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 COL6/24/2021 CH. 18 THE CONTRACT OF INSURANCE

(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.