Actemra family (tocilizumab) — J3262 + biosimilars

Genentech (Roche) / Biogen / Fresenius Kabi / Celltrion · 80, 200, 400 mg single-dose IV vials (20 mg/mL) · 1 unit = 1 mg on J3262

Tocilizumab IV is billed as J3262 (Actemra reference). The biosimilar landscape is evolving: Tofidence (Q5135, Biogen) launched 2024; Tyenne (Fresenius Kabi) and Avtozma (Celltrion) are newer — verify current HCPCS at billing time. Six FDA-approved indications drive distinct dosing: RA, polyarticular JIA, systemic JIA, GCA, CAR-T-induced CRS, and hospitalized COVID-19. Q2 2026 ASP+6% for J3262: $5.530 per 1 mg unit (~$1,548 per 4 mg/kg dose at 70 kg). Non-chemo admin codes (96365/96366) — not 96413/96415.

ASP data:Q2 2026 (live, J3262)
Payer policies:verified May 2026
Manufacturer guides:Genentech 2025–2026
FDA labels:verified 2025–2026
Page reviewed:

Instant Answer — the 5 things you need to bill Actemra (J3262)

HCPCS
J3262
1 unit = 1 mg
RA dose (4 mg/kg, 70 kg)
280 units
~3.5 vials · q4wk
Modifier
JZ · JW
JW common (weight-based)
Admin CPT
96365 + 96366
Non-chemo IV (NOT 96413)
Medicare ASP+6%
$5.530
per 1 mg unit, Q2 2026 · ~$1,548/280 mg
HCPCS descriptor
J3262 — "Injection, tocilizumab, 1 mg" 1 mg / unit
Family codes
J3262 Actemra IV (Genentech) · Q5135 Tofidence (tocilizumab-bavi, Biogen) · Tyenne (tocilizumab-aazg, Fresenius Kabi) — verify HCPCS · Avtozma (tocilizumab-anoh, Celltrion) — verify HCPCS
Indications (J3262)
RA, polyarticular JIA, systemic JIA, GCA, CAR-T-induced CRS (severe/life-threatening), hospitalized COVID-19, SSc-ILD (some IV use)
SC formulation
NOT under J3262. Actemra SC prefilled syringe (PFS) and ACTPen are dispensed via specialty pharmacy by NDC.
Lead NDC (Actemra)
50242-135-01 (80 mg) / 50242-136-01 (200 mg) / 50242-137-01 (400 mg) — Genentech labeler 50242
Vials
80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL single-dose vials (20 mg/mL concentration)
Route
Intravenous infusion over 60 minutes (J3262 + biosimilars)
Benefit channel
Medical (provider buy-and-bill) for IV; pharmacy benefit for SC self-injection
FDA boxed warning
Serious infections — TB (active + latent), invasive fungal, bacterial sepsis, viral, opportunistic. TB screening required pre-therapy.
⚠️
FDA BOXED WARNING — Serious infections. Tocilizumab can cause TB reactivation, invasive fungal infection (candidiasis, aspergillosis, pneumocystis), bacterial sepsis, viral reactivation, and other opportunistic infections leading to hospitalization or death. TB screening (IGRA or PPD) is required before initiation. Treat latent TB before starting therapy. See boxed warning & monitoring.
ℹ️
Tocilizumab biosimilar landscape is evolving (May 2026). Tofidence (Q5135) is permanent; Tyenne (Fresenius Kabi) and Avtozma (Celltrion) are newer — verify their current HCPCS at billing time. New biosimilars sometimes use J3490 or C9399 (NOC) until permanent Q-codes are assigned. Note: Q5142 is Simlandi (adalimumab) — not a tocilizumab code. See the biosimilar table.
⚠️
Tocilizumab is non-chemo — use 96365/96366, NOT 96413/96415. Tocilizumab is a non-cytotoxic biologic (IL-6 receptor antagonist). The standard 60-minute infusion uses 96365 alone. Billing chemotherapy admin codes is a denial trigger and a coding compliance issue.
ℹ️
IV vs. SC disambiguation. J3262 covers only the intravenous Actemra vials. The Actemra SC prefilled syringe (162 mg/0.9 mL) and the ACTPen autoinjector are dispensed through specialty pharmacy under the pharmacy benefit and are billed by NDC, not by J-code. See IV vs. SC channel.
Phase 1 Identify what you're billing Reference J3262 plus an evolving biosimilar field. Confirm code, dose, and channel before billing.

Tocilizumab biosimilars — verify HCPCS at billing time CMS HCPCS + FDA verified May 2026

Tofidence (Q5135) is permanent; Tyenne and Avtozma are newer and may temporarily bill under NOC codes (J3490 / C9399) until permanent Q-codes are assigned.

Tocilizumab products with HCPCS, manufacturer, FDA approval status, and Q2 2026 ASP+6% where assigned.
HCPCSBrandMfrStatusQ2 2026 ASP+6% / 1 mg
J3262 Actemra (tocilizumab) Genentech (Roche) Reference product $5.530
Q5135 Tofidence (tocilizumab-bavi) Biogen FDA-approved biosimilar (permanent code, eff. 2024) verify
Verify Tyenne (tocilizumab-aazg) Fresenius Kabi FDA-approved biosimilar (newer; HCPCS may be NOC initially) verify
Verify Avtozma (tocilizumab-anoh) Celltrion FDA-approved biosimilar (newest; HCPCS may be NOC initially) verify
Verify current HCPCS for Tofidence, Tyenne, and Avtozma at billing time. HCPCS Q-code assignment for new biosimilars typically lags FDA approval by 6–12 months. Until a permanent code is assigned, claims may use J3490 (unclassified drug) or C9399 (unclassified drug, hospital outpatient) with the NDC and dose documented. Note that Q5142 = Simlandi (adalimumab), not a tocilizumab code — do not use Q5142 for any tocilizumab product.

All tocilizumab products carry the same FDA boxed warning for serious infections (TB, invasive fungal, bacterial, viral, opportunistic). TB screening pre-therapy is required regardless of brand. Hepatitis B serology is recommended due to HBV reactivation risk.

IV vs. SC channel — J3262 covers IV only FDA labels verified 2025–2026

The Actemra subcutaneous prefilled syringe and ACTPen are not billed under J3262 — they go through specialty pharmacy under the pharmacy benefit by NDC.

Intravenous Actemra versus subcutaneous Actemra: code, channel, dispensing, and indications.
Actemra IV (J3262)Actemra SC (PFS / ACTPen)
RouteIntravenous infusion (60 min)Subcutaneous self-injection
HCPCSJ3262 — "Injection, tocilizumab, 1 mg"NOT under J3262. Billed by NDC under pharmacy benefit.
Benefit channelMedical (provider buy-and-bill)Pharmacy (specialty pharmacy dispense)
Strengths / vials80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL SDV (20 mg/mL)162 mg/0.9 mL prefilled syringe; 162 mg ACTPen autoinjector
Approved indicationsRA, PJIA, SJIA, GCA (IV q4wk available), CRS (CAR-T), COVID-19 (hospitalized), SSc-ILD (some IV use)RA, GCA (preferred), SSc-ILD, PJIA / SJIA select dosing
Frequencyq4wk (RA, PJIA, GCA), q2wk (SJIA), single dose (CRS, COVID)Weekly or every other week per indication
Practice impactInfusion suite buy-and-bill economics; weight-based dosing → JW commonSpecialty pharmacy ships direct to patient; no medical-benefit billing
Common error: billing J3262 for an SC prefilled syringe or ACTPen administered in an office setting. SC tocilizumab is a pharmacy-benefit product. If a practice administers the SC product as an in-office service (rare), the visit is typically billed only as an E/M plus 96372 (therapeutic SC injection); the drug itself is patient-supplied via specialty pharmacy.

Dosing matrix per FDA-approved indication FDA Actemra label + ACR / NCCN / NIH guidelines

Six approved indications, each with its own dosing logic. All weight-based regimens trigger partial-vial waste — expect JW.

Tocilizumab IV dosing per FDA-approved indication including age and weight bands.
IndicationPatient populationDoseFrequency / max
RA Adults 4 mg/kg (may escalate to 8 mg/kg based on response) q4wk · max 800 mg per dose
Polyarticular JIA (PJIA) ≥ 2 yr, < 30 kg 10 mg/kg q4wk
Polyarticular JIA (PJIA) ≥ 2 yr, ≥ 30 kg 8 mg/kg q4wk
Systemic JIA (SJIA) ≥ 2 yr, < 30 kg 12 mg/kg q2wk
Systemic JIA (SJIA) ≥ 2 yr, ≥ 30 kg 8 mg/kg q2wk
Giant cell arteritis (GCA) Adults SC 162 mg weekly preferred; IV q4wk available (per label, in combination with tapering glucocorticoids) q4wk IV (when used)
CAR-T-induced CRS Adults & pediatric ≥ 2 yr 8 mg/kg IV (12 mg/kg if < 30 kg per CRS protocol) Single dose · may repeat q8h up to 4 doses · max 800 mg/dose
COVID-19 (hospitalized) Adults & pediatric ≥ 2 yr requiring supplemental O₂ / MV / ECMO + corticosteroids 8 mg/kg IV Single dose · max 800 mg
SSc-ILD Adults Generally SC 162 mg weekly; some IV use per protocol Weekly SC
Unit conversion shortcut: mg = units (1 unit = 1 mg). Worked examples:
  • RA 4 mg/kg × 70 kg = 280 mg = 280 units
  • RA escalated 8 mg/kg × 70 kg = 560 mg = 560 units
  • SJIA 12 mg/kg × 25 kg = 300 mg = 300 units
  • CRS / COVID 8 mg/kg @ 100 kg, capped = 800 mg = 800 units
Premedications. Routine tocilizumab IV does not require mandatory premedication per the FDA label, but many practices use diphenhydramine + acetaminophen if prior infusion-reaction history. Patients on chronic glucocorticoids (especially for GCA) continue per the prescribed taper. CRS and COVID patients are typically already receiving corticosteroids per protocol.

NDC reference — Actemra IV vials FDA NDC Directory verified May 2026

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

Actemra (J3262) — Genentech labeler 50242

NDC (10-digit)NDC (11-digit, claim form)Package
50242-135-0150242-0135-0180 mg / 4 mL single-dose vial
50242-136-0150242-0136-01200 mg / 10 mL single-dose vial
50242-137-0150242-0137-01400 mg / 20 mL single-dose vial

Tofidence (Q5135) — Biogen / Bio-Thera

Verify current Tofidence labeler and packaging NDCs at billing time. Strengths mirror Actemra (80, 200, 400 mg SDV at 20 mg/mL).

Tyenne — Fresenius Kabi

Newer biosimilar. Verify HCPCS (may be NOC initially) and NDCs at billing time.

Avtozma — Celltrion

Newest biosimilar (FDA approved 2024–2025). Verify HCPCS and NDCs at billing time.

11-digit NDC required on most claim forms. Pad the labeler-product-package segments to 5-4-2. Example: Actemra 200 mg 50242-136-0150242-0136-01. Use N4 qualifier in CMS-1500 Box 24A shaded area with unit of measure (ML) and quantity actually drawn from the vial.
Phase 2 Code the claim Therapeutic IV admin (96365) only — tocilizumab is non-chemo. JZ + JW per CMS rules.

Administration codes CPT verified May 2026

Tocilizumab is a non-cytotoxic biologic IL-6 receptor antagonist. Use therapeutic infusion codes (96365/96366), not chemotherapy codes (96413/96415).

CPTDescriptionUse for
96365 Therapeutic, prophylactic or diagnostic IV infusion; up to 1 hour Standard for J3262 IV. Actemra infusion is 60 min — 96365 alone covers most cases.
96366 Therapeutic IV infusion; each additional hour Rare for tocilizumab (60-min infusion). Add only if infusion extends beyond 60 min.
96413 Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance Not appropriate. Tocilizumab is non-cytotoxic. Billing 96413 is a denial trigger.
96415 Chemotherapy administration, IV infusion technique; each additional hour Not appropriate. Same as 96413 above.
96372 Therapeutic SC injection For office-administered SC tocilizumab (drug supplied by patient via specialty pharmacy — rare)

First-dose administration setting

Tocilizumab does not carry the same hospital-outpatient mandate that some IL-6 / monoclonal-antibody infusions do. Most RA, PJIA, SJIA, and GCA patients receive Actemra in an office (POS 11) or ambulatory infusion center (POS 49). CRS is by definition inpatient (POS 21 or hospital outpatient at the CAR-T center). Hospitalized COVID-19 dosing is inpatient.

Modifiers — JZ, JW, and weight-based waste CMS verified May 2026

All Actemra vials are single-dose. Weight-based dosing means partial-vial waste is the rule, not the exception.

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 tocilizumab, JZ would apply only when the calculated dose exactly matches the vial set drawn (rare with weight-based dosing). The 800 mg cap (CRS / COVID / max RA escalation) hits exactly two 400 mg vials — a JZ scenario.

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

Because almost every tocilizumab indication uses weight-based mg/kg dosing (4, 8, 10, or 12 mg/kg), the calculated dose rarely matches an integer combination of 80, 200, and 400 mg vials. CMS requires the JW modifier on a separate claim line for the discarded units (rounded per CMS rules), with wastage documented in the medical record. Bill administered units (with JZ) and discarded units (with JW) on two separate lines, same date of service.

Worked JW example — Actemra IV, RA, 4 mg/kg @ 70 kg:
Calculated dose: 4 mg/kg × 70 kg = 280 mg Vials drawn: 1 × 200 mg + 1 × 80 mg = 280 mg total Administered: 280 mg Discarded: 0 mg (exact match!) Convert to units (1 unit = 1 mg): Administered units: 280 Discarded units: 0 Claim line: Line 1: J3262 · JZ · 280 units (administered, no waste)
Worked JW example — Actemra IV, RA, 4 mg/kg @ 75 kg: Calculated dose: 4 mg/kg × 75 kg = 300 mg Vials drawn: 1 × 200 mg + 2 × 80 mg = 360 mg OR 1 × 400 mg = 400 mg Choosing 1x400 mg vial (less manipulation): Administered: 300 mg Discarded: 400 − 300 = 100 mg Convert to units (1 unit = 1 mg): Administered units: 300 Discarded units: 100 Claim lines: Line 1: J3262 · JZ · 300 units (administered) Line 2: J3262 · JW · 100 units (discarded)

Apply each MAC’s rounding convention. Vial selection should minimize total waste and document why the chosen combination was used. Refer to your local MAC billing article for the exact rounding rule.

JG / TB — 340B drug pricing

Hospitals that purchase tocilizumab through 340B and bill Medicare report the JG modifier (acute-care hospitals) or TB modifier (rural sole community / critical-access hospitals), per CMS guidance.

Modifier 25 — same-day E/M

Append modifier 25 to the same-day E/M code if a significant, separately identifiable evaluation occurred (DAS-28 reassessment for next-cycle decision in RA, GCA flare 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. Each FDA indication has a distinct code family.

IndicationICD-10 familyExamples
RA — w/ rheumatoid factor M05.x M05.79 (RA w/ RF, multi-site, w/o organ involvement); M05.9 (RA w/ RF, unspec)
RA — w/o rheumatoid factor M06.x M06.09 (RA w/o RF, multi-site); M06.9 (RA, unspec)
Polyarticular JIA / Systemic JIA M08.x M08.00 (PJIA, unspec site); M08.20 (SJIA, unspec site); M08.3 (juvenile polyarthritis seronegative)
Giant cell arteritis (GCA) M31.6 M31.6 (other giant cell arteritis); M31.5 (giant cell arteritis with polymyalgia rheumatica)
CAR-T cytokine release syndrome T80.89XA T80.89XA (other complications following infusion / transfusion / therapeutic injection, initial); D89.83x (cytokine release syndrome)
COVID-19 (hospitalized) U07.1 U07.1 (COVID-19, virus identified); pair with respiratory failure / pneumonia codes (J96.0x, J12.82)
Systemic sclerosis (SSc-ILD) M34.x + J84.10 M34.0 (progressive systemic sclerosis); M34.1 (CR(E)ST); J84.10 (interstitial lung disease, unspec)
Pair the diagnosis with the right product channel. J3262 (IV) covers the full Actemra indication panel. For SC-only indications (chronic GCA, SSc-ILD weekly maintenance), the pharmacy benefit and SC NDC apply — do not bill J3262 in those cases.

Site of care & place of service Verified May 2026

RA, PJIA, SJIA, GCA infusions move easily to office or AIC. CRS and COVID dosing is inpatient.

SettingPOSClaim formElectronicTypical use
Physician office / infusion suite11CMS-1500837PRA, PJIA, GCA chronic dosing — payer-preferred
Ambulatory infusion center (AIC)49CMS-1500837PRA, PJIA, GCA — payer-preferred site post cycle 1
On-campus hospital outpatient22UB-04 / CMS-1450837ISJIA pediatric infusions; first-dose with reaction history
On-campus hospital outpatient (alt)19UB-04 / CMS-1450837IHospital-affiliated rheumatology
Inpatient hospital21UB-04 / CMS-1450837ICRS, COVID-19 hospitalized, severe RA flare — bundled into DRG

Payer site-of-care steering

UnitedHealthcare, Aetna, Cigna, and most BCBS plans apply site-of-care UM to specialty infusion drugs. For chronic Actemra (RA, PJIA, GCA), payers typically require dosing at office (POS 11) or in-network AIC (POS 49) where facility fees are lower. The 60-minute Actemra infusion fits these sites cleanly. Hospital outpatient (POS 19/22) is generally limited to first-dose with reaction history or pediatric SJIA scenarios where a tertiary-center setting is medically necessary.

POS choice affects total reimbursement. Office (POS 11) and AIC (POS 49) generally pay the drug at the physician fee schedule with separate admin codes; hospital outpatient (POS 19/22) bills under OPPS/APC packaging with separate facility-fee considerations. Inpatient (POS 21) tocilizumab is bundled into the DRG — no separate J3262 charge to Medicare Part B for hospitalized CRS or COVID.

Claim form field mapping Genentech billing PDF + payer guides

CMS-1500 / 837P (physician office, AIC; POS 11/49) example for a 280 mg RA dose of J3262.

InformationCMS-1500 boxNotes
NDC qualifier + 11-digit NDC + UoM + qty24A shaded areaFormat: N450242013601ML10.0 for one 200 mg vial; one line per NDC drawn
HCPCS J3262 + JZ24D (drug line)280 mg = 280 units; JZ when no waste (exact-match dose)
HCPCS J3262 + JW (when waste)24D (separate line)Discarded units (per weight-based dosing & vial choice)
Drug units24G280 (or split: administered + waste)
CPT 96365 (+ 96366 if >1 hr)24D (admin lines)1 unit 96365 covers 60-min infusion; add 96366 only if extended
ICD-1021Indication-specific (M05.x, M06.x, M08.x, M31.6, T80.89XA, U07.1, M34.x)
Dates of service24ASame date for drug + admin lines
NPI17b / 24J / 33aRendering and billing provider NPI
PA number (when required)23Required by UHC, Aetna, Cigna, most BCBS for chronic-use indications (RA, GCA, JIA)
JG / TB modifier (340B sites only)24DHospital outpatient 340B claims only

Source: Genentech Actemra Billing & Coding Brochure; payer-specific medical policy documents.

Phase 3 Get paid Step therapy from TNFi for RA new starts is the dominant UM lever. Biosimilar steerage emerging.

Payer policy snapshot — tocilizumab UM 2026 Reviewed May 2026

RA new starts almost universally require step therapy from a TNF inhibitor. CRS and COVID inpatient indications generally bypass PA because the drug is hospital-billed under DRG.

Tocilizumab prior-authorization, step-therapy, and biosimilar-preference policies at major commercial payers as of May 2026.
PayerPA?Step therapy (RA)Biosimilar steerageCRS / COVID inpatient
UnitedHealthcare commercial
Tocilizumab medical drug policy
Yes Yes — TNFi failure required for RA new starts Tofidence (Q5135) trending preferred No PA — hospital DRG
Aetna commercial
Pharmacy CPB
Yes Yes — TNFi failure for RA Biosimilar-preferred trending No PA — hospital DRG
Cigna commercial
Tocilizumab coverage policy
Yes Yes — TNFi failure for RA Biosimilar-preferred trending No PA — hospital DRG
BCBS (most plans)
Plan-by-plan
Yes TNFi step common; verify plan Biosimilar trending; verify plan No PA — hospital DRG
CVS Cordavis / ESI Quallent
Private-label biosimilar programs
n/a (drug source) n/a Yes — may steer to Tofidence (Q5135) or other biosimilar n/a
RA step therapy is the most common Actemra denial reason. Most payers require documented failure of, intolerance to, or contraindication to at least one TNF inhibitor (adalimumab, etanercept, infliximab, golimumab, certolizumab) before approving tocilizumab for RA. Submit clinical notes showing objective measures (DAS-28, CDAI, swollen-joint count) before and after the TNFi trial.

2026 trend — biosimilar steerage

Tofidence (Q5135) launched in 2024 as the first tocilizumab biosimilar; Tyenne and Avtozma have since added competition. CVS Cordavis and ESI Quallent — the private-label biosimilar arms of CVS Health and Express Scripts — are increasingly steering practices to biosimilar tocilizumab. Expect formal biosimilar-preferred designations from major payers during 2026 as competition matures, mirroring the rituximab and trastuzumab biosimilar transitions of 2023–2025.

What to document for step-therapy approval

  • TNFi tried (drug name, HCPCS / NDC, dates of administration, dose)
  • Duration of trial (most policies: at least 3 months adequate dosing)
  • Documented inadequate response, intolerance, or contraindication (with objective measures: DAS-28, CDAI, CRP, ESR)
  • For GCA: glucocorticoid taper documentation; tocilizumab is steroid-sparing
  • For SJIA / PJIA: pediatric rheumatology consult notes, growth parameters, joint count

Medicare reimbursement CMS Q2 2026 (live)

Quarterly ASP from CMS Part B Drug Pricing File. J3262 refreshes every quarter; biosimilar ASPs (where assigned) refresh on the same cycle.

Q2 2026 payment snapshot — J3262 Actemra

Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions

ASP + 6%
$5.530
per 1 mg unit
280 mg dose (RA, 70 kg)
$1,548.40
280 units × ASP+6%
After sequestration
~$1,517
~2% reduction (actual paid)

Dose-band reimbursement at Q2 2026 ASP+6%

ScenarioDose (mg)UnitsReimbursement
RA 4 mg/kg @ 60 kg240240$1,327.20
RA 4 mg/kg @ 70 kg280280$1,548.40
RA 4 mg/kg @ 80 kg320320$1,769.60
RA escalated 8 mg/kg @ 70 kg560560$3,096.80
SJIA 12 mg/kg @ 25 kg child300300$1,659.00
CRS / COVID 8 mg/kg, capped800800$4,424.00

Annual reimbursement — chronic RA

At 4 mg/kg q4wk for a 70 kg patient (280 mg / dose, 13 doses / year), annual J3262 reimbursement is approximately $20,129 at Q2 2026 ASP+6%. Escalated 8 mg/kg dosing roughly doubles this. Biosimilar dispense (Tofidence Q5135 or other) is generally lower — verify current biosimilar ASP at billing time.

Coverage

No NCD specific to tocilizumab. Each MAC publishes a billing & coding article covering the drug with covered ICD-10 ranges per indication. All MACs cover J3262 for FDA-approved indications. CRS and COVID-19 inpatient dosing is bundled into the DRG — no separate Part B claim. Hospitalized COVID-19 use follows NIH treatment guidelines (8 mg/kg for hospitalized adults requiring O₂ / MV / ECMO with corticosteroids).

Canonical code source: CMS HCPCS quarterly update file.

Patient assistance — per manufacturer Manufacturer sites verified May 2026

  • Actemra (J3262, Genentech):
    • Genentech Access Solutions: 1-866-422-2377 — benefits investigation, PA support, appeals.
    • Actemra Co-pay Card: eligible commercially-insured patients, up to $25,000/year.
    • Genentech Patient Foundation: free drug for uninsured/underinsured (income-eligible).
    • Independent foundations (PAN, HealthWell) for Medicare patients — verify open funds quarterly.
  • Tofidence (Q5135, Biogen): Biogen Patient Support — benefits investigation, copay support for eligible commercially-insured patients, free-drug pathway for qualifying uninsured patients.
  • Tyenne (Fresenius Kabi): Fresenius Kabi Patient Support — manufacturer support program for eligible patients.
  • Avtozma (Celltrion): Celltrion patient support — verify program details at billing time as program is newer.
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance, and OOP max? Run a CareCost Estimate — J3262 (and Q5135) pre-loaded.
Phase 4 Fix problems Top three: chemo-vs-non-chemo admin code, missing JW on weight-based claims, RA step therapy not met.

Boxed warning & ongoing monitoring FDA Actemra label verified 2025–2026

FDA BOXED WARNING — Serious infections. Tocilizumab can cause active TB (reactivation of latent TB), invasive fungal infections (candidiasis, aspergillosis, pneumocystis, cryptococcus, histoplasmosis), bacterial sepsis, viral infections, and other opportunistic infections leading to hospitalization or death. Most serious infections occur in patients on concomitant immunosuppressants (e.g., methotrexate, corticosteroids).

Pre-therapy screening

  • TB screening required: interferon-gamma release assay (IGRA, e.g., QuantiFERON-TB Gold) or tuberculin skin test (PPD) before initiating tocilizumab.
  • Treat latent TB before starting Actemra. Continue TB-directed therapy concurrent with tocilizumab if active TB diagnosed during screening.
  • Hepatitis B serology: screen HBsAg and anti-HBc; consult hepatology for HBV-positive or occult-infected patients prior to starting due to HBV reactivation risk.
  • Lipid panel: baseline lipids; tocilizumab causes lipid elevations (total cholesterol, LDL, triglycerides).
  • CBC + LFTs: baseline neutrophil count, platelets, ALT, AST, total bilirubin.

Other significant warnings & precautions

  • GI perforation: reported in tocilizumab-treated patients, especially with diverticulitis history. Use caution and educate patients to report acute abdominal pain.
  • Hepatotoxicity: serious hepatic injury (some fatal, requiring transplant) reported. Monitor LFTs at baseline and every 4–8 weeks.
  • Laboratory abnormalities: neutropenia, thrombocytopenia, transaminitis, lipid elevations — monitor q4–8wk per label. Hold dose if ANC < 1,000 / mm³, platelets < 100,000 / mm³, or ALT/AST > 5× ULN.
  • Hypersensitivity / anaphylaxis: reported with IV and SC. Have resuscitation equipment available.
  • Demyelinating disorders: rare CNS demyelinating events reported.
  • Live vaccines: avoid concurrent live vaccines.
  • Pregnancy: limited data; pregnancy registry available.
Hold-dose criteria (per FDA label). Hold tocilizumab and reassess if: ANC drops below 1,000 / mm³; platelets drop below 100,000 / mm³; ALT/AST exceeds 5× ULN. Restart per label guidance once labs recover. Permanent discontinuation criteria are stricter (ANC < 500, platelets < 50,000, ALT/AST > 5× ULN with persistent elevation).

Common denials & how to fix them

Denial reasonCommon causeFix
Wrong admin code (96413/96415 instead of 96365/96366) Biller defaulted to chemo admin code; tocilizumab is non-cytotoxic biologic Resubmit admin lines as 96365 (and 96366 only if >1 hr). Tocilizumab is non-chemo.
Step therapy not met (RA new start) New RA start on J3262 without documented TNFi failure / intolerance / contraindication Submit TNFi trial documentation (drug, dates, dose, objective response measures) on appeal.
JZ missing Single-dose-vial claim without JZ when no drug was discarded Resubmit with JZ on the J3262 line (exact-match doses: 800 mg cap = 2×400 mg vials).
JW missing on weight-based claim Weight-based dose with vial waste not reported Add separate line with JW for discarded units (per CMS rounding); document waste in chart.
SC product billed under J3262 Actemra SC PFS or ACTPen billed on medical benefit Re-route to specialty pharmacy under pharmacy benefit. J3262 is IV-only.
Wrong J-code (J3262 instead of biosimilar) Reference Actemra billed when patient received Tofidence/Tyenne/Avtozma Verify drug administered. Match HCPCS to NDC drawn: Q5135 = Tofidence; verify Tyenne/Avtozma codes.
Q5142 used for tocilizumab Coder confused Q5142 (Simlandi adalimumab) with a tocilizumab biosimilar code Q5142 is NOT tocilizumab. Use Q5135 for Tofidence; verify current code for Tyenne / Avtozma.
TB screening not documented Audit-vulnerable; payer requests pre-treatment IGRA / PPD per FDA boxed warning Confirm pre-treatment IGRA / PPD result in chart; supply on appeal.
Site-of-care denial (HOPD) Chronic Actemra at hospital outpatient when payer requires office / AIC Move infusion to POS 11 or 49; or submit medical-necessity justification (rare).
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.
Duplicate billing — CRS / COVID inpatient Hospital billing J3262 to Part B when drug is bundled into inpatient DRG Inpatient tocilizumab is bundled. Do not file separate Part B claim.
ICD-10 mismatch Diagnosis does not match approved indication (e.g., M06.x for SJIA — should be M08.x) Re-verify diagnosis and resubmit with correct ICD-10 family for the indication.

Frequently asked questions

What is the HCPCS code for Actemra?

Intravenous Actemra (tocilizumab) is billed as J3262 — "Injection, tocilizumab, 1 mg." One billing unit equals 1 mg of drug. Q5135 is Tofidence (tocilizumab-bavi, Biogen), the first FDA-approved tocilizumab biosimilar (effective 2024). Tyenne (tocilizumab-aazg, Fresenius Kabi) and Avtozma (tocilizumab-anoh, Celltrion) are newer biosimilars — verify their current HCPCS at billing time, as new biosimilars may temporarily use J3490 / C9399 (NOC) until permanent Q-codes are assigned. The subcutaneous Actemra prefilled syringe and ACTPen are dispensed through specialty pharmacy and are NOT billed under J3262.

How many units of J3262 do I bill for a tocilizumab dose?

J3262 uses 1 unit = 1 mg. A 4 mg/kg dose for a 70 kg RA patient = 280 mg = 280 units. An 8 mg/kg CRS dose at the 800 mg cap = 800 units. A 12 mg/kg systemic JIA dose for a 25 kg child = 300 mg = 300 units. Because dosing is weight-based for almost every indication, partial-vial waste is the rule — expect to bill JZ on the administered units and JW on a separate line for discarded units.

What administration codes apply to Actemra?

Tocilizumab is a non-cytotoxic biologic, so administration uses 96365 (therapeutic IV infusion, initial up to 1 hour) — not the chemotherapy codes 96413 / 96415. The standard Actemra IV infusion is 60 minutes, so 96366 (each additional hour) is rarely needed. Billing 96413/96415 for tocilizumab is a denial trigger and a coding compliance issue.

What is the Q2 2026 Medicare reimbursement for J3262 Actemra?

Q2 2026 ASP + 6% for J3262 (Actemra reference) is approximately $5.530 per 1 mg unit. A 4 mg/kg RA dose for a 70 kg patient (280 mg) reimburses ~$1,548. The 800 mg single-dose CRS or COVID-19 administration reimburses ~$4,424. Annual RA at q4wk dosing is ~$20,129 per 70 kg patient. Biosimilar pricing (Q5135 Tofidence and others) is generally lower — see the live snapshot.

Are Actemra biosimilars interchangeable?

Tofidence (tocilizumab-bavi, Q5135), Tyenne (tocilizumab-aazg), and Avtozma (tocilizumab-anoh) are FDA-approved biosimilars to Actemra. Each is approved separately and has its own HCPCS code (verify Tyenne and Avtozma codes at billing time — new biosimilars may temporarily use NOC codes). FDA interchangeability designation is not automatic — pharmacy/infusion-center substitution depends on FDA labeling and state law. Payers including CVS Cordavis and ESI Quallent are increasingly steering to biosimilar tocilizumab in 2026.

Is the Actemra subcutaneous form billed under J3262?

No. The Actemra subcutaneous prefilled syringe (162 mg/0.9 mL PFS) and the ACTPen autoinjector are dispensed through specialty pharmacy under the pharmacy benefit, not the medical benefit. They are billed by NDC, not by J-code, and J3262 applies only to intravenous administration. Practices providing only IV Actemra need not address the SC channel; coordination is required when patients transition from IV (often initial GCA or RA induction) to SC self-injection.

Why is TB screening required before starting Actemra?

All tocilizumab products carry an FDA boxed warning for serious infections, including TB reactivation, invasive fungal infections (candidiasis, aspergillosis), bacterial sepsis, viral infections, and other opportunistic infections. The Actemra label requires TB screening (interferon-gamma release assay or tuberculin skin test) before starting therapy. Patients with latent TB must complete treatment before initiating tocilizumab. Hepatitis B serology is also recommended due to HBV reactivation risk.

How does Actemra dosing differ across indications?

Adult RA: 4 mg/kg q4wk (may escalate to 8 mg/kg q4wk, max 800 mg). Polyarticular JIA (≥ 2 yr): 10 mg/kg q4wk if < 30 kg, 8 mg/kg q4wk if ≥ 30 kg. Systemic JIA (≥ 2 yr): 12 mg/kg q2wk if < 30 kg, 8 mg/kg q2wk if ≥ 30 kg. GCA: SC 162 mg weekly is preferred; IV q4wk is available. CRS (CAR-T cytokine release syndrome): 8 mg/kg IV (max 800 mg), may repeat q8h up to 4 doses. COVID-19 (hospitalized requiring supplemental O₂ / MV / ECMO + corticosteroids): 8 mg/kg IV (max 800 mg) single dose. SSc-ILD: generally SC; some IV use.

What payer step-therapy applies to Actemra in 2026?

Most major payers (UnitedHealthcare, Aetna, Cigna, BCBS) require prior authorization plus step therapy from a TNF inhibitor for RA new starts. Biosimilar substitution policies are emerging in 2026 — CVS Cordavis and ESI Quallent are private-label biosimilar programs that may steer to Tofidence or Tyenne. CRS and COVID-19 inpatient indications generally do not require PA because the drug is hospital-billed under the inpatient DRG. Verify each payer’s medical drug policy before scheduling chronic-use patients.

Reference Sources & methodology Every claim on this page is sourced. Methodology and review history below.

Source documents

  1. AAPC — HCPCS J3262 (Actemra / tocilizumab)
    Code descriptor and crosswalk reference
  2. AAPC — HCPCS Q5135 (Tofidence / tocilizumab-bavi)
    Biosimilar code descriptor (Biogen)
  3. FDA Actemra (tocilizumab) label
    Reference tocilizumab prescribing information; boxed warnings; indication panel; dosing per indication
  4. Genentech — Actemra prescribing information
    Full label including TB screening, hepatic monitoring, GI perforation precautions
  5. Genentech — Actemra Billing & Coding resources (HCP)
    CMS-1500 field guidance; admin code clarification (96365 non-chemo)
  6. Genentech Access Solutions — Actemra
    Co-pay program (up to $25,000/yr); Patient Foundation; benefits investigation; 1-866-422-2377
  7. Biogen — Tofidence (tocilizumab-bavi)
    First FDA-approved tocilizumab biosimilar (Q5135); manufacturer support
  8. Fresenius Kabi — Tyenne (tocilizumab-aazg)
    Tocilizumab biosimilar; verify HCPCS at billing time
  9. Celltrion — Avtozma (tocilizumab-anoh)
    Tocilizumab biosimilar; verify HCPCS at billing time
  10. UnitedHealthcare — Tocilizumab Commercial Medical Drug policy
    RA step therapy (TNFi); biosimilar trend; site-of-care UM
  11. Aetna — Tocilizumab CPB
    Step therapy criteria; covered indications; documentation requirements
  12. ACR — Rheumatoid Arthritis & JIA Treatment Guidelines
    RA, polyarticular JIA, systemic JIA treatment recommendations
  13. NCCN — CAR-T Cell-Related Toxicities (Cytokine Release Syndrome)
    Tocilizumab dosing for CRS grade 2–4; repeat-dose protocol
  14. NIH COVID-19 Treatment Guidelines — Tocilizumab
    Hospitalized COVID-19 dosing; eligibility (O₂/MV/ECMO + corticosteroids)
  15. CMS — Medicare Part B Drug ASP Pricing File
    Q2 2026 quarterly file (J3262, Q5135)
  16. CMS — HCPCS quarterly update file
    Canonical HCPCS code source for tocilizumab family
  17. 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 tocilizumab IV family. Medicare ASP pricing for J3262 (and Q5135 Tofidence where assigned) 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, biosimilar approval, or major payer policy changes.

Found an error? Email hello@carecostestimate.com.

Refresh cadence

ElementCadenceHow it's refreshed
Medicare ASP pricing (J3262, Q5135)QuarterlyAuto-bound to CareCost ASP layer; updates on CMS file release.
Payer policies (UHC, Aetna, Cigna, BCBS)Semi-annualManual review against published payer policy documents; biosimilar designations re-checked annually at year-start.
HCPCS / CPT / NCCI rulesAnnualReviewed against CMS HCPCS quarterly files, AMA CPT releases, and NCCI edit updates.
Biosimilar HCPCS assignmentsEvent-drivenTracked at FDA approval and CMS code publication; verify at billing time for new biosimilars.
NDC, dosing, FDA labelEvent-drivenTied to FDA label revision date and manufacturer document version.

Reviewer

Pending SME review. This page is staff-authored from primary sources (FDA Actemra label, CMS, Genentech billing PDFs and Access Solutions materials, ACR rheumatology guidelines, NCCN CAR-T toxicity management guidance, NIH COVID-19 treatment guidelines, and payer policies — all linked above). Editorial review in progress. Until that review is complete, treat this as a draft reference and verify each cited source for high-stakes claims — especially biosimilar HCPCS assignments for Tyenne and Avtozma, which are still evolving.

Change log

  • — Initial publication of the tocilizumab IV family reference. ASP data: Q2 2026 (J3262 live; Q5135 verify). Indication coverage: RA, PJIA, SJIA, GCA, CRS (CAR-T), COVID-19 (hospitalized), SSc-ILD. Biosimilar coverage: Tofidence (Q5135) permanent; Tyenne and Avtozma flagged "verify HCPCS." Payer policies: UHC commercial, Aetna CPB, Cigna, BCBS step therapy from TNFi for RA. CVS Cordavis and ESI Quallent biosimilar steerage noted.

Methodology

Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File for J3262 and Q5135. Payer policies are read directly from each payer’s published medical policy documents. We do not paraphrase from billing-software vendor blogs. When the FDA label and clinical guidelines provide different dosing detail (e.g., GCA preferring SC 162 mg weekly while the IV q4wk option remains available), we surface both rather than picking a side.

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