§ 27-18-89. Coverage for biomarker testing.
(a) As used in this section:
(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 other biospecimen for the presence of a biomarker. Biomarker testing includes, but is not limited to, single-analyte tests, multi-plex panel tests, and whole genome 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 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. These statements are aimed at specific clinical circumstances and base the statements on the best available evidence for the purpose of optimizing the outcomes of clinical care.
(5) “Nationally recognized clinical practice guidelines” means evidence-based clinical practice guidelines developed by independent organizations or medical professional societies utilizing a transparent methodology and reporting structure and with a conflict of interest policy. Clinical practice guidelines establish standards of care informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options and include recommendations intended to optimize patient care.
(b) Every individual or group health insurance contract, or every individual or group hospital or medical expense insurance policy, plan, or group policy delivered, issued for delivery, or renewed in this state on or after January 1, 2024, shall provide coverage for the services of biomarker testing in accordance with each health insurer’s respective principles and mechanisms of reimbursement, credentialing, and contracting. Biomarker testing must be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s disease or condition to guide treatment decisions, when the test provides clinical utility as demonstrated by medical and scientific evidence, including, but not limited to:
(1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an FDA-approved drug;
(2) Centers for Medicare Services (“CMS”) national coverage determinations or Medicare Administrative Contractor (“MAC”) local coverage determinations; or
(3) Nationally recognized clinical practice guidelines and consensus statements.
(c) Coverage as defined in subsection (b) of this section shall be provided in a manner that limits disruptions in care including the need for multiple biopsies or biospecimen samples.
(d) The patient and prescribing practitioner shall have access to clear, readily accessible, and convenient processes to request an exception to a coverage policy of a health insurer, nonprofit health service plan, and health maintenance organization. The process shall be made readily accessible on the health insurers’, nonprofit health service plans’, or health maintenance organizations’ website.
History of Section.
P.L. 2022, ch. 151, § 1, effective June 27, 2022; P.L. 2022, ch. 152, § 1, effective
June 27, 2022.