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24 Mar 2014
A shortcut to medical device repayment in france They can be a second article in this series.You know france presents the 2nd largest market for medical devices in europe and you have already got a few french physicians interested in using your product.Yet, how do you get the french payers, aka insurance coverage funds(Caisses chemical malahie)To cash fast? Here is one it can be, second time beginners mechanism, designed to serve as a gateway for introducing innovative medical devices into the french inpatient payment system. Repayment for a hospital inpatient stay in the us is determined according to a medicare severity diagnosis related group(Master of science drg).Likewise, repayment for a hospital inpatient stay in france is determined according to a homogeneous group of stay(Groupe homog nufactured s ghs).In the two cases, if a new device does not fit into an existing drg/ghs a medical facility may not be properly reimbursed for its added cost and thus may not want to use it. You will discover, forming a new ghs code to reflect the added expenses related to your new device requires data collection of procedure utilization.But since your device doesn currently fit into one of in france they ghs codes, hospitals are too embarrassed to use it, in so doing it will never reach sufficient utilization to justify the creation of a new ghs code. Looks like a catch 22, correctly? To encourage entry of new and innovative web sites into the french healthcare system, innovative devices may be contributed to the list(En sus presents hospitals with the required financial incentive to use a new device, prior to it being properly reimbursed under the ghs system.Still, it seems as if most us medical device companies are unaware of this mechanism that could shorten their time to market and even improve their chances of influencing the payment rate of a relevant ghs code in the future. In the next part i make a short description of the french ghs system, and mowi2 outlet uk physician the liste en sus mechanism in detail. French drg system, or ghs function, groups several variables to classify each patient's stay in a homogeneous group of patients(Groupe homog de illnesses, ghm).Afterwards, each ghm is assigned to its financial counterpart, any ghs. The ghs method is a 'leaning system', relying on quantitative data supplied to the technical agency of information on a hospital stay(Agence approach de l sur l atih)By 45 reporting hospitals all through the year.The outcome gathered during 2011 is applied in the 2013 ghs catalog. To get on the liste en sus, the item needs to get listed on france's list of reimbursable products(Liste des produits et prestations remboursables, lppr), Under this system trade name(Alternate to under a general description). The validity of the request for inclusion on the lppr is evaluated by the nation's committee for the evaluation of medical devices and health technologies(Commission nationale d des dispositifs m et des expertise de sant cnedimts), Which bases its decision in particular on the dossier requesting reimbursement that is typically submitted by producer. The device return tariff, and moreover the hospital ghs tariff, is then negotiated involving the healthcare products pricing committee(Comit economique signifiants produits delaware sant ceps)And the software creator. Inclusion using the brand name will probably be temporary.Truthfully, as soon as a competitor appears for therapeutic massage product, inclu using the generic details form could be justified. 4.Loan for inclusion on the liste en sus In the case of an initial get inclusion, the guidance of cnedimts is based particularly on assessment of the product expected service(Assist attendu, sa)And additionally, if the correct, on assessment of the advance of expected service(Am du services attendu, asa). 4.1 Assessment of anticipated service(Sa) Assessment of the sa is by indication and it's essentially based on an assessment: 4.2 Assessment of advance of expected service(Asa) If the expected serVice will justify listing for reimbursement, the guidance of cnedimts will also be based on the asa when it comes to a comparable product, known to be the current gold standard, regardless if this gold standard is reimbursed.This assessment groups the added clinical Value as major(I will), Crucial(Ii), Limit(Iii), Child(IV)Or lack(V)For each indication for which the committee considers that there are evidence to justify listing. Determination of the tariffs mainly considers sa, but also asa, when practical additional studies requested, tariffs and prices of comparable surgeries or products, as well as services included out there, the volume of estimated sales and predicted and real conditions of use. Based on the law, the whole process can't take more than 6 months.Although, some companies reported much longer routines. To remain on the list with the assigned level of repayment, the producer should resubmit its applications every three years in order to demonstrate real life data generated by post marketing studies, supporting claims that were used at the basis of preliminary application. If the post marketing study is either not played, or not whole, or there is limited evidence to show that the product performs as well in actual life, the what are known as rendu rating may drop, and with it the compensation level. Out of the 148 reviews furnished by cnedimts during 2009, 76(51.3%)Were provided for products submitted responsible for, 12(8.1%)Concerned requests for adjustments, 51(34.5%)Uneasy renewals and 9(6.1%)Were restricted as other requests. Out of the 88 reviews that concerned first submittals and amendment requests, 62 were issued a sa grade, while 26 were awarded a sa.For the assessment of enlargement of expected service(Asa), Only 2 products confirmed ASA level I(Premier)And 4 gained asa level ii(Big). Inclusion on the liste en sus can lead to immediate increase in procedure and sales volume. As opposed to very same nub process in germany, the producer and not each individual hospital, negotiates the added compensation, which is then applied for all hospitals, for as much as 3 years. The process requires review having a minimum of two separate agencies(Cnedimts as well as the ceps), Which lengthens the process and requires substantial resources from the maker side.


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