The role of telemedicine in ensuring the accessibility and development of medical care in Russia, United States of America and India

Размещено на http://www.allbest.ru/

GOVERNMENT OF THE RUSSIAN FEDERATION

FEDERAL STATE AUTONOMOUS EDUCATIONAL INSTITUTION

HIGHER VOCATIONAL EDUCATION

NATIONAL RESEARCH UNIVERSITY

HIGHer SCHOOL OF ECONOMICS

Faculty of Social Sciences

Department of Healthcare Administration and Economics

GRADUATION THESIS

«The Role of Telemedicine in ensuring the Accessibility and Development of Medical Care in Russia, United States of America and India»

38.03.04 State and Municipal Administration

Master's Program Health Care Administration and Economics

Shounak Mukherjee

Moscow 2020

Contents

• Introduction
• Chapetr 1. The role of telemedicine in health care provision
• 1.1 Quality of Care
• 1.1.1 U.S.A.
• 1.1.2 Russia
• 1.1.3 India
• 1.2 Major Developments
• 1.3 Comparative Analysis of telemedicine services in U.S.A, Russia and India
• Chapter 2. Regulation of Telemedicine
• 2.1 The problems of Regulation of Telemedicine in U.S.A.
• 2.2 The problems of Regulation of Telemedicine in Russia
• 2.3 The problems of Regulation of Telemedicine in India
• 2.4 Comparative analysis of the laws of telemedicine in U.S.A, Russia and India
• Chapter 3. Impact of Telemedicine on the medical care system in Russia, United States of America and India
• 3.1 Clinical Outcomes
• 3.1.1 Asthma Control and Patient's quality of Life Assessment in U.S.A.
• 3.1.2 Improved treatment compliance of pediatric HIV patients in India
• 3.1.3 Effective tele-ophthalmology examinations in India
• 3.2 Accessibility
• 3.2.1 Outcomes of Handheld tele-ECG for health care delivery in rural India
• 3.2.2 Expanding telemedicine services throughout Russia
• 3.3 Cost Effectiveness
• 3.3.1 U.S.A.
• 3.3.2 India
• 3.3.3 Russia
• 3.4 Other Benefits
• 3.4.1 Benefits for patients
• 3.4.2 Profitable for providers
• 3.5 Recommendations
• Conclusion
• Bibliography
• Introduction
• Centuries of doctor-patient relations have centered on in-person communication and physical examination. We have been conditioned to view that as the norm of traditional method of healthcare provision, causing us to see telemedicine as disembodied and impersonal, making us reluctant to embrace it.
• But challenges and new technologies dictate the need for a transition to a new organizational mode of healthcare-telemedicine. And recently a new challenge has appeared in front of the whole world -the Covid-19 ambush. With mandated social distancing policies in place to counter the rapid spread of a highly infective virus, health care providers have been forced to resort to telemedicine.
• Telemedicine has many advantages, including keeping patient safe from possible exposure to the coronavirus that causes Covid-19, improving access to care, cutting health care costs etc.
• The main aim of this study is to provide an understanding of the Russian, American and Indian telemedicine systems at the current stage, their legal aspects (and their insufficiencies) as well as to analyze the impact and outcomes of telemedicine in the development of quality medical care provided in the countries mentioned above and develop recommendations to strengthen telemedicine services in Russia and India and establish the significance of telemedicine especially in the times of a pandemic like COVID-19.
• The use of telemedicine in modern medicine makes a positive shift in focus from only the detection and treatment of diseases to identify a predisposition to the development of diseases (P1 - prediction), prevent the onset of diseases (P2 - prevention), an individual approach to each patient (P3 - personalization) and motivated patient participation in disease prevention (P4 -participatory).Consequently inclusion of telemedicine makes provision of modern healthcare more personalized and safer.
• Research Questions-
• * To analyze the need for telemedicine in healthcare system
• * To overview the regulation and the legal aspects of telemedicine in Russia, United States of America and India
• * To compare the telemedicine issues and highlight the insufficiencies in providing telemedicine services in Russia and India with the existing laws and guidelines
• * To develop recommendations for strengthening telemedicine in Russia and India
• Methods - The principle method in the study of this issue is the analytical method. Comparative studies of data on clinical, cost, or intermediate outcomes associated with the use of any technology to facilitate consultations for inpatient, emergency, or outpatient care, were conducted. Based on the analysis of the current legislative base, the materials of the Federal Services of respective countries, as well as the publications of leading researchers on issues related to the availability of medical services to the population, the author's own point of view on the issues of development and accessibility of telemedicine services was determined.
• As a result, conclusions are drawn and possible directions for solving the identified problems are outlined. Recommendations for the development of telemedicine and innovative medical services in Russia and India are given.
• Data sources-Laws, regulatory acts and policy documents of healthcare systems in Russia, United States of America and India, foreign and Russian literature on telemedicine, statistical data from research centers (analytical articles concerning the current stage of the telemedicine services in Russia, United States of America and India) and as well as data from official web sites of the Russian, American and Indian healthcare institutions.
• The study is divided into 3 parts. The first part describes the role of telemedicine including quality of care, major developments and comparative analysis of volumes of telemedicine services provided in Russia, United States of America and India.
• The second part is devoted to the legal background of provision of telemedicine services in Russia, United States of America and India as well as the challenges in the existing laws, guidelines and legal procedures.
• The third part focuses on impact of telemedicine on clinical outcomes, accessibility of care and cost. Also recommendations are made to resolve the issues pertaining to the field of telemedicine in Russia and India to strengthen telemedicine services.
• Chapter 1. The role of telemedicine in health care provision
• 1.1 Quality of Care
• In the twentieth century, the main driver of development and improvement of quality of medical care was the development of pharmaceuticals, in particular the emergence of biomedical drugs and cancer therapy, as well as the improvement of diagnostic methods and high-tech surgical tactics. Today, telemedicine, whose solutions are at the intersection of healthcare and consumer technologies, is making an increasing contribution to improving the quality of medical care and increasing the life expectancy of patients.
• Telemedicine already allows you to collect information for clinical trials, analyze patient data and share them for a more accurate diagnosis, as well as establish operational processes in the healthcare system. For example, in the United States, the ability to collect online medical consultations and the rapid exchange of patient information eliminate the need to transport seriously ill patients from one intensive care unit to another or other departments. This saves about $ 0.5 billion annually - the introduction of telemedicine technologies has reduced the number of patients transported in the United States from 2.2 million to 1.4 million [3].
• But the main purpose of telemedicine is to create comfortable and safe living conditions for people: to monitor changes in the body, to prevent complications or critical situations. The patient not only gets access to high-class specialists of central clinics and doctors, but also saves on transportation costs and reduces travel time.

1.1.1 U.S.A.

The United States spends more than a trillion dollars annually on healthcare (over a quarter of the federal budget). Costs are increasing every year, and the quality of treatment is gradually decreasing (vivid proof of this is the number of medical errors). At present, neither the republican nor the democrat party have a rational plan to modernize the healthcare system and this has lead to the launch of a large-scale campaign to legalize telemedicine (telemedicine), a way to provide doctoral services at a distance through video linking a doctor and a patient through a smart-phone, computer and other devices [4].

Proponents of this “progressive” method of treatment want to equate telemedicine with traditional visits to doctors and get it covered by Medicaid, Medicare and other insurance.

Professors from several American universities tested the 16 largest telemedicine companies in the year 2016[4]. The results were disappointing: virtual doctors mistakenly diagnosed various diseases (including skin cancer, herpes and syphilis), and asked patients too few questions. Negligent attitude to patients was felt in most of the virtual receptions.

There are two directly opposite points of view on the future of telemedicine. Critics consider remote treatment a trivial fraud that will help enrich a certain portion of people in the areas of healthcare and higher technologies, but ultimately this will destroy American medicine.

But many Americans see telemedicine as a good alternative to Barack Obama's medical reform (Obamacare). Talking with a doctor through a computer or smart-phone is still better than paying $ 300 - $ 400 per month for insurance that doesn't really cover anything and requires an extra charge for most procedures [4].

In general, however, the development of telemedicine is further evidence that the national health system is going down the drain. There is a catastrophic lack of money to treat Americans, and the government is looking for ways to cut costs. Medical marijuana and telemedicine are what Americans ultimately get in exchange for traditional treatment.

However many critics of telemedicine believe that theoretically treatment at a distance is possible, but for this the patient should be attached with various sensors/detectors, and the doctor should hold in his hands his detailed analyzes.

But there are more than a few reasons why hospitals across the country are choosing to implement telemedicine. For some, telemedicine can provide a board-certified emergency physician for consultation in the event they need to perform an infrequent procedure. Others rely on telemedicine to support providers, delivering a better work-life balance to clinicians. Many opt for virtual consults with the aim of keeping care local, avoiding unnecessary transfers and offering specialized services.

1.1.2 Russia

Geographical remoteness and poor development of the transport system do not allow many residents of Russia, in particular residents of rural areas, to make the necessary number of visits to primary care medical institutions with medical and preventive goals. Residents of a number of regions are often “cut off” from access to the services of specialist doctors due to geographical or socio-economic conditions. The state proclaims the principle of accessibility of medical assistance to all citizens of the country, regardless of place of residence. In that context, an important advantage of telemedicine is that it is able to support the emerging positive dynamics, as one of its most important functions is to overcome geographical inequalities in access to medical care, increase and, in the long term, full provision of access to qualified medical care assistance for rural residents, remote and inaccessible areas.

However, another important function of telemedicine, in addition to overcoming geographical inequality, is to reduce the costs of the health system and provide quality healthcare. Healthcare information and communication technologies potentially reduce needin consultations of outpatient hospitals and, as a result, reduce the total costs of medicine. Telemedicine video consultation is about 20 times cheaper for a patient than a trip from the Urals to Moscow, and for patients from Yakutia and Transbaikalia - about 40 times [1]. If a patient is accompanied by a relative or anyone, the cost of the trip is doubled.

Providing tele-consultation assistance in resolving issues of diagnosis, treatment (including surgery), and rehabilitation of patients implies the possibility of working in on-line and off-line modes, i.e. directly at the time of contact or in the form of a delayed consultation at an agreed time, as well as in the form of an exchange of data and opinions by e-mail. A prerequisite is to provide the consultant with complete initial information (identical with that of the attending physician) for making a decision (issuing an opinion) on the diagnosis, plan for further examination and treatment of patients.

This approach, when working in the videoconference mode, implies the possibility of direct consultations in the process of surgical intervention and even remote operation (tele-surgery) at a certain level of technical equipment.

Existing telemedicine centers differ in methodological approaches, level of technology, principles of organization of work. Considering the importance of consultation video data in combination with doctors' participation in the analysis process, technical solutions should support and provide an opportunity based on generally accepted standards for the presentation and transmission of information [6].

Nevertheless, for citizens of Russia this is a relatively new way of getting medical care and more and more people are showing interest in it. As a result, new digital services are appearing on the market, and insurers are increasing the possibility of receiving remote consultations - via chat or via video calls - in their products as additional options [16].

When interacting with medical professional through service providers, law enforcement agencies in peacetime and wartime, are planning to conduct tele-consultations by the central and field hospitals of the Ministry of Internal Affairs of Russia, the Ministry of Defense of Russia, and specialized healthcare institutions of the Ministry of Health of Russia.

1.1.3 India

India is a country with a vast territory and population exceeding one billion human. She continues to strive to improve her weak health indicators. Despite a carefully planned public health system the state of access to health care in rural areas is far from satisfactory. During a number of case studies conducted at home and abroad have been confirmed the technical capabilities of telemedicine to ensure a satisfactory transfer of knowledge and information related to patient care, as well as professional development and skills of healthcare providers and administrators at all levels - primary, secondary and tertiary.

In conditions of huge inequality in the development of urban and rural infrastructure, the use of telemedicine-based medical services seems promising. Over the past years, a number of initiatives have emerged, aimed at developing various e-health services.

Today, almost every area ofmedicine is implemented through communication. The lack of medical staff in some regions of the country (especially in rural areas) places on telemedicine an important role in unifying medical services among the population. However, there are medical specialties that are represented in this area more than the rest. They formed the main directions of modern telemedicine.

India's healthcare system is developing rapidly in both the public and private sectors. To encourage private sector development, the government has been providing tax incentives to many companies. The use of electronic technology in the healthcare sector is gaining popularity in India. As a result, telemedicine is developing very successfully. In 2012, this segment was estimated at $ 7.5 million, but by 2017 it grew to $ 18.7 million [9].

Thanks to these promising figures and opportunities, not only the training of sufficient doctors will be achieved, but also improved patient care at all the levels. Public and private institutions carry out activities in the field of distance medical care by providing communication lines, as well as hardware and software.

1.2 Major Developments

The introduction of ICT in medicine is not the introduction of a new method of treatment - it is a new medical care tool that uses the exchange of medical and official data of the patient and recommendations for the diagnosis and treatment of the patient. Based on data Doctors make the same diagnoses and make decisions about treatment, as before the use of modern ICT [2].

ICTs have played an important role in advances in medicine and healthcare. There are different approaches to understanding the history of telemedicine, in a wide version,it appeared at the end of the XIX century. When the newly invented phone began to be used to provide consultations at a distance, doctors were among the first to use in their work phone.

The inventions of the first commercial computer and the Internet provoked dramatic changes in healthcare due to new ways of delivering medical services, telemedicine has become an alternative method of medical care. Today telemedicine is already being used by patients who can use a variety of tools and monitor their condition, including personal computers, smart-phones, other gadgets and applications.

According to reviews by experts from the healthcare industry, in Russiain the face of widespread inequalities in access to medical care, telemedicine services can expand the ability of the population to receive quality healthcare facilities.

The prospects for the development of telemedicine in the Russian Federation are due to a number of factors, among which:

* Low population density in most regions, remoteness settlements from district and regional centers;

* Insufficiently developed transport infrastructure, in addition, season and weather dependent, irregular and high cost of passenger transportation;

* Severe climatic conditions in the northern and equivalent to the northern regions of the country;

* Lack of qualified medical personnel in sparsely populated and remote regions of the country.

The process of developing modern standards does not consist in fixing existing, established methods of structuring medical information, but is a systematic process of working out the whole range of related issues of telemedicine - from the requirements development phase to the implementation phase. At the same time, the methodology for developing functional standards should take into account such aspects as compatibility, quality, implementation time of the standard, the presence of a variety of platforms and applications on the network, and language differences.

The methodology of the systematic process of developing functional standards is a typical development cycle of a complex information project:

Requirements development phase - analysis phase - implementation phase.

Within each phase, issues specific to it are examined for compliance with requirements, consistency, and functionality, which is reflected in the corresponding phase of the model. In turn, each phase can be divided into stages. The number of stages may depend on the complexity of the subject area, but in general, in the analysis phase, we can distinguish:

• Functional analysis

• Information analysis

In the implementation phase, the following stages can be distinguished:

• Formalization of interactions

• Formalization of messages

• Message standardization

The main stages of the process of developing message standards in the field of telemedicine from the point of view of the general approach can be represented as follows:

Table.1 Stages of MessageDevelopment

Stage	Phase	Content
1	Developing message requirement	Defining and describing the scope and functionality of standards using UseCase UML diagrams. The result is a UseCase model that represents and documents the scope of use of this set of standards. UseCase-model is the basis for the subsequent development of standards.
2	Content Analysis	The definition of the data constituting the content of messages and transitions in the states of the main object classes of this subject area, consistent with the basic information model. For these purposes, UML class and transition diagrams are used. The result is an information model representing, on the one hand, in a clear and consistent form the content of messages, on the other hand, realizing the basis for a behavior model through transition diagrams.
3	Analysis of nature of the message	Identification of the main information flows necessary to maintain a messaging system. Identify events that trigger messaging. For development, class interaction tables and sequence diagrams are used. The result is an interaction model consistent with UseCase model scenarios. The interaction model is the direct basis for the implementation of standards.
4	Implementation of message	The final specification based on the developed models of the information model of messages as an integral part of the basic information model. The specification is a hierarchical description and is presented in the form of tables of message attributes and the correspondence of messages to events. Based on the specification and the selected implementation technology, a technological specification is formed - the implementation standard.

Today, one of the most promising technologies for developing requirements for large projects is UML technology, a universal modeling language). It also turns out to be very effective in the analysis phase.

In the implementation phase, implementation technology should be selected that is adequately related to the planned use of standards. It can be connected with specific information technologies - CORBA, OLE, EDIFACT, COM / DCOM, or it can be independent of them [2].

The most promising is the implementation of standards based on XML (extensible markup language) - a universal, platform-independent information exchange and storage standard [2].

HL7 designed all the documentation on the basic model of medicine using UML. Its experience is repeated by the Western European Committee CEN / TC 251 (Enabling Technologies - UML). However, CEN / TC 251 adopted a recommendation to use XML syntax as the only alternative to structuring exchanged messages (Enabling Technologies - XML). In the HL7 Version 3 standard, XML is planned as the main way to structure messages in the system [2].

International Telemedicine Standards Development Organizations

At present, there are already quite a lot of commercial and public organizations in the world engaged in solving problems related to telemedicine. Two large organizations as mentioned above already can be distinguished from the developers of medical standards: the European Committee CEN / TC 251 and the American organization HL7 (Health Level 7). They are undoubted leaders in this area, and their standards claim the role of wide international use.

HL7, an American public organization, is developing the most widely used standard in North America for the exchange of medical electronic data, while the CEN / TC 251 committee works in the European space and is focused on the development of medical information standards for Europe.

Standards HL7 and CEN / TC 251 are the main ones in the American and European medical information space, which today makes up 80% of the world [2]. Several meetings of specialists from HL7 and CEN / TC 251 have been organized with the aim of closer cooperation between these organizations and the development of compatible standards for Europe and America.

The above mentioned systems have indeed contributed to the development of different streams of telemedicine, some of them are as follows.

The main streams of telemedicine:

Teleradiology - It is one of the earliest areas of telemedicine, which appeared in the early 1960s. Teleradiology was developed with the aim of expanding access to radiological diagnostics. Such solutions allow users to securely send x-rays to a qualified radiologist at a great distance [7].

Telepsychiatry - It is a medical field that has become popular in the communication environment primarily due to the lack of qualified psychiatrists and the lack of the need for physical interaction between the doctor and the patient [7].

Teledermatology - Allows the patient to send photographic images of any skin pathology to the doctor. Although this method of treatment is superficial, it provides an opportunity to receive the initial recommendation of a specialist without leaving home [7].

Teleophthalmology - Helps ophthalmologists to examine the condition of a patient's eyes being at a distance. A typical example is the diagnosis and treatment of eye infection [7].

Telesurgery - Enables obstetricians to provide prenatal care at a distance, for example, recording a baby's heartbeat [7].

Teleoncology - Over the past few years, this new stream of telemedicine has gained great popularity due to the provision of convenient and qualified care for cancer patients. While some teleoncology solutions offer tools for storing and sending diagnostic data, others are video platforms that allow patients to consult with an oncologist in real time [7].

Telerehabilitation - Allows medical workers to provide rehabilitation assistance to patients at a distance, including a service such as physiotherapy [7].

Developments in India

In India, the first telemedicine pilot project was started by Indian Space Research Organization (ISRO) in collaboration with Apollo Hospitals Group in 2001, under which a telemedicine link was established between an Apollo rural hospital at Aragonda village in the Chittor district of Andhra Pradesh and the Apollo hospital at Chennai [11]. ISRO provided the necessary communication links via its INSAT satellites while Apollo group equipped their hospitals with desired medical infrastructure. Since then various government agencies like Department of Information Technology and Ministry of Health and Family Welfare, State governments, Premier medical and technical institutions, Private hospitals and Companies of India have taken several initiatives with the aim of providing quality healthcare facilities to rural and remote parts of the country.

In India, telemedicine programs are actively supported by:

Department of Information Technology (DIT)

· Indian Space Research Organization

· NEC Telemedicine program for North-Eastern states

· Apollo Hospitals

· Asia Heart Foundation

· State governments

· Telemedicine technology also supported by some other private organizations

DIT as a facilitator with the long-term objective of effective utilization / incorporation of Information Technology (IT) in all major sectors, has taken the following leads in Telemedicine:

· Development of Technology

· Initiation of pilot schemes-Selected Specialty, e.g., Oncology, Tropical Diseases and General telemedicine system covering all specialties

· Standardization

· Framework for building IT Infrastructure in health

The telemedicine software system has also been developed by the Centre for Development of Advanced Computing, C-DAC which supports Tele-Cardiology, Tele-Radiology and Tele-Pathology etc. It uses ISDN, VSAT, POTS and is used to connect the three premier Medical Institutes of the country (viz. All India Institute of Medical Sciences (AIIMS), New Delhi, Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGIMS), Lucknow and Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh).

India has also developed two great devices - the case disaster management system "DISAMED 2000" and a van equipped with mobile means. Both are the result of the efforts of Infocom Private Limited (IPL) and its research Structure - The Online Telemedicine Research Institute (OTRI).

The DISAMED 2000 disaster management system helped to deliver remote health initiatives immediate medical attention and services in the area of ??natural disasters such as earthquakes, floods, typhoons, exodus, etc.

The system is “removable” and can be arranged in the form of a set of telemedicine instruments that can be delivered to remote and without transport routes places on horses, camels, etc., or dropped from aircraft in affected areas during severe natural disasters to provide primary medical care.

Intensive Care Units (ICU) with telemedicine in U.S.A-

ICU telemedicine in the United States linked to federal data had a substantial expansion from 2003 to 2010. This increase was most rapid immediately following the introduction of commercial programs in 2000 and the publication of an early study demonstrating significant mortality reductions and cost savings associated with the technology [8].

However, the rate of increase slowed in more recent years, with few new installations. One can interpret the slowing growth of ICU telemedicine as the saturation point which the technology reached in a very short time [8].

Infrastructure in India-

India faces a great challenge of providing affordable healthcare to all. About 67% of the total population lives in rural areas. Healthcare system in these areas has to cope-up with lot of problems like severe shortage of healthcare professionals, lack of medical facilities, basic infrastructure etc. About 60-80 % of the physician positions in different specialties are vacant in rural healthcare services. According to a study conducted in 2009 by the Indian Medical Society, 75% of the qualified consulting doctors in India reside in urban areas, 23% in semi-urban areas and only 2% in rural areas. In such a scenario, telemedicine is playing a pivotal role in providing healthcare services to rural population of India. As the government has recognized the value of healthcare provision to the most remote areas of the country through telemedicine, till now 105 telemedicine centers have been set-up in the country [10]. The facilities are also useful in training medical students and doctors. As part of the tele-education project, the intension is to connect 41 medical colleges across India so that medical students can have access to specialist lectures in top medical institutes, such as AIIMS in Delhi.

1.3 Comparative Analysis of telemedicine services in U.S.A, Russia and India

The need for telemedicine services, its technological developments and the spread in the past recent years show us that all the three countries mentioned above are counting on it and wish to make it the new big thing in healthcare provision to the remotest areas and as well as in the urban setups in each of the countries respectively. But each one of them has made specific improvements and that's why their expanse differs from each other. Let's take a look at the individual achievements mentioned below:

• Telemedicine services accessibility

Currently, 76 percent of U.S. hospitals connect with patients and consulting practitioners at a distance through the use of video and other technology [12]. Almost every state Medicaid program has some form of coverage for telemedicine services, and private payers are embracing coverage for many telemedicineservices.According to the annual report [13] of American Hospital Association published in 2018, there are a total of 6,146 hospitals in the U.S. out of which 4,301 hospitals provide telemedicine services to the patients and customers.

Picture.1 Growth of use of telemedicine in the US(2010-2017)

As mention previously, 67% of the total population of India lives in rural areas. The main facilitator of telemedicine services in those rural areas of India has been ISRO. Since 2001 ISRO initiated many projects and since thenit has been able to set-up 384 telemedicine centers, and has connected 73 super-specialty hospitals, 306 district hospitals, 13 super-specialty + patient end hospitals and 18 telemedicine mobile units [14].Apart from this there's a huge contribution of private healthcare providers especially in primary telemedicine services, whereas in Russia, by the end of 2018, more than 700 medical facilities in all regions of the country were connected to the telemedicine system [15].Telemedicine consultations is provided by specialists from 21 national medical research centers specializing in oncology, cardiology, neurosurgery, traumatology, cardiovascular surgery, radiology, endocrinology and others. The centers are equipped with world-classtelemedicine equipments and connected to the telecommunications infrastructure of the Russian Ministry of Health.

· Telemedicine specialties

Each country has its own share of specialties regarding telemedicine services that are mostly accessed by their people. The specialties of telemedicine services in U.S.A and Russia are depicted in graph forms.

Picture.2 Specialties of Telemedicine Services in U.S.A

In India the most common telemedicine specialties are - teleophthalmology, teleradiology, telecardiology and telepathology.

• Telemedicine consultations



Picture.3 Specialties of Telemedicine Services in Russia

In 2018, about 1.25 million tele-consultations were conducted in the United States (evaluation by the American Telemedicine Association). In Russia, after the adoption of the law, more than 1 million consultations were provided, by the end of 2018. India with the leading figures had around 3.5 million tele-consultations in 2018 [25].

Picture.4Telemedicine consultations in 2018

Based on the observations of past few years, in the area of telemedicine in the United States, where $ 4.7 billion was invested in digital healthcare in 2017 and 70% of employers offered telemedicine services to their employees, one can judge the development of distance medical consultations in Russia($5 billion by the end of 2020) and India($32 million by the end of 2020) [17] as well, in the near future and the years to come.

In Russia, the state, represented by the Ministry of Health of the Russian Federation, has focused on organizing the “doctor-doctor” interaction in real time, which is built between federal centers and regional clinics and hospitals. In the field of working with medical data, the priority is the creation of a unified state medical information analytical system.

In the coming years, it will be the cornerstone of the development of information technology in healthcare. Several projects for testing remote interactions in the “doctor - doctor” mode are now being conducted in the regions of Russia.

In India, most hospitals use manual processes that make access difficult to information. The insurance industry needed a more efficient storage and retrieval system information. Only automation could have helped hospitals meet these requirements. With the advent and inclusion of telemedicine into the healthcare system the systematization is ultimately happening.

Leading IT companies such as the Advanced Computing Environment Development Center(CDAC), Wipro GE Healthcare, Tata Consultancy Services (TCS) and Siemens Information Systems Ltd (SISL) and others, have developed many reliable solutions in the field of telemedicine.

In 2005, the Health Ministry formed the National Telemedicine Task Force, dealing with various issues in the field of telemedicine.

In addition, a number of specialized hospitals run by state and corporate sectors, as well as state governments, support a number of new telemedicine programs and are constantly evolving.

Chapter 2. Regulation of Telemedicine

2.1 TheproblemsofRegulation of Telemedicine in U.S.A

Legal and Regulatory Framework

In the United States, during the 103^rd Congress, 22 pieces of legislation specifically related to telemedicine were introduced (Telemedicine Monitor, 1995) [26]. In U.S.A. telemedicine refers to the audiovisual communication of a patient with a doctor/specialist in real time [18]. The more general term telehealth is used which has a broader understanding and includes phone calls, remote monitoring, storage and transfer of medical images (obtaining images and video information that the specialist can examine later). But many organizations tend to confuse/misinterpret the terms, although in some legislative acts this separation is important.

In this country, in addition to federal legislation, there is legislation of each state, which is often very different from each other in different areas and in relation to telemedicine, in particular. Telemedicine in the US began to formally legislate in accordance with the following laws:

The first authorized partial reimbursement of costs through Medicare insurance for telehealth services in rural areas where there is a shortage of doctors, was first addressed in The Balanced Budget Act of 1997 [18]. At the same time, reimbursement for "live" services is strictly limited, where the presence of Medicare doctors with the patient during the video consultation is required.

Benefits Improvement and Protection Act of 2000. Here payments for telemedicine services have been expanded. This law [18] eliminated the need for a Medicare representative to be present at the patient during tele-consultation and expanded geographically permitted areas to include areas that are not within the statistical scope of megacities.

Act on the Protection of Medical Information in Economics and Medicine (HITECH Act) of 2009. This law [18] imposed certain requirements on organizations working with personal health information in order to prevent the risk of privacy violations. It continues the course previously set by the Health Insurance Mobility and Accountability Act (HIPAA) and encourages the transfer of medical information into electronic format, coupled with tightening data protection regulations. The use of electronic health record (EHR)was boosted by the adoption of the HITECH ACT in the health care system as a critical national goal and incentivized EHR adoption. The goal was not just adoption/incorporation but proper use of EHRs -- by providers to achieve significant improvements in healthcare provision.

Under the HITECH Act entities covered by the HIPAA are required to report data breaches, which affect 500 or more persons, to the United States Department of Health and Human Services (U.S.HHS), to the news media, and to the people affected by the data breaches. This extends the complete Privacy and Security Provisions of HIPAA to the business associates of covered entities also.

Now these laws have already changed significantly thanks to numerous changes and additions. Currently, far from all telemedicine services are subject to reimbursement. Medicare only compensates for live tele-consultations that are similar to a personal visit to the doctor, and the patient must be in a medical institution and live in a place where reimbursement of such services is allowed. In 2015, the list of possible services was somewhat expanded - it included psychotherapy and an annual general examination, but this had little effect on payments in the field of telemedicine. Now, by the way, telemedicine services related to mental illness and psychotherapy are one of the most popular and promising areas in this area.

Irrespective of the fact Medicare has limited reimbursement, through the Medicaid federal insurance program for low-income US citizenstoday 48 states plus Washington are reimbursing patients for certain types of telemedicine services.(video advice). But in more than 20 states compensation for telemedicine costs are made by private insurance companies.

States can choose to limit the reimbursement based on a number of parameters, for example the type of medical institution and patient, format of technology, location, and type of service, but in about half of the states, reimbursement through Medicare and Medicaid is expanded by not registering the patient's place of residence and type. In the past few years, investment in telemedicine in the United States has increased dramatically, which has been facilitated by several Congressional bills that have simplified cost recovery policies. Only in 2016 there were considered 50 changes in the legislation related to telemedicine (in 2017 - about 20 such changes were already considered).

In particular, the coverage area was expanded where reimbursement of telemedicine services was allowed, which included large cities, as well as an increase in the list of services provided from the patient's house, which are on the list of reimbursed. The list of specialties of telemedicine services which are now being reimbursed through Medicare in each state are different [20]. However there are some specific reimbursements such as when patients are in hospices, for people who mainly undergo hemo-dialysis at home, for older people who do not leave their homes, for women who have a difficult pregnancy, consultations of psychiatrists, radiology and endocrinology consultations, etc.

In addition, despite opposition from medical associations in different states, a law will probably be enacted in the near future allowing doctors to treat patients living in other states without having to obtain multiple licenses from each state.

True, not all new laws are aimed at making life easier for telemedicine providers, for example, a law is being prepared for approval, according to which telemedicine services must provide proof that they are at least not more expensive than traditional medical services in order to receive compensation. Especially in remote areas regular visits to a medical facility are very costly. For eliminating unnecessary emergency room (ER) visitstelehealth applications and technologies, such as video conferencing, help a lot to minimize healthcare spending. Patients who are suffering from a cold or have a minor sprain, or some other non-emergency ailment, telehealth is a very affordable and efficient alternative to the emergency room/face-to-face visit to a doctor. ER visits cost above $1734 to the patient and a face-to-face consultation costs about $146, while telemedicine services average about $79 per consultation [19].

Significant activity is also visible at the state level. Although not all states are sure that telemedicine will be beneficial. For example, in 2015, in Texas, a local Medical Council introduced a requirement that a Texas doctor must first meet with his patient in person before starting to provide services to him through telemedicine services.

Disadvantages of telemedicine functioning in the USA and steps to overcome existing barriers.

Despite all these successes, the development of telemedicine in the USA, its wide distribution has not yet been resolved by a number of problems that need to be addressed at the legislative level:

• Lack of broadband internet access

In 2015, 35% of lower-income households with school-age children did not have a broadband internet connection at home, according to a Pew Research Center analysis of U.S. Census Bureau data [21].

• Licensing at the state level.

A doctor is required to be licensed in this state to provide telemedicine services. True, at the same time, many of them are not eligible for the type of “doctor-doctor” [20].

In2014, most state medical boards made it mandatory for the physicians/doctors to be licensed in the state in which they “see” the patient, whether in-person or virtually, which created one of the biggest barriers to telemedicine utilization [22].

The Interstate Medical Licensure Compact Commission came up with a new option to overcome this barrier. The Commission developed an exceptional process which would allow the physicians/doctors with a license in one state to practice in all states belonging to the Compact. Till date, 24 states and Guam have passed a legislation to adopt the Compact.

• Online prescribing

Prescription of drugs varies from state to state. Some states have enacted online prescribing regulations, specifically ones that involve scheduled drugs or those used for chronic pain management whereas some states mandate an in-person physical exam in order to legally prescribe any medication to a patient over telemedicine.

• Coverage areas for insurance compensation are not fully defined.

It is necessary to clearly determine which telemedicine services are subject to reimbursement and how such reimbursement is determined in comparison with the patient's personal visit to the doctor. Moreover, this must be done both at the federal level and at the level of each state [18]. However, today only about half of the states require Medicaid and private insurance companies to compensate for telemedicine services as well as personal consultations of patients with doctors

Different payers have different policies, as shown below:

Medicare- Reimbursable telemedicine services under Medicare have been limited by law only to professional consultations, office visits, and office psychiatry services. And some more restrictions include the technology used (typically live video) and the location in which the services are provided (federally-designed rural areas. Thus, less than 1% of beneficiaries use telehealth compared to 12% in the veteran's health administration (VHA). Now this is finally changing. The 2019 fiscal year physician fee schedule from the Centers for Medicare & Medicaid (CMS) relaxed some of those restrictions because of the changes in the law. In addition, CMS recently formulated a rule that will pay doctors for virtual visits.This also includes reimbursement for:

a) Checking on a patient more than seven days after a professional consultation.

b) Remote evaluation of patient's health status, with the help of store-and-forward video or image technology.

c) Interprofessional telehealth consultations, that is doctors interacting with other doctors for advice/suggestions.

d) End-stage renal disease clinical assessments provided in all renal dialysis facilities and an individual's home.

e) Telemedicine help and treatment of acute stroke.

f) Remote monitoring of psychological state of patients.

Some advocates are not convinced and think that proposed reimbursement rates still might be too low to encourage adopting it widely. The lack of reimbursement for most services provided in the patient's home and requirements that services are delivered in federally designated rural areas is also pointed out. However, CMS is currently trying to test several telemedicine programs with lesser amount of restrictions.

• Compliance with HIPAA.

The preservation and protection of personal medical data is still a big problem for the US healthcare system, and this problem is even more acute with the use of telemedicine services. Telemedicine providers must ensure the same level of confidentiality that the patient receives in the doctor's office, but so far this is practically not regulated or controlled [18].

• Technology

Another barrier to adoption is technology. Experts from the industry are pushing for a national rollout of 5G wireless networks, which would provide “lightning-fast speed” which is required for real-time examinations and diagnosis.

In July 2018, the Federal Communications Commission (FCC) announced the Connected Care Pilot Program to increase telemedicine connectivity of about $100 million. The program is designed to provide support to low-income individuals, particularly veterans and those living in rural areas for telemedicine services [20]. In addition, a bill pending in Congress would speed development of the 5G infrastructure [22].

• Healthcare Providers and Consumers

Most payers and Medicaid systems report low utilization of telemedicine services. Lack of consumer awareness is one of the reasons. Barriers to providers include the need for training, concern over the quality of service, and fear of losing business to third-party companies. Payers, including state Medicaid systems, also have confusions over how to bill for the services and high start-up costs.

Telemedicine can be a significant tool to improve the delivery and quality of healthcare in this country at the same time reducing cost. Still there are several barriers that remain and hinder in its widespread adoption, particularly reimbursement. Until those barriers are removed, the full potential and benefits of telemedicine to employers, patients, and the US healthcare system will remain unrealized.

• Misdiagnosis

Misdiagnosis has the potential to increase overall costs to the general health care system as well, because misdiagnosis leads to wrong prescriptions and treatments. According to the CDC, one third of antibiotics prescriptions are already unnecessary. If a doctor/specialist through telehealth servicecannot determine a diagnosis, the patient may have to be counseled to go to an ER or an urgent care service. With these unnecessary visits, it may result in a large cost to both the patient and the system as a whole.

2.2 The problems of Regulation of Telemedicine in Russia

Legal and Regulatory Framework

Telemedicine is a unique field of activity from the standpoint that it is based on three types of technology: medical, information and telecommunication. Accordingly, its services are regulated by three groups of legal acts - computer science, communications and healthcare.

Therefore, in the created regulatory framework, three levels of legal regulation can be distinguished:

• development of telemedicine-specific legal norms;

• creating a system of departmental normative acts detailing the organizational and substantive aspects of the activities of telemedicine structures - first of all, the procedures and standards for the provision of services.

In 1998, a state program was formed and adopted in the Russian Federation under the name “Russian telemedicine” [27]. In 2000, the coordinating council of the Ministry of Health of the Russian Federation on telemedicine was established, and in 2007, the project "Strategy for the Development of the Information Society in Russia" was adopted [27].Its main goal was to make the country one of the leaders in the field of post-industrial development and to significantly strengthen its information security.

...