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Innovative diagnosis and treatment methods – regulation of their reimbursement in the German healthcare sector

The German healthcare cost reimbursement system differentiates between in- and outpatient medical products. In an interview with Caroline Ref and Jasmin Dabrowski from BIOPRO Baden-Württemberg, Michael Weißer, Chief Operating Officer of AiM GmbH in Lörrach, gives interesting insights into the reimbursement of medical care products, in particular with regard to the introduction of new and innovative diagnosis and treatment methods.

Glossary

  • The differentiation of cells describes their specialisation in their function and structure. Different cell types like myocardial, neural or liver cells with totally different appearance and functions develop from undifferentiated stem cells in this way.
  • New examination and treatment methods (NUB) are medical procedures whose diagnostic and therapeutic benefit and economic efficiency has not been sufficiently proven or been recognised by the G-BA. In inpatient care settings, innovative procedures are permitted with the so-called reservation of prohibition and in outpatient settings, innovative procedures are prohibited until they have been officially approved. However, innovative products (NUBs) whose benefit is not documented by the G-BA must be removed from the ISH’s benefit catalogue. Hospitals can therefore apply all innovative medical devices that have received the CE mark. In outpatient care settings, new technologies need to be listed on the EBM in order to be reimbursed, and the decision on acceptance of new procedures for coverage by the SHI needs to be ratified by the G-BA. However, since the introduction of trial regulations in 2012, the G-BA is also entitled to decide on the testing of a NUB.
  • The German system of diagnosis-related groups (German DRG; G-DRG) is a system that uses specific criteria to classify hospital cases (in-patient and day-care patients) into certain groups. Patients that require similar types of treatment are grouped into specific groups; every individual patient is thus assigned to a specific group. The DRG-financing system was introduced in Germany in 2003. The G-DRG system is maintained by the Institute for the Hospital Remuneration System (InEK).

Medical products are used both in outpatient and inpatient care. How is the remuneration system for in- and outpatient medical services regulated in Germany?

Michael Weißer, Chief Operating Officer of AiM GmbH, studied economics and specialised in hospital management and social insurance systems. He has been with AiM for eight years and advices the industry. © AiM GmbH – Assessment in Medicine, Research and Consulting

As far as ambulatory treatment is concerned, the therapeutic and diagnostic methods used are subject to authorisation from the respective authorities. This means that innovative medical procedures and products do not become part of the statutory health insurance (SHI) reimbursement system until they have been officially examined and approved essentially on the basis of their application. This is where the Federal Joint Committee (G-BA) plays a decisive role. The G-BA carries out a benefit assessment in order to determine the benefits of the method and whether it should become an integral part of SHI remuneration. Benefit assessments can take several years. Different rules apply to certain medical products (notably medical aids, drug-like medical products, wound dressings) and in some cases also application procedures initiated by manufacturers.

Federal Joint Committee (G-BA) and Institute for Quality and Efficiency in Healthcare (IQWiG)

The Federal Joint Committee (G-BA) is the highest decision-making body of the German joint self-governing system of physicians, dentists, hospitals and health insurance funds. The G-BA has the authority to make decisions relating to the benefits catalogue of SHI schemes, thus specifying which medical care services are reimbursed by the SHI. In addition, the G-BA specifies measures for quality assurance in inpatient and outpatient areas of the German healthcare system.

Prior to making any decision, the G-BA regularly commissions the Institute for Quality and Efficiency in Healthcare (IQWiG) to prepare scientific reports/assessments on the relevant medical measure. The IQWiG also develops comprehensible health information for the public, as well as scientific reports on health topics suggested by members of the public.

Quite the opposite applies to the reimbursement of inpatient treatment. In this case, innovative procedures are permitted with so-called reservation of prohibition. This means that an innovative diagnosis and treatment method may in principle be applied by hospitals as long as it has not been excluded by the G-BA in accordance with § 137c SGB V.

Reimbursement of hospital services by the health insurance funds is based on the German Diagnosis Related Groups system (G-DRG system). It goes without saying that the hospitals have to adhere to certain principles. Basic quality and profitability requirements must be met. The method must also have the potential to be a valid alternative to the current standard.

DRG codes

Since January 2004, German hospitals have been required to classify diseases into so-called “Diagnosis Related Groups” (DRG). The DRG system is used to classify treatment cases based on financial aspects. A DRG code is assigned to each patient during a hospital stay. Hospitals for patient cases with similar medical problems and similar treatment costs are given the same DRG for the hospital stay.

What about methods that are not included in the DRG code, where costs would therefore exceed the current base rates?

The InEK GmbH groups new and innovative diagnosis and treatment methods into four different result categories. © AiM GmbH based on InEK GmbH information

Every autumn, all hospitals are given the opportunity to submit requests for reimbursement of “new and innovative diagnosis and treatment methods” (NUB; Neue Untersuchungs- und Behandlungsmethoden) that have not yet obtained a G-DRG code to the InEK, the Institut für das Entgeltsystem im Krankenhaus (Institute for the Hospital Remuneration System), which subsequently checks whether the method is already properly remunerated as part of the existing DRG pricing system and whether it is in principle a “new and innovative diagnosis and treatment method”. If the method meets InEK criteria, it is given status 1 and the InEK recognises the method as NUB. The following year, the hospital may negotiate with insurance companies regarding additional charges for the method.

How long does it take for DRG codes to be adjusted, i.e. before “innovative diagnosis and treatment methods” are included in DRG codes?

From experience we can say that it takes between three and five years to adjust DRG codes. The lengthy delay is down to the following: an OPS (operation and procedure key) has to be submitted in order to generate a corresponding code. OPS codes represent therapy and diagnosis methods that are used for patient treatment. The German Institute for Documentation and Information (DIMDI) maintains the OPS catalogue and adds new entries every year. If the proposed code becomes part of the OPS catalogue during annual revision, hospitals can use this code for documenting the methods used and for billing patient treatment. In addition, the InEK assigns the new OPS code to one or more DRG base rates. The InEK works with a number of hospitals that voluntarily collect patient-level cost data. These hospitals provide the InEK with information about the real case costs associated with patient treatment, case numbers, diagnosis and procedures carried out on the basis of the OPS codes.

This data is analysed by the InEK the following year, and the corresponding DRG-based payments are adjusted the year after. This means that data gathered during 2015 is applied in the 2017 catalogue. If, however, the hospitals that collect patient-level cost data do not have enough cases and data, it may take longer, sometimes several years before the InEK can calculate valid costs for the respective method. During the period that the innovative method is not properly represented in the DRG base rates, any hospital that wants to use such a method and have it covered completely, needs to submit a request for NUB reimbursement to the InEK and negotiate the hospital-specific additional charges for the method with the cost bearers at a later stage.

How many requests for NUB reimbursement are submitted per year?

Up to around 700 different NUB reimbursement requests have so far been submitted on an annual basis. Around 25% of these have been given positive status, i.e. status 1. 

In short, obtaining remuneration status requires a great deal of patience. So when should start-ups start dealing with this topic?

From experience, I would say that it makes sense to start dealing with the issue around a year before CE certification is planned. Especially in cases when the start-ups plan to start commercialising their products immediately after obtaining the CE mark.

In any case, it is important to deal with the issue at a very early stage, find out how everything works and which clinical evidence is needed. As I see it, it's also important to find out what needs to be done in order to guarantee that the end customers can actually get the product/procedure reimbursed. Furthermore, the start-up can already start looking at the markets that it wants to serve and how the reimbursement systems of these markets are structured.

About AiM GmbH

AiM GmbH has been providing support to the medical device industry for 10 years and since 2014 has been part of the IGES Group, a network of research and consulting companies from the infrastructure and healthcare fields. The core of the IGES Group is the IGES Institute, founded in 1980. The IGES Institute provides comprehensive knowledge and tools to healthcare system, transport and education sector stakeholders to enable them to make well-informed decisions. In addition, the company network also involves the CSG Clinical Studies Group, which is active in the field of clinical research, as well as IMC clinicon, a consulting and service institute specialised in hospitals.

With regard to "evidence-based cost reimbursement", AiM GmbH develops concepts for the smoothest possible market introduction of medical devices. AiM’s support includes advice on appropriate study protocols, the performance of cost reimbursement research, the elaboration and implementation of market access strategies.

Another area that AiM is involved in is the preparation of benefit assessments and health economy models. The company uses scientifically established methods used by evaluation institutes or decision-makers such as the IQWiG and the G-BA. AiM also provides support for preparing and monitoring selective contractual negotiations between service providers and cost bearers.

Website address: https://www.gesundheitsindustrie-bw.de/en/article/news/innovative-diagnosis-and-treatment-methods-regulation-of-their-reimbursement-in-the-german-healthcare-sector/