§ 27-41-77. Coverage for individual participating in approved clinical trials. (a) As used in this section.

(1) "Approved clinical trial" means a phase I, phase II, phase III or phase IV clinical trial that is conducted in relation to the prevention, detection or treatment of cancer or a life-threatening disease or condition and is described in any of the following:

(A) The study or investigation is approved or funded, which may include funding through in-kind contributions, by one or more of the following:

(i) The federal National Institutes of Health;

(ii) The federal Centers for Disease Control and Prevention;

(iii) The federal Agency for Health Care Research and Quality;

(iv) The federal Centers for Medicare & Medicaid Services;

(v) A cooperative group or center of any of the entities described in items (i) through (iv) or the U.S. Department of Defense or the U.S. Department of Veteran Affairs;

(vi) A qualified non-governmental research entity identified in the guidelines issued by the federal National Institutes of Health for center support grants; or

(vii) A study or investigation conducted by the U.S. Department of Veteran Affairs, the U.S. Department of Defense, or the U.S. Department of Energy, if the study or investigation has been reviewed and approved through a system of peer review that the Secretary of U.S. Department of Health and Human Services determines:

(I) Is comparable to the system of peer review of studies and investigations used by the federal National Institutes of Health; and

(II) Assures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.

(B) The study or investigation is conducted under an investigational new drug application reviewed by the U.S. Food and Drug Administration; or

(C) The study or investigation is a drug trial that is exempt from having such an investigational new drug application.

(2) "Participant" has the meaning stated in section 3(7) of federal ERISA [29 U.S.C. § 1002].

(3) "Participating provider" means a health care provider that, under a contract with the health carrier or with its contractor or subcontractor, has agreed to provide health care services to covered persons with an expectation of receiving payment, other than coinsurance, copayments or deductibles, directly or indirectly from the health carrier.

(4) "Qualified individual" means a participant or beneficiary who meets the following conditions:

(A) The individual is eligible to participate in an approved clinical trial according to the trial protocol with respect to the treatment of cancer or other life-threatening disease or condition; and

(B)(i) The referring health care professional is a participating provider and has concluded that the individual's participation in such trial would be appropriate based on the individual meeting the conditions described in subdivision (A) of this subdivision (3); or

(ii) The participant or beneficiary provides medical and scientific information establishing the individual's participation in such trial would be appropriate based on the individual meeting the conditions described in subdivision (A) of this subdivision (3).

(5) "Life-threatening condition" means any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted.

(b)(1) If a health maintenance organization offering group or individual health insurance coverage provides coverage to a qualified individual, it:

(A) Shall not deny the individual participation in an approved clinical trial.

(B) Subject to subdivision (3) of this subsection, shall not deny or limit or impose additional conditions on the coverage of routine patient costs for items and services furnished in connection with participation in the approved clinical trial; and

(C) Shall not discriminate against the individual on the basis of the individual's participation in the approved clinical trial.

(2)(A) Subject to subdivision (B) of this subdivision (2), routine patient costs include all items and services consistent with the coverage typically covered for a qualified individual who is not enrolled in an approved clinical trial.

(B) For purposes of subdivision (B) of this subdivision (2), routine patient costs do not include:

(i) The investigational item, device or service itself;

(ii) Items and services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient; or

(iii) A service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis.

(3) If one or more participating providers is participating in a clinical trial, nothing in subdivision (1) of this subsection shall be construed as preventing a health maintenance organization from requiring that a qualified individual participate in the trial through such a participating provider if the provider will accept the individual as a participant in the trial.

(4) Notwithstanding subdivision (3) of this subsection, subdivision (1) of this subsection shall apply to a qualified individual participating in an approved clinical trial that is conducted outside this state.

(5) This section shall not be construed to require a health maintenance organization offering group or individual health insurance coverage to provide benefits for routine patient care services provided outside of the coverage's health care provider network unless out-of-network benefits are other provided under the coverage.

(6) Nothing in this section shall be construed to limit a health maintenance organization's coverage with respect to clinical trials.

(c) The requirements of this section shall be in addition to the requirements of Rhode Island general laws §§ 27-41-41 - 27-41-41.3.

(d) This section shall not apply to insurance coverage providing benefits for: (1) Hospital confinement indemnity; (2) Disability income; (3) Accident only; (4) Long-term care; (5) Medicare supplement; (6) Limited benefit health; (7) Specified disease indemnity; (8) Sickness or bodily injury or death by accident or both; and (9) Other limited benefit policies.

History of Section. (P.L. 2012, ch. 256, § 10; P.L. 2012, ch. 262, § 10.)