Medicare’s New Math on CAR-T Reimbursement Changes: Who Wins, Who Hurts, and What Could Break
For a decade, CAR-T has been the ultimate “no-brainer” innovation story: breathtaking responses, transformative outcomes, and an ecosystem racing to catch up with the science. Now Medicare’s FY 2026 CAR-T reimbursement changes are forcing a very different kind of calculus—less about cell biology and more about hospital balance sheets. It turns out T cells are not the only ones that need to expand; margins do too.
Effective October 2025, the Centers for Medicare & Medicaid Services (CMS) rewired the economics of CAR-T under MS-DRG 018. On the surface, it looks like a win: a 16.8% increase in the base rate to $314,231, up from $269,139, coupled with a 13% reduction in the fixed-loss outlier threshold to $40,397. But buried in the details is a seismic hit to clinical research: instead of the higher clinical trial payment level anticipated in the proposed rule, CMS finalized a much lower adjustment factor, producing a base payment of USD $50,277 for CAR-T clinical trial cases—about a 43% drop from the proposed $72,260 level.
The message is clear: CMS will pay more for commercially approved CAR-T—and substantially less, relative to expectations, for experimentation.
The New Incentive Structure for CAR-T reimbursement changes: Commercial or Bust
Medicare did not just tweak the knobs; it flipped the incentive stack.
- Commercial cases are now financially safer. Higher DRG payment plus a lower outlier threshold gives hospitals more room to absorb high-cost complications in routine, on-label CAR-T use.
- Clinical trial cases are now financially fragile. The finalized trial adjustment factor (0.16) yields a base payment of $50,277 for CAR-T trial cases, versus roughly $72,260 under the proposed 0.23 factor—a roughly 43% reduction from the proposed level.
For health systems, a new priority order emerges:
- Protect and expand commercially reimbursed CAR-T volume.
- Selectively participate in trials that come with strong financial backstops.
- Reconsider marginal trials that pile operational complexity on top of under‑reimbursed care.
For sponsors, especially in cell and gene therapy, this is a blunt message: “Interesting science” is no longer enough to guarantee site participation. Trials must be operationally clean, financially viable, and aligned with how hospitals are actually paid—or they will sit at the bottom of the start‑up pile.
Outpatient CAR-T: From Concept to Default Setting
At the same time, REMS guardrails around CAR-T have relaxed as safety data accumulates, opening a much wider door to outpatient use. When you combine:
- Higher inpatient DRG payments (but expensive bed days),
- Lower thresholds for outliers (more protection against catastrophic cost), and
- Growing comfort with managing lower-risk patients in outpatient or hybrid models,
the delivery model begins to tilt.
Outpatient CAR-T is moving from boutique experiment to likely default for selected risk profiles. Hospitals will increasingly:
- Reserve inpatient beds for the sickest, most complex CAR-T cases.
- Push lower-risk, protocol-refined regimens into outpatient infusion centers or partnered community sites.
That shift cascades through the value chain: apheresis scheduling, patient logistics, monitoring infrastructure, and post‑discharge surveillance all need to function in a world where the “CAR-T stay” might look more like a long chemotherapy day than an ICU‑adjacent admission.
Where Mobile Leukapheresis Centers Come In
This is where mobile leukapheresis stops being a cool infrastructure story and starts being a strategic lever.
Mobile leukapheresis centers are designed to decouple collection from large tertiary centers and bring starting material capture to the same geographies where outpatient CAR-T infusion and monitoring sites are emerging. Instead of forcing every CAR-T patient to travel to a limited set of academic hubs for collection, mobile units can:
- Anchor regional CAR-T “spokes.” A mobile leukapheresis center can serve as the upstream enabler for community-based infusion sites. Supplying starting material while those sites focus on infusion, toxicity management, and follow-up.
- Reduce the cost and operational burden on hospitals. As inpatient bed days become more expensive and trial cases less financially attractive, shifting collection out of the hospital and into specialized mobile infrastructure helps hospitals participate in CAR-T programs without bearing the full operational footprint.
- Support payer-aligned delivery models. Payers are signaling a preference for more distributed, cost-efficient care; mobile leukapheresis, paired with outpatient infusion and remote monitoring. This then creates a delivery stack that fits the new economic reality.
For the field, the implication is straightforward. If reimbursement is pulling CAR-T toward outpatient and regional models, mobile leukapheresis is one of the few practical tools that can make that shift operationally and geographically real at scale. It becomes part of the blueprint for expanding access without exploding cost.
What This Means for the Blueprint We Have for Breakthroughs
This Medicare change could be a design constraint or design makeover for the next generation of cell and gene therapy development.
For integrated advanced therapy organizations:
- Trial strategy must follow the money. Study designs that assume abundant hospital capacity and unlimited institutional goodwill will increasingly fail. Sponsors will need to build financial support into site contracts, simplify operational burdens, and make “easy to run, financially neutral or better” a core trial attribute.
- Decentralized and hybrid models gain real leverage. If inpatient CAR-T becomes more expensive and trial reimbursement is compressed, models that reduce bed days—mobile leukapheresis, community-based collections, outpatient infusion plus remote monitoring—shift from “innovative” to “economically necessary.”
- Access narratives must be grounded in economics, not just ethics. Policymakers are signaling a willingness to pay more for proven therapies and much less for exploratory care without clear, demonstrable value. Any access strategy that ignores hospital P&L reality will feel disconnected from the front lines.
The Blueprint Question
The real question for the field is:
Can we design therapies, trials, and delivery models that survive the new Medicare math—and use infrastructure improvements and efficiencies to make outpatient CAR-T truly scalable?
FY 2026 CAR-T reimbursement is a preview of a future where payers reward maturity, penalize exploratory care without clear value, and push delivery out of the hospital and into more distributed, cost-efficient infrastructure. In that world, the organizations that win the next decade of cell and gene therapy will be the ones that treat reimbursement policy and delivery infrastructure—mobile collection, regional infusion, remote monitoring—as core design inputs, right alongside vector choice, construct design, and manufacturing platform.
If that sounds less romantic than “curing cancer,” remember: even the best CAR-T needs a viable revenue cycle and a reachable infusion chair to get from the lab to the bedside.
Blueprint for Breakthroughs is a LinkedIn newsletter published by Adrienne B. Mendoza, MHA, SVP BioBridge Global and Chief Operating Officer (COO), BBG Advanced Therapies
