Abstract

The National Institute for Public Health and the Environment (RIVM) of the Netherlands and the Dutch National Health Insurance Board (CVZ) have collaborated to formulate an assessment framework for the decision-making process involved in reimbursing medical devices. This framework enables the CVZ to systematically assess whether or not certain devices should be included in the basic social healthcare insurance package. The CVZ then advises the Dutch Ministry of Health, Welfare and Sport (VWS) of its assessment. The framework also provides insight into the requirements to be met by reimbursement applications. Medical devices falling within this framework are those providing assistance to handicapped persons and the elderly, such as a rollator.
The stakeholders in the Dutch healthcare system, from users to manufacturers, have divergent interests in terms of reimbursing healthcare costs. These interests can be scientific, economical, social or ethical in nature. To do justice to this diversity of interests, the CVZ assesses all forms of care provision against four principles: necessity, effectiveness, cost-effectiveness and feasibility.
For assistive devices, these principles have been elaborated upon in detail in a questionnaire, which is used by the CVZ to systematically assess if the device requested is eligible for reimbursement according to established standards. A set of guidelines has also been compiled for manufacturers of assistive devices, which present the information to be provided to CVZ with any application for the inclusion of a device in the basic healthcare insurance package.
The assessment framework as presented is supported by information gathered from a literature survey, meetings with healthcare experts and the experiences of healthcare systems in other countries.