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Clinicians Split On Warfarin Gene Testing As A New Standard Of Care

This article was originally published in The Gray Sheet

Executive Summary

FDA's drug and device centers are increasingly putting their weight behind the use of genetic tests to determine proper dosing of the anti-clotting drug warfarin, but convincing doctors is proving a bigger challenge

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Under a CMS proposal, genomic testing to predict warfarin response would receive Medicare coverage in the context of a clinical trial comparing the frequency of five kinds of adverse events with and without the tests.

Genomic Tests For Warfarin Could Gain Coverage With Study Participation

CMS wants more evidence that genetic testing of individuals' responsiveness to the blood thinner warfarin actually improves health outcomes in Medicare populations, and the agency is using the national coverage process to call for randomized clinical trials

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