N.J.S.A. 26:2J-4.51 — Biomarker precision medical testing coverage, health maintenance organization contracts.

26:2J-4.51 Biomarker precision medical testing coverage, health maintenance organization contracts. 8. a. Each health maintenance organization contract for health care services that is delivered, issued, executed, or renewed in this State pursuant to P.L.1973, c.337 (C.26:2J-1 et seq.) or is approved for issuance or renewal in this State by the Commissioner of Banking and Insurance, on or after the effective date of this act, shall provide health care services for biomarker precision medical testing, as defined by subsection g. 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 an enrollee when the efficacy and appropriateness of biomarker precision medical testing for the diagnosis, treatment, appropriate management, or guiding treatment decisions for an enrollee'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 an enrollee. d. (1) If utilization review is required, a health maintenance organization shall provide a decision pursuant to the guidelines and timeframes set forth in P.L.2023, c.296 (C.17B:30-55.1 et al.). (2) The enrollee and the treating health care provider or treating health care entity prescribing biomarker precision medical testing for the enrollee shall have access to clear, readily accessible, and conspicuous information on the process to submit an appeal to an adverse determination. e. The health care services shall be provided to the same extent as for any other medical condition under the contract, including determinations of clinical review criteria used for utilization review of health care services along with copayment, deductible, and coinsurance provisions. f. The provisions of this section shall apply to those contracts for health care services by health maintenance organizations under which the right to change the schedule of charges for enrollee coverage is reserved. g. 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. L.2025, c.49, s.8.

This is the verbatim text of N.J.S.A. 26:2J-4.51, retrieved from the New Jersey Legislature's public statute corpus. Statutes are amended periodically — for the most current version, check the external source link above. Kyzer is not a law firm and this page is not legal advice.