The Affordable Care Act at 10 Years: Evaluating the Evidence and Navigating an Uncertain Future.

The year 2020 marks the 10th anniversary of the signing of the Affordable Care Act (ACA). Perhaps the greatest overhaul of the US health care system in the past 50 y, the ACA sought to expand access to care, improve quality, and reduce health care costs. Over the past decade, there have been a number of challenges and changes to the law, which remains in evolution. While the ACA's policies were not intended to specifically target surgical care, surgical patients, surgeons, and the health systems within which they function have all been greatly affected. This article aims to provide a brief overview of the impact of the ACA on surgical patients in reference to its tripartite aim of improving access, improving quality, and reducing costs.

Malpractice Litigation for Compartment Syndrome.

BACKGROUND: The aim of this study was to analyze litigation involving compartment syndrome to identify the causes and outcomes of such malpractice suits. A better understanding of such litigation may provide insight into areas where clinicians may make improvements in the delivery of care. METHODS: Jury verdict reviews from the Westlaw database from January 1, 2010 to January 1, 2018 were reviewed. The search term "compartment syndrome" was used to identify cases and extract data on the specialty of the physician defendant, the demographics of the plaintiff, the allegation, and the verdict. RESULTS: A total of 124 individual cases involving the diagnosis of compartment syndrome were identified. Medical centers or the hospital was included as a defendant in 51.6% of cases. The most frequent physician defendants were orthopedic surgeons (45.96%) and emergency medicine physicians (20.16%), followed by cardiothoracic/vascular surgeons (16.93%). Failure to diagnose was the most frequently cited claim (71.8% of cases). Most plaintiffs were men, with a mean age of 36.7 years, suffering injuries for an average of 5 years before their verdict. Traumatic compartment syndrome of the lower extremity causing nerve damage was the most common complication attributed to failure to diagnose, leading to litigation. Forty cases (32.25%) were found for the plaintiff or settled, with an average award of $1,553,993.66. CONCLUSIONS: Our study offers a brief overview of the most common defendants, plaintiffs, and injuries involved in legal disputes involving compartment syndrome. Orthopedic surgeons were most commonly named; however, vascular surgeons may also be involved in these cases because of the large number of cases with associated arterial involvement. A significant percentage of cases were plaintiff verdicts or settled cases. Failure to diagnosis or delay in treatment was the most common causes of malpractice litigation. Compartment syndrome is a clinical diagnosis and requires a high level of suspicion for a timely diagnosis. Lack of objective criteria for diagnosis increases the chances of medical errors and makes it an area vulnerable to litigation.

Economic evaluation of an active search system to monitor the outcomes of health-related claims.

OBJECTIVE: Economic evaluation of a scientific advisory program with the Public Defenders Office to mitigate the impacts of the judicialization on health in the municipality, as well as the implementation of an active follow-up program to monitor health outcomes arising from court demands. METHODS: A two-step study, the first documental, retrospective, with data collection of lawsuits in the region of Barbalha (CE), Brazil, from 2013 to 2018, and the second stage, prospective and intervention, through mediation between the citizen and the Public Defenders Office, aiming to reduce the occurrence of the judicialization, and the monitoring of the health outcomes of the processes. The study adopted the Consolidated Health Economic Evaluation Reporting Standards protocol for economic health assessments. The data obtained from the processes were grouped and treated for characterization of the scenario. A comparison of the profile of the lawsuits in the period of 12 months before and after the installation of the program to delimit a complete fiscal cycle was carried out. RESULTS: The advisory service promoted a decrease of 40% (p=0.01) in lawsuits. There was a 31% reduction in court costs (p=0.003), with medicines accounting for 33% of this amount. There was a decrease in inputs outside the Sistema Único de Saúde lists (27%; p=0.003), however there was no statistical difference among several demanding groups, suggesting an equanimous approach. CONCLUSION: Data from the initial survey were comparable to those reported in Brazil regarding the profile of judicial demands. In view of the scenario, the proposal proved feasible as a means to mitigate the costs of the judicialization through mediation. Finally, the initiative can serve as a model for adoption by municipalities that have characteristics similar to those presented in this study.

The Financial Effect of Medicare Coverage Design and Safety Net Options for Cancer Care.

BACKGROUND: National spending on specialty medications accounted for approximately $193 billion in 2016. The coverage design for Medicare Parts B and D has shifted medication costs to patients, which may prohibit patients from starting or maintaining therapy due to affordability. As a result, patients have enrolled in safety net financial options, such as patient assistance and foundation programs. Safety net options may provide savings not otherwise realized by Medicare; however, they may have a negative financial effect on health systems and pharmaceutical manufacturers. OBJECTIVES: To (a) quantify financial savings to Medicare as a result of patient enrollment in patient assistance programs and (b) quantify the financial effect of safety net options for patients, manufacturers, and the academic medical center that participated in this study. METHODS: A single-center, nonrandomized, retrospective pilot study of Medicare beneficiaries was conducted. Patients who were prescribed hematology/oncology specialty medications and enrolled in safety net options between July 2015 and June 2017 were included. Investigators collected data related to fill history, drug cost, and prescription coverage. The primary outcome was the overall cost savings to Medicare as a result of patient enrollment in patient assistance programs. Secondary outcomes included total patient out-of-pocket savings as a result of foundation copayment support, financial effect on manufacturers as a result of patient assistance programs, and health system revenue impact as a result of safety net options. Descriptive statistics were used. RESULTS: This study included 114 patients. Medicare saved $5,083,816.83 over 2 years as a result of patient assistance programs. Eight foundations provided $240,350.04 in patient insurance copayments. Nine manufacturers provided 2,243 free drug doses, valued at $3,379,032.34. The participating medical center missed the opportunity for $6,481,543.55 in revenue due to patient assistance programs. CONCLUSIONS: The participating medical center's efforts to improve access to oncology care took considerable time and resources. These activities, as well as unreimbursed infusion services, were costs to the medical center that may not be recognized by Medicare. Manufacturers also supported patient access through their sponsored patient assistance programs. The use of these services and safety net options resulted in cost savings to Medicare and their beneficiaries. DISCLOSURES: No outside funding supported this study. The authors have nothing to disclose. Findings from this study were part of a podium research presentation at the Great Lakes Pharmacy Residency Conference; April 25, 2018; West Lafayette, IN.

Economic evaluation of an active search system to monitor the outcomes of health-related claims / Avaliação econômica de um sistema de busca ativa para monitoramento de desfechos em demandas de saúde judicializadas

ABSTRACT Objective: Economic evaluation of a scientific advisory program with the Public Defenders Office to mitigate the impacts of the judicialization on health in the municipality, as well as the implementation of an active follow-up program to monitor health outcomes arising from court demands. Methods: A two-step study, the first documental, retrospective, with data collection of lawsuits in the region of Barbalha (CE), Brazil, from 2013 to 2018, and the second stage, prospective and intervention, through mediation between the citizen and the Public Defenders Office, aiming to reduce the occurrence of the judicialization, and the monitoring of the health outcomes of the processes. The study adopted the Consolidated Health Economic Evaluation Reporting Standards protocol for economic health assessments. The data obtained from the processes were grouped and treated for characterization of the scenario. A comparison of the profile of the lawsuits in the period of 12 months before and after the installation of the program to delimit a complete fiscal cycle was carried out. Results: The advisory service promoted a decrease of 40% (p=0.01) in lawsuits. There was a 31% reduction in court costs (p=0.003), with medicines accounting for 33% of this amount. There was a decrease in inputs outside the Sistema Único de Saúde lists (27%; p=0.003), however there was no statistical difference among several demanding groups, suggesting an equanimous approach. Conclusion: Data from the initial survey were comparable to those reported in Brazil regarding the profile of judicial demands. In view of the scenario, the proposal proved feasible as a means to mitigate the costs of the judicialization through mediation. Finally, the initiative can serve as a model for adoption by municipalities that have characteristics similar to those presented in this study.

RESUMO Objetivo: Avaliação econômica de um programa de aconselhamento científico junto à defensoria pública para minimizar o impacto da judicialização da saúde no município, bem como da implementação de um programa de pesquisa ativa para monitorar os desfechos em saúde provenientes de demandas judiciais. Métodos: Estudo conduzido em duas etapas. A primeira foi documental, retrospectiva, e composta por dados coletados de processos judiciais de 2013 a 2018 da região de Barbalha, no estado do Ceará. A segunda etapa foi prospectiva e de intervenção, conduzida por meio da mediação entre o cidadão e a defensoria pública, com o objetivo de reduzir a ocorrência da judicialização e monitorar os resultados dos processos de saúde. O estudo adotou o protocolo para avaliações econômicas em saúde Roteiro para Relato de Estudos de Avaliação Econômica. Os dados obtidos foram agrupados e tratados para caracterização do cenário. Comparou-se o perfil dos processos no período de 12 meses antes e após a instalação do programa para delimitar ciclo fiscal completo. Resultados: O serviço de consultoria promoveu redução de 40% (p=0,01) nas ações judiciais. Além disso, observou-se redução de 31% nos custos judiciais (p=0,003) com a medicação sendo responsável por 33% desse valor. Observou-se redução no uso de insumos não constantes nas listas do Sistema Único de Saúde (27%; p=0,003), contudo, sem diferença estatística entre os grupos. Conclusão: Os dados desta pesquisa foram comparáveis aos já relatados em pesquisas brasileiras quanto ao perfil de demandas. A proposta mostrou-se viável como meio de mitigar os custos da judicialização por meio da mediação. Essa iniciativa pode servir como modelo para os municípios que possuem características similares às apresentadas em nosso estudo.

Profile of the judicialization of the Therasuit Method and its direct cost in the scope of the state of Rio de Janeiro. / Perfil da judicialização do Método Therasuit e seu custo direto no âmbito do Estado do Rio de Janeiro.

INTRODUCTION: The lack of availability of the Therasuit Method by the Unified Health System associated with its high cost has led to the prosecution of this treatment. The study aimed to outline the profile of this judicialization, as well as to estimate the direct costs resulting from compliance with the deferred judicial decisions. METHOD: Weanalyzed the cases submitted to the Court of Justice of Rio de Janeiro between January 2013 and January 2017, in which the Therasuit Method was applied. Demographic, clinical, advocacy and legal data were extracted, as was the timing of the court's decision and the required technology budgets. RESULTS: Atotal of 11 processes was analyzed. The authors had a mean age of 6.8 years and a median of 6, the majority being male, and resident in thestate capital. Quadriparesis was the most reported condition. The gratuity of justice was requested by all, and the Public Defender's Officewas used by 9 of the 11 processes. The judicial decisions at first instance were considered. In all of processes there was application of the legal tool called guardianship. The time of the judicial decision was on average of 266.5 days with a median of 35.5. The deferral index was 90%, totaling an annual direct cost of R$501,894.09. DISCUSSION: The judicialization of this treatment can cause an unforeseen displacement of public funds, transgressing the principles of equity and the integrality of Unified Health System. CONCLUSION: It was observed a high rate of deferred processes, resulting in a high cost spent by the Public Power to attend a small portion of patients.

INTRODUÇÃO: O Método Therasuit possui alto custo e não é disponibilizado pelo Sistema Único de Saúde, o que tem ocasionado a judicialização desse tratamento. O estudo visou traçar o perfil dessa judicialização, bem como estimar os custos diretos decorrentes do cumprimento das decisões judiciais deferidas. MÉTODO: Foram analisados processos submetidos ao Tribunal de Justiça do Rio de Janeiro entre janeiro de 2013 e janeiro de 2017, no qual foi solicitado o Método Therasuit. Os dados demográficos, clínicos, advocatícios e jurídicos foram extraídos, assim como o tempo da decisão judicial e os orçamentos da tecnologia requerida. RESULTADOS: O total de 11 processos foi analisado. Os autores tinham uma média de idade de 6,8 anos e mediana de 6, sendo a maioria do sexo masculino e residentes na capital do estado. A quadriparesia foi a condição mais relatada. A gratuidade de justiça foi solicitada por todos, e a Defensoria Pública foi utilizada em 9 dos 11 processos analisados. Foram consideradas as decisões judiciais em primeira instância. O tempo da decisão judicial foi em média de 266,5 dias com uma mediana de 35,5. Em todos houve requerimento da ferramenta jurídica tutela antecipada. O índice de deferimento foi de 90%, totalizando um custo direto anual de R$501.894,09. DISCUSSÃO: A judicialização desse tratamento pode ocasionar um deslocamento não previsto de verba pública, podendo impactar nos princípios da equidade e na integralidade do Sistema Único de Saúde. CONCLUSÃO: Constatou-se elevada taxa de processos deferidos, acarretando um alto custo despendido pelo Poder Público para atender a uma pequena parcela de pacientes.