Corporate

August 17, 2015 - Revised: 05.30.18

Technical Assessment (TA) Process (CM00011, V1)

CGS Administrators is pleased to announce they are working with the MolDx contractor to determine coverage for molecular pathology tests.  As such since the MolDX contractor has a test assessment in place CGS will follow their lead and cover all tests that has been through the MolDX process and approved. We ask our providers to please follow the MolDx process for their molecular test approval process.

To determine coverage, a TA is required for molecular assays that are laboratory developed tests (LDT), employ new or novel technology, or have undefined or unproven clinical utility. During the TA period, developers should suspend claims submission for the test service. TA submissions may be completed through the McKesson Diagnostic Exchange™ at https://app.mckessondex.com. This online tool will prompt providers to enter the required information and provide a time-based tool to track the progress of the evaluation process. Reference (M00115, V1 - see below)

During the TA process, subject matter experts (SME) and the MolDX Team determine if an assay demonstrates clinical utility (CU) and fulfills the CMS 'reasonable and necessary' criteria. In order to receive favorable review results, the assay must also meet analytical and clinical validity (AV/CV) standards. In addition to these three broad categories of evidence, CMS has directed Palmetto to follow the ACCE criteria developed by the Centers for Disease Control and Prevention. Reference (M00096, V2 - see below)

The six forms listed below were developed to reduce delays and unfavorable determinations caused by invalid, incomplete, and inaccurate information in submitted TA dossiers. Please complete the appropriate form for the test platform (NGS vs non-NGS) and submit along with the dossier per the TA submission instructions.

Based on the determination for each assay reviewed, Palmetto GBA may publish information to inform the provider community of the following: full coverage, limited coverage, or non-coverage, and coding guidelines.

Pricing Determination:

After the successful completion of the TA, tests that meet the Medicare criteria for coverage will progress to the final phase of price determination.

Test developers should collect the following information:

  • Provide list price; prices paid by other insurers
  • Breakdown of costs to perform the test including, but not limited to, the following categories:
    • Cost of special equipment required to perform the test
    • Labor costs
    • All supplies, such as reagents, used to perform the test
    • Published health-economics studies, if available
  • Submit pricing information to MolDX@PalmettoGBA.com

Additional Links/References:

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