How to Use German NUB Reimbursement Without Getting Trapped
After nearly two decades of operational data, one conclusion is unavoidable: German NUB reimbursement is not a neutral innovation gateway.
It selectively rewards certain types of technologies, structurally disadvantages others, and—most critically—does not reliably lead to permanent DRG integration. Yet NUB remains one of the most frequently misunderstood and misused reimbursement mechanisms in Europe.
For MedTech, diagnostics, and digital health innovators, the strategic question is not whether to use NUB, but how to use it deliberately and when to avoid it entirely.
This article sets out a practical, experience-driven framework for treating NUB as what it really is:
a controlled, temporary hospital funding instrument, not a long-term reimbursement strategy.
What NUB Actually Is / And What It Is Not
Germany’s Neue Untersuchungs- und Behandlungsmethoden (NUB) mechanism allows hospitals to apply annually for temporary additional funding for new diagnostic or therapeutic methods that are not adequately reimbursed within the existing DRG system.
Crucially:
- NUB applications are submitted by hospitals, not manufacturers
- Decisions are made annually by InEK
- Positive Status 1 does not create a tariff
- It merely allows hospital-by-hospital negotiations with sickness funds
NUB therefore provides access to funding, not reimbursement certainty.
At a European level, NUB is classified as an unconditional innovation payment mechanism. Unlike Coverage with Evidence Development (CED) schemes used in France, Belgium, the Netherlands, or Switzerland, NUB does not formally require evidence generation or a defined exit pathway.
That structural feature explains both its appeal and its risk.
Neue Untersuchungs- und Behandlungsmethoden (NUB) is the German hospital mechanism for the temporary reimbursement of new examination and treatment methods that are not yet adequately covered by the existing aG-DRG system due to their novelty.
NUB is designed to close the systemic reimbursement gap that exists before innovative medical products or procedures are fully integrated into standard care. This transition typically takes around three years.
NUB payments are extrabudgetary. They compensate hospitals for additional costs arising from methods that are not yet part of the statutory health insurance (SHI) service catalog and are therefore not reflected in DRG tariffs or reference values. Each year, InEK reviews whether the available data are sufficient to transfer a NUB into standard care, either via a DRG adjustment or a permanent add-on payment (Zusatzentgelt, ZE).
OPS Coding and Data Collection
For all NUBs granted Status 1 or Status 11, data collection is mandatory. An OPS code is automatically generated for these methods through an internal process between InEK and BfArM.
As a result:
No separate OPS proposal to BfArM and no ZE proposal to InEK is required for NUBs with Status 1 or 11.
This is a frequent point of confusion and an important procedural simplification.
NUB for Medical Devices
For medical devices, a completed CE marking — or one expected in the near future — is a prerequisite for NUB submission. Once CE-marked, devices may be used in the inpatient setting under the principle of “permission with prohibition reservation”, meaning use is allowed unless explicitly excluded by the Gemeinsamer Bundesausschuss (G-BA).
To qualify for NUB reimbursement, the method must demonstrate a verifiable additional or incremental benefit compared with established care, in line with the efficiency requirement of the SHI system.
Since 2016, procedures involving high-risk medical devices (Class IIb and III) are additionally subject to benefit assessment under §137h SGB V.
NUB for Pharmaceuticals and ATMPs
For pharmaceuticals, key criteria include EMA approval (or pending approval) and significant additional costs not covered by existing DRGs, combined with demonstrable patient benefit.
A specific pathway exists for Advanced Therapy Medicinal Products (ATMPs). Hospitals may submit NUB inquiries for ATMP-based methods by 30 April. If submitted on time, hospital-specific reimbursement agreements can be concluded from 1 July, even if InEK’s formal assessment is still pending.
ATMPs include:
- Gene therapies
- Somatic cell therapies
- Biotechnologically processed tissue products
Who Actually Submits a NUB Application and Why That Matters
One of the most persistent misunderstandings about German NUB reimbursement is who controls the application process and on what basis decisions are made.
NUB applications are submitted exclusively by hospitals, via the annual portal operated by InEK.
Manufacturers cannot submit applications themselves, nor can they appeal decisions independently.
Within hospitals, the application is typically coordinated by the Medical Controlling Department (Medizincontrolling), often led by a Head of Medical Controlling (Leitung Medizincontrolling) or DRG Manager, working closely with:
- The Chief Financial Officer (Kaufmännische Direktion / CFO)
- The DRG Coding Team
- The Clinical Department Head (Chefarzt) sponsoring the method
- In some cases, the Hospital Controller (Kostenrechnung / Controlling)
This structural reality shapes everything that follows.
NUB is not a manufacturer-led innovation process. It is a hospital-led reimbursement imbalance claim.
The Annual NUB Timeline (Why Timing Is Non-Negotiable)
The NUB process runs on a fixed statutory annual cycle, aligned with the German hospital financing calendar:
- September–October
Hospitals prepare and submit NUB applications via the InEK portal - 31 October
Absolute submission deadline (no extensions, no late entries) - January (following year)
InEK publishes NUB status decisions (Status 1–4) - Following calendar year
Hospitals with Status-1 approvals may negotiate innovation payments with sickness funds
Two strategic implications follow immediately:
- Missing the October deadline means waiting an entire year, regardless of clinical urgency or market readiness
- Evidence generation, cost modelling, and internal hospital alignment must be completed months before submission
NUB is therefore not an “on-demand” mechanism.
It rewards anticipation, preparation, and internal hospital readiness, not speed.
What Hospitals Must Submit and Why DRG Analysis Is Central
A NUB application is not a clinical value dossier.
It is a formal argument that the existing DRG system fails to reimburse a method appropriately.
To submit a credible application, hospitals must provide:
- A structured description of the new examination or treatment method
- Justification that the method is new or substantially modified
- Evidence that the method is not adequately reimbursed under current DRGs
- A DRG-based cost analysis, typically including:
- DRGs currently assigned to the cases
- Actual hospital costs per case
- Cost components not recovered by the DRG tariff
- Explanation of why existing DRGs cannot reasonably be adapted or split
This DRG analysis is the scientific and economic core of the application.
From InEK’s perspective, the decisive question is not:
“Is this technology innovative or clinically valuable?”
but rather:
“Does this method create a reproducible, structural mismatch between hospital costs and DRG reimbursement?”
If that mismatch cannot be demonstrated quantitatively, the application will fail — regardless of clinical merit.
How DRG Reimbursement Analysis Is Actually Constructed
In practice, the DRG analysis submitted with a NUB application draws on:
- Internal cost accounting (Kostenrechnung)
- Case-mix data for comparable patients
- Cost centre allocation (e.g. OR time, ICU stay, consumables, implants)
- Incremental cost comparison between standard care and the new method
- Identification of non-recoverable cost elements, such as:
- Additional device costs
- Extended procedure time
- Increased staffing intensity
- ICU or intermediate-care utilisation not reflected in the DRG
Importantly, downstream savings (e.g. reduced readmissions, fewer complications, shorter long-term care needs) carry little weight unless they materialise within the index admission and DRG accounting window. NUB applications are assessed annually by the Institute for the Hospital Remuneration System (InEK), which evaluates whether new examination and treatment methods are inadequately reimbursed under the existing DRG framework.
NUB is therefore governed by micro-economic hospital accounting, not system-level cost-effectiveness.
Why DRG Analysis Is So Often the Failure Point
Many NUB applications fail not because the technology lacks value, but because that value cannot be expressed in DRG logic.
Common failure modes include:
- Costs distributed across multiple departments
- Savings occurring post-discharge
- Resource use that is real but invisible to DRG accounting
- Insufficient internal cost-tracking granularity
- Reliance on generic health-economic arguments rather than hospital data
From InEK’s perspective, these are not innovation problems.
They are accounting problems.
This explains why technologies that are:
- Procedural
- Implantable
- Capital-intensive
- Per-case cost visible
perform far better than technologies that:
- Improve outcomes without adding billable activity
- Optimise workflows
- Deliver longitudinal or system-level savings
NUB does not reward value in theory.
It rewards cost imbalance in practice.
The Strategic Consequence for Innovators
Because hospitals submit the application, manufacturers live or die by hospital capability, not enthusiasm.
This creates three unavoidable strategic realities:
- Hospital selection matters more than clinical interest
A motivated clinical champion without strong medical controlling support will not succeed. - Manufacturers must actively support the DRG analysis
Leaving cost modelling entirely to hospitals is one of the most common causes of failure. - Evidence must be designed to feed the DRG argument
If data cannot be translated into per-case cost imbalance, it will not influence InEK decisions.
NUB is not a marketing exercise.
It is a joint hospital–manufacturer reimbursement construction exercise.
Why This Explains So Much of the NUB Data
This submission structure explains several long-observed patterns in NUB outcomes:
- Why pharmaceuticals outperform medical devices
- Why complex implants dominate Status-1 approvals
- Why digital and workflow technologies struggle
- Why repeated resubmission does not guarantee progression
NUB does not select for “innovation”.
It selects for technologies that hospitals can cost, code, and defend within DRG logic.
Lesson 1: Treat NUB as a Time-Limited Bridge, Not a Destination
The most common strategic error is assuming that repeated NUB approval implies eventual DRG inclusion.
The evidence shows this is false.
In practice:
- Many NUBs remain in the system for years
- Only a minority convert into DRGs or Zusatzentgelte
- Persistence does not equal progression
NUB has no built-in graduation mechanism. Without a planned transition, it becomes a holding pattern rather than a bridge.
Practical implication
Before the first NUB application is filed, innovators should already know:
- Where the technology is meant to land (DRG adaptation, Zusatzentgelt, OPS change, DiGA, outpatient shift, or exit)
- What German-specific evidence InEK would need to justify that move
- Whether that evidence can realistically be generated within 2–3 years
If these questions cannot be answered upfront, NUB is unlikely to help.
Lesson 2: Design the NUB Case Around Cost Traceability Not Clinical Novelty
NUB is frequently described as an innovation mechanism. In reality, it is an accounting mechanism first.
InEK consistently rewards what it can cost-trace.
This explains why pharmaceuticals and certain implants perform well in NUB:
- Costs sit in discrete cost centres
- Budget impact is immediately visible
- Accounting logic maps cleanly onto DRG calculations
By contrast, many MedTech and digital solutions:
- Shift costs across departments
- Reduce downstream complications rather than add billable activity
- Generate value outside the index admission
Practical implication
A strong NUB dossier is written for hospital controllers, not clinicians.
That means:
- Explicit mapping of affected cost centres
- Clear demonstration of current DRG under-recovery
- Quantification of hospital-level financial imbalance
Clinical excellence alone is not sufficient. NUB does not reward “value” unless it is visible in hospital accounting.
Lesson 3: Use NUB to Generate the Right Evidence Not Generic Evidence
A recurring failure mode in NUB strategies is misaligned evidence generation.
Many companies collect:
- Regulatory-grade clinical endpoints
- International health-economic models
- Outcomes that never translate into DRG logic
But InEK decisions hinge on:
- Hospital cost data
- Utilisation patterns
- Reproducibility across sites
- Stability of accounting assumptions
Practical implication
NUB-linked pilots must be explicitly designed to answer German reimbursement questions, not generic HTA ones.
This requires:
- Sites with strong cost accounting
- Capture of workflow, staffing, and resource use
- Evidence that supports a concrete DRG or Zusatzentgelt argument
NUB is one of the few European mechanisms where claims-level reality matters more than formal HTA elegance.
Lesson 4: For Digital Health, NUB Is Rarely the Right End-Game
Digital health innovators are often drawn to NUB as a hospital entry point. In most cases, this is a strategic mismatch.
Digital technologies typically:
- Do not map cleanly onto DRG cost centres
- Deliver value longitudinally, not per admission
- Depend on behavioural uptake rather than procedural volume
Germany already recognises this mismatch. This is why separate digital pathways exist, and why performance-based reimbursement is increasingly discussed at federal and sickness-fund level.
Practical implication
For digital health, NUB should only ever be:
- A narrowly scoped pilot mechanism, or
- A short-term evidence generator
Long-term reimbursement logic should sit elsewhere:
- DiGA
- Hybrid or outcome-linked contracts
- Disease-management funding
- Regional or sickness-fund agreements
Trying to force digital value into DRG logic via NUB is usually a dead end.
Lesson 5: Plan the Exit From Day One
The strongest NUB strategies are designed backwards.
Rather than asking “How do we get Status 1?”, successful innovators ask:
“What must be true for us to exit NUB in three years?”
Possible exits include:
- A new Zusatzentgelt
- A DRG split or recalculation
- A shift to outpatient or digital reimbursement
- A conscious decision to abandon the hospital pathway
Practical implication
Every NUB strategy should include:
- A defined maximum duration
- Clear transition criteria
- An explicit kill decision if progression stalls
Without this discipline, NUB becomes a pricing ceiling, not a growth enabler.
Lesson 6: NUB Can Trigger Mandatory Benefit Assessment for High-Risk Devices
For Class IIb and Class III medical devices, NUB is not merely financial — it is regulatory.
Under §137h SGB V, hospitals applying for NUB funding for methods involving high-risk devices must notify the G-BA, in coordination with the manufacturer. This applies regardless of whether InEK approves the NUB.
Critically:
- Hospitals do not decide whether a method is “new” or “particularly invasive”
- That determination rests solely with the G-BA
- Once triggered, formal benefit assessment can follow
Practical implication
Submitting a NUB application for a high-risk device without a coordinated regulatory strategy can:
- Accelerate scrutiny
- Restrict use
- Expose the technology to early exclusion
This helps explain why high-risk devices often face:
- Lower Status-1 rates
- Longer stagnation
- Higher drop-out
NUB should only be pursued when clinical evidence, hospital alignment, and §137h consequences are fully understood.
What Recent NUB Statistics Actually Tell Us
In January 2025, InEK published the outcomes of 1,025 NUB applications submitted for 2024.
- 300 technologies (29%) received Status 1
- A small fraction received conditional approval
- The majority were rejected
Approved technologies clustered tightly around:
- Cardiovascular implants
- Endovascular valve systems
- Neuromodulation
- Extracorporeal support
- Complex endoscopic and surgical interventions
This pattern is instructive.
It confirms that NUB still functions but only for technologies with clear procedural definition, visible hospital costs, and strong DRG alignment.
Status 1 does not imply long-term reimbursement. It merely opens a negotiation window.
Why Evidence Generation Still Fails After Adoption
One of the least discussed barriers to exiting NUB is the hospital evidence gap.
German hospitals frequently adopt new technologies without structured research involvement. Even when utilisation is high, prospective, reimbursement-relevant evidence is rare and strongly correlated with academic status and hospital size.
For innovators, this creates a brutal reality:
- Adoption ≠ Evidence
- Presence ≠ Influence
- Use ≠ Reimbursement progression
Evidence generation is not optional. It must be actively designed into the NUB strategy from the outset.
Governance, Pricing, and the Hidden Risks
Many NUB failures stem from weak hospital–manufacturer governance.
Hospitals submit applications annually.
Manufacturers carry regulatory, evidence, and commercial risk.
Yet alignment is often informal or absent.
At a minimum, governance should define:
- Evidence responsibilities
- §137h notification handling
- Data ownership
- Exit and kill criteria
Poorly negotiated NUB prices are another silent trap. Early NUB pricing often anchors future discussions, compressing long-term value.
NUB prices are rarely as temporary as companies assume.
A Final Decision Gate: Should You Use NUB at All?
Before committing to NUB, innovators should be able to answer yes to all of the following:
- Can we demonstrate a clear hospital-level cost imbalance?
- Can our costs be isolated in DRG accounting?
- Do we have sites capable of German-relevant RWE?
- Are we prepared for §137h scrutiny if applicable?
- Do we know our exit before we enter?
- Can we walk away if progression stalls?
If not, NUB is unlikely to help and may actively delay the correct reimbursement pathway.
Final Synthesis
German NUB reimbursement is not broken.
What fails is the assumption that it is a reimbursement strategy.
In reality, NUB is a temporary, conditional funding tool designed for a narrow class of technologies that can demonstrate immediate hospital cost imbalance and survive early scrutiny.
For MedTech and digital health innovators, success does not come from:
- More applications
- Louder clinical claims
- Longer persistence
It comes from strategic discipline:
- Knowing when NUB fits — and when it does not
- Designing evidence for German decision logic
- Planning the exit before the first submission
Used properly, NUB can accelerate adoption.
Used naïvely, it delays real reimbursement sometimes by years.
What Happens After You Successfully Secure a NUB — and Where the Real Risks Begin
A positive NUB Status 1 (or 11) decision is often interpreted as a breakthrough. In reality, it is best understood as permission to negotiate, not reimbursement certainty.
Once a NUB is granted, innovators and hospitals enter a phase that is commercially, operationally, and strategically fragile.
Issue 1: NUB Does Not Create a Price It Creates a Negotiation
A NUB approval does not establish a tariff, reference price, or national payment.
Instead:
- Each hospital must negotiate individually with sickness funds
- Prices vary by region, hospital, and payer
- Negotiations can fail, stall, or result in uneconomically low payments
There is no minimum price protection.
Why this matters
Early NUB prices often become informal benchmarks for future reimbursement discussions. A weak negotiation can permanently anchor expectations downward.
Issue 2: Volume Risk Is Extreme
NUB funding is:
- Hospital-specific
- Case-by-case
- Dependent on clinical uptake
Even with Status 1:
- Some hospitals never use the method
- Some restrict it to a handful of patients
- Some abandon it after one year
There is no guaranteed volume.
Practical consequence
Revenue forecasts based on “number of NUB hospitals” are almost always wrong.
Issue 3: Annual Re-Approval Risk (Nothing Is Secure)
NUB status is valid for one year only.
Each year:
- Hospitals must reapply
- InEK reassesses whether:
- Costs are still inadequately covered
- Data are sufficient to move the method into DRG or Zusatzentgelt
- Status can be downgraded or removed
Many technologies lose NUB status without having secured an exit.
Issue 4: Evidence Expectations Quietly Increase
Although NUB is classified as an “unconditional” innovation payment, expectations escalate over time.
After approval:
- InEK expects better cost data
- Payers expect utilisation justification
- Hospitals expect workflow stability
- For high-risk devices, the Gemeinsamer Bundesausschuss (G-BA) may scrutinise benefit and safety under §137h SGB V
If evidence does not mature, progression stalls.
Issue 5: Operational Burden on Hospitals Increases
Once a NUB is active, hospitals must:
- Track cases precisely
- Assign OPS codes correctly
- Document costs and outcomes
- Defend negotiations with payers
This workload often falls on Medizincontrolling teams already under pressure.
If the burden outweighs the perceived benefit, hospitals quietly disengage — even if the technology is clinically valued.
Issue 6: The Exit Problem (The Biggest Risk)
The most common failure scenario is NUB without an exit.
Outcomes often look like this:
- NUB renewed for several years
- Prices remain flat or decline
- No DRG or Zusatzentgelt transition
- Hospital interest fades
- Manufacturer is trapped at a temporary price point
This is why NUB is frequently described as a holding pattern, not a launchpad.
Issue 7: Investor and Board Misinterpretation
From the outside, a NUB looks like “reimbursement success”.
Internally, it is:
- Conditional
- Local
- Time-limited
- Reversible
When NUB is presented as validation rather than risk-managed early access, it creates:
- Over-optimistic projections
- Misaligned commercial strategy
- Difficult follow-on funding conversations
The Core Lesson
A successful NUB does not answer the reimbursement question.
It merely postpones it.
The technologies that benefit from NUB are those that:
- Use the period to generate German-relevant cost evidence
- Negotiate prices defensively
- Actively plan the transition to DRG, ZE, or alternative pathways
- Are prepared to walk away if the exit does not materialise
Those that do not often find themselves stuck at temporary prices with no route forward.
Frequently Asked Questions: NUB Reimbursement in Germany
1. What does NUB stand for in the German healthcare system?
NUB stands for Neue Untersuchungs- und Behandlungsmethoden, meaning New Examination and Treatment Methods. It refers to the annual hospital-led mechanism that allows temporary additional funding for inpatient methods that are not adequately reimbursed under existing DRGs.
2. Who is allowed to submit a NUB application in Germany?
Only hospitals can submit NUB applications, via the annual portal operated by InEK.
Medical device manufacturers, diagnostics companies, and digital health providers cannot submit applications themselves.
3. What is the annual timeline for NUB applications?
NUB follows a fixed yearly cycle:
- Applications are prepared and submitted between September and 31 October
- InEK publishes decisions in January
- Approved hospitals may negotiate innovation payments during the following calendar year
Missing the October deadline means waiting a full year.
4. What does a hospital have to demonstrate to secure NUB approval?
A hospital must demonstrate a structural reimbursement imbalance, showing that:
- The method is new or significantly modified
- Existing DRGs do not adequately cover the actual hospital costs
- The imbalance is reproducible and case-based
Clinical value alone is insufficient; DRG-level cost evidence is decisive.
5. Why is DRG cost analysis so critical in a NUB application?
Because NUB is fundamentally an accounting-based mechanism.
InEK evaluates whether real hospital costs exceed DRG reimbursement in a systematic way. If the cost imbalance cannot be shown using hospital accounting data, the application will fail regardless of clinical merit.
6. Why do pharmaceuticals perform better than many medical devices in NUB?
Pharmaceuticals often:
- Sit in discrete cost centres
- Have visible per-case costs
- Map cleanly onto DRG logic
Many medical devices and digital technologies generate value that is diffuse, downstream, or longitudinal, which is harder to defend within DRG accounting.
7. Does NUB approval guarantee long-term reimbursement or DRG inclusion?
No.
A positive Status 1 decision only allows hospitals to negotiate temporary payments with sickness funds. There is no automatic pathway from NUB to DRG adaptation or permanent Zusatzentgelt inclusion.
8. Can a NUB application trigger regulatory or benefit assessment scrutiny?
Yes.
For Class IIb and Class III medical devices, a NUB application can trigger notification obligations under §137h SGB V, involving the Gemeinsamer Bundesausschuss.
This can lead to early benefit assessment or restrictions, even if NUB funding is not granted.
9. Is NUB an appropriate pathway for digital health technologies?
In most cases, no.
Digital health solutions typically deliver longitudinal or workflow-based value that does not align with DRG logic. NUB may be used as a short-term pilot or evidence generator, but long-term reimbursement usually requires alternative pathways such as DiGA, performance-based contracts, or regional agreements.
10. When should a company not pursue NUB reimbursement?
NUB is usually the wrong pathway if the technology:
- Does not create a clear per-case hospital cost delta
- Primarily delivers downstream or outpatient savings
- Is workflow- or behaviour-based
- Cannot be cleanly costed within DRG accounting
- Cannot tolerate early regulatory scrutiny
In these cases, NUB delays rather than accelerates sustainable reimbursement.
References
- Institut für das Entgeltsystem im Krankenhaus (InEK).
Neue Untersuchungs- und Behandlungsmethoden (NUB).
InEK annual guidance and application materials for NUB reimbursement within the German DRG system.
InEK, Siegburg, Germany.
https://www.g-drg.de/ag-drg-system/nub - Institut für das Entgeltsystem im Krankenhaus (InEK).
Aufstellung der Informationen nach §6 Abs. 2 KHEntgG – NUB 2025.
Official publication of NUB applications, status decisions, and submitting hospitals.
InEK, January 2025.
https://www.g-drg.de/ag-drg-system-2025/neue-untersuchungs-und-behandlungsmethoden-nub - Gemeinsamer Bundesausschuss (G-BA).
Hinweise zur Informationsübermittlung nach §137h SGB V bei neuen Untersuchungs- und Behandlungsmethoden.
Federal guidance on benefit assessment and patient safety obligations for high-risk medical devices.
G-BA, Berlin.
https://www.g-ba.de/service/fachnews/80/ - German Social Code Book V (SGB V).
§137h – Early benefit assessment for methods involving high-risk medical devices.
Federal Republic of Germany.
https://www.gesetze-im-internet.de/sgb_5/__137h.html - German Hospital Remuneration Act (KHEntgG).
§6 – Additional payments and innovation funding mechanisms.
Federal Republic of Germany.
https://www.gesetze-im-internet.de/khentgg/ - Federal Institute for Drugs and Medical Devices (BfArM).
OPS Coding System and Interaction with DRG and NUB Data Collection.
BfArM, Bonn, Germany.
https://www.bfarm.de - Hoffmann A, Irps S, Kersting T.
Development of reimbursement of new examination and treatment methods (NUB) in the German DRG system.
ISPOR 19th Annual European Congress, Vienna, 2016. - Schreyögg J, Busse R.
Hospital payment systems in Europe: a comparison of DRG-based reimbursement mechanisms.
Health Policy, 2011; 102(2–3): 209–215. - Busse R, Blümel M.
Germany: Health System Review.
European Observatory on Health Systems and Policies.
Health Systems in Transition, 2014; 16(2). - Burgdorf F, Schmitz H, et al.
Mind the (research) gap: utilisation of new medical technologies and research activity in German hospitals.
International Journal of Health Policy and Management, 2024.
https://pmc.ncbi.nlm.nih.gov/articles/PMC12124022/ - Augurzky B, Beivers A, et al.
Innovative payment schemes for medical technologies in Europe.
Rheinisch-Westfälisches Institut für Wirtschaftsforschung (RWI), 2023. - European Medicines Agency (EMA).
Advanced Therapy Medicinal Products (ATMPs): regulatory framework.
https://www.ema.europa.eu/en/human-regulatory/overview/advanced-therapy-medicinal-products-overview
Glossary of Terms
aG-DRG (German Diagnosis-Related Groups)
The German hospital payment system that reimburses inpatient care using case-based tariffs. Each DRG reflects an average cost for a defined diagnosis and procedure combination. New methods are often not adequately captured when first introduced.
ATMP (Advanced Therapy Medicinal Product)
A category of innovative medicines including gene therapies, somatic cell therapies, and tissue-engineered products. ATMPs follow a specific NUB submission timeline and may allow earlier hospital-specific agreements due to their high cost and novelty.
BfArM (Federal Institute for Drugs and Medical Devices)
Germany’s federal authority responsible for medical device oversight and the OPS coding system. For NUBs with Status 1 or 11, OPS codes are generated automatically through an internal process between BfArM and InEK.
CE Marking
Regulatory certification indicating that a medical device complies with EU safety and performance requirements. A completed (or imminent) CE mark is a prerequisite for NUB submission in the inpatient sector.
CED (Coverage with Evidence Development)
A reimbursement approach used in several European countries where temporary funding is explicitly linked to mandatory evidence generation and a predefined transition to permanent reimbursement. Unlike CED schemes, NUB does not formally require evidence at exit.
DRG Analysis (Cost Imbalance Analysis)
A hospital-level economic assessment demonstrating that the actual costs of a method exceed reimbursement under existing DRGs. This analysis is central to every NUB application and typically includes cost centres, resource use, and unrecovered costs.
G-BA (Federal Joint Committee)
Germany’s highest decision-making body for healthcare coverage. The G-BA assesses clinical benefit and patient safety. For high-risk medical devices, a NUB application may trigger early benefit assessment under §137h SGB V.
InEK (Institute for the Hospital Remuneration System)
The national body responsible for maintaining the German DRG system and assessing NUB applications. InEK evaluates whether new examination and treatment methods are inadequately reimbursed under existing DRGs and assigns NUB status annually.
Medizincontrolling (Medical Controlling)
A hospital department responsible for DRG coding, reimbursement optimisation, and economic analysis. NUB applications are typically coordinated by the Head of Medical Controlling or a DRG Manager, in collaboration with finance and clinical leads.
NUB (Neue Untersuchungs- und Behandlungsmethoden)
The German mechanism for temporary, extrabudgetary reimbursement of new examination and treatment methods that are not yet adequately covered by the DRG system. NUB funding is hospital-specific, time-limited, and does not guarantee long-term reimbursement.
NUB Status (1, 2, 3, 4, 11)
Outcome categories assigned by InEK to NUB applications.
- Status 1 / 11: Eligible for negotiation with sickness funds
- Other statuses: Not eligible for negotiation in that year
OPS (Operationen- und Prozedurenschlüssel)
The German procedure coding system used for hospital reimbursement and data collection. For NUBs with Status 1 or 11, OPS codes are generated automatically without a separate proposal.
PEPP
A separate payment system for psychiatric and psychosomatic services. NUB-PEPP follows the same submission window as NUB-DRG but applies to mental health settings.
SGB V (Social Code Book V)
The legal framework governing statutory health insurance in Germany. §137h SGB V regulates early benefit assessment for new methods involving high-risk medical devices.
SHI (Statutory Health Insurance)
Germany’s mandatory public health insurance system covering the majority of the population. Services must be included in the SHI catalog to be reimbursed as standard care.
Status-1 Negotiation
Hospital-level negotiations between a hospital and sickness funds following a positive NUB decision. These negotiations determine temporary innovation payments but do not create national tariffs.
Zusatzentgelt (ZE)
A permanent add-on payment outside the DRG tariff for specific high-cost items or procedures. Some NUBs may eventually transition into a ZE, but this is not automatic.