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.

Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free!

GET STARTED

What is it?

STAT Plus is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What's included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • Online intelligence briefings
  • Frequent opportunities to engage with veteran beat reporters and industry experts
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.

Leave a Comment

Please enter your name.
Please enter a comment.

  • Really buried the lead in there: “Wednesday’s announcement does not, however, ensure that hospitals are breaking even when offering CAR-T treatments. CMS’ coverage policy does not change how much CMS reimburses for CAR-T treatments, which currently cost over $300,000.”

  • “The agency also abandoned its previous idea of requiring hospitals collect data on how patients fare when they receive these treatments.” Why was this not put in the final policy? As a taxpayer and cancer patient I want to know how well these drugs work over the broadest, most varied population. There may be exceptions.

    • All hospitals and healthcare facilities are already collecting data on CAR-T patient outcomes, as dictated by the CIBMTR. The proposed questions from CMS were more about tracking patients’ perceptions of their outcomes, and they offered no centralized registry with which to do the tracking.

  • I’m glad to hear that they will cover these. Nothing’s sadder than the thought of a child having a curable otherwise fatal illness and them getting a call from your insurance company “Hey, I got something funny to tell you. Since you are on indigent insurance, we won’t pay for your medicine. Your parents should have chosen a better paying profession.”

  • So…Medicare is going broke in just a few years without reductions in reimbursement to hospitals and physicians, BUT it will pay for a $300,000 drug therapy??? How does that make ANY sense?

    • Medicare is not going broke just as the sky is not falling. If you needed this treatment to live, would you say “no, let me die, this treatment cost too much”?

    • Teresa,

      A doctor walks in. They tell you: $30,000 chemo = 90% chance you will die a slow painful death. A $300,000 cell therapy = 93% chance you will survive. You want your insurance company to say well Teresa, I sure hope you have $300,000 saved up today. If not, well let me write you a referral to a good mortician.

A roundup of STAT’s top stories of the day in science and medicine

Privacy Policy