Reimbursement and Pricing

Medical device reimbursement in Europe is complex, sometimes burdensome, and often poses significant challenges for medical device companies. This is particularly true for innovative and high-priced technologies.

The reimbursement of medical technology in Europe is not centrally regulated at the European level. The question of whether a medical device is covered (i.e. ultimately paid for) by the public or state healthcare system is decided by the member states of the European Union themselves. This may be regulated centrally within the respective European country, in which case there is a uniform solution for a country and a medical device, but it may also be the case that reimbursement varies regionally in the country or depends on the public system in which a person is insured. 

Outpatient or inpatient reimbursement?

In general, it is advisable to first check whether a medical device will be used in the outpatient or inpatient area. This is because the reimbursement channels for both segments are different in all European countries. This means that there are separate rules depending on whether the product will be used in the hospital or outside the hospital.

The DRG billing system in hospitals.

Most European countries use a DRG-system for billing hospital servicves. Diagnosis Related Groups refer to a classification system for a flat-rate billing procedure. These systems are referred to differently from country to country and differ considerably in terms of the design and the amounts managed. However, these systems are generally advantageous for medical device companies, because they can bill their medical device within the existing flat rate per case, provided that it pays for itself within the flat rate.

Outpatient dispensing of the medical device based on a physician's prescription?

If a medical device is prescribed to a patient by a physician in the outpatient area, the physician must regularly observe various rules. These rules are also regulated quite differently within the European countries. In most countries, doctors are only allowed to prescribe medical devices that are listed as eligible for prescription. Either a state committee decides on inclusion in the list or there is a tendering process. A health economic analysis must be carried out regularly for innovative products.