Remote medical monitoring enables healthcare professionals to remotely interpret a patient's health data via digital medical devices (DMDs). This innovative approach is designed to improve the quality of patient care, and can be particularly useful for patients with chronic pathologies, offering interactive, coordinated and personalized medical support.
Telemonitoring helps to reduce hospitalizations and emergency room visits, reorganize care paths and significantly improve patient comfort.
The reimbursement of remote medical monitoring is now at the heart of the French healthcare system, heralding a new era in patient care. With the entry into force of the ETAPES program, remote medical monitoring has become part of common law, paving the way for broader medical coverage.
Telemonitoring, defined as the remote monitoring of patients by healthcare professionals using digital medical devices, is enjoying increasing recognition. The ETAPES program, which has been undergoing trials since 2014, has gradually laid the groundwork for the sustainable integration of this practice into care pathways.
To date, five pathologies have received a favorable opinion from the French National Authority for Health (HAS) for remote monitoring within the framework of common law:
To find out more about the latest definitions, prerequisites and pricing for telemonitoring in France, we suggest you read the latest article published by the health insurance in February 2024: read the article.
Following on from the ETAPES program (2014-2023), two new avenues are now open for registering the management of new pathologies on the list of Remote Medical Monitoring Activities (LATM). The two options are Prise En Charge Anticipée Numérique (PECAN) or brand name registration.
The Prise en Charge Anticipée Numérique (PECAN) scheme enables the French Assurance Maladie to waive a one-year reimbursement period for sufficiently mature solutions. This anticipated phase enables the operator to finalize the demonstration of clinical and/or organizational benefits, while already being reimbursed.
At the end of PECAN, if the Ministers of Health and Social Security give a favorable opinion, the solution can be integrated into common law for a renewable period of several years.
A first in France, Cureety Techcare recently obtained reimbursement via PECAN for remote monitoring of cancer patients treated with systemic therapy and/or radiotherapy, whatever the cancer or the treatment/protocol prescribed. Their application is a CE-marked Class I medical device.
This route is aimed at manufacturers of DMNs who consider that their device provides an improvement in medical service rendered in a therapeutic area other than those already covered for telemonitoring procedures.
To be eligible, manufacturers must :
This route was chosen by Resilience, for example, which offers a class IIa medical device dedicated to remote monitoring and support for oncology patients. Having received a favorable opinion from the HAS (Haute Autorité de Santé) for inclusion on the LATM, it became the first remote monitoring solution in oncology to obtain reimbursement.
There are several stages in the PECAN process. First, theeligibility of the Digital Medical Device (DMD) must be verified. This eligibility is based on the following criteria:
To qualify for PECAN, applications must be submitted simultaneously on theANS Convergence platform and on the HAS EVATECH platform, according to a precise timetable. The two agencies have a maximum of 60 days in which to study the application.
The ANS assesses the application for interoperability and safety certification. The ANS interoperability and safety requirements are grouped into 9 sections:
User identification / Pro Santé Connect (PSC) / Health Directory / Data portability / Electronic user authentication - ApCV / Electronic identification of players in the health, medico-social and social sectors (ASPP) / Electronic user identification / Administration, security and traceability of system data / General Data Protection Regulation (GDPR).
Assessment by the HAS consists of a clinical and/or organizational opinion by the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS).
The decision to provide advance reimbursement for an MND used for therapeutic purposes or as part of a medical telemonitoring activity is established by joint order of the ministers responsible for health and social security, after consultation with the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS), a specialized commission of the French National Authority for Health, and the French Digital Health Agency (ANS) (art L.162-1-23 of the Social Security Code).
Repayment can then be made for a renewable period of several years, before entering into common law.
The management of chronic wounds represents a major medical and economic challenge. These include ulcers, pressure sores and diabetic foot sores. Their prevalence is estimated at 2.5 million people in France.
Many healthcare professionals are involved in the care of patients suffering from chronic wounds. Here is an example of a typical care pathway:
However, the diversity of the professionals involved makes care coordination complex, often resulting in gaps in patient care. This increases the risk of complications in wound healing.
A Norwegian study showed that regular remote monitoring of diabetic foot wounds, with photos, questionnaires, e-mails and calls, helped to reduced amputation rates by 58%. (6.2% vs. 14.8%). Source
In order to strengthen the monitoring of patients with chronic wounds in their own homes, we are proposing the introduction of a new care pathway based on regular remote medical monitoring of the patient's wound, in coordination with all the players involved in its management.
To encourage collaboration, we want to bring this medical team together around a common platform for monitoring wound progress and enabling secure exchanges between caregivers. The aim is to create a care network with experts available remotely to advise less expert caregivers and ensure continuity of care in the event of complications.
This medical network will limit the number of gaps in the treatment process, where current delays often extend over several days before treatment is adjusted.
What's more, it will offer patients equal opportunities in the quality of their care, by putting wound and scar experts in touch with other caregivers who are not experts, but who are involved in the patient's day-to-day care. Thanks to a secure IT platform, the prescribing physician can generate a Personalized Wound Care Plan (PWCP).
A Swedish study shows that regular monitoring of leg ulcers can reduce average healing time by 48% (139 days vs. (139 days vs. 269) and costs by 46%.. Source
Accessible to all caregivers via a unique QR code, the PPSP will be a collaborative file hosted in the Pixacare application. The PPSP contains :
Patient history / Care protocols / Prescriptions / Wound photographs in chronological order / Responses to wound-related clinical questionnaires (pain, measurements, notes, etc.) / Wound progress reports.
All these elements will be centralized in the Pixacare application and accessible to all caregivers coordinated around the patient (homecare nurses, GPs, specialist doctors, dermatologists, surgeons, gerontologists, diabetologists, physiotherapists, occupational therapists).
The PPSP will therefore evolve throughout the course of treatment, with the addition of new photographs of wound follow-up, answers to medical questionnaires and kinetic curves showing the evolution of wound healing (evolution of wound surface, % of each tissue, quantity of exudate, etc.).
Each caregiver will have the prerogative to adapt the PPSP to his or her level of expertise. The various parties involved will also be able to give their opinions and exchange information via a secure shared messaging system.
Two innovative features will help healthcare professionals standardize wound documentation.
Firstly, WoundTrack I, a dimensional wound analysis tool. Simply take a photo of the wound, outline it with your finger and the tool calculates its surface area in cm2. It's a precise, rapid and standardized way of assessing the size of a wound.
A preliminary internal study shows that the percentage of error in wound measurement is 28% with a ruler versus 5.4% with WoundTrack I.
Next, we're going to introduce a system of automatic, customizable alerts. The physician who initiates remote monitoring will be able to define the relevant monitoring indicators from the chronic wounds questionnaire, with automatic messages triggered when these indicators are present or exceed a certain threshold. These indicators will relate to the following monitoring parameters: body temperature, pain, wound size, percentage of necrosis/fibrin, nature and quantity of exudate, peripheral redness, keratosis, bone and/or tendon exposure.
To this end, a clinical trial is planned in partnership with the Lille University Hospital. This randomized, prospective study will involve a cohort of 100 patients over a 4-month treatment period. The study will assess the impact of the Pixacare application on wound follow-up, measuring various key indicators.
The expected results are promising. We hope to see a reduction in unnecessary face-to-face consultations, better coordination between caregivers and a reduction in associated costs. All this while maintaining quality of care.
A review of the literature on telemedicine in general reveals numerous clues confirming the high potential of telemonitoring of chronic wounds to improve the efficiency of care. The levers identified to reduce the cost of chronic wound care through telemonitoring are :
In concrete terms, the monitoring of chronic wounds by a specialized team will enable better adaptation of treatments, which is likely to lead to a reduction in healing kinetics, a reduction in the overall duration of treatment, a reduction in the frequency of care, a reduction in the cumulative duration of hospitalization, a reduction in the rate of amputations and therefore, ultimately, an overall reduction in costs.
Telemonitoring applied to chronic wounds is able to provide this specialized follow-up while reducing the number of face-to-face consultations with experts, thereby cutting both travel and consultation costs. Remote monitoring also promises to improve quality of life for frail patients living at a distance from specialist centers.
We are making active progress in setting up a reimbursement strategy. Discussions are underway with several university hospitals and healthcare establishments, as well as with the BPI, to launch multicenter clinical studies. These studies will aim to enrich our dossier with medico-economic evidence. Details will be announced in the coming months.
In the meantime, we are delighted to announce that our clinical study, carried out in partnership with Lille University Hospital, will begin in June 2024.
On the product development front, we are preparing a significant update of our remote monitoring module. This will include the integration of automatic alerts and ergonomic improvements, scheduled to coincide with the launch of the Lille study.
Finally, we are working to align our Digital Medical Record (DMN) with ANS security and interoperability standards. Our goal is to submit our PECAN file in early 2025.
https://has-sante.fr/upload/docs/application/pdf/2023-03/pecan_guide_de_depot_de_dossier.pdf
https://www.ameli.fr/bas-rhin/medecin/exercice-liberal/telemedecine/telesurveillance#text_205983
https://www.has-sante.fr/jcms/p_3455755/fr/cureety-techcare
