Obstacles to Prosthetic Care—Legal and Ethical Aspects of ...

Author: Daisy

Sep. 09, 2024

Obstacles to Prosthetic Care—Legal and Ethical Aspects of ...

1. Introduction

Artificial limb prostheses have become more sophisticated, with improved performance and decreased weight due to the use of latest material science and engineering technologies. Nevertheless, acceptance and usage rates vary strongly between different patients. While performance is one acceptance factor and may be objectively measured, there are more subjective factors relating to social aspects that appear to strongly influence the single person in his or her attitude to accept or reject the use of an artificial limb 1

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An important research aim of ours was thus to produce an overview of social acceptance factors from the literature. As a focus for the present article, we selected the cost factor, as an international study [ 1 ] found that it has a high impact on usage rates and satisfaction of users. The authors of this study had concluded that analyses of national legal frameworks and empirical studies in different countries are needed to better understand the situation of prosthetic care with regard to reimbursement matters. Accordingly, our second research question for this paper was how the German reimbursement system works for prosthetics and whether injustices with regard to access might result from it.

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The consideration of costs of prosthetics leads inevitably to the ethical problem of health care resource allocation and rationing in general. In this respect, Germany is a particularly interesting case: Explicit, open rationing of health services based on cost-effectiveness analysis is avoided for ethical reasons in Germany [ 2 ] but not in other countries [ 3 ]. However, ethicists think that explicit rationing is inevitable in the long term also in a rich country such as Germany and that it is in any case preferable to implicit rationing [ 3 5 ]&#;which, as a matter of fact, already taking place in many ways also in the German health care system [ 5 ].

In the present article, we discuss two basic alternative solutions for the resource allocation problem (which may however be combined in reality). The first solution would be to make prosthetic care more efficient in order to alleviate the financial burden from health care systems (and individual users in case their insurance does not reimburse the whole price). Here, we ask how this could be achieved. The second solution would be to find just processes and criteria for explicit rationing. One key prerequisite would then be to assess the benefit of prosthetics, ideally in an objective way, set it in relation to costs, and at the same time incorporate individual, subjective user preferences and needs into the equation.

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With respect to the latter, we specifically ask which role Health Technology Assessment (HTA) could play to help meet this requirement. HTA is a branch of Technology Assessment (TA), which is exclusively concerned with health technologies, and has its very specific and own methods, functions and institutions if compared to other areas of TA. There is a worldwide network of national HTA institutions today (Health Technology Assessment International, HTAi). In Germany, the IQWiG (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, i.e., Institute for Quality and Efficiency in Health Care), assesses mostly pharmaceuticals, but also medical devices. Benefits are assessed in comparison to an existing, standard treatment for the same medical indication, in order to inform policy and other decision makers about the additional benefit of new products, and also as a basis to negotiate prices between manufacturers and the insurances [ 6 ]. The evidence base which is used to assess a new treatment option are clinical studies, which analyse what effects relevant to the patient, if any, a medical device or pharmaceutical has, for example for the patient&#;s quality of life, a blood parameter, or the capability to walk or grasp objects. The methods used for HTA reports are similar in different countries, but their function may differ according to the national regulatory framework in place [ 7 ].

The paper is structured as follows. Based on a review of some of the most important social factors for acceptance and successful use of prosthetics, as found in the social-scientific and psychological literature (2.), we make some recommendations for an improvement of prosthetic care (3.). We then (4.) give an overview of the reimbursement process for prosthetics for upper and lower limbs in Germany and discuss ethical implications of this process. This overview is based on documents from online sources, grey literature and academic publications from several disciplines (law, social sciences, prosthetic care research, HTA, health ethics and economics). Concluding the paper (5.), we reflect on the role of HTA and more generally value or benefit assessment of prosthetic technology and care for reimbursement decisions.

We will argue that prosthetic care is so important for the overall health of users that it is economically beneficial for health insurances to deliver the best possible care. This has already been pointed out in some studies [ 8 9 ], but is still not widely acknowledged by insurances, in Germany also due to the short-term budget allocation scheme in the health care system [ 10 ] (p. 61). We posit that there are ways to efficiently improve prosthetic care, minimising the burden on the health care budget, in particular social aspects of acceptance are taken more systematically into account.

Furthermore, we argue that the current reimbursement process for prosthetics in Germany is prone to injustices, and that a stakeholder dialogue is urgently needed to approach this issue. As a starting point for this dialogue, we propose ideas for a role of HTA in the processes and adapted ways of cost and effectiveness evaluation of prosthetics and assessment of individual needs and preferences of its users.

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