In a recent final decision, CMS concluded there was not enough evidence to show that pharmacogenomic testing of two different alleles (gene variants) to predict responsiveness to the anticoagulant drug improves health outcomes in Medicare beneficiaries. Thus, it “is not reasonable and necessary,” two criteria for coverage.

Warfarin is a self-administered oral blood thinner and affects vitamin K dependent clotting factors. It has a trade name of Coumadin, but also is marketed by various manufacturers under different names. Regular testing is used to monitor and adjust dosage.

The final decision, effective Aug. 3, endorses the warfarin coverage policy that CMS proposed in May for public comment.

But the agency left the door open to reconsider based on further evidence development.

CMS said a clinical study seeking Medicare payment for testing of CYP2C9 or VKORC1 gene variants must compare “the frequency and severity of major and minor hemorrhaging, different thrombolic events, and mortality to patients whose warfarin therapy management does not include pharmacogenomic testing.”