Carvykti (ciltacabtagene autoleucel) — HCPCS Q2056
CareCost Estimate · CAR-T Billing Cheat Sheet
Janssen Biotech (J&J) / Legend Biotech
Autologous anti-BCMA CAR-T (NOT CD19) · Dual BCMA-binding domain, 4-1BB costim · Single IV infusion
FACT-accredited center only
First CAR-T in 2L+ MM (Apr 5, 2024, CARTITUDE-4)
Reviewed: May 22, 2026
ASP: Q2 2026
GATE: FACT (or FACT-JACIE) accreditation + CARVYKTI REMS certification (Janssen, separate from Abecma/BMS/Kite REMS) + indication gate: 2L+ MM = lenalidomide-refractory (CARTITUDE-4); 4L+ MM = ≥4 prior lines incl. PI + IMiD + anti-CD38 (CARTITUDE-1) + baseline neurological exam + planned Parkinsonism/MNT surveillance schedule. Missing any = #1 cause of Carvykti claim denial.
The 5-stage Carvykti CAR-T workflow
- ApheresisCPT 38206 / 0540T
FACT center
- Manufacture~5-7 weeks (longest commercial CAR-T)
Dual VHH BCMA CAR build
- LymphodepleteFlu 30 + Cy 300 mg/m^2
days -5 to -3
- CAR-T infusionQ2056 + 0537T-0541T
Single bag, 0.5-1.0 x 10^6/kg
- CRS / ICANS + MNTToci J3262 acute
Parkinsonism surveillance ≥1 yr
HCPCS
Q2056
BCMA (NOT CD19) · 1 unit = 1 dose
Route
Single IV bag
Patient-specific
Inpatient DRG
018
Outpatient APC rare
Admin CPTs
0537T-0541T
Cat III CAR-T set
Q2 2026 ASP+6%
$622,908.548
per single dose
Codes & NDC
| HCPCS | Q2056 — "Ciltacabtagene autoleucel, up to 100M autologous BCMA-directed CAR+ T cells, per therapeutic dose" |
|---|
| NDC | 57894-502-XX Janssen labeler 57894 + product suffix 502; patient-specific lot |
|---|
| ICD-10-PCS | XW033C3 peripheral / XW043C3 central — drives MS-DRG 018 (inpatient only) |
|---|
| Indications | R/R MM 2L+ lenalidomide-refractory (CARTITUDE-4); R/R MM 4L+ post-PI/IMiD/anti-CD38 (CARTITUDE-1) |
|---|
| Benefit | Medical (hospital buy-and-bill); REMS-restricted |
|---|
The 4-claim cadence (+ extended surveillance)
| 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 | Q2056 x 1 unit + 0537T-0541T + XW033C3/XW043C3 |
| D | CRS readmit (if) | Principal manifestation DRG + D89.83x + G92.0x |
| E+ | MNT surveillance | 99213-99215 + G20.A1/A2 (Parkinsonism) at baseline, +1mo, +3mo, +6mo, +12mo |
Encounter spans 8-12 weeks across 3-4 distinct index claims, plus ≥1 year of neurological surveillance. Vein-to-vein ~5-7 weeks (longest of any commercial CAR-T). Document chain of identity (Janssen labeler 57894) on every claim file.
CARVYKTI REMS & FACT — required
Closed distribution. All three layers must be in place before any apheresis:
- Facility on Janssen Carvykti Treatment Center list (FACT or FACT-JACIE + CRS/ICANS capability + tocilizumab on hand + neurological monitoring infrastructure for MNT)
- Prescriber completed CARVYKTI REMS training (includes Parkinsonism/MNT module) + enrolled
- Pharmacy / cell lab verifies prescriber + facility cert before accepting cellular product
Common error: Abecma cert does NOT extend to Carvykti. Janssen administers its own REMS independent of BMS Cell Therapy 360. Verify Janssen Carvykti-specific certification before scheduling Stage 1.
BCMA cellular therapy disambiguation
| Brand | HCPCS | Class & positioning |
|---|
| Carvykti (cilta-cel) | Q2056 | BCMA CAR-T, dual binding, 4-1BB; 2L+ MM lenalidomide-refractory; Janssen 57894 |
| Abecma (ide-cel) | Q2055 | BCMA CAR-T, single binding, 4-1BB; 3L+ MM; BMS |
| Tecvayli (teclistamab) | J9380 | BCMA x CD3 bispecific Ab; SC dosing; 4L+ MM; Janssen |
| Elrexfio (elranatamab) | J-code | BCMA x CD3 bispecific Ab; SC dosing; 4L+ MM; Pfizer |
Carvykti is the only CAR-T approved at 2L+ in multiple myeloma. NOT a CD19 CAR-T. Q2056 (BCMA) is NOT interchangeable with Q2041/Q2042/Q2053/Q2054 (CD19 for lymphoma/leukemia). Chain-of-identity label is authoritative.
ICD-10 — myeloma + Carvykti-specific
| Code | For |
|---|
C90.00 | Multiple myeloma, not in remission (primary) |
C90.02 | Multiple myeloma in relapse (primary) |
| Chart narrative | Lenalidomide-refractory (2L+) / 4L+ triple-class |
Z79.899 | Long-term drug therapy / prior CAR-T history |
Z94.84 | Stem cell transplant status (post-HSCT) |
D89.831-D89.835 | CRS by grade (G1-G5) |
G92.0x | ICANS (acute + delayed MNT per current guidance) |
G20.A1 / G20.A2 | Drug-induced Parkinsonism (Carvykti MNT, FY2024+) |
D76.1 / D76.2 | HLH / MAS (boxed warning) |
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 (default) | Inpatient (21) most common | MS-DRG 018 bundled |
| Stage 4 CAR-T (outpatient rare) | HOPD (22) | OPPS APC 9248 + Q2056 line item |
| Stage 5 CRS readmit | Inpatient (21) | DRG by manifestation |
| Stage 5 MNT surveillance | Outpatient neurology (11/22) | E/M or Carvykti-bundled case rate |
Carvykti outpatient share is the lowest in CAR-T class (~5-15% vs Breyanzi 30-50%) because of moderate CRS rate and MNT monitoring complexity. MS-DRG 016 ≠ 018 (016 = autologous BMT). Confirm XW033C3/XW043C3 in current-FY grouper.
Medicare & NTAP (FY 2026)
| Field | Value |
|---|
| Q2056 ASP+6% | $622,908.548 / single dose (Q2 2026) |
| MS-DRG 018 | Dedicated CAR-T Immunotherapy DRG (since FY 2021) |
| NTAP | Verify current FY 2026 IPPS Final Rule for Carvykti NTAP status |
| Outpatient APC | APC 9248 historically; verify current OPPS Addendum B |
| NCD | NCD 110.24 (CAR-T) — covers both Carvykti indications |
Top denials — Carvykti-specific
| # | Reason |
|---|
| 1 | Non-FACT / non-CARVYKTI-REMS-certified center (Abecma cert does not extend) |
| 2 | 2L+: lenalidomide-refractory not documented (#1 CARTITUDE-4 gate) |
| 3 | 4L+: PI / IMiD / anti-CD38 triple-exposure not documented |
| 4 | Wrong Q-code: Q2055 (Abecma) on Carvykti claim |
| 5 | Wrong Q-code: CD19 CAR-T code (Q2041-Q2054) on Carvykti claim |
| 6 | Missing neurological monitoring plan in PA |
| 7 | Outpatient pathway denied (Carvykti default = inpatient) |
| 8 | Lymphodepletion: Cy 500 mg/m^2 billed when Carvykti uses 300 |
| 9 | Manufacturing failure / no product (do NOT bill Q2056) |
| 10 | Extended MNT E/M denied as bundled (check Carvykti contract) |
Patient assistance — Janssen CarePath
- Janssen CarePath — benefits, PA, appeal, case mgmt; copay (commercial). Same hub as other Janssen oncology products.
- Johnson & Johnson Patient Assistance Foundation (JJPAF) — free product for eligible uninsured / underinsured
- Foundations: PAN, HealthWell, LLS Co-Pay (myeloma funds open quarterly)
- Travel grants via Janssen CarePath + International Myeloma Foundation for patients >50-100 mi from FACT center
BOXED WARNING — CRS, ICANS, Parkinsonism/MNT, HLH/MAS, prolonged cytopenias, secondary malignancies: Carvykti carries delayed Parkinsonism/MNT unique among CAR-T products (median onset ~3 mo; CARTITUDE-1 ~5% incidence, lower in CARTITUDE-4 after risk-mitigation). REMS requires baseline + serial neuro assessments through ≥1 yr. ICD-10 G20.A1/A2 captures drug-induced Parkinsonism. Tocilizumab (J3262) on hand per REMS; ICU backup required.