The NUB procedure remains a key component for the reimbursement of innovative medical technologies in the German hospital market. The legislative changes associated with the Contribution Rate Stabilization Act were intended to expand the requirements for certain NUB-relevant procedures.
The Joint Federal Committee has now clarified that the expanded procedure under Section 137h of Book V of the Social Code (SGB V) can only be applied after the amended rules of procedure take effect. Since this requirement will not be met before October 31st, 2026, the expansion does not yet affect the current round of NUB applications for the year 2027.
For hospitals and medtech companies, the existing procedural framework therefore remains in place for the time being. NUB applications can continue to be submitted as usual via the InEK data portal.
While the postponement gives companies time, it should not be confused with a delay in strategic preparation. Manufacturers of innovative medical devices, in particular, should begin assessing today whether their technologies might fall under the expanded evaluation requirements in the future and what evidence will be required for a successful reimbursement strategy.
Healthcare Heads supports medtech companies, investors, and market access professionals in assessing regulatory changes early on, evaluating the impact on existing reimbursement strategies, and determining the next steps in the NUB process.
Would you like to know how the latest decisions will affect your product or your NUB strategy? Feel free to contact us.
Author: Healthcare Heads GmbH
Phone: +49 431 800 1470
E-Mail: info@healthcareheads.com