Medicare Coverage of Spinal Disk Unlikely
A 30-day comment period on a proposal to designate a Johnson & Johnson artificial spinal disk as not "reasonable and necessary" therapy for Medicare beneficiaries ended Friday, the New York Times reports. FDA approved the Charite spinal disk, a surgically implanted disk used in patients with lower back pain, in October 2004.
However, sales of the device reached only one-third of J&J's projected $100 million in 2005, in part because so few insurers cover Charite.
CMS' proposal to deny coverage for Charite, which can cost as much as $50,000, was based on a lack of data from clinical trials about the device's ability to perform over the 20 years or more it is expected to last. The trials compared Charite "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," the Times reports.
The federal government also did not find convincing evidence that Charite and other spinal disks substantially improved range of motion over time or did less damage to neighboring disks.
Proponents say rather than refusing coverage, CMS should wait for more data or allow coverage for Medicare beneficiaries under age 60.
A final ruling from CMS is expected in mid-May.
According to the Times, analysts do not expect a reversal in the proposal. They note that a decision "would end the confusion that has led some locally administered Medicare plans to pay for the spinal surgery," while others do not (Feder, New York Times, 3/18).