I am very disappointed that the federal medical reimbursement folks have not approved the use of genetic tests to make warfarin dosing more precise. This would be an opportunity for CMS to start the personalized medicine revolution, and to make the public aware that we physicians can do better than guessing in the use of dangerous medications. We were part of an effort published in February that showed very clearly that genetics helps predict much more accurate doses of warfarin, and that 40% of patients are at risk for over- or under-dosing without this information. I am not an expert on the CMS approval process, but I would wager that there are MANY things reimbursed for which there is not a similar level of likely cost-effectiveness. Here was an opportunity for the new administration to take leadership, and it was a lost opportunity.
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I dunno how CMS makes decisions either — but if I only had access to the small randomized trial in Circulation — I would have also rejected reimbursement.
Even the paper from your group doesn’t make a point for clinical end-points. Although its pretty obvious that this should translate to clinical end points — if you want to establish a proof-of-principle for “personalized medicine”, you need to get to hard end points for the first case, before sailing along on future cases.