Belgium

New material codes and related conditions of reimbursement for middle ear implants were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in August 2020.

In September 2020, the list of companion diagnostic tests, which are evaluated for reimbursement, was updated. INAMI has a specific reimbursement framework for companion diagnostic tests. INAMI Nomenclature codes from Article 33ter can only be reimbursed in relation to specific biomarker tests and drugs from Chapter VIII of the reimbursable pharmaceutical specialties (Royal Decree of February 1, 2018).

In August 2020, mHealthBelgium announced two more health application accomplished M2 validation - Well@Home and AirView. After achieving M2 level, developers will get access to more options, like risk assessment framework, test centers, a lot of useful information.

In July 2020, new material code and related conditions of reimbursement concerning the endoscopic treatment of primary or secondary vesicoureteral reflux were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV).

In July 2020, two new apps entered the level 1 of the mHealthBelgium validation pyramid. Healthentia is an eClinical platform to record Real World Data, that can be used either in clinical trials or by healthy individuals. Sunrise (class IIa) sleep testing device allows rapid and at home diagnosing respiratory sleep disorders.

On July 14, 2020, the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) announced a new framework for reimbursement of the app supporting rehabilitation program for the total hip or knee replacement (moveUP app). The pilot study will start on October 1, 2020, in 15 hospitals. Reimbursement to other patients is planned to be established by September 2021.

New material codes and related conditions of reimbursement for an isolated iliac bifurcation endoprosthesis were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in June 2020.

On 05 June 2020, mHealthBelgium announced the activation of Level 2 of the validation pyramid. This indicates that health applications that meet certain criteria can achieve Level 2. The National Institute for Health and Disability Insurance (INAMI) is working on the next step (level 3) - to introduce a structural framework for funding.

In June 2020, two new apps entered the level 1 of the mHealthBelgium validation pyramid. Guardian Connect smartphone application is a component of the Guardian Connect Continuous Glucose Monitoring (CGM) system for diabetes management. The icompanion software is a decision-making tool that helps physicians to choose medication for patients with multiple sclerosis.

On May 4, 2020, a new web platform called Brizzy entered the level 1 of the mHealthBelgium validation pyramid. Brizzy (class IIa) sleep testing device allows diagnosing respiratory sleep disorders efficiently and accurately and avoids the complexity and discomfort associated with traditional systems. The web platform allows for the analysis of the assessment of the collected data.

In April 2020, the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) introduced four new nomenclature codes for stereotactic radiotherapy (Belgian Monitor of April 27, 2020). Physicians also must register data on provided stereotactic radiotherapy series in the specific module of Cancer Registry Foundation.

New material codes for a locking stylus for extraction of endovenous electrodes and system with recovery lasso for the extraction of endovenous electrodes by femoral approach were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in April 2020. Some reimbursement conditions were updated as well.