Technical Assessment
To determine compliance with a policy, a Technical Assessment (TA) is required for molecular assays that are laboratory developed tests (LDT). 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 DEX® 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 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)
Technical Assessments should be sent to MolDX@PalmettoGBA.com.