There is not enough evidence to support coverage of pharmacogenomic testing that predicts a patient's response to warfarin, the Centers for Medicare and Medicaid Services announced in May.
The testing can be covered if it is part of a prospective, randomized trial that meets certain criteria proposed by the agency, said the CMS, which opened a 30-day comment period on the proposal.
In particular, the study should determine whether the test can predict the frequency and severity of major and minor hemorrhage, thromboembolism related to the primary indication for anticoagulation, other thromboembolic events, and mortality, the agency noted. In addition, any such trial should determine whether the results are generalizable to the Medicare population.
There are a number of lab tests already approved by the Food and Drug Administration, and many labs offer so-called “home-brew” tests.
Although there is evidence to indicate that these tests accurately identify people with certain gene variants that might heighten their responsiveness to warfarin, there is not any direct evidence of any improvement in health as a result, the agency indicated in its proposed decision.
The CMS proposal is not much of a surprise. In February, a Medicare Evidence Development and Coverage Advisory Committee determined that there were not enough data to support national coverage of the testing. The panel suggested that the data be compiled from a Coverage with Evidence Development study, which the CMS suggested in its proposed decision.
In comments to the CMS, there was a split of opinion among various professional societies.
The American Association for Clinical Chemistry and the College of American Pathologists supported coverage.
The American Society of Hematology, American College of Chest Physicians, and American College of Medical Genetics said there was not sufficient evidence at the moment.
The agency said it is possible that trials will show genetic testing to be of benefit.
“The ability to more effectively treat or prevent blood thrombosis and avoid the risk of hemorrhage due to overanticoagulation by guiding warfarin dosing based on genetic testing results would be a worthwhile potential benefit for the numerous Medicare beneficiaries, perhaps exceeding one million annually, who are initiating anticoagulant therapy,” the agency noted in its decision.