Herceptin family (trastuzumab) — J9355, Q5112, Q5113, Q5114, Q5116, Q5117, Q5144

Seven trastuzumab products — the disambiguation table CMS HCPCS + FDA verified May 2026

Reference Herceptin and six IV biosimilars. All share one unit basis (10 mg) and the same FDA boxed warnings, but each has its own HCPCS code, NDCs, manufacturer, and ASP. All seven are IV products — J9356 Herceptin Hylecta (SC) is a separate product on a separate page.

All seven products carry the same four FDA boxed warnings (cardiomyopathy, infusion reactions, pulmonary toxicity, embryo-fetal toxicity) and require the same baseline + q3-month LVEF surveillance. See the cardiomyopathy & LVEF surveillance section below.

HER2 testing requirement — the gating biomarker FDA labels + ASCO/CAP 2018 Guideline

Trastuzumab is approved only for HER2-overexpressing tumors. The HER2 result must be in the medical record before the first dose — payers commonly request it on prior authorization.

HER2 test billing (separate claim)

HER2 testing is billed separately from trastuzumab administration, on the pathology claim. Common codes:

• 88360 — HER2 IHC, manual
• 88361 — HER2 IHC, computer-assisted quantitation
• 88374 — HER2 by in situ hybridization (ISH), manual or computer-assisted, single probe
• 88377 — HER2 by ISH, manual or computer-assisted, dual probe (most common for FISH)
• G9418 — (PQRS / quality-reporting context) HER2 test result documented

Dosing per indication FDA labels + Genentech billing PDFs

Three FDA-approved indications. Two scheduling options for breast cancer (weekly OR every-3-week). All dosing is mg/kg — partial-vial waste is the rule. See modifiers.

Combination context (for documentation)

Trastuzumab is most often given in combination with other agents. In adjuvant HER2+ breast, trastuzumab + pertuzumab (Perjeta) dual blockade is standard with chemo (TCHP regimen — docetaxel/carboplatin/trastuzumab/pertuzumab). See the Perjeta (J9306) page for combination dosing and billing. In metastatic gastric, trastuzumab is paired with cisplatin + 5-FU (or capecitabine) per ToGA trial. Each agent bills separately on its own HCPCS line.

NDC reference — all seven products FDA NDC Directory verified May 2026

Pad to 11 digits with a leading zero in the appropriate segment for CMS-1500 Box 24A.

Herceptin (J9355) — Genentech labeler 50242

Ontruzant (Q5112) — Samsung Bioepis / Organon labeler 78206 / 67919

Herzuma (Q5113) — Celltrion / Teva labeler 63459

Ogivri (Q5114) — Mylan / Biocon (Viatris) labeler 67457

Trazimera (Q5116) — Pfizer labeler 0069

Kanjinti (Q5117) — Amgen labeler 55513

Hercessi (Q5144) — Accord BioPharma labeler 16729

Administration codes CPT verified May 2026

Trastuzumab is biller-classified as a chemotherapeutic agent (HCPCS chemo flag) for IV admin in all indications.

Premedications & observation

Premedication is not routinely required for trastuzumab (unlike rituximab or paclitaxel). Acetaminophen + diphenhydramine may be given at provider discretion, particularly if the patient had any infusion-reaction symptoms during the loading dose. The FDA label requires 1-hour observation post-infusion for the loading dose; subsequent doses can step down to 30-minute observation if loading was tolerated.

Co-administered chemo / dual-agent context

In adjuvant breast (TCHP regimen), trastuzumab is given the same day as docetaxel, carboplatin, and pertuzumab. Each agent gets its own J-code line, the longest infusion is the primary (96413), additional sequential infusions are 96417, and concurrent infusions (rare) are 96416. Confirm sequencing per regimen protocol.

Modifiers — JZ, JW, and the mg/kg waste calculation CMS verified May 2026

JW applies to almost every trastuzumab claim. The 420 mg multi-dose vial reduces (does not eliminate) waste vs. 150 mg single-dose vials.

JZ — required when no drug discarded

Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. For trastuzumab, JZ applies on the rare claim where the calculated dose exactly matches an integer combination of vials (e.g., 150 mg dose using one 150 mg single-dose vial). Append JZ to the J9355 / Q5112-Q5117 / Q5144 line. Note: the 420 mg multi-dose vial is NOT a single-dose container, so JZ/JW do not apply when only the multi-dose vial is used — verify your MAC’s position.

JW — required for documented waste of unused single-dose-vial drug

For all weight-based trastuzumab dosing, the calculated dose almost never matches an integer combination of 150 mg single-dose vials. CMS requires the JW modifier on a separate claim line for the discarded units (rounded per CMS rules), with the wastage documented in the medical record. Bill administered units (with JZ if applicable, otherwise unmodified) and discarded units (with JW) on two separate lines, same date of service.

Waste mitigation — the 420 mg multi-dose vial

The 420 mg multi-dose vial reconstituted with the supplied bacteriostatic water (BWFI) has a 28-day BUD when refrigerated. Practices that infuse multiple HER2+ patients per week can amortize a single 420 mg multi-dose vial across patients, eliminating per-patient waste. The 150 mg single-dose vial is required when reconstituted with sterile water for injection (SWFI) for a known hypersensitivity to benzyl alcohol (the BWFI preservative) — SWFI-reconstituted vials are single-use only.

Apply each MAC’s rounding convention. Some MACs require billing the total drawn from the vial as administered units and reporting waste only when an entire additional vial would otherwise be required. Refer to your local MAC billing article for the exact rounding rule.

JG / TB — 340B drug pricing

Hospitals that purchase trastuzumab through 340B and bill Medicare report the JG modifier (acute-care hospitals) or TB modifier (rural sole community / critical-access hospitals), per CMS guidance. Most infusion suites do not use 340B pricing; only the hospital-outpatient setting does.

Modifier 25 — same-day E/M

Append modifier 25 to the same-day E/M code if a significant, separately identifiable evaluation occurred (cycle re-staging, treatment-decision encounter, post-LVEF-decline reassessment, etc.). Routine pre-infusion check-in is bundled.

ICD-10-CM diagnosis codes FY2026 verified May 2026

Use the most specific code supported by chart documentation. Trastuzumab covers three indication families: HER2+ breast (C50.x), HER2+ gastric (C16.x), and HER2+ gastroesophageal junction (C15.x).

Site of care & place of service Verified May 2026

First infusion (90 min loading + 60 min observation = 2.5 hours) typically office, AIC, or hospital outpatient. Subsequent doses (30 min + 30 min observation) move easily to office or AIC under payer site-of-care UM rules.

Payer site-of-care steering

UnitedHealthcare, Aetna, Cigna, and most BCBS plans apply site-of-care UM to specialty infusion drugs. After the loading dose is tolerated, payers typically require subsequent 30-minute trastuzumab infusions to move out of HOPD (POS 19/22) into office (POS 11) or an in-network AIC (POS 49) where facility fees are lower. The 30-minute trastuzumab maintenance infusion is well-suited to non-hospital sites.

Claim form field mapping Genentech / biosimilar mfr billing PDFs

CMS-1500 / 837P (physician office, AIC; POS 11/49) example for a 480 mg q3wk maintenance dose of J9355 in an 80 kg patient.

Source: Genentech Herceptin Billing & Coding Brochure; Pfizer Trazimera Billing Guide; Amgen Kanjinti Resource Guides; Samsung Bioepis Ontruzant payer reference; Celltrion Herzuma billing materials; Mylan Ogivri reimbursement guide; Accord Hercessi billing reference.

Payer policy snapshot — biosimilar mandate 2026 Reviewed May 2026

National payers have moved beyond preference to mandate. Reference Herceptin (J9355) requires medical-necessity documentation at UHC and most major commercial payers. PBM private-label (Cordavis, Quallent, Nuvaila) further pushes biosimilars.

PBM private-label biosimilar distribution

Three major PBMs now distribute trastuzumab biosimilars under their own private labels:

• CVS Cordavis — CVS Caremark’s private-label subsidiary; distributes biosimilars including trastuzumab through Caremark-managed lives
• Express Scripts Quallent — Cigna/ESI private-label subsidiary; trastuzumab biosimilar distribution under Quallent label for ESI-managed lives
• OptumRx Nuvaila — UHG/Optum private-label arm; trastuzumab biosimilar distribution for OptumRx-managed lives (overlaps with UHC commercial coverage)

These arrangements typically rebate manufacturer biosimilars under the PBM private-label brand. The underlying NDC and HCPCS code may remain the manufacturer’s (e.g., Q5117 Kanjinti) or may be a repackaged NDC under the private-label labeler — verify the NDC drawn against the PBM’s bulletin. Billing the wrong HCPCS for a private-label product is a denial trigger.

What to document for biosimilar approval / J9355 medical-necessity exception

• HER2 IHC 3+ or ISH-amplified pathology report (required for any trastuzumab claim)
• Brand of trastuzumab biosimilar tried (when seeking step-through), HCPCS code, dates of administration, doses
• Documented intolerance, infusion reaction, or inadequate response to the biosimilar (rare; biosimilars share the same molecular structure as reference Herceptin)
• For J9355 medical-necessity: clinical justification for reference product (rarely accepted — biosimilars are clinically equivalent per FDA and NCCN)
• Baseline LVEF result (echo or MUGA) within institutional normal limits

Medicare reimbursement CMS Q2 2026 (live)

Quarterly ASP from CMS Part B Drug Pricing File. All seven trastuzumab codes refresh together each quarter (Hercessi Q5144 may not yet appear in the Q2 2026 file as it was recently added).

Cross-product price comparison (Q2 2026 ASP+6%, 480 mg q3wk maintenance dose)

Coverage

No NCD specific to trastuzumab as a class. Each MAC publishes a billing & coding article covering trastuzumab and biosimilars with covered ICD-10 ranges per indication. All MACs cover J9355, Q5112, Q5113, Q5114, Q5116, Q5117, and Q5144 for FDA-approved on-label HER2+ indications. Bill with the indication-specific ICD-10 (see ICD-10 by indication) and ensure the HER2 pathology result is in the chart.

Canonical code source: CMS HCPCS quarterly update file.

Patient assistance — one program per manufacturer Manufacturer sites verified May 2026

• Herceptin (J9355): Genentech Access Solutions — 1-866-422-2377. Genentech Oncology Co-pay Program for eligible commercially-insured patients (up to $25,000/year). Genentech Patient Foundation for free drug to qualifying uninsured/underinsured patients (1-888-941-3331). Independent foundations (PAN, HealthWell, CancerCare) for Medicare patients — verify open funds quarterly.
• Ontruzant (Q5112): Samsung Bioepis Patient Support program. Organon distributes Ontruzant in the US — verify current support program contact via the Ontruzant prescribing information.
• Herzuma (Q5113): Celltrion Connect — 1-866-466-4046. Copay assistance and patient navigation.
• Ogivri (Q5114): Mylan Advocate / Biocon Connect (Viatris). Patient assistance for uninsured/underinsured.
• Trazimera (Q5116): Pfizer Oncology Together — 1-877-744-5675. Patient navigation, copay support, and Pfizer Patient Assistance Program for free drug to qualifying uninsured patients.
• Kanjinti (Q5117): Amgen Assist 360 — 1-888-427-7478. Amgen SupportPlus copay assistance for eligible commercially-insured patients; Amgen Safety Net Foundation for free drug.
• Hercessi (Q5144): Accord Patient Support program (Accord BioPharma) — verify current contact via the Hercessi prescribing information.

Cardiomyopathy & LVEF surveillance FDA labels + ASCO/AHA cardio-oncology 2026

Cardiac monitoring is a payer audit-vulnerable area. Document baseline LVEF before the first dose and at every 3-month interval during therapy.

LVEF assessment billing

• 93306 — transthoracic echocardiography, complete with spectral Doppler and color flow Doppler
• 93307 — transthoracic echocardiography, complete
• 78451 / 78452 — myocardial perfusion imaging / MUGA scan
• 78472 / 78473 — cardiac blood pool imaging (gated equilibrium / first-pass technique)

LVEF assessment bills separately from the trastuzumab claim and uses the appropriate cardiology / nuclear medicine code per modality. Document the LVEF result in the medical record alongside each trastuzumab dose decision — payers may request the cardiac surveillance documentation on audit.

Common denials & how to fix them

Frequently asked questions

What are the HCPCS codes for trastuzumab?

There are seven trastuzumab IV HCPCS codes: J9355 (reference Herceptin), Q5112 (Ontruzant — trastuzumab-dttb), Q5113 (Herzuma — trastuzumab-pkrb), Q5114 (Ogivri — trastuzumab-dkst), Q5116 (Trazimera — trastuzumab-qyyp), Q5117 (Kanjinti — trastuzumab-anns), and Q5144 (Hercessi — trastuzumab-strf). All seven share the same billing unit basis: 1 unit = 10 mg. Note: J9356 is the separate code for Herceptin Hylecta (trastuzumab + hyaluronidase, subcutaneous) — do not confuse with the IV family.

How many units do I bill for a trastuzumab dose?

All seven trastuzumab IV codes use 1 unit = 10 mg, NOT 1 mg. Worked examples for an 80 kg patient: adjuvant breast 4 mg/kg loading = 320 mg → 32 units; weekly maintenance 2 mg/kg = 160 mg → 16 units; q3wk maintenance 6 mg/kg = 480 mg → 48 units; q3wk loading 8 mg/kg = 640 mg → 64 units. Metastatic gastric loading 8 mg/kg = 640 mg → 64 units.

Does the JW modifier apply more often to trastuzumab than to fixed-dose drugs?

Yes. All trastuzumab dosing is weight-based (mg/kg), so the calculated dose almost never matches an integer combination of 150 mg and 420 mg vials. Partial-vial waste is the rule, not the exception. Bill JZ on the administered units line and JW on a separate line for the discarded units, with waste documented in the medical record. The 420 mg multi-dose vial reduces waste when reconstituted bacteriostatic water is used (28-day BUD), but most settings use single-dose 150 mg vials and incur waste.

Why does the biller need to distinguish reference Herceptin from biosimilars?

Each trastuzumab product has its own HCPCS code, NDC, and ASP. Billing reference Herceptin (J9355) when the patient received Kanjinti (Q5117) is a denial trigger and a compliance issue. UnitedHealthcare designates a preferred trastuzumab biosimilar and denies J9355 unless medical necessity is documented. CVS Cordavis, ESI Quallent, and OptumRx Nuvaila now distribute private-label trastuzumab biosimilars under their own labels, further driving biosimilar-mandatory billing.

What administration codes are used for trastuzumab?

For all IV trastuzumab products (J9355, Q5112, Q5113, Q5114, Q5116, Q5117, Q5144): 96413 (chemo IV infusion, initial hour) plus 96415 (each additional hour). Loading-dose infusion is 90 minutes; subsequent infusions are 30 minutes if the loading dose was tolerated. Trastuzumab is a chemotherapeutic agent for HCPCS classification purposes — non-chemo recoding (96365/96366) is rarely accepted by payers.

What HER2 testing is required before billing trastuzumab?

All trastuzumab products require documented HER2 overexpression: IHC 3+ OR IHC 2+ confirmed by FISH/CISH/SISH (in situ hybridization) showing HER2 gene amplification. The HER2 test result must be in the medical record before the first trastuzumab dose. Payers commonly request this documentation on prior-authorization. Use CPT 88374 / 88377 (HER2 ISH) and 88360 / 88361 (HER2 IHC) for the test billing on a separate claim.

What is the Q2 2026 Medicare reimbursement for J9355 Herceptin?

Q2 2026 ASP + 6% for J9355 (reference Herceptin) is approximately $73.425 per 10 mg unit. A typical 480 mg q3wk maintenance dose for an 80 kg patient (6 mg/kg) = 48 units × $73.425 = $3,524.40 before sequestration. Biosimilars are substantially cheaper: Q5116 Trazimera ~$10.425/unit (lowest), Q5112 Ontruzant ~$29.808/unit, Q5114 Ogivri ~$35.783/unit, Q5113 Herzuma ~$56.019/unit, Q5117 Kanjinti ~$56.379/unit. ASP refreshes quarterly — see the live snapshot above.

Are trastuzumab biosimilars interchangeable with Herceptin?

All six trastuzumab biosimilars (Q5112 Ontruzant, Q5113 Herzuma, Q5114 Ogivri, Q5116 Trazimera, Q5117 Kanjinti, Q5144 Hercessi) are FDA-approved biosimilars to Herceptin, but as of May 2026 none are designated “interchangeable” under FDA standards — pharmacy/infusion-center substitution is not automatic. However, payers increasingly mandate biosimilar use through formulary, step-therapy rules, and outright J9355 denials (UnitedHealthcare). PBM private-label arrangements (CVS Cordavis, ESI Quallent, OptumRx Nuvaila) further push biosimilar adoption.

What FDA boxed warnings apply to all trastuzumab products?

All seven trastuzumab products carry the same four FDA boxed warnings: (1) cardiomyopathy — left-ventricular dysfunction, CHF, and decline in LVEF (incidence higher with anthracycline co-administration); (2) infusion reactions — fever/chills, dyspnea, hypotension, anaphylaxis, primarily during the first infusion; (3) pulmonary toxicity — interstitial pneumonitis, ARDS; (4) embryo-fetal toxicity — oligohydramnios, fetal renal failure (Pregnancy Category D). LVEF assessment by echo or MUGA is required at baseline and every 3 months during therapy, with mandatory dose interruption on ≥16% LVEF decline from baseline or LVEF below institutional lower limit.

Source documents

1. AAPC — HCPCS J9355 (Herceptin)
   Code descriptor and crosswalk reference
2. AAPC — HCPCS Q5112 (Ontruzant / trastuzumab-dttb)
   Biosimilar code descriptor (Samsung Bioepis)
3. AAPC — HCPCS Q5113 (Herzuma / trastuzumab-pkrb)
   Biosimilar code descriptor (Celltrion / Teva)
4. AAPC — HCPCS Q5114 (Ogivri / trastuzumab-dkst)
   Biosimilar code descriptor (Mylan / Biocon)
5. AAPC — HCPCS Q5116 (Trazimera / trastuzumab-qyyp)
   Biosimilar code descriptor (Pfizer)
6. AAPC — HCPCS Q5117 (Kanjinti / trastuzumab-anns)
   Biosimilar code descriptor (Amgen)
7. AAPC — HCPCS Q5144 (Hercessi / trastuzumab-strf)
   Biosimilar code descriptor (Accord BioPharma)
8. NCI SEER CanMED HCPCS — trastuzumab and biosimilars
   Authoritative HCPCS / NDC linkage for oncology drugs
9. FDA Herceptin label (Genentech, BLA 103792)
   Reference trastuzumab prescribing information; boxed warnings; HER2 testing requirement; LVEF surveillance protocol
10. Genentech — Herceptin Billing & Coding Brochure
    CMS-1500 field guidance; J9355 billing reference
11. Pfizer Trazimera medical information & billing guide
    Q5116 biosimilar dosing and admin reference
12. Amgen Kanjinti resource & billing guide
    Q5117 biosimilar billing reference
13. Samsung Bioepis / Organon — Ontruzant prescribing information
    Q5112 biosimilar prescribing information
14. Celltrion Healthcare — Herzuma billing reference
    Q5113 biosimilar billing materials
15. Mylan / Viatris — Ogivri reimbursement guide
    Q5114 biosimilar billing reference
16. Accord BioPharma — Hercessi prescribing information
    Q5144 biosimilar prescribing information
17. NCCN Clinical Practice Guidelines in Oncology — Breast Cancer
    HER2-positive systemic therapy; trastuzumab + pertuzumab dual blockade in adjuvant and metastatic settings
18. NCCN Clinical Practice Guidelines in Oncology — Gastric Cancer
    HER2-positive metastatic gastric / GEJ first-line systemic therapy
19. ASCO/CAP HER2 Testing Guideline (2018 update)
    IHC and ISH interpretation criteria for HER2 status determination
20. UnitedHealthcare — Trastuzumab Commercial Medical Drug policy
    2026 biosimilar-mandatory designation; J9355 medical-necessity criteria
21. CMS — Medicare Part B Drug ASP Pricing File
    Q2 2026 quarterly file (J9355, Q5112, Q5113, Q5114, Q5116, Q5117, Q5144)
22. CMS — HCPCS quarterly update file
    Canonical HCPCS code source for trastuzumab family
23. CMS — JW / JZ modifier guidance
    Single-dose-container waste reporting (effective 7/1/2023)

About this page

We maintain this page as a living reference for the entire trastuzumab IV family. Medicare ASP pricing for all seven HCPCS codes (J9355, Q5112, Q5113, Q5114, Q5116, Q5117, Q5144) is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files. (Hercessi Q5144 was added to HCPCS recently and may not yet appear in every quarterly file.) Coding and policy content is reviewed at least quarterly and updated whenever a manufacturer guide, FDA label, or major payer policy changes.

Found an error? Email hello@carecostestimate.com.

Refresh cadence

Reviewer

Change log

• May 2, 2026 — Initial publication of the seven-product trastuzumab IV family reference. ASP data: Q2 2026 (J9355, Q5112, Q5113, Q5114, Q5116, Q5117). Q5144 Hercessi noted as ASP pending publication. Payer policies: UnitedHealthcare commercial biosimilar-mandatory, UHC MA Part B step therapy, Aetna pharmacy CPB, Cigna trastuzumab coverage, BCBS plan-by-plan biosimilar-preferred. PBM private-label distribution (CVS Cordavis, ESI Quallent, OptumRx Nuvaila) noted. Cardiomyopathy boxed warning + LVEF surveillance protocol surfaced as primary clinical-billing intersection.

Methodology

Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File for all seven trastuzumab codes. Payer policies are read directly from each payer’s published medical policy documents. We do not paraphrase from billing-software vendor blogs. When manufacturer guidance and payer policy conflict, we surface the conflict rather than picking a side.