Published Papers

Brönneke, Jan B., A. Herr, S. Reif and A. Stern (2023) “Dynamic HTA for Digital Health Solutions: Opportunities and Challenges for Patient-Centered Evaluation” In International Journal of Technology Assessment in Health, Vol. 39(1): pp. e72.

Objectives: Germany’s 2019 Digital Healthcare Act (Digitale-Versorgung-Gesetz, or DVG) created a number of opportunities for the digital transformation of the healthcare delivery system. Key among these was the creation of a reimbursement pathway for patient-centered digital health applications (digitale Gesundheitsanwendungen, or DiGA). Worldwide, this is the first structured pathway for “prescribable” health applications at scale. As of October 10, 2023, 49 DiGA were listed in the official directory maintained by Germany’s Federal Institute for Drugs and Medical Devices (BfArM); these are prescribable by physicians and psychotherapists and reimbursed by the German statutory health insurance system for all its 73 million beneficiaries. Looking ahead, a major challenge facing DiGA manufacturers will be the generation of the evidence required for ongoing price negotiations and reimbursement. Current health technology assessment (HTA) methods will need to be adapted for DiGA. Methods: We describe the core issues that distinguish HTA in this setting: (i) explicit allowance for more flexible research designs, (ii) the nature of initial evidence generation, which can be delivered (in its final form) up to one year after becoming reimbursable, and (iii) the dynamic nature of both product development and product evaluation. We present the digital health applications in the German DiGA scheme as a case study and highlight the role of RWE in the successful evaluation of DiGA on an ongoing basis. Results: When a DiGA is likely to be updated and assessed regularly, full-scale RCTs are infeasible; we therefore make the case for using real-world data and real-world evidence (RWE) for dynamic HTAs. Conclusions: Continous evaluation using RWD is a regulatory innovation that can help improve the quality of DiGAs on the market.

Reif, S., S. Schubert, J. Stiefel, F. Husri, T. Fischlein, M. Pauschinger and J. Klucken (2022) “Supporting patients with heart failure with digital therapeutics—A pilot study in Germany” In Digital Health, Vol. 8: pp. 1-8.

Objective: Continuous monitoring and targeted behavioral interventions have been shown to improve health status and quality of life for heart failure patients. Digital therapeutics offer the possibility to make more frequent monitoring and targeted behavioral interventions available for more people. Methods: We conduct a pilot study with 71 patients who were given a smartphone app and wearables for a 3-month period. Clinical indicators as well as patient-reported outcomes were collected at entry and exit examinations. Results: The New York Heart Association class remained stable or improved. Most quantitative outcome measures improved (6-minute walk test distance +21 m, Kansas City Cardiomyopathy Questionnaire summary score +6.0 points, European Heard Failure Self-care Behavior Scale summary score +6.6 points, correct answers in the Atlanta Heart Failure Knowledge Test +2.1), although the changes were mainly not significantly different from zero. There was no change in EQ-5D weight and 9-item Shared Decision-Making Questionnaire summary score. Conclusions: This before–after comparison shows that an app-based intervention can work as a digital therapeutic for heart failure patients.

Stern, A., J. Broenneke, J. Debatin, J. Hagen, H. Matthies, S. Patel, I. Clay, B. Eskofier, A. Herr, K. Hoeller, A. Jaksa, D. Kramer, M. Kyhlstedt, K. Lofgren, N. Mahendraratnam, H. Muehlan, S. Reif, L. Riedemann and J. Goldsack (2022) “Advancing digital health applications: Priorities for innovation in real-world evidence generation” In The Lancet Digital Health, Vol. 4: pp. e200-06.

In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a “Fast-Track” regulatory and reimbursement pathway for digital health applications in the German market. The pathway explicitly provides for flexibility in how researchers can present evidence for new digital products, including the use of real-world data and real-world evidence. Against this backdrop, the Digital Medicine Society and the Health Innovation Hub of the German Federal Ministry of Health convened a set of roundtable discussions to bring together international experts in evidence generation for digital medicine products. This Viewpoint highlights findings from these discussions with the aims of (1) accelerating and stimulating innovative approaches to digital medical product evaluation, and (2) promoting international harmonisation of best evidentiary practices. Advancing these topics and fostering international agreement on evaluation approaches will be vital to the safe, effective, and evidence-based deployment and acceptance of digital health applications globally.

Billner, M., S. Reif, German Burn Registry and B. Reichert (2022) “The effect of self-inflicted burns on ABSI score prediction power: A four-year prospective multicenter study of the German Burn Registry” In Burns.

Background: Suicide attempted by self-inflicted burns are associated with lower survival rates compared to accident related burns. Objective: We investigate the relation between self-inflicted burns (SIB) and survival rates and how this relation is moderated by variables used to predict survival rates in the ABSI score, a widely used measure. Additionally, we compare the predicted survival rates by the ABSI score to the actual rates in our sample for SIB and accident patients. Methods: In this prospective multicenter study data from the German Burn Registry are statistically analyzed using two sided t-test and multivariate linear regression models. Results: 5330 patients (214 with SIB) met our inclusion criteria. We find a 6.8 percentage points lower survival rate for patients with SIB when we control for patient condition with the five ABSI components as covariates. These higher mortality rates can be explained by the higher rate of therapy restrictions for patients with self-inflicted burns. Additionally, different ABSI modifications can improve the predictive power of the score. Conclusion: Patients with SIB have lower survival rates compared to accident patients. Recently proposed modifications of the ABSI score can improve the accuracy of survival rate prediction for SIB.

C. Bünnings, L. Hafner, S. Reif and H. Tauchmann (2021) “In Sickness and in Health? Health Shocks and Relationship Breakdown: Empirical Evidence from Germany” in Journal of Economic Behavior & Organization, Vol. 190: pp. 164-190.

From an economic perspective, marriage and long-term partnership can be seen as a risk-pooling device. This informal insurance contract is, however, not fully enforceable. Each partner is free to leave when his or her support is needed in case of an adverse life event. An adverse health shock is a prominent example for such events. Since relationship breakdown itself is an extremely stressful experience, partnership may backfire as informal insurance against health risks, if health shocks increase the likelihood of relationship breakdown. We address this question empirically, using survey data from Germany. Results from various matching estimators indicate that adverse shocks to mental health substantially increase the probability of a couple splitting up over the following two years. In contrast, there is little effect of a sharp decrease in physical health on relationship stability. If at all, physical health shocks that hit both partners simultaneously stabilize a relationship.

Reif, S., L. Hafner and M. Seebauer (2020) “Physician Behavior under Prospective Payment Schemes - Evidence from Artefactual Field and Lab Experiments” in International Journal of Environmental Research and Public Health, Vol. 17(15), 5540.

Recent experimental studies analyze the behavior of physicians towards patients and find that physicians care for their own profit as well as patient benefit. In this paper, we extend the experimental analysis of the physician decision problem by adding a third party which represents the health insurance that finances medical service provision under a prospective payment scheme. Our results show that physicians take into account the payoffs of the third party, which can lead to underprovision of medical care. We conduct a laboratory experiment in neutral as well as in medical framing using students and medical doctors as subjects. Subjects in the medically framed experiments behave weakly more patient orientated in contrast to neutral framing. A sample of medical doctors exhibits comparable behavior to students with medical framing.

Marcus, J., S. Reif, A. Wuppermann and A. Rouche (2020) “Increased Instruction Time and Stress-Related Health Problems among School Children” in Journal of Health Economics, Vol. 70, 102256.

While several studies suggest that stress-related mental health problems among school children are related to specific elements of schooling, empirical evidence on this causal relationship is scarce. We examine a German schooling reform that increased weekly instruction time and study its effects on stress-related outpatient diagnoses from the universe of health claims data of the German Social Health Insurance. Exploiting the differential timing in the reform implementation across states, we show that the reform slightly increased stress-related health problems among school children. While increasing instruction time might increase student performance, it might have adverse effects in terms of additional stress.

Reif, S., S. Wichert and A. Wuppermann (2018) “Is it good to be too light? Birth weight thresholds in hospital reimbursement systems” in Journal of Health Economics, Vol. 59: pp. 1-25.

Birth weight manipulation has been documented in per-case hospital reimbursement systems, in which hospitals receive more money for otherwise equal newborns with birth weight just below compared to just above specific birth weight thresholds. As hospitals receive more money for cases with weight below the thresholds, having a (reported) weight below a threshold could benefit the newborn. Also, these reimbursement thresholds overlap with diagnostic thresholds that have been shown to affect the quantity and quality of care that newborns receive. Based on the universe of hospital births in Germany from the years 2005–2011, we investigate whether weight below reimbursement relevant thresholds triggers different quantity and quality of care. We find that this is not the case, suggesting that hospitals' financial incentives with respect to birth weight do not directly impact the care that newborns receive.

Billner, Moritz, Anne Wirthmann, Simon Reif and Ulrich M. Rieger (2016) “Poly Implant Prothèse and Rofil Substandard Breast Implant Explantations from a Large German Single Centre from 2011 to 2014: A Comparative Study” in Aesthetic Plastic Surgery, Vol. 40, No. 4: pp. 507–513.

Background: Following a Europe-wide scandal, substandard breast implants containing silicone for industry purposes produced by Poly Implant Prothèse (PIP&Rofil) were explanted due to its potential health risks. We investigated whether these implants actually imposed a threat to patients’ health. In this retrospective single-centre case–control study, we compared patients with breast augmentation receiving implant explantation (01/2011–01/2015). Raw mean comparison showed higher rupture rates for non-PIP implants, 28.42 % (PIP 23.48 %). However, when controlling for implant indwelling time, PIP implants had shown higher rupture rates. Both groups had similar rates of capsular contracture (PIP: 71.30 %, Others: 72.63 %) with different distribution of Baker Scores (Baker 2/3/4: PIP 5/8/13 and non-PIP 3/24/135).

Policy Reports

S. Reif, S. Schubert and A. Wambach (2024) “Reformvorschlag für einen Nachhaltigen Risikostrukturausgleich”. ZEW Policy Brief Nr. 24-03.

S. Reif, J. Köhler and S. Schubert (2023) “Behandlungsgespräche in der Arztpraxis – Ein Europäischer Vergleich”. ZEW Projektbericht, Mannheim.

Fischer, M., H. Jürges, S. Mangelsdorf, S. Reif, H. Ullrich and A. Wuppermann (2023) “Gesundheitsdaten: Von Nachbarländern lernen”, Wirtschaftsdienst, Vol. 103(11): pp. 737-740.

Andres, R., J. Axenbeck, I. Bertschek, P. Breithaupt, R. Janßen, E. Kollmann, T. Niebel, S. Reif and M. Seifried (2021), “Metastudie – Chancen und Herausforderungen der Digitalisierung in Baden-Württemberg”. Ministerium für Inneres, Digitalisierung und Migration Baden-Württemberg, Mannheim.

Reif, S. and S. Schubert (2021) “Vorsorgelücke während der Coronavirus-Pandemie – Vorsorgeuntersuchungen in der Krise”. ZEW-Kurzexpertise Nr. 21-02, Mannheim.

Augurzky, B., S. Decker, A. Mensen and S. Reif (2020) “BARMER Krankenhausreport 2020 - Volume-Outcome im Krankenhaus”. Schriften zur Gesundheitssystemanalyse, Band 25.

Augurzky, B., T. Korfhage, S. Reif and D. Reifferscheid (2019) “Reformvorschläge für die Krankenhausabrechnung und MDK-Abrechnungsprüfung”. Projektbericht im Auftrag des Verband der Ersatzkassen e. V. (vdek).

Augurzky, B., Haering, A. and S. Reif (2019) “Ausbildungspauschalen für die generalistische Pflegeausbildung in NRW - Endbericht”. RWI Projektbericht im Auftrag der Krankenhausgesellschaft Nordrhein-Westfalen.