A Shortcut To Medical Device Reimbursement In France

By Amir Inbar

This is a second article in this series. The first article, A Shortcut to Medical Device Reimbursement in Germany, can be downloaded at: http://www.mediclever.com/resources/5.pdf

You 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 dassurance 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, reimbursement for a hospital inpatient stay in France is determined according to a Homogeneous Group of Stay (Groupe Homogne de Sjour, GHS). In both cases, if a new device does not fit into an existing DRG/GHS 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 doesnt 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, 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, or GHS system, groups several parameters to classify each patient’s stay in a Homogeneous Group of Patients (Groupe Homogne 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 linformation sur lhospitalisation, ATIH) by ~45 reporting hospitals throughout the year. The data gathered during 2011 is applied in the 2013 GHS catalog.

[youtube]http://www.youtube.com/watch?v=OVvm6k9Koa0[/youtube]

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 products 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 Technologies (Commission Nationale dvaluation des Dispositifs Mdicaux et des Technologies de Sant, CNEDiMTS), which bases its decision in particular on the dossier requesting reimbursement that is typically submitted by the manufacturer.

The devices reimbursement tariff, in addition to the hospital GHS tariff, is then negotiated between the healthcare products pricing committee (Comit Economique des Produits de Sant, 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, inclusion 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 products Expected Service (Service Attendu, SA) and, if sufficient, on assessment of the Improvement of Expected Service (Amlioration 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:

of the risk/benefit ratio;

of the role of the device within therapeutic strategy;

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, 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, 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 more than 6 months. However, some companies reported much longer time periods.

4.4 Maintaining the Listing

To remain on the list with the assigned level of reimbursement, the manufacturer 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 the initial application.

If the post marketing study is either not performed, or incomplete, or there is insufficient evidence to show that the product performs as well in actual life, the so-called service rendu rating may drop, and with it the reimbursement level.

5. Statistics

Out of the 148 reviews provided by CNEDiMTS during 2009, 76 (51.3%) were provided for products submitted for the first time, 12 (8.1%) concerned requests for modifications, 51 (34.5%) concerned renewals and 9 (6.1%) were classified as other requests.

Out of the 88 reviews that concerned first submittals and modification requests, 62 were granted a sufficient SA grade, while 26 were granted a non-sufficient SA. For the assessment of improvement of expected service (ASA), only 2 products received ASA level I (major) and 4 received ASA level II (substantial).

6. Benefits and Disadvantages

6.1 Benefits:

* Inclusion on the liste en sus could lead to immediate increase in procedure and sales volume.

* As opposed to the equivalent NUB process in Germany, the manufacturer and not each individual hospital, negotiates the added reimbursement, which is then applicable for all hospitals, for up to 3 years.

6.2 Disadvantages:

* The process requires review of at least two separate agencies (CNEDiMTS and CEPS), which lengthens the process and requires substantial resources from the manufacturers side.

* On an annual average, only 3 to 4 new products receive an ASA level of I or II that justifies separate reimbursement.

7. Summary

The French healthcare system is trying to cope with the built-in delays of integrating innovative diagnostic and therapeutic treatments into the system. Similar to the French liste en sus, comparable reimbursement mechanisms exist in Germany, the UK and in some regions of Italy. Utilizing these mechanisms can help US companies obtain reimbursement in Europe faster and bring their products to market sooner.

To verify the existence of relevant GHS codes, to develop the appropriate dossier for inclusion in the liste en sus or for the inclusion of your product under any reimbursement mechanisms in the US and Europe, please contact us at Mediclever.

About the Author: Amir Inbar founded Mediclever

Reimbursement Consultants

, which provides end-to-end

medical device reimbursement

consulting services to life-science companies, selling pharmaceuticals and medical technology products in the US and Europe.

Source:

isnare.com

Permanent Link:

isnare.com/?aid=975791&ca=Medical+Business

14 November

What Are The Most Comfortable Contact Lenses On The Market?

By A. Nutt

Leonardo da Vinci was said to have invented the concept of the contact lens in 1508. Since the penning of his historic and innovative Codex of the eye, Manual D, the contact lens has greatly evolved and is the option of choice for corrective wear.

Developed as an option for men and women who needed visual enhancement but didn’t like to appearance or hassle associated with glasses, the original lenses were originally very hard. They also had a myriad of drawbacks, like popping off the cornea and getting lost. A version of the earlier hard contacts lens still exists today, and are now called gas permeable (GP or RGPs or rigid gas permeable). Unlike their predecessors, they allowed oxygen to pass through the lens to the eye, which makes them healthier to wear.

Unfortunately, like their predecessors, these hard contacts are still a bit uncomfortable.

Enter soft contact lenses, which were also gas permeable and far easier on the eyes. Yet and still, even among the softer lenses, some are more comfortable than others.

So, what kind of contact lens offers the highest comfort?

[youtube]http://www.youtube.com/watch?v=J1dg_FSCS8I[/youtube]

Disposable contact lenses

Disposable contact lenses come in single day, weekly, or monthly use. These contact lenses often offer a higher degree of comfort because and there is less of a chance of protein buildup and warping, which can feel scratchy to the eye. To date, many soft contact lens buyers say that these lenses are the best ones on the market in regards to ease of wear, however, they may not be the ultimate option for true vision correction.

Color contact lenses

Color contact lenses can be fairly easy on the eye if they are the soft variety. Although most color contacts are used to produce an aesthetic effect, ease of use is still very important. Because these contacts are most often come in the soft lens, they are generally very comfortable. Some companies even make them with a prescription in them, although the prescription may not be as strong as with plain lenses.

Gas permeable lenses

As stated before, gas permeable lenses are often harder but with the proper fitting they can be a bit healthier and easier to wear than soft contact lenses. This is due to the fact that they allow oxygen into the cornea, which is important since this delicate part of the eye needs oxygen to ‘breath’. For this reason, they are also called the ‘breathable’ contact lens.

Hybrid lenses

Hybrid lenses can offer the best of both the gas permeable and disposable contact lens. These lenses are often comprised of a GP center and softer outer ring. This makes the contact lenses a bit easier to wear while giving all the benefits of gas permeable contacts. The lenses are a great option fro people who suffer from astigmatism as they may not be able to wear certain soft lenses.

All of the above lenses have their pros and cons, and in the end, it is really up to you to decide which type best fits your lifestyle. Some people who are very active seek soft lenses because they stay in place far easier than gas permeable. On the other hand, others have vision correction problems that soft contacts can’t fix and need to get gas permeable or hybrids.

If you are interested in getting contacts, or just want to switch to a far more accommodating brand, be sure to make an appointment with your ophthalmologist. He will be best able to tell you what would be a good fit, and knows which contact lenses have been reputed to yield the highest amount of comfort.

About the Author: Premiere online retailer of contact lenses including special effects lenses and colored lenses. Offers the widest selection of contact lenses for huge savings online.

Source: isnare.com

Permanent Link: isnare.com/?aid=323509&ca=Medical+Business

6 April

When Representation Is Needed For Domestic Violence

byAlma Abell

Life is full of joys, love, stress and difficulties. Just as in life, relationships with loved ones and family members can bring some of life’s greatest pleasures and some of the most difficult emotional situations. With high emotional involvement, there are times when things can get out of hand. One of the most unfortunate things that can happen is when an argument in a relationship results in an act of violence. Once one of the people involved in this type of situation is faced with being charged, the situation becomes even more difficult.

While it is important to face any responsibility one has and to be honest with themselves and others about what happened, so that they can grow from the experience and not have it repeat itself in the future, the fact is that charges mean the law will have to be dealt with. Anytime a person is facing a judge in a courtroom, they need to have the best representation they can get so that they will be treated fairly. This doesn’t mean just having the money to hire a high-priced attorney, it means hiring a Domestic Violence Lawyer Burlington that has experience dealing with these complicated cases.

With the experience of having successfully handled domestic violence cases in the past, the lawyer will not only be familiar with what to expect in the courtroom and how best to proceed, they will also be experienced with handling all the emotional difficulties that the person being charged is dealing with. Unlike many other criminal charges, domestic violence can involve more emotions from all the parties involved.

By working with a lawyer and their staff who have dealt with many of these types of cases before, they should be ready and willing to answer any questions their client has about what they are facing. Knowing what may happen, how it needs to be prepared for and what can be done to help achieve as positive an outcome as possible goes a long way to ease the mind of those facing charges such as these. It is possible to find out More Info by speaking with an attorney about the charges and how to move forward.

7 August

Being Local Online}

Being Local Online

by

Susan Payton

So you own a small boutique in a small town. Or youre a doctor. Or you run a produce shop. You think marketing online is for people who have customers nationwide. You couldnt be further from the truth.

More people are throwing out their hefty phone books in favor of using the internet to find local businesses. I, for one, wont even consider a local business if they dont have some kind of web presence. Why? I want to:

a) See what they offer before driving to the business (try before you buy). Im a big menu reader online!

b) Determine whether they deem it worthwhile to develop a decent professional presence on the web. It doesnt have to be fancy, but having a website goes a long way toward making me feel the business understands the value.

If I, for instance, need to find a car collision repair shop in Orlando near where my car was rear-ended last week (true story), I type car repair Orlando in a Google search. I find one where I want it, and call. It may not be true, but if the business has a website, I feel theyre less likely to be a fly-by-night operation. Its all image.

If I searched in the phone book, it would take me five times as long to find a place. Thats how people are wired today. Many of us have found it faster to search for local businesses online.

With that in mind, why ARENT you online?!! You miss out on valuable business by not having a website and being listed with local search sites, and for the amount of money it costs to do this (try $0), you have no excuse!

Here are a few must haves to get up and running in marketing your business online.

1. Website. It should go without saying, but Ill say it anyway. You need a website. It should consist of at least 3 pages, including an overview of what you do, where youre located, and a list of services. If you want to include testimonials or client info, do it. Hire a professional, because a cheaply designed website is an automatic turnoff.

2. Register with search engines. Sites like Google and Yahoo! dont automatically know to find your site, so help them out. Both of these sites (as well as MSN, Alta Vista and many, many more) have a page where you can register your site. This means it will appear in a search for specific keywords the search engine finds on your site. There are even free services that register your website with multiple search engines.

3. Check your keywords. If you sell dog treats, make sure your website says so. Because search engines (which are robots, not people) search your site to get an idea of what you do, make sure you use keywords that people would search for to find you. In this case, include dog treats, doggie bakery, pet food, and dog bone.

4. Go Local. Yahoo! and Google have local business services (free) that allow you to post your company info and address so that it appears on a map for searchers. Because these sites are ranked so highly, if someone searches for dog treats in your area, this will be one of the top results, getting you even more eyeballs on your webpage!

5. Google AdWords. This is optional, but in the vast world of cyberspace, its easy to get lost in the mix without a little advertising. You can create text ads that will appear when someone searches for one of your specified keywords (dog treats). You are charged per click. Its a great way to get exposure to your business, and usually its affordable.

6. Pump your site. Put your website address in your email signature. Put it on your business card and business collateral. Encourage customers to visit and share the site with others.

As you can see, marketing your local business online is a breeze! Try these tips and see if your business doesnt start to escalate!

Susan Payton is Managing Partner of Egg Marketing & Public Relations. She assists small businesses with marketing strategy and corporate communications. She is also the author of 101 Entrepreneur Tips, a handy guide that helps entrepreneurs make repeat customers, close the sale, and delegate work. For more information on Susan and Egg Marketing, visit www.eggmarketingpr.com or email her at smpayton@eggmarketingpr.com. Get free shoestring marketing advice on Susan’s blog, www.eggmarketingblog.com.

Article Source:

Being Local Online}

30 July

How To Translate Document Successfully?

How to Translate Document Successfully?

by

Carmen

Research translation companies who can start the translation of your product and see it to success in other countries from start to finish.

Translation Company investing in a

[youtube]http://www.youtube.com/watch?v=_iulnWMS0nE[/youtube]

translation

company is the first step in moving your product into the global market. If people cannot read and make sense of your great American product- how can you expect anyone to know what it is, what it does and why it\’s great? A translation company knows how communication works in other countries. They know the languages, the ethics and they specialize in having their professionals help other professionals.

Once you and the translation company have talked about your goals for your business and what you hope to gain by joining with them, they will talk about their localization services. Localization services are imperative to reaching out to the global market. Besides hiring a person who speaks Hebrew and lives in those places where that is the common spoken

language

, a Hebrew translator is going to be able to translate the document accurately as well as stay sensitive to the ethics and cultural demands that go along with communicating to the Hebrew speaking community.

Having people translate your software and website to specific countries and their languages and laws is a part of securing your place in the global market. Especially if your product is a piece of software, the coding in the software as well as the website needs to smoothly transition into other countries you are trying to reach out to. With a translation company that specializes in software and localization services, they have people working in those targeting countries who are software and website technicians translating your products.

Excellent communication and customer service for as long as you sell your product needs to be a huge priority. You have created a great software product, it\’s been properly translated and localized for the countries in which your product is sold, what is the next step? Making sure that you have customer service representatives who can be \”help support\” to different countries and vary in customer service as well as technical support to make sure any questions someone should have in any country that your product is being sold in, are accurately and properly answered.

Aunes Oversettelser AS has been in the business for 26 years, and we are specialized in technical translations. We are specializing in the Nordic languages, and can offer services into Swedish, Danish, Finnish, Norwegian and Icelandic. The premier translation agency for Norway and the Nordic region! Technical translation services for businesses in the Nordic countries and translation agencies world-wide.

Aunes Oversettelser AS

has been in the business for 26 years, and we are specialized in technical translations. We are specializing in the Nordic languages, and can offer services into Swedish, Danish, Finnish, Norwegian and Icelandic. The premier translation agency for Norway and the Nordic region! Technical translation services for businesses in the Nordic countries and translation agencies world wide.

Article Source:

ArticleRich.com

29 April