Cross-Sectional Analysis of US Health Insurance Payer Policies for Humanitarian Device Exemption Indications for Deep Brain Stimulation

Background: The US Food and Drug Administration (FDA) has granted deep brain stimulation (DBS) approval under the humanitarian device exemption (HDE) pathway for both dystonia and obsessive-compulsive disorder (OCD). However, recent reports from the community of functional neurosurgeons suggest that insurance authorization remains a disproportionate barrier to OCD DBS implantation despite both conditions having similar support from the FDA. This cross-sectional study of health insurance policies quantifies the current payer landscape for these two interventions. Objectives: The aim of this study was to quantify the current payer policy coverage of DBS under HDE status for OCD as compared to DBS for dystonia for eligible patients in the US insurance market. Methods: A commercial health insurance policy database was queried for documentation on DBS for dystonia and OCD. Results were individually analyzed for payer policy coverage statements on DBS for either dystonia or OCD and categorized as unique or nonunique policies. Unique policy positions were then coded for the geographic region, whether coverage was offered, and guidelines cited as evidence and justification. Results: From the 80 policies in the database, there were 34 unique policies addressing DBS for either dystonia or OCD representing coverage of all 50 states. Of the 34 unique policies, 3 (9%) covered DBS for OCD, while 32 (94%) covered dystonia. Only 2 policies covered neither intervention. Conclusions: In spite of similar levels of support from the FDA, DBS for OCD has less support from insurance companies on a national level. This study begins to quantify the disparity noted by functional neurosurgeons in recent literature.