Experimental Medical Services: FSA Eligibility

What are experimental medical services?

Experimental medical services are any service that treats a medical condition or disease and are considered experimental due to lack of U.S. Food and Drug Administration (FDA) approval.

Medical services are deemed experimental if they are a service unable to be lawfully marketed without FDA approval; if the service is the subject of an ongoing authoritative study in Phase I, II, or III clinical trials; and if the service is shown, by reliable evidence, that there is a consensus among qualified objective experts that further work is necessary to determine the safety, efficacy, and anticipated outcome as compared with existing approved services for a specific condition or disease. Further work may be defined as basic scientific research, laboratory based clinical studies, clinical studies, clinical outcomes research, or clinical trials.

For an experimental medical service to be considered medically necessary, it may be sponsored by a National Cancer Institute (NCI) program, a National Institute of Health (NIH) program, an FDA-approved experimental or investigational program, or a Center for Disease Control and Prevention (CDC) program. An experimental medical service may also be considered medically necessary if it is not yet fully approved by the FDA but appears to be the most effective and most appropriate treatment for an immediate life-threatening illness or serious disease which has no satisfactory alternative treatment (National Academy for State Health Policy).