Like most research institutions in the United States, UF uses Medicare rules to determine if a clinical research study qualifies to bill patients/insurance for protocol-required routine costs. Both terms are defined by Medicare.
Routine Costs in a qualifying clinical research study include all items and services that are otherwise generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national non-coverage determination) that are provided in either the experimental or the control arms of a study.
Routine costs include:
- Items or services that are typically provided absent a study (e.g. conventional care)
- Items or services required solely for the provision of the investigational item or service (e.g., administration of a non-covered chemotherapeutic agent)
- The clinically appropriate monitoring of the effects of the item or service, or the prevention of complications
- Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service in particular, for the diagnosis or treatment of complications.
Routine costs do NOT include:
- The investigational item or service itself (unless otherwise covered outside of the study)
- Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan)
- Items and services customarily provided by the research sponsors free-of-charge for any enrollee in the trial
What is Conventional Care?
- is widely accepted and used by most healthcare professionals and
- would have been provided to the study participant even if they were not in the study.