In a final Medicare coverage decision, regional contractors have been given the leeway to pay for implantation of the Charité artificial lumbar spinal disk, but only in beneficiaries who are younger than 60 years of age—about 6 million people.
The Centers for Medicare and Medicaid Services had originally proposed that the disk not be covered in any circumstances. After examining the evidence, however, CMS decided that although the data were unconvincing and “[did] not provide a sufficient basis for a national coverage decision at this time,” regional Medicare payers could reimburse for the procedure.
CMS also concluded that it would not be reasonable or necessary to cover the Charité disk for people over age 60. That position was supported by the North American Spine Society, the Scoliosis Research Society, and the Spine Arthroplasty Society. The American Association of Neurological Surgeons and the Congress of Neurological Surgeons had argued in comments on the proposal that the surgeon should decide which patients would benefit from the procedure.
CMS was lobbied to cover the procedure for all patients. The agency reported that it received a total of 604 comments, 470 of which were a form letter that had been created by the Texas Back Institute and were signed by patients, family members, and others. The agency said it was “skeptical” of form letters, and that it was not clear how many of the signees were Medicare beneficiaries.
Only seven of the comments overall backed the agency's proposal to not cover the procedure nationally. One physician told CMS that DePuy Spine Inc. was “orchestrating an aggressive letter-writing campaign asking surgeons to write CMS and request that coverage be granted.” Because of the pressure, he said that he felt compelled to come out against coverage.
“I believe that the DePuy strategy is self-serving and is clearly intended to bolster the device's stagnant sales figures,” the physician alleged.
Charité, made by DePuy Spine of Raynham, Mass., was approved in late 2004 for 18- to 60-year-old patients with either level L4/L5 or L5/S1 degenerative disk disease. It has not been studied in patients over the age of 60.
DePuy reported that 5,000 disks have been implanted since its approval, but only 205 procedures have been covered by insurers.
“We hope this decision will provide further support to other insurers of the importance of the Charité as a treatment option for patients with degenerative disk disease,” Dr. Richard Toselli, DePuy worldwide vice president for research and development, said in a statement.