RS 22:1028.3

§1028.3. Required coverage for genetic testing for cancer A. The legislature hereby finds that cancer is a leading cause of death in this state. Medical advances in genetic testing for various types of cancer including but not limited to breast, ovarian, colon, thyroid, prostate, pancreatic, lung, melanoma, sarcoma, kidney, and stomach cancers greatly assist in estimating the chance of developing cancer in an individual's lifetime. Genetic testing can help predict the risk of a particular cancer and assist in determining if a patient has genes that may pass increased cancer risks to their children. B.(1) Any health coverage plan renewed, delivered, or issued for delivery in this state shall include coverage for genetic or molecular testing for cancer including but not limited to tumor mutation testing, next generation sequencing, hereditary germline mutation testing, pharmacogenomic testing, whole exome and genome sequencing, and 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 plan. The biomarker test shall be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an individual's disease or condition when the test is supported by medical and scientific evidence, including any one of the following: (a) Labeled indications for diagnostic tests to direct treatment decisions that are approved or cleared by the United States Food and Drug Administration or indicated diagnostics tests for a drug that is approved by the United States Food and Drug Administration. (b) Centers for Medicare and Medicaid Services National Coverage Determinations or Medicare Administrative Contractor Local Coverage Determinations. (c) Nationally recognized consensus statements and clinical practice guidelines such as but not limited to those of the National Comprehensive Cancer Network or the American Society of Clinical Oncology. C. For purposes of this Section, "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. "Health coverage plan" does not include a plan providing coverage for excepted benefits defined in R.S. 22:1061, limited benefit health insurance plans, short-term policies that have a term of less than twelve months, nor any plan offered through the office of group benefits. D. 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. Biomarkers include but are not limited to gene mutations or protein expression. (2) "Biomarker testing" means the analysis of a patient's tissue, blood, or fluid biospecimen for the presences of a biomarker. Biomarker testing includes but is not limited to single-analyte tests, multi-plex panel tests, and partial or whole genome, whole exome, and whole transcriptome sequencing. (3) "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. Such statements are aimed at specific clinical circumstances and based on the best available evidence for the purpose of optimizing the outcomes of clinical care. (4) "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. Such guidelines establish standards of care informed by a systematic review of evidence and an assessment of the benefits and costs alternative care options and include recommendations intended to optimize patient care. Acts 2021, No. 43, §1, eff. Jan. 1, 2022; Acts 2022, No. 412, §1, eff. Jan. 1, 2023.