§ 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.