Tecartus (brexucabtagene autoleucel) — HCPCS Q2053

About Tecartus (brexucabtagene autoleucel)

Tecartus is the brand name for brexucabtagene autoleucel (brexu-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 third FDA-approved CAR-T cell therapy (July 24, 2020) and the first CAR-T approved in mantle cell lymphoma. Each Tecartus dose is a patient-specific cellular product: the patient's own T cells are collected by leukapheresis, shipped to the Kite manufacturing facility, undergo an additional T-cell enrichment step that selects CD4+/CD8+ T cells out of the apheresis product, are then 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. Tecartus's vein-to-vein time is approximately 16-19 days, slightly longer than Yescarta because of the added enrichment step.

Tecartus carries two FDA-approved indications:

• Adult relapsed/refractory mantle cell lymphoma (MCL) after Bruton tyrosine kinase (BTK) inhibitor therapy — accelerated approval July 24, 2020 based on the ZUMA-2 trial. This was the first CAR-T approved in MCL.
• Adult relapsed/refractory B-cell precursor acute lymphoblastic leukemia (B-ALL), age 18 years or older — approved October 1, 2021 based on the ZUMA-3 trial. Note: this is the adult ALL space; Kymriah covers pediatric and young adult ALL (up to and including age 25).

Tecartus is billed under HCPCS Q2053 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 TECARTUS REMS program (separate certification cycle from the YESCARTA REMS). Approximate list price (single dose): ~$424,000 USD.

CD19 CAR-T class — Tecartus vs Yescarta vs Kymriah 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.

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.

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. Dose/schedule is indication-specific (see Dosing section).
3. Claim C — CAR-T admission: UB-04 inpatient with ICD-10-PCS procedure (XW033C3 or XW043C3) driving MS-DRG 018. Q2053 line-item is included in the DRG bundle. Or, in outpatient infusion path, UB-04 outpatient with APC payment + Q2053 + 0537T-0541T line items. Outpatient pathway is uncommon for B-ALL cases.
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

Tecartus is one therapeutic dose, but the target cell count and lymphodepletion regimen differ between MCL and adult ALL.

Lymphodepletion dosing (Stage 3) — differs by indication

Per the FDA label, the lymphodepletion regimen differs between MCL and ALL:

• MCL: fludarabine 30 mg/m^2 IV daily x 3 days (J9185) plus cyclophosphamide 500 mg/m^2 IV daily x 3 days (J9070), days -5 to -3.
• Adult B-ALL: fludarabine 25 mg/m^2 IV daily x 3 days (J9185) plus cyclophosphamide 900 mg/m^2 IV daily x 3 days (J9070), days -4 to -2.

Each chemotherapy agent and each administration day generates a separate billable line. The B-ALL regimen uses higher-dose cyclophosphamide on a tighter pre-infusion schedule because of the higher tumor burden typical of relapsed ALL.

NDC reference FDA NDC Directory + Kite verified May 2026

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

TECARTUS REMS + FACT accreditation Kite + FACT verified May 2026

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

The TECARTUS 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 Tecartus 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 the elevated Grade 3+ CRS rate in B-ALL), immediate availability of tocilizumab (Actemra) for IV use (minimum 2 doses on hand per certified site), and qualified ICU backup. Centers must also have demonstrated experience with high-burden hematologic malignancies for the B-ALL indication.
• Healthcare provider certification: prescribing physicians must complete the TECARTUS 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 TECARTUS REMS portal — check the most recent Tecartus Prescribing Information for the current REMS URL and contact. Kite Konnect (the patient hub, shared with Yescarta) 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.

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

Stage 3 - Lymphodepletion (chemo admin)

Stage 4 - CAR-T infusion administration set

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). Tecartus B-ALL cases have the highest Grade 3+ CRS rate in the CD19 CAR-T class (~26% in ZUMA-3) — pharmacy preparation protocols should stock additional tocilizumab doses for B-ALL admissions.

Modifiers CMS + CPT verified May 2026

Modifiers rarely apply to Q2053 itself

Unlike weight-based drug J-codes, the single-dose Q2053 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 Q2053 is not billed). There is no partial-vial waste scenario analogous to small-molecule oncology drugs.

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 Q2053, 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 Q2053 billing. Note that the B-ALL cyclophosphamide regimen uses higher doses (900 mg/m^2), which may increase the operational frequency of JW reporting on partial-vial residuals.

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

ICD-10-PCS procedures (inpatient claims)

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 but uncommon for Tecartus B-ALL.

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 high cell product acquisition cost; the actual hospital payment under MS-DRG 018 still typically falls short of total acquisition cost in many cases — particularly Tecartus B-ALL cases where the CRS-driven ICU length of stay extends the admission.

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 Q2053 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).

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)

Claim B — Lymphodepletion (Stage 3)

Claim C — CAR-T infusion (Stage 4)

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

Payer policy snapshot Reviewed May 2026

All major payers require PA, FACT documentation, REMS enrollment confirmation, indication-specific eligibility (BTKi failure or age + CD19+), and ECOG performance status.

NCCN Guidelines

NCCN B-Cell Lymphomas Guidelines (current version) include Tecartus as a Category 2A recommendation for R/R MCL in the post-BTKi setting. NCCN ALL Guidelines list Tecartus for adult R/R B-cell precursor ALL. NCCN compendium support strengthens coverage arguments and bridges any payer-policy lag for emerging indications.

Required PA documentation checklist

• FACT (or FACT-JACIE) accreditation certificate for the treatment center
• TECARTUS REMS certification letter for the prescribing physician and the facility (NOT the Yescarta REMS letter — these are separate certifications)
• Prior therapy log: each regimen, dates, response, reason for discontinuation
• For MCL: explicit documentation of BTK inhibitor (ibrutinib, acalabrutinib, or zanubrutinib) exposure, dates, and reason for stopping (progression vs intolerance) — the ZUMA-2 eligibility gate
• For adult B-ALL: explicit documentation of patient age ≥18, CD19+ B-precursor ALL by flow cytometry, prior line(s) of therapy — the ZUMA-3 eligibility gate
• ECOG performance status (most policies require 0-2)
• Diagnostic pathology confirming CD19+ disease
• 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; particularly enforced for B-ALL)
• Cardiac and pulmonary clearance (LVEF, pulmonary function tests as required)
• Absence of active autoimmune disease requiring systemic immunosuppression

Medicare reimbursement CMS Q2 2026 (live)

Q2053 has a quarterly ASP payment limit; MS-DRG 018 sets the inpatient DRG payment; OPPS APC handles outpatient.

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 — particularly Tecartus B-ALL cases where the CRS-driven ICU length of stay extends the admission. ICD-10-PCS principal procedure XW033C3 (or XW043C3, often used in B-ALL where central access is in place) drives the DRG assignment.

NTAP history

• FY 2021 - FY 2023: Tecartus received CMS NTAP add-on payment after the July 2020 MCL approval, recognizing the gap between historical DRG payment and acquisition cost.
• FY 2024 onward: NTAP for brexucabtagene autoleucel expired after the standard 3-year window. Tecartus inpatient admissions are now reimbursed under MS-DRG 018 alone, without separate NTAP.
• 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. The October 2021 adult B-ALL approval did not separately trigger new NTAP; the existing MS-DRG 018 covers all autologous CAR-T regardless of indication.

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. Q2053 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. Outpatient Tecartus pathway is operationally rare for B-ALL.

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. Tecartus's MCL (2020) and adult B-ALL (2021) approvals are both covered under the same NCD without separate coverage decisions.

Patient assistance — Kite Konnect Kite verified May 2026

• Kite Konnect: Kite-administered patient hub for Tecartus and Yescarta — 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 Tecartus 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 The Leukemia & Lymphoma Society (LLS) Co-Pay Assistance for MCL and ALL. Verify open MCL and ALL funds quarterly.
• Travel and lodging: Tecartus 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. LLS also maintains travel grants for ALL patients.

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Tecartus?

Tecartus (brexucabtagene autoleucel) is billed under HCPCS Q2053 — "Brexucabtagene autoleucel, 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. The Q-code is the same for both MCL and adult B-ALL indications even though the per-kg cell target and lymphodepletion regimen differ.

How is Tecartus different from Yescarta?

Both are autologous anti-CD19 CAR-T products from Kite Pharma / Gilead with the same CD28 costimulatory domain. The defining difference is manufacturing: Tecartus (Q2053) adds a T-cell enrichment step that removes circulating tumor cells from the apheresis product before transduction — critical in MCL and B-ALL where peripheral disease is common. Yescarta (Q2041) does not include this step because LBCL and FL typically have less circulating disease. Indications differ entirely: Tecartus covers R/R MCL (ZUMA-2) and adult R/R B-ALL (ZUMA-3); Yescarta covers LBCL and FL. The products are NOT interchangeable. The carton NDC pattern disambiguates: Yescarta 71287-119-XX, Tecartus 71287-129-XX.

What does ZUMA-2 mean for Tecartus billing in MCL?

ZUMA-2 (NEJM 2020, Wang ML et al.) established Tecartus for R/R mantle cell lymphoma after BTK inhibitor failure. FDA granted accelerated approval July 24, 2020 - the first CAR-T approved in MCL. For PA, the patient must have received and failed (or been intolerant of) a BTK inhibitor (ibrutinib, acalabrutinib, or zanubrutinib). The PA narrative must explicitly document the BTKi exposure, date of progression or intolerance, and the line of therapy. Submitting an MCL Tecartus PA without explicit BTKi failure documentation is the #1 cause of MCL Tecartus denial.

What does ZUMA-3 mean for Tecartus billing in adult B-ALL?

ZUMA-3 (Lancet 2021, Shah BD et al.) established Tecartus for adults aged 18 years or older with R/R B-precursor acute lymphoblastic leukemia. FDA approved Tecartus for adult B-ALL on October 1, 2021. This is an adult-only approval - patients under age 18 with B-ALL should be referred for Kymriah (tisagenlecleucel) under its pediatric/young adult ALL indication (≤25 years). The PA must document patient age ≥18, confirm CD19+ B-precursor ALL pathology, list prior therapy with R/R disease, and confirm absence of active CNS-3 leukemia. Adult ALL is a much smaller market than MCL for Tecartus and concentrated at academic CAR-T centers.

Why does Tecartus include a T-cell enrichment step?

MCL and B-precursor ALL both commonly involve circulating CD19+ tumor cells in the peripheral blood. Without enrichment, those tumor cells would contaminate the bioreactor, reduce manufacturing yield, and potentially exhaust the CAR-T product through in-vitro engagement before infusion. The Tecartus manufacturing process therefore includes a step that selects CD4+/CD8+ T cells out of the apheresis product before CAR transduction. Yescarta does not include this step because LBCL and FL typically have less circulating disease. This manufacturing difference is the reason Tecartus exists as a separate Q-code rather than as a Yescarta indication extension. The added step is also why Tecartus vein-to-vein is ~16-19 days (vs Yescarta's ~14-17).

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

Five stages: (1) Apheresis — CPT 38206 or 0540T at a FACT-accredited center; (2) Manufacturing wait of approximately 16-19 days (longer than Yescarta due to T-cell enrichment) with no billing; (3) Lymphodepletion with fludarabine (J9185) and cyclophosphamide (J9070) — regimen differs by indication: MCL uses 30/500 mg/m^2 days -5 to -3, adult B-ALL uses 25/900 mg/m^2 days -4 to -2; (4) CAR-T infusion — Q2053 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 — near-universal in B-ALL.

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. XW043C3 (central vein) is especially common in B-ALL where central access is already in place from prior chemotherapy.

Does Tecartus have NTAP add-on payment status?

Tecartus received CMS NTAP starting FY 2021 (after the July 2020 MCL approval); NTAP for brexucabtagene autoleucel expired after FY 2023. Tecartus inpatient admissions are now reimbursed under MS-DRG 018 alone, without separate NTAP. The October 2021 adult B-ALL 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?

Tecartus may only be administered at healthcare facilities certified through the TECARTUS 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 that is FACT-accredited and Yescarta-certified is NOT automatically Tecartus-certified — each Kite product has its own REMS certification cycle. Confirm Kite Tecartus certification BEFORE Stage 1.

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

Historically Tecartus was almost always inpatient under MS-DRG 018. For MCL cases at qualifying high-volume centers with low tumor burden, outpatient pathway is increasingly available. For adult B-ALL cases, inpatient is near-universal because of the high circulating tumor burden and elevated Grade 3+ CRS rate in ZUMA-3 (~26%). Most payers default Tecartus B-ALL to inpatient regardless of outpatient policy. Outpatient billing reports Q2053 as a separately payable line under OPPS (APC 9248 historically) plus the 0537T-0540T administration codes. Verify per-payer and per-indication.

What apheresis CPT do I bill for Tecartus - 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. The apheresis is identical to Yescarta from the billing standpoint; Tecartus's T-cell enrichment happens at the Kite manufacturing facility, not at the apheresis center.

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 Tecartus 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. B-ALL Tecartus cases have the highest Grade 3+ CRS rate in the CD19 CAR-T class (~26% in ZUMA-3) making this readmission pathway less common (because most are inpatient infusion to begin with) but the in-admission CRS management is operationally intensive.

What is the difference between Tecartus and Kymriah for ALL?

Both Tecartus and Kymriah have R/R B-cell ALL indications but in non-overlapping populations. Kymriah (Q2042) was approved August 30, 2017 for B-cell precursor ALL in patients up to and including age 25 — the pediatric/young adult ALL space. Tecartus (Q2053) was approved October 1, 2021 for adults aged 18 years or older with R/R B-precursor ALL — the adult-only space. There is a small overlap window at ages 18-25 where both products technically apply by label; in practice site-specific protocol and physician preference determine which is selected. PA submissions must match the patient's age to the correct product's label.

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

Tecartus manufacturing failure rates are slightly higher than Yescarta's because of the additional T-cell enrichment step (historical ~5-8% for Tecartus vs ~2-4% for Yescarta). 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.

Source documents

1. Tecartus HCP page (Kite Pharma / Gilead)
   Manufacturer dosing, REMS, treatment center locator, and Kite Konnect patient support reference
2. DailyMed — TECARTUS (brexucabtagene autoleucel) Prescribing Information
   FDA-approved label, most recent revision (BLA 125703)
3. FDA Approval Announcement — Brexucabtagene Autoleucel for R/R MCL (July 24, 2020)
   First CAR-T approved in mantle cell lymphoma (ZUMA-2)
4. FDA Approval — Tecartus Adult R/R B-cell ALL (October 1, 2021, ZUMA-3)
   Adult B-precursor ALL indication
5. Wang ML et al. - ZUMA-2 trial (R/R MCL post-BTKi), NEJM 2020
   Pivotal MCL data — basis of July 2020 FDA approval
6. Shah BD et al. - ZUMA-3 trial (adult R/R B-precursor ALL), Lancet 2021
   Pivotal adult B-ALL data — basis of October 2021 FDA approval
7. FACT (Foundation for the Accreditation of Cellular Therapy)
   Accreditation standards for cellular therapy programs (FACT and FACT-JACIE)
8. CMS — Medicare Part B Drug ASP Pricing File
   Q2 2026 quarterly file, effective April 1 – June 30, 2026
9. CMS — FY 2026 IPPS Final Rule (MS-DRG 016 / 018, NTAP)
   CAR-T DRG assignments and add-on payment policy
10. CMS — CY 2026 OPPS Final Rule (CAR-T outpatient APC)
    Outpatient CAR-T APC assignment and rate
11. CMS NCD 110.24 — Chimeric Antigen Receptor (CAR) T-cell Therapy
    National Coverage Determination for CAR-T
12. NCCN B-Cell Lymphomas Guidelines
    MCL section — Tecartus Category 2A post-BTKi
13. NCCN Acute Lymphoblastic Leukemia (ALL) Guidelines
    Tecartus listed for adult R/R B-precursor ALL
14. Gilead Advancing Access Patient Assistance
    Patient assistance program covering Tecartus 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

Reviewer

Change log

• May 22, 2026 — SME audit pass. Verified HCPCS Q2053 (200M cell descriptor) and CMS ASP entry; verified BLA 125703 and the two FDA-approved indications (ZUMA-2 R/R MCL July 24, 2020; ZUMA-3 adult R/R B-ALL October 1, 2021) against the current DailyMed label revision (April 1, 2026); confirmed manufacturer source URLs (tecartus.com, gileadadvancingaccess.com) live; pivotal trial DOIs (Wang NEJM 2020 / Shah Lancet 2021) functional. T-cell-enrichment manufacturing differentiator vs Yescarta and TECARTUS REMS separate-certification distinction verified. Reviewer callout flipped from "Pending SME review" to "SME-audited".
• May 22, 2026 — 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 with indication-specific lymphodepletion regimens (MCL vs adult B-ALL). FACT accreditation and TECARTUS REMS gate emphasized as #1 denial driver — including the separate-certification-from-Yescarta distinction. CD19 CAR-T class disambiguation (Tecartus vs Yescarta vs Kymriah vs Breyanzi, plus BCMA-class Abecma and Carvykti) included for code-selection accuracy. ZUMA-2 BTKi-failure documentation and ZUMA-3 age + CD19+ documentation emphasized as #1 PA denial causes per indication.

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 Tecartus label revision. REMS program details are verified through Kite Pharma materials. Pivotal trial evidence is cited from peer-reviewed publications (NEJM, Lancet). We do not paraphrase from billing-software vendor blogs.