MolDX: Prostate Cancer Genomic Classifier Assay for Men with Localized Disease - Effective December 06, 2020

This Local Coverage Determination (LCD) has completed the Open Public Meeting and comment period and is now finalized under contractor numbers: 02101 (AK), 02201 (ID), 02301 (OR), 02401 (WA), 03101 (AZ), 03201 (MT), 03301 (ND), 03401 (SD), 03501 (UT), and 03601 (WY). Responses to comments received may be found as a link at the bottom of the final LCD.

Medicare Coverage Database (MCD) Number/Contractor Determination Number: L38341
LCD Title: MolDX: Prostate Cancer Genomic Classifier Assay for Men with Localized Disease
FORMERLY: MolDX: Decipher® Biopsy Prostate Cancer Classifier Assay for Men with Favorable Intermediate Risk Disease
Effective Date: December 06, 2020
Summary of LCD: 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. 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.

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            Last Updated Thu, 22 Oct 2020 18:09:15 +0000