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{"DID":"crit1e3ca3","Sites":"MolDx","Start Date":"11-21-2022 07:27","End Date":"11-25-2022 20:28","Content":"The Palmetto GBA MolDX Program will be closed on November 24 and 25, 2022, in observance of the Thanksgiving holiday.","URL":"","Target":null,"Color":"green","Mode":"Standard\n","Priority":"yes"}, {"DID":"crit2d41e3","Sites":"MolDx","Start Date":"06-30-2023 07:27","End Date":"07-04-2023 20:28","Content":"The Palmetto GBA MolDX Program will be closed on July 4, 2023, in observance of Independence Day.","URL":"","Target":"_self","Color":"green","Mode":"Standard\n","Priority":"yes"}, {"DID":"crit32abe3","Sites":"MolDx","Start Date":"09-02-2022 07:27","End Date":"09-05-2022 20:28","Content":"The Palmetto GBA MolDX Program will be closed on September 5, 2022, in observance of Labor Day.","URL":"","Target":null,"Color":"green","Mode":"Standard\n","Priority":"yes"}, {"DID":"crit3c2b5d","Sites":"MolDx","Start Date":"01-17-2022 18:00","End Date":"02-06-2022 22:38","Content":"Attention: New and Updated Technical Assessment forms added on 01/06/2022. Click for more information.","URL":"/palmetto/moldxv2.nsf/DIDC/UMPUJNFSV0","Target":"_self","Color":"blue","Mode":"Standard\n"}, {"DID":"crit431d3a","Sites":"DEX^MolDx","Start Date":"09-01-2023 09:33","End Date":"09-04-2023 18:00","Content":"DEX Customer Service will be closed on September 4, 2023, in observance of Labor Day.","URL":"","Target":null,"Color":"blue","Mode":"Standard\n","Priority":"no"}, {"DID":"crit453aba","Sites":"MolDx","Start Date":"09-01-2023 09:33","End Date":"09-04-2023 18:00","Content":"The Palmetto GBA MolDX Program will be closed on September 4, 2023, in observance of Labor Day.","URL":"","Target":null,"Color":"blue","Mode":"Standard\n","Priority":"no"}, {"DID":"crit4ca1be","Sites":"DEX^MolDx","Start Date":"12-20-2023 08:00","End Date":"12-26-2023 18:00","Content":"The Palmetto GBA MolDX Program will be closed on December 25 and 26, 2023, in observance of the Christmas holiday.","URL":"","Target":null,"Color":"green","Mode":"Standard\n","Priority":"no"}, {"DID":"crit5b4b5e","Sites":"DEX^MolDx","Start Date":"12-20-2023 08:00","End Date":"12-26-2023 18:00","Content":"DEX Customer Service will be closed on December 25 and 26, 2023, in observance of the Christmas holiday.","URL":"","Target":null,"Color":"green","Mode":"Standard\n","Priority":"no"}, {"DID":"crit5cc411","Sites":"MolDx","Start Date":"12-19-2022 07:27","End Date":"12-26-2022 20:28","Content":"The Palmetto GBA MolDX Program will be closed on December 23 and 26, 2022, in observance of the Christmas holiday.","URL":"","Target":null,"Color":"green","Mode":"Standard\n","Priority":"yes"}, {"DID":"critd15e11","Sites":"MolDx","Start Date":"01-13-2023 08:25","End Date":"01-16-2023 16:30","Content":"The Palmetto GBA MolDX Program will be closed on January 16, 2023, in observance of Martin Luther King Jr. Day.","URL":"","Target":"_self","Color":"green","Mode":"Standard\n","Priority":"no"}, {"DID":"critdaccbd","Sites":"MolDx","Start Date":"12-30-2022 07:27","End Date":"01-02-2023 20:28","Content":"The Palmetto GBA MolDX Program will be closed on January 2, 2023, in observance of the New Year's Day holiday.","URL":"","Target":null,"Color":"green","Mode":"Standard\n","Priority":"yes"}, {"DID":"criteca5c4","Sites":"DEX^MolDx","Start Date":"11-21-2023 09:17","End Date":"11-24-2023 18:00","Content":"The Palmetto GBA MolDX Program will be closed on November 23 and 24, 2023, in observance of the Thanksgiving holiday.","URL":"","Target":null,"Color":"green","Mode":"Standard\n","Priority":"no"}

Technical Assessment

Published 06/23/2023

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 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)

Technical Assessments should be sent to MolDX@PalmettoGBA.com.