Remote monitoring: a cost or an investment?

Transcription

1 Europace (2011) 13, ii44 ii48 doi: /europace/eur082 Remote monitoring: a cost or an investment? Haran Burri 1 *, Hein Heidbüchel 2, Werner Jung 3, and Pedro Brugada 4 1 Cardiology Service, University Hospital of Geneva, Switzerland; 2 Cardiology-Electrophysiology service, University Hospital Gasthuisberg, Leuven, Belgium; 3 Schwarzwald-Baar Klinikum, Academic Hospital of the University of Freiburg, Germany; and 4 Heart Rhythm Management Center, UZ Brussel Vrjie Universiteit Brussel, Brussels, Belgium Remote management of pacemakers and implantable defibrillators is being increasingly used in Europe, due to its potential to improve follow-up efficiency and patient outcome. However, this paradigm shift needs to be economically viable for it to be sustainable in the long term. This article covers the economic aspects of remote device management, and reviews the current evidence in this field Keywords Cost Cost-effectiveness Implantable cardiac defibrillator Pacemaker Remote monitoring Introduction Since the 1970s, the capability for transtelephonic interrogation of pacemakers was developed. It allowed remote follow-up with evaluation of heart rate, rhythm, and battery status and, to a limited degree, also of sensing and capture function. With evolution of device and communication technology, device checks that were done manually in-office can now be fully performed accurately by the device itself at the patient s home. The data are sent automatically to the physician by wireless communication to a home transmitter and then to the physician, without requiring any intervention by the patient. Thus, remote follow-up may safely replace in-office visits, 1 as long as no changes in programming are required. Another aspect is remote monitoring, which involves automatic transmissions of predefined alerts, such as onset of atrial fibrillation or abnormal lead impedance. Even though systems from all the manufacturers work in a similar way, there are differences that have been outlined in recent reviews. 2,3 Economic evaluation of remote monitoring and follow-up Unfortunately, economic evaluation regarding remote device management is hampered by a number of obstacles: (1) Paucity of available data regarding clinical effectiveness, efficacy, and costs, requiring assumptions that decrease robustness of the analyses. (2) The multitude of parameters that affect cost in this field, and the inhomogeneity of these parameters (e.g. variations in distances travelled, different reimbursement policies, etc.). This is particularly true in Europe. (3) Possible differences in performance between systems that may affect the drivers of economic models. (4) Medical devices and communication technology are in constant evolution, making it difficult to make mid- or long-term projections of cost. Economic analysis of remote follow-up involves essentially costs and measures of preferences of patients and physicians, whereas remote monitoring involves analysis of cost-effectiveness (i.e. using outcome measures such as hospitalization, heart failure events, etc.). Evaluation of remote monitoring is particularly complex, due to few available data on impact of this strategy on outcome such as reduction in heart failure events, stroke, or inappropriate shocks. Costs related to remote monitoring are also difficult to anticipate, as on the one hand, disease management may lead to reduced hospitalization costs (for instance, due to earlier therapeutic intervention, or willingness of physicians to discharge patients earlier due to the patient being remotely monitored), but may increase use of resources in response to alert messages. The paucity of available data on economic analysis related to remote device and patient management stems from a number of factors. Until recently, there have been no randomized controlled trials demonstrating effectiveness and efficacy of remote management to provide robust data for performing economic analysis. In most healthcare systems worldwide, despite a strong growing interest in health economics, reimbursement decisions do not require formal health economic evaluations. Reimbursement for remote patient follow-up was granted in the USA in 2006 and in Germany in 2008, without any requirement for proof of cost savings. Therefore, there was no need thereafter to conduct cost analysis in these countries. In Europe, reimbursement for remote follow-up is restricted to a few countries, limiting the numbers of patients and thus the possibility of conducting large international registries. Implications of remote device management according to the different parties involved are shown in Table 1, and costs (from * Corresponding author. Tel: ; fax: , haran.burri@hcuge.ch Published on behalf of the European Society of Cardiology. All rights reserved. & The Author For permissions please journals.permissions@oup.com.

2 Remote monitoring: a cost or an investment? ii45 Table 1 Impact of remote monitoring and follow-up as seen from different perspectives Accessibility Quality Efficiency Costs Financial incentive... Patients Increased, especially Better care received Less travel No extra cost Less costs (travel, meals, if remote Quality of life Less time spent accompanying person, Reduced mortality and etc.) morbidity a Medical personnel Hospital Device manufacturer Insurance company State Increased access to patient data Networking of patient data Data centralization Data on healthcare use Increased access of patient care a Proof pending from randomized controlled trials. b Depends on reimbursement. the payer s perspective) are listed in Table 2. The financial implications resulting from remote management vary according to the perspective. For example, if remote monitoring reduces number of hospitalizations, this is financially attractive for the payer, but may result in a loss of income for the healthcare provider (i.e. hospital or physician). However, if only duration of hospital stay is reduced, then the provider is likely to benefit financially, especially if a Diagnostic-Related Group system is applied, as the same reimbursement will be received for less use of resources. Another example is monitoring of battery status. Automatic device transmissions use additional energy that may shorten battery life (the magnitude of this impact is however not well defined by manufacturers), but on the other hand does not make it mandatory to increase frequency of in-office visits and may allow delaying the box change in selected patients (e.g. those who are not pacemaker dependent), since an alert message is sent when elective replacement is reached. For the device manufacturer, the cost of the home transmitter hardware is only a fraction of that of the service provided. Maintenance of the server database, telecommunication costs, and staffing of the technical support helpline (especially as this has to be provided in multiple local languages in Europe), all come at a significant cost. The 2010 UK list prices of systems are 1500 for a landline system and 2100 for a mobile system (including the hardware and service provided). 4 In the French EVATEL study (see Table 3), the device manufacturers receive E1000 compensation for each patient equipped with a home transmitter. It is unlikely that an increase in numbers of patients on remote monitoring Better care given Quicker follow-up No extra cost Possibility to increase total Increased satisfaction Fewer missed visits Increased flexibility Less administrative work number of follow-ups Reputation More efficient use of Transmitter purchase b Shorter hospital stay (for hospital resources same DRG) Increased satisfaction of personnel Product quality control Better patient care Better public service Increased (avoids participation in in-office follow-up) Management of healthcare system Management of healthcare system Data analysis Patient education Transmitter Telecom Database servicing Helpline Scientific studies Transmitter b Transmitter b Marketing value Cost control Fewer cost-intensive clinical events a Cost control Fewer cost-intensive clinical events a will reduce prices, as service costs will also increase proportionately. However, as remote device management is anticipated to become the standard of care in the near future, 5 device companies have a marketing interest in proposing efficient telemonitoring systems. For the provider, there are virtually no fixed costs specifically related to remote implantable device management. The existing computer terminals and internet access require no specific additional investment. The main cost is related to personnel involved in device follow-up. However, due to greater efficiency of remote follow-ups compared to in-office visits (less administrative work in scheduling visits, shorter time spent for performing the follow-up, fewer missed follow-ups, etc.), 1 remote follow-up has a potential to be economically attractive for physicians and hospitals due to the possibility of handling a greater volume of device checks with a more efficient utilization of resources. Adoption of remote device follow-up however requires a learning curve for using this new approach (especially as web interfaces are specific to each device manufacturer), and usually requires several weeks before its use becomes efficient. Education of the patient on proper installation and use of the system is also important to avoid unnecessary troubleshooting and to ensure that alerts may be transmitted properly (e.g. in the CONNECT trial, 45% of the alerts were not transmitted mainly because the system was not set up and initiated to send transmissions). 6 In-clinic instruction to the patient and/or use of material such as brochures, DVDs, etc. are useful for this purpose. Finally, adoption of remote device management will depend on reimbursement, as

3 ii46 H. Burri et al. providers are unlikely to forego income related to in-hospital visits. Reimbursement of remote device management varies across Europe and is an ongoing process in many countries. For the payer (private insurance companies or national health services), the major challenge lies in proposing improved healthcare service without unacceptable increases in cost (and if ideally, at a cost saving). Part of the difficulty lies in the fact that the cost of the transmitter may have to be reimbursed up-front at device implantation, whereas cost saving (due to reduced in-office visits or increased delay to box change) may only be perceived in the long term. Table 2 Direct and indirect costs related to remote device monitoring and follow-up, as seen from the payer s perspective Direct healthcare Indirect costs costs... In-office Remote follow-up Nurse/physician consultation Sickness allowance Home transmitter Nurse/physician consultation Administrative work scheduling data entry to EMR report preparation and mailing billing Transportation Accommodation, meals Administrative work data entry to EMR report preparation and mailing billing Patient education Phone transmissions Maintenance and service of server Impact on device longevity EMR, electronic medical record. Some systems allow direct transfer of device data to the EMR (avoiding manual input of the data). It is still not clear as to whether remote device and patient management should be proposed to all patients or only to a subset that is most likely to benefit from this technology. Regarding remote follow-up, this would include patients living at a long distance from the device clinic or those with reduced mobility. Concerning remote monitoring, even patients living at close proximity to the device clinic may benefit if they are at increased risk of developing adverse clinical events that may benefit from early detection (e.g. atrial fibrillation, heart failure, lead dysfunction, etc.). Device manufacturers may allow the home transmitter to be reprogrammed so that it may be used in different patients, thereby allowing it to be employed only when required most (e.g. at signs of battery depletion, or if a lead issue is suspected). Studies on economic evaluation of remote monitoring and follow-up There are few reports on economic analysis of remote cardiac device management based on prospectively collected data. Cost analyses in telemedicine have been published for a variety of other applications such as teleconsultations and medical videoconferencing, but health and economic implications are very different in these contexts. Furthermore, many reports suffer from limitations that have been addressed in a recent publication that suggests a framework for economic evaluation of telemedicine networks. 7 In 2009, the UK National Health Service (NHS) Purchasing and Supply Agency performed an economic evaluation of remote follow-up. 8 Assuming neither impact on clinical outcome, nor on quality of life with remote follow-up, and a cost of 1000 per home transmitter (including service), it was calculated that the strategy led to reduction in costs after 6 years if the frequency of in-office visits were reduced to once a year. However, details of the analysis (such as travel costs, numbers of remote follow-ups, their reimbursement, etc.) were not reported. Remote monitoring may even allow longer intervals between in-office visits than yearly as currently recommended. 5 In the CONNECT trial 6 ICD and CRT-D patients were seen in-office after a 14-month interval, and in the COMPAS trial 9 in pacemaker patients, this was even extended to 18 months, without increased risk. For remote monitoring to fall below the accepted threshold of per quality-adjusted life year gained, it was calculated that it only Table 3 List of ongoing multicentre randomized controlled trials with cost analysis as a primary or a secondary endpoint, as registered on (accessed on 20 July 2010) Study Sponsor Device Size Primary endpoint Status... COMPAS Biotronik DR-PM 543 Serious adverse events Not recruiting ECOST Biotronik ICD-VR/DR 440 Serious adverse events Not recruiting EuroEco Biotronik ICD-VR/DR 312 Costs Not recruiting EVATEL French ministry of health ICD-VR/DR 1600 Major cardiovascular events Not recruiting EVOLVO Medtronic CRT-DICD-VR/DR 200 Rate of unplanned visits Recruiting MONITOR-ICD Biotronik ICD-VR/DR 416 Costs Recruiting MORE CARE Medtronic CRT-D 1721 Mortality, hospitalization Recruiting

4 Remote monitoring: a cost or an investment? ii47 requires a 5% relative risk reduction of stroke (resulting from earlier detection of atrial fibrillation). 8 With a 20% relative risk reduction, the incremental cost-effectiveness ratio would only be 4069/QALY. Data from a computer-based simulation 10 estimated an 18% yearly reduction in the risk of atrial fibrillation-associated stroke, and the rate was reported to be as high as 25% in the COMPAS trial 9 over an 18-month follow-up. Furthermore, the NHS analysis did not take into account other potential impacts of remote monitoring such as reduction in stroke-related deaths, heart failure hospitalizations, or inappropriate shocks, which would have made remote monitoring even more cost-effective. The first studies evaluating the economic impact of remote follow-up focused on estimated savings of transportation costs. In many countries, these costs are paid by the healthcare insurer. Depending on the distance to be covered, 5-year cumulative avoidable transportation costs ranged from 1377 to 4113 USD. This would not only allow recovery of the technology-related costs (transmitter+communication; estimated at 1200 USD) but would also lead to substantial savings after a few years. 11 Other, rather small studies have further focused on the cost effect from a societal perspective (i.e. of the healthcare payer). In a Finnish study, 12 savings on reimbursement for consultation, transportation (with a mean distance of 130 km), and sickness allowance, led to reduced expenditures of E524/patient over the 9-month study period. Most recent trials on remote monitoring have safety or efficacy primary endpoints. Some of them include estimation of economic variables as a secondary outcome (Table 3). Preliminary results of the REFORM trial have been published, involving 115 patients with a MADIT II ICD indication randomized to three monthly in-hospital visits vs. yearly in-hospital visits (and 3-monthly remote follow-ups), with remote monitoring of events in both groups. 13,14 Time taken for performing the visits and costs related to transportation were tracked. Remote follow-up reduced the total number of visits by 63%. This led to a reduction in transportation costs of E110/patient/year. Also, there was a reduction in the physician s time of 40% (representing about 50 min/patient/year), which translated into an estimated cost saving for the hospital of E712/patient/year, assuming reallocation or reduction of resources. In the CONNECT trial, 6 patients in the remote arm had an 18% reduction in hospitalization duration (P ¼ 0.002), which translated into an estimated saving of 1659 USD/ hospitalization. Time needed to evaluate scheduled remote follow-up and to respond to remote monitoring alerts is a major cost driver for remote device management. Efficiency may be improved by tailoring the alert settings (adjusted at a clinic or individual patient level) and setting up a tiered organization where specialized nurses evaluate alerts before discussing them with physicians. This required weekly connection times of about 1 h by the nurse and about 15 min by the physician in a study involving 117 patients on home monitoring. 15 Data from the Cleveland clinic indicated that an average of 18.7 min/transmission was required by the nurse. 16 Also, the time required to contact and communicate with a patient to seek care averaged 52 min (as it was often difficult to reach patients by phone). These data indicate that time and workflow issues with remote patient management may not be insignificant. The ongoing EuroEco trial is a prospective health-economic trial. It will evaluate the cumulative follow-up costs for physicians and hospitals (from a provider s perspective), and for the healthcare payer (societal perspective). Its premise is that remote monitoring will lead to cost savings for the healthcare payer but that it may have a negative impact on the balance sheet of hospitals and physicians despite reduced time allocation and overall costs, due to the decreases in reimbursement for in-hospital visits. By combining trial data with country- and hospital-specific input it will allow cost calculations for each individual centre, region, or country. The trial uses dedicated time measurement tracking tools for all remote monitoring-associated contacts, such as scheduled remote followups or response to remote alerts. Conclusions There is a paucity of published data on economic aspects of remote device management, but ongoing studies (most of which are conducted in Europe), will hopefully help in assessing the economic viability of this new technology. Remote follow-up has shown to be safe, and is preferred by both patients and physicians to in-office visits. It is likely to add little overall cost to follow-up, and will probably be readily adopted in Europe as it has been in the USA, although reimbursement still needs to be addressed. Remote monitoring however is a more complex issue, as the increase in workload and possibly in costs related to alert messages needs to be offset by improved patient outcome. Nevertheless, with the ongoing technological progress a remote management strategy is likely to become the standard of care. Society and physicians alike should start working on a viable economic model to make this transition possible with a benefit for all parties concerned: patients, providers, and payers. Acknowledgments The authors wish to thank the members of the Eucomed CRM Telemonitoring Working Group for their useful feedback. Conflict of interest: H.B. receives research grants and fellowship support through the University Hospital of Geneva from Medtronic, St-Jude Medical, Boston Scientific, and St-Jude Medical and Sorin. H.H. is holder of the AstraZeneca Chair in Cardiac Electrophysiology, University of Leuven. H.H. received research funding through the University of Leuven from Siemens Medical Solutions. H.H. is Coordinating Clinical Investigator for the Biotroniksponsored EuroEco study on health-economics of remote device monitoring. H.H. is a member of the scientific advisory board of Biosense Webster Inc., St Jude Medical Inc., Siemens Medical Solutions, Boehringer-Ingelheim, Bayer and Sanofi-Aventis, and receives unconditional research grants through the University of Leuven from St Jude Medical, Medtronic, Biotronik and Boston Scientific Inc. References 1. Varma N, Epstein AE, Irimpen A, Schweikert R, Love C, for the TRUST Investigators. Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up. The Lumos-T safely reduces routine office device follow-up (TRUST) trial. Circulation 2010;122:

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