Technical Assessment requirement for NGS Cancer Tests

MolDX has released two new draft LCDs regarding next generation sequencing (NGS) testing for solid tumor and myeloid malignancies. Among the coverage requirements for tests within the scope of these LCDs is a requirement that all of these tests undergo technical assessment by the MolDX program. This requirement will apply not only to new tests seeking coverage but also to tests that are currently covered in order to maintain coverage. While MolDX has always required technical information on tests before processing claims for tests, there are now new technical assessment documents requiring a level of information that has only previously been required for coverage of comprehensive genomic profiles. As such, any tests currently covered or being reimbursed that are within the scope of these LCDs that are not:

  • FDA approved, or
  • Already covered as a comprehensive genomic profile, or
  • Covered with their own LCD or article

will require submission of new technical assessment information and verification by the MolDX program that the test has been adequately validated so as to be reasonable and necessary to maintain coverage. Please see the full text of the LCDs and documents linked below for further information.

The open comment period for these LCDs will start on May 6, 2019. Comments may be submitted to moldx.policy@palmettogba.com. Please include the LCD name and number being commented on in the subject of the email.

Technical assessment documents should be emailed to moldx@palmettogba.com. Please note in the subject line that it is a technical assessment as well as the Z-code for the test. Please include only one technical assessment per email.

If you do not have an NGS test registered with MolDX and do not wish to receive coverage for an NGS test within the scope of these LCDs, no action is required. 

  • MolDX’s Technical Assessment website with links to technical assessment documents 
  • Proposed Local Coverage Determination (LCD): MolDX: Next-Generation Sequencing for Solid Tumors (DL38045
  • Proposed Local Coverage Determination (LCD): MolDX: Next-Generation Sequencing for Myeloid Malignancies and Suspected Myeloid Malignancies (DL38047
  • Local Coverage Article: MolDX: Targeted and Comprehensive Genomic Profile Next-Generation Sequencing Testing in Cancer (A54795