma are typically not eligible to switch to Opdualag without a documented progression event and an off-label exception. Verify per payer before changing the regimen.

Is Opdualag approved for pediatric patients?

Yes — Opdualag is FDA-approved for pediatric patients aged 12 years and older with unresectable or metastatic melanoma, dosed at the same fixed flat 480 mg nivolumab + 160 mg relatlimab IV q4w as adults. The pediatric label does not include weight-based dosing — the flat dose applies to any patient ≥12 years old. Pediatric patients under 12 are not labeled.

Why does Opdualag dose every 4 weeks instead of q2w or q3w like Opdivo?

The q4w schedule was the dosing studied in RELATIVITY-047 and is the only FDA-labeled schedule. Alternative schedules (q2w, q3w) are not approved. The longer interval reduces chair-time visits to 13 per year (vs 26 for Opdivo q2w) and lowers irAE monitoring frequency burden, while still delivering meaningful PFS benefit over Opdivo monotherapy in 1L melanoma. Do not modify the dosing interval — payers will deny off-schedule claims.

What is the Medicare reimbursement for J9298?

For Q2 2026, the Medicare Part B payment limit for J9298 is $201.755 per combo unit (ASP + 6%). The standard 480/160 mg q4w dose reimburses at approximately $32,280.80 per infusion. Annualized cost (Medicare ASP+6%): approximately $419,650.40 per year for 13 q4w doses. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%. ASP is updated quarterly by CMS.

Source documents

1. DailyMed — OPDUALAG (nivolumab and relatlimab-rmbw) Prescribing Information
   FDA-approved label, BLA 761234, initial approval March 18, 2022
2. FDA Opdualag label PDF (initial approval, March 2022)
   FDA Drugs@FDA database, BLA 761234
3. Tawbi HA, et al. Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma. NEJM 2022;386:24-34 (RELATIVITY-047)
   Pivotal phase 2/3 trial, NCT03470922 — PFS 10.1 mo (Opdualag) vs 4.6 mo (nivo mono), HR 0.75
4. NCCN Clinical Practice Guidelines — Melanoma (Cutaneous)
   Current version lists Opdualag as Category 1 preferred regimen for 1L unresectable / metastatic melanoma
5. CMS — Medicare Part B Drug ASP Pricing File
   Q2 2026 quarterly file, effective April 1 – June 30, 2026; J9298 payment limit $201.755 per combo unit
6. CMS HCPCS Quarterly Updates — J9298 effective April 1, 2023
   Permanent code descriptor: "Injection, nivolumab 3 mg and relatlimab 1 mg"
7. SEER CanMED — HCPCS J9298 reference
8. BMS Access Support — Opdualag Codes & Coverage
   Manufacturer billing & coding guidance, copay program, foundation referrals
9. UnitedHealthcare — Oncology Medication Clinical Coverage Policy
10. Aetna CPB 0892 — Immune Checkpoint Inhibitors (covers Opdivo + Yervoy + Opdualag)
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

Reviewer

Change log

• May 22, 2026 — Initial publication. ASP data: Q2 2026 ($201.755 per combo unit). Manufacturer source: BMS Access Support 2026. FDA label: March 2022 initial approval (BLA 761234). HCPCS J9298 permanent effective April 1, 2023. Disambiguation from Opdivo (J9299) and Opdivo Qvantig (J9289) prominently featured.

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 scope is verified against the current FDA label revision. We do not paraphrase from billing-software vendor blogs.