As far as ambulatory treatment is concerned, the therapeutic and diagnostic methods used are subject to authorisation from the respective authorities. This means that innovative medical procedures and products do not become part of the statutory health insurance (SHI) reimbursement system until they have been officially examined and approved essentially on the basis of their application. This is where the Federal Joint Committee (G-BA) plays a decisive role. The G-BA carries out a benefit assessment in order to determine the benefits of the method and whether it should become an integral part of SHI remuneration. Benefit assessments can take several years. Different rules apply to certain medical products (notably medical aids, drug-like medical products, wound dressings) and in some cases also application procedures initiated by manufacturers.

Quite the opposite applies to the reimbursement of inpatient treatment. In this case, innovative procedures are permitted with so-called reservation of prohibition. This means that an innovative diagnosis and treatment method may in principle be applied by hospitals as long as it has not been excluded by the G-BA in accordance with § 137c SGB V.

Reimbursement of hospital services by the health insurance funds is based on the German Diagnosis Related Groups system (G-DRG system). It goes without saying that the hospitals have to adhere to certain principles. Basic quality and profitability requirements must be met. The method must also have the potential to be a valid alternative to the current standard.

Every autumn, all hospitals are given the opportunity to submit requests for reimbursement of “new and innovative diagnosis and treatment methods” (NUB; Neue Untersuchungs- und Behandlungsmethoden) that have not yet obtained a G-DRG code to the InEK, the Institut für das Entgeltsystem im Krankenhaus (Institute for the Hospital Remuneration System), which subsequently checks whether the method is already properly remunerated as part of the existing DRG pricing system and whether it is in principle a “new and innovative diagnosis and treatment method”. If the method meets InEK criteria, it is given status 1 and the InEK recognises the method as NUB. The following year, the hospital may negotiate with insurance companies regarding additional charges for the method.

From experience we can say that it takes between three and five years to adjust DRG codes. The lengthy delay is down to the following: an OPS (operation and procedure key) has to be submitted in order to generate a corresponding code. OPS codes represent therapy and diagnosis methods that are used for patient treatment. The German Institute for Documentation and Information (DIMDI) maintains the OPS catalogue and adds new entries every year. If the proposed code becomes part of the OPS catalogue during annual revision, hospitals can use this code for documenting the methods used and for billing patient treatment. In addition, the InEK assigns the new OPS code to one or more DRG base rates. The InEK works with a number of hospitals that voluntarily collect patient-level cost data. These hospitals provide the InEK with information about the real case costs associated with patient treatment, case numbers, diagnosis and procedures carried out on the basis of the OPS codes.

This data is analysed by the InEK the following year, and the corresponding DRG-based payments are adjusted the year after. This means that data gathered during 2015 is applied in the 2017 catalogue. If, however, the hospitals that collect patient-level cost data do not have enough cases and data, it may take longer, sometimes several years before the InEK can calculate valid costs for the respective method. During the period that the innovative method is not properly represented in the DRG base rates, any hospital that wants to use such a method and have it covered completely, needs to submit a request for NUB reimbursement to the InEK and negotiate the hospital-specific additional charges for the method with the cost bearers at a later stage.

Up to around 700 different NUB reimbursement requests have so far been submitted on an annual basis. Around 25% of these have been given positive status, i.e. status 1. 

From experience, I would say that it makes sense to start dealing with the issue around a year before CE certification is planned. Especially in cases when the start-ups plan to start commercialising their products immediately after obtaining the CE mark.

In any case, it is important to deal with the issue at a very early stage, find out how everything works and which clinical evidence is needed. As I see it, it's also important to find out what needs to be done in order to guarantee that the end customers can actually get the product/procedure reimbursed. Furthermore, the start-up can already start looking at the markets that it wants to serve and how the reimbursement systems of these markets are structured.