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…)

Robots, robots, everywhere…even when they’re NHS 111 online algorithms

click to enlargeThe NHS continues to grope its way towards technology adoption, gets slammed–but is it justified? The Daily Telegraph (paywalled–see The Sun) revealed a draft December NHS report that recommended that the NHS 111 urgent non-emergency care line’s “enquiries will be handled by robots within two years.” Moreover, “The evaluation by NHS England says smartphones could become “the primary method of accessing health services,” with almost 16 million inquiries dealt with by algorithms, rather than over the telephone, by 2020.” (That is one-third of demand, with one-quarter by 2019.)

Let’s unpack these reported statements.

  • An algorithm is not a ‘robot’. This is a robot.click to enlarge
  • What is so surprising about using algorithmically based questions for quick screening? Zipnosis in the US has been using this method for years as a pre-screener in major health systems. They call it an ‘online adaptive interview’ guiding the patient through branching logic of relevant questions; a provider can review the provided clinical note and make a diagnosis and treatment recommendation in 2 minutes. It also captures significant data before moving to an in-person or telemedicine visit if needed. Babylon Health uses a similar methodology in its chatbot-AI assisted service [TTA 26 Apr 17].
  • Smartphones as a primary means of accessing health services? How is this surprising when the Office of National Statistics says that 73 percent of adults use the internet from their mobiles? 51 percent go online for health information.
  • Based on the above, 66 percent would still be using telephonic 111 services.

It seems like when the NHS tries to move forward technologically, it’s criticized heavily, which is hardly an incentive. Over New Year’s, NHS 111 had a 20 percent unanswered call rate on its busiest day when the flu epidemic raged (Sun). Would an online 111 be more effective? Based on the four-location six-month test, for those under 35, absolutely. Yes, older people are far less likely to use it, as undoubtedly (but unreported) the disabled, sight-impaired, the internet-less, and those who don’t communicate in English well–but the NHS estimates that the majority of 111 users would still use the phone. This also assumes that the online site doesn’t crash with demand, and that the algorithms are constructed well.

Not that the present service has been long-term satisfactory. David Doherty at mHealth Insight/3G Doctor takes a 4G scalpel to its performance and offers up some alternatives, starting with scrapping 111.

Rounding up the roundups in health tech and digital health for 2017; looking forward to 2018’s Nitty-Gritty

click to enlargeOur Editors will be lassoing our thoughts for what happened in 2017 and looking forward to 2018 in several articles. So let’s get started! Happy Trails!

2017’s digital health M&A is well-covered by Jonah Comstock’s Mobihealthnews overview. In this aggregation, the M&A trends to be seen are 1) merging of services that are rather alike (e.g. two diabetes app/education or telehealth/telemedicine providers) to buy market share, 2) services that complement each other by being similar but with strengths in different markets or broaden capabilities (Teladoc and Best Doctors, GlobalMed and TreatMD), 3) fill a gap in a portfolio (Philips‘ various acquisitions), or 4) payers trying yet again to cement themselves into digital health, which has had a checkered record indeed. This consolidation is to be expected in a fluid and relatively early stage environment.

In this roundup, we miss the telecom moves of prior years, most of which have misfired. WebMD, once an acquirer, once on the ropes, is being acquired into a fully corporate info provider structure with its pending acquisition by KKR’s Internet Brands, an information SaaS/web hoster in multiple verticals. This points to the commodification of healthcare information. 

click to enlargeLove that canary! We have a paradigm breaker in the pending CVS-Aetna merger into the very structure of how healthcare can be made more convenient, delivered, billed, and paid for–if it is approved and not challenged, which is a very real possibility. Over the next two years, if this works, look for supermarkets to get into the healthcare business. Payers, drug stores, and retailers have few places to go. The worldwide wild card: Walgreens Boots. Start with our article here and move to our previous articles linked at the end.

US telehealth and telemedicine’s march towards reimbursement and parity payment continues. See our article on the CCHP roundup and policy paper (for the most stalwart of wonks only). Another major change in the US is payment for more services under Medicare, issued in early November by the Centers for Medicare and Medicaid Services (CMS) in its Final Rule for the 2018 Medicare Physician Fee Schedule. This also increases payment to nearly $60 per month for remote patient monitoring, which will help struggling RPM providers. Not quite a stride, but less of a stumble for the Grizzled Survivors. MedCityNews

In the UK, our friends at The King’s Fund have rounded up their most popular content of 2017 here. Newer models of telehealth and telemedicine such as Babylon Health and PushDoctor continue to struggle to find a place in the national structure. (Babylon’s challenge to the CQC was dropped before Christmas at their cost of £11,000 in High Court costs.) Judging from our Tender Alerts, compared to the US, telecare integration into housing is far ahead for those most in need especially in support at home. Yet there are glaring disparities due to funding–witness the national scandal of NHS Kernow withdrawing telehealth from local residents earlier this year [TTA coverage here]. This Editor is pleased to report that as of 5 December, NHS Kernow’s Governing Body has approved plans to retain and reconfigure Telehealth services, working in partnership with the provider Cornwall Partnership NHS Foundation Trust (CFT). Their notice is here.

More UK roundups are available on Digital Health News: 2017 review, most read stories, and cybersecurity predictions for 2018. David Doherty’s compiled a group of the major international health tech events for 2018 over at 3G Doctor. Which reminds this Editor to tell him to list #MedMo18 November 29-30 in NYC and that he might want to consider updating the name to 5G Doctor to mark the transition over to 5G wireless service advancing in 2018.

Data breaches continue to be a worry. The Protenus/DataBreaches.net roundup for November continues the breach a day trend. The largest breach they detected was of over 16,000 patient records at the Hackensack Sleep and Pulmonary Center in New Jersey. The monthly total was almost 84,000 records, a low compared to the prior few months, but there may be some reporting shifting into December. Protenus blog, MedCityNews

And perhaps there’s a future for wearables, in the watch form. The Apple Watch’s disconnecting from the phone (and the slowness of older models) has led to companies like AliveCor’s KardiaBand EKG (ECG) providing add-ons to the watch. Apple is trying to develop its own non-invasive blood glucose monitor, with Alphabet’s (Google) Verily Study Watch in test having sensors that can collect data on heart rate, gait and skin temperature. More here from CNBC on Big Tech and healthcare, Apple’s wearables.

Telehealth saves lives, as an Australian nurse at an isolated Coral Bay clinic found out. He hooked himself up to the ECG machine and dialed into the Emergency Telehealth Service (ETS). With assistance from volunteers, he was able to medicate himself with clotbusters until the Royal Flying Doctor Service transferred him to a Perth hospital. Now if he had a KardiaBand….WAToday.com.au  Hat tip to Mike Clark

This Editor’s parting words for 2017 will be right down to the Real Nitty-Gritty, so read on!: (more…)

Babylon Health: correcting our NW London CCG report; objects to concerns raised by CQC report (latest updates)

Correcting and commenting on our earlier report. This Editor had earlier published on 11 Dec, as follow up to the extensive coverage on Babylon Health’s ‘GP at hand’ pilot activity in London, summarizing a report in Digital Health stating that the North West London Collaboration of Clinical Commissioning Groups (CCG) ended plans for expanding a test of the Babylon video consult/symptom checker app for GP practices in that area and that the app could be ‘manipulated’ to secure GP appointments faster and would not reduce demands on GPs. The original article was first corrected at an NHS England‘s representative’s request to reinforce that this was a local CCG project and that NHS England was not involved. The second request we received last Friday was from Babylon Health’s PR representative, Giles Kenningham, principal at Trafalgar Strategy. It was certainly strong and quoted here, edited as indicated to remove the link to the original article and Mr. Kenningham’s signature:

Your recent article on Babylon is factually wrong and misleading (link removed):
You claim the babylon app was dropped after being manipulated by patients. The term ‘manipualtion’ has been removed from the board papers and is wrong. Similarly the planned pilot had never begun so there so nothing to roll out.
This story is based on incorrect board papers which have now been corrected.

Please find a spokesman quote below. (closing signature removed)

A spokesperson for Babylon said:

“No pilot was ever carried out, nor any agreement signed with Babylon for such a pilot.

“Discussions were held after Babylon was selected in a competitive procurement exercise as the best technology to trial in GP practices across North West London. Subsequently, a decision was taken not to fund the pilot.”

This Editor then checked on the Digital Health article and found it had been removed without any follow-up or correction. Thus on Friday 8 Dec, this Editor removed the article, thanked Mr. Kenningham for bringing it to attention, and added that our report cited Digital Health as the source. I also requested a reference or third-party confirmation of his corrections. (This last request was not received as of the time of this writing.)

Wanting to get to the bottom of this for our Readers–and as a marketer who’s corrected more than a few inaccurate reports, your Editor has located the CCG’s report which is here published 22 November. It corresponds with Mr. Kenningham’s full note. The CCG report appears to have been revised (the URL indicates a v3), there never was a Babylon pilot, this version does not use the word ‘manipulation’, and the end result was that the CCG decided not to proceed to the pilot stage. In short, it appears to this Editor that the Digital Health report was based on an earlier and incorrect version of the report (perhaps as early as 25 Oct) and we are of course happy to correct. My fault and apology to our Readers and to Babylon in that I should have located the 22 Nov revised report prior to publishing the article and essentially provided a correction to Digital Health‘s report.

However, the CCG’s report on their Babylon evaluation contains two findings that were included in Digital Health‘s now-deleted article and give some pause. The CCG used focus groups of potential users, which surfaced that, in the CCG’s words, “The focus groups had also commented that there is a risk of some people gaming the symptom checker to achieve a GP appointment. The insights gathered therefore revealed that the symptom checker in particular was unlikely to reduce demand for GP services.”

Our Editor Chrys has pointed out the Pulse article which also comments on this and was corrected for the CCG’s revised report. The comments here by practicing GPs are worth reading. Scroll down and you’ll see that  ‘gaming the system’ has happened using direct triage in practices using personal phone consults–no app required. Can this even work?

Focus groups are highly subjective, but they are great ways of surfacing the flaws that developers and companies have gone blind to.

We hope that Babylon Health does take this feedback seriously. This Editor makes no secret of her advocacy of technology that can speed the obtaining of care, but based on her experience with early-stage companies, every critique, every hole that can be kicked in a service, delivery, and logistics, exposing a weakness should be appreciated–and ruthlessly scrutinized for flaws that need solutions. This becomes harder to do when you’ve achieved Big Funding. Babylon is typically burning a hole through it (The Times, 1 Oct–hat tip to Chrys). The pressure on now to find The Road to Breakeven must be stunning.

Important updates: Speaking of finding solutions, Babylon differs strongly with the findings of the Care Quality Commission (CQC)(not to be confused with the CCG), in the CQC report on their service published on Friday 8 December. 

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Analysis of the CVS-Aetna merger: a new era, a canary in a mine–or both?

click to enlargeThis Editor has been at two healthcare conferences in the last four business days (with tomorrow being a third). They should be abuzz about how the CVS-Aetna merger may transform healthcare delivery. To her surprise, there’s been a surprising lack of talk. There is a certain element of ‘old news’, as the initial reports date back five weeks but the sheer size of it ($240bn combined future value, $69bn purchase, an estimated $750 million in near-term synergies), being the largest health insurance deal in history, and the anticipated effects on the health delivery model normally would be a breaking news topic. To this Editor, it is a sign that no one truly knows what to make of it, and perhaps it’s too big–or threatening–to grasp for provider and payer executives especially.

For an overview of what we saw at the time as reasons why and possible competitor reaction, Readers should look back to our original article [TTA 28 Oct]. It’s being presented by both companies as a vertical merger of two complementary organizations, which already were moving towards this model, integrating their different services into “America’s front door to quality health care” (CVS CEO Larry Merlo)–a lower cost setting that saves premium dollars and brings integrated care to consumers’ doorsteps.

CVS brings to the table huge point of care assets: 9,700 pharmacy locations, 1,100 MinuteClinics, Omnicare’s senior pharmacy solutions, Coram’s infusion services, and the more than 4,000 CVS Health nursing professionals providing in-clinic and home-based care. Aetna has about 23.1 million medical members, 14.5 million dental members, and 15.2 million pharmacy benefit management (PBM) services members. Aetna also has a wealth of advanced data analytics capabilities through two subsidiaries, ActiveHealth Management and  Medicity’s health information exchange technology.

Seeking Alpha has an intriguing POV on this entry into a ‘new era’: that both CVS and Aetna consider this to be a long-term reshaping of their business model under the threat posed by Amazon, and are willing to do this despite little short-term financial benefit for either company. The problem as the writer sees it: execution. This is re-engineering care on a national scale, and its benefits are based upon combining intangibles, a murky area indeed especially in healthcare. Time is also a factor, as Amazon is getting pharmacy licenses in multiple states, and is rather an expert at combining intangibles.

Does it signal that the approach to a ‘new era’ in healthcare is accelerating? If this is a preview, 2018 will be extremely interesting. Our ‘canary in the coal mine’ may tweet–or fall over on its perch, asphyxiated.

Some additional points to consider: (more…)

HeyDoctor! Come and get your diagnosis via text here!

An app that makes this semi-grizzled pioneer feel…not quite on board the wagon. HeyDoctor is not for horses, but for those who Text to Live. Yes, all you need to do if you feel under the weather is to download the app, text the doc, get your diagnosis, and prescription. Like that. No need to comb your hair and wash your face for that video visit. According to the website, you can get anything from a UTI to acne to erectile dysfunction diagnosed and treated. Out of birth control? Handled. You can get tests ordered up for blood typing, HIV, and metabolic analysis. Not happy with your lash thickness and growth? Here’s the topical med for you! Trying to quit smoking? Done. All you need do is text one of their in-house board-certified physicians and live in one of 19 states where it’s offered.

For our UK Readers, this is a service with similarities to Babylon Health‘s chatbot service but without the decision support ladder–it goes straight to the doctor.

They claim on the website that most visits are five minutes and under $20 in cost, plus affiliations with leading medical centers like UCSF and Georgetown, although this Editor doubts that Amazon Web Services (AWS) is a ‘healthcare organization’ in the same category.

MedCityNews confirms their playbook, for now, is B2C, but the San Francisco-based founders are considering partnering with health systems. According to Crunchbase, funding so far is seed from the two founders, Brendan Levy, MD, a SF-based family medicine practitioner, and Rohit Malhotra, an attorney. LinkedIn counts three employees.

So why not on board the Conestoga? While the convenience is very attractive, there’s also the opportunity for misdiagnosis–the kind of thing we used to worry about with telemedicine. Does the app secure the texts for privacy? Many of these conditions aren’t hangnails–HIV and UTIs come to mind. Oddly, photo upload isn’t mentioned–important with acne. Testimonials point to convenient prescription renewals, but that information can be falsified–easy to do with text. Identity too with smartphones can be faked. A video consult also permits the doctor to see the patient and pick up at least some physical signs of illness. Also not inspiring confidence: a website that crashed when I looked for FAQs and had a chatbot named Brendan (same face as Dr. Levy’s) constantly popping up after X’ing him out. To this Editor, it feels like some verification and diagnostic layers are…missing.

Some reflections on ATA and a future CEO–your ‘nominations’ wanted!

This Editor and publication have had relationships at different levels with the American Telemedicine Association (ATA) since at least 2006. Our Readers know of TTA’s long-standing support of ATA’s annual meeting as a media partner. As a marketer, I’ve negotiated booths, sponsorships, and sent staff (including myself) to meetings, which makes this experience like many of our Readers.

It is worth reflecting that in 1993, when Jon Linkous took the ATA helm, few of us other than academics had email or used the Internet except in limited ways like IBMMail or Minitel. Once telemedicine, video consults, and vital signs data capture were the future and mostly theory. We went through the whiz-bang gadget phase, where every new one was going to change healthcare as we know it. Now we are past the buzzy cocktail party hangover into trying to make it work. We are in 2.0 and 3.0 where it’s all about integration of telemedicine and telehealth into patient engagement, behavior change, data analytics, predictive care, genomics, improving life for the aging and chronically ill population, managing the tsunami of patient data for better outcomes, smart pills, hacking and data security, EHRs, ACOs, meeting standards such as MACRA…and heavy engagement with national (Federal) and local entities. And always–getting paid enough to stay afloat!

As an organization, ATA faces an ever-expanding HIMSS, which has expanded far beyond its health information/IT/data analytics raison d’être to media properties, multiple health tech conferences, and now presence with early-stage companies through acquiring Health 2.0.

Dizzying changes, and more to come.

Who do you want to see at the helm of ATA? What will be the new CEO’s problems to solve? List your choices and thoughts in Comments below! (If you wish to be anonymous, email Editor Donna in confidence.)

The Theranos Story, ch. 37: the Object Lessons for future healthcare entrepreneurs

click to enlargeThere’s an interesting take on the Theranos debacle in Entrepreneur by management consultant/author Steve Tobak. He takes a step back from the healthcare technology that didn’t work, the big money lost and the puffery, where most of us have concentrated. Mr Tobak instead sketches a case study of a Startup House of Cards as an Object Lesson in how entrepreneurialism is NOT supposed to work.

Theranos was a Top Ten List of fatal errors. This Editor’s summary:

  1. They generated no revenue. In just over a decade, Theranos blew through hundreds of millions in funding (he says $700 million, the WSJ has estimated $900 million).
  2. They weren’t anywhere near break-even. By the time Theranos was in 40 Walgreens Wellness Centers, it should have been on a road to break-even and scalable.
  3. The company was built as a fraud from the start or near-start, much like Enron and WorldCom
  4. The company was doomed by a culture of utter secrecy (Editor’s note: none of their technology was peer reviewed, tested or published)
  5. The company was doomed by Ms Holmes’ falsity and hubris in not having a backup plan; black turtlenecks aren’t it
  6. The company was doomed by its own hype: a PR machine AND gullible press, who created a Steve Jobs-esque icon sans accomplishments out of Ms Holmes
  7. The company sold a bill of goods to EVERYONE, including multiple Federal regulators, patients and the public (Editor’s note: he doesn’t mention the Board of Directors and Stanford University!)
  8. Investors, swept up in the private equity bubble, didn’t do their due diligence (though some did)
  9. Ms Holmes had no ability to run this business, but she controlled it 100 percent so no one said boo
  10. “This is what happens when people treat ventures so casually and callously that risk becomes immaterial.”–Mr Tobak

Perhaps we should be grateful that the Edison lab didn’t actually work with all these dysfunctions on parade!

The close to this article is sobering: “Today, there are 186 venture-backed startups valued at $1 billion or more and countless companies valued above $100 million, according to CB Insights. Not too long ago, Theranos was near the top of that unicorn list with a valuation of $9 billion. We still have no idea if it’s a one-off or the beginning of a trend. Remember the Theranos saga as a cautionary tale. Nothing about it is the way business should be. Nothing.” And it will continue, because $900 million makes Theranos a Big Cautionary Tale. Hat tip to our Eye on Theranos, Bill Oravecz of Stone Health Innovations.

See here for the 36 previous TTA chapters in this Continuing, Consistently Amazing Saga

Anthem to Cigna: That’s Sabotage! You’re staying, like it or not! (updated 21 Feb)

Breaking News in The War of the Payers. Late on Wednesday (15 Feb), Anthem received a temporary restraining order to block Cigna from terminating the merger. Judge Travis Laster’s decision in the Delaware Court of Chancery maintains the “legal status quo’ until an April 10 hearing, where he will hear arguments from both sides. Anthem is now able to proceed with a fast-tracked appeal in the DC Federal Court of Appeals to overturn the February 8 DC District Federal Court decision that denied the merger. The sole extension in the merger agreement is to April 30, which will be preceded by the Chancery Court hearing 20 days prior. Bloomberg, WSJ (via 4-traders.com)

Wednesday morning, Anthem had filed a temporary restraining order in Chancery Court to keep Cigna from ankling the merger, which would make an appeal moot. It was positioned in their February 15 release as “a temporary restraining order to enjoin Cigna from terminating, and taking any action contrary to the terms of, the Merger Agreement, specific performance compelling Cigna to comply with the Merger Agreement and damages.” Cigna wanted out immediately, as we noted on Feb 14, seeing no hope in challenging the District of Columbia Federal District Court ruling as Anthem does, and took the position that the extension was invalid. They also sought an additional $13 billion in damages for shareholders beyond the $1.85 billion breakup fee.

The language Anthem used in Wednesday’s release to justify the filing was harsh: “…Cigna does not have a right to terminate the Merger Agreement at all because it has failed to perform fully its obligations in a manner that has proximately caused or resulted in the failure of the merger to have been consummated.” Anthem then accused Cigna of actively working to sabotage the merger: “Cigna’s lawsuit and purported termination is the next step in Cigna’s campaign to sabotage the merger and to try to deflect attention from its repeated willful breaches of the Merger Agreement in support of such effort.”Also Forbes

Bottom line: ‘Cigna, you’re a bad and faithless partner, but we are going to force a merger by any means possible anyway.’ Cigna blames Anthem for botching the merger approvals. Does prolonging any of this make sense?

Updated 21 Feb The differences started at the very beginning, with C-level disputes on who would lead a merged company and other areas of governance, so obvious (and public) they were cited by DC Federal District Judge Amy Berman Jackson’s Feb. 8 decision. David Balto, an antitrust lawyer in Washington, dubbed it ‘a shotgun marriage that went sour’ and not to discount Cigna’s case for damages due to business harm. After reading this article, you’ll wonder why they even started. Hartford Courant

Analysis Any merger between Anthem and Cigna has become, despite the language, a hostile takeover, worthy of Frank Lorenzo in this Editor’s airline days, or more recently, Carl Icahn. Having worked for Mr Lorenzo years ago, observing from my tiny chair way over on the sidelines, I learned that hostile takeovers and poorly thought-out mergers don’t work out well, in service delivery or economics, short or long term. They usually end badly, in bankruptcy court, with many tears shed and lives wrecked.

Memo to Anthem and Cigna–is this really necessary? Here we are dealing with insurance, and service to policyholders/members, affecting both their health and wealth. You both talk a good game about saving on medical costs, accelerating the progress of value-based care, delivering value to shareholders, and improving quality. But you hate each other and have from the start. Playing the game of Who Blinks First, and the distraction of a long and bitter legal battle, cannot be anything other than harmful to your members, employees, doctor and health system providers, your bottom lines, and your future.

This is not the airline business, beverages or detergent. It’s people’s lives here–have you both forgotten? Enough! Stop now! Get back to the business of healthcare!

Previously and related in TTA: Cigna to Anthem: we’re calling it off too, Aetna’s Bertolini to Humana: let’s call the whole thing off, Anthem-Cigna merger nixed

Action This Day in US healthcare, coming to pharma, insurance, home care and innovation

Action This Day, in Churchill’s words. Today’s news of President Trump meeting with the CEOs of US pharmaceutical companies– Novartis, Merck, Johnson & Johnson, Lilly, Celgene, and Amgen–along with the PhRMA association head, indicates the speed of change that this two-week old Administration intends in healthcare. Trump’s points to the Pharma Giants: drug prices need to be brought down, especially for Medicare and Medicaid patients, through competitive bidding not price-fixing; bringing home production to the US; and that there is ‘global freeloading’ on US drugs. This last is a bit vague, and the pricing part may stir some Standard Republican Resistance, but what Trump also came down firmly for is speeding up the drug approval process. In return, the execs asked for tax reform.

Notable here is this quote:  “I’ll oppose anything that makes it harder for smaller, younger companies to take the risk of bringing their product to a vibrantly competitive market,” Trump said. “That includes price-fixing by the biggest dog in the market, Medicare, which is what’s happening.” The Hill, Business Insider

Does this mean an open door and encouragement for healthcare technology?

Certainly many startups, early-stage companies, and Grizzled Pioneers are eagerly anticipating a more open healthcare business environment than the many dictates, restrictions and the constant changing of goalposts they have faced for the past eight years. The hope is an openness of the Powers That Be on the Federal side (CMS, HHS, FDA) to innovation, patient-centered care and a change away from hammering constantly on lowering cost through a multitude of controls and top-down diktats on what Healthcare Should Be.

This Editor has seen companies straining to hang in there, playing the niches, moderating their equity raises, merging, projecting profitability sometime in the future. Some have not made it. One is the pioneer telehealth company Viterion Corporation, which was quietly dissolved by its parent company in Japan for various reasons at end of last year. (Editor’s disclaimer: I was marketing director for the company.)

Already innovation is reaching long-neglected areas like home care. Home support for the aging population isn’t buzzy, analytic or sexy, but it’s ready for change. The Financial Times takes a look at this $40 bn US market, focusing on the Hometeam caregiving service presently in New York, New Jersey and Pennsylvania, which has over $43 million in investment after only three years (Crunchbase); Honor, which has over $65 million in funding, operating California and Texas. Their points of difference from traditional home care agencies involve models and technology. Hometeam employs carers who are full employees with benefits and an average of $15/hour pay, double that of the usual minimum wage paid to independent contractors. They equip carers with iPads to track what happens in the home, and to report daily to families. Honor has an algorithm to help it scale up from the 100 or so carers who are the ‘break point’ in matching carers with patient needs. In contrast, the UK is far behind in development. The article looks at Vida which uses a mix of carers and technology for its private pay clients. Now approved by the Care Quality Commission, Vida is already in talks with local councils across London and Brighton. But funding is thin: £400,000 of start-up funding and planning to raise £1 million. Tech start-ups try to fix ailing US elderly care sector. If paywalled, search on the title. Hat tip to Susanne Woodman

Action Next Days? Predictions have been all over the place since the election. Many have been overheated (and highly political), but others explain the complexities of undoing the past six years. A reminder: the PPACA did not go into effect until 2010 and most of the provisions kicked in during 2011. Health tech law firm Epstein Becker Green trotted out its crystal ball (more…)

What are the impacts of NHS CCGs forcing disabled and LTC patients into care homes? (UK)

click to enlargeCare for elderly and disabled goes off the tracks again. A report in the Health Service Journal (subscription required), covered in an opinion piece in the Guardian, indicates that thousands of patients who are disabled and also those who require long-term care may be forcibly put into care homes (US=nursing homes) rather than being treated and maintained in home care. According to the HSJ, “Freedom of Information (FOI) requests from campaign group Disability United found that 37 NHS clinical commissioning groups (CCGs) in England were introducing rules about ongoing care that could force up to 13,000 people with health conditions into care homes.” CCGs due to NHS cuts have been setting limits on financing home care, between 10 and 40 percent above the care home option. In other words, where a care home is cheaper, the CCG will withdraw payment for home care, and unless the individual can self-pay or has an advocate who can organize a care plan, that person may be involuntarily moved.

The word ‘institutionalization’ deservedly strikes fear on both sides of the Atlantic as a recipe for patient decline, physical and verbal abuse, theft and generally bad care. It’s a blunderbuss solution to ‘bed-blocking’ which we discussed here [TTA 7 Sep 16]–the care plan becomes ‘move ’em out’. By going this way in policy, NHS England is going counter-trend, against more personalized care delivered in home settings, and setting an unfortunate trend for other countries like the US.

Outside the scope of the article, but in this Editor’s thoughts, is the knock-on effect it will have on the UK’s developers and providers of telehealth and telecare services/TECS designed to support home care. Many of these technologies are in a transition period to the greater capabilities (and freedom from land line) of digital from analogue care, which was discussed in TTA here. Cutting domestic demand may not only be critical not only to companies’ survival, but also to their expansion in the (now far more open to the UK) US market. Readers’ thoughts?