Prioritization and resource allocation in the context of the COVID-19 pandemic. Recommendations for colorectal and pancreatic cancer in Germany.

In the context of the COVID-19 pandemic, there has been a scarcity of resources with various effects on the care of cancer patients. This paper provides an English summary of a German guideline on prioritization and resource allocation for colorectal and pancreatic cancer in the context of the pandemic. Based on a selective literature review as well as empirical and ethical analyses, the research team of the CancerCOVID Consortium drafted recommendations for prioritizing diagnostic and treatment measures for both entities. The final version of the guideline received consent from the executive boards of nine societies of the Association of Scientific Medical Societies in Germany (AWMF), 20 further professional organizations and 22 other experts from various disciplines as well as patient representatives. The guiding principle for the prioritization of decisions is the minimization of harm. Prioritization decisions to fulfill this overall goal should be guided by 1. the urgency relevant to avoid or reduce harm; 2. the likelihood of success of the diagnostic or therapeutic measure advised; and 3. the availability of alternative treatment options. In the event of a relevant risk of harm as a result of prioritization, these decisions should be made by means of a team approach. Gender, age, disability, ethnicity, origin and other social characteristics, such as social or insurance status, as well as the vehemence of a patient's treatment request and SARS-CoV-2 vaccination status should not be used as prioritization criteria. The guideline provides concrete recommendations for 1. diagnostic procedures, 2. surgical procedures for cancer, and 3. systemic treatment and radiotherapy in patients with colorectal or pancreatic cancer within the context of the German healthcare system.

[Effectiveness and Ethical Evaluation of Nudging to Promote the Self-Management in Diabetes Mellitus Type 2]. / Wirksamkeit und ethische Bewertung von Nudging-Interventionen zur Förderung des Selbstmanagements bei Diabetes Mellitus Typ 2.

BACKGROUND: Nudges offer a wide range of options for protecting health in everyday life that supplements traditional public health measures. Against this background, we conducted initial investigations on the effectiveness and ethical aspects of different nudges for promoting self-management of patients with diabetes mellitus type 2 in the context of Disease Management Programs (DMPs). METHODS: The ethical assessment of the nudges was done within the systematic framework of Marckmann et al. (2015) for public health ethics. The existing evidence on the effectiveness of nudges was summarised by means of a narrative literature review. RESULTS: Target agreements with implementation plans, reminder, feedback reports, shared appointments of patients with physicians, peer mentoring, and behavior contracts are nudging interventions with moderate interference with personal rights and relatively unproblematic ethical requirements, which have demonstrated effectiveness in different contexts. Default enrollment for patient training courses, involvement of partners, confrontation with social norms, and shocking pictures may be effective as well; however, they interfere more deeply with the freedom and privacy of patients and, therefore, are bound to stronger ethical requirements and restrictions. The evidence base is still insufficient, especially for social support measures by relatives and peers. CONCLUSIONS: Nudging offers a wide range of targeted interventions for supporting self-management of patients with chronic diseases, the potential of which has not yet been fully realized. Particularly promising interventions should be tested in pilot studies for their acceptance, effectiveness and cost-effectiveness in the context of DMPs.

Risk-Adjusted Cancer Screening and Prevention (RiskAP): Complementing Screening for Early Disease Detection by a Learning Screening Based on Risk Factors.

Background: Risk-adjusted cancer screening and prevention is a promising and continuously emerging option for improving cancer prevention. It is driven by increasing knowledge of risk factors and the ability to determine them for individual risk prediction. However, there is a knowledge gap between evidence of increased risk and evidence of the effectiveness and efficiency of clinical preventive interventions based on increased risk. This gap is, in particular, aggravated by the extensive availability of genetic risk factor diagnostics, since the question of appropriate preventive measures immediately arises when an increased risk is identified. However, collecting proof of effective preventive measures, ideally by prospective randomized preventive studies, typically requires very long periods of time, while the knowledge about an increased risk immediately creates a high demand for action. Summary: Therefore, we propose a risk-adjusted prevention concept that is based on the best current evidence making needed and appropriate preventive measures available, and which is constantly evaluated through outcome evaluation, and continuously improved based on these results. We further discuss the structural and procedural requirements as well as legal and socioeconomical aspects relevant for the implementation of this concept.

[Medical Necessity: A Notoriously Fuzzy and Therefore Dispensable Concept?] / Medizinische Notwendigkeit: Ein entbehrlicher, da notorisch unscharfer Begriff?

The concept of a 'medical necessity' (medN) of interventions is used as a dichotomous attribute with steering and orientating function in various contexts without, however, being precisely defined. We see this lack as a virtue if medN is understood as the dynamic result of transparent, trustworthy, and coherent deliberative procedures on both facts and norms. We suggest using the medN concept relative to health care systems, but independent of economic aspects.

Risk-Adjusted Prevention. Perspectives on the Governance of Entitlements to Benefits in the Case of Genetic (Breast Cancer) Risks.

This article is a revised version of our proposal for the establishment of the legal concept of risk-adjusted prevention in the German healthcare system to regulate access to risk-reduction measures for persons at high and moderate genetic cancer risk (Meier et al. Risikoadaptierte Prävention'. Governance Perspective für Leistungsansprüche bei genetischen (Brustkrebs-)Risiken, Springer, Wiesbaden, 2018). The German context specifics are summarized to enable the source text to be used for other country-specific healthcare systems. Establishing such a legal concept is relevant to all universal and free healthcare systems similar to Germany's. Disease risks can be determined with increasing precision using bioinformatics and biostatistical innovations ('big data'), due to the identification of pathogenic germ line mutations in cancer risk genes as well as non-genetic factors and their interactions. These new technologies open up opportunities to adapt therapeutic and preventive measures to the individual risk profile of complex diseases in a way that was previously unknown, enabling not only adequate treatment but in the best case, prevention. Access to risk-reduction measures for carriers of genetic risks is generally not regulated in healthcare systems that guarantee universal and equal access to healthcare benefits. In many countries, including Austria, Denmark, the UK and the US, entitlement to benefits is essentially linked to the treatment of already manifest disease. Issues around claiming benefits for prophylactic measures involve not only evaluation of clinical options (genetic diagnostics, chemoprevention, risk-reduction surgery), but the financial cost and-from a social ethics perspective-the relationship between them. Section 1 of this chapter uses the specific example of hereditary breast cancer to show why from a medical, social-legal, health-economic and socio-ethical perspective, regulated entitlement to benefits is necessary for persons at high and moderate risk of cancer. Section 2 discusses the medical needs of persons with genetic cancer risks and goes on to develop the healthy sick model which is able to integrate the problems of the different disciplines into one scheme and to establish criteria for the legal acknowledgement of persons at high and moderate (breast cancer) risks. In the German context, the social-legal categories of classical therapeutic medicine do not adequately represent preventive measures as a regular service within the healthcare system. We propose risk-adjusted prevention as a new legal concept based on the heuristic healthy sick model. This category can serve as a legal framework for social law regulation in the case of persons with genetic cancer risks. Risk-adjusted prevention can be established in principle in any healthcare system. Criteria are also developed in relation to risk collectives and allocation (Sects. 3, 4, 5).

Non-invasive prenatal diagnostics (NIPD) in the system of medical care. Ethical and legal issues.

The procedures of prenatal and preimplantation diagnostics are discussed critically again and again in our community. In addition to the permanently controversial issues of embryo protection and abortion, considerations that discrimination on the basis of disability could occur with problematic consequences also for already born people with disabilities and their relatives now play a central role.

[Medical Methods: What Makes them Medically Necessary? Part II: Further Criteria, Overuse, Moving Thresholds, and Grey Zones]. / Medizinische Behandlungsmethoden: Was macht sie medizinisch notwendig? Teil II: Weitere Kriterien, Übermaßverbot, wandernde Grenzen und Grauzonen.

OBJECTIVES: "Medical necessity" (MedN) is a fuzzy term. Our project aims at concretising the concept between medical ethics, social law, and social medicine to support health care regulation, primarily within Germany's statutory health insurance system. In Part I, we identified efficacy, (net)benefit, and the corresponding bodies of evidence as obligatory criteria of MedN. This is the second part suggesting and discussing further criteria. METHODS: See Part I RESULTS: (Part II): As further MedN-criteria we critically assessed a method's effectiveness and acceptance in routine care, its potential beneficiaries, theoretical fundament, cost, and being without alternative as well as patients' self-responsibility, cooperation, and preferences. Since MedN has both lower and upper bounds, we had to consider certain cases of mis- and overuse, due for instance to "indication creep" or "disease mongering". CONCLUSIONS: The additional criteria neither establish MedN (when met singly or together) nor exclude it (when not met). If MedN is rejected in view of the 3 obligatory criteria then further information does not overturn the verdict. If a method is already assessed as being medn then further criteria do not make it "more or less necessary". Though we advocated for a binary MedN-concept (Part I) we are nonetheless convinced that not all medical methods deemed medn are equally medically relevant. Respective differences within the range of MedN could be assessed by techniques to prioritise medical conditions, methods, and aims.

[Medical Methods: What Makes them Necessary? Part I: Medical Methods, medical Necessity and its Main Criteria]. / Medizinische Behandlungsmethoden: Was macht sie medizinisch notwendig? Teil I: Medizinische Methoden, medizinische Notwendigkeit und ihre Hauptkriterien.

OBJECTIVES: "Medical necessity" (MedN) is a fuzzy term. Our project aims at concretising the concept between medical ethics, social law, and social medicine to support health care regulation, primarily within Germany's statutory health insurance system. In a previous publication we identified MedN as a tripartite predicate: A specific clinical condition requires a specific medical intervention to reach a specific medical goal. Our two-part text searches for and discusses criteria to classify medical methods as generally medically necessary (medn), provided a non-trivial clinical condition and a relevant, legitimate, and reachable goal actually exist. In this paper we present the first part of our results. METHODS: Based on an extensive ethical, sociolegal and sociomedical body of literature, and starting with an non-controversial case vignette (thrombolysis in acute stroke), we generally followed a critical reconstructive approach. First we defined the term "medical method". In several interdisciplinary rounds, we then collected and discussed criteria from three sources: methods to develop clinical practice guidelines as compendia of indication rules, the National Model of Prioritisation in Swedish Health Care, and the HTA Core Model of the European Network for Health Technology Assessment as an instrument of political counselling. RESULTS: We identified general clinical efficacy and benefit as the 2 main "medical" criteria of MedN. As a third - epistemic - criterion, the corresponding bodies of evidence are always to be considered. Since clinical and prioritising guidelines grade their recommendations, the question arises whether MedN should be conceptualised as a dichotomous or finer graded predicate. In accord with German social law we advocate for the binary form. Further discussions focused on multifactorial MedN-configurations, the range of the term, and the variability of evidence requirements. CONCLUSIONS: No matter how the content of MedN is conceptualised, it seems impossible to include its criteria in an algorithm. So deliberative effort is indispensable at any stage of developing a programme to classify medical methods as medically necessary.

The budgetary impact of genetic testing for hereditary breast cancer for the statutory health insurance.

Objectives: Potential opportunities and challenges of predictive genetic risk classification of healthy persons are currently discussed. However, the budgetary impact of rising demand is uncertain. This project aims to evaluate budgetary consequences of predictive genetic risk classification for statutory health insurance in Germany.Methods: A Markov model was developed in the form of a cohort simulation. It analyzes a population of female relatives of hereditary breast cancer patients. Mutation carriers are offered intensified screening, women with a BRCA1 or BRCA2 mutation can decide on prophylactic mastectomy and/or ovarectomy. The model considers the following scenarios: (a) steady demand for predictive genetic testing, and (b) rising demand. Most input parameters are based on data of the German Consortium for Hereditary Breast and Ovarian Cancer. The model contains 49 health states, starts in 2015, and runs for 10 years. Prices were evaluated from the perspective of statutory health insurance.Results: Steady demand leads to an expenditure of €49.8 million during the 10-year period. Rising demands lead to additional expenses of €125.5 million. The model reveals the genetic analysis to be the main cost driver while cost savings in treatment costs of breast and ovarian cancer are indicated.Conclusions: The results contribute to close the knowledge gap concerning the budgetary consequences due to genetic risk classification. A rising demand leads to additional costs especially due to costs for genetic analysis. The model indicates budget shifts with cost savings due to breast and ovarian cancer treatment in the scenario of rising demands.

[Entitlement to prophylactic treatment in cases of genetic predisposition for breast cancer : Interdisciplinary perspectives]. / Leistungsanspruch auf prophylaktische Behandlung bei genetischer Prädisposition für Brustkrebs : Interdisziplinäre Perspektiven.

Genetic tests can detect the predisposition to various diseases. The demand for gene diagnostics and corresponding prophylactic measures is increasing steadily. In the German healthcare system, however, legal uncertainties exist as to whether a mere risk of disease is reason enough to bear the costs for prophylactic measures. When medically effective prophylactic measures are available in certain cancer diseases, such as in hereditary breast cancer, the current practice of deciding in individual cases appears to be insufficient.The fact that persons with a high or very increased risk of breast cancer are precluded from a standard care procedure raises questions concerning ethical justification as well as medical plausibility. Moreover, it is remarkable that the statutory healthcare system treats persons at risk differently. In some cases there is a regulated way of reimbursement for preventive measures for persons at risk (factor V Leiden mutation) and in other cases there are only case-by-case decisions. Finally, in light of social regulations for persons at high and very increased risk this article considers the need of optimization regarding the risk communication in the decision-making process and the crucial question of budgetary impact for the German healthcare system.From a medical, ethical and legal perspective, a social regulation for persons at high and very increased risk of disease is inevitable and the consequences should be discussed in advance.

[The 'Myozyme' decision of the Federal Supreme Court of Switzerland and German Law: a constitutional rights and health insurance law perspective]. / Die Myozyme-Entscheidung des Schweizerischen Bundesgerichts aus der Perspektive des deutschen Verfassungs- und Krankenversicherungsrechts.

In November 2010, the Federal Supreme Court of Switzerland dismissed a plea seeking reimbursement for treatment of glycogen storage disease type II - a very rare genetic metabolic disease also referred to as acid maltase deficiency (AMD) or Pompe disease -with a drug called 'Myozyme'. The Court held that the medication was not sufficiently effective or, alternatively, there was insufficient evidence for its effectiveness. The Court argued that the cost was out of balance with respect to the effects of the drug and concluded that it would be against the principle of legal equality if taxpayers were required to defray excessive expenses benefiting only an extremely small fraction of the population. Cost-effectiveness, however, cannot be accepted as a standard criterion governing the allocation of health insurance benefits because diversity of individual health must be regarded as a risk which nature has distributed equally among the members of the population. Therefore, it is a manifestation, rather than a violation, of the principle of legal equality that a public health insurance provider should pay for medical treatment in a particular case even if such treatment could not necessarily be administered to all other insured parties as well. At the same time, if cost-effectiveness in public health care is taken into account carefully, the risk of irrational resource allocation may be minimised. (As supplied by publisher).

[Personal responsibility and solidarity]. / Solidarität und Eigenverantwortung--Spannung oder Gleichklang?

One of the most fundamental characteristics of a liberal order is that both the state and the law follow the principle of personal responsibility and assign to the citizens the responsibility for the consequences of their voluntary decisions. But to rely primarily on the principle of personal responsibility in the health care system holds the danger of attributing the cause of their health problems to the already disadvantaged ("blaming the victim") and of releasing the welfare state from its responsibility to foster social structures that support health-conscious decisions.