The Centers for Medicare and Medicaid Services (CMS) is reviewing its national coverage decision (NCD) regarding Lumbar Artificial Disc Replacement.
On May 16, 2006, CMS issued a NCD (NCD Manual Section 150.10) for LADR. The coverage decision was focused on the Charite lumbar artificial disc because that was the only lumbar artificial disc with FDA approval at that time. On August 14, 2006, the FDA approved another lumbar artificial disc called ProDisc.
LADR involves the surgical implantation of the artificial disc device between two vertebrae to replace a diseased or damaged intervertebral disc in the lumbar region of the spine. The surgical implantation of the device may reduce pain, restore intervertebral disc height, and preserve motion.
CMS is opening this NCD for reconsideration with a thorough review of the evidence on the ProDisc lumbar artificial disc and any other lumbar artificial disc that receives FDA approval during this national coverage analysis process.
November 28, 2006
CMS initiates this reconsideration for review of the LADR national coverage determination. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days.
CMS is requesting public comment on whether there is adequate evidence for evaluating health outcomes of the LADR in the Medicare population for the ProDisc lumbar artificial disc and any other lumbar artificial disc that has received FDA approval after May 16, 2006 (the original effective date of the NCD on LADR).
CMS considers all public comments, and is particularly interested in comments regarding clinical studies and other scientific information about the technology under review and short and long term outcomes.
Instructions on submitting public comments can be found at http://www.cms.hhs.gov/InfoExchange/02_publiccomments.asp. We strongly urge that all public comments be submitted through this website.
May 24, 2007
Posted comments [PDF, 3MB] received.
View comments received through the website.
May 25, 2007
CMS posts the proposed decision memorandum and invites public comment.
CMS is requesting public comment on this proposed decision memorandum. CMS considers all public comments and we are particularly interested in comments that include evidence we did not review or comments that assess how we evaluated the evidence included.
In general, CMS does not need individually identifiable health information to inform its proposed or final decisions. Any public comment received with individually identifiable health information will not be posted to the CMS website at this time. Examples of individual personal health information can be found at the bottom of the comment submission form.
Instructions on submitting public comments can be found at http://www.cms.hhs.gov/InfoExchange/02_publiccomments.asp. You can also submit a public comment by clicking on the highlighted word comment in the title bar at the top of this page. We strongly urge that all public comments be submitted through this website.
July 6, 2007
August 14, 2007