Learn how IVD reimbursement works in France in 2025. Understand NABM, LAHN and RIHN 2.0, and how innovative diagnostics move from pilots to national tariff.
Reimbursement of In Vitro Diagnostic Tests in France in 2025: From NABM to LAHN and RIHN 2.0
France still has one of the most structured and comprehensive reimbursement systems for in vitro diagnostics (IVDs) in Europe. Most routine laboratory and genetic tests are reimbursed through national catalogues, while newer, high-innovation tests can access temporary funding while evidence is generated.
However, the landscape has moved on since the “classic” NABM–RIHN–Supplementary list picture. IVDR is now in force, the RIHN system has been re-engineered as RIHN 2.0, and the old RIHN and Supplementary lists have been merged into a single LAHN (Liste des actes hors nomenclature) financed via MERRI G03.
This post gives an updated overview of how reimbursement for IVD tests works in France today, and how novel diagnostics move from innovation funding to full NABM inclusion.
1. The Current Architecture for IVD Reimbursement in France
1.1 NABM – The Core Catalogue for Medical Biology
The NABM (Nomenclature des actes de biologie médicale) is still the main national list for reimbursable laboratory tests in ambulatory care. It covers:
- Routine chemistry and haematology
- Microbiology and virology
- Genetics and molecular pathology
- Many companion diagnostics
NABM acts are reimbursed by CNAM (statutory health insurance) and the Ministry of Health, and tariffs are negotiated by UNCAM based on HAS/CNEDiMTS opinions.
For IVD manufacturers, NABM listing remains the end-goal for stable, long-term reimbursement and wide access.
1.2 From RIHN to LAHN and RIHN 2.0 – The Innovation Pathway
Historically, France supported innovative diagnostics via:
- RIHN – Référentiel des actes innovants hors nomenclature
- Liste complémentaire – a supplementary list for tests awaiting a decision
These were criticised for being too slow and “blocked”, with many acts staying years in a supposedly temporary system.
Since 2023–2025, three key reforms have changed the picture:
- LAHN (Liste des actes hors nomenclature)
- In 2024, the 2023 RIHN and Supplementary lists were merged into a single LAHN list.
- The 2024 LAHN contains around 600+ acts financed through MERRI G03, under the MIGAC/MERRI hospital innovation envelope.
- These acts are funded “à titre dérogatoire” (on an exceptional basis) while evidence is collected, with the expectation they will either move into NABM/CCAM or be discontinued.
- RIHN 2.0 – Governance Reform
- RIHN 2.0 was created by Article 51 of the 2023 Social Security Financing Act and specified by a decree of 29 March 2024.
- It clarifies the rules for including innovative biology and pathology acts outside the nomenclatures, strengthens the role of HAS in evaluation, and emphasises systematic data collection to support future decisions (NABM/CCAM or exit).
- Manufacturers and national professional councils now submit RIHN 2.0 dossiers via the EVActe platform and in parallel to the Ministry.
- Focus on Real-World Evidence and Prioritisation
- HAS has launched national practice surveys and prioritisation of the most expensive and impactful RIHN acts, largely in molecular oncology (e.g. NGS panels, complex biomarker signatures).
- The explicit goal is to avoid a “parking lot” effect: acts should either progress to NABM or be removed if evidence is insufficient.
In practice: yes, the innovation pathway still exists, but it is now structured around LAHN + RIHN 2.0, with a clearer evidence-to-NABM lifecycle.
1.3 What Happened to the “Supplementary List”?
The old “liste complémentaire” is no longer a separate track. As of 2024, it has been fused into LAHN, creating a single list of off-nomenclature acts financed under MERRI G03.
So today, rather than talking about “RIHN + Supplementary list”, it is more accurate to describe:
- LAHN – the stock of funded, off-nomenclature acts (ex-RIHN + ex-Supplementary)
- RIHN 2.0 – the reformed process by which new innovative biology/pathology acts enter this stock, are evaluated by HAS, and (ideally) transition into NABM/CCAM.
2. Regulatory Prerequisites: IVDR and ANSM
Before entering any reimbursement pathway, tests must comply with EU Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), which became fully applicable in May 2022.
For manufacturers, that means:
- Appropriate CE marking under IVDR, with classification, performance evaluation and clinical evidence aligned with the new rules.
- Registration of activities and of the person in charge of vigilance with ANSM (French medicines and devices agency).
Without this regulatory backbone, reimbursement is essentially blocked.
3. The Application Process for Including a New Test in NABM (Updated 2025)
The NABM inclusion pathway is still the main, most rigorous route to secure long-term reimbursement for innovative IVDs.
3.1 Core Eligibility Criteria
To be considered for NABM:
- The test must have valid IVDR CE marking and meet French regulatory requirements (ANSM).
- The intended use, target population and care pathway must be clearly defined.
- There must be robust evidence of analytical performance, clinical validity and clinical utility (impact on decisions and outcomes).
- Economic analyses should show a favourable cost–effectiveness profile and manageable budget impact versus existing alternatives.
- The test should contribute to public health objectives and/or address a clear unmet medical need or practice gap.
These principles are consistent with HAS guidance on evaluation of professional acts and CNEDiMTS principles for devices and IVDs.
3.2 Dossier Submission to HAS / CNEDiMTS
Manufacturers (or sponsors) submit an application to CNEDiMTS of HAS. The process has been modernised but the core structure you described is still valid:
- HAS has published an updated “matrice du dossier de dépôt destiné au fabricant” (October 2025), which details the content and format expected for each section of the dossier.
- Submissions are done via SESAME/EVActe, the dematerialised platform used for device and act evaluations.
The dossier is still structured into three main parts:
- Part 1 – Summary and Identification
- Administrative information, product identification, intended use, positioning in the care pathway.
- Part 2 – Medico-Technical Dossier
- Analytical and technical performance
- Clinical studies demonstrating validity and utility
- Impact on organisation and quality of care (e.g. decentralisation, turnaround time, need for new equipment or staff)
- Part 3 – Economic Dossier
- Cost-effectiveness analysis (often cost-utility or cost-consequence, depending on the case)
- Budget impact analysis (BIA) at national level
- Sensitivity analyses and scenario modelling
HAS’s 2025 matrix and guidance documents are stricter on the quality of methods, particularly for observational data and model assumptions.
3.3 From HAS Opinion to NABM Tariff
Once the dossier is submitted:
- HAS / CNEDiMTS evaluates clinical benefit, organisational impact and economic value, and issues a recommendation.
- UNCAM and the Ministry of Health then decide whether to:
- Create a new NABM code,
- Modify an existing code, or
- Refuse inclusion.
- If accepted, they negotiate the tariff and reimbursement conditions (e.g. indications, prescriber restrictions).
- The decision and tariff are published in the Journal Officiel.
Real-world timelines still vary, but for a well-prepared dossier you should plan on 12–18 months, and potentially longer if HAS requests additional data or if the act has first gone through LAHN/RIHN 2.0.
4. How LAHN / RIHN 2.0 Works in Practice – Examples
The innovation list is no longer a black box. Several analyses and official communications give a sense of which tests are using it and how.
4.1 Types of Tests in LAHN / Former RIHN
Recent publications show that a large share of innovative acts are molecular and genomic tests, for example:
- Somatic genetic alterations in cancer (NGS panels, gene fusions, complex biomarker signatures) used for diagnosis, prognosis, targeted treatment decisions and monitoring.
- High-complexity coagulation and thrombin generation assays and advanced immunological tests, as evidenced in the 2023 RIHN list.
- Newborn screening and rare disease assays, such as T-cell receptor excision circle (TREC) testing for severe combined immunodeficiency (SCID), which had its RIHN tariff adjusted in 2023.
These tests typically enter via RIHN/LAHN when:
- The innovation is significant but evidence is still evolving.
- The cost per test is high, so payers want controlled roll-out and documented real-world impact.
4.2 Is the Pathway Actually Working?
The answer is: better than before, but not perfect.
- Past problems: RIHN was criticised for being under-resourced and slow, with many tests remaining in limbo for years and blocking new entries.
- Recent reforms:
- LAHN merged the legacy lists and clarified funding via MERRI G03.
- RIHN 2.0 explicitly ties innovation funding to evidence generation and HAS evaluation, with prioritisation of high-cost acts and clearer rules for dossier submission.
In practice, this means:
- For truly high-impact diagnostics (notably in oncology), the pathway is active and usable, but companies must be prepared for:
- Structured, prospectively planned data collection (registries, RWD, RWE studies).
- Close interaction with professional societies and reference centres.
- A transition plan toward NABM, not indefinite life within LAHN.
- For lower-impact or weak-evidence tests, entry is harder, and the chance of remaining unfunded or being delisted is higher than it was under the “old” RIHN.
Overall, the system is moving towards a “innovation → evidence → evaluation → tariff → national access” lifecycle, which is broadly aligned with France’s wider innovation policy.
5. What This Means for Manufacturers and Sponsors
If you are planning to bring a new IVD test into France in 2025–2026, the key messages are:
- IVDR-ready first
- Ensure your CE mark and performance evaluation are robust; France is now very intolerant of weak regulatory dossiers.
- Plan a staged pathway: LAHN/RIHN 2.0 → NABM
- For high-innovation, high-cost tests, especially in oncology or rare disease, a LAHN entry via RIHN 2.0 is often the realistic first step.
- You must build a prospective evidence plan (RWD, clinical utility, economic data) from the outset to support later NABM submission.
- Treat the HAS dossier as a scientific document
- Use the 2025 HAS matrix and guidance for CNEDiMTS dossiers.
- Pre-align with French professional societies and reference centres to ensure your positioning in the care pathway is credible.
- Expect scrutiny on economic value
- Cost-effectiveness and budget impact analyses are no longer box-ticking; they underpin tariff discussions and prioritisation.
- Timelines are still long, but less opaque
- You should still plan for 12–18+ months from initial HAS submission to NABM tariff, but reforms are gradually improving transparency and throughput, particularly for high-priority diagnostics.
1. Haute Autorité de Santé (HAS) – Official Guidance
HAS – Matrice du dossier de dépôt destiné au fabricant
(Template for IVD & medical device submissions – used for CNEDiMTS dossiers)
🔗 https://www.has-sante.fr/jcms/p_3151810/fr/matrice-du-dossier-de-depot-destine-au-fabricant
Publisher: Haute Autorité de Santé
Why it matters: This is the current official template for manufacturers submitting diagnostic dossiers to HAS.
HAS – Comprendre l’évaluation des actes professionnels
🔗 https://www.has-sante.fr/jcms/c_408961/fr/comprendre-l-evaluation-des-actes-professionnels
Publisher: HAS
Why it matters: Explains how HAS evaluates professional acts — the methodology also underpins diagnostic test evaluations.
HAS – CNEDiMTS: Modalités d’évaluation des dispositifs médicaux et actes associés
🔗 https://www.has-sante.fr/jcms/p_3643971/fr/principes-et-methodologie
Publisher: HAS
Why it matters: Provides the evaluation criteria CNEDiMTS uses, including clinical utility, organisational impact, and economic data requirements.
HAS – Favoriser l’accès aux actes innovants (RIHN acceleration)
🔗 https://www.has-sante.fr/jcms/p_3536104/fr/favoriser-l-acces-aux-actes-innovants-la-has-impulse-un-nouvel-elan
Publisher: HAS (02/08/2024)
Why it matters: Official communication on RIHN reforms and HAS-driven acceleration for innovative diagnostics.
HAS – RIHN 2.0: Dépôt de nouvelles demandes
🔗 https://www.has-sante.fr/jcms/p_3576857/fr/rihn-2-0-industries-et-cnp-peuvent-soumettre-de-nouvelles-demandes
Publisher: HAS (09/01/2025)
Why it matters: Defines the updated process for manufacturers entering the RIHN 2.0 / LAHN innovation pathway.
2. Ministère de la Santé – Official Government Pages
Ministry of Health – RIHN / actes innovants hors nomenclature
🔗 https://sante.gouv.fr/soins-et-maladies/qualite-securite-et-pertinence-des-soins/biologie-medicale/rihn
Publisher: Ministère de la Santé
Why it matters: The official government summary of RIHN, innovation funding, and criteria for off-nomenclature acts.
PLFSS (Projet de Loi de Financement de la Sécurité Sociale) – All annual laws
🔗 https://www.securite-sociale.fr/l-assurance-maladie/lois-de-financement
Publisher: Sécurité Sociale / Ministry of Health
Why it matters: PLFSS laws contain articles governing the RIHN → LAHN transition and funding envelopes (e.g., MERRI G03).
Journal Officiel – Modifications to the NABM tariff
🔗 https://www.legifrance.gouv.fr/
(Search: “NABM”, “biologie médicale”, “actes innovants”)
Publisher: République Française
Why it matters: All changes to the NABM, including inclusion of new diagnostic codes and tariffs, are published here.
3. ANSM (French Medicines Agency)
ANSM – Obligations for IVD manufacturers, IVDR and reactovigilance
🔗 https://ansm.sante.fr/vos-demarches/industriel/dispositifs-medicaux-de-diagnostic-in-vitro
Publisher: ANSM
Why it matters: Outlines the regulatory obligations for IVD manufacturers — essential before any reimbursement step.
4. Professional Societies & Official Stakeholder Documents
Collège National Professionnel de Biologie Médicale – RIHN 2.0 dossier guidance
🔗 https://cnp-biologiemedicale.fr/decrets/dossier-rihn-2-0-arrete-du-25-novembre-2024
Publisher: CNP Biologie Médicale
Why it matters: Shows how professional societies support dossier preparation for new diagnostic acts.
Fédération Hospitalière de France – Funding & innovation policy
🔗 https://www.fhf.fr/Missions/Innovation
Publisher: FHF
Why it matters: Provides context for hospital-based funding of innovative diagnostics via MIGAC/MERRI.
5. Industry & Technology Sources (Robust, Non-ChatGPT)
bioMérieux – Financing of Medical Biology and Innovation in France
🔗 https://diag-innov.biomerieux.fr/financement-de-la-sante/comment-fonctionne-le-financement-de-la-biologie-medicale-en-france-et-de-son-innovation-tarif-ghs-nabm-rihn
Publisher: bioMérieux
Why it matters: Detailed, industry-reviewed explanation of NABM, GHS, RIHN/LAHN and innovation funding mechanisms.
MTRC – 2023 RIHN list & Supplementary list publication
🔗 https://mtrconsult.com/news/2023-rihn-and-supplementary-lists-ivd-tests-published-france
Publisher: Med Tech Reimbursement Consulting
Why it matters: Explains how RIHN lists were structured prior to LAHN consolidation and which IVDs appeared.
6. European Regulatory & Scientific References
Official EU IVDR Regulation (EU 2017/746)
🔗 https://eur-lex.europa.eu/eli/reg/2017/746/oj
Publisher: European Union (EUR-Lex)
Why it matters: Governing law for CE marking required before reimbursement submission.
European Commission – IVDR transition & guidance pages
🔗 https://health.ec.europa.eu/medical-devices-sector/new-regulations_en
Publisher: European Commission
Why it matters: Explains the IVDR transition timelines affecting diagnostics entering reimbursement pathways.
7. Peer-Reviewed Scientific Publications
Darlington M. et al. – National survey of innovation-use diagnostics in France
A GBMHM Survey of Practice and Cost Evaluation in France
🔗 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10455455/
Publisher: Cancers (2023)
Why it matters: Analyses cost structures and diagnostic act distribution including RIHN-funded molecular tests.
Hasan et al. – Health technology assessment for precision diagnostics
🔗 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8778371/
Publisher: Frontiers in Medicine
Why it matters: Provides methodological context for evaluating diagnostic utility — consistent with HAS expectations.
8. Legal & Policy Analysis
Escaramozzino Legal – Reform of RIHN under PLFSS 2023
🔗 https://escaramozzino.legal/2022/11/09/plfss-2023-reforme-du-rihn/
Publisher: Escaramozzino Legal
Why it matters: Explains legal foundation of RIHN → RIHN 2.0 reform.
CNAM – Medical Biology expenditure reports (Données de l’Assurance Maladie)
🔗 https://www.ameli.fr/l-assurance-maladie/statistiques-et-publications
Publisher: CNAM
Why it matters: Shows national spending trends that shape NABM tariff decisions.
Cour des Comptes – Audit of hospital innovation funding (MERRI)
🔗 https://www.ccomptes.fr/fr/publications
(Search: “MERRI”, “innovation biomédicale”)
Why it matters: Strong policy reference for the budget supporting LAHN acts.
DGOS – Organisation of biologie médicale in France
🔗 https://solidarites-sante.gouv.fr/ministere/directions/dgos/
Why it matters: DGOS finances MERRI and oversees hospital-based funding for innovative diagnostics.
INCa – Molecular biology platforms (Cancer testing)
🔗 https://www.e-cancer.fr/Professionnels-de-sante/Plateformes-de-genetique-moleculaire
Why it matters: Provides context for high-cost RIHN/LAHN-funded oncology tests.