News roundup: Philips allies with Humana for pop health, Dexcom’s outage outrage, Halamka ankles Lahey for Mayo, Google and NHS Wales changes, Agfa’s health sale, Victrix/WhatsApp, more

Insurer Humana is identifying high-acuity and chronic CHF Medicare Advantage members and deploying two support programs utilizing Philips PERS and remote patient monitoring (RPM) systems. The first program identifies at-risk older people with chronic conditions and offering them Philips Lifeline with AutoAlert, Lifeline’s fall detection technology, and their CareSage predictive analytics. Philips Lifeline is already offered in select Humana Medicare Advantage plans. The second is a pilot with telehealth RPM to monitor a select group of CHF patients. This will use a Philips interactive tablet and connected measurement devices for care teams to actively monitor congestive heart failure patients. The rationale in the press release is centered on population health management, quality of care, and positively influencing patient outcomes, with “more efficient resource utilization” a/k/a lowering cost of care. Philips release.

Health tech is great, when it works–and Dexcom found out how serious it can get when it doesn’t. Dexcom, a continuous glucose monitoring system, experienced a server outage over the US Thanksgiving holiday weekend into Monday. It knocked out its updates in the Follow feature, frequently used by parents to monitor Type 1 diabetic children, and those with artificial pancreas devices that adjust insulin based on monitored BG levels. Dexcom was not only blasted by users on the server outage, which they attributed to ‘overload’, but also on its communications of the problem to users which depended on Facebook postings and not on real-time direct contacts or messaging. It was a ‘big surprise’ to their CEO, who also dismissed the possibility of a data breach, which seems a bit premature. Both Google and Microsoft provide cloud and tech services to Dexcom. CNBC 12/2, 12/3

Comings and goings: HIT pioneer, strategist, and general guru John Halamka is following the AI Star, leaving Boston’s Beth Israel Lahey Health to head up a machine learning/AI initiative at the Mayo Clinic in Minneapolis. Mayo this fall announced a 10-year high-level partnership with Google Cloud to store patient data and analysis. Modern Healthcare  According to the Healthcare IT News article, he’ll be returning on weekends to the Bay State to his 250-acre working farm….Also moving on to Google Health is Facebook’s Hema Budaraju, a product management director. Business Insider has annoyingly hid the news behind its paywall, leading to speculation in Mobihealthnews that she will be engaged in Google’s “social and environmental impact” efforts as she was at FB…And speaking of Google, founders Larry Page and Sergey Brin are stepping down at long last from active management. Google CEO Sundar Pichai will now be running Google and its corporate parent, Alphabet. See their letter on the GoogleBlog.DigitalHealth reports on changes at the NHS Wales Informatics Service. Helen Thomas is now interim director as NWIS director Andrew Griffiths is departing this month. NWIS is also transitioning to a new Special Health Authority….Agfa’s Healthcare Information Solutions and Integrated Care, plus their imaging division, are definitely going to Italy’s Dedalus Holdings S.p.A. for €975 million. It awaits approval from various authorities, their employee groups, and the usual closing conditions. Release, DigitalHealth.

UK healthcare analytics company Victrix Socsan has signed a licensing agreement last month with WhatsApp. Victrix will use Whats App for communications with beneficiaries as part of their furnishing proactive preventive care services and provide secure information. Release.

SEC, DOJ charges Outcome Health founders Shah and Agarwal, others, with $487 million fraud, 26 counts of indictment (updated)

All the points of information here. While we here in the US were enjoying our Thanksgiving feasts of turkey, steak, lobster, and lasagna, Outcome Health founders former Chief Executive Rishi Shah, former President Shradha Agarwal, and former executives Brad Purdy (COO/CFO), and Executive VP Ashik Desai, were being served a vastly different dish on 25 November. Underreported in the run-up to the holiday were two major legal actions against these individuals:

  • SEC charges of $487 million in investor fraud by “misrepresent(ing) the company’s business successes while raising hundreds of millions of dollars from unsuspecting investors”, billing clients (primarily pharmaceutical companies) for ads that never ran in medical offices, and manipulating third-party studies to make the company’s ad delivery look more effective than it actually was to create the impression of meteoric growth. The falsification trail was such that even they had trouble matching up their claims versus actual in their ‘selling of futures’.
  • 26 counts from a Department of Justice grand jury indictment on criminal charges of fraud relating to their capital raises of about $1 bn during 2011 into 2017 and their business practices. The indictment alleges deception of their investors, lenders, and their own auditors for profit and misrepresenting to advertisers their delivery of actual advertising in doctors’ offices which they may or may not have had, in extreme and additional detail to the SEC complaint. Arraignments for the defendants started on Tuesday 3 Dec.

Two young analysts, Kathryn Choi and Oliver Han, reported to Mr. Desai and are being charged with wire fraud. They are alleged to have created statements to deceive company auditors and providing advertisers with false patient engagement metrics on Outcome Health’s tablets. Both were hired in 2014 and placed on leave in late 2017. This action is highly unusual in reaching down to this level and naming two young subordinates.

One-time unicorn Outcome Health is, of course, still in business, selling advertising and educational materials at point-of-care, having settled with the SEC in October for $70 million in advertiser make-goods [TTA 31 Oct]. It also restructured/recapitalized in May by selling a majority stake to private equity firm Littlejohn & Co. In coming down to earth, the posturing of the executives should be less than two years ago, when Outcome was going to build its own Chicago office building–but this early October article from FiercePharma hardly moderates the healthcare change-agent hype for what is really POC advertising to inform and mostly distract patients who wait…and wait.

Additional information:

In this Editor’s view, once both SEC and DOJ are double-teamed on an indictment, avoiding Club Fed will be extremely difficult for the four main executives. (One assumes their US passports have been confiscated.) There is a huge amount of financial fraud leading to losses by some powerful companies. Even when losses are small, the Feds get their man most of the time. This Editor had a view of this at a distance, as the CEO of a company where she formerly worked was convicted of financial fraud in an enterprise formed after that company. He and his accomplice are serving five years in a Federal prison. Not even Elizabeth Holmes is facing the full fury of both Federal agencies, and she’s facing only nine counts in her indictment. 

Is ‘age-tech’ a stereotype that misses the larger mark–and market?

Two thoughtful articles this week comment on the difference between the highly touted ‘age-tech’ and products and services that older people actually need and want. The first is by the Centre for Ageing Better’s Jemma Mouland, who quite ably points out that ‘age-tech’ as a category (apologies to Laurie Orlov) inherently screams ‘old’, ‘feeble’, and ‘ill’–while it searches desperately for the ‘silver unicorn’. Yes, older people (and the disabled) do need solutions that help with changes as we age, but even the things that we need tend to be couched in negatives, feel like they don’t fit in our lives, reinforce a feeling of decline, or stigmatize. (The real hot button issues are hearing, vision, and driving.)

Moreover, older consumers often feel left behind or neglected by (formerly) favorite brands or services. A recent UK retail study stated that this is the belief of over 80 percent of 55+ consumers–now edging into the older cohort of Gen X. (One observation this Editor will make is that a huge negative is current clothing appearance, fit and cut.) It’s disappointing to your Editor as a marketer–that means that this group, with 83 percent of household wealth in age 50+ hands, keeps their wallets shut.

MIT Technology Review this month is cited in Ms. Mouland’s article. Building on Joseph Coughlin’s work at the MIT AgeLab in its ‘Old Age Is Over!’ issue, he cites that old age and even retirement is an obsolete construct built on early 19th century beliefs around the depletion of ‘vital energy’ and 20th century social policy around that. The stereotype the latter built was one was either needy–needing social support, or greedy–living the easy retirement life off a pension and looking for early-bird specials.  That tends to frame how we look at older people in employment, in living at home, or in social policy as driving up the cost of care–just a problem to be solved, and certainly not productive or, in Ezekiel Emanuel’s end game, even worthy of anything other than palliative medical care or being part of the political polity.

Mr. Coughlin’s close may be a bit reductionist, but this Editor will take it. “By treating older adults not as an ancillary market but as a core constituency, the tech sector can do much of the work required to redefine old age. But tech workplaces also skew infamously young. Asking young designers to merely step into the shoes of older consumers (and we at the MIT AgeLab have literally developed a physiological aging simulation suit for that purpose) is a good start, but it is not enough to give them true insight into the desires of older consumers. Luckily there’s a simpler route: hire older workers.” And work on making your products and service meet the needs of a broad spectrum of people. Hat tip to Alistair Appleby of Optalis–whose team, in a bit of news, is moving over to Wokingham Borough Council at the end of the month.

The confusion within TEC/telehealth between machine learning and AI-powered systems

Defining AI and machine learning terminology isn’t academic, but can influence your business. In reading a straightforward interview about the CarePredict wearable sensor for behavioral modeling and monitoring in an AI-titled publication, this Editor realized that AI–artificial intelligence–as a descriptor is creeping into all sorts of predictive systems which are actually based on machine learning. As TTA has written about previously [TTA 21 Aug], there are many considerations around AI, including the quality of the data being fed into the system, the control over the systems, and the ability to judge the output. Using the AI term sounds so much more ‘techie’–but it’s not accurate.

Artificial intelligence is defined as the broader application of machines being able to carry out tasks in a ‘smart’ way. Machine learning is tactical. It’s an application that assumes that we give the machine access to data and let the machine ‘learn’ on its own. Neural networks in computer design have made this possible. “Essentially it works on a system of probability – based on data fed to it, it is able to make statements, decisions or predictions with a degree of certainty.”, as stated in this Forbes article by Bernard Marr.

CarePredict has been incorporating many aspects of machine learning, particularly in its interface with the wrist-worn wearable and its interaction with sensors in a residence. It gathers more over time than older systems like QuietCare (this Editor was marketing head) and with more data, CarePredict does more and progressed beyond the relatively simple algorithms that created baselines in QuietCare. They now claim effective fall detection, patterns of grooming and feeding, and environment. (Disclosure: this Editor did freelance writing for the company in 2017)

In wishing CEO Satish Movva much success, this Editor believes that using AI to describe his system should be used cautiously. It makes it sound more complicated than it is to a primarily non-techie, senior community administrative and clinical audience. Say what you do in plain language, and you won’t go wrong. AI for Healthcare: Interview with Satish Movva, Founder & CEO of CarePredict

 

Telecare – time to sweat the analogue assets, not dump them

Veteran Editor Charles climbs on his soapbox, one more time.

There must have been a moment, somewhere, when a bronze age warrior realised that iron really cut the mustard (and other things) better. Unfortunately, that resulting genetic preference for new over old has left us open to the blandishments of salespeople through the ages, encouraging us to take every opportunity to buy new and cast out old.

And it costs! A current example is the drive by many telecare companies to use the digitalisation of the telecoms network in the UK to encourage users to ditch their analogue equipment in favour of their new shiny digital kit…when there’s no need. The telecare world has of course an honourable tradition of encouraging box shifting – back when I ran a telecare programme at LB Newham, in 2007 the government was encouraged to offer a Preventive Technology Grant to all local authorities. Perhaps the most memorable campaign though was Three Million Lives which, from the outside, appeared to have that one aim. Indeed there must be few telecare consultants who have not at some point in their career opened a cupboard to find the shelves heaving with unused – and sadly in a few cases unusable – kit.

Wise telecare providers will resist the current pressures though – both BT and Virgin have been provided with a wide range of old analogue telecare kit to test in their digital simulators alongside the appropriate digital/analogue converters and, I am reliably informed, it has worked well every time. Some companies, I am told, may not have taken full advantage of these facilities and only tested their new digital offerings, whilst ignoring analogue; I’ll leave the reader to work out why they might have done that. This is important because telecare kit is built to last and whilst some service users will benefit from the latest tech wizardry, most will be completely happy with the older kit – indeed those with dementia may find it impossible to get used to any new kit, providing one more incentive not to change. The original cost of that analogue kit must conservatively be well over £500 million, so it would seem to be a crying shame just to dump it whilst it still works well – indeed with local authority budgets as they are, it effectively would hugely reduce their ability to provide a service for all who want it.

There is of course one potential issue, as no power comes down the fibre telecoms lines, unlike with copper, so the service could fail in a blackout. However I understand that both BT and Virgin are working on solutions to this. GSM alarms, supposedly the future, are also vulnerable; indeed apparently this already happened a a few weeks back when the country suffered widespread power outages, when mobile networks failed in some areas. I understand that many masts don’t currently have a power back-up for such occasions and those that do only last 30 minutes.

So, if you are responsible for a telecare provision budget and a nice salesperson pops by to encourage you to switch out your old, ask them how their old kit behaved in the network simulations when paired with an appropriate converter.

If they tell you anything other than that it went really well, look askance. If they say they haven’t tested their old kit, ask them why not.

Are AI’s unknown workings–fed by humans–creating intellectual debt we can’t pay off?

Financial debt shifts control—from borrower to lender, and from future to past. Mounting intellectual debt may shift control, too. A world of knowledge without understanding becomes a world without discernible cause and effect, in which we grow dependent on our digital concierges to tell us what to do and when.

Debt theory and AI. This Editor never thought of learning exactly how something works as a kind of intellectual paydown of debt on what Donald Rumsfeld called ‘known unknowns’–we know it works, but not exactly how. It’s true of many drugs (aspirin), some medical treatments (deep brain stimulation for Parkinson’s–and the much-older electroconvulsive therapy for some psychiatric conditions), but rarely with engineering or the fuel pump on your car. 

Artificial intelligence (AI) and machine learning aren’t supposed to be that way. We’re supposed to be able to control the algorithms, make the rules, and understand how it works. Or so we’ve been told. Except, of course, that is not how machine learning and AI work. The crunching of massive data blocks brings about statistical correlation, which is of course a valid method of analysis. But as I learned in political science, statistics, sports, and high school physics, correlation is not causality, nor necessarily correct or predictive. What is missing are reasons why for the answers they provide–and both can be corrupted simply by feeding in bad data without judgment–or intent to defraud.

Bad or flawed data tend to accumulate and feed on itself, to the point where someone checking cannot distinguish where the logic fell off the rails, or to actually validate it. We also ascribe to AI–and to machine learning in its very name–actual learning and self-validation, which is not real. 

There are other dangers, as in image recognition (and this Editor would add, in LIDAR used in self-driving vehicles):

Intellectual debt accrued through machine learning features risks beyond the ones created through old-style trial and error. Because most machine-learning models cannot offer reasons for their ongoing judgments, there is no way to tell when they’ve misfired if one doesn’t already have an independent judgment about the answers they provide.

and

As machines make discovery faster, people may come to see theoreticians as extraneous, superfluous, and hopelessly behind the times. Knowledge about a particular area will be less treasured than expertise in the creation of machine-learning models that produce answers on that subject.

How we fix the balance sheet is not answered here, but certainly outlined well. The Hidden Costs of Automated Thinking (New Yorker)

And how that AI system actually gets those answers might give you pause. Yes, there are thousands of humans, with no special expertise or medical knowledge, being trained to feed the AI Beast all over the world. Data labeling, data annotation, or ‘Ghost Work’ from the book of the same name, is the parlance, includes medical, pornographic, commercial, and grisly crime images. Besides the mind-numbing repetitiveness, there are instances of PTSD related to the images and real concerns about the personal data being shared, stored, and used for medical diagnosis. A.I. Is Learning from Humans. Many Humans. (NY Times)

News roundup: docs dim on AI without purpose, ‘medtail’ a mall trend, CVS goes SDH, Kvedar to ATA, Biden ‘moonshot’ shorts out, and Short Takes

Docs not crazy about AI. And Dog Bites Man. In Medscape‘s survey of 1,500 doctors in the US, Europe, and Latin America, they are skeptical (49 percent-US) and uncomfortable (35 percent-Europe, 30 percent-Latin America). Only 20 percent fess up to actually using an AI application, and aren’t crazy about voice tech even at home. Two-thirds are willing to take a look at AI-powered tech if it proves to be better than humans at diagnosis, but only 44 percent actually believe that will happen. FierceHealthcare

This dim view, in the estimation of a chief analytics and information officer in healthcare, Vikas Chowdhry, is not the fault of AI nor of the doctors. There’s a disconnect between the tech and the larger purpose. “Without a national urgency to focus on health instead of medical care, and without scalable patient person-centered reforms, no technology will make a meaningful impact, especially in a hybrid public goods area like health.” The analogy is to power of computing–that somehow when we focused behind a goal, we were able to have multiple moon missions with computing equivalent to a really old smartphone, but now we send out funny cat videos instead of being on Mars. (And this Editor growing up in NJ thought the space program was there to market Tang orange drink.) HIStalk.

Those vacant stores at malls? Fill ’em with healthcare clinics! And go out for Jamba Juice after! CNN finally caught up with the trend, apparent on suburbia’s Boulevards and Main Streets, that clinics can fill those mall spots which have been vacated by retail. No longer confined to ‘medical buildings’, outpatient care is popping up everywhere. In your Editor’s metro area, you see CityMDs next to Walmarts, Northwell Health next to a burger spot, a Kessler Health rehab clinic replacing a dance studio, and so on. The clever name for it is ‘medtail’, and landlords love them because they sign long leases and pay for premium spots, brighten up dim concourses, and perhaps stimulate food court and other shopping traffic. Of course, CVS and Aetna spotted this about years ago in their merger but are working expansion in the other direction with expanding CVS locations and on the healthcare side, testing the addition of social determinants of health (SDH) services via a pilot partnership, Destination: Health with non-profit Unite Us to connect better with community services. This is in addition to previous affordable housing investments and a five-year community health initiative. Forbes, Mobihealthnews

ATA announces Joseph Kvedar, MD, as President-Elect. Dr. Kvedar was previously president in 2004-5 and replaces John Glaser, PhD, Executive Senior Advisor, Cerner. He will remain as Vice President of Connected Health at Partners HealthCare and Professor of Dermatology at Harvard Medical School. A question mark for those of us in the industry is his extensive engagement with October’s Connected Health Conference in Boston, one of the earliest and now a HIMSS event. ATA’s next event is ATA2020 3-5 May 2020 in Phoenix–apparently no Fall Forum this year.

The Biden Cancer Initiative has shut down after two years in operation. This spinoff of the White House-sponsored ‘moonshot’ initiative was founded after the death of Beau Biden, son of Democrat presidential candidate Joe Biden. Both Mr. Biden and wife Jill Biden withdrew due to ethics concerns in April. According to Fortune, the nonprofit had trouble maintaining momentum without their presence. However, the setup invited conflict of interest concerns. The Initiative engaged and was funded by pharmas and other health tech companies, directly for Initiative support but mainly for indirect pledges to fund research. Most of these organizations do business with Federal, state and local governments. Shortly after the formal announcement, Mr. Biden the Candidate announced a rural health plan to expand a federal grant program to include rural telehealth for mental health and specialized services. Politico   But isn’t that already underway with the FCC’s Connected Care Pilot Program, coming to a vote soon? [TTA 20 June]

And…Short Takes

  • Philips Healthcare bought Boston-based patient engagement/management start-up Medumo. Terms not disclosed. CNBC
  • London’s Medopad launched with Royal Wolverhampton NHS Trust (RWT) in a three-year RPM deal. DigitalHealthNews
  • Parks Associates’ Connected Health Summit will be again in San Diego 27-29 August with an outstanding lineup of speakers. More information and registration here.

And in other news, Matt Hancock holds tight to his portfolio as UK Secretary of State for Health and Social Care in the newly formed Government under new PM Boris Johnson. Luckier than the other 50 percent!

 

 

Health tech bubble watch: Rock Health’s mid-2019 funding assessment amid Big IPOs (updated: Health Catalyst, Livongo, more)

Updated for IPOs and analysis. The big time IPOs add extra bubbles to the digital health bath. Rock Health’s mid-year digital health market update continues its frothy way with a topline of $4.2 bn across 180 deals invested in digital health during the first half of 2019. 2019 is tracking to last year’s spending rate across fewer deals and is projected to end the year at $8.4 bn and 360 deals versus 2018’s $8.2 bn and 376 deals.

This year has been notable for Big IPOs, which have been absent from the digital health scene for three years. Exits come in three flavors: mergers and acquisitions (43 in their count so far), IPOs, and shutdowns (like Call9). IPOs are a reasonable outcome of last year’s trend of mega deals over $100 million and a more direct way for VCs to return their money to investors. So far in 2019, 30 percent of venture dollars went to these mega deals. (Rock Health tracks only US digital health deals over $2 million, so not a global picture.)

Reviewing the IPOs and pending IPOs to date:

  • Practice intake and patient management system Phreesia closed its NYSE IPO of 10.7 million shares at $18 per share on 22 July. The company earned approximately $140.6 million and the total gross proceeds to the selling stockholders were approximately $51.6 million for a value over $600 million. The market cap as of 26 July exceeded $949 million with shares rising past $26. Not bad for a company that raised a frugal $92.6 million over seven rounds since 2005.  Yahoo Finance, Crunchbase
  • Chronic condition management company Livongo’s picture is frothier. Their 22 July SEC filing has their IPO at 10.7 million shares at $24 to $26 per share offered on NASDAQ. This would total a $267.5 million raise and a $2.2 bn valuation. This is a stunning amount for a company with reportedly $55 million at the end of its most recent reporting period, increasing losses, and rising cash burn. Livongo raised $235 million since 2014 from private investors. Crunchbase 
  • Analytics company Health Catalyst’s IPO, which will probably take place this week on NASDAQ with Livongo’s, expects to float 7 million shares. Shares will be in a range of $24 to $25 with a raise in excess of $171 million. Their quarterly revenue is above $35 million with an operating loss of $9.8 million. Since 2008, they’ve raised $377 million. IPO analysts call both Livongo’s and Health Catalyst’s IPOs ‘essentially oversubscribed’. Investors Business Daily, Crunchbase
    • UPDATE: Both Livongo and Health Catalyst IPOs debuted on Thursday 25 July, with Livongo raising $356 million on an upsized 12.7 million shares at $28/share, while Health Catalyst’s 7 million shares brought in $182 million at $26/share.  Friday’s shares closed way up from the IPOs Livongo at $38.12 and $38.30 for Health Catalyst. Bubbly indeed! Investors Business Daily, Yahoo Finance
  • Change Healthcare is also planning a NASDAQ IPO at a recently repriced $13 per share, raising $557.7 million from 42.8 million shares. With the IPO, Change is also offering an equity raise and senior amortizing note to pay off its over $5 bn in debt. The excruciating details are here. Investors here are taking a much bigger chance than with the above IPOs, but the market action above will be a definite boost for Change.
  • Connected fitness device company Peloton, after raising $900 million, is scheduled to IPO soon after a confidential SEC filing. (UPDATED–Ed. Note: Included as in the Rock Health report; however this Editor believes that their continued inclusion of Peleton in digital health is specious and should be disregarded by those looking at actual funding trends in health tech.) Forbes

Rock Health itself raised the ‘bubble’ question in considering 2018 results. Their six points of a bubble are:

  1. Hype supersedes business fundamentals
  2. High cash burn rates
  3. High valuations decoupled from fundamentals
  4. Surge of cash from new investors
  5. Fraud or misuse of funds
  6. Unclear exit pathways

This Editor’s further analysis of these six points [TTA 21 Jan] wasn’t quite as reassuring as Rock Health’s. As in 2018, #2, #3, and #6 are rated ‘moderately bubbly’ with even Rock Health admitting that #2 had some added froth. #3–high valuations decoupled from fundamentals–is, in this Editor’s experience, the most daunting, as as it represents the widest divergence from reality and is the least fixable. The three new ‘digital health unicorns’ they cite are companies you’ve likely never heard of and in ‘interesting’ but not exactly mainstream niches in health tech except, perhaps, for the last: Zipline (medicine via drone to clinics in Rwanda and Ghana), Gympass (corporate employee gym passes), and Hims (prescription service and delivery).

Editor’s opinion: When there are too many companies with high valuations paired with a high ‘huh?’ quotient (#3)–that one is slightly incredulous at the valuation granted ‘for that??’–it’s time to take a step back from the screen and do something constructive like rebuild an engine or take a swim. Having observed or worked for companies in bubbles since 1980 in three industries– post-deregulation airlines in the 1980s, internet (dot.com) from the mid-1990s to 2001, first stage telecare/telehealth (2006-8), and healthcare today (Theranos/Outcome Health), a moderate bubble never, ever deflates–it expands, then bursts. The textbook #3 was the dot.com boom/bust; it not only fried internet companies but many vendors all over the US and kicked off a recession.

Rock Health also downplayed #5, fraud and misuse of funds. It’s hard to tell why with troubles around uBiome, Nurx, and Cleo in the news, Teladoc isn’t mentioned, but their lack of disclosure for a public company around critical NCQA accreditation only two months ago and their 2018 accounting problems make for an interesting omission [TTA 16 May]. (And absurdly, they excluded Theranos from 2018’s digital health category, yet include drones, gym passes, connected fitness devices…shall we go on?)

Rock Health’s analysis goes deeper on the private investment picture, particularly their interesting concept of ‘net liquidity overhang’, the amount of money where investors have yet to realize any return, as an indicator of the pressure investors have to exit. Pressure, both in healthcare and in early-stage companies, is a double-edged sword. There’s also a nifty annual IPO Watch List which includes the five above and why buying innovation works for both early-stage and mature healthcare companies. 

(Editor’s final note: The above is not to be excessively critical of Rock Health’s needed analysis, made available to us for free, but in line with our traditionally ‘gimlety’ industry view.)

Care Technology Landscape Review: Socitm Advisory for Essex County Council (UK)

A independent report on the UK care technology market was released earlier this month which has both UK and international implications. Commissioned by Essex County Council and produced by Socitm Advisory, it is must reading for those engaged in the procurement and development of local care technology. In a wider sense, the study is part of a larger international trend around community-based health and wellbeing, data utilization and digital tools to promote self-care, mitigate acute illness, and better management of chronic conditions, including social determinants of health (SDH). Digital tools are integrated into care and measured on enabling outcomes, versus being ends in themselves as they tend to be today.

The envisioned emerging care technology solutions framework looks like this: Adrian Scaife of Alcuris Ltd was kind enough to send a link and review copy of this study to this Editor, the link which we are pleased to provide to our Readers. (Download it from Socitm’s website.) He has written a blog post in HousingLIN, Is it time for the next generation of telecare?, which provides a more detailed analysis of the 52-page study and its implications. 

A measured look at the uncertainty around the CVS-Aetna merger

Within two to three weeks, we will know whether Judge Richard Leon of the Federal District Court will–or can–block the CVS-Aetna merger. Already a fait accompli, the merger itself would have to unwound if this is the decision–and uncertainty reigns on whether this actually can be done, as the companies have been merged for several months and have divested what DOJ requested (e.g. PDP to WellCare).

The CVS-Aetna vision is for HealthHubs–combined stores, data, MinuteClinics, kiosks, and the retail business, ultimately combined at a macro level with pharmacy benefit management, external data, and also Aetna’s insurance business. While the HealthHubs are in test, the reach of CVS on both the national and local/individual levels will be huge, if only starting with the data and analytics side. And the retail side is no slouch. Their growth on the retail pharmacy side has been over three times the industry.

In the prescription drug plan (Medicare PDP) market, that horse already left the barn. 70 percent of the PDP market is controlled by three companies: CVS Health, Express Scripts (Cigna), and Optum (UnitedHealth Group). The concerns expressed at the hearings about premiums rising and reduction of competition has already largely happened, with a market not truly private and highly restricted.

Uncertainty may very well be the theme of the rest of the year as it has been since last fall. The smart money is betting that Judge Leon will block the merger on anti-competitive grounds, leading to another round of court actions. Both companies are healthy and will fight it. If forced to part, the  Seeking Alpha analyst bets on CVS doing just fine long term, which leaves little in choices for Aetna with its way forward in merging with other insurers blocked.

EHR system-generated emails/inbasket messages contributing to burnout in 36% of doctors: study

That crispy feeling is real. Unlike the overflowing paper forms, charts, and faxes of olden days (!), doctors and clinical staff now not only deal with paper, but also with what physicians call their ‘electronic masters’. The volume is astounding and has led to numerous studies of physician burnout. One of the latest has been published in Health Affairs (free access), a directional study which will not cheer up anyone concerned with doctor health and retention in the field.

A study of over 900 physicians at the Palo Alto Medical Foundation found that almost half (114, 47 percent) of the 243 weekly in-basket messages received per physician, on average, were algorithmically generated out of their Epic EHR. This far exceeded emails from colleagues (53), from themselves (31, e.g. reports), and patients (30). Other findings from the study:

  • 36 percent of the physicians reported burnout symptoms
  • 29 percent intended to reduce their clinical work time in the upcoming year
  • 45 percent with burnout symptoms received greater-than-average numbers of weekly EHR-generated in-basket messages
  • Receiving more than the average number of system-generated in-basket messages was associated with 40 percent higher probability of burnout and 38 percent higher probability of intending to reduce clinical work time
  • EHR message volume was highest for internal medicine, family medicine, and pediatrics

While this is only one group of physicians in one location, and limited by specialties,this excerpt from the concluding discussion tends to say nearly all:

Therefore, both perceived and realized loss of autonomy over their work schedules could leave physicians feeling defeated, even though some of these system-generated messages have been shown to improve certain processes of care for patients with chronic illnesses.

Health care organizations need to reconsider some of their approaches to improving the quality of care and population health. Physicians might not be the most appropriate recipients of some system-generated messages. Payers and government regulators may need to be part of the solution in enabling physicians to practice at the top of their license. EHR design engineers also need to reconsider whether system-generated automatic messages are the best way to ensure quality of care. It may be time to examine whether every reminder to order routine chronic disease management lab tests (for example, periodic glycosylated hemoglobin A1c tests) must be signed and placed by a physician.

Health care organizations may benefit from engaging with their physicians in creating optimal policies on email work, in addition to helping them with such work. (e.g delegation to non-physician clinicians–Ed.)

Add to that phone calls and endless prior authorizations from insurers–should we have a ‘Be Kind To Your Doctor Week’? Hat tip to HIStalk.

The GreatCall Lively Mobile Plus Federal District Court lawsuit–and TTA

Eight emails and two comments later, your Editor wonders why the full court press on TTA. Our Readers may have noted that at the end of our last article on Best Buy [TTA 25 June] and their expansion into digital health, there was a brief reference to a recall of their subsidiary GreatCall’s Lively Mobile Plus and a related lawsuit:

This is not without pitfalls. Earlier this month, Best Buy was sued for a defect found in its GreatCall Lively MobilePlus mobile PERS that in action failed to detect falls as described, after GreatCall discontinued the device in mid-May in what a letter from their CEO David Inns described as an “important safety recall,” offering buyers a Jitterbug flip phone or a full refund. 

The link above was to a fairly comprehensive 3 June article in Mobihealthnews on a Federal District Court-Central District of California class action lawsuit filed by firm Bisnar Chase on 22 May on behalf of plaintiff Scott Barnes of San Luis Obispo, California (document via Mobihealthnews).

  • Mr. Barnes purchased the device on 21 April.
  • In early May, Mr. Barnes fell twice but the device did not detect the fall and automatically alert emergency services. Mr. Barnes is a disabled veteran and relied on the device to detect falls. The lawsuit states that he suffered unspecified damages as a result.
  • In a letter from David Inns as we noted above, GreatCall notified purchasers/subscribers dated 15 May (letter) that it was recalling all devices. It acknowledged fault in a quality issue. It also asked customers to stop using the device immediately and return it for a full refund plus additional considerations.

More on this is from a Morning Call (Allentown PA) article (picked up from the San Diego Union-Tribune) provided by Mr. Barnes to this Editor. It makes the cogent point that the device as a PERS did not require FDA 510(k) clearance. Fall detection does not fall under Class I or II medical device regulation as it does not monitor vital signs.

Mr. Barnes has written five separate emails to this Editor within less than ten minutes, with another three after our reply. Obviously, this matter is important to him. Moreover, our email is public and we welcome direct contact (including confidential contact) from our Readers with pertinent information. We also welcome comments on articles and don’t mind it being lively.

However, there were two comments at the end of our earlier article on Best Buy’s acquisition of Critical Signal Technologies that are, in the opinion of this Editor, marginal. One from ‘Scott’ implied that there was a relationship between this publication and Best Buy: “What is your companies relationship with the Recalled Great Call/Best Buy Mobile Lively Plus defective device that is now under a Federal Legal Action and Lawsuits.” (My answer was, of course, is that we report on these two companies, and other than that, have no relationship.) The other from ‘Kennie’ was phrased as ‘Be Warned’ and made certain assertions about the device and the company which have yet to be proved in court. This was published with some trepidation.

We ask commenters to be respectful of other Readers, of the facts, and understand that we report–and comment–as we see it.

SNF emergency telehealth provider Call9 shuts down most operations, after $34M raise (updated)

Is it a symptom of a bubble’s downside? In an interview with CNBC, Dr. Timothy Peck, the CEO of Call9, profiled in TTA only a month ago, confirmed that his company will be shutting down operations. Call9 provided embedded emergency first responders in skilled nursing facilities (SNFs) on call to staff nurses. The first responders not only could provide immediate care to patients with over a dozen diagnostic tools, but also would connect via video to emergency doctors on call. 

Headquartered in Brooklyn, the shuttering of the four-year-old company has laid off over 100 employees as it winds down operations. They claimed 142,000 telemedicine visits and 11,000 patients who were treated via its services. In the past few months, Call9 had inked deals with Lyft for patient transportation and was expanding to Albany NY. They also operated a community paramedicine division utilizing their emergency doctor network.  

This Editor can now reveal that through a reliable industry source, I was informed of Call9’s difficulties earlier this month. Not wanting to ‘run with a rumor’, I contacted Dr. Peck. He confirmed to me information that later appeared in the CNBC article: that the company was refining its model in the face of a change in previous funders and working with some new partners to stay in a model with embedded clinical care specialists in nursing homes. While they would scale back, they still had current contracts. However, the changes in their model would mean that the company would be in a ‘bit of a stealth mode’. After we discussed the business situations that most early-stage health tech companies have faced with funding, we agreed to touch base in a few weeks when things developed.

CNBC, with a different source, had essentially the same information from Dr. Peck on the winding down of the company but in this case also confirmed layoffs, including a ‘pivot’ of the company into a different model around technology in nursing homes. They also confirmed that a part of the company, Call9 Medical, will remain in operations.

Update: Skilled Nursing News had additional detail on Call9’s partnerships which included SNF providers Centers Health Care, CareRite, and the Archdiocese of New York’s long-term care arm, ArchCare. Their first client was Central Island Healthcare, where Dr. Peck lived for three months testing the model. The article goes on with Central Island’s executive director explaining that he is now seeking a telemedicine provider, as they adjusted their services to Call9’s capabilities.

Payer providers included Anthem, Blue Cross Blue Shield, and Healthfirst, plus some Medicare Advantage plans, splitting the savings from avoiding unnecessary ER admissions. Another appeal made by the company for its services was to keep in place higher acuity–sicker–patients in SNFs who would otherwise have to go into the hospital.

As our Readers know, these pages have covered the comings and goings of many health tech and app companies. Some succeed on their own, are acquired/combined with others and go on in different form, or are bought out at their peak, leaving their founders and some employees cheerful indeed. On the other hand, and far more common: the demise of some is understandable, others regrettable, and nearly none of them are cause for celebration in our field–Theranos and Outcome Health being exceptions. This Editor has been a marketing head of two of them (now deceased except for their technology, out there somewhere), and has discussed marketing, funding, and business models with more startups and early-stage companies than she can count.

If anything, investors have less patience than they did back in the Grizzled Pioneer period of the early 2000s, when a $5 million round put together from a few personally (more…)

CVS-Aetna merger will run off the tracks in Federal court: reports

Reports emerging this past Monday after the close of last week’s DC Federal District Court hearings in indicate that the CVS-Aetna merger may be nixed by Judge Richard Leon. This may result in the full unwinding of the already-closed merger, a derailing of the settlement which involved selling the Aetna Medicare Part D business to government-plan insurer WellCare, or something in between.

The original report was in Monday’s New York Post. A source working with CVS and Aetna stated “I think Leon rules against us. If he rejects the settlement, we would have to figure out the next steps.” That settlement is significant because it represents the only major overlap between the CVS and Aetna businesses. In other words, there’s nothing left to divest or concede.

Judge Leon, based on reports, was consistently irritated with the Department of Justice, questioning everything from the Part D divestiture to the effects of adding 21 million Aetna customers to CVS’s pharmacy benefits management (PBM) business not being revealed in DOJ documents to him. Conversely, the sale of the Part D business to WellCare was batted one way–as not enough to reduce CVS’ market control and not competitive–and then the other, as WellCare remains a CVS PBM customer for 2.2 million members in its health plans. What was also clear from his selection of expert witnesses that Judge Leon was more interested in the anti-competitive effects of the merger than any of the benefits.

It is obvious both from Judge Leon’s in-court actions (such as not permitting DOJ attorneys to cross-examine any witnesses), assorted remarks, and delay for now over six months, that this merger is coming to a pre-ordained conclusion, at least by this judge. This is already a first under the Tunney Act enacted in 1974. A negative decision will certainly be appealed by CVS-Aetna and DOJ, which will drag out any finalization even if successful–and the sale of the Part D business, important to WellCare as part of its own pending acquisition by Centene–to the end of the year and possibly beyond.

With this background and oral arguments delayed until 17 July, according to Judge Leon, the legal teams on all sides won’t have much of a summer.  Also Barrons, video on NBR.

Digital health: why is it a luxury good in a world crying for health as a commodity?

Why digital health still struggles to find its stride. Those of us in the healthcare field, especially Grizzled Pioneers, have been wondering for the past decade why Digital Health’s Year is always Next Year. Or Next Decade. 

Looking back only to 2000, we’ve had 9-11, a dot-com bust, a few years in between when the economy thrived and the seed money started to pollinate young companies, a prolonged recession that killed off many, and now finally a few good economic years where money has flooded into the sector, to good companies and those walking the fine line of mismanagement or fraud. We’ve seen the rise/fall/rise of sensors, wearables, and remote monitoring, giants like Google and Microsoft out and back in, the establishment of EHRs, acceptance by government and private payers, quite a bit of integration, and more. All one has to look is at the investment trends breaking all records, with funding rounds of over $10 million raising barely a notice–enough to raise fears of a bubble. Then there’s another rising tide–that of cyberattack, ransomware, insider and outsider hacking.

Is it this year? It may not be. Despite the sunshine, interoperability holds it all back. Those giant EHRs–Cerner, Epic, Athenahealth, Allscripts–are largely walled gardens and so customized by provider application that they barely are able to talk to their like systems. There are regional health exchanges such as New York’s SHIN-NY, Maryland’s CRISP, and others, but they are limited in scope to their states. The VA’s VistA, the granddaddy of the integrated system, died of old age in its garden. Paul Markovich, CEO of Blue Shield of California cites the lack of interoperability and being able to access their personal health data as a major barrier to both patients and to the large companies who want to advance AI and need the data for modeling. (China and its companies, as we’ve noted, neatly solve this problem by force. [TTA 17 Apr]) Apple is back in with Health Records, but Mr. Markovich estimates it may take 10 years to gather the volume of data it needs to establish AI modeling. Some wags demand that Apple buy Epic, as if Epic was up for sale. BSC, like others, is testing interoperability workarounds like Notable, Ooda Health, and Manifest MedEx. Mr. Markovich cites interoperability and scaling as reasons why healthcare is expensive. CNBC

And what about those thriving startups? Hold on. During the Google Cloud/Rock Health 3 June event, one of the panelists–from Partners HealthCare, which works both side of the street with Pivot Labs–noted that hospitals have figured out their own revenue models, and co-development with hospitals is key. Even if validated, not every tech is commercially ready or lowers cost. And employers are far worse than hospitals at buying in because they ultimately look at financial value, even if initially they adopt for other reasons. In addition, the bar moved higher. The new validation standard is now provider-centric–workload, provider satisfaction, and implementation metrics, because meeting clinical outcomes is a given. Mobihealthnews

And still another barrier–data breaches and cyberattack–is still with us, and growing. Quest Diagnostics’ data breach affects nearly 12 million patients. It was traced to an individual at a vendor, American Medical Collection Agency, and it involved Optum360, a Quest contractor and part of healthcare giant Optum. The unauthorized person had access to the network for eight months – between 1 August 2018, and 30 March 2019–and involved both financial and some health records. Quest now is in the #2 slot behind the massive 79 million person Anthem breach, which, based on a Federal grand jury indictment in Indianapolis in May, was executed by a Chinese group in 2015 using spearfishing and backdoors that gathered data and sent it to China. There were three other US businesses in the indictment which are not identified. Securing health data is expensive — and another limitation on the cost-lowering effects of interoperability. Healthcare IT News

Digital Health’s Year, for now, will remain Next Year–and digital health for now will remain fractional, unable to do much to commoditize healthcare or lower major costs.

The CVS-Aetna hearing is on the move–finally

The train that is the CVS-Aetna hearing, in the courtroom presided over by Judge Richard Leon of the US District Court for the District of Columbia, is at long last chugging down the tracks. And Pauline is still tied up. Tuesday 4 June was Day 1 of this hearing. Early reports are just being filed. The issue is whether Judge Leon will authorize the Department of Justice’s approval of the merger or dissolve a closed merger, based on his authority under the Tunney Act and his own repeated intent to search for harm that the merger might do to the public. 

Today’s hearing focused on Aetna’s divestiture of its Medicare Part D business as a prelude to the merger, and whether it was quite enough. Much of the discussion was on the relative strength of the buyer, WellCare (itself in the early stages of being acquired), and whether it could be truly competitive in the Part D market. The other factor is that CVS as a dominant pharmacy benefits manager (PBM) could undermine WellCare in several ways. PBMs operate opaquely and are highly concentrated, with CVS, Optum (UnitedHealthcare), and Cigna-Express Scripts accounting for 70 percent of the market. Modern Healthcare

Other issues for Days 2 and 3 will cover the effects on competition in health insurance, retail pharmacy and specialty pharmacy.

Healthcare Dive discusses how these hearings are already setting precedent on how Tunney Act hearings are conducted, their scope (Judge Leon has ruled against every attempt by CVS-Aetna to limit it), and the unprecedented live testimony.  There is the good possibility that Judge Leon will decide to dissolve the merger for competitive reasons, which DOJ likely would appeal. Add to this the cost of the delayed integration and the precedent set by the District Court on scrutiny of any healthcare merger, and this tedious hearing along with Judge Leon’s actions leading to it hold major consequences.