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Towards reimbursement of Pixacare Application for remote monitoring of chronic wounds: what is our strategy?

What is remote surveillance?

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.

Reimbursement of telemonitoring: the state of play in France.

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.

ETAPES program: the beginnings of remote medical monitoring in France.

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.

As of July 1, 2023, 5 pathologies have received a favorable opinion from the HAS for remote monitoring coverage under common law.

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:

  • Chronic heart failure
  • Chronic renal failure
  • Chronic respiratory insufficiency
  • Diabetes
  • Wearing implantable cardiac prostheses for therapeutic purposes

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.

Since 2023, there have been two possible routes for requesting the inclusion of new pathologies covered under the general law.

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.

Digital advance care (PECAN)

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.

The industrial route in brand name

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 :

  • Have obtained CE marking for their device. It certifies that the medical device complies with the safety and performance requirements of MDR 2017/745.
  • Comply with the interoperability and security standards defined by the ANS (Agence du Numérique en Santé). These include requirements for INS (Identité Nationale de Santé), data portability, RGPD-compliant data protection (Règlement Général sur la Protection des Données), etc.
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.

PECAN: the path chosen by Pixacare.

PECAN eligibility criteria.

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:

  • Prior receipt of a valid CE mark for the indication in question (whatever the risk class of the MND).
  • The MND must be presumed to be innovative, particularly in terms of clinical benefit or progress in the organization of care, based on the first available data.
  • Compliance with the DMN interoperability and security reference framework established by the Agence du Numérique en Santé (ANS) to guarantee the exchange, sharing, security and confidentiality of patient health data.
  • Lastly, clinical studies must already have been launched to provide initial evidence of clinical and/or organizational benefit at the time the PECAN application is submitted.

Evaluation of the PECAN file.

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.

Assessment by ANS.

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 HAS.

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).

Submission of the file to the Ministers of Health and Social Security (main addressee) and to the CNEDiMTS (copy).

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.

How relevant is remote monitoring of chronic wounds for patients, caregivers and the healthcare system?

First of all, telemonitoring is a response to a problem of disruption in the care of chronic wounds.

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:

  • This often begins with a physical consultation with a general practitioner or specialist, such as a diabetologist, dermatologist, surgeon or gerontologist, in hospital or in town.
  • The patient is then continuously monitored in his or her own home by homecare nurses, who repair the dressings.
  • GPs and/or specialists provide regular follow-up consultations (weekly, fortnightly or monthly).
  • Physiotherapists and occupational therapists may also be involved in the overall care of patients.

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

How will remote monitoring of chronic wounds work with the Pixacare platform?

The first objective is to bring together the medical teams involved in the care pathway around a common platform.

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

The remote monitoring protocol will be based on the Personalized Wound Care Plan (PWCP) centralized in the Pixacare platform.

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.

Pixacare is also a cutting-edge medical tool incorporating innovative features such as dimensional wound analysis and an automatic alert 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.

We are going to evaluate the concrete medico-economic impact of remote monitoring in a joint study with Lille University Hospital.

The aim is to demonstrate a medico-economic impact that would justify adequate reimbursement.

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.

The expected benefits of remote monitoring :

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 :

  1. Fewer face-to-face expert consultations.
  2. Fewer amputations.
  3. Reduced hospital stays.
  4. Reduced healing time.
  5. A reduction in the frequency of home visits by homecare nurses.
  6. Earlier management of complications thanks to a warning system.

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.

Similar studies carried out by third parties have already demonstrated relevant results:

  • Regular monitoring of leg ulcers reduces the average healing time by 48% (139 days vs. 269) and cuts costs by 46%. (Swedish multicenter study done on 1073 patients in 2015). Source
  • Remote monitoring of diabetic foot wounds with remote follow-up via photos, questionnaires and e-mails and calls, reduced amputation rates by 58% (6.2% vs. 14.8%). Norwegian multicenter study involving 182 patients followed over 12 months in 2017). Source
  • A similar study carried out at the Centre Hospitalier Sud Francilien (CHSF) showed that remote monitoring of diabetic foot wounds by a specialist nurse can halve medical costs. Study conducted on 180 patients over 12 months. Source. ‍Tolearn more, read the related article : A new study confirms the benefits of telemonitoring for the treatment of diabetic foot ulcers.

Today, in February 2024, where do we stand and what are the next steps?

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.

Sources :









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