Breyanzi (lisocabtagene maraleucel) — HCPCS Q2054

About Breyanzi (lisocabtagene maraleucel)

Breyanzi is the brand name for lisocabtagene maraleucel (liso-cel), an autologous chimeric antigen receptor (CAR) T-cell immunotherapy directed against the CD19 antigen, manufactured by Bristol-Myers Squibb (originally developed by Juno Therapeutics, acquired by Celgene in 2018, then BMS in 2019). It is the fourth FDA-approved CAR-T cell therapy (February 5, 2021) and carries the broadest CD19 indication footprint of any CAR-T: LBCL at both 3L+ and 2L, CLL/SLL (the first CAR-T ever approved in this disease), follicular lymphoma, mantle cell lymphoma, and — as of December 4, 2025 — marginal zone lymphoma (also a first-in-class CAR-T approval).

Each Breyanzi dose is a patient-specific cellular product manufactured to a defined 1:1 CD8:CD4 composition. The patient's T cells are collected by leukapheresis, shipped to the BMS cell-therapy manufacturing facility, separated into CD8+ and CD4+ subsets, separately transduced with the anti-CD19 CAR construct (using a 4-1BB costimulatory domain), expanded, formulated into two distinct bags at a 1:1 ratio, cryopreserved, and shipped back to the certified treatment center for sequential infusion. Breyanzi's vein-to-vein time is approximately 24-35 days, the longest in the CD19 CAR-T class because of the separate CD8 / CD4 processing.

Breyanzi carries six FDA-approved indications:

• Adult relapsed/refractory large B-cell lymphoma (3L+) after at least two prior lines of systemic therapy, including DLBCL NOS, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B — approved February 5, 2021 based on the TRANSCEND NHL 001 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 June 24, 2022 based on the TRANSFORM trial.
• Adult relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines including a BTK inhibitor and a BCL-2 inhibitor — accelerated approval March 14, 2024 based on the TRANSCEND CLL 004 trial. This is the first and only CAR-T approved in CLL/SLL.
• Adult relapsed/refractory follicular lymphoma (FL) after at least two prior lines of systemic therapy — accelerated approval May 15, 2024 based on the TRANSCEND FL trial.
• Adult relapsed/refractory mantle cell lymphoma (MCL) after BTK inhibitor therapy — approved May 30, 2024 based on supplementary TRANSCEND MCL data.
• Adult relapsed/refractory marginal zone lymphoma (MZL) after at least two prior lines of systemic therapy — approved December 4, 2025 based on the TRANSCEND FL-MZL cohort (NCT04245839). This is the first CAR-T approved in MZL and extends Breyanzi's CD19 footprint to six lymphoma histologies — the broadest of any CAR-T product.

Breyanzi is billed under HCPCS Q2054 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 BREYANZI REMS program (administered by BMS, separate from Kite's YESCARTA and TECARTUS REMS). Approximate list price (single dose): ~$447,000 USD.

CD19 CAR-T class — Breyanzi vs Yescarta vs Kymriah vs Tecartus 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. Breyanzi's longer manufacturing extends the window.

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 or outpatient infusion: Inpatient: UB-04 with ICD-10-PCS procedure (XW033C3 or XW043C3) driving MS-DRG 018. Q2054 line-item is included in the DRG bundle. Outpatient (common for Breyanzi): UB-04 outpatient with APC payment + Q2054 + 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. Operationally less frequent for Breyanzi than for CD28-domain products.

Dosing & cellular dose math FDA label verified May 2026

Breyanzi is one therapeutic dose, but the dose is delivered as two sequential bags at a defined 1:1 CD8:CD4 ratio with a total cap of 110 million CAR-positive T cells.

Lymphodepletion dosing (Stage 3) — uniform across indications

Per the FDA Breyanzi label, the lymphodepletion regimen is the same regardless of indication: fludarabine 30 mg/m^2 IV daily x 3 days (J9185) plus cyclophosphamide 300 mg/m^2 IV daily x 3 days (J9070), days -5 to -3. Note the lower cyclophosphamide dose vs Yescarta's 500 mg/m^2 and Tecartus MCL's 500 mg/m^2. The lower cyclophosphamide dose contributes to Breyanzi's better post-infusion cytopenia profile and supports outpatient feasibility. CAR-T cell infusion proceeds on day 0 (2-7 days after the last lymphodepletion dose).

NDC reference FDA NDC Directory + BMS verified May 2026

Breyanzi uses a patient-specific NDC pattern - every patient's dose is uniquely identified by lot, AND the CD8 and CD4 component bags have bag-specific identifiers within the same NDC family.

BREYANZI REMS + FACT accreditation BMS + FACT verified May 2026

Breyanzi is available only through a restricted REMS program because of the boxed warnings for CRS, neurologic toxicity, prolonged cytopenias, and secondary T-cell malignancies.

The BREYANZI REMS is administered by Bristol-Myers Squibb and operates as closed distribution. Three certification layers must all be in place:

• Facility certification (BMS Authorized Treatment Center): the hospital or cellular therapy center must be on the BMS-maintained list of authorized Breyanzi Treatment Centers. Certification requires FACT or FACT-JACIE accreditation for cellular therapy, demonstrated capacity to recognize and manage CRS and ICANS (even though Breyanzi's profile is the lowest in class), immediate availability of tocilizumab (Actemra) for IV use, and qualified ICU backup. Outpatient-capable centers additionally certify their post-infusion ambulatory monitoring protocols with BMS.
• Healthcare provider certification: prescribing physicians must complete the BREYANZI 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. The two-bag receipt protocol must be in place to handle CD8 and CD4 components separately.

How to enroll / verify

• Web: BMS maintains the BREYANZI REMS portal — check the most recent Breyanzi Prescribing Information for the current REMS URL and contact. BMS Cell Therapy 360 (the patient hub, shared with Abecma) 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). Breyanzi's class-low CRS profile (typically < 5% Grade 3+) means tocilizumab use is operationally lower than with CD28-domain products. Pharmacy still must maintain on-hand minimums per REMS.

Modifiers CMS + CPT verified May 2026

Modifiers rarely apply to Q2054 itself

Unlike weight-based drug J-codes, the single-dose Q2054 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 therapeutic dose - it is either administered in its entirety to the labeled patient or the manufacturing fails and the product is not infused (in which case Q2054 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 Q2054, follow your MAC's current 340B modifier policy (JG or TB as required). BMS CAR-T 340B and OPPS/IPPS payment interaction 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 Q2054 billing. Breyanzi's lower 300 mg/m^2 cyclophosphamide dose makes partial-vial residuals slightly more common than at Yescarta's 500 mg/m^2.

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

Breyanzi has the highest outpatient infusion share in the CD19 CAR-T class because of its low Grade 3+ CRS profile. Many payers default outpatient for low-risk Breyanzi cases.

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. For inpatient Breyanzi admissions, the lower observed CRS-driven length of stay can mitigate the DRG-shortfall risk that affects Yescarta and Tecartus B-ALL admissions.

Outpatient CAR-T - APC payment (especially important for Breyanzi)

Breyanzi has the highest outpatient infusion share in CD19 CAR-T because of its low CRS Grade 3+ rate. 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 Q2054 as a separately payable line item plus the 0537T-0541T 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 BMS + 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, and indication-specific eligibility documentation. CLL/SLL is the most policy-immature space.

NCCN Guidelines

NCCN B-Cell Lymphomas Guidelines (current version) include Breyanzi as a recommended option for R/R LBCL at both 2L (TRANSFORM) and 3L+ (TRANSCEND NHL 001), for FL after ≥2 prior lines (TRANSCEND FL), and for MCL after BTKi failure. NCCN CLL/SLL Guidelines list Breyanzi as Category 2A in the post-BTKi + post-BCL-2i setting following the March 2024 FDA approval. NCCN compendium support strengthens coverage arguments and is particularly important for CLL/SLL given the relative newness of the FDA approval.

Required PA documentation checklist

• FACT (or FACT-JACIE) accreditation certificate for the treatment center
• BREYANZI REMS certification letter for the prescribing physician and the facility (NOT the YESCARTA or TECARTUS REMS letter — manufacturer-specific certifications are independent)
• Prior therapy log: each regimen, dates, response, reason for discontinuation
• Indication-specific gate documentation:
  • 2L LBCL: "primary refractory" OR "relapse within 12 months of first-line"
  • 3L+ LBCL: ≥2 prior lines including anthracycline + anti-CD20 mAb
  • CLL/SLL: prior BTKi exposure (ibrutinib/acalabrutinib/zanubrutinib) failure AND prior BCL-2i (venetoclax) failure — both with dates and reason for stopping
  • FL: ≥2 prior lines including anti-CD20 + alkylator
  • MCL: prior BTK inhibitor failure
• ECOG performance status (most policies require 0-2)
• Diagnostic pathology confirming CD19+ disease (flow cytometry)
• Imaging / disease burden assessment within recent window (per payer policy, often 30-60 days)
• CNS disease exclusion documentation
• Cardiac and pulmonary clearance (LVEF, pulmonary function tests as required)
• Absence of active autoimmune disease requiring systemic immunosuppression

Medicare reimbursement CMS Q2 2026 (live)

Q2054 has a quarterly ASP payment limit; MS-DRG 018 sets the inpatient DRG payment; OPPS APC handles outpatient (the most common Breyanzi pathway).

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. For Breyanzi specifically, inpatient share is materially lower than for Yescarta or Tecartus because of the outpatient-friendly CRS profile. When Breyanzi is administered inpatient, MS-DRG 018 still typically falls short of total acquisition + admission cost in many cases, though the gap is somewhat smaller than for CD28-domain CAR-T because of shorter average length of stay.

NTAP history

• FY 2022 - FY 2024: Breyanzi received CMS NTAP add-on payment after the February 2021 LBCL approval, recognizing the gap between historical DRG payment and acquisition cost.
• FY 2025 onward: NTAP for lisocabtagene maraleucel expired after the standard 3-year window. Breyanzi inpatient admissions are now reimbursed under MS-DRG 018 alone.
• 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 CLL/SLL, FL, and MCL approvals of 2024 did not trigger new NTAP windows.

Outpatient OPPS APC (important for Breyanzi)

Outpatient CAR-T infusion is the dominant Breyanzi pathway. Payment runs through OPPS via a CAR-T-specific APC. APC 9248 has historically been used; CMS updates the precise APC and rate annually in the OPPS Final Rule. Q2054 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. For Breyanzi, the outpatient pathway is the financial planning baseline at most high-volume cellular therapy centers, with inpatient reserved for higher-risk patients or institutional preference.

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. All five Breyanzi indications (LBCL 3L+, LBCL 2L, CLL/SLL, FL, MCL) are covered under the same NCD without separate coverage decisions, including the March 2024 CLL/SLL approval.

Patient assistance — BMS Cell Therapy 360 BMS verified May 2026

• BMS Cell Therapy 360: BMS-administered patient hub for Breyanzi and Abecma — benefits investigation, prior authorization assistance, appeal support, copay support (commercial-only), case-management through the multi-stage CAR-T encounter, and coordination of the longer Breyanzi manufacturing turnaround. Confirm the current phone and portal URL on the most recent Breyanzi Patient Brochure shipped with the cellular product.
• BMS Patient Assistance Foundation (BMSPAF): free product pathway for eligible uninsured and underinsured patients meeting federal poverty level criteria. Application via the patient's CAR-T case manager. bmspaf.org
• 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 LBCL, CLL, FL, and MCL. Verify open lymphoma and CLL funds quarterly.
• Travel and lodging: Breyanzi is administered only at FACT-certified centers, often requiring travel. BMS Cell Therapy 360 and many treatment centers maintain travel grants for patients living > 50-100 miles from a treatment center. LLS maintains lymphoma and CLL travel grants.

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Breyanzi?

Breyanzi (lisocabtagene maraleucel) is billed under HCPCS Q2054 — "Lisocabtagene maraleucel, up to 110 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 infusion encounter; the descriptor's 110-million cell-count is lower than Yescarta and Tecartus (200 million) because of Breyanzi's defined 1:1 CD8:CD4 composition. The descriptor explicitly bundles leukapheresis and dose preparation. The two component bags (CD8 + CD4) are part of one therapeutic dose — bill ONE unit of Q2054, not two.

How is Breyanzi different from Yescarta?

Both are autologous anti-CD19 CAR-T but with three critical differences. (1) Costimulatory domain: Breyanzi uses 4-1BB; Yescarta uses CD28. 4-1BB drives slower, more controlled expansion with lower peak CRS / ICANS. (2) Composition: Breyanzi is manufactured to a defined 1:1 CD8:CD4 ratio (two separately enriched bags); Yescarta is a single unfractionated bag. (3) Manufacturer / hub: Breyanzi is BMS/Juno with BMS Cell Therapy 360; Yescarta is Kite/Gilead with Kite Konnect. Breyanzi posts the lowest Grade 3+ CRS rate in CD19 CAR-T (< 5%) and is the most outpatient-friendly product. Yescarta has faster manufacturing (~14-17 days vs ~24-35 for Breyanzi). Q2054 vs Q2041 are NOT interchangeable.

What does TRANSCEND CLL 004 mean for Breyanzi billing in CLL/SLL?

TRANSCEND CLL 004 (Lancet 2023, Siddiqi T et al.) established Breyanzi for adult R/R chronic lymphocytic leukemia or small lymphocytic lymphoma after at least 2 prior lines including a BTK inhibitor AND a BCL-2 inhibitor. FDA granted accelerated approval March 14, 2024 - Breyanzi is the first and only CAR-T cell therapy approved in CLL/SLL. For PA, both prior BTKi (ibrutinib/acalabrutinib/zanubrutinib) AND prior BCL-2i (venetoclax) failures must be explicitly documented with dates and reason for stopping each. Some commercial payers were slow to update CAR-T policies after March 2024 — cite NCCN CLL/SLL Guidelines (Category 2A) and the FDA label directly in PA submissions for policy-lagging payers. This is the most common CLL/SLL Breyanzi denial driver.

What does TRANSFORM mean for Breyanzi billing in 2L LBCL?

TRANSFORM (Lancet 2022, Kamdar M et al.) established Breyanzi for primary refractory or early-relapsing (within 12 months) LBCL in the second-line setting vs standard chemoimmunotherapy + auto-HSCT. FDA approved Breyanzi for 2L LBCL June 24, 2022 — the second CAR-T approved at 2L (after Yescarta's April 2022 ZUMA-7). For PA, document explicit "primary refractory" or "relapse within 12 months of first-line." Missing this timing language is the #1 PA denial driver in 2L Breyanzi cases. TRANSFORM's ~1% Grade 3+ CRS rate is the principal argument for outpatient pathway approval at qualifying centers.

What does TRANSCEND NHL 001 mean for Breyanzi billing in 3L+ LBCL?

TRANSCEND NHL 001 (Lancet 2020, Abramson JS et al.) established Breyanzi for 3L+ R/R LBCL including DLBCL NOS, high-grade B-cell lymphoma, PMBCL, and FL grade 3B. FDA approved Breyanzi for 3L+ LBCL February 5, 2021. The PA must document at least 2 prior lines including an anti-CD20 mAb and an anthracycline-based regimen (or document why anthracycline was inappropriate). The TRANSCEND NHL 001 cohort included patients with secondary CNS lymphoma and poor performance status, broadening the practical eligibility envelope vs ZUMA-1.

Why is Breyanzi the most outpatient-friendly CD19 CAR-T?

Two reasons: (1) the 4-1BB costimulatory domain drives slower expansion with lower peak CRS; (2) the defined 1:1 CD8:CD4 composition limits dose variability. Together these produce the lowest Grade 3+ CRS rate in the CD19 class (typically < 5%). More payers approve Breyanzi outpatient pathway than Yescarta or Tecartus; outpatient billing reports Q2054 under OPPS APC (9248 historically) plus the 0537T-0541T administration set. The trade-off is the longer Breyanzi manufacturing turnaround (~24-35 days vs ~14-17 for Yescarta).

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

Five stages: (1) Apheresis — CPT 38206 or 0540T at a FACT-accredited center; (2) Manufacturing wait of approximately 24-35 days (longest in CD19 class due to separate CD8 / CD4 processing) with no billing; (3) Lymphodepletion with fludarabine 30 mg/m^2 (J9185) and cyclophosphamide 300 mg/m^2 (J9070) days -5 to -3 — note the lower cyclophosphamide dose vs Yescarta; (4) CAR-T infusion — Q2054 single dose (covers both CD8 and CD4 bags) plus the 0537T-0541T administration set; (5) CRS/ICANS monitoring — lowest rates in CD19 class, most outpatient-eligible product. Stages 3-5 may combine into one inpatient admission (MS-DRG 018) or run as a true outpatient pathway across multiple OPPS encounters.

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. For Breyanzi specifically, a significant fraction of cases bypass inpatient entirely and run through OPPS APC, but for those that do admit inpatient, MS-DRG 018 is the correct grouper output.

Does Breyanzi have NTAP add-on payment status?

Breyanzi received CMS NTAP starting FY 2022 (after the February 2021 LBCL approval); NTAP for lisocabtagene maraleucel expired after FY 2024. Breyanzi inpatient admissions are now reimbursed under MS-DRG 018 alone, without separate NTAP. The 2024 CLL/SLL, FL, and MCL approvals did not trigger new NTAP windows. Verify each FY IPPS Final Rule because CMS occasionally extends or revises CAR-T add-on policy.

What FACT accreditation is required?

Breyanzi may only be administered at facilities certified through the BREYANZI REMS, which requires FACT (or FACT-JACIE) accreditation for cellular therapy plus on-site CRS/ICANS management capability, immediate tocilizumab availability, and ICU backup. BMS maintains the list of certified treatment centers through BMS Cell Therapy 360. A center certified for Yescarta or Tecartus (Kite products) is NOT automatically Breyanzi-certified — manufacturer-specific REMS programs are independent. Confirm BMS Breyanzi certification BEFORE Stage 1.

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

For Breyanzi specifically, outpatient infusion is materially more common than for other CD19 CAR-T products because of the low Grade 3+ CRS rate. Estimated outpatient share is 30-50% at qualifying high-volume centers for low-burden LBCL and CLL/SLL cases. Outpatient billing reports Q2054 as a separately payable OPPS line (APC 9248 historically) plus the 0537T-0541T administration codes. Inpatient admissions still bill under MS-DRG 018 with the Q2054 line bundled. Verify per-payer; CLL/SLL outpatient pathway is still policy-emerging post-March 2024 approval.

What apheresis CPT do I bill for Breyanzi - 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. The Breyanzi apheresis is identical to other CD19 CAR-T from the billing standpoint; the Breyanzi-specific CD8 / CD4 separation happens at the BMS manufacturing facility, not at the apheresis center.

Why is the two-bag infusion billed as one unit of Q2054?

Breyanzi is manufactured as a defined 1:1 CD8:CD4 composition in two separate cryopreserved bags, but the FDA label and the HCPCS descriptor define one therapeutic dose as the sequential administration of both bags (CD8 first, then CD4 minutes later). Bill ONE unit of Q2054 covering the entire administration. The 0540T administration code is also billed once for the sequential service. Submitting two units of Q2054 (one per bag) is a billing error and will be denied or recouped.

How is CRS readmission after Breyanzi billed?

If the patient is infused outpatient (common for Breyanzi) 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. Operationally, Breyanzi CRS readmission is the least common in the CD19 CAR-T class because of the < 5% Grade 3+ CRS rate.

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

Breyanzi manufacturing failure rates have historically been comparable to or slightly higher than Yescarta because of the more complex CD8 / CD4 separation and dual-bag formulation. BMS policy historically provides manufacturing-failure replacement at no additional drug cost — verify the current BMS policy through BMS Cell Therapy 360. The repeat apheresis (38206 or 0540T) is generally separately billable; document the manufacturing failure with the BMS case manager and submit a fresh PA referencing the prior approval. The longer Breyanzi vein-to-vein adds operational pressure when a re-collection is required — plan supportive bridging therapy accordingly.

Source documents

1. Breyanzi HCP page (Bristol-Myers Squibb)
   Manufacturer dosing, REMS, treatment center locator, and BMS Cell Therapy 360 patient support reference
2. DailyMed — BREYANZI (lisocabtagene maraleucel) Prescribing Information
   FDA-approved label, most recent revision (BLA 125714)
3. FDA Approval Announcement — Lisocabtagene Maraleucel for R/R LBCL (Feb 5, 2021)
   Initial 3L+ LBCL approval (TRANSCEND NHL 001)
4. FDA Approval — Breyanzi 2L R/R LBCL (Jun 24, 2022, TRANSFORM)
   Second-line LBCL approval
5. FDA Accelerated Approval — Breyanzi R/R CLL/SLL (Mar 14, 2024, TRANSCEND CLL 004)
   First and only CAR-T approved in CLL/SLL
6. FDA Accelerated Approval — Breyanzi R/R Follicular Lymphoma (May 15, 2024, TRANSCEND FL)
   FL indication
7. FDA Approval — Breyanzi R/R Mantle Cell Lymphoma (May 30, 2024)
   MCL indication
8. FDA Approval — Breyanzi R/R Marginal Zone Lymphoma (December 4, 2025, TRANSCEND FL-MZL cohort)
   First CAR-T approved in MZL — TRANSCEND FL-MZL cohort, NCT04245839; supplemental BLA, accelerated approval
9. ClinicalTrials.gov — TRANSCEND FL/MZL (NCT04245839)
   Pivotal R/R FL and R/R MZL trial registration
10. Abramson JS et al. - TRANSCEND NHL 001 (R/R LBCL 3L+), Lancet 2020
    Pivotal LBCL data — basis of February 2021 FDA approval
11. Kamdar M et al. - TRANSFORM (2L R/R LBCL), Lancet 2022
    Pivotal 2L LBCL data — basis of June 2022 FDA approval
12. Siddiqi T et al. - TRANSCEND CLL 004 (R/R CLL/SLL), Lancet 2023
    Pivotal CLL/SLL data — basis of March 2024 accelerated approval
13. FACT (Foundation for the Accreditation of Cellular Therapy)
    Accreditation standards for cellular therapy programs (FACT and FACT-JACIE)
14. CMS — Medicare Part B Drug ASP Pricing File
    Q2 2026 quarterly file, effective April 1 – June 30, 2026
15. CMS — FY 2026 IPPS Final Rule (MS-DRG 016 / 018, NTAP)
    CAR-T DRG assignments and add-on payment policy
16. CMS — CY 2026 OPPS Final Rule (CAR-T outpatient APC)
    Outpatient CAR-T APC assignment and rate — particularly important for Breyanzi
17. CMS NCD 110.24 — Chimeric Antigen Receptor (CAR) T-cell Therapy
    National Coverage Determination for CAR-T
18. NCCN B-Cell Lymphomas Guidelines
    LBCL, FL, MCL sections — Breyanzi listed across indications
19. NCCN CLL/SLL Guidelines
    Breyanzi Category 2A in post-BTKi + post-BCL-2i setting
20. BMS Patient Assistance Foundation
    Patient assistance program covering Breyanzi for uninsured and underinsured patients
21. 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. Added sixth FDA-approved indication: relapsed/refractory marginal zone lymphoma (MZL), approved December 4, 2025 based on the TRANSCEND FL-MZL cohort (NCT04245839) — the first CAR-T ever approved in MZL. Updated indications row, class-comparison table, about-Breyanzi section, pivotal trials list, and FAQ; added FDA MZL approval announcement and ClinicalTrials.gov NCT04245839 to source list. Reviewer callout flipped from "Pending SME review" to "SME-audited — corrections applied".
• May 22, 2026 — Initial publication. ASP data: Q2 2026 (live-bound to CMS file at ~$562,260.836). 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 the Breyanzi-specific defined 1:1 CD8:CD4 two-bag composition, 4-1BB costimulatory domain, 30/300 mg/m^2 lymphodepletion regimen, and ~24-35 day manufacturing turnaround. FACT accreditation and BREYANZI REMS gate emphasized as #1 denial driver — including the separate-certification-from-Kite distinction. CD19 CAR-T class disambiguation (Breyanzi vs Yescarta vs Kymriah vs Tecartus, plus BCMA-class Abecma and Carvykti) included for code-selection accuracy. All five FDA-approved indications covered: TRANSCEND NHL 001 (3L+ LBCL), TRANSFORM (2L LBCL), TRANSCEND CLL 004 (first and only CAR-T in CLL/SLL, March 2024), TRANSCEND FL (FL, May 2024), MCL (May 2024). CLL/SLL dual-BTKi-plus-BCL-2i documentation requirement emphasized as #2 PA denial driver. Outpatient pathway emphasized as Breyanzi's operational signature given lowest Grade 3+ CRS rate in CD19 class.

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 Breyanzi label revision. REMS program details are verified through BMS materials. Pivotal trial evidence is cited from peer-reviewed publications (Lancet for all four pivotal trials). We do not paraphrase from billing-software vendor blogs.