§ 27-18-74. Coverage for individuals 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:
(i) The study or investigation is approved or funded, which may include funding through
in-kind contributions, by one or more of the following:
(A) The federal National Institutes of Health;
(B) The federal Centers for Disease Control and Prevention;
(C) The federal Agency for Health Care Research and Quality;
(D) The federal Centers for Medicare & Medicaid Services;
(E) A cooperative group or center of any of the entities described in subsections (a)(1)(i)(A)-(D)
or the U.S. Department of Defense or the U.S. Department of Veteran Affairs;
(F) A qualified nongovernmental research entity identified in the guidelines issued by
the federal National Institutes of Health for center support grants; or
(G) 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 the 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;
(ii) The study or investigation is conducted under an investigational new drug application
reviewed by the U.S. Food and Drug Administration; or
(iii) The study or investigation is a drug trial that is exempt from having such an investigational
new drug application.
(2) "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.
(3) "Participantâ€� has the meaning stated in section 3(7) of federal ERISA [29 U.S.C. §â€‚1002].
(4) "Participating provider� means a healthcare provider that, under a contract with the
health carrier or with its contractor or subcontractor, has agreed to provide healthcare
services to covered persons with an expectation of receiving payment, other than coinsurance,
copayments, or deductibles, directly, or indirectly from the health carrier.
(5) "Qualified individual� means a participant or beneficiary who meets the following
conditions:
(i) 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
(ii)(A) The referring healthcare professional is a participating provider and has concluded
that the individual's participation in such trial would be appropriate based on the
individual's meeting the conditions described in subsection (a)(5)(i); or
(B) The participant or beneficiary provides medical and scientific information establishing
the individual's participation in such trial would be appropriate based on the individual's
meeting the conditions described in subsection (a)(5)(i).
(b)(1) If a health insurance carrier offering group or individual health insurance coverage
provides coverage to a qualified individual, the health insurance carrier:
(i) Shall not deny the individual participation in an approved clinical trial;
(ii) Subject to subsection (b)(3), 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
(iii) Shall not discriminate against the individual on the basis of the individual's participation
in the approved clinical trial.
(2)(i) Subject to subsection (b)(2)(ii), 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.
(ii) For purposes of this subsection (b)(2), routine patient costs do not include:
(A) The investigational item, device, or service itself;
(B) 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
(C) 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 are participating in a clinical trial, nothing
in subsection (b)(1) shall be construed as preventing a health carrier 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 subsection (b)(3) of this section, subsection (b)(1) 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 insurance carrier offering
group or individual health insurance coverage to provide benefits for routine patient
care services provided outside of the coverage's healthcare provider network unless
out-of-network benefits are otherwise provided under the coverage.
(6) Nothing in this section shall be construed to limit a health insurance carrier's coverage
with respect to clinical trials.
(c) The requirements of this section shall be in addition to the requirements of §§â€‚27-18-36 — 27-18-36.3.
(d) This section shall not apply to grandfathered health plans. 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.
(e) This section shall be effective for plan years beginning on or after January 1, 2014.