§ 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.
Structure Rhode Island General Laws
Chapter 27-18 - Accident and Sickness Insurance Policies
Section 27-18-1. - “Policy of accident and sickness insurance” construed.
Section 27-18-1.1. - Definitions.
Section 27-18-2. - Form of policy.
Section 27-18-2.1. - Uniform explanation of benefits and coverage.
Section 27-18-3. - Required provisions.
Section 27-18-3.1. - Alternative coverage by employer.
Section 27-18-3.2. - Rules and regulations.
Section 27-18-3.3. - Penalties.
Section 27-18-3.4. - Judicial review.
Section 27-18-3.5. - Non-applicability.
Section 27-18-4. - Optional provisions.
Section 27-18-5. - Inapplicable or inconsistent provisions.
Section 27-18-6. - Sequence of provisions.
Section 27-18-7. - Third party ownership.
Section 27-18-8. - Filing of accident and sickness insurance policy forms.
Section 27-18-8.1. - Waiting period — Effective date of filings.
Section 27-18-8.2. - Notice of disapproval.
Section 27-18-8.3. - Withdrawal of approval.
Section 27-18-8.4. - Rules as to filing.
Section 27-18-9. - Policies of foreign insurers.
Section 27-18-10. - Compliance by domestic insurer with laws of other states.
Section 27-18-11. - Application of provisions to policy issued to nonresident.
Section 27-18-12. - Less favorable provisions prohibited.
Section 27-18-13. - Effect of policies inconsistent with chapter.
Section 27-18-14. - Copies of applications.
Section 27-18-15. - Alteration of application.
Section 27-18-16. - False statements in application.
Section 27-18-17. - Acts not constituting waiver of insurer’s defenses.
Section 27-18-18. - Acceptance of premiums after effective period of policy.
Section 27-18-19. - Insurance exempt from chapter.
Section 27-18-20. - Penalties for violations.
Section 27-18-21. - Appeals from commissioner.
Section 27-18-22. - Effect on other law.
Section 27-18-23. - Severability.
Section 27-18-24. - Immunity of benefits from process.
Section 27-18-25. - Unfair discrimination prohibited.
Section 27-18-26. - Physical examinations by insurance company.
Section 27-18-27. - Adoptive children.
Section 27-18-28. - [Repealed.]
Section 27-18-29. - Changing coverage.
Section 27-18-30. - Health insurance contracts — Infertility.
Section 27-18-31. - Insurance coverage for services of licensed midwives.
Section 27-18-32. - Discontinuance of coverage — Chronic disabilities.
Section 27-18-33. - Drug coverage.
Section 27-18-33.1. - Insurance coverage for post-partum hospital stays.
Section 27-18-36.1. - Repealed.
Section 27-18-36.2. - Repealed.
Section 27-18-36.3. - Repealed.
Section 27-18-38. - Diabetes treatment.
Section 27-18-39. - Mastectomy treatment.
Section 27-18-40. - Insurance coverage for mastectomy hospital stays.
Section 27-18-41. - Mammograms and pap smears — Coverage mandated.
Section 27-18-42. - Mammograms — Quality assurance standards.
Section 27-18-43. - Pap smears — Quality assurance standards.
Section 27-18-44. - Primary and preventive obstetric and gynecological care.
Section 27-18-44.1. - Hysterectomy or myomectomy treatment.
Section 27-18-45. - Whistleblowers protection.
Section 27-18-46. - Penalties and remedies.
Section 27-18-47. - Additional relief and damages — Reinstatement.
Section 27-18-48. - Third party reimbursement for services of certain healthcare workers.
Section 27-18-48.1. - Third party reimbursement for services of registered nurse first assistants.
Section 27-18-49. - Human leukocyte antigen testing.
Section 27-18-50. - Drug coverage.
Section 27-18-50.1. - Medication synchronization.
Section 27-18-51. - Restricted annual rate payments prohibited.
Section 27-18-52. - Genetic testing.
Section 27-18-52.1. - Genetic information.
Section 27-18-53. - Magnetic resonance imaging — Quality assurance standards.
Section 27-18-54. - Health insurance rates.
Section 27-18-55. - Acupuncture services.
Section 27-18-56. - Prohibition against dentists being required to indemnify provider.
Section 27-18-57. - F.D.A. approved prescription contraceptive drugs and devices.
Section 27-18-59. - Eligibility for children’s benefits.
Section 27-18-60. - Hearing aids.
Section 27-18-61. - Prompt processing of claims.
Section 27-18-62. - Mandatory coverage for certain lyme disease treatments.
Section 27-18-63. - Dental insurance assignment of benefits.
Section 27-18-64. - Coverage for early intervention services.
Section 27-18-65. - Post-payment audits.
Section 27-18-66. - Tobacco cessation programs.
Section 27-18-67. - Reimbursement for orthotic and prosthetic services.
Section 27-18-68. - Mandatory coverage for scalp hair prosthesis.
Section 27-18-69. - Licensed ambulance service.
Section 27-18-70. - Enteral nutrition products.
Section 27-18-71. - Prohibition on preexisting condition exclusions.
Section 27-18-72. - Prohibition on rescission of coverage.
Section 27-18-73. - Prohibition on annual and lifetime limits.
Section 27-18-74. - Coverage for individuals participating in approved clinical trials.
Section 27-18-75. - Medical loss ratio reporting and rebates.
Section 27-18-76. - Emergency services.
Section 27-18-77. - Internal and external appeal of adverse benefit determinations.
Section 27-18-78. - Primary care provider designation requirement.
Section 27-18-79. - Discretionary clauses.
Section 27-18-80. - Orally administered anticancer medication — Cost-sharing requirement.
Section 27-18-81. - Consumer notification.
Section 27-18-82. - Opioid antagonists.
Section 27-18-83. - Healthcare provider credentialing.
Section 27-18-84. - Health insurance contracts — Full year coverage for contraception.
Section 27-18-85. - Prohibition on discrimination in organ transplants.
Section 27-18-86. - Health insurance contracts — Copayments exemption for COVID-19 vaccinations.
Section 27-18-87. - Perinatal doulas.
Section 27-18-88. - Gender rating. [Effective January 1, 2023.]