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Printed Date: 9/22/2015
To determine coverage, a Technical Assessment (TA) is required for molecular assays that are laboratory developed tests (LDT), 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.
During the TA process, subject matter Experts (SME) and the MolDX team determine if an assay demonstrates clinical utility (CU) and fulfills the CMS 'reasonable and necessary' criteria. In order to receive favorable review results, the assay must also 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. Click on the link below for specific instructions on how to submit all required documentation for a TA.
Technical Assessment Submission Checklist (PDF, 148 KB)
To review the process used by the MolDX SMEs and the MOlDX Executive Committee (EC) to assess new tests, view:
Clinical Test Evaluation Process (CTEP) is being revised and will be available soon.
Technical Assessments should be sent to firstname.lastname@example.org.
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Last Updated: 1/01/2019
Applies to: MolDx
Article Topics: Appeals, Redeterminations, and PTANs