About this policy
Jurisdiction: JE Part B. States: California, Hawaii, Nevada, American Samoa, Guam, Northern Mariana Islands. Type: Active LCD
Coverage indications
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 w ith 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 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.
Codes in this policy
Code numbers and each code’s status as the policy records it. CPT code descriptions are left out of this page, as are the passages that cite CPT codes; the official document has them.