Abstract
Background:
The use of telemedicine is expanding worldwide in response to the COVID-19 pandemic, and deregulation is occurring even in countries with strict regulations, such as Japan.
Methods:
We conducted a narrative review of the activities and initiatives undertaken by the government and professional organizations to promote the use of telemedicine in Japan from January 2020, when the COVID-19 pandemic began, to September 2021.
Re
Conclusions:
With the COVID-19 pandemic, telemedicine is now moving toward widespread use. However, further activities and initiatives, including policy changes such as reimbursement and the establishment of evidence to show the effectiveness of telemedicine in Japan, are needed to properly disseminate telemedicine.
Background
The COVID-19 pandemic has caused a great deal of damage around the world and has affected the way society operates. In the realm of health care, the adoption of digital health, most notably telemedicine, has been accelerated. 1,2
There have been various surveys and studies on obstacles to the spread of telemedicine, and government regulations, policies, and laws have been pointed out as barriers. 3,4 However, the recent pandemic has led to deregulation in many countries around the world and the spread of telemedicine in various fields. 5 –7 For example, although Japan is a developed country with well-developed infrastructure, until the COVID-19 pandemic, the use of telemedicine was not widespread because of regulations and other factors, such as the inability to conduct first-visit consultations and reimbursement prices that were less than those for face-to-face (FTF) visits. 6,8 As a result of the COVID-19 pandemic, however, the use of telemedicine has increased in Japan due to deregulation, 6,7 but it is still not sufficiently widespread and further dissemination measures are required.
The purpose of this study was to conduct a narrative review of the activities and initiatives undertaken by the government and professional associations to promote telemedicine in Japan in response to the COVID-19 pandemic and to summarize the challenges for the promotion of telemedicine and how they can be overcome. The information compiled in this study is expected to provide useful insights to policy makers and medical practitioners who are grappling with similar issues.
Methods
We reviewed the activities and initiatives undertaken by the government and professional organizations to promote the use of telemedicine in Japan. The period covered was from January 2020, when COVID-19 cases were first confirmed in Japan, to September 2021, the time of writing. The information was collected based on the authors' knowledge and networks, and a narrative review was conducted to identify changes from previous regulations and remaining challenges.
Results
Progress of Deregulation
The first case of COVID-19 in Japan was confirmed on January 15, 2020. 9 The number of infected people gradually increased, reaching a total number of cases of 147 by February 25. 10 In response to this increase in the number of infected people, the Japanese government set up the “Novel Coronavirus Response Headquarters,” and the headquarters announced the “Basic Policies for Novel Coronavirus Disease Control.” 11 This group of policies included the statement “Systems should be in place to allow people who are receiving continuous treatment and medication to receive medical care by phone or other means without visiting a medical institution,” which was perceived as encouragement for the use of telemedicine.
In response, the Ministry of Health, Labor and Welfare (MHLW) issued a notice on February 28 relaxing some of the rules for telemedicine. 12 Previously, when telemedicine was performed in Japan, the original prescription had to be sent to the patient in paper form by mail; the relaxation allowed prescriptions to be sent to a pharmacy by fax. In addition, although telemedicine was previously allowed only for scheduled patients for whom a medical treatment plan had been prepared in advance, the new notice allowed telemedicine to be performed without advanced preparation of a medical treatment plan.
However, telemedicine covered by public health insurance was previously available only for specific diseases in Japan, and the deregulation on February 28 did not improve this situation. Accordingly, the “Council on Investments for the Future” was held on March 5 and was attended by the prime minister and several cabinet ministers. Japan's growth strategy was discussed with experts from the business world, and several participants spoke about the need to promote the spread of telemedicine and deregulation. 13 Similarly, at the March 10 meeting of the “Council on Economic and Fiscal Policy (CEFP),” where the prime minister and several cabinet ministers discussed economic and fiscal policies with experts, several participants spoke about the need for the spread of telemedicine and deregulation. 14
Against this backdrop, on March 11, the MHLW held the “Committee to Review the Guidelines for the Appropriate Operation of Online Medicine,” which had previously been a meeting to discuss the regulation of telemedicine with representatives of physician groups. 15 The MHLW, which served as the secretariat for the conference, proposed that changes and additions to drugs for chronic diseases be made possible through telemedicine, and this was approved. However, although some of the committee members who are physicians voiced their dissatisfaction with the fundamental restrictions on telemedicine in Japan, such as the limitations on the diseases covered by insurance, the low insurance prices, and the inability to conduct a first visit, the meeting as a whole did not actively discuss further deregulation.
In response to the results of this meeting, a notice was issued on March 19 that allowed telemedicine to prescribe medications that had not been previously prescribed for patients with chronic diseases and a history of regular medical visits. 16 In addition, on March 27, a notice was issued to slightly increase the price of reimbursement for telemedicine performed over the phone. 17 In general, however, telemedicine remains highly regulated and difficult to use.
In response to the MHLW's insufficient deregulation of telemedicine, there were many calls for the deregulation of telemedicine at the CEFP meeting held on March 31. Prime Minister Abe, who chaired the CEFP, instructed the “Council for the Promotion of Regulatory Reform (CPRR)” to take urgent measures to deregulate telemedicine. 18 The CPRR, from the standpoint of reviewing government-wide regulations, had often asked the MHLW to review regulations on telemedicine, and on March 10, a working group on medical care asked for a review of the regulations of telemedicine. 19 After the prime minister's endorsement on March 31, the CPRR set up a special task force on April 2.
During the COVID-19 pandemic, only two topics were taken up by the task force for regulatory reform—telemedicine and distance education in schools—indicating that political attention was high. The task force, which met on April 2, asked the MHLW to make three improvements: (1) to allow first visits through telemedicine, (2) to make the reimbursement price for telemedicine the same as that for FTF visits, and (3) to require pharmacists to provide medication guidance remotely. 20
However, the MHLW's “Committee to Review the Guidelines for the Appropriate Operation of Online Medicine,” which met on the same day (April 2), responded negatively to the issue of initial consultations in telemedicine and did not put forward a positive policy regarding deregulation. 21 In contrast, the second task force, held the following day on April 3, criticized the discussions held at the MHLW on the previous day and argued for the need for more aggressive deregulation. 22
As a result, based on the recommendations of the task force, the CPRR issued a statement on April 7 stating that further deregulation of telemedicine was necessary. 23 In addition, in the “Emergency Economic Measures to Cope with COVID-19” announced by the cabinet on April 7, the cabinet requested the MHLW to enable telemedicine to be administered from the first visit and to improve the price of telemedicine reimbursement, based on the recommendations of the task force. 24
In response to this, on April 10, 2020, the MHLW issued a notice regarding a temporary measure to allow telemedicine for first visits and to allow remote medication guidance. 25 At the same time, telemedicine became available for most diseases that can be covered by insurance, and the price of telemedicine coverage was increased somewhat but remained lower than that for FTF visits. 26 These deregulations have greatly advanced the regulation of telemedicine in Japan. In fact, the number of medical institutions implementing telemedicine has increased, and according to a list released by the MHLW on April 24, ∼10,000 medical institutions nationwide have started offering telemedicine for first visits. 27
Response of the Medical Community
The response of the medical community to this series of deregulation moves was not all that positive. First, the Japan Medical Association (JMA), the largest lobby group in the Japanese medical community, has long been opposed to the active use of telemedicine even before the COVID-19 pandemic, 28,29 and they have stated that the expansion of telemedicine based on convenience alone is unacceptable, even after deregulation. 30 In addition, organizations of private psychiatric hospitals and others expressed concern about the rush to introduce telemedicine. 31
In contrast, four societies, involved in the treatment of dementia patients, jointly released a statement calling for the deregulation of insurance points for cognitive function tests conducted remotely, noting that evidence for these tests is being established. 32 And, the Japan Primary Care Association and the Oto-Rhino-Laryngological Society of Japan created and published their own guidelines for telemedicine to provide support and information. 33,34 Furthermore, to address concerns about clinical safety, the Japanese Association of Medical Sciences, which includes all medical departments, compiled the opinions of representative societies for each medical department and published a proposal on June 1, 2021, outlining cases that are not suitable for a telemedicine first visit. 35
Moves Toward Further Deregulation
Both the CEFP and the CPRR continued to consistently call for the promotion of telemedicine and the permanent implementation of the current measures. 36,37 In response, the MHLW, at the “16th Committee to Review the Guidelines for the Appropriate Operation of Online Medicine,” held on June 30, 2021, decided to steer in the direction of making the measures to enable first visits through telemedicine permanent, including the classification of the diseases to be covered. 38
Discussion
We found that the COVID-19 pandemic led to several moves, including government deregulation and the actions of professional associations, that enabled the spread of telemedicine in Japan. Although few studies had analyzed obstacles to the spread of telemedicine in Japan before the COVID-19 pandemic, Shimizu et al. used the interpretive structural model method to stratify 18 factors that hinder the spread of telemedicine in Japan. 39 As a result, three factors, “Initial and Operation Cost,” “Research Data,” and “Risks for Clinical Safety” were listed as level 1 factors, the lowest level of the hierarchy.
In terms of these items, some improvements have been made in the “Initial and Operation Cost” area by raising the price of telemedicine reimbursement to be closer to that of FTF visits, but the price remains lower than that of FTF visits. According to a survey of mental health services offered in 17 countries and regions, the price of telemedicine reimbursement by public health insurance was lower than that of FTF visits, even after the start of the COVID-19 pandemic, only in Japan and some parts of China. 6 This deviation in pricing from international standards has been an obstacle to the spread of telemedicine in Japan.
As for “Risks for Clinical Safety,” the environment is becoming better than before the COVID-19 pandemic, with guidelines from academic societies 33,34 and recommendations from the Japanese Association of Medical Sciences. 35 As for “Research Data,” there is still a lack of evidence and practical examples of clinical effectiveness in Japan due to various regulations that were in place before the COVID-19 pandemic. However, with the relaxation of regulations after the start of the pandemic, large-scale clinical studies have started 40 ; for the time being, further accumulation of evidence in Japan will be required.
Another reason for the lack of widespread use may be that the MHLW has been cautious about implementing a policy because of opposition from the JMA and other organizations. In fact, as we have seen in this article, few deregulations have been initiated by the MHLW, and they have been responding incrementally to prodding by the CEFP and CPRR.
As an example of stakeholders in primary care, such as general practitioners, resisting the spread of telemedicine because of self-interest, a similar report from Korea has been published. 41,42 To promote telemedicine in Japan, obtaining the understanding of stakeholders and requesting deregulation from the MHLW will be necessary. In addition, it may be important to ensure that the “Initial and Operation Cost” of primary care physicians are adequately covered, and that “Research Data” and “Risks for Clinical Safety” are sufficiently improved to allow the understanding of all concerned stakeholders.
Conclusion
In this study, we conducted a narrative review of the activities and initiatives undertaken by the government and professional organizations to promote the use of telemedicine in Japan during the COVID-19 pandemic. Although various proposals and deregulations have been made to expand the use of telemedicine, further activities and initiatives, including the establishment of evidence in Japan, are needed to promote its widespread use. Promoting the spread of telemedicine is a complex policy area with many stakeholders, and it is important to discuss it in various contexts and establish an acceptable foundation.
Footnotes
Disclosure Statement
No competing financial interests exist.
Funding Information
No funding was received for this article.