Technical Assessment (TA) Process (M00095) for Jul. 2014

To determine coverage, a Technical Assessment (TA) is required for all new molecular assays prior to submission of claims and for any procedure/service determined by the contractor to need additional scientific documentation. The TA process includes a review of all submitted requests to determine if the assay is reasonable and necessary, and demonstrates clinical utility (CU) and analytical and clinical validity (AVCV). CMS has directed Palmetto to focus on these two broad categories of evidence and to follow the ACCE criteria developed by the Centers for Disease Control and Prevention. To reduce the delays and unfavorable determinations caused by invalid, incomplete, and inaccurate information submitted in the TA dossiers, MolDX has created three documents to further clarify the TA process.

Palmetto J11 for North Carolina, South Carolina, Virginia and West Virginia

Noridian JE for California, Nevada and Hawaii