Biomarker precision medical testing coverage, State Health Benefits Commission contracts

9. a. The State Health Benefits Commission shall ensure that every contract providing hospital or medical expense benefits, which is purchased by the commission on or after the effective date of this act, provides coverage for biomarker precision medical testing, as defined by subsection e. of this section. b. Biomarker precision medical testing shall be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a disease or condition, excluding asymptomatic screening, to guide treatment decisions of a covered person when the efficacy and appropriateness of biomarker precision medical testing for the diagnosis, treatment, appropriate management, or guiding treatment decisions for a covered person's disease or condition is recognized by: (1) labeled indications for an FDA-approved or -cleared test; (2) indicated tests for an FDA-approved drug; (3) actions to address warnings and precautions on FDA-approved drug labels; (4) Centers for Medicare and Medicaid Services National Coverage Determinations or Medicare Administrative Contractor Local Coverage Determinations; or (5) nationally recognized clinical practice guidelines. c. Coverage, pursuant to subsection b. of this section, shall be provided in a manner that limits disruption, including multiple biopsies or biospecimen samples, in the care of a covered person. d. (1) If utilization review is required, a decision shall be rendered pursuant to the guidelines and timeframes set forth in P.L.2023, c.296 (C.17B:30-55.1 et al.). (2) The covered person and the treating health care provider or treating health care entity prescribing biomarker precision medical testing to the covered person shall have access to clear, readily accessible, and conspicuous information on the process to submit an appeal to an adverse determination. e. As used in this section: "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 shall also include, but not be limited to, gene mutations, characteristics of genes, or protein expression. "Biomarker precision medical testing" means the analysis of tissue, blood, or other biospecimen for the presence of a biomarker. Biomarker precision medical testing includes, but is not limited to, single-analyte tests, multiplex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing. "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. The 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.