Five rituximab products — the disambiguation table CMS HCPCS + FDA verified May 2026
Reference IV, SC co-formulated, and three 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.
| HCPCS | Brand | Mfr | Route | HCPCS descriptor | Q2 2026 ASP+6% / 10 mg |
|---|---|---|---|---|---|
J9312 |
Rituxan | Genentech / Biogen | IV | "Injection, rituximab, 10 mg" | $74.158 |
J9311 |
Rituxan Hycela | Genentech | SC | "Injection, rituximab 10 mg and hyaluronidase" | $36.282 |
Q5115 |
Truxima (rituximab-abbs) | Teva / Celltrion | IV | "Injection, rituximab-abbs, biosimilar, (Truxima), 10 mg" | $31.278 |
Q5119 |
Ruxience (rituximab-pvvr) | Pfizer | IV | "Injection, rituximab-pvvr, biosimilar, (Ruxience), 10 mg" | $13.686 |
Q5123 |
Riabni (rituximab-arrx) | Amgen | IV | "Injection, rituximab-arrx, biosimilar, (Riabni), 10 mg" | $20.257 |
- Unit basis: all five rituximab codes are 10 mg per unit. Many billers default to "1 mg per unit" because that is the standard for most J-codes (J0177, J9271, J2323, etc.). For rituximab, divide milligrams by 10 to get the unit count.
- Q5115 vs. Q5119: some published references and EHR pick-lists swap these. Q5115 is Truxima (Teva/Celltrion); Q5119 is Ruxience (Pfizer); Q5123 is Riabni (Amgen). Always verify against the manufacturer’s billing PDF and the AAPC code lookup.
All five products carry the same four FDA boxed warnings (fatal infusion reactions, severe mucocutaneous reactions, HBV reactivation, and PML). Pre-treatment HBV serology screening is standard of care for any rituximab product.
IV (J9312/Q5115/Q5119/Q5123) vs. Hycela SC (J9311) FDA labels verified 2025–2026
Hycela is a co-formulated subcutaneous product with hyaluronidase. It is restricted to oncology use, cycle 2 and beyond.
| IV products (J9312, Q5115, Q5119, Q5123) | Rituxan Hycela SC (J9311) | |
|---|---|---|
| Route | Intravenous infusion | Subcutaneous injection |
| Co-formulation | Rituximab alone | Rituximab + recombinant human hyaluronidase |
| Approved indications | NHL, CLL, RA, GPA/MPA, PV (PV verify per product label) | Follicular lymphoma (FL), DLBCL, CLL — oncology only |
| First-cycle eligibility | Yes — first dose is IV | No — only after at least one full IV dose tolerated without serious infusion reaction |
| Standard dose | Indication-specific (BSA or flat — see dosing section) | 1,400 mg SC (FL/DLBCL) or 1,600 mg SC (CLL) |
| Hyaluronidase content | n/a | 23,400 U (1,400 mg) / 26,800 U (1,600 mg) |
| Admin time | ~3–6 hours initial; 90 min subsequent (per protocol) | 5 minutes (FL/DLBCL) / 7 minutes (CLL) |
| Admin CPT | 96413 + 96415 (chemo IV) — non-onc may use 96365/96366 per payer | 96401 (chemo SC) — verify; some payers downcode to 96372 |
Dosing per indication FDA labels + Genentech billing PDFs
Six common dosing patterns. BSA-based regimens (NHL, CLL, GPA/MPA induction) almost always trigger partial-vial waste — see modifiers.
| Indication | Regimen | Dose form | Vial waste likely? |
|---|---|---|---|
| Non-Hodgkin lymphoma (NHL) | 375 mg/m² IV weekly × 4 doses; or with CHOP × 8 cycles | BSA-based (mg/m²) | Yes — JW common |
| Chronic lymphocytic leukemia (CLL) | 375 mg/m² IV cycle 1; 500 mg/m² IV subsequent cycles (with FC) | BSA-based (mg/m²) | Yes — JW common |
| Rheumatoid arthritis (RA) | Two 1,000 mg IV doses 2 weeks apart; q24wk thereafter (premed: methylprednisolone 100 mg IV) | Flat dose (1,000 mg) | No — two 500 mg vials match dose exactly |
| GPA / MPA induction | 375 mg/m² IV weekly × 4 doses | BSA-based (mg/m²) | Yes — JW common |
| GPA / MPA follow-up | 500 mg IV × 2 doses (day 1 + day 14), then 500 mg q6 months | Flat (500 mg) | No — one 500 mg vial |
| Pemphigus vulgaris (PV) | Two 1,000 mg IV doses 2 weeks apart, then 500 mg at months 12 and 18 | Flat (1,000 mg / 500 mg) | No |
| Hycela FL / DLBCL (cycle 2+) | 1,400 mg SC over 5 minutes (with 23,400 U hyaluronidase) | Flat SC dose | No — matched vial |
| Hycela CLL (cycle 2+) | 1,600 mg SC over 7 minutes (with 26,800 U hyaluronidase) | Flat SC dose | No — matched vial |
- RA 1,000 mg dose → 100 units
- NHL 375 mg/m² × 1.7 m² ≈ 638 mg administered → bill ~70 units (700 mg vials drawn) administered + JW for waste
- GPA follow-up 500 mg → 50 units
- Hycela CLL 1,600 mg → 160 units of J9311
NDC reference — all five products FDA NDC Directory verified May 2026
Pad to 11 digits with a leading zero in the middle segment for CMS-1500 Box 24A.
Rituxan (J9312) — Genentech labeler 50242
| NDC (10-digit) | NDC (11-digit, claim form) | Package |
|---|---|---|
50242-051-21 | 50242-0051-21 | 100 mg / 10 mL single-dose vial |
50242-053-06 | 50242-0053-06 | 500 mg / 50 mL single-dose vial |
Rituxan Hycela (J9311) — Genentech labeler 50242
| NDC (10-digit) | NDC (11-digit, claim form) | Package |
|---|---|---|
50242-108-01 | 50242-0108-01 | 1,400 mg / 11.7 mL co-formulated SC vial (with 23,400 U hyaluronidase) |
50242-109-01 | 50242-0109-01 | 1,600 mg / 13.4 mL co-formulated SC vial (with 26,800 U hyaluronidase) |
Truxima (Q5115) — Celltrion / Teva labeler 63459
| NDC (10-digit) | NDC (11-digit, claim form) | Package |
|---|---|---|
63459-104-01 | 63459-0104-01 | 100 mg / 10 mL single-dose vial |
63459-103-10 | 63459-0103-10 | 500 mg / 50 mL single-dose vial |
Ruxience (Q5119) — Pfizer labeler 0069
| NDC (10-digit) | NDC (11-digit, claim form) | Package |
|---|---|---|
0069-0238-01 | 00069-0238-01 | 100 mg / 10 mL single-dose vial |
0069-0249-01 | 00069-0249-01 | 500 mg / 50 mL single-dose vial |
Riabni (Q5123) — Amgen labeler 55513
| NDC (10-digit) | NDC (11-digit, claim form) | Package |
|---|---|---|
55513-224-01 | 55513-0224-01 | 100 mg / 10 mL single-dose vial |
55513-326-01 | 55513-0326-01 | 500 mg / 50 mL single-dose vial |
50242-051-21 → 50242-0051-21. Ruxience
labeler 0069 pads to 00069: 0069-0238-01 → 00069-0238-01.
Use N4 qualifier in CMS-1500 Box 24A shaded area with unit of measure (ML) and quantity
actually drawn from the vial.
Administration codes CPT verified May 2026
Rituximab is biller-classified as a chemotherapeutic agent (HCPCS chemo flag) for IV admin even when the indication is autoimmune. Some commercial payers recode non-oncology rituximab to therapeutic infusion codes.
| CPT | Description | Use for |
|---|---|---|
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance | First hour of IV rituximab infusion (oncology and most non-oncology) |
96415 |
Chemotherapy administration, IV infusion technique; each additional hour | Hours 2–6 of IV rituximab infusion (typical first-cycle administration is 4–6 hours) |
96365 |
Therapeutic, prophylactic or diagnostic IV infusion; up to 1 hour | Some commercial payers recode non-oncology IV rituximab (RA, GPA/MPA, PV) to non-chemo codes |
96366 |
Therapeutic IV infusion; each additional hour | Paired with 96365 when payer requires non-chemo coding |
96401 |
Chemotherapy administration, subcutaneous | Standard for Rituxan Hycela (J9311) SC administration |
96372 |
Therapeutic SC injection | Some payers downcode Hycela SC admin to 96372 — verify per payer |
Premedications
Standard premed: acetaminophen + diphenhydramine 30–60 minutes pre-infusion to reduce infusion-reaction risk. RA dosing per FDA label requires methylprednisolone 100 mg IV (or equivalent glucocorticoid) 30 minutes prior to each infusion. Premed administration is billed as separate admin codes (96372 IM/SC, or 96374 IV push, with the appropriate J-code for the agent).
First-dose administration setting
Because the FDA boxed warning for fatal infusion reactions cites ~80% incidence with the first infusion (within 24 hours), the first IV dose of any rituximab product is typically administered in a setting with immediate access to resuscitation — most often hospital outpatient (POS 19/22). Subsequent doses can move to office (POS 11) or AIC (POS 49) depending on payer site-of-care UM rules.
Modifiers — JZ, JW, and the BSA waste calculation CMS verified May 2026
JW applies more often to rituximab than to fixed-dose biologics. Worked example below.
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 rituximab, JZ applies to the flat-dose regimens: RA (1,000 mg = exactly two 500 mg vials), GPA/MPA follow-up (500 mg = one 500 mg vial), pemphigus 500 mg maintenance, and Hycela SC (matched-vial dosing). Append JZ to the J9312/Q5115/Q5119/Q5123/J9311 line.
JW — required for documented waste of unused single-dose-vial drug
For BSA-dosed indications (NHL, CLL, GPA/MPA induction at 375 mg/m²), the calculated dose almost never matches an integer combination of 100 mg + 500 mg vials, so partial-vial waste is the norm. 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) and discarded units (with JW) on two separate lines, same date of service.
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 rituximab 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 (clinical reassessment for next-cycle decision, treatment-decision encounter, 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. Each indication has a distinct code family.
| Indication | ICD-10 family | Examples |
|---|---|---|
| NHL — follicular lymphoma | C82.x |
C82.00 (FL grade I, unspec site); C82.10/C82.90; C82.5x (diffuse follicle center) |
| NHL — DLBCL | C83.3x |
C83.30 (DLBCL unspec); C83.31 (lymph nodes head/neck); C83.38 (multi-site) |
| NHL — other | C85.x |
C85.10 (B-cell lymphoma unspec); C85.90 (NHL unspec); C85.2x (mediastinal LBCL) |
| NHL — Waldenström / MALT | C88.0 / C88.4 |
C88.0 (Waldenström macroglobulinemia); C88.4 (extranodal marginal zone B-cell / MALT) |
| CLL | C91.10 / C91.11 / C91.12 |
C91.10 (CLL not in remission); C91.11 (in remission); C91.12 (in relapse) |
| RA | M05.x / M06.x |
M05.79 (RA w/ rheumatoid factor multiple sites w/o organ involvement); M06.09 (RA w/o RF, multi-site) |
| GPA | M31.30 / M31.31 |
M31.30 (Wegener’s / GPA w/o renal involvement); M31.31 (with renal involvement) |
| MPA | M31.7 |
M31.7 (microscopic polyangiitis) |
| Pemphigus vulgaris | L10.0 |
L10.0 (pemphigus vulgaris) |
Site of care & place of service Verified May 2026
First IV dose typically hospital outpatient due to infusion-reaction risk; subsequent doses can move to office or AIC under most payer site-of-care UM rules.
| Setting | POS | Claim form | Electronic | Typical use |
|---|---|---|---|---|
| Physician office / infusion suite | 11 | CMS-1500 | 837P | Subsequent doses; Hycela SC |
| Ambulatory infusion center (AIC) | 49 | CMS-1500 | 837P | Subsequent doses post site-of-care steering |
| On-campus hospital outpatient | 22 | UB-04 / CMS-1450 | 837I | First dose, high-risk patients |
| On-campus hospital outpatient (alt) | 19 | UB-04 / CMS-1450 | 837I | First dose, hospital-affiliated |
| Off-campus hospital outpatient | 19 | UB-04 / CMS-1450 | 837I | First dose at off-campus HOPD |
Payer site-of-care steering
UnitedHealthcare, Aetna, Cigna, and most BCBS plans apply site-of-care UM to specialty infusion drugs. After the first infusion is tolerated, payers typically require subsequent doses to move out of HOPD (POS 19/22) into office (POS 11) or an in-network AIC (POS 49) where facility fees are lower. Hycela SC fits non-hospital sites cleanly.
Claim form field mapping Genentech / Pfizer / Amgen billing PDFs
CMS-1500 / 837P (physician office, AIC; POS 11/49) example for a 1,000 mg RA dose of J9312.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | Format: N450242005321ML50.0 for one 500 mg vial; one line per NDC drawn |
| HCPCS J9312 + JZ | 24D (drug line) | 1,000 mg = 100 units; JZ when no waste |
| HCPCS J9312 + JW (when waste) | 24D (separate line) | Discarded units (per BSA dosing) |
| Drug units | 24G | 100 (per 1,000 mg dose), administered + waste split |
| CPT 96413 + 96415 (or 96365/96366) | 24D (admin lines) | 1 unit 96413 + N units 96415 for hours 2+ |
| ICD-10 | 21 | Indication-specific (M05.x, C82.x, M31.3x, etc.) |
| Dates of service | 24A | Same date for drug + admin lines |
| NPI | 17b / 24J / 33a | Rendering and billing provider NPI |
| PA number (when required) | 23 | Required by UHC, Aetna, most BCBS for non-preferred Rituxan in 2026 |
| JG / TB modifier (340B sites only) | 24D | Hospital outpatient 340B claims only |
Source: Genentech Rituxan Billing & Coding Brochure (NHL, RA, GPA-MPA versions); Pfizer Ruxience Billing Guide; Amgen Riabni Resource Guides.
Payer policy snapshot — biosimilar preference 2026 Reviewed May 2026
National payers have moved decisively to biosimilar-preferred policies for rituximab in 2026. Reference Rituxan now requires step therapy at most major payers.
| Payer | PA? | Preferred products | Step therapy? | Effective |
|---|---|---|---|---|
| UnitedHealthcare commercial Rituximab medical drug policy |
Yes | Riabni (Q5123), Ruxience (Q5119), Truxima (Q5115) | Yes — biosimilar trial required before reference Rituxan / Hycela for new starts | 1/1/2026 |
| UnitedHealthcare MA Part B Step therapy program |
Yes | Rituximab biosimilars on step list | Yes for new starts on reference Rituxan | 2025–2026 |
| Aetna commercial Pharmacy CPB; non-onc IP0319 |
Yes | Biosimilar-preferred | Trending yes for non-oncology (RA, GPA/MPA, PV) | 2025–2026 |
| Cigna commercial IP0319 Rituximab Non-Oncology |
Yes | Biosimilar-preferred for non-oncology | Yes for non-oncology indications | 2024–2026 |
| BCBS (most plans) Plan-by-plan |
Yes | Biosimilar-preferred (most plans) | Verify per plan; non-oncology trending biosimilar-first | 2025–2026 |
2026 trend across national payers
UHC, Aetna, Cigna, and most BCBS plans now require biosimilar-first for non-oncology indications (RA, GPA/MPA, PV). Oncology (NHL, CLL) policies more often allow physician choice but are trending toward biosimilar mandates. Per AJMC, biosimilar market share reached 76% of new rituximab starts in Q1 2025, with continued growth expected through 2026 as preferred-product designations take effect.
What to document for step-therapy approval
- Brand of biosimilar tried (Truxima, Ruxience, or Riabni), HCPCS code, dates of administration
- Number of doses or duration of trial (most policies: at least one full cycle)
- Documented intolerance, infusion-reaction, or inadequate response (with objective measures where applicable: disease activity scores, OCT, B-cell depletion, etc.)
- Any clinical contraindication to the biosimilar pathway (rare; biosimilars share the same molecular structure)
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. All five rituximab codes refresh together each quarter.
Q2 2026 payment snapshot — J9312 reference Rituxan
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
Cross-product price comparison (Q2 2026 ASP+6%)
| Code | Brand | Per 10 mg unit | Per 1,000 mg dose | vs. J9312 |
|---|---|---|---|---|
J9312 | Rituxan | $74.158 | $7,415.80 | baseline |
J9311 | Rituxan Hycela | $36.282 | $3,628.20 | ~51% lower |
Q5115 | Truxima | $31.278 | $3,127.80 | ~58% lower |
Q5119 | Ruxience | $13.686 | $1,368.60 | ~82% lower |
Q5123 | Riabni | $20.257 | $2,025.70 | ~73% lower |
Coverage
No NCD specific to rituximab as a class. Each MAC publishes a billing & coding article covering rituximab and biosimilars (e.g., A52468, A57788) with covered ICD-10 ranges per indication. All MACs cover J9312, J9311, Q5115, Q5119, and Q5123 for FDA-approved on-label indications. Bill with the indication-specific ICD-10 (see ICD-10 by indication).
Canonical code source: CMS HCPCS quarterly update file.
Patient assistance — one program per manufacturer Manufacturer sites verified May 2026
- Rituxan oncology (NHL, CLL): Genentech Oncology Co-pay Program (eligible commercially-insured patients; up to $25,000/year). Genentech Patient Foundation for uninsured/underinsured: 1-888-941-3331. Independent foundations (PAN, HealthWell) for Medicare patients — verify open funds quarterly.
- Rituxan immunology (RA, GPA/MPA, PV): Rituxan Immunology Co-pay Program (eligible commercially-insured patients; up to $15,000/year). Genentech Patient Foundation for uninsured/underinsured.
- Rituxan Hycela (J9311): Genentech Oncology Co-pay Program (oncology-only product). Same Patient Foundation eligibility for free drug.
- Truxima (Q5115): TRUXIMA Cost Support Program (Teva). Teva Cares Foundation for free drug to qualifying uninsured patients.
- Ruxience (Q5119): Pfizer Oncology Together for support coordination. Pfizer Patient Assistance Program for free drug to qualifying uninsured patients.
- Riabni (Q5123): Amgen SupportPlus copay program for eligible commercially-insured patients. Amgen Safety Net Foundation for free drug.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Wrong unit count (10× over- or under-bill) | Biller defaulted to 1 mg/unit (most J-codes) instead of 10 mg/unit (rituximab) | Recalculate: mg ÷ 10 = units. 1,000 mg = 100 units, not 1,000. |
| Wrong J-code (J9312 instead of biosimilar) | Reference Rituxan billed when patient received Truxima/Ruxience/Riabni | Verify drug administered. Match HCPCS to NDC drawn: Q5115/Q5119/Q5123 each have distinct labelers. |
| Q5115 vs. Q5119 swap | Reference confusion; Q5115 = Truxima, Q5119 = Ruxience | Re-verify in EHR pick-list. Manufacturer billing PDF is authoritative for the brand-to-code mapping. |
| Step therapy not met (UHC 1/1/2026) | New start on J9312 / J9311 without documented biosimilar trial | Submit biosimilar trial documentation OR clinical justification to skip biosimilar (rare). |
| JZ missing | Single-dose-vial claim without JZ when no drug was discarded | Resubmit with JZ on the rituximab line (RA 1,000 mg, GPA 500 mg follow-up, Hycela SC, etc.). |
| JW missing on BSA-dosed claim | NHL/CLL/GPA induction at 375 mg/m² with vial waste not reported | Add separate line with JW for discarded units (per CMS rounding); document waste in chart. |
| J9311 (Hycela) on cycle 1 | SC product billed for first dose | Resubmit cycle 1 as IV (J9312 or biosimilar). Hycela is cycle 2+ only, after IV tolerated. |
| J9311 (Hycela) for non-oncology indication | Hycela billed for RA, GPA/MPA, or PV | Hycela is approved only for FL, DLBCL, CLL. Switch to an IV product for non-oncology indications. |
| NDC format / qualifier missing | 10-digit NDC submitted; missing N4 qualifier or unit-of-measure | Use 11-digit NDC with N4 qualifier in CMS-1500 Box 24A shaded area; report ML and quantity drawn. |
| HBV screening not documented | Audit-vulnerable; payer requests pre-treatment HBV serology per FDA boxed warning | Confirm pre-treatment HBsAg + anti-HBc results in chart; supply on appeal. |
| Site-of-care denial post cycle 1 | Subsequent infusion at HOPD when payer requires office/AIC | Move infusion to POS 11 or 49; or submit medical-necessity justification (e.g., recurrent reaction history). |
| Non-chemo recoding | Commercial payer rejects 96413/96415 for non-oncology rituximab | Resubmit admin lines as 96365/96366 per payer policy. Keep 96413/96415 for oncology indications. |
Frequently asked questions
What are the HCPCS codes for rituximab?
There are five rituximab HCPCS codes: J9312 (Rituxan IV), J9311 (Rituxan
Hycela SC, with hyaluronidase), Q5115 (Truxima — rituximab-abbs biosimilar),
Q5119 (Ruxience — rituximab-pvvr biosimilar), and Q5123 (Riabni —
rituximab-arrx biosimilar). All five share the same billing unit basis: 1 unit = 10 mg.
A common reference error swaps Q5115 and Q5119 — confirm: Q5115 = Truxima, Q5119 = Ruxience.
How many units do I bill for a rituximab dose?
All five rituximab codes use 1 unit = 10 mg, NOT 1 mg. This is the biggest billing trap on the
rituximab family because most J-codes default to 1 mg per unit. Examples: a 1,000 mg RA dose = 100 units;
a 700 mg administered NHL dose = 70 units; a 500 mg CLL maintenance dose = 50 units. Hycela 1,400 mg SC
dose = 140 units of J9311.
Does the JW modifier apply more often to rituximab than to fixed-dose drugs?
Yes. NHL, CLL, and GPA/MPA induction use mg/m² (BSA-based) dosing — partial-vial waste is routine. Only flat-dose RA (1,000 mg = two 500 mg vials, no waste) and pemphigus vulgaris (1,000 mg) avoid wastage. For BSA-dosed indications, expect to bill JZ for administered units AND JW for the discarded units on a separate line. Document the waste in the medical record.
Why does the biller need to distinguish reference Rituxan from biosimilars?
Each rituximab product has its own HCPCS code, NDC, and ASP. Billing reference Rituxan
(J9312) when the patient received Truxima (Q5115) is a denial trigger and a
compliance issue. Effective January 1, 2026, UnitedHealthcare designates Riabni, Ruxience, and Truxima
as preferred — Rituxan and Rituxan Hycela are non-preferred and require step therapy through a
biosimilar first.
What administration codes are used for rituximab?
For IV products (J9312, Q5115, Q5119, Q5123): 96413 (chemo IV infusion, initial hour) plus
96415 (each additional hour) for oncology indications (NHL, CLL). For non-oncology IV use
(RA, GPA/MPA, PV) most payers still accept 96413/96415; some commercial payers recode to
96365/96366 (non-chemo therapeutic infusion) — verify per payer. For
Rituxan Hycela SC (J9311): 96401 (chemo SC administration) is standard; some payers
downcode to 96372 — verify.
Can Rituxan Hycela be used as the first dose?
No. Rituxan Hycela (J9311) is only approved for cycle 2 and beyond, after the patient has tolerated at least one full IV dose of rituximab without a serious infusion reaction. The first cycle must be IV (J9312 or a biosimilar). Billing J9311 for cycle 1 will deny.
What is the Q2 2026 Medicare reimbursement for J9312 Rituxan?
Q2 2026 ASP + 6% for J9312 (reference Rituxan) is approximately $74.158 per 10 mg unit. A typical 1,000 mg RA dose = 100 units × $74.158 = $7,415.80 before sequestration. Biosimilars are substantially cheaper: Q5119 Ruxience ~$13.686/unit, Q5123 Riabni ~$20.257/unit, Q5115 Truxima ~$31.278/unit. ASP refreshes quarterly — see the live snapshot above.
Are biosimilars interchangeable with Rituxan?
Truxima (Q5115), Ruxience (Q5119), and Riabni (Q5123) are
FDA-approved biosimilars to Rituxan, but as of May 2026 none are designated “interchangeable”
under FDA standards — pharmacy/infusion-center substitution is not automatic. However, payers can
and do require biosimilar use through formulary and step-therapy rules. Biosimilar market share reached
76% of new rituximab starts in Q1 2025 (AJMC).
What FDA boxed warnings apply to all rituximab products?
All five rituximab products carry the same four FDA boxed warnings: (1) fatal infusion-related reactions (~80% with first infusion, within 24 hours — first dose typically given in hospital outpatient); (2) severe mucocutaneous reactions (paraneoplastic pemphigus, SJS, TEN); (3) hepatitis B virus reactivation (screen all patients pre-treatment); (4) progressive multifocal leukoencephalopathy (PML) from JC virus. Pre-treatment HBV screening is standard of care.
Source documents
- AAPC — HCPCS J9312 (Rituxan)
- AAPC — HCPCS J9311 (Rituxan Hycela)
- AAPC — HCPCS Q5115 (Truxima / rituximab-abbs)
- AAPC — HCPCS Q5119 (Ruxience / rituximab-pvvr)
- AAPC — HCPCS Q5123 (Riabni / rituximab-arrx)
- NCI SEER CanMED HCPCS — rituximab and biosimilars
- FDA Rituxan label (2021 revision, BLA 103705)
- Genentech — Rituxan Hycela prescribing information
- Rituxan Hycela — dosing schedules (HCP)
- Genentech — Rituxan Billing & Coding Brochure
- Pfizer Ruxience medical information & billing guide
- Amgen Riabni resource & billing guide
- UnitedHealthcare — Rituximab Commercial Medical Drug policy
- Cigna IP0319 — Rituximab Non-Oncology coverage policy
- AJMC — Q1 2025 biosimilar market share data
- CMS — Medicare Part B Drug ASP Pricing File
- CMS — HCPCS quarterly update file
- CMS — JW / JZ modifier guidance
About this page
We maintain this page as a living reference for the entire rituximab family. Medicare ASP pricing for all five HCPCS codes (J9312, J9311, Q5115, Q5119, Q5123) 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 manufacturer guide, FDA label, or major payer policy changes.
Found an error? Email hello@carecostestimate.com.
Refresh cadence
| Element | Cadence | How it's refreshed |
|---|---|---|
| Medicare ASP pricing (all 5 codes) | Quarterly | Auto-bound to CareCost ASP layer; updates on CMS file release. |
| Payer policies (UHC, Aetna, Cigna, BCBS) | Semi-annual | Manual review against published payer policy documents; preferred-product designations re-checked annually at year-start. |
| HCPCS / CPT / NCCI rules | Annual | Reviewed against CMS HCPCS quarterly files, AMA CPT releases, and NCCI edit updates. |
| NDC, dosing, FDA label | Event-driven | Tied to manufacturer document version + FDA label revision date for each of the five products. |
Reviewer
Change log
- — Initial publication of the five-product rituximab family reference. ASP data: Q2 2026 (J9312, J9311, Q5115, Q5119, Q5123). Payer policies: UnitedHealthcare commercial 1/1/2026 biosimilar-preferred update, UHC MA Part B step therapy, Aetna pharmacy CPB, Cigna IP0319 non-oncology rituximab. AJMC Q1 2025 biosimilar market share (76%) cited.
Methodology
Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File for all five rituximab 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 (as with non-oncology IV admin coding — chemo 96413/96415 vs. therapeutic 96365/96366), we surface the conflict rather than picking a side.