Medicare might not pay for implantation of the Charité artificial spinal disk if a proposed coverage decision becomes final in May.
According to the Centers for Medicare and Medicaid Services proposal, the evidence is not adequate to conclude that disk replacement with the Charité “is reasonable and necessary.”
CMS is accepting comments through April, and will make a final decision on May 6. The agency said it found little data in patients older than 65 years and, in addition, that the results of the pivotal Charité study “are unconvincing as a demonstration of net health benefit.”
Several specialty societies—including the North American Spine Society, the Scoliosis Research Society, and the Spine Arthroplasty Society—have commented, mostly saying that the jury is still out on older patients.
The Charité was approved by the Food and Drug Administration last November, but it has not been widely adopted and is rarely being paid for by insurers. So far, 176 procedures have been covered by insurers; Medicare has paid for a few cases as well, said Dr. Richard Toselli, worldwide vice president for research and development at DePuy Spine Inc. of Raynham, Mass., which makes Charité. The disk is indicated for 18- to 60-year-old patients with degenerative disk disease at one level, either L4/L5 or L5/S1. It has not been studied in patients older than age 60.
CMS began its coverage review at the request of Dr. Richard Deyo, an internist and professor of medicine and health services at the University of Washington, Seattle. In an interview, Dr. Deyo said he was concerned about the safety of the Charité in an older population partly because osteopenia and osteoporosis are contraindications.
Dr. Deyo also said the Charité had shown in trials only that it was not inferior to a type of fusion—Bagby and Kuslich (BAK) cages with iliac crest bone graft—a procedure he called “largely discredited.”
The disk is not intended to be implanted in patients older than age 65, so Medicare's proposal did not come as a great surprise, said Dr. Toselli. DePuy Spine is hoping that Medicare will pay for Charité implantation in its disabled beneficiaries, he said.
A split coverage decision would not be unprecedented. A CMS spokesman said the agency has in the past covered procedures or therapies for subgroups of the Medicare population, or has imposed restrictions on the prescribing or use of a device or therapy. In its Charité proposal, however, CMS said the data did not seem to support using the disk in the disabled, either.