PMID- 31662284 OWN - NLM STAT- MEDLINE DCOM- 20200424 LR - 20200424 IS - 0398-7620 (Print) IS - 0398-7620 (Linking) VI - 67 IP - 6 DP - 2019 Nov TI - Economic challenges of using innovative medical devices in major public health pathologies: Example of acute ischemic stroke management by mechanical thrombectomy. PG - 361-368 LID - S0398-7620(19)30481-X [pii] LID - 10.1016/j.respe.2019.08.003 [doi] AB - 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 Autorite de Sante) 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 euro10,492+/-6364 for a refund of euro9838+/-6749 per patient. The acts performed became profitable once the MD were registered on the positive list (euro-1017+/-3551 vs. euro560+/-2671; P<0.05). Despite this reimbursement, this activity remained in deficit for DRG lowest severity (level 1) patients (euro-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. CI - Copyright (c) 2019 Elsevier Masson SAS. All rights reserved. FAU - Nativel, F AU - Nativel F AD - Pharmacy department, university hospital, 85, rue Saint Jacques, 44093 Nantes, France. Electronic address: fabien.nativel90@gmail.com. FAU - Detraz, L AU - Detraz L AD - Neuroradiology department, university hospital, 44093 Nantes, France. Electronic address: lili.detraz@gmail.com. FAU - Mauduit, N AU - Mauduit N AD - Medical information department, university hospital, 44093 Nantes, France. Electronic address: nicolas.mauduit@chu-nantes.fr. FAU - Riche, V-P AU - Riche VP AD - Innovation cell, partnership and innovation department, directorate of medical affairs and research, university hospital, 44093 Nantes, France. Electronic address: valerypierre.riche@chu-nantes.fr. FAU - Desal, H AU - Desal H AD - Neuroradiology department, university hospital, 44093 Nantes, France; Inserm UMR1087, Institut du thorax, 44000 Nantes, France. Electronic address: hubert.desal@chu-nantes.fr. FAU - Grimandi, G AU - Grimandi G AD - Pharmacy department, university hospital, 85, rue Saint Jacques, 44093 Nantes, France. Electronic address: gael.grimandi@univ-nantes.fr. LA - eng PT - Journal Article DEP - 20191026 PL - France TA - Rev Epidemiol Sante Publique JT - Revue d'epidemiologie et de sante publique JID - 7608039 SB - IM MH - Aged MH - Aged, 80 and over MH - Brain Ischemia/complications/economics/epidemiology/*therapy MH - Cost-Benefit Analysis MH - Equipment and Supplies/*economics MH - Female MH - France/epidemiology MH - Humans MH - Insurance, Health, Reimbursement/economics MH - Inventions/*economics/trends MH - Length of Stay/economics/statistics & numerical data MH - Male MH - *Mechanical Thrombolysis/economics/instrumentation/trends MH - Middle Aged MH - Public Health/*economics/statistics & numerical data/trends MH - Retrospective Studies MH - Stroke/complications/economics/epidemiology/*therapy MH - Thrombectomy/economics/instrumentation/trends OTO - NOTNLM OT - Dispositifs medicaux OT - Health economics OT - Innovation OT - Mechanical thrombectomy OT - Medical devices OT - Micro-costing OT - Thrombectomie mecanique OT - Economie de la sante EDAT- 2019/10/31 06:00 MHDA- 2020/04/25 06:00 CRDT- 2019/10/31 06:00 PHST- 2019/02/28 00:00 [received] PHST- 2019/06/20 00:00 [revised] PHST- 2019/08/28 00:00 [accepted] PHST- 2019/10/31 06:00 [pubmed] PHST- 2020/04/25 06:00 [medline] PHST- 2019/10/31 06:00 [entrez] AID - S0398-7620(19)30481-X [pii] AID - 10.1016/j.respe.2019.08.003 [doi] PST - ppublish SO - Rev Epidemiol Sante Publique. 2019 Nov;67(6):361-368. doi: 10.1016/j.respe.2019.08.003. Epub 2019 Oct 26.