Guam § 18902 - Coverage of Routine Costs of Care During

§ 18902. Coverage of Routine Costs of Care During

Approved Clinical Trials.

(a) A health insurance company or healthcare plan shall

continue coverage of routine costs for any insured during the

approved clinical trial.

(b) For the purposes of this Section, routine costs of care

include any treatments, procedures, and services the insured may

need while participating in the clinical trial that would normally

be covered if the insured were not participating in a trial.

(c) For the purposes of this Section, approved clinical trials

are designed to study new methods to prevent, detect, or treat

cancer or another life-threatening illness. An approved clinical

trial must meet any of the following conditions:

(1) be federally approved or funded - this means that

one (1) or more of the organizations listed below approved

or funded the clinical trial:

(A) the National Institutes of Health (NIH),

including organizations under the NIH such as the

National Cancer Institute (NCI);

(B) organizations funded by the NIH or NCI,

including academic institutions, designated cancer

centers, and cooperative groups;

(C) the Centers for Disease Control and

Prevention (CDC);

(D) the Agency for Health Care Research and

Quality (ARHQ);

(E) the Center for Medicare and Medicaid

Services (CMS);

(F) the Department of Defense, the Department of

Veteran Affairs, or the Department of Energy, if the

trial is subject to unbiased, scientific review that is

similar to NIH requirements;

(2) have an investigational new drug application; or

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(3) be excused from investigational new drug

application requirements.

(d) Health insurance companies or healthcare plans are not

required to cover the cost of any clinical trials.