CMS Denies Add-On Payments for Charite
BY JOHN MCCORMICK, AUGUST 2, 2005
In an unambiguous statement yesterday, CMS took a hard line and denied add-on payments for J&J's Charite artificial lumbar disc. In this document on pages 309 - 322, CMS balanced numerous comments, studies and outcomes against each other and came up with the following conclusion:
"We remain concerned that the data supplied by the applicant did not demonstrate substantial clinical improvement long term, despite the product being available on the European market since 1987. We are also concerned about the degree of controversy surrounding the device within the orthopedic and spine surgery community. Therefore, we are denying this application for new technology add-on payments because we did not find enough evidence that the product meets the substantial clinical improvement criterion."
In addition, the Charite did not get reassigned to another DRG.
Two thoughts from our perspective. First, we view this as yet another case study in the trend toward evidence-based medicine in setting reimbursement policy. Second, despite this being only an add-on payment denial, the ruling does cause us to modestly reduce our market forecast for lumbar artificial discs. We will be releasing the forecast in an upcoming spine market white paper.
