The NUB procedure under Section 6(2) of the KHEntgG 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 31, 2026, the extension does not yet affect the current 2026–2027 NUB application round (but will apply to NUB procedures beginning in 2027–2028).
The postponement means that NUB applications can be submitted this year for the last time under the current, non-expanded requirements. The deadline for NUB applications under Section 6(2) of the KHEntgG remains October 31, as before.
For the upcoming NUB process in 2027–2028, manufacturers of innovative medical devices should begin assessing now 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