To determine coverage, a Technical Assessment (TA) is required for molecular assays that are laboratory developed tests (LDT), include Next Generation Sequencing (NGS) technology, employ new or novel technology, or have undefined or unproven clinical utility. During the TA period, developers should suspend claims submission for the test service. Before submitting a TA, labs must register a test and obtain a unique identifier through the DEXTM Diagnostics Exchange.
In order to receive favorable review results, the assay must demonstrate clinical utility (CU), fulfill the CMS "reasonable and necessary" criteria, and meet analytical and clinical validity (AV/CV) standards. In addition to these categories of evidence, CMS has directed MolDX to follow the ACCE criteria developed by the Centers for Disease Control and Prevention. For more information on the ACCE model, view cdc.gov/ACCE.
In order to reduce delays and unfavorable determinations, please ensure that the TA submission is complete. Select the link below for specific instructions on how to submit all required documentation for a TA.
Technical Assessment Submission Checklist (PDF, 4 MB)
Technical Assessments should be sent to MolDX@PalmettoGBA.com.