1. History

In early 2010 the Federal Public Service of Health, Food Chain Safety and Environment (FPS HFSE) decided to aim at reversing the upward trend of radiation exposure of the Belgian population due to diagnostic examinations and reaching the radiation levels of the neighbouring countries. Some of the options to achieve this goal are (1) enforcing a better adherence to the ?Guidelines for the proper use of Medical Imaging? (?the guidelines?) as published by the former Consilium Radiologicum, (2) sensitizing both the medical professionals and the general public about the improper or excessive use of ionizing radiation, and (3) establishing a standardized quality system. Through a more efficient use of the various radiological techniques, which includes, for example, the avoidance of redundant, double, or unnecessarily burdensome examinations, both a higher quality of the radiological service and a radiation reducing effect can be expected. The consequently expected decline in the number of examinations may also have a cost-saving effect. The saved money can be reinvested in modern, more radiation efficient techniques, as well as in a stimulating remuneration depending on the quality that is offered by a radiological service.

Right from the very start of the project?s development the FPS HFSE sought contact with Belgium?s radiological community. Indeed, radiological representatives were directly involved in devising a strategy, under the supervision of Prof. Dr. Guy Marchal, former Head of the Department of Radiology at the Leuven University Hospitals. Under his leadership, several subcommittees were set up, which divided the work among themselves. For instance, a working group on "Quality" was established, which is dedicated to quality criteria in radiology and the legislation in force in this area, the set-up of potential approval and accreditation requirements and the elaboration of a monitoring system in the form of a radiological audit.

The working group "Focus on Medical Imaging" is intended to update the guidelines for the proper use of medical imaging on a regular basis and spread them efficiently among the medical profession. A first update has already been published on FOD Health  ("Guidelines on Medical Imaging"). Furthermore, a non-profit association is founded that, among other things, will publish a periodical magazine (Focus on Medical Imaging), that, by analogy with the so-called Folia Farmacotherapeutica, will inform the medical profession about recent new insights or changes to the guidelines on a regular basis. The working Group ?Sensitization? has the mission to inform the general public, practitioners (doctors, nurses, paramedical staff) and prescribers of diagnostic examinations about the risks of improper or excessive use of ionizing radiation. The most visible activity of this group was the media campaign "Sparing with rays" in the spring of 2012.

Finally, the working group "Marchal" is the umbrella group that keeps an overview of the activities of the sub-working groups and brings together, verifies and integrates all relevant information. Prof. Marchal ceased his activities in this project in March 2011 and was succeeded by Prof. Dr. Geert Villeirs, Clinic Head of Urogenital Radiology at the Ghent University Hospital. Although initially the name of the project ("Commission Marchal")

was retained, at the end of 2012 it was renamed BELMIP (Belgian Medical Imaging Platform). In the meantime all working groups within BELMIP have a balanced composition, with representatives from the Federal Public Service, the National Institute for Health and Invalidity Insurance (NIHDI), the Federal Agency for Nuclear Control (FANC), the Belgian Health Care Knowledge Centre (KCE), the Superior Health Council, the college and professional group of medical imagers, and the professional groups of nuclear medicine physicians and radiologists.

2. Goals

On June 12, 2012, the objectives of the Belgian Medical Imaging Platform were defined in a policy paper, in consultation with representatives of the government, FPS HFSE, NIHDI and the radiological profession. These goals were further elaborated in a memorandum of November 1, 2012.

These objectives include four parts: encouraging the use of the Guidelines, sensitizing prescribers and general public about the dangers of overuse of medical imaging, introducing a radiological quality system and optimizing the range of medical imaging techniques.

2.A. Encouraging the use of the Guidelines

2.A.1. Context

Within the wide range of imaging examinations physicians strive to pick out the most appropriate technique. The choice of the most appropriate examination, however, is not evident. Domestic and foreign studies show that many medical imaging examinations are not chosen optimally from the wide range. This means that the examinations that have been carried out are not always the most indicated given the patient?s clinical context and that sometimes better alternatives are available. In order to support the applicants of medical imaging in their choice, the Guidelines for the Proper Use of Medical Imaging were drawn up. These are classified according to the clinical problem and recommendations are given for each type of examination. The term ?recommendation? is interpreted as a non-binding, general recommendation for best practice against which the needs of each individual patient are tested. Therefore, for the individual patient there may be deviations from these general recommendations when there is a reason, which is preferably explicitly documented in the medical record. The Guidelines are a joint initiative of FPS HFSE, NIHDI and the Federal Agency for Nuclear Control. They were developed by the Consilium Radiologicum in collaboration with Professor Dr. Guy Marchal and are based on French recommendations issued in 2005. The recommendations on radiological examinations have been updated by various experts and adapted to the Belgian situation.

2.A.2. BELMIP initiatives

2.A.2.a. Regularly reviewing the Guidelines

As medical imaging is an area in full evolution, the recommendations will need to be reviewed on a regular basis. For this purpose, an independent scientific body (named Focus on Medical Imaging) was established in collaboration with the different stakeholders. The NIHDI provides a recurring amount for the operation of this association. The association will play a facilitating role at updating the guidelines.

2.A.2.b. Publicizing the Guidelines and sensitizing prescribers

The non-profit association Focus on Medical Imaging will publish a periodical of the same name for the applicants. This publication will be similar to the already known Folia Farmacotherapeutica. In Focus on Medical Imaging current and new aspects in medical imaging will be discussed and recommendations may be updated and discussed.

The Guidelines will also be widely spread and made easily accessible through a dynamic website. This website is realized in collaboration with EBMPracticeNET.

2.A.2.c. Adapted prescription form

A standardized written prescription form for requesting medical imaging was introduced on March 1, 2013. It is a condition for health insurance reimbursement. It contains a clear obligation to formulate the diagnostic question for each application, provide relevant clinical data and warn for possible risk factors. Also, the prescriber is explicitly asked to indicate whether previous relevant examination(s) related to the diagnostic question have been performed previously.

Later on, steps will have to be taken in order to imbed a standardized electronic prescription using the technique of timestamping, organized by eHealth, by analogy with the electronic medicine prescription. Pilot projects both within (eHealth) and outside (Recipe) hospitals will be set up in order to test the technique of electronic prescribing of medical imaging prior to their general introduction. The prescription must be integrated in the patient?s electronic health record so that the treating physician is able to automatically verify the conformity with the Guidelines as an ?active decision support?. Also, as a part of an awareness policy, the prescriber should already be able to have an understanding of the costs and the accumulated radiation dose at the moment of prescribing. The results of the requested examinations must be integrated and centralized into the electronic health record.

2.A.2.d. Right of substitution

On April 1, 2014, radiologists were granted the right of substitution, which allows them to modify a prescription if it is not made in accordance with the Guidelines. The use of this "right of substitution" must be motivated in the health record.

2.A.2.e. Conditions of reimbursement

As of April 1, 2013 for the first time the observance of the Guidelines was set as a condition for the reimbursement of an act of medical imaging, more particularly the radiography of the lumbar spine.

2.A.2.f. Connexism

For connexists (non-radiological specialists who perform acts of medical imaging in the context of their practice) the same rules should apply as for radiologists as regards quality and safety requirements, application of Directives, good medical practice and registration of equipment.

The financial impact of the connexists? faculty of auto-prescription should be investigated and, if necessary, the existing funding mechanisms should be adjusted accordingly, e.g. by clustering the remuneration of certain examinations, tightening the reimbursement conditions, or integrating the fees for these acts in a specific fee.

2.A.2.g. Performance indicators

It will be examined how the study of the College of Radiology can be expanded as a monitoring and awareness-raising tool for a better use of the Guidelines and how the compliance with these Guidelines can be generalized over time, either through the WIV-ISP (Scientific Institute of Public Health) or through the association "Focus on medical imaging".

In collaboration with the profile committee work is underway to ensure the feedback of data on prescribing behavior. In that respect, the NIHDI already sent individual information to general practitioners and rheumatologists based on their practice. The GPs received their individual profile in July 2010; the rheumatologists received theirs in August 2010. These profiles contain a specific chapter in which the issues of medical imaging are addressed. By means of their own profile, physicians are able to ?benchmark? their prescribing behavior against their peers?. This feedback to the prescribers of medical imaging should be continued, firstly, by repeating the existing feedback to GPs and, secondly, by extending it to other specialties.

2.A.2.h. Legal framework

The Legal Service of the FPS HFSE will examine how a legal framework can be integrated into the legislation on the medical practice in order to give a more important impact to the Guidelines and enable the monitoring of the compliance with the Guidelines. An indicator for measuring the Guidelines? implementation will be sought. This implementation will be supervised and controlled by NIHDI?s Service for Medical Evaluation and Control.

2.B. Awareness Campaign for the general public

In addition to publishing recommendations, the government also organizes an awareness campaign aimed at the population. This campaign informs the public about the usefulness of medical imaging which is adapted to the context and it also warns against improper use. This approach must lead to a better communication between the requesting physician and the patient with regard to ?imagery? as such, enabling a closer involvement of the patient in his care process (patient empowerment).

The central information point of the campaign is an easily accessible website (zuinig met straling ? pas de rayons sans raisons), which informs its visitors in a comprehensible manner about medical imaging. In launching the campaign, the prescribing doctors were informed about the campaign and asked to support it by communicating with their patients about the subject. A waiting room poster, ads and banners were created. The campaign makes use of social media to refer people to the campaign website. It was launched in June 2012 and is repeated annually. For this purpose, the NIHDI puts an operational budget at the disposal of the

FPS Public Health. The impact of the awareness campaign will be assessed by means of indicators, which are to be defined.

2.C. Radiological quality system

The quality system is based on a clinical audit tool, which was published by the International Atomic Energy Agency (IAEA) in 2010 (Quality Assurance Audit for Diagnostic Radiology Improvement and Learning). Many criteria have already been converted into Belgian legislation, more particularly in the form of various royal decrees, accreditation standards and the General Regulations on the Protection of the Population, the Workers and the Environment against the Hazards of Ionizing Radiation (ARBIS). Furthermore, many recommendations are already applied by agencies such as the National Institute for Health and Disability Insurance (NIHDI) and the Federal Agency for Nuclear Control (FANC). The quality system will take the form of a graduated system in which the basic level includes mandatory minimum quality requirements. One or more higher levels are reached when a number of optional, but highly recommended more specific quality criteria are fulfilled.

This system is based on a quality control in the form of a radiological audit (internal and external). The radiological audit should be a requirement to attain a higher quality level than the "base level". A legal framework will be created in order to allow the accreditation of medical imaging services. It should be examined how incentives can be integrated in order to valorize the accreditation and audits.

2.D. Optimization of the offer of medical imaging

2.D.1. Context

An inquiry by the College of Radiology has shown that currently compliance of the Guidelines is still lacking. More specifically, it revealed that the number of CT examinations carried out is higher than desirable, whereas the number of MRI examinations is too low. Both phenomena can be explained partly by the programming in force in Belgium for MRI units, which means that only hospitals that have a government accreditation for this purpose are allowed to exploit a machine and receive funding in the form of fixed (Budget Financial Resources : A3 and B3) and variable (fees, consultance and lump-sum) remunerations. As a result of this programming a mismatch has grown between supply and demand for MRI examinations. Since 2009, the Permanent Audit has observed an annual increase in the number of MRI examinations of about 7%. As these additional examinations have to be performed with the same number of machines, the existing MRI capacity is overcharged, creating waiting lists ranging from 2-3 weeks to 2 months, depending on the case-mix and regional location of the hospital with other MRI facilities available in the area. A systematic long waiting time is both for doctors and patients difficult to accept. That?s why many requesting physicians often opt for a suboptimal alternative. Another determining factor, besides the waiting time, is the accessibility of MRI. Prescribing physicians in hospitals without MRI facility prefer an alternative examination in their own hospital over an MRI examination at another hospital (patient transport, waiting lists?). However, this alternative mostly happens to be a CT examination, a technique which is not subject to any programmed limitation in Belgium and, therefore, is abundantly available. Although, in accordance with the Guidelines, CT can be a viable alternative in some cases, it causes an extra radiation load for the patient, despite substantial (financial) efforts for dose-reducing programs.

2.D.2. BELMIP initiatives

2.D.2.a. Mapping of the current (heavy) equipment

In order to allow for targeted measures to be taken regarding expensive equipment or equipment with high radiation load (in terms of safety, quality of care delivered and the related funding), it is important that these can be ?physically? identified and cataloged. To this end, a register of medical imaging equipment will be set up, i.a. regarding CT and applications for hybrid imaging (PET-CT, SPECT-CT and in the future possibly PET-MRI). This register will be maintained by the FPS Public Health. For this kind of equipment a number of elements needs to be registered, such as the type of equipment, commissioning date, possible relocation and decommissioning of equipment, the average radiation dose and dose reducing measures (eg. iterative reconstruction). The set-up of this register requires the creation a legal basis, which should also admit the registration of outpatient services and machines.

Registration will be useful for the concerned authorities, each of them within their competence. For instance, in the context of reimbursement by sickness funds, the registration will need to be stated; acts performed with unregistered equipment shall not be charged to the patient or to the health insurance. The same applies to safety checks and accreditation procedures.

2.D.2.b. Moratorium on the number of CT scanners

As CT scanners produce a high radiation exposure, a moratorium on the number of these devices should be set, in particular for equipment producing high radiation exposure. Installation and replacement of CT units should only be allowed with a specific permission, in which the radiation impact of these units is taken into account. The moratorium should also apply to the so-called hybrid devices in which a CT technique with high radiation load is integrated. To that end, a definition of "high radiation exposure" will have to be created.

Article 55, whether or not combined with Article 60, of the Belgian coordinated hospital law, provides a legal basis for the introduction of a moratorium. In order that this moratorium would effectively be observed, any reimbursement of acts which are performed with units that are set up in disregard of the moratorium will be excluded.

2.D.2.c. Controlled deprogramming of the number of MRI units

With a view to a more optimal use of the Guidelines and to reduce the average radiation exposure of the Belgian population, in addition to a moratorium on the number of CT units, an increase in the number of MRI units is anticipated, including units with higher field strength. This plan will be based on an adjusted programming and take into account the technical evolution of these units.

The shift from CT to MRI must be a budget neutral operation, in accordance with the policy plan of June 12, 2012. This involves that an extension of the MRI park should not lead to a budget overrun, but that the freed-up budget (due to the correct use of the Guidelines) will be reinvested in techniques offering higher quality and better radiation hygiene.

With that intent, for the years 2015 and 2016 12 extra units will be included in the programming, of which 7 in Flanders and 5 in Wallonia. These extra units will be conceded to hospitals that currently don?t have an MR scanner, in order to allow an optimum shift from CT to MRI examinations.