REGISTRO ELETRÔNICO DE SAÚDE NA SAÚDE ......Sumário Executivo 1.1 Em 2010, o gasto médio em...
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REGISTRO ELETRÔNICO DE SAÚDE NA SAÚDE SUPLEMENTAR ANÁLISE DE IMPACTO REGULATÓRIO
Transcript of REGISTRO ELETRÔNICO DE SAÚDE NA SAÚDE ......Sumário Executivo 1.1 Em 2010, o gasto médio em...
REGISTRO ELETRÔNICO DE SAÚDE NA SAÚDE SUPLEMENTAR
ANÁLISE DE IMPACTO REGULATÓRIO
APRESENTAÇÃO
Cada vez mais, a realização de serviços assistenciais de qualidade exige que
profissionais de saúde obtenham acesso a informações sobre o paciente, que
certamente estarão distribuídas em vários locais ou instituições, em uma variedade
de formatos diferentes (papel, arquivos eletrônicos etc), e registradas como uma
mistura de textos (narrativas), códigos, áudio, imagens e vídeos.
Um Registro Eletrônico de Saúde (RES) centrado no paciente e mantido por
toda a vida de um indivíduo é reconhecidamente uma solução para esta questão.
Entretanto, o desafio de construir uma solução de RES que seja capaz de prover
para profissionais de saúde de qualquer especialidade uma visão integrada sobre a
condição de saúde e história clínica de cada paciente tem se mostrado não ser uma
atividade trivial. Esta necessidade é amplamente reconhecida atualmente como um
importante passo em prol da melhoria na qualidade dos serviços assistenciais
prestados ao paciente, seja por profissionais de saúde, instituições e governos a
nível internacional.
Alinhada com este desafio, a Agência Nacional de Saúde Suplementar (ANS)
está engajada em elaborar uma estratégia de RES para o setor de Saúde
Suplementar no Brasil. O desenvolvimento do Registro Eletrônico de Saúde (RES) é
um dos compromissos assumidos pela ANS na Agenda Regulatória, no âmbito da
Integração da Saúde Suplementar com o SUS e integra o Planejamento Estratégico
do Ministério da Saúde 2012/2015.
Através da Casa Civil da Presidência da República, como parte do Programa
de Fortalecimento da Capacidade Institucional para Gestão em Regulação – PRO-
REG, que tem como proposta aperfeiçoar a governança do sistema regulatório e a
coordenação entre as instituições que participam do processo regulatório, o projeto
foi selecionado para apropriação pela ANS da metodologia de Análise de Impacto
Regulatório. Assim, com o apoio do PRO-REG e da Embaixada Britânica no Brasil foi
contratada a Dra. Vindelyn Smith-Hillman, economista da Law Commission do
Reino Unido, para elaborar uma Análise de Impacto Regulatório da Implantação do
Registro Eletrônico de Saúde da Saúde Suplementar.
A análise se desenvolveu em três cenários sendo o primeiro o
desenvolvimento do Registro Eletrônico de Saúde (RES) de âmbito nacional; o
segundo cenário, a implementação do RES no âmbito da saúde pública; e o
terceiro, o desenvolvimento do RES exclusivo da saúde privada.
Sumário Executivo
1.1 Em 2010, o gasto médio em saúde pública nos países membros da OCDE foi de 72% de toda despesa de saúde. Em comparação, no caso do Brasil, o gasto foi de 47%1. A parcela proporcional de gastos com a saúde pública ainda permanece em um nível significantemente baixo, apesar dos aumentos nos três anos antecedentes. As projeções dos gastos em saúde pública para o período de 20 anos, terminando em 2030, estimam a necessidade de um aumento de pelo menos 1.0 a 2.0 pontos percentuais do PIB.2
1.2 A reforma do setor de saúde durante a fase de transição democrática (1985-88) levou ao Sistema Único de Saúde [SUS]. O objetivo central do SUS é o fornecimento universal de assistência à saúde de alta qualidade baseado na prevenção e tratamento de doenças; reabilitação e a promoção da saúde e um sistema de gestão descentralizado3. As decisões relacionadas à assistência à saúde envolvem relações entre grupos autônomos e independentes nos níveis federal, estatal e municipal. O Ministério da Saúde supervisiona a gestão nacional do SUS, trabalhando em conjunto com Conselho Nacional de Saúde e outros órgãos em questões estratégicas de alto nível, ex. formulação de políticas, financiamento e coordenação4.
1.3 Operando juntamente com o sistema público de saúde, está o setor privado de saúde
que, em 2012, atendeu cerca de 25% da população. Ele é responsável pelos 53% restantes de todos os gastos com saúde. O SUS é altamente dependente de disposições contratuais com o setor privado para ter acesso a camas hospitalares e centros terapêuticos e de diagnóstico.
1.4 Inevitavelmente, tal sistema encontrará problemas que limitam a capacidade de
proporcionar um resultado eficiente. Os problemas são os seguintes: a falta de um sistema de saúde integrado com a troca limitada de informações entre os setores público e privado; brechas nas trocas de informações no sub-setor público; a capacidade limitada de responder prontamente a desafios de saúde e, segurança e assistência a pacientes abaixo do ideal.
1.5 Os benefícios potenciais dos Registros Eletrônicos de Saúde (RES) foram
documentados mundialmente. Ele pode fornecer a base para uma economia de custo eficiente através de processos de informação otimizados e a capacidade de resolver, pelo menos em parte, alguns dos problemas identificados. Além disso, oferecem uma melhoria na segurança e qualidade de atendimento aos pacientes. O Brasil tem obtido sucesso com os Sistemas de Informação em Saúde [SIS]; as iniciativas inovadoras de
1 OECD, OECD Health Data 2012, How does Brazil Compare with OECD Countries, 2012. 2 International Monetary Fund, Macro-Fiscal Implications of Health Care Reform in Advanced and Emerging Economies, 2010. 3 Source – Ministry of Health of Brazil handout on SUS: Unified Health System 4 Pan American Health Organisation and USAID, Health Systems and Services Profile, Brazil, February 2008, page 22
2004 foram notavelmente aplicadas no sistema SIGA Saúde. Em 2008, havia pelo menos 10 SIS nacionais, dos quais a maioria era coordenada pelo Ministério da Saúde (MS), proporcionando uma diversidade de informações sobre saúde, de relatórios periódicos de saúde básica a perfis de despesas e receitas agregadas.
1.6 Após uma extensa pesquisa e consultas com especialistas brasileiros em saúde, foram
identificadas quatro opções para implantar os RES, que abrangem desde uma cobertura nacional até uma cobertura limitada específica de um setor. A avaliação de impacto providencia uma ferramenta para avaliar as opções, à medida que cada opção está sujeita a uma análise de custo benefício, que levará em conta as principais áreas de impacto. A avaliação sempre incluirá a Opção 0 – Não fazer nada/fazer o mínimo contra o que as outras opções avaliam. As três opções são: Opção 1 – Cobertura Nacional do RES; Opção 2 – RES para o sistema público de saúde; Opção 3 – RES para o sistema privado de saúde. A opção 1 é a mais completa e exige um mínimo de 16 ações centrais a fim de proporcionar as seguintes características: Identificador único de paciente; portal online que garante as seguintes funções aos pacientes: acesso às informações do sistema de saúde, marcação de consultas, visualização de seus registros de saúde online e com segurança, opção de consentir ou negar que prestadores de serviços de saúde vejam seus registros; além de garantir a capacidade de fazer prescrições médicas online; oferece funcionalidade de cobrança; e capacidade para pesquisas secundárias.
1.7 O Valor Presente Líquido [VPL] deriva do ano 0 ao ano 10, contando o ano atual, 2013, como o ano 0. O VPL estimado para a Opção 1 gira em torno de R$ 56.569,6 milhões e R$ 79.534,8 milhões. Os custos máximos estão estimados por volta do ano 6 e, então, declinam – refletindo o fim do custo mais caro e extensivo do software de TI e os custos de infraestrutura. Os benefícios são significantemente subestimados por causa dos dados em falta/não disponíveis e mostram um crescimento bastante modesto ao longo do tempo.
1.8 O VPL estimado para a opção 2 gira em torno de R$ 16.886,5 milhões e R$21.317,2
milhões. A partir do ano 7, existe uma clara evidência de que a divergência entre os custos anuais e os benefícios diminuem ao longo do tempo. Considerando a tendência mencionada acima em direção a uma abordagem conservativa quanto à estimativa, há grandes chances dos benefícios excederem os custos antes no ano 7.
1.9 O custo total para a opção 3 foi estimado em torno de R$ 58.241 milhões e R$39.705,5
milhões. Não foi possível identificar uma posição de benefício líquido. Na ausência de qualquer iniciativa pública a fim de garantir a interoperabilidade de prestação de serviços públicos de saúde, benefícios monetários são decorrentes da redução de custos – principalmente através de redução de armazenamento e na prevenção de duplicação de funções. Em grande escala, os benefícios acumulados vão quase inteiramente para os pacientes, por meio de melhoria no atendimento, e não para aqueles que fizeram o investimento.
1.10 Uma estimativa do cálculo do ano de vida ajustado pela qualidade (QALY ou AVAQ),
através de intervenções de saúde, é feito por meio da orientação da OMS nos valores do QALY apropriados para o contexto brasileiro. Esses possuem apenas fins
ilustrativos, mas claramente mostram a capacidade de se obter um ganho no QALY, por exemplo, de níveis de ansiedade reduzidos por meio de acesso online seguro que, em seu nível mais baixo, proporciona um ganho no QALY de cerca de R$ 93.000 milhões no período de dez anos.
1.11 Não obstante a alta proporção de gastos com TI como uma parte da despesa total, o
sucesso em longo prazo das implementações do RES baseiam-se no compromisso de investir em treinamento. A extensão do compromisso clínico fica em risco se o treinamento não for priorizado. Existe, também, o risco de que a implementação ocorra em um ritmo lento, em particular no setor privado de saúde, pois os principais beneficiados não são os que fizeram os investimentos.
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Dr. A. Vindelyn Smith-Hillman
MARCH 2013
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Contents Executive Summary ------ -------------------------------------------------------------------------- 5
1. Introduction---------------------------------------------------------------------------------------- 7
Background ---------------------------------------------------------------------------------- 7
EHR Challenges to implementation ----------------------------------------------------- 8
2. Socio-Economic context ---------------------------------------------------------------------- 10
Problem under consideration ------------------------------------------------------------- 12
3. Electronic health records --------------------------------------------------------------------- 16
England ---------------------------------------------------------------------------------- 18
United States --------------------------------------------------------------------------- 22
Developing countries ----------------------------------------------------------------- 23
4. Rationale for government intervention --------------------------------------------------- 25
Objectives -------------------------------------------------------------------------------------- 26
5. Scale and scope ---------------------------------------------------------------------------------- 27
Healthcare system ---------------------------------------------------------------------------- 27
Ehealth and internet usage ----------------------------------------------------------------- 28
Ownership of healthcare infrastructure and levels of access ---------------------- 29
Public and private healthcare plans ------------------------------------------------------ 31
Main stakeholders ----------------------------------------------------------------------------- 33
6. Option description ------------------------------------------------------------------------------- 34
Option 0 – Do nothing ------------------------------------------------------------------------ 34
Option 1 – Nation-wide EHR coverage --------------------------------------------------- 35
Option 2 – Public healthcare EHRs -------------------------------------------------------- 36
Option 3 - Private healthcare EHRs ------------------------------------------------------- 37
7. Cost benefit analysis ----------------------------------------------------------------------------- 38
Option 0 ------------------------------------------------------------------------------------------- 39
Option 1 ------------------------------------------------------------------------------------------- 40
Option 2 ------------------------------------------------------------------------------------------- 56
Option 3 ------------------------------------------------------------------------------------------- 58
Option summary -------------------------------------------------------------------------------- 60
Risks, sensitivity analysis and assumptions --------------------------------------------- 61
Equality analysis -------------------------------------------------------------------------- 62
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List of figures, tables and charts Table 1: Brazil Socio Economic Indicators 2012 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1 1
Table 2: Selected National Health Trends 1970 – 2010 --------------------------------- 12
Table 3: Leading Cause of Deaths in Brazil, 2004 --------------------------------------14
Figure 1: Health Process Domain Components ---------------------------------------------- 17
Chart 1: NHS Organizational Structure (England) ------------------------------------------- 18
Table 4: England, Breakdown of Private Healthcare Revenue, 2009 --------------------------19
Table 5: England, Progress in Delivering Care Records Systems as at 31 March 2011
----------------------------------------------------------------------------------------------------------- 21
Table 6: Public Healthcare Expenditure, [percentage of total], 2008 – 2010 ---------- 27
Table 7: Number of Family Health Teams, 1990 – 2010 [percentage of population] –
-------------------------------------------------------------------------------------------------------------- 29
Table 8: Supply of Healthcare Infrastructure, 2010 -------------------------------------------- 30
Table 9: Number of Hospital beds available for SUS, 2009 --------------------------------- 30
Table 10: Hospital Admissions, 2009 -------------------------------------------------------------- 31
Figure 2: Brazil: Private Medical Plan Beneficiaries with or without Dental Care, 2003 -2012
--------------------------------------------------------------------------------------------------------------- 32
Table 11: Brazil: Health Coverage Plan Type, as at September 2012 ------------------- 32
Table 12: Problems of the Current Healthcare System --------------------------------------- 34
Table 13: Option 1 Central Actions ----------------------------------------------------------------- 36
Table 14: Summary of Savings from Central Action 1 ----------------------------------------- 42
Table 15: Cost Summary of Central Action 2 ---------------------------------------------------- 43
Table 16: Savings from secure on-line Access -------------------------------------------------- 47
Table 17: Cost Summary of Central Action 6 ----------------------------------------------------- 48
Table 18: Cost Summary of Central Action 9 ----------------------------------------------------- 50
Table 19: Summary of Savings from Central Action 16 ---------------------------------------- 52
Table 20: Central Action 4, QALY Gain from the reduced number of Near-Miss Events
---------------------------------------------------------------------------------------------------------------- 54
Table 21: Central Action 5, QALY Gain from Reduced Anxiety Levels -------------------- 55
Chart 2: Option 1 – Estimated Annual Costs and Benefits ------------------------------------------- 57
Chart 3: Option 2 – Estimated Annual Costs and Benefits ------------------------------------------ 58
Chart 4: Option 3 - Estimated Annual Costs ------------------------------------------------------------ 61
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Abbreviations ANS Agencia Nacional de Saude Suplementar
EHRs Electronic Health Records
EMR Electronic Medical Record
EPR Electronic Patient Record
GDP Gross Domestic Product
HCT Health Care Teams
HIS Health Information System
IBGE Instituto Brailiero de Geografia e Estatistica
MOH Ministry of Health
NHS National Health Service [England]
NPfIT National Programme for IT
NPV Net Present Value
OECD Organisation for Economic Co-operation and Development
PCT Primary Care Trusts
QALYs Quality adjusted life years
SUS Sistema Unico de Saude
WHO World Health Organization
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Executive Summary 1.1 In 2010 average public health spending in OECD countries was about 72 percent of all
health expenditure. By comparison in the case of Brazil it was about 47 percent1. The proportionate share of public health expenditure still remains at a significantly low level in spite of increases in the preceding three-year period. Projections on public health spending over the 20 year period ending 2030 estimate a required increase of at least between 1.0 to 2.0 percentage points of GDP2.
1.2 Health sector reform during the democratic transition phase (1985-88) led to the current Unified Health System, Sistema ύnico de Saύde, [SUS]. The central goal of SUS is the universal provision of high quality healthcare based on disease prevention and treatment provision; rehabilitation and health promotion and a decentralised management system.3 Decisions regarding healthcare involve interface among autonomous and independent groups at the federal, state and municipal level. The Ministry of Health oversees the national management of SUS working in conjunction with the National Health Council and other federal agencies on high level strategic issues, e.g. policy formulation, financing and co-ordination4.
1.3 Operating alongside the public healthcare system is the private healthcare sector which, in 2012, is estimated to cover about 25 percent of the population. It accounts for the remaining 53 percent of total healthcare expenditure. SUS is heavily reliant on contractual arrangements with the private sector in order to access hospital beds and diagnostic and therapeutic centres.
1.4 Inevitably such a system will encounter problems that restrict the capacity to deliver an efficient outcome. The problems are as follows: the lack of an integrated healthcare system with the limited exchange of information between the public and private healthcare sectors; Gaps in information exchange at the public sub-sector; the limited ability to respond quickly to health challenges and sub-optimal patient safety and care.
1.5 The potential for benefits from EHRs have been globally documented. It can provide the basis for efficiency savings through more streamlined information processes and the capacity to resolve, at least in part, some of the identified problems. Moreover, it offers the potential for improved patient safety and quality of care. Brazil has had some success with Health Information Systems [HIS], notably the 2004 innovative initiative applied in the SIGA Saude system. By 2008 there were at least 10 national HIS, most of which were coordinated by the Ministry of Health [MOH], providing a diversity of health information from regular basic healthcare reports through to aggregate revenue and expenditure profiles.
1 OECD, OECD Health Data 2012, How does Brazil Compare with OECD Countries, 2012. 2 International Monetary Fund, Macro-Fiscal Implications of Health Care Reform in Advanced and
Emerging Economies, 2010. 3 Source – Ministry of Health of Brazil handout on SUS: Unified Health System 4 Pan American Health Organisation and USAID, Health Systems and Services Profile, Brazil,
February 2008, page 22
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1.6 Following extensive research and consultation with Brazilian health experts four options to implementing EHRs have been identified ranging from comprehensive nation-wide coverage to limited sector-specific coverage. The impact assessment provides a tool for option appraisal as each option is the subject of a cost benefit analysis evaluating the main areas of impact. The assessment will always include Option 0 - Do nothing/do minimum against which the other options are assessed. The three options are as follows: Option 1, Nation-wide EHR coverage; Option 2 – Public healthcare EHRs; and Option 3 – Private healthcare EHRs. The most comprehensive option 1 requires a minimum of 16 central actions in order to provide the following common features: Unique patient identifier; On-line portal site enabling patient access to healthcare information; Patient capacity to book appointments; Patient capacity to view secure online health records; Patient capacity to give/deny consent to providers to view patient records; E-prescribing capability; Billing functionality; and Secondary research capability.
1.7 The Net Present Value [NPV] has been derived for year 0 to year 10, with the current year, 2013, being year 0. The estimated NPV for Option 1 lies between -R$56,569.6 million and –R$79,534.8 million. The estimated costs peak at about year 6 and then decline – reflecting the end of the more extensive and expensive IT software and infrastructural costs. Benefits are significantly under-estimated due to missing/unavailable data and show only a very modest increase over time.
1.8 The estimated NPV for option 2 lies between –R$16,886.5 million and –R$21,317.2 million. As of year 7 there is clear evidence that the divergence between annual costs and benefits diminishes over-time. Given the aforementioned tendency towards a conservative approach to estimation there is the strong likelihood that benefits will exceed costs before year 7.
1.9 Total cost for option 3 was estimated to lie between R$58,241 million – R$39,705.5 million. It was not possible to identify a net benefit position. In the absence of any public initiative towards ensuring interoperability of public healthcare providers, monetary benefits are largely through efficiency savings - the potential for reduced storage and possible avoidance of duplication of functions. To a large extent the benefit accrues almost entirely to patients through improved patient care and not to those making the investment.
1.10 An estimate of the gain in quality adjusted life years [QALYs], from healthcare intervention is made using WHO guidance on QALY values that are appropriate for the Brazilian context. These are provided for illustrative purposes only but clearly indicate the capacity for a QALY gain, for example from reduced anxiety levels through secure on-line access which at its lowest level delivers a QALY gain of about R$93,000 million over ten years.
1.11 Notwithstanding the very high proportion of IT expenditure as a share of total expenditure, the long-term success of EHR implementation relies on a commitment to invest in training. If training is not prioritised the extent of clinical engagement is placed at risk. There is the separate risk that implementation occurs at a slow rate of take-up, particularly in the private healthcare sector, as the main beneficiaries are not those making the investment.
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1. INTRODUCTION
Background
1.12 Healthcare, whilst one of the most important policy areas, is also one of the most complex to reform because of interdependencies across a broad remit. For example nutrition, housing, employment, education, transportation and basic sanitation – are all recognised as impacting on health and well-being. The potentially extensive list of health considerations has budgetary implications for Brazil’s public health expenditure.
1.13 In 2010 average public health spending in OECD countries was about 72 percent of all health expenditure. By comparison in the case of Brazil it was about 47 percent5. Projections on public health spending in Brazil over the 20 year period ending 2030 estimate a required increase of at least between 1.0 to 2.0 percentage points of GDP6.
1.14 Against the background of the potentially significant rise in the budgetary outlay, health reform initiatives that provide value for money are an attractive proposition. Health Information Systems [HIS] - the umbrella term used to describe the secure transmission and management of health information – offer one such possibility.
1.15 The HIS environment in Brazil has been described as “second generation”7 – and is reflective of increasingly sophisticated data collection and flow and data utilization. In 2008, Brazil is estimated to have at least 10 national HIS, which are largely coordinated by the Ministry of Health [MOH]. They provide a diversity of information ranging from regular basic healthcare reports through to aggregate revenue and expenditure profiles. However, challenges remain in standardizing good practice.
1.16 The proposed policy intervention seeks to implement electronic health records [EHRs] throughout the healthcare sector. An EHR is a computer accessible interoperable resource providing a diverse source of clinical and administrative information to providers at different levels. The EHR concept is sometimes used interchangeably with electronic medical records [EMRs] which refer to a patient’s legal medical record and are often created within a hospital or an ambulatory setting. EMRs are the source material from which EHRs are generated. Throughout this impact assessment the term EHR is used interchangeably with electronic patient records [EPRs] which is a far more accurate approximation.
5 OECD, OECD Health Data 2012, How does Brazil Compare with OECD Countries, 2012. 6 International Monetary Fund, Macro-Fiscal Implications of Health Care Reform in Advanced and
Emerging Economies, 2010. 7 See Vital Wave Consulting, Health Information Systems in Developing Countries, May 2009.
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EHR Challenges to implementation
1.17 The top three key barriers to the adoption of EHRs are funding, time and staff [user] habits/organization8. There is also an important role in ensuring that the security of the system is given the highest priority in order to ensure widespread user engagement. Studies have demonstrated that if people do not trust the system it will be under-utilised9.
1.18 The estimated annual cost of running a national HIS can vary considerably depending on access to funding and typology of country. For example the estimated cost range in 2006 was US$0.53 per capita in low income countries and US$2.99 in high income countries10. In the case of Brazil with a population of about 195 million this translates to about US$343 million using a mid-point value.
1.19 The prospect of a good return on the significant financial outlay is much improved if there is early and on-going investment in appropriate training of all users of the system. Country studies reveal that the single largest cost is the time needed for doctors’/healthcare professionals’ engagement and not the cost of ICT11.
1.20 The EHR project is part of the regulatory agenda – Consolidating Better Regulation in Brazil. It is supported by the Civilian Household – Programme for the Strengthening of Institutional Capacity for Regulatory Management/PRO-REG and also the British Embassy. The terms of reference require an impact assessment of alternative options for EHR implementation.
1.21 An impact assessment identifies and assesses the main areas that are likely to be affected by policy intervention. It is intended to capture both the monetised and non-monetised costs and benefits and provides a transparent and structured approach to policy evaluation. It relies on a diversity of sources of evidence to inform policy-makers of the impact within and across different socio-economic groups. On this basis policy-makers are better equipped to deal with the consequences of policy intervention.
1.22 The impact assessment covers all healthcare with the exception of that related to dental/oral hygiene. It has been researched using primarily English language publications. The research draws on references cited in reviews and original-research articles, the WHO/OECD internet database for yearly reports and regular publications and the World Bank database. Data has been largely provided by the Brazilian authorities but also draws on data available in English from Brazilian sites such as the Brazilian Institute of Geography and Statistics [IBGE].
8 EMR adoption in Europe, Uwe Buddrus, presented at Leaders in Health IT Symposium, 10 May 2011.
9 OECD, Achieving Efficiency Improvements in the Health Sector Through the Implementation of Information and Communication Technologies.
10 See World Health Organisation Country Health Information Systems, A Review of the Current Situation and Trends, 2011. page 3.
11 Socio-economic Benefits of Interoperable Electronic Health Record Systems in Europe – The Evidence, Karl Stroetmann et al, at http//www.ehr-impact.eu
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1.23 The report is structured as follows: the next section provides the socio-economic context in which EHR is to be implemented and identifies the problems under consideration in relation to information management; section 2 provides a summarised account of EHR, its key features and net benefits, and appraises the English experience.12 This section also briefly covers the US experience and identifies lessons from the developing country experience; section 3 assesses the basis on which there is a justifiable case for intervention and identifies the objectives of the project. The objectives effectively signal the basis on which the project will be evaluated; section 4 provides the scale and scope of related healthcare issues and identifies the main stakeholders; section 5 describes the range of options, the feasible solutions to implementing the information architecture in support of EHR; section 6 provides the cost benefit analysis of all 3 options. The final section 7 identifies the associated risks for the achievement of the identified objectives and also provides an equality assessment as the project impacts on different socio-economic groups.
12 The National Programme for Information Technology [NPfIT] was not a UK-wide initiative which would have included Wales, Scotland and Northern Ireland – but was restricted to England.
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2. SOCIO-ECONOMIC CONTEXT
1.24 Brazil has the fifth largest global population of about 194 million at the end of August 201213. The vast region of over 8.5 million km2 is divided into five large geographic regions which collectively consist of 26 states and the federal district- and encompass 5,565 municipalities14.
1.25 A municipality is an administrative division of the Brazilian state in which it resides. On average it has a population size of about 35,000 people. Municipalities are autonomous with an elected local government, some law-making powers and are able to collect taxes.
1.26 The trend in economic macro variables over the last three decades reveals the significant economic gains that Brazil has made. Brazil is currently ranked in the top 50 [48th] in the global competitiveness rankings, having moved up 5 places from the previous years [2011/12] position.15 Per capita income is US$10,720 and is projected to grow by 4.0 percent in 2013 and 4.1 percent in 201716. Meanwhile the current unemployment rate at about 5.417 percent is relatively low compared to the rest of South America and the US.
1.27 However, in spite of impressive economic progress over the last twenty years there is also evidence of inequitable income distribution as captured by the gini coefficient18. With the exception of 1991, when the index reached 0.64, for the period 1970 to 2008 the index has fluctuated between 0.55 – 0.59. By comparison the average within OECD countries remains significantly lower fluctuating between 0.28 in the mid-1980s to 0.31 by the late 2000s19.
1.28 Income disparity is captured through considerable heterogeneity in the socio-economic conditions within, and between, each of the five regions. See table 1 below.
13 The latest population figures published by Instituto Brasileiro de Geografia e Estatística available at
http://www.ibge.gov.br/english/presidencia/noticias/noticia_visualiza.php?id_noticia=2204&id_pagina=1 accessed 13th January 2013.
14 See http://www.ibge.gov.br/english/estatistica/economia/perfilmunic/2011/default.shtm accessed 15th January 2013
15 http://www3.weforum.org/docs/WEF_GlobalCompetitivenessReport_2012-13.pdf accessed 15th January 2013
16 International Monetary Fund, World Economic Outlook, Table A4, Emerging Market and Developing Economies: Real GDP, October 2012, page 195.
17 Unemployment rate as at September 2012, http://www.tradingeconomics.com/brazil/unemployment-rate accessed on 5th November 2012
18 The gini coefficient is commonly used as a measure of inequality of income or wealth where a value of zero equates with perfect equality and one lies at the other extreme, one person has all the wealth.
19 http://www.oecd.org/social/socialpoliciesand data/ accessed 19th October 2012
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Table 1: Brazil Socio Economic Indicators, 2012
Region Population size [as % of total]
No. of states/ [Municipalities]
Percentage of GDP*
Gini Index
North 16.3 mn. [8.4%] 7 [449] 5.1 0.496
Northeast 53.9 mn. [27.8%] 9 [1,794] 13.1 0.522
Southeast 81.6 mn. [42.1%] 4 [1,668] 56.0 0.480
South 27.7 mn. [14.3%] 3 [1,188] 16.6 0.461
Centrewest 14.4 mn. [7.3%] 3 [466] 9.2 0.520
Total 193.9 26 [5,565] 100.0
Source: IBGE, latest available statistics for end August 2012. ftp://ftp.ibge.gov.br/Estimativas_Projecoes_Populacao/Estimativas_2012/serie_2001_2012_TCU.pdf accessed 11.01.13; * IBGE, latest figures for 2011.
1.29 Inequitable regional income distribution is most evident in the southeast region which accounts for about 56 percent of GDP and covers just over 42 percent of the population, whilst the northeast accounts for 13.1 percent of GDP but has just under 28 percent of the population. It is widely acknowledged that income disparities give rise to uneven access to education, sanitation and housing – which in turn impact on health outcomes.
1.30 Health sector reform during the democratic transition phase (1985-88) led to the current Unified Health System [Sistema ύnico de Saύde] SUS. The central purpose of SUS is the universal provision of high quality healthcare based on:
(1) Disease prevention and treatment provision;
(2) Rehabilitation and health promotion and;
(3) Decentralised management system.20
1.31 Notwithstanding the weak indicators on income distribution SUS is credited with contributing to the following improved national health statistics, see table 2 below.
20 Source – Ministry of Health of Brazil handout on SUS: Unified Health System
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Table 2: Selected National Health Trends, 1970 - 2010
1970 1980 1990 2000 2010
Infant mortality 113.9 69.1 45.22 27.4 19.0*
Life expectancy 52.3 62.6 66.6 70.4 72.8+
Fertility rate 5.8 4.35 2.85++ 2.38 1.86
Dependency ratio**
88.31 73.18 72.51++ 61.7 47.9+
Hospital admission- SUS
5.6 mn 13.1 mn 12.6 mn 11.9 mn 11.1 mn”
Source: Jairnilson Paim et al, The Brazilian Health System: History, Advances and Challenges, The Lancet , Vol 377, May 21, 2011, Tables 2 and 3, page 1782. ** number of people aged 65 and over to every 100 children and adolescent; ++ 1991; * 2007 ; + 2008 ; “ 2009
PROBLEM UNDER CONSIDERATION
1.32 Decisions regarding healthcare involve interface among autonomous and independent groups at the federal, state and municipal level. The Ministry of Health oversees the national management of SUS working in conjunction with the National Health Council and other federal agencies on high level strategic issues, e.g. policy formulation, financing and co-ordination21. Inevitably such a system will encounter problems that restrict the capacity to deliver an efficient outcome. The problems can be outlined as follows:
Lack of an integrated healthcare system with the limited exchange of information between the public and private healthcare sectors.
1.33 Whilst the public and private sphere of activity is distinct – they are interconnected. Private healthcare interfaces with the public by providing services contracted out by SUS, through out-of-pocket expenditure and ambulatory services and through private health plans and insurance.
1.34 The proportionately much greater supply of healthcare infrastructure owned by the private sector as against the public sector provides some indication of the extent of interdependence between the private and public sectors. Primary care clinics, emergency units are mainly public whilst the hospitals, outpatient clinics, diagnostic and therapeutic services are mainly private.
21 Pan American Health Organisation and USAID, Health Systems and Services Profile, Brazil, February 2008, page 22
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1.35 SUS relies on private facilities through contracted service arrangements in order to provide the requisite health care. In particular high cost procedures are largely available in the private sector but are authorized by the Ministry of Health. Those with private plans may also make use of SUS facilities. An estimated 8 percent of admissions to SUS hospitals between 1990 and 2010 were by individuals with private health plans22.
1.36 The large volume of transactions that takes place suggests efficiency gains are to be found through an integrated administrative system. This would deliver benefits through improved communication enabling enhanced patient care. Patient care is compromised as it is difficult to monitor health progress and deliver timely health interventions. This has an adverse effect on the quality of life for the long-term and also has a disproportionate impact on vulnerable groups. For example screening for cervical cancer is widely available but access remains at significantly lower levels in poor areas23.
1.37 There are also efficiency savings to be gained from improved administrative capabilities for secondary uses such as billing.
Gaps in information exchange at the public sub-sector
1.38 Even within the public sector there are bottlenecks evident in the exchange of information. At the primary care level there is the parallel existence of traditional primary care facilities that pre-date the establishment of the Family Health Program [now called the Family Health Strategy] which works through family Health Care Teams [HCTs]. Family HCTs are the front-line team interacting with patients and generally consist of one doctor, one nurse, one auxiliary nurse and 4-6 community health workers.
1.39 In 2010 there were an estimated 236,000 community health workers and 33,000 HCTs. An estimated 98 million people relied on HCTs which is equivalent to about 85 percent of the municipalities [4,737]. An estimated 15 percent do not have a PSF service and the traditional service is not integrated into the PSF framework.24
1.40 The significance of preventative treatment at the primary care level has been captured through ecological analyses. An estimated 8 percent reduction in adult deaths after just 8 years is thought to be due to the work of Family Health Programmes25.
22 Jairnilson Paim et al, The Brazilian Health System: History, Advances and Challenges, The Lancet, Vol 377, May 21, 2011, page 1782.
23 Maria Schmidt et al, Chronic non-communicable diseases in Brazil: Burden and current challenges, The Lancet, Vol. 377, June 4, 2011, page 1957
24 Jairnilson Paim et al, The Brazilian Health System: History, Advances and Challenges, The Lancet, Vol 377, May 21, 2011, page 1788.
25 Maria Schmidt et al, Chronic non-communicable diseases in Brazil: Burden and current challenges, The Lancet, Vol. 377, June 4, 2011, page 1957.
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Limited ability to respond quickly to health challenges
1.41 The leading cause of deaths in 2004 has not changed significantly from that in the 1990s, however there has been a shift in the epidemiological profile and persistence of endemic and communicable diseases.
1.42 Policy formulation suffers from incomplete information as a result of the lack of targeted data gathering and monitoring. There is a reduced capacity to pursue an informed research agenda aimed at preventative treatments and/or directed at the area of greatest urgency. There is clear evidence of a research active environment as publications by Brazilian researchers grew from 14,237 in 2003 to 30,415 in 2008. However research output may not be making the best use of resources. This is a particularly relevant concern as the Ministry of Health uses 1.5 percent of the SUS budget to finance health research26.
1.43 There is the related concern of the potentially delayed response to changing trends. The absence of intelligence impedes timely action to counter the harmful development of an as yet unnoticed trend. See table 3 below.
Table 3: Leading Cause of Deaths in Brazil, 2004
Cause of death Percentage of deaths with defined cause
Circulatory 31.8
Neoplasms 15.7
External causes 14.2
Respiratory 11.4
Infectious and parasitic diseases
5.1
Source: USAID and Pan American Health Organization, Health Systems and Services Profile, Brazil, February 2008, page 15,
1.44 Incomplete and/or misdirected research fosters far more costly healthcare in the long-term if delays in preventative treatments facilitate the development of chronic disease.
26 Cesar Victora et al, Health Conditions and Health Policy Innovations in Brazil: The Way Forward, The Lancet, Vol 377, June 11, 2011, page 2045.
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Patient safety and patient care is not optimised
1.45 WHO initiatives provide guidance on measures to ensure patient safety and quality of care and these are followed by the Ministry of Health and the National Sanitary Surveillance Agency. However in spite of this safeguard an estimated 67 percent of adverse events were thought to be preventable27.
1.46 The problem arises from patchy adherence to guidelines and also through the absence of information documenting patient experience through the system. Sao Paolo embarked on a highly successful HIS initiative and is one of the few states able to develop their own approach. It is widely acknowledged that data drives the management of quality in health care as it provides continuous feedback.
27 See Jairnilson Paim et al, The Brazilian Health System: History, Advances and Challenges, The Lancet, Vol 377, 21 May 2011 page 1793, at www.thelancet.com accessed on 19th October 2012
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3. ELECTRONIC HEALTH RECORDS
1.47 The definition of EHR used here is consistent with that of EPRs applied to the English experience. The EHR concept has been used interchangeably with that of EMRs which describes a record arising out of a health episode – generally within an ambulatory or hospital setting.28
1.48 The benefits of EHRs have been widely documented – chief of which is the potential for improved patient safety and improved quality of care. EHRs potentially provide increased scope for efficiency savings through more streamlined information processes. But this a contested view as the counter argument identifies the importance of context. For example small users are less likely to realise cost savings because of costly capital and maintenance costs and the limited capacity to access economies of scale29.
1.49 Brazil is credited with having considerable success with the innovative approach to HIS in the SIGA Saude system. The system was implemented in 2004 in Sao Paulo by the City Department of Health to address the needs of those on low income. It was innovative in being a “bottom-up” municipal approach – as distinct from the usual top-down approach. Success was measured through the increased number of patient visits and improved patient satisfaction – all of which was achieved without increased resource allocation.
1.50 An enterprise planning resource system was used to capture essential data on health encounters across a broad remit. Critical to its success was an appreciation of the role played by incentives in informing conduct. Those collecting the data were also involved in front line delivery and had an inherent incentive to ensure collection.
1.51 A key element securing success was credited with being a result of the following preceding events: Careful planning and modularisation ahead of implementation; investment in a program management office to oversee and resolve issues and the provision of training and technical support to every unit and deployment30.
1.52 An ideal level of EHR implementation when applied to the Brazilian context may envisage its application to both the public and private healthcare sectors. The outcome of the joint implementation of EHR in both the public and private healthcare sectors is illustrated in figure 1 below.
28 See Congressional Budget Office, Evidence on the Costs and Benefits of Health Information Technology, May 2008, page 30; J. Habib argues that the distinction between EMRs and EHRs is an important one. The EMR being the legal medical record and the EHR giving access to designated groups. See ‘EHRs, meaningful use and a model of EMR’, Drug Benefit Trends, Vol. 22, No. 4.
29 Economies of scale refer to the reduction in average costs with increased output. 30 See Vital Wave Consulting, Health Information Systems in Developing Countries, May 2009,
page 54.
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Figure 1 – Health Process Domain Components
1.53 This section outlines three HIS experiences – England, which had the most extensive civilian IT program in history; a brief overview of the US, which shares a similar extent of private health care expenditure [as a share of total health expenditure] as Brazil; and finally the list of developing country HIS lessons, a useful guide because of similarities in the socio-economic context. The aim of this section is to extract evidence of good practice to inform the choice of options for implementing EHR in Brazil.
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ENGLAND
1.54 The Department of Health oversees the management and delivery of the National Health Service [NHS] for England. The NHS was established in 1948 to provide universal care and is funded primarily through tax revenue. There has been the consistent increase in spending which by 2011/12 stood at about £106 billion.
1.55 Most of the population [52 million] relies on services provided by about 1.7 million employed by the NHS. An estimated 3 million people access some aspect every week31. In 2010 UK-wide public expenditure on health was estimated at about 8.0 percent of GDP whereas private health expenditure was just 1.6 percent32.
1.56 The NHS structure consists of broadly two main areas:
(1) Secondary care, also known as acute healthcare, which can be either elective or emergency care and
(2) Primary care, managed by Primary Care Trusts, which commissions secondary care. It controls about 80 percent of the budget and averaged £1,615 per head in 2011/12. See chart 1 below.
Chart 1: NHS Organizational Structure
Source: http://www.nhs.uk/NHSEngland/thenhs/about/Pages/nhsstructure.aspx
31 http://www.nhs.uk/NHSEngland/thenhs/about/Pages/overview.aspx, accessed 1st November 2012
32 Office for National Statistics, Expenditure on Healthcare in the UK, page 6 ,at http://www.ons.gov.uk/ons/rel/psa/expenditure-on-healthcare-in-the-uk/1997---2010/art-expenditure-on-healthcare-in-the-uk-1997---2010.html accessed on 5th November 2012
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1.57 An NHS Trust is the local management of health services. It represents an important health concept introducing social participation into health decision-making. Hospitals, for example are managed by a local team of people through Acute Trusts and there are also Foundations Trusts. These were first introduced in 2004 and represent further decentralisation as they have much more financial and operational freedom than other NHS Trusts.
1.58 Currently Primary Care Trusts [PCTs] oversee the work of 39,409 general practitioners [GPs] and 22,800 dentists; Acute Trusts oversee 170 acute hospital trusts and 58 mental hospitals; Care trusts oversee 1,600 NHS hospitals and specialist centres; Foundation Trusts have 129 hospitals and Ambulance trusts have 11 emergency services33.
1.59 Private healthcare accounts for a much smaller proportion of healthcare in the UK than is the case of Brazil. However, similar to the Brazilian case private healthcare is largely concentrated in the secondary care sector. The total value of the UK market for acute health care in the private healthcare market was estimated at just over £4.94 billion34 in 200935. See table 4 below.
Table 4: England: Breakdown of Private Healthcare Revenue, 2009
Category Revenue value (£)
Facilities 2.83 bn
Fees to surgeons, anaesthetists and physicians
1.64 bn
Private inpatient and outpatient treatment in NHS facilities
0.47 bn
TOTAL 4.94 bn
Source: Office of Fair Trading, Private Healthcare Market Study, OFT1396, December 2011, page 15
33 http://www.nhs.uk/NHSEngland/thenhs/about/Pages/nhsstructure.aspx accessed 1st November 2012
34 The £4.94 billion figure excludes revenue from the purchase of acute care by the NHS from independent facilities, revenue from mental health facilities or long term care of the elderly
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Electronic Patient Records
1.60 EPRs are a central feature of the 10 year National Programme for IT in England [NPfIT]. The programme was launched in 2000 to provide a fully integrated electronic care record system enabling the rapid transmission of information between the different parts of the NHS. The budgeted cost was £11.4 billion and the intended effect was error reduction and improved quality of care experienced by patients.
1.61 The focus was on care records which required two separate EPR systems:
(1) Local Detailed Care Records [DCR], to provide full details of a patients’ medical history and be available to the local health network, and
(2) Nationally available Summary Care Records [SCR], to provide a summarised version of key information accessible only to those with direct medical involvement in treatment and also patients via the HealthSpace website.
There was also a secondary uses service [SUS UK] providing access to aggregated data for management, research and other secondary purposes36.
1.62 The Patient Administrative System [PAS] was a critical component enabling DCR link-up. The success or failure of the Programme was linked to the capability of PAS in facilitating nation-wide connectivity. An arms length body “Connecting to Health” was appointed by the Department of Health with responsibility for delivering the NPfIT.
1.63 Procurement of HIS was managed centrally and in 2003/04 the Department awarded five 10 year contracts to four private companies with specified regional responsibilities:
(a) Accenture - East and North-east
(b) Bt – London
(c) Computer Sciences Corporation – North west and West midlands and
(d) Fujitsu - South;
1.64 It was envisaged that local service providers [LSPs] would in turn choose and change sub-contractors as the need dictated. The contracts stipulated delivery by 2007 with increased functionality and integration added in 2010. Critical to developments that subsequently occurred was the fact that the software was proprietary and used an output based specification.
35 See Office of Fair Trading, Private Healthcare Market Study, OFT1396, page 15. 36 House of Commons Health Committee, The Electronic Patient Record, 6th Report of Session
2006-07, Volume 1, September 2007, page 3.
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1.65 Proprietary software uses a secret source code, known only to the computer programmer, turns into machine code enabling the computer to execute. By contrast with open source software (OSS) the code is available to the user to access and modify to suit changing needs.37
1.66 The quality of the HIS is not necessarily affected by the selected product however there are downstream cost implications if users are unsure of requirements and the license terms fail to meet their needs. This was evident to some extent in termination of contracts with two LSPs in 2007-09 amid claims of their being “new requirements” that required further payment.
1.67 As at 03/2011 total expenditure on the Programme was estimated at £6.4 billion and the Programme has been considerably scaled down. The Care Record system will no longer be delivered throughout the NHS. Progress in delivering care records is indicated in table 5 below.
Table 5: England: Progress in delivering care records systems as at 31 March 2011
Trust type
Total delivered
Total remaining (%)
Acute Trust 19 103 (84)
Community Health Services
95 36 (27)
GP Practices 1,377 3,023 (69)
Ambulance Trusts
6
0 (0)
Source: National Audit Office, The National Programme for IT in the NHS: An Update on the
Delivery of Detailed Care Records Systems, page 11.
1.68 Each Acute Trust without a system will be able to build on its own in-house system but must ensure interoperability against standards set down by the Department of Health.
1.69 There were successes in the implementation of the NPfIT as indicated through the identification of a universal coding language for the NHS – SNOMED-CT. This standardised the use of clinical terminology and reduced the capacity for errors due to the divergent use of common terms between discipline groups. There was also the creation of a single unique patient identifier – the NHS number - enabling the subsequent assignation of a patient with his/her medical history with the reduced risk of mistakes. The system has also been commended for the introduction of choose and book enabling easier access and more efficient use of NHS resources.
37 See Carl Reynolds et al, Open Source, Open Standards, and Health Care Information Systems, Journal of Medical Internet Research, Vol 13, No.1, 2011.
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1.70 But there were also shortcomings in the implementation of EPRs which demonstrate the importance of pursuing a measured approach to the implementation of EHR. Attempting to digitilize entire population health records in just 4 years, the biggest IT project in the world – suggests a cautious approach at all stages.
1.71 One of the earlier learning opportunities arrived in respect of the risk to confidentiality and data security posed by SCRs. Following consultation an ‘opt-out’ system was formulated for the creation of the SCR with the additions of clinical information being triggered by an ‘opt-in’. Sealed envelopes are used to restrict access to sensitive information38.
1.72 There was evidence of a missed opportunity to explore other less costly options such as open-source coding. It also became increasingly apparent that over-dependence on commercial, proprietary companies carries its own risks. In particular computer software tends to be secret and proprietary – and this does not foster wide dissemination. Moreover, whereas the public sector is subject to well-established codes of conduct the private sector is answerable only to its shareholders. A close working relationship between the two sectors may give rise areas of tension and conflict.
1.73 Finally a top-down approach as carried out by the NHS risked the exclusion of other points of view from the range of stakeholders, especially front line staff who are most affected by the change. There was subsequent NHS staff resistance to change and also lack lustre support from clinicians as a result of insufficient technical support.
1.74 In May 2012, following consultation on all aspects of information within the health and care and support sector, the Department for Health published the information strategy for the next 10 years. The Power of Information39 sets out the framework for transforming information for the NHS. It recognises the contribution from earlier initiatives, especially with respect to providing the necessary IT infrastructure enabling wider connectivity and interoperability, but also identifies key areas for redress.
UNITED STATES
1.75 The US health care system has been described as “funded by a patchwork of private and public insurance, imposes large point of service fees on many users, and provides care through private, not for profit and public providers in a largely competitive delivery system that is proudly ungoverned40.”
1.76 US Health spending in 2010 at about 17.6 percent of GDP represented the highest of all other OECD countries. It is equivalent to about US$8,233 per capita spent on health in a country of about 312 million. However the public sector share of health expenditure is low relative to other OECD countries at about 48.2 percent41.
38 House of Commons Health Committee, The Electronic Patient Record, Sixth Report of Session 2006-07, House of Commons, London
39 See http://informationstrategy.dh.gov.uk/about/background/ 40 Healthcare Reforms in the USA and England: Areas for Useful Learning, The Lancet, Vol 380,
Oct 13, 2012. page 1352 41 http://www.oecd.org/unitedstates/BriefingNoteUSA2012.pdf accessed 4th November 2012
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1.77 There are many EHR initiatives in operation across the USA in both the public and private sphere of activity. According to a 2006 study by the Health Information Exchange Initiatives and Organization, 28 states had initiated health information technology plans42. There are examples of jointly funded public-private undertakings, for example Massachusetts launched a state-wide initiative partially funded by the Blue Cross43.
1.78 For the most part EHR has made use of proprietary software which has made it a relatively expensive option when compared to OSS. There has been generally poor take-up and limited interoperability. Perhaps the best example of success is the VA VISTA hospital system which forms a core part of the software serving approximately 30 million.
1.79 Financial incentives are increasingly evident and are used to encourage exchange in good practice including sharing information with patients. The publication of good practice in health outcomes is encouraged and disseminated through monthly performance indicators.
1.80 The purer national model is focussed on the more technical parts of EHR. In particular the building of national information architecture and establishing data interoperability and compatibility. For example the identification of core standardised EHR terminology and standardised event terminology to avoid misunderstandings through use of similar terminology to different events.
1.81 The US experience identifies common contentious areas to those experienced within England. In particular reservations regarding the scope for cost savings as information standardisation [and adoption] has not reduced the time spent on form-filling.
42 See Laura Dunlop, Electronic Health Records: Interoperability Challenges Patients Right to Privacy, 3 Sidler J.L. Com & Tech 16 (Apr. 6, 2007)
43 Tracy D Gunter and Nicolas P Terry, The Emergence of National Electronic Health Record Architectures in the United States and Australia: Models, Costs and Questions. Journal of Medical Internet Research, 2005, 7(1)
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DEVELOPING COUNTRIES
1.82 The diversity of country environmental circumstances makes it impossible to encapsulate all experiences into a single expression. However it is possible to highlight frequently occurring considerations specific to the developing country experience as follows44:
(1) System interoperability is of considerable benefit;
(2) HIS must be adapted to the environmental conditions in which it operates and must reflect user capabilities;
(3) It is important to spend time deciding what data is to be collected [re-phrase as time investment in data collection yields long-term benefits];
(4) There is the increased likelihood of a successful HIS outcome when part of wider healthcare reform and;
(5) A measured approach allows time to reflect on mistakes and identify possible solutions.
44 See Vital Wave Consulting, Health Information Systems in Developing Countries, May 2009, page 54
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4. RATIONALE FOR GOVERNMENT INTERVENTION
1.83 Market failure describes a price/output outcome which is sub-optimal. This means that resources are not allocated to their most efficient activity, or in the most productive manner. The existence of a market failure does not necessarily signal a role for government intervention. It may be that the problem is not sufficiently large and/or significant to warrant costly intervention. Moreover, there is an opportunity cost attached to increased expenditure in one area as it reduces that amount available for other areas.
1.84 In this instance the implementation of EHR provides strong arguments in favour of government intervention. EHR represents a significant cost investment occurring over a long time period. Many costs are tangible and need to be delivered upfront. For example the costs of IT infrastructure and its maintenance. There are risks and uncertainties regarding the potential for increased costs, through optimism bias in the scope of capital investment. It may be that actual costs are significantly greater than the estimated allocation due to the increased prices of key components on the world market.
1.85 There are also intangible costs that arise from security breaches and/or the loss of confidential information. Information can be misused to select clients by private health plans or can be disclosed to employers and others. These events have considerable economic implications in addition to emotional costs and cause distress to those whom are directly affected by the violation of their privacy. A central agency such as the government is required to protect against this loss. This may require the provision of guidance and creation of the legal and/or administrative framework to incentivise those with data responsibility to minimise the incidence of security breaches.
1.86 A final consideration is that the government has a co-ordinating role to play in assisting the healthcare market to operate at a more efficient level. This requires establishing the governance framework enabling the supply of key resources. There is the problem of rising healthcare expenditure as Brazil exhibits one of the fastest ageing populations in the world and this requires urgent attention.
1.87 On the other hand there are also benefits and savings to be gained, particularly in the long-term through the potential for considerable positive externalities. EHR delivers the prospect for improved health outcomes – impacting directly on the potential for enhanced economic growth prospects. Increased growth provides the possibility for greater investment in new areas, some of which may have been neglected because of competing priorities.
1.88 Governments also intervene on equity grounds – and there is evidence that an improved outcome may have a disproportionate benefit for those on low incomes. In the 1996 to 2007 period non-communicable disease mortality declined in all regions. However, the decline in the richer south and southeast was significantly greater than the poorer north and northeast45.
45 Maria Schmidt et al, Chronic non-communicable diseases in Brazil: Burden and current challenges, The Lancet, Vol. 377, June 4, 2011, page 1950.
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OBJECTIVES
1.89 Objectives provide a measurable means of evaluating the success of a project and are as follows:
(1) A more integrated healthcare system with public and private sectors exchanging information.
(2) Improved planning for the needs of the population, for example the enhanced capacity to respond quickly to health challenges.
(3) More efficient use of resources.
(4) Improved patient safety and patient care.
1.90 The intended effect is to have an efficient healthcare system that enables a joined-up approach between all healthcare providers aimed at providing patients with the best possible healthcare.
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5. SCALE AND SCOPE
Brazil’s Healthcare system
1.91 The organisation of the healthcare system is made up of the following distinct but inter-connected three sub-sectors:
(1) Public sub-sector i.e. SUS, financed by the state to provide primary healthcare and the national delivery of secondary and tertiary care through contracted clinics and hospitals. Universal access is facilitated through Health Councils [HCs], consisting of users, managers and health workers operating at the federal, state and municipal level;
(2) Private [for profit and not for profit] sub-sector financed with public and private funds and;
(3) Private health insurance sub-sector with different forms of health plans varying insurance premiums and tax subsidies46.
1.92 The level of public healthcare expenditure as a proportion of total healthcare has increased over the three-year period, 2008-2010. However it still remains at a significantly lower level than the OECD average. See table 6 below.
Table 6: Public Healthcare expenditure, [percentage of total] 2008-2010
Percentage of total healthcare
expenditure
2008 2009 2010
Public healthcare expenditure
42.8 43.6 47.0
Private healthcare expenditure
57.2 56.4 53.0
Total 100.0 100.0 100.0
Source: http://data.worldbank.org/indicator/SH.XPD.PUBL, accessed 15th January 2013
1.93 The main bodies involved in the organisation and delivery of healthcare are:
(1) The Ministry of Health - responsible for strategic oversight – planning and budgeting healthcare expenditure with the support of five specific secretariats;
46 See Jairnilson Paim et al, The Brazilian Health System: History, Advances and Challenges, The Lancet, Vol 377, May 21, 2011, page 1785.
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(2) SUS - consisting of subsystems at the state and municipal levels. The state provides oversight of strategic resources and delegates responsibility to the municipality to implement health plans;
(3) Private Healthcare providers;
(4) National forums delivering joint inter-sectoral actions reflecting the multifaceted approach to healthcare.
ehealth and internet usage
1.94 There are over 10 Health Information Systems that feed directly into SUS providing information to managers and the population. For example SIAB, the Basic Healthcare Information System records healthcare actions and services carried out by the Family Health Program [PSF]; SIH-SUS, the Hospital Information System generates monthly data on SUS-provided hospital services and SINAN, the National Disease Notification System, records and processes data on diseases requiring mandatory notification from the entire country47. Many of Brazil’s most significant systems were established in the 1970s and 1980s.
1.95 In 1985 the Virtual Health Library was created in recognition of different requirements of a multicultural population. Of particular significance is the Live Birth Information System [SINASC] established in 1990 which is recognised for providing standardised data correction procedures to a high quality at all hospitals.
1.96 MOH is the national coordinator of the HIS network through RNIS. There are also joint actions with PAHO/WHO through the interagency health information network RIPSA. The information systems are linked into other governmental bodies such as Instituto Brasileiro de Geografia e Estatística [IBGE] which provide statistics and important surveys such as the household survey PNAD.
1.97 Academic links encourage the research of health issues through such networks as SCIELO, an electronic journals portal enabling comprehensive and unrestricted access to scientific content, and CAPES, which provides free access to international journals to teaching institutions. There is a health portal provided by the MOH.
1.98 The governmental role extends to the regulation of standards of information exchanged within the private healthcare sector. The National Regulatory Agency for Private Health Insurance and Plans [ANS] applies a TISS standard to information exchanges at the medical and administrative levels within private healthcare. This is underpinned by the assumption of interoperability to MOH standards. Standardisation aims to facilitate common clinical terminology and to foster uniform good practice in all activities involving the exchange of information48.
47 Pan American Health Organisation and USAID, Health Systems and Services Profile, Brazil, February 2008, page 26
48 See http://www.ans.gov.br/index.php/the-sector/information-exchange-standard
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1.99 The growing use of mobile and internet technology enhances the prospect of greater communication of health information to others not directly connected to the healthcare industry. In particular there is increased scope for participation by the general public. Nearly 70 percent of the population has a cell providing the possibility for messaging on a larger scale.
1.100 A recent IBGE survey in 2011 identified 77.7 million users [40 percent of the population]10 years old and over, had used the internet in the last 3 months49.There is however uneven internet usage between the different age groups. Young persons aged between 18-19 years have particularly high internet usage recording 74.1 percent access within three months of the survey whereas the 50 years old and over group recorded recent internet access of only 18.4 percent.
Ownership of healthcare infrastructure and levels of access
1.101 Three levels of care are provided within a healthcare system – primary, secondary and tertiary level. The public sector dominates provision of primary care which generally takes place at the community level through family health care teams located in PSF clinics and also community health workers. Care offered at this level is particularly important in providing preventative treatment forestalling the development of more chronic disease. Family Health Teams cover a significant proportion of the population. See table 7 below.
Table 7: Number of Family Health Teams, 1990-2010
[Percentage of population covered]
Family Health Teams
1990 2000 2010
Community Health workers
78,705+ [29.6]
134,273 [42.8]
244,000 [60.4]*
Family Health Teams
3,062 [6.6]
8,503 [17.4]
33,000 [49.5]
+ data only available for 1998; *data only available for 2008. Source: Jairnilson Paim et al, The Brazilian Health System: History, Advances and Challenges,
The Lancet Vol 377, 21 May 2011 page 1782, at www.thelancet.com.
1.102 Healthcare professionals operating in the primary care sector are effectively the gate-keepers to the secondary level. Secondary care provides specialist treatment and arranges further diagnostic tests which are usually [but not exclusively] done within a hospital setting. Medical specialists are unlikely to be the first point of contact.
1.103 The private sector has a disproportionately large share in the ownership of hospitals and healthcare infrastructure. See table 8 below.
49 See http://www.ibge.br/english/prsidencia/noticias/noticia_visualiza.php?id_noticia=.... accessed 14th January 2013
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Table 8: Supply of Healthcare Infrastructure, 2010
Healthcare Infrastructure
Number
Public ownership
(%)
Private ownership
(%)
Diagnostic and therapeutic centres
16,226 6.4 93.6
Health posts and Centres 39,518 98.7 1.3
Hospitals 6,384 30.9 69.1
Specialist outpatient clinics 29,374 10.7 89.3
MRI scanners 409 13.4 86.6
Mammography machines 1,753 28.4 71.6
Radiography machines 15,861 58.9 41.1
Source: Jairnilson Paim et al, The Brazilian Health System: History, Advances and Challenges, The Lancet Vol 377, 21 May 2011 page 1792, at www.thelancet.com.
1.104 SUS is heavily reliant on contractual arrangements with the private sector in order to access hospital beds. In 2009 there was an inpatient bed density of 1.9 beds per 1000 population, a reduction from 3.3 beds per 1000 population in 199350. The number of hospital beds available to SUS in 2009 is indicated in table 9 below.
Table 9: Number of Hospital beds available for SUS, 2009
Region Public Private
Total Profit Nonprofit
North 17,052 4,724 1,978 23,754
Northeast 53,866 15,518 21,773 91,157
Southeast 49,404 15,883 60,002 125,289
South 13,304 6,873 31,180 51,357
Midwest 12,551 4,791 6,071 23,413
Brazil 146,177 47,789 121,004 314,970
Source: Data provided from Brazilian authorities
50 Jairnilson Paim et al, The Brazilian Health System: History, Advances and Challenges,
The Lancet Vol 377, 21 May 2011 page 1792
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1.105 In 2010 there were 35.4 percent of hospital beds in the public sector and 38.7 percent of beds in the private sector available to SUS through contract51. The number of hospital admissions SUS required through contractual arrangements from the private sector are indicated in table 10 below.
Table 10: Hospital Admissions, 2008
Region Public Private
Total Total SUS
North 1,048,395 621,857 380,105 1,670,252
Northeast 2,828,735 2,769,134 2,099,300 5,597,869
Southeast 2,942,967 6,930,576 4,673,433 9,873,543
South 627,460 3,418,762 2,858,655 4,046,222
Midwest 693,960 1,316,899 882,704 2,010,859
Brazil 8,141,517 15,057,228 10,894,197 23,198,745
Source: Data provided by Brazilian health authorities
Public and private healthcare plans
1.106 Although the private sector accounts for a disproportionately large share of healthcare infrastructure across a range of specialist areas, the proportion of the population with private health insurance was just over 25 percent in 2012. However, there has been a gradual increase in the number of beneficiaries from just over 32,000 in 2003 to nearly 49,000 by late 2009. See figure 2 below.
51 As above.
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Figure 2Brazil: Private medical aid plan beneficiaries with or
without dental care, 2003- 2012
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10,000,000.0
20,000,000.0
30,000,000.0
40,000,000.0
50,000,000.0
60,000,000.0
Dec
-03
Dec
-04
Dec
-05
Dec
-06
Dec
-07
Dec
-08
Dec
-09
Dec
-10
Dec
-11
Years
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mb
er o
f b
enef
icia
ries
1.107 The proportion of the population covered by private health insurance has consistently grown year on year from 17.9 percent in 2003 to 25.1 percent in 2012. The capacity to access coverage is strongly influenced by occupation. The largest proportion of policies were purchased by employers for employees, see table 11 below.
Table 11: Brazil, Health coverage plan type, as at September 2012
Coverage/Contract Type
Number Proportion
of total
Individual/Family plan 9,963,950.0 0.20
Employer based 30,764,188.0 0.63Group by Association 6,637,238.0 0.14
Group not identified 32,155.0 0.00
Not stated 1,263,174.0 0.03
Total 48,660,705.0 Source: http://www.ans.gov.br/index.php/the-sector/sector-data
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1.108 The health plan and insurance market is highly concentrated in terms of geography and also size. In 2010 about 65 percent of all contracts were held in the south-east and 8.2 percent of all companies [of 1017 = 83 companies] accounted for just over 80 percent of all customers. Insurance revenues have consistently increased over the nine year period, 2003 to 2012, from R$28.242 million to R$82,449 million – an average annual increase of R$6,022 million52.
1.109 Better healthcare access through private health insurance has vouchsafed higher admission rates relative to those without health insurance, i.e. eight admissions per 100 population as against 7 admissions per 100 population53. However, in spite of improved access to largely privately owned facilities, many high cost complex procedures are estimated to be carried out through the SUS.
MAIN STAKEHOLDERS
1.110 The main stakeholders are:
(1) Healthcare providers – public and private sector [hospitals; clinics; HCTs];
(2) Healthcare workers;
(3) IT specialists;
(4) Insurance companies;
(5) Government – Mainly the Ministry of Health - all three levels [national, state, municipal] and related agencies including the Ministry of Finance;
(6) Health Unions;
(7) Research community
(8) General public and Patient organisations.
52 See table on Insurer revenues through premiums, R$, 2003-2011 at http://www.ans.gov.br/index.php/the-sector/sector-data
53 See Jairnilson Paim et al, The Brazilian Health System: History, Advances and Challenges, The Lancet Vol 377, 21 May 2011 page 1793
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6. OPTION DESCRIPTION
1.111 This section identifies and describes the range of options in implementing EHR. The following four options have been derived through the research of countries’ EHR experience – and have benefited from feedback from the Brazilian health authorities:
(1) Option 0 – Do nothing/do minimum
(2) Option 1 – Nation-wide EHR coverage
(3) Option 2 – Public healthcare EHRs
(4) Option 3 – Private healthcare EHRs
Option 0 - Do Nothing/minimum
1.112 Table 12 identifies the key features and the problems that are associated with existing healthcare provision.
Table 12: Problems of the current healthcare system
Current provision Key features and problems
Considerable reliance of SUS on secondary care facilities within the private sector.
Lack of exchange of information between the private and public sector leads to administrative adversely impacts on the quality of patient care.
Primary care at the publicly funded level is largely provided by HCTs through SUS, but some provision pre-dates the Family Health Strategy and lies outside the SUS framework.
Information from one sector is often not available in the other – critical healthcare details compromise the efficacy of healthcare interventions. There is the inherent difficulty in tracking health treatments.
Research activity is supported by Ministry of Health incentives
The absence of key data sets limits the capacity for research to inform the direction of healthcare policy.
Patchy adherence to WHO initiatives on patient safety and the absence of regular published performance indicators.
Patient safety/care is placed at risk through insufficient attention to good practice guidelines.
1.113 The problems with current arrangements provide the background against which alternatives are proposed. A minimum position would be the nation-wide distribution of unique patient identification – which is currently taking place – providing the framework enabling more effective monitoring of patients’ healthcare.
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Option 1 – Nation-wide EHR coverage
1.114 In this option decision-making resides with the Ministry of Health to formulate national standards, oversee IT procurement in the public arena and facilitate widespread EHR adoption. Decision-making takes place at the local level within these set parameters. IT infrastructure will either:
(1) Build on existing local IT systems or
(2) MOH commissions a new national system
1.115 Common features across this option are assumed to be as follows:
(1) Unique patient identifier;
(2) On-line portal site enabling patient access to healthcare information;
(3) Patient capacity to book appointments;
(4) Patient capacity to view secure online health records;
(5) Patient capacity to give/deny consent to providers to view patient records;
(6) E-prescribing capability;
(7) Billing functionality; and
(8) Secondary research capability.
1.116 The central actions associated with the delivery of this option are outlined in table 13 below.
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Table 13: Option 1 Central Actions
No. Action description 1 MOH to oversee provision of IT infrastructure enabling country-wide
interoperability and facilitating billing and e-prescribing. 2 Information system procurement at the local level must be
underpinned by robust business cases. 3 MOH to oversee the identification of all patients by a unique
identifier. 4 All healthcare providers to establish EHR capability
5 MOH to oversee the establishment of infrastructure for patients and authorised users for secure online access.
6 MOH to lead on standard setting on national and/or regional networking systems; clinical terminology; professional record keeping and best practice information governance.
7 MOH to organise stakeholder partnership with patient groups supporting patient access
8 Providers at the local level assess training needs at all levels and provide training in keeping with best practise.
9 EHR champions to be identified in every organisation
10 MOH to oversee IT infrastructure for portals to be used by providers to gain professional access to view records across specialisms.
11 MOH to lead on development of evidence base for patient and professional portal.
12 MOH to lead on national and local stakeholder engagement to improve health literacy.
13 MOH to lead and coordinate work on commissioning data sets.
14 MOH to identify of a research centre to provide a secure data linkage service for research.
15 MOH to provide guidance assisting patient engagement
16 Use of e-communication encouraged at all levels
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Option 2 – Public Healthcare EHRs
1.117 It is envisaged that all of the public healthcare sector will have EHRs in place. Since most of the primary care is publicly provided this is where the greater proportion of change will be felt. There is much less public ownership outside of the primary care area, see table 8.
1.118 Primary healthcare is a very important area of focus because of its preventative role. Early health interventions potentially reduce the prospect of subsequent more costly secondary care in the treatment of non-communicable chronic diseases. Access to primary care requires health-seeking conduct on the part of an individual. This is the point at which patients potentially have the most visible health-seeking actions through booking appointments and researching healthcare information.
1.119 The central actions associated with the delivery of this option are very similar to those in table 13, but are narrower in scope as they do not include the private healthcare sector.
Option 3 – Private Healthcare EHRs
1.120 In this option EHR initiatives are restricted to the private healthcare sector. The approach draws on the United States experience which has a mixture of solely private-led initiatives alongside joint private and public and public-only examples. There is very small private healthcare provision within primary care, about 1.3 percent of total provision54. The greater proportion of private healthcare activity takes place within secondary and tertiary care.
1.121 Unlike the previous option 2 where all central actions remained relevant, albeit on a reduced scale in some cases, this is not the case with option 3. Specifically in relation to the first two actions 1 and 2 – these will no longer be required. The 2007 TISS standard on the exchange of information by private healthcare providers is grounded on the assumption of interoperability. All private healthcare providers are assumed to be fully compliant with interoperability requirements by 2014.
1.122 There is likely to be less interest in central action 9 – the identification of EHR champions. Internal cost procedures within the private healthcare industry are incentivised to operate at the most efficient level. On this basis there is the strong likelihood of an already high commitment towards operationalising action 16, i.e. widespread use of e-communication.
1.123 With the exception of central actions 1, 2 and possibly 9 - all other actions identified in table 13 are relevant in option 3. However the cost/benefit implications will be less pronounced as this option is even more limited in scope relative to option 2.
54 See Jairnilson Paim et al, The Brazilian Health System: History, Advances and Challenges,
The Lancet Vol 377, 21 May 2011 page 1789,
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7. COST BENEFIT ANALYSIS
1.124 There are both monetised and non-monetised impacts of intervention that impact on society and the wider environment. The costs and benefits of each option are measured against the “do nothing” option.
1.125 Impact assessments place a strong emphasis on valuing the costs and benefits in monetary terms (including estimating the value of goods and services that are not traded). However there are important aspects that cannot sensibly be monetised. These might include impacts on equity and fairness, and/or public confidence.
1.126 Specifically within the context of health interventions quality adjusted life years [QALYs] are used to measure health improvement as a guide to healthcare resource allocation. Value for money considerations are particularly important in publically funded healthcare systems especially when confronted by a growing budgetary outlay. There are two perspectives to consider – the societal perspective, assessing the value to the society through improved health and enhanced productivity and the system perspective – which is more focussed on efficiency gains.55
1.127 The UK applies a value of £60,000 per QALY, but there is not a similar approach adopted in Brazil. WHO suggests a value of three times per capita GDP is appropriate for countries such as Brazil56. However, in general there is a lack of consensus on what constitutes a suitable value partly because of the extreme variability in the cost/charge ratio between the two dominant interests – the public and private healthcare systems.
1.128 The impact assessment incorporates non-quantifiable benefits and also uses some illustrative examples of what the health benefits might be using the QALY measure where appropriate. The QALY illustrative examples are located at the end of each option’s non-QALY cost-benefit analysis.
1.129 The impact assessment process requires an assessment of the quantifiable costs and benefits even when there is insufficient material on which to base those calculations. Where possible consultation with practitioners is used to inform a view of the likely aspects to be affected by the change in policy.
1.130 Evidence has been collected from a range of sources and scaled to fit the case and has included:
(1) Data from the Brazilian national statistical body – IBGE;
55 Samuel Aballea, The cost-effectiveness of influenza vaccination for people aged 50 to 64 years: An international model, International Society for Pharmaeconomics and Outcomes Research, Volume 10, Number 2, 2007, page 99.
56 Rodrigo Antonni Ribeiro et al, Cost-Effectiveness of Implantable cardioverter defibrillators in Brazil in the public and private sectors, Arq Bras Cardiol, 2010, 95(5), page 582
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(2) International evidence of the cost benefit of large scale integrated health record systems57;
(3) Published evidence on patient access to records on-line;
(4) Evidence from the pilot sites offering patient access to records;
(5) Evidence from the IT industry including intellect; and
(6) Evidence on hospital activity and cost data.
1.131 In the absence of sufficient data a conservative approach is taken and figures that are likely to under-estimate benefits and over-estimate costs are used. Some of the assumptions apply in both the cost and benefit calculations. It is beyond the temporal and budgetary constraints of the study to perform detailed observational studies or to engage in comprehensive modelling in order to improve the precision of estimates used.
1.132 When calculating the net present value (NPV) for the impact assessment a time frame of ten years is used with the current year (2013) being year 0.58 A discount rate of 5 percent has been applied to the final cost and benefit values59. Unless stated, all figures are in 2013 prices, and have been uprated where relevant using the GDP deflator.
Option 0 – Do nothing/minimum
Costs
1.133 Delays in patient treatment due to indecipherable doctors’ notes and/or misplaced records are problematic at the private/public healthcare interface and also within both sectors. Delays in patient care potentially result in significant long-term costs as treatable ailments become long-term chronic diseases which require far more expensive treatment.
1.134 Administrative expense created by the “work-arounds” imposed through trying to access medical records for billing reasons. The private sector accounts for nearly 70 percent of all hospitals which means that there is significant and regular reliance on this sector.
1.135 There is a high opportunity cost attached to research expenditure which is allocated to areas that are less responsive to health needs. Data is needed to clearly identify emerging health trends of significance.
57 See http://www.ehr-impact.eu/cases/cases.html 58 The net present value is the discounted stream of benefits less the discounted stream of costs. The present value of an annual cost is the discounted stream of that cost. 59The Ministry of Health uses a 5 percent rate for clinical guidelines and technology appraisals. In the UK the government generally applies a 3.5 percent rate across all projects but a 3-7 percent rate is evident across most developed economies and 8 – 15 percent in developing countries.
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1.136 The most vulnerable groups – e.g. those on low income – have the lowest level of access to health care. Part of the reason for this is due to inconvenient appointment times. The ability to book appointments may increase attendance rates. Occasional access means that it is difficult to monitor the efficacy of health care treatments which potentially has adverse long-term health implications.
1.137 Inaccurate data can lead to errors in treatment or near-misses leading to increased costs for the healthcare system.
Benefits
1.138 The only benefit that flows from the continued system is the avoidance of costs associated with proposed reform.
1.139 The net present value is zero because the current system is compared against itself.
Option 1 – Nation-wide EHR coverage
Central Action 1: MOH to oversee provision of IT infrastructure enabling country-wide interoperability and to facilitate billing.
1.140 The TISS standard requires all information exchanged in the private healthcare sector conform to a standard based on interoperability. This was not a requirement of the public healthcare sector which has a variety of IT systems in place. These may not be consistent with country-wide interoperability and will require an upgrade in order to meet the required national standard.
1.141 The impact assessment assumes phased regional implementation over a 5 year period beginning January 2015. The implementation year is consistent with the government indicated milestone of the entire population in receipt of National Health Cards – unique patient identifier – by 2014.
1.142 The main sources of evidence have been:
(1) The DATASUS60 presentation
(2) IBGE data
(3) The Power of Information impact assessment61
60 See https://docs.google.com/viewer?a=v&q=cache:a_2CRnJTzOYJ:www.itu.int/ITU-D/cyb/events/2012/e-health/Nat_eH_Dev/Session%25202/WHO-ITU_eHealth%2520BRAZIL%252020120725.pdf+&hl=en&gl=uk&pid=bl&srcid=ADGEESjirJx2HwbRXNw796vG060SbXqIJmDs8qaBQOskK-yzPDfBR62W7j0pOm8H2xguSGqlqgULqNXOZGbRBRVJuHYM3YLPkAcmlCUlG5WQs1PQBIwr0y2WCp2z1W2l6DufOCM7ppCe&sig=AHIEtbTaqkX4lzMMzYwB94iL7PdIXOodHQ . Accessed 22nd January 2012.
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(4) The socio-economic impact of the EHR system at Northshore University HealthSystem, Evanston, IL (Chicago), USA62.
1.143 The cost estimates enabling nation-wide delivery of an interoperable health system makes the following assumptions:
(1) MOH IT procurement cost applies only to the public healthcare sector. Phased regional implementation begins January 2015 [year 2]. It is assumed that each region aims to achieve an annual target of 20 percent IT coverage each year. England achieved variable rates of coverage during the 7 year period 2003/04 to 2011. The 5 year period applied here reflects the increased likelihood of an improved success rate which mirrors aspects of the new NHS strategy introduced in May 2012.
(2) The most extensive cost scenario is assumed – 100 percent upgrade/replacement of IT infrastructure – partly in order to compensate for any optimism bias63 .
1.144 The MOH bears all the costs which are both transitional and on-going. The upgrade costs are likely to be the most substantial and represent the transitional element. On-going annual costs arise from the requisite maintenance.
1.145 Benefits flow from cheaper more cost efficient electronic record pulls rather than manual record pulls in relation to public healthcare patients using private healthcare facilities. Health experts have advised that about 30 minutes of an administrator’s time per record pull is saved. On this basis a conservative estimate of between 15 to 30 minutes of an administrator’s time is applied as savings which arise from SUS use of private healthcare facilities with respect to outpatient procedures and hospital admissions. The lower range takes account of the possibility of batch record pulls that reduces the average time. Such savings reflect the phased approach to implementation.
1.146 There is no data available on the extent of paper storage – but in the case of England this was assumed to be extensive. Brazil’s population, which is nearly four times larger, suggests the similar scope for savings – although these have not been monetised.
1.147 Table 14 below identifies the savings over a ten year period from a switch to electronic record pulls for billing purposes. For further details and calculations see accompanying spreadsheet to this impact assessment, excel – central action 1.
61 See http://www.google.co.uk/url?sa=t&rct=j&q=&esrc=s&frm=1&source=web&cd=2&cad=rja&ved=0CDsQFjAB&url=http%3A%2F%2Fwww.dh.gov.uk%2Fen%2FPublicationsandstatistics%2FPublications%2FPublicationsPolicyAndGuidance%2FDH_134181&ei=CNEDUfvGAcfW0QWIs4HQAQ&usg=AFQjCNEM3axdqkoXhFtUwMO_frw_ISLNlw&sig2=Y9z5xJkC0Vsr3PVg9yunPg&bvm=bv.41524429,d.d2k. accessed October 2012.
62 See http://www.ehr-impact.eu/cases/cases.html. Accessed November 2012. 63 Optimism bias is generally applied to capital purchases where project appraisers are overly
optimistic about prices and project timings.
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Table 14: Summary of savings from central action 1
Year No. of
Hospital admissions
No. of Outpatient procedures
Savings 15 mins 30 mins
0 0 0 0 0
1 0 0 0 0
2 2,178,839 72,809,124 R$ 163,098,820 R$ 326,197,639
3 4,357,679 145,618,247 R$ 326,197,639 R$ 652,395,278
4 6,536,518 218,427,371 R$ 489,296,459 R$ 978,592,917
5 8,715,358 291,236,494 R$ 652,395,278 R$ 1,304,790,556
6 10,894,197 364,045,618 R$ 815,494,098 R$ 1,630,988,195
7 10,894,197 364,045,618 R$ 815,494,098 R$ 1,630,988,195
8 10,894,197 364,045,618 R$ 815,494,098 R$ 1,630,988,195
9 10,894,197 364,045,618 R$ 815,494,098 R$ 1,630,988,195
10 10,894,197 364,045,618 R$ 815,494,098 R$ 1,630,988,195
Total 10 894 197 364,045,618 R$ 5,708,458,683 R$ 11,416,917,367
Central Action 2: Information system procurement at the local level must be underpinned by robust business cases.
1.148 If each public healthcare facility is to be in charge of procurement at the local level a project team will need to be created. The work of the project team involves consideration of all feasible alternatives to enabling EHR which may require a joined-up approach between several health facilities if the costs of an individual health facility proves to be prohibitive.
1.149 The project team is assumed to reflect the composition of a Family Health Care Team plus an administrative staff member. A team is required to research the options, consult with staff and make informed recommendations. Team size varies between 5 to 10 persons dependent on the size of the health facility.
1.150 About 60 percent of hospitals have 50 or fewer beds64 and these are assumed to have a project team of 5 members operating over a four month period to the full time equivalent of 2 months work. Health centres also fit within this category. Larger hospitals [40 percent of all hospitals] have 10 persons in a project team operating to a similar time scale65.
64 See Jairnilson Paim et al, The Brazilian Health System: History, Advances and Challenges,
The Lancet Vol 377, 21 May 2011 page 1792, 65 Assumptions on the timescale required for a project team draw on the experience of Northshore.
In this case a project team was set up for 3 months to oversee procurement and EHR issues to do with a 4 hospital complex.
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1.151 The transitional costs are borne by the MOH. Although the private healthcare is not subject to a similar requirement the expectation is that a similar activity will also take place and the costs will be borne by private providers.
1.152 The benefits of this approach are largely qualitative through the opportunity to engage with a diversity of stakeholders at an early stage. The project proceeds as a “medical initiative” as against an “IT project”. One of the acknowledged limitations of the earlier approach applied in England was its technological bias.
1.153 This approach provides a better guarantee of system usability and improves the chance of uptake by all users. Moreover, it reduces the potential for future cost escalation through insufficient account of critical aspects affecting key groups. Such an approach reduces the risk of the diminished capacity for EHR benefits due to the system being under-utilised.
1.154 Table 15 below provides a cost summary over a ten year period reflecting the phased approach to implementation. For further details and calculations see accompanying excel spreadsheet to this impact assessment, central action 2.
Table 15: Cost summary of central action 2
Year Public
healthcare sector
Private healthcare sector
TOTAL
0 R$ 0 R$ 0 R$ 0
1 R$ 472,274,732 R$ 392,138,244 R$ 864,412,976
2 R$ 472,274,732 R$ 392,138,244 R$ 864,412,976
3 R$ 472,274,732 R$ 392,227,712 R$ 864,502,444
4 R$ 472,274,732 R$ 392,227,712 R$ 864,502,444
5 R$ 472,274,732 R$ 392,272,446 R$ 864,547,178
6 R$ 0 R$ 0 R$ 0
7 R$ 0 R$ 0 R$ 0
8 R$ 0 R$ 0 R$ 0
9 R$ 0 R$ 0 R$ 0
10 R$ 0 R$ 0 R$ 0
Total R$ 2,361,373,658 R$ 1,961,004,358 R$ 4,322,378,016
Central Action 3: MOH to oversee the provision of a unique patient identifier for all patients.
1.155 MOH is in the process of issuing National Health Cards. By October 2012, about 16 percent of the population had received cards. The cost to MOH covers the development, design and administration. The administrative cost is a transitional one ending in 2014 when it is scheduled for completion.
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1.156 As at February 2013 - 146,250,000 cards had been issued at a total cost of R$267 million. In order to cover the entire population by 2014 about 48.0 million additional cards will need to be issued. In the absence of further details it is assumed that each card costs about 183 reais to produce [R$267 million/146.25 million]. On this basis the additional 48 million cards are estimated to cost a further R$87.84 million. This estimate potentially exceeds actual costs as a large proportion of the R$267 million is likely to be due to the initial development and design (fixed cost) with each additional card costing a significantly lower sum.
1.157 The benefit of the population having a unique card is that it provides a more reliable system and reduces the incidence of mistaken identity. This improves patient safety and there are savings from less avoidable mistakes. An estimated 67 percent of all adverse mistakes are thought to be preventable66. Whilst there is no indication of how many adverse events occur or what proportion may be due to poor documentation the evidence from studies in England suggest this may be as high as 10 percent67 .
Central Action 4: All healthcare providers to establish EHR capability
1.158 Establishing EHR capability has two key cost aspects: training and IT requirements. Training of all [public and private] healthcare employees includes new work-flow re-design, drafting new in-house systems and procedures and familiarisation with data input. This aspect is a transitional cost borne by the relevant healthcare provider, i.e. the costs associated with public healthcare fall on the MOH and private healthcare providers bear their own costs.
1.159 Additionally, there will also be related IT costs [hardware and software and also the establishment of in-house IT support] – some will be transitional – set-up arrangements – and there will also be on-going maintenance including the need for support. As in the case of training MOH will bear costs incurred in public healthcare, both the transitional and on-going IT-related costs. Similar cost categories will also fall on private healthcare providers.
1.160 In the case of the private healthcare sector there is the risk that costs are passed onto those with private healthcare arrangements. The market is a highly concentrated one where demand has steadily increased over the years. The responsiveness of demand to increased prices is likely to be weak.
1.161 In estimating the training cost implications it is assumed that all healthcare workers require some form of training, from 1 to 2 days. The cost of training is allocated evenly throughout the phased implementation.
1.162 Savings/benefits flow from the improved reliability of health information as there is now a more comprehensive picture of interventions informing patient health and well-being. This potentially reduces the extent of hospital stays as more time is spent on preventative treatment at the primary care level.
66 See Jairnilson Paim et al, The Brazilian Health System: History, Advances and Challenges,
The Lancet Vol 377, 21 May 2011 page 1793. 67 The Power of information: putting us all in control of the health and care information we need,
impact assessment, Department of Health, page 51.
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1.163 The Sao Paulo HIS initiative provides some indication of the capacity for benefit. SIGA Saude was implemented in 2004 and shares some similarities with features enabling EHRs - i.e. residents received a unique patient identifier and all healthcare units were registered enabling real time data capture. By 2008/09 there had been a 30 percent increase in patient visits – without any new resources allocated; improved patient satisfaction from 32 percent to 50 percent and increased productivity of outpatient services by about 35 percent68.
1.164 There is the potential for increased prescriber productivity as less frequent calls are received checking on prescriptions and fielding queries regarding appropriate medication. Moreover e-prescribing facilitates are likely to give rise to less mistakes from reading illegible doctor notes.
1.165 See table 16 below for a cost summary. For further details and calculations see accompanying excel spreadsheet to this impact assessment, central action 4.
Central Action 5: MOH to oversee the establishment of infrastructure for patients and users for secure online access.
1.166 Secure on-line access to patient health records is to be made available to patients, healthcare professionals and authorised users. It is assumed that phased implementation of interoperability will be on-going until end of 2019 when all regions will be covered.
1.167 Patient on-line access over the ten year period is assumed to grow from 1 percent to 10 percent of the population. This is based on current internet usage of about 40 percent. Of this proportion the 17 to 19 year olds are significantly more active than those in the 50 + year category - which is the group most likely to begin suffering from health issues69 .
1.168 The costs of facilitating secure on-line access are transitional and are as follows:
(1) The business set-up and training costs for both patients and staff;
(2) Security authentication and
(3) IT upgrade and running costs.
1.169 All costs are borne by the relevant healthcare provider, although it is possible that the MOH might finance the full extent of costs associated with security authentication. No cost information is available.
1.170 Secure on-line access delivers benefits to patients and to the healthcare system. Patients gain specifically through reduced travel and phone calls following improved health awareness. Such benefits are restricted to those who make use of on-line access. The impact assessment assumes that on average the clinic makes 2 calls per patient. Following on-line access these calls will no longer be required.
68 See Vital Wave Consulting, Health Information Systems in Developing Countries, May 2009, page 40 69 In the case of England, which has 80 percent internet access, growth in patient on-line access
was projected to be from 3 percent to 30 percent over a ten year period.
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1.171 Patients will avoid lengthy waiting times through the scheduling of convenient appointments and/or improved health awareness that negates the need for medical treatment. Health experts suggest 2-3 hours is an appropriate estimate for waiting time. The value of time is based on the lowest minimum wage that is available of 694 reais per month [4weeks] and a 40 hour week is assumed to be the normal working pattern70.
1.172 Clinics/healthcare centres are likely to have less missed appointments and therefore operate at a more efficient level. The time savings to the healthcare system are assumed to be re-directed to more effective use elsewhere within the system. This means that any increase in patient numbers through improved outreach can be absorbed using existing resources as demonstrated in the case of SIGA suade.
1.173 Over time hospitals will potentially have fewer admissions as preventative treatment halts the escalation of chronic disease and also reduces the need for diagnostic tests. For example it is estimated that in Belo Horizonte there was a 23 percent reduction in ambulatory care sensitive hospital admissions in the four years following the implementation of Family Health Programmes71.
1.174 The reduction in the number of hospital admissions and diagnostic tests represents an improved patient outcome. However, it occurs as a reduced revenue stream to private healthcare providers which account for a greater share of hospital and diagnostic clinic ownership on which SUS is heavily dependent.
1.175 Table 16 below provides a summary of the monetised benefits over the identified range. For further details and calculations see accompanying spreadsheet to this impact assessment, central action 5.
70 A minimum wage is available in 5 states. Sectoral variations are evident between states and can be significant, for example in 2012 the minimum wage for the agricultural sector in Rio de Janeiro was R$693,77 and in Santa Catarina it was R$765,00
71 Maria Schmidt et al, Chronic non-communicable diseases in Brazil: Burden and current challenges, The Lancet, Vol. 377, June 4, 2011, page 1957
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Table 16: Central Action 5: Savings from secure on-line access
Year A. Number of Patients
B. Call savings 2mins 3mins
C . Savings from avoided journeys 2 hours 3 hours
0 - 0
1 0 0
2 1,940,000 R$ 1,241,600 R$ 1,862,400 R$ 16,684,000 R$ 25,026,000
3 3,880,000 R$ 2,483,200 R$ 3,724,800 R$ 33,368,000 R$ 50,052,000
4 5,820,000 R$ 3,724,800 R$ 5,587,200 R$ 50,052,000 R$ 75,078,000
5 7,760,000 R$ 4,966,400 R$ 7,449,600 R$ 66,736,000 R$ 100,104,000
6 9,700,000 R$ 6,208,000 R$ 9,312,000 R$ 83,420,000 R$ 125,130,000
7 11,640,000 R$ 7,449,600 R$ 11,174,400 R$ 100,104,000 R$ 150,156,000
8 13,580,000 R$ 8,691,200 R$ 13,036,800 R$ 116,788,000 R$ 175,182,000
9 15,520,000 R$ 9,932,800 R$ 14,899,200 R$ 133,472,000 R$ 200,208,000
10 17,460,000 R$ 11,174,400 R$ 16,761,600 R$ 150,156,000 R$ 225,234,000
Total R$ 55,872,000 R$ 83,808,000 R$ 750,780,000 R$ 1,126,170,000
Central Action 6: MOH to extend standard setting on national and regional networking systems to public healthcare facilities; clinical terminology; professional record keeping and best practice information governance.
1.176 The TISS specification for information exchanged within the private healthcare sector is also appropriate to providers within the public healthcare sector. Therefore it is assumed that no further additional cost is needed to draft new guidance. Clinical coding and mapping of national and international terminologies via SNOMED-CT is work in progress and there will be cost implications associated with drafting guidance and disseminating good practice guidelines.
1.177 It has previously been established that the extent of user engagement is heavily influenced through perceptions of privacy and how seriously this is treated. The MOH will need to assume a leading role in drafting legislation, providing guidance and establishing the framework to monitor and enforce standards in line with good practice.
1.178 A related activity requires the MOH to oversee the drafting of guidance on information sharing and the publication of such guidance. The cost associated with this action are:
(1) Drafting of guidance;
(2) Consultation on guidance;
(3) Publication of a toolkit to be used by all healthcare providers.
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1.179 Guidance on information governance produced in England makes the distinction between data controllers and data processors in managing data flow72. Each healthcare facility must identify a senior information risk owner [SRO] who is responsible for the data streams on health intelligence. Each healthcare facility is also required to undertake self-assessment via the Department of Health drafted toolkit and must have a clear information management procedure in place. The department also publishes regular performance indicators.
1.180 It is assumed that a similar system will be established in Brazil. All staff dealing with healthcare data require initial training of 3 hours following the implementation of EHRs. This is followed by regular updates facilitated through on-line learning forming part of the continuing/regular job-related training.
1.181 The cost of drafting and publishing guidance, and also developing the toolkit, is a transitional cost which falls on MOH. Initial training within the public healthcare also falls on MOH – transitional costs. The private sector bears the cost of both the initial training and regular updates provided within their sector.
1.182 The benefit of a structured programme of information management is to reduce the risk of confidential data being disclosed to unauthorised persons. The credibility of EHRs depends in part on patient confidence in a system that only allows designated persons access to health records.
72 Information governance for Transition, National Information Governance Board for Health and Social Care, Department for Health
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1.183 Table 17 below provides a cost summary. For further details and calculations see accompanying spreadsheet to this impact assessment, central action 6.
Table 17: Cost summary of central action 6
Year Phased
implementation
Total SRO + 3 hour session Public Private
0 0 R$ 0 R$ 0
1 0 R$ 0 R$ 0
2 20% R$ 3,455,230 R$ 1,735,653
3 20% R$ 4,330,727 R$ 2,443,338
4 20% R$ 5,206,223 R$ 3,151,022
5 20% R$ 6,081,804 R$ 3,858,707
6 20% R$ 6,957,301 R$ 4,566,392
7 0% R$ 4,377,500 R$ 3,538,423
8 0% R$ 4,377,500 R$ 3,538,423
9 0% R$ 4,377,500 R$ 3,538,423
10 0% R$ 4,377,500 R$ 3,538,423Total R$ 43,541,285 R$ 29,908,806
Central Action 7: MOH to organise stakeholder partnership with patient groups supporting patient access
1.184 SUS is modelled on a de-centralised approach enabling the participation of a diversity of groups at the state, federal and municipal level. Patient groups may be incorporated within existing structures to facilitate the discussion of EHR related patient issues. The evidence can be disseminated through existing channels. If this route is chosen it is unlikely to give rise to significant additional costs.
1.185 The benefit of this approach is patient involvement in improving the usability of EHRs.
Central Action 8: Providers at the local level assess training needs at all levels and to provide training in keeping with best practise.
1.186 Training is recognised as being a central limb contributing to the success of the initiative. Each action includes an assessment of training implications, for some actions training can be incorporated into existing provision – for others that introduce a new dimension, training is explicitly factored into additional costs requirements for that particular central action.
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Central Action 9:EHR champions to be identified in every organisation
1.187 EHR champions have a central role to play in communicating information throughout the organisation. Revised work practices are likely to be a regular occurrence during the early years following implementation. A central liaison person is required to communicate regular updates throughout the health facility. It is an important function required to keeping staff informed and able to adjust arrangements to reflect new requirements on a timely basis. It is also important to maintaining staff morale and keeping unions reassured that staff are being properly consulted on changes in their work environment.
1.188 It is assumed that one person – a doctor, or someone at an equivalent level with a good understanding of data implications at all levels, from each facility will have this championship role. It requires 10 days per year on a sliding scale over the 5 year period. The time reflects attendance at internal and external workshops, disseminating information and keeping abreast of current developments and being the acknowledged point of contact for any information requests.
1.189 The costs are largely transitional but over an extended period. The costs within public healthcare facilities fall on the MOH. The costs within the private healthcare sector fall on the private sector.
1.190 The benefits are mainly qualitative in having a visible point of reference that is well-informed. Savings are secured through the spread of good practice; the speedy identification of problem areas and the improved capacity to deal with problems. All of which fosters the long-term prospects of the initiative and lays the basis for enduring savings to be made.
1.191 See table 18 below for a cost summary. For further details and calculations see accompanying spreadsheet to this impact assessment, central action 9.
Table 18: Cost summary of central action 9
Year
A. % of total facilities
B. Public healthcare
C. 448 reais x 10 days per year
D. Private Healthcare
E. 448 reais x 10 days per year TOTAL [C + E]
0 0 0 0 0 0 0
1 0 0 0 0 0 0
2 20% 10404 R$ 46,609,920 8410 R$ 37,676,800 R$ 84,286,720
3 20% 20808 R$ 93,219,840 16820 R$ 75,353,600 R$ 168,573,440
4 20% 31212 R$ 139,829,760 25230 R$ 113,030,400 R$ 252,860,160
5 20% 41616 R$ 186,439,680 33640 R$ 150,707,200 R$ 337,146,880
6 20% 52020 R$ 233,049,600 42050 R$ 188,384,000 R$ 421,433,600
7 0% 41616 R$ 186,439,680 33640 R$ 150,707,200 R$ 337,146,880
8 0% 31212 R$ 139,829,760 25230 R$ 113,030,400 R$ 252,860,160
9 0% 20808 R$ 93,219,840 16820 R$ 75,353,600 R$ 168,573,440
10 0% 10404 R$ 46,609,920 8410 R$ 37,676,800 R$ 84,286,720
Total
R$1,165,248,000 R$ 941,920,000 R$ 2,107,168,000
Central Action 10: MOH to oversee IT infrastructure for portals to be used by providers to gain professional access to view records across specialisms.
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1.192 The deadline for an MOH provided portal to be established is by 2013. Some provision is already in place through SCIELO and CAPES. However there is need for high quality connectivity enabling more comprehensive and secure connections and this will have cost implications.
1.193 The potential for cost savings increases if existing portals are incorporated into a single MOH portal. This may facilitate improved ease of navigation and enhance the extent of health awareness.
Central Action 11: MOH to lead on development of evidence base for patient and professional portal
1.194 An established HIS network is in place and MOH is the national co-ordinator through RNIS with well-developed partnerships in place. The challenge lies in engaging with hard to reach groups to develop the evidence base
1.195 Negligible additional cost implications are suggested from this action.
Central Action 12: MOH to lead on national and local stakeholder engagement to improve health literacy
1.196 The existing framework at the federal, state and municipal level provides the basis from which further liaison with stakeholders can take place to identify further ways to improve health literacy. If this is the approach used this action suggests negligible additional costs.
Central Action 13: MOH to lead and coordinate work on commissioning data sets
1.197 New data sets are required to provide information on hard to reach groups. There is the recognised deficit on information from rural populations in the Amazon rainforest and also the Northeast. Simultaneously the southeast which does not have the highest burden of disease has possibly the largest concentration of biomedical and public health research centres73.
1.198 The process used to commission new data sets will affect the extent of costs. The costs are borne by the MOH.
1.199 Non-quantifiable benefits include the enhanced capacity to identify future epidemiological changes and to respond accordingly through the mobilisation of resources in line with emerging needs.
Central Action 14: Identification of a research centre to provide a secure data linkage service for research.
1.200 The extent to which there is an existing research centre capable of providing a secure data linkage service suggests negligible additional costs.
73 Barreto, M. et al, Successes and failures in the control of infectious diseases in Brazil: Social and environmental context, policies, interventions, and research needs. The lancet, Vol 377, May 28 2011, page 1885.
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Central Action 15: MOH to provide guidance assisting patient engagement
1.201 The cost implications of MOH to draft guidance assumes consultation with patient organisations to agree a procedure. The MOH bears the cost of both consultation and drafting guidance made available to all health facilities via on-line access.
Central Action 16: Use of e-communication encouraged at all levels
1.202 A paperless healthcare sector is the desired outcome and a strong emphasis will be placed on e-communication from 2013 onwards.
1.203 Savings are indicated through the reduced need for paper storage – more efficient use of office space. In particular there are savings from reduced posted correspondence between health facilities. Savings are estimated on the basis that there are at least two phone calls between a health clinic and a hospital following admission. Health experts have indicated that about 60 percent are initiated at the primary care level by the health clinic. The impact assessment applies a 50 percent threshold.
1.204 For further details and calculations see accompanying spreadsheet to this impact assessment, central action 16. Table 19 below provides a summary of the monetised benefits.
Table 19: Summary of savings from Central Action 16
QALY benefits
Year Phased
Implenentation
No. of hospital admission-related
calls Public Private
Savings Public Private
TOTAL SAVINGS
0 0 - 0 R$ 0 R$ 0 R$ 0
1 0 - 0 R$ 0 R$ 0 R$ 0
2 20% 1,628,303
3,011,446 R$ 781,586 R$ 1,445,494 R$ 2,227,080
3 40% 3,256,607
6,022,891 R$ 1,563,171 R$ 2,890,988 R$ 4,454,159
4 60% 4,884,910
9,034,337 R$ 2,344,757 R$ 4,336,482 R$ 6,681,239
5 80% 6,513,214
12,045,782 R$ 3,126,343 R$ 5,781,976 R$ 8,908,318
6 100% 8,141,517
15,057,228 R$ 3,907,928 R$ 7,227,469 R$ 11,135,398
7 100% 8,141,517
15,057,228 R$ 3,907,928 R$ 7,227,469 R$ 11,135,398
8 100% 8,141,517
15,057,228 R$ 3,907,928 R$ 7,227,469 R$ 11,135,398
9 100% 8,141,517
15,057,228 R$ 3,907,928 R$ 7,227,469 R$ 11,135,398
10 100% 8,141,517
15,057,228 R$ 3,907,928 R$ 7,227,469 R$ 11,135,398
Total 8,141,517
15,057,228 R$ 27,355,497 R$ 50,592,286 R$ 77,947,783
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QALY Benefits
1.205 QALY benefits are evident specifically in relation to the following central actions:
(1) Central action 4: All healthcare providers to establish EHR capability
(2) Central action 5: MOH to oversee the establishment of infrastructure for patients and users for secure online access.
(3) Central action 10: MOH to lead on development of evidence base for patient and professional portal.
(4) Central action 16: Use of e-communication encouraged at all levels
1.206 Some examples of QALY benefits are presented here as an illustration of the types of health benefits that might be possible. These are only estimates which are based on limited evidence. The QALY value used here is between 2 to 3 times per capita GDP, R$21,252 [in 2011 prices].
Central action 4: All healthcare providers to establish EHR capability
1.207 The current maternal mortality ratio [MMR] is about 50 per 100,000. In spite of the high coverage of antenatal and delivery care a number of studies have highlighted the poor integration between antenatal services, which are generally provided by government health facilities, and birthing facilities, which are privately owned but contracted out to SUS. For example expectant mothers will often seek access of an unsuitable health facility such that a high risk pregnancy will present at a low risk facility and vice versa, with the end result being patients denied admission.
1.208 The quality of maternal care is said to be variable and inconsistent. For example in Rio de Janeiro the leading cause of maternal deaths is hypertension but only 25 percent of expectant mothers had their blood pressure measured during pregnancy; despite more than 8 antenatal visits – 50 percent of women in the city of Pelotas had not had a breast examination and 25 percent had not had a pelvic examination74.
1.209 There were about 3 million births in Brazil in 2007. An estimated 4 percent of all deliveries involve a near-miss event and often involves infection, pre-eclampsia and haemorrhage. This rate is times higher than developed country rates.
1.210 EHR provides immediate access to a patients’ health history. The breadth of involvement increases the prospect of identifying a programme of health intervention that is targeted to the particular needs of the individual. Early intervention reduces the incidence of near miss events in which the patient narrowly avoids death.
74 See Cesar G Victora, Maternal and child Health in Brazil: progress and challenges. The Lancet, Vol. 37, May 28, 2011, page 1866.
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1.211 In the absence of any studies providing a measure of possible QALYs this impact assessment illustrates the potential for gain based on solely on evidence provided on maternal care. A small reduction in the proportion of near miss events from 4 percent to 3 percent still places the rate at significantly higher levels but provides an indication of the scope for an improved outcome. The avoidance of a near miss event is estimated to be in the realm of 0.3 per QALY given that 1 = perfect health and 0 = death. Given that there are about 3 million births per year75 the estimated QALY gain is indicated in table 20 below where 2xpcGDP refers to two times the per capita GDP.
Table 20: Central Action 4, QALY gain from the reduced number of near-miss events
Year No. of
patients (4 % near miss)
25% of 4% near misses
avoided
QALY value @ 2x per capita @3x per capita
0 0 0 0 0
1 0 0 0 0
2 24,000 6,000 R$ 75,600,000 R$ 113,400,000
3 48,000 12,000 R$ 151,200,000 R$ 226,800,000
4 72,000 18,000 R$ 226,800,000 R$ 340,200,000
5 96,000 24,000 R$ 302,400,000 R$ 453,600,000
6 120,000 30,000 R$ 378,000,000 R$ 567,000,000
7 120,000 30,000 R$ 378,000,000 R$ 567,000,000
8 120,000 30,000 R$ 378,000,000 R$ 567,000,000
9 120,000 30,000 R$ 378,000,000 R$ 567,000,000
10 120,000 30,000 R$ 378,000,000 R$ 567,000,000
TOTAL R$ 2,646,000,000 R$ 3,969,000,000
Central action 5: MOH to oversee the establishment of infrastructure for patients and users for secure online access.
1.212 Increased health awareness fosters health-seeking activity. If health-seeking activity leads to earlier health interventions this potentially improves the success rate of cures. Studies have identified physician counselling as one of the most effective forms of intervention76 – access to doctors’ notes is assumed to provide a similar experience.
75 As above, page 1864 76 Michele Cecchini, et al, Tackling of unhealthy diets, physical inactivity and obesity: health effects
and cost effectiveness, The Lancet, November 11, 2010, page 6.
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1.213 Studies of the English experience identified reduced anxiety levels as a result of access to doctors’ notes and comprehensive health information and this provided a benefit that was equivalent to 5 percent of their QALY score. A similar approach is applied to those that have on-line access within the Brazilian context. However, adopting a very conservative approach – the benefit has been reduced by 50 percent. See table 21 below for an estimate of the 10 year benefit through reduced anxiety levels.
Table 21: Central Action 5, QALY gain from reduced anxiety levels
Central action 10: MOH to lead on development of evidence base for patient and professional portal.
1.214 The WHO identifies four chronic diseases which account for 60 percent of global deaths. Of this number two, neoplasms and respiratory disorders, are the leading cause of death in Brazil [see table 3]. Many of the chronic diseases are a result of largely preventable behavioural risk factors such as unhealthy diets, physical inactivity and obesity77.
1.215 Between 1975 to 2003 obesity rates tripled in men and almost doubled in women. However there is the further complication of the duel existence of under-weight alongside over-weight reflecting the high levels of income inequality.
77 As above.
Year Uptake of patients - % of pop
No. of patients
QALY value
2 x pcGDP 3 x pcGDP
0 0 0 0 0
1 0 0 0 0
2 1 1,940,000 R$ 4,122,500,000 R$ 6,111,000,000
3 2 3,880,000 R$ 8,245,000,000 R$ 12,222,000,000
4 3 5,820,000 R$ 12,367,500,000 R$ 18,333,000,000
5 4 7,760,000 R$ 16,490,000,000 R$ 24,444,000,000
6 5 9,700,000 R$ 20,612,500,000 R$ 30,555,000,000
7 6 11,640,000 R$ 24,735,000,000 R$ 36,666,000,000
8 7 13,580,000 R$ 28,857,500,000 R$ 42,777,000,000
9 8 15,520,000 R$ 32,980,000,000 R$ 48,888,000,000
10 9 17,460,000 R$ 37,102,500,000 R$ 54,999,000,000
Total R$ 185,512,500,000 R$ 274,995,000,000 50% of total R$ 92,756,250,000 R$ 137,497,500,000
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1.216 Studies on the EHR experience in England reveal that a portal providing comprehensive health information, that was valued and trusted, played a significant role in improving health outcomes. In particular interventions targeting adults and other high-risk groups have been found to generate immediate benefits after implementation78. The largest beneficiary group are those in the 40 – 80 age range. Of particular relevance to a QALY gain is the capacity for interventions to improve the quality of life and delay the onset of chronic disease.
Central action 16: Use of e-communication encouraged at all levels
1.217 E-communication between health facilities reduces the incidence of delays in follow-up actions. A phone call is quick but this assumes the relevant body is accessed at first contact. E-mail correspondence increases the likelihood of reaching the relevant, often identified, contact and more importantly provides a paper trail which assigns accountability and is more likely to produce action.
1.218 In 2012 cancer was estimated to be the second most common cause of death in most of the five regions79. In the case of breast cancer in particular, studies have shown detection and early treatment are linked to higher cure rates for early breast cancer80. E-communication reduces the potential for delays and also reduces the potential for more lengthy hospital admissions and costly treatment if cancer progresses to the next stage.
1.219 In 2010 the mortality rate for cancer-related deaths was 11.5 per 100,000 [14.6 male and 8.4 female]. The rates displayed considerable variability between the regions such that the south had the highest rates of 20.4 per 100,000 and the north the lowest, 4.9 per 1000,000.
Option Summary
1.220 The estimated NPV over 10 years lies between -R$79,534.8 million and -R$56,569.6 million. The greatest contributor to total costs is I.T. infrastructure and set-up costs which account for about 90 percent of total costs over the ten years. Much of this cost is borne by the private healthcare sector because they have the greater proportion of hospitals, i.e. 70 percent. Hospitals incur a significantly greater set-up cost than does primary care units. See option 1 summary sheet in attached excel worksheet. The estimated present value of annual costs and benefits (based on the low estimates) are shown in chart 2 below.
78 Michele Cecchini, et al, Tackling of unhealthy diets, physical inactivity and obesity: health effects and cost effectiveness, The Lancet, November 11, 2010, page 7.
79 Gilberto Schwartsmann, Lung cancer in Brazil, See http://www.asco.org/ASCOv2/Home/Education%20&%20Training/Educational%20Book/PDF%20Files/2012/zds00112000426.PDF accessed 18.02.13
80 Hannah Christina Trufelli, Analysis of delay in diagnosis and treatment of breast cancer in a public hospital, Journal of the Brazilian Medical Association, ISSN 0104-4230
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Chart 2: Option 1 - Estimated Annual Costs and Benefits [R$Million]
R$ 0.00
R$ 2,000.00
R$ 4,000.00
R$ 6,000.00
R$ 8,000.00
R$ 10,000.00
Year 0
Year 2
Year 4
Year 6
Year 8
Year 1
0
Present value of annualbenefits
Present value of annualcosts
1.221 The estimated costs peak at about year 6 and then decline – reflecting the end of the more extensive and expensive IT software and infrastructural costs. Benefits are significantly under-estimated due to missing/unavailable data and show only a very modest increase over time. In England’s experience the greatest source of savings flowed from access to records and it is possible that the savings indicated here are significantly under-estimated. Commissioned surveys will enable a more robust measure of the potential for savings.
Option 2 – Public Healthcare EHRs
1.222 Within this option central action 4 has a significant cost/benefit divergence from that outlined in option 1 and is discussed in detail below. All other actions potentially carry much smaller cost implications as a result of the exclusion of the private healthcare sector. These are discussed further in the summary at the end of this section.
Central Action 4: All healthcare providers to establish EHR capability
1.223 Training of all public healthcare employees covers a comprehensive list to include new work-flow re-design, drafting new in-house systems and procedures and familiarisation with data input. It is assumed that all public healthcare workers require some form of training, from 1 to 2 days. The cost of training is allocated evenly throughout the phased implementation.
1.224 MOH bears all the training costs to the public healthcare sector which are all transitional. The IT set-up costs are also transitional but the annual costs of maintenance will be on-going and all will be borne by MOH.
1.225 For further details and calculations see accompanying spreadsheet to this impact assessment, central action 4.
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QALY benefits
1.226 QALY benefits deliver similar values to that of option 1 above with respect to central actions 5 and 16. However there is the reduced potential for benefit from central actions 4 and 10 given the exclusion of private sector which has a significant secondary care role.
Option Summary
1.227 As in the case of option 1 benefits flow from the improved reliability of health information at the primary care level in which the public sector dominates. The estimated Net Present Value over 10 years lies between -R$16,886.5 million and -R$21,317.2 million. In spite of returning a negative value it represents a significantly improved outcome relative to option 1. The Benefit Cost ratio at 0.22 mirrors the improvement. IT remains the greatest contributor to total costs accounting for just under 85 percent of total costs over the ten years. See attached option 2 summary, excel worksheet. The estimated annual costs and benefits (using the low estimates) are shown in chart 3 below.
Chart 3: Option 2 - Estimated annual costs and benefits [R$Million]
R$ 0.00R$ 500.00
R$ 1,000.00R$ 1,500.00R$ 2,000.00R$ 2,500.00R$ 3,000.00R$ 3,500.00
Yea
r 0
Yea
r 1
Yea
r 2
Yea
r 3
Yea
r 4
Yea
r 5
Yea
r 6
Yea
r 7
Yea
r 8
Yea
r 9
Yea
r 10
Present value of total annualcosts
Present value of total annualbenefits
1.228 As of year 7 there is clear evidence that the divergence between annual costs and benefits diminishes over-time. The point has been previously made that benefits are significantly under-estimated. A continuation in the declining cost trend would realise a significantly improved position.
1.229 However, the absence of private healthcare participants reduces the potential for benefits at the secondary care level because ownership is heavily concentrated within the excluded private sector. There is the commensurate reduced capacity to access an established patient health profile – and to formulate an informed health treatment plan - because core elements may be missing. However, whilst there is a significant cost reduction relative to option 1 – this does not come at the expense of a proportionate reduction in benefits.
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1.230 The fact that benefits are left largely intact reflects the capacity for interventions at the primary care level to delay, if not necessarily prevent, the development of non-communicable chronic diseases. QALY gains attempt to provide some indication of the personal benefit but there is also the potential for economic benefit, through the reduced demand for hospitalisation, and enhanced productivity through a healthier population - but this is a long term projection. In the short-time the exclusion of private healthcare also limits the capacity to develop an evidence base enabling the monitoring and evaluation of different health treatments at the secondary level.
Option 3 – Private healthcare EHRs
1.231 The following costs and benefits are derived on the assumption that private healthcare will have full interoperability throughout the sector by 2015. This is based on the requirements satisfying the TISS standard. There is therefore no relevance of central action 1 and 2 outlined in option 1.
1.232 The most significant divergence from cost/benefit estimates previously outlined in option1 is with respect to the requirement to provide EHR capability and also option 16. Both are discussed further below. All other relevant actions identified in table 13 have similar resource implications as outlined in option 1. However, this does not necessarily mean that there will also be a similar level of benefits. These are discussed further in the summary at the end of this section.
Central Action 4: All healthcare providers to establish EHR capability
1.233 Training of private healthcare employees includes new work-flow re-design, drafting new in-house systems and procedures and familiarisation with data input. It is assumed that all healthcare workers require some form of training, from 1 to 2 days. The cost of training is transitional and is allocated evenly throughout phased implementation on the basis of an assumed 20 percent per annum EHR implementation. There is the further cost of establishing EHR capability and maintaining the system over time.
1.234 Private healthcare providers bear all the costs. At its most extensive is the cost of providing EHRs throughout the entire sector. Hospitals only and outpatients only represent smaller sub-sectors and carry commensurate lower implementation costs. However, the cost savings in delivering the two sub-sectors independently may be minimal if there is a high fixed cost associated with establishing the requisite IT system and if training requirements do not differ significantly.
1.235 As in the case of option 1 benefits flow from the improved reliability of health information. The dominant role of the private healthcare in secondary care and in the ownership of healthcare infrastructure provides the basis for more detailed patient coverage. This potentially informs the extent of data that can be collected informing future health focus.
1.236 For further details and calculations see accompanying spreadsheet to this impact assessment, central action 4.
Central Action 16: Use of e-communication encouraged at all levels
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1.237 The use of e-communication beyond the private healthcare sector is curtailed in the absence of public healthcare interoperable capacity. On this basis there is no opportunity to extend the use of e-communication beyond that which is already likely to be in place between private healthcare providers.
QALY benefits
1.238 The QALY gain across all the central actions is significantly reduced. In particular the potential for central action 4 is curtailed because of the exclusion of the public sector role which has a significant primary care presence. Central action 5 is also very small because of very low levels of provision at the primary healthcare level. No additional benefits accrue from central action 16.
Options Summary
1.239 Option 1 carries the full extent of costs as a result of comprehensive large-scale action involving both the public and private healthcare sectors. Extensive private sector hospital provision extracts a significantly higher cost than that faced at the primary care level where SUS dominates because of divergent cost assumptions. These assumptions are informed by limited evidence on EHR experience. There is very little evidence on the potential for savings and this has informed the conservative approach applied throughout.
1.240 The societal value of intervention at the primary care level, in which public healthcare dominates, can be inferred by the QALY gain. Notwithstanding the lack of consensus on what constitutes a meaningful measure, different values applied to very small areas illustrate the potential for gain to different groups. The benefits are evident in options 1 and 2 but are absent in option 3.
1.241 Option 3 records negligible gain at the primary care level as a result of having just over 550 health facilities at this level. An insufficient number to deliver benefits of any magnitude. Whilst this option may not have a significant presence at the primary level it does have a critical role to play in patient care and contributing to the build-up of the evidence base. There was insufficient information available to provide a monetised estimate of the benefit. However, such benefits are likely to occur in the medium to long-term, i.e. from 5 years onwards after implementation.
1.242 It was not possible to identify a net benefit position for option 3 but chart 4 below provides an indication of the cost trend over a ten year period. The costs fall primarily on private healthcare providers. In the absence of any public initiative towards ensuring interoperability of public healthcare providers, monetary benefits are largely through efficiency savings - the potential for reduced storage and possible avoidance of duplication of functions. To a large extent the benefit accrues almost entirely to patients through improved patient care.
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Chart 4: Option 3 - Present value of annual costs [R$Million]
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Present value of annualcosts
1.243 Common to all three options are the costs incurred by the MOH in providing the necessary regulatory governance framework which is critical in supporting and encouraging IT use by all stakeholders.
7. Risk and assumptions
1.244 EHR implementation is assumed to take place over a 5 year phased period, twenty percent of all health facilities per year. It is assumed that a similar health facility mix of hospitals, health centres, diagnostic centres, etc. undergoes implementation on each occasion.
1.245 Implementation is assumed to be preceded by an in-house project team which makes recommendations regarding the most feasible course of action. The phased approach impacts on the flow of costs and also benefits. Costs are assumed to remain constant over the implementation period such that the IT cost of implementation in year 2 is the same as that of a similar facility in year 6.
1.246 The long-term success of EHR implementation relies heavily on a commitment to invest in training. If training is not prioritised the extent of clinical engagement is placed at risk as the emphasis is perceived as being overly focussed on technology change with little attention placed on service engagement. There is the related risk that cost pressures lead to cut-backs in vulnerable intangible areas such as training.
1.247 Capital investment carries the commensurate risk of optimism bias. The considerable scale of the project is aimed at a current population of 194 million. The demand for IT staff and IT resources in general may lead to higher cost demands. The 5 year phased IT procurement may prove to be of too short a duration to facilitate nation-wide EHR implementation. If this timescale is exceeded there will be the knock-on effect impacting on reduced benefits.
1.248 In Option 3 private healthcare providers are required to implement EHRs. There is the risk that they are not sufficiently incentivised to implement EHR. Many of the benefits flow to patients whilst the immediate costs impact directly on the providers. In order to encourage private healthcare providers to implement EHRs there may be the need for financial incentives as was the case in the US. This leads to a greater governmental cost outlay.
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1.249 There is the inherent risk that full reliance on an electronic system increases the hazards associated with system failure. Sufficient acknowledgement of this may require government leadership on establishing threshold preventative measures where all systems have in-built mechanisms to recover in acceptable time.
1.250 EHRs provide access to health information and carry the risk of the misuse of confidential information. A strong incentive towards behaviour complaint with set standards is the regular publication of performance indicators. This may require the establishment of an information commissioner to provide a regulatory and monitoring role.
1.251 EHRs potentially provide increased scope for efficiency savings through more streamlined information processes. But small users, for example small health clinics, are less likely to realise cost savings because of costly capital and maintenance costs. The impact assessment takes an aggregate approach.
1.252 All private healthcare providers are assumed to have interoperability in place by 2015. This appears to be a reasonable assumption because as of 2009, two years post-TISS, 62 percent coverage was in place. On this basis no additional costs have been assumed to be incurred by this group. If this is incorrect and some private healthcare providers are not fully compliant this will increase the extent of costs and reduce the capacity for efficiency savings.
1.253 The capacity to provide robust estimates is significantly influenced by the availability of evidence used to inform the analytical approach. Reliance on a single value, or point in time, can give rise to misleading estimates. Limited data availability has led to the use of a range, i.e. intervals, to partly overcome this limitation. The impact assessment provides the opportunity to identify gaps in evidence and to put in place systems and procedures enabling data collection in order to expand the awareness of policy implications as it impacts on different groups.
Equality analysis
1.254 It is well-developed in the literature that a strong link exists between the level of literacy and the ability to understand health information. EHRs and initiatives aimed at raising health awareness are the basis on which the benefits of implementation are realised.
1.255 There is no evidence that the proposed initiative will adversely impact on those with the following protected characteristics81 - disability, race, age, sexual orientation or sex. A number of positive group impacts have been identified and are discussed below.
81 http://www.equalityhumanrights.com/advice-and-guidance/new-equality-act-guidance/protected-characteristics-definitions/
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1.256 Brazil displays a high degree of income inequality that also reveals a divergence in exposure to health risks. Health risks are disproportionately felt and tend to have a race component such that black and brown ethnic groups have a higher proportion living in poverty than do Caucasians and have greater health risk exposure. A high risk factor surrounds the increase in obesity and related health complications such as diabetes. Representative household anthropometric surveys from 1975 to 1989 show the similar rise in the prevalence of overweight in adolescents for all income and sex groups. However, from 1989 to 2003 there was a noticeable shift with the increase being disproportionately borne by those on low income82. EHRs provide the basis to monitor health developments and to provide health interventions that target different groups as appropriate.
1.257 Earlier evidence revealed the extent to which the north and northeast does not have the same access to resources that is seen in the rest of the country. Programs aimed at patient engagement are particularly important for the hard to reach groups as it identifies the nature of some of these limitations. It also invests in stakeholder engagement to explore a variety of approaches that may be more suited to the needs of particular groups in enabling greater health awareness.
1.258 MOH portals foster the capacity to reach a greater number. It is recognised that the capacity to access information is clearly linked to internet awareness. It is evident that there is wide variation in access dependent on both an age and also from an income perspective. Hence central actions are also focussed on alternative actions.
82 Maria Schmidt et al, Chronic non-communicable diseases in Brazil: Burden and current challenges, The Lancet, Vol. 377, June 4, 2011, page 1954.
