Major regulatory shifts as a driver of organizational change in health care: A macro and a micro perspective

In this dissertation, I explore how major shifts in the regulatory environment of actors involved in the delivery of health service trigger and shape organizational change. To do so, I conceptualize different types of policy intervention as exogenous shocks and use a range of qualitative and quantitative research methods. Chapter 1 portrays the general framework of this dissertation. Adopting a macro and a micro perspective respectively, I explore two distinct types of regulatory shift: First, in Chapters 2 and 3, I focus on regulation of market entry, whereas, in Chapter 4, I focus on reimbursement regulation by analyzing how the introduction of a system based on diagnosis-related groups (DRG) affects health care provision. To do so, I analyze how two acute care hospitals that had implemented kaizen—a management technique that aims to improve business processes—in a preparatory attempt to deliver their services in a more cost-efficient way. Chapter 5 concludes and suggests an agenda for future research. In Chapter 2, I analyze how the regulatory shift induced by the new European Union Medical Device Regulation (MDR) affects the main stakeholders of the medical device industry. The theoretical framework of this review draws on the main objectives that the MDR asserts to pursue in its preamble: to facilitate free trade and enhance public health. Taking a descriptive approach based on both theoretical considerations and empirical evidence, I assess whether the new regulation is likely to achieve these two objectives. To my knowledge, this analysis represents the most comprehensive scholarly review of the MDR so far. In Chapter 3, I conceptualize the new European Union Medical Device Regulation (MDR) as an exogenous shock that elicits a major shift in the regulatory environment of the medical device industry. To make sense of this new environment, firms are forced to reorient and recreate their working practices. Using Switzerland as ground for the subject of this study, I aim to determine the preliminary economic impact of the MDR on the European medical device industry. In this study, top executives and business leaders of medical device firms based in Switzerland completed an online survey with a Likert-scale-design. I used structural equation modeling (1) to determine whether some firms are more capable of change than others when faced with a major shift in their regulatory environment, and, (2) to outline ways in which firms may seek to improve their capacity to react to such a shift. My results suggest that higher levels of organizational capacity for change (OCC) are generally positively associated with financial performance (p < 0.01) but that small and medium-sized firms show higher levels of OCC (p < 0.01) and lower levels of performance than their larger competitors (p < 0.01). Furthermore, I outlined (1) strategies business leaders may wish to consider if they were to make their organizations more capable of change, and (2) measures policy makers could take to ensure that medical devices with no close substitutes are withdrawn from the market, especially in times of a global pandemic. In Chapter 4, I examine how providers of inpatient care respond to shifts in the reimbursement regulation of their services. I move forward towards an analysis from a micro perspective by examining organizational change on the example of individual providers. Additionally, I contrast examples of positive and negative implementation of kaizen—an approach thus far missing in the literature on health management research. By examining how two acute care hospitals had recently implemented the continuous improvement technique, I aim to (1) explore and understand the experiences of nurses, and (2) identify factors affecting the implementation of the technique. By means of purposeful sampling, I selected 30 nurses from different units in two private acute care hospitals in Switzerland in May 2018. I used the Organizational Transformation Model developed by Lukas, et al. (2007) to conduct semi-structured interviews and perform qualitative content analysis. Lastly, originating from the two-factor motivation theory (Herzberg et al., 1959), I suggested two types of factor influencing the implementation of kaizen—hygiene factors that may prevent nurses from getting demotivated, and motivational factors that may boost their motivation. Overall, nurses experienced kaizen as a positive practice that enabled them to discuss work-related activities in a more comprehensive manner. In some cases, however, a lack of visible improvement in the workplace lowered nurses’ motivation to make suggestions. Nurses’ attitudes towards kaizen differed across both hospitals depending on the available managerial support, resources such as infrastructure and staffing levels. To reap the benefits of kaizen, hospital managers should promote the exchange of opinions across hierarchy levels, allocate the necessary resources in terms of personnel and infrastructure, and show nurses how the technique can help them improve their workplace.In dieser Dissertation untersuche ich, wie drastische regulatorische Veränderungen im Gesundheitswesen Organisationswandel auslösen und gestalten. Dazu betrachte ich unterschiedliche Arten von Regulierungen als exogene Schocks und wende dabei eine Reihe von qualitativen und quantitativen Forschungsmethoden an. Kapitel 1 beschreibt den konzeptionellen Rahmen der Dissertation. Zunächst aus einer Makro- und darauf aus einer Mikro-Perspektive untersuche ich zwei verschiedene Arten von regulatorischen Veränderungen: In den Kapiteln 2 und 3 konzentriere ich mich auf Marktzugangsregulierung am Beispiel der Medizinprodukteindustrie, während ich in Kapitel 4 die Rückerstattungsregulierung als Forschungshintergrund nehme und analysiere, wie die bevorstehende Einführung eines auf diagnosebezogenen Fallgruppen basierenden Abrechnungssystems die stationäre Gesundheitsversorgung beeinflusst. Kapitel 5 hält die wichtigsten Schlussfolgerungen sowie Handlungsempfehlungen für Politik, Praxis und Wissenschaft fest und schliesst mit Vorschlägen für künftige Forschung. In Kapitel 2 untersuche ich, wie sich der regulatorische Wandel, der durch die neue Verordnung der Europäischen Union über Medizinprodukte (MDR) ausgelöst wurde, auf die zentralen Akteure der Medizinprodukteindustrie auswirkt. Meines Wissens stellt diese Studie die bisher umfassendste wissenschaftliche Analyse der MDR dar. Zusammenfassend zeigt meine Analyse, dass die MDR höchstwahrscheinlich den europäischen Binnenmarkt stärken wird, da sie regulatorische Vorgaben über die Grenzen der Mitgliedsstaaten hinweg weiter spezifiziert und harmonisiert. Die endgültigen Auswirkungen der Verordnung auf die Patientensicherheit bleiben jedoch unklar, da bis dato keine belastbaren Längsschnittstudien zu diesem Thema vorhanden sind. In Kapitel 3 stelle ich die neue MDR als einen exogenen Schock dar, der die regulatorischen Rahmenbedingungen der Medizinprodukteindustrie erheblich verändert. Um sich in diesem neuen Umfeld zurechtzufinden, sind Unternehmen gezwungen, ihre bestehenden Geschäftspraktiken anzupassen und neue einzuführen. Das Ziel dieser Studie ist, am Beispiel der Schweiz die vorläufigen wirtschaftlichen Folgen der MDR auf die europäische Medizinprodukteindustrie zu untersuchen. Abschliessend skizziere ich (1) Strategien, die Führungskräfte in Betracht ziehen könnten, um die OCC ihres Unternehmens zu erhöhen, und zeige (2) Massnahmen auf, die politische Entscheidungsträgerinnen und -träger ergreifen könnten, um sicherzustellen, dass Unternehmen in finanzieller Notlage Medizinprodukte nicht vom Markt nehmen, für die es keine Substitute gibt und deren Rückzug die gesundheitliche Versorgung von Patientinnen und Patienten beeinträchtigen kann. In Kapitel 4 untersuche ich, wie die Anpassung der Rückerstattungsregulierung stationärer Behandlungen Organisationswandel auslösen kann. Vor diesem Hintergrund betrachte ich, wie zwei private Akutspitäler Kaizen-Management im Hinblick auf die zum damaligen Zeitpunkt bevorstehende Einführung eines Fallpauschalensystems für die Abrechnung von gesundheitlichen Leistungen im stationären Bereich (DRG-System) implementiert haben. Kaizen stellt eine niederschwellige Managementtechnik dar, die die kontinuierliche Verbesserung einer Organisation durch kleine aber ständige Anpassungen von Unternehmensstrukturen und -prozessen bezweckt. In dieser Studie stelle ich Beispiele positiver und negativer Implementierung von Kaizen gegenüber – ein Ansatz, der in der Fachliteratur bislang fehlt. Mein Ziel ist, (1) die Erfahrungen der Pflegefachkräfte zu untersuchen und (2) Faktoren zu identifizieren, die die Implementierung der Managementtechnik beeinflussen können. Aus meinen Erkenntnissen leite ich mehrere Bewältigungsstrategien ab, die Führungskräften helfen sollen, Kaizen zum Nutzen ihrer Organisation und ihrer Angestellten zu implementieren: Um die Vorteile des Managementansatzes zu nutzen, sollten Führungskräfte den Meinungsaustausch über Hierarchieebenen hinweg fördern, die notwendigen Ressourcen in Form von Personal und Infrastruktur bereitstellen und den Pflegefachkräften zeigen, wie die Technik ihnen helfen kann, ihren Arbeitsplatz zu verbessern

How to pay primary care physicians for SARS-CoV-2 vaccinations: An analysis of 43 EU and OECD countries.

Vaccinations are crucial to fighting SARS-CoV-2, and high coverage rates can in most countries probably only be achieved with the involvement of primary care physicians (PCPs). We aimed to explore how SARS-CoV-2 vaccination payment schemes in 43 countries differ with regard to the (i) type of payment scheme, (ii) amount paid, (iii) degree of bundling, and (iv) use of pay-for-performance elements. We collected information on payments and health system characteristics, such as PCP income and employment status, in all EU and OECD countries over time. We regressed the payment amount on the income of PCPs for countries with activity-dependent schemes using a linear regression (OLS), and we interpreted the residuals of this regression as a vaccination payment index. The majority of countries (30/43) had chosen payment schemes that reward PCPs for the activity they perform. Seventeen countries paid less per vaccination than the income-adjusted average, whereas 13 countries paid more. Twelve countries used pay-for-performance elements

Improving health care from the bottom up: Factors for the successful implementation of kaizen in acute care hospitals

Background Kaizen—a management technique increasingly employed in health care—enables employees, regardless of their hierarchy level, to contribute to the improvement of their organization. The approach puts special emphasis on frontline employees because it represents one of their main opportunities to participate directly in decision making. In this study, we aimed to (1) understand the experiences of nurses in two hospitals that had recently implemented kaizen, and (2) identify factors affecting the implementation of the technique. Methods By means of purposeful sampling, we selected 30 nurses from different units in two private acute care hospitals in Switzerland in May 2018. We used the Organizational Transformation Model to conduct semi-structured interviews and perform qualitative content analysis. Lastly, originating from Herzberg’s motivation theory, we suggest two types of factor influencing the implementation of kaizen—hygiene factors that may prevent nurses from getting demotivated, and motivational factors that may boost their motivation. Results Nurses generally experienced kaizen as a positive practice that enabled them to discuss work-related activities in a more comprehensive manner. In some cases, however, a lack of visible improvement in the workplace lowered nurses’ motivation to make suggestions. Nurses’ attitudes towards kaizen differed across both hospitals depending on the available managerial support, resources such as infrastructure and staffing levels. Conclusions From our findings, we derived several coping strategies to help health practitioners implement kaizen for the benefit of their organization and employees: Strong managerial support, appropriate use of kaizen tools, and a greater sense of team cohesion, among other factors, can influence how effectively hospital teams implement kaizen. To reap the benefits of kaizen, hospital managers should promote the exchange of opinions across hierarchy levels, allocate the necessary resources in terms of personnel and infrastructure, and show nurses how the technique can help them improve their workplace

Why the US spends more treating high-need high-cost patients: a comparative study of pricing and utilization of care in six high-income countries.

One of the most pressing challenges facing most health care systems is rising costs. As the population ages and the demand for health care services grows, there is a growing need to understand the drivers of these costs across systems. This paper attempts to address this gap by examining utilization and spending of the course of a year for two specific high-need high-cost patient types: a frail older person with a hip fracture and an older person with congestive heart failure and diabetes. Data on utilization and expenditure is collected across five health care settings (hospital, post-acute rehabilitation, primary care, outpatient specialty and drugs), in six countries (Canada (Ontario), France, Germany, Spain (Aragon), Sweden and the United States (fee for service Medicare) and used to construct treatment episode Purchasing Power Parities (PPPs) that compare prices using baskets of goods from the different care settings. The treatment episode PPPs suggest other countries have more similar volumes of care to the US as compared to other standardization approaches, suggesting that US prices account for more of the differential in US health care expenditures. The US also differs with regards to the share of expenditures across care settings, with post-acute rehab and outpatient speciality expenditures accounting for a larger share of the total relative to comparators

After the four-year transition period: Is the European Union's Medical Device Regulation of 2017 likely to achieve its main goals?

Following a series of major scandals over the past two decades, the medical device industry is now undergoing a major regulatory change: the implementation of the European Union Medical Device Regulation (MDR) of 2017. After a transitional period of four years, the MDR became fully binding in May 2021. Although the medium- and long-term impacts of the MDR are still unclear, a range of scholars, health care professionals, and industry representatives have begun to publish early evidence and publicize their views on how the new regulation may impact free trade and patient safety. Even a cursory view of their output reveals hypotheses and opinions that could hardly be more divergent. The reasons for this disagreement are unclear and may extend beyond the different interests of the various stakeholder groups. To find out why this might be the case, we examine the MDR and seek to improve scholarly understanding of this most extensive regulation of medical devices since the early 1990s. We offer policymakers suggestions to help them improve future regulation. Based on theoretical considerations, we conclude that while the MDR is highly likely to strengthen the internal market of the EU, its impact on patient safety will remain unclear as long as there are no comprehensive studies on this topic that are based on empirical data

Regulatory and HTA early dialogues in medical devices

Abstract Introduction: Specific guidance and examples for health technology assessment (HTA) of medical devices are scarce in medical device development. A more intense dialogue of competent authorities, HTA agencies, and manufactures may improve evidence base on clinical and cost-effectiveness. Especially as the new Medical Device Regulation requires more clinical evidence. Methods: We explore the perceptions of manufacturers, competent authorities, and HTA agencies towards such dialogues and investigate how they should be designed to accelerate the translational process from development to patient access using semi-structured interviews. We synthesized the evidence from manufacturers, competent authorities, and HTA agencies from 14 different jurisdictions across Europe. Results: Eleven HTA agencies, four competent authorities, and eight manufacturers of high-risk devices expressed perceptions on the current situation and the expected development of three types of early dialogues. Discussion: The MDR has to be taken into account when designing the early dialogue processes. Transferring insights from medicinal product regulation is limited as the regulatory pathways differ substantially. Conclusion: Early dialogues promise to accelerate the translational process and to provide faster access to innovative medical devices. However, health policy-makers should promote and fully establish regulatory and HTA early dialogues before introducing parallel early dialogues of regulatory, HTA agencies, and manufacturers. For initiating change, the legislator must create the legal basis and set the appropriate incentives for manufacturers

Surrogate endpoints in health technology assessment: an international review of methodological guidelines

Decision uncertainty associated with reliance on surrogate endpoints is a risk to patients and society. HTA agencies may develop more detailed methodological guidance for consistent selection and evaluation of health technologies without definitive final patient-relevant outcome evidence at the time of the assessment

International comparison of health spending and utilization among people with complex multimorbidity

Objective The objective of this study was to explore cross-country differences in spending and utilization across different domains of care for a multimorbid persona with heart failure and diabetes. Data Sources We used individual-level administrative claims or registry data from inpatient and outpatient health care sectors compiled by the International Collaborative on Costs, Outcomes, and Needs in Care (ICCONIC) across 11 countries: Australia, Canada, England, France, Germany, the Netherlands, New Zealand, Spain, Sweden, Switzerland, and the United States (US). Data Collection/Extraction Methods Data collected by ICCONIC partners. Study Design We retrospectively analyzed age–sex standardized utilization and spending of an older person (65–90 years) hospitalized with a heart failure exacerbation and a secondary diagnosis of diabetes across five domains of care: hospital care, primary care, outpatient specialty care, post–acute rehabilitative care, and outpatient drugs. Principal Findings Sample sizes ranged from n = 1270 in Spain to n = 21,803 in the United States. Mean age (standard deviation [SD]) ranged from 76.2 (5.6) in the Netherlands to 80.3 (6.8) in Sweden. We observed substantial variation in spending and utilization across care settings. On average, England spent $10,956 per person in hospital care while the United States spent$30,877. The United States had a shorter length of stay over the year (18.9 days) compared to France (32.9) and Germany (33.4). The United States spent more days in facility-based rehabilitative care than other countries. Australia spent $421 per person in primary care, while Spain (Aragon) spent$1557. The United States and Canada had proportionately more visits to specialist providers than primary care providers. Across almost all sectors, the United States spent more than other countries, suggesting higher prices per unit. Conclusion Across 11 countries, there is substantial variation in health care spending and utilization for a complex multimorbid persona with heart failure and diabetes. Drivers of spending vary across countries, with the United States being the most expensive country due to high prices and higher use of facility-based rehabilitative care