Digital Health: New EU Guidance on reimbursement

On 30 April 2019, the European Commission eHealth Stakeholder Group (eHSG) issued a set of proposed guiding principles for reimbursement of "digital health products and solutions" (the Guidance).

The proposed eHSG recommendations come at an interesting time, where many digital health technologies are under scrutiny by manufacturers and competent authorities ahead of the application date of the EU Medical Devices Regulation 2017/745 (MDR).

Beyond MDR-compliance issues, the eHSG Guidance identifies pathways to facilitate reimbursement of digital health products and solutions at national and EU levels, understanding that digital tools have the ability to avoid or significantly reduce the increase in spending on care delivery through efficiency gains throughout the patient pathway.

What is the eHSG?

The eHSG is a European Commission Expert Group, which provides input on the design, implementation and evaluation of eHealth policy activities, addresses the deliverables of the Joint Action to support the eHealth Network and advises the European Commission on eHealth-related activities by preparing reports and opinions.

The proposed Guidance has been enacted by the eHSG sub-group on "Reimbursement" led by MedTech Europe in collaboration with other European associations such as COCIR, the European Society of Cardiology (ESC), the Personal Connected Health Alliance (PCH Alliance), the Pharmaceutical Group of the European Union (PGEU) and the Europea Union of Private Hospitals (UEHP).

Which products and solutions are in scope of the proposed Guidance?

The proposed Guidance covers "digital health products and solutions" that (i) support the delivery of health services, (ii) address the health and social care of individuals, and (iii) can be considered for reimbursement by the public sector or sickness funds.

According to the eHSG, "digital health products and solutions" should be understood as medical technologies and related services which utilise information and communication technologies (ICTs) across the whole range of functions that affect the health sector, that can improve prevention, diagnosis, treatment, monitoring, prediction, prognosis and management “of health and lifestyle” (emphasis added). On the other hand, the eHSG is clear in that the Guidance excludes lifestyle products and services that (i) are not based on evidence “and” (emphasis added) (ii) are not CE-marked under medical device legislation.

This definition raises two questions.

Firstly, would the proposed Guidance apply to a lifestyle product that is based on evidence but does not - by definition - bear the CE-mark for medical devices? Many lifestyle solutions are currently marketed in the EU to manage or facilitate lifestyle decisions based on users’ input, via algorithms supported by (various thresholds of) clinical and non-clinical evidence. Such solutions can be proposed by employers to their employees or by private insurers to insured persons to enhance and/or monitor their wellbeing subject to user consent. Expected outcomes can include tips to quit smoking or alcohol consumption, diet advice, physical performance trackers, or simply facilitating / encouraging appointments with a physiotherapist or a fitness coach after business hours.

Secondly, what is a medical technology or related service that utilises ICTs to improve “prevention, diagnosis, treatment, prediction (…) of (…) lifestyle”? By basing the above definition partly on the first indent of the MDR definition of a "medical device" - which is meant to include only products with a medical purpose – the eHSG may have missed an opportunity to address some of the specifics of evidence-based lifestyle solutions. In this regard, the proposed Guidance merely recommends that solutions with evidence-based benefits for healthcare delivery, organisations and/or patient outcomes be distinguished from lifestyle products.

To whom is the proposed Guidance addressed?

Reimbursement of health technologies being a Member State competence, the proposed Guidance is mainly directed to Member States, namely national policymakers and competent authorities. It is described as a supportive tool for Member States’ authorities in their efforts to modernise national reimbursement and financing schemes for the purpose of enabling digital transformation in EU healthcare systems. However, in the area of evidence generation, the Guidance goes further and provides recommendations to the European Commission itself.

What are the eHSG recommendations?

The proposed Guidance articulates four needs (“guiding principles”) to consider for facilitating reimbursement of digital health products and solutions:

  1. The need for specific criteria to make appropriate reimbursement decisions for digital health products and solutions

    Recommendations include: setting up clear and transparent pathways for national assessment and coverage decision; developing dialogue with all stakeholders from the early stage of the development and implementation of products / solutions; and promoting flexible processes and additional reimbursement criteria for assessing the value of digital healthcare products and solutions, considering the fast-paced nature of digital innovation.

  2. The need for EU or national funding within innovation investment funds that cover relevant digital health products and solutions

    Reference is made to the upcoming EU Multiannual Financial Framework (2021 – 2027) and other EU instruments designed to foster innovation, with the expectation that they may allocate budgets for the development and implementation of innovative digital health products and solutions across the Union.

    In this area, the eHSG proposes creating special innovation investment budgets for digital health solutions and services, implementing and testing new cross-sector payment mechanisms, and considering public-private partnerships (PPP) on digital health products and solutions.

  3. The need for European guidelines for relevant and fit-for purpose evidence generation for digital health products and solutions

    The proposed Guidance advises that the European Commission should actively inform developers and all healthcare actors involved of existing evidence generation frameworks. It stresses the Commission’s role in developing further guidance for the relevant stakeholders on generating "meaningful evidence" for digital health products and solutions.

    Interestingly, the eHSG considers the on-going MDR implementation discussions as an opportunity to shape European guidance in the area of evidence generation for digital health products and solutions. It should be noted in this regard, that the level of (clinical or non-clinical) evidence required for MDR-compliance may not necessarily match the economic rationale integrated in national reimbursement schemes. Other opportunities in this area also include the current revision of the EU framework for HTA, which we have previously discussed here.

  4. The need to consider the specifics of digital health products and solutions when developing instruments for assessing and rewarding their value

    In order to capture the specifics of digital health technologies, the Guidance stresses the importance of training, education and multi-disciplinary approaches in all things digital health related, beyond the investment itself. Member States are encouraged to finance continuous professional development for the assessment of transformative digital health products and solutions and develop a value-based approach to public procurement of innovative solutions.

Success stories and practical examples

In conclusion, the eHSG provides a non-exhaustive list of “good examples of modernised reimbursement systems” in selected EU member States, demonstrating how payers are (already) embracing digital tools such as connected devices and telemedicine.

Examples include (further details can be found in the Annex to the Guidance):

  • the reimbursement of functional analyses of cardiac resynchronisation therapy devices and implantable cardioverterdefibrillators by the German national statutory health insurance - including, in certain cases, the telemedical infrastructure (app or transmitter) required to send data to doctors
  • the reimbursement of some teleconsultations as hospital visits by the Dutch national statutory health insurance
  • the reimbursement of some video consultations by the German national statutory health insurance
  • the reimbursement of remote monitoring performed for all cardiac rhythm implants (PM, ICD, CRT, ILR) by the Swiss national statutory health insurance, with a limitation of invoices per year
  • the financial coverage for telemedicine (teleconsultation and tele-expertise) provided the French national statutory health insurance, and
  • the French HTA Framework for connected medical devices issued by the French national Haute Autorité de Santé with guidance for manufacturers seeking reimbursement for connected medical devices to build their reimbursement dossier, including in terms of required evidence.

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The proposed Guidance is available on the MedTech Europe website.

For further information about Simmons & Simmons initiatives in the area of Digital Health, please visit our Digital Fusion microsite.

This document (and any information accessed through links in this document) is provided for information purposes only and does not constitute legal advice. Professional legal advice should be obtained before taking or refraining from any action as a result of the contents of this document.