MolDX: Prostate Cancer Genomic Classifier Assay for Men with Localized Disease

Summary of Evidence Analysis of Evidence General Information Associated Information Sources of Information Bibliography Revision History Information Associated Documents Attachments Related Local Coverage Documents Related National Coverage Documents Public Versions Keywords Local Coverage Determination (LCD) MolDX: Prostate Cancer Genomic Classifier Assay for Men with Localized Disease L38292 Expand All | Collapse All  Email Document  Download  Add to basket Contractor Information Contractor Name Contract Type Contract Number Jurisdiction States LCD Information Document Information LCD ID L38292 LCD Title MolDX: Prostate Cancer Genomic Classifier Assay for Men with Localized Disease Proposed LCD in Comment Period N/A Source Proposed LCD DL38292 Original Effective Date For services performed on or after 11/08/2020 Revision Effective Date For services performed on or after 07/03/2025 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 09/24/2020 Notice Period End Date 11/07/2020 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved.

This is a limited coverage policy for Genomic derived tests that assess risk in localized (non-metastatic) prostate cancer. The review is focused on the Decipher ® Prostate Cancer Classifier Assay (identified as Decipher ® to follow). The test is considered reasonable and necessary to help identify men with localized Prostate Cancer and a life expectancy of at least 10 years who are good candidates for active surveillance according to the most recent National Comprehensive Cancer Network (NCCN) guidelines. Decipher ® is covered for men with prostate cancer: With localized or biochemically recurrent adenocarcinoma of the prostate (i.e., no clinical evidence of metastasis) who have a life expectancy of greater than or equal to 10 years if they are a candidate for and are considering (or being considered for) at least 1 of the following: Conservative management and yet would be eligible for definitive therapy (radical prostatectomy (RP), radiation or brachytherapy), or; Radiation therapy and yet would be eligible for the addition of a brachytherapy boost, or; Radiation therapy and yet would be eligible for the addition of short-term androgen deprivation therapy (ADT), or; Radiation therapy with short-term ADT yet would be eligible for the use of long-term ADT, or; Radiation with standard ADT yet would be eligible for systemic therapy intensification using next generation androgen signaling inhibitors or chemotherapy, or; Observation post-prostatectomy yet would be eligible for the addition of post-operative adjuvant radiotherapy, or; Salvage radiotherapy post-prostatectomy yet would be eligible for the addition of ADT. The following criteria must also be met for coverage: The assay is performed on formalin-fixed paraffin embedded (FFPE) prostate biopsy tissue with at least 0.5 mm of linear tumor diameter or FFPE tissue from a prostate resection specimen, and; Result will be used to determine treatment according to established practice guidelines, and; Patient has not received pelvic radiation or ADT prior to the biopsy or prostate resection specimen, and; Patient is monitored for disease progression according to established standards of care. Other genomic tests that demonstrate an equivalent analytical validity and clinical validity will be considered reasonable and necessary for the same indications. Analytical and clinical validity will be assessed as part of a thorough and comprehensive technical assessment (TA) by the Molecular Diagnostic Services Program (MolDX ® ) and will similarly attain coverage for indications that are supported by the evidence and intended use within the scope of this policy.