State Clinical Trials Law
Wis. Stat. 632.87(6) – Coverage of Clinical Trials
Who must cover the costs? Insurance policies, plans, or contracts
What must be covered? Routine patient care that is administered to an insured in a cancer clinical trial satisfying the criteria that it would be covered under the policy, plan, or contract if the insured were not enrolled in a cancer clinical trial. This coverage applies for clinical trials of any phase but is subject to the terms and conditions of the underlying plan or policy.
Requirements for Coverage: The trial must be designed and the treatment intended to improve the health outcomes of the patient; it may not be designed exclusively to test toxicity or disease pathophysiology. The trial must also do one of the following: (a) Tests how to administer a health care service, item, or drug for the treatment of cancer, (b) Test responses to a health care service, item, or drug for the treatment of cancer, (c) Compare the effectiveness of health care services, items, or drugs for the treatment of cancer with that of other health care services, items, or drugs for the treatment of cancer, or (d) Study new uses of health care services, items, or drugs for the treatment of cancer.
Qualifying Trials: The trial must be approved by one of the following: (1) NIH, or one of its cooperative groups or centers, under the federal department of health and human services, (2) The FDA, (3) The U.S. Dept. of Defense; or (4) the U.S. Dept. of Veterans Affairs.
(Current as of 08/2022)