The use of innovative procedures in hospitals depends to a large extent on whether a NUB fee can be negotiated. After reviewing the appropriate remuneration, the InEK assigns a status to each submitted procedure. Parallel to the NUB enquiry procedure, there has been an early benefit assessment for high-risk products by the G-BA since 2016. In addition, all NUBs assessed with status 1 and 4 are subjected to a brief appraisal by the Medical Service of the Central Association. These assessments are used in the fee negotiations between payers and service providers.
Assignment of status by the InEK
The InEK evaluates the submitted NUB applications by the end of the year and assigns them a status. These are published in January of the following year.
The InEK assigns the following statuses to all applications received on time:
Status 1: Criteria of the NUB agreement of the contracting parties fulfilled.
In plain language: The hospital can now enter into negotiations with the payers.
Status 2: Criteria of the NUB agreement of the contracting parties not fulfilled.
Plain text: Negotiation with the payers is therefore excluded because criteria are not fulfilled or reimbursement is available.
Status 3: Not fully processed within the set deadline.
Plain text: No longer exists in reality -> see graphic below!
Status 4: Criteria of the NUB agreement for evaluation not sufficiently presented.
Plain text: The InEK was not able to make a conclusive statement. In justified individual cases, it is possible for the hospital to negotiate a remuneration level with the payer.
Reasons for non-negotiability
The exact reasons that led to a negotiable or non-negotiable status allocation are not communicated.
The German Hospital Institute (DKI) prepared an expert opinion on behalf of BVMed on the topic of “Entitlement and reality of budget negotiations for the implementation of medical technology innovations” and summarised the following reasons:
- Appropriate remuneration of the requested procedure within the currently valid G-DRG system could be proven.
- The CE marking of the product to be used for the procedure was not completed at the time of the application.
- The benefit could not be sufficiently proven / lack of evidence.
- Justification of the novelty of the procedure was not sufficiently described (differentiation from the standard procedure).
- The number of cases is too small.
- There is a restriction to certain centres with corresponding specialisation.
to the DKI report (german version)
What follows after the NUB application procedure?
If a NUB application has been evaluated with a correspondingly positive status, this will normally remain until integration takes place.
As a rule, a positively rated NUB (after approx. 3 years) is automatically integrated into one of the reimbursement mechanisms of the G-DRG system.
In most cases, reimbursement is made by way of a lump sum (DRG). The data generated during this time is the basis for the calculation / development of the system.
Reimbursement of the DRG can be made in various ways.
- The costs of the new procedure could be included in the DRG on the basis of the data. Reimbursement is made via the adjusted relative weight of a DRG.
- The OPS code is used as a trigger and can lead to a higher-rate DRG.
- There is a redesign/differentiation of existing basic DRG groups.
The list of therapies/procedures which result in an additional fee can be found in the fixed-price catalog (FPK) of the respective year. This is usually done for particularly expensive therapies. The award of an additional fee is rarely made. An additional charge is almost always linked to the use of an OPS. These OPSs are shown in the FPK in connection with the supplementary charge.
NUB fee negotiation with the payers
Only those hospitals that have submitted a NUB request for the new examination and treatment method within the defined period can enter into NUB fee negotiations with the payers at the state level if NUB status 1 or 4 is assigned.
The approved NUB fee is valid for one year and must be reapplied for and negotiated annually until integration into the aG-DRG system.
Note: A positive assessment of the new examination and treatment method does not automatically lead to a successful negotiation between the service provider and the payer (health insurance fund). The CE mark (minimum criterion for opening up the hospital market) as well as the assessment by the InEK do not prove the evidence of the new treatment method to be introduced!