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 2^nd 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, reimbursement for a hospital inpatient
stay in France is determined according to a Homogeneous Group of Stay (Groupe Homogène de Séjour, 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 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, 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
Homogène 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, 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
Technologies (Commission Nationale d’évaluation des Dispositifs Médicaux et
des Technologies de Santé, CNEDiMTS), which bases its decision in
particular on the dossier requesting reimbursement that is typically submitted
by the manufacturer.
The device’s reimbursement tariff, in addition to the hospital GHS
tariff, is then negotiated between the healthcare products pricing committee (Comité
Economique des Produits de Santé, 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 product’s Expected Service
(Service Attendu, SA) and, if sufficient, on assessment of the Improvement
of Expected Service (Amélioration 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[1].
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 manufacturer’s 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:
Amir Inbar, CEO, Mediclever Ltd.
www.mediclever.com
amir@mediclever.com

Recently, a few companies selling implantables in the Belgian market faced reimbursement difficulties due to new regulations requiring the listing of their products in the Belgian publication list of notified products. As of July 1^st, implants that are not published will not be reimbursed by the compulsory health insurance.

To adjust to these changes, we wanted to share with you the steps that should be taken by any company selling implantables in the Belgian market.

• To get listed, each company or its distributor, should fill in a form that can be accessed via this link: https://www.riziv.fgov.be/webprd/appl/pimplants/
• The required details include: the product’s name, the distributor’s and manufacturer’s name and the target price in Euro.
• Once the National Institute for Health and Disability Insurance (NIHDI) verifies the application, the products are published on the website and may be reimbursed in Belgium.

Mediclever’s team of European reimbursement experts can work with your company to prepare an application that matches your company’s interests (instead of the distributor’s).

You plan on getting your product approved in Europe and complete the CE mark process relatively quickly.  You know Germany presents the largest market for medical devices in Europe and you already have a few German physicians interested in using your product.  But, how can you get those German Sickness Funds (Payers) to pay for it – fast?

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

1. The Problem

Just as in the US acute care hospital inpatient stays are reimbursed according to Medicare Severity Diagnosis Related Groups (MS-DRGs), in Germany they are reimbursed according to German Diagnosis Related Groups (G-DRGs).

In both cases, if your new device does not fit into an existing DRG, the hospital may not get paid for using it and thus may not want to use it.  On the other hand, forming a new DRG code for your device (in the US or in Germany) requires data collection of procedure utilization.  But since your device doesn’t currently fit into an existing DRG, hospitals are reluctant to use it, and therefore it will never reach sufficient utilization to justify the creation of a new DRG code.

Sounds like a Catch-22, right?

To encourage entry of new and innovative technologies into the German healthcare system, there is a short-term, intermediate reimbursement mechanism, called NUB, which provides hospitals with the required financial incentive to use a new device, before it is properly reimbursed under the G-DRG system.  However, it seems as if most US medical device companies are unaware of this NUB mechanism that could shorten their time-to-market and even increase their chances of obtaining a relevant G-DRG code in the future.

In the next part I will provide a short description of the German G-DRG system, and then discuss the NUB mechanism in detail.

2. German G-DRG System

The German DRG system, or G-DRG system, groups several parameters, such as: the patient’s main and sub diagnosis (using ICD-10 diagnostic codes), performed procedures (using OPS procedure codes) as well as additional characteristics including the patient’s age, complications and co-morbidities into a single G-DRG code and assigns each code with a price tag (with different adaptations that are outside the scope of this article).

The G-DRG system is a ‘leaning system’, relying on quantitative data supplied to the Agency for the Hospital Payment System (InEK) by the ~250 reporting hospitals throughout the year.  The data gathered during 2010 is applied in the 2012 catalog.

3. NUB Reimbursement

Article 6.2 of the Hospital Remuneration Law (KHEntgG) allows hospitals to submit requests for reimbursement of “new and innovative diagnosis and treatment methods” that did not obtain a G-DRG code yet.

It should be emphasized that the device manufacturer is not the one applying for NUB reimbursement.  Mediclever typically assists the manufacturer in preparing the application and then each relevant hospital receives a copy and submits it on its own.

3.1 Required Criteria

The NUB reimbursement request must fulfill the following criteria:

*  The new and innovative method affects several existing G-DRGs.

*  The new and innovative method can be clearly defined.

*  The cost of using this new and innovative method affects the cost structure of the relevant procedure and the overall cost structure of the hospital.

*  The requesting hospital’s financial situation would be worse if the request is rejected.

3.2 The Application Process

Any hospital, interested in submitting a request for NUB reimbursement, should fill out a request form, which could be downloaded from the InEK site (www.g-drg.de).  The application must be submitted by October 31^st and provide information regarding the substituted (old) method, date of first applying the new method, number of patients treated and expected number of patients that will be treated according to this new and innovative method.  Furthermore, a cost analysis comparing between the old and new methods should be added.

InEK checks all submitted applications and replies with a value of 1 to 4 for each application by January 31^st. 

*  Value 1:

-  The innovative method corresponds with the requirements and will be reimbursed.

-  Usually, InEK will not have a national database that enables a uniform reimbursement rate, therefore each hospital and local GKV negotiation committee will negotiate the reimbursement rate.

-  InEK will also check if the innovative method can be adapted into the G-DRG framework

*  Value 2:

-  The innovative method does not correspond with the requirements.

-  The hospital is not allowed to negotiate reimbursement with any Sickness Fund.

*  Value 3:

-  InEK is overloaded and cannot reply to the submitted application until the deadline of Jan 31st.

-  The hospital may negotiate NUB reimbursement with interested Sickness Funds

*  Value 4:

-  The application was not clear or did not explain clearly why NUB reimbursement is needed.

-  The hospital may negotiate NUB reimbursement with interested Sickness Funds.

3.3 Benefits and Disadvantages

*  Benefits:

-  Obtaining NUB reimbursement takes a relatively short time.  This could lead to immediate increase in procedure and sales volume.

-  There are no risks in receiving a rejection and a negative reply will not affect chances of obtaining another reimbursement mechanism in the future.

*  Disadvantages:

-  NUB reimbursement only applies to submitting hospitals and requires bilateral negotiations between each hospital and the local Sickness Funds.

-  Each agreement is only valid for one year, but may be renewed, relatively easy, unless it has become a part of the G-DRG system.

In a recent research conducted by the Institute of Health Economics (IFG), it was suggested that hospital submissions will be available throughout the year and innovative methods that received a value 1 reply will automatically be reimbursed until included in G-DRG and apply to all relevant hospitals.

3.4 Statistics

For 2010, out of 13,865 requests for 546 new methods, 7,480 (representing 87 new methods) were assigned with Value 1, 6,005 (representing 444 new methods) were assigned with Value 2, none with Value 3 and 245 (representing 11 new methods) were assigned with Value 4. (Source: InEK).

4. Summary

The German healthcare system is trying to cope with the built-in delays of integrating innovative diagnostic and therapeutic treatments into the system.  Similar to the German NUBs, comparable reimbursement mechanisms exist in the UK and in some regions of Italy.  Utilizing these mechanisms can help US companies obtain reimbursement in Europe faster, bring their products to market sooner and increase their chances of obtaining a specific DRG code at a later stage.