This is a second article in this series. The first article Air Max2 Light Italia , "A Shortcut to Medical Device Reimbursement in Germany", can be downloaded at: plan on getting your product approved in Europe and complete the CE mark process relatively quickly. You know France presents the 2nd largest market for medical devices in Europe and you already have a few French physicians interested in using your product. But, how can you get the French payers, aka health insurance funds (caisses d'assurance maladie) to pay for it - fast?

Here is one possible, intermediate mechanism, designed to serve as a gateway for introducing innovative medical devices into the French inpatient reimbursement system.

1. The Problem
Reimbursement for a hospital inpatient stay in the US is determined according to a Medicare Severity Diagnosis Related Group (MS-DRG). Similarly Air Max Deluxe Italia , reimbursement for a hospital inpatient stay in France is determined according to a Homogeneous Group of Stay (Groupe Homog猫ne de S茅jour, GHS). In both cases, if a new device does not fit into an existing DRGGHS the hospital may not be properly reimbursed for its added cost and thus may not want to use it.
On the other hand, forming a new GHS code to reflect the added costs associated with your new device requires data collection of procedure utilization. But since your device doesn't currently fit into one of the French GHS codes, hospitals are reluctant to use it, and therefore it will never reach sufficient utilization to justify the creation of a new GHS code.

Sounds like a Catch-22 Air Max 93 Italia , right?

To encourage entry of new and innovative technologies into the French healthcare system, innovative devices may be added to the "add-on list" ("liste en sus"), which provides hospitals with the required financial incentive to use a new device, before it is properly reimbursed under the GHS system. However, it seems as if most US medical device companies are unaware of this mechanism that could shorten their time-to-market and even increase their chances of influencing the payment rate of a relevant GHS code in the future.

In the next part I will provide a short description of the French GHS system, and then discuss the liste en sus mechanism in detail.

2. French GHS System
The French DRG system Air Max Axis Italia , or GHS system, groups several parameters to classify each patient's stay in a Homogeneous Group of Patients (Groupe Homog猫ne de Maladies, GHM). Thereafter, each GHM is associated with its financial counterpart, the GHS.

The GHS system is a 'leaning system', relying on quantitative data supplied to the Technical Agency of Information on Hospitalization (Agence technique de l'information sur l'hospitalisation Scarpe Just Do It Italia , ATIH) by ~45 reporting hospitals throughout the year. The data gathered during 2011 is applied in the 2013 GHS catalog.

3. Liste en Sus
To get listed on the liste en sus, the product needs to get listed on France's list of reimbursable products (Liste des Produits et Prestations Remboursables, LPPR), under the product's trade name (rather than under a general description).
The validity of the request for inclusion on the LPPR is evaluated by the national Committee for the Evaluation of Medical Devices and Health Technologiesg reimbursement that is typically submitted by the manufacturer.

The device's reimbursement tariff Air Max 120 Italia , in addition to the hospital GHS tariff, is then negotiated between the healthcare products pricing committee (C Economique des Produits de San CEPS) and the manufacturer.
Inclusion using the brand name is intended to be temporary. In fact, as soon as a competitor appears for the innovative product, inclu卢sion using the generic description form could be justified.

4. Application for Inclusion on the Liste en Sus
In the case of an initial request for inclusion, the guidance of CNEDiMTS is based in particular on assessment of the product's Expected Service (Service Attendu Air Max Fury Italia , SA) and, if sufficient, on assessment of the Improvement of Expected Service (Am茅lioration du Service Attendu, ASA).

4.1 Assessment of the expected service (SA)
Assessment of the SA is by indication and is essentially based on an assessment:
聲 of the riskbenefit ratio;
聲 of the role of the device within therapeutic strategy;
聲 of its benefit to public health

4.2 Assessment of improvement of expected service (ASA)
If the expected service is sufficient to justify listing for reimbursement, the guidance of CNEDiMTS will also be based on the ASA in relation to a comparable product, considered to be the current gold standard Air Max Plus Italia , whether or not this gold standard is reimbursed. This assessment classifies the added clinical value as major (I), substantial (II), moderate (III), minor (IV) or absent (V) for each indication for which the committee considers that there is evidence to justify listing.

4.3 Setting the Tariff
Determination of the tariffs mainly takes into account SA, and ASA, when appropriate additional studies requested Air Max Flair Italia , tariffs and prices of comparable procedures or products, as well as services included on the list, the volume of anticipated sales and predicted and real conditions of use.

According to the law, the whole process should not take m