NEW YORK – Decipher Biosciences announced Friday its Decipher Prostate test received expanded coverage from Medicare Administrative Contractor Palmetto GBA.
Decipher Prostate, which includes Decipher Prostate Biopsy and Decipher Prostate RP, will be covered for all men with localized prostate cancer being considered for treatment. For initial treatment, the local coverage determination covers men in very low through very high and pelvic lymph node positive National Comprehensive Cancer Network risk groups, the company said. Patients must have a life expectancy of at least 10 years and cannot have received pelvic radiation or androgen deprivation therapy prior to the biopsy or prostate resection specimen.
For patients who have had surgery removing the prostate, the test is covered for all men being considered for treatment immediately after surgery and after disease recurrence, the company said.
"While there are no randomized controlled trials of outcomes using the Decipher test, numerous studies from different institutions have all had similar and consistent findings, providing evidence that this test accurately risk stratifies patients based on genetic information and accurately predicts risk of biochemical recurrence, metastatic disease, or prostate cancer-specific mortality," the LCD said.
In December, Palmetto announced a final LCD covering the Decipher Prostate Biopsy test in men diagnosed with favorable or unfavorable intermediate-risk prostate cancer. That LCD will likely be retired in November, before the new one goes into effect.
The LCD, which generally covers genomic tests that assess risk in localized prostate cancer, goes into effect Nov. 8. Two other contractors, CGS Administrators and Wisconsin Physicians Service Insurance Corporation, released LCDs aligning their coverage with Palmetto's.