HCPCS
J9286
1 unit = 2.5 mg
Phase 1
Identify what you're billing
2.5 mg unit basis, mandatory Gazyva pretreatment, step-up cycle 1, and 12-cycle fixed duration.
The CD20 × CD3 bispecific landscape FDA verified May 2026
Columvi sits alongside Lunsumio (FL) and Epkinly (DLBCL SC). Columvi is the IV bispecific for DLBCL with mandatory obinutuzumab pretreatment.
Bispecific T-cell engagers (BiTEs) for B-cell lymphoma redirect cytotoxic T cells against CD20+ malignant B cells. Three CD20×CD3 bispecifics now share this space, but they differ on indication, route, dosing schedule, and pretreatment requirement. Coding teams must pick the right HCPCS, route, and step-up schedule for each — and Columvi additionally adds a mandatory same-week Gazyva pretreatment claim.
| Lunsumio (mosunetuzumab-axgb) | Epkinly (epcoritamab-bysp) | Columvi (glofitamab-gxbm) | |
|---|---|---|---|
| HCPCS | J9350 (1 mg = 1 unit) | J9321 | J9286 (2.5 mg = 1 unit) |
| Manufacturer | Genentech (Roche) | AbbVie / Genmab | Genentech (Roche) |
| Indication | R/R FL (≥2 prior lines) | R/R DLBCL (≥2 prior lines) | R/R DLBCL NOS or LBCL from FL (≥2 prior lines) |
| FDA approval | Dec 22, 2022 (accelerated) | May 19, 2023 (accelerated) | Jun 15, 2023 (accelerated) |
| Route | IV | SC | IV |
| Maintenance dose | 30 mg IV q3wk (C3+) | 48 mg SC q4wk (after C9) | 30 mg IV q3wk (C3+) |
| Treatment duration | Fixed: 8 or up to 17 cycles | Until progression | Fixed: 12 cycles |
| Pretreatment | None (premed only) | None (premed only) | Gazyva 1,000 mg IV Day -7 (mandatory) |
| Step-up complexity | 3 doses (C1: 1 / 2 / 60 mg) | 3 doses (priming / intermediate / full) | 2 doses (C1 D8: 2.5 mg / C1 D15: 10 mg) |
| Admin CPT | 96413 + 96415 | 96401 (chemo SC) | 96413 + 96415 |
| REMS? | No | No | No |
| Boxed warning | CRS | CRS, ICANS | CRS |
What sets Columvi apart. Three things distinguish J9286 from its peers in coding workflow:
(1) 2.5 mg unit basis — unique among the three bispecifics; (2) mandatory
Gazyva pretreatment on Day -7 — a separate same-day claim under J9301; (3) a clean 12-cycle
fixed duration with no response-based extension. Lunsumio splits at C8 (CR vs PR); Columvi does not.
Don't confuse with BCMA bispecifics. Tecvayli (teclistamab-cqyv, J9380), Elrexfio
(elranatamab-bcmm), and Talvey (talquetamab-tgvs) are SC bispecifics for multiple myeloma — different
target (BCMA, not CD20), different indication, and they carry formal FDA REMS. Columvi does NOT have a REMS
program but does carry a CRS Boxed Warning.
2.5 mg unit basis — biller error trap CMS HCPCS verified May 2026
J9286 uses an unusual 2.5 mg unit basis. Submitting in mg (instead of units) overbills by 2.5x.
The HCPCS Level II descriptor for J9286 reads "Injection, glofitamab-gxbm, 2.5 mg." Each billable unit corresponds to 2.5 mg of drug. This is unusual — most oncology J-codes use 1 mg per unit (Lunsumio J9350, Opdivo J9299, Keytruda J9271, Tecentriq J9022). Columvi joins a small set of J-codes that deviate from the 1 mg standard.
| Dose administered | Convert | Units billed (J9286) | Common error |
|---|---|---|---|
| 2.5 mg (C1 D8 step-up) | 2.5 ÷ 2.5 | 1 unit | Submitting 2 or 2.5 units |
| 10 mg (C1 D15 step-up) | 10 ÷ 2.5 | 4 units | Submitting 10 units (overbills 2.5x) |
| 30 mg (C2+ treatment dose) | 30 ÷ 2.5 | 12 units | Submitting 30 units (overbills 2.5x) |
Error trap: submitting mg as units. A 30 mg maintenance dose billed as 30 units of J9286
equals 75 mg in CMS payment terms — an effective 2.5x overbill that will trigger CMS or RAC recovery.
Always divide the administered mg dose by 2.5 to derive units. Verify against the CMS HCPCS descriptor on
every claim.
Per-mg vs per-unit pricing. The Q2 2026 ASP+6% is $2,840.677 per unit
(per 2.5 mg). Equivalently, per mg = $2,840.677 ÷ 2.5 = $1,136.27/mg. Either basis
is correct mathematically, but claims must be submitted in units (per CMS), not mg.
Gazyva pretreatment — Day -7 (mandatory) FDA label verified May 2026
Obinutuzumab depletes circulating CD20+ B-cells before Columvi exposure. This is a unique requirement among CD20xCD3 bispecifics — and a separate same-day claim.
Columvi requires a single 1,000 mg IV dose of Gazyva (obinutuzumab) administered 7 days before the first Columvi step-up dose (Day -7, where Day 1 is Cycle 1 Day 1 of Columvi). Gazyva depletes circulating CD20+ B-cells, which substantially reduces cytokine release syndrome (CRS) risk during the Columvi step-up phase. This pretreatment is not optional. Skipping it is a label deviation with both safety and reimbursement implications — payers will deny Columvi PA if Gazyva pretreatment is not documented.
Gazyva pretreatment billing (J9301)
| Element | Value | Notes |
|---|---|---|
| HCPCS | J9301 | "Injection, obinutuzumab, 10 mg" — 10 mg = 1 unit |
| Pretreatment dose | 1,000 mg IV | Single dose, 7 days before Columvi C1 D8 |
| Units billed | 100 units | 1,000 mg ÷ 10 mg per unit |
| Admin CPT | 96413 + 96415 | Standard chemo IV admin (typical 4–6 hr Gazyva infusion) |
| Modifier | JZ (single-dose vials) | Same as Columvi modifier rules |
| Claim type | Separate same-day claim | Gazyva is not bundled into the Columvi claim — submit as separate drug line on the Day -7 visit |
Same-day claim, separate drug line. The Day -7 Gazyva infusion generates its own admin
codes and its own J9301 drug line on the CMS-1500 (or UB-04). Both Gazyva and the C1 D8 Columvi dose share
the cycle 1 PA but post as different visits and different drug claims. Many denials trace to the Gazyva
pretreatment being omitted from PA submission documentation.
Premedication for Gazyva. Standard Gazyva premed (corticosteroid + antihistamine +
antipyretic) is required before the Day -7 infusion. Same regimen as before each Columvi step-up dose.
Step-up dosing & cycle math FDA label verified May 2026
Cycle 1 uses two step-up doses (after Gazyva pretreatment) to mitigate CRS. Cycle 2 is the first full dose. Cycle 3 through 12 is maintenance.
Pretreatment + Cycle 1 schedule (mandatory)
| Day | Drug / dose | HCPCS | Units billed | Premedication | Post-dose observation |
|---|---|---|---|---|---|
| Day -7 | Gazyva 1,000 mg IV (pretreatment) | J9301 | 100 units | Yes — standard Gazyva premed 60 min prior | Per Gazyva label |
| C1 Day 8 | Columvi 2.5 mg IV (step-up dose 1) | J9286 | 1 unit | Yes — corticosteroid + antihistamine + antipyretic 60 min prior | 24 hours recommended |
| C1 Day 15 | Columvi 10 mg IV (step-up dose 2) | J9286 | 4 units | Yes — same regimen | 24 hours recommended |
Cycle 2 onward (q21 days through C12)
| Cycle | Day | Dose | HCPCS | Units billed | Notes |
|---|---|---|---|---|---|
| C2 | Day 1 | 30 mg IV (first full treatment dose) | J9286 | 12 units | Premedication required for first full dose |
| C3 through C12 | Day 1 (q21 days) | 30 mg IV | J9286 | 12 units | Maintenance through fixed end of treatment at C12 |
Worked example — full 12-cycle course
# Day -7 (Gazyva pretreatment, billed under J9301 not J9286)
100 units of J9301
# Cycle 1 (2 step-up doses)
Day 8: 2.5 mg = 1 unit · Day 15: 10 mg = 4 units = 5 units of J9286
# Cycles 2-12 (eleven 30 mg full doses)
11 × 12 units = 132 units of J9286
# Total Columvi units over 12-cycle course
Total J9286 units billed: 137 units (= 342.5 mg cumulative drug)
Total Columvi drug cost (Q2 2026 ASP+6%): ~$389,173 before sequestration
# Plus Day -7 Gazyva pretreatment (J9301, separate claim)
100 units × J9301 ASP+6% ≈ ~$8,500–$9,500 additional (verify live ASP at billing time)
100 units of J9301
# Cycle 1 (2 step-up doses)
Day 8: 2.5 mg = 1 unit · Day 15: 10 mg = 4 units = 5 units of J9286
# Cycles 2-12 (eleven 30 mg full doses)
11 × 12 units = 132 units of J9286
# Total Columvi units over 12-cycle course
Total J9286 units billed: 137 units (= 342.5 mg cumulative drug)
Total Columvi drug cost (Q2 2026 ASP+6%): ~$389,173 before sequestration
# Plus Day -7 Gazyva pretreatment (J9301, separate claim)
100 units × J9301 ASP+6% ≈ ~$8,500–$9,500 additional (verify live ASP at billing time)
Premedication
Required 60 minutes before Day -7 Gazyva pretreatment, each cycle 1 step-up dose (C1 D8, C1 D15), and the first full treatment dose (C2 D1):
- Corticosteroid: dexamethasone 20 mg IV
- Antihistamine: diphenhydramine 50–100 mg IV or PO
- Antipyretic: acetaminophen 500–1000 mg PO
From subsequent maintenance cycles, premedication may be modified per FDA label and prior-cycle CRS history. Document premed administration in the chart for each in-scope dose.
Fixed-duration therapy — 12 cycles maximum FDA label verified May 2026
Columvi is NOT continued indefinitely. Treatment caps at 12 cycles regardless of response. This is a critical billing and capacity-planning fact.
Columvi is administered as a fixed-duration regimen with a hard cap at 12 cycles total, in contrast to most multiple myeloma bispecifics (Tecvayli, Elrexfio) which dose until disease progression and to Lunsumio's response-based 8 vs 17 cycle split. Columvi does not extend based on partial vs complete response — the course is the course.
| Element | Value | Implication |
|---|---|---|
| Maximum cycles | 12 cycles | Treatment stops after C12 regardless of response |
| Cycle length | 21 days | ~36 weeks total drug administration window from C1 D1 |
| Total course duration | ~9 months from C1 D1 to end of C12 | Plus Day -7 pretreatment week |
| Response-based extension? | No | Unlike Lunsumio (CR → 8 cycles, PR → up to 17), Columvi does not extend |
| Progression during therapy | Discontinue | Move to next-line therapy (CAR-T, allogeneic SCT, clinical trial) |
Why fixed-duration matters for billing: Annual drug-cost projections must account for the
finite 12-cycle course rather than indefinite dosing. A patient who starts in Q1 will complete the entire
course within ~9 months. After C12, J9286 charges stop entirely — the patient transitions to surveillance
imaging and clinical follow-up. This is materially different from MM bispecifics that may invoice for years.
Contrast with MM bispecifics and Lunsumio. Tecvayli, Elrexfio, and Talvey continue dosing
until progression — multi-year drug spend. Lunsumio splits at C8 by response — 8 cycles for CR,
up to 17 for PR. Columvi is the simplest: 12 cycles for everyone who completes treatment, stop. This is the
easiest course to forecast and counsel patients on.
NDC reference FDA NDC Directory verified May 2026
| Vial | Use | Notes |
|---|---|---|
| 2.5 mg / 2.5 mL single-dose vial | Cycle 1 Day 8 step-up dose (2.5 mg = 1 vial) | Used for first step-up only; whole vial = whole dose |
| 10 mg / 10 mL single-dose vial | Cycle 1 Day 15 step-up (10 mg = 1 vial); Cycle 2+ treatment dose (30 mg = 3 vials) | Standard treatment-dose vial |
Pull manufacturer NDC at billing time. Genentech publishes carton-level NDCs in their
Columvi access materials. Always use the carton-level NDC on CMS-1500 box 24A shaded area with the N4
qualifier and ML unit-of-measure (volume in mL: 2.5 mL for 2.5 mg dose; 10 mL for 10 mg dose; 30 mL for
30 mg dose).
Vial waste accounting: The 2.5 mg vial used for the C1 D8 dose has no waste. The 10 mg
vial used for the C1 D15 dose has no waste. The 30 mg treatment dose uses 3 × 10 mg vials with no
waste. JZ applies to all standard adult dosing; JW only if a partial vial is discarded (unusual at label doses).
Phase 2
Code the claim
Chemo admin codes (96413 + 96415) for IV bispecific. JZ on every claim. 2.5 mg unit basis.
Administration codes CPT verified May 2026
Columvi is billed as chemotherapy administration (complex monoclonal antibody) despite being immunotherapy in mechanism.
| Code | Description | When to use |
|---|---|---|
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug | Primary code for every Columvi infusion (and Day -7 Gazyva infusion). Covers the first hour. |
96415 |
Chemotherapy administration, IV infusion; each additional hour | Required. Pair with 96413: first step-up dose (~4 hr) bills 96413 + 96415 × 3; subsequent doses (~2 hr) bill 96413 + 96415 × 1. Day -7 Gazyva infusion typically 4–6 hr. |
96365 / 96366 |
Therapeutic IV infusion (non-chemo) | NOT appropriate. Columvi is a complex monoclonal antibody and bills under chemo admin per AMA classification. |
96401 |
Chemotherapy administration, SC/IM | NOT applicable to Columvi (IV only). Use for Epkinly SC formulation, not Columvi. |
Why chemo admin for bispecific antibody: CPT chemotherapy administration codes
(96409–96425) apply to complex monoclonal antibody administration regardless of mechanism of action.
Bispecific T-cell engagers are billed under chemo admin codes per AMA classification. This pays materially
more than 96365 therapeutic infusion.
Modifiers CMS verified May 2026
JZ — required on virtually every claim
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. Columvi dosing aligns to whole-vial multiples at every label dose: 2.5 mg uses one 2.5 mg vial; 10 mg uses one 10 mg vial; 30 mg uses three 10 mg vials. JZ applies to virtually every Columvi claim.
JW — report partial-vial waste
JW reports the discarded portion of a single-dose vial. For Columvi at standard label doses, JW rarely applies because every dose lands on whole-vial multiples. If a partial dose is administered (e.g., dose adjustment for toxicity managed at the bedside) and a portion is discarded, bill JW with the actual discarded units on a separate claim line. One of JZ or JW must be on every J9286 claim.
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 (e.g., a CRS workup during cycle 1 step-up). Routine pre-infusion clinical assessment is bundled with 96413.
340B modifiers (JG, TB)
For 340B-acquired Columvi, follow your MAC's current 340B modifier policy. Genentech's billing guide does not provide 340B-specific instructions.
ICD-10-CM — DLBCL family FY2026 verified May 2026
Columvi is approved for adult R/R DLBCL NOS or LBCL arising from FL. Use the most specific C83.3x or C82.x code supported by histology.
| ICD-10 | Description | Notes |
|---|---|---|
C83.30 | Diffuse large B-cell lymphoma, unspecified site | Common when site not further specified |
C83.31 | DLBCL, lymph nodes of head, face, and neck | Site-specific |
C83.32 | DLBCL, intrathoracic lymph nodes | Site-specific |
C83.33 | DLBCL, intra-abdominal lymph nodes | Site-specific |
C83.34 | DLBCL, lymph nodes of axilla and upper limb | Site-specific |
C83.35 | DLBCL, lymph nodes of inguinal region and lower limb | Site-specific |
C83.36 | DLBCL, intrapelvic lymph nodes | Site-specific |
C83.37 | DLBCL, spleen | Splenic involvement |
C83.38 | DLBCL, lymph nodes of multiple sites | Multi-site nodal |
C83.39 | DLBCL, extranodal and solid organ sites | Extranodal involvement |
C82.x | Follicular lymphoma family | Use when LBCL arose from prior FL (transformation) — document histologic transformation in chart and PA |
Documentation requirements: Most payers require documented DLBCL diagnosis (with histology
confirmation by IHC), prior treatment with at least 2 lines of systemic therapy (typically including
anti-CD20 mAb such as rituximab plus chemoimmunotherapy like R-CHOP and a
salvage regimen), and disease progression or refractory status before Columvi PA approval. For LBCL
arising from FL, biopsy documentation of the transformation event is critical.
Site of care & place of service Verified May 2026
Columvi's 24-hour observation recommendation after each step-up dose has historically pushed cycle 1 administration into hospital outpatient or extended-stay outpatient settings. However, many cancer centers now run 24-hour observation in extended-stay outpatient infusion suites with telemetry capability — this is increasingly viewed as outpatient-manageable, distinguishing Columvi from MM bispecifics that require 48-hour inpatient observation.
| Setting | POS | Claim form | Columvi applicability |
|---|---|---|---|
| Outpatient cancer center (extended observation) | 22 / 11 | Varies | Increasingly common for cycle 1 step-up; ideal site once site has 24-hr obs capability |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Common for cycle 1 step-up; subsequent doses may shift to lower-acuity setting |
| Hospital inpatient observation | 21 | UB-04 / 837I | Sometimes used for first step-up if site lacks extended OP observation capability |
| Physician oncology office | 11 | CMS-1500 / 837P | Acceptable for C3+ maintenance once CRS risk has stabilized |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Acceptable for C3+ maintenance with CRS protocols in place |
| Patient home | 12 | CMS-1500 | Not appropriate — requires CRS-capable site |
Outpatient cancer center capability is the differentiator. A site that can run 24-hour
telemetry-capable observation in an outpatient infusion suite can keep Columvi cycle 1 entirely outpatient,
avoiding inpatient admission and the higher cost-share that comes with it. Sites without that capability
will default to hospital outpatient observation status or short inpatient admission.
Less stringent than MM bispecifics. Tecvayli, Elrexfio, and Talvey require 48-hour
observation after each step-up dose — effectively forcing inpatient admission. Columvi's 24-hour
recommendation keeps it outpatient-manageable.
Claim form field mapping Genentech 2026
From Genentech Access Solutions Columvi coding & coverage materials.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + carton NDC + ML + total volume (2.5 mL for 2.5 mg dose; 10 mL for 10 mg dose; 30 mL for 30 mg dose) |
| HCPCS J9286 + JZ (or JW for partial-vial waste) | 24D (drug line) | JZ on virtually every adult claim |
| Drug units (J9286) | 24G | 1 (C1D8, 2.5 mg), 4 (C1D15, 10 mg), or 12 (C2+ maintenance, 30 mg) — remember 1 unit = 2.5 mg |
| Day -7 Gazyva line (J9301) | 24D | Separate same-day claim on the Day -7 visit. 100 units of J9301 for 1,000 mg pretreatment. |
| CPT 96413 (admin line, initial hour) | 24D (admin line) | Always required for IV chemo admin (both Columvi and Day -7 Gazyva) |
| CPT 96415 (admin line, each additional hour) | 24D (admin line) | Add lines for hours beyond the first — first step-up dose ~4 hr = 96413 + 96415 × 3 |
| ICD-10 | 21 | Most specific C83.3x code per histology and site (or C82.x for transformation from FL) |
| PA number | 23 | Required by all major payers |
Phase 3
Get paid
PA + documented ≥2 prior lines + DLBCL pathology + Gazyva pretreatment plan are the universal requirements.
Payer policy snapshot Reviewed May 2026
PA universal. Documentation of ≥2 prior systemic therapies + DLBCL/LBCL confirmation by histology + Gazyva pretreatment plan required.
| Payer | PA? | Documentation required | Site-of-care UM |
|---|---|---|---|
| UnitedHealthcare Oncology Med Coverage Policy |
Yes | DLBCL Dx (IHC), ≥2 prior systemic therapies (anti-CD20 chemoimmuno + salvage), disease status, Gazyva pretreatment plan documented | Aggressive: prefers extended-OP infusion centers; HOPD challenges after first cycle |
| Aetna CPB + Medical Drug policy |
Yes | DLBCL/LBCL confirmation (histology + IHC), prior therapies documentation, line of therapy ≥3, Gazyva pretreatment plan | Yes — separate Site-of-Care policy for oncology bispecifics |
| Cigna Oncology medical policy |
Yes | Aligned with FDA label and NCCN B-Cell Lymphoma Guidelines (DLBCL bispecific antibody options) | Plan-specific; oncology UM via eviCore on some lines of business |
| BCBS plans Vary by plan |
Yes | Generally aligned with NCCN guidelines + FDA label | Plan-specific; most have oncology bispecific site-of-care steering |
| Medicare (Part B) | No (covered for label indication) | MAC LCDs cover for FDA-approved use with appropriate ICD-10 and prior-therapy documentation | No CMS site-of-care UM |
Step therapy
Effectively built into the FDA label: patients must have failed ≥2 prior systemic therapies, which in DLBCL almost always includes an anti-CD20 monoclonal antibody (rituximab) plus a chemoimmunotherapy regimen (R-CHOP) and a salvage regimen (R-ICE, R-DHAP, or post-CAR-T relapse). Document these prior lines clearly in the PA submission — missing prior-therapy documentation is the #1 PA denial reason. The mandatory Gazyva Day -7 pretreatment plan must also be documented in the PA.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J9286
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions · 1 unit = 2.5 mg
ASP + 6% per unit (per 2.5 mg)
$2,840.677
per unit / per 2.5 mg
Per-mg equivalent
$1,136.27
$2,840.677 ÷ 2.5
30 mg dose (12 units, C2+)
$34,088.12
12 units × ASP+6%
Course-total cost (full 12-cycle course): 137 total Columvi units (1 + 4 + 11 × 12)
× $2,840.677 = ~$389,173 total Columvi drug cost (Medicare ASP+6%) before sequestration.
Add ~$8,500–$9,500 for the Day -7 Gazyva pretreatment (J9301, 100 units). Total course drug cost
approaches ~$398,000 across both drugs. After ~2% sequestration: ~$390,000.
Among the highest per-mg drugs in oncology. At $1,136.27/mg-equivalent, J9286 is one of the
most expensive Part B drugs by unit cost. The fixed 12-cycle duration caps total course exposure but the
per-cycle reimbursement is substantial. Site-of-care UM and PA scrutiny correspondingly aggressive.
Coverage
No NCD specific to glofitamab. Coverage falls under MAC LCDs for biologics + the generic drug-coverage framework. All MACs cover J9286 for the FDA-approved R/R DLBCL indication with appropriate ICD-10 and prior-therapy documentation.
Code history
- J9286 — permanent code, "Injection, glofitamab-gxbm, 2.5 mg" — replaced earlier unclassified J3490 / J9999 use during the post-approval / pre-permanent-code period
Patient assistance — Genentech Access Solutions Genentech verified May 2026
- Genentech Access Solutions: 1-866-422-2377 — benefits investigation, prior authorization assistance, appeal support, alternate funding identification
- Genentech Oncology Co-pay Assistance Program: commercial copay support up to $25,000/year ($0 copay for eligible commercially-insured patients; excludes Medicare, Medicaid, federal program patients)
- Genentech Patient Foundation: free product for uninsured / underinsured patients meeting income requirements
- Foundations: for Medicare patients, refer to PAN, HealthWell, CancerCare, Leukemia & Lymphoma Society Co-Pay Assistance — verify open lymphoma funds quarterly
- Web: genentech-access.com/hcp/brands/columvi.html
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance,
and OOP max? Run a CareCost Estimate — J9286 pre-loaded.
Phase 4
Manage safety & fix denials
CRS protocols, Tocilizumab on hand, mandatory Gazyva pretreatment, and clean PA documentation prevent the most expensive errors.
CRS management — Boxed Warning protocol FDA label verified May 2026
CRS occurred in ~70% of patients in the pivotal trial, most commonly during step-up cycle 1. Mostly Grade 1–2; Grade 3+ in ~4%. Gazyva pretreatment substantially mitigates risk.
BOXED WARNING: Cytokine release syndrome (CRS), including life-threatening or fatal
reactions, can occur in patients receiving Columvi. Initiate Columvi only after the recommended Day -7
Gazyva (obinutuzumab) pretreatment, and follow the recommended cycle 1 step-up dosing schedule. Administer
pretreatment medications. Monitor patients for signs and symptoms of CRS. Withhold or permanently
discontinue Columvi based on severity.
CRS preparedness checklist
- Day -7 Gazyva pretreatment completed — CD20+ B-cell depletion is the primary CRS mitigation strategy. Skipping is a label deviation.
- Tocilizumab (Actemra) on hand — minimum 2 doses available before any Columvi administration
- Premedication completed 60 min before each step-up dose and first full treatment dose (corticosteroid + antihistamine + antipyretic)
- 24-hour post-dose observation in a setting with telemetry and rapid response capability after each step-up dose (C1 D8, C1 D15)
- Vital signs monitoring per CRS grading protocol
- CRS grading per ASTCT consensus criteria; intervention threshold typically Grade 2+
- Hospital admission contingency plan for Grade 3+ CRS
ICANS (neurotoxicity)
ICANS (immune effector cell-associated neurotoxicity syndrome) has been reported with Columvi but is NOT in the Boxed Warning (unlike Epkinly which carries an ICANS Boxed Warning). Monitor for neurologic symptoms (confusion, dysphasia, tremor, seizures). Manage per ASTCT ICANS consensus criteria; severe ICANS may require corticosteroids and supportive care.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Units in mg instead of 2.5 mg units | Submitting 30 units for 30 mg dose (overbills 2.5x) | Resubmit with correct unit count: divide mg by 2.5. 30 mg = 12 units. 10 mg = 4 units. 2.5 mg = 1 unit. |
| Gazyva pretreatment not documented | PA submitted without Day -7 Gazyva plan | Resubmit PA with Gazyva 1,000 mg IV Day -7 documented in treatment plan. Include J9301 billing line for Day -7 visit. |
| Insufficient prior therapy documentation | PA submitted without clearly documenting ≥2 prior systemic therapies | Resubmit with clear treatment history: anti-CD20 chemoimmuno (R-CHOP), salvage regimen, dates, response/progression. Top denial reason. |
| DLBCL diagnosis not confirmed | Generic NHL ICD-10 used instead of specific C83.3x | Use most specific C83.3x code per histology. Submit IHC pathology confirming DLBCL. |
| Wrong admin code (96365) | Therapeutic IV billed instead of chemo IV | Resubmit with 96413 + 96415. Columvi is chemo admin per CPT classification. |
| Missing 96415 add-on | Only 96413 billed for >1 hour infusion | Add 96415 lines for each additional hour. 4-hr first step-up = 96413 + 96415 × 3. |
| JZ missing on claim | Single-dose vial claim without JZ | Resubmit with JZ. Required since 7/1/2023 on every claim with no waste. |
| Step-up dosing not followed | Patient billed for 30 mg on C1 D8 without step-up | Cycle 1 MUST follow Day -7 Gazyva → D8 2.5 mg → D15 10 mg sequence. Skipping step-up is a label deviation and a CRS safety issue. |
| Confused with Lunsumio or Epkinly | Wrong HCPCS used (J9350 or J9321 instead of J9286) | Columvi = J9286 (DLBCL, IV, 2.5 mg unit). Lunsumio = J9350 (FL, IV, 1 mg unit). Epkinly = J9321 (DLBCL, SC). Verify drug + indication match. |
| Site of care (HOPD) | HOPD billing for maintenance doses on commercial plan with site-of-care UM | Move C3+ maintenance to office (POS 11) or AIC (POS 49). Submit medical necessity letter if HOPD required. |
Frequently asked questions
What is the HCPCS code for Columvi?
Columvi (glofitamab-gxbm) is billed under HCPCS J9286 — "Injection, glofitamab-gxbm,
2.5 mg." 1 billable unit = 2.5 mg, NOT 1 mg. The 30 mg maintenance dose bills as
12 units (30 ÷ 2.5); the 10 mg cycle 1 day 15 step-up bills as 4 units; the 2.5 mg cycle 1 day 8
step-up bills as 1 unit.
How is Columvi dosed?
Columvi requires mandatory Gazyva (obinutuzumab) pretreatment plus step-up dosing in cycle 1, then fixed maintenance dose for up to 12 cycles total. Day -7: Gazyva 1,000 mg IV (depletes circulating CD20+ B-cells). Cycle 1: Day 8 = 2.5 mg IV (step-up dose 1), Day 15 = 10 mg IV (step-up dose 2). Cycle 2: Day 1 = 30 mg IV (first treatment dose). Cycle 3 through 12: Day 1 = 30 mg IV every 21 days. Total: 12 cycles maximum.
Why does Columvi require Gazyva pretreatment?
Gazyva (obinutuzumab, HCPCS J9301) is administered 7 days before the first Columvi dose to
deplete circulating CD20+ B-cells, which substantially mitigates cytokine release syndrome (CRS) risk.
Gazyva 1,000 mg IV on Day -7 is mandatory per the FDA label. Gazyva is billed as a separate same-day claim
under J9301 (10 mg = 1 unit, so 1,000 mg = 100 units). This is unique among CD20×CD3 bispecifics
— Lunsumio and Epkinly do not require obinutuzumab pretreatment.
How is the 2.5 mg unit basis for J9286 different from other HCPCS codes?
Most J-codes use 1 mg = 1 unit (Lunsumio J9350, Opdivo J9299, Keytruda J9271). Columvi J9286 uses 2.5 mg = 1 unit, which is unusual. A 30 mg maintenance dose is 12 units, NOT 30 units. Submitting 30 units for a 30 mg dose would overbill by 2.5x. The Q2 2026 ASP+6% is $2,840.677 per unit (per 2.5 mg), or equivalently $1,136.27 per mg. Always verify the unit basis from the official HCPCS descriptor before submitting Columvi claims — this is the #1 biller error trap for J9286.
What administration CPT do I use for Columvi?
CPT 96413 for the initial hour, plus 96415 for each additional hour. The first
step-up dose runs ~4 hours (96413 + 96415 × 3); the 30 mg maintenance doses run ~2 hours (96413 +
96415 × 1). The same-day Day -7 Gazyva infusion bills its own admin codes separately. Do NOT bill
96365 (therapeutic IV).
Does Columvi have a REMS program?
No formal FDA REMS for Columvi — like Lunsumio and unlike the multiple myeloma bispecifics (Tecvayli, Elrexfio, Talvey) which carry REMS programs for CRS and neurotoxicity. However, Columvi carries a Boxed Warning for CRS, and sites must be equipped to recognize and manage CRS. Tocilizumab (Actemra) must be on hand. 24-hour observation is recommended after each step-up dose — less stringent than the 48-hour observation MM bispecifics require.
What is the Medicare reimbursement for J9286?
For Q2 2026, the Medicare Part B payment limit for J9286 is $2,840.677 per unit (per 2.5 mg, ASP + 6%) — equivalent to $1,136.27 per mg, among the highest per-mg drug reimbursements in oncology. The 30 mg maintenance dose (12 units) reimburses at approximately $34,088.12; the 10 mg cycle 1 day 15 step-up (4 units) at approximately $11,362.71; the 2.5 mg cycle 1 day 8 step-up (1 unit) at approximately $2,840.68. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.
What indication is Columvi approved for?
Columvi is FDA-approved (accelerated approval, June 15, 2023) for adult patients with relapsed or
refractory diffuse large B-cell lymphoma (DLBCL) NOS or large B-cell lymphoma arising from follicular
lymphoma after at least 2 prior lines of systemic therapy. Primary ICD-10 codes are in the C83.3
family by site (or C82.x for transformation from FL). Most patients have failed prior anti-CD20
chemoimmunotherapy (R-CHOP) and salvage regimens before reaching bispecific therapy.
How long do patients stay on Columvi?
Columvi is fixed-duration therapy — 12 cycles maximum, NOT continued indefinitely until progression. After 12 cycles complete, patients are observed off therapy. Unlike Lunsumio (which splits at C8: 8 cycles for CR, up to 17 for PR), Columvi does not extend based on response. The course is the course. This is a major differentiator vs the indefinite multiple myeloma bispecific antibodies (Tecvayli, Elrexfio).
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- Genentech HCP — Columvi prescribing information
- FDA Columvi label PDF (BLA 761309)
- Genentech Access Solutions — Columvi coding & coverage
- CMS — Medicare Part B Drug ASP Pricing File
- NCCN B-Cell Lymphomas Guidelines
- UnitedHealthcare — Oncology Medication Clinical Coverage Policy
- Aetna — CPB / Medical Drug policy for bispecific antibody therapies
- FDA National Drug Code Directory
- SEER CanMED — HCPCS J9286 reference
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, Cigna, 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 | Event-driven | Tied to manufacturer document version + FDA label revision date. Watch for confirmatory trial readout that may convert accelerated approval to full approval. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS,
manufacturer, 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
- — Initial publication. ASP data: Q2 2026. Manufacturer source: Genentech 2026 access materials. FDA label: accelerated approval Jun 15, 2023. Approved indication: R/R DLBCL NOS or LBCL arising from FL after ≥2 prior systemic therapies. CD20×CD3 bispecific landscape (Lunsumio IV / Epkinly SC / Columvi IV) referenced. 2.5 mg unit basis flagged as biller error trap. Day -7 Gazyva pretreatment requirement documented.
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 and dosing are verified against the current FDA label revision. We do not paraphrase from billing-software vendor blogs.