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To be or not to be… reimbursed?

30 November 2016 - 9:35


Every day, new innovations are developed impacting patients’ health. Nowadays, a big part of these health-related innovations rely on New Technologies of Information and Communication (NTIC). This emerging field is called e-health or digital health. E-health reaches from medical data transfer technologies to telehealth equipment, software for medical devices or even health monitoring applications. One of the challenges for these innovations is to reach the market. In Belgium, reimbursement is one of the keys to this access. However, it is not always easy for startups to find the right door to INAMI/RIZIV., MIC Vlaanderen, MIC Brussels and the Caring Entrepreneurship Fund joined forces to open a communication channel between tomorrow’s health providers and the federal institution. Mr. Jo De Cock, CEO of the National Institute of Health and Disability Insurance (NIHDI/ INAMI/RIZIV), presented his vision about innovation to 40 e-health entrepreneurs looking for the reimbursement Grail. Three of these entrepreneurs presented their solution and were given the opportunity to ask directly their reimbursement-related questions to the CEO and the Program Manager for  ICT, Brecht Stubbe, who gave some interesting perspectives…

A few basic principles…

For Mr. De Cock, innovation is an essential part of each healthcare system, but not all innovations are to be reimbursed. For startups, it is very important to understand what principles drive the decision to reimburse or not a solution.

First of all, it is important to understand the difference between reimbursement of services and products because the processes are different. Services, such are consultations, tests, hospitalizations etc..are only reimbursed trough care centers. The present principle is a pay-per-act principle. To be reimbursed, an act should be included in the nomenclature of the INAMI/RIZIV, i.e. the database of all possible services that are recognized as such and therefore reimbursed at a particular rate.

For products to be reimbursed, the company has to submit a file to the INAMI/RIZIV where the pertinence of the product will be assessed. Important to note is that this procedure – which is very clearly described for pharmaceuticals – will be clarified for medical devices in the next years, as determined by the Pact of the Future[1] signed by the Minister of Public Health Maggie De Block and the Medical industry, beMedTech.

Yet, the principles of reimbursement are going to evolve along with the sector. Mr. De Cock emphasized the willingness of INAMI/RIZIV to shift to value-based medicine and more integrated care, where the final result is the main parameter rather than the used means. Concretely, it means that bundled payments (a lump sum per patient with a certain disease, covering all expenses for its treatment – per time lapse) are well-considered. These will be tested via pilot projects such as the Mobile Health pilot project. This principles will also allow to open the possibility to reimburse integrated solutions including a combination of pharmaceuticals, medical technologies and e-health.

Where value for patients needs to meet economical value…

Every healthcare system aims to find the cross section between 4 dilemmas: make the highest standard of care (1) accessible to everyone, taking into account (2) the economic impact, (3) social concern (accessibility to everyone) and (4) the policy constraints.

Medical innovations are blooming. However, more and more questions arise regarding innovation because of their potential cost. Therefore, the added value of new innovations should be measured in regard to their social and economic impact, differentiating a nice-to-have from a need-to-have. The cost of innovation is not to be considered in absolute numbers, but with regard to the added value it brings to health.

Three main questions need to be asked to assess the impact:

  1. What is the impact of this innovation in comparison to the actual treatment?
  2. What are the consequences of this innovation at social, health and economic level?
  3. What are the changes that need to be taken into account?

These three questions will define the pertinence of reimbursement for a new solution.

If a solution does not bring clear answers to these questions, or if the answers do not demonstrate an improvement in treatment or economic efficiency, why would public money pay for it?

Note that one exception exists: when a solution targets an unmet medical need, the procedures are eased to facilitate reimbursement and give patients rapidly access to it.

In the future, a fourth criterion will be important. A project led jointly by the Kind Baudouin Foundation and INAMI/RIZIV aimed to identify which criteria are important to patients, since their role evolves toward a more active player of their health. The results of this study show the importance of patient centricity – instead of disease centricity – bringing prevention to the foreground. Criteria such as impact on quality of life, affordability, more integrated care and efficacy (versus effectiveness) were highlighted by the citizens.

Not only innovation in the healthcare system but also innovation of the healthcare system

Developing new innovations is one challenge, facilitating their use is another one. It requires changes of habits to be implemented. To facilitate this process, it is important to consider the factors that can facilitate innovation stimulation and uptake. The Pacts of the Future signed respectively with the pharma and the medical technologies industries, as well as the EHealth roadmap[2] that bring tools to promote innovation uptake. However, this is not enough. New incentives are required to stimulate healthcare professionals to adopt new technologies and new means are needed to teach them how to use those technologies properly.

On the other hand, the healthcare system needs to adapt in order to better match with the evolving environment. One of the challenges is a better integrated healthcare system. We need legislation change to promote remote control and home care, but also we need to develop specific procedures for accelerating mobile health reimbursement. And the same goes for other challenges such as personalized medicine, health promotion and education of the healthcare providers to the (correct) use of new technologies.

In the future, evaluation procedures will be adapted in order to evolve towards more value-based medicine. Evolution towards bundled payments will require de-silo-isation of these procedures, but also a holistic view of the costs associated with a pathology (assistance for nutrition, psychological care, new technologies,…). Mr. De Cock also mentioned direct payment to patients as a future possibility.

For product, companies will still have to make demands, but we might evolve towards reimbursement of combined solutions (composed of pharmaceuticals, medical devices and digital solutions) and more pilot-projects.

Opening a direct dialog between INAMI/RIZIV and Belgian startups

The exchange between the 3 selected startups and Mr. De Cock showed how some questions can be difficult for one counterpart and simple for the other one.

Thibault Helleputte, CEO of DNAlytics, active in data mining for precision medicine and omics-based diagnosis, emphasized how important transparency and openness is to foster innovation, not only regarding clear procedures – for IVD product reimbursement there is none, neither clear criteria or deadlines – but also regarding the healthcare databases, which contain crucial data to design and develop new products or quantify the need for new solutions (for instance pharmacy-economic data) . This concern was shared by Mr De Cock, who expressed clearly that open data is one of his priorities, but the best way to open data has not been identified yet. A clearer procedure for reimbursement of diagnostics and medical devices can be expected by 2019, as proposed in the Pact for the future that was signed with BeMedTech this fall.

Qompium that developed the Fibricheck app, enabling remote cardiac rhythm monitoring of patients after a stroke, shared their difficulties to access reimbursement since the technology they are based on is not included in the actual nomenclature – a frequent hurdle for innovative solutions. What was obviously a big trouble for the startup appeared to be seen as a technicality for Mr. De Cock, who invited Jo Van der Auwera to demonstrate that their solution offer a better or at least an equivalent result as the “nomenclated” technology. However, Mr. De Cock agreed with the importance to attract INAMI/RIZIV’s attention on this type of issues. An exercise that will also take place during the analysis of the 92 projects submitted in the Mobile Health Pilot project Call initiated by Maggy De Block.

Bastien Ritzen, from Zebra Academy questioned the ability of the healthcare system to take up telemedicine solution including tele-radiology and teleconsultations. This is important to the start-up that developed a tool enabling early diagnosis of stroke patients in the ambulances. As no legal framework exists for the moment, a solution regarding this particular case could come from the emergency related service Zebra Academy offers. On the long run, equivalence of teleconsultation with traditional activity is under construction, but it has to be stated by experts first.

A first step…

For the organizers, this event proved its value by creating a direct communication channel between two worlds. There was a consensus on the usefulness of the exchanges. Fostering development and uptake of new innovations in Belgium is a common goal of all the present stakeholders and actions points have been identified to reach it. Startups need better information about INAMI/RIZIV procedures and criteria, but also about the initiatives taken by them. The co-development (by the organizers and the INAMI/RIZIV) of a Startup Kit, gathering the information about the procedures, produced by INAMI/RIZIV will be a first step towards more transparency. Moreover, keeping the communication channel open through this type of Health Forum is one of the goals of the four organizers.

We really would like to thank Mr. De Cock for his openness during the exchanges.

We hope to see you soon for a next edition! – MIC Vlaanderen – MIC Brussels – The Caring Entrepreneurship Fund


Author : Camille Mommer

[1] Text in French here.

[2] In Flemish here.