The science driving personalized medicine continues to push innovation in the advanced diagnostics space. Patient access to these new technologies is requiring thoughtful coverage approaches reflecting their value. FDA and CMS took historic action in 2017 to review and provide national coverage for FDA-approved-or-cleared genomic tests that encompass broad gene panels for advanced cancer patients. While this national coverage policy marked a substantial shift in determining how advanced diagnostic tests are evaluated for coverage, the CMS policy is only binding for Medicare beneficiaries. Private payers and state Medicaid programs may choose to limit their coverage for genomic tests.

This expert panel will provide insight into the evolving status of coverage for NGS-based diagnostic tests and other advanced diagnostics by private payers. Panelists will discuss the potential impact of these coverage approaches on product development and access for patients with other conditions.

Ability Level: Intermediate

Session ID: 503508