Reimbursement for the LiMAx® test: MEL Commission includes Humedics GmbH's LiMAx® test in the MEL list 2022

Berlin, 2022/05/09 - The MEL Commission of the Austrian Ministry of Social Affairs has included the LiMAx® test in the MEL list 2022. In the new service catalog, the new group "APG07.02 - Special diagnostics - Gastrointestinal tract 2" was created. Under APG07.02 A, the new service "HL510 - Liver function test with application of a C13-labeled substrate (LE=per session)" is listed - the LiMAx® test, the use of which can be coded with 458 points in an outpatient setting.

The listing was based to a large extent on the results of the Mini Health Technology Assessment conducted in 2019 by the Competence Center for Medical Devices (CCMD). At the time, the institute confirmed the clinical and economic advantage of the LiMAx® system for interventional use in liver surgery and highlighted the non-invasive breath test as particularly innovative.

With the help of the worldwide unique Liver Maximum Capacity Test (LiMAx®), which quantifies the maximum functional capacity of the liver, physicians can specifically examine the liver for possible diseases. The results can be used to better plan interventions on the liver and thus minimize risks for patients.

"The inclusion on the MEL list confirms our assessment of the LiMAx® test in terms of the validity of our clinical data and its relevance for healthcare. This will now result in our unique diagnostic method, which measures the functional capacity of the liver in real time, not only helping patients and physicians alike, but also generating significant economic benefits for the healthcare system in Austria," assesses Ralf Kohnen, CBO of Humedics GmbH.

Liver disease leads to approximately two million deaths per year worldwide. Current diagnostic tools often prove to be of limited applicability for the accurate measurement of liver function or for the prediction of various liver-related pathologies. A novel way of determining global liver function is the LiMAx® (maximum liver function capacity) test, which measures, in exhaled breath, the effectiveness of the liver to metabolize an intravenously administered solution (13C-methacetin).

For numerous diseases, such as malignant liver tumors, the resection of segments of the liver is necessary. In surgical management, the use of the LiMAx® system leads to safer procedures and a reduction in postoperative intensive care unit days as well as days in hospital.

The LiMAx® test is the first and only breath test in liver diagnostics to be included in the MEL list. In addition to convincing clinical data, the economic cost-benefit analysis has confirmed the cost-effectiveness of the LiMAx® system for use in surgery management and this led to its reimbursement.

For more information about Humedics and the LiMAx® test, visit: www.humedics.eu or contact Kajo Wiest, Tel. +49-(0)30-62939550, kajo[email protected]