G-BA reminds hospitals of their obligation to provide information when applying for additional fees for new methods with high-risk medical devices

10.08.2023 15:45

In September/October, the annual window opens again in which clinics can apply for additional fees beyond the flat rate per case from the Institute for the Hospital Fee System (InEK) for new examination and treatment methods (NUB). On this occasion, the Federal Joint Committee (G-BA) reminds once again of the hospitals' obligation to transmit information.

If medical devices in high risk classes (Class IIb and III) are used with such a method, the applying hospital must submit information about this method to the G-BA in agreement with the medical device manufacturer. This obligation (according to Section 137h of SGB V) exists regardless of whether the InEK ultimately approves an additional fee or not. And contrary to what is often assumed, it is not at the discretion of the submitting hospital to assess whether the method is new or whether the medical device is particularly invasive. The G-BA determines this and then makes a decision.

New online portal for transmitting information

Affected hospitals have until the end of October 2023 to submit an NUB application to the InEK and to transmit information to the G-BA. This is easy and convenient using the G-BA's new portal 137h (see below). The hospital provides information about the state of scientific research on the method and the medical device used. Other hospitals and manufacturers can contribute information about the method upon request by the G-BA. This is also done via the 137h portal, where essential parts of the information submitted by the hospital can be viewed publicly.

Hospitals and medical device manufacturers can have the G-BA determine in advance whether the requirements for an assessment procedure in accordance with Section 137h SGB V exist: Advice on procedures according to Section 137h SGB V

Patient protection in focus

The background to the obligation to transmit information is security and patient protection. The G-BA has been legally commissioned to take a closer look at new, invasive methods with high-risk medical devices. In a fast-track evaluation of these methods with high-risk medical devices, the G-BA assesses, based on the scientific information submitted by the hospital, whether the new method improves patient care and does not pose a safety risk. He can initiate testing of the method in order to gain the necessary insights to evaluate its benefits.