Breyanzi (lisocabtagene maraleucel) — HCPCS Q2054
CareCost Estimate · CAR-T Billing Cheat Sheet
Bristol-Myers Squibb (Juno Therapeutics)
Autologous anti-CD19 CAR-T (4-1BB costim, 1:1 CD8:CD4) · Two-bag IV infusion
FACT-accredited center only
First CAR-T in CLL/SLL (Mar 14, 2024, TRANSCEND CLL 004)
Reviewed: May 22, 2026
ASP: Q2 2026
GATE: FACT (or FACT-JACIE) accreditation + BREYANZI REMS certification (BMS, separate from Kite REMS) + indication gate: 2L LBCL = "primary refractory" or "≤12 mo relapse"; CLL/SLL = prior BTKi failure AND prior BCL-2i (venetoclax) failure; MCL = BTKi failure; 3L+ LBCL / FL = ≥2 prior lines incl. anti-CD20. Missing any = #1 cause of CAR-T claim denial.
The 5-stage Breyanzi CAR-T workflow
- ApheresisCPT 38206 / 0540T
FACT center
- Manufacture~24-35 days
CD8 + CD4 separate
- LymphodepleteFlu 30 + Cy 300 mg/m^2
days -5 to -3 (Cy lower than Yescarta)
- CAR-T infusionQ2054 + 0537T-0541T
2 bags (CD8 then CD4) = 1 dose
- CRS / ICANSTocilizumab J3262
Lowest rates in CD19 class
HCPCS
Q2054
1 unit = 1 dose (both bags)
Route
2 sequential IV bags
CD8 first, CD4 minutes later
Inpatient DRG
018
Outpatient APC also common
Admin CPTs
0537T-0541T
Cat III CAR-T set
Q2 2026 ASP+6%
$562,260.836
per single dose
Codes & NDC
| HCPCS | Q2054 — "Lisocabtagene maraleucel, up to 110M autologous anti-CD19 CAR+ viable T cells, incl leukapheresis + dose prep, per therapeutic dose" (110M, not 200M like Yescarta/Tecartus) |
|---|
| NDC | 73154-001-XX BMS/Juno labeler 73154 + product suffix 001; patient-specific lot. Two component bags share NDC family with bag-specific COI tags. |
|---|
| ICD-10-PCS | XW033C3 peripheral / XW043C3 central — drives MS-DRG 018 (inpatient only) |
|---|
| Indications | R/R LBCL 2L+ & 3L+ (TRANSFORM, TRANSCEND NHL 001); R/R CLL/SLL 1st CAR-T (TRANSCEND CLL 004); R/R FL (TRANSCEND FL); R/R MCL post-BTKi |
|---|
| Benefit | Medical (hospital buy-and-bill); REMS-restricted |
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The 4-claim cadence
| Claim | Stage | Codes |
|---|
| A | Apheresis | 38206 or 0540T + 6A550Z2 (inpt) |
| B | Lymphodepletion | J9185 30 mg/m^2 + J9070 300 mg/m^2 + 96413/96415 days -5 to -3 |
| C | CAR-T infusion | Q2054 x 1 unit (covers both bags) + 0537T-0541T + XW033C3/XW043C3 |
| D | CRS readmit (if) | Principal manifestation DRG + D89.83x + G92.0x |
Encounter spans 5-8 weeks across 3-4 distinct claims. Vein-to-vein ~24-35 days (longest in CD19 class — CD8 + CD4 separate processing). Document chain of identity on every claim file. Do NOT bill Q2054 twice for the two bags — one therapeutic dose, one unit.
BREYANZI REMS & FACT — required
Closed distribution. All three layers must be in place before any apheresis:
- Facility on BMS Breyanzi Treatment Center list (FACT or FACT-JACIE + CRS/ICANS capability + tocilizumab on hand)
- Prescriber completed BREYANZI REMS training + enrolled
- Pharmacy / cell lab verifies prescriber + facility cert before accepting cellular product; two-bag receipt protocol must be in place
Common error: Kite cert (Yescarta/Tecartus) does NOT extend to Breyanzi. BMS administers its own REMS independent of Kite. Verify BMS Breyanzi-specific certification before scheduling Stage 1.
CD19 CAR-T disambiguation
| Brand | HCPCS | Primary indication |
|---|
| Breyanzi (liso-cel) | Q2054 | Broadest CD19 footprint: R/R LBCL 2L+, CLL/SLL (1st CAR-T), FL, MCL |
| Yescarta (axi-cel) | Q2041 | R/R LBCL 2L+/3L+, R/R FL (Kite labeler 71287) |
| Kymriah (tisa-cel) | Q2042 | Peds/young adult ALL (≤25), R/R DLBCL/FL |
| Tecartus (brexu-cel) | Q2053 | R/R MCL post-BTKi, adult R/R B-ALL (Kite labeler 71287) |
Breyanzi is the only CD19 with 4-1BB + 1:1 CD8:CD4 + two-bag administration + 110M cell-count basis. BMS labeler 73154 distinguishes from Kite (71287) and Novartis. Verify against chain-of-identity label.
ICD-10 — by indication (5 indications)
| Code | For |
|---|
C83.30-C83.39 | DLBCL (LBCL 2L+ / 3L+) |
C85.20-C85.29 | PMBCL |
C91.10-C91.12 | CLL (NEW Mar 2024) |
C83.00-C83.09 | SLL |
C82.0x-C82.9x | Follicular lymphoma |
C83.10-C83.19 | MCL |
| Chart narrative | 2L LBCL timing / CLL dual BTKi+BCL-2i / MCL BTKi |
D89.831-D89.835 | CRS by grade (G1-G5) |
G92.0x | ICANS |
Site of care & payment
| Stage | Setting / POS | Payment |
|---|
| Stage 1 Apheresis | HOPD (22) or office (11) at FACT center | OPPS APC or MPFS |
| Stage 3 Lympho | HOPD (22) or office (11) | APC + J-codes |
| Stage 4 CAR-T (LBCL/CLL/FL low-risk) | Outpatient (22) common at qualifying centers | OPPS APC 9248 + Q2054 line item |
| Stage 4 CAR-T (higher-risk) | Inpatient (21) | MS-DRG 018 bundled |
| Stage 5 CRS readmit | Inpatient (21) | DRG by manifestation |
Breyanzi has highest outpatient share in CD19 CAR-T class (~30-50% at qualifying centers) thanks to <5% Grade 3+ CRS. MS-DRG 016 ≠ 018 (016 = autologous BMT). Confirm XW033C3/XW043C3 in current-FY grouper.
Medicare & NTAP (FY 2026)
| Field | Value |
|---|
| Q2054 ASP+6% | $562,260.836 / single dose (Q2 2026) |
| MS-DRG 018 | Dedicated CAR-T Immunotherapy DRG (since FY 2021) |
| NTAP | Expired for Breyanzi after FY 2024; 2024 CLL/FL/MCL approvals did not trigger new NTAP |
| Outpatient APC | APC 9248 historically (Breyanzi's dominant pathway); verify current OPPS Addendum B |
| NCD | NCD 110.24 (CAR-T) — covers all 5 Breyanzi indications |
Top denials — Breyanzi-specific
| # | Reason |
|---|
| 1 | Non-FACT / non-Breyanzi-REMS-certified center (Kite cert does not extend) |
| 2 | CLL/SLL: prior BTKi + BCL-2i failure not documented (#1 CLL/SLL gate) |
| 3 | 2L LBCL timing not documented ("primary refractory" / "≤12 mo") |
| 4 | Prior therapy lines not satisfied (LBCL 3L+, FL) |
| 5 | MCL: BTKi failure not documented |
| 6 | Wrong REMS letter (Kite REMS on a Breyanzi claim) |
| 7 | Q2054 billed twice for two bags (1 unit = 1 dose) |
| 8 | Wrong Q-code (Q2041/Q2042 on Breyanzi claim) |
| 9 | Lymphodepletion: Cy 500 mg/m^2 billed when Breyanzi uses 300 |
| 10 | Outpatient pathway rejected (cite low Grade 3+ CRS data) |
Patient assistance — BMS Cell Therapy 360
- BMS Cell Therapy 360 — benefits, PA, appeal, case mgmt; copay (commercial). Same hub as Abecma.
- BMS Patient Assistance Foundation (BMSPAF) — free product for eligible uninsured / underinsured
- Foundations: PAN, HealthWell, LLS Co-Pay (open lymphoma + CLL funds quarterly)
- Travel grants via BMS Cell Therapy 360 + LLS for patients >50-100 mi from FACT center
BOXED WARNING — CRS, ICANS, prolonged cytopenias, secondary T-cell malignancies: Breyanzi consistently posts lowest Grade 3+ CRS in CD19 CAR-T class (TRANSCEND NHL 001 ~2%, TRANSFORM ~1%, TRANSCEND CLL 004 ~9%). 4-1BB costim + 1:1 CD8:CD4 composition drive the favorable profile. Tocilizumab (J3262) still on hand per REMS; ICU backup still required.