What Is the NUB Process in Germany (2026): Who Can Apply, Inek Deadlines, Status 1 & G‑BA Steps

Understanding what is the NUB process in Germany is essential for every hospital, medical device manufacturer, and market‑access team seeking temporary reimbursement for innovative inpatient treatments outside the standard DRG catalogue. NUB, short for Neue Untersuchungs‑ und Behandlungsmethoden (new examination and treatment methods), is the annual procedure through which German hospitals apply to the Institute for the Hospital Remuneration System (InEK) for recognition and interim funding of novel clinical methods. With the 2026 application window closing on 31 October and the Federal Joint Committee (G‑BA) tightening its benefit‑assessment expectations for high‑risk medical devices under §137h SGB V, the stakes for getting the process right have never been higher.

This guide walks through every stage, from eligibility and portal submission to status assignment, payer negotiations, and legal escalation routes, so that hospital reimbursement officers, procurement managers, and device manufacturers can plan the autumn 2026 cycle with confidence.

Key takeaways at a glance:

• Deadline. NUB applications for the following budget year must be submitted through the InEK data portal by 31 October each year.
• Who applies. Only hospitals may submit a NUB application; manufacturers supply clinical evidence and supporting documentation but cannot file directly.
• Status 1 unlocks negotiation. A Status 1 classification from InEK confirms formal eligibility and permits hospitals to negotiate temporary surcharges with statutory health insurers (SHI funds).
• §137h SGB V overlay. For methods involving high‑risk medical devices of Class IIb or III, the G‑BA may initiate an early benefit assessment that runs parallel to, or instead of, the standard NUB pathway.

NUB Explained, Statutory Basis and Purpose

Germany’s inpatient reimbursement system relies on diagnosis‑related groups (G‑DRGs) administered by InEK. Each DRG bundles a set of procedures and diagnosis codes into a flat‑rate payment. When a hospital introduces a genuinely new method, whether it is a novel implant, a first‑in‑class pharmaceutical protocol, or an innovative diagnostic procedure, the existing DRG catalogue often provides no adequate payment code. The NUB process bridges this gap by creating a structured pathway through which hospitals can secure temporary additional funding while InEK and the G‑BA evaluate whether the method warrants permanent integration into the DRG system.

Legal Basis: SGB V and How NUB Fits into the DRG System

The NUB mechanism is anchored in Social Code Book V (Sozialgesetzbuch V, SGB V), specifically the provisions governing hospital remuneration and the introduction of new treatment methods. §137 SGB V establishes the general framework under which the G‑BA oversees quality and innovation in inpatient care, while §6 Abs. 2 of the Hospital Remuneration Act (Krankenhausentgeltgesetz, KHEntgG) provides the procedural basis for NUB applications and temporary surcharges. For methods that involve implantable, high‑risk medical devices, §137h SGB V adds an additional statutory layer by empowering the G‑BA to demand an early benefit assessment before temporary reimbursement may proceed.

The interplay between these provisions means that a NUB application in Germany is never purely an administrative filing, it carries regulatory and, in certain cases, quasi‑judicial implications that require careful legal planning.

Who Can Apply and Who Decides? Roles and Responsibilities in the NUB Process

A common misconception is that device manufacturers or pharmaceutical companies can submit NUB applications directly. They cannot. The formal applicant is always the hospital. However, the success of a NUB application Germany almost always depends on close collaboration between the treating hospital, the product manufacturer, and, in complex cases, specialist reimbursement counsel.

Hospital Responsibilities

The hospital identifies the innovative method, confirms that no existing DRG or supplementary payment (Zusatzentgelt) adequately covers the cost, and prepares the NUB application through the InEK data portal. This includes completing the standardised online form, uploading clinical documentation, and providing case‑level cost data. The hospital bears full responsibility for the accuracy and completeness of the submission.

Manufacturer Role

Although manufacturers are not formal applicants, their involvement is critical. They supply the clinical study data, technical dossiers, CE‑marking documentation, and, where relevant, health‑economic analyses that form the evidential backbone of the application. In practice, many manufacturers proactively prepare “NUB support packages” to ensure that all hospitals using their product submit consistent, high‑quality applications. Industry observers expect this coordinating role to grow in importance as InEK raises its evidential expectations.

InEK and G‑BA Decision Roles

InEK performs the initial administrative and substantive review. It checks formal completeness, evaluates whether the method genuinely qualifies as “new,” and assigns a status classification (see below). InEK does not, however, make final reimbursement decisions, those are negotiated bilaterally between the hospital and the relevant SHI fund, or escalated to the arbitration board (Schiedsstelle). The G‑BA enters the picture when a method triggers §137h SGB V or when broader policy questions arise about whether the innovation should be admitted to standard care on a permanent basis.

Step‑by‑Step NUB Process: The Operational Workflow

The NUB application follows a structured annual cycle. While precise internal processing timelines vary, the core workflow remains consistent from year to year. Below is the step‑by‑step NUB process that hospitals and manufacturers should follow for the 2026 cycle.

Pre‑Submission Checklist

Before opening the InEK data portal, the hospital team should confirm three things. First, is the method genuinely new, meaning it is not already mappable to an existing OPS code or DRG within the current catalogue? Second, is there sufficient clinical evidence (studies, case series, or real‑world data) to support the claim of clinical benefit? Third, has the manufacturer provided all required technical and safety documentation? Completing this internal audit before submission significantly reduces the risk of a formal rejection or a Status 2 classification.

Submission via the InEK Data Portal

Hospitals submit NUB applications exclusively through the InEK data portal at www.g-drg.de/inek. The portal requires registration with institutional credentials and accepts structured data fields covering the description of the method, the target patient population, clinical evidence summaries, relevant OPS and ICD codes, and estimated incremental costs. Supporting documents, typically in PDF format, are uploaded alongside the form. The portal opens each year well in advance of the 31 October deadline, and hospitals are strongly advised to submit early to allow time for technical corrections.

InEK Validation and Processing

After the portal closes, InEK reviews each submission for formal completeness and substantive merit. Applications that are incomplete or that describe methods already covered by existing payment mechanisms are rejected at this stage. For eligible applications, InEK assigns a status classification, most importantly, Status 1 or Status 2, and publishes the results. InEK also communicates its findings to the contracting parties (hospitals and SHI funds) so that budget negotiations can proceed on an informed basis.

Negotiation Phase with Payers

A Status 1 classification does not automatically generate revenue. It merely authorises the hospital to enter bilateral negotiations with the relevant SHI fund for a temporary surcharge (NUB‑Entgelt). The negotiation covers the price level, the eligible patient group, documentation requirements, and the duration of the interim arrangement. If the parties cannot agree, either side may invoke the arbitration board. Industry observers note that well‑prepared clinical and economic evidence significantly strengthens the hospital’s negotiating position.

Timeline and Deadlines for the 2026 NUB Cycle

Timing is everything in the NUB process. Missing the annual deadline means waiting an entire year before resubmitting, a delay that can cost hospitals and manufacturers critical market‑access momentum and leave patients without access to innovative treatments.

Key Annual Milestones

What to Do If You Miss the 31 October Deadline

The 31 October submission deadline is generally treated as firm. InEK does not routinely accept late NUB applications. If a hospital misses the window, the practical options are limited: it must wait for the next annual cycle or, in exceptional circumstances, explore whether the method can be accommodated through an existing supplementary payment code or an individual contract with the SHI fund outside the NUB framework. For this reason, hospitals are advised to begin preparation no later than mid‑year and to coordinate with manufacturers well in advance of the G‑BA NUB deadline on 31 October.

NUB Status Categories: Status 1 vs Status 2, Criteria and Consequences

The status classification assigned by InEK is the single most important outcome of the NUB application. It determines whether the hospital can negotiate a temporary surcharge and, by extension, whether the innovative method has a viable path to reimbursement in the German inpatient market.

NUB Status 1 Criteria

Status 1 is the target classification. InEK grants Status 1 when the following conditions are met:

• Novelty. The method is genuinely new and cannot be adequately mapped to an existing OPS code, DRG, or supplementary payment within the current catalogue.
• Formal completeness. The application has been submitted through the InEK data portal by the deadline, all required fields are populated, and supporting documentation is attached.
• Preliminary evidence of clinical benefit. There is sufficient evidence, from clinical studies, case series, or structured real‑world data, to suggest that the method offers a meaningful diagnostic or therapeutic advantage over existing alternatives.
• Cost plausibility. The hospital has demonstrated that the incremental cost of the method exceeds what the existing DRG payment covers, making additional funding necessary.

When InEK assigns Status 1, the hospital is authorised to enter payer negotiations. The NUB Status 1 criteria are therefore central to any market‑access strategy for NUB innovation funding in 2026 and beyond. Without Status 1, the application effectively stalls.

Status 2 and Longer Assessment

Status 2 means that InEK has determined the method does not (yet) meet the requirements for negotiation authorisation. This may occur because the method is not sufficiently novel, because the evidence base is too thin, or because InEK considers the existing DRG structure adequate. A Status 2 classification does not necessarily end the road, the hospital can reapply in a subsequent annual cycle with strengthened evidence. However, it does mean that no temporary surcharge can be negotiated for the current period. Early indications suggest that InEK is applying increasingly rigorous standards to the novelty and evidence thresholds, making upfront evidence planning more important than ever.

§137h SGB V and High‑Risk Devices, Early Benefit Assessment Interactions

For certain categories of medical devices, the standard NUB pathway intersects with a separate, more demanding statutory process: the early NUB benefit assessment under §137h SGB V. Understanding this intersection is critical for manufacturers of implantable and high‑risk devices.

When §137h SGB V Applies

Under §137h SGB V, the G‑BA may initiate an early benefit assessment when a new examination or treatment method involves a medical device of high risk class, specifically, implantable devices of Class IIb or Class III under the EU Medical Device Regulation, or active implantable devices. The trigger is typically the first NUB application or the first request for a new DRG payment code involving such a device. Once triggered, the G‑BA evaluates whether there is sufficient evidence that the method offers a benefit compared to existing alternatives. If the evidence is deemed insufficient, the G‑BA may restrict or prohibit the use of the method in SHI‑funded care, a far more consequential outcome than a simple NUB Status 2 classification.

Manufacturer Obligations and Evidence Expectations

When §137h is triggered, the evidentiary burden shifts significantly. Manufacturers must be prepared to supply:

• Clinical study data. Ideally randomised controlled trials (RCTs); at minimum, well‑designed comparative studies.
• CE‑marking and technical documentation. Full regulatory dossier including the device’s conformity assessment reports.
• Safety data. Post‑market surveillance reports and any relevant communications to the BfArM (Federal Institute for Drugs and Medical Devices).
• Health‑economic analysis. Cost‑effectiveness or budget‑impact modelling relevant to the German inpatient setting.

The practical effect is that manufacturers of high‑risk devices need to plan for the §137h pathway from the earliest stages of their Germany drug pricing and reimbursement strategy, not as an afterthought once a NUB application has already been filed.

Evidence Expectations and Dossier Checklist

Whether the NUB application follows the standard pathway or triggers a §137h review, the quality of the evidence dossier is the single most influential variable. InEK and the G‑BA evaluate clinical, coding, and economic evidence according to a tiered framework.

Clinical Evidence

Coding and Billing Documentation

The NUB application must include proposed OPS procedure codes and relevant ICD‑10‑GM diagnosis codes. If no suitable code exists, the application should explain how the method would be coded and why existing codes are inadequate. Accurate coding is essential because InEK uses it to determine whether the method is truly “new” or whether it can already be captured within the current DRG structure.

Health Economics and Pricing Negotiation Points

Hospitals and manufacturers should prepare an incremental cost analysis comparing the new method to the standard of care. This analysis forms the basis for negotiating the temporary surcharge level with SHI funds. Common pitfalls include underestimating learning‑curve costs, failing to account for consumables, and omitting downstream savings (such as reduced length of stay) that can strengthen the economic case.

After a NUB Decision, Reimbursement Outcomes, Negotiation and Escalation

A favourable NUB status is the beginning, not the end, of the reimbursement journey. The practical outcome depends on the negotiations that follow and, if those fail, on the legal remedies available.

Negotiation Tips for Hospitals and Manufacturers

• Anchor on evidence. Present the clinical and economic data early and in a format that mirrors InEK’s evaluation criteria, this reduces friction and builds credibility with payer counterparts.
• Benchmark regionally. Where other hospitals have already negotiated NUB surcharges for the same method, reference those agreements (anonymised where necessary) to establish a pricing corridor.
• Include volume commitments. Offering minimum case‑volume thresholds can reassure SHI funds that the surcharge reflects genuine clinical use rather than speculative billing.
• Set a review clause. Temporary agreements should include a clear review date, evidence‑update trigger, and pathway toward permanent DRG integration.

Legal Dispute Options and G‑BA Interactions

If bilateral negotiations break down, either party may refer the dispute to the arbitration board (Schiedsstelle). The arbitration board issues a binding determination of the surcharge level and conditions. Beyond arbitration, hospitals or manufacturers who believe that InEK’s status classification or the G‑BA’s §137h assessment contains procedural or substantive errors may seek administrative judicial review before the competent social court (Sozialgericht). These legal escalation routes are used sparingly but remain an important safeguard, particularly where a negative NUB decision or an adverse §137h finding could foreclose an entire product’s market access in Germany.

Reporting Obligations and Timeline by Entity Type

Practical Checklist and Templates

Hospital Submission Checklist

• Confirm the method is not mappable to an existing DRG, OPS code, or supplementary payment.
• Register for and test access to the InEK data portal well before October.
• Complete all mandatory fields in the online NUB application form.
• Upload clinical evidence summaries in PDF format.
• Include proposed OPS and ICD‑10‑GM codes with justification for “new” classification.
• Provide case‑level incremental cost data.
• Coordinate with manufacturer for consistency across multi‑site submissions.
• Submit by 31 October 2026, do not rely on last‑day uploads.

Manufacturer Evidence Pack

• Clinical study reports (RCTs, comparative studies, or case series).
• CE‑marking certificate and conformity assessment documentation.
• Instructions for use (IFU) and relevant product specifications.
• Post‑market surveillance and safety reports (for BfArM‑regulated devices).
• Health‑economic model or budget‑impact analysis for the German inpatient setting.
• Template NUB application text for distribution to hospital partners.

Conclusion

The NUB process in Germany remains the primary gateway for hospitals to obtain interim funding for genuinely innovative inpatient methods that fall outside the established DRG catalogue. Success requires early preparation, robust clinical and economic evidence, close hospital–manufacturer coordination, and, particularly for high‑risk devices subject to §137h SGB V, a clear understanding of the G‑BA’s benefit‑assessment expectations. With the 31 October 2026 deadline approaching, hospitals and manufacturers should treat the NUB application not as a routine form‑filling exercise but as a strategic market‑access milestone.

Those navigating the NUB process in Germany for the first time, or facing a complex §137h interaction, are advised to seek specialist counsel through the Global Law Experts lawyer directory to develop a tailored reimbursement strategy before the autumn submission window closes.

Last updated: 6 July 2026. This guide is refreshed annually before the October application window.

Sources

1. Institute for the Hospital Remuneration System (InEK), Official Site
2. Gemeinsamer Bundesausschuss (G‑BA), Official Site
3. Gesetze im Internet, Social Code Book V (SGB V), §137h
4. Bundesministerium für Gesundheit (BMG)
5. Bundesanzeiger (Official Gazette)
6. Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
7. Value in Health, NUB/DRG Pathway Analysis