Despite numerous and robust proofs of clinical and medico-economic benefits, Cardiac electronic implantable devices (CIEDs) remote monitoring was not broadly adopted in France until a few years ago due to the lack of the service reimbursement for healthcare professionals. France has around 80,000 implanted patients each year (85% pacemakers (PM) and 15% defibrillators (ICD)). Currently, there are 350,000 PM implants for 60,000 ICD. About 40,000 devices are subject to activation of their remote monitoring system.
The French ETAPES program launched in 2018 had addressed the financial obstacle slowing down the adoption of remote cardiac monitoring by setting-up a pre-figurative price for the reimbursement of CIED remote monitoring before permanent implementation in the French common law.
The ETAPES program, an encouraging framework for the deployment of cardiac remote monitoring in France
The 2014 social security funding act introduced the principle of telemedicine experimentation with its ETAPES (experimentation in telemedicine for the improvement of healthcare pathways) program. The objective of ETAPES was to develop telemedicine activities, define a legal framework in which they can be implemented, and establish an initial draft for the pricing of the procedures. The telemedicine trials involved teleconsultation, tele-expertise and telemonitoring. Initially planned for nine regions as of January 2014, the trials were extended throughout French territory in the 2017 Social Security Funding Act. The 2018 Social Security Funding Act led to teleconsultation and tele-expertise entering into common law, and extended telemonitoring experimentation for 4 years, until 2021.
The ETAPES program aims at :
- targeting patients at risk of recurrent hospitalizations or patients at risk of medium to long-term complications;
- achieving a state of disease stability, or even improvement, through rapid access to advice from a specialist or expert in their field;
- improving the quality and cost-effectiveness of care;
- improving patient quality of life.
Initially published in December 2016 for heart failure, respiratory failure and kidney failure. The program had included diabetes in April 2017 and patients with CIEDs in November 2017. The last specifications – simplified & standardized – were published in October 2018 in the 2018 Social Security Funding Act (Art. 54). They still comprehend the same five conditions. As of September 2019, the number of patients benefiting from ETAPES was estimated at more than 33,000.
ETAPES brought awareness to healthcare professionals about CIEDs telemonitoring. Thanks to the remuneration allocated to this activity, there was no barrier holding them back from adopting this practice.
In the case of the CIED remote monitoring specifications, the solutions providers already benefit from reimbursement through the standard market access procedure for the telemonitoring system linked to the CIED. No therapeutic support has been put in place. Therefore, ETAPES program only covers the remuneration of the physician responsible for telemonitoring at a rate of 65 euros per patient per semester.
the French Institute for Research and Documentation in Health Economics (IRDES) will evaluate ETAPES program to provide independent scientific support in public authorities’ decision-making processes regarding its inclusion in the common law. The objectives of the evaluation will be: “ to evaluate whether the rollout of telemedicine would affect the organization of patient management, patient satisfaction, or recourse to care” and will combine both quantitative and qualitative analyses. No progress report has been published yet and the final evaluation report is expected for June 2021. However, a working group composed of public institutions and industrial stakeholders was required to submit formal recommendations; regarding its organization, funding, and assessment, for the potential entry of telemonitoring into common law following the end of the ETAPES program. The workshops led to a publication of recommendations at the end of 2019.
How has Remote Monitoring been boosted with ETAPES? Implicity experience
CIED remote monitoring has been rapidly covering around 70% of all ETAPES patients, and Implicity alone represents 30% of all ETAPES patients as of September 2019 (current estimate is around 50%): this shows the great interest of healthcare professionals for Remote Monitoring. Implicity’s commercialization started in 2018 in France with the introduction of CIED Remote monitoring within the ETAPES program. This was a big momentum for the company and for the public & private hospitals with an electrophysiology department. Implicity remote cardiac monitoring, being so effective and easy to use, also greatly helped in accelerating the adoption of this process. Today, Implicity’s platform is used by 50+ medical centers in France and more than 20 000 French patients have been remotely monitored since its start.
Implicity is a French digital Medtech founded in 2016 by Dr. Arnaud Rosier, cardiologist and expert in symbolic Artificial Intelligence, designed to provide a smart & universal remote monitoring platform of connected medical devices. The platform is enhanced with AI-based software and uses the full potential of data to enhance patient care and help health teams work efficiently.
Implicity solves the issue of complex workflows hindering the adoption of remote monitoring as it offers a solution that aggregates data from all CIEDs across manufacturers. Implicity is also developing AI-based digital medical devices serving the future of preventive medicine.
Implicity’s ambition is to democratize patient remote monitoring in Cardiology and to leverage the power of data to bring digital innovation into Cardiology practices.
 See Literature & recommendations review attached
 Currently, in France, a “bonus” of 700-1000 euros is granted by the National Health Insurance to the manufacturer providing a tele-transmission & telemonitoring system, through the LPPR, list of reimbursable products and services
 coming from the “Health and cost efficiency” round table No. 3 of the 35th National pharmacology and clinical research meetings for therapeutic innovation and health technology evaluation