CMS Changes its Charite Decision
BY DAVID KRESSEL, MAY 17, 2006
In a surprising but welcome change of heart, the Centers for Medicare and Medicaid Services revised its proposed National Noncoverage Decision and will reimburse the Charite in specific circumstances. In the February draft of the NCD, CMS proposed national noncoverage of the Charite lumbar artificial disc because the data excluded most of the Medicare population, did not show superiority, and showed how difficult revision was.
The vast majority of comments to CMS before and after the draft was published were in support of the disc or, more importantly, in support of supporting the disc. By this, we mean that not everyone thought Charite was the be-all and end-all, but even people who didn't think highly of the Charite recognized the broader implications of CMS's decision. In particular, private payors would likely not cover the device or any similar devices, which beyond the obvious effect on patients, would send a negative signal to all companies developing lumbar and cervical artificial discs. This would make R&D money scarce and scare off any efforts to improve on the concept and successfully develop a product that would satisfy all payors, physicians and patients.
When the draft was published, CMS received 604 comments, and only 7 supported the non-coverage decision. Another interesting factoid was that 470 of the comments received were in the form a Texas Back Institute form letter, which CMS stated it discounted heavily, but given the outcome, they probably didn't discount entirely.
In CMS's words:
The Centers for Medicare and Medicaid Services (CMS) has found that lumbar artificial disc replacement (LADR) with the Charite lumbar artificial disc is not reasonable and necessary for the Medicare population over sixty years of age. Therefore, we are issuing a national noncoverage determination for LADR with the Charite lumbar artificial disc for the Medicare population over sixty years of age. For Medicare beneficiaries sixty years of age and under, there is no national coverage determination, leaving such determinations to be made on a local basis.
This change sounds minor, but most patients over 60 years of age are not good candidates for the procedure anyway, given the numerous contraindications. Therefore, CMS will be paying for the Charite for most beneficiaries that would have it prescribed.
The full text of the decision can be found here. It is, as usual, a very complete discussion and an interesting read.
