College of American Pathologists
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  Press Release


Published on September 4, 2008

Contact: Jodi Greenblatt
Phone: (202) 354-7102

CAP Advises CMS on Validity of Testing for Warfarin Metabolism

Washington, D.C.—The College of American Pathologists advised the Centers for Medicare and Medicaid Services Sept. 3 that there is evidence for the clinical validity and utility of pharmacogenomic testing for warfarin in predicting variability in patients’ response to therapy with the metabolism.

The College’s comments cited recent findings issued by the Brookings Center, which summarized the likely improvements in outcome and healthcare cost savings in pursuing this strategy.

The comments came in response to CMS’ request for feedback on a proposed National Coverage Analysis, aimed at determining if the use of pharmacogenomic testing for warfarin is reasonable, effective and necessary for the Medicare beneficiary population.

The College stated that prospective outcomes clinical trials are underway, and the results of the trials are anticipated to corroborate and enhance support for implementation of the testing.

According to the College, “The improved outcomes related to pharmacogenetic testing include a decreased time to achieving optimal therapeutic range of warfarin, and a decreased time outside the therapeutic range, with the consequent expected benefits of fewer major hemorrhagic and thrombotic events.”

Furthermore, the College advised that if CMS determines current evidence from completed studies is insufficient to reach a decision, CMS should delay the National Coverage Analysis until the completion of another clinical trial which is already underway, sponsored by the National Heart, Lung, and Blood Institute.

The complete comments are available on the CAP Web site.

The College of American Pathologists (CAP) is a medical society serving about 17,000 physician members and the laboratory community throughout the world. It is the world’s largest association composed exclusively of pathologists and is widely considered the leader in laboratory quality assurance. The CAP is an advocate for high quality and cost-effective patient care.