(a) As used in this section:(1) “Biomarker”:(A) 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, including known gene-drug interactions for medications being considered for use or already being administered; and(B) Includes gene mutations, characteristics of genes, and protein expression;(2) “Biomarker testing”:(A) Means the analysis of a patient's tissue, blood, or other biospecimen for the presence of a biomarker; and(B) Includes single-analyte tests, multi-plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing;(3) “Health benefit plan” means health insurance coverage as defined in § 56-7-109 that is offered under a state or local insurance program pursuant to title 8, chapter 27;(4) “Health insurer” means a health insurance entity, as defined in § 56-7-109, that offers a health benefit plan; and(5) “Nationally recognized clinical practice guideline” means an evidence-based clinical practice guideline developed by an independent organization or professional medical society utilizing a transparent methodology and reporting structure that includes a conflict of interest policy, and that establishes standards of care informed by a systematic review of evidence and an assessment of the benefits and risks of alternative care options, including recommendations intended to optimize patient care.
(1) “Biomarker”:(A) 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, including known gene-drug interactions for medications being considered for use or already being administered; and(B) Includes gene mutations, characteristics of genes, and protein expression;
(A) 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, including known gene-drug interactions for medications being considered for use or already being administered; and
(B) Includes gene mutations, characteristics of genes, and protein expression;
(2) “Biomarker testing”:(A) Means the analysis of a patient's tissue, blood, or other biospecimen for the presence of a biomarker; and(B) Includes single-analyte tests, multi-plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing;
(A) Means the analysis of a patient's tissue, blood, or other biospecimen for the presence of a biomarker; and
(B) Includes single-analyte tests, multi-plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing;
(3) “Health benefit plan” means health insurance coverage as defined in § 56-7-109 that is offered under a state or local insurance program pursuant to title 8, chapter 27;
(4) “Health insurer” means a health insurance entity, as defined in § 56-7-109, that offers a health benefit plan; and
(5) “Nationally recognized clinical practice guideline” means an evidence-based clinical practice guideline developed by an independent organization or professional medical society utilizing a transparent methodology and reporting structure that includes a conflict of interest policy, and that establishes standards of care informed by a systematic review of evidence and an assessment of the benefits and risks of alternative care options, including recommendations intended to optimize patient care.
(b) A health insurer that issues, amends, delivers, or renews a contract or agreement for a health benefit plan to take effect on or after January 1, 2027, shall include coverage for biomarker testing pursuant to subsection (c).
(c) A health benefit plan must provide coverage for biomarker testing when ordered by a healthcare provider for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring to guide treatment decisions for an enrollee's disease or condition when the test is supported by medical and scientific evidence, including, but not limited to:(1) Labeled indications for a federal food and drug administration (FDA)-approved or FDA-cleared test;(2) Indicated tests for an FDA-approved drug;(3) Warnings and precautions on FDA-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.
(1) Labeled indications for a federal food and drug administration (FDA)-approved or FDA-cleared test;
(2) Indicated tests for an FDA-approved drug;
(3) Warnings and precautions on FDA-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.
(d) A health insurer shall ensure that biomarker testing coverage under this section is provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples.
(e) This section does not require coverage of biomarker testing for the purpose of screening asymptomatic individuals.
(f) If utilization review, including, but not limited to, prior authorization, is required, then the health insurer, nonprofit health service plan, health maintenance organization, utilization review entity, or a third party acting on behalf of an organization or entity subject to this section must approve or deny a prior authorization request and notify the enrollee, the enrollee's healthcare provider, and each entity requesting authorization of the service in accordance with state law.
(g) A patient and prescribing practitioner must have access to a clear, readily accessible, and convenient process to request an exception to a coverage policy or an adverse utilization review determination of a health insurer, nonprofit health service plan, or health maintenance organization. The process must be made readily accessible on the public website of the health insurer, nonprofit health service plan, or health maintenance organization.
(h) This section does not limit a health insurer's ability to require prior authorization or other utilization management techniques.