CMS finalizes long-sought rules for Medicare CAR-T coverage

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 that lack of clear rules from the Centers for Medicare and Medicaid Services, combined with these treatments’ sky-high price tags, has hindered uptake.

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“Today’s coverage decision provides consistent and predictable patient access nationwide,” CMS Administrator Seema Verma said in a press release. “CMS will work closely with our sister agencies to monitor outcomes for Medicare patients receiving this innovative therapy going forward.”

CMS’ decision to write these rules, known as a national coverage determination, has been shrouded in controversy.  The two drug makers already selling CAR-T treatments have argued the national coverage policy is entirely unnecessary, because the contractors that administer Medicare’s hospital claims were already paying for the treatment. Others, including doctors groups, criticized a number of policies in the draft proposal.

CMS attempted to assuage some of those concerns in the final policy. For example, it walks back previous restrictions requiring CAR-T treatments only be administered in hospitals — the final policy instead states that it will cover treatments when they’re administered at “healthcare facilities,” a not-so-subtle nod to oncologists, who have complained their standalone clinics would have been left out under the draft version.

The agency also abandoned its previous idea of requiring hospitals collect data on how patients fare when they receive these treatments. 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 has been “struggling” to set those payment rates, and it could be years before that issue is solved, Verma told STAT in an interview earlier this week.