TeleCheck-AF is a well-defined and standardised mHealth-based care pathway for the remote management of patients with AF in outpatient clinics, known for its effective scalability and for being patient-friendly, as previously described [8,9,10,11]. Implementation of the TeleCheck-AF approach in the MUMC+ AF Clinic resulted in a significant reduction in healthcare utilisation (face-to-face visits and diagnostic tests), leading to a change in DBC care products. Specifically, there was a decrease in medium-weight and an increase in light-weight DBC care products compared to usual care in 2019, resulting in a disproportionate drop in reimbursement received by healthcare providers, as the actual costs for the TeleCheck-AF approach, e.g. for technology, personnel and implementation procedures, are not covered. This highlights the inflexibility of reimbursement codes, which have not been adapted to the ongoing digital transformation of healthcare delivery models. This problem has previously been noted in surveys to represent a significant burden for future mHealth implementation [3, 12]. Based on the healthcare utilisation and reimbursement data presented in this paper, as well as previously published data on feasibility [8,9,10,11], the MUMC+, together with a major Dutch health insurance company, requested an optional billing code from the Dutch Healthcare Authority (NZa). This optional billing code (‘Telecheck atriumfibrilleren’; TB/REG-21679-01, https://puc.overheid.nl/nza/doc/PUC_695550_22/1/) is specifically for use in the Netherlands. The code is not for the direct reimbursement of costs involved in the use of mHealth, but can be used to compensate for the financial gap resulting from an overproportional drop in reimbursement for AF disease management through use of the TeleCheck-AF approach. Based on the experience and data that will be collected 1 year after the introduction of the optional billing code, it will be discussed whether the TeleCheck-AF approach should be integrated in the existing DBC care product system and whether this on-demand mHealth approach can be expanded to other clinical scenarios.

Some specific limitations should be considered when PPG is used in the TeleCheck-AF setting. Compared to ECG, PPG measurements are not able to definitely diagnose underlying heart rhythms and cannot differentiate between ventricular and supraventricular beats or sinus tachycardia and atrial flutter [14, 15]. Nevertheless, these limitations can be addressed by confirming PPG-detected arrhythmia episodes by ECG documentation [15]. Additionally, the quality of PPG signals can be impacted by various factors, such as the effects of ambient light, accommodating different skin pigmentations and conditions (tattoos, low skin temperature, eczema, etc.), or movement artefacts [14]. Moreover, irrespective of the technology used, intermittent recordings (e.g. 3 measurements a day as used in TeleCheck-AF) may miss asymptomatic and short arrhythmia episodes, which could otherwise be captured by continuous monitoring. In our study, we present data from a patient survey, suggesting that continuous ECG monitoring (e.g. Holter) may be burdensome for patients, whereas intermittent PPG recordings (3 times a day) were accepted as a patient-friendly alternative.

By implementing TeleCheck-AF as a telemedicine approach, the potential burden on patients caused by, for example, travel costs and time investment could be significantly lowered. Additionally, it may represent a good strategy to prepare for future crises, when attendance at outpatient clinics or travelling to the hospital is not possible or undesirable. Integrated AF management through the TeleCheck-AF infrastructure could therefore be an example of creating alternatives to standard care for sustainable and future-oriented telemedical care pathways. However, data from randomised controlled trials and cost-effectiveness analysis are needed to support these findings.

The development of the TeleCheck-AF project and a reimbursement model for this specific clinical scenario involved a multidisciplinary team consisting of cardiologists, electrophysiologists, nurses and patients, as well as regulatory agencies, health insurance companies, hospital finance departments and mHealth companies. The FibriCheck app was selected for the TeleCheck-AF approach [13, 16] after being validated prior to creation of the AF management pathway [17] (step 1). To define the TeleCheck-AF approach, standard operating procedure documents [9], involving a case manager and patient education [8], were prepared. Also, an educational, structured, stepwise practical guide on how to interpret PPG signals was developed for healthcare professionals to facilitate the use of an on-demand PPG technology in a clinical scenario [14] (step 2). Extensive feedback from healthcare providers using the TeleCheck-AF approach and patient experience were collected and used to continuously refine the approach to overcome challenges related to mHealth-guided pathways [7] (step 3). With expansion of the project, the feasibility and scalability of TeleCheck-AF were proven [10]. Centre and patient characteristics as well as data on patient motivation and adherence to such an approach were collected [11], and the ability to integrate mHealth data in clinical decision-making processes was demonstrated [18] (step 4). Data presented in this article summarise the results of activities focusing on steps 5 and 6. Together with the finance department at MUMC+, a major Dutch health insurance company and the Dutch Healthcare Authority (NZa), data on healthcare utilisation, DBC care products, safety and effectiveness were collected (step 5), which formed the basis for discussions on reimbursement (step 6). The herein proposed roadmap (Fig. 4) for future mHealth implementation can support the ongoing digital transformation of healthcare delivery models and the design of further reimbursement strategies for broader and sustained mHealth use.

Roadmap of mobile health device implementation in healthcare system. CE Conformité Européenne, FDA Food and Drug Administration, SOP standard operating procedure. See also description in Discussion section

TeleCheck-AF was initiated during the COVID-19 pandemic, which may have impacted healthcare utilisation and admission rates due to limited availability and regional restrictions. To address this limitation, we included only patients with a routine follow-up visit at the MUMC+ AF Clinic in 2019, for whom a routine AF clinic follow-up appointment was already scheduled for 2020. We excluded patients with a first consultation and patients with DBC care product codes related to AF ablation, pacemaker implantations and other invasive procedures. To validate the impact of the TeleCheck-AF approach on long-term outcomes and cost-effectiveness in AF populations beyond the COVID-19 pandemic, evidence from a randomised clinical trial is needed.