Create NUB Application
The content of a NUB request (application) must provide information on the methodological approach of the new procedure, if possible in differentiation from standard care. In particular, the well-founded justification of the inappropriate remuneration via the currently calculated aG-DRG system must be plausibly elaborated. The essential basis, like the medical evidence that justifies the increased costs, is the CE marking / approval of the medical product that is to be used for the procedure.
Creating a NUB request – who assumes what?
In principle, the wish to use a new examination and treatment method arises in the provision of services. Therefore, the request must also be submitted to this institution. Particularly in the preparation of NUB applications based on innovative approaches, the service providers are dependent on the cooperation of the manufacturers/specialist associations in the formulation.
Here, the manufacturer can clearly specify the information already available, such as indication area, active principle, delimitation or contraindications. It is important that no product is ever implicated!
In addition to the comprehensive information on the procedure, the calculation as well as the well-founded argumentation on the cost underrecovery is decisive. This is because the NUB application serves the purpose of compensating for precisely this. Here you will find criteria that speak for or against the award of a negotiable status.
Early benefit assessment for medical devices
Based on §137h SGB V, new examination and treatment methods are subjected to an early benefit assessment. These include procedures based on the use of medical devices,
- which were not applied for in NUB procedures before 01.01.2016,
- which are subject to a high risk class,
- which only have a specific OPS after 23 July 2015
- or which are based on a new theoretical scientific concept
In addition to a concise abbreviation, it is requested to provide plausible information on the function/application, technique, materials/quantities, active mechanism, active substance, dosages, frequency and duration of the application, etc. Furthermore, the OPS with which the procedure is currently encrypted, is to be used. If there is no encryption option, the procedure is to be described.
Since 2016, there have been extended queries based on the early benefit assessment for medical products of the high-risk classes.
This information represents the heart of a NUB application and therefore special attention is needed here. First, the patients’ questionnaire, which is to benefit from the NUB, is requested here. In case one or more DRGs which can be associated with the requested NUB are known, these are also to be mentioned. In further course, the previously established procedure for the treatment of the aforementioned patient group, which will replace or supplement the NUB, is described. In order to meet the criteria of the NUB procedure, it is necessary to draw a distinction from existing procedures for the treatment of the indication of the product. In addition, it is necessary to explain why, from the applicant’s point of view, this is a new and innovative procedure. Furthermore, a justified assessment as far as possible is to be made to influence the course of treatment on the duration of the stay.
This information is not obligatory. However, it must be specified individually by the hospital. In addition to requesting the date of admission of the medical device, the applicant is requested to provide information on the number of treatments already carried out. An estimate for the following year must also be made.
A key criterion is the costs that have not yet been properly covered. A detailed description of the expected costs should be provided. If possible, this should be in line with the current procedure with which the patient has been treated so far. These must be separated according to personnel and material costs. Additional expenses may include, for example, prolonged operating times, a higher qualification of the personnel to be deployed, additional staff, the dosage of the drug, the administration of additional drugs to support the treatment outcome of the new method, implant costs and so on.
If the application does not correspond to the formal data or if the required information is missing, the application is disqualified and not processed further!
The individual fields, which are necessary for a detailed description of a NUB application, can be viewed free of charge in the NUB exchange on the online platform reimbursement.INFO.