Financial risk protection from high costs for care is a main goal of health systems. Health system characteristics typically associated with universal health coverage and financial risk protection, such as financial redistribution between insureds, are inherent to, e.g. social health insurance (SHI) but missing in private health insurance (PHI). This study provides evidence on financial protection in PHI for the case of Germany's dual insurance system of PHI and SHI, where PHI covers 11% of the population. Linked survey and claims data of PHI insureds (n = 3105) and population-wide household budget data (n = 42,226) are used to compute the prevalence of catastrophic health expenditures (CHE), i.e. the share of households whose out-of-pocket payments either exceed 40% of their capacity-to-pay or push them (further) into poverty. Despite comparatively high out-of-pocket payments, CHE is low in German PHI. It only affects the poor. Key to low financial burden seems to be the restriction of PHI to a small, overall wealthy group. Protection for the worse-off is provided through special mandatorily offered tariffs. In sum, Germany's dual health insurance system provides close-to-universal coverage. Future studies should further investigate the effect of premiums on financial burden, especially when linked to utilisation.

Most hospital payment systems based on diagnosis-related groups (DRGs) provide payments for newly approved technologies. In Germany, they are negotiated between individual hospitals and health insurances. The aim of our study is to assess the functioning of temporary reimbursement mechanisms. We used multilevel logistic regression to examine factors at the hospital and state levels that are associated with agreeing innovation payments. Dependent variable was whether or not a hospital had successfully negotiated innovation payments in 2013 (n = 1532). Using agreement data of the yearly budget negotiations between each German hospital and representatives of the health insurances, the study comprises all German acute hospitals and innovation payments on all diagnoses. In total, 32.9% of the hospitals successfully negotiated innovation payments in 2013. We found that the chance of receiving innovation payments increased if the hospital was located in areas with a high degree of competition and if they were large, had university status and were private for-profit entities. Our study shows an implicit self-controlled selection of hospitals receiving innovation payments. While implicitly encouraging safety of patient care, policy makers should favour a more direct and transparent process of distributing innovation payments in prospective payment systems.

Background: The aim of this study was to assess the quality of reporting sample size calculation and underlying design assumptions in pivotal trials of high-risk medical devices (MDs) for neurological conditions.

Methods: Systematic review of research protocols for publicly registered randomized controlled trials (RCTs). In the absence of a published protocol, principal investigators were contacted for additional data. To be included, trials had to investigate a high-risk MD, registered between 2005 and 2015, with indications stroke, headache disorders, and epilepsy as case samples within central nervous system diseases. Extraction of key methodological parameters for sample size calculation was performed independently and peer-reviewed.

Results: In a final sample of seventy-one eligible trials, we collected data from thirty-one trials. Eighteen protocols were obtained from the public domain or principal investigators. Data availability decreased during the extraction process, with almost all data available for stroke-related trials. Of the thirty-one trials with sample size information available, twenty-six reported a predefined calculation and underlying assumptions. Justification was given in twenty and evidence for parameter estimation in sixteen trials. Estimates were most often based on previous research, including RCTs and observational data. Observational data were predominantly represented by retrospective designs. Other references for parameter estimation indicated a lower level of evidence.

Conclusions: Our systematic review of trials on high-risk MDs confirms previous research, which has documented deficiencies regarding data availability and a lack of reporting on sample size calculation. More effort is needed to ensure both relevant sources, that is, original research protocols, to be publicly available and reporting requirements to be standardized.

Objectives: To review and compare current Health Technology Assessment (HTA) activities for medical devices (MDs) across European HTA institutions.

Methods: A comprehensive approach was adopted to identify institutions involved in HTA in European countries. We systematically searched institutional Web sites and other online sources by using a structured tool to extract information on the role and link to decision making, structure, scope, process, methodological approach, and available HTA reports for each included institution.

Results: Information was obtained from eighty-four institutions, forty-seven of which were analyzed. Fifty-four methodological documents from twenty-three agencies in eighteen countries were identified. Only five agencies had separate documents for the assessment of MDs. A few agencies made separate provisions for the assessment of MDs in their general methods. The amount of publicly available HTA reports on MDs varied by device category and agency remit.

Conclusions: Despite growing consensus on their importance and international initiatives, such as the EUnetHTA Core Model®, specific tools for the assessment of MDs are rarely developed and implemented at the national level. Separate additional signposts incorporated in existing general methods guides may be sufficient for the evaluation of MDs.