Health care disruption: Thinking broadly about regulation and innovation

2018 has been a breakout year for health innovation.

Major tech companies plunged fully into the health care arena, hiring teams of health care experts and launching major initiatives. Google conducted landmark artificial intelligence studies; Apple signed up 500 health systems to provided patient data to its digital health records platform; and Amazon announced a health care venture with Berkshire Hathaway and JPMorgan led by writer and surgeon Atul Gawande. Investments by health IT startups topped $6.8 billion by the end of September, well over the previous year’s total.

At the same time, health care systems intensified low-tech, hands-on efforts to improve care and lower costs, adding navigators, coaches and community health workers. Issues such as food security, housing and transport took root in board rooms, and the phrase, “social determinants of health” swept the industry. Telemedicine expanded as hospital systems used consults through email, phone and Skype-like encounters to offer cheaper and more convenient patient care. All this against the backdrop of a health care landscape being transformed by new partnerships and mergers, including some configurations not seen before.

POLITICO convened a working group of 13 thoughtful health care leaders in mid-November for a discussion aimed at pinpointing the most important areas of innovation in health care and offering suggestions on paths forward. The conversation, co-moderated by executive editor for health care Joanne Kenen and eHealth editor Arthur Allen, found consensus about the growing influence of tech players like Amazon, Apple and Google, but disagreement on whether their contributions will be transformative, whether ultimately tech will fix health care or whether health care must fix health care.

The panelists agreed that technology and cost pressures are causing a “shift left” in health care, with responsibilities moving from expensive specialists to primary care physicians, and from physicians to nurses, aides, social workers and even patients themselves. They forecast that companies like Amazon are well-placed to take advantage of younger, healthier consumers’ desires for cheaper, more convenient health care. The outlook for technology to transform more significant treatment is murkier, at least in the short run — in part because of the thick overlay of regulation that slows technology-fueled change.

Panelists’ remarks underscored the remarkable pace and breadth of innovation — from vertical integration to virtual reality. This report focuses on four areas that participants highlighted as undergoing rapid development or change: telemedicine; artificial intelligence and predictive analysis; patient engagement and consumerism, and government policies.

Government could help guide smart growth of telemedicine

The growing use of telemedicine responds to patient demands for better health care. While Medicare still mainly pays for telemedicine in rural areas, private urban-based health care systems have moved aggressively into the technology, in part because they see it as a way to keep patients out of their emergency rooms and avoid penalties for readmissions and long hospital stays. Some of these systems are also employing more community health workers or health coaches to respond to issues raised in telemedicine consults.

One panelist, familiar with industry trends, described telemedicine as the most important innovation in health care currently. Consults by phone or video save patients time and money in lost wages, carfare and parking and are safer for frail patients for whom travel is difficult, whether by car or on public transport. Telepsychiatry — used in a quarter of all U.S. psychiatric practices, according to a recent AMA survey — is especially popular.

Policy Takeaway: The business case for telemedicine expansion is not always clear because hospital systems are unsure it will reduce their costs; currently it is relatively uncompensated in fee-for-service. To enable more telemedicine, panelists said, states and the federal government need to clear away restrictive laws that limit telemedicine by out-of-state physicians. The VA this year enabled its physicians to offer telemedicine across state lines in homes in clinics; legislation taking effect next year allows Medicare to reimburse telemedicine for stroke and a few other ailments.

“They should remove the law that prevents telemedicine across state lines. I think that needs to be redefined.”

“We’ll have 100,00 telehealth visits a year, funded primarily out of philanthropy, and out of the bottom line, because the insurance company, which is one of our big issues. Telehealth has been around since the ‘50s, and we’ve not moved forward with it for a variety of reasons. But we think it’s to our benefit to be able to provide remote monitoring at home.

Perhaps most pressingly, a consumer representative noted, the FCC needs to complete its job of providing broadband to rural and isolated urban communities, where underserved populations badly need medical innovation.

“For remote access monitoring we needed these faster streaming lines, but last year the FCC ran out of money to give grants to health centers. It’s going to happen again, so we’re not building these systems that help to fuel wanting to bring technology to rural areas. That’s a big red flag.”

Artificial intelligence, deep learning, predictive analytics

Smart machines — computer software tools such as predictive analytics and deep learning — could also feed into a “shift left” toward the primary care doctor and the patient. With the data fluidity sought by the 2016 21st Century Cures Act, new computer algorithms could process that data to make interactions between insurance companies and providers more frictionless, automating treatment and drug approvals or reducing phone calls and faxes. In the medium term, computer intelligence is likely to take over some doctoring work itself — interpreting MRIs and X-rays, identifying skin lesions as benign or cancerous, finding signals of heart disease in EKGs or identifying the best cancer treatments.

These kinds of automation could bring more of the treatments traditionally handled by specialists into the primary care office. That would reduce costs and enable nurses and aides to take over more tasks, while giving physicians more time to put hands on and speak with patients.

“The streamlining of health care administrative processes, using machine learning, deep learning, artificial intelligence or however you want to call it, is a very significant innovation right now as we speak and it’s going to improve cost, quality, timeliness and reduce frustration in delivery of care. I think primary care is going to become a nurse and PA specialty that is assisted by artificial intelligence with small amounts of oversight.”

“You move what happened in dermatology to primary care; you move what’s happening in primary care to [retail clinics.]

Policy Takeaway: While no one in the group would gainsay the future significance of advanced informatics, there was skepticism that such tools would replace the deep knowledge of physicians and nurses. There was also a note of caution about high-tech investments that leave behind the neediest patients, deepening rather than resolving disparities.

“For the quote-unquote innovators of the sector, they need to make sure they’re looking at the full patient base. Because everything that I’ve heard is that if we’re using this technology on those that can self-diagnose and know they need a strep test, already have that informed patient perspective, then we’re not necessarily going to improve the entire health care system.”

Getting patients more engaged as consumers of health care — and the Amazon factor

Before too long, common clinical tools such as strep tests could be purchased on Amazon and used at home as readily as the electronic thermometer. The combination of higher deductibles, readily available Internet information and easier remote communication with clinicians could make it easier for patients to deal with more maladies at home.

Several panelists stated that Amazon — which provoked much more discussion at the working group than other tech giants — could easily cordon off and capture less efficient areas of health care. The online retail giant is good at finding solutions that consumers like, and consumers are not happy about the hassles and prices they have to pay for medicine and treatments. One panelist said his daughter recently found herself having to go to an ER for a strep test and came home with a $750 bill. Amazon appears poised to disrupt health care in two major areas. First, its partnership with Berkshire Hathaway and JPMorgan Chase seeks a lower-cost health care model for employers, although it might not differ enormously from existing company-run in-house clinics.

More remarkable, or troubling, depending on the panelist’s perspective, is Amazon’s move into pharmacy, health data and medical devices. The company has announced plans to create a proprietary device chain, purchased a drug distributor and created algorithms to scrape medical notes out of digital health records and analyze them for health care system. Amazon — like Google — already holds vast data, much of it relevant to health, on millions of consumers.

“Twenty percent of Google searches are health care-related, so they know much more about us than our clinicians do. And Amazon likely knows much more about the way in which we’re accessing care than, again, our providers do.”

“We have right now massive number of young healthy millennial types. And folks my own age use Amazon for everything. So it is not that far-fetched that I would find myself, five years from now, purchasing things or accessing things through Amazon.… If you’ve got an Amazon Echo sitting in your kitchen and you say, ‘I have a fever. What do I do?’ they’re going to send you a bottle of Tylenol…. Or connect you to the nurse line.’”

But there were a few notes of skepticism that Amazon could move into this terrain, no matter what it’s successes in retail and entertainment.

“One of the reasons health care costs money is because it’s very specialized and it’s expensive … it’s not like selling books.”

Policy Takeaway: Amazon, Google and other tech firms are moving into various areas of tech with varying levels of regulation. This fits with the aging of demographics who are more accustomed to using tech to solve their problems. But there are many problems tech can’t or won’t try to solve.

“[You] still can’t use this all to fix the really chronic conditions, the really sick patients. You cannot remove the provider, and not provide the need for contact there.”

How will the regulatory framework adapt to new technology?

The highly regulated character of health care raises some big questions about the move to more patient-centered care as well as the implementation of technologies. The 21st Century Cures Act laid the groundwork for this adaptation, and FDA, CMS and other agencies have already made strides to implement the law. But much of what we currently think of as “regulation” — or even measurement — is not matched to the disruption that is occurring.

Policy Takeaways:

Quality measures, which have become a standard of reimbursement schemes over the past two decades, will have to be adjusted to incorporate things like shared decision-making and patient engagement. There is more thought, but not yet clear answers, about how to measure quality of what one panelists called “sets and systems” — not just processes or outcomes.

“The patients are like, ‘Okay, I can go to Amazon now and go buy my health products, or I can go to an urgent care.’ But we’re not able to then monitor what kind of care is being given, and we’re not able to put a stake in the ground and say, yes the patients are being cared for appropriately.”

— Making sure tech advances have broad and equitable reach: One participant spoke of bringing broadband to an impoverished urban neighborhood. While it will enable hospital providers to communicate with sick patients via telemedicine, most of the people in this area are used to getting their health care in the emergency room, which they treat like a community center. Breaking that habit will be hard.

Broadening regulation and liability law: Expanding role of tech companies into health may well require shifting or broadening to new regulatory, quality and liability frameworks away from the traditional focus on health care providers like doctors and hospitals. In addition, new legal frameworks will have to address new roles for physicians — for instance, if insurers begin to require that physicians rely on artificial intelligence for certain decisions once AI is shown to be more accurate, in general, than clinician judgment. But how will the U.S. health care system pivot to such a requirement? In China, one speaker noted, authorities in one province are requiring primary care patients to see a robot before they can obtain a referral to a doctor.

“There’s the question about how we are even going to certify to the effectiveness of the technology.”

Government as incubator – Making sure government agencies — such as the Center for Medicare and Medicaid Innovation — take tech disruption into account in a more significant way as they continue testing new value-based delivery and payment systems.

Innovation and disruption are here. Some “breakthroughs” will be ephemeral; others will be profound, lasting and arrive quickly. They will redefine provider roles, shift responsibility and help bring care from the hospital to the community. Yet patients may not be as engaged as some of the innovators assume; the well-educated urban millennial clicking on an app to find a strep test isn’t typical of the American population, and certainly not of the sickest and most complex (or expensive) part of the American population. To balance old and new challenges, the government and the regulatory and legal systems will have to think broadly about which regulations to lighten in a new health-tech driven world, and which new players will require new approaches to balance innovation and patient safety.

Participants:

Arthur Allen, eHealth Editor, POLITICO *ModeratorPaul Bleicher, MD, PhD, CEO, OptumLabs
Emme Levin Deland, MBA, Senior Vice President and Chief Strategy Officer, NewYork-Presbyterian
Roshni Ghosh, MD, MPH, Vice President and Chief Medical Information Officer, Premier, Inc.
Kathleen Giblin, Senior Vice President, Quality Innovation, National Quality Forum
Adrian Gropper, MD, CTO, Patient Privacy Rights
Joanne Kenen, Executive Editor, Health Care, POLITICO *Moderator
Dan Mendelson, Founder, Avalere Health
Jason Patnosh, Associate Vice President, Partnerships and Resource Development, National Association of Community Health Centers
Jacob Reider, MD, CEO, Alliance for Better Health; former Deputy National Coordinator of Health IT, Department of Health and Human Services
Barak Richman, Bartlett Professor of Law and Business Administration, Duke University
Brian Scarpelli, Senior Global Policy Counsel, Connected Health Initiative, ACT | The App Association
Mona Siddiqui, MD, MPH, Chief Data Officer, U.S. Department of Health and Human Service
Lisa Suennen, Managing Director, Manatt Phelps & Phillips (and Venture Valkyrie blog)
Debbie Witchey, Executive Vice President and Chief Operating Officer, Healthcare Leadership Council

Date: December 19, 2018

Source: POLITICO