MolDX: Phenotypic Biomarker Detection in Circulating Tumor Cells

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: Phenotypic Biomarker Detection in Circulating Tumor Cells L38566 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 L38566 LCD Title MolDX: Phenotypic Biomarker Detection in Circulating Tumor Cells Proposed LCD in Comment Period N/A Source Proposed LCD DL38566 Original Effective Date For services performed on or after 07/25/2021 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 06/10/2021 Notice Period End Date 07/24/2021 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee schedules, relative val

This is a limited coverage policy for assays that detect biomarkers from circulating tumor cells (CTCs). Criteria for Coverage Cancers with established biomarker testing, as recommended by society or national guidelines Assays that detect biomarkers from CTCs are covered when ALL of the following are met: The patient has been diagnosed with cancer The specific cancer type has an associated biomarker The associated biomarker has already established clinical utility (CU) in the peer-reviewed published literature for the intended cancer type and for the specific indication in the intended patient population The biomarker’s CU may include any of the following: it can be used to diagnose, risk-stratify, predict, or monitor response to therapy, as recommended by national or society guidelines (i.e., American Society of Clinical Oncology (ASCO), National Comprehensive Cancer Network (NCCN)) At least 1 of the following criteria are met AND there is clear documentation of at least 1 of these in the medical record: The patient’s cancer has not previously been tested for the specific biomarker, OR The patient has newly metastatic cancer, and a metastatic lesion has not been tested for the specific biomarker, OR The patient demonstrates signs of clinical, radiological or pathologic disease progression, OR There is concern for resistance to treatment based on specific and well-established clinical indications Testing for the biomarker can be performed using CTCs The CTC-based biomarker test successfully completes a comprehensive Technical Assessment (TA) by Molecular Diagnostic Services Program (MolDX ® ) that will ensure that Analytical Validity (AV) (including an analytical and clinical validation), Clinical Validity (CV), and CU criteria are met to establish the test as Reasonable and Necessary. The clinical validation has demonstrated performance that is equivalent or superior to tissue-based testing or another already-accepted test for the same biomarker for the same intended use. CV (for new analytes) must be established through studies published in the peer-reviewed literature for the intended use of the test in the intended population. Tissue-based testing for the specific biomarker is infeasible (e.g., quantity not sufficient or invasive biopsy is medically contraindicated) OR will not provide sufficient information for subsequent medical management (e.g., in cases where human epidermal growth factor receptor 2 (HER2) overexpression is negative in a tissue biopsy but may be positive in the CTCs, due to tumor heterogeneity). There is clear documentation of at least 1 of these reasons for testing in the medical record. For a given patient encounter, only 1 test for assessing the biomarker may be performed UNLESS a second test, meeting all the criteria established herein, is reasonable and necessary as an adjunct to the first test. Duplicate testing of the same biomarker ( from the same sample type and for the same clinical indication ) using different methodologies is not covered. For example, testing for androgen receptor splice variant 7 (AR-V7) from CTCs by messenger RNA (mRNA) as well as immunohistochemistry (IHC)-based methodologies, for the same clinical indication, will not be covered.