Based on available scientific evidence, genetic testing to predict warfarin responsiveness was declared not reasonable or necessary by the Centers for Medicare & Medicaid in a proposed decision memo dated May 4.
However, in the memo, officials at the Centers for Medicare & Medicaid (CMS) identified a possible path for coverage based on the data they reviewed.
We do believe the available evidence suggests that Coverage with Evidence Development (CED) under 1862(a)(1)(E) of the Social Security Act is appropriate, they wrote in the coverage proposal memo.
With the CED approach, coverage of pharmacogenetic testing to determine optimal warfarin dosing on an individualized basis would apply only to Medicare beneficiaries in whom the anticoagulation therapy is indicated and only when they are participating in qualified prospective, randomized, controlled clinical studies. Such qualifying clinical studies must meet the key criteria of clinical trials and compare the frequency and severity of complications in study subjects who undergo pharmacogenetic testing to
those who do not.
CMS said it is seeking public comments on the proposed decision.
In 2007, the Food and Drug Administration approved a genetic test for warfarin sensitivity that showed promise for helping clinicians identify who may have an unexpected response to the blood thinning drug, based on variations in two genes.
An investigation published in the New England Journal of Medicine in February found a pharmacogenetic algorithm was better at predicting an initial dose of warfarin that might lead to a stable therapeutic dose of the drug compared to either a clinical algorithm or a fixed-dosing approach.