In Vivo: 医療用医薬品・医療機器産業の経営層向けニュース
By Lucie Ellis 06 Aug 2020
A selection of articles you might have missed from July 2020, including exclusive interviews with industry leaders and a review...
The COVID-19 pandemic has pushed telehealth services to the forefront of health care and many expect its widespread use to continue far beyond the current crisis.
As of late-April, more than 3 million cases of coronavirus had been detected worldwide and the global death toll had passed 200,000, according to the US Centers for Medicare and Medicaid Services (CMS).
The fast-spreading virus has prompted the CMS and Health and Human Services (HHS) Office for Civil Rights to roll back major restrictions to telehealth services to protect health workers, which has led to skyrocketing demand.
Joseph Brennan, a telehealth consultant at Moonshot Health Consulting, highlighted key actions in the US that had removed barriers previously preventing the widespread use of telehealth. CMS’s expansion of Medicare benefits under the 1135 waiver authority and the Coronavirus Preparedness and Response Supplemental Appropriations Act, has provided reimbursement for a variety of clinicians to provide telehealth services for Medicare beneficiaries. Prior to that announcement, Medicare was only allowed to pay clinicians for telehealth services, such as routine visits, under certain circumstances, and from a specific list of providers.
Now seniors can receive mental health counseling, preventive care screenings, physical therapy, occupational therapy, speech therapy, among other health services over the phone, which is a significant expansion. Prior to COVID-19, seniors also had to live in a rural area and travel to a local medical health facility for telehealth services. This can now be done from their own home, a nursing home or any other health facility.
Another key change is the “enforcement discretion” on the Health Insurance Portability and Accountability Act (HIPAA), which allows patients to use online tools such as FaceTime, Google Hangouts and Skype to visit with doctors by phone or video conference at no additional cost. HIPAA-compliant telehealth platforms can be very expensive and not everyone can access them, Brennan explained. “Where that is really going to have the biggest impact is when you think about those two to three physician practices in rural communities, or the one- or two- doctor office in the urban settings,” Brennan said. “They can now use the technology they already have in place to connect with patients.”
A further expansion occurred on 16 March with the Drug Enforcement Agency (DEA) allowing DEA-registered practitioners to issue prescriptions for controlled substances to patients via telemedicine without a prior in-person exam. Practitioners must comply with both federal and state laws. Some states prohibit prescribing controlled substances via telemedicine while others allow it with some restrictions, such as only for treating psychiatric disorders or for treating chronic pain.
Brennan said the reimbursement for Medicare beneficiaries, the waiver of HIPAA requirements for technology use and the ability to prescribe controlled substances had really given telehealth momentum. “All of the barriers that we had before all started to fall and the last big one was the removal the state-licensure requirement,” Brennan said.
Before COVID-19, physicians had to be licensed in the state where the patient was located at the time of treatment. CMS also temporarily waived that requirement for Medicare patients, but recommended that physicians check with their state board of medicine or local department of health to ensure they are not violating state laws. As of last week, 48 states had waived the state licensure requirement to some extent.
Brennan said that the removal of the state licensure requirement was significant, because COVID-19 hit some areas more than others. In areas where there is a shortage of health providers, this removal allows health professionals from less impacted areas to provide care to those in need. He gave the example of his wife, an occupational therapist, who can now practice across state lines.
A guidance document, issued by the FDA on 20 March, also reduces the burden on health care systems during the current health crisis by allowing manufacturers of patient-monitoring devices to add or improve remote-monitoring features without first getting regulatory clearance.
On 13 April, CMS updated its guidance document on Medicare reimbursement to help health care providers plan for implementing a telehealth program.
The removal of these barriers has led to a boom in the telehealth industry with several companies reporting unprecedented growth. Among them are US-based digital health companies Tyto Care and Eko Health.
Tyto Care markets a handheld device that allows for the remote examination of the ears and throat. It can also listen to the heartbeat and lungs, and is used by health professionals and consumers.
April Radford, vice president of telehealth at Ochsner’s CareConnect 360, said during a webinar hosted by Tyto Care on 22 April, that it had stepped up its virtual care services in response to the COVID-19 crisis. The system has trained thousands of providers to use video services and saw an explosive use of digital health tools such as TytoCare. Ochsner’s home sales of TytoCare devices rose from 1,000 devices sold in 2019 to 2,500-3,000 devices sold in mere weeks since the crisis hit, speaking to the demand by providers and patients to use a virtual tool, Radford said.
In an interview with In Vivo’s sister publication Medtech Insight, Tyto Care’s VP of provider solutions, David Bardan, said the company had seen an “unprecedented demand for their products across the board.” (Also see "Telehealth Sees Skyrocketing Demand Amid Regulatory Expansion, Hopes To Last Beyond COVID-19 Crisis" - Medtech Insight, 23 Mar, 2020.)
Similarly, Connor Landgraf, CEO and co-founder of Eko Health, which markets a digital stethoscope with an AI-powered cardiac screening platform, said he had noticed “well over a 100% rise in orders” in three weeks – with the widest usage being on the front lines by clinicians who are using the technology to limit the spread of COVID-19.
Both company leaders said the waived restrictions on telehealth were major driving forces behind the sudden explosion of telehealth services and products. Bardan said the loosened restrictions on phones had greatly benefitted the company, because it allowed for asynchronous visits where a patient could collect health data and then forward it to the physician for later review. The elimination of the originating site requirement and ability to provide telehealth services in senior living facilities has led to new partnerships and the expansion of its product. He called the drop in the licensure requirement across state lines a “game changer.”
In April, the US Food and Drug Administration has given Dexcom Inc. and Abbott Laboratories permission to bring their continuous glucose monitoring (CGM) systems into hospitals for the duration of the COVID-19 pandemic. Brennan considers this first introduction of CGMs in hospitals a big deal for two reasons. “One it allows that technology [CGM] to be used within the four walls of the hospital. Two, when that patient is discharged, they already know how to use the device, they’re already comfortable with it. There is that continuity of care even after they are discharged from the hospital.”
Health care workers will be introduced to Dexcom’s G6 CGM and Abbott’s FreeStyle Libre 14-day system to remotely monitor patients with diabetes, which helps minimize their exposure to COVID-19 patients and preserve the use of personal protective equipment.
While it remains uncertain what post-COVID health care will look like, several industry experts expect that the wide adoption of telehealth by health providers and patients will create a fundamental shift in how patients and practitioners communicate.
Glenn Snyder, principal medtech practice leader for Deloitte Consulting LLP, expects social distancing and the inability to interact face-to-face will prompt all companies to rethink the way they do business. He advises companies to re-evaluate all of their processes and identify work that can be done virtually – from monitoring the performance of a product through its entire lifecycle to understanding the patient journey from start to finish, as well as points of engagement. He also advises medtech companies to work closely with hospitals to find solutions together in the future.
Brennan and Snyder agree that some telehealth restrictions may be reinstated after the initial pandemic eases, but that cannot stop the tailwind the industry is experiencing.
“What we’ve seen over the last four to six weeks is that all the barriers and rules as it relates to health care are being pushed to the side, so that we can bring the care that the patient needs in real time,” Brennan said. “
Many groups will be pushing to keep these new changes in place and the American Telemedicine Association is expected to lead the charge. Brennan does not expect reimbursement for telehealth to return to how it was before COVID-19. While privacy regulations are likely to be amended to make it easier for people to access telehealth. However, he does anticipate state licensure restrictions to be reinstated eventually.
COVID-19 has led to a huge demand for virtual care and triaging of symptoms. Both Brennan and Snyder expect that triaging patients in the future will continue its course of being digital, virtual and then physical. “Executives of health plans and hospital systems agree that that is the way the industry is going to permanently shift,” Snyder said.
He expects patients will do a self-assessment using a mobile application or website with the next level of engagement being a virtual visit with the doctor, and lastly, a physical visit, if needed – for non-emergency cases. Snyder also expects certain services might permanently move out to freestanding centers or separate areas in hospitals to separate people who come in physically healthy from others that may be sick with an infectious disease. This continuation of social distancing within health facilities would help keep health care workers and the public safe from potential infection.
Brennan said the current crisis had led to an explosion of health chatbots and consumers’ use of asynchronous care, relying on technology to make a diagnosis rather than talking to a provider. This trend is likely to continue.
More health systems will use chat bots as “health navigators” or first contacts to guide a consumer in the right direction. Examples of these are Ada Health, which uses a vast artificial intelligence-based database to check symptoms, or British company Babylon Health, which offers AI consultation based on personal medical history and live video consultation with a doctor. That may be followed by a video visit, and if needed, a physical visit.
“I don’t believe it will ever go back to the way it was,” Brennan said. “There are too many things that have changed, and health care has progressed more in the last two months than it has in many years,” Brennan said.
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