Folks,
I had a conversation with a CMS official, but I must confess I’ve not taken the requisite billion hours to really delve into; research; analyze and present the distilled issues at stake with this multifaceted issue.
For what it’s worth, here’s a few excerpted comments from my conversation with a helpful CMS employee that may guide your possible actions:
2. Under the reconsideration of the LADR national coverage determination it clearly states that the reconsideration will involve a thorough review of the evidence on the ProDisc lumbar artificial disc and any other lumbar artificial disc that receives FDA approval during the national coverage analysis. Comments should be within the scope of this reconsideration.
3. Comments can be made on our web site by clicking on the highlighted word comment at the top of the tracking sheet.
4. As stated in the tracking sheet CMS is particularly interested in comments regarding clinical studies and other scientific information about the technology under review (ProDisc or any other disc that receives FDA approval during our review process) and the short and long term outcomes documented in these studies.
If you care to comment, with the above in mind, visit the aforementioned link and click on the comment button found at:
http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=197