NUB Applications & §137h SGB V
NUB Applications and §137h SGB V
Each year, hospitals and medical device manufacturers in Germany face a critical deadline: October 31st. This is the cut-off date for submitting applications under the NUB (Neue Untersuchungs- und Behandlungsmethoden) New Examination and Treatment Methods process. For certain high-risk medical devices, this also marks the beginning of the early benefit assessment under §137h of the German Social Code Book V (SGB V), conducted by the Federal Joint Committee (G-BA), which serves as Germany’s health technology assessment (HTA) body.
The G-BA (Gemeinsamer Bundesausschuss) is the highest decision-making body in the German healthcare system. As the national HTA authority, it is responsible for evaluating the added benefit of new medical interventions (including specific high-risk medical devices) before they can be widely reimbursed within the statutory health insurance system.
These regulatory pathways are essential for gaining market access and reimbursement for innovative technologies. At inspiring-health, we help hospitals and manufacturers navigate these requirements with confidence. Ideally, planning should start well before CE marking, at the latest, by the second quarter of the year you want to submit a NUB-application, to ensure timely and strategic alignment with regulatory timelines.
What Is NUB?
The NUB process enables hospitals to negotiate additional, temporary reimbursement for new diagnostic or therapeutic methods that are not yet covered under the existing DRG system. Applications are submitted to InEK (the German Institute for Hospital Remuneration), which assesses whether the proposed method is:
- genuinely innovative,
- not yet reflected in the DRG catalogue, and
- plausible, well-defined, and suitable for cost negotiation.
A positive NUB status (Status 1) allows hospitals to negotiate supplementary payments with statutory health insurers. If InEK does not grant this status, reimbursement on top of DRG is not possible.
Because InEK follows strict formal standards, a well-prepared and clearly structured application is essential. This includes a precise description of the method, coding, initial clinical experience, and a convincing justification for the costs and underfunding of the intervention.
What Is §137h SGB V?
When a hospital applies for a NUB involving a high-risk medical device or active implant, the submission automatically triggers a review under §137h SGB V. In this process, the Federal Joint Committee (G-BA) assesses whether the method requires a formal benefit evaluation.
The G-BA is responsible for:
- determining whether the method falls within the scope of §137h,
- assessing if a formal benefit evaluation is required, and
- defining the evaluation guideline for a potential trial.
While this regulatory process can be complex and rigorous, it also presents valuable opportunities for well-prepared manufacturers to demonstrate the value of their innovation.
Conditional Reimbursement Through Evidence Development
A key advantage of the §137h process is the possibility of temporary access to care while evidence is being developed. If the G-BA sees all criteria apply, it will decide on an evaluation trial. This decision can open the door to continued funding through existing structures, such as NUB reimbursement.
While the G-BA does not set reimbursement levels, its decision is critical. A positive outcome allows hospitals and insurers to negotiate payment, often based on NUB Status 1 granted by InEK. This makes strategic preparation essential.
G-BA Consultations: A Critical Planning Tool
Before the §137h evaluation process, manufacturers can request a formal consultation with the G-BA. These consultations provide important insights into:
- whether the method is subject to §137h,
- what endpoints, comparators, and study designs are expected, and
- what conditions may apply for continued use during evidence generation.
The consultation is not about reimbursement amounts, but it offers essential guidance for planning clinical development and assessing the viability of the pathway. It enables stakeholders to identify potential challenges early and align their strategies accordingly. A clear, well-supported request enhances the quality of feedback, supporting informed decision-making throughout the process. inspiring-health helps you design these submissions to maximize their strategic value.
How inspiring-health Supports You?
- Strategic planning for NUB and §137h submissions
- Preparation of high-quality documents for InEK and G-BA
- Support for G-BA consultations
- Evidence analysis and health economics argumentation
- Coordination between manufacturers and hospitals
- Communication with relevant authorities and stakeholders
Whether you are a hospital preparing to implement an innovative procedure or a MedTech company planning to enter the German market, we provide comprehensive support throughout the entire process.