Innovative Medical Technology,Health Technology Assessment,and Health Policy: The Case of Remote Patient Monitoring of Cardiac Implantable Electronic Devices in South Korea

Introduction

South Korea, in common with other developed countries, is experiencing demographic and other changes, which impact healthcare, including an aging population, increasing prevalence of chronic diseases, community demands for more patient-oriented individualized care, and better quality of life. These factors contribute to rapidly increasing healthcare expenditure, leading government, usually the key payer under universal coverage, to seek effective and efficient healthcare service delivery and management. An area of innovation in healthcare delivery involves telemedicine and e-health, where medical technologies are interfaced with Internet-based data monitoring systems, aiming toward more patient-oriented and more efficient and cost-effective diagnostic and therapeutic processes, and therefore, many countries are adopting telemedicine into their healthcare systems. ¹ One such innovation is remote monitoring of patients fitted with cardiac implantable electronic devices (CIEDs) such as pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization therapy devices. ^{2 –4}

Health technology assessment (HTA), by focusing on safety, effectiveness, and cost-effectiveness, plays a pivotal role in driving the adoption of innovative medical technologies, which deliver improved health outcomes, societal benefits, and efficient healthcare delivery. ⁵ As in Australia and other developed countries with universal coverage healthcare systems, policy makers in South Korea have adopted HTA as a filter for reimbursement coverage decisions, and consequently, market access for new medical technologies. ⁶ However, although an important and very useful tool for assessing the value of new medical technology, HTA is not always applied appropriately or the sole criterion for decision-making regarding market access, and health policy and other factors may override the evidence—as illustrated by the case of remote monitoring of cardiac patients fitted with implanted electronic devices in South Korea.

Remote Patient Monitoring Technology in Cardiac Care

Conventionally, the standard of care for patients fitted with CIEDs involves regular follow-up visits to their health provider to receive in-person consultation and monitoring of their cardiac devices. Remote patient monitoring (RPM) technology has been developed to remotely and wirelessly monitor patients with CIEDs. This novel technology is able to remotely monitor patients, deliver the data to their treating physicians and, thereby, reduce the need for regular in-office or hospital outpatient follow-up visits and evaluation. RPM technology has been rapidly adopted globally because of its proven advantages in terms of improved survival, as well as improved safety and efficacy, compared with conventional in-person consultation; for instance, reduction in the frequency of inappropriate shocks, shorter lead-time to detection of clinical and device-related adverse events, fewer emergency room visits, and hospitalizations. ^3,4,7 RPM has also demonstrated cost-saving benefits, for instance, extension of CIED battery longevity and reduction in overall procedural costs, as well as reduction in follow-up visits, leading to savings in travel time and costs for patients. ⁸

It is widely recognized that RPM is an effective complement to in-person consultation and follow-up. Recently, the Heart Rhythm Society and European Heart Rhythm Association Expert Consensus concluded that RPM technology is an integral part of the standard of care in managing patients with CIEDs. ⁹ The expert consensus statement was developed through international collaboration of cardiac societies and paves the way for RPM to be accepted internationally as the standard of care.

RPM for CIED in South Korea

Despite global recognition of the value of RPM for CIED, its adoption varies depending on the particular healthcare system in each country. In several cases, HTA is the key evaluation process determining adoption of new medical technology. However, successful HTA may not be sufficient to secure market access for RPM because its implementation for CIED generally requires changes to healthcare delivery settings, and these unprecedented changes may cause controversy among stakeholders, which impacts adoption.

In some Asia-Pacific countries with universal healthcare systems, RPM for CIED is available, and reimbursement coverage is secured. ¹⁰ For instance, in Australia, funding was approved after careful scrutiny of the safety, effectiveness, and cost-effectiveness of RPM for CIED by the Medical Services Advisory Committee, the peak HTA body for medical services and associated technology. ^11,12 In Japan, RPM for CIED has been available and reimbursed since 2010. ^13,14 On the contrary, however, despite the similarity in governance and function of the Japanese and Korean universal healthcare systems, and the established use of HTA for decision-making in the latter, in South Korea, the technology is not only unavailable but also its use is prohibited.

This anomaly is extraordinary for a number of reasons: first, South Korea has a proud history of rapidly adopting and utilizing new medical technologies; and second, the country has excellent information and communication technology infrastructure for embracing new technology. ¹⁵ In fact, physician-to-physician remote medical treatment has been allowed since March 2002 and implementation of the Medical Service Act (MSA) amendment. ¹⁶ However, physician-to-patient remote medical treatment, including RPM for CIED, remains prohibited and illegal.

With the aspiration of more efficient management of the national healthcare insurance system and better chronic disease management, the Ministry of Health and Welfare (MoHW) proposed in December 2013 an amendment to the MSA to allow physician-to-patient remote medical treatment. ¹⁷ However, the Korean Medical Association (KMA), which represents mostly general practitioners in primary care, strongly opposed the amendment bill with political support from the major opposition party in the National Assembly.

The KMA's opposition to physician-to-patient remote medical treatment was on the following grounds. ^18,19 First, remote medical treatment was unlikely to be effective in South Korea because, globally, it is actively used in only those countries with poor access to care due to low physician density (in turn due to large land mass). However, Korea has a physician density of 0.98 per km², second highest in the world, and 100 times larger than Canada, Australia, and Russia. ¹⁸

Second, physician-to-patient remote medical treatment would exacerbate the distortions already in the healthcare delivery system. Healthcare delivery in South Korea depends heavily on the private sector; for instance, only about 10% of healthcare providers are in the public sector. ²⁰ Because the primary care referral system does not function well, and healthcare providers, from general practitioners to teaching (general) hospitals, provide similar medical services, they compete with each other for patients under the private sector-dominated healthcare delivery system rather than offer coordinated care. Since the role of general practitioners as primary care gatekeepers is very weak and patients have complete freedom to select their healthcare provider, ^20,21 the introduction of physician-to-patient remote medical treatment would fuel the fierce competition between providers, and by giving a patient recruitment advantage to teaching hospitals, perhaps would facilitate the deterioration of an already weak primary care infrastructure and the access of patients to medical care.

Third, as seen with the problems encountered by the MoHW remote medical treatment pilot program, ²² physician-to-patient remote medical treatment would pose a cybersecurity problem for patient health information, requiring a high level data security management system to first be in place.

Health Policy and RPM for CIED in South Korea

In South Korea, new medical technology, which replaces or complements conventional medical practice, and which also satisfies HTA for safety and efficacy, is rarely the subject of controversy among stakeholders, particularly between MoHW and KMA. However, the prohibition of physician-to-patient remote medical treatment, including RPM for CIED, is a unique case. There are several issues as follows: because remote medical treatment requires a different medical service pathway, healthcare provider engagement, and demands on patient cooperation, it is essential to have careful deliberation, transparent discussion, and proper exploration to evaluate the real benefits and risks of remote medical treatment. To move forward the policy on remote medical treatment and patient access to a beneficial technology, we make the following proposals.

First, a clear definition and scope of physician-to-patient remote medical treatment should be developed and agreed by stakeholders. Various remote medical treatment services are available, each using different technologies with different characteristics and outcomes in terms of safety, efficacy, and cost-effectiveness, and with varying levels of quality of clinical and economic evidence to support HTA for market access. However, because so far the discussions have been based on poorly defined services, with little understanding of the characteristics of the specific technologies involved, it has been difficult for stakeholders to be productive and reach agreement. RPM for CIED is a good example of a case where the clinical safety, effectiveness, and cost-effectiveness of the service have been accepted (as shown by the Heart Rhythm Society statement and reimbursement coverage in Australia and Japan); the KMA's grounds for opposing its implementation are mostly not applicable and, therefore, achieving consensus among stakeholders about its introduction should be easily made.

Second, a higher level of engagement and trust between stakeholders needs to be developed. This would be greatly facilitated if the MoHW agreed to transparently share the findings about safety, efficacy, and cost-effectiveness of remote medical treatment from its pilot program, thereby relieving the concerns of stakeholders and fostering better engagement and trust—particularly between MoHW and healthcare providers, including the KMA. Most healthcare providers believe that current healthcare policies do not reflect reality, in that although the national health insurance (NHI) system and its rapid expansion have been a success for the community, it has required significant sacrifice from them. In extending the NHI system to the entire population, government policy included maintaining medical fees at low levels and restraining the requirement for higher health insurance premiums, with the result that the fees paid to healthcare providers are inadequate to cover the cost of providing medical services. ^15,23

As previously discussed, although Korea has shown remarkable improvements in its universal healthcare system in recent decades, fundamental problems remain, for example, a weak primary care and ineffective referral system and an overemphasis on (reflecting patient preference for) hospital-based healthcare services. Teaching (general) hospitals increasingly attract outpatients and tend to oppose their transfer to primary care practitioners. ²³ This distorts the healthcare delivery system by causing an imbalance between hospital and primary care physician fees. Therefore, primary care providers tend to resist new policies initiated by MoHW, concerned that they would simply make the imbalance even worse. However, RPM for CIED does not induce competition for patients between healthcare providers, neither does it distort the referral system, because all CIED implanting procedures are performed in hospitals only, and in-person consultations are also made there. For these reasons, RPM for CIED is a good subject for exploring and opening discussions about physician-to-patient remote medical treatment services.

A health policy model that would begin to address the issues around ineffective referral, primary care practitioner resistance to physician-to-patient remote medical treatment, and the lack of trust would be a program wherein the roles and responsibilities of healthcare providers are shared. The program could be introduced in stages, with less risky devices (for instance, pacemakers) in the initial “pilot” phase; later, RPM for CIED would initially be conducted by the implanting hospitals (for instance, in the first year or two postoperatively), but once patients were stabilized the responsibility for RPM would transfer to primary care practitioners and remain with them until a replacement procedure was necessary (at which point the cycle of responsibility would begin again). This clarification and sharing of roles and responsibilities would address the major issues, afford patients the benefit of advanced technology, and also lead to seamless care. However, for this policy to succeed reimbursement coverage in relation to RPM must be appropriate for both hospitals and primary care practitioners; in this respect, the recent MoHW effort to improve patient referral by creating unique referral fee schedules is an encouraging development. ²⁴

Third, it is crucial to have healthcare provider engagement at the initial stages of health policy development. Remote medical treatment is a new and rapidly evolving class of healthcare service, and healthcare providers play a pivotal role in its successful adoption. Given healthcare providers' primary interest in patient safety, their concerns about the potential risks of remote medical treatment (including risk of professional liability) may be reduced by recognizing that remote medical treatment, as in the case of RPM for CIED, is complimentary to in-person consultations and not a replacement for them.

Fourth, to tackle the issue of cybersecurity risk, again appropriate government intervention and collaboration with stakeholders are important. Although the application of information and communication technology in medicine increases ease of use and efficiency, it increases concerns about loss (accidentally or maliciously) of confidential patient information and risk of adverse outcomes due to technology malfunction. At present, in South Korea, patient medical information is protected by the Personal Information Protection and MSAs; ^25,26 however, it would be most helpful to study the measures put in place by the U.S. Food and Drug Administration to raise awareness of, and to prevent, cybersecurity risks posed by medical devices. ²⁸

Finally, patient benefit should be placed at the center of policy development and the value the community places on healthcare should be the top priority. New medical technologies, which deliver better clinical outcomes to patients and better economic value to the healthcare system, will continue to become available; RPM, including RPM for CIED, fits into this category, not replacing traditional physician-patient encounters and compassionate communication between them, but offering another channel for treating patients.

Conclusions

Generally, clinical and economic benefits are the key determinants for successful market access of new medical technologies. Unfortunately, the introduction and adoption of RPM for CIED in South Korea, despite its potential to deliver better patient care and efficiencies for the health system, have been hampered by controversy originating in a poorly designed healthcare delivery system and deep mistrust between key stakeholders. While healthcare providers' opposition to physician-to-patient remote medical treatment is understandable in some respects, many issues could be resolved through better stakeholder collaboration—collaboration led by government initiatives in response to demands for an efficient and consumer-oriented healthcare system, as well as aiming to intervene in professional conflicts of interest.

At a time when it is critical that healthcare systems be efficient and sustainable, it is very important to pay more attention to preventive and good quality postprocedure management opportunities, particularly in chronic disease states such as heart failure. In this respect, it is essential that health policy development be based on collaborative engagement of all stakeholders—and also on evaluation of the evidence—so then legislative barriers can be removed to allow the community access to the clinical and economic benefits of new medical technology, such as RPM for CIED. Because health policy is crucial to the introduction of new medical technology, it is very important to ensure that poorly designed aspects of a healthcare delivery system, which act as a barrier to access useful medical technology, are quickly corrected, so that Koreans may also reap the benefits, which their counterparts in other developed countries enjoy.