Five interesting things we learned from CMS’ latest spending projections
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Senior Manager, Health Research Institute, PwC USMarch 01, 2019
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Healthcare providers using chimeric antigen receptor T-cell (CAR-T) therapies to treat cancer patients could see greater Medicare coverage for the procedure under a new proposed coverage decision from CMS. Under the proposal, CMS would cover FDA-approved CAR-T therapies conducted in inpatient settings. The proposal also would require these hospitals to participate in a CMS-approved registry or clinical study to help the agency monitor outcomes for the treatment.
CAR-T therapy is a type of immunotherapy in which a patient’s T-cells are altered so they can kill cancer cells. The coverage would apply to Medicare patients with cancer that has relapsed or become resistant to treatment. Evidence from the registries and studies would be used to inform future coverage determinations for CAR-T therapies. CMS is seeking public comment through March 15.
HRI impact analysis
The first CAR-T therapy was approved by the FDA in August 2017 to treat some patients under 26 years old with B-cell precursor acute lymphoblastic leukemia. The second was approved by the FDA a few months later to treat some adult patients with certain types of large B-cell lymphoma. The FDA’s two approved CAR-T therapies can cost between $350,000 to $500,000, according to a 2017 report from the Institute for Clinical and Economic Review.
In a letter sent to CMS this week, the American Hospital Association (AHA) praised CAR-T’s “extraordinary potential to save lives” but also cited concerns about the therapy’s “extraordinary costs.” In its letter, the AHA asked CMS to make technical changes to its reimbursement policies so hospitals could avoid losing money on Medicare CAR-T inpatients. The AHA wrote that the losses could amount to up to $200,000 per patient because CMS’ policies had failed to keep up with the cost of the therapy.
“As technology continues to advance, therapies such as these will become more and more prevalent, and it is critical that a precedent is set that ensures beneficiary access to care,” the AHA wrote in its letter. “This requires not only appropriate payment, but also provider certainty in terms of coverage determinations, as one post-care-provision denial would be devastating to both providers and beneficiaries.”