On the CMS Lumbar Disc Non Coverage Proposal
BY JOHN MCCORMICK, MAY 29, 2007
At the end of Friday, CMS published a sweeping proposal that denies coverage for all lumbar artificial discs in the age 60-and-over Medicare population. The proposal can be found here on the CMS website.
Falling into line with its previous noncoverage decision for Johnson & Johnson's Charite artificial lumbar disc, this CMS proposal is the result of the agency's review of the Synthes ProDisc-L citing clinical trial data evidencing statistical non-inferiority to lumbar fusion. Contributing factors to the proposal include (i) the lack of data for seniors and (ii) the risks associated with revision surgeries.
Two immediate reactions:
- This is a proposed determination at this point not a final decision. Before issuing a final decision, CMS is requesting public comment. Only after weighing public comments, will CMS then make its final determination. We do think that the final decision is unlikely to deviate from this proposal, however.
- We think this line of thinking at CMS may not be a directional indicator with respect to cervical disc arthroplasty coverage. Seeing (i) data in the public realm that demonstrates reliable results and even superiority to cervical fusion and (ii) less revision risk.
The CMS proposal does maintain an open view with respect to younger patients and we note that for there is no current national coverage ruling on patients under 60 which effectively leaves such coverage decisions to local Medicare intermediaries.
