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The German healthcare market is the largest medical device market in Europe and the third largest in the world, taking about 10% of the global medical technology production after the US (approximately 40%) and China (approximately 11%).
The German system is also one of the most cost sensitive markets, that is why the Reimbursement of therapies using innovative medical devices is one of the key factors for a successful Market Access.
To understand the importance The following three sections will answer the questions:
Why is Reimbursement mandatory for medical device manufacturers in Germany?
It is mandatory to achieve Reimbursement for your product and its medical technology if you as a medical device company want to be successful on the German market. This is mandatory because more than 99% of the 81 million German population have a mandatory (statutory) health insurance. This means that 99% of the population and therefore potential patients do not even receive an invoice of the medical treatment as all necessary medical treatments are covered by the payers (the health insurances). It is important that the cost and expenses for medical technologies and devices are reimbursed and payed for by the insurance.
The healthcare market covered by health insurance funds is referred to as the primary healthcare market. It is by far the largest health market in Germany. All therapies, technologies and treatments deemed necessary are covered by the payers on the first healthcare market. Only services and methods deemed not necessary, ineffective and inefficient for medical purposes can be offered directly to the patient for out of pocket payment. This so-called second healthcare market includes over-the-counter medicines, individual health services, fitness and wellness, sports, leisure, nutrition, living and health tourism. A medical device can only be successful on the German healthcare market if coverage (reimbursement) is obtained and the products can be sold on the first healthcare market. Specific reimbursement for medical products is the central requirement for successful market adoption in Germany.
What is needed to achieve Reimbursement in the German healthcare system?
The German healthcare system has strongly regulated reimbursement processes for medical devices. The regulations and the starting point to achieve the specific reimbursement are unique to each healthcare segment, product and indication. In addition to this strongly regulated process, there is enough space for decision makers to have an influence on the result of a reimbursement process one way or the other. This means that the implementation of a specific reimbursement for medical devices can only be achieved with an experienced local expert team, with specific language skills and a strong network to decision makers and payers. These local experts will help you to navigate through the reimbursement landscape and achieve specific reimbursement for your device.
The Reimbursement processes are mainly defined by a range of structural application processes related to annual deadlines. On the one hand this means that there is a clear pathway how to achieve a sufficient Reimbursement and on the other hand these processes take some time and cannot be by-passed.
One exception is the well-known NUB-process, which, if successful, can mean important benefits for patients, providers and the industry.
Typically, a specific tariff or code (e.g. OPS-code) can be achieved within a period of three to five years if started early enough (before launch and CE-approval).
How can Reimbursement be achieved in the German healthcare system?
If studied carefully, the uncountable regulations unveil the appropriate process and the alternative activities needed to achieve specific Reimbursement. Especially in the inpatient sector, a compensation for a treatment in the hospital might already exist. Whether this is the case and if the Reimbursement is already sufficient can be explored with an appropriate analysis.
A Reimbursement analysis is a complex multistage procedure and in many cases the first relevant project to define the starting point for further navigation activities for the Reimbursement landscape in the German health system. This analysis might clarify if a Reimbursement already exists, whether and how it is generally achievable and how much time and effort might be associated with it. The results of the analysis gives youvaluable information, especially for medical manufacturer start-ups and their investors.
In addition to the numerous different application procedures such as the NUB-process, OPS-code application, DRG proposal, DiGA application, medical aid catalogue (HMV) application and other, a multitude of different possible activities and projects in the areas of Market Access, evidence, economics and external affairs are also available to support the successful achievement of a specific medical devices and technologies Reimbursement in Germany.
The Reimbursement schemes of the outpatient sector are completely separate and the regulatory requirements differ from treatments in hospitals (the inpatient sector).
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