Last month I blogged about an artificial spinal disk called Charite by (Johnson & Johnson). The Centers for Medicare and Medicaid Services proposed to deny coverage for the surgery, citing lack of evidence that it is “reasonable and necessary.” The 30-day period for comments ended last Friday, and it appears Medicare will not cover the procedure. The final ruling is due in May.
From the New York Times:
The Medicare decision was based on several well-known criticisms of Charité. The trials to gain F.D.A. approval did not provide data on how it would perform over the two decades or more that it is expected to last.
In addition, the trials compared the device with a form of spinal fusion no longer considered state of the art and they were designed to show that it was equivalent, not an improvement. Nor did the government find convincing evidence that Charité and other spinal disks leave patients with substantially more range of motion over time and that they do less damage to neighboring disks.
Proponents argue that the government was ignoring or playing down data that cast the disk in a more favorable light while giving too much weight to outdated reports of performance problems.
If Medicare won’t cover Charite, private insurers may follow suit. If CMS decides not to cover surgery for Johnson & Johnson’s product, beneficiaries may still have options. According to the article, a Swiss company has developed a similar product, which could be approved by September.