Roy Silverstein, MD
Recently, the Centers for Medicare & Medicaid Services (CMS) proposed to improve the reimbursement currently given to hospitals that provide chimeric antigen receptor (CAR) T-cell therapy to patients with blood cancer as part of the Fiscal Year 2020 Inpatient Prospective Payment System proposed rule. American Society of Hematology (ASH) President Roy Silverstein, MD, of the Medical College of Wisconsin, commented on the news:
Cell and gene therapies are emerging as potential cures for patients with blood diseases. The recent approvals of CAR T-cell products for patients with certain types of relapsed or treatment-resistant blood cancers are examples of rapid innovation, bringing hope to those who have exhausted all other treatment options.
Despite there being two CAR T-cell products now approved—and more in the development pipeline—we are concerned that not every patient whose hematologist prescribes these innovative therapies will have access to them. For example, some centers are unable to offer CAR T-cell therapies to Medicare beneficiaries because the overall cost is unsustainable. CMS reimburses centers for CAR T-cell therapies using the same classification as a stem cell transplant, which does not recognize the high costs of treating adverse events in the intensive care unit (ICU). Many patients are admitted to the ICU to treat high fevers, which are a hallmark of CAR T-cell therapies and a sign treatment is successful, as well as other potential toxicities specific to this therapy. The absence of an appropriate payment model has life-or-death ramifications for patients. Insufficient reimbursement will also significantly slow innovation—the payment model for CAR T-cell therapies will set the precedent for other cell and gene therapies to come.
CMS recognizes the consequences of not keeping up with innovation. ASH is pleased that the agency is currently examining its existing payment policies to identify ways to more realistically account for the costs of administering this life-saving therapy. The proposed rule would increase the payment given to institutions for new technologies, such as CAR T-cell therapies, to 65%, which would reimburse centers for 15% more of the product cost than they receive now. While ASH had originally suggested a higher payment, any increase is an improvement. The agency also proposed allowing all institutions to receive the maximum add-on payment for the cost of the therapy, which simplifies and improves the reimbursement methodology for CAR T-cell therapies.
While the proposal from CMS is promising, it is not a one-stop solution for making CAR T-cell therapies more accessible to patients. Just as these therapies are innovative, it is going to take some innovation on the part of CMS to develop a plan that equitably compensates providers and institutions so that offering the therapy is sustainable. ASH looks forward to continuing to work with CMS with the goal of establishing a funding model that recognizes the complexity of this care. ■