Economic challenges of using innovative medical devices in major public health pathologies: Example of acute ischemic stroke management by mechanical thrombectomy.

Background: Activity-based Funding can induce financial imbalances for health institutions if innovative medical devices (MD) used to perform acts are included in Diagnosis Related Groups (DRG) tariff. To be reimbursed in addition to the DRG tariff, innovative MD must have received a favorable evaluation by the French National Authority for Health (Haute Autorité de Santé) and be registered on the positive list. The aim of this study was to evaluate the expenses and incomes generated by each scenario (before and after the reimbursement of MD), and the financial reports. This study concerned the management of ischemic stroke by mechanical thrombectomy devices, in high-volume French hospital.
Methods: All patients who have had an acute ischemic stroke and admitted to the interventional neuroradiology unit between January 2016 and December 2017 were included retrospectively in this monocentric study. They were divided into four subgroups based on the severity of the DRG. The cost study was carried out using the French National Cost Study Methodology adjusted for the duration of the stays and by micro-costing on MD.
Results: A total of 267 patients were included. Over the study period, the average cost of the hospital stay was €10,492±6364 for a refund of €9838±6749 per patient. The acts performed became profitable once the MD were registered on the positive list (€-1017±3551 vs. €560±2671; P<0.05). Despite this reimbursement, this activity remained in deficit for DRG lowest severity (level 1) patients (€-492±1244). Specific MD used for mechanical thrombectomy represented 37% of the total cost of stay.
Conclusion: The time required to evaluate MD reimbursement files is too long compared to their development. As a result, practitioners are in difficulty to be able to carry out acts according to the consensual practices of their learned societies, without causing any financial deficit of their institutions.
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