Telemedicine and Telehealth
Telemedicine seeks to improve a patient's health by permitting two-way, real time interactive communication between the patient, and the physician or practitioner at the distant site. This electronic communication means the use of interactive telecommunications equipment that includes, at a minimum, audio and video equipment. The implementation of telemedicine in routine health services has been impeded in many setting because of a lack of scientific evidence for its clinical and cost effectiveness.
But things are changing. Based on advances in information and communications technologies, medical professionals as well as other "health and care" providers can now offer increasingly robust, remote (from their location to another), interactive (two-way) services to consumers, patients and caregivers.
The terms used to describe these broadband-enabled interactions include telehealth, telemedicine and telecare. "Telehealth" evolved from the word "telemedicine." "Telecare" is a similar term that you generally hear in Europe. All three of these words are often – but not always – used interchangeably. They can also have different meanings depending on who you ask. And that's precisely why you should ask your doctor, your insurance provider, your nurse, anyone who's part of your health and care universe.
Telemedicine can be defined as using telecommunications technologies to support the delivery of all kinds of medical, diagnostic and treatment-related services usually by doctors. For example, this includes conducting diagnostic tests, closely monitoring a patient's progress after treatment or therapy and facilitating access to specialists that are not located in the same place as the patient.
Telehealth is similar to telemedicine but includes a wider variety of remote healthcare services beyond the doctor-patient relationship. It often involves services provided by nurses, pharmacists or social workers, for example, who help with patient health education, social support and medication adherence, and troubleshooting health issues for patients and their caregivers.
Telecare generally refers to technology that allows consumers to stay safe and independent in their own homes. For example, telecare may include consumer-oriented health and fitness apps, sensors and tools that connect consumers with family members or other caregivers, exercise tracking tools, digital medication reminder systems or early warning and detection technologies.
Although the terms “telemedicine” and “telehealth” are often used to describe similar types of technologies, the term “telemedicine” has historically been used to refer specifically to bilateral, interactive health communications with clinicians on both “ends” of the exchange (e.g., video conferenced Grand Rounds, x-rays transmitted between radiologists or consultations where a remote practitioner presents a patient to a specialist). Whereas, the term “telehealth” incorporates not only technologies that fall under “telemedicine,” but also direct, electronic patient-to-provider interactions and the use of medical devices (e.g., smartphone applications (“apps”), activity trackers, automated reminders, blood glucose monitors, etc.) to collect and transmit health information, often with the intent to monitor or manage chronic conditions. Currently, there are four basic modalities, or methods, of telehealth:
1. Live video (synchronous): Live, two-way interaction between a person (patient, caregiver, or provider) and a provider using audiovisual telecommunications technology. While these videoconferences had historically and exclusively been provider-to-provider telemedicine encounters, many companies such as Teladoc and LiveHealth Online are now videolinking patients directly to clinicians on a daily basis.
2. Store-and-forward (SFT): Transmission of videos and digital images such as x-rays and photos through a secure electronic communications system. As compared to a “real-time” visit, this service provides access to data after it has been collected. Generally, diagnostic information (e.g., x-rays, CT scans, EEG printouts) are recorded or captured at the patient’s site of care, and then sent to a specialist in another location. Because of the lag, or delay, between the time an image is sent and when it is interpreted, SFT is often referred to as “asynchronous.”
3. Remote patient monitoring (RPM): Personal health and medical data collection from an individual in one location, which is transmitted to a provider in a different location. RPM is used primarily for the management of chronic illness, using devices such as Holter monitors to transmit information including vital statistics (e.g., blood pressure, blood oxygen levels) to clinicians.
4. Mobile health (mHealth): Smartphone apps designed to foster health and well-being. These apps range from programs which send targeted text messages aimed at encouraging healthy behaviors to alerts about disease outbreaks to programs or apps that help patients with reminders to adhere to specific care regimens. Increasingly, smartphones may use cameras, microphones, or other sensors or transducers to capture vital signs for input to apps and bridging into RPM.
In the current environment of a shortage of healthcare professionals, greater incidence of chronic conditions, and rising healthcare costs, telemedicine offers a potential tool to improve efficiency in the delivery of healthcare. The need for telemedicine is further compounded by the following factors:
• Significant increase in the U.S. population—estimated growth of 20 percent (to 363 million) between 2008-2030
• Shortage of healthcare professionals being educated, trained and licensed
• Increasing incidence of chronic diseases around the world, including diabetes, congestive heart failure and obstructive pulmonary disease
• Need for efficient care of the elderly, home-bound, and physically challenged patients
• Lack of specialists and health facilities in rural areas
• Adverse events, injuries and illness at hospitals and physician’s offices
• Need to improve community and population health
For purposes of Medicaid, telemedicine seeks to improve a patient's health by permitting two-way, real time interactive communication between the patient, and the physician or practitioner at the distant site. This electronic communication means the use of interactive telecommunications equipment that includes, at a minimum, audio and video equipment.
Telemedicine is viewed as a cost-effective alternative to the more traditional face-to-face way of providing medical care (e.g., face-to-face consultations or examinations between provider and patient) that states can choose to cover under Medicaid. This definition is modeled on Medicare's definition of telehealth services (42 CFR 410.78). Note that the federal Medicaid statute does not recognize telemedicine as a distinct service.
Medicaid guidelines require all providers to practice within the scope of their State Practice Act. Some states have enacted legislation that requires providers using telemedicine technology across state lines to have a valid state license in the state where the patient is located. Any such requirements or restrictions placed by the state are binding under current Medicaid rules.
Reimbursement for Medicaid covered services, including those with telemedicine applications, must satisfy federal requirements of efficiency, economy and quality of care. States are encouraged to use the flexibility inherent in federal law to create innovative payment methodologies for services that incorporate telemedicine technology. For example, states may reimburse the physician or other licensed practitioner at the distant site and reimburse a facility fee to the originating site. States can also reimburse any additional costs such as technical support, transmission charges, and equipment. These add-on costs can be incorporated into the fee-for-service rates or separately reimbursed as an administrative cost by the state. If they are separately billed and reimbursed, the costs must be linked to a covered Medicaid service.
Telemedicine is viewed as a cost-effective alternative to the more traditional face-to-face way of providing medical care (e.g., face-to-face consultations or examinations between provider and patient). As such, states have the option/flexibility to determine whether (or not) to cover telemedicine; what types of telemedicine to cover; where in the state it can be covered; how it is provided/covered; what types of telemedicine practitioners/providers may be covered/reimbursed, as long as such practitioners/providers are "recognized" and qualified according to Medicaid statute/regulation; and how much to reimburse for telemedicine services, as long as such payments do not exceed Federal Upper Limits.
If the state decides to cover telemedicine, but does not cover certain practitioners/providers of telemedicine or its telemedicine coverage is limited to certain parts of the state, then the state is responsible for assuring access and covering face-to-face visits/examinations by these "recognized" practitioners/providers in those parts of the state where telemedicine is not available.
Therefore, the general Medicaid requirements of comparability, state wideness and freedom of choice do not apply with regard to telemedicine services.
CMS Approach to Reviewing Telemedicine SPAs
•States are not required to submit a (separate) SPA for coverage or reimbursement of telemedicine services, if they decide to reimburse for telemedicine services the same way/amount that they pay for face-to-face services/visits/consultations.
•States must submit a (separate) reimbursement (attachment 4.19-B) SPA if they want to provide reimbursement for telemedicine services or components of telemedicine differently than is currently being reimbursed for face-to-face services.
•States may submit a coverage SPA to better describe the telemedicine services they choose to cover, such as which providers/practitioners are; where it is provided; how it is provided, etc. In this case, and in order to avoid unnecessary SPA submissions, it is recommended that a brief description of the framework of telemedicine be placed in an introductory section of the State Plan and then a reference made to telemedicine coverage in the applicable benefit sections of the State Plan. For example, in the physician section it might say that dermatology services can be delivered via telemedicine provided all state requirements related to telemedicine as described in the state plan are otherwise met.
Whether expanding Medicare coverage for telemedicine services would increase or decrease federal spending is difficult to predict, but doing so depends on two main considerations:
•The payment rates that would be established for those services, and
•Whether those services would substitute for (or reduce use of) other Medicare-covered services or would be used in addition to currently covered services.
It is believed that if all or most telemedicine services substituted for or prevented the use of more expensive services, coverage of telemedicine could reduce federal spending. If instead telemedicine services were mostly used in addition to currently covered services, coverage of telemedicine would tend to increase Medicare spending. Many proposals to expand coverage of telemedicine strive to facilitate enrollees’ access to health care. Therefore, such proposals could increase spending by adding payments for new services instead of substituting for existing services.
Because coverage of telemedicine services in Medicare’s traditional fee-for-service program is limited, so is evidence about the effects of such coverage. Thus, Congressional Budget Office (CBO) must often draw inferences from other sources—such as the experience of private managed care plans—when developing cost estimates. However, an important limitation of that evidence is that private plans generally have more ways to influence doctors’ choices and to limit the services that their enrollees use than are available in Medicare’s fee-for-service program (which the Department of Health and Human Services and its contractors run). As a result, even if coverage of telemedicine reduced net costs for some private plans, the greater difficulties involved in ensuring that services are used appropriately in the fee-for-service Medicare program mean that proposals to expand coverage of services in that program could increase federal spending.
Given the substantial interest in proposals related to telemedicine, CBO has prepared the discussion below, which further describes the issues that arise in defining a telemedicine benefit and how CBO estimates the budgetary effects of those proposals.
Telemedicine services include virtual visits with doctors or other professionals, remote monitoring of patients’ conditions, and off-site analysis of medical imaging or test results. Providers may offer telemedicine through various means of communication, including phone calls, video chats, text messages, email, and websites. With the varied possibilities, proposals to expand coverage for telemedicine or telehealth services in Medicare would need to define several factors, including:
•The services that would be covered and their allowed methods of delivery,
•The types of providers and sites of care that could be paid to offer those services, and
•The types of patients or beneficiaries who would be eligible to receive such services.
CBO’s analysis of such proposals would take into account how they differed from Medicare’s coverage of telemedicine services under current law. Now, Medicare providers can be paid to furnish certain telemedicine services by using specified methods and sites of service—but only for patients who live in rural areas. (Those patients generally visit a facility that has some staff but that accesses some doctors remotely.) In general, Medicare pays the distant doctor or other provider of telemedicine the same fee that Medicare would have paid for an in-person office visit, and the site where the patient receives the services is paid a facility fee. Medicare’s total payments are thus higher for telemedicine services than for equivalent services delivered conventionally. Whether similar arrangements would apply for any expansion of coverage for telemedicine depends on the details of legislative proposals.
Although offering telemedicine to rural enrollees could improve the quality of care that such enrollees receive and could be more convenient for them, doing so might not reduce Medicare spending on their care. More broadly, if rural or urban enrollees would otherwise not have received care because of difficulties in obtaining access to doctors, providing telemedicine might well increase spending on services Medicare covers instead of substituting for services that would have been covered without telemedicine. Without other constraints, the added convenience for enrollees of receiving telemedicine rather than face-to-face care could increase their demand for and use of Medicare-covered services. Provisions governing the cost-sharing requirements that enrollees face for telemedicine services would also affect their demand for those services.
The National Center for Telehealth & Technology (T2)
The National Center for Telehealth & Technology (T2) is a component center of the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury (DCoE). DCoE is a principal component of the Healthcare Operations Directorate under the Defense Health Agency.
The mission of T2 is to lead the innovation of health technology solutions for psychological health and traumatic brain injury, and deliver tested, valued health solutions that improve the lives of our nation’s warriors, veterans, and their families.
The vision is world-class health care and optimized health in the DoD through effective leveraging of behavioral science and technology.
T2’s advanced health technology solutions are user-friendly, valued by our warriors, and cost-effective. These qualities align with the Military Health System Quadruple Aim to ensure readiness, population health, experience of care, and responsible management of the total cost of health care. T2 also supports the DoD’s goals of increasing access to care, establishing best practices and quality standards for health technology and telehealth, and reducing both military suicide rates and the prevalence of stigma associated with seeking behavioral health services.
The products developed by T2 meet the needs and requirements of the DoD and its beneficiaries. DCoE provides requirements to T2 based on guidance from various sources that include:
T2 leads the DoD in applying existing and emerging technologies for delivering psychological health care options to the military community. As the benefits of these services grow, the need will continue.
T2 is organized into Mobile Health and Telehealth programs, which are supported by the Technology, Operations, National Capital Region, and Research, Outcomes and Investigations divisions.
T2 is located on Joint Base Lewis-McChord near Tacoma, Washington, with an office in the National Capitol Region that represents and coordinates T2’s program activities with DCoE and partners in the Military Health System.
Link: http://t2health.dcoe.mil/about.html
Using the latest technology, T2 seeks to identify, treat and minimize or eliminate the short- and long-term adverse effects of war. The Center’s research and outreach programs support the following major initiatives:
•Create virtual reality mental health applications
•Oversee suicide surveillance/automation programs across the DoD
•Facilitate telehealth and Web-based care for PH/TBI (video teleconferencing, After Deployment, interactive media)
•Develop mobile applications to support 24/7 access to behavioral health tools and critical support systems
As a leader in military mobile health, T2 seeks to improve patient outcomes. As one way to reach patients, we offer training for military providers on how to use mobile health to integrate best practices, evidence-based research and other resources into clinical care. T2 offers the following free resources:
Usability testing is a critical step in the production of mobile apps, websites, and virtual reality tools. By applying rigorous and repeated instrumented testing in a controlled environment, usability testing is the most effective way to be certain that users will understand, interact with, and benefit from technology as designed.
T2’s new Technology Enhancement Center (TEC) enhances our development of accessible and effective technologies targeting PTSD, traumatic brain injury as well as suicide reporting and prevention within the military community.
The TEC allows testing and evaluation at every stage of the development lifecycle and helps developers optimize the user experience through input from representative end-users. In this way, technology development is more efficient and the end product is more useful to the Warrior and Veteran populations we support.
T2 consulted with some of the industry’s most accomplished design engineers to ensure the utility, flexibility and longevity of the new facility. The result is a state-of-the-art facility encompassing 4,260 square feet of testing, observation, and monitoring facilities, as well as meeting rooms and offices for the comfort of participants and visiting observers. Through this service, T2 is delivering technological solutions using industry-standard best practices.
Testing and observation rooms are equipped with a wide array of technologies to allow developers and other observer-stakeholders to track and record virtually every aspect of user interaction:
•Multiple remote-controlled video cameras capture user actions and reactions from all angles.
•Eye-tracking hardware pinpoints precise areas of users’ focus as they review websites and other applications.
•Usability software records and combines user website or mobile screen activity, the audio/video of the testing session, as well as usability specialists observational comments about testing into an indexed reviewing and reporting file allowing for statistical analysis of testing sessions.
•Testing across a wide range of commercially available and prototype user interface devices and most popular operating systems including iOS, Android, Windows, OS X, Xbox, PlayStation, and Wii.
•Push-to-talk and passive intercom systems facilitate communication between participants and usability specialists.
•Sound attenuating construction to allow observers to converse without distracting or influencing test subjects.
Supporting the growth of telehealth within the DoD has always been a core objective for T2. The successful integration of telehealth into the overall DoD health services system requires enterprise-wide strategies, policies and guidance. T2 has led telehealth growth efforts by leveraging partnerships with the Services, VA, TRICARE and civilian providers. These efforts include:
•Publishing the first evidence-based study in 2015 for in-home evidence-based telehealth for service members. This clinical trial demonstrated the efficacy and safety of a using telehealth to deliver mental health treatment.
•Representing the DoD in inter-agency federal telehealth working groups.
•Completing the first joint DoD/VA telemental health pilot under the auspices of the DoD/VA Health Executive Council (HEC).
T2 offers the following telemental health (TMH) training and tools (available here for download) to provide military behavioral health clinicians and administrators with the clinical and technical skills required to understand and deliver health services in this way:
T2’s clinical programs focus on innovative approaches to providing health care to warriors and their families. These approaches include Web-based tools, Virtual Reality and Virtual Worlds technologies.
After Deployment offers modularized content across a spectrum of post-deployment conditions (combat stress and triggers; conflict at work; re-connecting with family and friends; depression; anger; sleep problems; substance abuse; stress management; kids and deployment; spiritual guidance; living with physical injuries; health and wellness).
The web resource provides an interactive self-care solution: users can take assessments, view video-based testimonials, and access narrator-guided workshops. Accessing online resources from the comfort of one’s home eliminates concerns about stigma associated with in-person care. Along with anonymity, online resources offer the following benefits:
•Anonymous, portable, 24/7 access
•Assessment, education, and prevention
•Skills-building exercises
•Change strategies and interactive workshops
•Augment face-to-face care
Smart phones, and other portable devices, provide new opportunities for the development of the next-generation of psychological health content. The fit between health-related content and handheld devices is particularly applicable within the military community. Age groups using such devices are well-represented in the military. Interventional tools available on smart devices can provide “always-on” support for highly mobile, on-the-go individuals. Users receive evidence-based tools via standardized content and would have immediate two-way contact with support systems during a crisis or to manage unexpected acute symptoms.
Creating self-assessment software for a handheld device would offer a number of advantages. Significantly, real-time assessments (rather than retrospective assessments) would be possible. Handheld devices would provide un-tethered portability and facile data transmission to a central server available to the provider. A “virtual handheld clinic” would allow the user to personalize content and access hotline links, psychological tools (e.g., relaxation exercises), and appointment reminders.
DCoE’s National Center for Telehealth & Technology and the VA Office of Mental Health Services developed the Moving Forward mobile app as part of the DoD/VA Integrated Mental Health Strategy (IMHS). The Moving Forward mobile app and the companion online course features problem-solving therapy (PST) tools designed to teach skills for overcoming life problems. PST is an evidence-based cognitive behavioral treatment for depression and other distress.
T2 is dedicated to coordinating and implementing cutting edge research to improve the psychological and traumatic brain injury healthcare of our Warfighters and their families. The T2 staff maintains an active internal research program and continues to develop collaborative research opportunities with a broad network of stakeholders. Recent projects have focused on the use of Virtual Reality (VR) in clinical practice; the detection of suicide risk factors; the impact of deployment on psychological health; the use of technology to improve health outcomes; and Service Member assessments of technology-based approaches to care.
T2’s research projects have been competitively funded by the Congressionally Directed Medical Research Programs (CDMRP) and the Telemedicine and Advanced Technologies Research Center (TATRC).
The Food and Drug Administration Digital Health Initiatives
The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. Providers and other stakeholders are using digital health in their efforts to:
•Reduce inefficiencies,
•Improve access,
•Reduce costs,
•Increase quality, and,
•Make medicine more personalized for patients.
Patients and consumers can use digital health to better manage and track their health and wellness related activities. The use of technologies such as smart phones, social networks and internet applications is not only changing the way we communicate, but is also providing innovative ways for us to monitor our health and well-being and giving us greater access to information. Together these advancements are leading to a convergence of people, information, technology and connectivity to improve health care and health outcomes.
Why is the FDA focusing on Digital Health?
Many medical devices now have the ability to connect to and communicate with other devices or systems. Devices that are already FDA approved or cleared are being updated to add digital features. New types of devices that already have these capabilities are being explored.
Many stakeholders are involved in digital health activities, including patients, health care practitioners, researchers, traditional medical device industry firms, and firms new to FDA regulatory requirements, such as mobile application developers.
FDA’s Center for Devices and Radiological Health is excited about these advances and the convergence of medical devices with connectivity and consumer technology. The following are topics in the digital health field on which the FDA has been working to provide clarity using practical approaches that balance benefits and risks:
•Wireless Medical Devices
•Mobile medical apps
•Health IT
•Telemedicine
•Medical Device Data Systems
•Medical device Interoperability
•Software as a Medical Device (SaMD)
•General Wellness
•Cybersecurity
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