University of Kansas Medical Center

“Scenario 4: Expanded Access / Humanitarian Use / Compassionate Care The investigational drug [drugs/devices] will be provided by the manufacturer free of charge. Any additional costs for administering the drug and monitoring its use are considered routine medical care and will be billed to you and your insurance carrier as well as any medical treatments you receive that are not related to the drug. Your insurance may not cover some or all of the services if you are part of a research study or taking an investigational drug outside of a clinical trial. There is no requirement by CMS (Medicare and Medicaid) to cover services related to investigational drugs and devices outside of a clinical trial. Pre-Certification is not a guarantee of payment, and you may want to talk to your insurance company and review your specific benefits and coverage before deciding to use this drug. You will be responsible for normal co-pays, deductibles, and non-covered services. You can still receive the investigational drug even if your insurance denies coverage of the routine medical services or if you are uninsured. The hospital has a financial assistance program which is available to all patients who qualify.”

Examples include Clinical Trial Agreements, Investigator Initiated Study/Trial Agreements, Collaborative Research Agreements, Industry Funded Subcontracts and Expanded Access Program Agreements.