In France, gaining access to the hospital market involves more than securing a price: a product must also be adequately funded by the healthcare institution using it. A coding strategy involves identifying, from the clinical development stage onwards, how a medicine, medical device or associated medical procedure will be funded under the French activity-based hospital payment system (T2A), and anticipating the necessary steps with the ATIH, the Ministry of Health and the French statutory health insurance system to secure appropriate funding.
Coding Strategy and Hospital Funding
What Is a Healthcare Coding Strategy?
A coding strategy involves analysing how the use of a healthcare product fits within the classification of medical procedures and hospital stays in order to determine:
- Whether the procedure associated with the product is already included in the French Classification of Medical Procedures (CCAM), or whether a new code or an amendment to an existing code is required;
- Whether the relevant hospital stay falls within an existing Diagnosis-Related Group (GHM), or whether the patient population justifies a revision of the classification;
- Whether the cost of the product is already covered by the corresponding hospital stay tariff (GHS).
Failure to anticipate coding requirements is a common barrier to hospital adoption: a product may have received regulatory approval and an agreed price, yet still see limited use if hospitals do not receive sufficient funding to cover its cost.
Activity-Based Payment (T2A)
Hospital Funding in France
Hospital funding in France is largely based on the activity-based payment system (Tarification à l’Activité – T2A). Each hospital stay is assigned to a Diagnosis-Related Group (GHM), which corresponds to a fixed reimbursement tariff (GHS) covering the care provided, including most medicines and medical devices used during the stay.
For an innovative healthcare product, this means that its cost is generally expected to be covered within the fixed payment, unless a dedicated supplementary funding mechanism applies.
The Liste en Sus
Additional Funding for High-Cost Products
Certain particularly expensive medicines and medical devices, whose inclusion within the standard GHS tariff would create a significant financial burden for hospitals, may be included on the liste en sus (supplementary reimbursement list). Their costs are then reimbursed to the hospital in addition to the standard GHS payment, subject to appropriate documentation of their use.
Inclusion on this list is subject to specific eligibility criteria, including high costs and variations in prescribing patterns. It is a major strategic consideration for innovative hospital products, particularly in oncology.
Early Access Schemes
Temporary Funding Pathways
For innovative technologies whose clinical effectiveness requires further confirmation in real-world setting, the French schemes accès précoce, forfait innovation or RIHN (innovation funding scheme for drugs, medical devices or IVDs) provides exceptional, temporary funding in return for the generation of additional evidence. The aim is to support subsequent access to established reimbursement pathways, such the liste en sus, the LPPR or the NABM.
Those schemes offer relevant early access for breakthrough technologies.
How We Can Help
We support pharmaceutical, medical device and in vitro diagnostic manufacturers in developing their hospital coding and funding strategies. Our services include mapping applicable funding mechanisms, preparing applications to the ATIH and the Ministry of Health, and aligning coding and hospital funding requirements with the overall pricing and reimbursement strategy.
Why Anticipating Coding Requirements During Clinical Development?
The choice of clinical study design, care pathway and comparators directly influences the ability to demonstrate eligibility for supplementary funding mechanisms at a later stage. Addressing these considerations during clinical development makes it possible to:
- Align the clinical development plan with hospital funding requirements;
- Identify early on whether changes to existing classifications (CCAM, GHM) will be necessary, and initiate the relevant procedures with the ATIH within a timeframe compatible with commercial launch;
- Avoid situations where a product has obtained regulatory approval and an agreed price but remains financially inaccessible to hospitals.
Frequently Asked Questions
What is the liste en sus in French hospitals?
The liste en sus is a supplementary reimbursement mechanism that allows certain particularly expensive medicines and medical devices to be funded in addition to the standard hospital stay tariff (GHS), where including their cost within the fixed payment would place a significant financial burden on the hospital.
What is the forfait innovation?
The forfait innovation is a temporary, exceptional funding mechanism for innovative healthcare technologies and medical devices. It provides funding in return for the generation of additional clinical evidence, with the aim of supporting subsequent access to established reimbursement pathways.
Why might a product without an agreed price still have limited uptake in hospitals?
Because commercialization in the hospital setting does not automatically guarantee adequate funding within the hospital stay tariff (GHS). Without a supplementary funding mechanism, hospitals may have to absorb the additional cost, which can discourage adoption.
What is the difference between CCAM and GHM?
The CCAM is the French classification system used to code medical and surgical procedures. The GHM classifies hospital stays according to patient characteristics and the procedures performed, and is used to determine the corresponding hospital reimbursement tariff (GHS).