Is it time for Congress to step in on CAR-T? 

CMS finalized a modest payment bump Friday for hospitals administering CAR-T treatments, the splashy new therapies that use patients’ own immune cells to fight cancer. Medicare will now reimburse hospitals for 65% of the additional costs associated with administering these new treatments, versus the previous 50%. That means hospitals will get paid roughly $55,000 more for administering Novartis’ Kymriah and Gilead’s Yescarta. That might seem like a lot, but it’s pretty meager. As my former colleague Ike Swetlitz wrote earlier this year, hospitals have been struggling to figure out how they can afford to offer these treatments to patients, since these treatments alone cost as much as $475,000 and the rest of the treatment costs are often much higher. 

Reaction to Friday’s announcement, which came as part of a massive payment rule (Ever heard of summer Fridays, CMS?) was relatively muted. But it’s clear CMS didn’t deliver the types of changes the health industry was hoping for. Hospitals, drug makers, and doctors groups alike were all pushing for a much larger bump. The American Hospital Association, for example, had requested that CMS reimburse hospitals 100% of the costs for these treatments. A spokesperson for BIO, which represents the two companies with CAR-T treatments on the market, also lamented to me Monday that CMS’ current reimbursement rate is insufficient “even with this modest increase.” 

In an interview Monday evening with STAT, CMS Administrator Seema Verma admitted that the agency is “struggling” with the payment policy. “I’m equally frustrated about the challenges that we’ve had with figuring out how to pay for CAR-T,” Verma said.

Verma, however, defended the administration's decision not to boost payments at the levels suggested by some hospitals and drug makers, arguing that hospitals should be encouraged to negotiate down the price of these treatments. And despite hospitals’ complaints about the financial toxicity of CAR-T, she insisted that some hospitals have found a way to get their reimbursement close to these treatments' average prices.

So what’s next?
Multiple drug industry lobbyists told me Monday that Congress may have to get involved, but any such effort is a long way away. (BIO said it is “still evaluating the best path forward, in consultation with our members.”)

If they do get involved, lawmakers aren’t likely to speak out until until after CMS finalizes a much larger regulation that could set out a more sweeping national coverage policy for CAR-T treatments. Nevertheless, there’s already early signs of congressional interest in the topic. A number of House members wrote to CMS in October 2018 raising concerns about how Medicare was paying for these cutting-edge treatments.