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Public Comment Phase on Warfarin Genetic Test Reimbursement Ends Tomorrow

NEW YORK (GenomeWeb News) – The Center for Medicare and Medicaid Services will stop taking public comments tomorrow, Sept. 3, about whether Medicare should provide reimbursement for DNA tests for the common anticoagulant warfarin.
Tomorrow marks the end of a public comment phase begun a month ago as part of a CMS National Coverage Analysis investigation to determine whether there is sufficient evidence that a pharmacogenomic test for warfarin is effective enough for coverage.
The US Food and Drug Administration updated the label for warfarin in 2007 to state that people with variations of the genes CYP2C9 and VKORC1 may respond to warfarin differently than patients without those variations.
FDA Deputy Commissioner Janet Woodcock said at the time that the administration was not directing doctors to use genetic tests, and that the agency intended it as “informational” to doctors about the variability of drug response.
Public comments about the CMS review are available here.

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