2014 Volume 4 Issue 3 Pages 257-264
Introduction: Health technology assessments (HTA) of medical devices require analyses of claims data to understand utilization statuses. However, these analyses are inhibited by the functional group-based reimbursement regulations applied to medical devices.
Objective: To investigate the feasibility of analyzing claims data regarding medical devices.
Methods: This study reviewed 735 insurance coverage documents regarding brand names, functional groups, and starting dates of coverage for B-class and C-class devices between April 2002 and February 2013. A “solo interval” was defined as the duration from the starting coverage date of a C-class device to that of a B-class device within one functional group. Associations between the types of devices and the solo intervals were also evaluated.
Results: There were 139 (18.9%) functional groups newly covered as C-class devices; the median (interquartile range) solo interval was 16 (5-31) months. Of these, 67 (48.2%) functional groups were also covered as B-class devices. A solo interval of 6 months or less was observed in 23 C-class devices, accounting for 34.3% of 67 functional groups. Data could not be extracted by brand name in the majority of cases (71.6%) after 2 years had elapsed from coverage commencement. There was no association between the types of devices and the solo intervals (P = 0.622).
Conclusion: The functional groupbased reimbursement regulations inhibit analysis of claims data to assess medical devices utilization. To assess the cost-effectiveness of medical devices though postmarketing surveillance, it may be necessary to apply brand name-based reimbursement regulations for HTA of medical devices.
