Clinical integration of next generation sequencing: coverage and reimbursement challenges

J Law Med Ethics. 2014 Fall;42 Suppl 1(Suppl 1):22-41. doi: 10.1111/jlme.12160.

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.

MeSH terms

  • Genome, Human*
  • High-Throughput Nucleotide Sequencing / economics*
  • Humans
  • Insurance Coverage*
  • Insurance, Health*
  • Medical Laboratory Science / economics*
  • Precision Medicine / economics
  • Reimbursement Mechanisms*
  • Sequence Analysis, DNA*
  • United States