The Scripps Research Digital Trials Center is partnering with a wide range of digital health companies and stakeholders in a PowerMom consortium, aimed at using innovative technology to help monitor new and soon-to-be moms.
The Scripps Research Digital Trials Center is partnering with Microsoft in a new consortium aimed at improving research and care for new and impending mothers.
The PowerMom consortium, managed by the San Diego-based digital health think tank and including Microsoft, WebMD, the March of Dimes, Mae, the Happy Mama Happy Baby Alliance, and the African American Wellness Center for Children and Families, “leverages innovative digital and mobile technologies to recruit, monitor, and communicate with pregnant study participants,” officials said.
The project will use technology like smartphones, wearables, mHealth apps, and telehealth to address the rising maternal mortality rate in the US. Digital health companies participating in the consortium include Fitbit, CareEvolution, Sharecare and Woebot Health.
“Historically, pregnant people have been excluded from most clinical research resulting in significant knowledge gaps when it comes to understanding pregnancy on an individual level,” Toluwalasé Ajayi, MD, a physician and clinical researcher at Scripps Research and the principal investigator of PowerMom, said in a press release. “Staggering racial inequities make it all the more urgent for scientists to help tackle this national public health crisis.”
The PowerMom team has developed an app-based research platform, using Apple’s ResearchKit open-source framing network, that will allow participants to share their data through surveys, electronic health records platforms and wearables, such as fitness trackers and smartwatches.
The project’s launch follows a 2017 pilot phase during which more than 3,5000 pregnant women shared their health data with researchers through the mHealth platform. That pilot program proved the value of a ResearchKit-based platform in recruiting a diverse population of participants, and was featured in a recent study in npj Digital Medicine.
That study also laid the groundwork for the platform’s expansion.
“As the availability of an increasing variety of wireless, connected sensors grows, we anticipate including the automated daily (or even more frequent) collection of multiple parameters known to be germane to pregnancy such as BP, HR, activity, sleep, stress, nutrition, and glucose levels,” the study noted. “We can also assess the impact of new digital platforms and home-based sensors at improving positive behavior change to improve health. In addition to conducting research, a primary future objective of this study is to help women meaningfully interpret and understand their personal data through visualizations, risk profiles, and comparisons to other individuals like them. Ultimately, this will make for more informed decisions for pregnant women when it comes to things from medication choices, to healthy weight gain and ideal sleep during pregnancy.”
“Additionally, participant collected data from this app, such as BP changes over time, can potentially be shared with health care providers to help identify pregnancy complications and better understand an individual’s ‘normal’ values,” the researchers concluded. “Future evaluation of how to best aggregate and share this data with clinicians in a manner that is useful and not burdensome is also necessary.”
With a patient population that might know more than 350 different languages, healthcare organizations like Yale New Haven Health are turning to telehealth to make sure their care teams and patients are communicating with each other.
Healthcare organizations are turning to telehealth to help medical staff communicate with patients who speak a language other than English.
Bogged down by the challenges of finding on-demand interpreters who know everything from Spanish to Mandarin, the Yale New Haven Health System (YNHHS) recently partnered with UpHealth, a Florida-based telehealth company focused on patient engagement. The health system has since deployed more than 1,000 of the company’s Martti telehealth devices across the network, allowing staff to converse with patients in more than 250 languages.
“The ability for healthcare providers to communicate clearly and effectively with people of all backgrounds and cultures is critical,” Tina Bennett, Yale New Haven’s interim chief experience officer, said in a press release. “Martti’s interpretation ability helps ensure that our patients are understood by the clinical team and that they understand what is going on with their and their loved ones’ healthcare.”
Roughly 1 in 11 Americans, or 25 million people, are classified as having limited English proficiency – and, just as problematic, there are more than 350 languages that that could be conversant in. They run the risk of not being able to convey their concerns properly to doctors and nurses, and not understanding their diagnoses or treatments.
The value of communication in front-line healthcare is well-known, and made even more so by the onset of the pandemic. In Boston, Brigham and Women’s Hospital estimated that during the early days of COVID-19, patients who didn’t speak English had a 35 percent higher chance of dying because they weren’t able to communicate properly with care providers.
With more than 3.8 million patient encounters a year in a highly diverse, urban area, YNHHS needs far more than a staff of multilingual care providers. Through a telehealth platform, care teams and patients can connect in real-time to translation services in the correct language. And while the service ensures that diagnoses and treatments are understood, it also goes a long way toward boosting patient engagement and improving patient satisfaction scores.
Informaticists with iPads are accompanying doctors on rounds at Georgetown University Medical Center, and they're using complex search technology to improve patient care.
Doctors making rounds at Georgetown University Medical Center have a new digital health tool at their disposal that can speed up diagnoses and treatment plans, improve clinical outcomes, and even perk up patient engagement.
Rounding teams at the Washington, D.C. hospital can now include an informaticist armed with an iPad and AI-based text-mining technology that scans medical literature for the latest information on patient care, including disease symptoms, medications, and suggested treatments. The resource gives physicians an instant, on-demand link to clinical decision support while they meet with patients.
"Doctors are busy on rounds and often don't have the time to look things up at all," says Jonathan Hartmann, director of clinical information services and data discovery at the health system, which has been partnering with Linguamatics since 2012 on text mining capabilities.
The support addresses several care gaps for physicians, whether they're checking up on patients in the hospital's general population or treating critically ill children in the pediatric ICU. Just as important, it allows them to access information with minimal interruption to the conversation they might be having with the patient, the patient's family, or others attending rounds.
"Their time is limited," says Hartmann. "They have quite a lot to do without looking anything up."
But an informaticist with an iPad changes that dynamic. Hartmann and his colleagues are far more skilled at digging up data than the traditional doctor, who might pull out his smartphone or tablet and type a word or phrase into a traditional medical search engine. An AI-supported platform moves beyond the simple keyword search, traveling down alleyways of relationships and side roads of context, going far beyond the description of a disease to pull up symptoms, side effects, and associated research.
Healthcare organizations have been excited about the prospect of AI for many years, particularly in automating and improving the clinical decision support process. Physicians are under constant pressure to stay on top of their game—with patients' lives in the balance. It's estimated that medical knowledge now doubles every 73 days, and those coming out of medical school now will have learned only about 6% percent of what they need during those first three years.
Forget the good old days of the kindly doctor dispensing homegrown advice with a lollipop or George Clooney look-alikes solving a medical mystery in the nick of time after a night in the library. Physicians need a resource that can allow them on-demand access to the knowledge they need to treat the patient in front of them. And while many can now pull out the smartphone and access a CDS platform on the fly, they still need to know what they're looking for.
Hartmann says Georgetown University Medical Center may be the only healthcare system in the world sending informaticists on rounds with doctors (a practice that has been curtailed by the pandemic). He notes that physicians often have their own unique way of searching for things, or they favor one search engine over another, while informaticists are focused on the search itself.
"We have expertise in searching and can do complex searches quickly," he says.
The value is there, particularly in the pediatric ICU. Hartmann says there have been instances where these searches have helped to save lives, and one physician in particular has credited the process with helping him treat a young patient with three different health concerns, a challenging task when taking into account how treatments and medications might interact.
The potential for this platform is even bigger. AI-enhanced data mining technology is only now being integrated into the electronic health record system, giving physicians and researchers access not only to literature but unstructured data contained in clinical notes and scientific papers, even—potentially— information stored on medical devices, wearables, and mobile platforms. The platform might then be used not only by physicians treating their patients, but by researchers looking to identify genes associated with certain diseases or pharmacists tackling the molecular challenges or drug targeting and repurposing.
The challenge, of course, is in cost. There's a reason Georgetown University Medical Center is unique in sending informaticists out on rounds. Most health organizations can't afford to dedicate specialists to those duties or free up the technology for clinical care. In time, it's expected that AI and data mining will become more fully integrated in the EHR, as the technology becomes more malleable and commonplace.
For now, data mining and AI are more commonly associated with research. Hartmann says the examples of the technology saving lives or dramatically improving treatment are few and far between.
"Not many people realize the value of it," he says. "They do not realize how [this] could help physicians."
And that's where the technology needs to go next. Hartmann envisions that integration into the EHR, perhaps through an "info button" that a doctor simply pushes on a tablet or laptop to launch the process.
"We have all of this information available," he says. "The big problem is getting the knowledge into the physician's head quickly."
The Patient-Centered Outcomes Research Institute is funding three research studies that will study the effectiveness of mHealth tools and telehealth platforms in treatments for smoking cessation, pain and depression.
The Patient-Centered Outcomes Research Institute (PCORI) is investing $23.5 million in three studies aimed at using mHealth and telehealth tools to help quit smoking, manage pain and deal with mild to moderate depression.
“With the explosion of telehealth, especially during the COVID-19 pandemic, studies assessing how well telehealth strategies work in different contexts are highly relevant for many Americans, and we look forward to the insights gleaned from these studies as well as all the other newly approved research projects,” PCORI Executive Director Nakela L. Cook, MD, MPH, said in a press release.
The three projects are part of a nine-project slate of clinical effectiveness research (CES) studies approved by the Washington-based profit, totalling $49.5 million.
At the University of Florida, researchers are getting almost $4.5 million to study the effectiveness of two programs: iCanQuit, which uses mHealth-based cognitive-behavioral treatments to promote cessation through a greater acceptance of triggers for smoking and commitment to personal values; and Motiv8, which promotes smoking cessation with automatic financial rewards based on evidence of abstinence. The study will co pare a combination of the two to iCanQuit alone and the Florida Quitline.
At Stanford University, researchers are getting roughly $10.3 million to study the effectiveness of a two-hour, online “Empowered Relief” cognitive behavioral therapy (CBT) session for treating chronic pain against what’s considered the gold standard – 8 CBT sessions, totalling 16 hours, delivered either in-person or online. The six-site study will involve 1,200 adults with a variety of pain conditions and income levels spread across the country.
And at Massachusetts General Hospital, researchers are getting about $8.7 million to study whether virtual yoga sessions, delivered either individually or remotely to a group of participants, compare favorably against psychotherapy and medication of helping people with mild to moderate depression. The study will help to determine whether virtual yoga is effective and offer evidence to payers that the treatment should be covered.
In addition, the board announced two targeted funding announcements for 2022: a $30 million fund to support studies targeting alcohol abuse among youth 12 to 17 years old, and a $30 million fund to support research on delirium in older adults. They’re part of a three-year, $1.8 billion funding commitment announced this week, comprised of $1.5 billion for research studies, $180 million for dissemination and implementation projects, and $160 million for projects related to infrastructure and accelerating patient-centered outcomes research.
The state is issuing $150,000 grants to community health providers around the state to purchase telehealth and remote monitoring technology to help underserved communities access care.
New York is investing $3 million in a program aimed at helping community health providers purchase new telehealth technology to expand access to care in underserved communities.
Governor Kathy Hochul said the program will spurt public-private support for technology platforms that enable more residents to access virtual care services, particularly in areas where access is difficult due to geographic or economic barriers.
“Every New Yorker should have access to high-quality health care no matter where they live,” she said in a press release. “Telehealth is an important tool that brings healthcare to underserved communities and saves New Yorkers both time and money. Through these investments, we are working to make sure that everyone has access to high-quality health care and can see their doctor.”
The grants are divided into $150,000 allotments and will be distributed to each of the state’s 10 regions in 2022. They’ll be used to help community health providers purchase technology – including audio-visual telemedicine platforms and remote monitoring devices – for use in telehealth stations located in public locations such as libraries, pharmacies and homeless shelters.
Telehealth use has skyrocketed during the pandemic, as healthcare organizations sought to reduce traffic at hospitals and clinics and shift more in-person services onto virtual platforms. The effort is being fueled by federal and state programs aimed at helping providers purchase the necessary technology and broadband connectivity.
New York is one of several states actively supporting telehealth expansion. Along with the grants for technology purchases, the state has updated its telehealth laws to, among other things, reduce barriers that prevent providers from either using telehealth or being reimbursed for it.
“Telehealth is a critical component to the future of healthcare in New York State,” Kristin Proud, Acting Deputy Commissioner for the state’s Department of Health, said in the press release. “By expanding access to telehealth, we are removing barriers that will help expand the care and treatment New Yorkers need and deserve in a timely manner. These investments will also provide high quality and reliable care to historically underserved communities, increasing equity and helping to close the gaps in healthcare.”
The re:Vive platform, developed by Miami-based Heru and the University of Miami's Bascom Palmer Eye Institute, enables care providers to use an AR/VR headset to screen and diagnose - and eventually be reimbursed for - several diagnostic and health and wellness eye issues.
A digital health platform that allows care providers to use virtual and augmented reality to diagnose visual defects has been named a CES 2022 Innovation Awards Honoree.
The re:Vive platform, developed by Miami-based Heru in a partnership with the University of Miami’s Bascom Palmer Eye Institute, will be showcased at the Consumer Technology Association’s CES 2022 conference next January in Las Vegas. The tool uses VR/AR software inside a specialized headset to guide patients and their providers through several diagnostic vision and health and wellness exams.
The technology is designed not only to improve and expand upon the basic eye exam, but enable care providers to conduct exams in remote locations, or even through a telehealth platform, opening up access to underserved populations in the US and elsewhere. It also builds on the rapidly developing VR/AR market, which got its start in gaming and has spread to other areas, including healthcare.
“Globally, approximately 450 million people are affected by visual defects caused by strokes, glaucoma, age-related macular degeneration, and other disorders,” Maurice R. Ferré, MD, chairman of Heru’s Board of Directors and CEO for Insightec, said in a press release. “Yet the decades-old standard of care is immobile, bulky, expensive, and requires a skilled technician or clinician to operate, limiting patients’ access to care. Limited access means that millions of individuals suffering from visual defects remain undiagnosed, causing irreversible damage to their eyesight. Heru’s technology brings us into an era in healthcare where improved access is no longer a goal, it is the new reality.”
“Screening for visual defects is only the beginning,” added Frederic H. Moll, MD, Chief Development Officer for Johnson & Johnson Robotics and a Heru advisor and investor. “In clinical development are therapeutic applications which include augmented vision correction. This new, cutting-edge technology will be the first of its kind and will transform the lives of patients with compromised vision around the world.”
Heru’s collaboration with one of the nation’s leading eye hospitals helps to give the platform traction in the clinical space – and standing with the payer market. To that extent, the company recently expanded the platform to include three new testing modalities, which will enable providers to perform six new tests that are supported by five reimbursable CPT codes.
Re:Vive was selected from among more than 1,800 innovative consumer technology products for the Innovation Award, which is judged by a panel of experts and handed out in 27 product categories.
Athenahealth, an established provider of electronic health records and digital healthcare platforms, has been acquired by a pair of private equity firms, the latest evidence of the rapid growth of cloud-based services in the wake of the pandemic.
Athenahealth, a longtime stalwart in the healthcare IT space, is being acquired by a pair of private equity firms.
Bain Capital Private Equity, Bain Capital Tech Opportunities, and Hellman & Friedman LLC are joining forces to purchase the Watertown, MA-based developer of enterprise-based cloud software solutions for physician practices for $17 billion.
“athenahealth is at the frontier of digital health in the United States, enhancing the clinical quality, operational efficiency, and delivery of preventive care to nearly 20 percent of the population today, unlocking the front door of the consumer healthcare journey and positioning the Company to support physicians in the continuing shift towards value-based care,” Devin O’Reilly, a managing director at Bain Capital Private Equity, said in a press release.
Launched in 1997 by Johnathan Bush and Todd Park as Athena Women’s Health, a women’s health and birthing center, the company took off two years later when Bush and Park pivoted to focus on digitizing medical data, beginning with claims data. The pair changed the company’s name to athenahealth and, in 2000, unveiled the athenaCollector platform.
The company debuted its first electronic medical records platform, athenaClinical, in 2006, then debuted the athenaCommunicator communications platform in 2008. In 2018, it was acquired by Elliott and Veritas Capital for $5.7 billion and taken private, then merged with Virence Health, a software company acquired by Veritas from General Electric.
Company officials say the athenaOne platform is used by more than 140,000 ambulatory care providers across more than 120 specialties. It includes modules for a wide array of services, including revenue cycle management, telehealth, patient engagement, population health management and value-based care management.
The acquisition points to the growing value of healthcare IT companies that specialize in cloud-based services, including telehealth. The healthcare industry saw a surge in online and virtual services during the pandemic, when health systems shifted from in-person to virtual care and consumers sought more healthcare services online. That trend is expected to continue as the nation shifts to a hybrid model that balances in-person and virtual care and gives consumers more options.
“Given our deep experience in software and healthcare, we are excited to work with Bob and the executive team to rapidly scale the business and continue to innovate and grow alongside our most disruptive and innovative ambulatory care clients to build the foundations of a multi-sided digital care network between patient, payer, and provider,” Allen Thorpe, a partner at Hellman & Friedman, added in the press release.
The Centers for Medicare & Medicaid Services has added new codes to its 2022 Physician Fee Schedule that will enable care providers to be reimbursed for more home-based services.
Health systems are looking at remote patient monitoring as an emerging piece of the care delivery puzzle, but they need help embracing the strategy. Recent moves by the Centers for Medicare & Medicaid Services to improve coverage are a step in the right direction, but experts say the effort is still very much a work in progress.
Remote patient monitoring, or RPM, is a relatively new concept, though its roots trace back a few decades to the concept of connecting with patients at home between visits to the clinic or doctor's office. The platform involves connecting with patients at home to track key health metrics, such as vital signs, to shape and modify care management. Providers often use mHealth devices to collect and transmit that data and telehealth platforms to analyze the results and communicate with the patient.
RPM was thrust into the spotlight during the pandemic, when providers sought to push more care services out of the hospital and into the home. Now they're looking to continue that momentum, and to develop use cases that work well for a variety of patients, including those who have been discharged from the hospital and those with chronic care management needs.
CMS first recognized remote patient monitoring in 2019, with a handful of CPT codes aimed at covering remote physiological monitoring, or the gathering of physiological data—such as heart rate, blood pressure and blood sugar—from patients at home. Those codes—also called RPM—have been tweaked each year to expand coverage incrementally, and with the recent release of the 2022 Physician Fee Schedule, CMS is adding new coverage for what it calls remote therapeutic monitoring (RTM), or the tracking of certain non-physiological data, such as medication or therapy response and adherence and pain level.
Healthcare providers and remote patient monitoring advocates hailed the RTM codes as a step in the right direction when they were proposed earlier this year, but many said the coverage was incomplete and confusing. With the final rule released this month, some of those concerns were addressed. But not all.
"It is definitely a step in the right direction," says Carrie Nixon, Esq., a co-founder and managing partner in the Nixon Gwilt law firm and an expert in healthcare innovation. "And there is absolutely more to be done."
"While CMS in the Final Rule explicitly adopted important portions of this framework by expanding 1) the types of patient data captured and analyzed for remote monitoring, and 2) the types of practitioners who can order and bill for remote monitoring, it stopped short of fully aligning RPM and RTM, stating: 'In the interest of coding efficiency for these services, we hope to continue to engage in dialogue with stakeholders, including the AMA CPT, in the immediate future on how best to refine the coding for the RTM services to address some of the specific concerns raised by stakeholders,' " she said in a recent online analysis of the new codes. "This language leaves room for hope that remote patient monitoring stakeholders will not be forced to wait another full year for improvements to policy around RPM and RTM."
New Codes for Remote Therapeutic Monitoring
The RTM codes to be included in the 2022 PFS are as follows:
CPT code 98975, Initial Set-up and Patient Education: Remote therapeutic monitoring (e.g., respiratory system status, musculoskeletal system status, therapy adherence, therapy response); initial set-up and patient education on use of equipment;
CPT code 98976, Supply of Device for Monitoring Respiratory System: Remote therapeutic monitoring (e.g., respiratory system status, musculoskeletal system status, therapy adherence, therapy response); device(s) supply with scheduled (e.g., daily) recording(s) and/or programmed alert(s) transmission to monitor respiratory system, each 30 days;
CPT code 98977, Supply of Device for Monitoring Musculoskeletal System: Remote therapeutic monitoring (e.g., respiratory system status, musculoskeletal system status, therapy adherence, therapy response); device(s) supply with scheduled (e.g., daily) recording(s) and/or programmed alert(s) transmission to monitor musculoskeletal system, each 30 days;
CPT code 98980, Monitoring/Treatment Management Services, first 20 minutes: Remote therapeutic monitoring treatment management services, physician/ other qualified health care professional time in a calendar month requiring at least one interactive communication with the patient/caregiver during the calendar month; first 20 minutes; and
CPT code 98981, Monitoring/Treatment Management Services, each additional 20 minutes: Remote therapeutic monitoring treatment management services, physician/other qualified health care professional time in a calendar month requiring at least one interactive communication with the patient/caregiver during the calendar month; each additional 20 minutes (List separately in addition to code for primary procedure).
Some Good (And Not So Good) Reactions
One of the criticisms of the RTM codes is that they don't cover enough conditions. In a recent analysis, Nathaniel Lacktman, a partner with the Foley & Lardner law firm and chair of its Telemedicine & Digital Health Industry Team, and Thomas Ferrante, a partner and member of that team, point out that the RTM device supply codes (98976 and 98977) are limited to monitoring the musculoskeletal and respiratory systems and don't take into account, for example, neurological, vascular, endocrine, or digestive concerns.
"In the final rule, CMS acknowledged it received comments that a general device code should be created that would be system-agnostic and not restrict RTM reimbursement to monitoring patients' musculoskeletal and respiratory systems, (but the agency) did not include such a general device code in the final rule," the two wrote, adding that they're optimistic that CMS will expand that list in the future.
"That is craziness," Nixon says, noting there are many more opportunities for remote patient monitoring that extend beyond musculoskeletal or respiratory care management.
"In its final rule, CMS discusses RTM in the context of 'therapy adherence' and 'therapy response,' " she wrote in her analysis. "CMS further references monitoring of 'health conditions, including musculoskeletal system status, respiratory system status,' where 'non-physiologic data' is collected. While 'health conditions' can be interpreted broadly, the focus on 'musculoskeletal system status' and 'respiratory system status' comes into play with the two device codes, which may be interpreted as limiting reimbursement for 'device supply' to devices related solely to those two systems. CMS should rectify this with a system-agnostic device code as soon as possible to allow reimbursement for RTM services beyond monitoring patients' musculoskeletal and respiratory systems."
Nixon, Lacktman, and Ferrante also note that the RTM codes are classified as general medicine codes, rather than evaluation and management (E/M) codes, which is how the RPM codes are classified. This means they can't be used for care management services, or for services that are ordered by a physician and carried out by non-physician practitioners. So, while physicians can leverage their staff to manage RPM services, they must do the RTM monitoring themselves to qualify for Medicare reimbursement.
Nixon points out that the two sets of codes can be confusing. Healthcare providers are under a lot of pressure, and many would like to delegate or even outsource some remote patient monitoring services, thereby improving patient monitoring and care and avoiding workflow stress. They can't do that with RTM codes, which require their participation. And while many new providers can take advantage of the RTM codes, they'd like to use the RPM codes to collect data, but can't.
"There are cases where that's absolutely relevant," she says. "It would be very useful to allow these practitioners to be able to bill for RPM. … That's where we need alignment."
In any case, RTM codes do open the door to more care providers using the platform, including physical and occupational therapists, speech and language pathologists, physician assistants, nurse practitioners, and clinical social workers.
"In the final rule, CMS stated the primary billers of RTM codes are projected to be psychiatrists, nurse practitioners, and physical therapists," Lacktman and Ferrante note in their analysis. "The new RTM codes, classified as general medicine codes, should open up opportunities for therapists, psychologists, and other eligible practitioners who cannot currently bill for RPM."
In addition, CMS has amended the RTM codes in the final rule to allow self-reported data, or information either reported by the patient or uploaded by the patient into the monitoring device, as long as the device meets the U.S. Food and Drug Administration's definition of a medical device or a smartphone app or online platform defined as software-as-a-medical device (SaMD). This differs from the RPM codes, which require that data be collected and uploaded digitally, without any patient participation.
Looking to the Future
The codes give healthcare providers some reimbursement for new RPM services, and they represent a subtle step forward. And they fall in line with CMS' line of thinking, which has always been that it wants to see proof that these technologies improve clinical outcomes and reduce wasteful expenses before they're embraced by federal regulators.
The challenge is that CMS is taking a piecemeal approach to RPM and providing two different sets of codes that don't mesh well together.
"On the one hand, it's great that there's acknowledgement that there are different types of data" to be gathered in remote patient monitoring programs, Nixon says. "On the other hand, this piecemeal approach is inhibiting" RPM adoption.
She says CMS has signaled more of an interest this past year in working with stakeholders, something the agency had been criticized for avoiding in the past. She's hoping for that discussion soon on how to better align RPM and RTM codes.
"I really don't want to wait another year for that to happen," she says.
Healthcare providers will soon be able to prescribe a virtual reality treatment that uses cognitive behavioral therapy to help patients manage their lower back pain.
Federal regulators have approved a prescription-based virtual reality platform designed to help people manage pain.
The US Food and Drug Administration this week authorized the marketing of AppliedVR’s EaseVRx product, which uses cognitive behavioral therapy (CBT) and an immersive VR platform to help patients manage chronic lower back pain. The treatment, designed as a prescription for at-home use, consists of a VR headset, controller, and “breathing amplifier” that attaches to the headset and guides the user through breathing exercises.
“Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life,” Christopher Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a press release issued by the FDA. “Pain reduction is a crucial component of living with chronic lower back pain. Today’s authorization offers a treatment option for pain reduction that does not include opioid pain medications when used alongside other treatment methods for chronic lower back pain.”
The agency’s action continues a slow and steady advance for digital therapeutics, or digital health tools and platforms designed to support clinical treatment, in many cases replacing in-person services or even medications. Advocates say these tools can improve access to care for patients at home and help reduce the nation’s ongoing opioid abuse epidemic.
The treatment consists of 56 VR sessions of between two and 16 minutes in length, part of an eight-week regimen that includes behavioral therapy and is designed to give the user skills to “achieve relief and reduction in the interference of pain in daily activities.”
The FDA’s approval is based on a study of roughly 180 people living with chronic lower back pain who were assigned either the EaseVRx program or a control 2-D program that didn’t include skills-based CBT treatment. After an almost nine-month period that included baseline assessment, eight weeks of therapy and follow-up assessments, two-thirds of the EaseVRx participants reported a reduction in pain greater than 30 percent, compared to 41 percent of the control group, and 46 percent of the EaseVRx participants reported a reduction in pain of more than 50 percent, compared to 26 percent of the control group.
AppliedVR executives say the platform also reduces sleep interference and stress, improves mood and offers a high level of patient engagement, with more than 90 percent of those in the study seeing the program through to its end.
FDA officials say there were no adverse events associated with using the technology, though about 20 percent reported discomfort with the headset and about 10 percent experienced motion sickness and nausea.
Driven by the popularity of AR and VR technology in gaming, health systems have been experimenting with the technology for years, particularly in treatments that involve behaviors. This includes Cedars-Sinai in Los Angeles, which hosts an annual symposium on VR in healthcare.
Los Angeles-based AppliedVR, meanwhile, is partnering with the University of California at San Francisco on a business accelerator aimed at finding ways to use VR to improved access to care for underserved populations. And one of its chief competitors, Israel-based XRHealth, launched a handful of VR clinics last year where patients could be referred for VR therapy.
An automated messaging platform helped Penn medicine save two lives per week during the early days of the pandemic by allowing care providers to monitor patients at home.
An automated messaging platform that helped Penn Medicine monitor patients with COVID-19 at home is being credited with saving two lives per week during the early days of the pandemic.
The platform, called COVID Watch, sent AI-enhanced text messages to patients twice a day, asking about their symptoms. If patients reported worsening symptoms, they were sent follow-up questions, then called by designated clinical staff at the hospital, who could recommend hospitalization.
According to a study supported by the National Institutes of Health and the Patient-Centered Outcomes Research Institute (PCORI) and recently published in the Annals of Internal Medicine, nearly 20,000 patients have been monitored at home since the platform was launched on March 23, 2020. In the eight months after the program’s launch, only three of the 3,448 patients died within 30 days of enrollment, compared to 12 patients in a similar-sized group who weren’t in the program, and five died within 60 days, compared to 16 outside the program.
The research team, from Penn Medicine’s Perelman School of Medicine, concluded that COVID Watch reduced a patient’s chances of dying by 68 percent, and that 1.8 lives per 1,000 patients were saved over the first 30 days and 2.5 patients per 1,000 were saved at 60 days.
“Automation isn’t something that will replace human clinical care, but it is something that can extend it,” David Asch, MD, a co-author of the study and executive director of the Center for Health Care Innovation, said in a press release. “Without an automated system to help us watch over the thousands of COVID patients in our community, our doctors and nurses would have been stretched even thinner than they were. This is a promising model for the future.”
Penn Medicine’s program fits neatly into the strategy behind remote patient monitoring, or expanding care management options for patients at home instead of admitting them to a hospital or waiting for them to visit their doctor’s office or a clinic. By creating a platform that uses automated and intuitive messaging to connect with them twice a day, the health system is able to monitor them daily and take action if they’re trending downward. The platform is designed to catch patients before they become serious and require hospitalization.
To manage the program, the health system created a small team of nurses focused on tracking those patients at home. Those nurses can very easily track 1,000 patients around the clock, as well as provide support, such as helping to arrange tests and discussing the results.
“At the beginning of the pandemic, we instinctually thought patients needed extra support at home, even if they weren’t sick enough or ill yet. And if they were to get very sick, we wanted to help them get to the emergency department earlier, so COVID Watch was our solution,” Krisda Chaiyachati, MD, medical director of Penn Medicine OnDemand, an assistant professor of m and co- primary investigator of the study, said in the press release. “Our evaluation found that a small team of five or six nurses staffing the program during some of the most hectic days of the pandemic directly saved a life every three to four days.”
Researchers also noted that the platform works well across all populations, including communities that traditionally face barriers to accessing care.
“We saw a higher proportion of higher-risk patients and also low-income and Black patients enrolled in COVID Watch, but the fact that we measured a significant benefit associated with enrollment in the program is a good indicator that there truly is a treatment benefit for everyone,” M. Kit Delgado, MD, an assistant professor of emergency medicine and epidemiology, deputy director of the Penn Medicine Nudge Unit, and the study’s lead author and co-primary investigator, said in the press release. “It’s crucial that we found all major racial and ethnic groups benefited because non-white and low-income communities have had disproportionately higher infection rates, lower access to care, and higher death rates. This implies that this model of care could have reduced disparities in COVID outcomes if it was scaled up more broadly to these communities.”
Penn Medicine officials noted the platform was originally modeled to monitor at home patients living with chronic obstructive pulmonary disease (COPD), and was redesigned to handle COVID-19. Now they’ll look to see how the platform can be reconfigured to monitor other patient populations, such as those with chronic care needs.
