Digital Therapeutics Reimbursement System in Germany and Its Implications

The current paradigm in mine closure is continuous, or progressive, mine closure, which is the industry standard for best closure outcomes. However, this is a complex management challenge because mine closure is a long, evolving process that can be hampered by changes in ownership and management. It involves external stakeholders, and the jointly planned post-closure land uses influence all closure plans and actions. Closure is also an official process with regulatory requirements and financial sureties. Continuous closure also means continuous reduction of unknowns, risks and (financial) liabilities. Therefore, the constant accumulation of data and plans and the whole process need to be well documented. Such a complex undertaking needs tools that help in managing the process. We must take this beyond the conventional closure management plans (CMPs) written on paper to a digital system with enhanced capabilities for continuous closure management. At the same time, the authorities are going digital. Some European Union Member States and other countries around the world have set up, and are pursuing, egovernment initiatives that are designed to help interaction with the authorities when applying for permits and licences, and submitting environmental impact assessments, etc. (EIAs) (e.g. the digital permit process management system in Germany called BergPass). This also concerns mining projects and the closure of mines. This development also means that CMPs need to comply with these systems, which also emphasises the need for digital closure management systems such as Closurematic: Management Tool for Continuous Mine Closure. The Closurematic project (2018–2021), funded by the European Institute of Innovation and Technology on RawMaterials (EIT RM), is creating a new digital system for managing the mine closure process. Closurematic is a versatile digital tool to help mining companies and consultants plan, carry out, manage, monitor, communicate, and document mine closure at every step of a mining project. The tool adds value to a mining company’s assets by creating continuity in the long-term management of closure-related data. Its main functions will include an easily adaptable master plan (using tailored templates), extended interactive guidance to help the user, links to the best international practices, a geographic information system (GIS) interface, a file repository to store documents relating to the closure, and interactive tables and charts to monitor the closure actions and associated costs.

Traffic Telematics in Europe

Current standards for the ergonomics design of software for visual digital assistance systems in Germany: ISSN 2223-6775 Ukrainian journal of occupational health Vol.19, No 3, 2023https://doi.org/10.33573/ujoh2023.03.218 Current standards for the ergonomics design of software for visual digital assistance systems in Germany Böckelmann I.1, van Schelve J.

(Acetyl-)cholinesterase (ChE) inhibitors have been approved for the treatment of mild to moderate Alzheimer's disease (AD). However, use of ChE inhibitors is limited by budget constraints and disincentives on the side of health insurances and nursing care insurances. To analyse under what conditions the application of the acetylcholinesterase inhibitor donepezil is favourable for the treatment of patients with AD from the perspective of health insurance and nursing care insurance companies in Germany, taking into account factors such as start and duration of treatment, duration of follow-up, drug costs, internalization of opportunity costs and varying mortality and efficacy rates. Transition probabilities from a Swedish study and German cost data for donepezil were merged in a Markov model to follow a cohort of patients over a period of 5-10 years. We defined a base case with 1 year treatment and follow-up over 5 years and varied treatment length, follow-up interval and cost factors in sensitivity analyses. In the base case, the ChE inhibitor donepezil did not lead to cost savings but to a cost-effective outcome on side of health insurances and nursing care insurances. Early treatment of AD and internalization of opportunity costs (caring time devoted to patients) led to less costs per quality adjusted life years gained. However, results are very sensitive with respect to varying mortality and efficacy rates. The application of donepezil may be cost-effective, but considerable uncertainties remain. Moreover, the way the reimbursement system in Germany is presently arranged does not support the application of ChE inhibitors.

Psychiatric comorbidity in cardiovascular inpatients: Costs, net gain, and length of hospitalization

Starting on 01.01.2003 the hospital reimbursement system in Germany will be transferred completely to a diagnosis-related groups (DRG) system based on the data of 2001. As the reimbursement system is of vital importance for the development of a speciality, current information is given about the impact of the new payment system on ophthalmology. The Australian AR-DRG system to be adopted in Germany distinguishes 20 DRGs for ophthalmology. The patients are grouped into the DRGs according to their principal diagnoses and comorbidities and the procedures coded by electronic data processing. Errors in coding and missing data may cause reductions in the hospital budget as do economically inhomogeneous DRGs. The tight timetable given by the legislation requires completion of determining DRG groups and weightings by 31.12.2001. However, important prerequisites such as the mapping tables of the Australian DRGs are still missing, which means that hospitals have to prepare for the new system like a pilot flying blind with no instruments.

Virtually no other topic has attracted more attention in oncology in recent years than chimeric antigen receptor (CAR) T‑cell therapy (CART). On the one hand it opens up completely new treatment options for cancer patients, while on the other it generates treatment costs exceeding € 300,000 per treatment. The aim of this work is to analyze the economic, procedural and organizational challenges of CAR T‑cell therapy from the perspective of the service provider, the cost-bearer and the pharmaceutical manufacturer. The current German diagnosis-related-group (G-DRG) catalog, the G‑DRG tariff, of the German Federal Joint Committee (G-BA) guidelines and G‑DRG coding principles were used to evaluate the reimbursement and remuneration system in Germany. Practical experiences of medical sites were integrated in the analysis. The findings demonstrate great economic challenges especially from the perspective of aCART site. Increasing certification and qualification efforts lead to financial pressure. Insufficient reimbursement and inadequate cost-covering for CART treatment result in budget restrictions for hospitals. High drug costs as well as enormous personnel and infrastructural requirements demand transparent and sufficient reimbursement for hospitals. Interaction between hospital and pharmaceutical manufacturer in the CART process might enable new means of cooperation.

Since the introduction of a per-case reimbursement system in Germany (German Diagnosis-Related Groups, G-DRG), the correct reimbursement for the treatment of severely injured patients has been much debated. While the classification of a patient in a polytrauma DRG follows different rules than the usual clinical definition, leading to a high number of patients not grouped as severely injured by the system, the system was also criticized in 2005 for its shortcomings in financing the treatment of severely injured patients. The development of financial reimbursement will be discussed in this paper. 167 patients treated in 2006 and 2007 due to a severe injury at the University-Hospital Münster and grouped into a polytrauma-DRG were included in this study. For each patient, cost-equivalents were estimated. For those patients treated in 2007 (n=110), exact costs were calculated following the InEK cost-calculation method. The reimbursement was calculated using the G-DRG-Systems of 2007, 2008 and 2009. Cost-equivalents/costs and clinical parameters were correlated. A total of 167 patients treated in 2006 and 2007 for a severe injury at the Münster University Hospital and grouped into a polytrauma DRG were included in this study. Cost equivalents were estimated for each patient. For those patients treated in 2007 (n=110), exact costs were calculated following the InEK (Institute for the Hospital Remuneration System) cost calculation method. Reimbursement was calculated using the G-DRG systems of 2007, 2008 and 2009. Cost equivalents/costs and clinical parameters were correlated. With the ongoing development of the G-DRG system, reimbursement for the treatment of severely injured patient has improved, but the amount of underfinancing remains substantial. As treatment of severely injured patients must be reimbursed using the G-DRG system, this system must be further adapted to better meet the needs of severely injured patients. Parameters such as total surgery time, injury severity score (ISS) and LOS in ICU could be used for this purpose. In future, data obtained in trauma networks can help optimize reimbursement for the treatment of these patients.

German diagnosis-related groups (G-DRG) have been introduced in Germany as a reimbursement system for in-patient care. The aim of this study was to report data-based experiences from the introduction process and to evaluate the impact on in-patient dermatology. A quantitative analysis including clinical data from two large university centres of dermatology over a time period of 4 years (2003-06) has been performed. Characteristics and trends of case-mix index, number of cases, average age, length of stay (LOS), surgical and medical treatments and in-patient case groups were studied in detail. It was found that the case-mix index values increased after the introduction period, but subsequently declined on the initial value. At the same time, an increase of dermatological hospital admissions can be noticed parallel to a significant reduction of LOS (P < 0.001) and a moderate increase of average age (P < 0.001). Analysis of DRG assignment revealed an initial significant decline of surgical in-patient procedures and increasing medical treatments, however, without obvious long-term changes. Furthermore, a growing importance for dermatological oncology and inflammable skin diseases within the in-patient setting could be observed. The introduction of the G-DRG system in Germany induced changes in in-patient care affecting hospital admission rates, LOS and cases treated in an in-patient setting. In-patient activities have not been reduced with the DRG introduction; however, long-term interdisciplinary research approaches are needed to explore the future impact on health care providing and quality of health care in depth.

The article is devoted to the problems of legal adjusting of relations concerning the reimbursement of the cost of medical services by the state for the benefit of subjects of the pharmaceutical industry: manufacturers, pharmacies, healthcare institutions, etc. The nature of reimbursement relations was investigated. Current domestic legislation on reimbursement is fairly new and is the result of implementing the principles of regulatory policy in the field of health care adopted in the EU. It was also developed to implement the provisions of the Association Agreement between Ukraine and the EU. Therefore, it is logical to conclude that the domestic legislation has a number of disadvantages, in particular regarding the extremely narrow list of diseases for the treatment of which medicines can be reimbursed. In addition, the fact that only the NHSU may be party to reimbursement agreements significantly reduces the opportunities for practical implementation of state guarantees in the sphere of public health care. Instead, expanding the scope of subjective relationships at the expense of local governments will significantly increase the effectiveness of public policies on the availability of medicines. The analysis of foreign experience has made it possible to establish the effectiveness of such principles of the reimbursement system as therapeutic expediency and value for money / treatment. These principles are the foundations of the reimbursement systems in Germany, France, the United Kingdom, the Baltic States, the Czech Republic, Slovakia, etc. The attention is also drawn to the experience of the United Kingdom in maintaining a register of medicinal products which may be subject to reimbursement mechanisms, the inclusion to which is based solely on information about the efficacy of such medicinal products as confirmed by clinical trials. All of this requires further study in order to introduce the legal support of the medicines reimbursement relations into the domestic practice.

Nosocomial pneumonia is a common hospital infection extending the hospital stay as complication of an underlying disease. From the hospital’s perspective nosocomial pneumonia is an unfavourable disease, as reimbursement by the statutory health insurance is practically not concerned since the implementation of the new diagnosis related reimbursement system in Germany in 2004. Therefore, an efficient antimicrobial therapy is mandatory. A prospective cohort study investigated costs and effectiveness of treatment of nosocomial pneumonia with piperacillin/tazobactam (Tazobac®1, Wyeth Pharma GmbH) or meropenem (Meronem®1, AstraZeneca GmbH). The results were transferred to the implemented DRG-reimbursement modalities. The multicentre cohort study was conducted open-label and prospectively in German hospitals in 1999/2000. Patients suffering from nosocomial pneumonia and receiving treatment with piperacillin/tazobactam or meropenem were observed. There was no intervention regarding the physicians’ decision concerning diagnostic and therapeutic measures, as cost determination was predominant. Since the effectiveness of the two alternative treatment regimens was comparable, a cost-minimisation-analysis was performed. The costs incurred due to the prolongation of the hospital stay were calculated from the perspective of the German statutory health insurance funds and the hospital. As nosocomial pneumonia is a complication that occurs during the hospital stay, it does not represent a specific disease related group; thus, the costs incurred by the hospital and the health insurance funds were calculated by using common DRG examples. The analysis included 114 patients of the piperacillin/tazobactam cohort (PT) and 84 patients of the meropenem cohort (M). No significant differences concerning demographics or outcome of therapy were observed between the two cohorts. For the group of postoperative patients (97 pat., PT: 63, M: 34) the German DRG I03C (femoral neck fracture followed by total endoprosthesis) was assumed. Prolongation of the hospital stay of 8.43 days (PT) and 11.32 days (M), respectively, lead to an average additional reimbursement of € 124 in the PT-cohort (M-cohort € 258). From the hospitals’ perspective costs amounting to € 3,034 (PT) and € 4,076 (M) were calculated. For non-postoperative patients (101 pat., PT: 51, M: 50) the DRG F62B and F62A (congestive heart failure) were used. Prolongation of the hospital stay was 7.45 days (PT) and 6.55 days (M), respectively. The average additional reimbursement was € 62 for PT and € 0 for M. Compared to the additional reimbursement the costs from the hospitals’ perspective amounted to € 1.635 (PT) and € 1.465 (M). Comparing the perspectives of statutory health insurance funds and hospitals a redistribution of economic burden is demonstrated in the example of nosocomial pneumonia. Before the implementation of the DRG system, a prolongation of hospital stays was completely covered by the statutory health insurance funds; now, the hospitals have to take over most of the costs. Therefore, an efficient antimicrobial therapy of nosocomial pneumonia is important for the hospitals from an economical point of view. In this case, the combination piperacillin/tazobactam and meropenem represent comparable alternatives.

It is not that innovative technology in measuring medical outcomes with a digital or electronic means is a particularly new thing. In the early 1960s the Holter monitor for measuring ECG heart activity became available for use. At first these devices were not digital, nor were they even portable. But today a Holter monitor is clearly a digital device that can be used to monitor your ECG, but also can be used to record ECG endpoints. Is the Holter monitor the first medical digital device? If not, it is in the running. What is certain, however, is that it is not the last. About 2012 one of the authors of this editorial was a statistician on a study in which historically the endpoint of interest was gathered with a paper diary in which subjects noted each time an event happened, the analysis endpoint being the number of times the event happened over 24 hours. There was a company that we became aware of that could develop a device for patients in which they could record their events in a device. This made sense. We worked with them and we had an electronic means to collect these data and transmit them automatically into a database. Now, there became new concerns, such as what do you do when a patient says they have had 70,000 events in a day? These ended up, however, being issues that one could fix with intelligent design. Time goes by and one starts seeing Fit Bits being all the rage. People are recording steps and vital signs and other things to keep track of their own health. It does not take long to recognize that if an individual can do this with a phone then we ought to be able to collect similar sorts of information for clinical trials this easily. Why is this important? Well, it could mean less or shorter visits for patients during a clinical trial. The possibility of continuous 24-hour monitoring became more feasible. With more data, could we require fewer subjects? All kinds of possibilities became apparent. But more excitingly is that nonapparent ideas that could revolutionize medicine could take place. Improved data quality and improved assessment of clinical outcome can have profound implications for clinical research—increased accuracy, reduced need for clinical site visits, shift from treatment to prevention (due to longitudinal data monitoring), streamlined clinical decision-making, etc. However, these promises necessarily come with challenges—more data does not always mean better data, and data analysis must be done properly so that the results are convincing. Digital technologies are powerful tools that hold much promise in clinical research and development. However, the success of their implementation will require care: well-trained and qualified individuals with necessary medical and statistical expertise. Discussions among stakeholders in academia, industry, and health authorities, and development of new statistical methodologies to design and analyze clinical trials utilizing wearable devices and digital medicine products, will be inevitable for making progress in this direction. To some extent, the artificial pancreas notions that seem to have a lot of promise for those with Type 1 diabetes will most likely be powered by digital technology. With a digital device like Dexcom1 for monitoring of blood glucose along with an insulin pump which can now deliver insulin electronically, we see not only the possibility of better endpoints but better healthcare delivery. Will it take long to bring an implantable artificial kidney2 for testing in clinical trials for chronic kidney disease? If this device shows favorable risk–benefit properties for such a high unmet medical need, it could bring tremendous help and improve quality of life for many patients who are on hemodialysis. Will we see drug–digital combinations in the near future? On November 13th 2017, the US Food and Drug Administration (FDA) announced approval of Abilify MyCite for the treatment of schizophrenia, bipolar I disorder, and as an adjunctive treatment of adults with major depressive disorder.3 Abilify MyCite contains an ingestible event marker sensor embedded into oral Abilify tablets. The sensor tracks if patients have ingested their medication and communicates this information to the patient and healthcare provider, thereby providing an objective summary of drug ingestion over time and offering a new way of monitoring patients. This is perhaps the first example of when two previously approved products (psychiatric drug Abilify and the ingestible sensor) are combined to produce a novel drug–digital medicine. Will there be more? The articles in this special issue attempt to reveal the potential of intelligent digital devices in clinical research and development. Izmailova et al.4 discuss various applications of wearable technologies in clinical trials as well as corresponding promises and challenges. The authors highlight the utility and use of wearables in many therapeutic areas while emphasizing the need for more scientifically rigorous experiments before wearable technologies can be widely adopted. Rogozinska5 provides nice examples of how the use of digital health technologies can potentially enhance productivity of drug development by increasing speed, quality, and product commercial value, and reducing cost and workload. The described regulatory, scientific, and operational challenges can also be viewed as opportunities for pharmaceutical companies to improve their business performance. Walton et al.6 describe a new type of clinical trial design, the Micro-Randomized Trial (MRT), for development of adaptive mobile health interventions. In this design, treatment options for each individual are selected based on carefully defined randomization algorithms, applied 100s or even 1,000s of times per individual during a study. The MRT is an example of an adaptive trial design to create an optimal treatment strategy for further testing in large randomized comparative studies. Koydemir and Ozkan7 describe innovative ways of using smartphones as biomedical sensors and platforms for collection, display, and/or sharing biomedical data acquired by wearable devices. The authors cleverly argue that smartphones can democratize advanced measurement and can potentially create transformative opportunities in various fields, including but not limited to medicine and education. Byrom et al.8 give a thorough overview of brain monitoring digital devices in neuroscience clinical research. The scope of applications is very broad and includes studies of pain, Alzheimer's disease, traumatic brain injury, epilepsy, sleep, etc. While data from many of these technologies cannot replace clinical endpoints, the authors provide a good rationale and justification for implementing them as exploratory tools in clinical trials. The high-frequency data can provide valuable insights into brain functioning, cognition, patterns of sleep, etc. which can also aid interpretation of the clinical outcomes. Finally, Sverdlov et al.9 discuss digital therapeutics—a new treatment modality in which digital systems can be used to treat medical conditions. It is argued that digital therapeutic technologies have broad applications, including cognitive behavioral therapies, gaming consoles for postdischarge rehabilitation, hybrid closed-loop systems, and many more. The authors also present business models and regulatory considerations for developing digital therapeutics, and provide some recent examples of digital therapeutics that have gained regulatory approval. Digital technology is in its infancy. There will be a lot of failure. The natural evolution of humans took millions (or billions?) of years, recycling imperfections or redundancies. Today, science and technology have reached a state when discoveries and advances in medicine and healthcare will be made at much faster speeds. It does not take a rocket scientist (or a clinical pharmacologist) to see that this technology will be revolutionary and we imagine that will change much of what is done in clinical trials and will have a major impact on how medicine is practiced in the future. No funding was received for this work. The authors declare no competing interests for this work.

Using Digital Health Technology to Prevent and Treat Diabetes.

Digital therapeutics represent a new treatment modality in which digital systems such as smartphone apps are used as regulatory-approved, prescribed therapeutic interventions to treat medical conditions. In this article we provide a critical overview of the rationale for investing in such novel modalities, including the unmet medical needs addressed by digital therapeutics and the potential for reducing current costs of medical care. We also discuss emerging pathways to regulatory approval and how innovative business models are enabling further growth in the development of digital therapeutics. We conclude by providing some recent examples of digital therapeutics that have gained regulatory approval and highlight opportunities for the near future.

BackgroundColorectal cancer survivors often experience decline in physical performance and poor quality of life after surgery and during adjuvant therapies. In these patients, preserving skeletal muscle mass and high-quality nourishment are essential to reduce postoperative complications and improve quality of life and cancer-specific survival. Digital therapeutics have emerged as an encouraging tool for cancer survivors. However, to the best of our knowledge, randomized clinical trials applying personalized mobile application and smart bands as a supportive tool to several colorectal patients remain to be conducted, intervening immediately after the surgical treatment.MethodsThis study is a prospective, multi-center, single-blinded, two-armed, randomized controlled trial. The study aims to recruit 324 patients from three hospitals. Patients will be randomly allocated to two groups for one year of rehabilitation, starting immediately after the operation: a digital healthcare system rehabilitation (intervention) group and a conventional education-based rehabilitation (control) group. The primary objective of this protocol is to clarify the effect of digital healthcare system rehabilitation on skeletal muscle mass increment in patients with colorectal cancer. The secondary outcomes would be the improvement in quality of life measured by EORTC QLQ C30 and CR29, enhanced physical fitness level measured by grip strength test, 30-sec chair stand test and 2-min walk test, increased physical activity measured by IPAQ-SF, alleviated pain intensity, decreased severity of the LARS, weight, and fat mass. These measurements will be held on enrollment and at 1, 3, 6 and 12 months thereafter.DiscussionThis study will compare the effect of personalized treatment stage-adjusted digital health interventions on immediate postoperative rehabilitation with that of conventional education-based rehabilitation in patients with colorectal cancer. This will be the first randomized clinical trial performing immediate postoperative rehabilitation in a large number of patients with colorectal cancer with a tailored digital health intervention, modified according to the treatment phase and patient condition. The study will add foundations for the application of comprehensive digital healthcare programs focusing on individuality in postoperative rehabilitation of patients with cancer.Trial registrationNCT05046756. Registered on 11 May 2021.