{"data":{"id":"us-ky/krs-304.17a-263","jurisdiction":"us-ky","citation":"KRS 304.17A-263","heading":"Coverage under health benefit plan for biomarker testing.","body":"(1) As used in this section:\n(a) \"Biomarker\":\n1. Means a characteristic that is objectively measured and evaluated as an\nindicator of normal biologic processes, pathogenic proc esses, or\npharmacologic responses to a specific therapeutic intervention,\nincluding known gene -drug interactions for medications being\nconsidered for use or already being administered; and\n2. Includes but is not limited to gene mutations and protein expression;\n(b) \"Biomarker testing\":\n1. Means the analysis of a patient's tissue, blood, or other biospecimen for\nthe presence of a biomarker; and\n2. Includes but is not limited to single -analyte tests, multiplex panel tests,\nand whole genome sequencing;\n(c) \"Consensus statements\" means statements that are:\n1. Developed by an independent, multidisciplinary panel of experts\nutilizing a transparent methodology and reporting structure with a\nconflict of interest policy;\n2. Aimed at specific clinical circumstances; and\n3. Based on the best available evidence for the  purpose of optimizing the\noutcomes of clinical care;\n(d) \"FDA\" means the United States Food and Drug Administration; and\n(e) \"Nationally recognized clinical practice guidelines\" means evidence -based\nclinical practice guidelines that:\n1. Are developed by a n independent organization or medical professional\nsociety utilizing a transparent methodology and reporting structure with\na conflict of interest policy;\n2. Establish standards of care informed by:\na. A systematic review of evidence; and\nb. An assessment of the benefits and risks of alternative care options;\nand\n3. Include recommendations intended to optimize care.\n(2) A health benefit plan shall provide coverage for biomarker testing when ordered by\na qualified health care provider operating within the pr ovider's scope of practice for\nthe purpose of diagnosis, treatment, appropriate management, or ongoing\nmonitoring of an insured's disease or condition when the test is supported by\nmedical and scientific evidence, including but not limited to:\n(a) Labeled indications for an FDA-approved or FDA-cleared test;\n(b) Indicated tests for an FDA-approved drug;\n(c) Warnings and precautions on FDA-approved drug labels;\n(d) Centers for Medicare and Medicaid Services national coverage\ndeterminations;\n(e) Medicare Administrative Contractor local coverage determinations;\n(f) Nationally recognized clinical practice guidelines; or\n(g) Consensus statements.\n(3) The coverage required under this section shall be provided in a manner that limits\ndisruptions in care, including t he need for multiple biopsies or biospecimen\nsamples.\n(4) When coverage for biomarker testing is restricted by an insurer or a third party\nacting on behalf of the insurer, the insured and prescribing practitioner shall have\naccess to a clear, readily accessible, and convenient process on the insurer's website\nto request an exception to the coverage policy.\n(5) Any prior authorization requirement applicable to coverage required under this\nsection shall comply with any existing prior authorization laws, inclu ding but not\nlimited to KRS 304.17A-607.\n(6) Nothing in this section shall be construed to:\n(a) Require coverage of biomarker testing for screening purposes; or\n(b) Limit coverage required under:\n1. KRS 304.17A-259;\n2. KRS 205.522; or\n3. Any other law.","path":[],"source_url":"https://apps.legislature.ky.gov/law/statutes/statute.aspx?id=54217","current_through":"Includes enactments through the 2026 Regular Session","vintage":"09/05/2026","retrieved_at":"2026-09-05T20:57:47Z","sha256":"70bc96166603b6bd847cc7ae1127797dda900ef6929fe586b5e8325afa3a8a36","source_id":"us-ky","stale":false,"prev":"us-ky/krs-304.17a-262","next":"us-ky/krs-304.17a-264"},"notice":"GroundRules: Original legal text. Not legal advice."}