Use and Abuse of Medical Foods

Background: The cost of medical foods, outside of those for inborn errors of metabolism (IEM), is increasing within workers’ compensation systems. The Food and Drug Administration (FDA), insurance companies, and medical providers have varying and broad definitions of medical foods; the incongruity raises questions of whether certain medical food products are medically necessary and deserve reimbursement.

Methods: This study reviews reimbursement policies and regulations for medical foods from workers’ compensation systems across the United States. Specifically, we examine reimbursement claims for medical foods from the California Workers’ Compensation (CAWC) database from 2011-2013 to determine frequency and costs over time. We also evaluate if CAWC’s most prevalent medical foods have sufficient scientific evidence to qualify as a medical food under FDA’s definition.

Results: The top two reimbursed medical foods in the CAWC database are Theramine^™ and GABAdone^™ for the treatment of chronic pain and sleep disorders, respectively.  The annual average cost per patient for medical foods have increased by 30% over three years to as much as $1309 billed.  It is questionable whether these products meet FDA requirement for adequate scientific evidence.

Conclusion: This study highlights the gap between the FDA definition for medical foods (not required for IEM) and the availability of scientific evidence.  The lack of clear reimbursement policies in the workers’ compensation systems encourages further increase in cost for unnecessary medical foods. We suggest a reevaluation of medical foods that qualifies for reimbursement to ensure that workers’ are receiving appropriate and efficient treatments.