Cornelia Henschke

Disease Management Programs for Type 2 Diabetes in Germany: A Systematic Literature Review Evaluating Effectiveness

BACKGROUND Disease management programs (DMPs) are intended to improve the care of persons with chronic diseases. Despite numerous studies there is no unequivocal evidence about the effectiveness of DMPs in Germany. METHOD We conducted a systematic literature review in the MEDLINE, EMBASE, Cochrane Library, and CCMed databases. Our analysis included all controlled studies in which patients with type 2 diabetes enrolled in a DMP were compared to type 2 diabetes patients receiving routine care with respect to process, outcome, and economic parameters. RESULTS The 9 studies included in the analysis were highly divergent with respect to their characteristics and the process and outcome parameters studied in each. No study had data beyond the year 2008. In 3 publications, the DMP patients had a lower mortality than the control patients (2.3%, 11.3%, and 7.17% versus 4.7%, 14.4%, and 14.72%). In 2 publications, DMP participation was found to be associated with a mean survival time of 1044.94 (± 189.87) days, as against 985.02 (± 264.68) in the control group. No consistent effect was seen with respect to morbidity, quality of life, or economic parameters. 7 publications from 5 studies revealed positive effects on process parameters for DMP participants. CONCLUSION The observed beneficial trends with respect to mortality and survival time, as well as improvements in process parameters, indicate that DMPs can, in fact, improve the care of patients with diabetes. Further evaluation is needed, because some changes in outcome parameters (an important indicator of the quality of care) may only be observable over a longer period of time.

Coronary Stents and the Uptake of New Medical Devices in the German System of Inpatient Reimbursement

OBJECTIVES This study aims to analyze mechanisms for facilitating the uptake of new medical devices in the German system of hospital reimbursement, focusing on the example of coronary stents, including (1) trends in their coding, (2) associated diagnosis-related group (DRG) payments, (3) their integration in the German DRG (G-DRG) system, and (4) their diffusion within the inpatient sector. METHODS Published and gray literature provide the basis for analyzing the system of hospital reimbursement. Data on coronary stents were obtained from various regulatory and government bodies and examined in a longitudinal fashion. RESULTS Although German Procedure Classification (Operationen- und Prozedurenschlüssel; OPS) codes were created for a range of stent technologies between 2004 and 2009, the regular system of G-DRG reimbursement does not distinguish between different stents by means of unique DRGs. Instead, supplementary payments or extrabudgetary payments are used to ensure that newer technologies are reimbursed adequately. The limitations of extrabudgetary payments restrict the use of some devices to a small proportion of patients. Data on the diffusion of different stents show that factors other than the reimbursement regime likely also play a role in the frequency with which certain technologies are used. Bare metal stents currently account for most stent implantation procedures in Germany, followed by drug-eluting stents. CONCLUSION The current system of G-DRG reimbursement and of extrabudgetary payments ensures that even the most recently developed technologies can be used in the German inpatient sector. Nevertheless, certain technologies may not be reaching the broad patient population.

TAXONOMY OF MEDICAL DEVICES IN THE LOGIC OF HEALTH TECHNOLOGY ASSESSMENT

OBJECTIVES The suitability of general HTA methodology for medical devices is gaining interest as a topic of scientific discourse. Given the broad range of medical devices, there might be differences between groups of devices that impact both the necessity and the methods of their assessment. Our aim is to develop a taxonomy that provides researchers and policy makers with an orientation tool on how to approach the assessment of different types of medical devices. METHODS Several classifications for medical devices based on varying rationales for different regulatory and reporting purposes were analyzed in detail to develop a comprehensive taxonomic model. RESULTS The taxonomy is based on relevant aspects of existing classification schemes incorporating elements of risk and functionality. Its 9 × 6 matrix distinguishes between the diagnostic or therapeutic nature of devices and considers whether the medical device is directly used by patients, constitutes part of a specific procedure, or can be used for a variety of procedures. We considered the relevance of different device categories in regard to HTA to be considerably variable, ranging from high to low. CONCLUSIONS Existing medical device classifications cannot be used for HTA as they are based on different underlying logics. The developed taxonomy combines different device classification schemes used for different purposes. It aims at providing decision makers with a tool enabling them to consider device characteristics in detail across more than one dimension. The placement of device groups in the matrix can provide decision support on the necessity of conducting a full HTA.

Struktur-, Prozess- und Kostenparameter sektorenübergreifender, telemedizinisch gestützter Versorgungskonzepte für herzinsuffiziente Patienten – ein modulares Referenzmodell

In Deutschland leiden rund 40 % der Bevolkerung an einer oder mehreren chronischen Krankheiten. Fur eine qualitativ hochwertige Versorgung dieser Patienten ist es erforderlich, eine kontinuierliche und ganzheitliche Betreuung uber die verschiedenen Sektoren und Arztdisziplinen hinweg zu realisieren. Verschiedene Studien haben gezeigt, dass dieses Erfordernis bisher nur unzureichend umgesetzt wird.