44-7,122. Biomarker testing; terms, defined.

For purposes of sections 44-7,122 to 44-7,124:

(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, including known gene-drug interactions for medications being considered for use or already being administered. Biomarkers include, but are not limited to, gene mutations, characteristics of genes, or protein expression;

(2) Biomarker testing means the analysis of tissue, blood, or other biospecimen for the presence of a biomarker. Biomarker testing includes, but is not limited to, single-analyte tests, multi-plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing;

(3) Clinical utility means sufficient medical and scientific evidence indicating that the use of a biomarker test will provide meaningful information that affects treatment decisions and guides improvement of net health outcomes including an improved quality of life or longer survival;

(4) Consensus statements means statements developed by an independent, multidisciplinary panel of experts utilizing a transparent methodology and reporting structure and with a conflict of interest policy. These statements are aimed at specific clinical circumstances and based on the best available evidence for the purpose of optimizing the outcomes of clinical care;

(5) Health carrier has the same meaning as in section 44-1303; and

(6) Nationally recognized clinical practice guidelines means evidence-based clinical practice guidelines developed by independent organizations or medical professional societies utilizing a transparent methodology and reporting structure and with a conflict of interest policy. Clinical practice guidelines establish standards of care informed by a systematic review of evidence and an assessment of the benefits and risks of alternative care options and include recommendations intended to optimize patient care.

Source:Laws 2025, LB77, ยง 14.
Operative Date: September 3, 2025