CMS publishes draft coverage decision for Decipher Prostate Cancer Classifier

GenomeDx Biosciences today announced that a draft local coverage determination (LCD) for its Decipher® Prostate Cancer Classifier has been published by the Centers for Medicare and Medicaid Services (CMS) describing a coverage and payment policy for use of the Decipher test in men who have undergone radical prostatectomy. An LCD is a decision by Medicare contractors to cover an item or service. Decipher is the only genomic test for prostate cancer to receive a draft LCD for use in the post-surgery setting.

"The draft LCD is a major step toward providing access to Decipher for the thousands of prostate cancer patients weighing treatment options after radical prostatectomy," said Doug Dolginow, M.D., CEO of GenomeDx. "We appreciate the opportunity to have worked collaboratively with the MolDX Program by Palmetto GBA®, and will continue to do so through the final steps in obtaining coverage."

Under Medicare policies, a 45-day comment period will commence on November 10, 2014, for the draft LCD. After comments are received and revisions, if any, are made to the draft LCD, the final LCD will be posted within 45 calendar days.

Palmetto GBA, a national contractor that administers Medicare benefits, has issued the draft LCD through the MolDX Program for Decipher. 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.

Decipher is a unique genomic test intended for men who have had prostate surgery and are considered by guidelines to be at high-risk for their cancer returning. These are men who have specific risk factors for cancer recurrence, including positive surgical margins, stage T3 disease (seminal vesicle invasion, extraprostatic extension, bladder neck invasion) or rising PSA after initial PSA nadir.