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Reimbursement summary for angioplasty of arteries of lower extremities

This post presents an extract from our reimbursement analysis for angioplasty of arteries lower extremities using plain and drug-coated balloons (DCBs) for peripheral artery disease in England, France and Germany. Plain balloon angioplasty is reimbursement via DRG solely and DCBs are reimbursement via combination of DRG and add-on reimbursement.
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Reimbursement scheme for health apps launched in Belgium

On January 20, 2021, the National Institute for Health and Disability Insurance (INAMI-RIZIV) announced the reimbursement pathway for health apps. Health apps can now reach level M3 of the validation pyramid. 

The mHealthBelgium platform, created in 2018, is managed by the Belgian Federation of the medical technology industry (beMedTech) and the Belgian Federation of Technology Companies (Agoria). Health apps reach level M1 of the platform when they meet the basic requirements (i.e., recognition as a medical device (CE marking) and compliance with European data protection regulations, as well as product notification in the Federal Agency for Medicines and Health Products (FAMHP) database).

Level M2 can be achieved if a health app meets certain quality criteria in identification and authentication of a user, verification of the therapeutic relationship and informed consent, interoperability, and data protection. Currently, there are seven health apps at the level M2 of the validation pyramid.

Once the first two levels are achieved, the app can be submitted for reimbursement (level M3). The framework to obtain reimbursement (achieving level M3 of the validation pyramid) is now functioning. Only after achieving level M3 of the pyramid, the health app is reimbursed.

The full details in French can be found here and here.

This news is just one of about 300 market access news collected by our team in the subscription services "HTA Alerts" and "Reimbursement Alerts" every two weeks from more than 80 organizations. Access our paid subscription services to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). First EU issues of both newsletters are available for download free-of-charge.

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