The Centers for Medicare & Medicaid Services today proposed Medicare cover chimeric antigen receptor T-cell (CAR T) therapies approved by the Food and Drug Administration when they are prescribed by the treating oncologist and performed in a hospital meeting certain criteria. The proposed “coverage with evidence development” decision would require eligible patients receiving CAR T to be enrolled in a national registry or CMS-approved clinical study, and followed for at least two years to examine patient outcomes, clinical characteristics and health-related quality of life. The FDA in 2017 approved two CAR T-cell therapies for treating certain leukemias and lymphomas, which require safety monitoring through an FDA risk evaluation and mitigation strategy. The treatments are individually made by modifying the patient’s own T-cells, a type of white blood cell. CMS will accept comments on the proposed coverage decision through March 17. 

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