Toward evidence-based assessment for coverage and reimbursement of laboratory-based diagnostic and genetic tests.

Despite the pervasiveness of laboratory tests and their importance to medicine, evidence for their appropriate use often is very limited. In this article, we argue for a fundamental restructuring of the process by which laboratory tests are evaluated and reimbursed. We present an approach that would promote more evidence- based appraisals for laboratory tests. In addition, we urge that coverage and reimbursement for laboratory tests move toward an evidence- and value-based approach, using the tools that largely have been adopted for pharmaceuticals by many US healthcare payers. To address this information gap for laboratory tests, we note several potential strategies to encourage manufacturers, laboratory service providers, and payers to collect outcome and cost data that will better support effective use of new laboratory tests. Integral to increasing appropriate use and reimbursement will be the development of a common language and format for dialogue--facilitating the development, review, and delivery of evidence-based tests by manufacturers, clinical laboratories, and healthcare payers.