§135, §137c, §137e and §137h SGB V
No sample with the testing scheme
With the entry into force of the statutory health insurance law to strengthen medical care on July 23, 2015, §§ 135, 137c, 137e and 137h SGB V also became a topic of discussion on the German health care market. In particularly for manufacturers as well as for users, the discussions raised open questions. Some of them are still not fully answered today.
How about my product? What is to be considered in which risk class? And what do I have to do if I want to get market access for my product for the ambulatory or inpatient market? These and similar questions are most frequently asked by involved parties who are not involved daily in the approval process for medical devices on the German market. Absolutely comprehensible, we think – the way to admission to the German market has become more and more complex over the years.
We provide a brief overview of the relevant laws in practice, possible hurdles in the process and a brief outlook on the future.
How did it begin?
In 2012, the Statutory Health Insurance law came into effect, which, according to the Association of Statutory Health Insurance Physicians, was at that time „… as one of the most important laws in the recent health policy … surely it is the most comprehensive.“
In any case, the Statutory Health Insurance law should provide for better patient medical care, more flexible medical care structures in the rural regions, a good framework for doctors as well as a targeted demand planning. And it should take care for the innovations of medical devices. The German market should remain attractive for medical device innovations and therefore the new Federal Joint Committee (G-BA) got a tool, the new testing scheme for new examination and treatment methods, to ensure the rapid and targeted access of innovations to the medical care sector.
By this date, the Federal Joint Committee (G-BA) could only accept a method and exclude it if the benefits were not sufficiently documented. Within the framework of the new testing scheme, the Federal Joint Committee (G-BA) was able to commission an independent scientific institute to conduct scientific steering and evaluation in order to test this method, if the potential for a necessary treatment alternative was available. This had been regulated in detail in §137e SGB V.
The testing scheme was already part of the evaluation procedure of the G-BA according to §135 SGB V for the ambulatory sector as well as §137c SGB V for the inpatient sector. In these sectors, the test procedure could be initiated, subject to the suspension of the assessment procedure.
On January 1, 2016 §137h SGB V completed the quartet around the „testing scheme“. §137h SGB V introduced the obligation to provide information to the Federal Joint Committee (G-BA) for hospitals, which for the first time submitted a NUB inquiry (new method of examination or treatment) for a treatment with a medical device of the highest risk class. §137h SGB V concludes here back to the §137e SGB V. If the G-BA does not find a sufficient state of evidence, the G-BA decides according to §137e SGB V about the execution of the test scheme. The medical device manufacturers are involved here, and the hospitals that want to provide this treatment/ method are even obliged to participate in the trial.
Today the G-BA describes us three paths in the testing of examination and treatment methods, which we will briefly explain below for our common understanding.
- Application-controlled trial according to §137e para. 7 SGBV
This shall be carried out at the request of a manufacturer whose product is relevant for the method to be tested, or at the request of a supplier of the method to be tested. If the application is admissible and the benefit of this treatment/ method has not yet been established, it is decided whether the potential for a necessary treatment alternative exists and whether a trial can be planned.
If a question is answered with no, the process is already terminated at this point. In the case of the positive answer to both questions, the next step is to examine the potential assessment by systematic literature research.
If this is done with a positively result, the application will take part in the annual selection of the methods to be tested.
After the selection has been made, it passes into the admission for the advice of a test guideline per method. This decision only takes place if the necessary costs are covered by the medical device manufacturer.
If these points are ensured, the study management is determined by means of an invitation to tender, as well as the implementation and subsequent evaluation of the trial study. In best case it leads to the positive decision of a directive for the ambulatory treatment (§135 SGB V), hospital treatment (§137c SGB V) or the early detection of diseases (§§25 SGB V).
- Testing according to benefit assessment by the Federal Joint Commission (G-BA)
This way into a possible trial is carried out by the Federal Joint Committee (G-BA) within the scope of the methodological evaluation for the ambulatory treatment (§135 SGB V), the hospital treatment (§137c SGB V) or the early detection of diseases (§§25 SGB V).
If the Federal Joint Committee (G-BA) considers that the benefit of a method/ treatment is still not sufficiently documented, the question of the potential of a necessary treatment alternative is decided.
If this is not recognized, the method is excluded. In the case of a positive decision, the evaluation procedure is suspended and the method takes part in the annual selection procedure of the methods to be tested.
The subsequent steps of the test procedure are identical with those from the path described first.
- Testing scheme of methods with high-risk medical devices
The medical products of the high risk class (particularly invasive and the risk class IIb or III or actively implantable) are treated according to §137h SGBV.
If the benefit of a method/ treatment in the meaning of the G-BA is not yet adequately documented, the question of the potential of a necessary treatment alternative is also decided at this point.
If the potential is not available, the method is assessed according to §137c SGB V. If potential is recognized, the application takes part in the annual selection procedure of the methods to be tested.
The subsequent steps are then again identical with those from the two previously described paths.
What are the hurdles?
As clear as the possible paths into the testing scheme may appear, the notion of „potential“ is being raised and thus often in the focus of various specialist discussions.
The Federal Joint Committee (G-BA) is responsible for the respective review of the potential which assigned it to the Institute for Quality and Efficiency in Health Care (IQWIG).
According to the IQWIG, the potential assessment includes both the potential of the testing and the potential of the method and must be completed within a few weeks.
If the G-BA decides positively based on the potential assessment, the IQWIG is normally commissioned again by the G-BA to carry out a literature review, which is then carried out in the form of an addendum. The aim is to ensure that all relevant studies are taken into account.
The fact that the results of the potential assessment are confidential and are published on the IQWIG website only after a positive decision and after entry into force of the corresponding directive is to be viewed from both sides. On one hand, it is good that data protection is preserved when the decision is negative, in order to prevent any possible misuse. On the other hand, it entails some uncertainty whether all relevant studies have been correctly taken into account.
In the future, the discussion on the potential will probably not be fully resolved and only with confidence-building measures and the possible transparency reduced.
In addition, the content of the application and evaluation process is extremely complex in terms of content and time. Currently, the G-BA itself assumes an approximate duration of approximately 13 to 27 months before the at least 2-year trial can start.
As a result, the path to the introduction of innovations in the medical device sector on the German market is slowing down. The introduction of products from small and medium-sized manufacturers could be impossible due to the lack of financing possibilities or the hard-to-reach financing possibilities.
The costs incurred during the trial should also be considered critically.
Pursuant to section 137e SGB V (6), the costs incurred are to be assumed to an appropriate extent by the respective manufacturer or supplier. The extent to which they will be located can only be roughly estimated today. For this reason, we do not name a concrete amount but we would like to take this opportunity to mention this potential hurdle.
What will happen in the future?
For many medical device manufacturers, Germany is still the second most attractive market behind the US.
Undoubtedly, the changes described above lead to the fact that many companies are geared towards other markets which have a shorter and, if appropriate, less cost-intensive approval process. Here is the current focus on the Asian markets.
But is that really the solution? Certainly not if we trust the statements of the Federal Ministry of Health (BMG) – it was nevertheless the stated goal of the last laws among other things to promote the innovations of medical devices on the German market.
In any case it is certain that the currently valid approval process is time- and cost-intensive for the German market and that manufacturers and suppliers should be well thought-out and should plan in advance in order to avoid unnecessary time loops and additional costs.
Whichever way you choose, the development of new markets and/ or the process of admission to the German market – we will gladly accompany you with our experience and answer your questions about this exciting and challenging topic.
About „use it AG“
As an independent partner, „use it AG“ combines industry-specific know-how and focuses on the disruptive innovation of existing business models, products, technologies and services.
The company is focussing on the digitization of the organizational structure and the development of new solutions in an increasingly challenging digital world, taking into account human performance.
The references include international corporations, major medium-sized companies, important organizations such as cooperatives, associations, societies and institutions of public law.
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