Yescarta (axicabtagene ciloleucel) — HCPCS Q2041

Kite Pharma (a Gilead company) · Autologous anti-CD19 CAR-T cell therapy · Single IV infusion at a FACT-accredited center · First FDA-approved 2L CAR-T (April 1, 2022, ZUMA-7)

Yescarta is the Kite/Gilead anti-CD19 CAR-T product and the first CAR-T approved in the second-line LBCL setting based on ZUMA-7. The Q2041 single-dose code sits at the center of a five-stage encounter: leukapheresis, ~14-17 day manufacturing (fastest in class), lymphodepleting chemotherapy, CAR-T infusion, and CRS/ICANS monitoring. Administration is restricted to FACT-accredited centers certified under the YESCARTA REMS. Most admissions are billed inpatient under MS-DRG 018 (CAR-T Immunotherapy); commercial payers are increasingly steering low-risk cases to outpatient infusion. Q2 2026 Medicare payment limit per single dose: $531,849.118.

ASP data:Q2 2026 (live)
Payer policies:verified May 2026
IPPS/OPPS rules:FY 2026 Final Rule
FDA label:most recent rev
Page reviewed:

Instant Answer — the 5 things you need to bill Q2041

HCPCS
Q2041
1 unit = 1 dose
Therapeutic dose
1 unit
Single IV infusion, patient-specific
Setting
MS-DRG 018
FACT-accredited; outpatient APC option
Admin CPT
0537T–0541T
Cat III CAR-T administration set
Medicare ASP+6%
$531,849.118
per single dose, Q2 2026
HCPCS descriptor
Q2041 — "Axicabtagene ciloleucel, up to 200 million autologous anti-CD19 CAR positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose" Permanent
Indications (FDA)
(1) Adult R/R DLBCL after ≥ 2 prior lines including transformed FL and high-grade B-cell lymphoma — approved Oct 18, 2017 (ZUMA-1); (2) R/R follicular lymphoma after ≥ 2 prior lines — accelerated approval Mar 5, 2021 (ZUMA-5); (3) 2L R/R LBCL — primary refractory or relapse within 12 months of first-line chemoimmunotherapy — approved Apr 1, 2022 (ZUMA-7)
NDC
Patient-specific lot. Manufacturer carton NDC pattern: 71287-119-XX (Kite Pharma labeler 71287) for the cell product bag; verify the actual lot/NDC on the chain-of-identity label shipped with the patient's dose.
Cellular product
Single-dose IV infusion bag, autologous CD19 CAR-T cells with CD28 costimulatory domain. Target dose: 2 x 10^6 CAR-positive viable T cells per kg (max 2 x 10^8 total) for adult patients.
Lymphodepletion
Required, typically days -5 to -3: fludarabine 30 mg/m^2/day (J9185) + cyclophosphamide 500 mg/m^2/day (J9070). Separately billable.
Boxed warning
Cytokine Release Syndrome (CRS) · Neurologic Toxicity / ICANS · T cell malignancies — all three boxed warnings per FDA label rev. Feb 12, 2026. Yescarta has the highest CRS Grade 3+ rate in the CD19 CAR-T class. Tocilizumab (Actemra J3262) immediately available is mandatory for CRS management. T-cell malignancy warning class-wide for genetically modified T-cell immunotherapies (added 2024).
REMS
YESCARTA REMS required — only FACT-accredited centers certified by Kite Pharma can dispense and administer; prescriber + facility + pharmacy certification
Pivotal trials
ZUMA-1 (3L+ DLBCL), ZUMA-5 (R/R FL), ZUMA-7 (2L LBCL — practice-changing); supporting: ZUMA-12 (high-risk 1L), ZUMA-2 (Tecartus / sister product)
⚠️
FACT accreditation + YESCARTA REMS certification gate every Q2041 claim. Sites that administer Yescarta without both will be denied at adjudication, paid claims recouped, and may face FDA reporting. This is the #1 cause of Q2041 denial across all CAR-T products. Verify Kite Pharma certification and FACT/FACT-JACIE accreditation BEFORE scheduling apheresis. See REMS section and CD19 CAR-T class comparison.

The 5-stage Yescarta workflow at a glance

  1. Apheresis — 38206 / 0540T at FACT center
  2. Manufacture — ~14-17 day wait; no billing
  3. Lymphodeplete — flu (J9185) + cy (J9070)
  4. CAR-T infusion — Q2041 + 0537T-0541T
  5. CRS / ICANS — monitor + readmit if needed
Phase 1 Identify what you're billing CAR-T is a multi-stage encounter, not a single claim. Map the workflow first.

About Yescarta (axicabtagene ciloleucel)

Yescarta is the brand name for axicabtagene ciloleucel (axi-cel), an autologous chimeric antigen receptor (CAR) T-cell immunotherapy directed against the CD19 antigen, manufactured by Kite Pharma, a Gilead Sciences company. It is the second FDA-approved CAR-T cell therapy (October 18, 2017, six weeks after Kymriah) and the first CAR-T approved in the 2L LBCL setting based on the practice-changing ZUMA-7 trial (April 1, 2022). Each Yescarta dose is a patient-specific cellular product: the patient's own T cells are collected by leukapheresis, shipped to the Kite manufacturing facility, genetically modified to express the anti-CD19 CAR construct with a CD28 costimulatory domain, expanded, cryopreserved, and shipped back to the certified treatment center for infusion. Yescarta's vein-to-vein time is approximately 14-17 days, one of the fastest in the CAR-T class.

Yescarta carries three FDA-approved indications:

  • Adult relapsed/refractory large B-cell lymphoma (3L+) after at least two prior lines of systemic therapy, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma — approved October 18, 2017 based on the ZUMA-1 trial.
  • Relapsed/refractory follicular lymphoma (FL) after at least two prior lines of systemic therapy — accelerated approval March 5, 2021 based on the ZUMA-5 trial.
  • Adult relapsed/refractory large B-cell lymphoma in the second-line setting — primary refractory or relapse within 12 months of first-line chemoimmunotherapy — approved April 1, 2022 based on the ZUMA-7 trial. This was the first CAR-T approved at 2L and remains the dominant data-driven positioning argument vs Kymriah and Breyanzi.

Yescarta is billed under HCPCS Q2041 as a single therapeutic dose. The HCPCS descriptor explicitly bundles the leukapheresis and dose preparation procedures into the Q-code, though most payers and CMS still permit separate billing of the apheresis CPT and lymphodepletion drugs in practice. Administration is restricted to FACT-accredited centers certified under the YESCARTA REMS program. Approximate list price (single dose): ~$424,000 USD.

CD19 CAR-T class — Yescarta vs Kymriah vs Tecartus vs Breyanzi FDA + payer review May 2026

Four anti-CD19 CAR-T products exist, plus two BCMA-targeted CAR-T products for myeloma. Coding and PA logic are not interchangeable.

ProductGenericHCPCSTargetPrimary indicationsManufacturer
Yescartaaxicabtagene ciloleucelQ2041CD19 (CD28 costim)R/R DLBCL/LBCL (2L+ & 3L+), R/R FLKite / Gilead
KymriahtisagenlecleucelQ2042CD19 (4-1BB costim)Peds ALL (≤25), R/R DLBCL, R/R FLNovartis
Tecartusbrexucabtagene autoleucelQ2053CD19 (CD28 costim)R/R mantle cell lymphoma, adult B-ALLKite / Gilead
Breyanzilisocabtagene maraleucelQ2054CD19 (4-1BB costim)R/R LBCL (2L+ incl. 2L), CLL/SLL, MCL, FLBMS / Juno
Different target class — BCMA CAR-T for myeloma (NOT CD19):
Abecmaidecabtagene vicleucelQ2055BCMAR/R multiple myeloma (3L+)BMS
Carvykticiltacabtagene autoleucelQ2056BCMAR/R multiple myeloma (1L+ as of 2024)Janssen / Legend
Do not substitute Q-codes. Each CAR-T product has its own Q-code, REMS program, and FACT certification. A claim submitted with the wrong Q-code will be denied even if every other field is correct. The chain-of-identity label on the patient's cellular product is the authoritative source for which Q-code to bill. Q2041 (Yescarta) and Q2042 (Kymriah) are the most-commonly-confused pair because both are adult CD19 CAR-T products.
When Yescarta is the typical choice over other CD19 CAR-T: primary refractory or early-relapsing (within 12 months) LBCL at 2L — Yescarta is the only CAR-T with full FDA approval at 2L based on a head-to-head superiority trial (ZUMA-7 vs SOC chemoimmunotherapy + auto-HSCT). Breyanzi has a 2L LBCL approval based on TRANSFORM, also active. Yescarta is NOT approved for pediatric/young adult ALL (use Kymriah) or for mantle cell lymphoma (use Tecartus, the Yescarta sister product). Yescarta's faster vein-to-vein time (~14-17 days) is preferred for high-tumor-burden patients where time-to-infusion is clinically critical.
CD28 vs 4-1BB costimulatory domain. Yescarta and Tecartus use a CD28 costimulatory domain; Kymriah and Breyanzi use 4-1BB. CD28 generally drives faster, more potent T-cell expansion with higher early-peak CRS and ICANS rates; 4-1BB tends toward slower expansion with longer persistence. This is the principal pharmacological reason Yescarta has the highest CRS Grade 3+ rate (~13-25% in ZUMA registries) among CD19 CAR-T products — an operational consideration for outpatient pathway decisions and ICU readiness.

The 5-stage CAR-T workflow FDA label + REMS verified May 2026

CAR-T billing is fundamentally different from standard drug billing because the encounter spans 4-6 weeks across multiple claims.

Stage 1
Apheresis
38205 / 38206 / 0540T
Autologous T-cell collection at a FACT-accredited apheresis center. Single 3-5 hour session, usually outpatient.
Stage 2
Manufacturing
No billing
~14-17 day wait (fastest in CAR-T class). Cells shipped to Kite facility for CAR transduction (CD28 costim), expansion, cryopreservation, release testing.
Stage 3
Lymphodepletion
J9185 + J9070
Days -5 to -3: fludarabine + cyclophosphamide. Outpatient or inpatient; bills separately under the drug J-codes and admin CPTs.
Stage 4
CAR-T infusion
Q2041 + 0537T-0541T
Day 0. Single IV bag infused over ~30 min at certified center. Inpatient MS-DRG 018 or outpatient OPPS APC.
Stage 5
CRS / ICANS
Tocilizumab J3262
Day +1 to +28+. Inpatient monitoring (or readmission from outpatient pathway). CRS in ~78-93%, ICANS in ~28-65% — highest in CD19 class.

Typical claim cadence

  1. Claim A — Apheresis encounter: CMS-1500 or UB-04 with 38206 (or 0540T) + supporting ICD-10. Often paid as outpatient hospital service or office procedure.
  2. Claim B — Lymphodepletion encounter(s): J9185 + J9070 with admin CPTs 96409/96413/96415 as appropriate. May span 3 outpatient visits or one short admission.
  3. Claim C — CAR-T admission: UB-04 inpatient with ICD-10-PCS procedure (XW033C3 or XW043C3) driving MS-DRG 018. Q2041 line-item is included in the DRG bundle. Or, in outpatient infusion path, UB-04 outpatient with APC payment + Q2041 + 0537T-0541T line items.
  4. Claim D — CRS/ICANS readmission (if applicable): Inpatient DRG based on principal manifestation (sepsis, respiratory failure, encephalopathy) with tocilizumab and supportive care billed within the DRG.

Dosing & cellular dose math FDA label verified May 2026

Yescarta is one therapeutic dose, calculated to a target 2 x 10^6 CAR-positive viable T cells per kg, capped at 2 x 10^8 total.

IndicationPatient populationTarget doseBill
R/R LBCL (3L+)Adult2 x 10^6 CAR-positive viable T cells per kg (max 2 x 10^8 total)1 unit of Q2041
R/R LBCL (2L — ZUMA-7)Adult, primary refractory or ≤12 mo relapse2 x 10^6 CAR-positive viable T cells per kg (max 2 x 10^8 total)1 unit of Q2041
R/R FLAdult2 x 10^6 CAR-positive viable T cells per kg (max 2 x 10^8 total)1 unit of Q2041
Q2041 is billed as one therapeutic dose regardless of the actual cell count infused. Unlike weight-based J-codes, you do not multiply units by mg or by cell count. The chain-of-identity label and Certificate of Analysis (COA) shipped with the cell product document the actual viable cell count and CAR-positivity for the patient record — but only one billable unit goes on the claim. Yescarta's HCPCS descriptor caps at 200 million CAR+ T cells; the per-kg target keeps doses for smaller patients well under the cap, while larger patients receive the fixed 2 x 10^8 ceiling.

Lymphodepletion dosing (Stage 3)

Per the FDA label, lymphodepletion is administered days -5 through -3 prior to Yescarta infusion. The Yescarta label regimen is fludarabine 30 mg/m^2 IV daily x 3 days (J9185) plus cyclophosphamide 500 mg/m^2 IV daily x 3 days (J9070) — identical for all three Yescarta indications. Each chemotherapy agent and each administration day generates a separate billable line.

# Adult, 1.85 m^2 BSA, 70 kg, R/R DLBCL receiving full Yescarta sequence

# Stage 1 (apheresis):
CPT 38206 (autologous hematopoietic harvesting) x 1
ICD-10-PCS 6A550Z2 (apheresis, leukapheresis, single)

# Stage 3 (lymphodepletion, days -5 to -3):
Fludarabine 30 mg/m^2 = 55.5 mg/day x 3 days = 167 mg total
Bill: J9185 167 units (1 mg = 1 unit) across 3 dates of service
Cyclophosphamide 500 mg/m^2 = 925 mg/day x 3 days
Bill: J9070 3 units (per 100 mg unit basis, days x 1)
Admin: 96413 + 96415 per infusion day

# Stage 4 (CAR-T infusion, day 0):
Target: 2 x 10^6 CAR+ T cells/kg x 70 kg = 1.4 x 10^8 CAR+ T cells (under the 2 x 10^8 cap)
Bill: Q2041 1 unit
Admin CPTs: 0537T (planning), 0538T (administration), 0539T (post-admin eval), 0541T (preparation)
Inpatient: MS-DRG 018 case, ICD-10-PCS XW033C3 (CAR-T cell therapy, peripheral vein, new technology, group 3)

# Stage 5 (monitoring +/- readmit):
Tocilizumab (Actemra) J3262 at 8 mg/kg IV per CRS dose if Grade 2+ develops
Bundled in DRG 018 if same admission; separately billable in outpatient pathway

NDC reference FDA NDC Directory + Kite verified May 2026

Yescarta uses a patient-specific NDC pattern - every patient's dose is uniquely identified by lot.

NDCStrengthPackage SizeUnits/Vial
71287-119-XX (Kite Pharma labeler 71287; XX = patient-specific lot suffix) Up to 2 x 10^8 CAR-positive viable T cells (target 2 x 10^6 / kg) Single-dose cryopreserved infusion bag, patient-specific 1 unit of Q2041 (= 1 therapeutic dose)
Patient-specific NDC pattern. Yescarta is not a stocked, fungible NDC. Each infusion bag is manufactured for one named patient and labeled with a chain-of-identity (COI) tag matching that patient. The carton-level NDC follows Kite labeler 71287; the lot suffix is patient-specific and must be transcribed exactly from the COI label onto the claim's N4 NDC field. Confirm the NDC on the shipped COA before infusion - the claim form NDC must match.
Why this matters for billing: Some payer claim-adjudication systems will not validate a CAR-T NDC against their formulary master file because the lot-specific NDC may not appear in static reference data. If you receive an automated NDC-not-found denial, escalate to the medical drug review queue and reference the Kite chain-of-identity documentation. Kite Konnect (the Yescarta patient hub) can supply documentation directly to payer escalation queues.

YESCARTA REMS + FACT accreditation Kite + FACT verified May 2026

Yescarta is available only through a restricted REMS program because of the boxed warnings for CRS and neurologic toxicity.

The YESCARTA REMS is administered by Kite Pharma and operates as closed distribution. Three certification layers must all be in place:

  • Facility certification (Kite Authorized Treatment Center): the hospital or cellular therapy center must be on the Kite-maintained list of authorized Yescarta Treatment Centers. Certification requires FACT or FACT-JACIE accreditation for cellular therapy, demonstrated capacity to recognize and manage CRS and ICANS (with particular attention to Yescarta's elevated CRS Grade 3+ rate), immediate availability of tocilizumab (Actemra) for IV use (minimum 2 doses on hand per certified site), and qualified ICU backup.
  • Healthcare provider certification: prescribing physicians must complete the YESCARTA REMS training and be enrolled.
  • Pharmacy / chain-of-custody certification: the receiving pharmacy and cellular therapy lab must verify physician + facility certification before accepting the patient-specific cellular product.

How to enroll / verify

  • Web: Kite maintains the YESCARTA REMS portal — check the most recent Yescarta Prescribing Information for the current REMS URL and contact. Kite Konnect (the patient hub) can route facility questions to the REMS team.
  • FACT accreditation: factwebsite.org — verify accreditation status of any center before referral.
  • Documentation: retain REMS enrollment confirmation in the patient chart and on every PA submission. Submit FACT accreditation certificate as a PA attachment.
Common error: referring a patient to an apheresis center that is FACT-accredited but NOT YESCARTA-REMS-certified. Apheresis collection at a non-certified center is the most common operational failure - the cells cannot be released to manufacturing without Kite confirmation of treatment-center certification. A center may be Kymriah-certified but not Yescarta-certified (each REMS is separately administered by each manufacturer). Confirm BOTH FACT accreditation AND Kite Yescarta certification for the apheresis facility, the manufacturing chain, and the infusion facility before scheduling Stage 1.
Phase 2 Code the claim (each stage has its own) Apheresis, lymphodepletion, CAR-T infusion, and CRS readmission each generate distinct claims with distinct logic.

Administration codes — the multi-stage code set CPT 2026 verified May 2026

Each of the 5 stages has its own administration code family. Map them to the correct claim.

Stage 1 - Apheresis

CodeDescriptionWhen to use
38206Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; autologousMost common code for CAR-T leukapheresis at most centers; broadly accepted by MACs and major commercial payers.
38205Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneicNOT applicable to autologous CAR-T. Listed here for disambiguation only.
0540TInsertion of central venous catheter for therapeutic apheresis (Category III, CAR-T-specific)Required by some commercial payers for CAR-T-specific apheresis service capture. Verify per-payer.
36511Therapeutic apheresis; for white blood cellsSome legacy payer policies prefer this code for the apheresis service itself. Verify.

Stage 3 - Lymphodepletion (chemo admin)

CodeDescription
96413Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug
96415each additional hour (List separately in addition to code for primary procedure)
96417each additional sequential infusion (different substance/drug), up to 1 hour
96409Chemotherapy administration; IV push, single or initial substance/drug

Stage 4 - CAR-T infusion administration set

CodeDescriptionWhen to use
0537TChimeric antigen receptor T-cell (CAR-T) therapy; harvesting of blood-derived T lymphocytes for development of genetically modified autologous CAR-T cells, per day (Category III)Planning / pre-collection encounter at the CAR-T center.
0538TCAR-T therapy; preparation of blood-derived T lymphocytes for transportation (Category III)Cell preparation and shipping service.
0539TCAR-T therapy; receipt and preparation of CAR-T cells for administration (Category III)Receipt of returned product and prep for infusion.
0540TCAR-T therapy; CAR-T cell administration, autologous (Category III)The infusion service itself. Bill on the day of Q2041 infusion. (Note: 0540T overloads as the apheresis admin code in some payer policies - verify usage by stage.)
96365 / 96413Standard IV infusion / chemo administration codesNOT appropriate. CAR-T cellular product infusion is a distinct service from standard drug infusion.
Category III status as of CPT 2026. The 0537T-0540T family remains Category III (emerging technology). AMA may transition these to Category I in a future revision. Always check the current AMA CPT release for code status changes - if Category I codes have been issued, payer adjudication logic shifts accordingly. Some payers reimburse 0537T-0540T at a fixed-fee or invoice-priced rate; others bundle into MS-DRG 018 for inpatient claims.

Stage 5 - CRS / ICANS management

Tocilizumab (Actemra, HCPCS J3262) is the FDA-approved CRS treatment. Dose for CRS: 8 mg/kg IV (max 800 mg), up to 4 doses. Bill J3262 with appropriate IV infusion admin code (96365). When CRS occurs during the inpatient CAR-T admission, tocilizumab is bundled in MS-DRG 018; when administered outpatient or during a separate readmission, bill J3262 line-item against the relevant ICD-10 (D89.83x for CRS - see ICD-10 section). Yescarta's higher CRS Grade 3+ rate means toci utilization is operationally higher than with Kymriah or Breyanzi — pharmacy preparation protocols should reflect this.

Modifiers CMS + CPT verified May 2026

Modifiers rarely apply to Q2041 itself

Unlike weight-based drug J-codes, the single-dose Q2041 code does not generate JW (drug waste) or JZ (no-waste single-dose container) reporting in most circumstances. The cellular product is one patient-specific infusion bag - it is either administered in its entirety to the labeled patient or the manufacturing fails and the product is not infused (in which case Q2041 is not billed). There is no partial-vial waste scenario analogous to small-molecule oncology drugs.

Some MACs still require JZ. Per the July 1, 2023 CMS single-dose container policy, a few MACs have interpreted Q2041 as a single-dose container subject to JZ when no waste occurs. Most do not. Check your MAC's article on JW/JZ applicability to cellular products before suppressing or adding the modifier.

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 a CAR-T-related procedure. Pre-infusion clinical assessment is bundled; a same-day workup for a new complication is separately reportable with 25.

340B modifiers (JG, TB)

Most CAR-T treatment centers are 340B-covered entities. For 340B-acquired Q2041, follow your MAC's current 340B modifier policy (JG or TB as required). Kite CAR-T discount and 340B interaction with the OPPS/IPPS payment is jurisdiction-specific - verify with your 340B compliance team.

Modifiers on lymphodepletion (Stage 3)

Lymphodepletion uses standard chemotherapy modifier rules - JW on partial-vial waste for fludarabine and cyclophosphamide as needed; JZ when no waste. These follow the standard J9185 and J9070 modifier logic and are unrelated to Q2041 billing.

ICD-10-CM & ICD-10-PCS coding FY2026 verified May 2026

Two coding systems matter: ICD-10-CM for diagnosis (every claim), ICD-10-PCS for the CAR-T procedure (inpatient only - drives MS-DRG 018).

ICD-10-CM diagnoses

IndicationCodeDescription
DLBCL / LBCLC83.30Diffuse large B-cell lymphoma, unspecified site
C83.31 - C83.38DLBCL, site-specified (nodal, abdominal, intrathoracic, etc.)
C83.39DLBCL, extranodal and solid organ sites
Primary mediastinal LBCLC85.20 - C85.29PMBCL (Yescarta-specific indication)
High-grade B-cell lymphomaC83.30 + clinical docHGBCL with MYC and BCL2 / BCL6 rearrangements; documented in chart
Follicular lymphomaC82.00 - C82.09FL grade 1
C82.10 - C82.19FL grade 2
C82.20 - C82.29FL grade 3a
Transformed FL to DLBCLC83.3x + C82.xUse both: principal C83.3x for DLBCL transformation, secondary C82.x for underlying FL history
Post-HSCTZ94.81Bone marrow transplant status (use when CAR-T follows prior HSCT)
CRSD89.831 - D89.835Cytokine Release Syndrome, by grade (D89.831 = G1, D89.832 = G2, D89.833 = G3, D89.834 = G4, D89.835 = G5)
ICANSG92.0xImmune effector cell-associated neurotoxicity syndrome (new code family, FY 2023+)

ICD-10-PCS procedures (inpatient claims)

CodeDescriptionUse
XW033C3Introduction of engineered autologous chimeric antigen receptor T-cell immunotherapy into peripheral vein, percutaneous approach, new technology group 3The primary PCS code that drives MS-DRG 018 for peripheral IV CAR-T administration.
XW043C3Introduction of engineered autologous CAR-T immunotherapy into central vein, percutaneous approach, new technology group 3For central-line CAR-T administration. Also maps to MS-DRG 018.
6A550Z2 / 6A551Z2Apheresis, leukapheresis, single/multipleStage 1 apheresis encounter (when billed inpatient).
Document prior therapy lines explicitly in the PA — especially for 2L. ICD-10 alone is not sufficient. For the 2L ZUMA-7 indication, the PA narrative MUST document either "primary refractory" or "relapse within 12 months of completion of first-line chemoimmunotherapy" — this is the distinguishing feature of 2L Yescarta eligibility. For 3L+ indications, list each prior regimen with class (anthracycline + anti-CD20 mAb for DLBCL/FL) and outcome. UHC, Aetna, Cigna, and most Medicare Advantage plans enforce this rigorously - missing 2L timing detail is the #1 cause of Yescarta PA denial in the 2L setting.

Site of care, place of service & DRG/APC mapping FY 2026 IPPS/OPPS verified May 2026

Inpatient FACT-accredited centers remain the dominant CAR-T setting; outpatient infusion is rising at qualifying centers.

StageSettingPOSClaim formPayment mechanism
Stage 1 ApheresisOutpatient hospital / FACT apheresis suite22UB-04 / 837IOPPS APC (apheresis-related)
Stage 1 Apheresis (office)Cellular therapy office at FACT center11CMS-1500 / 837PMPFS line-item 38206/0540T
Stage 3 LymphodepletionHospital outpatient infusion22UB-04 / 837IOPPS APC + J9185 + J9070
Stage 3 Lymphodepletion (alt)Oncology office11CMS-1500 / 837PJ9185 + J9070 line-item
Stage 4 CAR-T (primary)Inpatient FACT-accredited center21UB-04 / 837IMS-DRG 018 (CAR-T Immunotherapy) bundled
Stage 4 CAR-T (outpatient)Hospital outpatient cellular therapy22UB-04 / 837IOPPS APC 9248 (or current CAR-T APC) + Q2041 + 0537T-0540T
Stage 5 CRS readmitInpatient21UB-04 / 837IDRG by principal manifestation (sepsis, ARDS, encephalopathy)

MS-DRG 018 details

Effective FY 2021, CMS introduced MS-DRG 018 - "Chimeric Antigen Receptor (CAR) T-cell Immunotherapy" as a dedicated CAR-T DRG. Before FY 2021, CAR-T admissions defaulted to MS-DRG 016 (Autologous Bone Marrow Transplant w/ CC/MCC) which significantly under-reimbursed the cellular product cost. MS-DRG 018 is assigned when the ICD-10-PCS principal procedure is XW033C3, XW043C3, or a related new-technology code for autologous CAR-T administration. The relative weight for MS-DRG 018 is among the highest in the IPPS to reflect the ~$424K-650K cell product acquisition cost; the actual hospital payment under MS-DRG 018 still typically falls short of total acquisition cost in many cases.

MS-DRG 016 vs 018: MS-DRG 016 is reserved for traditional autologous bone marrow transplant cases; MS-DRG 018 is the dedicated CAR-T DRG. Submitting an XW033C3 procedure code with an MS-DRG 016 grouper output usually indicates an error in the encoder or DRG grouper version - verify against the current FY IPPS Final Rule grouper.

Outpatient CAR-T - APC payment

Where commercial payers (or select Medicare Advantage plans) require outpatient CAR-T infusion at a qualifying outpatient cellular therapy center, payment runs through OPPS. CMS established a CAR-T outpatient APC pathway; the specific APC number is updated annually in the OPPS Final Rule (APC 9248 has been used historically; verify the current rule). Outpatient billing reports Q2041 as a separately payable line item plus the 0537T-0540T administration set. If CRS develops within 7-30 days, admit to inpatient under a CRS-driven DRG (not back into MS-DRG 018).

Site-of-service trends, May 2026: approximately 15-25% of CAR-T cases now run through outpatient pathways at high-volume cellular therapy centers when CRS risk is low (low tumor burden, well-controlled comorbidities). For Yescarta specifically, payer outpatient steering is more cautious because Yescarta has the highest CRS Grade 3+ rate in the CD19 class; many payers reserve outpatient pathway for Breyanzi or Kymriah while keeping Yescarta inpatient. Verify per-payer.

Claim form field mapping - 4 claims, one encounter Kite + CMS verified May 2026

The CAR-T encounter spans 4 separate claims. Each has its own form, fields, and PA reference.

Claim A — Apheresis (Stage 1)

InformationUB-04 / 1500 fieldNotes
HCPCS / CPT24D (1500) or 44 (UB-04)38206 or 0540T per payer policy
ICD-10-CM21 (1500) or 67 (UB-04)Underlying diagnosis (e.g., C83.30 DLBCL)
ICD-10-PCS (inpatient only)74 (UB-04)6A550Z2 for the leukapheresis procedure
PA reference23 (1500) or 63 (UB-04)CAR-T PA approval number from payer

Claim B — Lymphodepletion (Stage 3)

InformationFieldNotes
Fludarabine24DJ9185 units = mg administered (1 mg = 1 unit); JZ or JW per waste
Cyclophosphamide24DJ9070 per 100 mg unit basis; multiple units per day
Admin CPT24D96413 + 96415 per chemo infusion day
NDC24A shadedN4 + 11-digit NDC for each chemo agent
ICD-1021Underlying diagnosis + Z51.11 (encounter for chemotherapy)

Claim C — CAR-T infusion (Stage 4)

InformationFieldNotes
Drug HCPCS44 (UB-04)Q2041 - 1 unit per single dose
NDC43 (UB-04)Patient-specific lot from chain-of-identity label (Kite labeler 71287)
ICD-10-CM principal67 (UB-04)Primary indication (e.g., C83.30 DLBCL, C82.20 FL grade 3a)
ICD-10-PCS principal74 (UB-04)XW033C3 (peripheral) or XW043C3 (central) - drives MS-DRG 018
CAR-T admin CPTs44 (UB-04)0537T, 0538T, 0539T, 0541T per service rendered (outpatient pathway)
REMS confirmationChart attachment + PAYESCARTA REMS certification letter for facility and prescriber
FACT documentationPA attachmentFACT or FACT-JACIE accreditation certificate
2L timing (if ZUMA-7)PA narrative + chartDocument "primary refractory" or "relapse within 12 months of 1L completion" explicitly

Claim D — CRS / ICANS readmission (Stage 5, if applicable)

InformationFieldNotes
Principal ICD-10-CM67 (UB-04)Principal manifestation (sepsis A41.x, ARDS J80, encephalopathy G93.x) - NOT D89.83x as principal
Secondary ICD-10-CM67 (UB-04)D89.831-D89.835 (CRS by grade), G92.0x (ICANS), T80.89XA (other complication post-infusion) as secondary
Tocilizumab44 (UB-04)J3262 bundled in DRG when administered inpatient
Z-code67 (UB-04)Z51.11 history of CAR-T receipt may be added per coding guidance
Phase 3 Get paid REMS + FACT + prior lines + ECOG. CAR-T PA is the most documentation-heavy in oncology.

Payer policy snapshot Reviewed May 2026

All major payers require PA, FACT documentation, REMS enrollment confirmation, prior therapy lines, and ECOG performance status.

PayerPA?Key requirementsSite-of-care UM
UnitedHealthcare
Oncology Cellular Therapy Policy
Yes FACT certification, YESCARTA REMS center, prior lines per indication, ECOG 0-2 (varies by indication), no active CNS-2/3 disease, no active autoimmune disease, adequate organ function. For 2L: documented primary refractory or ≤12 month relapse. Approved CAR-T center only; outpatient pathway permitted at qualifying high-volume centers (less commonly approved for Yescarta vs Breyanzi due to CRS profile)
Aetna
CPB CAR-T cellular therapy
Yes FACT + YESCARTA REMS, indication-specific prior lines, ECOG 0-2; 2L LBCL aligned with ZUMA-7 Yes; outpatient pathway being evaluated case-by-case
Cigna
CAR-T Coverage Policy
Yes Aligned with FDA label and NCCN B-cell lymphoma Guidelines; FACT + REMS; 2L coverage matches ZUMA-7 criteria Plan-specific; most have cellular-therapy site steering
Medicare (NCD 110.24)
National Coverage Determination
No formal PA NCD 110.24 covers FDA-approved autologous CAR-T for FDA-approved indications at a FACT-accredited (or equivalent) hospital with appropriate ICD-10. 2L LBCL Yescarta is covered per the April 2022 FDA approval. Coverage with Evidence Development sunset 2022; standard coverage now applies. N/A FFS (Medicare Advantage plans apply their own UM)

NCCN Guidelines

NCCN B-Cell Lymphomas Guidelines (current version) include axicabtagene ciloleucel as a Category 1 recommendation for the 2L LBCL indication (post-ZUMA-7) and Category 2A for 3L+ DLBCL and R/R FL. NCCN compendium support strengthens 2L coverage arguments and bridges any payer-policy lag for newer indications like ZUMA-5 FL.

Required PA documentation checklist

  • FACT (or FACT-JACIE) accreditation certificate for the treatment center
  • YESCARTA REMS certification letter for the prescribing physician and the facility
  • Prior therapy log: each regimen, dates, response, reason for discontinuation
  • For 2L LBCL: explicit documentation of "primary refractory" or "relapse within 12 months of first-line chemoimmunotherapy completion" (the ZUMA-7 eligibility gate)
  • ECOG performance status (most policies require 0-2)
  • Diagnostic pathology confirming CD19+ disease (for DLBCL/LBCL/FL)
  • Imaging / disease burden assessment within recent window (per payer policy, often 30-60 days)
  • CNS disease exclusion documentation (CNS-2/3 active disease is typically excluded for LBCL CAR-T)
  • Cardiac and pulmonary clearance (LVEF, pulmonary function tests as required)
  • Absence of active autoimmune disease requiring systemic immunosuppression

Medicare reimbursement CMS Q2 2026 (live)

Q2041 has a quarterly ASP payment limit; MS-DRG 018 sets the inpatient DRG payment; OPPS APC handles outpatient.

Q2 2026 payment snapshot — Q2041

Effective April 1 – June 30, 2026 · Based on Q4 2025 ASP submissions

Q2041 ASP + 6%
$531,849.118
per single therapeutic dose
MS-DRG 018 base
FY 2026 IPPS
CAR-T Immunotherapy DRG; weight set in IPPS Final Rule
NTAP status
Expired
Original Yescarta NTAP ended FY 2021 - verify each FY
ASP for Q2041 is unusual. Most CAR-T products have intermittently been ASP-priced in the CMS Part B Drug Pricing File, with quarter-to-quarter variability and occasional gaps where the manufacturer ASP submission has not been published. When Q2041 is not ASP-priced in the current quarter, MACs default to invoice pricing (provider's acquisition cost + 6%) or wholesale acquisition cost (WAC) as the payment basis. Verify the current quarter's ASP file before quoting reimbursement.

MS-DRG 018 - CAR-T Immunotherapy

Inpatient CAR-T admissions are reimbursed under MS-DRG 018, introduced in FY 2021. The DRG weight is set annually in the IPPS Final Rule and reflects the high cellular product acquisition cost. Despite MS-DRG 018's elevated weight, most hospitals report DRG 018 payment falls short of the total acquisition + admission cost in a material proportion of cases. ICD-10-PCS principal procedure XW033C3 (or XW043C3) drives the DRG assignment.

NTAP history

  • FY 2019 - FY 2021: Yescarta received CMS NTAP add-on payment, recognizing the gap between historical DRG payment and acquisition cost.
  • FY 2021 onward: NTAP for axicabtagene ciloleucel expired after the standard 3-year window. CMS replaced NTAP-and-old-DRG with the new MS-DRG 018 to set a permanent CAR-T-appropriate DRG.
  • Verify each FY: CMS occasionally extends or revises CAR-T add-on policy through the IPPS Final Rule. Confirm in the current Final Rule before assuming or disclaiming NTAP. Newer CAR-T indications (e.g., the 2022 2L ZUMA-7 approval) did not separately trigger new NTAP; the existing MS-DRG 018 covers all autologous CAR-T regardless of line of therapy.

Outpatient OPPS APC

Outpatient CAR-T infusion (Stage 4 in the outpatient pathway) is paid under OPPS through a CAR-T-specific APC. APC 9248 has historically been used for CAR-T cell therapy; CMS updates the precise APC and rate annually in the OPPS Final Rule. Q2041 is paid separately under OPPS when the infusion is outpatient (it is not packaged into the APC). Always verify the current OPPS Addendum B for the precise APC assignment.

Coverage

Medicare coverage of CAR-T is governed by NCD 110.24 (Chimeric Antigen Receptor T-cell Therapy). The NCD covers FDA-approved autologous CAR-T for FDA-approved indications administered at a facility enrolled in the FDA-required REMS program and with FACT (or equivalent) accreditation. Coverage with Evidence Development requirements (CED) sunset in 2022; standard coverage applies. Yescarta's 2022 2L LBCL approval (ZUMA-7) is covered under the same NCD without a separate coverage decision.

Patient assistance — Kite Konnect Kite verified May 2026

  • Kite Konnect: Kite-administered patient hub for Yescarta and Tecartus — benefits investigation, prior authorization assistance, appeal support, copay support (commercial-only), case-management through the multi-stage CAR-T encounter. Confirm the current phone and portal URL on the most recent Yescarta Patient Brochure shipped with the cellular product.
  • Gilead Advancing Access (PAP): Kite is a Gilead subsidiary; the Gilead Advancing Access Patient Assistance Program offers free product pathway for eligible uninsured and underinsured patients meeting federal poverty level (typically 500% FPL income threshold for oncology products; verify current). Application via the patient's CAR-T case manager. gileadadvancingaccess.com
  • Independent foundations (Medicare-eligible): for Medicare patients facing affordability gaps on lymphodepletion drugs, monitoring, and travel costs - refer to Patient Access Network Foundation (PAN), HealthWell Foundation, and CancerCare. Verify open DLBCL/LBCL and FL funds quarterly.
  • Travel and lodging: Yescarta is administered only at FACT-certified centers, often requiring travel. Kite Konnect and many treatment centers maintain travel grants for patients living > 50-100 miles from a treatment center.
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance, and OOP max? Run a CareCost Estimate — Q2041 pre-loaded.
Phase 4 Manage toxicity and fix problems Top denial reasons specific to CAR-T billing + the FAQ block.

Common denials & how to fix them

Denial reasonCommon causeFix
#1 - Non-FACT-accredited centerApheresis or infusion at a center without current FACT (or FACT-JACIE) accreditation, or center is Kymriah-certified but not Yescarta-certifiedRefer patient to a Kite-authorized Yescarta Treatment Center. Submit FACT certificate + Kite REMS letter as PA attachment. There is no workaround - non-FACT and non-Yescarta-REMS centers cannot bill Q2041.
#2 - 2L timing not documented (ZUMA-7 cases)PA narrative for 2L Yescarta missing explicit "primary refractory" or "≤12-month relapse from 1L" languageAdd explicit timing documentation: date of 1L completion, date of relapse, classification per ZUMA-7. Resubmit PA. This is the #1 cause of 2L Yescarta denial.
#3 - Prior therapy lines not satisfied (3L+ cases)PA narrative missing one or more required prior lines per indicationSubmit complete prior therapy log with regimen, dates, response, reason for stopping. For DLBCL/LBCL 3L+: must show anthracycline + anti-CD20 mAb. For FL: anti-CD20 mAb + alkylating agent.
#4 - REMS enrollment missingYESCARTA REMS certification letter not in chart or PASubmit Kite-issued REMS certification for prescriber and facility. Add to chart and PA narrative for all CAR-T claims at this center going forward.
#5 - Apheresis-to-infusion timeline not documentedChain of custody from apheresis through manufacturing to infusion not clearly mapped on the claim fileDocument apheresis date, ship date, manufacturing start, return ship date, and infusion date. Attach Kite chain-of-identity records. Use Z-codes and accurate DOS on each stage's claim.
#6 - Lymphodepletion missing or wrong agentsLymphodepletion not billed, or substitute agents (bendamustine, ATG) used in place of label fludarabine + cyclophosphamideBill J9185 + J9070 on the correct days (typically days -5 to -3 pre-infusion). If clinical contraindication required non-label lymphodepletion, document and appeal with letter of medical necessity.
#7 - CRS not coded properly post-infusionD89.83x (CRS by grade) or G92.0x (ICANS) not coded as secondary on the CAR-T admission or readmissionAdd D89.831-D89.835 by clinical grade on the CAR-T admission's secondary diagnosis list. For readmissions, code principal manifestation + CRS/ICANS as secondary. Yescarta cases require especially careful CRS grade documentation.
#8 - Wrong Q-code (Q2041 vs Q2042 confusion)Submitting Q2042 (Kymriah) on a Yescarta claim or vice versaVerify Q-code against the chain-of-identity label on the physical cellular product bag. Resubmit with correct code. Kite labeler 71287 = Yescarta; Novartis labeler 0078 = Kymriah.
#9 - Wrong DRG (MS-DRG 016 vs 018)Encoder grouping CAR-T admission to MS-DRG 016 (autologous BMT) instead of 018 (CAR-T)Confirm XW033C3 / XW043C3 principal PCS code is coded and that encoder is current-FY IPPS grouper. Rebill if DRG was assigned 016 in error.
#10 - Outpatient pathway rejected as inappropriateOutpatient CAR-T billed but payer policy requires inpatient for Yescarta (especially given CRS profile)Submit risk stratification documentation; for Yescarta specifically, many payers default to inpatient regardless of risk. If rejected, admit inpatient and rebill MS-DRG 018.
#11 - NDC not validatedPatient-specific lot NDC not in payer formulary master fileEscalate to medical drug review; reference Kite chain-of-identity. Most payers will manually approve once they confirm the carton-level NDC (71287-XXX-XX) is Kite. Kite Konnect can supply documentation.

Frequently asked questions

What is the HCPCS code for Yescarta?

Yescarta (axicabtagene ciloleucel) is billed under HCPCS Q2041 — "Axicabtagene ciloleucel, up to 200 million autologous anti-CD19 CAR positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose." The unit basis is one therapeutic dose per single IV infusion. The descriptor explicitly bundles leukapheresis and dose preparation, though most payers and CMS still permit separate billing of apheresis CPT and lymphodepletion drugs.

How is Yescarta different from Kymriah?

Both are autologous anti-CD19 CAR-T products, but they are distinct biologics with their own HCPCS codes, REMS programs, and FACT certifications. Yescarta (axi-cel, Q2041, Kite/Gilead) uses a CD28 costimulatory domain; Kymriah (tisa-cel, Q2042, Novartis) uses 4-1BB. Yescarta has a faster manufacturing turnaround (~14-17 days vs ~3-4 weeks for Kymriah), is approved at 2L LBCL (ZUMA-7) where Kymriah is not, and is NOT approved in pediatric/young adult ALL (which Kymriah is). Yescarta has a higher CRS Grade 3+ rate (~13-25%) and higher ICANS rate than Kymriah, attributable to the CD28 costimulatory design. Patient support is through Kite Konnect (not Kymriah Cares).

What does ZUMA-7 mean for Yescarta billing?

ZUMA-7 (NEJM 2022) established Yescarta as superior to standard-of-care chemoimmunotherapy + autologous HSCT in primary refractory or early-relapsing (within 12 months of first-line) LBCL. FDA approved Yescarta for 2L LBCL on April 1, 2022. For PA, a patient with primary refractory or early-relapsing LBCL can receive Yescarta after only ONE prior line of therapy. The PA must document the timing of relapse explicitly: "primary refractory" or "relapse within 12 months of first-line chemoimmunotherapy." Missing this timing detail is the #1 PA error in 2L Yescarta cases.

What is the multi-stage CAR-T billing workflow for Yescarta?

Five stages: (1) Apheresis — CPT 38206 or 0540T at a FACT-accredited center; (2) Manufacturing wait of approximately 14-17 days (fastest in CAR-T class) with no billing; (3) Lymphodepletion with fludarabine (J9185) and cyclophosphamide (J9070), typically days -5 to -3; (4) CAR-T infusion — Q2041 single dose plus the 0537T-0541T administration set; (5) CRS/ICANS monitoring and any 30-day readmission management. Stages 3-5 most often combine into one inpatient admission billed under MS-DRG 018.

What are MS-DRG 016 and 018 for CAR-T?

Effective FY 2021 CMS created MS-DRG 018 ("Chimeric Antigen Receptor (CAR) T-cell Immunotherapy") as the dedicated CAR-T DRG. MS-DRG 018 is assigned when the ICD-10-PCS principal procedure is XW033C3 / XW043C3 or related CAR-T new-tech codes. MS-DRG 016 covers some autologous bone marrow transplant cases - it is not the right CAR-T DRG. If your encoder is sending a CAR-T case to 016 instead of 018, the issue is usually a missing or out-of-version PCS code or an outdated grouper.

Does Yescarta have NTAP add-on payment status?

Yescarta received CMS NTAP starting FY 2019; NTAP for axicabtagene ciloleucel expired after FY 2021 and CAR-T was reclassified into the new MS-DRG 018. Yescarta inpatient admissions are now reimbursed under MS-DRG 018 alone, without separate NTAP. The April 2022 2L ZUMA-7 approval did not trigger new NTAP. Verify each FY IPPS Final Rule because CMS occasionally extends or revises CAR-T add-on policy.

What FACT accreditation is required?

Yescarta may only be administered at healthcare facilities certified through the YESCARTA REMS, which requires FACT (or FACT-JACIE) accreditation for cellular therapy plus on-site CRS/ICANS management capability, immediate tocilizumab availability, and ICU backup. Kite maintains the list of certified treatment centers. A center may be FACT-accredited and Kymriah-certified but NOT Yescarta-certified — each manufacturer's REMS is separately administered. Confirm Kite Yescarta certification BEFORE Stage 1.

Outpatient vs inpatient CAR-T - which setting do I bill?

Historically Yescarta was almost always inpatient under MS-DRG 018. Since 2023 some commercial payers and select Medicare Advantage plans require outpatient CAR-T infusion at qualifying outpatient cellular therapy centers when CRS risk is low. For Yescarta specifically, payer outpatient steering is more cautious due to the elevated CRS Grade 3+ rate; many payers default outpatient pathway to Breyanzi or Kymriah while keeping Yescarta inpatient. Outpatient billing reports Q2041 as a separately payable line under OPPS (APC 9248 historically) plus the 0537T-0540T administration codes. Always verify the payer's site-of-service requirement before scheduling.

What apheresis CPT do I bill for Yescarta - 38205, 38206, or 0540T?

38206 (autologous hematopoietic harvesting) has historically been the most common code for CAR-T leukapheresis. 38205 is allogeneic and does not apply to autologous CAR-T. 0540T is a Category III code specific to CAR-T-associated apheresis service. Payer acceptance varies - most MACs accept 38206; some commercial payers require 0540T. Confirm per-payer before submission.

What are the CAR-T infusion administration codes (0537T family)?

The Category III CAR-T administration set: 0537T (harvesting / planning), 0538T (preparation for transportation), 0539T (receipt and prep for administration), 0540T (CAR-T cell administration), and 0541T (preparation of CAR-T product). Standard IV infusion codes (96365, 96413) are not appropriate substitutes - CAR-T cellular product infusion is a distinct service.

How is CRS readmission after Yescarta billed?

If the patient is infused outpatient and develops Grade 2+ CRS or ICANS requiring inpatient admission within 30 days, the readmission is billed under the inpatient DRG for the principal manifestation (sepsis, respiratory failure, encephalopathy) with D89.83x (CRS) and G92.0x (ICANS) as secondary diagnoses. Tocilizumab (J3262) is billable inpatient bundled in DRG; outpatient is line-item billable. Yescarta's higher CRS rate (78-93% any-grade, 13-25% Grade 3+) makes this readmission pathway operationally common. Some payers maintain CAR-T bundled-payment arrangements that include all 30-day post-infusion care - check the contract.

What happens if Yescarta manufacturing fails - is re-collection billable?

Yescarta's manufacturing failure rate is low (~2-4%, lower than Kymriah's historical 7-10%), and Kite policy historically provides manufacturing-failure replacement at no additional drug cost — verify the current Kite policy through Kite Konnect. The repeat apheresis (38206 or 0540T) is generally separately billable; document the manufacturing failure with the Kite case manager and submit a fresh PA referencing the prior approval. Some payers require a new PA cycle; others amend the existing authorization.

Reference Sources & methodology Every claim on this page is sourced. Methodology and review history below.

Source documents

  1. Yescarta HCP page (Kite Pharma / Gilead)
    Manufacturer dosing, REMS, treatment center locator, and Kite Konnect patient support reference
  2. DailyMed — YESCARTA (axicabtagene ciloleucel) Prescribing Information
    FDA-approved label, revision February 12, 2026 (BLA 125643, Kite Pharma, Inc. / Gilead). Three boxed warnings: CRS, neurologic toxicities/ICANS, T-cell malignancies.
  3. FDA Approval Announcement — Axicabtagene Ciloleucel (Oct 18, 2017)
    Second FDA-approved CAR-T cell therapy
  4. FDA Approval — Yescarta 2L LBCL (April 1, 2022, ZUMA-7)
    First CAR-T approval at second-line
  5. Neelapu SS et al. - ZUMA-1 trial (3L+ DLBCL), NEJM 2017
  6. Jacobson CA et al. - ZUMA-5 trial (R/R FL), Lancet Oncology 2022
  7. Locke FL et al. - ZUMA-7 trial (2L LBCL), NEJM 2022
    Practice-changing 2L LBCL data — basis of April 2022 FDA approval
  8. FACT (Foundation for the Accreditation of Cellular Therapy)
    Accreditation standards for cellular therapy programs (FACT and FACT-JACIE)
  9. CMS — Medicare Part B Drug ASP Pricing File
    Q2 2026 quarterly file, effective April 1 – June 30, 2026
  10. CMS — FY 2026 IPPS Final Rule (MS-DRG 016 / 018, NTAP)
    CAR-T DRG assignments and add-on payment policy
  11. CMS — CY 2026 OPPS Final Rule (CAR-T outpatient APC)
    Outpatient CAR-T APC assignment and rate
  12. CMS NCD 110.24 — Chimeric Antigen Receptor (CAR) T-cell Therapy
    National Coverage Determination for CAR-T
  13. NCCN B-Cell Lymphomas Guidelines
    DLBCL, LBCL, and FL CAR-T recommendations (Yescarta Category 1 for 2L)
  14. Gilead Advancing Access Patient Assistance
    Patient assistance program covering Yescarta for uninsured and underinsured patients
  15. FDA National Drug Code Directory

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, MS-DRG/APC, and policy content is reviewed at least quarterly and updated whenever a source document changes.

Found an error? Email hello@carecostestimate.com.

Refresh cadence

ElementCadenceHow it's refreshed
Medicare ASP pricing (Q2041)QuarterlyAuto-bound to CareCost ASP layer; updates on CMS file release.
MS-DRG 018 weight + OPPS APC rateAnnualReviewed against the current FY IPPS Final Rule and CY OPPS Final Rule.
NTAP statusAnnualVerified against the current FY IPPS Final Rule.
Payer policies (UHC, Aetna, Cigna)Semi-annualManual review against published payer policy documents.
HCPCS / CPT (Category III)AnnualReviewed against CMS HCPCS quarterly files and AMA CPT releases for Category I conversions.
NDC, dosing, FDA label, YESCARTA REMSEvent-drivenTied to manufacturer document version + FDA label revision date + REMS program updates.
FACT accreditation requirementsAnnualVerified against FACT standards revisions.

Reviewer

SME-audited 2026-05-22 — corrections applied. This page was audited against primary sources on May 22, 2026. Verified: HCPCS Q2041 descriptor, three FDA indications (3L+ LBCL, R/R FL, 2L LBCL), BLA 125643 label revision February 12, 2026, Kite Pharma / Gilead as manufacturer, YESCARTA REMS requirement, FACT accreditation, NEJM/Lancet Oncology pivotal trial citations (ZUMA-1 / ZUMA-5 / ZUMA-7), April 1, 2022 ZUMA-7 2L approval, Q2 2026 ASP payment limit bound to live CMS file. Correction applied: boxed warnings expanded to include T-cell malignancy (added class-wide 2024 per FDA). Outstanding items requiring annual verification: current FY MS-DRG 018 weight, current CAR-T OPPS APC assignment, NTAP status.

Change log

  • — Initial publication. ASP data: Q2 2026 (live-bound to CMS file). FY 2026 IPPS Final Rule referenced for MS-DRG 016/018 and NTAP status. Multi-stage CAR-T workflow (apheresis through CRS) documented end-to-end. FACT accreditation and YESCARTA REMS gate emphasized as #1 denial driver. CD19 CAR-T class disambiguation (Yescarta vs Kymriah vs Tecartus vs Breyanzi, plus BCMA-class Abecma and Carvykti) included for code-selection accuracy. ZUMA-7 2L LBCL positioning and timing documentation emphasized as #1 PA denial cause in the 2L setting.

Methodology

Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File. DRG and APC content is read directly from the current IPPS and OPPS Final Rules. Payer policies are read directly from each payer's published cellular therapy / oncology coverage documents. Indication and dosing are verified against the current FDA Yescarta label revision. REMS program details are verified through Kite Pharma materials. Pivotal trial evidence is cited from peer-reviewed publications (NEJM, Lancet Oncology). We do not paraphrase from billing-software vendor blogs.

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