Overcoming Barriers to Clinical Adoption of NGS: Quality Coverage and Data Access.

Although NGS, the hallmark of precision medicine, facilitates testing of whole genomes and exomes as well as more targeted testing of large panels of genes, multiple challenges hamper the integration of NGS into clinical practice, including the complexity of FDA regulations, clinical lab oversight and liability, data-sharing or ethics – the tension between privacy and security - and the economics of personalized medicine such as coverage and reimbursement. 

Public and private payer organizations, who separately assess and write policies for coverage and reimbursement of new clinical tests, have been slow to embrace NGS-based clinical testing, making this one of the most challenging barriers of implementation.  Our presentation covers the financial/coverage issues concerning genomic testing.  For tests to be approved, the question is always “is it FDA approved?”.  Many payors limit coverage of tests to only those that are FDA approved.  Regarding these tests – do they meet the regulatory pathway? Why should they be covered?  What rationale do payors use to NOT cover these tests? How do these tests change health outcomes?

Our expert panel will address the regulatory, clinical, and ethics questions of NGS and WGS, challenges in coverage and reimbursement for the provision of these services, and what HCPs should consider when evaluating a patient and determining that NGS and WGS should be provided.

Go to https://www.acmgeducation.net/URL/SatelliteSymposia2020Free  Sign up for a free ACMG account.  Then access the link for our symposia.  Expires in 2023.