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Understanding what is the NUB process in Germany is essential for every hospital reimbursement team and medtech market-access manager preparing for the 2026 funding cycle. NUB, short for Neue Untersuchungs‑ und Behandlungsmethoden (new examination and treatment methods), is the statutory mechanism through which German hospitals can secure temporary additional reimbursement for innovative procedures, devices and pharmaceuticals that are not yet adequately reflected in the G‑DRG catalogue. With the InEK data portal opening each autumn and the firm October 31 submission deadline approaching, stakeholders must act early to assemble clinical evidence, coordinate with manufacturers and prepare for potential interactions with the Federal Joint Committee (G‑BA) under §137h SGB V.
This guide maps every step, from eligibility and portal logistics to status outcomes, evidence requirements and negotiation tactics with payers.
Quick-answer summary:
The NUB process is rooted in the German Social Code Book V (Sozialgesetzbuch V), specifically in the provisions governing hospital reimbursement. Its purpose is to close a funding gap: when a hospital adopts a genuinely new medical method, whether a novel implant, a cutting-edge surgical technique or an innovative drug regimen, the existing DRG (Diagnosis-Related Group) flat rates may not cover the true cost of delivery. The NUB pathway allows hospitals to apply for time-limited supplementary payments (NUB-Entgelte) so that adoption of clinically beneficial innovations is not blocked by reimbursement shortfalls.
The Institut für das Entgeltsystem im Krankenhaus (InEK GmbH) is the body that operates the NUB process. InEK maintains the G‑DRG system, publishes the annual NUB status lists, and runs the dedicated InEK data portal through which applications are submitted. Each year, InEK evaluates every NUB application and assigns a status category (1 through 4) that determines whether, and on what basis, the applying hospital may negotiate additional payments with statutory health insurance funds (Krankenkassen). InEK’s status lists are published on its official portal and serve as the definitive reference for payer negotiations.
The German DRG system reimburses inpatient care through standardised case-based payments. When an innovation is too new or too costly to be captured by an existing DRG, the NUB mechanism provides a temporary bridge. A successful NUB application, one that receives Status 1, entitles the hospital to negotiate a hospital-specific surcharge on top of the applicable DRG payment. This surcharge applies for one budget year and must be renegotiated annually until the method is either incorporated into the DRG catalogue, assigned a supplementary payment (Zusatzentgelt) or discontinued. The interplay between NUB and the broader Germany drug pricing and reimbursement framework is therefore critical to any hospital’s innovation funding strategy.
Under the NUB process in Germany, only hospitals that participate in the G‑DRG system may submit NUB applications. This is a fundamental structural point: manufacturers, distributors, consultants and other third parties cannot file a NUB application on their own behalf. The rationale is straightforward, it is the hospital that delivers the new method and bears the cost gap, so only the hospital can demonstrate that the innovation is being used in clinical practice and that current DRG reimbursement is inadequate. Each application is tied to a specific hospital and must describe the method as implemented at that institution.
Hospitals may, and frequently do, submit identical or near-identical applications for the same innovation, and InEK considers all submissions collectively when determining status.
Although manufacturers cannot submit a NUB application directly, their role is pivotal. Manufacturers typically provide the clinical evidence, product documentation, cost data and economic modelling that underpin a hospital’s submission. In practice, many medtech and pharmaceutical companies prepare “NUB dossiers”, standardised evidence packages, that partner hospitals can adapt and upload. Manufacturers may also enter contractual agreements with hospitals governing data sharing, evidence generation obligations and post-market follow-up commitments. Industry observers note that these manufacturer-hospital evidence agreements have become increasingly sophisticated, often including provisions for joint real-world evidence (RWE) collection during the NUB funding period.
For certain high-risk medical devices or methods based on a new theoretical-scientific concept, a parallel statutory pathway under §137h SGB V may be triggered. This can lead to an early benefit assessment by the G‑BA, adding a layer of regulatory complexity beyond the standard NUB application. The interaction between the NUB process and §137h is examined in detail below.
| Milestone | Indicative timing | Action required |
|---|---|---|
| InEK portal opens for new NUB applications | September 2026 | Register / log in; begin drafting application forms |
| Internal evidence assembly and manufacturer coordination | July – September 2026 | Collect clinical data, cost breakdowns, product documentation |
| Submission deadline (NUB deadline October 31) | October 31, 2026 | All applications must be fully submitted via the InEK data portal by this date |
| InEK review and status determination | November 2026 – January 2027 | Await status assignment; prepare negotiation strategy |
| Publication of NUB status lists | Typically Q1 of the following year | Check status; begin payer negotiations if Status 1 is awarded |
| Hospital-payer negotiations on NUB surcharges | Q1–Q2 of the following year | Negotiate NUB Entgelte for the budget year |
The InEK data portal is the exclusive submission channel. Hospitals must first register an institutional account (if one does not already exist) and designate authorised users. Once logged in, the application form requires the hospital to describe the new method, specify the relevant OPS (Operationen‑ und Prozedurenschlüssel) codes, explain why existing DRG payments are inadequate, and upload supporting evidence. Common errors that lead to delays or rejection include incomplete OPS code mapping, failure to quantify the cost gap versus the applicable DRG, and uploading evidence documents in unsupported formats. Best practice is to prepare all materials offline, using InEK’s published guidance, and to submit at least one week before the October 31 cut-off to allow time for portal troubleshooting.
The portal typically accepts PDF, Excel and structured data files; hospitals should confirm accepted formats in the current year’s InEK guidance notes.
The October 31 deadline is strict. Late applications are not accepted for the current cycle. Hospitals that miss the window must wait for the next annual cycle. In exceptional circumstances, industry observers suggest that engaging legal counsel to explore whether a formal objection or expedited review might be possible is advisable, though there is no established statutory right to a late submission.
| Status | InEK determination | Hospital action |
|---|---|---|
| Status 1 | Method is innovative; not adequately reimbursed by existing DRGs. NUB status 1 criteria met. | Hospital may negotiate a NUB surcharge (NUB-Entgelt) with payers for the upcoming budget year. |
| Status 2 | Method is not new, already mappable within existing DRGs or supplementary payments. | No NUB surcharge available. Hospital should review DRG coding to ensure correct reimbursement. |
| Status 3 | Insufficient information to make a determination. | Hospital may resubmit in the next cycle with enhanced documentation and evidence. |
| Status 4 | Method cannot be assessed (e.g., falls outside the DRG scope or is not a hospital service). | Hospital should seek legal or regulatory advice on alternative funding routes. |
A Status 1 determination is the gateway to NUB innovation funding. It confirms that InEK recognises the method as genuinely novel and that standard DRG payments do not cover its costs. Crucially, once a method has received Status 1, the hospital does not need to re-inquire about its NUB eligibility for the next year, the status listing itself serves as the basis for opening budget negotiations with the relevant statutory health insurance fund. The published NUB status lists on the InEK portal therefore become the hospital’s primary negotiation credential. Early indications suggest that the volume of Status 1 determinations has remained broadly stable in recent cycles, though the threshold of evidence required has gradually increased.
Hospitals should download the published status list from InEK and cross-reference each listed method against their own service catalogue. Where a hospital has received Status 1 for a specific innovation, it should prepare a concise negotiation brief for payers that includes the InEK status reference number, the quantified cost gap and the supporting clinical evidence. The status list effectively replaces the need for the payer to independently verify innovation credentials, it is InEK’s authoritative word.
InEK does not prescribe a single evidence standard for NUB applications, but the quality and relevance of clinical documentation materially affect the outcome. Randomised controlled trials (RCTs) carry the greatest weight, but prospective registries, controlled observational studies and well-documented case series are also accepted, particularly for device-based innovations where RCTs may be impractical. Key clinical endpoints should demonstrate safety, efficacy or a meaningful clinical advantage over existing methods. Increasingly, real-world data (RWD) collected during prior NUB funding periods is viewed favourably, as it demonstrates the method’s performance in routine German hospital settings.
Beyond clinical evidence, hospitals benefit from presenting clear health economic data. This includes a transparent cost breakdown showing the gap between current DRG revenue and the true cost of delivering the new method, as well as any economic offsets, such as reduced length of stay, fewer complications or avoided downstream interventions. These figures strengthen both the InEK application and subsequent payer negotiations. Cost data should be specific to the applying hospital wherever possible.
For methods that involve a medical device classified in a higher risk class and that are based on a new theoretical-scientific concept (neues theoretisch-wissenschaftliches Konzept), §137h SGB V mandates an additional step: the hospital must notify the G‑BA, which then conducts an early benefit assessment. This requirement exists alongside, not instead of, the NUB process. The evidence package for a §137h assessment is more rigorous than a standard NUB application, typically requiring a structured dossier comparable to a health technology assessment (HTA). Hospitals and manufacturers should identify early whether §137h applies, because the G‑BA assessment timeline and evidence demands can significantly affect the NUB negotiation calendar.
| Evidence type | Minimum requirement | Source of proof |
|---|---|---|
| Clinical efficacy / safety | Published study or registry data demonstrating outcomes | Peer-reviewed journals, manufacturer clinical dossier, hospital registry |
| Innovation / novelty | Description of new mechanism or therapeutic principle | Product documentation, IFU, CE marking dossier |
| Cost gap analysis | Quantified shortfall between DRG revenue and delivery cost | Hospital cost accounting, manufacturer pricing data |
| Real-world data (RWD) | Case-level data from prior use (if available) | Hospital EHR extracts, post-market surveillance reports |
| §137h dossier (if triggered) | Structured HTA-grade evidence, comparative analysis | Clinical trials, systematic reviews, economic modelling |
Section 137h of Social Code Book V establishes that when a hospital first requests a NUB surcharge for a method that uses a high-risk medical device and is based on a new theoretical-scientific concept, the hospital must simultaneously report this to the G‑BA. The G‑BA then determines whether the method requires a formal benefit assessment. This provision was introduced to ensure that innovative but potentially risky technologies receive independent scientific scrutiny before they become widely reimbursed through the NUB channel. The statutory text specifically targets methods where the device itself is integral to the therapeutic principle, not merely ancillary.
| Item | Hospital NUB route | G‑BA / §137h route |
|---|---|---|
| Who initiates | Hospital submits to InEK | Hospital notifies G‑BA; manufacturer or authority may also trigger |
| Purpose | Temporary reimbursement / negotiation with payers | Formal benefit assessment for broader statutory coverage decisions |
| Timing | Annual portal cycle (Sept–Oct; October 31 cut-off) | Triggered by statutory referral; separate timetable set by G‑BA |
| Evidence standard | Practical operational evidence; RWD and case series often accepted | More rigorous HTA-grade evidence; comparative clinical trials preferred |
| Outcome | Status 1–4 determination; negotiation basis | G‑BA decision on benefit; potential inclusion or exclusion from statutory coverage |
The decision to pursue the standard NUB route, prepare for a §137h assessment, or both simultaneously is a strategic legal question. For methods that clearly fall within the §137h scope, early engagement with the G‑BA is unavoidable and delay can jeopardise the NUB application itself. Industry observers expect that hospitals increasingly retain specialist market-access and health-law counsel to navigate the dual-track process. The likely practical effect is that well-prepared institutions, those that assemble HTA-grade evidence proactively, gain a significant advantage, because a positive or neutral G‑BA assessment reinforces the NUB negotiation position with payers. Conversely, failing to identify a §137h trigger can result in procedural delays and, in the worst case, suspension of NUB funding pending the G‑BA outcome.
Once a hospital receives a Status 1 determination, it enters bilateral negotiations with the relevant statutory health insurance fund to agree on the amount and duration of the NUB surcharge. The negotiation is hospital-specific, meaning that two hospitals with Status 1 for the same method may agree on different surcharge amounts depending on their respective cost structures and patient volumes. Key negotiation points include the per-case surcharge amount, volume caps, documentation obligations during the funding period and provisions for renegotiation if case volumes differ materially from projections. Hospitals should approach these negotiations with a prepared brief that includes the InEK status reference, a transparent cost-gap calculation and the supporting clinical evidence package.
If InEK assigns an unfavourable status (Status 2, 3 or 4), the hospital’s immediate options are limited, there is no formal statutory appeal against InEK’s NUB status determination in the same way that a court judgment can be appealed. However, hospitals can resubmit in the following cycle with strengthened evidence, corrected documentation or a revised clinical rationale. Where a G‑BA decision under §137h adversely affects a method, the manufacturer or hospital may seek judicial review before the social courts (Sozialgerichte), although such proceedings are complex and lengthy. Early indications suggest that the most effective strategy is to avoid an adverse determination in the first place through rigorous preparation rather than to challenge one after the fact.
Given the manufacturer’s critical role in supplying evidence, the contractual framework between manufacturer and hospital deserves careful attention. Agreements should address:
The NUB process in Germany remains the principal mechanism for hospitals to secure funding for clinical innovations that outpace the DRG catalogue. Success depends on early preparation, rigorous evidence assembly, accurate OPS mapping and strategic coordination with manufacturers, all before the October 31 InEK deadline. Where §137h SGB V applies, the stakes and the evidence requirements rise significantly. Hospitals and manufacturers that invest in specialist market-access and health-law guidance position themselves to navigate both the NUB and G‑BA pathways efficiently, maximising their chances of securing innovation funding and delivering advanced care to patients.
This article was produced by Global Law Experts. For specialist advice on this topic, contact Dr. Christian Rybak at Greenberg Traurig Germany, LLP, a member of the Global Law Experts network.
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