WASHINGTON -- Medicare will pay for vagus nerve stimulation (VNS) for treatment-resistant depression and has tentatively decided to do the same for chimeric antigen receptor T-cell (CAR-T) therapies -- but only under Coverage with Evidence Development, which means patients and their treating physicians must be part of an approved research protocol.
For VNS, the limitation stipulates that patients must be in a "double-blind, randomized, placebo-controlled trial with a follow-up duration of at least one year," among other conditions. It also spells out nine research questions that the trial must address, as well as particular inclusion and exclusion criteria for recruitment.
VNS devices must also have been approved by the FDA. Several have been on the market for more than a decade.
The Center for Medicare and Medicaid Services' proposed decision on CAR-T therapies has somewhat broader criteria, allowing coverage for patients enrolled in registries as well as those in randomized trials. Protocols must specify that patients will be followed for at least 2 years. Treatments must have an FDA approval, although the studies may be for investigational indications. The first was approved in August 2017 and a second a few months later.
Comments on the proposed CAR-T therapy coverage will be accepted for the next 30 days, the agency noted, with a final decision 3 months from now.