GenomeDx Biosciences, San Diego, a leader in the field of urologic cancer genomics, has announced that Medicare administrative contractor Palmetto GBA has issued a draft local coverage determination (LCD) and completed the public comment period for use of the Decipher Prostate Biopsy genomic classifier in patients with very low and low risk of prostate cancer according to National Comprehensive Cancer Network guidelines. These patients are candidates for active surveillance, and may be closely monitored rather than undergoing treatment such as surgery, radiation, or hormone therapy.
As described in the draft LCD, the Decipher Prostate Biopsy genomic classifier has been demonstrated across multiple studies to predict the risk of critical clinical endpoints such as metastasis, prostate cancer-specific mortality, and high-grade disease. It is the only commercially available test in the United States that measures risk of disease progression independent of clinical and pathological risk factors. Physicians use the Decipher classifier to determine which patients are more likely to have a good outcome on active surveillance and thus may be spared immediate treatment.
“We currently have Medicare coverage for Decipher testing in men following radical prostatectomy, and are excited to proceed with Medicare in the coverage process for Decipher in men with very low and low NCCN risk prostate cancer,” says Elai Davicioni, PhD, president and chief scientific officer of GenomeDx. “We believe that use of Decipher Prostate Biopsy will significantly improve the health and well-being of Medicare beneficiaries diagnosed with prostate cancer.”
In 2015, GenomeDx received Medicare coverage for the Decipher Prostate RP genomic classifier for use in patients with adverse pathological findings after radical prostatectomy.
Interested parties can view the draft LCD on the Centers for Medicare and Medicaid Services website.1 The public comment period ended on July 19, 2018. The remainder of Medicare’s review process must be completed before the proposed LCD can be finalized and made effective.
To learn more, visit, GenomeDx.
1. Proposed Local Coverage Determination (LCD): MolDX: Decipher Biopsy Prostate Cancer Classifier Assay for Men with Very Low and Low Risk Disease [LCD ID no.DL37785, online]. Baltimore: Centers for Medicare and Medicaid Services, 2018. Available at: www.cms.gov/medicare-coverage-database/search/document-id-search-results.aspx?DocID=DL37785&bc=gAAAAAAAAAAA&. Accessed August 17, 2018.