MolDX Program Requires Technical Assessment for NGS Tests by February 10 2020
Updated: Feb 6, 2020
The following MolDX LCDs will be finalized on February 10, 2020:
MolDX: Next-Generation Sequencing Lab-Developed Tests for Solid Tumors DL38045 MolDX: Next-Generation Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies DL38047
MolDX has revised the Technical Assessment process. These changes are meant to streamline and clarify the process, reduce provider burden, and provide MolDX with pertinent test information necessary to make a coverage determination.
As part of this revision to the Technical Assessment (TA) process, MolDX requires TAs for all Targeted Next-Generation Sequencing (NGS) panels seeking coverage, including those seeking coverage with CPT codes 81445 and 81450. (Please see relevant definitions in our coverage Article: Targeted and Comprehensive Genomic Profile Next-Generation Sequencing Testing in Cancer (A54795)). This applies to all NGS tests, including new submissions and tests that are already covered.
Tests that have already undergone a formal TA and have had a dossier reviewed are considered complete and no further action is necessary. Tests that have not undergone such review are required to do so. The due date for TA submissions is February 10, 2020. If your lab chooses not to submit a TA by February 10, 2020, existing coverage will automatically end effective February 11, 2020.