CMS received an external formal request for a national coverage determination on lumbar artificial intervertebral disc. The artificial disc, made from metal and plastic with two endplates and a sliding core, is used to treat pain associated with degenerative disc disease.
Charite™, approved in October of 2004, is currently the only FDA approved artificial disc. The disc is surgically implanted between vertebrae to replace a diseased or damaged intervertebral disc in the lumbar region. Surgical implantation of the device may reduce pain, increase movement at the site of surgery, and restore intervertebral disc height. The approved indication is for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level from L4-S1. Two notable contraindications to the surgery are osteoporosis and osteopenia, which may be more prevalent in the Medicare population.
We are currently reviewing literature and evidence for all artificial discs to include those currently being reviewed by FDA.
CMS is requesting public comments on this proposed decision memorandum pursuant to section 731 of the Medicare Modernization Act, with particular interest in comments on any additional evidence we did not review or that assess how we evaluated the evidence included. CMS is also requesting public comment on whether there is interest in performing further clinical trials for lumbar artificial disc replacement with the Charite lumbar artificial disc.
CMS encourages public comment on this proposed decision through our website: http://www.cms.hhs.gov/InfoExchange/02_publiccomments.asp#TopOfPage. After considering public comments, we will release a final decision memorandum.