Author: Connected Health Ireland Clinical Lead, Kieran Murphy MSc Digital Health, BSc Nursing
Ireland is seen as having an ideal eco-system to capitalize on the digital health market due to its strong base in medical technologies, ICT, pharmaceuticals, bio-pharmaceutical/ technology, high caliber universities and the graduates they produce. As in many countries, the COVID-19 pandemic highlighted the severe deficiencies within the Irish healthcare system but it also demonstrated and purely acted as the catalyst for the rapid introduction of many new health technology solutions and more importantly, a new way of creative thinking to aid in the response to the pandemic. But how do we continue to triumph to meet the healthcare challenges of the post-pandemic era and capitalize on the populations’ digital leapfrogging development?
Ireland’s population is growing, with the most significant growth in the older age groups. An aging society living longer with increased health conditions will put more strain on a heavily burdened healthcare system. It is estimated that by 2024, Ireland will have a total population of 943,000 over the age of 50 that will be affected by a chronic condition of one or more (CardiovascularDisease, Chronic Obstructive Pulmonary Disease, Asthma or Diabetes). This will have a significant impact on services in the acute sector, with readmissions to hospitals and increased emergency department visits certain. The impact on health service utilization is particularly evident in the acute sector with chronic diseases accounting for 40% of admissions and 75% of bed days. An ageing population, with high levels of risk factors for chronic disease, presents a challenging future for the healthcare services in Ireland. The time has come to make a change.
During the pandemic, many private companies answered Ireland’s call and deployed remote monitoring solutions for patients to clear the emergency departments and wards, so the hospital’s resources could be realigned, with the impending waves of patients needing to be centralized and closely monitored. The rapid adoption of these innovations demonstrates what the healthcare system is capable of implementing in a short time. Was this a key milestone in breaking Irish mentality of visiting a nurse or doctor or going to a hospital for healthcare?
Within the Irish homecare market, many clients are suffering from chronic conditions and would benefit from remote monitoring and digital health technologies. Most home support in Ireland is provided by private providers. Connected Health is a private homecare company that is also approved by the HSE to provide care in the home. The organisation has taken inspiration from the Irish government’s ‘Sláintecare’ reforms, as well as the HSE digital transformation teams’ ‘Stay Left, Shift Left’ strategy to utilize increased digital technology within the broader healthcare sector and have invested in healthcare innovations that will improve patient outcomes, keep them well and keep them at home.
The Health Service Executive (HSE) must be commended in their efforts to transform healthcare but assistance is now needed from the policy makers to amend and update current policies to assist with the transformation to unleash its true capabilities. We believe that updating these policies and creating new ways of paying and reimbursement will make healthcare more accessible to all. We also believe that by removing these roadblocks, it will pave the way to achieve a main aim of the HSE’s digital transformation strategy, to make Ireland a Digital Health leader in Europe by 2025.
Irish Healthcare initiatives to go from digital laggard to digital leader
The HSE is changing the way healthcare is being delivered in Ireland and has recognised and undertaken complex projects to implement critical infrastructure that will be crucial to its success, such as the national electronic health record and unique health identifier projects. The Government has also realised the need for change and in 2017 published “The Sláintecare report” by the Oireachtas Committee on the Future of Healthcare in Ireland.
Itis aimed to reform and transform how we deliver healthcare in Ireland and abolish the current two-tier, public/ private system, building towards equal access to services for every citizen based on patient need and not their ability to pay. By putting people at the centre of the health system and developing primary and community health services, the Department of Health and HSE are working together to provide new models of care that allow people to stay healthy in their homes and communities for as long as possible. The aim is to deliver the Sláintecare vision of one universal health service for all, providing the right care, in the right place, at the right time. The current plans of Sláintecare are focusing on prevention and shifting care from acute hospitals into the community and closer to people’s homes and has led to the HSE strategy “stay left, shift left”.
‘Stay left, Shift left’
The strategy is based on partnering with innovative companies, universities and individuals to utilise the power of digital applications, data and technology, in order to improve quality of life and quality of care, while reducing the cost of care. The concept of ‘Stay Left’ is to use technology to keep people well in their homes, and allow people with chronic conditions to manage themselves in the best way possible at home. ‘Shift left’ is about finding technologies that help people move as quickly as possible from the acute setting to a community setting and finally, to a home setting.
Tax Reliefs and Reimbursement
There are many tax reliefs, incentives and reimbursement options when choosing to follow the “traditional model” of care in Ireland as briefly outlined in following paragraphs and table below. Clients and their families can avail of the following schemes to make care more affordable:
Within the public system, a citizen will still have to pay for healthcare unless they have a medical card, meaning certain health services will be free of charge. Medical cards are given to individuals who have an income below a certain level or who have a long-term illness and is means tested.
Employ a Carer “HK1 Form”
For those looking to stay at home but require a carer for extra assistance can seek an allowance to pay for a carer. Clients can fill out a HK1 form where the payer can receive 20-40% tax relief depending on their income or the income of the person paying the bill.
People looking for nursing home care can avail of the Government Nursing Home Support Scheme called the Fair Deal. The Fair Deal scheme offers financial support to people who need long term nursing home care. This scheme is operated by the Health Service Executive (HSE). Based on a financial assessment, the client will contribute to the weekly cost of care and the HSE will pay the balance. However, the amount that the client pays will vary from person to person.
Private funding means that an individual covers the full cost of nursing home care without any public assistance. The client can claim tax relief on Nursing Home fees paid. This can be claimed at their highest rate of tax. The amount of relief can be claimed at 20 – 40%, depending on the amount of income tax paid by the payer.
Employing a carer “HK1”
20 – 40%
Maximum € 75,000
20 – 40 % return on balance paid by client
Financial means test
20 – 40%
What happened to the person in “person centered care”?
Despite the unprecedented growth of the digital health market over the past few years, reimbursement and securing revenue remain key obstacles for those trying to establish their place in the market. We talk about person centered care and creating innovations for prevention, diagnostics and interventions to support better, more efficient, more patient centered care but the reality is, we don’t financially back the brave. We need leadership from local and government authorities to address this issue. As a nation, we need to create new funding pathways and reimbursement strategies that will encourage and enable and empower citizens to look after themselves.
In a recent survey as part of the EU State of Play on Telemedicine Services and Uptake Recommendations Report, 55% of the countries indicated that their country has mechanisms of reimbursement, and that 80% of these are from public health insurance companies, followed by 50% from government. In the UK and European countries (Germany, France, Netherlands, Spain) patients or health-conscious citizens can choose to pay for a digital health solution to manage their general health or existing medical conditions.
Although we are part of the European Union, we experience less access to innovative therapies and solutions than our European peers as citizens are generally reluctant to pay for extras but why? If we have the data, and approved clinical grade products that will save the government revenue in proactive self-care.
The current lack of clear and formally established funding and reimbursement mechanisms hinders their use in Europe, at the expense of patients, healthcare professionals and healthcare systems. We urge policymakers in Ireland learn from systems developed in neighbouring countries and even have uniform funding and reimbursement policies for digital health apps across Europe.
Learning from the UK and other European countries:
Mhealthbelgium founded in 2018 is the Belgian digital platform for all relevant information covering validated apps for patients, healthcare professionals, and healthcare institutions. National authorities are involved in assessing their safety, quality and clinical effectiveness to determine the level of reimbursement received. Three national authorities are involved in defining the criteria:
• The Federal Agency for Medicine and Health Products (FAMHP), i.e., the competent authority responsible for assessing the safety, quality and efficacy of drugs and health products (level M1 of the validation pyramid)
• The eHealth Platform, i.e., the federal digital health organisation responsible for building the infrastructure for information exchange in healthcare and ensuring that devices are safely connected (level M2 of the validation pyramid);
• The National Institute for Health and Disability Insurance (NIHDI), i.e., the competent authority responsible for reimbursement of healthcare products and services (level M3+/- of the pyramid).
While level M1 was launched in January 2019 and level M2 in May 2020, it was not until January 2021 that level M3, the new financing framework for mobile health applications, was completed and launched.
Other reimbursement initiatives in Belgium include, using funds from innovation budgets and health insurance companies could at least partially support the use of the app.
The 2019 DVG (Digital Health Act) in Germany, which is designed specifically for digital health goods, offers excellent opportunities for national access and reimbursement. There are numerous alternative avenues for compensation, depending on, whether a solution is for inpatient or outpatient hospital care, preventative care, or for care that is eligible for reimbursement by the nation’s innovation fund. It was created to support innovative care delivery models that will improve current standards. The national reimbursement catalog includes digital health solutions that meet particular safety, data-privacy, and efficacy requirements.
To qualify for reimbursement, the manufacturer submits an application to the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). This represents a brand-new method of payment for those particular health apps. Within three months of receiving the application, BfArM decides whether to cover the applicant. The health app can be prescribed and covered by statutory health insurances if the requirements for inclusion are satisfied and it is listed permanently in the directory (SHI).
One condition that exists, is that apps have to be prescribed by the physician / specialist, psychotherapist (outpatient sector) or directly approved by the SHI are subject to reimbursement.
The DiGA encourages companies to produce data on the clinical effectiveness of their products and is currently being looked at to be rolled out in the care settings. Germany has also had success in securing reimbursement directly from large German insurance companies for digital therapeutics applications.
In France, companies of medical devices can apply to the LPPR (list of reimbursed devices), a committee will assess the SA (benefits) and the ADA (Clinical added value is further assessed considering comparative efficacy and safety data versus alternative solutions) to determine if reimbursement is possible and if so at a premium. The French government is currently considering new reimbursement mechanisms modelled on the previously discussed DiGA mechanism in Germany.
The HSE has a similar finance Shared Service, called the Primary Care Reimbursement Service (PCRS) which supports the delivery of primary healthcare by providing reimbursement services to primary care contractors for the provision of health services to members of the public in their own community. In order to receive reimbursement, approval from one of the state schemes in Ireland, a product supplier must apply to the HSE to be included on the reimbursement list. Even after a product has completed rigorous testing and assessment from the Health Products and Regulatory Authority (HPRA) and deemed safe for use, it may not be on the list and therefore not an option for the patient who now has to privately pay for the product or service.
Currently, there is no top-down framework developed by the Dutch government to assess the application and adoption of health apps. The Netherlands has insurers actively offering digital health products to their clients they cover. Private health insurance may cover the cost depending on the service or provided on the level of cover.
There is no national reimbursement framework for health apps in the UK and it is the responsibility of local Clinical Commissioning Groups (CCGs) and NHS Trusts to negotiate reimbursement with the developers. If an app is listed in the library, it simply demonstrates standards of clinical safety, data protection, technical assurance, interoperability and usability, and accessibility. Health app developers can also annually submit proposals for the Innovation and Technology Payment mechanism (ITP), if the technology qualifies for the determined inclusion criteria.
Age is a significant driver of service utilization within the acute sector in Ireland with individuals aged 65 years and over accounting for the vast majority of overnight hospital stays. The over-reliance on the provision of hospital-based care, is unsustainable and we need to continue to progress the aim of shifting care to the community.
The use of technology to move people as quickly as possible from an acute, to a community, to a home setting is a space that needs careful consideration but is essential to transform the traditional healthcare model.
We can learn from other countries, Belgium, Germany, France, Netherlands and the United Kingdom are relatively mature markets where governments are promoting the digitization of care and have standardised reimbursement pathways.
The provision of long-term care for older persons is of particular relevance to health policymaking in Ireland at present, given the programme for government commitment to introduce a statutory scheme to support people to live in their own homes that will provide equitable access to high-quality care and the Sláintecare commitment to expand community-based care. The financing model for the scheme has still yet to be determined.
In Ireland at present, companies who have viable solutions to assist with the concept of treating people in their homes need assistance from the government and policy makers to assist with reimbursement pathways in order to focus on the stakeholders to adopting their solutions to truly disrupt the home and healthcare sector.
Reimbursement and funding is a major obstacle to digital health transformation and adoption and will need to be addressed by Government to make Ireland a real digital health leader by 2025.