Kymriah (tisagenlecleucel) — HCPCS Q2042
CareCost Estimate · CAR-T Billing Cheat Sheet
Novartis Pharmaceuticals
Autologous anti-CD19 CAR-T · Single IV infusion
FACT-accredited center only
First FDA-approved CAR-T (Aug 30, 2017)
Reviewed: May 22, 2026
ASP: Q2 2026
GATE: FACT (or FACT-JACIE) accreditation + KYMRIAH REMS certification (Novartis) + prior therapy lines documented per indication. Missing any one = #1 cause of CAR-T claim denial.
The 5-stage Kymriah CAR-T workflow
- ApheresisCPT 38206 / 0540T
FACT center
- Manufacture~3-4 wk wait
No billing
- LymphodepleteFlu J9185
+ Cy J9070
- CAR-T infusionQ2042 + 0537T-0541T
MS-DRG 018
- CRS / ICANSTocilizumab J3262
Monitor / readmit
HCPCS
Q2042
1 unit = 1 therapeutic dose
Route
Single IV
Patient-specific bag
Inpatient DRG
018
CAR-T Immunotherapy
Admin CPTs
0537T-0541T
Cat III CAR-T set
Q2 2026 ASP+6%
$614,180.808
per single dose
Codes & NDC
| HCPCS | Q2042 — "Tisagenlecleucel, up to 600M CAR+ viable T cells, incl leukapheresis + dose prep, per therapeutic dose" |
|---|
| NDC | 0078-0846-XX Novartis labeler 0078; patient-specific lot suffix from chain-of-identity label |
|---|
| ICD-10-PCS | XW033C3 peripheral / XW043C3 central — drives MS-DRG 018 |
|---|
| Indications | Peds B-ALL ≤25 (refr / 2nd+ relapse), R/R DLBCL 2L+, R/R FL 2L+ |
|---|
| Benefit | Medical (hospital buy-and-bill); REMS-restricted |
|---|
The 4-claim cadence
| Claim | Stage | Codes |
|---|
| A | Apheresis | 38206 or 0540T + 6A550Z2 (inpt) |
| B | Lymphodepletion | J9185 + J9070 + 96413/96415 |
| C | CAR-T infusion | Q2042 + 0537T-0541T + XW033C3 |
| D | CRS readmit (if) | Principal manifestation DRG + D89.83x + G92.0x |
Encounter spans 5-8 weeks across 3-4 distinct claims. Document chain of identity (apheresis date → ship → manufacture → return → infuse) on every claim file.
KYMRIAH REMS & FACT — required
Closed distribution. All three layers must be in place before any apheresis:
- Facility on Novartis KYMRIAH Treatment Center list (FACT or FACT-JACIE accredited + CRS/ICANS capability + tocilizumab on hand)
- Prescriber completed REMS training + enrolled
- Pharmacy / cell lab verifies prescriber + facility cert before accepting cellular product
Common error: apheresing at a FACT-accredited but non-Kymriah-certified center. Manufacturing cannot release without Novartis confirmation of treatment center certification.
CD19 CAR-T disambiguation
| Brand | HCPCS | Primary indication |
|---|
| Kymriah (tisa-cel) | Q2042 | Peds ALL, R/R DLBCL/FL |
| Yescarta (axi-cel) | Q2041 | R/R DLBCL/FL/LBCL |
| Tecartus (brexu-cel) | Q2053 | R/R MCL, adult B-ALL |
| Breyanzi (liso-cel) | Q2054 | R/R LBCL, CLL, FL, MCL |
Verify Q-code against the chain-of-identity label. Wrong-Q denials are common and final.
ICD-10 — by indication
| Code | For |
|---|
C91.02 | ALL in relapse (most common for ALL) |
C91.00 | ALL not in remission |
C83.30-C83.39 | DLBCL (site-stratified) |
C82.0x-C82.2x | FL grades 1-3a |
D89.831-D89.835 | CRS by grade (G1-G5) |
G92.0x | ICANS |
Z94.81 | Bone marrow transplant status (post-HSCT cases) |
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 (primary) | Inpatient FACT center (POS 21) | MS-DRG 018 bundled |
| Stage 4 CAR-T (outpt) | HOPD cellular therapy (22) | OPPS APC 9248 + Q2042 line-item |
| Stage 5 CRS readmit | Inpatient (21) | DRG by manifestation |
MS-DRG 016 ≠ 018. 016 = autologous BMT; 018 = CAR-T Immunotherapy. Confirm XW033C3/XW043C3 PCS code drives 018 in current-FY grouper.
Medicare & NTAP (FY 2026)
| Field | Value |
|---|
| Q2042 ASP+6% | $614,180.808 / single dose (Q2 2026) |
| MS-DRG 018 | Dedicated CAR-T Immunotherapy DRG (since FY 2021) |
| NTAP | Expired for Kymriah after FY 2021. Verify each IPPS Final Rule. |
| Outpatient APC | APC 9248 historically; verify current OPPS Addendum B |
| NCD | NCD 110.24 (CAR-T) — CED sunset 2022, standard coverage |
Top denials — CAR-T-specific
| # | Reason |
|---|
| 1 | Non-FACT-accredited center |
| 2 | Prior therapy lines not satisfied |
| 3 | REMS enrollment missing |
| 4 | Apheresis-to-infusion timeline not documented |
| 5 | Lymphodepletion missing or wrong agents |
| 6 | CRS / ICANS not coded properly |
| 7 | Wrong Q-code (Q2041 vs Q2042) |
| 8 | Wrong DRG (016 vs 018) |
Patient assistance — Novartis
- Kymriah Cares — benefits, PA assistance, copay (commercial)
- Novartis Patient Assistance Foundation (NPAF) — free product for eligible uninsured / underinsured
- Medicare foundations: PAN, HealthWell, CancerCare — verify open ALL / DLBCL / FL funds quarterly
- Travel grants available for patients >50-100 mi from FACT center
BOXED WARNING — CRS & ICANS: Cytokine release syndrome (~58-77%) and ICANS (~20-40%) are life-threatening. Tocilizumab (J3262) on hand mandatory. Inpatient observation per protocol. ICU backup required at all FACT centers.