Rhode Island General Laws 27-41-94. 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” is 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” as used here are 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” as used here are 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.
Terms Used In Rhode Island General Laws 27-41-94
- Contract: A legal written agreement that becomes binding when signed.
- Enrollee: means an individual who has been enrolled in a health maintenance organization. See Rhode Island General Laws 27-41-2
- Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
- Health maintenance organization: means a single public or private organization that:
(i) Provides or makes available to enrolled participants healthcare services, including at least the following basic healthcare services: usual physician services, hospitalization, laboratory, x-ray, emergency, and preventive services, and out-of-area coverage, and the services of licensed midwives;
(ii) Is compensated, except for copayments, for the provision of the basic healthcare services listed in subsection (20)(i) of this section to enrolled participants on a predetermined periodic rate basis;
(iii)(A) Provides physicians' services primarily:
(I) Directly through physicians who are either employees or partners of the organization; or
(II) Through arrangements with individual physicians or one or more groups of physicians organized on a group practice or individual practice basis;
(B) "Health maintenance organization" does not include prepaid plans offered by entities regulated under chapter 1, 2, 19, or 20 of this title that do not meet the criteria above and do not purport to be health maintenance organizations; and
(iv) Provides the services of licensed midwives primarily:
(A) Directly through licensed midwives who are either employees or partners of the organization; or
(B) Through arrangements with individual licensed midwives or one or more groups of licensed midwives organized on a group practice or individual practice basis. See Rhode Island General Laws 27-41-2
(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) is 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, § 4, effective June 27, 2022; P.L. 2022, ch. 152, § 4, effective June 27, 2022.