§1028.5. Required coverage for biomarker testing

            A. The legislature hereby finds that medical advances in genomic testing for diseases and other medical conditions including but not limited to biomarker testing can identify characteristics of disease or any other medical condition more accurately and greatly improve the individual's outcome by providing personalized care.

            B.(1) Any health coverage plan renewed, delivered, or issued for delivery in this state shall include coverage of biomarker testing.

            (2) The coverage provided in this Section may be subject to annual deductibles, coinsurance, and copayment provisions as are consistent with those established under the health coverage plan. Biomarker testing shall be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an individual's disease or condition when the test provides clinical utility as demonstrated by medical and scientific evidence, including any one of the following items:

            (a) Labeled indications for diagnostic tests approved or cleared by the United States Food and Drug Administration or indicated diagnostic tests for a drug approved by the United States Food and Drug Administration.

            (b) Warnings and precautions listed on a United States Food and Drug Administration approved drug label.

            (c) National Coverage Determinations of the Centers for Medicare and Medicaid Services or Local Coverage Determinations of Medicare Administrative Contractors.

            (d) Nationally recognized clinical practice guidelines.

            (3) This Section does not require a health coverage plan to cover biomarker testing for screening purposes.

            C. The individual and healthcare provider shall have access to a clear, readily accessible, and convenient process to request an exception to a coverage policy or adverse utilization review determination of a health coverage plan. The process shall be made readily accessible on the health coverage plan's website or be clearly outlined in the notification of adverse determination.

            D. A health coverage plan shall ensure that the coverage prescribed in Subsection B of this Section is provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples.

            E. As used in this Section, the following definitions apply unless the context indicates otherwise:

            (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 medication being considered for use or currently administered. A "biomarker" includes but is not limited to gene mutations, characteristics of genes, or protein expression.

            (2) "Biomarker testing" means the analysis of a patient's 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)(a) "Clinical utility" means a test result to provide information that is used in the formulation of a treatment or monitoring strategy that informs a patient's outcome and impacts the clinical decision.

            (b) The most appropriate test may include both information that is actionable and information that cannot be immediately used in the formulation of a clinical decision.

            (4) "Health coverage plan" means any hospital, health, or medical expense insurance policy, hospital or medical service contract, employee welfare benefit plan, contract, or other agreement with a health maintenance organization or a preferred provider organization, health and accident insurance policy, or any other insurance contract of this type in this state, including a group insurance plan or self-insurance plan, and the office of group benefits. "Health coverage plan" does not include a plan providing coverage for excepted benefits defined in R.S. 22:1061, limited benefit health insurance plans, or short-term policies that have a term of less than twelve months.

            (5) "Nationally recognized clinical practice guidelines" means evidence-based clinical 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.

            Acts 2023, No. 324, §1, see Act for effectiveness; Acts 2024, No. 160, §1, eff. May 23, 2024.

NOTE: Acts 2024, No. 160 changed the special effective date of Acts 2023, No. 324 to June 12, 2023.