Medicare To Cover Artificial Spinal Disk
CMS in a final decision has agreed to allow local medical directors to approve Medicare coverage for the artificial spinal disk Charite, manufactured by Johnson & Johnson subsidiary DePuy Spine, for beneficiaries younger than age 60, J&J said on Tuesday, Reuters/New York Times reports. In February, CMS had proposed to deny Medicare coverage for Charite, a surgically implanted disk for patients with lower back pain that FDA approved in October 2004 (Reuters/New York Times, 5/16).
CMS cited a lack of clinical trial data to indicate that the surgery to implant Charite -- which costs about $11,500 and as much as $50,000 to implant -- is "reasonable and necessary" (California Healthline, 3/20). At the time, CMS said that J&J did not prove that Charite benefited patients more than spinal fusion surgery.
In addition, CMS raised concerns about potential complications from the surgery to implant Charite. J&J said that the decision by CMS to approve Medicare coverage for Charite likely will prompt more private health insurers to cover the device (Reuters/New York Times, 5/16).