Details on new RIHN reform process released in France

The General Directorate for Healthcare Services (DGOS) of the French Ministry of Labor, Health and Solidarity (Ministre du Travail, de la Santé et des Solidarités, MTSS) has undertaken steps to reform the Repository of Innovative Services outside the Nomenclature of biology and anatomopathology (RIHN List), as announced in March 2024.

At the end of July 2024, the MTSS published a document describing the reform work on theIVD tests outside the Nomenclature (Liste des actes hors nomenclatures, AHN, i.e., the merged 2023 RIHN List and the Supplementary List, with a total of 616 tests as of July 2024). More specifically, the document describes new procedures for registering a new test with the RIHN, but also the process of evaluation of tests currently in the AHN, for the purpose of cleaning and reforming this Nomenclature. 

Namely, the MTSS has asked the French High Authority for Health (HAS) to evaluate expensive tests listed in the AHN, with the purpose of deciding whether these tests will be granted permanent reimbursement, or will be excluded from coverage within the statutory health insurance. Cleaning the current AHN List will allow for the financing of truly innovative tests patients need.

At the first stage, the HAS is evaluating the eleven most expensive RIHN tests (11 RIHN codes) that relate to two molecular biology techniques (high-throughput sequencing of gene panels in cancer and rare diseases, and nucleic acid amplification tests in infectious diseases). More assessments will be published by the end of 2024, and will continue over the next years.

In addition, the MTSS confirms that the tariffs of the tests in the AHN List (currently paid for by the MERRI budget) will be subject to an annual discount of 20% of the value from 2025 (up till 2029). Furthermore, the industry and the clinical societies may submit applications (according to the new RIHN procedure) to keep the tests currently in the AHN List in the RIHN List again for a maximum period of six years.

More details can be found here (Ministry) and here (HAS).

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