HCPCS
J92891 unit = 2 mg nivolumab + hyaluronidase
Phase 1
Identify what you're billing
Confirm SC vs IV, dose, and unit conversion before any claim leaves the door.
Opdivo Qvantig SC vs. Opdivo IV FDA verified May 2026
Same antibody, very different billing. Qvantig was approved December 27, 2024 and now has its permanent J-code.
BMS offers nivolumab in two formulations: the original intravenous Opdivo (J9299), approved September 2014, and the subcutaneous Opdivo Qvantig, approved December 27, 2024 under separate BLA 761381. Qvantig is co-formulated with hyaluronidase-nvhy, an enzyme that temporarily breaks down subcutaneous hyaluronic acid to enable injection of the full antibody dose into the SC tissue. The two products are different SKUs with different J-codes, different NDCs, and different payer pathways.
| Opdivo Qvantig (SC) | Opdivo (IV) | |
|---|---|---|
| HCPCS | J9289 (eff. 7/1/2025) | J9299 (eff. 1/1/2016) |
| HCPCS unit | 1 unit = 2 mg nivolumab | 1 unit = 1 mg nivolumab |
| Active ingredient | nivolumab + hyaluronidase-nvhy | nivolumab |
| NDC (carton) | 00003-3120-01 (300 mg) / 00003-6120-01 (600 mg) | 00003-3772-11 (single) / 00003-3734-13 (dual) |
| Manufacturer | Bristol Myers Squibb | Bristol Myers Squibb |
| FDA approval | December 27, 2024 (BLA 761381) | September 2014 (BLA 125554) |
| Adult dose | 600 mg q2w / 900 mg q3w / 1200 mg q4w | 240 mg q2w / 480 mg q4w |
| Administration time | 3–5 minutes (SC injection) | 30 minutes (IV infusion) |
| Admin CPT | 96401 (chemo SC/IM) | 96413 (chemo IV) |
| Pediatric approved? | Yes, age ≥12 & ≥30 kg — melanoma (advanced + adjuvant) and MSI-H/dMMR CRC only | Broader: cHL (incl. pediatric), additional MSI-H/dMMR solid tumors |
| Yervoy (ipilimumab) combo? | No — IV only | Yes (multiple indications) |
| Pivotal trial | CheckMate-67T (NCT04810078) — non-inferiority in advanced RCC | Multiple registration trials per indication |
Why Qvantig matters operationally: SC injection in 3–5 minutes removes the
infusion-chair bottleneck. Practices that have been space-constrained for IV checkpoint patients can
absorb Qvantig volume in injection rooms or even exam rooms. Expect commercial payers to start steering
eligible patients toward Qvantig once formulary placement stabilizes.
Cannot substitute Qvantig for IV without payer authorization. Different BLA, different
NDC, different J-code. Submit a separate PA when switching from IV to SC and document the rationale.
Pediatric patients and Yervoy combo regimens must remain on IV.
Dosing & unit math FDA label Dec 2024
From the BMS Opdivo Qvantig prescribing information (BLA 761381).
Adult dosing options (indication-specific)
- 600 mg SC every 2 weeks (matches 240 mg q2w IV equivalent)
- 900 mg SC every 3 weeks (combo-regimen alignment)
- 1200 mg SC every 4 weeks (matches 480 mg q4w IV equivalent)
- 1 HCPCS unit = 2 mg nivolumab — bill 300, 450, or 600 units respectively
- Hyaluronidase units are not billed separately; the J9289 descriptor covers both components
Unit conversion (this is where claims go wrong)
| Dose | HCPCS units | Vials used (no waste) |
|---|---|---|
| 600 mg q2w | 300 units | 1 × 600 mg vial |
| 900 mg q3w | 450 units | 1 × 600 mg + 1 × 300 mg vials |
| 1200 mg q4w | 600 units | 2 × 600 mg vials |
Pediatric dosing — age ≥12 and ≥30 kg, select indications only
Per current FDA label (rev. Nov 24, 2025), Opdivo Qvantig is approved for pediatric patients age ≥12 years and ≥30 kg in three indications only: unresectable or metastatic melanoma, adjuvant melanoma (Stage IIB / IIC / III / IV resected), and unresectable or metastatic MSI-H or dMMR colorectal cancer.
- 30–40 kg: 300 mg + 5,000 units hyaluronidase q2w SC, or 600 mg + 10,000 units q4w SC
- ≥40 kg: use adult dosing (600 mg q2w / 900 mg q3w / 1200 mg q4w)
Pediatric classical Hodgkin lymphoma and broader pediatric MSI-H/dMMR solid tumor indications outside the three above remain on IV Opdivo (J9299).
Combo regimens
- RCC + cabozantinib: Opdivo Qvantig 600 mg q2w + cabozantinib 40 mg PO daily (per CheckMate-9ER analog)
- With chemotherapy: approved across select solid-tumor combo indications carried over from IV
- NOT approved with Yervoy (ipilimumab) — if a patient is on a nivo + ipi regimen, both components remain IV
Worked example — first-year billing for an RCC monotherapy patient (600 mg q2w SC)
# 26 doses/year (q2w schedule)
Dose: 600 mg SC
HCPCS units billed per dose: 300 (J9289 × 300)
HCPCS: J9289 · Modifier: JZ · Vials: 1 × 600 mg (NDC 00003-6120-01)
Admin: 96401 (chemo SC, 3–5 min)
# Year-1 totals (Medicare ASP+6%, Q2 2026)
Drug per dose: $8,318.70 (300 units × $27.729)
Year-1 drug total: ~$216,286
Sequestration ~2% → net ~$211,960
Dose: 600 mg SC
HCPCS units billed per dose: 300 (J9289 × 300)
HCPCS: J9289 · Modifier: JZ · Vials: 1 × 600 mg (NDC 00003-6120-01)
Admin: 96401 (chemo SC, 3–5 min)
# Year-1 totals (Medicare ASP+6%, Q2 2026)
Drug per dose: $8,318.70 (300 units × $27.729)
Year-1 drug total: ~$216,286
Sequestration ~2% → net ~$211,960
Premedication
No routine premedication required. Observe per FDA label after first dose for injection-site reactions and the rare systemic infusion-related reaction profile that carries over from IV nivolumab.
NDC reference BMS Access Q2 2026
| NDC | Strength | Package Size | Units/Vial |
|---|---|---|---|
00003-3120-01 |
300 mg nivolumab + 5,000 units hyaluronidase-nvhy | Single-dose vial, 2.5 mL (120 mg/mL) | 150 HCPCS units (1 unit = 2 mg) |
00003-6120-01 |
600 mg nivolumab + 10,000 units hyaluronidase-nvhy | Single-dose vial, 5 mL (120 mg/mL) | 300 HCPCS units (1 unit = 2 mg) |
Use the 11-digit NDC on the claim. The 10-digit catalog format (0003-6120-01) must be
zero-padded to 11 digits (00003-6120-01) in claim form box 24A. Payers reject vial NDCs that don't match
their crosswalk.
Companion IV NDCs for the same molecule: IV Opdivo (J9299)
uses
00003-3772-11 (single-vial carton) and 00003-3734-13 (dual-vial carton)
— do not mix them with Qvantig billing.
Phase 2
Code the claim
SC chemo admin code, JZ on every claim, and the right ICD-10 with biomarker docs.
Administration codes CPT verified May 2026
Subcutaneous nivolumab is chemotherapy administration even though clinically it is immunotherapy.
| Code | Description | When to use |
|---|---|---|
96401 |
Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic | Primary admin code for Opdivo Qvantig. Covers the 3–5 minute SC injection. |
96372 |
Therapeutic, prophylactic, or diagnostic injection (SC/IM); specify substance or drug | NOT appropriate. CPT classifies anti-neoplastic monoclonal antibody SC administration under 96401, not the non-chemo therapeutic injection code. |
96413 / 96415 |
Chemotherapy IV infusion codes | NOT for Qvantig. Use these only for IV Opdivo (J9299). |
Why 96401 and not 96372: AMA CPT classifies SC administration of non-hormonal
anti-neoplastic monoclonal antibodies (including PD-1 checkpoint inhibitors) under the chemotherapy
administration family (96401–96425), regardless of mechanism of action. 96401 pays materially more
than 96372 and is the correct code; 96372 will trigger a denial or recoupment.
One admin unit per injection. Even when 900 mg or 1200 mg is split across two vials
and two injection sites in the same encounter, bill 96401 × 1 per CPT guidance
for the same drug administered in a single encounter. The drug line carries the unit math.
Modifiers CMS verified May 2026
JZ — required on virtually every claim
Effective July 1, 2023, CMS requires the JZ modifier on every single-dose container claim when no drug is discarded. Opdivo Qvantig vials are single-dose and the three approved doses (600 / 900 / 1200 mg) all combine cleanly across the 300 mg and 600 mg vial sizes with zero waste. JZ applies to virtually every J9289 claim.
JW — only when a vial is breached and discarded
Because the three approved doses fit whole-vial combinations exactly, JW is rare for J9289. If a vial is breached (e.g., contamination, dose change after reconstitution prep, patient cancellation after draw) and the remainder is discarded, bill the wasted portion on a separate claim line with JW. One of JZ or JW must appear on every J9289 claim.
Worked modifier example — standard 600 mg q2w dose
# Single 600 mg vial, no waste
Patient: adult RCC monotherapy, 600 mg q2w
Vial drawn: 1 × 600 mg / 5 mL (NDC 00003-6120-01)
Drug administered: 600 mg (entire vial)
Drug discarded: 0 mg
# Drug line on CMS-1500
24D: J9289 JZ · 24G units: 300
24A NDC qualifier: N4 + 00003-6120-01 · UoM: ML · Qty: 5
# Admin line
24D: 96401 · 24G units: 1
Patient: adult RCC monotherapy, 600 mg q2w
Vial drawn: 1 × 600 mg / 5 mL (NDC 00003-6120-01)
Drug administered: 600 mg (entire vial)
Drug discarded: 0 mg
# Drug line on CMS-1500
24D: J9289 JZ · 24G units: 300
24A NDC qualifier: N4 + 00003-6120-01 · UoM: ML · Qty: 5
# Admin line
24D: 96401 · 24G units: 1
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 SC injection. Routine pre-injection clinical assessment is bundled into 96401.
340B modifiers (JG, TB)
For 340B-acquired Opdivo Qvantig, follow your MAC's current 340B modifier policy. BMS does not publish Qvantig-specific 340B guidance — follow standard nivolumab/IV Opdivo 340B handling.
ICD-10-CM by indication group FY2026 verified May 2026
Per the December 2024 FDA approval, most adult solid-tumor Opdivo monotherapy and chemo/cabozantinib combo indications carried over. Pediatric indications and Yervoy combos did NOT.
| Indication | ICD-10 family | SC approval notes |
|---|---|---|
| Renal cell carcinoma (RCC) — advanced/metastatic | C64.x | Mono or + cabozantinib; pivotal CheckMate-67T cohort |
| Melanoma — unresectable/metastatic mono | C43.x | Adult mono; ipi combo remains IV |
| Melanoma — adjuvant | C43.x + Z85.820 | Stage IIB/IIC/III/IV resected adult |
| NSCLC — mono (PD-L1 ≥1%) | C34.x | Adult mono; chemo combos with platinum doublet carried over per label; ipi-containing regimens IV-only |
| NSCLC — adjuvant | C34.x + Z85.118 | Resected adult NSCLC |
| HNSCC — recurrent/metastatic | C00–C14, C32 | Post-platinum adult |
| Urothelial carcinoma — advanced/metastatic | C67.x | Mono per label; some combo lines remain IV (verify per indication) |
| Urothelial — adjuvant | C67.x + Z85.51 | Adult muscle-invasive post-radical resection |
| MSI-H / dMMR CRC | C18–C20 + biomarker | Adult mono |
| HCC (hepatocellular) | C22.0 | Adult 2L post-sorafenib mono |
| Esophageal SCC / adenoCa | C15.x | + chemo regimens for first-line per label |
| Gastric / GEJ adenoCa | C16.x | + chemo per label |
| Encounter for antineoplastic immunotherapy | Z51.12 | Required secondary diagnosis on most payer policies |
Indication-specific PA criteria are the norm. Most payers require ICD-10 plus prior
therapies, line of therapy, AND biomarker results (PD-L1 by Dako 28-8 pharmDx, MSI-H/dMMR, etc.).
Cross-reference the biomarker section on the IV Opdivo page — the
same companion diagnostics apply to Qvantig.
Pediatric SC use is limited; Yervoy combos are not approved SC. SC pediatric use is
restricted to age ≥12 and ≥30 kg in three indications: advanced melanoma (C43.x), adjuvant
melanoma (C43.x + Z85.820), and MSI-H/dMMR CRC (C18–C20 + biomarker). Do NOT bill Qvantig for
pediatric cHL (C81.x), broader pediatric MSI-H solid tumors, or any ipilimumab-containing combo
regimen — those patients remain on IV Opdivo (J9299).
Site of care & place of service Verified May 2026
The 3–5 minute SC injection time fundamentally changes the site-of-care math vs IV Opdivo. Qvantig fits cleanly in physician offices and injection rooms without occupying an infusion chair. Commercial site-of-care UM (UnitedHealthcare, Aetna, BCBS) generally treats Qvantig as office-preferred from dose one — there is no HOPD acclimation argument like there is for new IV starts.
| Setting | POS | Claim form | Payer steering |
|---|---|---|---|
| Physician oncology office | 11 | CMS-1500 / 837P | Preferred — SC fits without chair time |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Preferred |
| Oncology ASC | 24 | CMS-1500 / 837P | Acceptable |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I · Rev 0636 + 0331 | Disfavored — SC has no HOPD justification |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored |
| Patient home | 12 | CMS-1500 (home infusion benefit) | Not currently in label; payers do not cover home SC for oncology checkpoint inhibitors as of May 2026 |
Site-of-care opportunity: Practices switching IV checkpoint volume to Qvantig free
infusion chairs for combo and complex IV regimens. Run the payer mix — commercial UM teams will
often approve a Qvantig switch faster than they will approve an IV Opdivo HOPD continuation.
Claim form field mapping BMS Access Q2 2026
From the BMS Access Support — Opdivo Qvantig Codes & Coverage page.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b / 24J | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 00003-6120-01 (or 00003-3120-01) + ML + total mL drawn |
| HCPCS J9289 + JZ (or JW for documented waste) | 24D (drug line) | Adult dose → JZ on virtually every claim |
| Drug units (1 unit = 2 mg) | 24G | 300 for 600 mg, 450 for 900 mg, 600 for 1200 mg |
| CPT 96401 (admin line) | 24D (admin line) | One admin unit per encounter |
| ICD-10 primary + Z51.12 secondary | 21 | Indication-specific — see ICD-10 table |
| PA number | 23 | Required by virtually all commercial payers |
Hospital outpatient (UB-04 / 837I): Use revenue code
0636 (drugs requiring
detailed coding) for the J9289 line and 0331 (chemotherapy administration, injected) for
the 96401 admin line. Some facilities also report 0250 for pharmacy general.
Phase 3
Get paid
Qvantig has its own PA, its own coverage policies, and its own financial assistance pathway.
Payer policy snapshot Reviewed May 2026
Major payers cover Opdivo Qvantig per FDA-labeled indications with PA. Biomarker testing requirements mirror IV Opdivo.
| Payer | PA? | Biomarker enforcement | Site-of-care UM |
|---|---|---|---|
| UnitedHealthcare Oncology Med Coverage Policy |
Yes | Same as IV Opdivo: strict for NSCLC 1L mono (PD-L1), HNSCC, gastric, CRC (MSI-H/dMMR) | Office/AIC preferred from dose 1 |
| Aetna CPB 0892 (ICIs) |
Yes | PD-L1 for relevant indications; MSI-H/dMMR for CRC | Yes — Qvantig steered out of HOPD immediately given short admin time |
| BCBS plans Vary by plan |
Yes | Aligned with NCCN + FDA label biomarker requirements | Plan-specific; most have ICI site-of-care steering |
| Medicare (MAC LCDs) No nivolumab-specific NCD |
No PA | Coverage per FDA label + NCCN compendium | Standard Part B drug rules |
Biomarker test billing (mirrors IV Opdivo)
Companion diagnostics for Qvantig are the same as for IV nivolumab. The Dako 28-8 pharmDx PD-L1 assay
(CPT 88360 / 88361), MMR IHC (88342 ×4), MSI by PCR
(81301), and TMB NGS panels apply identically. See the
IV Opdivo biomarker table for the full crosswalk.
Step therapy
Generally NOT required for FDA-labeled 1L mono indications. Some commercial payers may require a documented trial of IV nivolumab before approving Qvantig in the maintenance setting — verify per-payer.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J9289
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions · 1 unit = 2 mg nivolumab + hyaluronidase-nvhy
ASP + 6%
$27.729
per unit (per 2 mg nivolumab)
600 mg dose (q2w)
$8,318.70
300 units × ASP+6%
1200 mg dose (q4w)
$16,637.40
600 units × ASP+6%
Annualized cost: 600 mg q2w × 26 doses = ~$216,286/year
(Medicare ASP+6%). 900 mg q3w × ~17 doses = ~$212,127/year. 1200 mg q4w ×
13 doses = ~$216,286/year. After ~2% sequestration: ~$212,000/year actual paid across
all three schedules.
Coverage
No NCD specific to nivolumab. Coverage falls under MAC LCDs for biologics + the generic drug-coverage framework. All MACs cover J9289 for FDA-approved on-label adult solid-tumor indications with appropriate ICD-10 and biomarker documentation.
Code history & next update
- J9289 — permanent code, effective July 1, 2025 (descriptor: "Injection, nivolumab, 2 mg and hyaluronidase-nvhy")
- Pre-permanent-code period (Jan–Jun 2025): unclassified
J3490/J9999with NDC and dose documentation - ASP refreshes quarterly — next CMS update: July 1, 2026 for Q3
Patient assistance — BMS Access Support BMS verified May 2026
Opdivo Qvantig is covered by the same BMS Access Support program as IV Opdivo, with a dedicated Qvantig codes & coverage portal. Benefits investigation, prior authorization assistance, and appeals support are available for all enrolled patients.
- BMS Access Support: 1-800-861-0048 (Mon–Fri 8 AM – 8 PM ET) · bmsaccesssupport.com/opdivoqvantig
- BMS Oncology Co-Pay Assistance Program: commercial copay support for eligible commercially-insured patients prescribed Opdivo Qvantig, Opdivo, or Opdivo + Yervoy. Excludes Medicare, Medicaid, TRICARE, VA, and other federal program patients.
- Bristol Myers Squibb Patient Assistance Foundation (BMSPAF): free product for uninsured / underinsured patients meeting income requirements (typically ≤500% FPL; verify current threshold). Administered by BMSPAF, a 501(c)(3). Web: bmspaf.org
- Independent foundations (Medicare patients): PAN Foundation, HealthWell, CancerCare — verify open oncology funds quarterly
- Online enrollment: bmsaccesssupport.com/enrollment
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance,
and OOP max? Run a CareCost Estimate — J9289 pre-loaded.
Phase 4
Fix problems
Unit math, wrong J-code (J9299 vs J9289), and wrong admin code (96372 vs 96401) are the top three.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Unit count mismatch | Bill submitted at 1 unit = 1 mg (IV math) instead of 1 unit = 2 mg | For 600 mg dose, bill 300 units. For 900 mg, 450 units. For 1200 mg, 600 units. Resubmit corrected claim. |
| Wrong J-code (J9299 instead of J9289) | SC formulation billed under IV Opdivo code | Resubmit with J9289 and Qvantig NDCs. J9299 is IV only. |
| Wrong admin code (96372) | Therapeutic SC injection billed instead of chemo SC | Resubmit with 96401. Per AMA classification, monoclonal antibody anti-neoplastics use chemo admin codes regardless of route. |
| JZ missing | Single-dose vial claim without JZ | Resubmit with JZ. Required since 7/1/2023 on every claim with no waste. |
| Wrong NDC format (vial-only or 10-digit) | Truncated NDC submitted in 24A | Use 11-digit zero-padded: 00003-3120-01 (300 mg) or 00003-6120-01 (600 mg). |
| Biomarker not documented | PA submitted without PD-L1 / MSI-H / dMMR result | Submit biomarker test result + retroactive PA. Schedule biomarker testing FIRST for any indication that requires it. |
| Site of care (HOPD) | HOPD administration on commercial plan with site-of-care UM | Move to office (POS 11) or AIC (POS 49). SC has weak HOPD justification given 3–5 min admin. |
| Yervoy-combo claim under J9289 | Patient on nivo + ipi regimen billed as Qvantig | Yervoy combos remain IV — bill J9299 + J9228 (Yervoy). Qvantig is NOT approved with ipilimumab. |
| Pediatric claim under J9289 outside approved age/indications | Patient <12, <30 kg, or indication outside melanoma / adjuvant melanoma / MSI-H CRC billed Qvantig | Verify age ≥12 & weight ≥30 kg AND indication is on the Qvantig pediatric label (advanced melanoma, adjuvant melanoma, or MSI-H/dMMR CRC). For pediatric cHL and other MSI-H solid tumors, switch to IV Opdivo (J9299). |
Frequently asked questions
What is the HCPCS code for Opdivo Qvantig?
Opdivo Qvantig (nivolumab and hyaluronidase-nvhy, subcutaneous) is billed under HCPCS J9289
— "Injection, nivolumab, 2 mg and hyaluronidase-nvhy." One unit equals 2 mg of nivolumab, so the
600 mg q2w dose is billed as 300 units, the 900 mg q3w dose as 450 units,
and the 1200 mg q4w dose as 600 units. J9289 became effective July 1, 2025. Do NOT bill
Opdivo Qvantig under J9299 (IV Opdivo); they are separate BLAs with separate codes.
How does Opdivo Qvantig differ from IV Opdivo?
Opdivo Qvantig is the subcutaneous formulation of nivolumab co-formulated with hyaluronidase-nvhy, FDA-approved December 27, 2024 under BLA 761381. It is injected SC over 3 to 5 minutes into the abdomen or thigh — vs IV Opdivo's 30-minute infusion. Doses are higher and frequencies different: 600 mg q2w, 900 mg q3w, or 1200 mg q4w SC. Non-inferiority to IV nivolumab was established in CheckMate-67T (advanced RCC). Most adult solid-tumor monotherapy and chemo/cabozantinib combo indications carried over; pediatric and Yervoy combos are NOT approved SC.
Can patients switch from IV Opdivo to Qvantig mid-treatment?
Clinically, yes — the FDA label and major payers allow switching from IV nivolumab to SC Opdivo Qvantig within an approved adult solid-tumor indication. Operationally, a separate prior authorization is required because Qvantig has its own NDC, J-code, and product. Submit a new PA with the SC formulation, document the switch rationale (chair-time, vascular access, patient preference), and align dose/interval to the SC label (600 mg q2w, 900 mg q3w, or 1200 mg q4w). Yervoy (ipilimumab) combos and pediatric indications cannot move to Qvantig.
What CPT administration code do I use for Opdivo Qvantig SC?
CPT 96401 — "Chemotherapy administration, subcutaneous or intramuscular; non-hormonal
anti-neoplastic." Despite being immunotherapy, nivolumab is billed under chemotherapy administration
codes per AMA classification. SC injection takes 3 to 5 minutes into the abdomen or thigh, so 96401 is
the sole admin code for monotherapy. Do NOT bill 96372 (therapeutic SC/IM injection) — chemo SC
codes are required for nivolumab regardless of route.
Do I bill JZ or JW for Opdivo Qvantig?
Bill JZ on virtually every Opdivo Qvantig claim. The 600 mg dose uses one 600 mg
single-dose vial with zero waste; the 900 mg dose uses one 600 mg vial plus one 300 mg vial with zero
waste; the 1200 mg dose uses two 600 mg vials with zero waste. JW is not expected unless a
vial is breached and discarded. One of JZ or JW must appear on every J9289 claim per CMS's July 2023
single-dose container policy.
What is the Medicare reimbursement for J9289?
For Q2 2026, the Medicare Part B payment limit for J9289 is $27.729 per unit (where 1 unit = 2 mg nivolumab + hyaluronidase, ASP + 6%). The 600 mg q2w dose reimburses at approximately $8,318.70 per injection; 900 mg q3w at approximately $12,478.05; 1200 mg q4w at approximately $16,637.40. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%. ASP refreshes quarterly — next update July 1, 2026 for Q3.
What indications are approved for Opdivo Qvantig?
Most adult solid-tumor Opdivo indications carried over per the December 27, 2024 initial approval (label currently revised November 24, 2025): RCC (mono or with cabozantinib), melanoma (adjuvant and unresectable/metastatic mono), NSCLC (resectable neoadjuvant / neoadjuvant + adjuvant; metastatic), HNSCC, urothelial carcinoma (multiple lines), MSI-H/dMMR CRC, HCC (multiple lines), esophageal cancer, and gastric/GEJ/esophageal adenocarcinoma — generally monotherapy or with chemotherapy or cabozantinib. Pediatric age ≥12 and ≥30 kg is now approved SC for advanced melanoma, adjuvant melanoma, and MSI-H/dMMR CRC only. Pediatric cHL and broader pediatric MSI-H/dMMR solid tumors remain IV. Yervoy (ipilimumab) combos are not approved SC per the label. Verify against the current FDA label before billing each indication.
Is Opdualag available subcutaneously?
No. Opdualag (nivolumab + relatlimab-rmbw) is IV-only and is billed under J9298. There is no SC version of Opdualag, and Opdivo Qvantig cannot substitute — the relatlimab component is required. If switching a melanoma patient from IV Opdualag to SC monotherapy, that requires a regimen change to nivolumab monotherapy (Opdivo Qvantig), which is a separate clinical decision and a separate PA.
Is Keytruda Qlex (SC pembrolizumab) the same billing as Opdivo Qvantig?
No. They are different molecules, different manufacturers, and different codes. Keytruda Qlex (pembrolizumab + berahyaluronidase-pmph, Merck) bills under J9277. Opdivo Qvantig (nivolumab + hyaluronidase-nvhy, BMS) bills under J9289. Indications overlap but are not identical. Confirm the prescribed product before submitting PA — substituting one PD-1 SC product for the other will be denied.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- BMS Access Support — Opdivo Qvantig Codes & Coverage
- BMS — OPDIVO QVANTIG (nivolumab and hyaluronidase-nvhy) Prescribing Information
- DailyMed — OPDIVO QVANTIG (nivolumab and hyaluronidase-nvhy) injection, solution
- FDA Opdivo Qvantig original label PDF (761381s000, Dec 2024)
- FDA — Approval announcement, nivolumab and hyaluronidase-nvhy SC injection
- CMS — Medicare Part B Drug ASP Pricing File
- SEER CanMED — NDC 00003-6120 Opdivo Qvantig
- UnitedHealthcare — Oncology Medication Clinical Coverage Policy
- Aetna CPB 0892 — Immune Checkpoint Inhibitors (covers Opdivo, Opdivo Qvantig, Opdualag)
- Bristol Myers Squibb Patient Assistance Foundation (BMSPAF)
- 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
| 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) | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules + biomarker test codes | Annual | Reviewed against CMS HCPCS quarterly files and AMA CPT releases. |
| NDC, dosing, FDA label, indication list | Event-driven | Tied to manufacturer document version + FDA label revision date. Qvantig indications can expand as BMS files sBLAs against the parent IV label. |
Reviewer
SME audit pass — May 22, 2026. J-code, ASP+6%/unit, FDA-label setid
(DailyMed
7f8c38fa-42f4-4387-9e8c-7a1c66855d8b, rev Nov 24, 2025), pediatric approval
scope (age ≥12 and ≥30 kg for melanoma + adjuvant melanoma + MSI-H/dMMR CRC), Yervoy-combo
exclusion, and CheckMate-67T pivotal trial all verified against primary sources. Initial draft had
pediatric listed as "not approved" — corrected to reflect current label.
Change log
- — SME audit pass. Corrected pediatric scope (now approved age ≥12 / ≥30 kg in select indications per Nov 24, 2025 label rev). Added DailyMed setid + verified ASP and J-code. Tightened indication list per current label.
- — Initial publication. ASP data: Q2 2026 (J9289 = $27.729/unit). Manufacturer source: BMS Access Support Opdivo Qvantig Codes & Coverage. FDA label: original Dec 2024 approval (BLA 761381). Sibling to IV Opdivo (J9299).
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 is verified against the current FDA label and the BMS Access Support Codes & Coverage portal. We do not paraphrase from billing-software vendor blogs.