1. The Problem: The Reimbursement Catch-22
Just as in the US acute care hospital inpatient stays are reimbursed according to Medicare Severity Diagnosis Related Groups (MS-DRGs), in Germany they are reimbursed according to German Diagnosis Related Groups (G-DRGs).
In both cases, if your new device does not fit into an existing DRG, the hospital may not get paid for using it and thus may not want to use it. On the other hand, forming a new DRG code for your device (in the US or in Germany) requires data collection of procedure utilization. But since your device doesn’t currently fit into an existing DRG, hospitals are reluctant to use it, and therefore it will never reach sufficient utilization to justify the creation of a new DRG code.
Sounds like a Catch-22, right?
To encourage entry of new and innovative technologies into the German healthcare system, there is a short-term, intermediate reimbursement mechanism that provides hospitals with the required financial incentive to use a new device, before it is properly reimbursed under the G-DRG system. Utilizing this shortcut to reimbursement can significantly shorten your time-to-market.
2. The German G-DRG System
The German DRG system, or G-DRG system, groups several parameters, such as the patient’s main and sub diagnosis (using ICD-10 diagnostic codes), performed procedures (using OPS procedure codes) as well as additional characteristics including the patient's age, complications and co-morbidities into a single G-DRG code and assigns each code with a price tag.
The G-DRG system is a "leaning system," relying on quantitative data supplied to the Institute for the Hospital Payment System (InEK) by approximately 250 reporting hospitals throughout the year. The data gathered during one year is typically applied in the catalog two years later (e.g., data from 2024 is applied to the 2026 catalog).
3. NUB Reimbursement
Article 6.2 of the Hospital Remuneration Law (KHEntgG) allows hospitals to submit requests for reimbursement of "new and innovative diagnosis and treatment methods" (NUB) that did not obtain a G-DRG code yet.
It should be emphasized that the device manufacturer is not the one applying for NUB reimbursement. Mediclever typically assists the manufacturer in preparing the application, and then each relevant hospital receives a copy and submits it on its own.
3.1 Required Criteria
- The new and innovative method affects several existing G-DRGs.
- The method can be clearly defined.
- The cost of using the method affects the cost structure of the relevant procedure and the overall hospital cost structure.
- The requesting hospital's financial situation would be worse if the request is rejected.
3.2 The Application Process
Any hospital interested in NUB reimbursement must fill out a request via the InEK data portal. The application must be submitted by October 31st and provide information regarding the substituted (old) method, date of first applying the new method, and a cost analysis comparing the old and new methods.
InEK checks all submitted applications and replies with a value of 1 to 4 by January 31st:
- Value 1: The method meets requirements. The hospital can negotiate a reimbursement rate with local Sickness Funds.
- Value 2: Requirements not met. No negotiation allowed.
- Value 3: InEK overloaded; hospital may proceed with negotiations with interested Sickness Funds.
- Value 4: Application unclear. Hospital may still attempt to negotiate with interested Sickness Funds in specific cases.
3.3 Benefits and Disadvantages
3.4 Statistics & Market Reality
4. Summary
Frequently Asked Questions About NUBs
What is the NUB deadline?
Applications must be submitted to the InEK by October 31st each year.
How long is a NUB agreement valid?
Agreements are typically valid for one calendar year and must be renewed unless the method is integrated into the G-DRG system.
Can multiple hospitals apply for the same device?
Yes. In fact, having more hospitals apply often signals stronger medical adoption to the InEK.
Medical Device Reimbursement Services by Country
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