What is the Gazyva dosing for CLL 1L (with chlorambucil)?

Per FDA label (CLL11 regimen): Cycle 1 Day 1 = 100 mg IV; Cycle 1 Day 2 = 900 mg IV (split first dose to mitigate infusion reactions; Days 1 and 2 may be combined into a single 1,000 mg Day 1 infusion in some protocols); Cycle 1 Days 8 and 15 = 1,000 mg IV each; Cycles 2 through 6 Day 1 = 1,000 mg IV. Total = 6 cycles of 28 days each, in combination with chlorambucil. Total Gazyva billable units across the regimen: ~800 units (8,000 mg).

What is the Gazyva dosing for follicular lymphoma (FL)?

Per FDA label (GADOLIN regimen for rituximab-refractory FL): Induction Cycle 1 Days 1, 8, 15 = 1,000 mg IV each; Cycles 2–6 Day 1 = 1,000 mg IV every 28 days, in combination with bendamustine. Maintenance: 1,000 mg IV every 2 months for up to 2 years in patients who achieve at least stable disease. The GALLIUM regimen (untreated FL) uses Gazyva 1,000 mg IV with CHOP/CVP/bendamustine for 6–8 cycles followed by maintenance every 2 months for up to 2 years.

What administration CPT codes do I use for Gazyva?

CPT 96413 ('Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug') plus 96415 ('each additional hour') based on actual infusion duration. First infusion (~4 hours for the 1,000 mg dose): 96413 + 96415 × 3. Subsequent infusions (~90 min if tolerated): 96413 + 96415 × 1. Some commercial payers will accept 96365/96366 (therapeutic IV, non-chemo) but Medicare and most major payers expect chemo admin codes for anti-CD20 monoclonal antibody therapy — verify per payer.

What is the Q2 2026 Medicare reimbursement for J9301?

Q2 2026 ASP + 6% for J9301 is $81.806 per 10 mg unit. A standard 1,000 mg dose = 100 units × $81.806 = $8,180.60 (drug only, before ~2% sequestration). A complete 6-cycle CLL 1L course (~8,000 mg total) reimburses approximately $65,444.80 in drug cost before sequestration. ASP refreshes quarterly — see the live snapshot below for the current quarter's value.

Gazyva (J9301) Billing & Coding Guide | Obinutuzumab

Phase 1 Identify what you're billing Confirm Gazyva (J9301) vs Rituxan (J9312) and the correct indication regimen first.

About Gazyva (obinutuzumab) FDA label + Genentech PI 2025–2026

Glycoengineered Type II humanized anti-CD20 monoclonal antibody from Genentech (Roche). Designed for enhanced ADCC vs first-generation anti-CD20s.

Gazyva (obinutuzumab) is a glycoengineered Type II humanized anti-CD20 monoclonal antibody manufactured by Genentech, a member of the Roche Group. The afucosylated Fc region produces enhanced antibody-dependent cellular cytotoxicity (ADCC) and lower complement-dependent cytotoxicity (CDC) than first-generation CD20s such as Rituxan (rituximab). The mechanistic difference translated into superior progression-free survival in the pivotal CLL11 trial (Gazyva + chlorambucil vs Rituxan + chlorambucil in untreated CLL), which is why CLL 1L is a Gazyva indication and not a Rituxan indication. The brand is billed under HCPCS J9301 at one billable unit per 10 mg administered — a 1,000 mg flat dose therefore equals 100 units on the claim.

FDA approval history: November 1, 2013 for chronic lymphocytic leukemia (CLL) in combination with chlorambucil for previously untreated patients (CLL11 trial); February 26, 2016 for follicular lymphoma (FL) in combination with bendamustine followed by Gazyva monotherapy maintenance for patients who relapsed after or are refractory to a rituximab-containing regimen (GADOLIN trial); November 16, 2017 for previously untreated stage II bulky, III, or IV FL in combination with chemotherapy followed by Gazyva monotherapy maintenance (GALLIUM trial). Effective December 15, 2023, the Columvi (glofitamab) FDA label added Gazyva as a mandatory Day -7 pretreatment for relapsed/refractory DLBCL to deplete circulating CD20+ B-cells before Columvi step-up dosing.

Gazyva is supplied in a single SKU: a 1,000 mg / 40 mL (25 mg/mL) single-dose vial (NDC 50242-070-01). One vial matches the standard 1,000 mg flat dose exactly — no partial-vial waste in routine practice, so the JZ modifier is the default and JW does not apply for the standard 1,000 mg dose. The CLL Cycle 1 split-dose pattern (100 mg Day 1 + 900 mg Day 2) is the only routine scenario where a single vial spans two encounters; both encounters still draw from one vial so JW is not billable across the cycle. The drug carries two FDA Boxed Warnings: hepatitis B virus reactivation (HBsAg + anti-HBc screening required before initiation) and progressive multifocal leukoencephalopathy (PML) from JC virus.

CD20 class — J9301 (Gazyva) vs J9312 (Rituxan) CMS HCPCS + FDA verified May 2026

Both target CD20 but use different antibody engineering, carry different labels, and bill under distinct HCPCS codes. They are not interchangeable.

Gazyva and Rituxan share the CD20 target but represent two distinct antibody engineering approaches. Gazyva is a glycoengineered Type II humanized anti-CD20 with afucosylated Fc producing enhanced ADCC; Rituxan is a Type I chimeric anti-CD20. The mechanistic difference matters at the bedside (Gazyva has higher rates of grade 3+ first-infusion reactions, which is why premedication is mandatory at every infusion and the first infusion is given over 4+ hours) and at the claim form (different HCPCS codes, substantially different ASPs).

Side-by-side comparison of Gazyva (J9301) and Rituxan (J9312) billing and clinical parameters.
	Gazyva (J9301)	Rituxan (J9312)
HCPCS	`J9301` — "Inj, obinutuzumab, 10 mg"	`J9312` — "Inj, rituximab, 10 mg"
Class	Type II humanized anti-CD20 (glycoengineered, afucosylated)	Type I chimeric anti-CD20
Manufacturer	Genentech (Roche)	Genentech / Biogen
Unit basis	1 unit = 10 mg	1 unit = 10 mg
CLL 1L	Yes — with chlorambucil (CLL11)	No (off-label / non-preferred in 1L untreated CLL)
Follicular lymphoma	Yes — untreated (GALLIUM) + rituximab-refractory (GADOLIN)	Yes (multiple FL regimens; biosimilar-preferred in 2026)
RA / GPA / MPA / PV	No	Yes (RA, GPA/MPA, PV)
DLBCL bispecific pretreatment	Yes — mandatory before Columvi (glofitamab)	No
Premedication	Mandatory at every infusion (corticosteroid + acetaminophen + antihistamine)	Mandatory at first infusion; may be tapered if tolerated
First infusion duration	~4 hours (titrated 50 → max 400 mg/hr)	~3–6 hours (titrated)
Boxed warnings	HBV reactivation, PML	HBV reactivation, PML, fatal infusion reactions, mucocutaneous reactions
ASP per 10 mg (Q2 2026)	$81.806	$74.158 (J9312); biosimilars from ~$13.69 (Q5119)
Biosimilars available?	No — single-source brand	Yes — Truxima (Q5115), Ruxience (Q5119), Riabni (Q5123)

Common error: Submitting J9312 (Rituxan) when Gazyva was actually administered, or vice versa. Both are 10 mg per unit but the brands, ASPs, and label indications differ. Reconcile chemo order, MAR, and pharmacy dispense record before posting the claim. For CLL 1L, J9301 is the expected code; submitting J9312 in untreated CLL will fail medical-necessity review on most plans.

No biosimilars for Gazyva. Unlike Rituxan (J9312), which has three FDA-approved biosimilars (Truxima Q5115, Ruxience Q5119, Riabni Q5123), obinutuzumab has no biosimilar or therapeutic equivalent as of May 2026. Genentech is the sole manufacturer. There is no payer step therapy through a Gazyva biosimilar because none exists.

Indication-specific roles — one drug, three billing patterns FDA label verified May 2026

Same drug and same HCPCS, but the indication determines the cycle structure, combo agent, and total exposure.

Gazyva use patterns by indication: CLL 1L, FL induction + maintenance, and Columvi pretreatment.
Indication	Combo agent	Cycle structure	Total Gazyva exposure
CLL 1L (untreated) CLL11 trial	Chlorambucil (oral, Days 1 + 15)	6 cycles × 28 days; C1 split dose (100 mg D1 + 900 mg D2) + D8 + D15; C2–C6 D1	~8 doses × 1,000 mg ≈ 8,000 mg (~800 units)
FL untreated (GALLIUM)	CHOP, CVP, or bendamustine	Induction 6–8 cycles; maintenance q2mo × 2 yr	Induction ~8,000 mg + maintenance ~12,000 mg (~2,000 units total)
FL rituximab-refractory (GADOLIN)	Bendamustine	Induction C1 D1/8/15 + C2–C6 D1 (each 1,000 mg); maintenance q2mo × 2 yr	Induction ~8,000 mg + maintenance ~12,000 mg (~2,000 units total)
Active lupus nephritis (NEW Oct 2025) REGENCY trial	Added to standard therapy (MMF + corticosteroids)	1,000 mg IV Day 1 and Day 15, then Month 6 (Day 168) and Month 12 (Day 350); 4 total doses over 12 months	4 doses × 1,000 mg = 4,000 mg (~400 units total)
Columvi pretreatment (DLBCL)	Columvi (glofitamab) cycles begin Day 1	Single dose Day -7 only (not repeated)	1 dose × 1,000 mg = 1,000 mg (100 units)

NEW indication — active lupus nephritis (October 2025). Gazyva's first non-oncology approval, based on the REGENCY phase 3 trial (Furie et al., NEJM 2025) showing superior complete renal response at week 76 when added to standard therapy (mycophenolate mofetil + corticosteroids) vs standard therapy alone in patients with active class III or IV lupus nephritis. The lupus regimen is substantially shorter than oncology dosing (4 total infusions over 12 months vs ~20 doses in FL induction + maintenance). Bill ICD-10 M32.14 (Glomerular disease in systemic lupus erythematosus). Payer coverage policies are still being updated; expect early PA submissions to require documentation of biopsy-proven class III/IV LN, prior or concurrent MMF + corticosteroid therapy, and the same CD20-class HBV serology screen.

Cross-link for DLBCL: If your patient is on Gazyva as a Columvi pretreatment (rather than CLL or FL therapy), see the Columvi (J9286) billing page for the complete bispecific regimen including step-up dosing and 12-cycle fixed duration. The Gazyva Day -7 infusion is billed as a separate same-week claim under J9301; the Columvi cycle begins seven days later under J9286.

Dosing & unit math FDA label + Genentech PI verified May 2026

Flat 1,000 mg dosing across indications. One 1,000 mg vial = exactly one dose, so JZ (no waste) is the default modifier.

CLL 1L regimen (with chlorambucil)

Cycle / Day	Gazyva dose	Units	Notes
C1 Day 1	100 mg IV	10 units	Slow ramp-up to mitigate IRR/CRS
C1 Day 2	900 mg IV	90 units	Remainder of first 1,000 mg dose (split D1/D2)
C1 Day 8	1,000 mg IV	100 units
C1 Day 15	1,000 mg IV	100 units
C2–C6 Day 1	1,000 mg IV each	100 units each	5 cycles × 1,000 mg = 5,000 mg / 500 units
Total CLL 1L course	8,000 mg	800 units	6 cycles × 28 days

Note: Some institutional protocols combine C1 Days 1 + 2 into a single 1,000 mg Day 1 infusion if the first 100 mg ramp is tolerated. Combined-dose practice is acceptable per FDA label as an alternative to the split.

FL induction (GADOLIN / GALLIUM patterns)

Cycle / Day	Gazyva dose	Units	Notes
C1 Day 1	1,000 mg IV	100 units	Slow titrated first infusion (4+ hr)
C1 Day 8	1,000 mg IV	100 units
C1 Day 15	1,000 mg IV	100 units
C2–C6 Day 1	1,000 mg IV each	100 units each	Each 28-day cycle (GADOLIN) or 21-day cycle (GALLIUM + CHOP); see protocol
Total FL induction	~8,000 mg	~800 units	Combined with bendamustine (GADOLIN) or CHOP/CVP/bendamustine (GALLIUM)

FL maintenance (responders to induction)

Gazyva 1,000 mg IV every 2 months for up to 2 years (12 maintenance doses) in patients with at least stable disease following induction. Each maintenance infusion bills as 100 units of J9301. Total maintenance exposure: ~12,000 mg / 1,200 units across 2 years.

Columvi pretreatment (single Day -7 dose)

For Columvi-treated relapsed/refractory DLBCL: single 1,000 mg IV Gazyva dose on Day -7 (7 days before Columvi Cycle 1 Day 1) — 100 units of J9301. Not repeated; the rest of the regimen is Columvi. See /drugs/columvi.

Worked example — standard 1,000 mg flat dose

# Calculate units Dose: 1,000 mg flat IV Units: 1,000 mg \div 10 mg/unit = 100 units Vials needed: 1 \times 1,000 mg vial = 1,000 mg drawn Discarded: 1,000 - 1,000 = 0 mg (no waste) # Drug claim line Line 1: J9301 \cdot 100 units \cdot modifier JZ (JW does NOT apply — one vial matches the dose exactly) # Admin claim lines (first infusion, ~4 hr) 96413 (chemo IV, initial up to 1 hr) \times 1 96415 (chemo IV, each additional hr) \times 3 # Drug reimbursement (Q2 2026) 100 units \times $81.806 = $8,180.60 (before ~2% sequestration)

Worked example — CLL Cycle 1 Day 1 (100 mg ramp-up)

# Calculate units Dose: 100 mg IV (10% of vial) Units: 100 mg \div 10 mg/unit = 10 units Vials opened: 1 \times 1,000 mg vial # Note on waste: Same vial may be reused for C1 Day 2 (900 mg) the next day per institutional pharmacy practice and FDA label storage allowance (2-8°C, 24 hr post-dilution). When vial is shared across two encounters within stability window, do not bill JW on Day 1 — the remaining 900 mg is administered on Day 2 and billed on the Day 2 claim. If vial is discarded after Day 1, bill 90 units of JW on the Day 1 claim and use a fresh vial Day 2. # Drug claim line (Day 1, vial shared scenario) Line 1: J9301 \cdot 10 units \cdot modifier JZ (no waste this encounter; remaining 900 mg pending Day 2)

JW edge case in CLL Cycle 1: The 100 mg + 900 mg split-dose pattern is the only routine Gazyva scenario where a single 1,000 mg vial spans two encounters. Pharmacy practice varies on whether the partially used vial is held for Day 2 (within label stability) or discarded. Confirm your institution's practice and document accordingly. For the simpler combined 1,000 mg Day 1 alternative, no JW question arises — one vial, one encounter, full dose.

NDC reference FDA NDC Directory verified May 2026

Gazyva NDC table with strength, package size, and units per vial.
NDC	Strength	Package Size	Units/Vial
`50242-070-01`	1,000 mg / 40 mL (25 mg/mL)	Single-dose vial — 1 vial per carton	100 units (1 unit = 10 mg)

Single SKU. Gazyva is supplied only as the 1,000 mg / 40 mL single-dose vial — there is no smaller-strength SKU. The 100 mg CLL Cycle 1 Day 1 ramp dose is drawn from the same 1,000 mg vial.

Use 11-digit carton NDC with N4 qualifier in 24A shaded area. Vial-level NDC format variants trigger denial. The N4 qualifier prefix is required on most commercial and Medicare claims.

Single-source product: No biosimilar or therapeutic equivalent for obinutuzumab as of May 2026. Genentech (Roche) is the sole manufacturer worldwide.

Phase 2 Code the claim Chemo admin codes with multiple 96415 add-ons for the 4-hour first infusion. JZ is the default modifier.

Administration codes CPT verified May 2026

Anti-CD20 monoclonal antibody therapy. Use chemo admin codes (96413 + 96415), not therapeutic infusion codes (96365/96366), for Medicare and most commercial payers.

Code	Description	When to use
`96413`	Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug	Primary code for Gazyva. Bill once per encounter as the initial infusion code.
`96415`	Chemotherapy administration, IV infusion; each additional hour (List separately)	First infusion (~4 hr): bill × 3. Subsequent infusion (~90 min if tolerated): bill × 1. Add per actual infusion hours after the initial 1-hour block.
`96417`	Chemo IV infusion, each additional sequential infusion (different drug)	For a second chemo agent in the encounter (e.g., bendamustine after Gazyva in FL combo). List separately from the Gazyva 96413.
`96365` / `96366`	Therapeutic IV infusion (non-chemo)	Some commercial payers will accept these for monoclonal antibody therapy; Medicare and most major payers expect chemo admin codes for anti-CD20. Verify per payer.

First infusion billing pattern (~4 hours): 96413 × 1 + 96415 × 3. The slow titrated rate (50 → 100 → 150 → max 400 mg/hr in 50 mg/hr increments q30 min) for a 1,000 mg dose typically lands the total infusion time at 3.75–4.25 hours; round up per CMS time rules (each 96415 unit covers an additional hour or fraction thereof beyond the initial 60 minutes).

Subsequent infusions (~90 minutes if tolerated): 96413 × 1 + 96415 × 1. Per FDA label, subsequent infusions in patients who tolerated the first without grade 3+ reaction may be initiated at 100 mg/hr and increased by 100 mg/hr every 30 minutes to max 400 mg/hr — total time typically ~90 minutes.

Premedication drug claim lines: Premed (dex 20 mg IV + diphenhydramine 50 mg IV + acetaminophen 650–1,000 mg PO) is mandatory at every Gazyva infusion per FDA label. Bill the IV premeds (J1100 dex, J1200 diphenhydramine) as separate same-day claim lines with their own admin codes (96372 IV push or included in the chemo session per payer); oral acetaminophen is not separately billable. Hold-and-recover documentation for any IRR/CRS during infusion supports payer audit defense.

Modifiers CMS verified May 2026

JZ — the default for Gazyva

Gazyva is supplied in a single 1,000 mg / 40 mL vial that matches the standard 1,000 mg flat dose exactly. Because the dose and the vial size are identical for the routine 1,000 mg infusion (CLL C1 Days 8/15 and all subsequent doses; FL induction every dose; FL maintenance every dose; Columvi pretreatment Day -7), there is no partial-vial waste and the JZ modifier applies on every claim. One of JZ or JW must be on every J9301 claim per CMS's July 2023 single-dose container policy.

JW — rarely applicable

JW reports discarded drug from a single-dose vial. For Gazyva, JW only becomes relevant in the CLL Cycle 1 Day 1 / Day 2 split-dose scenario if the vial is discarded after Day 1 rather than held for the next-day 900 mg administration. Most institutional pharmacies hold the partially used vial within the 2–8°C 24-hour stability window for the Day 2 administration — in that case, no JW is billed and the full 1,000 mg crosses two encounters with JZ on each (10 units D1 + 90 units D2). If your pharmacy practice discards the Day 1 vial, bill 90 units of J9301 with JW on the Day 1 claim.

Worked example — 1,000 mg flat dose, JZ line

# Standard 1,000 mg infusion (FL induction, CLL C1 D8, etc.) Dose: 1,000 mg from one 1,000 mg / 40 mL vial Units administered: 100 Units wasted: 0 # Drug claim line Line 1: J9301 \cdot 100 units \cdot modifier JZ (no JW line — vial matches dose exactly) # JZ-required statement (CMS July 2023) JZ certifies "no discarded amount from single-dose container" — required when no waste occurs.

Modifier 25 — same-day E/M

Use modifier 25 on the E/M code when a significant, separately identifiable evaluation and management service is performed on the same day as the infusion. Routine pre-infusion clinical assessment is bundled into the chemo admin code.

340B modifiers (JG, TB)

For 340B-acquired Gazyva, follow your MAC's current 340B modifier policy. Hospital outpatient departments billing under OPPS are subject to specific 340B reporting requirements; office-based 340B reporting varies by MAC.

ICD-10-CM by indication FY2026 verified May 2026

Use the most specific code supported by encounter documentation. CD20+ histology confirmation is required in chart for payer review.

Indication	ICD-10 family	Notes
CLL — unspecified site	`C91.10`	Chronic lymphocytic leukemia of B-cell type not having achieved remission
CLL — in remission	`C91.11`	Chronic lymphocytic leukemia of B-cell type in remission
CLL — in relapse	`C91.12`	Chronic lymphocytic leukemia of B-cell type in relapse
Follicular lymphoma	`C82.0x` – `C82.9x`	Grade I (C82.0x), II (C82.1x), III (C82.2x/C82.3x), unspecified (C82.9x); add 5th-character anatomic site (0–9 nodes)
DLBCL (Columvi pretreatment context)	`C83.30` – `C83.39`	Diffuse large B-cell lymphoma by anatomic site; relapsed/refractory documented in chart
Personal history of malignant lymphoma (maintenance)	`Z85.72`	For FL maintenance phase if active disease is in remission
Active lupus nephritis (NEW Oct 2025)	`M32.14`	Glomerular disease in systemic lupus erythematosus — class III/IV LN on biopsy required for PA
Other SLE manifestations (secondary, if present)	`M32.10`, `M32.11`–`M32.19`	Code additional SLE manifestations per documentation; M32.14 must be primary for the LN-indicated infusion
Antineoplastic therapy encounter (oncology indications only)	`Z51.11`	Secondary code on infusion encounter for CLL/FL/DLBCL — do NOT use Z51.11 for the lupus nephritis indication

CD20+ histology confirmation required. All major commercial payers require chart documentation of CD20+ tumor histology (flow cytometry or IHC) before approving Gazyva. The ICD-10 code alone is not sufficient. For FL rituximab-refractory indication (GADOLIN regimen), prior rituximab regimen and disease progression/refractoriness documentation are also required in the PA submission.

Site of care & place of service Verified May 2026

Gazyva is administered in oncology offices, ambulatory infusion centers, and hospital outpatient departments. Hospital outpatient (HOPD) is strongly preferred for the first infusion for severe infusion-reaction / CRS monitoring; the 4-hour titrated rate plus mandatory full premedication regimen places the first encounter outside what most office-based infusion suites can safely accommodate. Subsequent infusions in patients who tolerated the first without grade 3+ reaction may be moved to office or AIC settings.

Setting	POS	Claim form	Payer steering
Hospital outpatient (on-campus)	22	UB-04 / 837I	Preferred for first infusion (reaction monitoring); some commercial payers steer subsequent infusions to office
Hospital outpatient (off-campus PBD)	19	UB-04 / 837I	Acceptable for first infusion; site-of-care UM may push subsequent infusions to lower-cost setting
Physician oncology office	11	CMS-1500 / 837P	Acceptable for subsequent infusions once tolerance established
Ambulatory infusion suite (AIC)	49	CMS-1500 / 837P	Acceptable for subsequent infusions; verify the suite can manage IRR/CRS escalation
Oncology ASC	24	CMS-1500 / 837P	Acceptable
Patient home	12	CMS-1500 (home infusion)	Not appropriate for Gazyva due to IRR/CRS risk

First-dose monitoring requirements: Per FDA label, patients must be monitored closely during and after the first infusion for signs of severe infusion reactions (hypotension, bronchospasm, respiratory distress, cardiac symptoms). HOPD or hospital-affiliated infusion center is the clinically appropriate first-dose setting. Document IRR monitoring in chart for audit defense.

Claim form field mapping Genentech Access Solutions 2026

From Genentech Access Solutions Gazyva coding & coverage materials.

Information	CMS-1500 box	Notes
NPI	17b	Rendering provider
NDC qualifier + 11-digit NDC + UoM + qty	24A shaded area	N4 + 50242-070-01 + ML + total volume drawn (e.g., 40 mL for 1,000 mg vial)
HCPCS J9301 (drug line)	24D	Administered units (e.g., 100 for 1,000 mg)
JZ modifier	24D modifier slot	Default for 1,000 mg dose — no waste from single vial
Drug units	24G	Actual mg administered ÷ 10 (e.g., 100 for 1,000 mg)
CPT 96413 (admin line)	24D (admin line)	Initial chemo IV up to 1 hr
CPT 96415 × 3 (first infusion)	24D add-on	Three additional hours for the ~4-hour first infusion
CPT 96415 × 1 (subsequent)	24D add-on	One additional hour for the ~90-min subsequent infusion
Premedication IV (J1100 dex, J1200 DPH)	24D separate lines	Same-day premed claim lines with 96372 or bundled per payer
ICD-10	21	Indication-specific (see ICD-10 table)
PA number	23	Required by all major commercial payers

UB-04 / 837I (HOPD setting): For first-infusion HOPD billing, mirror the same NDC, HCPCS, modifier, and CPT structure on the institutional form. Revenue code 0335 (infusion therapy) typically pairs with the chemo admin CPTs. Confirm your facility coding team's local conventions.

Phase 3 Get paid HBV serology + CD20+ histology + indication-specific PA are the gate. Genentech Access Solutions assists.

Payer policy snapshot Reviewed May 2026

All major payers require PA. HBV serology and CD20+ histology documentation are universal requirements. FL rituximab-refractory indication adds prior rituximab regimen documentation.

Payer	PA?	Indication-specific requirements	Site-of-care UM
Medicare (LCDs vary by MAC)	Generally no PA for on-label use	CD20+ histology + HBV serology in chart; FDA-approved indication match; NCCN compendium covers off-label uses with documentation	None at federal level
UnitedHealthcare Oncology Med Coverage Policy	Yes	HBsAg + anti-HBc results; CD20+ histology; CLL 1L OR FL (untreated or rituximab-refractory) OR Columvi pretreatment documentation; for FL refractory: prior rituximab regimen + progression details	Aggressive: chemo steered out of HOPD via Optum-managed program for subsequent infusions
Aetna CPB + Medical Drug policies	Yes	Aligned with NCCN + FDA label; HBV serology required; documentation of disease stage and prior therapy	Yes (separate Site-of-Care policy)
BCBS plans Vary by plan	Yes	Generally aligned with NCCN + FDA label; HBV serology required	Plan-specific; most have oncology site-of-care steering

Step therapy

For FL rituximab-refractory indication (GADOLIN regimen), prior rituximab therapy plus documented progression or refractoriness is the gating requirement — UHC and Aetna both ask for the prior rituximab regimen and treatment dates in the PA submission. For CLL 1L, no step is generally required because Gazyva is the preferred 1L anti-CD20 in this setting per CLL11 data. For FL untreated (GALLIUM), some plans prefer a Rituxan biosimilar + chemotherapy as the step before Gazyva + chemotherapy; document NCCN preference or clinical rationale to overcome.

NCCN compendium support

Gazyva is included in NCCN CLL/SLL, B-Cell Lymphomas (FL), and Diffuse Large B-Cell Lymphoma guidelines as a Category 1 or 2A regimen for the FDA-labeled indications. The Columvi-DLBCL pretreatment role is included in NCCN B-Cell Lymphomas under glofitamab. Off-label NCCN-supported uses may be coverable under compendium-based PA but require additional documentation.

Medicare reimbursement CMS Q2 2026 (live)

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

Q2 2026 payment snapshot — J9301

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

ASP + 6%

$81.806

per 10 mg unit

1,000 mg flat dose

$8,180.60

100 units · standard CLL/FL/Columvi pretreat

CLL 1L full course (~8,000 mg)

$65,444.80

~800 units across 6 cycles

No partial-vial waste in standard practice. A 1,000 mg dose draws exactly one 1,000 mg vial — no JW reimbursement. Bill 100 units of administered drug with JZ on the single line. ASP + 6% is the published payment limit; effective Medicare paid amount after ~2% sequestration is approximately ASP + 4.3%.

Next ASP update: CMS updates Part B Drug ASP files quarterly. Next update is July 1, 2026 for Q3 2026. This page's $ figures auto-refresh against the live CMS data layer.

Coverage

No NCD specific to obinutuzumab. Coverage falls under MAC LCDs for monoclonal antibody therapy + the generic chemo coverage framework. All MACs cover J9301 for FDA-approved on-label indications (CLL 1L with chlorambucil; FL untreated and rituximab-refractory; Columvi pretreatment) with appropriate ICD-10 and clinical documentation including HBV serology. NCCN compendium support extends Medicare coverage to additional NCCN-listed regimens.

Code history

J9301 — permanent code effective January 1, 2015 (post-November 2013 FDA approval, replacing transitional unclassified J9999 / C9021 period); "Injection, obinutuzumab, 10 mg"

Patient assistance — Genentech Access Solutions Genentech verified May 2026

Genentech Access Solutions: 1-866-422-2377 / genentech-access.com — benefits investigation, prior authorization assistance, denials and appeals support, billing & coding hotline
Genentech Co-pay Assistance Program (commercial patients): eligible commercially-insured patients pay as little as $5 per infusion for the Gazyva drug cost, with an annual benefit cap (verify current cap with Genentech Access Solutions); excludes Medicare, Medicaid, and federal program patients
Genentech Patient Foundation: free product for uninsured / underinsured patients meeting income and clinical criteria (typically up to 400–500% FPL depending on indication); 1-888-941-3331 / genentech-patientfoundation.com
Foundations (Medicare patients): PAN Foundation, HealthWell Foundation, LLS Co-Pay Assistance Program, CancerCare Co-Payment Assistance — verify open CLL / NHL / lymphoma funds quarterly (open and close throughout the year)
Reimbursement support: Genentech Access Solutions Billing & Coding hotline can confirm Q2 2026 ASP and assist with claim form mapping if denials occur
Web: genentech-access.com

Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance, and OOP max? Run a CareCost Estimate — J9301 pre-loaded.

Phase 4 Fix problems Missing HBV serology is the #1 denial. CD20+ histology and Rituxan-vs-Gazyva confusion are #2 and #3.

Common denials & how to fix them

Denial reason	Common cause	Fix
#1 — HBV serology not documented (Boxed Warning trigger)	PA submitted or claim posted without HBsAg + anti-HBc results in chart	Submit chart note documenting both HBsAg AND anti-HBc with results and date. For patients with prior or current HBV evidence, attach hepatology consultation and antiviral prophylaxis plan per AASLD. This is the #1 audit/PA item for Gazyva and the most common denial.
CD20+ histology not confirmed	PA submitted without flow cytometry or IHC confirmation of CD20+ tumor	Submit pathology report with CD20+ flow cytometry or IHC. For CLL, peripheral blood flow cytometry is acceptable; for FL/DLBCL, lymph node biopsy IHC is standard.
Prior rituximab regimen not documented (FL rituximab-refractory)	GADOLIN-pattern PA submitted without prior rituximab regimen + progression details	Submit chart documenting prior rituximab-containing regimen (drug, dates, response, reason for discontinuation including progression or refractoriness).
Wrong HCPCS (J9312 instead of J9301)	Rituxan code used when Gazyva was administered (the products are not interchangeable)	Resubmit with J9301. Reconcile chemo order, MAR, and pharmacy dispense record before next claim. CLL 1L with chlorambucil is a Gazyva indication, not Rituxan.
Wrong admin code (96365)	Therapeutic IV billed instead of chemo IV for anti-CD20 monoclonal antibody	Resubmit with 96413 + 96415 add-on units. Most payers including Medicare expect chemo admin codes for Gazyva.
Insufficient 96415 add-on units (first infusion)	96413 alone billed for 4-hour first infusion	Add 96415 × 3 for the first infusion (~4 hr). Document actual start/stop times in chart for audit defense.
Premedication drug lines denied	Premeds not bundled correctly with chemo session	Verify payer rule. Some payers bundle premeds into chemo admin; others pay separately with 96372. Adjust per payer.
Infusion reaction monitoring not documented	Severe IRR/CRS occurred but no chart documentation of monitoring + recovery	Document infusion start/stop times, vital signs at each rate increase, reaction details, hold-and-recover protocol if applied. This supports the medical necessity of HOPD site of care for subsequent infusions.
Wrong NDC format (vial-level)	Vial NDC submitted instead of carton NDC with N4 qualifier	Use 11-digit carton NDC `50242-070-01` with N4 qualifier in 24A shaded area.
Site-of-care UM denial (subsequent infusions in HOPD)	Commercial plan with HOPD site-of-care UM steering chemo to office/AIC	Submit medical necessity letter for continued HOPD use (history of IRR/CRS, monitoring requirements). For tolerant patients, transition to office (POS 11) or AIC (POS 49) for subsequent infusions.

Frequently asked questions

What is the HCPCS code for Gazyva?

Gazyva (obinutuzumab) is billed under HCPCS J9301 — "Injection, obinutuzumab, 10 mg." Every 10 mg administered equals one billable unit. A standard 1,000 mg flat dose therefore bills as 100 units. Gazyva is supplied in a single 1,000 mg / 40 mL single-dose vial, so a 1,000 mg dose uses exactly one vial with no waste — the JZ modifier applies and JW does not.

How does Gazyva differ from Rituxan?

Both target CD20, but Gazyva is a glycoengineered Type II humanized anti-CD20 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC), whereas Rituxan (rituximab) is a Type I chimeric anti-CD20. They are NOT interchangeable. Gazyva (J9301) and Rituxan (J9312) have different HCPCS codes (though both are 10 mg per unit), different ASPs, and different label indications. In CLL 1L, Gazyva + chlorambucil demonstrated superior PFS vs Rituxan + chlorambucil in the CLL11 trial — this is why CLL 1L is a Gazyva indication and not a Rituxan indication. See the class comparison table.

Is HBV serology screening required before Gazyva?

Yes. Gazyva carries an FDA Boxed Warning for hepatitis B virus reactivation that can result in fulminant hepatitis, hepatic failure, and death. Per FDA label, screen ALL patients for HBV (HBsAg AND anti-HBc) before initiating Gazyva. Patients with evidence of prior or current HBV infection require hepatology consultation, monitoring, and antiviral prophylaxis per AASLD guidance. Documentation of HBV serology in the chart is the #1 audit/PA item for Gazyva and the most common denial trigger.

What is the Gazyva dosing for CLL 1L versus FL 2L+?

Both use the same 1,000 mg flat IV dose per infusion but differ in cycle structure and combo agent. CLL 1L (CLL11 regimen): with chlorambucil for 6 cycles × 28 days, with a split Cycle 1 Day 1 (100 mg) + Day 2 (900 mg) ramp-up; standard 1,000 mg on Days 8 and 15, then 1,000 mg Cycle 2–6 Day 1 each. FL rituximab-refractory (GADOLIN): with bendamustine, 1,000 mg Cycle 1 Days 1/8/15 and Cycle 2–6 Day 1; followed by 1,000 mg every 2 months maintenance for up to 2 years in responders. FL untreated (GALLIUM): with CHOP/CVP/bendamustine, same induction pattern, same 2-year maintenance.

What is the Gazyva premedication protocol?

Mandatory at every infusion per FDA label: corticosteroid (dexamethasone 20 mg IV) + acetaminophen (650–1,000 mg PO) + antihistamine (diphenhydramine 50 mg IV or PO), all administered 30–60 minutes before infusion start. Premed is not optional and is independent of patient tolerance — unlike Rituxan, Gazyva does not have a "may be tapered" provision in the label for premedication after early infusions.

What is the FL maintenance dosing?

Gazyva 1,000 mg IV every 2 months for up to 2 years (~12 maintenance doses) in FL patients who achieved at least stable disease after induction. Each maintenance infusion is 100 units of J9301. Total maintenance exposure across 2 years is approximately 12,000 mg / 1,200 units.

Why is the first Gazyva infusion 4 hours or longer?

Gazyva carries a high risk of severe infusion-related reactions and cytokine release syndrome (CRS), particularly with the first infusion as circulating CD20+ B-cells are rapidly depleted. Per FDA label, the first infusion is given at a slow titrated rate (typically 50 mg/hr initial, escalated by 50 mg/hr every 30 minutes to a maximum 400 mg/hr) — total time is typically 4+ hours for the 1,000 mg dose. Subsequent infusions, if tolerated without grade 3+ reaction, can be given over ~90 minutes. Bill 96413 + 96415 × 3 for the first infusion; 96413 + 96415 for subsequent.

Why is Gazyva given before Columvi in DLBCL?

Columvi (glofitamab, J9286) is a CD20xCD3 bispecific T-cell engager used in relapsed/refractory DLBCL. Per FDA label, Columvi requires mandatory Gazyva 1,000 mg IV pretreatment on Day -7 (7 days before Columvi Cycle 1 Day 1) to deplete circulating CD20+ B-cells and substantially mitigate cytokine release syndrome risk during Columvi step-up dosing. This Gazyva pretreatment is a single 1,000 mg dose billed separately under J9301 as 100 units. This is unique among CD20xCD3 bispecifics — Lunsumio (J9350) and Epkinly (J9321) do not require obinutuzumab pretreatment.

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

Source documents

FDA — GAZYVA (obinutuzumab) prescribing information (BLA 125486, 2025 revision)
FDA-approved label; Boxed Warnings (HBV, PML); CLL/FL/lupus nephritis indications; dosing and administration
DailyMed — GAZYVA (obinutuzumab) prescribing information
SetID df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda (Genentech, Inc.); revised 2025 with LN indication
FDA — Gazyva supplemental BLA approval for active lupus nephritis (October 2025)
First non-oncology Gazyva indication; REGENCY pivotal trial
Genentech Access Solutions — Gazyva HCP coding & coverage
Manufacturer billing guide, claim form mapping, copay assistance program; 1-866-422-2377
CMS — Medicare Part B Drug ASP Pricing File
Q2 2026 quarterly file, effective April 1 – June 30, 2026
SEER CanMED — HCPCS J9301 reference
CLL11 trial — Goede et al., NEJM 2014 (Obinutuzumab + chlorambucil in untreated CLL)
Pivotal trial supporting CLL 1L indication; superior PFS vs Rituxan + chlorambucil
GADOLIN trial — Sehn et al., Lancet Oncology 2016 (Obinutuzumab + bendamustine in rituximab-refractory FL)
Pivotal trial supporting FL rituximab-refractory indication
GALLIUM trial — Marcus et al., NEJM 2017 (Obinutuzumab-based chemoimmunotherapy in untreated FL)
Pivotal trial supporting FL untreated indication
NCCN Clinical Practice Guidelines in Oncology — CLL/SLL, B-Cell Lymphomas (FL), DLBCL
Compendium support for Gazyva regimens (Category 1/2A)
UnitedHealthcare — Oncology Medication Clinical Coverage Policy
Aetna Clinical Policy Bulletins — Antineoplastic agents
CMS HCPCS Level II Quarterly Updates
FDA National Drug Code Directory
CMS — JW/JZ modifier policy (CR 12056, eff. July 2023)

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	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.

Reviewer

Pending SME review. This page is staff-authored from primary sources (FDA, CMS, Genentech Access Solutions, payer documents — 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.

Change log

May 22, 2026 — SME audit pass: added new active lupus nephritis indication (FDA approved October 2025 via REGENCY trial, Gazyva's first non-oncology approval). Indication pattern (4 doses over 12 months: Day 1, Day 15, Month 6, Month 12) added to the indication-roles table; ICD-10 M32.14 added; FDA label/DailyMed source link updated to 2025 revision (setid df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda). Previously documented oncology indications (CLL 1L, FL induction + maintenance, Columvi DLBCL pretreatment) unchanged. ASP data: Q2 2026. Manufacturer source: Genentech Access Solutions 2026.

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 and dosing are verified against the current FDA label revision. We do not paraphrase from billing-software vendor blogs.

Gazyva (obinutuzumab) — HCPCS J9301

Instant Answer — the 5 things you need to bill J9301

About Gazyva (obinutuzumab) FDA label + Genentech PI 2025–2026

CD20 class — J9301 (Gazyva) vs J9312 (Rituxan) CMS HCPCS + FDA verified May 2026

Indication-specific roles — one drug, three billing patterns FDA label verified May 2026

Dosing & unit math FDA label + Genentech PI verified May 2026

CLL 1L regimen (with chlorambucil)

FL induction (GADOLIN / GALLIUM patterns)

FL maintenance (responders to induction)

Columvi pretreatment (single Day -7 dose)

Worked example — standard 1,000 mg flat dose

Worked example — CLL Cycle 1 Day 1 (100 mg ramp-up)

NDC reference FDA NDC Directory verified May 2026

Administration codes CPT verified May 2026

Modifiers CMS verified May 2026

JZ — the default for Gazyva

JW — rarely applicable

Worked example — 1,000 mg flat dose, JZ line

Modifier 25 — same-day E/M

340B modifiers (JG, TB)

ICD-10-CM by indication FY2026 verified May 2026

Site of care & place of service Verified May 2026

Claim form field mapping Genentech Access Solutions 2026

Payer policy snapshot Reviewed May 2026

Step therapy

NCCN compendium support

Medicare reimbursement CMS Q2 2026 (live)

Q2 2026 payment snapshot — J9301

Coverage

Code history

Patient assistance — Genentech Access Solutions Genentech verified May 2026

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Gazyva?

How does Gazyva differ from Rituxan?

Is HBV serology screening required before Gazyva?

What is the Gazyva dosing for CLL 1L versus FL 2L+?

What is the Gazyva premedication protocol?

What is the FL maintenance dosing?

Why is the first Gazyva infusion 4 hours or longer?

Why is Gazyva given before Columvi in DLBCL?

Source documents

About this page

Refresh cadence

Reviewer

Change log

Methodology

Stop calculating Gazyva copays by hand.