Delaware Code
Subchapter I. General Provisions
§ 3351. Clinical trials.

(a) This section applies to every policy or contract of health insurance, including each policy or contract issued by a health service corporation, which is delivered or issued for delivery in this State.
(b) Definitions. — (1) “Clinical trials,” for purposes of this section, include clinical trials that are approved or funded by use of the following entities:

a. One of the National Institutes of Health (NIH);
b. An NIH cooperative group or center which is a formal network of facilities that collaborate on research projects and have an established NIH-approval peer review program operating within the group, including, but not limited to, the NCI Clinical Cooperative Group and the NCI Community Clinical Oncology Program;
c. The federal Departments of Veterans' Affairs or Defense;
d. An institutional review board of an institution in this State that has a multiple project assurance contract approval by the Office of Protection for the Research Risks of the NIH; and
e. A qualified research entity that meets the criteria for NIH Center Support grant eligibility.
(2) “Routine patient care costs,” as used in this section, include all items and services that are otherwise generally available to a qualified individual that are provided in the clinical trial except:

a. The investigational items or service itself;
b. Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patients; and
c. Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial.
(3) Any clinical trial receiving coverage for routine costs under this section must meet the following requirements:

a. The subject or purpose of the trial must be the evaluation of an item or service that falls within the covered benefits of the policy and is not specifically excluded from coverage.
b. The trial must not be designed exclusively to test toxicity or disease pathophysiology.
c. The trial must have therapeutic intent.
d. Trials of therapeutic interventions must enroll patients with diagnosed disease.
e. The principal purpose of the trial is to test whether the intervention potentially improves the participant's health outcomes.
f. The trial is well supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.
g. The trial does not unjustifiably duplicate existing studies.
h. The trial is in compliance with federal regulations relating to the protection of human subjects.
(c) Every policy described in subsection (a) of this section, including each policy or contract issued by a health service corporation, shall provide coverage for routine patient care costs as defined in paragraph (b)(2) of this section for covered persons engaging in clinical trials for treatment of life-threatening diseases. Nothing in this section, however, independently requires coverage for expense of such clinical trials which are otherwise not covered under the policy or contract.

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