Germany postpones broader §137h assessment requirements for first-time NUB applications

On September 17, 2026, the Federal Joint Committee (G-BA) clarified that the expanded mandatory assessment procedure for new inpatient methods under §137h SGB V will apply only once the amended G-BA Rules of Procedure enter into force. According to the G-BA, this will not happen before October 31, 2026. 

Until then, hospitals and medical device manufacturers submitting information to the G-BA will remain subject to the current scope of §137h, which is limited to new examination and treatment methods involving high-risk medical devices. The existing Rules of Procedure will also continue to govern subsequent procedural steps and legal consequences until the amended version takes effect. 

The Contribution Rate Stabilization Act (Beitragssatzstabilisierungsgesetz, BStabG) significantly broadened the scope of the §137h SGB V procedure. Under the new legislation, the mandatory information submission and assessment procedure will in the future apply to all new methods for which a NUB request is submitted to the Institute for the Hospital Remuneration System (InEK) for the first time. 

What does it mean? 

The clarification confirms that, until the amended G-BA Rules of Procedure enter into force, the broader §137h requirements will not yet apply. For the current NUB application period, the procedure therefore remains limited to new inpatient methods involving high-risk medical devices. 

Once the new rules take effect, however, the change will be substantial. A much wider range of new inpatient devices linked to first-time NUB requests may become subject to G-BA assessment, including technologies that currently fall outside the §137h procedure. 

For medical device companies planning NUB applications in Germany, this increases the importance of assessing early whether a new method may trigger §137h requirements and what evidence may be needed. The timing of the amended Rules of Procedure should therefore be monitored closely, particularly for technologies expected to enter the NUB process from 2027 onward. 

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