Changes in new examination and treatment methods (NUB) application requirements in Germany

On September 1, 2023, the Institute for Hospital Remuneration Systems (INeK) announced the start of the application process for the innovation funding of the new examination and treatment methods (NUB) for 2024. The Federal Joint Committee (G-BA) reminds applying hospitals of an important obligation in this regard.

If medical devices of high-risk classes (Class IIb and III) are used in connection with a method applied for innovation funding via the NUB mechanism, the applying hospital must submit information about this method to the G-BA in agreement with the medical device manufacturer. This requirement should be met (according to §137h of SGB V) regardless of whether the InEK ultimately approves the method for innovation funding or not. The background to the obligation to transmit information is security and patient protection.

Moreover, it is not at the discretion of the submitting hospital to assess whether the method is new or the medical device is particularly invasive. The G-BA determines this and then makes a decision. Hospitals and medical device manufacturers can have the G-BA determine in advance whether the requirements for an assessment procedure in line with §137h SGB V are met.

Within the current application window, the hospitals should submit a NUB application to the InEK and transmit information to the G-BA by October 31, 2023.

The full details in German can be found here.

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