Medical Research: A Consumer's Guide for Participation

• U.S. Department of Veterans Affairs
• The Institutional Review Board (IRB) of an
institution in West Virginia that has a Multiple
Project Assurance contract approved by the
NIH Office of Protection from Research Risks
Who is required to pay? Private insurers, managed
care plans, Medicaid or state medical assistance,
public employee health plans.
Other key provisions:
• The treatment must have therapeutic intent.
• There is no clearly superior, noninvestigational
alternative.
• The available clinical or pre-clinical data
provide a reasonable expectation that the treatment
will be more effective than the noninvestigational
treatment alternative.
• Does not require reimbursement for clinical
trials intended to:
– Extend the patent of any existing drug.
– Gain approval of or coverage for a metabolite
of an existing drug.
– Gain approval or coverage relating to additional
clinical indications for an existing
drug.
– Keep a generic version of a drug from
coming to market.
– Gain approval of or coverage for reformulated
or repackaged version of an existing
drug.
Wisconsin
Legislation: Assembly Bill 617
Effective: Nov. 1, 2006
What clinical trials are covered? All phases of cancer
clinical trials, as approved 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
Who is required to pay? All health benefit plans operating
in the state, including self-insured plans.
Other key provisions:
• The cancer trial must have therapeutic intent,
not exclusively testing toxicity or disease pathophysiology.
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