Abstract

ObjectivesTo (1) describe the (evidence-based) reimbursement process of hospital individual services, (2) evaluate the accordance between evidence-based recommendations and reimbursement decision of individual services and (3) elaborate potential aspects that play a role in the decision-making process in Austria.MethodThe reimbursement process is described based on selected relevant sources such as official documents. Evidence-based recommendations and subsequent reimbursement decisions for the annual maintenance of the hospital individual service catalogue in Austria between 2008 and 2020 were analysed using a mixed methods approach, encompassing descriptive statistics and a focus group with Austrian decision makers.Results118 evidence-based recommendations were analysed. There were 93 (78.8%) negative and 25 (21.2%) positive evidence-based recommendations. In total, 107 out of 118 evidence-based recommendations (90.1%) did not lead to a deviating reimbursement decision. We identified six aspects that may have played a role in the decision-making process for the annual maintenance of the hospital individual service catalogue, with clinical evidence being the most notable. Further aspects included quality assurance/organisational aspects (i.e., structural quality assurance), costs (if comparable to already existing medical services, not: cost-effectiveness), procedural aspects (e.g., if certain criteria for adoption have not been met formally through the proposals), “other countries” (i.e., taking into account how other countries decided) and situational aspects (such as the COVID-19 pandemic).ConclusionsThere is good accordance between evidence-based recommendations and reimbursement decisions regarding hospital individual services in Austria. Beyond clinical evidence, organisational aspects seem to be considered often with regard to quality assurance but costs do not appear to play a major role. The Austrian system has mechanisms in place that can restrict widespread adoption of novel hospital individual services with uncertain clinical benefits. Future studies could investigate how well these mechanisms work and how they compare to other health systems in Europe.

Highlights

  • Coverage decision making is challenging because of concerns with incremental novelty of new interventions, their ever rising costs as well as a significant increase in expectations from patients [1]

  • The challenges in coverage decisions on new medical services utilising medical devices have long been exacerbated by comparably less strict European Union (EU) regulation when compared to drugs

  • Even high-risk medical devices were often approved without the support of high-quality clinical evidence; in a comparative analysis of clinical evidence for market authorisation in Europe and the USA, it was revealed that approval in Europe was generally 3–5 years faster and subsequently associated with increased risk of harms for patients [3,4,5]

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Summary

Introduction

Coverage decision making is challenging because of concerns with incremental novelty of new interventions, their ever rising costs as well as a significant increase in expectations from patients [1]. Approval is generally faster and there is subsequently potentially an increased risk of harms for patients [3]. Even high-risk medical devices were often approved without the support of high-quality clinical evidence; in a comparative analysis of clinical evidence for market authorisation in Europe and the USA, it was revealed that approval in Europe was generally 3–5 years faster and subsequently associated with increased risk of harms for patients [3,4,5]. Many safety incidents and the criticism of the lax regulation led to a new EU regulation on medical devices (EUMDR 2017/745), to be implemented in 2021 [6, 7] It remains to be proven, if regulation alone can ensure safety/efficacy of novel interventions and lead to better accountability and transparency [8, 9]

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