Pharmacogenomic Testing for Warfarin Response

CMS covers pharmacogenomic testing for CYP2C9 or VKORC1 alleles to predict warfarin response only under Coverage with Evidence Development (CED): Medicare beneficiaries who are candidates for warfarin, have not been previously tested, have received fewer than five days of warfarin for the regimen in question, and are enrolled in qualifying prospective randomized controlled clinical trials that meet CMS research standards. Testing outside qualifying clinical studies is not covered, and claims must document study enrollment, ClinicalTrials.gov registration, and compliance with specified protocol and reporting requirements.

"Medicare beneficiary who is a candidate for anticoagulation therapy with warfarin."

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