30:4D-6y Biomarker precision medical testing, Medicaid recipients, no cost-sharing.
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/nj/title-30/chapter-4d/30-4d-6yA research copy — for the controlling text, always check the official state or federal source. Not legal advice.
11. a. Notwithstanding any State law or regulation to the contrary, the Department of Human Services shall ensure that expenses incurred for biomarker precision medical testing shall be provided with no cost-sharing to persons served under the Medicaid program, established pursuant to P.L.1968, c.413 (C.30:4D-1 et seq.).
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 individual when the efficacy and appropriateness of biomarker precision medical testing for the diagnosis, treatment, appropriate management, or guiding treatment decisions for an individual'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 individual.
d. If the Division of Medical Assistance and Health Services in the Department of Human Services contracts with a third-party entity to deliver biomarker precision medical testing services pursuant to this section to beneficiaries under the Medicaid program, the third-party entity shall provide biomarker precision medical testing at the same scope, duration, and frequency as the Medicaid program otherwise provides to individuals.
e.
(1)If utilization review is required, a decision shall be provided pursuant to the guidelines and timeframes set forth in P.L.2023, c.296 (C.17B:30-55.1 et al.).
(2)The individual and the treating health care provider or treating health care entity prescribing biomarker precision medical testing for the individual shall have access to clear, readily accessible, and conspicuous information on the process to submit an appeal to an adverse determination.
f. 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.
L.2025, c.49, s.11.