Myriad Genetics, Inc., has announced that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, has issued a draft local coverage determination (LCD) for Prolaris, Myriad’s prostate cancer test.
The LCD is posted to the Medicare Coverage Database on the Centers for Medicare & Medicaid Services (CMS) website and establishes the coverage policy for Medicare beneficiaries. The current language in the draft LCD provides reimbursement coverage for the approximately 50% of prostate cancer patients defined as low and very low risk. Under Medicare rules, the draft LCD is subject to a minimum 45-day public comment period. After comments are considered, a final LCD is issued, which goes into effect after a minimum 45-day notification period.
Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease progression in prostate cancer patients. It provides a quantitative measure of the RNA expression levels of genes involved in the progression of tumor growth. Low gene expression is associated with a low risk of disease progression in men who may be candidates for active surveillance and high gene expression is associated with a higher risk of disease progression in patients who may benefit from additional therapy. According to Myriad representatives, Prolaris has been proven to predict prostate cancer-specific disease progression in 11 clinical trials with more than 6,000 patients. Learn more about Prolaris.
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