Intro to the medical device reimbursement system in Germany

A high level overview of the rather complex medical device reimbursement system in European's biggest market

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Yes, it can seem like a maze. Reimbursement systems are notorious for being difficult to navigate, always changing and with timelines for approval being very long, they are not necessarily every medtech marketers favourite topic. Thankfully, there are highly qualified reimbursement experts in each market who will be more than happy to help you. You will need a basic understanding nevertheless, so you can actually understand what your (rightfully expensive!) reimbursement consultant is trying to explain. Let's have a look at Germany!

First things first: Your device needs to be compliant with the European Medical Device Regulation (MDR), meaning it needs to have a CE-mark.

Contrary to other European countries, the German health system is not solely governed by the government in Germany. It follows the principle of the shared self-governance, meaning it includes several stakeholders (e.g. patient associations, payers, physicians etc.). Their main committee is called "G-BA" which is funded by the ministry of health. The G-BA has several organizations with experts helping them. At the end of the day, the G-BA has the say when it comes to accepting new treatments and devices into general reimbursement.

In Germany about 90% of people are insured by one of the insurers offering the general health insurance which is mandatory by law. So as a medical device manufacturer, you want to get reimbursement with the general health insurance.

Here is when we come to the split between procedures being performed in hospitals and in ambulatory settings. For procedures in hospitals procedures are allowed and reimbursable, unless it is forbidden. In the ambulatory setting procedures are forbidden and not reimbursed, unless it is explicitly allowed. Makes sense in most cases, hospitals are places of last-resort medical care so physicians should be able to perform any procedure necessary to help.

To be allowed and reimbursable in the ambulatory setting, the G-BA assess & approves the procedures/devices medical usefulness and economic viability. And this might take a while. Depending on weather the device is seen as a completely new method (longer time frame) or a new service within an existing method (not as long), it takes between 3-5 years to get your application ready, liaise with the G-BA and for them making a decision with the inputs from all their stakeholder groups and expert committees.

This is a gross simplification so of course! E.g. ambulatory reimbursement is not just a yes/no decision, the G-BA will also have to come up with a reimbursable amount (which will vary by state). Same goes for the reimbursement of procedures in hospital. But the main steps are described.

There are two ways to get an ambulatory reimbursement for your device at least for parts of the market if you can't wait that long or while you wait that long:

1. Single-case applications in which physicians need to argue for an individual patients with their specific health insurer to get the device/procedure reimbursed because it offers unique medical benefits. Health insurers do not like to do that at all. Success rates are <5% on average.
   

2. Selective contracts which groups of physicians/hospitals/surgical centres have with selected health insurers. Physicians do that because they think a device is beneficial or because they feel they can differentiate themselves. Health insurers do this for the same reason or (happens more often) because they can safe cost (e.g. because the same device is reimbursed a lot higher in the hospital setting). Medical device manufacturers can get into these negotiations to get their device into these contracts too.

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So this is it already. I tried to keep it short and understandable. Please let me know your thoughts and experiences with reimbursement systems and if you'd like to get more detailed information on Germany's reimbursement system.