NUB application
Creation
NUB inquiry procedure
Content and structure of a NUB request
The content of a NUB request (application) must provide information about the methodological approach of the new procedure, if possible in differentiation from standard care. In particular, the substantiated justification of the inappropriate remuneration via the currently calculated aG-DRG system must be plausibly elaborated.
Description
In addition to a concise abbreviated name, it is requested that plausible information be provided on the mode of operation/application, technique, materials/quantities, mechanism of action, active ingredient, dosages, frequency and duration of use, etc. The OPS must also be used to code the procedure. Furthermore, the OPS with which the procedure is currently coded must be indicated. If there is no coding option, the procedure must be described. Since 2016, there have been extended queries based on the high-risk classes.
Method details
This information is the core of a NUB request and therefore requires special attention. First, the patient clientele that is to benefit from the NUB is queried here. If one or more DRGs are already known that can be associated with the requested NUB, these must also be named. In the further course, the previously established procedure for the treatment of the aforementioned patient group, which will replace or supplement the NUB, is to be described. In order to meet the criteria of the NUB procedure, it is necessary to differentiate it from existing procedures for the treatment of the indication of the product. In addition, it must be explained why, from the applicant’s point of view, this is a new and innovative procedure. Furthermore, an assessment of the influence of the course of treatment on the length of stay must be made, if possible with sufficient evidence and justification.
Key figures
In addition to the request for the date of approval of the medical device, the applicant is asked to provide information on the number of treatments performed retrospectively. This information is not mandatory. However, it is mandatory to provide information on the date of introduction, the planned number of patients in the application year and an estimate for the following year.
Additional costs
The most important criterion is probably the expected additional costs. Here, the most accurate and well-founded information possible must be provided. If possible, this should be in contrast to the current procedure with which the patient clientele has been/is being treated to date. These should be separated into personnel and material costs. Additional expenses can be, for example, extended operating times, higher qualification of the personnel to be employed, operation, additional personnel, the dosage of the drug, the administration of additional drugs to support the treatment success of the new method, material costs, implant costs or similar.
In our book “The aG-DRG System – Complex, Logical… and Fair?“, the query points as well as the criteria and evaluation bases are explained in detail.
Further information
Integration of external support
Basically, the desire to use a new examination and treatment method arises in the provision of services. Thus, the request must also be made to this institution. Particularly when preparing NUB requests based on innovative approaches, the service providers are dependent on the cooperation of the manufacturers/specialty societies when formulating the request.
Here, the manufacturer can evidently provide the information already available, such as indication area, active principle, delimitation or contraindications. It is important that the procedure and not the product is the subject of the inquiry.
In addition to the comprehensive information on the procedure, the calculation as well as the well-founded argumentation on the cost under-recovery is decisive. This is because the purpose of the NUB request is precisely to compensate for this.
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,
- that only have a specific OPS after July 23, 2015
- or which are based on a new theoretical scientific concept
underlying.
NUB criteria
The exact reasons that led to a negotiable or non-negotiable status allocation are not communicated by InEK. In principle, some criteria can be summarized that stand in the way of a negotiable status award:
- Appropriate reimbursement of the requested procedure within the currently applicable aG-DRG system could be demonstrated.
- CE marking / approval (EMA) of the procedure or the active ingredient, is not expected for the requested year.
- The benefit could not be sufficiently proven / lack of evidence.
- Justification of the novelty of the procedure was not sufficiently described (differentiation from standard procedure).