MedTech Insight - Telehealth Sees Skyrocketing Demand Amid Regulatory Expansion, Hopes To Last Beyond COVID-19 Crisis

Marion Webb

March 23, 2020

Executive Summary

US telehealth companies are seeing skyrocketing demand for devices and services, which offers opportunities and challenges during this COVID-19 crisis.

TytoCare Ltd. and Eko Health are among the many telehealth companies that are seeing skyrocketing demand for devices that help health care professionals communicate with Medicare beneficiaries, reducing their need to travel to a medical site and risk exposure or the wider spread of COVID-19.

Many in the telehealth industry believe that the major expansion of telemedicine options, announced by the US Centers for Medicare and Medicaid Services (CMS) on 17 March, is a major leap forward for the telemedicine industry and will shape the way health care is delivered far beyond the COVID-19 crisis.

"We are seeing an unprecedented demand for our products across the board," David Bardan, vice president of provider solutions for TytoCare, told Medtech Insight. TytoCare markets a handheld device to health care professionals and consumers. It comes with a series of adapters that allows for the remote examination of ears and throat as well as listening the heartbeat and lungs. (Also see "Start-Up Spotlight: Tyto Care Brings Medical Exams To Homes " - Medtech Insight, 24 Dec, 2019.)

"Obviously the health care system right now is going through a major shock across the US," he said. "And due to that, there will be lingering effects that over time will require modalities that are more efficient in terms of providing care for patients and consumers [and] those will likely come from telemedicine and telehealth."

Connor Landgraf, CEO and co-founder of Eko Health, which markets a digital stethoscope with an AI powered cardiac screening platform, told Medtech Insight that Eko has seen "well over a 100% rise in orders" in the last three weeks alone.

The company's Eko DUO, which combines an ECG and digital stethoscope and Eko AI, which helps clinicians detect atrial fibrillation and other irregular heart rhythms, is used in some 4,000 health systems in the US and Europe. The US Food and Drug Administration-cleared devices have seen unprecedented demand from clinicians since the COVID-19 outbreak, Landgraf said.

"The widest usage has been on the front lines…. [but now] it's clinicians across the board who are mobilizing and trying to use these technologies to limit the possible spread of the [COVID-19] virus," Landgraf said.

Nathaniel Weathington, a pulmonary and critical care specialist and technical lead of the pulmonary telemedicine program at the University of Pittsburgh Medical Center, a 40-hospital health care system, said new telemedicine services are being rolled out almost daily in anticipation of a rising influx of coronavirus patients.

"I think that this is something like the way that wartime escalates technology and adoption," he said.

Spurred By Regulatory Changes

Both Bardan and Landgraf agree that last week's announcement by the White House to waive federal restrictions on telehealth are major driving forces behind the sudden explosive demand for telehealth services and products.

CMS expanded telehealth services for Medicare patients allowing them to use online tools such as FaceTime and Skype to visit with doctors by phone or videoconference at no additional cost. The administration's action also stopped enforcing several elements under the Health Portability and Accountability Act that previously regulated providers delivering care remotely.

Bardan said loosening the restrictions on phones has been a huge plus, because it allows telehealth companies such as TytoCare to leverage asynchronous visits where a patient can collect health data and then forward it to the physician for review later.

"That's very powerful, because of the fact that right now there is a lot of strain on the health care system," Bardan said. Minneapolis-based software company Zipnosis developed an online questionnaire, based on US Centers for Disease Control and Prevention (CDC) guidelines for assessing a person's risk of having COVID-19, that is based on an asynchronous interaction. Zipnosis' CEO Jon Pearce said in a 20 March company video that it has seen an "8,900% increase in utilization in 11 days across the platform.

"It highlights the power of the technology and the ability for asynchronous care to meet the needs of coronavirus screening in the hands of local providers," Pearce said.

Asynchronous care means that consumers are not talking to a provider in real time but use technology to make a diagnosis. In synchronous telemedicine, providers use a video connection or the phone to talk to a consumer or patient. Pearce said that using asynchronous technology cuts the diagnosis time to 89 seconds compared to 18 minutes using synchronous care.

The loosened geographical restrictions around a patient's location at the time services are received is another win for the telehealth industry.

Medicare had previously restricted telehealth benefits to seniors living in rural areas who had already sought care through a provider.

"Eliminating originating site requirements enables providers to use telehealth in rural and urban areas as well as in the patient's home for all types of care," Bardan noted. "This allows for remote care of seniors potentially related or unrelated to the coronavirus, eliminating the need to travel in person to clinics and to do coronavirus screening from home for people who are exhibiting symptoms."

Bardan said the ability to provide telehealth services in senior living facilities has led to new partnerships and the expansion of its product.

Providers are no longer required to be licensed in the state where they are providing services, which means they can offer telehealth services across state lines.

Bardan called this a "game changer" as it opens the door for many health systems partners to serve populations they haven't been able to serve before.

But Elliot Vice, director of government affairs at the National Council of State Board for Nursing, who is also a member of the American Telemedicine Association (ATA), told Medtech Insight that the federal government has not preempted state licensing laws and that policies differ from state to state.

Therefore, "Every provider needs to make sure they have the appropriate licensing authority in the state where the patient is located," Vice said. Vice also views the regulatory changes as a "real opportunity for elehealth providers and different telehealth modalities to demonstrate how technology has transformed and helped develop high-quality health care delivery."

Another big win for the telehealth industry is the relaxation of reimbursement regulations retroactive to 6 March, which applies to treatments for any conditions for Medicare patients via telemedicine, not just potential coronavirus symptoms.

In a webinar, hosted by the ATA on 20 March, Joseph Brennan, a telehealth consultant at Moonshot Health Consulting, told providers that reimbursement for telehealth services is now the same for Medicare patients as doing a "face-to-face" consultation.

However, that is not the case for serving Medicaid patients, he pointed out.

Landgraf said CMS reimbursement will also be tremendously important for Eko to help facilitate both care across state lines and to reduce friction points for patients to get seen by clinicians.

Weathington said that the Eko technology allows nurses, who work in hospitals in rural areas, to share an audio feed of patients' heart and lung sounds during the exam with specialists on the main UPMC campus.

"Like a standard in-person stethoscope exam, we are able to use this technology to understand whether someone has normal or abnormal organ function and get some determination of what may be abnormal," he said.

He noted that especially during this time of crisis, addressing patients' needs remotely greatly reduces human-to-human contact as well as consumption of personal protective equipment, elements that are critical to both protect health care workers and patients and help reduce the spread of the virus.

Overburdened

While the loosened regulatory restrictions are exciting for the telehealth industry, the sudden explosion in demand for services during this pandemic has already overwhelmed the technical and logistical capabilities of some device and software companies.

And these challenges are likely to increase, given that in the US, the coronavirus epidemic is still in its early stages, according to experts.

Teladoc Health said that between 6 March and 13 March it provided an estimated 100,000 telehealth visits, a 50% increase from the previous week to US patients, Credit Suisse analyst Jailendra Singh wrote in a note from 17 March.

"We believe these figures are likely to continue to increase as people have just started to work remotely, cancel travel, etc.," Singh wrote.

Doctor on Demand, which offers physician visits for $50 to $75 is not experiencing IT problems, but is looking to hire hundreds of doctors, according to published reports.

A new guidance document, effective immediately, issued by the FDA on 20 March, also reduces the burden on the health care system during the COVID-19 pandemic by allowing manufacturers of patient monitoring devices to add or improve remote-monitoring features without first getting regulatory clearance. As with the eased restrictions on telehealth services for seniors, the FDA guidance will be enforced for the duration of the COVID-19 crisis. (Also see "FDA Lets Some Changes To Monitoring Tools Bypass Clearance Process During COVID-19 Pandemic" - Medtech Insight, 20 Mar, 2020.)

The document covers a range of non-invasive devices including clinical electronic thermometers, electrocardiographs, cardiac monitors, electronic stethoscopes and pulse oximetry units.

Brennan said that while the adoption of remote patient monitoring has traditionally been slow, primarily because of the resources needed to stand up and sustain a program, what was normally developed and deployed in months is now being launched in days.

"Providers are happy to have the tools – I believe that this pandemic will permanently change how care is delivered and providers will embrace this new technology-driven care delivery," Brennan told Medtech Insight.

Weathington echoed this view.

“This is a crisis era, and in order to respond effectively, the normal rules and regulations are being appropriately relaxed for physicians to deliver care to patients in need," Weathington said. "The COVID crisis is a health care-based state of emergency that is going to facilitate adoption of telemedicine technology and that in the months and years following this crisis, there will be a new standard for health care that includes telemedicine as a large portion of care delivery."

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