Telehealth and mHealth will make headlines in 2019 as providers, payers and consumers look to adopt – and adapt to – connected health technology. Here’s what some of the experts in the field think about the coming year.

By Eric Wicklund

December 31, 2018 – With 2019 on the doorstep, healthcare leaders are looking for clues as to what the coming year will hold for telehealth and mHealth. And while most of the experts have long since tossed out the time-worn “tipping point” terminology, they do see a big year ahead for connected health.

So what telemedicine topics will make the headlines in the coming year? Will Amazon make its long-awaited move into healthcare? Will AI find its place in the health ecosystem? Will data become more than just numbers? Will remote patient monitoring be the next big thing?

To get a sense of what’s on the horizon, mHealthIntelligence asked one question of a cross-section of mHealth and telehealth experts: What’s the one big issue, good or bad, that will hit the spotlight in the coming year and make us forget about the final season of Game of Thrones?

DTC Telehealth and Integration

For Nathaniel Lacktman, chair of the national Telemedicine & Digital Health Industry Team at Foley & Lardner LLP, the year ahead will see a surge in on-demand virtual care.

“I firmly believe that direct-to-consumer asynchronous telemedicine services will be the hottest area in telehealth for 2019,” he says. “Many of these companies are thinking bigger, and pairing clinically valid medical protocols with at-home diagnostic tests, or even FDA-approved software integrated into their app.”

“The low cost and high user experience of asynchronous e-commerce has been seen across all industries, and healthcare is no different,” Lacktman adds. “Good medicine should be more than merely treating a disease; it should also offer patients a satisfying experience at an affordable price point. I welcome this next wave of innovative virtual care companies that place the patient-consumer experience at the forefront.” 

Andrew Watson, MD, UPMC’s Medical Director of Telemedicine and Vice President,ofClinical Information Technology Transformation (International Division) – and the current president of the American Telemedicine Association (ATA) – sees a year ahead filled with integration.

“The biggest issues regarding telehealth adoption is the integration into core operations of a healthcare business,” he says. “If you are a payer, provider or consumer focused organization, how you envision telehealth as an integral part of your work is crucial. Approaching it as an added layer or ‘good to have’ is not sufficient.”

“The biggest issue to telehealth adoption is, as Andrew suggests, whether telehealth is ‘baked into’ the way services are provided,” Adds Ann Mond Johnson, who became the ATA’s new CEO this past year. “For organizations where reimbursement is ‘off the table’ (such as the VA and Kaiser) telehealth is a modality and not a technology. One way to test this is with progress in reimbursement, will we see increases in adoption across the board by both providers and consumers?”

Reimbursement Remains in the Spotlight

Over the past few years, provider interest in telehealth and mHealth has been tempered by a lack of reimbursement for adopting (and adapting to) the technology. This past year saw some give-and-take from the Centers for Medicare & Medicaid Services and the American Medical Association, both of which have created new avenues that will help to pay providers. Joseph Kvedar, MD, Vice President of Connected Health at Partners HealthCare, says that issue will stay in the spotlight in the coming year.

“I’ve had the privilege of co-chairing the (AMA’s) Digital Medicine Payment Advisory Group (DMPAG) for the past two years,” he says. “I’ve come to appreciate that, for us to speed adoption of connected health in the provider community, we need more billing codes, even as value-based reimbursement is growing and value-based contracts are very telehealth friendly. AMA’s CEO, Dr. James Madara, shared his insights on this, noting that, until recently, we had no mechanism for providers to document the level of work required to take care of patients in the context of remote monitoring, even in a value-based care delivery system. This has helped me understand why adoption of remote monitoring for care of chronically ill patients has lagged.”

“However, I’m very pleased that (CMS is) now on board, embracing new codes for telehealth reimbursement,” Kvedar adds. “While the impact is not yet obvious, this will make a huge difference in time. I predict that adoption of these new codes in 2019 will be modest, but as third party carriers follow CMS’ lead, their use will take off. This will act as a springboard for new care models, including asynchronous, patient-initiated e-visits, remote monitoring for chronic illness and brief online inter-professional consultations between primary care providers and specialists.”

Fatema Zanzi, a Partner at Manatt Health, agrees with Kvedar.

“One of the biggest issues to positively affect adoption of telehealth in 2019 is increased reimbursement available by Medicare,” she says. “Specifically, Medicare for the first time will be loosening geographic restrictions so that dialysis and stroke patients may receive care via telehealth. Additionally, Medicare will pay for certain types of virtual consultations (with a brief virtual check in with the patient or by reviewing an image from a patient) in order to determine if a patient needs to come in for an office visit. These changes are monumental given that CMS has been reluctant to pay for telemedicine in the past except in very limited circumstances.”

Using Telehealth to Tackle Pain Points

Mei Wa Kwong, Executive Director of the Center for Connected Health Policy, sees the coming year as a crucial one for connected health, especially as it’s used to address on ongoing national crisis.

“I would say the continued attention to the opioid epidemic will continue to have a large effect on telehealth because of the potential impact it will have on telehealth policies,” she says. “This past year and (during) 2017, we started seeing state and federal governments make changes to policies to allow for greater utilization of telehealth to treat substance use disorders (SUD) that impacted the areas that are often cited as barriers to the use of telehealth such as reimbursement and prescribing. However, some of the changes have been piecemeal, so the impact may not be as extensive as one initially thought they may be.”

“For example, you change a policy to allow for reimbursement of some services if provided via telehealth, but you leave intact the narrow policy of what type of provider can get reimbursed for those services if provided via telehealth,” she adds. “The provision of those services may not be as expansive as you think because you haven’t allowed all the possible practitioners who provide that service to get reimbursed. As policymakers see these other areas they need to address if they want their policies to have the impact they hope, I think we’ll see more changes on the policy side that would address some of the continued barriers for telehealth.”

Rene Quashie, Vice President of Policy and Regulatory Affairs for the Consumer Technology Association, sees two trends on the horizon: the increasing role of payers in digital health adoption and the emergence of virtual reality as a training tool.

“Payers are going to be a primary driver of digital health adoption, particularly private payers,” he says. “Health plans (both insurers and employer-funded plans) will be able to use many levers to drive adoption, including leveraging claims data, developing more effective and comprehensive communication and awareness campaigns regarding the availability of digital health solutions, developing plan benefit designs that encourage the use of digital health as a core component of service, collaborating with ACOs to incentivize the use of digital health solutions, and incorporating tools such as telemedicine into additional lines of business (like Medicare Advantage).”

“Recent moves by major insurers highlights the bend toward greater acceptance of digital health by payers, he adds. “For example, Cigna has committed $250 million in capital to Cigna Ventures to fund healthcare startups and emerging companies focused on digital health, care delivery and analytics. Cigna has been involved in venture activity, including investments in companies like Omada Health and Cricket Health. And Humana plans to open a new digital health and analytics center (Humana Studio H) in Boston that it hopes will eventually employ 250 people. Humana also named its first chief digital health analytics officer, who will be responsible for developing the company’s digital health and analytics strategies.  AHIP, the leading health plan trade association, hosts its own separate conference dedicated to digital health and the consumer experience.” 

“One of the biggest, sometimes underreported issues in healthcare involve challenges around technical training and assessment,” Quashie continues. “The data is alarming.  In one study, researchers found that almost 31 percent of graduating surgical residents, after 14 years of education and six-figure debt, still could not operate independently. This is attributed to, among other things, the pace at which new technologies and procedures are introduced, and how difficult it is for physicians to keep up. Virtual reality training has the potential to directly address this looming crisis.”

“VR allows clinicians to effectively practice procedures anytime and anywhere in order to more rapidly work one’s way up the longer learning curves of modern techniques,” he says. “One company’s studies – which are currently submitted for publication – show that users trained with virtual reality perform surgery on average 230 percent better than non-VR trained individuals. Furthermore VR allows you to easily assess surgical skill, ensuring a provider is safe to perform a procedure before laying hands on a patient. In addition, VR connects providers from around the globe, allowing them to easily share expertise and rehearse as a team. Also note, that due to its incredible affordability, this type of training can be scaled up worldwide. Among the advances coming are improvements in headset visual quality and resolution.”

Roy Schoenberg, MD, MPH, CEO of American Well, says the coming year will see a shift in how telehealth is used.

“While telehealth will continue to expand and things like video visits with your own (primary care provider) and the coverage of Medicare Advantage patients offer transformative and much-needed modernization to how we experience care, none will impact the industry as much as the arrival of ‘Virtual First,’” he says. “In a nutshell, I see this as a health insurance product that is structured around an always-available (dynamically allocated) PCP on your phone. It offers speed and convenience previously associated with costly concierge medicine but requires that you actually engage with a remote clinician before you consume physical healthcare services. The clinician will not only help triage and care for the issue at hand but – if needed – will help schedule for you any additional services or labs in a (cost-effective) theater near you.”

“The use of telehealth technology to bundle superior healthcare experience with the mechanism to appropriate consumption will offer a rare opportunity to reign in healthcare costs — an alignment between patients/members and payers,” Schoenberg adds. “In my opinion, Virtual First will be a game-changer to healthcare in the same way Uber changed the way we commute, and Amazon changed the way we buy.”

Bridging the Provider-Consumer Gap

Catering to the healthcare consumer also means finding the mHealth platform that they prefer using. For Adam Pellegrini, General Manager and Senior Vice President of Fitbit Health Solutions, the coming year will be all about bridging that gap between what providers prefer and what consumers demand.

“I’m optimistic that 2019 will be the year we’ll see the broad adoption of virtual care technologies that have the potential to address many of the current challenges in our healthcare system,” he says. “As these technologies become seamless, intuitive and delightful to use, more consumers will engage with them. Furthermore, as they continue to prove their value to consumers and payers alike, we’ll see new reimbursement models that will incentivize further uptake.”

“Another important factor that will impact virtual care adoption is the widespread use of fitness trackers and smartwatches,” Pellegrini adds. “With access to data on their physical activity, heart rate and sleep, consumers can become more engaged in reaching their health goals. The natural progression is for health plans to integrate this type of information into their virtual care offerings and for healthcare providers to use it to inform personalized care plans.”

Drew Schiller, co-founder and CEO of Validic, also sees more emphasis on that bridge between provider and consumer.

“Remote healthcare delivery in 2019 will increase given the growing consumer-driven landscape and the need to manage the increasing population of chronically ill patients without increasing the cost or number of resources required to deliver care,” he says. “While inertia will present a barrier to funding programs for some organizations, many others are recognizing that patients are attracted to forward-thinking healthcare companies that are willing to partner in their health outside of the clinic.”

A Big Year Ahead for the FDA and Digital Health

Bradley Merrill Thompson, a partner with Epstein Becker Green and one of the nation’s top digital health experts, says the US Food & Drug Administration will be on many minds as the agency works to implement a precertification program for software.

“We are expecting the program to be released in draft form sometime before the end of this year, and … in 2019 they will pilot it with nine volunteer companies,” he says. “The goal then is to put together a finished program by the end of 2019. In a sense, this is both very good and very bad.”

“The very good is that FDA is at least promoting this new program on the basis that it will significantly accelerate market introduction of new digital health products,” Thompson says. “It is focused on software-only medical devices – no hardware included. FDA’s goal – and we will have to see if they truly meet this goal – is to exempt more of these products from premarket review, and for those that need to undergo premarket review, accelerate that process significantly. But until we see it in action, we really have no idea just how much it will accelerate the process.”

Thompson also sees more FDA interest in AI technology, as it will have the ability to monitor safety and effectiveness and remove the technology from the marketplace if it’s not up to par.

But there are costs and disadvantages, he says.

“In terms of cost, FDA has – in moments of candor – acknowledged that the excellence appraisal that will be required for companies that want to participate in this program will be very rigorous,” Thompson says. “FDA offers the view that the vast majority of companies now would not pass the standards required for organizational quality. So companies that want to participate are going to have to invest in new quality-related processes. If companies hate GMPs – as many software companies do—they will certainly hate this excellence appraisal process. Another cost is the required monitoring of the products over their lifecycle, and sharing that data with FDA.”

In disadvantages, Thompson says: “FDA says that it’s only willing to do this if it can have much greater power post-market to both monitor the performance of software products, and direct the software vendors to take corrective action. I’ve been doing FDA work for almost 35 years, and while companies get frustrated if their products don’t get approved quickly, that frustration is nothing compared to the angst that companies feel when FDA requires them to conduct a recall that the company doesn’t believe is appropriate. But that’s what FDA is asking for: heighten powers to order a recall whether the company agrees are not.”

“The other main disadvantage is heightened transparency,” he adds. “Transparency sounds lofty, and how can anyone argue that transparency is not good? But the simple fact is that medicine and software are both very complicated, and it is easy for people who are not well versed in both to misunderstand data on the performance of software products. If data on the software performance has to be released not just to FDA but the public, and if the FDA and the public do not have the context to understand what is going on that the company has, there will be many folks who overreact to what they perceive to be safety signals.”

“At any rate, this is high-stakes stuff,” Thompson concludes. “If FDA proceeds with it, it will change the digital medical device industry profoundly. And the process will be interesting, because FDA seems to be suggesting that it does not need congressional authority to proceed. But as an attorney, I can’t fathom that position. The statute is very specific about the current 510(k) process, and changes to that cannot be implemented without Congress amending the legislation.”

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