Criteria for health insurance coverage

(The Health Insurance Act covers various health care activities, such as patient accommodation and transport, but also oral care, for example. The following relates to health care and products provided by medical specialists and general practitioners. )

For a full implementation into the Dutch health insurance system two branches will need to be covered:

The care solution should fall under the insured care, so should meet the criteria set for Dutch health care. The question that needs to be answered is: do we, as a society, want to cover the costs of this care within the basic health care package? The main responsibility in supervising this question lies at the Zorginsituut (ZiN).
The care solution should fit within the administrative system. Meaning it should have the right labels and identifiers linked to it, such that the care giver can use these labels and identifiers to declare the costs to the insurer. The responsibility in supervising the administrative labels lies with the NZA.

Key messages

Below, general information is provided on reimbursement criteria and the system that is set up to assess these. The main advice that stems from this information:

Make sure you have sufficient and appropriate evidence of the clinical benefit. The following questions will need to be answered:

Which target group is the intervention aimed at?
What is the current standard of care; With which intervention should the intervention to be assessed be compared?
Which outcomes are considered crucial/important and should therefore be included in the comparison?
Is the outcome of the comparison (the relative effect) large enough (i.e. is the outcome clinically relevant)?

Make sure you have sufficient and appropriate evidence of the cost effectiveness of the novel application. ( see also this page on HTA)
Make sure you have medical specialists and patients on your side. Preferably by having support from specialist- and patient associations. If they see the added value and are willing to strive for implementation, this is a compelling argument of the relevance of the innovation. Moreover, medical specialists are authorized to apply for changes in the reimbursement system.
Get familiar with the system and the general rules and involve experts whenever and wherever you can. See also this page.

Experts who can help you on this topic

THINC The Healthcare Innovation Center, part of the UMC Utrecht, offers short-cycle tailor-made research into innovations in healthcare. With a multidisciplinary team of enthusiastic professionals, we evaluate your innovation on, among other things, cost-effectiveness, usability and feasibility. We also provide expert methodological advice. All this to build a convincing portfolio for your innovation. From idea to implementation, we help developers of healthcare innovations move forward

HI-NL is a party that can help innovators that have established a proof of concept to evaluate the potential and the risks of the invention, and if it is considered valuable, helps design the route of validation and implementation. Their approach is based on the inclusion of all relevant stakeholders, in their own words: "Health Innovation Netherlands (HI-NL) is based on the proven fact that early dialogue between innovators and relevant stakeholders improves the value and effectiveness of health innovations. By bringing all relevant innovators and stakeholders together in one place through the HI-NL Round Table service, comprehensive well-structured guidance can be provided to accelerate the introduction of innovations that directly meet end-user needs."

Panaxea (Amsterdam Science Park): "Our goal is to support informed decision-making around innovations to improve health".

Your name here? Please contact [email protected]

The process of including a health care solution in insured care

The health insurance system has a solid foundation of laws and regulations, but that does not mean that the inclusion of novel health care application is a straight, clearly defined path. Zorginstituut Nederland, the institute that provides the Ministery of Health with advice on the basic health care package formulates this accordingly:

“We are faced with the task of striking the right balance between what is socially desirable and what is socially possible when it comes to the composition of the package... Package advice cannot be viewed separately from the context and that is precisely what makes advising on the package much more than a filling-in exercise of technical information about criteria that are as objective as possible... A deliberative process is used, in which every party has a contribution, such as parties in healthcare, the Zorginstituut and its advisory committees. This interactive process culminates in a well-considered advice to the minister on whether to reimburse care from the basic insurance or not.”

Criteria for including a health care solution in insured care: Which care can be insured?

In order to enter insured medical specialist care, an innovation must meet the following criteria:

A. Does the care work for the condition in question? (effectiveness)

B. Are the costs of the care in a reasonable proportion to the benefits? (cost-effectiveness)

C. Is the condition so serious and are the costs of the care so high that reimbursement from the basic package is justified? (necessity)

D. Can society bear the total costs of including the care in the basic package? (feasibility)

Criteria C and D are very much dependent on the application and context. For discussion and examples see Zorginstituut Nederland

For criterium B HTA analyses are important, read more about that on this page.

Criterium A is assessed using the principles discussed below.

Effectiveness: state of science and practice (“stand van wetenschap en praktijk”)

When assessing the effectiveness criterion, it is checked whether the innovation meets "the state of science and practice". (Read more on this topic on the Zorginstituut-website). Briefly put, it is examined whether the effect has been scientifically proven, and if not, whether there is sufficient evidence from practice. Two key concepts are important here: “relative effectiveness” and “Evidence Based Medicine”.

Relative effectiveness is used as a measure for effectiveness

The effectiveness of a care product is determined relative to existing methods. It is checked if the novel treatment policy (diagnosis, treatment), in view of its favorable and unfavorable consequences (side effects, safety), leads to relevant (added) value for the patient compared to standard or usual treatment.

To be able to make that comparison, it is determined:

With which intervention should the intervention to be assessed be compared?
Which target group is the intervention aimed at?
Which outcomes are considered crucial/important and should therefore be included in the comparison?
Is the outcome of the comparison (the relative effect) large enough (i.e. is the outcome clinically relevant)?

The above questions are a good starting point for assessing the situation of your innovation.

Evidence Based Medicine is the foundation in determining effectiveness

The core of Evidence Based Medicine is that the available evidence is systematically sought and selected and weighed and used in a structured manner. The fixed steps in this process are searching and selecting information, assessing the information found and drawing a conclusion.

The evidence for effectiveness can range from randomized comparative research to practical experience. High-quality scientific research has the highest weight in the assessment of the evidence: meaning that a well-designed and conducted randomized comparative study (randomized controlled clinical trial – RCT) is considered evidence of the highest quality.

If an RCT is absent and/or not executable, evidence from practice can be the basis of an assessment, but only under the following conditions:

There are convincing reasons to believe that further research that could increase the quality of the evidence on the effectiveness of the intervention is unlikely to take place;
Professional associations have substantiated soundly and convincingly why, despite the mediocre or low quality of the evidence, they still consider the intervention an effective treatment method for a certain indication. Preferably there is also support from patient associations;
This view from professional associations should be based on broad consensus within/among the relevant associations and formalized in a publication (e.g., in a guideline or consensus document).

Special situation I: the technical variant
Sometimes a new intervention is a technical improvement/variation of an existing intervention, for example a surgical intervention that is performed endoscopically instead of 'open', or an e-health form of an existing intervention that has been proven to be effective. This raises the question: if an intervention is a technical variant, can it be assumed that the variant also belongs to the insured package or is a separate assessment necessary?
ZiN says the following about this on their website: “... it is difficult to give an unambiguous, precise definition of the term technical variant. Nor can it be clearly defined in advance when a technical variant can be equated in terms of effectiveness with the intervention for which it is a technical variant. It will have to be considered on a case-by-case basis whether there is a technical variant and, if so, what that means for effectiveness.”

Special situation II: Medical test (diagnostics)
Special criteria apply for the assessment of medical tests. Medical tests include interventions that establish a diagnosis, prognosis, or prediction about the course of the disease. This may include, for example, blood tests, questionnaires, imaging techniques, etc.
When assessing a medical test, the reliability of the test is of course considered, but the effectiveness is also a criterium. The assessment of medical tests is based on the principle that the test must have a positive effect on the health gain of the person tested. Health gains will not be achieved by merely having a more detailed, or more beautiful picture, but depend on the combination of the test and the treatment strategy. Therefore, effectiveness of medical tests is measured by comparative research between the usual ('old') and the proposed ('new') test-plus-treatment strategy.

The process of including a health care solution in the administrative system

Your product or solution will need to have a “betaaltitel", so appropriate registration based on which the costs can be declared. Step one in this process is to familiarize yourself with the basics of the system. You can use this page as a starting point.

The right registration for the novel care solution

The main label in declaring health care is the care product number (zorgproduct). There are roughly two categories in this; the DBCs and “other care products" as explained here.

Does the health care solution fall within one of the “other care products” categories? Then check if the health care solution falls under current care products, if not a request for a novel care product needs to be filed.
If the care product does not fit within one of the “other care products” categories, it should be covered by a DBC care product. DBC care products are packages of different care activities linked to a specific diagnosis. Therefore, to be included in a DBC two factors should be set correctly: 1) there should be a registered care activity (zorgactiviteit) that describes the health care solution, and 2) there should be a DBC for the relevant diagnosis, that includes the care activity. If one or both are not in place, a request to change a DBC will have to be filed with the NZA.

The process

If current registration cannot cover the health care solution, a change will need to be requested at the NZA. Read more about this process on their website.

Programs and options for early reimbursement of novel health care solutions

The careful and intricate process of admitting novel health care solutions to the basic insurance package can be a lengthy procedure and there are cases that fall outside the set frames of the system. These factors can delay or block the availability of good novel health care solutions. Therefore, there are several options and programs that (financially) support the introduction of innovative health care.

Veelbelovende Zorg

The program “veelbelovende zorg” is intended for relatively expensive care that appears to be effective, but is not reimbursed from the basic package, because it has not been proven that the care is at least as effective as the existing (usual) treatment in the Netherlands. Research into the effectiveness is hampered, because the care is not financially covered, with the result that potentially effective care does not reach the patient. With the financial support through “veelbelovende zorg”, practitioners can carry out the necessary research into the effectiveness and cost-effectiveness of the care compared to existing treatments.

https://www.zorginstituutnederland.nl/over-ons/werkwijzen-en-procedures/adviseren-over-en-verduidelijken-van-het-basispakket-aan-zorg/subsidieregeling-veelbelovende-zorg

Facultatieve prestatie

Healthcare providers and healthcare insurers can apply for other healthcare products for (new) initiatives that are difficult to finance with regular DBCs. For this they can jointly apply to the NZa. Upon approval, a determined performance decision ( vastgestelde prestatiebeschikking) is issued, which can be used for all healthcare providers who want to provide that care. This must be included in contracts between health insurer and care provider.

Conditions:

The application has been submitted jointly and signed by at least one health insurer and one healthcare provider.
The application contains a clear description of the content of the service that is requested.
It must concern regular (ie existing) specialist medical care.
Healthcare providers may only declare the determined optional benefit if agreements have been made about this with the health insurer of the patient in question.
All healthcare providers and health insurers can use the determined optional benefit, provided they have made a contract agreement about this.
Duration time approx. 4 weeks

https://www.nza.nl/zorgsectoren/medisch-specialistische-zorg/registreren-en-declareren/facultatieve-prestatie-medisch-specialistische-zorg

Beleidsregel innovatie van de NZa

The NZa has a policy rule for innovations in healthcare. With this they want to give care providers and health insurers the space to experiment with innovative care performance on a small-scale and within a limited time frame. The objective is to improve the price/quality ratio of care. The innovative care performance can be aimed at:

new or renewed healthcare with a better price/quality ratio;
efficient care organization, including substitution of second-line health care by primary health care;
improving the quality of care for the patient.

Conditions:

Temporary performance: A maximum of 3 years with the option to extend to a maximum of 5 years
Limited scope (specific patient group, a few healthcare providers, a few health insurers or a limited region).
An interim evaluation and a final evaluation.

By submitting the final evaluation, experimental parties can request regular care performance