An innovative in vitro diagnostic (IVD) test follows a specific reimbursement pathway in France: assessment of its clinical value by CEDiag, followed by inclusion either in the NABM — the established reimbursement classification for medical laboratory procedures — or, for newer tests, in the RIHN, a transitional framework that enables hospital funding while additional clinical evidence is generated.
In Vitro Diagnostics: CEDiag Assessment and NABM/RIHN Listing
In Vitro Diagnostic Tests and CEDiag Assessment
As with other medical and healthcare professional procedures performed for diagnostic purposes, CEDiag assesses in vitro diagnostic tests against a set of predefined criteria.
For an innovative test, demonstrating its analytical performance (sensitivity and specificity) and, above all, its clinical utility — the actual impact of the test result on treatment decisions — is central to the dossier submitted to CEDiag.
NABM: The Reimbursement Classification for Medical Laboratory Procedures
The Nomenclature des Actes de Biologie Médicale (NABM) is the official French reimbursement classification for medical laboratory procedures covered by the statutory health insurance system, whether performed in community or hospital settings. Each procedure has a specific code and a relative value (B coefficient), which determines its reimbursement tariff.
Inclusion in the NABM represents the completion of the reimbursement pathway for a diagnostic test, providing access to an established reimbursement mechanism and a nationally applicable tariff.
RIHN: A Transitional Funding Pathway for Innovative Tests
The Référentiel des Actes Innovants Hors Nomenclature (RIHN) provides funding through hospital budgets for innovative tests that have not yet been included in the NABM. This pathway addresses a genuine need: a test may demonstrate significant clinical potential before all the evidence required for a comprehensive health technology assessment has been generated.
The RIHN therefore enables:
- Early patient access to the test through hospital funding, pending its final assessment.
- The generation of real-world evidence, often essential to demonstrate the clinical utility required for a full assessment.
- Annual listing, subject to renewal until the test is transferred to the NABM or removed from the RIHN.
From RIHN to NABM: Planning the Transition
Transitioning from RIHN to NABM is not automatic. It requires submission of a comprehensive dossier for CEDiag assessment, demonstrating the test’s clinical value on the basis of evidence collected during the RIHN funding period.
Planning this transition from the moment of RIHN inclusion — by organising the collection of evidence needed to demonstrate clinical utility — is essential to prevent a test from remaining indefinitely under transitional funding arrangements or losing its funding before permanent reimbursement is secured.
(Internal link to be added: “Market Access for Medicines in France”, for companion diagnostics associated with targeted therapies.)
How We Can Help
We support in vitro diagnostic manufacturers with:
- Preparing their CEDiag assessment dossiers;
- Selecting the most appropriate reimbursement listing strategy (RIHN or direct NABM inclusion);
- Planning the transition towards an established reimbursement pathway.
Frequently Asked Questions
What is the difference between NABM and RIHN?
The NABM is the established reimbursement classification for medical laboratory procedures in France. The RIHN is a transitional framework that enables hospital funding for innovative tests not yet included in the NABM, pending their full assessment.
How does a test move from RIHN to NABM?
The transition requires submission of a dossier for CEDiag assessment, demonstrating the test’s clinical utility using evidence collected during its RIHN listing period.
Can a test remain on the RIHN indefinitely?
No. RIHN inclusion is subject to annual renewal and progress towards a full assessment. A test with no prospect of transitioning to the NABM may be removed from the framework.