STAT August 7, 2019
WASHINGTON — The Trump administration finalized late Wednesday long-sought rules for when Medicare will cover CAR-T treatments, the cutting-edge, often curative therapies that harness patients’ own immune cells against their cancer.
Under the new policy, Medicare will pay for CAR-T therapies so long as they’re administered in health care facilities that follow the Food and Drug Administration’s special safety rules, known as risk evaluation and mitigation strategies, or REMS. Medicare will also pay for CAR-T even when it’s used to treat conditions that aren’t FDA-approved. The two CAR-T treatments on the market, Gilead’s Yescarta and Novartis’ Kymriah, are approved to treat non-Hodgkin lymphoma and acute lymphoblastic leukemia, respectively.
The policy is likely a positive development for hospitals, which have groused...
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