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Technical Assessment (TA) Summary Form (M00116) Technical Assessment (TA) Summary Form (M00116)

Technical Assessment (TA) Summary Form (M00116) Technical Assessment (TA) Summary Form (M00116) 2025

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The document is a Technical Assessment Summary Form (M00116 v2) that outlines the requirements for summarizing evidence related to various validation elements in a dossier. It includes sections for accuracy, method comparisons, specimen types, analytical sensitivity, precision, and clinical validity among others. Each section requires detailed descriptions of experimental designs, final results with statistical analyses, and references to specific pages or sections in the dossier.

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Click ‘Get Form’ to open the Technical Assessment (TA) Summary Form (M00116) in the editor.
Begin by filling out Table 1, which summarizes evidence. For each validation element, provide a brief description of the experimental design, final results including confidence intervals, and reference page numbers from your dossier.
In the Method Comparison section, indicate the orthogonal reference method and estimate method bias as required.
Complete sections for specimen types and matrix comparisons by listing all validated specimen types and sample matrices along with descriptions of how they were validated.
Proceed to fill in details regarding analytical sensitivity, specificity, and any interfering substances. Ensure you provide clear explanations for each cell.
Finally, review all entries for accuracy before saving or exporting your completed form.

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What is a technical assessment for Moldx?

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. Technical Assessment - MolDX - Palmetto GBA palmettogba.com moldxv2.nsf DID palmettogba.com moldxv2.nsf DID

Where does the Dex Z-Code go on a claim form?

Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types: Line SV202-7 for 837I electronic claim.

What is the Z-Code technical assessment?

The Z-Code allows the payer to reproducibly and reliably assess medical necessity based on registered test information (such as intended use, methodology, and performance).

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What is a MolDX Z identifier?

A Z-Code Identifier is a unique 5-character alpha-numeric code associated with certain molecular diagnostics (MDx) tests and is used by certain payers as an adjunct to non-specific CPT codes.

Which MACs follow MolDX?

Participating MACs These include Noridian JE and JF, CGS J15, and WPS J5 and J8. Each of these MACs have coverage policies and websites dedicated to the MolDX program. If you are a provider in one of these jurisdictions, please check you MACs website for more information.

Technical Assessment (TA) Summary Form (M00116) Technical Assessment (TA) Summary Form (M00116) 2025

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