Care Innovations sells off Validation Institute. But is there more to the story? And a side of Walmart Health action.

The Health Value Institute, part of Woburn, Massachusetts-based conference organizer World Congress, announced late last week the acquisition of the Validation Institute from Care Innovations. Terms were not disclosed. The Health Value Institute and the Validation Institute recently partnered to validate the outcomes for the Health Value Award finalists and awards this past April at the 15th Annual World Health Care Congress. According to both parties, the acquisition will help to expand the membership of validated companies, and the present offerings for HR, broker, and benefit executives. Release.

The Validation Institute was launched with fanfare back in June 2014, when GE still had a chunk of the company and during the 2 1/2 year repositioning (revival? resuscitation?) led by Sean Slovenski from the doldrums of the prior Louis Burns regime. Mr. Slovenski departed in early 2016 to be president of population health at Healthways/Sharecare, which lasted a little over a year. However, this week Mr. Slovenski made headlines as the new SVP Health & Wellness of Walmart, reporting directly to the head of their US business.  The hiring of a senior executive with a few years at Humana and a short time at Sharecare, another Walmart partner, coupled with several years in healthcare tech and provider-side is certainly indicative of Walmart’s serious focus on healthcare provision. It’s a fascinating race with Amazon and CVS-Aetna–with the mystery of what Walgreens Boots Alliance will do. Also Healthcare Dive.

But back to Care Innovations. Signs of a new direction–and a loss. The case can be made that the Validation Institute, the Jefferson College of Population Health, and validating individuals and companies was no longer core to their business which is centered around their RPM platform Health Harmony (with QuietCare still hanging in there!) However, this Editor notes the prominent addition of  ‘platform-as-a-service’ advisory services for those who are developing health apps, which appears to be a spinoff of their engineering/IT services. Vivify Health, a competitor, already does this. There is a vote of confidence; in June, Roche signed on with a strategic investment (undisclosed) as well as integration of the mySugr integrated diabetes management/app solution (release).

Looking around their recently refreshed website, there is an absence–that of the two or three pages previously dedicated to the Veterans Health Administration (VA) and the press release of the VA award. This tends to lend credence to the rumors that there was a second company that did not pass the Trade Adjustment Act (TAA) requirements that knocked out Iron Bow/Vivify Health from the VA, or for another undisclosed reason CI bowed out of a potentially $258 million five-year contract. If so, that leaves for the VA Medtronic and 1Vision/AMC Health. It’s certainly a limited menu for the supposedly growing numbers of veterans requiring telehealth and a limited choice for their care coordinators–and not quite as presented to the public or the 2015 competitors in the solicitation. Who benefits? Who loses? (Disclosure: This Editor worked for one of the finalists and a VA supplier from 2003, Viterion.)  Hat tip to one of our ‘Industry Insiders’, but the opinions expressed here are her own.

The Theranos Story, ch. 52: How Elizabeth Holmes became ‘healthcare’s most reviled’–HISTalk’s review of ‘Bad Blood’

click to enlargeA Must Read, even if you don’t have time for the book. During the brief Independence Day holiday, this Editor caught up with HISTalk’s review of John Carreyrou’s ‘Bad Blood’, his evisceration of the Fraud That Was Theranos and The Utter Fraud That Is Elizabeth Holmes. Even if you’ve read the book, it’s both a lively recounting of how the scam developed and the willingness–nay, eagerness!–of supposedly savvy people and companies to be duped. The reviewer also reveals that Mr. Carreyrou wasn’t the first to raise questions about Theranos after raves in the press and kudos from the prestigious likes of Eric Topol. Mr. Carreyrou’s first article was in October 2015 [TTA 16 Oct 15] whereas Kevin Loria wrote the first exposé in Business Insider on 25 April 15 which raised all the fundamental questions which Theranos spun, hyped, or otherwise ignored–and Mr. Carreyrou eventually answered. (Our blow by blow, from him and other sources, is here.)

The review also picks out from the book the scabrous bits of Ms. Holmes’ delusions; her makeover to become the blond Aryan female Steve Jobs mit Margaret Keane-ish waif eyes–something she took far too literally; the affair between her and Sunny Balwani, certainly in violation of the usual ethics–and her Hitler in the Bunker, April ’45 behavior as Theranos collapsed around her. 

The review concludes by telling the healthcare community something we need said plainly, often, and written in 50-foot letters:

Theranos is a good reminder to healthcare dabblers. Your customer is the patient, not your investors or partners. You can’t just throw product at the wall and see what sticks when your technology is used to diagnose, treat, or manage disease. Your inevitable mistakes could kill someone. Your startup hubris isn’t welcome here and it will be recalled with great glee when you slink away with tail between legs. Have your self-proclaimed innovation and disruption reviewed by someone who knows what they’re talking about before trotting out your hockey-stick growth chart. And investors, company board members, and government officials, you might be the only thing standing between a patient in need and glitzy, profitable technology that might kill them even as a high-powered founder and an army of lawyers try to make you look the other way.

In other words, what you (the innovator, the investor) is holding is not a patient’s watch, it could be his heart, lungs, or pancreas. (Musical interlude: ‘Be Careful, It’s My Heart’)

The Theranos Effect is real in terms of investment in small companies out there on the ‘bleeding edge’. The cooling is mostly salutory, and we’ve been seeing it since late last year (see here). But…will we remember after it wears off, after the fines are collected, the prison time is served?

Rock Health’s ‘Another record-breaking first half’ in digital health funding is actually–flat. (With a Soapbox Extra!)

The Breathless Tone was the clue. “It’s déjà vu for digital health, with yet another record breaking half for venture funding.” It was déjà vu, but not of the good sort. This Editor hates to assume, so she checked the year-to-year numbers–and first half 2018 versus 2017 broke no records:

  • 2018:  $3.4 bn invested in 193 digital health deals 
  • 2017: $3.5 bn invested in 188 digital health companies [TTA 11 July 17]

But ‘flat’ doesn’t make for good headlines. Digging into it, there are trends we should be aware of — and Rock Health does a great job of parsing–but a certain wobbliness carried over from 2017 even though the $5.8 bn year finished 32 percent up over 2016, analyzed here [TTA 5 Apr 18]. Their projection for 2018 full year is $6.9 bn and 386 deals.

Let’s take a look at their trends:

  • “The future of healthcare startups is inextricably linked to the strategies of large, enterprise-scale healthcare players—as customers, partners, investors, and even potential acquirers.” It’s no mistake that the big news this week was Amazon acquiring tiny, chronic-conditions specializing prescription supplier PillPack after a bidding war with Walmart for an astounding $1bn, making its 32 year-0ld founder very rich indeed and gaining Amazon pharmacy licenses in 49 states. (Prediction: Walmart will be pleased it lost the war as it will find its own solutions and alliances.) 
    • Enterprise healthcare players are cautious, even by Rock Health’s admission, but the big money is going into deals that vertically integrate and complement, at least for a time–for example, Roche’s purchase of Flatiron Health. And when it doesn’t work, it tends to end in a whimper–this May’s quiet sale by Aetna of Medicity to Health Catalyst for an undisclosed sum. Back in 2011, Aetna bought it for $500 million. (Notably not included in the Rock Health analysis, even though they track Health Catalyst and the HIE/analytics sector.)
  • The market is dependent on big deals getting bigger. If you are well-developed, in the right sector, and mature (as early-stage companies go), you have a better shot at that $100 million B, D, E or Growth funding round. B rounds actually grew a bit, with seed and A rounds dipping below 50 percent for the first time since 2012. 
  • The Theranos Effect is real. Unvalidated, hyped up claims don’t get $900 million anymore. In fact, there’s real concern that there’s a reluctance to fund innovation versus integration. The wise part of this is that large fundings went to companies validating through clinical trial results, FDA clearance (or closing in on it), and CDC blessing.
  • The dabbling investor is rapidly disappearing. 62 percent of investors in first half had made prior investments in digital health including staying with companies in following rounds.
  • Digital health companies, like others, are staying private longer and avoiding public markets. Exits remain on par with 2017 at 60. Speculation is that Health Catalyst and Grand Rounds are the next IPOs, but there hasn’t been one since iRhythm in October 2016. The Digital Health public company index is showing a lot less pink these days as well, which may be an encouraging sign.
  • Behavioral health is finally getting its due. “Behavioral health startups received more funding this half than in any prior six-month period, with a cumulative $273M for 15 unique companies (nearly double the $137M closed in H1 2016, the previous record half for funding of behavioral health companies). Of these 15 companies, more than half have a virtual or on-demand component.”

Keep in mind that Rock Health tracks deals over $2 million in value from venture capital, excluding government and grant funding. They omit non-US deals, even if heavily US funded. 

Their projection for 2018 full year is $6.9 bn and 386 deals. Will their projection pan out? Only the full year will tell!

A Soapbox Extra!

Rock Health, like most Left Coast companies, believes that Vinod Khosla is a semi-deity. This Editor happens to not be convinced, based on predictions that won’t pan out, like machines replacing 80 percent of doctors; making statements such as VCs have less sexual harassment than other areas, and even banning surfers off his beach. He was at a Rock Health forum recently and made this eye-rolling (at least to this Editor) statement:

Is there one area in the last 30 years where the initial innovation was driven by an institution of any sort? I couldn’t think of a single area where innovation—large innovation—came from a big institution. Retailing wasn’t disrupted by Walmart, it was by Amazon. Media wasn’t changed by CBS or NBC, it was by YouTube and Twitter. Cars weren’t transformed by Volkswagen and GM—and people said you can’t do cars in startups—but then came Tesla.

Other than making a point that Clayton Christensen made a decade or more ago, the real nugget to be gained here is that formerly innovative companies that get big don’t grow innovation (though 3M tends to be an exception, and Motorola didn’t do too badly with the cell phone). They can buy it–and always have. 

Go back a few more decades and all of these companies were disrupters–and bought out (or bankrupted) other disrupters. CBS and NBC transformed entertainment through popularizing radio and then TV. VW created the small car market in the US and saved the German auto industry. GM innovated both horizontally (acquiring car companies, starting other brands) and integrated vertically (buying DELCO which created the first truly workable self-starting ignition system in 1912).

YouTube? Bought by innovator Google. Twitter? Waiting, wanting to be bought. Innovation? Khosla is off the beam again. Without Walmart, there would be no Amazon–and Amazon’s total lifetime profit fits nicely into one year of Walmart’s. Tesla is not innovative–it is a hyped up version of electric car technology in a styled package that occasionally blows up and remains on the borderline of financial disaster. (Model 3, where art thou?)

I’d argue that Geisinger, Mayo Clinic, and Intermountain Healthcare have been pretty innovative over the last 30 years. Mr. Khosla, read Mr. Christensen again!

The 50,000 foot pick as CEO of the JP Morgan Chase-Berkshire Hathaway-Amazon health joint venture

US healthcare is abuzz at the choice that JP Morgan Chase-Berkshire Hathaway-Amazon made to head their healthcare JV: Dr. Atul Gawande, currently practicing general and endocrine surgery at Brigham and Women’s Hospital and teaching as a professor at the Harvard T.H. Chan School of Public Health and Harvard Medical School. Dr. Gawande is presently an executive director of Ariadne Labs, a healthcare innovation center, a writer of four best sellers on healthcare and noted as an outspoken theorist on how the ‘broken’ healthcare system in the US can be fixed. (This Editor’s definition of ‘broken’ is slightly different, encompassing countries like Venezuela, Cuba, Zimbabwe, post-WWII Germany, and the Ceausescu-era Romania where the basics are simply not there for the average person.)

Dr. Gawande will transition to chairman of Ariadne and retain his surgical and teaching positions.

Praise for Dr. Gawande comes from many quarters. Andy Slavitt, the former head of CMS during the previous administration, said “There are few better people in health care” and praised his ‘moral leadership’ when approached by Messrs. Dimon, Bezos, and Buffett. Jeff Bezos: “We said at the outset that the degree of difficulty is high and success is going to require an expert’s knowledge, a beginner’s mind, and a long-term orientation. Atul embodies all three, and we’re starting strong as we move forward in this challenging and worthwhile endeavor.”

What is missing from this sterling public health advocate and practitioner’s resumé is obvious: real business management experience. Among his three soon-to-be-bosses, there is plenty of pontificating from 50,000 feet–for but one example, see this Editor’s POV on Jamie Dimon’s annual shareholder letter [TTA 10 Apr]. Here is what they stated as the purpose of the JV back in January: “partnering on ways to address healthcare for their U.S. employees, with the aim of improving employee satisfaction and reducing costs” and setting up an independent company “free from profit-making incentives and constraints. The initial focus of the new company will be on technology solutions that will provide U.S. employees and their families with simplified, high-quality and transparent healthcare at a reasonable cost.” And more in that vein. (Whew!) It was eye-rolling, even shortly after the announcement back in February.

But actually getting this done is not a TEDTalk. First, there is the hard in-the-trenches work to bring both the management and the 1 million employees of three very different companies onto the same page. Second, it is running the gauntlet of regulations on the national level (that CMS and HHS) plus in 50 states, if this combine chooses to operate as an insurer or PBM. Third, if they don’t, there is getting the cooperation of insurers (payers) who aren’t in business to lose money. There is not only regulation, but also what they are willing and can afford to do. This Editor noted back in January that large companies, including these three, “generally self-insure for healthcare. They use insurers as ASO–administrative services only–in order to lower costs. Which leads to…why didn’t these companies work directly with their insurers to redo health benefits? Why the cudgel and not the scalpel?”

This Editor would expect that a group of skilled senior, operationally focused executives will be hired to work under Dr. Gawande in Boston, where this unnamed-yet venture will be headquartered. There may be some more high-profile senior executives with unconventional backgrounds. From this (lower than 50,000 feet) perspective, Dr. Gawande will be the attention-getting CEO, spokesman, and pace-setter; others will be doing the heavy lifting behind the scrim. 

Beyond the usual glowing coverage on CNBC and TechCrunch, those in the business of healthcare are already expressing more sanguine opinions on the enterprise and how Dr. Gawande will be leading it with multiple medical, teaching, and writing commitments. Modern Healthcare has a fairly balanced article.

The Theranos Story, ch. 49: CEO Holmes reportedly raising funds for a new company–and feeling like Joan of Arc

click to enlargeHere’s the place where your money will go if you’re an investor. John Carreyrou has now compiled his reporting for the Wall Street Journal on Theranos into a new book, Bad Blood: Secrets and Lies in a Silicon Valley Startup, and it is a Must Read for this Editor and anyone interested in the nexus of Tech, Healthcare, and Hype. (The link goes to AbeBooks, a worthy marketplace for independent booksellers.)

According to Mr. Carreyrou, the founder/CEO Miss Elizabeth Holmes–still leading the company despite settling with the SEC on fraud charges, surrendering her voting control, barred from serving as a public company director or officer for 10 years, and still fighting civil lawsuits–is raising fresh funds for a new venture.

Your eyes did not fool you.

Theranos was a Dogpile of Deceit. From hacking standard Siemens blood testing machines to work with tiny samples, falsifying test results, faking up the Edison test machine, to company financials, it was one lie on the other, chronicled for our Readers in nearly 50 chapters and multiple references. 

Mr. Carreyrou was asked by former Timesman and Vanity Fair reporter Nick Bilton whether, in this unmistakable pattern, Ms. Holmes was a sociopath. Mr. Carreyrou wisely refrained from diagnosis based on a used DSM-V, being a reporter and not her psychiatrist. From Mr. Bilton’s interview podcasted on ‘Inside the Hive’:

“At the end of my book, I say that a sociopath is described as someone with no conscience. I think she absolutely has sociopathic tendencies. One of those tendencies is pathological lying. I believe this is a woman who started telling small lies soon after she dropped out of Stanford, when she founded her company, and the lies became bigger and bigger,” Carreyrou said. “I think she’s someone that got used to telling lies so often, and the lies got so much bigger, that eventually the line between the lies and reality blurred for her.”

Mr. Carreyrou, and by inference anyone who doubted her, like her CFO, and especially those who went public with criticism–well, we are the Bad Guys:

“She has shown zero sign of feeling bad, or expressing sorrow, or admitting wrongdoing, or saying sorry to the patients whose lives she endangered,” he said. He explained that in her mind, according to numerous former Theranos employees he has spoken to, Holmes believes that her entourage of employees led her astray and that the bad guy is actually John Carreyrou. “One person in particular, who left the company recently, says that she has a deeply engrained sense of martyrdom. She sees herself as sort of a Joan of Arc who is being persecuted,” he said.

Mr. Carreyrou was set upon by this ‘martyr’s’ legal pitbulls, one David Boies, until he wisely exited stage left with a bushelful of worthless stock [TTA 21 Nov 16].

(And what is it about Stanford University that fosters people like Ron Gutman, recently ousted from HealthTap over employee abuse and intimidation charges in what may be a Silicon Valley First? [TTA 3 May] Here we have someone who plays with people’s lives and health in vital blood testing. Aren’t some ethics courses long overdue?) 

Mr. Bilton makes the extremely fine point that Silicon Valley will continue to be magnetically attracted to founders equipped with a ‘reality-distortion field’ (as he termed Steve Jobs). SV will relegate Theranos to a biotech outlier. Yet as long as Silicon Valley MoneyMen like Tim Draper will back the likes of Elizabeth Holmes as long as they have a good line of (stuff), despite being embarrassingly proven not just (and only) wrong, but now perpetrating fraud, the Jobsian Myth and black turtlenecks will rise again like Dracula. (Another analogy comes to mind, but precocious children might be reading this.)

We haven’t heard the last of her.

An excellent interview by Tom Dotan of Mr. Carreyrou is podcasted on The Information’s 411 in “You’re So Vein”, which gets the award for Title of the Week (trial signup required, or listen on SoundCloud). Starting at 15:00, interesting comments on the why of Sunny Balwani and Ms. Holmes’ series of ‘marks’ including George Shultz. Also Gizmodo and Politico’s Morning eHealth newsletter.

OnePerspective: Analogue telecare is a dead horse: stop flogging it

Editor’s Note: ‘OnePerspective’ articles are written by industry contributors on issues of importance to our Readers. They reflect the opinions of their authors and are archived under ‘Perspectives’.

click to enlargeBy: Tom Morton

Call failures to alarm receiving centres in the UK are rising but the reasons for this are currently the subject of hot debate.

The problem is linked to the roll out of the next generation network (NGN) replacing the UK’s analogue Public Switched Telephone Network (PSTN), a task which will be complete by 2025.

What is not debatable is that 1.7m of the most vulnerable in our society are being placed at risk as calls to alarm receiving centres (ARCs) increasingly fail or are delayed in their delivery due to incompatibilities of existing technologies.

At the Telecare Services Association (TSA) conference in November 2017, technology-enabled care services company Appello, with circa 100k telecare system users, identified a 7.5 percent call failure rate and announced the problem as “deeply worrying”.

At the same event, Communicare247 presented a report which highlighted a significant 12.3 percent spike in call failures identified by Falkirk Council. This was part of an ongoing analogue to digital assessment program operating across 12 percent of the existing Scottish telecare user base, and significantly this spike occurred in Falkirk within a short three month period. Both Falkirk Council and Appello have published their evidence of increasing call failures in a TSA whitepaper.

The TSA white paper, A Digital Future For Technology Enabled Care, highlights that the 1.7million people in the UK reliant on telecare need answers as their service is “threatened by disruption as UK telecommunications shift from analogue to digital”.

Yet the link to call failures and the rollout of NGN has been called into question by a major equipment provider. In a recent blog, they asked a very challenging question: Are network issues causing a greater number of alarm call failures?

Their answer delivered by the blog was, in essence, ‘maybe not yet’.

In a comparison between one ARC, where call failures were high versus another where they were low, the blog claimed that “while the use of NGN networks has grown in the last few years this cannot account for the increasing trend”.

As a potential compromise, the author also said that they could overcome any potential issues through the use of hybrid terminal adaptors (ATAs).

However, evidence both in the UK and Sweden plainly demonstrates call failures increase as the network switches to digital. (more…)

Health tech founder ousted over alleged ‘acts of intimidation, abuse, and mistrust’: some reflections (Soapbox)

And we thought they were par for the course. Those of us who have worked for company founders, CEOs, and senior execs have learned that some interesting personalities come with the territory, especially in entrepreneurial companies. This Editor has worked for at least one diagnosed ADHD, a bipolar ADHD, another with anger management/impulse control issues, and a gentleman who is now spending a few years in a Federal penitentiary for securities fraud. One of her most memorable CEOs made the cover of Fortune with the caption, “Is this America’s Toughest Boss?” and no, his name was not Donald Trump. (Clue: he was chairman of what was for a time the world’s largest airline conglomerate.)

Of late, there’s been the behavioral quirks of their founders leading to disastrous problems at Uber, Theranos, and Zenefits. It often seems that the more hype, the more sunshine, daisies, puppy dogs, mission, and ‘fab culture’ are on the website, the worse the dysfunctional reality and mistreatment of the troops.

Perhaps no longer. Monday’s very public firing by his board of Ron Gutman, CEO of HealthTap, a digital health all-over-the-map company that now has settled into a members-only patient-doctor mobile health platform, over non-financial behavior may be a first. Mr. Gutman was given the heave-ho by his board after, notably, months of effort. Recode cited a termination letter to him that he “committed acts of intimidation, abuse, and mistrust, and that [he] repeatedly mistreated, threatened, harassed and verbally abused employees.” The coup de grâce: “The toxicity you introduced into the workplace ends now.”

An all-hands memo to employees was more restrained:

After receiving concerning reports by employees about Ron’s conduct as CEO, the Board of Directors hired an outside law firm to conduct an investigation into these allegations. What we learned left us with no choice but to make this change, and we did so after taking the necessary steps from a corporate governance perspective.

The replacing CEO is Bill Gossman, a serial founder and a partner in one of the investors, Mohr Davidow Ventures.

Mr. Gutman has denied it all, stating that he did not abuse employees and that the VCs are in violation of their duties. (FYI, not a whiff here of #MeToo antics.)

Funded to the tune of $38 million by Khosla Ventures, Mayfield Fund, and Eric Schmidt’s Innovation Endeavors, but without fresh funding in five years, the public face of both Mr. Gutman and HealthTap (of which he is the very public face, appearing all over their website still) is one with a very large smile. Mr. Gutman gained some fame from his TED talk and book on the power of smiling. One wonders how the smile is doing today. A frown turned upside down. TechCrunch, Mobihealthnews

Soapbox: JPM’s Dimon takes the 50,000 foot view on the JP Morgan Chase-Berkshire Hathaway-Amazon health joint venture

Mr. Jamie Dimon, the chairman and CEO of JP Morgan Chase, had a few thoughts about the JPM-Berkshire Hathaway-Amazon healthcare JV for all three companies. You’ll have to fill up the tea or coffee mug (make it a small pot) for it’s an exceedingly prolix Annual Shareholder Letter you’ll have to sled through to find those comments. Your Editor has taken her punishment to find them, towards the end of the letter in ‘Public Policy’. 

They demonstrate what this Editor suspected–an headache-inducing mix of generalities and overreach, versus starting modestly and over-delivering.

  • Point #1 sets up what has gone wrong. Among several, “Our nation’s healthcare costs are twice the amount per person compared with most developed nations.” Under point 2 on how poor public policy happened, an admission that Obamacare fixed little:

Here’s another example: We all know that the U.S. healthcare system needs to be reformed. Many have advocated getting on the path to universal healthcare for all Americans. The creation of Obamacare, while a step in the right moral direction, was not well done. America has 290 million people who have insurance — 180 million through private enterprise and 110 million through Medicare and Medicaid. Obamacare slightly expanded both and created exchanges that insure 10 million people. But it did very little to fix our broken healthcare system and has, in fact, torn up the body politic over 10 years — and this tumult may go on for another 10 years.

  • Point #7 is about fixing the deficit and the ill effects if we don’t. In Mr. Dimon’s view, healthcare is a major part of this through the uncontrolled growth of entitlements, with Medicare, Medicaid and Social Security leading the pack–skipping over the fact that nearly all Americans pay into Medicare and SSI well in advance of any entitlement collection. Healthcare is also an offender through unnecessary costs such as administrative and fraud (25-40 percent),  and six mainly chronic conditions accounting for 75 percent of spending.
  • The experts–specifically, their experts–will fix it! “While we don’t know the exact fix to this problem, we do know the process that will help us fix it. We need to form a bipartisan group of experts whose direct charge is to fix our healthcare system. I am convinced that this can be done, and if done properly, it will actually improve the outcomes and satisfaction of all American citizens.”
  • The generalities continue with
    • The JV “will help improve the satisfaction of our healthcare services for our employees (that could be in terms of costs and outcomes) and possibly help inform public policy for the country.” 
    • Aligning incentives systemwide ‘because we’re getting what we incentivize’
    • “Studying the extraordinary amount of money spent on waste, administration and fraud costs.”
    • “Empowering employees to make better choices and have the best options available by owning their own healthcare data with access to excellent telemedicine options, where more consumer-driven health initiatives can help.”
    • “Developing better wellness programs, particularly around obesity and smoking — they account for approximately 25% of chronic diseases (e.g., cancer, stroke, heart disease and depression).”
    • “Determining why costly and specialized medicine and pharmaceuticals are frequently over- and under-utilized.”
    • “Examining the extraordinary amount of money spent on end-of-life care, often unwanted.”
    • “To attack these issues, we will be using top management, big data, virtual technology, better customer engagement and the improved creation of customer choice (high deductibles have barely worked”).

This Editor has observed from the vantage of the health tech, analytics, payer, and care model businesses that nearly every company has addressed or is addressing all these concerns. So what’s new here? Perhaps the scale, but will they tap into the knowledge base those businesses represent or reinvent the wheel? 

A bad sign is Mr. Dimon’s inclusion of ‘end of life care’. This last point is a prime example of overreach–how many of the JV’s employees are in this situation? The ‘attack’ tactics? We’ve seen, heard, and many of us have been part of similar efforts.

Prediction: This JV may be stuck at the 50,000 foot view. It will take a long time, if ever, to descend and produce the concrete, broadly applicable results that it eagerly promises to its million-plus employees, much less the polity. 

PARO: The robotic therapy seal that benefits so few

click to enlargeI have a problem with that cute, robotic seal cub PARO.

More accurately, I have a problem with the ethics of the business model of the Japanese company that makes it, Intelligent System Co. Ltd.

PARO started development in 1993 and the first English press release was in 2004 – a year before Telehealth and Telecare Aware started! Since then the indications that PARO is good for people with dementia have been building and building, as Editor Donna most recently highlighted in this item: PARO therapy robot tested, cleared by NHS for — hygiene.

I have no problem believing, as Donna summarised, “the research has shown that it lowers stress and anxiety, promotes social interaction, facilitates emotional expression, and improves mood and speech fluency.”

However, in response to an enquiry last week, it was confirmed to me that neither price or delivery time information is available but that PARO seals continue to be made individually, by hand. This is a huge production bottleneck and cost.

It is entirely proper for a company that produces handmade cars to have high prices and long waiting lists for their rich man’s toys but I am completely at a loss to conjure up any justification to apply that thinking to PARO. (PARO cost $6,400 in 2017.)

I believe that the insistence that PARO continues to be made in this way is an unethical denial of a benefit to millions of people.

Does Intelligent System not have the will or the skill to scale up production and bring down the cost so that every care home or dementia ward could acquire a PARO (or even a ‘PARO lite’) within a few years? If not, they should license it to a company that can.

At least they should stop pretending that PARO is benefiting people with dementia when it reaches so few.

This Telehealth and Telecare Aware Soapbox item is the personal opinion of TTA founder and Editor Emeritus Steve Hards.

Blockchains, EHRs, roadblocks and baby steps

TTA founder and former editor Steve Hards crawls out of his retirement tent to squint at the misty landscape of blockchain technology.

In a recent dream I was observing an auditorium full of people chanting “Blockchain! Blockchain! Blockchain!” and yes, mantra-like, blockchain is now popping up all the time in health technology articles and presentations.

It has taken a while to get to this stage. It was January 2016 when Editor-in-Chief Donna first mentioned blockchain. Since then there appears to have been more talk than action.

A year ago, in February 2017, health IT guru Brian Ahier was able to say in a comment here “Blockchain of course, is going to sneak up on a lot of people…”

Where we have seen developments occurring is in the trickle of ‘coins’ or ‘tokens’ in health-related Initial Coin Offerings (ICOs) of dubious investment worthiness. I may rant about those in a follow-up article if anyone is interested. (Let me know in a comment.)

The terminology is still in its ‘shakedown phase’ (see this great terminology rant) and, because of the publicity around Bitcoin, which is on a blockchain, the distinction between blockchains and distributed ledger databases is blurred. There are technical differences: blockchains are a sub-set of distributed ledgers (Wikipedia), which is the term I’ll generally use in this article.

Distributed ledgers and EHRs

What are the implications of distributed ledgers for the biggest databases in healthcare, electronic health records (EHRs)?

The two principal characteristics that differentiate distributed ledgers from the databases with which we are familiar are that they are more robust and, potentially, more private. Some even claim to be quantum computing hack proof although we will have to wait for hackers with quantum computers to test that.

Traditional databases are formed from one large or several linked entities that have a centralised control from where performance, data integrity and security are monitored and managed. There are human and technological factors that introduce weaknesses to all such systems, as the number of data breaches reported here over the years testify.

(more…)

Digital health is not here. Or it is. Or it’s still “the future” and we’re waiting for the ship to come in.

click to enlargeAnother bit of convergence this week and last is the appearance of several articles, closely together, about digital health a/k/a health tech or ‘Dr. Robot’. It seems like that for every pundit, writer, and guru who believes “We’ve Arrived”, there’s some discouraging study or contra-news saying “We’re Nowhere Near The New Jerusalem”. This Editor’s been on the train since 2006 (making her a Pioneer but not as Grizzled as some), and wonders if we will ever Get There. 

Nearing Arrival is the POV of Naomi Fried’s article in Mobihealthnews giving her readers the keys to unlock digital health. “Digital health will be the dominant form of non-acute care.” It has value in chopping through the thicket of the low clinical impact technologies that dominate the current scene (Research2Guidance counted only 325,000 health apps and 3.6bn downloads in 2017). Where the value lies:

  1. Diagnosis and evaluation–devices that generate analyzable data
  2. Virtual patient care–telehealth and remote patient monitoring
  3. Digiceuticals–digital therapeutics delivered via apps
  4. Medication compliance–apps, sensors, games, ingestibles (e.g. Proteus) 

At the Arrival Platform and changing the timetable is machine learning. Already algorithms have grown into artificial neural networks that mimic animal learning behavior. Though the descriptions seem like trial and error, they are fast cycling through cheap, fast cloud computing. Machine learning already can accurately diagnose skin cancer, lung cancer, seizure risk, and in-hospital events like mortality [TTA 14 Feb]. It’s being debated on how to regulate them which according to Editor Charles Lowe will be quite difficult [TTA 25 Oct 17]. Returning to machine learning, its effect on diagnosis, prognosis, and prediction may be seismic. Grab a coffee for The Training Of Dr. Robot: Data Wave Hits Medical Care (Kaiser Health News). Hat tip to EIC Emeritus Steve Hards.

The (necessary?) bucket of Cold Water comes from KQED Science which looked at two studies and more, and deduced that the Future Wasn’t Here. Yet.:

  1. NPJ Digital Medicine’s 15 Jan meta-analysis of 16 remote patient monitoring (RPM) studies using biosensors (from an initial scan of 777) and found little evidence that RPM improves outcomes. The researchers found that many patients are not yet interested in or willing to share RPM data with their physicians. The fact that only 16 randomized controlled trials (RCTs) made the cut is indicative of the lack of maturity (or priority on research) for RPM. 
  2. In JMIR 18 Jan, a systematic review of 23 systematic reviews of 371 studies found that efficacy of mobile health interventions was limited, but there was moderate quality evidence of improvement in asthma patients, attendance rates, and increased smoking abstinence rates. 

Even a cute tabletop socially assistive robot given to COPD patients that increases inhaler medication adherence by 20 points doesn’t seem to cut hospital readmissions. The iRobot Yujin Robot helping patients manage their condition through medication and exercise adherence lets patients admit that they are feeling unwell so that a clinician could check on them either through text or phone and if needed to see their regular doctor. The University of Auckland researchers recommended improvements to the robot, integration to the healthcare system, and comparisons to other remote monitoring technology. JMIR (18 Feb), Mobihealthnews.

As Dr. Robert Wachter of UCSF put it to the KQED reporter, we’re somewhere on the Gartner Hype Cycle past the Peak of Inflated Expectations. But this uneven picture may actually be progress. Perhaps we are moving somewhere between the Slough (ok, Trough) of Disillusionment and the Slope of Enlightment, which is why it’s so confusing?

Updated–Rounding up this week’s news: VA budget, Shulkin’s troubles, ATA’s new CEO, Allscripts’ wheeling-dealing, Roche buys Flatiron, Nokia out of health?, NHS Carillioning?

click to enlargeHere’s our roundup for the week of 12 February:

VA wins on the budget, but the Secretary’s in a spot of bother. Updated. Last week started off as a good week for Secretary Shulkin with a White House budget proposal that increased their $83.1 billion budget by 11.7 percent, including $1.2 billion for Year 1 of the Cerner EHR implementation in addition to the agency’s $4.2 billion IT budget which includes $204 million to modernize VistA and other VA legacy IT systems in the interim. While the Cerner contract went on hold in December while record-sharing is clarified, the freeze is expected to be lifted within a month. POLITICO  Where the trouble started for Dr. Shulkin was in the findings of a spending audit by the VA’s Inspector General’s Office of an official European trip to Copenhagen and London which included unreimbursed travel by Mrs. Shulkin and free tickets to Wimbledon, at least partly justified by a doctored email. This has led to the early retirement of the VA Chief of Staff Vivieca Wright Simpson and also an investigation of hacking into Wright Simpson’s email. It also appears that some political appointees in the VA are being investigated for misconduct. CNBC, FierceHealthcare.

Updated: POLITICO doesn’t feel the love for Dr. Shulkin in today’s Morning eHealth, linking to articles about the supposed ‘internal war’ at the VA, with veterans’ groups, with the Trump Administration, and within the VA. It’s the usual governmental infighting which within the 16 Feb article is being whipped by POLITICO and co-author ProPublica to a fevered pitch. Dr. Shulkin comes across as doctor/tech geek who underestimated the politicization of and challenges within an agency with the mission to care for our veterans. It’s also an agency having a hard time facing the current demands of a dispersed, younger and demanding veteran group plus aging, bureaucratic infrastructure. As usual the ‘privatization’ issue is being flogged as an either/or choice whereas a blend may serve veterans so much better.

Digital health entrepreneur named CEO of the American Telemedicine Association. A first for ATA is a chief from the health tech area who is also one of the all-too-rare executive women in the field. Ann Mond Johnson, who will be starting on 5 March, was previously head of Zest Health, board chair and advisor to Chicago start-up ConnectedHealth (now part of Connecture), and had sold her first start-up company Subimo to WebMD in 2006. She began her career in healthcare data and information with The Sachs Group (now part of Truven/IBM Watson). Ms. Johnson replaces founding CEO Jonathan Linkous, who remained for 24 years before resigning last August and is now a consultant. ATA release, mHealth Intelligence. ATA relocated in January from Washington DC to nearby Arlington Virginia. And a reminder that ATA2018 is 29 April – 1 May in Chicago and open for registration.

Allscripts’ ‘Such a Deal’! Following up on Allscripts’ acquisitions of Practice Fusion for $100 million (a loss to investors) and earlier McKesson’s HIT business for $185 million [TTA 9 Jan], it hasn’t quite paid for itself, but came very close with the sale of McKesson’s OneContent, a healthcare document-management system, for a tidy $260 million. Net price: $25 million. Their CEO is some horse trader! Some of the savings will undoubtedly go to remedying the cyberattack in January that affected two data centers in North Carolina, shutting down EHR and billing applications for approximately 1,500 physician practices, which have launched a class action lawsuit. FierceHealthcare 

Flatiron Health acquired by Roche. (more…)

Scary Monsters, Take 4: further investor thoughts on CVS-Aetna, the Amazon Threat–and Aetna’s skeleton in the closet? (updated)

click to enlargeThis Editor is always interested in Following the Money as a way to cut through the Fog of Hype and Headlines. The proposed CVS-Aetna merger is no exception. This recent article in Seeking Alpha is a must-read despite its click-bait headline because it not only looks at CVS-Aetna (a thumbs up generally) but also dissects the ‘Amazon Threat‘ and finds that like Oakland, there is (not much) there, there. Let’s look at the writer’s POV–who represents an investor group with no position:

  • CVS is in retail. Amazon is in retail. But CVS’ difference is that by and large, their retail is not a ‘destination’ (only 25 percent of their retail revenue) but a stop-off while a prescription is filled or there’s a visit to the MinuteClinic. I’d differ with this as many of their stores are semi-convenience stores and, at least in this New York metro area, located away from both traditional supermarkets and convenience stores. Some of us also don’t like to pay shipping on a few necessities, want the items now, prefer to pay cash, or coupon-clip. (And I just remembered I need a quart of milk, saving me a trip to the market….)
  • Amazon has exhibited some hesitancy in entering the pharmacy area. They won’t use their licenses to sell prescription drugs (CNBC, Nov) and canceled a wholesaler application in Maine. In the writer’s estimation, the threat to traditional PBM and prescription drugs is exaggerated because “For some reason, the market has been temporarily duped into thinking that a non-existent company with zero customers and zero experience is a real threat to a $70 Billion behemoth that has been at the top of its field for over 50 years.” Pharmacy is also heavily mail order for recurrent prescriptions or needed immediately, not suitable for the Amazon model unless they develop a true PBM and retail delivery. That isn’t to say that Amazon will never be a threat–just not right away. And what will happen before that is…
  • Through a merger with Aetna, CVS is demonstrating to shareholders that they are willing to diversify revenue and profit streams by adding over $60 billion in insurance business. An integration with Aetna (and providers) will help the profitable MinuteClinics grow and thrive, perhaps in non-traditional ways (e.g. anchoring malls).

Again, Amazon needs to enter profitable businesses (see our Follow the Money article) and create shareholder value, even at a $500bn valuation.

What may be a skeleton in Aetna’s closet is prior authorization procedures. Possibly spoiling a rosy CVS-Aetna merger picture is an investigation by the California insurance commissioner into Aetna’s prior authorization practices. It’s a result of a lawsuit in California Superior Court by a patient denied coverage for an intravenous immunoglobulin (IVIG) treatment. A former Aetna medical director admitted under oath in the case that he never looked at patients’ case files before denying authorization, accepting Aetna’s procedure of nurses making recommendations. This will not only affect Aetna, but also any payer doing business in California. Aetna claims that the plaintiff didn’t have necessary blood testing done prior to the authorization review and in fact avoided having it done. A decision here will be watched closely by every doctor who slaves on prior authorizations. With the CNN exclusive, expect many headlines and scrutiny with the spotlight on Aetna. Hat tip to Reader Howard Green, MD, via LinkedIn.

Updated. Colorado’s Division of Insurance is reviewing this information to see if it violates Colorado laws concerning patients’ right to appeal and review procedures that meet standards of care for the state. Expect more states to follow.  Healthcare Dive  

But will this slow or stop the merger? Likely not, but roll ‘dem bones. Lawyers surveyed by the National Law Journal say probably not, as past conduct is usually known by the merging party and factored in. However, this merger must be approved by 50 states’ insurance departments (and more). The caveat is that they use a ‘public interest’ standard that is broader than the Federal anti-trust or fair trade regulations. Look for states to extract concessions before this merger is done.

Scary Monsters, Take 2: Amazon, Berkshire Hathaway, JPMorgan Chase’s addressing employee healthcare

Shudders through the US financial markets resulted from Tuesday’s Big Reveal of an Amazon-Berkshire Hathaway-JPMorgan Chase combine. Ostensibly they will be “partnering on ways to address healthcare for their U.S. employees, with the aim of improving employee satisfaction and reducing costs” and setting up an independent company “free from profit-making incentives and constraints. The initial focus of the new company will be on technology solutions that will provide U.S. employees and their families with simplified, high-quality and transparent healthcare at a reasonable cost.” This and the Warren Buffett quote about ballooning healthcare costs being a “hungry tapeworm” on the American economy have gained the most notice. Mr. Bezos’ and Mr. Dimon’s statements are anodyne. The company will initially and unsurprisingly be spearheaded by one representative from each company. The combined companies have 1.1 million employees. Release. CNBC.

There is a great deal in those lead quotes which is both cheering and worrisome. To quote a long time industry insider in the health tech/med device area, “What this tells me is finally, enough pain has been felt to actually try to do something. We need more of this.” This Editor notes the emphasis on ‘technology solutions’ which at first glance is good news for those of us engaged in 1) healthcare tech and 2) innovative care models.

But what exactly is meant by ‘technology’? And will they become an insurer?

What most of the glowing initial comments overlooked was the Absolute Torture of Regulation around American healthcare. If this combine chooses to operate as an insurer or as a PBM, for starters there are 50 states to get through. Each state has a department of insurance–in California’s case, two. Recall the Aetna-Humana and Cigna-Anthem mergers had to go through the gauntlet of approval by each state and didn’t succeed. PBM regulation varies by state, but in about half the US states there are licensing regulations either through departments of insurance or health. On the Federal level, there’s HHS, various Congressional committees, Commerce, and possibly DOJ.

Large companies generally self-insure for healthcare. They use insurers as ASO–administrative services only–in order to lower costs. Which leads to…why didn’t these companies work directly with their insurers to redo health benefits? Why the cudgel and not the scalpel?

Lest we forget, the Affordable Care Act (ACA, a/k/a Obamacare) mandated what insurance must cover–and it ballooned costs for companies because additional coverages were heaped upon the usual premium increases. Ask any individual buyer of health insurance what their costs were in 2012 versus 2017, and that’s not due to any tapeworm. Forbes

Conspicuously not mentioned were doctors, nurses, and other healthcare providers. How will this overworked, abused, and stressed-out group, on whose shoulders all this will wind up being heaped, fare? And what about hospitals and their future? Health systems? The questions will multiply.

Disruption is now the thing this year. Of course, shares of healthcare companies took a beating today, many of which do business with these three companies: CNBC names Cigna, Express Scripts, CVS, Aetna (themselves partnering for innovation), and UnitedHealthGroup. Amazon uses Premera Blue Cross (a non-profit). 

Because of Amazon’s recent moves in pharmacy [TTA 23 Jan], there is much focus on Amazon, but the companies with direct financial and insurance experience are…JPMChase and Berkshire Hathaway.

An Editor’s predictions:

  • Nothing will be fast or simple about this, given the size and task. 
  • The intentions are good but not altruistic. Inevitably, it will focus on what will work for these companies but not necessarily for others or for individuals.
  • An insurer–or insurers–will either join or be purchased by this combine in order to make this happen.

Hat tips to Toni Bunting and our anonymous insider.

Another unicorn loses its horn–Outcome Health finally loses the CEO and president

click to enlargeAnother Theranos? Outcome Health is a point of ‘sale’ advertising company that has wrapped itself in ‘behavior change technology’. It’s been a Chicago darling and closed a $500 million Series A led by Goldman Sachs and Alphabet only last May. Its business in ‘transforming healthcare’ is the prosaic but highly lucrative placement of monitors in doctors’ offices that provide relentless health educational content liberally laced with DTC sponsorship messages, free to the doctors but paid for by pharma companies. This also includes tablets, exam room demo wallboards, and Wi-Fi in offices. The Series A pushed up the company’s valuation to $5.5 bn and made its CEO a billionaire.

What it didn’t do, like Theranos, was deliver. Before October last year, advertisers, backed up by former employees’ testimony, realized that the data were inflated in several ways: number of screens in offices, verification of actual runs, match lists that didn’t match to the screens, made-up survey numbers, and puffed up third-party analyses of the ads’ effectiveness, e.g. for prescriptions written. A Wall Street Journal article in October last year exposed the practices. When advertisers are fleeced, they may get mad, but then they get even. There were reported refunds in the millions to Pfizer, plus millions in advertising make-goods to Sanofi SA and Biogen Inc. 250 ad campaigns are now in review across 40,000 doctors’ offices. A search for the guilty ensued, some culpable employees were suspended, the usual layoffs of 33 percent of the staff and belt-tightening ensued, and an outside person was hired to investigate and impose the usual ‘best practices’. Also MedCityNews

The mea culpas didn’t work because it’s real money and there were signs it was moving. In November, investors in that Series A, including Goldman Sachs, Alphabet, and Pritzker Group Venture Capital, attempted to claw back $225 million they gave to CEO Rishi Shah and President Shradha Agarwal held in a special fund. The investors accused them of moving the money. The court documents indicated they received subpoenas from the Justice Department (see Chicago Tribune below). The filing was in New York State Supreme Court, not in Illinois. Outcome’s response was to trumpet their integrity and that “the equity investors led by Goldman Sachs are misusing the court system to advance their own short-term, self-interest of winning an advantage over debt-holders — all to the detriment of the business, its employees and customers.” MedCityNews

Last week, they settled. Both Mr. Shah and Ms. Agarwal announced they are ‘stepping down’ from direct operations to become chairman and vice chair of the now seven-person board of directors, now including three independent directors and two representing investors. The investors, lenders, and founders are funneling $159 million to reduce the company’s debt by $77 million and buttress their operations. The COO is taking on interim CEO duties while the board searches for a new head. The release trumpets ‘reinvestment in the future’. And that HQ move to an ‘Outcome Tower’? Nixed. Illinois also pulled away two tax credit deals. Chicago TribuneMedCityNews

How three major investors didn’t do their ‘due diligence’ before writing big checks is beyond this Editor’s ken. This tale won’t be as drastic or lead to moral questions as Theranos did. There are no malfunctioning tests, misled patients and doctors– after all, it’s just advertising in offices paid by everyone’s favorite pharmas. But as yet another blot on healthcare transformation, like Theranos it’s turned into a corporate saga of posturing–ah, here’s a fig leaf to cover, a shoe to drop, and here’s your large feathered fan.

What’s up with Amazon in healthcare? Follow the money. (updated)

Updated–click to see full page. Amazon is the Scary Monster of the healthcare space, a veritable Godzilla unleashed in Tokyo, if one listens to the many rumors, placed and otherwise, picked up in mainstream media which then are seized on by our healthcare compatriots.

According to CNBC’s breathless reporting, they have set up a skunk works HQ’d in Seattle. When they posted job listings, they were under keyword “a1.492” or as “The Amazon Grand Challenge a.k.a. ‘Special Projects’ team.” In late July, these ads for people like a UX Design Manager and a machine learning director with experience in healthcare IT and analytics plus a knowledge of electronic medical records were deleted. Amazon has separate initiatives on selling pharmaceuticals and building health applications to be compatible with Echo/Alexa and other smart home tech. Both have come up in the context of the CVS-Aetna merger, where buying up state pharmacy licenses cannot be kept secret (see end of our 8 Dec article) and that efforts to extend Alexa and Echo’s capabilities aren’t particularly secret.

A quick look at Bezos Expeditions, Amazon supremo’s Jeff Bezos’ personal fund, on Crunchbase reveals several healthcare investments, such as GRAIL (cancer), Unity Biotechnology (aging), Rethink Robotics, and Juno Therapeutics (cancer). Not really things easy to sell on Amazon.

Last week, Amazon reportedly hired Dr. Martin Levine, who ran integrated primary health Iora Health’s Seattle-based clinics, according to CNBC and Becker’s. They met with Iora, Kaiser, and the now-defunct Qliance about a year ago on innovative healthcare models. More breathless reporting: they are hiring a “HIPAA compliance lead.” 

What does this all mean? It may be more–or less–than what the speculation is. Here’s what this Editor believes as some options:

  • Alexa and Echo are data collectors as well as assistants–information that has monetary value to healthcare providers and pharma. To this Editor, this is the most likely and soonest option–the monetization of this data and the delivery of third-party services as well as monitoring.
  • Amazon now employs a lot of people. It is large enough to create its own self-funded health system. It’s already had major problems in the UK, Italy, and even in the US with healthcare and working conditions in its warehouses. Whole Foods’ non-union workers are prime for unionization since the acquisition (and also if, as rumored, robots and automation start replacing people).
  • A self-funded health system may also be plausible to sell  (more…)