This document was created by MolDX to clarify the current process and does not represent a change to the TA process as stated in the active Molecular Diagnostic Testing (MDT) LCD. To determine coverage, a TA is required for all new molecular assays prior to submission of claims and for any procedure/service determined by the contractor to need additional scientific documentation. During the review period of the TA, claims submission for the service should be suspended in order to avoid denial. The TA process includes a review of all submitted requests to determine if the assay is reasonable and necessary, and demonstrates clinical utility (CU) and analytical and clinical validity (AVCV). CMS has directed Palmetto to focus on these two broad categories of evidence and to follow the ACCE criteria developed by the Centers for Disease Control and Prevention. To reduce the delays and unfavorable determinations caused by invalid, incomplete, and inaccurate information submitted in the TA dossiers, MolDX has created three documents to further clarify the TA process: 1. MolDX: Clinical Test Evaluation Process (CTEP) - this document outlines the process used by the MolDX Subject Matter Experts (SME) and the MolDX Executive Committee (EC) to assess new tests. 2. MolDX: Analytical and Clinical Validation Guidelines - this document may be used by laboratory staff to understand specific element detail with its applicable CLSI guidance document. 3. MolDX: Technical Assessment Checklist - This document may be used by staff designated to compile the dossier to ensure that all required documents/information has been included prior to submission.