Experimental Medical Services: FSA Eligibility

Experimental medical services are eligible for reimbursement with a flexible spending account (FSA), health savings account (HSA) or a health reimbursement arrangement (HRA). Experimental medical services are not eligible with a limited care flexible spending account (LCFSA) or a dependent care flexible spending account (DCFSA).

What are experimental medical services?

Experimental medical services may be eligible for reimbursement with a consumer-directed healthcare account if deemed medically necessary by a medical professional for treatment of a specific condition or disease. Experimental medical services are any service that treats a medical condition or disease and are considered experimental due to lack of 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.

Eligibility Table

Flexible Spending Account (FSA) Limited Care FSA Dependent Care FSA Health Savings Account (HSA) Health Reimbursement Account (HRA)

Eligible

Eligible with Rx

Eligible with LMN

Not Eligible

 


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