For more information about insurance coverage of clinical trial costs, see this feature's main page: States That Require Health Plans to Cover Patient Care Costs in Clinical Trials. Legislation: Senate Bill 1026; Senate Bills 567 & 792 Effective: August 28, 2002 (S.B. 1026); May 12, 2006 (S.B. 567 & 792) What clinical trials are covered? Phase II, III or IV clinical trials for the prevention, early detection, or treatment of cancer, as approved or funded by one of the following: - National Institutes of Health (NIH)
- NIH Cooperative Group or Center
- U.S. Food and Drug Administration
- U.S. Department of Defense
- U.S. Department of Veterans Affairs
- An Institutional Review Board in Missouri that has been approved by the U.S. Department of Health and Human Services
- A qualified research entitity that meets the criteria for NIH Center support grant eligibility
Who is required to pay? Specified insurers, including health maintenance organizations. Other key provisions: - There must be identical or superior noninvestigational treatment alternatives available before providing clinical trial treatment, and there must be a reasonable expectation that the clinical trial treatment will be superior to the noninvestigational alternatives.
- Requires coverage of FDA-approved drugs and devices used in cancer clinical trials even if those drugs and devices have not been approved for use in treatment of the patient's particular condition.
- Health benefit plans may limit coverage of routine care costs of patients in phase II trials to those facilities within the plans' provider network.
- For individually underwritten health plans, the phase II provision is not mandatory but must be offered as an option.
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