CMS has proposed covering a new form of cancer therapy, CAR T-cell therapy, under Medicare. The proposal would create a uniform standard of covering the treatment, which uses a patient’s own immune system to fight the disease.
Currently, Medicare Advantage contractors discern whether they cover the therapy or not for enrollees under Coverage for Evidence Development (CED).
“CAR T-cell therapy was the first FDA-approved gene therapy, marking the beginning of an entirely new approach to treating serious and even life-threatening diseases,” CMS Administrator Seema Verma said in a statement. “Today’s proposed coverage decision would improve access to this therapy while deepening CMS’s understanding of how patients in Medicare respond to it, so the agency can ensure that it is paying for CAR T-cell therapy for cases in which the benefits outweigh the risks.”
The proposal would require Medicare to cover the therapy under a National Coverage Determination when it is offered in a CMS-approved registry or clinical study, according to CMS. Under the terms, patients are monitored for at least two years post-treatment. The studies and registries will inform CMS of which types of patients can benefit from the therapy and in which cases Medicare should cover it.
CMS will utilize the FDA’s requirements for post-approval studies for CAR-T when reviewing studies for the agency’s approval.
See the proposed decision here.