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National Coverage Analysis (NCA) Tracking Sheet for Lumbar Artificial Disc Replacement (CAG-00292N)

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.

Inpatient Hospital Services
Physicians' Services
Requestor Name(s)Richard A. Deyo MD, MPH, University of Washington, School of Medicine
Requestor Letter(s)View Letter
Formal Request Accepted and Review Initiated08/16/2005
Expected NCA Completion Date05/16/2006
Public Comment Period08/16/2005 - 09/16/2005
Proposed Decision Memo Released02/15/2006
Proposed Decision Memo Public Comment Period: 02/15/2006 - 03/17/2006 
Decision Memo Released05/16/2006
Comments for this NCA:View Public Comments
Lead Analyst(s)
Lead Medical Officer(s)
  • Jyme Schafer MD, MPH

August 16, 2005

CMS opens this national coverage determination (NCD) request to review the coverage of the lumbar artificial intervertebral disc. CMS is requesting public comment on whether there is adequate evidence for evaluating health outcomes of the lumbar artificial intervertebral disc surgery in the Medicare population? After considering the public comments and reviewing relevant evidence, we will release a proposed decision memorandum. Instructions for submitting public comments can be found at https://www.cms.hhs.gov/coverage/8h.asp

September 12, 2005

Meeting with DePuy Spine.

September 16, 2005

The initial 30 day public comment period ended.

February 15, 2006

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.

May 16, 2006

The final decision  is now posted.
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