HCPCS
J9321
0.16 mg = 1 unit
Phase 1
Identify what you're billing
Unusual unit basis, SC vs IV bispecifics, step-up dosing, and cycle-dependent maintenance frequency.
The CD20 × CD3 bispecific landscape FDA verified May 2026
Three CD20xCD3 bispecifics now share the relapsed/refractory B-cell lymphoma space. Epkinly is the only SC formulation.
Bispecific T-cell engagers for B-cell lymphoma redirect cytotoxic T cells against CD20+ malignant B cells. All three approved CD20×CD3 bispecifics carry a CRS Boxed Warning, but they differ on indication, route, unit basis, dosing schedule, and treatment duration. Coding teams must pick the right HCPCS, route, unit basis, and frequency schedule for each — with Epkinly's 0.16 mg per unit standing out as the single most error-prone billing element across the class.
| Epkinly (epcoritamab-bysp) | Lunsumio (mosunetuzumab-axgb) | Columvi (glofitamab-gxbm) | |
|---|---|---|---|
| HCPCS | J9321 | J9350 | J9286 |
| Unit basis | 0.16 mg = 1 unit | 1 mg = 1 unit | 1 mg = 1 unit |
| Manufacturer | AbbVie / Genmab | Genentech (Roche) | Genentech (Roche) |
| Indication | R/R DLBCL & R/R FL (≥2 prior lines) | R/R FL (≥2 prior lines) | R/R DLBCL (≥2 prior lines) |
| FDA approval | DLBCL: May 19, 2023 (full); FL: Jun 26, 2024 (accelerated) | Dec 22, 2022 (accelerated) | Jun 15, 2023 (accelerated) |
| Route | SC | IV | IV |
| Full treatment dose | 48 mg SC = 300 units | 30 mg IV = 30 units (60 mg = 60) | 30 mg IV = 30 units (1000 mg obinutuzumab pretreatment) |
| Maintenance frequency | Weekly C1–3, q2wk C4–9, q4wk C10+ | q3wk (C3+) | q3wk (C3+) |
| Treatment duration | Until progression | Fixed: 8 or up to 17 cycles | Fixed: 12 cycles |
| Step-up complexity | 2-step (0.16 / 0.8 mg) + intermediate (48 mg) + full (48 mg) | 3 doses (1 / 2 / 60 mg) | 2 doses (2.5 / 10 mg) + obinutuzumab pretreatment |
| Admin CPT | 96401 (chemo SC) | 96413 + 96415 | 96413 + 96415 |
| REMS? | No | No | No |
| Boxed warning | CRS + ICANS | CRS | CRS |
SC vs IV matters operationally. Epkinly's SC injection takes minutes and can fit into
office workflows once cycle 1 observation is complete. Lunsumio's IV infusion mandates infusion-suite chair
time (4 hr first dose, 2 hr subsequent). Columvi is also IV with extended chair time. The SC route is the
single biggest operational differentiator for Epkinly — lower chair-hour utilization, faster patient
throughput, and easier home-administration potential (though not yet labeled).
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. Epkinly does NOT carry REMS
but does carry a Boxed Warning for CRS + ICANS. The MM bispecifics also use 1 mg = 1 unit, not Epkinly's
0.16 mg unit basis.
The 0.16 mg unit basis — biller error trap CMS HCPCS verified May 2026
J9321 has the most unusual unit basis in the specialty oncology catalog. A 6.25× conversion error costs ~$15K per dose.
Unit-basis trap
J9321 = 0.16 mg per unit. NOT 1 mg per unit.
The CMS HCPCS descriptor for J9321 reads:
A 48 mg full treatment dose × (1 unit / 0.16 mg) = 300 units. A 0.8 mg step-up dose = 5 units. A 0.16 mg priming dose = 1 unit. A practice that sees "48 mg" on the order and bills "48 units" by reflex (the way Lunsumio and Columvi work at 1 mg = 1 unit) will under-bill by 252 units per dose — approximately $14,343 in lost reimbursement per administration.
"Injection, epcoritamab-bysp, 0.16 mg." Each
billable unit equals 0.16 milligrams of epcoritamab. To convert from milligrams (the unit
you order, dispense, and document) to billable units, divide milligrams by 0.16 — or
equivalently, multiply milligrams by 6.25.
A 48 mg full treatment dose × (1 unit / 0.16 mg) = 300 units. A 0.8 mg step-up dose = 5 units. A 0.16 mg priming dose = 1 unit. A practice that sees "48 mg" on the order and bills "48 units" by reflex (the way Lunsumio and Columvi work at 1 mg = 1 unit) will under-bill by 252 units per dose — approximately $14,343 in lost reimbursement per administration.
| Dose administered (mg) | Calculation | Billed units (J9321) | Reimbursement (Q2 2026 ASP+6%) |
|---|---|---|---|
| 0.16 mg (C1 D1 priming step-up) | 0.16 / 0.16 | 1 unit | $56.92 |
| 0.8 mg (C1 D8 intermediate step-up) | 0.8 / 0.16 | 5 units | $284.58 |
| 4 mg (informational / vial size) | 4 / 0.16 | 25 units | $1,422.90 |
| 48 mg (full treatment dose) | 48 / 0.16 | 300 units | $17,074.80 |
Audit your billing software conversion. Before processing a single Epkinly claim, validate
in your billing software that 48 mg administered triggers 300 units billed. Test the math
with a sample claim before going live. Many oncology billing modules default to mg-to-unit 1:1 conversion
and require explicit configuration for fractional unit basis HCPCS codes.
Per-mg reimbursement (informational)
For practices used to thinking in $/mg for cost comparisons, the implied per-mg ASP+6% is $355.73 per mg ($56.916 / 0.16 mg per unit). This is the apples-to-apples comparison vs Lunsumio at $654.542/mg and Columvi (varies by quarter). Epkinly's per-mg cost is materially lower than Lunsumio per mg, but Epkinly's full treatment dose is 48 mg vs Lunsumio's 30 mg maintenance — so per-dose cost ends up higher for Lunsumio.
Step-up dosing & cycle math FDA label verified May 2026
Cycle 1 has four scheduled doses with mandatory step-up. Premedication required for all four C1 doses.
Cycle 1 schedule (mandatory step-up + intermediate + first full)
| Day | Dose | Units billed (J9321) | Premedication | Post-dose observation |
|---|---|---|---|---|
| C1 Day 1 | 0.16 mg SC (priming step-up dose 1) | 1 unit | Yes — corticosteroid + antihistamine + antipyretic 30–120 min prior | Per CRS protocol |
| C1 Day 8 | 0.8 mg SC (intermediate step-up dose 2) | 5 units | Yes — same regimen | Per CRS protocol |
| C1 Day 15 | 48 mg SC (intermediate dose — first 48 mg) | 300 units | Yes — same regimen | 24 hours recommended (first 48 mg dose) |
| C1 Day 22 | 48 mg SC (first full treatment dose) | 300 units | Yes — same regimen | Per institutional protocol |
Worked example — first month total (Cycle 1 only)
# Cycle 1 (4 scheduled doses)
Day 1: 1 unit · Day 8: 5 units · Day 15: 300 units · Day 22: 300 units
Total Cycle 1 units: 606 units
# Cycle 1 drug cost (Q2 2026 ASP+6%)
606 units × $56.916 = $34,491.10
# Cycles 2-3 (4 weekly doses each = 8 weekly maintenance doses)
8 doses × 300 units = 2,400 units → $136,598.40
# Cycles 4-9 (2 q2wk doses each = 12 doses)
12 doses × 300 units = 3,600 units → $204,897.60
# First 9 cycles total (~9 months)
Year-1-equivalent total: ~6,606 units → ~$375,987
# Cycle 10+ (q4wk indefinite, 1 dose per 28-day cycle)
13 q4wk doses/year × 300 units = 3,900 units/year → ~$221,972/year ongoing
Day 1: 1 unit · Day 8: 5 units · Day 15: 300 units · Day 22: 300 units
Total Cycle 1 units: 606 units
# Cycle 1 drug cost (Q2 2026 ASP+6%)
606 units × $56.916 = $34,491.10
# Cycles 2-3 (4 weekly doses each = 8 weekly maintenance doses)
8 doses × 300 units = 2,400 units → $136,598.40
# Cycles 4-9 (2 q2wk doses each = 12 doses)
12 doses × 300 units = 3,600 units → $204,897.60
# First 9 cycles total (~9 months)
Year-1-equivalent total: ~6,606 units → ~$375,987
# Cycle 10+ (q4wk indefinite, 1 dose per 28-day cycle)
13 q4wk doses/year × 300 units = 3,900 units/year → ~$221,972/year ongoing
Premedication regimen
Required 30–120 minutes before each Cycle 1 dose (Days 1, 8, 15, AND 22). Per FDA label, premedication should be administered for all four scheduled C1 doses, not just step-up doses. Premedication may be modified or discontinued in subsequent cycles if no Grade 2 or higher CRS occurs.
- Corticosteroid: prednisolone 100 mg PO/IV (or equivalent: dexamethasone 15 mg PO/IV; methylprednisolone 80 mg IV)
- Antihistamine: diphenhydramine 50 mg PO/IV
- Antipyretic: acetaminophen 650–1000 mg PO
Cycle frequency schedule — weekly to q4wk taper FDA label verified May 2026
Maintenance frequency tapers in three stages: weekly (C1–3), q2wk (C4–9), then q4wk (C10+ until progression).
Cycle 1 (28 days)
Step-up → weekly
D1: 0.16 mg · D8: 0.8 mg · D15: 48 mg · D22: 48 mg
4 doses
4 doses
Cycles 2–3
48 mg weekly
Days 1, 8, 15, 22
4 doses per cycle × 2 cycles = 8 doses
4 doses per cycle × 2 cycles = 8 doses
Cycles 4–9
48 mg q2wk
Days 1 and 15
2 doses per cycle × 6 cycles = 12 doses
2 doses per cycle × 6 cycles = 12 doses
Cycle 10+ (until progression)
48 mg q4wk
Day 1 only
1 dose per cycle — indefinite ongoing
1 dose per cycle — indefinite ongoing
| Phase | Cycle range | Schedule | Doses per cycle | Cumulative doses |
|---|---|---|---|---|
| Step-up + first full | Cycle 1 | D1 (0.16 mg) · D8 (0.8 mg) · D15 (48 mg) · D22 (48 mg) | 4 | 4 (end C1) |
| Weekly maintenance | Cycles 2–3 | 48 mg SC weekly (D1, D8, D15, D22) | 4 | 12 (end C3) |
| q2wk maintenance | Cycles 4–9 | 48 mg SC every 2 weeks (D1, D15) | 2 | 24 (end C9) |
| q4wk maintenance | Cycle 10+ (until progression) | 48 mg SC every 4 weeks (D1) | 1 | 25 + 13 per year ongoing |
Why frequency tapers: Reduced risk of CRS and ICANS recurrence after the patient has
completed cycle 1 step-up and demonstrated tolerance. Weekly dosing during cycles 1–3 maintains
target serum levels during the highest-risk window for both CRS and tumor lysis. The q2wk taper at C4
and q4wk taper at C10 dramatically reduce visit burden and cost compared to indefinite weekly dosing.
Calendar planning: Cycles are 28 days. Patient who starts Cycle 1 in week 1 of January
will reach Cycle 4 (q2wk) in early April, Cycle 10 (q4wk) in early September of year 1. Practices should
model expected billing volume per quarter to reflect the tapering frequency — cycle 1–3 is the
peak billing period.
Until-progression therapy — major differentiator FDA label verified May 2026
Epkinly is continued indefinitely until disease progression or unacceptable toxicity. NOT fixed-duration like Lunsumio or Columvi.
Epkinly is dosed until disease progression or unacceptable toxicity, in contrast to its CD20×CD3 bispecific peers Lunsumio (fixed 8 or up to 17 cycles) and Columvi (fixed 12 cycles). This makes Epkinly's long-tail billing profile more similar to the multiple myeloma BCMA bispecifics (Tecvayli, Elrexfio) than to its CD20×CD3 peers.
| Bispecific | Treatment duration | Annual billing assumption |
|---|---|---|
| Epkinly (J9321) | Until progression | 13 q4wk doses/year ongoing once at C10+ (~$222K/year drug cost at Q2 2026 ASP+6%) |
| Lunsumio (J9350) | Fixed 8 cycles (CR) or up to 17 cycles (PR) | Course-total billing model; J9350 charges stop at end of fixed course |
| Columvi (J9286) | Fixed 12 cycles | Course-total billing model; J9286 charges stop at end of cycle 12 |
| Tecvayli (J9380) | Until progression | Indefinite ongoing dosing |
| Elrexfio | Until progression | Indefinite ongoing dosing |
Why this matters for projections and PA renewals: Epkinly patients require ongoing PA
re-authorization (typically annual) and ongoing copay assistance enrollment renewal. Annual cost projections
should assume q4wk dosing once the patient has reached Cycle 10. Fixed-duration peers stop drug billing
entirely after the protocol-defined endpoint — Epkinly does not.
NDC reference FDA NDC Directory verified May 2026
| Vial | Use | Notes |
|---|---|---|
| 4 mg / 0.8 mL single-dose vial | Cycle 1 step-up doses (Day 1 = 0.16 mg priming; Day 8 = 0.8 mg intermediate) | Step-up vial; small partial doses are drawn from this vial — JW (waste) commonly applies in step-up week |
| 48 mg / 0.8 mL single-dose vial | C1 D15 (48 mg intermediate), C1 D22 (first full), and all subsequent treatment doses | Standard treatment-dose vial; full-vial use, JZ applies (no waste) |
Pull manufacturer NDC at billing time. AbbVie publishes carton-level NDCs in their Epkinly
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).
Vial waste accounting: The 4 mg vial used for the C1 D1 (0.16 mg) and C1 D8 (0.8 mg) doses
will have substantial waste — bill JW (waste modifier) for the discarded portion on a separate claim
line, with units corresponding to the discarded mg / 0.16. The 48 mg vial used for all 48 mg doses has no
waste at the labeled dose. JZ applies to all 48 mg dose claims; JW typically applies on the C1 D1 and C1 D8
step-up dose claims.
Phase 2
Code the claim
SC chemo admin (96401) for SC oncology bispecific. JZ on full-vial doses; JW on step-up partial-vial waste.
Administration codes CPT verified May 2026
Epkinly is billed as chemotherapy administration SC (96401) — not therapeutic injection (96372) — and not IV chemo admin (96413).
| Code | Description | When to use |
|---|---|---|
96401 |
Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic | Primary code for every Epkinly SC injection. Most accurate for SC oncology bispecific. Pays materially more than 96372. |
96372 |
Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular | Some payers accept for SC immunotherapy. Verify per payer. 96401 is the more accurate code; 96372 may produce lower reimbursement. |
96413 / 96415 |
Chemotherapy administration, IV infusion (initial hour / each additional hour) | NOT applicable to Epkinly (SC only). Use these for IV bispecifics Lunsumio (J9350) and Columvi (J9286). |
96365 / 96366 |
Therapeutic IV infusion (non-chemo) | NOT appropriate. Wrong route (IV) and wrong category (therapeutic vs chemo). |
Why chemo admin SC for bispecific antibody: CPT chemotherapy administration codes apply to
complex monoclonal antibody administration regardless of mechanism of action. CPT 96401 is the SC analog of
96413 (IV chemo admin) and is the appropriate code for SC oncology biologics including bispecific T-cell
engagers. 96372 is the lower-paying generic SC therapeutic injection code — some payers will require
96372 by policy, but 96401 is the more accurate clinical reflection.
Same-day E/M and CRS observation: If the patient requires a significant separately
identifiable E/M service on the same day (e.g., CRS workup during cycle 1 step-up), bill the E/M with
modifier 25. Routine pre-injection clinical assessment is bundled with 96401.
Modifiers CMS verified May 2026
JZ — required when no waste
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. For Epkinly's 48 mg doses, the 48 mg / 0.8 mL single-dose vial is fully used — JZ applies to virtually every full-dose claim. JZ should be appended to the J9321 line for any C1 D15, C1 D22, and all C2+ doses (48 mg full doses).
JW — required for step-up waste
JW reports the discarded portion of a single-dose vial. For Epkinly step-up doses, the 4 mg vial is the smallest available size and is partially discarded for both the C1 D1 (0.16 mg used, 3.84 mg discarded = 24 units waste) and C1 D8 (0.8 mg used, 3.2 mg discarded = 20 units waste) doses. JW with the appropriate discarded units must be billed on a separate claim line for these step-up encounters. One of JZ or JW must be on every J9321 claim.
| Encounter | Vial | Used | Discarded | JZ or JW |
|---|---|---|---|---|
| C1 Day 1 (0.16 mg) | 4 mg vial | 1 unit (0.16 mg) | 24 units (3.84 mg) | JW on separate line for 24 discarded units |
| C1 Day 8 (0.8 mg) | 4 mg vial | 5 units (0.8 mg) | 20 units (3.2 mg) | JW on separate line for 20 discarded units |
| C1 Day 15 (48 mg) | 48 mg vial | 300 units (48 mg) | 0 units | JZ |
| C1 Day 22 (48 mg) | 48 mg vial | 300 units (48 mg) | 0 units | JZ |
| C2+ all 48 mg doses | 48 mg vial | 300 units (48 mg) | 0 units | JZ |
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 SC injection (e.g., CRS workup during cycle 1 step-up, ICANS neurologic exam).
340B modifiers (JG, TB)
For 340B-acquired Epkinly, follow your MAC's current 340B modifier policy. AbbVie's billing guide does not provide 340B-specific instructions for J9321.
ICD-10-CM — DLBCL and follicular lymphoma FY2026 verified May 2026
Epkinly is approved for adult R/R DLBCL (and high-grade B-cell lymphoma arising from indolent lymphoma) and R/R follicular lymphoma.
DLBCL family (C83.3x, C83.7x)
| ICD-10 | Description | Notes |
|---|---|---|
C83.30–C83.39 | Diffuse large B-cell lymphoma, by site | Primary DLBCL codes — including DLBCL not otherwise specified (NOS) and DLBCL arising from indolent lymphoma |
C83.70–C83.79 | Burkitt lymphoma, by site | For high-grade B-cell lymphoma per FDA label, when histologically appropriate |
C83.80–C83.89 | Other non-follicular lymphoma, by site | For high-grade B-cell lymphoma not otherwise classified; verify histology supports |
C85.20–C85.29 | Mediastinal (thymic) large B-cell lymphoma, by site | NOT a labeled indication; verify per-payer if used |
Follicular lymphoma family (C82.x)
| ICD-10 | Description | Notes |
|---|---|---|
C82.00–C82.09 | Follicular lymphoma grade 1, by site | Common low-grade FL |
C82.10–C82.19 | Follicular lymphoma grade 2, by site | Common low-grade FL |
C82.20–C82.29 | Follicular lymphoma grade 3, by site | Higher-grade FL |
C82.30–C82.39 | Follicular lymphoma grade 3a, by site | Subset of grade 3 |
C82.40–C82.49 | Follicular lymphoma grade 3b, by site | Subset of grade 3 |
C82.50–C82.59 | Diffuse follicle center lymphoma, by site | Variant FL pattern |
C82.60–C82.69 | Cutaneous follicle center lymphoma, by site | Cutaneous variant; verify per-payer eligibility |
Documentation requirements: Most payers require documented DLBCL or FL diagnosis (with
histology confirmation by IHC), prior treatment with at least 2 lines of systemic therapy (typically
including anti-CD20 mAb such as rituximab or obinutuzumab plus chemoimmunotherapy
like R-CHOP, R-bendamustine, or BR), and disease progression or refractory status before Epkinly PA approval.
For DLBCL, prior CAR-T failure is increasingly required as well.
Site of care & place of service Verified May 2026
Epkinly's SC route makes it more amenable to outpatient delivery than the IV CD20×CD3 bispecifics (Lunsumio and Columvi). However, the 24-hour observation requirement after the Cycle 1 Day 15 first 48 mg dose typically anchors that single encounter to a hospital outpatient or extended-stay infusion suite. All other doses can be administered in standard oncology office or AIC settings with CRS-management capabilities and tocilizumab on hand.
| Setting | POS | Claim form | Epkinly applicability |
|---|---|---|---|
| Outpatient cancer center (extended observation) | 22 / 11 | Varies | Common for C1 D15 first 48 mg dose (24-hr observation required); ideal site once CRS-capable |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Common for C1 step-up encounters; subsequent doses may shift to office setting |
| Hospital inpatient observation | 21 | UB-04 / 837I | Sometimes used for first 48 mg dose if site lacks extended OP observation |
| Physician oncology office | 11 | CMS-1500 / 837P | Acceptable for C2+ doses once CRS risk has stabilized; SC injection fits office workflow |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Acceptable for C2+ doses with CRS protocols and tocilizumab in place |
| Patient home | 12 | CMS-1500 | Not currently appropriate — requires CRS-capable site per label |
SC route enables faster site-of-care transition. Once the patient completes Cycle 1
with no Grade 2+ CRS, subsequent SC doses can move to lower-acuity settings (office, AIC) with substantially
lower facility cost-share for the patient and shorter visit times. This is a meaningful operational
advantage vs the IV bispecifics that require infusion-suite chair time for every dose indefinitely.
Less stringent than MM bispecifics. Tecvayli, Elrexfio, and Talvey require 48-hour
observation after each step-up dose — effectively forcing inpatient admission. Epkinly's 24-hour
requirement (only after C1 D15 first 48 mg dose) keeps it predominantly outpatient-manageable.
Claim form field mapping AbbVie 2026
From AbbVie Epkinly access & coding 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 (0.8 mL for 4 mg or 48 mg vial) |
| HCPCS J9321 + JZ (or JW for step-up partial-vial waste) | 24D (drug line) | JZ on 48 mg full-vial doses; JW on C1 D1 and C1 D8 step-up doses for discarded portion |
| Drug units | 24G | 1 unit = 0.16 mg. 48 mg = 300 units. 0.8 mg = 5 units. 0.16 mg = 1 unit. |
| CPT 96401 (admin line) | 24D (admin line) | Required for SC chemo admin (oncology bispecific) |
| ICD-10 | 21 | Most specific C83.3x / C83.7x (DLBCL) or C82.x (FL) per histology and site |
| PA number | 23 | Required by all major payers |
Phase 3
Get paid
PA + documented ≥2 prior lines + DLBCL/FL pathology are the universal requirements.
Payer policy snapshot Reviewed May 2026
PA universal. Documentation of ≥2 prior systemic therapies + DLBCL/FL confirmation by histology required.
| Payer | PA? | Documentation required | Site-of-care UM |
|---|---|---|---|
| UnitedHealthcare Oncology Med Coverage Policy |
Yes | DLBCL or FL Dx (IHC), ≥2 prior systemic therapies (anti-CD20 mAb + chemoimmunotherapy; CAR-T history typical for DLBCL), disease status | Aggressive: prefers extended-OP infusion centers and office for C2+ doses; HOPD challenges after first cycle |
| Aetna CPB + Medical Drug policy |
Yes | DLBCL or FL confirmation (histology + IHC), prior therapies documentation, line of therapy ≥3 | 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 and FL 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. In DLBCL, this almost always includes an anti-CD20 mAb (rituximab or obinutuzumab), a chemoimmunotherapy regimen (R-CHOP, R-EPOCH, or salvage R-ICE), and increasingly CAR-T (axi-cel or liso-cel) failure. In FL, the prior lines typically include anti-CD20 mAb plus chemoimmunotherapy (R-CHOP, R-bendamustine, or BR). Document prior lines clearly in PA submission — missing prior-therapy documentation is the #1 PA denial reason.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J9321
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6% per unit (0.16 mg)
$56.916
per 0.16 mg unit (J9321 unit basis)
ASP + 6% per mg (informational)
$355.73
$56.916 / 0.16 mg per unit
48 mg full dose (300 units)
$17,074.80
300 units × ASP+6%
Cycle 1 cost (4 doses): 1 + 5 + 300 + 300 = 606 units × $56.916 = ~$34,491.
Cycles 2–3 (8 weekly doses): 2,400 units × $56.916 = ~$136,598.
Cycles 4–9 (12 q2wk doses): 3,600 units × $56.916 = ~$204,898.
Cycle 10+ ongoing (q4wk, 13 doses/year): 3,900 units/year × $56.916 = ~$221,972/year
ongoing until progression. After ~2% sequestration: ~$217,500/year.
The 0.16 mg unit basis matters for sequestration math. When converting per-mg cost to
per-unit cost or vice versa, always include the 6.25 multiplier. ASP+6% per mg ($355.73) × 48 mg =
$17,074.80 = ASP+6% per unit ($56.916) × 300 units. The two methods must reconcile or your unit
conversion is wrong.
Coverage
No NCD specific to epcoritamab. Coverage falls under MAC LCDs for biologics + the generic drug-coverage framework. All MACs cover J9321 for the FDA-approved R/R DLBCL and R/R FL indications with appropriate ICD-10 and prior-therapy documentation.
Code history
- J9321 — permanent code, "Injection, epcoritamab-bysp, 0.16 mg" — replaced earlier unclassified J3490 / J9999 use during the post-approval / pre-permanent-code period
Patient assistance — AbbVie myAbbVie Assist AbbVie verified May 2026
- myAbbVie Assist (Patient Assistance Foundation): 1-844-EPKINLY (1-844-375-4659) — benefits investigation, prior authorization assistance, appeal support, alternate funding identification; free product for uninsured / underinsured patients meeting income requirements
- Epkinly Co-Pay Card (commercial only): $0 copay for eligible commercially-insured patients; specific annual maximum — verify current cap with AbbVie. Excludes Medicare, Medicaid, federal program patients.
- Foundations: for Medicare patients, refer to PAN Foundation, HealthWell, CancerCare, Leukemia & Lymphoma Society Co-Pay Assistance — verify open lymphoma / DLBCL / FL funds quarterly
- Web: epkinly.com / abbviepatientassistancefoundation.org
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance,
and OOP max? Run a CareCost Estimate — J9321 pre-loaded with the
correct 0.16 mg unit basis.
Phase 4
Manage safety & fix denials
CRS + ICANS protocols, Tocilizumab on hand, and clean PA documentation prevent the most expensive errors.
CRS & ICANS management — Boxed Warning protocol FDA label verified May 2026
CRS occurred in ~51% of patients; ICANS in ~6%. Both Boxed Warning. Mostly Grade 1–2 in pivotal trials.
BOXED WARNING: Cytokine release syndrome (CRS), including life-threatening or fatal
reactions, occurred in patients receiving Epkinly. Initiate Epkinly according to the recommended step-up
dosing schedule. Administer pretreatment medications. Monitor patients for signs and symptoms of CRS.
Withhold or permanently discontinue Epkinly based on severity.
Immune effector cell-associated neurotoxicity syndrome (ICANS), including life-threatening or fatal reactions, occurred in patients receiving Epkinly. Monitor patients for signs and symptoms of ICANS. Withhold or permanently discontinue Epkinly based on severity.
Immune effector cell-associated neurotoxicity syndrome (ICANS), including life-threatening or fatal reactions, occurred in patients receiving Epkinly. Monitor patients for signs and symptoms of ICANS. Withhold or permanently discontinue Epkinly based on severity.
CRS preparedness checklist
- Tocilizumab (Actemra) on hand — minimum 2 doses available before any Epkinly administration
- Premedication completed 30–120 min before each Cycle 1 dose (D1, D8, D15, AND D22) — corticosteroid + antihistamine + antipyretic
- 24-hour post-dose observation in a setting with telemetry and rapid response capability after the C1 D15 first 48 mg dose
- Vital signs monitoring per CRS grading protocol throughout Cycle 1
- CRS grading per ASTCT consensus criteria; intervention threshold typically Grade 2+
- Hospital admission contingency plan for Grade 3+ CRS
ICANS preparedness checklist
- Baseline neurologic exam before Cycle 1 Day 1; repeat before each subsequent dose during Cycle 1
- Monitor for confusion, dysphasia, tremor, headache, seizures throughout Cycle 1 and into Cycles 2–3
- ICANS grading per ASTCT consensus criteria
- Severe ICANS (Grade 3+) requires corticosteroids (dexamethasone or methylprednisolone), supportive care, and hospital admission
- Anti-seizure prophylaxis per institutional protocol for high-risk patients
CRS/ICANS incidence (pivotal trial)
| Event | Any grade | Grade 3+ | Most common timing |
|---|---|---|---|
| Cytokine Release Syndrome (CRS) | ~51% | ~2.5% | Cycle 1 (Days 1–22), peak around C1 D15 first 48 mg dose |
| ICANS (neurotoxicity) | ~6% | <1% | Cycle 1, less common after step-up |
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Severe under-billing — 48 units instead of 300 units | Practice billed 48 units for the 48 mg dose (1 mg = 1 unit reflex from Lunsumio/Columvi) | Resubmit corrected claim with 300 units. Audit billing software for 0.16 mg unit basis. This is the #1 J9321 error. |
| Insufficient prior therapy documentation | PA submitted without clearly documenting ≥2 prior systemic therapies | Resubmit with clear treatment history: anti-CD20 mAb course, chemoimmunotherapy regimen, CAR-T history (DLBCL), dates, response/progression. |
| DLBCL or FL diagnosis not confirmed | Generic NHL ICD-10 used instead of specific C83.3x or C82.x | Use most specific C83.3x (DLBCL) or C82.x (FL) code per histology. Submit IHC report. |
| Wrong admin code (96365 or 96413) | IV admin code billed for SC injection | Resubmit with 96401 (chemo SC, non-hormonal). Epkinly is SC only. |
| 96372 paid lower than expected | Therapeutic injection code billed instead of chemo SC | Use 96401 (chemo SC) where payer allows; appeal denial if 96401 rejected on payer policy grounds. |
| JZ missing on full-dose claim | 48 mg single-dose vial claim without JZ | Resubmit with JZ. Required since 7/1/2023 on every claim with no waste. |
| JW missing on step-up claim | 4 mg vial used for 0.16 mg or 0.8 mg dose without reporting waste | Bill JW on separate line for discarded units (24 units for C1 D1; 20 units for C1 D8). Required for full reimbursement of vial cost. |
| Step-up dosing not followed | Patient billed for 48 mg on C1 D1 without step-up | Cycle 1 MUST follow 0.16 / 0.8 / 48 / 48 mg schedule. Skipping step-up is a label deviation and a CRS safety issue. |
| Site of care (HOPD) | HOPD billing for maintenance doses on commercial plan with site-of-care UM | Move C2+ doses to office (POS 11) or AIC (POS 49). Submit medical necessity letter if HOPD required. |
| Confused with Lunsumio or Columvi | Wrong HCPCS used (J9350 or J9286 instead of J9321) | Epkinly = J9321 (DLBCL+FL, SC). Lunsumio = J9350 (FL, IV). Columvi = J9286 (DLBCL, IV). Verify drug + indication + route + unit basis. |
Frequently asked questions
What is the HCPCS code for Epkinly?
Epkinly (epcoritamab-bysp) is billed under HCPCS J9321 — "Injection, epcoritamab-bysp,
0.16 mg." The unit basis is highly unusual: 1 unit = 0.16 mg, which means 1 mg = 6.25 units.
The full 48 mg treatment dose bills as 300 units; the 0.8 mg step-up dose as 5 units; the
0.16 mg priming step-up dose as 1 unit. This is the most unusual unit basis in the specialty oncology
catalog and a major source of biller error.
How is Epkinly dosed?
Cycle 1: Day 1 = 0.16 mg SC (priming step-up), Day 8 = 0.8 mg SC (intermediate step-up), Day 15 = 48 mg SC (intermediate dose with 24-hour observation), Day 22 = 48 mg SC (first full treatment dose). Cycles 2–3: 48 mg SC weekly. Cycles 4–9: 48 mg SC every 2 weeks. Cycle 10+: 48 mg SC every 4 weeks until disease progression or unacceptable toxicity. Treatment is NOT fixed-duration like Lunsumio (8–17 cycles) or Columvi (12 cycles).
Is Epkinly IV or subcutaneous?
Epkinly is subcutaneous (SC) injection only. This distinguishes it from the IV CD20×CD3 bispecifics Lunsumio (J9350) for FL and Columvi (J9286) for DLBCL. SC injection takes minutes; IV peers require infusion-suite chair time of 2–4 hours per dose. Bill CPT 96401 (chemo SC, non-hormonal anti-neoplastic) for the SC oncology bispecific.
What administration CPT do I use for Epkinly?
CPT 96401 — "Chemotherapy administration, subcutaneous or intramuscular; non-hormonal
anti-neoplastic" — is the primary code. Some payers accept 96372 (therapeutic SC/IM
injection) for SC immunotherapy, but 96401 is the more accurate code and pays materially more. Do NOT bill
IV chemo admin (96413, 96415) — Epkinly is SC, not IV.
Does Epkinly have a REMS program?
No formal FDA REMS for Epkinly — like the other CD20×CD3 bispecifics Lunsumio and Columvi, and unlike the multiple myeloma BCMA bispecifics (Tecvayli, Elrexfio, Talvey) which carry REMS programs. However, Epkinly carries a Boxed Warning for both Cytokine Release Syndrome (CRS, ~51%) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS, ~6%). Tocilizumab (Actemra) must be on hand. 24-hour observation is required after the Cycle 1 Day 15 first full treatment dose.
What is the Medicare reimbursement for J9321?
For Q2 2026, the Medicare Part B payment limit for J9321 is $56.916 per 0.16 mg unit (ASP + 6%), which equals $355.73 per mg. The 48 mg full treatment dose bills as 300 units and reimburses at approximately $17,074.80; the 0.8 mg step-up dose bills as 5 units and reimburses at $284.58; the 0.16 mg priming dose bills as 1 unit and reimburses at $56.92. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.
What indications is Epkinly approved for?
Two indications: (1) adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified — including DLBCL arising from indolent lymphoma — and high-grade B-cell lymphoma, after at least 2 prior lines of systemic therapy (full approval May 19, 2023); and (2) adult patients with relapsed or refractory follicular lymphoma (FL) after at least 2 prior lines of systemic therapy (accelerated approval June 26, 2024). DLBCL ICD-10 codes are in the C83.3x (DLBCL) and C83.7x (Burkitt) family; FL codes are in the C82.x family.
How long do patients stay on Epkinly?
Epkinly is continued until disease progression or unacceptable toxicity — NOT fixed-duration. This is a major differentiator vs Lunsumio (fixed 8–17 cycles) and Columvi (fixed 12 cycles). Patients who tolerate therapy and continue to respond may stay on Epkinly for years, with dosing frequency tapering: weekly during Cycles 1–3, every 2 weeks during Cycles 4–9, then every 4 weeks from Cycle 10 onward. The cycle-dependent frequency reduces patient burden over time but billing continues until discontinuation.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- AbbVie — Epkinly Prescribing Information (FDA-approved label)
- AbbVie — Epkinly HCP information
- 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 J9321 reference
- AbbVie Patient Assistance Foundation / myAbbVie Assist
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 AbbVie document version + FDA label revision date. Watch for FL accelerated-approval confirmatory readout that may convert to full approval. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS, AbbVie,
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 — particularly the 0.16 mg unit basis math, which is the highest-error-risk element on this page.
Change log
- — Initial publication. ASP data: Q2 2026. Manufacturer source: AbbVie 2026 access materials. FDA label: DLBCL full approval May 19, 2023 (BLA 761324); FL accelerated approval June 26, 2024. CD20×CD3 bispecific landscape (Epkinly SC / Lunsumio IV / Columvi IV) referenced. Unit basis (0.16 mg = 1 unit) flagged as primary biller-error risk.
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.