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Experience of an Italian Hospital Claims Management Committee: A tool for extrajudicial litigations resolution
Legal Medicine 42 (2020) 101657
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Legal Medicine journal homepage: www.elsevier.com/locate/legalmed
Short Communication
Experience of an Italian Hospital Claims Management Committee: A tool for extrajudicial litigations resolution
T
⁎
Patrizia Gualnieraa, Cristina Mondelloa, , Serena Scurriaa, Antonio Olivab, Simone Grassib, Jacopo Pizzicannellac, Angela Alibrandid, Daniela Sapienzaa, Alessio Asmundoa a
Departmental Section of Legal Medicine, Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Italy Section of Legal Medicine, Institute of Public Health, Catholic University, Fondazione Policlinico A. Gemelli, IRCCS, Italy c Department of Medical, Oral and Biotechnological Sciences, University “Gabriele d’Annunzio”, Chieti-Pescara, Italy d Department of Economics, Unit of Statistical and Mathematical Sciences, University of Messina, Via dei Verdi 75, 98122 Messina, Italy b
A R T I C LE I N FO
A B S T R A C T
Keywords: Medical malpractice Healthcare Claims Patient damage Litigation
Litigation related to medical liability has a great impact on Italian healthcare expenditure. Recently, many Italian Regions have adopted a “self-insurance system” and, in Sicilian Hospitals, were established the Claims Management Committees (CMC) to provide the direct management of claims. Here the experience of a Sicilian University Hospital CMC was described to analyze the claims features and their outcomes providing evidence on CMC usefulness. The analysis involved claims for compensation received during 4 years, using data obtained by a retrospective analysis of claims database created by Forensic Medicine Service. Claims data, obtained from the insurance broker, were used to perform the statistical comparison. During the examined period a total of 377 claims were received by CMC, respectively 63.6% for professional liability and 36.4% for other causes (damages not related to medical malpractice). The prevalence of complaints about malpractice regarded surgery. The CMC had expressed an opinion on 120 claims related to malpractice with the percentages of admission or rejection of liability respectively of 55% and 45%. The statistical analysis revealed a greater number of lawsuits in the Insurance system and, moreover, the CMC higher probability to reach the amicable settlement of litigations. CMC provides specific data on claims trend and economic expenditure, demonstrating its usefulness for analysis and monitoring the causes of patients/people damage. It is a tool for medical malpractice risk assessment and prevention. It can encourage the amicable settlement and prevention of civil action. It seems to be an efficient system to reduce the health liability costs.
1. Introduction
claim for healthcare institutions was nearly € 70.000, while the cost for individual practitioners was around € 40.000 [3]. These data confirm the great impact of the litigation related to medical liability on Italian healthcare expenditure, considering especially that the Italian National Health System (INHS) is financed by public funds provided by the government through central and regional taxes. Those funds differ from region to region because INHS is based on central guidelines, common throughout the territory, combined with decentralized administration and organization assigned to Regions each of which has different demography, economic development, health care infrastructures and, thus, health expenditures [4]. The Italian malpractice crisis is also associated with other unfavorable effects related to the implementation of medical treatment or
Italy, as well as other countries, was affected by the so-called “malpractice crisis” characterized by the increasing of malpractice claims against the healthcare institutions and the professionals [1,2]. The report 2016–2017 of Association of Italian Insurers (Ania p.172–187) highlighted a premium volume from public healthcare institutions of € 343.5 million, compared to the just above € 87 million came from private healthcare institutions; while the premiums of individual healthcare practitioners were nearly € 208 million. It was also reported that the number of claims received by insurance companies, that in 2016 was 14.803, of which 6.884 from healthcare institutions and 7.919 from individual practitioners. Moreover, the average cost per
⁎ Corresponding author at: Departmental Section of Legal Medicine, Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, A.O.U. “G. Martino” Via Consolare Valeria n. 1, 98100 Messina, Italy. E-mail addresses: [email protected] (C. Mondello), [email protected] (A. Alibrandi).
https://doi.org/10.1016/j.legalmed.2019.101657 Received 8 May 2019; Received in revised form 23 October 2019; Accepted 15 November 2019 Available online 14 December 2019 1344-6223/ © 2019 Elsevier B.V. All rights reserved.
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and 1st July 2018. The Hospital is one of the biggest Sicilian Health institutions and provides activities, also, involving all surgery disciplines (except the Cardiac Surgery), intensive care, radiology, and interventional radiology, interventional cardiology, gynecology, and obstetrics. It is composed by 40 Operative Units and possesses 569 beds, with an annual average (between 1st July 2014 and 1st July 2018) of hospitalizations of 24.146 of which 12.220 were in the emergency; the total number of surgeries was 59.625, of which 12.946 were for gastrointestinal disease. Data were obtained by a retrospective analysis of claims management database created by Forensic Medicine Service. For all claims, the database reports: personal data of claimant, year of claim presentation, complaint type (professional liability or other), malpractice type (diagnostic error, therapeutic error, other causes of healthcare-related damage), medical specialty involved, CMC opinion (awaiting or expressed opinion), opinion type (admitted liability/compensable, rejected liability), claim status (closed/compensated, AEDR, sue, unknown). The analysis was performed on claims in relation to the type of complaints that were subdivided as malpractice, other (“other” represents damage to people not related to professional liability - as injuries due to trauma occurred to visitors) and monetary damage. In relation to malpractice claims, the study evaluated the type of disciplines involved in malpractice and year by year trend of opened claims in relation to the activities of CMC. Then, a claims database related to complaints about malpractice received, during the above reported time interval, from two hospitals and managed by an insurance broker was investigated. The database regarded only claims in which the medico-legal analysis was performed and, thus, the data investigated were the disciplines involved, malpractice type, insurance opinion (admitted liability/compensable, rejected liability) and claims status.
procedure to avoid exposure to malpractice litigation (the so-called “defensive medicine”) [5,6], and the courtrooms jamming due to the increase of civil sue, both associated with additional costs. For many years, the Health Institutions had commissioned the management of claims for medical malpractice to Insurance Companies, paying an annual premium; the contract provided also a really high deductible under which the compensation was paid by the hospital. In the last years, many Italian Regions have adopted a “self-insurance system” aimed at saving the costs of insurance premiums, the tax on insurance contracts (representing the 22.2% of premium) and the costs of distributing insurance contracts (mostly represented by broker commissions, 5–10%). Last but not least, this system led to direct claims management by each healthcare institution and to greater awareness about clinical risk and to better clinical risk management. Sicily is one of the regions that adopted the “self-insurance system”, canceling the insurance policy in 2013, and, from July 2014, the Sicilian hospital network has undertaken a direct management path of claims for damages occurred in its context. The claims management activities have been referred to Claims Management Committees (CMC), which were defined and established by the Sicilian Health Councilor by the Council Decree of 28 December 2011, published in Official Gazette of Sicilian Region n. 2 of January 13, 2012. The CMC is a multidisciplinary working group established in each health institution and dedicated to improving and speeding up claim management and damage compensation. The CMC tasks are: assistance and organization for the collection of information and records useful for claims analysis; prompt identification of the event and assessment of any responsibilities that, if not properly managed, could result in judicial litigation; evaluation and monitoring of proposals for the claim definition, through a specific opinion; direct assessment of the responsibilities and the entities of damages (in terms of foreseeable economic impact); management of relationships with the damaged subjects and/or their attorneys in order to promote the out-of-court settlement of the litigation (transactional way); proposals for actions to prevent risks emerging by claims assessment; integration of database with claims statistics to make more effective interventions for risk management. The group is composed of: a member of Hospital Health Directorate, a member of Hospital Legal Service, a member of Hospital Technical Office, a member of Hospital Protection and Prevention Service, a member of Forensic Medicine Service, the hospital Risk Manager, and the Loss Adjuster. The CMC analyses all claims presented to the Hospital, regarding injury or death due to professional malpractice, injury not related to malpractice, monetary damage to people and things, and provides an opinion on the detection or not of liability; if liability is detected, CMC quantifies the damage and proposes the compensation payment. In this group, the role of the forensic practitioners is very important, because it provides a forensic opinion on malpractice cases (in collaboration with a specialist often employed by the Hospital) and other types of people damage, by the analysis of clinical records and medical examination of damaged subject, furthermore they are directly involved in the process of medicolegal causal analysis and damage quantification aimed at subject compensation. This study aims to describe the experience of a Sicilian University Hospital CMC and to analyze the claims features and their outcomes providing evidence on CMC usefulness. Then, the CMC data were compared to claims data provided from a broker, who manages professional liability for an insurance company, to evaluate differences in claims outcome and thus to compare the performance of both CMC and insurance systems.
2.1. Statistical analysis All categorical variables were expressed as absolute frequencies and percentages. The Chi-Square test was applied to carry out a comparison, between the claims received from CMC and those provided from the broker, concerning the type of errors and specialties. In addition, with the same test, the “opinion” on liability and the “status” of claims variables were used to analyze differences in evaluative activities between CMC and insurance. Moreover, the performances of the two systems were evaluated by the reorganization of the status variables in two groups as “extrajudicial dispute resolution” (claims closed/compensated and AEDR) and “judicial dispute resolution” (claims with recourses to civil court). Finally, the estimation of odds ratio by the Mantel-Haenszel test was performed by the analysis of the variables related to claims status, as extrajudicial or judicial dispute resolution, to quantify the probability of obtaining a “positive” settlement (extrajudicial resolution of the claim) in the two systems. A P-value smaller than 0.05 was considered to be statistically significant. Statistical analyses were performed using the SPSS 22.0 for Windows package. 3. Results 3.1. CMC management In the examined period, 377 claims for both professional liability and “other” were received respectively 69 in 2014 (second semester), 98 in 2015, 83 in 2016, 80 in 2017, 47 in 2018 (first semester). The percentage of claims for professional liability was 63.6%, while for other causes was 36.4%.
2. Materials and methods The study investigates the analysis of claims for compensation received from the University Hospital of Messina between 1st July 2014 2
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Fig. 1. A: percentage of health disciplines involved in total received claims received from CMC between 1st July 2014 and 1st July 2018; B: percentage of disciplines recorded in broker database.
40.900. Fig. 3 shows the overview of claims due to malpractice analyzed by CMC reporting the status of claims admitted and rejected and the data on following actions carried out from damaged people. At July 1th 2018 the amicable settlement was not achieved in 17% cases of admitted liability due to the failure of economic quantification sharing and alternative extrajudicial dispute resolutions (AEDR, i.e. mediation) were brought by the damaged; the summonses were recorded in 10% of cases; the 35% of cases of admitted liability were “in progress” for negotiations. The analysis of rejected claims revealed that 24% was followed by AEDR and suits, while 76% resulted “without further action”.
Fig. 1A reports the received claims related to malpractice subdivided by specialties. As showed, the prevalence of complaints regarded the surgery, representing 48% of the cases, with greater involvement of gastrointestinal branch in 56% of cases, followed by neurosurgery resulting equal to 20%. Then, 13% of claims involved Obstetrics/Gynecology, especially related to damages that occurred during labor (i.e. perinatal asphyxia, nerve palsy). The same percentage was observed in the macro-group of Clinics including disciplines as cardiology, endocrinology, nephrology, gastroenterology, and neurology. Orthopedics resulted in 8% of cases. The analysis of the complained type of malpractice showed the same trend in each year with the prevalence of therapeutic errors (71.2%), while diagnostic errors resulted in the 10.8% of the cases (Fig. 2A). The other causes of healthcare-related damage represented the 15%, predominantly by infections (27.8%), followed by medical device-related damages and dental injury (each equal to 22.2%) (Fig. 2B). There was one claim related to attempted suicide. The total number of claims opened from CMC was 166, respectively 31 in 2014, 53 in 2015, 38 in 2016, 29 in 2017, 14 in 2018; the highest number of claims regarded professional liability resulting in the 71%. A total number of 84 CMC sessions (about twice a month) were performed during the analyzed period to examine the open claims. The evaluation of the status of open claims showed that 46 cases were not related to malpractice (“other”) admitting the Hospital responsibility for the people damage. In the 120 cases related to malpractice, the percentages of liability admission or rejection resulted respectively of 55% (n. 66) and 45% (n. 54). The claims closed with compensation were 51 of which the 49% regarded medical malpractice. The total expenditure for closed claims was € 2.544.91164 with an annual average of € 636.22791 and the average cost per claim around €
3.2. Insurance management In the examined period, 187 claims for medical malpractice were recorded. Surgery appears the specialty most involved representing the 32% (Fig. 1B), with a predominance of complaints related to gastrointestinal surgery (17.1%), followed by neurosurgery (8%). Obstetrics/ Gynecology was involved in the 20.3% of claims involved as well as the macro-group of Clinics including disciplines as cardiology, endocrinology, nephrology, gastroenterology, and neurology. Orthopedics resulted in 11.8% of cases. In most cases, the complaints were related to therapeutic error (62.6%) followed by diagnostic errors (23%). As other causes of healthcare-related damage (13.9%) the infections resulted in 80.8% of cases (Fig. 2A and B). The professional liability was admitted in the 43.2% of the cases (80) and rejected in 56.8% (105). In 77.3% of all claims, the recourse to civil court was reported (Fig. 4).
Fig. 2. A: Data on type of errors comparing CMC and broker database; B: Other causes of healthcare-related errors observed in the database distinguished in subcategories. 3
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Fig. 3. Overview of the status of malpractice claims with CMC expressed opinion.
was proposed to reduce the economic impact related to the “malpractice crisis”, with the main purpose of promoting extrajudicial conciliation in cases of healthcare liability occurring in Health Institution due to both organizational-managerial factors and health practitioner malpractice. The CMC activities regard not only the damage due to professional responsibility but all the damages that may occur in the Health Institution to both patients and visitors and therefore people damage and monetary damage. Tuscany was one of the regions that experienced the CMC for first, reporting efficiency and economic savings compared to insurance management [7]. The promotion of amicable settlement in professional liability disputes was also demonstrated by the Italian legislative evolution that led to the Law n. 24/2017 in which the legislator envisaged the mandatory attempt at conciliation through mediation or technical advice as defined in section 696-bis of the Italian Code of Civil Procedure; the failure of conciliation could be followed by the recourse to Civil Judge. In this setting, the CMC activity represents an even earlier phase in the resolution process of malpractice complaints which can be very useful in preventing the judicial dispute. Moreover, it resorts to the collaboration of healthcare practitioners with several specialties to better analyze the professional liability and to solve the most difficult case, anticipating what has been recently established by the Law n. 24 in section 15 (“The Civil and Criminal judge entrusts the evaluation of the cases related to professional liability to forensic experts and to one or more practitioners specialized in the involved discipline”). The reported CMC experience revealed 240 professional liability complaints, showing a slight reduction during the analyzed four years. Considering both the annual average of hospitalization (24.146) and the heterogeneity and complexity of provided health services, the annual average of malpractice claims was low, resulting in 74.5 cases [7,8]; about a third of total claims (36.4%) were for other causes as visitors’ injuries (i.e. falls, trauma) or monetary damage. The highest number of medical malpractice claims were for surgery, obstetrics/gynecology and clinics specialties as observed in other studies performed both in Italy and other countries [9–11]. Surgery was involved in 48% of the cases and, in general, it can be attributed to several factors as invasiveness, the severity of the disease of the admitted patients and treatment complexity (major procedures may encounter a higher degree of risk) [12]. The analysis of surgery specialties showed a great involvement of the gastrointestinal branch, probably due to the largest number of hospitalizations and surgery treatments registered in the University Hospital compared to other “surgery disciplines”. The results observed in Orthopedics revealed a low number of claims if compared to national and international reports [9,13], but this could be because of the presence of many specialized orthopedic facilities.
Fig. 4. Graphical summary of percentage of claims status highlighting the differences related to the judicial dispute observed between the two systems. Unknown are cases without information.
3.3. Statistical results The analysis of the expressed opinion in relation to admission or rejection of liability showed significant statistical differences (p = 0.045); a prevalence of liability admission was observed in CMC management (55% admitted vs 43.2% rejected); on the contrary, the prevalence of rejection was highlighted in insurance system (56.8% rejected vs 45% admitted). The evaluation of the variables related to the status of claims revealed significant statistical differences (p < 0.0005). This finding resulted also related to the significant statistical differences (p < 0.0005) highlighted in the comparison between the extrajudicial and judicial disputes resulting in a judicial dispute resolution percentage equal to 29.9% and 93.5% respectively for CMC and Insurance systems. The odds ratio analysis revealed a significantly greater probability (p < 0.0005) to get the amicable settlement by CMC management (OR = 34.04, 95% C.I. 15.21–76.18). 4. Discussion In Italy, the implementation of the Claims Management Committee 4
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2946) provides that the compensation right for damages is prescribed in ten years from the day on which the patient becomes aware of the damage. Anyway, considering the elapsed time of four years, it is possible to assume the claims rejected in 2014 and 2015 as without sequel, supporting the CMC role in order to clarify the event and to better explain to patients and/or their attorneys because the liability was rejected. Moreover, the CMC activities could be a deterrent for pretentious claims limiting the number of civil summons for cases without liability. The status of claims analyzed by CMC revealed interesting findings when compared to the status of claims recorded in the insurance broker database. Significant statistical differences were observed in relation to the extrajudicial or judicial variables of management of malpractice cases. The analysis of recourses to Civil Court, considering the mandatory attempt to reach an amicable settlement highlighted by Italian Legislator can be considered as an evaluative parameter of system management and resolution of litigations. The CMC system showed a smaller percentage of summonses associated with significantly greater probability (p < 0.001) to reach the amicable settlement if compared to the Insurance system. The estimation of this probability resulted in thirty-four times higher in CMC management (OR = 34.04, 95%C.I. 15.21–76.18). The total number of defined and compensated claims was 51. The total expenditure was € 2.544.91164 with an annual average of € 636.22791 representing a lower economic outlay if compared to the expenditure during insurance management. This is because the deductible of insurance that hospital paid, in any case, was equal to € 150.000 and most of the claims were paid with compensations lower than this cost. The average cost per claim was around € 40.900 which was lower than that reported in ANIA report and studies conducted in other countries [3,24]. The analysis of the compensation showed also that the largest was due to nosocomial infection-related death (€ 470.000), supporting the relevance of the economic expenditure deriving from people damage (both injury and death) due to the aforementioned sub-categories of therapeutic errors. The analyzed CMC experience gives an overview of the complaints received in an Italian health institution providing specific data on the claims trend as well as on economic expenditure, demonstrating its usefulness for analysis and monitoring the causes of patients (or other people) damage. It can represent a tool for medical malpractice risk assessment being able to acquire a fundamental role in hospital management and patient damage prevention. From this perspective, the purpose of the CMC is not only to identify responsibilities in facilitating the amicable settlement and costs saving, but also to use systematically the claims to improve risk awareness and organizational learning. Despite the presented study showed limits due to the short period of observation, that does not allow to have the detail of the evolution and definition of all claims, it is highlighted that CMC activities can fill data gaps came from insurance companies (often not public and deficient) [9] providing more informative and educative feedback on both claim management and prevention of any harmful events. Furthermore, it seems to be an efficient system for the direct management of damage compensation through which health liability costs can be lower, reducing the impact on public expenditure. In conclusion, CMC activities can help in reducing the number of civil sue by the efficient medicolegal evaluation of claims leading to both amicable settlement and prevention of civil action, in cases without factual assumptions.
The analysis of the complained type of malpractice showed a prevalence of therapeutic errors, followed by those due to other causes of healthcare-related damage in which the infections appeared to be 27.8%, medical device-related damages equal to 22.2% and the drug extravasation injuries the 5.6%. Although these events showed a low incidence, the attention was paid because they can be related to serious damage and big compensation; moreover, they can often derive from management-organizational deficiencies as highlighted by the Italian national recommendations for their prevention [14]. It is well known the great impact on morbidity and mortality of infections, though the improvements in therapy [15–17]. Hospital-acquired sepsis has particular importance from the worldwide public health standpoint and its prevention is the key element resulting potentially preventable with proper activities (i.e. suitable access techniques, earlier discontinuation of central venous and urinary catheters) [18,19]. In light of the above exposed, the CMC could be a tool for monitoring infection trends, identifying risk factors and implementing specific prevention measures to promote better healthcare quality and hospital management. About damages provoked by medical devices, it was already highlighted that retained surgical sponge cases continue to occur, despite the implementation of surgical count policies and procedures to prevent them [20]; these raise numerous medicolegal questions regarding the legal responsibility of the operating room team, the methodological approach to assigning responsibility, and the medicolegal evaluation of damage related to such events. The CMC has an important role to quickly define these claims that in case of judgment lead, often, to the detection of Hospital liability and to the obligation of damage compensation. The correct management of drugs is a fundamental aspect of patient safety considering that related errors are burdened by complications even lethal [21]. In this field, there are the extravasation injuries due to the inadvertent extra-venous administration of a medication or solution that determines severe tissue or cellular damage into the surrounding tissue [22]. Furthermore, the lesions may present different degrees of severity, up to tissue necrosis, which can result in severe aesthetic and functional damage (as decreased mobility and permanent nerve, soft tissue, and/or tendon damage) associated with substantial compensations. In literature, the evidence for the management of extravasation is largely limited especially regarding the treatment of particularly devastating substances, thus preventive measures remain the most optimal approach [23]. It follows that the analysis of cases of extravasation injuries carried out by the CMC allows having data on the incidence of such events and the modalities of occurrence, resulting in useful toward implementation of prevention safety procedures. During the evaluated period, the working group opened 166 claims of which the 71% were due to medical malpractice. This, apparently, negative data must be related to many factors and above all the complexity of the evaluation of each case of professional responsibility in which the analysis and discussion were carried out by several CMC sessions. The importance of an accurate and efficient analysis derives from the responsibility for CMC when the liability is admitted and the Institution grants compensation of damaged through public funds; in fact, this is a great “decision-making power” that is burdened by the risk of prosecution of CMC members by administrative court for economic loss in cases of improper evaluation and compensation. The described Hospital CMC has, thus, three forensic members who collegially contribute to the medicolegal opinion to provide a more accurate analysis of each case. It must be more highlighted that the claims evaluation was provided by forensic and specialist practitioners employed by the hospital, thus engaged in main welfare tasks. The analysis of the claims related to health-care responsibility revealed the admission of liability in 55% of the cases and the rejection in the 45%. The most important data of the rejected claims were represented by the 76% “without further action” (i.e. AEDR or suit) even if this result could be temporary. In fact, the Italian Civil Code (section
Funding No funding sources. Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to 5
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influence the work reported in this paper.
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Legal Medicine journal homepage: www.elsevier.com/locate/legalmed
Short Communication
Experience of an Italian Hospital Claims Management Committee: A tool for extrajudicial litigations resolution
T
⁎
Patrizia Gualnieraa, Cristina Mondelloa, , Serena Scurriaa, Antonio Olivab, Simone Grassib, Jacopo Pizzicannellac, Angela Alibrandid, Daniela Sapienzaa, Alessio Asmundoa a
Departmental Section of Legal Medicine, Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Italy Section of Legal Medicine, Institute of Public Health, Catholic University, Fondazione Policlinico A. Gemelli, IRCCS, Italy c Department of Medical, Oral and Biotechnological Sciences, University “Gabriele d’Annunzio”, Chieti-Pescara, Italy d Department of Economics, Unit of Statistical and Mathematical Sciences, University of Messina, Via dei Verdi 75, 98122 Messina, Italy b
A R T I C LE I N FO
A B S T R A C T
Keywords: Medical malpractice Healthcare Claims Patient damage Litigation
Litigation related to medical liability has a great impact on Italian healthcare expenditure. Recently, many Italian Regions have adopted a “self-insurance system” and, in Sicilian Hospitals, were established the Claims Management Committees (CMC) to provide the direct management of claims. Here the experience of a Sicilian University Hospital CMC was described to analyze the claims features and their outcomes providing evidence on CMC usefulness. The analysis involved claims for compensation received during 4 years, using data obtained by a retrospective analysis of claims database created by Forensic Medicine Service. Claims data, obtained from the insurance broker, were used to perform the statistical comparison. During the examined period a total of 377 claims were received by CMC, respectively 63.6% for professional liability and 36.4% for other causes (damages not related to medical malpractice). The prevalence of complaints about malpractice regarded surgery. The CMC had expressed an opinion on 120 claims related to malpractice with the percentages of admission or rejection of liability respectively of 55% and 45%. The statistical analysis revealed a greater number of lawsuits in the Insurance system and, moreover, the CMC higher probability to reach the amicable settlement of litigations. CMC provides specific data on claims trend and economic expenditure, demonstrating its usefulness for analysis and monitoring the causes of patients/people damage. It is a tool for medical malpractice risk assessment and prevention. It can encourage the amicable settlement and prevention of civil action. It seems to be an efficient system to reduce the health liability costs.
1. Introduction
claim for healthcare institutions was nearly € 70.000, while the cost for individual practitioners was around € 40.000 [3]. These data confirm the great impact of the litigation related to medical liability on Italian healthcare expenditure, considering especially that the Italian National Health System (INHS) is financed by public funds provided by the government through central and regional taxes. Those funds differ from region to region because INHS is based on central guidelines, common throughout the territory, combined with decentralized administration and organization assigned to Regions each of which has different demography, economic development, health care infrastructures and, thus, health expenditures [4]. The Italian malpractice crisis is also associated with other unfavorable effects related to the implementation of medical treatment or
Italy, as well as other countries, was affected by the so-called “malpractice crisis” characterized by the increasing of malpractice claims against the healthcare institutions and the professionals [1,2]. The report 2016–2017 of Association of Italian Insurers (Ania p.172–187) highlighted a premium volume from public healthcare institutions of € 343.5 million, compared to the just above € 87 million came from private healthcare institutions; while the premiums of individual healthcare practitioners were nearly € 208 million. It was also reported that the number of claims received by insurance companies, that in 2016 was 14.803, of which 6.884 from healthcare institutions and 7.919 from individual practitioners. Moreover, the average cost per
⁎ Corresponding author at: Departmental Section of Legal Medicine, Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, A.O.U. “G. Martino” Via Consolare Valeria n. 1, 98100 Messina, Italy. E-mail addresses: [email protected] (C. Mondello), [email protected] (A. Alibrandi).
https://doi.org/10.1016/j.legalmed.2019.101657 Received 8 May 2019; Received in revised form 23 October 2019; Accepted 15 November 2019 Available online 14 December 2019 1344-6223/ © 2019 Elsevier B.V. All rights reserved.
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and 1st July 2018. The Hospital is one of the biggest Sicilian Health institutions and provides activities, also, involving all surgery disciplines (except the Cardiac Surgery), intensive care, radiology, and interventional radiology, interventional cardiology, gynecology, and obstetrics. It is composed by 40 Operative Units and possesses 569 beds, with an annual average (between 1st July 2014 and 1st July 2018) of hospitalizations of 24.146 of which 12.220 were in the emergency; the total number of surgeries was 59.625, of which 12.946 were for gastrointestinal disease. Data were obtained by a retrospective analysis of claims management database created by Forensic Medicine Service. For all claims, the database reports: personal data of claimant, year of claim presentation, complaint type (professional liability or other), malpractice type (diagnostic error, therapeutic error, other causes of healthcare-related damage), medical specialty involved, CMC opinion (awaiting or expressed opinion), opinion type (admitted liability/compensable, rejected liability), claim status (closed/compensated, AEDR, sue, unknown). The analysis was performed on claims in relation to the type of complaints that were subdivided as malpractice, other (“other” represents damage to people not related to professional liability - as injuries due to trauma occurred to visitors) and monetary damage. In relation to malpractice claims, the study evaluated the type of disciplines involved in malpractice and year by year trend of opened claims in relation to the activities of CMC. Then, a claims database related to complaints about malpractice received, during the above reported time interval, from two hospitals and managed by an insurance broker was investigated. The database regarded only claims in which the medico-legal analysis was performed and, thus, the data investigated were the disciplines involved, malpractice type, insurance opinion (admitted liability/compensable, rejected liability) and claims status.
procedure to avoid exposure to malpractice litigation (the so-called “defensive medicine”) [5,6], and the courtrooms jamming due to the increase of civil sue, both associated with additional costs. For many years, the Health Institutions had commissioned the management of claims for medical malpractice to Insurance Companies, paying an annual premium; the contract provided also a really high deductible under which the compensation was paid by the hospital. In the last years, many Italian Regions have adopted a “self-insurance system” aimed at saving the costs of insurance premiums, the tax on insurance contracts (representing the 22.2% of premium) and the costs of distributing insurance contracts (mostly represented by broker commissions, 5–10%). Last but not least, this system led to direct claims management by each healthcare institution and to greater awareness about clinical risk and to better clinical risk management. Sicily is one of the regions that adopted the “self-insurance system”, canceling the insurance policy in 2013, and, from July 2014, the Sicilian hospital network has undertaken a direct management path of claims for damages occurred in its context. The claims management activities have been referred to Claims Management Committees (CMC), which were defined and established by the Sicilian Health Councilor by the Council Decree of 28 December 2011, published in Official Gazette of Sicilian Region n. 2 of January 13, 2012. The CMC is a multidisciplinary working group established in each health institution and dedicated to improving and speeding up claim management and damage compensation. The CMC tasks are: assistance and organization for the collection of information and records useful for claims analysis; prompt identification of the event and assessment of any responsibilities that, if not properly managed, could result in judicial litigation; evaluation and monitoring of proposals for the claim definition, through a specific opinion; direct assessment of the responsibilities and the entities of damages (in terms of foreseeable economic impact); management of relationships with the damaged subjects and/or their attorneys in order to promote the out-of-court settlement of the litigation (transactional way); proposals for actions to prevent risks emerging by claims assessment; integration of database with claims statistics to make more effective interventions for risk management. The group is composed of: a member of Hospital Health Directorate, a member of Hospital Legal Service, a member of Hospital Technical Office, a member of Hospital Protection and Prevention Service, a member of Forensic Medicine Service, the hospital Risk Manager, and the Loss Adjuster. The CMC analyses all claims presented to the Hospital, regarding injury or death due to professional malpractice, injury not related to malpractice, monetary damage to people and things, and provides an opinion on the detection or not of liability; if liability is detected, CMC quantifies the damage and proposes the compensation payment. In this group, the role of the forensic practitioners is very important, because it provides a forensic opinion on malpractice cases (in collaboration with a specialist often employed by the Hospital) and other types of people damage, by the analysis of clinical records and medical examination of damaged subject, furthermore they are directly involved in the process of medicolegal causal analysis and damage quantification aimed at subject compensation. This study aims to describe the experience of a Sicilian University Hospital CMC and to analyze the claims features and their outcomes providing evidence on CMC usefulness. Then, the CMC data were compared to claims data provided from a broker, who manages professional liability for an insurance company, to evaluate differences in claims outcome and thus to compare the performance of both CMC and insurance systems.
2.1. Statistical analysis All categorical variables were expressed as absolute frequencies and percentages. The Chi-Square test was applied to carry out a comparison, between the claims received from CMC and those provided from the broker, concerning the type of errors and specialties. In addition, with the same test, the “opinion” on liability and the “status” of claims variables were used to analyze differences in evaluative activities between CMC and insurance. Moreover, the performances of the two systems were evaluated by the reorganization of the status variables in two groups as “extrajudicial dispute resolution” (claims closed/compensated and AEDR) and “judicial dispute resolution” (claims with recourses to civil court). Finally, the estimation of odds ratio by the Mantel-Haenszel test was performed by the analysis of the variables related to claims status, as extrajudicial or judicial dispute resolution, to quantify the probability of obtaining a “positive” settlement (extrajudicial resolution of the claim) in the two systems. A P-value smaller than 0.05 was considered to be statistically significant. Statistical analyses were performed using the SPSS 22.0 for Windows package. 3. Results 3.1. CMC management In the examined period, 377 claims for both professional liability and “other” were received respectively 69 in 2014 (second semester), 98 in 2015, 83 in 2016, 80 in 2017, 47 in 2018 (first semester). The percentage of claims for professional liability was 63.6%, while for other causes was 36.4%.
2. Materials and methods The study investigates the analysis of claims for compensation received from the University Hospital of Messina between 1st July 2014 2
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Fig. 1. A: percentage of health disciplines involved in total received claims received from CMC between 1st July 2014 and 1st July 2018; B: percentage of disciplines recorded in broker database.
40.900. Fig. 3 shows the overview of claims due to malpractice analyzed by CMC reporting the status of claims admitted and rejected and the data on following actions carried out from damaged people. At July 1th 2018 the amicable settlement was not achieved in 17% cases of admitted liability due to the failure of economic quantification sharing and alternative extrajudicial dispute resolutions (AEDR, i.e. mediation) were brought by the damaged; the summonses were recorded in 10% of cases; the 35% of cases of admitted liability were “in progress” for negotiations. The analysis of rejected claims revealed that 24% was followed by AEDR and suits, while 76% resulted “without further action”.
Fig. 1A reports the received claims related to malpractice subdivided by specialties. As showed, the prevalence of complaints regarded the surgery, representing 48% of the cases, with greater involvement of gastrointestinal branch in 56% of cases, followed by neurosurgery resulting equal to 20%. Then, 13% of claims involved Obstetrics/Gynecology, especially related to damages that occurred during labor (i.e. perinatal asphyxia, nerve palsy). The same percentage was observed in the macro-group of Clinics including disciplines as cardiology, endocrinology, nephrology, gastroenterology, and neurology. Orthopedics resulted in 8% of cases. The analysis of the complained type of malpractice showed the same trend in each year with the prevalence of therapeutic errors (71.2%), while diagnostic errors resulted in the 10.8% of the cases (Fig. 2A). The other causes of healthcare-related damage represented the 15%, predominantly by infections (27.8%), followed by medical device-related damages and dental injury (each equal to 22.2%) (Fig. 2B). There was one claim related to attempted suicide. The total number of claims opened from CMC was 166, respectively 31 in 2014, 53 in 2015, 38 in 2016, 29 in 2017, 14 in 2018; the highest number of claims regarded professional liability resulting in the 71%. A total number of 84 CMC sessions (about twice a month) were performed during the analyzed period to examine the open claims. The evaluation of the status of open claims showed that 46 cases were not related to malpractice (“other”) admitting the Hospital responsibility for the people damage. In the 120 cases related to malpractice, the percentages of liability admission or rejection resulted respectively of 55% (n. 66) and 45% (n. 54). The claims closed with compensation were 51 of which the 49% regarded medical malpractice. The total expenditure for closed claims was € 2.544.91164 with an annual average of € 636.22791 and the average cost per claim around €
3.2. Insurance management In the examined period, 187 claims for medical malpractice were recorded. Surgery appears the specialty most involved representing the 32% (Fig. 1B), with a predominance of complaints related to gastrointestinal surgery (17.1%), followed by neurosurgery (8%). Obstetrics/ Gynecology was involved in the 20.3% of claims involved as well as the macro-group of Clinics including disciplines as cardiology, endocrinology, nephrology, gastroenterology, and neurology. Orthopedics resulted in 11.8% of cases. In most cases, the complaints were related to therapeutic error (62.6%) followed by diagnostic errors (23%). As other causes of healthcare-related damage (13.9%) the infections resulted in 80.8% of cases (Fig. 2A and B). The professional liability was admitted in the 43.2% of the cases (80) and rejected in 56.8% (105). In 77.3% of all claims, the recourse to civil court was reported (Fig. 4).
Fig. 2. A: Data on type of errors comparing CMC and broker database; B: Other causes of healthcare-related errors observed in the database distinguished in subcategories. 3
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Fig. 3. Overview of the status of malpractice claims with CMC expressed opinion.
was proposed to reduce the economic impact related to the “malpractice crisis”, with the main purpose of promoting extrajudicial conciliation in cases of healthcare liability occurring in Health Institution due to both organizational-managerial factors and health practitioner malpractice. The CMC activities regard not only the damage due to professional responsibility but all the damages that may occur in the Health Institution to both patients and visitors and therefore people damage and monetary damage. Tuscany was one of the regions that experienced the CMC for first, reporting efficiency and economic savings compared to insurance management [7]. The promotion of amicable settlement in professional liability disputes was also demonstrated by the Italian legislative evolution that led to the Law n. 24/2017 in which the legislator envisaged the mandatory attempt at conciliation through mediation or technical advice as defined in section 696-bis of the Italian Code of Civil Procedure; the failure of conciliation could be followed by the recourse to Civil Judge. In this setting, the CMC activity represents an even earlier phase in the resolution process of malpractice complaints which can be very useful in preventing the judicial dispute. Moreover, it resorts to the collaboration of healthcare practitioners with several specialties to better analyze the professional liability and to solve the most difficult case, anticipating what has been recently established by the Law n. 24 in section 15 (“The Civil and Criminal judge entrusts the evaluation of the cases related to professional liability to forensic experts and to one or more practitioners specialized in the involved discipline”). The reported CMC experience revealed 240 professional liability complaints, showing a slight reduction during the analyzed four years. Considering both the annual average of hospitalization (24.146) and the heterogeneity and complexity of provided health services, the annual average of malpractice claims was low, resulting in 74.5 cases [7,8]; about a third of total claims (36.4%) were for other causes as visitors’ injuries (i.e. falls, trauma) or monetary damage. The highest number of medical malpractice claims were for surgery, obstetrics/gynecology and clinics specialties as observed in other studies performed both in Italy and other countries [9–11]. Surgery was involved in 48% of the cases and, in general, it can be attributed to several factors as invasiveness, the severity of the disease of the admitted patients and treatment complexity (major procedures may encounter a higher degree of risk) [12]. The analysis of surgery specialties showed a great involvement of the gastrointestinal branch, probably due to the largest number of hospitalizations and surgery treatments registered in the University Hospital compared to other “surgery disciplines”. The results observed in Orthopedics revealed a low number of claims if compared to national and international reports [9,13], but this could be because of the presence of many specialized orthopedic facilities.
Fig. 4. Graphical summary of percentage of claims status highlighting the differences related to the judicial dispute observed between the two systems. Unknown are cases without information.
3.3. Statistical results The analysis of the expressed opinion in relation to admission or rejection of liability showed significant statistical differences (p = 0.045); a prevalence of liability admission was observed in CMC management (55% admitted vs 43.2% rejected); on the contrary, the prevalence of rejection was highlighted in insurance system (56.8% rejected vs 45% admitted). The evaluation of the variables related to the status of claims revealed significant statistical differences (p < 0.0005). This finding resulted also related to the significant statistical differences (p < 0.0005) highlighted in the comparison between the extrajudicial and judicial disputes resulting in a judicial dispute resolution percentage equal to 29.9% and 93.5% respectively for CMC and Insurance systems. The odds ratio analysis revealed a significantly greater probability (p < 0.0005) to get the amicable settlement by CMC management (OR = 34.04, 95% C.I. 15.21–76.18). 4. Discussion In Italy, the implementation of the Claims Management Committee 4
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2946) provides that the compensation right for damages is prescribed in ten years from the day on which the patient becomes aware of the damage. Anyway, considering the elapsed time of four years, it is possible to assume the claims rejected in 2014 and 2015 as without sequel, supporting the CMC role in order to clarify the event and to better explain to patients and/or their attorneys because the liability was rejected. Moreover, the CMC activities could be a deterrent for pretentious claims limiting the number of civil summons for cases without liability. The status of claims analyzed by CMC revealed interesting findings when compared to the status of claims recorded in the insurance broker database. Significant statistical differences were observed in relation to the extrajudicial or judicial variables of management of malpractice cases. The analysis of recourses to Civil Court, considering the mandatory attempt to reach an amicable settlement highlighted by Italian Legislator can be considered as an evaluative parameter of system management and resolution of litigations. The CMC system showed a smaller percentage of summonses associated with significantly greater probability (p < 0.001) to reach the amicable settlement if compared to the Insurance system. The estimation of this probability resulted in thirty-four times higher in CMC management (OR = 34.04, 95%C.I. 15.21–76.18). The total number of defined and compensated claims was 51. The total expenditure was € 2.544.91164 with an annual average of € 636.22791 representing a lower economic outlay if compared to the expenditure during insurance management. This is because the deductible of insurance that hospital paid, in any case, was equal to € 150.000 and most of the claims were paid with compensations lower than this cost. The average cost per claim was around € 40.900 which was lower than that reported in ANIA report and studies conducted in other countries [3,24]. The analysis of the compensation showed also that the largest was due to nosocomial infection-related death (€ 470.000), supporting the relevance of the economic expenditure deriving from people damage (both injury and death) due to the aforementioned sub-categories of therapeutic errors. The analyzed CMC experience gives an overview of the complaints received in an Italian health institution providing specific data on the claims trend as well as on economic expenditure, demonstrating its usefulness for analysis and monitoring the causes of patients (or other people) damage. It can represent a tool for medical malpractice risk assessment being able to acquire a fundamental role in hospital management and patient damage prevention. From this perspective, the purpose of the CMC is not only to identify responsibilities in facilitating the amicable settlement and costs saving, but also to use systematically the claims to improve risk awareness and organizational learning. Despite the presented study showed limits due to the short period of observation, that does not allow to have the detail of the evolution and definition of all claims, it is highlighted that CMC activities can fill data gaps came from insurance companies (often not public and deficient) [9] providing more informative and educative feedback on both claim management and prevention of any harmful events. Furthermore, it seems to be an efficient system for the direct management of damage compensation through which health liability costs can be lower, reducing the impact on public expenditure. In conclusion, CMC activities can help in reducing the number of civil sue by the efficient medicolegal evaluation of claims leading to both amicable settlement and prevention of civil action, in cases without factual assumptions.
The analysis of the complained type of malpractice showed a prevalence of therapeutic errors, followed by those due to other causes of healthcare-related damage in which the infections appeared to be 27.8%, medical device-related damages equal to 22.2% and the drug extravasation injuries the 5.6%. Although these events showed a low incidence, the attention was paid because they can be related to serious damage and big compensation; moreover, they can often derive from management-organizational deficiencies as highlighted by the Italian national recommendations for their prevention [14]. It is well known the great impact on morbidity and mortality of infections, though the improvements in therapy [15–17]. Hospital-acquired sepsis has particular importance from the worldwide public health standpoint and its prevention is the key element resulting potentially preventable with proper activities (i.e. suitable access techniques, earlier discontinuation of central venous and urinary catheters) [18,19]. In light of the above exposed, the CMC could be a tool for monitoring infection trends, identifying risk factors and implementing specific prevention measures to promote better healthcare quality and hospital management. About damages provoked by medical devices, it was already highlighted that retained surgical sponge cases continue to occur, despite the implementation of surgical count policies and procedures to prevent them [20]; these raise numerous medicolegal questions regarding the legal responsibility of the operating room team, the methodological approach to assigning responsibility, and the medicolegal evaluation of damage related to such events. The CMC has an important role to quickly define these claims that in case of judgment lead, often, to the detection of Hospital liability and to the obligation of damage compensation. The correct management of drugs is a fundamental aspect of patient safety considering that related errors are burdened by complications even lethal [21]. In this field, there are the extravasation injuries due to the inadvertent extra-venous administration of a medication or solution that determines severe tissue or cellular damage into the surrounding tissue [22]. Furthermore, the lesions may present different degrees of severity, up to tissue necrosis, which can result in severe aesthetic and functional damage (as decreased mobility and permanent nerve, soft tissue, and/or tendon damage) associated with substantial compensations. In literature, the evidence for the management of extravasation is largely limited especially regarding the treatment of particularly devastating substances, thus preventive measures remain the most optimal approach [23]. It follows that the analysis of cases of extravasation injuries carried out by the CMC allows having data on the incidence of such events and the modalities of occurrence, resulting in useful toward implementation of prevention safety procedures. During the evaluated period, the working group opened 166 claims of which the 71% were due to medical malpractice. This, apparently, negative data must be related to many factors and above all the complexity of the evaluation of each case of professional responsibility in which the analysis and discussion were carried out by several CMC sessions. The importance of an accurate and efficient analysis derives from the responsibility for CMC when the liability is admitted and the Institution grants compensation of damaged through public funds; in fact, this is a great “decision-making power” that is burdened by the risk of prosecution of CMC members by administrative court for economic loss in cases of improper evaluation and compensation. The described Hospital CMC has, thus, three forensic members who collegially contribute to the medicolegal opinion to provide a more accurate analysis of each case. It must be more highlighted that the claims evaluation was provided by forensic and specialist practitioners employed by the hospital, thus engaged in main welfare tasks. The analysis of the claims related to health-care responsibility revealed the admission of liability in 55% of the cases and the rejection in the 45%. The most important data of the rejected claims were represented by the 76% “without further action” (i.e. AEDR or suit) even if this result could be temporary. In fact, the Italian Civil Code (section
Funding No funding sources. Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to 5
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influence the work reported in this paper.
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