The Centers for Medicare and Medicaid Services published two draft local coverage determinations for prostate cancer tests. The drafts were issued through Medicare contractor Palmetto GBA’s MolDx Program.
One a draft LCD, for use of the Decipher Prostate Cancer Classifier test in men who have undergone radical prostatectomy, is the only genomic test for prostate cancer to receive a draft LCD for use in the post-surgery setting. The Decipher test is developed by GenomeDx Biosciences.
Under Medicare policies, a 45-day comment period will commence on Nov. 10. After comments are received and revisions, if any, are made to the draft LCD, the final LCD will be posted within the following 45 calendar days.
MolDX, developed in 2011, facilitates the clinical review, coverage and payment policies for molecular diagnostic tests. The MolDX Program is a contractor to Noridian, a national contractor that administers Medicare benefits for Jurisdiction E, where GenomeDx is located.
According to GenomeDx, Decipher predicts the aggressiveness of a patient’s disease based on genomic information that is distinct from that provided by PSA and other clinical risk factors. Clinical studies have demonstrated that Decipher can accurately predict aggressive disease and help physicians make more informed treatment decisions for men with prostate cancer. Decipher was developed in partnership with the Mayo Clinic.
Palmetto also issued a draft local coverage determination for Prolaris, a prostate cancer test developed by Myriad Genetics Inc.
The determination is posted to the Medicare Coverage Database on the Centers for Medicare & Medicaid Services website, and establishes the coverage policy for Medicare beneficiaries. The current language in the Prolaris draft LCD provides reimbursement coverage for the approximately 50 percent of prostate cancer patients defined as low and very low risk.
