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beMedTech: striving for better reimbursed applications from the medical device industry

An interview with Mr Marnix DENYS, Director, beMedTech

What are the key figures of beMedTech? Created in 1958, beMedTech is the Belgian federation of the medical device industry and represents more than 200 companies, accounting for 80% of the market involved. The members are manufacturers and / or distributors of medical devices. Together they bring more than 500,000 medical technologies to the patient. They realize an annual turnover of € 2.4 billion, excluding exports, accounting for around 17,000 jobs in Belgium.

Furthermore, beMedTech has set up 40 working groups on a wide range of issues such as hearing aids, pacemakers, diabetes care, in vitro diagnostics, etc. It relies upon a team of 9 people, including 5 advisors (one for each pillar, see below). This team makes it possible to offer education programs to members and run communication campaigns on the benefits and added value of new medical technologies.

What are the mission and priorities of beMedTech? Remember first the context: in Belgium today the number of 65+ people amounts to 2.2 million and should reach 2.9 million in 2030. This evolution has two immediate effects: first it exerts a high pressure on the health budget, knowing that health expenditure increases with age; second it exerts a huge stress on human resources since care givers are getting old too! It is therefore foreseeable that the shortage of manpower to support the elderly will increase. And yet we do believe that medical devices can help solve the problem at one condition: a deep reform of the health budget. I will come back to this in the last question.

beMedTech represents the companies active in the medical device industry, which is more and more regulated by European laws. As a member federation, it defends their interests at various levels, including regulatory affairs (legal framework) and the reimbursment of medical devices. Over the past years it has built up a wide expertise thanks to its close collaboration with the main stakeholders in Belgium: FAMHP, the Federal Agency for Medicines and Health Products, NIDHI, the national institution for disease and health insurance, and the federal ministry for Health, without forgetting the regional authorities, since mobility aids (starting with electric wheel chairs) now come under their jurisdiction. Could you present us the expertise of beMedTech? Medical devices cover an area much wider than it seems at first glance. That is why beMedTech is organized in 5 pillars: - Implants; - Medical investment goods (Medical Equipment and Systems – MES, with or without software); - Medical Consumables (hearing aids, needles, wound care, eye contact lenses, mobility aids, etc.); - In vitro diagnostics (IVD); - Extra Muros Interdisciplinary Services and Care, including Digital Health, as part of a transfer of care from the hospital to the home or in elderly homes; these devices, which encompass dialysis, nutrition and oncology care, need specific machinery and framework as well as the education of patients and families to handle and maintain the equipment. What services do you offer to your members? Basically, beMedTech helps them to be successful within the Belgian context. This implies to get the right reimbursment for new technologies, the right legislation, the right regulation of companies… Let me give you an example: before 2018 companies responding to a tender for a scanner in a hospital had to pay individually for the services of an engineer to ensure that the hospital floor could support the weight of the scanner. But if the winning company returned to its expenses thanks to the sale of the scanner, the others had paid for nothing. That is why we made the following proposal: the hospital itself appeals to an engineer to draw up an expert report and the winning company pays. This solution is far better for all stakeholders! © beMedTech

Could you introduce the dataforbetterhealth, mHealthBelgium and HealthTechBelgium initiatives that you are implementing in collaboration with Agoria and the federal government? beMedTech is not directly part of “dataforbetterhealth” which is essentially an initiative of the federal government. It is a central portal for universities, researchers and the industry with the aim of getting access to anonymous data in order to support financing requests and help economic calculation to justify the reimbursment of certain devices.

that medical applications are approved (CE-marked, level 1, which is obligatory to be featured on the platform),interconnected with eHealth services (level 2) and potentially reimbursed, (level 3). Such information is crucial for patients, hospitals and healthcare professionals. Today 11 health applications have been published (level 1) but some work remains. Currently it is unclear for companies what procedures they are supposed to follow in order to move from level 2 to level 3.

Finally, “HealthTechBelgium” has been set up so that innovation and R&D in the field of health meet the needs of patients and health actors as quickly as possible. Let me give you an example in imaging: in certain circumstances it is very useful to offer an alternative to invasive procedures to measure the venous pressure in the heart. Yet the hospital will only get paid for the invasive measurement if the patient subsequently receives a stent. It is as if the diagnosis had no value in itself. Thus a hospital will never be interested in an imaging device fitted with a software allowing to know whether a stent is needed or not! Clearly, the current incentive is suboptimal. As long as reimbursment procedures are not changed new technologies will not be accepted.

What do you see as the main challenges facing the medical device industry? The first challenge is definitely a health budget reform. Today 20% of this budget is wasted because of pernicious incentives. Indeed, hospitals are encouraged to perform acts to be paid regardless of whether these acts are really necessary or not. In other words, they are paid to do something, not to keep someone healthy. It would be better to make sure that healthcare providers are paid for the quality of their acts, i.e. for the result for the patient. Let me take the example of low variable care: these are standardized procedures (cataract surgery, hip replacement…) with low risks. Hospitals receive a lump sum for this kind of interventions which include both diagnosis and care itself. A quality component could be added in the financing scheme, rewarding the absence of infection or penalizing the

occurrence of an infection for instance. In this case hospitals would no longer run the risk of buying cheap, foreign devices, regardless of the quality of care provided.

It is also paramount to work on chronic disease prevention by allocating a larger share of the health budget and thereby rewarding those who get good results in this field. Today regions pay and the federal government gets the benefit; the common interest of the population remains unheeded and too many levels of political decision make no difference to the case.

Today Health minister Maggie De Block has just started to make things happen. But the healthcare system still has a lot of potential to become more efficient with the help of medical devices such as diagnostics, software, machinery, and artificial intelligence: all of them could supplement the expertise of healthcare professionals and therefore save precious time. Let us not forget that the biggest part of the healthcare budget concerns the human resources. In comparison the share of medical devices is rather small, which makes them a very economical solution. We have to face the facts, the healthcare system is not sustainable as it is run today. And yet NIDHI, which is co-managed by sick funds and healthcare professionals, has a hard time to reinvent itself to tackle the future challenges. The medical device industry should be better represented in this agency: it only enjoys a non-voting seat in the commission on implants. As a society, we miss the opportunities to suggest reform and innovative funding schemes. With a better representation of our sector in various commissions, more insights on new technologies can be provided, and NIDHI’s decisions would become more transparent.

But NIDHI is not the only one involved: it is equally difficult to have new technologies in medical devices accepted by the federal government. Even though the right data are available, the assessment and implementation procedures of new technologies will have to be speeded up if we want to avoid already outdated applications to arrive on the market. Let’s not forget that industrial cycles are much shorter than political decision-making processes!