Does the proposal cover the cost of experimental drugs?
No. The cost of investigational drugs and other direct research costs are borne by the sponsor of the research. Medicare will not cover costs of an investigational drug (unless the Secretary of Health and Human Services has authorized the manufacturer to charge for the drug) or any item or service supplied without charge by the sponsor of the trial. 8. Is treatment in a clinical trial more expensive than treatment outside a study? There has been intense debate about whether the cost of care provided in a clinical trial is greater than, equal to, or less than the cost of conventional treatment. Under the demonstration project, this issue will be studied using data from coverage of NIH clinical trials, and the Secretary will report to the Congress on this issue. 9. How will the demonstration project be evaluated? The Secretary of HHS, in consultation with the National Cancer Policy Board (a freestanding body established to address issues that arise in the prevention, control, diagnosis,