{"data":{"id":"us-ok/okla.-stat.-tit.-36-36-6060.5a","jurisdiction":"us-ok","citation":"Okla. Stat. tit. 36, § 36-6060.5a","heading":"Biomarker testing","body":"A. As used in this section:\n\n1. \"Biomarker\" means a biological molecule found in blood,\n\nother body fluids, or tissues that is a sign of a normal or abnormal\n\nprocess, or of a condition or disease. A biomarker may be used to\n\nsee how well the body responds to a treatment for a disease or\n\ncondition or for other purposes. Biomarkers shall include but are\n\nnot limited to gene mutation or protein expression;\n\n2. \"Biomarker testing\" means the analysis of a patient’s\n\ntissue, blood, or other biospecimen for the presence of a biomarker.\n\nBiomarker testing shall include but not be limited to single-analyte\n\ntests, multiplex panel tests, gene or protein expression, and whole\n\nexome, whole genome, and whole transcriptome sequencing;\n\n3. \"Clinical utility\" means the test result provides\n\ninformation that is used in the formulation of a treatment or\n\nmonitoring strategy that informs a patient's outcome and impacts the\n\nclinical decision. The most appropriate test may include both\n\ninformation that is actionable and some information that cannot be\n\nimmediately used in the formulation of a clinical decision;\n\n4. \"Consensus statement\" means a statement that:\n\na. is developed by an independent, multidisciplinary\n\npanel of experts that use a transparent methodology\n\nand reporting structure that includes a conflict of\n\ninterest policy,\n\nb. is based on the best available evidence for the\n\npurpose of optimizing clinical care outcomes, and\n\nc. is aimed at specific clinical circumstances;\n\n5. \"Health benefit plan\" means a plan as defined pursuant to\n\nSection 6060.4 of Title 36 of the Oklahoma Statutes; and\n\n6. \"Nationally recognized clinical practice guidelines\" means\n\nevidence-based clinical practice guidelines that:\n\na. are developed by independent organizations or medical\n\nprofessional societies using a transparent methodology\n\nand reporting structure and a conflict of interest\n\npolicy, and\n\nb. establish standards of care that are informed by a\n\nsystemic review of evidence and an assessment of the\n\nbenefits and costs of alternative care options that\n\nincludes recommendations intended to optimize patient\n\ncare.\n\nB. Any health benefit plan, including the Oklahoma Employees\n\nInsurance Plan, that is offered, issued, or renewed in this state on\n\nor after the effective date of this act shall provide coverage for\n\nbiomarker testing. A contract provided with a health benefit plan\n\nunder this section shall include biomarker testing for the purpose\n\nof diagnosis, treatment, appropriate management, or ongoing\n\nmonitoring of an insured’s disease or condition to guide treatment\n\ndecisions when the biomarker test provides clinical utility as\n\ndemonstrated by medical and scientific evidence including, but not\n\nlimited to:\n\n1. Labeled indications for tests that are approved or cleared\n\nby the United States Food and Drug Administration;\n\n2. Indicated tests for a drug that is approved by the United\n\nStates Food and Drug Administration;\n\n3. Warnings and precautions on United States Food and Drug\n\nAdministration-approved drug labels;\n\n4. Centers for Medicare and Medicaid Services national coverage\n\ndeterminations or Medicare administrative contractor local coverage\n\ndeterminations; or\n\n5. Nationally recognized clinical practice guidelines and\n\nconsensus statements.\n\nC. A health benefit plan shall ensure that coverage is provided\n\nin a manner that limits disruptions in care, including the need for\n\nmultiple biopsies and biospecimen samples.\n\nD. An insured and a prescribing practitioner shall have access\n\nto a clear, readily available, and convenient process to request an\n\nexception to a coverage policy of a health benefit plan under this\n\nsubsection. The process shall be readily accessible on the plan’s\n\nwebsite. This subsection shall not be construed to require a\n\nseparate process if the health benefit plan’s existing process\n\ncomplies with this subsection.","path":["OK Code","Title 36"],"source_url":"https://www.oklegislature.gov/OK_Statutes/CompleteTitles/os36.pdf","current_through":"2026-08-14","vintage":"open-us-law v2026.08, retrieved 2026-09-14","retrieved_at":"2026-09-14T18:32:36Z","sha256":"5311c96c053e7dbb16d2ee56312ba95f780be3d7b7c3ba828b5bacb0a9b99ab1","source_id":"us-ok","stale":false,"prev":"us-ok/okla.-stat.-tit.-36-36-6060.52","next":"us-ok/okla.-stat.-tit.-36-36-6060.5b"},"notice":"GroundRules: Original legal text. Not legal advice."}