NUB 2027 and the revised §137h SGB V: A new early HTA gate for medical devices in Germany?

Each year, 31 October is a critical deadline for hospitals and medical device manufacturers seeking additional reimbursement for innovative procedures in Germany.

The 2026 NUB application cycle for reimbursement in 2027 may be particularly important. Germany has fundamentally expanded the scope of §137h SGB V. Once the revised G-BA Rules of Procedure enter into force, a first-time NUB request for a new non-drug method may trigger an early G-BA benefit assessment, regardless of the risk class of the medical device used.

However, not every first-time NUB request will automatically require a positive potential decision. The G-BA must first determine whether the method is based on a new theoretical-scientific concept, commonly referred to by the German abbreviation NTWK.

The timing is also unresolved. The legislation was published in the Federal Law Gazette on 29 July 2026, but the expanded procedure will only apply once the amended G-BA Rules of Procedure have entered into force. This creates considerable uncertainty for the NUB 2027 application cycle.

What has changed under §137h SGB V?

Under the previous framework, the mandatory §137h procedure was limited to new methods whose technical application was substantially based on a high-risk medical device.

The new legislation removes this restriction.

Once the new procedure becomes applicable, a first-time NUB request may fall within the scope of §137h if it concerns a new examination or treatment method that is not solely or substantially based on the administration of a pharmaceutical drug. For device-based methods, the risk classification of the medical device is therefore no longer the decisive filter.

This means that methods involving lower-risk devices, which would previously not have entered the mandatory §137h pathway, may now also trigger G-BA involvement.

When the technical application of the method substantially relies on a medical device, the hospital must submit the scientific information in agreement with the manufacturer. The submission must include information on the clinical benefit of the device and complete data from clinical studies conducted with it.

However, a full assessment only follows if the G-BA determines that the method is based on a New Theoretic and Scientific Concept (NTWK).

If an NTWK is confirmed, the G-BA assesses whether:

1. the clinical benefit of the method is sufficiently proven;

2. the benefit is not yet sufficiently proven, but the method offers the potential of a required treatment alternative; or

3. the method does not offer such potential, particularly because it is considered harmful or ineffective.

This changes the evidence threshold. Previously, the intermediate outcome only required that neither benefit nor harm or ineffectiveness was sufficiently proven. Under the revised framework, the available evidence must positively support a finding of potential alternative, introducing a stronger comparative element.

What remains unchanged?

The established InEK NUB reimbursement assessment remains in place.

InEK continues to determine whether the reimbursement-related criteria of the NUB procedure are fulfilled. The G-BA addresses a different question: whether the method involves an NTWK and, where applicable, whether its benefit or potential can be established.

The two processes are therefore separate, although their practical consequences may be linked.

In particular, a first-time NUB request does not automatically require a positive potential assessment:

- If the G-BA determines that the method does not involve an NTWK, the full §137h assessment does not proceed.

- The method may nevertheless receive NUB Status 1 if the established InEK criteria are fulfilled.

A finding that the method does not involve an NTWK is not a negative NUB decision. Benefit or potential under §137h are not assessed, while NUB Status 1 remains possible if the established InEK criteria are met.

Why is this a significant change for manufacturers?

For manufacturers, the reform involves more than an expansion from high-risk devices to all device risk classes.

A first-time NUB request may now become an early clinical evidence and HTA trigger. This is particularly relevant for manufacturers of technologies that previously would not normally have entered the mandatory §137h pathway.

The relevant assessment threshold is also changing.

Under the previous §137h framework, the G-BA could conclude that:

- benefit was sufficiently proven;

- harm or ineffectiveness was sufficiently proven; or

- neither benefit nor harm or ineffectiveness was sufficiently proven.

In the third scenario, no positive finding of potential was required. The available evidence only had to avoid a sufficiently substantiated conclusion that the method was harmful or ineffective.

CE marking and the supporting regulatory evidence could be relevant in this context. However, CE marking itself has never established clinical benefit within the German HTA framework.

Under the new framework, the intermediate outcome requires a positive potential assessment. The method must plausibly offer a required treatment alternative, rather than merely avoiding a finding of harm or ineffectiveness.

The exact evidence threshold will have to be specified in the amended G-BA Rules of Procedure. Nevertheless, potential is inherently comparative.

How is treatment during the study financed?

The treatment provided within the evidence-generation study remains part of statutory health insurance-funded care.

In the inpatient setting, the services are reimbursed through the applicable hospital payment arrangements. This generally includes the procedure and the use of the medical device as components of the treatment, although it does not necessarily mean that the device receives a separate payment.

Where the existing hospital reimbursement is inadequate, the NUB payment remains relevant. Following a potential decision under the revised §137h, however, such a payment may only be negotiated by university hospitals and other hospitals that meet the G-BA quality requirements.

Who pays for the independent scientific institution?

One key implementation issue remains unresolved.

A finding of potential under §137h leads to an evidence-generation guideline pursuant to §137e. However, the newly amended §137e paragraph 7 expressly requires the applicant in a manufacturer-initiated evidence-generation procedure to commission and finance an independent scientific institution, or UWI, unless the application is withdrawn or the G-BA decides to commission and fund the scientific support itself.

A §137h procedure is triggered differently: by a hospital submitting a first-time NUB request and providing the scientific information to the G-BA. It is therefore unclear whether either the manufacturer or the hospital becomes the “applicant” within the meaning of §137e paragraph 7.

A manufacturer will likely remain able to commission and finance the UWI voluntarily. The critical question arises where the manufacturer does not wish to assume these costs: must the G-BA then commission and fund the UWI, or is further legislative clarification required?

The revised G-BA Rules of Procedure may clarify the operational pathway and indicate which existing financing mechanism applies. However, they cannot simply create a new substantive funding obligation for a manufacturer or hospital without a sufficient statutory basis.

And surely the answer cannot be that the hospital, merely because it submitted the NUB request as the relevant service provider, is ultimately expected to finance the scientific infrastructure of a nationwide G-BA evidence-generation study?

This is more than a procedural detail. It may have substantial financial consequences for manufacturers and hospitals considering a first-time NUB request.

Why does the timing for NUB 2027 remain unclear?

The legislation was published on 29 July 2026, requiring the G-BA to define the expanded procedure by 31 October 2026. However, as the new §137h trigger will apply only once the amended Rules of Procedure enter into force, it remains unclear whether and how first-time NUB requests submitted for 2027 will already fall under the revised framework.

How inspiring-health supports manufacturers and hospitals

At inspiring-health, we support manufacturers and hospitals throughout the NUB, §137h and §137e pathways, including:

- strategic assessment of whether a NUB request is appropriate;

- analysis of previous NUB requests and reimbursement options;

- NTWK analysis and definition of the relevant method;

- preparation of NUB requests for InEK;

- preparation of information submissions under §137h;

- planning and preparation of G-BA consultations;

- systematic clinical evidence analyses;

- comparator and endpoint strategies;

- assessment of potential evidence-generation requirements; and

- coordination between manufacturers, hospitals and clinical experts.

The expanded §137h framework makes early alignment between reimbursement, clinical development and HTA strategy more important than ever.