title: Clinical integration of next generation sequencing: coverage and reimbursement challenges.
abstract: Public and private payers face complex decisions regarding whether, when, and how to cover and reimburse for next generation sequencing (NGS)-based tests. Yet a predictable reimbursement pathway is critical both for patient access and incentives to provide the market with better clinical evidence. While preliminary data suggests that payers will use similar evidentiary standards as those used to evaluate established molecular diagnostic tests, the volume and complexity of information generated by NGS raises a host of additional considerations for payers that are specific to this technology.
authors.affiliation: Adjunct Associate Professor at the University of North Carolina at Chapel Hill School of Pharmacy where she focuses on issues related to personalized medicine, comparative effectiveness research, evidence standards and stakeholder engagement.
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Deverka
authors.forename: Jennifer C
authors.initials: JC
authors.lastname: Dreyfus
mesh_terms: D015894:Genome, Human; D059014:High-Throughput Nucleotide Sequencing / Q000191:economics*; D006801:Humans; D019458:Insurance Coverage; D007348:Insurance, Health; D013677:Medical Laboratory Science / Q000191:economics*; D057285:Precision Medicine / Q000191:economics; D012051:Reimbursement Mechanisms; D017422:Sequence Analysis, DNA; D014481:United States