Medical research using governments' health claims databases: with or without patients' consent?

Taking advantage of its single-payer, universal insurance system, Taiwan has leveraged its exhaustive database of health claims data for research purposes. Researchers can apply to receive access to pseudonymized (coded) medical data about insured patients, notably their diagnoses, health status and treatments. In view of the strict safeguards implemented, the Taiwanese government considers that this research use does not require patients' consent (either in the form of an opt-in or in the form of an opt-out). A group of non-governmental organizations has challenged this view in the Taiwanese Courts, but to no avail. The present article reviews the arguments both against and in favor of patients' consent for re-use of their data in research. It concludes that offering patients an opt-out would be appropriate as it would best balance the important interests at issue.

No payments, copayments and faux payments: are medical practitioners adequately equipped to manage Medicare claiming and compliance?

The complexity of Medicare claiming means it is often beyond the comprehension of many, including medical practitioners who are required to interpret and apply Medicare every day. A single Medicare service can be the subject of 30 different payment rates, multiple claiming methods and a myriad of rules, with severe penalties for non-compliance, yet the administrative infrastructure and specialised human resourcing of Medicare may have decreased over time. As a result, medical practitioners experience difficulties accessing reliable information and support concerning their claiming and compliance obligations. Some commentators overlook the complexity of Medicare and suggest that deliberate misuse of the system by medical practitioners is a significant contributor to rising healthcare costs, although there is currently no empirical evidence to support this view. Quantifying the precise amount of leakage caused by inappropriate claiming has proven an impossible task, although current estimates are $1-3 billion annually. The current government's proposed copayment plan may cause increases in non-compliance and incorrect Medicare claiming, and a causal link has been demonstrated between medical practitioner access to Medicare education and significant costs savings. Medicare claiming is a component of almost every medical interaction in Australia, yet most education in this area currently occurs on an ad hoc basis. Research examining medical practitioner experiences and understanding regarding Medicare claiming and compliance is urgently required to adapt medicine responsibly to our rapidly changing healthcare environment.

Bases científicas y bioéticas del análisis de validez en medicina evaluadora / Bioethical and scientific basis of validity analysis in disability assessment medicine

El contexto médico legal en el que se desarrolla la Medicina Evaluadora, permitiendo el acceso a prestaciones económicas, obliga a considerar la validez -firmeza, consistencia y valor legal- en las consultas de valoración médica de incapacidad. Por otra parte, en el ámbito médico asistencial son habituales los casos biomédicamente inexplicables que, además, se acompañan de elevados niveles subjetivos de sufrimiento, para los que se ha propuesto el término MUPS. Lógicamente, para proteger el principio deontológico de Justicia, en un contexto de recursos limitados, resulta necesario considerar una posible distorsión clínica -discrepancias marcadas entre la afectación o las limitaciones funcionales mostradas y los elementos clínicos objetivos- y sus principales causas; desde trastornos conversivos o somatomorfos en el extremo de lo involuntario, hasta el fraude de la simulación pura. Adicionalmente, dado que la enfermedad y la discapacidad son conductas sujetas al aprendizaje y condicionamiento operante, el mismo análisis de validez nos permitirá actuar conforme a los principios de Beneficiencia y No Maleficencia, evitando reforzar las conductas injustificadas de enfermedad que pueden cristalizar en un Síndrome de Invalidez Aprendida

The forensic context in which dissability assessment medicine is practised, allowing access to workers' compensation benefits, requires consideration of the validity -firmness, consistency and legal acceptability- of medical disability assessment interviews. On the other hand, in assistential medicine biomedically unexplained cases -for which the term MUPS is proposed- are common, often accompanied by high levels of subjective suffering. Logically, to protect the ethic principle of Justice in a context of limited resources, to consider any clinical distortion -marked discrepancy between the person's claimed stress or disability and the objective clinical findings- and their root causes, from somatoform or conversion disorders at the end of the involuntary, to pure malingering is mandatory. Additionally, since disease and disability are subject to learning and operant conditioning behaviors, the same validity analysis will allow us to act according to the principles of Beneficence and Non-maleficence, avoiding reinforce abnormal illness behaviors that can crystallize in the Learned Disability Syndrome

High rate of awarding compensation for claims of injuries related to clinical trials by pharmaceutical companies in Japan: a questionnaire survey.

INTRODUCTION: International norms and ethical standards have suggested that compensation for research-related injury should be provided to injured research volunteers. However, statistical data of incidence of compensation claims and the rate of awarding them have been rarely reported. METHOD: Questionnaire surveys were sent to pharmaceutical companies and medical institutions, focusing on industry-initiated clinical trials aiming at new drug applications (NDAs) on patient volunteers in Japan. RESULTS: With the answers from pharmaceutical companies, the incidence of compensation was 0.8%, including 0.06% of monetary compensation. Of the cases of compensation claims, 99% were awarded. In turn, with the answers from medical institutions, the incidence of compensation was 0.6%, including 0.4% of serious but not death cases, and 0.04% of death cases. Furthermore, most claims for compensation were initiated by medical institutions, rather than by the patients. On the other hand, with the answers from clinical trial volunteers, 3% of respondents received compensations. These compensated cases were 25% of the injuries which cannot be ruled out from the scope of compensation. CONCLUSION: Our study results demonstrated that Japanese pharmaceutical companies have provided a high rate of compensation for clinical trial-related injuries despite the possibility of overestimation. In the era of global clinical development, our study indicates the importance of further surveys to find each country's compensation policy by determining how it is being implemented based on a survey of the actual status of compensation coming from statistical data.

Revisions to rules of conduct and standards of responsibility for representatives. Final rules.

We are revising our rules of conduct and standards of responsibility for representatives. These revisions further clarify our expectations regarding representatives' obligations to competently represent their clients and constitute official notice concerning our requirements and procedures. We are also updating other rules about the representation of parties. These changes are necessary because our current regulations are insufficient to address some representative conduct that is inappropriate, but has technically fallen outside the scope of our regulations. These changes will allow us to better protect the integrity of our administrative process, ensure that claimants receive competent and effective representation, and further clarify representatives' responsibilities in their dealings with us and with claimants.

A review of internet sites regarding independent medical examinations: implications for clinical neuropsychological practitioners.

Independent medical examinations (IMEs) are evaluations requested by third parties as a means of obtaining information regarding the level of treatment an individual requires as the result of an accident or injury. A number of Web sites have been created with the purpose of advising individuals on how to prepare for IMEs. A thorough search of the Internet, using several different search terms and search engines, revealed 7 such Web sites. These sites contain detailed recommendations of the steps an individual should take before, during, and following an IME. While the majority of recommendations are not likely to affect the validity of a neuropsychological IME, some contain information that may have a negative impact on evaluation outcomes. Details from each site and their implications for clinical neuropsychological practitioners are highlighted.