Kymriah (tisagenlecleucel) — HCPCS Q2042

About Kymriah (tisagenlecleucel)

Kymriah is the brand name for tisagenlecleucel, an autologous chimeric antigen receptor (CAR) T-cell immunotherapy directed against the CD19 antigen, manufactured by Novartis Pharmaceuticals Corporation. It is the first CAR-T cell therapy approved by the FDA (August 30, 2017) and remains a benchmark product for the CD19 CAR-T class. Each Kymriah dose is a patient-specific cellular product: the patient's own T cells are collected by leukapheresis, shipped to a Novartis manufacturing facility, genetically modified to express the anti-CD19 CAR construct, expanded, cryopreserved, and shipped back to the certified treatment center for infusion approximately 3 to 4 weeks later.

Kymriah carries three FDA-approved indications:

• Pediatric and young adult B-cell ALL (age up to and including 25 years) that is refractory or in second or later relapse — approved August 30, 2017 based on the ELIANA trial.
• Adult relapsed/refractory diffuse large B-cell lymphoma (DLBCL) after at least two prior lines of systemic therapy, including high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma — approved May 1, 2018 based on the JULIET trial.
• Relapsed/refractory follicular lymphoma (FL) after at least two prior lines of systemic therapy — accelerated approval May 27, 2022 based on the ELARA trial.

Kymriah is billed under HCPCS Q2042 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 KYMRIAH REMS program. Approximate list price (single dose): ~$475,000 USD.

CD19 CAR-T class — Kymriah vs Yescarta 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.

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 5-8 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.
3. Claim C — CAR-T admission: UB-04 inpatient with ICD-10-PCS procedure (XW033C3 or XW043C3) driving MS-DRG 018. Q2042 line-item is included in the DRG bundle. Or, in outpatient infusion path, UB-04 outpatient with APC payment + Q2042 + 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

Kymriah is one therapeutic dose, but the cellular dose target is indication- and weight-dependent.

Lymphodepletion dosing (Stage 3)

Per the FDA label, lymphodepletion is administered days -5 through -3 prior to Kymriah infusion. Standard regimen for adult DLBCL/FL: fludarabine 25 mg/m^2 IV daily x 3 days (J9185) plus cyclophosphamide 250 mg/m^2 IV daily x 3 days (J9070). For pediatric ALL: fludarabine 30 mg/m^2 daily x 4 days plus cyclophosphamide 500 mg/m^2 daily x 2 days. Each chemotherapy agent and each administration day generates a separate billable line.

NDC reference FDA NDC Directory + Novartis verified May 2026

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

KYMRIAH REMS + FACT accreditation Novartis + FACT verified May 2026

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

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

• Facility certification (Novartis Treatment Center): the hospital or cellular therapy center must be on the Novartis-maintained list of certified Kymriah Treatment Centers. Certification requires FACT or FACT-JACIE accreditation for cellular therapy, demonstrated capacity to recognize and manage CRS and ICANS, immediate availability of tocilizumab (Actemra) for IV use (minimum 2 doses on hand), and qualified ICU backup.
• Healthcare provider certification: prescribing physicians must complete the KYMRIAH 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: Novartis maintains the KYMRIAH REMS portal — check the most recent Kymriah Prescribing Information for the current REMS URL and contact.
• 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).

Modifiers CMS + CPT verified May 2026

Modifiers rarely apply to Q2042 itself

Unlike weight-based drug J-codes, the single-dose Q2042 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 Q2042 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 Q2042, follow your MAC's current 340B modifier policy (JG or TB as required). Novartis 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 Q2042 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

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 at qualifying centers.

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 ~$475K-650K cell product acquisition cost; the actual hospital payment under MS-DRG 018 still typically falls short of total acquisition cost in many cases.

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 Q2042 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 Novartis + 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, prior therapy lines, and ECOG performance status.

NCCN Guidelines

NCCN B-Cell Lymphomas Guidelines (current version) and NCCN Pediatric ALL Guidelines (current version) both include tisagenlecleucel as a Category 2A recommendation for the FDA-approved indications. NCCN compendium support strengthens off-label coverage arguments and bridges any payer-policy lag for the FL indication (May 2022 approval).

Required PA documentation checklist

• FACT (or FACT-JACIE) accreditation certificate for the treatment center
• KYMRIAH REMS certification letter for the prescribing physician and the facility
• Prior therapy log: each regimen, dates, response, reason for discontinuation
• ECOG performance status (most policies require 0-2)
• Diagnostic pathology confirming CD19+ disease (for DLBCL/FL) or CD19+ B-ALL
• 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 DLBCL 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)

Q2042 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. ICD-10-PCS principal procedure XW033C3 (or XW043C3) drives the DRG assignment.

NTAP history

• FY 2019 - FY 2021: Kymriah received CMS NTAP add-on payment (up to $186,500 per case in early years), recognizing the gap between historical DRG payment and acquisition cost.
• FY 2021 onward: NTAP for tisagenlecleucel 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 products (e.g., Carvykti, Breyanzi line extensions) may carry active NTAP - those are product-specific.

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. Q2042 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.

Patient assistance — Kymriah Cares Novartis verified May 2026

• Kymriah Cares: Novartis-administered patient hub for Kymriah - benefits investigation, prior authorization assistance, appeal support, copay support (commercial-only). Confirm the current phone and portal URL on the most recent Kymriah Patient Brochure shipped with the cellular product.
• Novartis Patient Assistance Foundation (NPAF): 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 npaf.org or the patient's CAR-T case manager. novartis.com/us-en/patients/patient-assistance
• 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 ALL, DLBCL, and FL funds quarterly.
• Travel and lodging: Kymriah is administered only at FACT-certified centers, often requiring travel. Novartis and many treatment centers maintain travel grants for patients living > 50-100 miles from a treatment center.

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Kymriah?

Kymriah (tisagenlecleucel) is billed under HCPCS Q2042 — "Tisagenlecleucel, up to 600 million 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.

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

Five stages: (1) Apheresis — CPT 38206 or 0540T at a FACT-accredited center; (2) Manufacturing wait of approximately 3-4 weeks with no billing; (3) Lymphodepletion with fludarabine (J9185) and cyclophosphamide (J9070), typically days -5 to -3; (4) CAR-T infusion — Q2042 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 Kymriah have NTAP add-on payment status?

Kymriah received CMS NTAP starting FY 2019 (up to $186,500 per case in early years); NTAP for tisagenlecleucel expired after FY 2021 and CAR-T was reclassified into the new MS-DRG 018. Kymriah inpatient admissions are now reimbursed under MS-DRG 018 alone, without separate NTAP. Verify each FY IPPS Final Rule because CMS occasionally extends or revises CAR-T add-on policy.

What FACT accreditation is required?

Kymriah may only be administered at healthcare facilities certified through the KYMRIAH REMS, which requires FACT (or FACT-JACIE) accreditation for cellular therapy plus on-site CRS/ICANS management capability, immediate tocilizumab availability, and ICU backup. Novartis maintains the list of certified treatment centers. Apheresis collection at a non-REMS-certified center will block manufacturing release - confirm certification BEFORE Stage 1.

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

Historically Kymriah 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. Outpatient billing reports Q2042 as a separately payable line under OPPS (APC 9248 historically; verify current OPPS Addendum B) plus the 0537T-0540T administration codes. Always verify the payer's site-of-service requirement before scheduling.

What apheresis CPT do I bill for Kymriah - 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 Kymriah 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. Some payers maintain CAR-T bundled-payment arrangements that include all 30-day post-infusion care - check the contract.

Pediatric ALL vs adult DLBCL coverage differences?

Pediatric/young adult ALL (age ≤ 25) requires refractory disease or 2nd-or-later relapse - no specific prior line count required, but documentation of induction, consolidation, and any post-HSCT relapse is critical. Adult R/R DLBCL requires ≥ 2 prior lines including an anthracycline-based regimen and an anti-CD20 mAb. R/R FL requires ≥ 2 prior lines including an anti-CD20 mAb plus an alkylating agent. ECOG performance status requirements also vary slightly by indication; verify the current payer policy for the specific indication.

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

Approximately 7-10% of Kymriah manufacturing attempts fail to meet release specifications. Novartis policy historically provided manufacturing-failure replacement at no additional drug cost - verify the current Novartis policy. The repeat apheresis (38206 or 0540T) is generally separately billable; document the manufacturing failure with the Novartis 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. Kymriah HCP page (Novartis Pharmaceuticals)
   Manufacturer dosing, REMS, treatment center locator, and patient support reference (kymriah.com 301 → us.kymriah.com)
2. DailyMed — KYMRIAH (tisagenlecleucel) Prescribing Information
   FDA-approved label, revision December 16, 2025 (BLA 125646, Novartis Pharmaceuticals Corporation). Three boxed warnings: CRS, neurologic toxicities/ICANS, T-cell malignancies.
3. FDA Approval Announcement — Tisagenlecleucel (Aug 30, 2017)
   First FDA-approved CAR-T cell therapy
4. Maude SL et al. - ELIANA trial (peds ALL), NEJM 2018
5. Schuster SJ et al. - JULIET trial (adult DLBCL), NEJM 2019
6. Fowler NH et al. - ELARA trial (R/R FL), Nature Medicine 2022
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
    DLBCL and FL CAR-T recommendations
13. NCCN Pediatric ALL Guidelines
    Pediatric/young adult ALL CAR-T recommendations
14. Novartis Patient Assistance Foundation
    Patient assistance 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 — 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 KYMRIAH REMS gate emphasized as #1 denial driver. CD19 CAR-T class disambiguation (Kymriah vs Yescarta vs Tecartus vs Breyanzi, plus BCMA-class Abecma and Carvykti) included for code-selection accuracy.

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