NUB Application – Basics
The NUB request procedure (or NUB application procedure) is used for the temporary remuneration of new examination and treatment methods which, due to their novelty, have not yet been included in the calculation of the existing aG-DRG system and are therefore not remunerated appropriately. Additional NUB fees therefore serve to compensate for innovative methods that are not yet part of the SHI service catalogues.
Did you know?
New examination and treatment methods (NUB) are new and innovative drugs, medical devices and procedures that can be used by the hospital, i.e. inpatiently on the patient, before they are billable via DRG or additional fees.
In order to be able to integrate new examination and treatment methods into the G-DRG system, the NUB request procedure was introduced for the first time in 2005. For this purpose, NUB requests (InEK) can be submitted within a certain period of time.
In principle, NUBs are subject to the economic efficiency principle. Additional costs are only negotiable if they show a verifiable additional benefit that is considered sufficient, appropriate and economic.
NUB for medical devices
The prerequisite for the NUB request procedure is the completed approval procedure (CE) for medical devices. Once the CE marking for medical devices has been obtained, it is possible for the inpatient sector to use these products. In principle, the “permission with prohibition reservation” applies here. This means that the use of the product is possible at the discretion of the medical staff as long as the Joint Federal Committee (G-BA) has not explicitly excluded it from care.
If the medical product or the underlying procedure has the potential to improve the existing standard of care, this must first be proven according to the criteria of evidence-based medicine. In order to keep the contributions of the insured stable in the long term, only those procedures are reimbursed or negotiable via a NUB Entglet in accordance with the efficiency requirement that show a verifiable added or additional benefit in comparison to established procedures. From 2016, this additional benefit will also be examined by the G-BA for procedures with medical devices of high risk classes (§ 137h SGB V).
NUB for medicines
In the case of medicinal products, imminent approval (EMA – ideally within half a year after 31.10.), as well as significant additional costs that are not reflected in the G-DRG system, are essential criteria for an application. Here, too, there must be a verifiable additional benefit for patients, which is described in the course of the AMNOG process.
What is a NUB application?
The NUB application procedure serves to close the systemic gap, which consists of the incorporation of innovative medical products into the G-DRG system. This usually takes three years. Submitting hospitals must record the so-called NUB charges for the new examination and treatment method in the annual budget negotiations, as long as the application has been assessed by the InEK with a corresponding status.
This can be done in the context of annual budget negotiations, but also in an isolated NUB negotiation, e.g. at the beginning of the year. NUB charges are extra budgetary and represent the possibility for the hospitals to generate additional, so-called extra budgetary revenues.
Who may submit NUB requests to the InEK?
Since the introduction of the procedure in 2005, it has been the exclusive responsibility of service providers to submit NUB requests to the InEK for innovative procedures without appropriate remuneration.
Only those service providers who have submitted a NUB request for a new examination and treatment method within the defined period can enter into the final fee negotiations with the payers at Land level if the response is positive (status 1 or 4).
Submission deadlines of the NUB enquiry procedure
The request must be submitted annually from the beginning of September to 31 October via the InEK data portal by the service providers who wish to use the new procedure.
In the case of a repeated request for a NUB from the previous year, it is advisable to wait for the publication of the DRG catalogue. If the new examination and treatment method has been transferred to the aG-DRG system and thus to the SHI benefit catalogues, a new request is not necessary.
At the end of January of the following year, the requested methods are published by InEK, stating the status and the number of submitting hospitals.