Key Topics
There is only one key theme describing market access for medical technologies in Belgium:
- Reimbursement: payment via composite model, including physician fees for procedures (INAMI/RIZIV Nomenclature or DRG system), ward stay, and individual implants and invasive non-implantable materials
There is no separate funding (approval by the payer) or health technology assessment challenges in Belgium. Elements of HTA are integrated into reimbursement decision-making.
Belgium has one innovative payment scheme for medical technologies (Restricted Clinical Application for invasive medical devices and implants, Application Clinique Limitée).
Reimbursement
Belgium has one of the most complicated reimbursement systems in Europe. It is mainly based on the mixed model of per diem, per procedure (fee for service), and per material used payment:
- Per diem payment: for hospital ward stays
- Fee for service: for all services performed (interventional procedures, laboratory and imaging services, etc.)
- Material fees: for implantable devices, non-implantable consumables, pharmaceuticals
The overall payment made to the hospital is based on the sum of these individual fees, which are incurred during the period of admission.
Reimbursed procedures are listed in the INAMI/RIZIV Nomenclature. Each procedure has associated codes and physician fees for ambulatory and hospital use.
Invasive non-implantable devices and implants are reimbursed via the so-called “List of benefits” maintained by INAMI/RIZIV. There are eight different models of pricing that are determined within the “List of benefits,” ranging from free pricing to price registered per brand via Nominative Lists.
Since 2019, several low-cost and simple (low-variability) procedures are reimbursed not via individual INAMI/RIZIV codes but via APR-DRGs. The APR-DRG tariff covers only the procedural component (physician fees which are otherwise covered by the INAMI/RIZIV Nomenclature).
Ward stay, and pharmaceuticals are paid separately in the system.
Specifics for IVD Tests
Reimbursement of laboratory testing includes several components:
- Fee for individual tests performed using INAMI/RIZIV Nomenclature (usually reimbursed at 25% of the tariff; there are certain exceptions, e.g., genetic tests, where 100% tariff is reimbursed)
- Lump-sum payment per day of stay (in hospitals)
- Lump-sum payment per admission (in hospitals)
- Lump-sum payment per prescription (in out-patient settings)
- Copayment per test by patients
- Specific reimbursement projects by INAMI/RIZIV (NGS, gene expression profiling tests, companion diagnostic tests)
The reimbursement tariff is covered by insurance companies at the 25% level for the majority of the IVD tests. The remaining amount is recovered by laboratories via lump sum payments and copayments (depending on the type of settings, e.g., using lump-sum payment per day of stay and per admission in hospital settings).
In order to be reimbursed, IVD tests shall be included in INAMI/RIZIV Nomenclature and/or be part of the specific agreements with INAMI/RIZIV (for specific projects, e.g., on NGS or gene expression profiling tests for early-stage breast cancer).
How can MTRC Help?
Development of reimbursement analysis (procedure coding, payment mechanism, reimbursement tariffs, and policy considerations)
Development of market access strategy
Adaptation of the global health economic model to the Belgian settings
Access to an educational seminar on the Belgian reimbursement system
MTRC has experience with more than 168 projects in Belgium
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