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Palmetto Issues Final LCD for Decipher Biosciences Prostate Cancer Test
January 7, 2020Decipher Biosciences announced on Tuesday that Medicare Administrative Contractor Palmetto GBA has issued a final local coverage determination (LCD) for the use of the company’s Decipher Prostate Biopsy test in men diagnosed with favorable or unfavorable intermediate-risk prostate cancer.
The Medicare LCD, “Decipher Biopsy Prostate Cancer Classifier Assay for Men with Intermediate Risk Disease,” will become effective on Jan. 6, 2020. Decipher also said it has effective Medicare coverage for use of Decipher Prostate in men with very low and low-risk prostate cancer as well as men with adverse pathological findings after surgical removal of the prostate.
According to the Palmetto LCD, the test will be covered when several criteria are met, including a needle biopsy with localized adenocarcinoma of prostate, but no clinical evidence of metastasis or lymph node involvement; FFPE prostate biopsy specimen with at least 0.5 mm of cancer length, and favorable or unfavorable intermediate-risk disease as defined in the most recent available NCCN guideline; an estimated life expectancy for the patient of greater than or equal to 10 years; a possibility for the patient to undergo definitive therapy; if the result of the test can be used to determine treatment among definitive therapy modalities or observation; that the patient has not received pelvic radiation or androgen deprivation therapy prior to the biopsy; and that the patient is monitored for disease progression according to established standard of care.