The molecular diagnostic services program (MolDx) of Medicare administrative contractor Palmetto GBA has issued a final local coverage determination (LCD) supporting use of the Decipher prostate biopsy genomic test from Decipher Biosciences, San Diego, in men diagnosed with favorable and unfavorable intermediate-risk prostate cancer.1
During 2019, it is estimated that 56,000 men were diagnosed with intermediate-risk prostate cancer in the United States. Most such patients receive surgery or radiation, with or without hormone therapy, or are carefully monitored over time. The factors that are used to make the treatment determination are currently limited in their scope and ability to identify aggressive disease. The Decipher prostate biopsy genomic test has been shown to be a better predictor of disease progression in more than 1,000 unique patients over a wide range of clinical validation studies.
“We believe that use of Decipher prostate biopsy in intermediate-risk men with prostate cancer helps to match selection and intensity of treatment with the metastatic potential of the tumor, decreasing the number of men who are over- or undertreated, resulting in improved patient outcomes,” says Tina Nova, PhD, president and chief executive officer of Decipher Biosciences. “For a single test to be applicable across the spectrum of therapeutic options, including monitoring, surgery, radiation, and the addition of hormone therapy, is a significant breakthrough for the management of patients with prostate cancer.”
The Medicare LCD provides coverage for the Decipher prostate biopsy genomic test for men with both favorable and unfavorable intermediate-risk prostate cancer. The final LCD is posted on the Centers for Medicare and Medicaid Services website and became effective January 6, 2020. LCDs are subject to annual review by the Medicare administrative contractor.
- MolDx: Decipher Biopsy Prostate Cancer Classifier Assay for Men with Intermediate-Risk Disease [Local coverage determination L38029, online]. Baltimore, Md: Centers for Medicare and Medicaid Services, 2019. Available at: www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=38029&ver=5&Cntrctr=All&UpdatePeriod=860&bc=AAAAEAAAAAAA&. Accessed January 29, 2020.
PC-3 human prostate cancer cells, stained with Coomassie blue, under differential interference contrast microscope. Image © Heiti Paves, courtesy Dreamstime (ID 71915237).