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With Medicare denying the Johnson & Johnson Corporation’s request to have its Charite artificial disc replacement covered by insurance during 2006, the company is scrambling to find data to possibly get their product approved for use in 2007.
J&J’s artificial spinal disc got FDA approval in 2004 for helping symptoms of lower back pain. Several studies since then have resulted in many problems that occur in patients with the implants, including serious health risks if the implants are removed.
Doctors have overall been reluctant to prescribe the Charite disc, in part because of reimbursement problems they have because the units are not covered through many public health insurers. Only a very small amount of private insurers offer limited coverage.
Johnson & Johnson’s chairman of medical devices, Michael Dormer, recently stated in an interview that the company is awaiting data from a four to five year study on the discs. They are also considering doing extra research in order to convince insurers to cover the devices.
Medicare, however, has repeatedly said that the devices do not appear to meet an improvement over spinal fusion surgery, especially due to their serious side effects and potential risks involved. The company has said they will reconsider approval for 2007 coverage when additional data becomes available.
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