Happy with your knowledge on the reimbursement of medical devices in Germany?

Hello again, and welcome to the second post in the 3-part series on reimbursement. Last week, we focused on the reimbursement of drugs in Germany, so this time we move on to medical devices. In this post, you’ll find out about:

If you want to find out more, have a look at the additional reading as well.

Next week, we’ll round up the reimbursement series by looking at private health insurance compared with SHI.

In Germany, non-drug interventions, i.e. medical devices, are assessed within the context of the treatment method. The reimbursement of methods and thus medical devices by SHI funds differs for outpatient and inpatient care.

Reimbursement of medical devices in Germany – Outpatient care

If a method does not fall within an existing reimbursement code, then the G-BA needs to first assess the method and determine that it

  • has a benefit for patients,
  • is required, and
  • is economical,

in order for SHI funds to cover specific methods used in outpatient care.

Then, the evaluation committee of physicians and the SHI funds need to agree on the amount of reimbursement and add the method to the EBM.

Only then, SHI funds have to cover the costs. This process of requiring approval first is known as “reservation for approval” (“Erlaubnisvorbehalt”).

However, SHI funds are free to offer and reimburse additional outpatient methods for their insured population, unless these methods have been explicitly excluded from reimbursement by the G-BA. Examples of such special offers by SHI funds are vaccinations or IVF treatments.

Reimbursement of medical devices in Germany – Inpatient care

Methods used in inpatient care can be offered and are reimbursed by the SHI funds through the G-DRG unless they have explicitly been excluded from reimbursement by the G-BA. The directive “hospital treatment methods“ lists all excluded hospital methods.

This is the opposite of the process for outpatient methods. It is also described as “reservation for prohibition” (“Verbotsvorbehalt”). This means SHI funds have to reimburse all methods and medical devices used in the hospital setting from the point they become available in the German market, until or unless the G-BA determines that they are excluded from reimbursement.

In order to decide whether to exclude a method, the G-BA assesses the benefit of a method. If the G-BA sees no benefit (yet), it will then determine whether there is the potential of showing a benefit in the future. In that case, the G-BA will outline the design of so-called testing studies (“Erprobungsstudien”). The G-BA will then initiate these studies to get clarity on the benefit.

Exceptions

As always, there are some exceptions to the strict rules. In very specific cases, the SHI funds will also have to reimburse the use of a method, even if the G-BA had excluded it. According to a ruling from December 2005, basic rights mean that the G-BA or SHI funds can’t exclude a person with statutory health insurance from receiving treatment with a method, if

  • they have a life-threatening and generally fatal illness,
  • a generally recognized medical standard treatment is not available,
  • the chosen method shows some prospect of a cure or a noticeable positive effect on the course of the disease.

Reimbursement within the DRG

As mentioned above, hospitals can treat patients with novel methods as soon as they become available. The treatment is reimbursed by SHI funds through the G-DRG system. The German DRG, or G-DRG, dictates a flat fee for reimbursement based on the diagnosis for each admitted case. This flat G-DRG fee also includes the costs for drugs and medical devices. Therefore, when a manufacturer introduces a new innovative (and likely costly) drug or device into German hospital care, the existing G-DRG for that diagnosis often does not sufficiently cover these additional costs. This means the hospital compensation is not appropriate. Therefore, hospitals can request additional funding, called “Zusatzentgelte” or “NUB-Entgelte”, so they are able to offer these treatments to their patients without a financial loss.

The InEK decides on these applications. For methods that are using high-risk medical devices, the InEK will ask the G-BA to conduct a benefit assessment. These so-called NUB assessments are entirely based on the data provided by the hospitals. The G-BA or IQWiG won’t conduct a systematic review and evaluation of the evidence.

NUB method assessments 2021

In 2021, hospitals requested additional funds for 6 methods using high-risk medical devices. These are:

  • Minimally invasive left ventricular reconstruction in heart failure using an anchoring system
  • Transcervical radiofrequency ablation with intrauterine ultrasound guidance in uterine fibroids
  • Endoscopic injection implantation of 32P microparticles in irresectable, locally advanced pancreatic tumors
  • Use of a stent retriever to treat cerebral artery vasospasm after subarachnoid hemorrhage
  • Transvascular, transcatheter-assisted implantation of an aortic valve for the treatment of aortic regurgitation and aortic stenosis
  • Use of normothermic and pulsatile organ preservation with function monitoring in liver transplantation

The G-BA will check whether the requirements for a benefit assessment are fulfilled, and then they’ll publish their decision within 3 months. If sufficient research results are not yet available, the G-BA initiates a testing study or awaits the results of already ongoing studies on the subject.

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Anja Pownell

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