The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have published proposed final rules on interoperability and data blocking as part of implementing the 21st Century Cures act. In this series we will explore the ideas behind the rules, why they are necessary and the expected impact. Given that these are complex, controversial topics, and open to interpretation, we invite readers to respond with their own ideas, corrections, and opinions.
Health IT 1.0, the basic digitalization of health care, succeeded in getting health care to stop using pens and start using keyboards. Now, Health IT 2.0 is emerging and will build on this foundation by providing better, more diverse applications. Health care is following the example set by the rest of the modern digital economy and starting to leverage existing monolithic applications like electronic health records (EHRs) to create platforms that support a robust application ecosystem. Think “App Store” for healthcare and you can see where we are headed.
This is why interoperability and data blocking are two of the biggest issues in health IT today. Interoperability – the ability of applications to connect to the health IT ecosystem, exchange data and collaborate – is a key driver of the pace and breadth of innovation. Free flowing, rich clinical data sets are essential to building powerful, user-friendly applications. Making it easy to install or switch applications reduces the cost of deployment and fosters healthy competition. Conversely, when data exchange is restricted (data blocking) or integration is difficult, innovation is stifled.
Given the importance of health IT in enabling the larger transformation of our health system, the stakes could hardly be higher. Congress recognized this when it passed the 21st Century Cures Act in 2016. Title IV of the act contains specific provisions designed to “advance interoperability and support the access, exchange, and use of electronic health information; and address occurrences of information blocking”. In February 2019, ONC and CMS simultaneously published proposed rules to implement these provisions.
Jessica DaMassa interviews Paul Simms, the Chairman of eyeforpharma. Eyeforpharma are the “media moguls” when it comes to the Pharma industry. In order to innovate the industry, they are holding two different conferences this year to bring pharma leaders and health technology startups together to foster relationships and strategic partnerships with one another. Their first conference will be held in Barcelona in March, and the second one will be in Philadelphia in April.
Paul speaks to Jess about how health tech startups are maturing in their ways and realizing that health care is an institutionalized game, causing them to pivot their companies’ directions to fit that model. He also comments on how the pharmaceutical industry is trying to build strong relationships with particular startups to innovate their business practices, whether it be in R&D, drug discovery, or clinical research. Paul argues that the future of Pharma is more akin to a platform model, where pharma companies are not just limited to their internal capacity but are much more reliant on a larger ecosystem of moving parts that will help develop and grow the space. He also mentions that Pharma companies could really benefit from taking a page out of Google’s or Facebook’s business model which allows people to innovate and create their own content on these platforms. He further states that large B2C companies, like Amazon, will change the entire game of how people receive and curate their health insurance plans.
eyeforphrama’s conference theme is “medicine is just the beginning”. Paul and his team believe if they bring together specific groups of people, it will benefit the pharmaceutical industry in the short term as well as the long term. Paul believes that “Pharma companies need to have a wider portfolio of innovation that goes far beyond medicine, whether that is drug+plus a solution or without the pill at all.”Currently, Paul states, that the merging of pharma companies with other pharma companies is like having “s*x with your cousins” and believes that Pharma companies need to bridge out of their own space to keep up with the times. If you are a startup in this space, be sure to check out eyeforpharma’s upcoming conferences.
Last week’s announcement by Aetna and Apple of their Attain “experience” designed to enable Aetna members to achieve better health using the Apple watch was the latest in a series of partnerships vying to shake up healthcare from an unconventional angle. Others include Amazon-Berkshire Hathaway-JP Morgan’s collaboration to reshape health insurance, and Uber and Lyft’s numerous partnerships with Sutter, CareMore Health, and other healthcare systems to address transportation challenges for patients.
The Heat is On
Big changes in healthcare—including the shift to value-based care, the growing influence of consumerism, and a recognition that health outcomes depend on a wide array of everyday life factors ranging from foods to moods—are forcing the old guard in healthcare to recalibrate. Healthcare provider organizations alone engaged in a record-breaking 115 mergers and acquisitions in 2017, and continued apace until now, with deals already announced in 2019 between Dignity Health and Catholic Health Initiatives (CHI), among others.
The most interesting partnerships, from my perspective, pair traditional healthcare players with non-traditional ones: it’s a recognition that something fundamental has to change, a point which hasn’t been lost on the 84% of the Fortune 50 companiesthat are already in healthcare, up from 76% in 2013. Everyone from tech giants to car manufacturers seems to gambling to some extent on healthcare. And why not, when the potential jackpot just keeps growing?
The official 2017 statistics from the U.S. Department of Health and Human Services (DHHS) are out, and there are some good news: The annual growth rate of health care spending is slowing down, and is the lowest since 2013 at 3.9%—it was 4.3% for 2016 and 5.8% for 2015. The bad news is that our health care cost increases are still well above inflation, and that we spent $3.5 trillion in this area, or 17.9% of GDP. Americans spent $10,739 on health care in 2017, more than twice as much as of our direct economic competitors: This per capita health care spending was $4,700 in Japan; $5,700 in Germany; $4,900 in France; $4,200 in the U.K.; $4,800 in Canada; and an average of $5,300 for a dozen such wealthy countries, according to the Peterson -Kaiser health system tracker from the Kaiser Family Foundation, and OECD data. Spending almost a fifth of our GDP on health care, compared to 9-11% for other large developed economies (and much less in China), is like having a chain tied to our ankles when it comes to our economic competitiveness.
Could 2019 be the year when our health care spending actually decreases, or at least grows at a slower pace than inflation? Or will we see instead an uptick in costs for health care consumers?
To answer these questions, we need to look in more detail at the largest areas of health care spending in America, and at the recent but also longer term spending trends in these areas. Using the annual statistics from the DHHS, we can compare the growth in spending in half a dozen critical health care categories with the growth in total spending, and this for the last three years as well as the last decade. Over the last decade, since 2007, these costs grew 52% in aggregate (from $2.3T to $3.5T) and 41% per capita (from $7,630 to $10,740).
Abbott Ventures chief Evan Norton may have spent part of his youth on a farm, but there’s no manure in his manner when speaking of the medical device and diagnostics market landscape. The key, he says, is to avoid being blindsided by the transformational power of digital data.
“We’ve been competing against Medtronic and J&J, so that has the risk of us being disintermediated by other players that come into the market,” Norton told attendees at MedCity Invest, a meeting focused on health care entrepreneurs. “Physicians are coming to us and asking for access to data for decisions, and they don’t care who the manufacturer [of the device] is. Are we enabling data creation?”
Abbott, said Norton, wrestles with whether they are simply data creators or want to get paid for providing algorithmic guidance on how the data is used. (Full disclosure: I own Abbott shares.) Other panelists agreed making sense of the digital data deluge remains the central business challenge.
Amazon has transformed the way we read books, shop online, host websites, do cloud computing, and watch TV. Can they apply their successes in all these other areas to healthcare?
Just last week, Amazon announcedComprehend Medical, machine learning software that digitizes and processes medical records. “The process of developing clinical trials and connecting them with the right patients requires research teams to sift through and label mountains of unstructured clinical record data,” Fred Hutchinson CIO Matthew Trunnell is quoted saying in a MedCity News article. “Amazon Comprehend Medical will reduce this time burden from hours to seconds. This is a vital step toward getting researchers rapid access to the information they need when they need it so they can find actionable insights to advance life-saving therapies for patients.”
Deriving insights from data and making those available in a user-friendly way to patients and clinicians is just what we need from technology innovators. But these tools are useless without data. If an oncology patient is hospitalized, her provider may not be informed of her hospitalization for days or even weeks (or ever). And the situation is repeated for that same patient receiving care from cardiologists, endocrinologists, and other providers outside of her oncology clinic. When it comes to personalized health and medicine, both the quantity and quality of data matter. Providers need access to comprehensive patient health data so they can accurately and efficiently diagnose and treat patients and make use of technology that helps them identify “actionable insights.”
FDA Commissioner Scott Gottlieb has said biosimilars are “key to promoting access and reducing health care costs. And it’s a key to advancing public health.” While the Administration works to reduce barriers to bringing biosimilars to market, payers and providers can help increase adoption of biosimilars in clinical practice and ensure cost savings.
Biosimilars are developed in a similar way as existing biologics and have the same safety, efficacy, and quality profiles, but are more competitively priced to ensure more patients have access to these important medicines and that the system can afford them. A ten-year growing body of real-world use in the EU shows biosimilar medicines increase usage of biologic medicines, while matching their reference biologics in terms of safety, efficacy and quality.
On Episode 62 of Health in 2 Point 00, Jess and I are reporting from Nashville—while enjoying some delicious barbecue. We’re in town for AHIP’s Consumer Experience & Digital Health Forum, where Jess did an amazing job as a moderator and I was on a panel. In this episode, Jess asks me about my key takeaways from the forum, what the deal is with Tivity Health acquiring Nutrisystem, and how I managed to get into a fight on Twitter while at AHIP. —Matthew Holt
There was a very sobering piece in NEJM by the FDA last month in which the authors try to explore what went wrong with the Keynote-183, Keynote-185 and checkmate 602 trials testing PD-1 inhibitors combinations with pomalidomide or lenalidomide and dexamethasone in multiple myeloma. Interim analysis of Keynote 183 and 185 revealed detrimental effects on overall survival (OS) with hazard ratios of 1.61 and 2.06, not explained by differences in toxicities alone. The checkmate 602 trial was also halted in light of these findings and also showed higher mortality in the nivolumab combination arm.
In the thoughtful NEJM piece, the authors make at least three important points. First, they question why these PD-1 inhibitors were tested in combination despite their having limited single-agent activity. In fact, a couple of years ago, Vinay Prasad and I asked the same question: why are novel cancer drugs being tested in combination despite having limited activity as a single agent? We found that these drugs, even when ultimately approved, provide relatively low value and recommended that drugs with poor single agent activity not be tested in combinations unless there are specific reasons to expect synergy.
The second important point in the article is that many cancer drug approvals are lately based on durable response rates in single arm trials without a control group, a situation in which it is difficult to evaluate the safety and efficacy of drug combinations. Indeed, without an RCT, the oncology community would never have known these signals of detrimental effect. If the FDA had approved these PD-1 inhibitors in multiple myeloma on the basis of non-randomized trials, which it often does in other oncology contexts, who knows how long it would have taken to recognize the increased mortality in patients—and at what cost. This is another reason why we need RCTs more now than ever. Finally, the authors point out that these PD-1 inhibitors in multiple myeloma were directly advanced to phase 3 trials after phase 1 trials were completed, without phase 2 information. Indeed, in a recent paper, Alfredo Addeo and I showed that a substantial percentage of drugs that fail in phase 3 trials do not have supporting phase 2 data. Continue reading…
The 2019 ACA plan year is notable for the increase in insurer participation in the marketplace. Expansion and entry have been substantial, and the percent of counties with one insurer has declined from more than 50 percent to approximately 35 percent. While urban areas in rural states have received much of the new participation, entire rural states have gained, along with more metropolitan urban areas.
Economic theory and common sense lead most to believe that increased competition is unquestionably good for consumers. Yet in the paradoxical world of the subsidized ACA marketplace, things are not so simple. In some markets, increased competition may result in a reduction in the purchasing power of subsidized consumers by narrowing the gap between the benchmark premium and plans that are cheaper than the benchmark. Even though the overall level of premiums may decline, potential losses to subsidized consumers in some markets will outweigh gains to the unsubsidized, suggesting that at the county level, the losers stand to lose more than the winners will win.
One way to illustrate this is to hypothetically subject 2018 marketplace enrollees to 2019 premiums in counties where new carriers have entered the market. Assuming that enrollees stay in the same metal plan in both 2018 and 2019, and that they continue to buy the cheapest plan in their metal, we can calculate how much their spending would change by income group.
Under these assumptions, in about one quarter of the counties with federally facilitated marketplaces (FFM) that received a new carrier in 2019, both subsidized and unsubsidized enrollees would be better off in 2019, meaning that they could spend less money and stay in the same metal level. In about thirty percent of these counties, all enrollees are worse off. In almost all of the rest, about forty percent, there are winners and losers, but in the aggregate, the subsidized lose more than the unsubsidized win. Overall, in about 70 percent of FFM counties with a new carrier, subsidized enrollees will lose purchasing power, while in about 66 percent of these counties, unsubsidized customers will see premium reductions. In population terms, about two-thirds of subsidized enrollees in counties with a new carrier will find plans to be less affordable, while a little more than half of unsubsidized enrollees will see lower premiums.