NUB application
Basics
NUB inquiry procedure
New examination and treatment methods (NUB)
The NUB inquiry procedure (colloquially referred to as NUB application) is used for the temporary reimbursement of a new examination and treatment method which, due to its novelty, has not yet been included in the calculation of the existing aG-DRG system and is therefore not appropriately reimbursed. It therefore closes the systemic gap that exists until innovative medical products are included in the G-DRG system. This usually takes three years.
Additional NUB fees thus serve to compensate for the costs of medical and therapeutic procedures that are not yet part of the SHI service catalogs and thus have not yet been or could not be transferred to standard care.
They are therefore extrabudgetary and are not included in the calculation of the reference value. The InEK therefore checks each year whether the data collected are sufficient to transfer a NUB to standard care (DRG or ZE).
For data collection, an OPS code is mandatory, which is generated automatically for each NUB with status 1 or 11 without sending out an OPS proposal. This is done via an internal process between InEK and BfArM.
⇒ For all procedures that have received a NUB status of 1 or 11, it is therefore not necessary to send an OPS proposal to the BfArM or a ZE proposal to the InEK!
Submitting organizations
The submission of NUB requests is the sole responsibility of the service providers. That is, the hospitals that plan to include a new examination and treatment method in their service portfolio. In principle, only those hospitals that have submitted an inquiry to the Institute for the Hospital Remuneration System (InEK) within the defined period can enter into NUB fee negotiations with the payers at the state level.
Deadlines
Submission takes place annually via the InEK data portal within the following periods:
- NUB-DRG: beginning of September to October 31
- NUB-PEPP: beginning of September to October 31
- NUB-ATMP: beginning of September to April 30
Note: In case of a repeated request for a NUB from the previous year, the publication of the fee per case catalog should be awaited. If the new examination and treatment method has been transferred to the aG-DRG system and thus to the SHI service catalogs, a new inquiry is not necessary.
At the end of January of the following year, the InEK publishes the requested methods, indicating the status and the number of submitting hospitals.
NUB for medical devices
The prerequisite for the NUB inquiry procedure is the completed approval procedure (CE) for medical devices or one expected in the near future. Once the CE marking for medical devices has been obtained, it is possible for the inpatient sector to use these products. Here, the “permission with prohibition reservation” applies in principle. 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 device 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 fee in accordance with the efficiency requirement that show a verifiable added or additional benefit in contrast to established procedures. As of 2016, this additional benefit will also be assessed by the Federal Joint Committee for procedures involving high-risk medical devices (§ 137h SGB V).
NUB for pharmaceuticals
In the case of pharmaceuticals, the essential criteria for a NUB request are approval or pending approval (EMA), as well as significant additional costs that are not reflected in the G-DRG system. Here, too, there should be an additional benefit for the patient.
New regulation for advanced therapy medicinal products (ATMP): According to printed matter 19/30550 dated June 9, 2021 of the 19th legislative period of the German Bundestag, in the future a hospital can submit an inquiry to the Institute for Hospital Remuneration Systems for a new method that includes the administration of advanced therapy medicinal products within the meaning of Section 4 (9) of the German Medicines Act in addition to the regular NUB inquiry procedure by April 30 at the latest. If the request is made in due time, a hospital-specific agreement can be reached for ATMPs from July 1 of a year by the contracting parties in accordance with Section 11 Hospital Payment Act, even without the information from the InEK, if the information is not yet available. ATMPs include gene therapeutics, somatic cell therapeutics or biotechnologically processed tissue products.