In this chapter:
(1) “Biomarker” means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention. The term includes:
(A) gene mutations; and
(B) protein expression.
(2) “Biomarker testing” means the analysis of a patient’s tissue, blood, or other biospecimen for the presence of a biomarker. The term includes:
(A) single-analyte tests;
(B) multiplex panel tests; and
(C) whole genome sequencing.
(3) “Consensus statements” means statements that:
(A) address specific clinical circumstances based on the best available evidence for the purpose of optimizing clinical care outcomes; and
(B) are developed by an independent, multidisciplinary panel of experts that uses a transparent methodology and reporting structure and is subject to a conflict of interest policy.
(4) “Nationally recognized clinical practice guidelines” means evidence-based clinical practice guidelines that:
(A) establish a standard of care informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options;
(B) include recommendations intended to optimize patient care; and
(C) are developed by an independent organization or medical professional society that uses a transparent methodology and reporting structure and is subject to a conflict of interest policy.