By MICHAEL MILLENSON
Can combining health tech “rah-rah,” health policy “blah-blah” and the “meh” of academic research accelerate the uptake of digital health innovation?
AcademyHealth, the health services research policy group, is co-locating its Health Datapalooza meeting, rooted in cheerleading for “Data Liberación,” with the National Health Policy Conference, rooted in endless debate about policy detail.
Sharing a hotel room, however, does not a marriage make. In order to get better digital health interventions to market faster, we need what I’m calling a Partnership for Innovators, Policymakers and Evidence-generators (PIPE). As someone who functions variously in the policy, tech and academic worlds, I believe PIPE needn’t be a dream.
The potential of digital health is obvious. Venture funding of digital health companies soared to $8.1 billion in 2018, up 40 percent from 2017, according to Rock Health, with another $4.2 billion invested during the first half of this year. Meanwhile, MedCityNews proclaimed 2019 “the year of the digital health IPO,” such as HealthCatalyst and Livongo.
Separately, Congress has sought to speed digital health innovation through bipartisan efforts such as the 21stCentury Cures Act and the formation last year of the Bipartisan Health Care Innovation Caucus. The Department of Health and Human Services (HHS) is also pursuing innovator and advocacy group input on regulatory relief.
One word: implementation.
Increasingly, I’m convinced that the underappreciated challenges of implementation describe the ever-expanding gap between the promise of emerging technologies (sensors, AI) and their comparatively limited use in clinical care and pharmaceutical research. (Updated disclosure: I am now a VC, associated with a pharma company; views expressed, as always, are my own.)
Technology Promises Disruption Of Healthcare…
Let’s start with some context. Healthcare, it is universally agreed, is “broken,” and in particular, many of the advances and conveniences we now take for granted in virtually every other domain remain largely aspirational goals, or occasionally pilot initiatives, in medicine.
Healthcare is viewed by many as an ossified enterprise desperately in need of some disruption. As emerging technologies shook up other industries originally viewed as too hide-bound to ever change, there was in many quarters a profound hope that advances like the smart phone or AI, and approaches like agile development and design thinking, could reinvent the way care is delivered, and more generally, help to reconceptualize the way each of us think about health and disease.
I’ve written several posts over the past two years about the need for innovation in healthcare IT – deploying self-developed apps, leveraging third party cloud hosted functions, and embracing the internet of things.
I’ve previously discussed establishing a center for innovation. In preparation, I’ve worked on innovative projects in industry accelerators, academic collaborations, and government sponsored hack-a-thons.
What has worked?
1. I’ve learned that it is very important to make innovation a part of the day to day work inside an organization. Creating change externally and then trying to graft it internally results in a disconnect between research and operations. At BIDMC, we’ve created a meritocracy in which those have competitively illustrated out of the box thinking are given reserved time each week to focus on highly speculative areas of innovation. The project started as ExploreIT and is now being formalized as the Center for Information Technology Exploration in Health Care.
There is optimism that Congress will soon pass the 21st Century Cures bill. The draft bill proposed by the House Energy and Commerce Committee aims to foster medical innovation by streamlining the FDA regulatory process and increasing NIH research funding by $10 billion. The draft bill has overwhelming bipartisan support and will benefit patients, medical researchers and pharmaceutical companies. However, it also includes a passage, which aims to amend the Sunshine Act and exempt pharmaceutical companies from reporting the payments they make to physicians for continued medical education (CME) programs. The supporters of this change argue that physicians learn about the latest developments in medical science through CME programs and that requiring the disclosure of these payments would discourage pharmaceutical companies from financially supporting educational programs. Ultimately they believe it could inhibit the diffusion of medical innovation among doctors.
I took a look at the data released by CMS on the financial transactions between the pharmaceutical companies and individual physicians. In the last five months of 2013, more than $120 million were paid to physicians who participated (as faculty or speakers) in CME programs. The payments constitute 26 percent of the total financial transactions between pharma and individual physicians. The proposed change essentially allows pharmaceutical companies to hide more than a quarter of their payments to physicians. Exempting the pharmaceutical companies from reporting the largest part of their financial relationship with doctors will not help to foster medical education, rather it will add to current suspicions about the unjustified impact of such payments on the drugs that physicians prescribe to their patients.
If CME programs legitimately increase the awareness of physicians about the latest medical innovations and provide them with unbiased information about new drugs, then both pharmaceutical companies and those physicians who serve as speakers and faculties of such programs should be extremely proud of their role as champions of innovation and envoys of the latest knowledge in the medical community. If that is the case, one would wonder why they wouldn’t embrace and support the efforts that shed light on their noble role.
Patients heavily rely on the recommendations of their doctors to make any kind of decision regarding their health and thus have the right to be informed about the possibility that their doctors have a conflict of interest. Congress should refrain from amending the Sunshine Act and avoid jeopardizing the patients’ right to have access to information.
Niam Yaraghi is a fellow at the Brookings Institute Center For Technology Innovation. His posts appear regularly on THCB and on the Brookings Institute Tech Talk blog, where this post first appeared. This post also appeared as an opinion column on the US News and World Report site.
Investments in digital health have never been higher, with reports indicating that $5 Billion has been invested in health tech startups in 2014. Encouraged by the increasingly favorable changes being made to health policy in the U.S., many entrepreneurs have answered the call to action to solve problems related to health care delivery and access, disease management, and cost reduction. Venture capitalists recognize the value of innovation in health care through technology yet few of these tools have gained widespread adoption. Health care organizations and providers are wary of implementing new technologies that haven’t been tested for fear of disrupting their workflows and causing more problems than before.
Market R&D Pilot Challenge Website
Recognizing these high barriers to entry for digital health startups the Office of the National Coordinator for Health Information Technology (ONC) is hosting the Market R&D Pilot Challenge to bridge the gap between health care providers and innovators. This competition, which is administered by Health 2.0, may award pilot proposals in four different domains: clinical environments (e.g., hospitals, ambulatory care, surgical centers), public health and community environments (e.g., public health departments, community health workers, mobile medical trucks, and school-based clinics), consumer health (e.g., self-insured employers, pharmacies, laboratories) and research and data (e.g, novel ways of collecting data from patients).Continue reading…
The best way to get your startup noticed is to have your product validated by experts in the industry. As a young startup connecting with that community of experts can be quite difficult. Participating in a developer challenge can not only lead to funding and credibility but provides a valuable testing ground for products.
What is a developer challenge? These virtual competitions build on the concept of their in-person cousin the code-a-thon/hack-a-thon, prompting teams to develop technologies to address some of healthcare’s most complex issues. Over 3 – 6 months teams work on design concepts and prototypes for a variety of challenges sponsored by all types of organizations from charitable foundations to for-profit companies. Final submissions are judged by a panel of industry experts and winners are awarded cash prizes.
Health 2.0 has run over 75 challenges in the past 4 years and awarded over $6M in funding to burgeoning digital health companies. But its not only money that draws teams to these competitions, participants gain validation of their product, publicity and market access.Reflecting on the past few years, we want to share the successes of these challenges.
Ready? Here we go!
Startups announce new technologies to solve healthcare problems every week, but how much of these new technologies hit the public market and reach widespread adoption? Even more, how much technology gets adopted by key institutions that work directly with patients and deliver care? 6 out of 10 physicians reported that they did not use digital health technology for clinical purposes, including communication with patients and other providers and only 27% of physicians actively encourage their patients to use digital health applications, according to PriceWaterhouseCooper’s Top Health Industry Issues 2014 report. While many health systems are beginning to explore different avenues for innovation, some even creating internal departments to address innovation, many are still slow to adopt. As many as 36% of healthcare service organizations report that their organization has no mobile technology or innovation strategy.
Digital health startups, compared to traditional technology startups, have the additional burden of breaking into an established health care system before their solution can really gain traction. Whether it’s a hospital network, health plan provider or direct consumers, all of these groups want to see a product or service that has been validated. With so much activity in the digital health space, potential customers, especially large health systems, want to mitigate risk by purchasing a solution that has shown evidence of the benefits they claim to deliver.
Few people know that new prescription drugs have a 1 in 5 chance of causing serious reactions after they have been approved. That is why expert physicians recommend not taking new drugs for at least five years unless patients have first tried better-established options and need to. Faster reviews advocated by the industry-funded public regulators increase the risk of serious harm to 1 in 3. Yet most drugs they approve are found to have few offsetting clinical advantages over existing ones.
Systematic reviews of hospital charts by expert teams have found that even properly prescribed drugs (aside from misprescribing, overdosing, or self-prescribing) cause about 1.9 million hospitalizations a year. Another 840,000 hospitalized patients given drugs have serious adverse reactions for a total of 2.74 million. Further, the expert teams attributed as many deaths to the drugs as people who die from stroke. A policy review done at the Edmond J. Safra Center for Ethics at Harvard University concluded that prescription drugs are tied with stroke as the 4th leading cause of death in the United States. The European Commission estimates that adverse reactions from prescription drugs cause 200,000 deaths; so together, about 328,000 patients in the US and Europe die from prescription drugs each year. The FDA does not acknowledge these facts and instead gathers a small fraction of the cases.
Perhaps this is “the price of progress”? For example, about 170 million Americans take prescription drugs, and many benefit from them. For some, drugs keep them alive. If we suppose they all benefit, then 2.7 million people have a severe reactions, it’s only about 1.5 percent – the price of progress?
However, independent reviews over the past 35 years have found that only 11-15 percent of newly approved drugs have significant clinical advantages over existing, better-known drugs. While these contribute to the large medicine chest of effective drugs developed over the decades, the 85-89 percent with little or no clinical advantage flood the market. Of the additional $70 billion spent on drugs since 2000 in the U.S. (and another $70 billion abroad), about four-fifths has been spent on purchasing these minor new variations rather than on the really innovative drugs.
In a recent decade, independent reviewers concluded that only 8 percent of 946 new products were clinically superior, down from 11-15 percent in previous decades. (See Figure) Only 2 were breakthroughs and another 13 represented a real therapeutic advance.
Spokesmen for the pharmaceutical industry point out that therapeutically similar drugs have advantages. First, physicians need some choice within a therapeutic class because some patients do not respond well to a given drug. This is true, but after about three choices, there is little evidence to justify a 4th , 5th, or 6th in a class.
There is a saying that “culture eats strategy for lunch.” Never has this been truer than when looking at primary care or physician group delivery system innovation. Health care industry leaders must invest more time creating and scaling the right culture as they innovate.
There has been a great deal of controversy on the ability of the Primary Care Medical Home (PCMH) to impact total medical costs. Critics have noted that PCMH is adding additional costs to the structure without systematically demonstrating improvement in total costs and quality.
A great deal of time has been spent debating the proper structures, processes and financial incentives that are necessary to create value in physician-led-risk or shared-savings models. However, I suspect the real issue is that culture is a major driver of performance, and it has not been systematically measured or managed.
At ChenMed, we have developed a primary-care-led model focused on the care of seniors with multiple and chronic health conditions. Funded through full-risk arrangements with Medicare Advantage plans, we outlined an overview of the original Miami-based model in Health Affairs last year .
Over the last three years, we have scaled the model from five centers in Miami to 36 centers in eight markets in the Southeast and Midwest. This has required us to adjust our model in ways that allow it to readily scale. We have been able to make the fundamental economics work while rapidly scaling the medical practice, and are actively working on innovations to improve value every day.
One of the foundations of our strategy is getting the physician culture right. This is not easy to measure from a health services and policy research perspective.Yet, it matters a great deal from a practical and business perspective. McKinsey and Company has developed an influence model on how organizations create the right behavior and mindset shifts, which we have found useful .