A. As used in this section: 1. "Biomarker" means a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition or for other purposes. Biomarkers shall include but are not limited to gene mutation 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 shall include but not be limited to single-analyte tests, multiplex panel tests, gene or protein expression, and whole exome, whole genome, and whole transcriptome sequencing; 3. "Clinical utility" means the test result provides information that is used in the formulation of a treatment or monitoring strategy that informs a patient's outcome and impacts the clinical decision. The most appropriate test may include both information that is actionable and some information that cannot be immediately used in the formulation of a clinical decision; 4. "Consensus statement" means a statement that: a. is developed by an independent, multidisciplinary panel of experts that use a transparent methodology and reporting structure that includes a conflict of interest policy, b. is based on the best available evidence for the purpose of optimizing clinical care outcomes, and c. is aimed at specific clinical circumstances; 5. "Health benefit plan" means a plan as defined pursuant to Section 6060.4 of Title 36 of the Oklahoma Statutes; and 6. "Nationally recognized clinical practice guidelines" means evidence-based clinical practice guidelines that: a. are developed by independent organizations or medical professional societies using a transparent methodology and reporting structure and a conflict of interest policy, and b. establish standards of care that are informed by a systemic review of evidence and an assessment of the benefits and costs of alternative care options that includes recommendations intended to optimize patient care. B. Any health benefit plan, including the Oklahoma Employees Insurance Plan, that is offered, issued, or renewed in this state on or after the effective date of this act shall provide coverage for biomarker testing. A contract provided with a health benefit plan under this section shall include biomarker testing for the purpose of diagnosis, treatment, appropriate management, or ongoing monitoring of an insured’s disease or condition to guide treatment decisions when the biomarker test provides clinical utility as demonstrated by medical and scientific evidence including, but not limited to: 1. Labeled indications for tests that are approved or cleared by the United States Food and Drug Administration; 2. Indicated tests for a drug that is approved by the United States Food and Drug Administration; 3. Warnings and precautions on United States Food and Drug Administration-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 and consensus statements. C. A health benefit plan shall ensure that coverage is provided in a manner that limits disruptions in care, including the need for multiple biopsies and biospecimen samples. D. An insured and a prescribing practitioner shall have access to a clear, readily available, and convenient process to request an exception to a coverage policy of a health benefit plan under this subsection. The process shall be readily accessible on the plan’s website. This subsection shall not be construed to require a separate process if the health benefit plan’s existing process complies with this subsection.
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