France has entered a new, more disciplined era in the governance of diagnostic innovation—an era in which public funding is tied directly to evidence, real-world performance, and measurable system-level value, rather than to novelty, political support, or industrial momentum. The replacement of the long-standing Référentiel des actes innovants hors nomenclature (RIHN) with the unified Liste des actes innovants hors nomenclature (LAHN) in 2024 marks not a cosmetic update, but a structural reset of how France determines which diagnostic technologies warrant national investment.
Where RIHN operated as a broad, sometimes permissive transitional mechanism for innovative laboratory and anatomocytopathology procedures, LAHN establishes a single, consolidated innovation stock, financed through MERRI G03, and governed by mandatory, systematic evaluation by the Haute Autorité de Santé (HAS). Innovation support is no longer open-ended: each diagnostic admitted to LAHN is now placed on a time-limited runway, during which it must demonstrate analytical validity, clinical utility, population relevance, and readiness for integration into the NABM. The Haute Autorité de Santé (HAS)https://www.has-sante.fr
This shift carries profound implications across oncology, genomics, haematology, infectious diseases, microbiology, and ctDNA-based liquid biopsy technologies. What previously resembled a patchwork of pilot projects has been transformed into one of Europe’s most structured and evidence-based ecosystems for advanced diagnostics. LAHN preserves space for innovation—but it demands proof. Every procedure is continuously assessed against real-world clinical practice, public-health priorities, and healthcare-system impact, ensuring that the diagnostics which remain funded are those that deliver
Why France Abandoned RIHN: Ending a System that Rewarded Novelty but Not Value
For more than a decade, the Référentiel des actes innovants hors nomenclature (RIHN) acted as France’s mechanism for allowing hospitals to deploy innovative biological and anatomocytopathology tests outside the strict boundaries of the NABM. Although conceived as a transitional pathway, conditional on evidence generation and designed to support promising diagnostics, it gradually became a victim of its own flexibility.
In policy terms, the weakness of RIHN resembled a classic problem in evidence-generation economics: a mechanism designed for exploration gradually became an instrument of avoidance. Hospitals used RIHN to gain early access to advanced procedures, but without aligned incentives for systematic data collection, the result was a widening gap between technical promise and demonstrable clinical value. This pattern—well-documented in diffusion models for medical technologies—creates an illusion of innovation, in which activity expands while evidence remains flat. France’s move from RIHN to LAHN can therefore be interpreted not merely as administrative consolidation, but as a correction of a structural market failure: the failure to convert experimentation into measurable knowledge.
The Structural Problems of RIHN
RIHN evolved into what policymakers increasingly described as a “parking zone” for unassessed technologies. Key issues included:
- No enforced timeline for evaluation or exit.
- Inconsistent evidence requirements, leaving some tests permanently under innovation funding.
- Wide variation between hospitals in how RIHN-coded diagnostics were prescribed or reimbursed.
- Chronic oversaturation of MERRI-based innovation budgets (especially MERRI G03).
- Lack of a unified national view on which tests were supported, why, or for how long.
In effect, the system allowed diagnostics to remain in subsidised limbo long after their clinical value should have been demonstrated—or, in some cases, disproven.
Policy Pressure for a New Model
By 2021–2023, the Ministry of Health, DGOS, HAS, and UNCAM all recognised that France needed to:
- reintroduce discipline and accountability into innovation funding
- ensure that laboratories demonstrated real-world utility, not just analytical novelty
- integrate diagnostics into care pathways, especially oncology, haematology, infectious diseases, microbiology, and precision medicine
- protect innovation budgets from stagnation and unnecessary expenditure
The result was a collective decision: RIHN in its existing form was no longer sustainable. French Ministry of Health
https://solidarites-sante.gouv.fr
The LAHN Framework: Structured Innovation with a Defined Runway
Time-limited innovation mechanisms are grounded in the principle of progressive evidence accumulation, analogous to adaptive trial frameworks in pharmaceuticals. By constraining the duration of public funding, LAHN forces a transition from hypothesis to validation. This mirrors Bayesian decision theory: an innovation budget represents an initial prior, and the continuation of funding is conditional on updated evidence that shifts the posterior probability of clinical value. France’s LAHN system is one of the first national diagnostic frameworks to formalise this logic at scale, effectively requiring innovators to “earn” staying power through measurable, real-world performance.
The 2024 introduction of the Liste des actes innovants hors nomenclature (LAHN) represents France’s most significant diagnostic-policy reset in years. Unlike RIHN, LAHN is not a permissive list—it is a structured, time-bound, evidence-driven innovation ecosystem.
The Core Design Principles of LAHN
LAHN operates on three foundational principles:
1. Consolidation into a single national innovation stock
RIHN and all its complementary lists were merged into one coherent system, eliminating fragmentation and creating a unified catalogue of funded innovative diagnostics.
This consolidation:
- improves transparency
- avoids duplication
- allows national tracking of utilisation
- ensures every test is visible to DGOS, HAS, and UNCAM
2. Mandatory and systematic HAS evaluation
The most important structural change is the requirement that every test on LAHN undergo formal assessment by HAS, including:
- analytical validity
- clinical validity
- clinical utility
- comparative performance
- population-level relevance
- public-health impact
This brings diagnostics in line with the scientific rigour seen in pharmaceuticals and medical devices.
3. A limited, conditional innovation runway
Under LAHN:
- innovation funding is time-limited, not indefinite
- every test must eventually:
- progress to NABM reimbursement, or
- exit the system, or
- be reclassified with revised conditions
- MERRI G03 is no longer a permanent refuge for unassessed technologies
This model forces a sharper link between public funding and clinical evidence.
What Counts as Evidence Under LAHN? France’s New Expectations
For a diagnostic to survive LAHN’s innovation runway, it must provide more than technical superiority. HAS now evaluates diagnostics across multidimensional criteria. The LAHN pathway France now represents the country’s central mechanism for evidence-driven diagnostic innovation.”
✔ Analytical validity
Can the test produce accurate, reproducible results consistent with its technical claims?
✔ Clinical validity
Do the results correlate meaningfully with clinical conditions, biomarkers, or actionable disease states?
✔ Clinical utility
Does use of the test change clinical decision-making, improve triage, or guide therapy?
✔ Comparative performance
How does it perform relative to current NABM-listed diagnostics?
Incremental value is essential.
✔ Impact on care pathways
Does the test:
- shorten diagnostic delay?
- reduce reliance on invasive procedures?
- streamline or personalise therapy?
✔ Economic and organisational value
Does the test deliver:
- faster time-to-result
- improved patient flow
- reduced overtreatment
- more efficient resource use
- potential cost savings
✔ Alignment with public-health priorities
For infectious disease, oncology, AMR, genomics and liquid biopsy, LAHN prioritises diagnostics tied to real population benefit.
This framework means that for innovative tests—whether NGS panels, ctDNA assays, rapid infectious disease tests, or AI-enabled diagnostics—evidence must be multidimensional and measurable.
The scientific challenge in diagnostic evaluation lies in its inherently multilayered structure. Analytical validity establishes whether a test can measure what it claims; clinical validity determines whether that measurement corresponds to meaningful pathology; and clinical utility assesses whether the result improves decisions or outcomes. These are not interchangeable—it is entirely possible for a test to demonstrate flawless analytical performance while providing no clinically actionable insight. LAHN’s insistence on evaluating all three dimensions represents an alignment with international best practice in diagnostic science and reduces the long-standing problem of “false innovation,” where technically impressive assays fail to generate real-world benefit.
Early LAHN Evaluations: Myeloma and NSCLC as Proof of the New System
The first evaluations under LAHN illustrate how the new framework rewards diagnostics with strong supporting evidence.
1. Targeted NGS Panel for Multiple Myeloma
HAS concluded that the test demonstrated:
- sufficient clinical relevance (SA)
- high added value (ASA II)
- clear benefits for therapeutic stratification
This shows that advanced molecular diagnostics can progress rapidly when they meet evidence expectations.
NGS and ctDNA technologies are perfect stress-tests for the LAHN framework because they embody the three scientific pillars of advanced diagnostics: molecular resolution, clinical relevance, and pathway impact. In both myeloma and NSCLC, genomic profiles directly influence therapy selection, resistance monitoring, and prognostic stratification. This creates a closed analytical loop between what the test measures, how clinicians act on it, and how patients ultimately respond. By granting high or moderate added-value scores to these assays, HAS is signalling that LAHN is not anti-innovation—it is pro-evidence. Technologies that sit at the intersection of precision biology and real-world decision-making are precisely the kind that LAHN seeks to accelerate into routine practice.
2. Liquid Biopsy ctDNA Panel for NSCLC
The ctDNA-based panel was assessed with:
- moderate but meaningful added value (ASA III)
- strong justification when tissue biopsy is not feasible
- relevance for mutation detection and therapy assignment
This marks a milestone for liquid biopsy adoption in France and demonstrates HAS’ openness to high-complexity technologies when the evidence is sound.
What LAHN Means for Diagnostic Manufacturers
LAHN fundamentally reshapes how diagnostic companies should approach the French market.The emerging reality in France is that diagnostics must become evidence-responsive technologies—systems that generate data not only from biological samples but also about their own clinical performance. Under LAHN, manufacturers are incentivised to embed real-world evidence mechanisms into their platforms, whether through integrated reporting, reflex testing algorithms, or prospective outcome tracking. This represents a philosophical shift: diagnostics are no longer evaluated solely as laboratory instruments, but as components of intelligent clinical ecosystems capable of demonstrating value dynamically, not retrospectively. Companies that design with this in mind will have a structural advantage in LAHN-era France.
1. Evidence is now the currency of access
Companies must plan for:
- prospective studies
- real-world evidence
- post-market data
- clear demonstration of clinical decision change
2. Workflow integration matters
HAS is evaluating how tests operate within care pathways, not just their laboratory accuracy.
3. Economic value is now a condition for reimbursement
NABM integration increasingly requires:
- cost-offset evidence
- public-health impact
- stewardship benefits (e.g., AMR reduction)
4. Companies must act earlier
LAHN favours manufacturers who build evidence early and engage with HAS proactively.
5. Innovation without proof will exit the system
The era of “innovation for its own sake” is finished.
demonstrable value.
France’s New Diagnostic Landscape: A More Scientific, Measurable, and Accountable Ecosystem
The introduction of the LAHN pathway represents more than a technical correction; it signals a shift in the philosophy of diagnostic adoption within France’s healthcare system. Diagnostics—once treated as ancillary tools—are now positioned as core drivers of clinical decision-making, population health outcomes, and resource allocation.
France’s policymakers have effectively communicated that innovation is welcome, but it must be earned. Under LAHN:
- funding is conditional
- evaluation is mandatory
- timelines are enforced
- claims must be validated
- and every test is measured against the realities of clinical practice
This aligns France with a broader European trajectory—spanning Germany (G-BA), the Netherlands (ZIN), Belgium (KCE), and the UK (NICE HTE)—toward structured diagnostic governance, where adoption depends on transparent evidence standards.
LAHN ensures that innovation funding is not a staging ground for promise, but a proving ground for value.
LAHN Rewards Real Innovation, Not Speculation
The fusion of RIHN into LAHN closes the chapter on an era where diagnostics could remain indefinitely subsidised without clear proof of benefit. France has now constructed an environment where analytical excellence must translate into clinical impact, and where innovation budgets feed into national value, rather than being absorbed by inertia. The LAHN pathway France now represents the country’s central mechanism for evidence-driven diagnostic innovation.
For manufacturers, laboratories, and policymakers, LAHN offers a more predictable, rational, and scientifically anchored pathway:
- Diagnostics with strong evidence will move faster toward NABM integration.
- Those without will exit the system efficiently.
- The incentives now favour technologies that change decisions, improve outcomes, and create public-health value.
Ultimately, LAHN strengthens France’s ability to deploy diagnostics that matter—those that refine therapy, accelerate diagnosis, optimise pathways, and support population-level priorities like AMR containment, cancer precision medicine, and rapid infectious disease detection.
It is a framework that protects public expenditure while accelerating access to truly transformative diagnostics.
One of the deeper conceptual shifts underpinning LAHN is the recognition that diagnostics are not only clinical tools but information infrastructure. They shape how health systems perceive disease, allocate resources, and respond to population-level challenges such as antimicrobial resistance, cancer stratification, and viral outbreaks. By tying funding to real-world data and pathway impact, France is reframing diagnostics as components of the national evidence architecture. This reclassification—subtle but profound—aligns diagnostics with fields like epidemiology and public-health intelligence, where value is measured not in isolation but in how systems learn and adapt.
Reference List
Haute Autorité de Santé (HAS). Favouriser l’accès aux actes innovants : la HAS impulse un nouvel élan au RIHN.
Official HAS communication explaining the policy drivers behind the reform of RIHN and the integration into LAHN.
https://www.has-sante.fr/jcms/p_3536104/fr/favoriser-l-acces-aux-actes-innovants-la-has-impulse-un-nouvel-elan-au-rihn
Haute Autorité de Santé (HAS). Séquençage haut débit ciblé d’un panel d’altérations moléculaires dans la prise en charge du myélome multiple.
Formal evaluation of a targeted NGS panel for Multiple Myeloma, demonstrating how LAHN supports high-impact molecular diagnostics.
https://www.has-sante.fr/jcms/p_3412489
Haute Autorité de Santé (HAS). Séquençage haut débit ciblé d’un panel de gènes sur ADN tumoral circulant (ctDNA) dans le cancer du poumon.
HAS assessment of a ctDNA-based NGS panel for NSCLC, illustrating the clinical utility expectations under LAHN.
https://www.has-sante.fr/jcms/p_3412493
Ministère de la Santé et de la Prévention. Réforme du RIHN et création de la Liste des Actes Hors Nomenclature (LAHN).
Government guidance detailing the purpose, structure, and implementation of the LAHN pathway.
https://solidarites-sante.gouv.fr/soins-et-maladies/qualite-securite-et-pertinence-des-soins/biologie-medicale/rihn
DGOS – Direction Générale de l’Offre de Soins. Missions d’intérêt général et d’aide à la contractualisation (MIGAC) / MERRI.
Overview of national funding frameworks, including MERRI G03, used historically to support innovative diagnostic acts.
https://solidarites-sante.gouv.fr/systeme-de-sante-et-medico-social/organisation-de-loffre-de-soins/les-missions-dinteret-general
UNCAM – Union Nationale des Caisses d’Assurance Maladie. Procédures d’inscription et de tarification des actes de biologie médicale (NABM).
National payer guidance on how diagnostics transition from innovation mechanisms to permanent NABM reimbursement.
https://www.ameli.fr/assure/remboursements/etre-bien-rembourse/biologie-medicale
Assemblée Nationale. Rapport d’information sur l’accès à l’innovation en santé (2023).
Parliamentary analysis underpinning France’s decision to impose stricter evidence requirements on diagnostic innovation.
https://www.assemblee-nationale.fr/dyn/16/rapports/cion-soc/l16b0970_rapport-information
Cour des comptes. Analyse de la pertinence et du financement de la biologie médicale (2024).
Independent audit highlighting inefficiencies in diagnostic funding structures and the need for reform.
https://www.ccomptes.fr/fr/publications
European Commission. Regulation (EU) 2017/746 — In Vitro Diagnostic Medical Devices (IVDR).
EU-wide regulatory framework shaping evidence expectations for IVDs across Member States.
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0746
INCa – Institut National du Cancer. Recommandations en biologie moléculaire appliquées à la cancérologie.
National guidelines describing molecular diagnostics in oncology, providing context for LAHN’s oncology-related decisions.
https://www.e-cancer.fr/Professionnels-de-sante/Recommandations-et-standards
The Scientist. Breaking Cross-Industry Barriers to Advance Companion Diagnostics.
Industry perspective on the challenges and opportunities for adopting innovative diagnostics in regulated healthcare systems.
https://www.the-scientist.com/breaking-cross-industry-barriers-to-advance-companion-diagnostics-73687
Odelle Technology (2025). Internal Policy Analysis: France tightens the science of innovation – the LAHN framework for IVD reimbursement.
Internal expert review providing strategic interpretation of the LAHN pathway for market access planning.
Internal publication — not publicly available.
FAQ
What is the LAHN pathway in France?
LAHN (Liste des actes innovants hors nomenclature) is France’s official innovation pathway for advanced diagnostics. It provides temporary funding while requiring systematic HAS evaluation and evidence generation before tests can transition to permanent NABM reimbursement. The LAHN pathway in France transforms innovation funding through stricter HAS evaluation and clearer evidence requirements for advanced diagnostics.
How does LAHN differ from RIHN?
RIHN allowed open-ended innovation funding with variable evidence requirements. LAHN introduces strict, time-limited funding, mandatory HAS assessment, and clear expectations for clinical utility, analytical validity, and economic value.
What happens to a diagnostic after entering LAHN?
It must demonstrate sufficient evidence to either progress to NABM reimbursement, be reclassified, or exit the system entirely if its value cannot be shown.
Why did France reform the diagnostic innovation system?
The previous system became over-saturated and poorly controlled. LAHN ensures innovation funding is tied to measurable clinical and public-health benefit.
Which diagnostic areas are most affected?
Oncology, genomics, haematology, infectious diseases, microbiology, and emerging liquid biopsy/ctDNA technologies are the primary domains undergoing structured evaluation under LAHN.
Glossary
LAHN — Liste des actes hors nomenclature
France’s national list for innovative diagnostic procedures that are not yet included in the NABM (Nomenclature des actes de biologie médicale).
Created in 2023–2024 to replace the RIHN, LAHN provides transitional, conditional funding—primarily via MERRI G03—for diagnostic acts that show promise but still require real-world data.
Progression from LAHN to full reimbursement depends on evaluation by HAS and tariff-setting by UNCAM.
RIHN — Référentiel des actes innovants hors nomenclature
The predecessor to LAHN historically used to support innovative biological and anatomopathological tests.
RIHN allowed early deployment but became structurally overloaded with obsolete, unevaluated, or low-value tests, prompting DGOS and HAS to reform the system.
RIHN is now fully absorbed into LAHN.
HAS — Haute Autorité de Santé
France’s national health authority responsible for HTA (évaluation des technologies de santé), clinical guidelines, and reimbursement recommendations.
For diagnostics, HAS provides:
- Service Attendu (SA): baseline clinical benefit
- Amélioration du Service Attendu (ASA): added clinical value versus existing alternatives
These ratings directly shape UNCAM tariff decisions.
Service Attendu (SA)
A core HAS metric assessing whether a diagnostic test provides meaningful clinical benefit (utilité clinique).
A test must achieve an SA rating of “suffisant” to be considered for reimbursement or to remain within the LAHN system.
Amélioration du Service Attendu (ASA)
HAS’s comparative value rating for diagnostics and therapeutics, graded from ASA I (major improvement) to ASA V (no improvement).
ASA influences:
- tariff
- pace of reimbursement
- positioning within the NABM
- prioritisation by UNCAM
High ASA levels (I–III) signal significant clinical and organisational value.
NABM — Nomenclature des actes de biologie médicale
The official catalogue of reimbursable laboratory tests in France.
Inclusion requires:
- A favourable HAS opinion (SA + ASA),
- A tariff determined by UNCAM,
- Publication of the updated code and coefficient.
Moving from LAHN → NABM represents full integration into national reimbursement.
UNCAM — Union nationale des caisses d’assurance maladie
The national body representing France’s public insurance funds.
UNCAM is responsible for:
- setting reimbursement tariffs (tarification),
- determining indication restrictions (conditions d’utilisation),
- adding new acts to the NABM,
- ensuring compliance with national budget constraints.
UNCAM’s decisions complete the reimbursement cycle.
MERRI — Missions d’enseignement, de recherche, de référence et d’innovation
Dedicated hospital funding streams supporting education, research, and innovation.
Under LAHN, many innovative diagnostics receive temporary funding through MERRI G03, which covers acts pending evaluation and potential NABM integration.
MIGAC — Missions d’intérêt général et d’aide à la contractualisation
Broader hospital financing envelope in which MERRI funding sits.
Historically a source of innovation funding for RIHN-listed tests.
Reforms are progressively shifting innovation financing toward performance-based, evidence-dependent allocation.
FMG2025 — France Médecine Génomique 2025
The national genomics programme establishing sequencing hubs (AURAGEN, SeqOIA) and defining priority genomic markers.
LAHN and FMG2025 are structurally aligned: genomic tests that fit FMG2025 priorities and show strong evidence typically advance faster toward NABM.
NGS — Next-generation sequencing
High-throughput DNA/RNA sequencing used in oncology, rare diseases, and infectious disease diagnostics.
Under the LAHN → HAS → UNCAM pathway, NGS panels must demonstrate:
- clinical relevance for French patient populations,
- clear impact on therapeutic decisions,
- compatibility with national genomic strategy.
ctDNA — ADN tumoral circulant (circulating tumour DNA)
Liquid-biopsy–derived DNA fragments used to detect mutations in cancers such as NSCLC.
HAS’s 2025 favourable opinion signalled France’s formal recognition of ctDNA as a reimbursable diagnostic tool under defined clinical contexts.
RWE — Données de vie réelle (Real-world evidence)
Clinical data generated outside controlled trials — including registries, hospital EHRs, SNDS data, and prospective observational cohorts.
Under LAHN, RWE is a mandatory component: it determines whether an innovation progresses to full reimbursement or is withdrawn.
DGOS — Direction générale de l’offre de soins
The Ministry of Health directorate responsible for hospital organisation and financing.
DGOS led the RIHN-to-LAHN reform and manages the LAHN stock, ensuring tests are regularly re-reviewed and reprioritised.
ARS — Agences régionales de santé
Regional health agencies responsible for implementing national policy locally.
ARS play a key role in monitoring diagnostic utilisation, AMR stewardship, and deployment of innovative tests.
INCa — Institut national du cancer
France’s national cancer institute, heavily involved in defining biomarker priorities, molecular pathways, and genomic testing strategies.
INCa’s frameworks often guide HAS and UNCAM decisions in oncology diagnostics.
Innovation → Evidence → Evaluation → Tariff → National Access
The modern French translational pathway for diagnostics:
- Innovation enters LAHN.
- Evidence is generated (RWD + clinical utility).
- Evaluation is performed by HAS (SA/ASA).
- Tariff is set by UNCAM.
- National Access is achieved via NABM listing.
This is now the standard lifecycle for any diagnostic seeking reimbursement in France.