The Theranos Story, ch. 68: the texts told the tech failure–and please omit Holmes’ ‘luxurious lifestyle’ and profane meeting language from trial

The trials of Elizabeth Holmes and ‘Sunny’ Balwani churn on towards a March 2021 court date. Two major revelations have entered the record from last Friday 20 November’s flurry of filings on both sides. 

  • The prosecution introduced panicky Holmes/Balwani texts, iMessages, and Skype messages indicating that Theranos was having major trouble with validating its lab technology from 2014 on. One text from Balwani described a lab as a ‘disaster zone’. “The spreadsheets are replete with admissions by defendant and Balwani that demonstrate their knowledge that their statements to investors were false and misleading and that Theranos’s testing was beset with problems.”  CMS in 2015 concluded that their California lab posed an “immediate jeopardy to health and safety.” The messages were from previous civil cases and collected by securities regulators, with many still under seal from those cases.
  • The defense for Holmes moved to prohibit prosecutors as ‘unfairly prejudicial’ evidence of Holmes’ wealth, spending, and lifestyle,  citing Federal rules of evidence and that this information is not relevant to Holmes’ guilt or innocence on the fraud charges. In 2015, Holmes was worth an estimated (by Forbes) $4.5 bn despite what is claimed as a moderate salary and not selling equity. The government has detailed her company-paid perks such as a luxury SUV, a rented luxury house, and luxury-level travel, in addition to a ‘substantial salary’. 
  • The defense is also seeking to omit any references to Theranos employees making claims about the technology, including Theranos sales representatives falsely claiming that the FDA approved the company’s lab machines. The grounds to omit are that Holmes could not be responsible for their false statements.
  • The defense also seeks to omit transcripts of a company meeting that used profane language to refer to reporting in the Wall Street Journal investigating the company and a competitor at that time, on the grounds that such language is par for the course in High-Tech-Land. Mercury News (may be paywalled)

Fox Business 23 November, 24 November. BNNBloomberg.

In a separate case, a former Theranos lab scientist, Diana Dupuy, has claimed that she was wrongfully terminated from her job with medical testing company DiaSorin nine days after receiving a subpoena to testify at the Theranos trial. DiaSorin is claiming the reason is unrelated to Theranos. The suit has been filed in US District Court in San Francisco. Anecdotally, many former Theranos employees have reported that Theranos has been a glaring black mark in their resumes that make them close to unhireable. Mercury News

Weekend reading: HISTalk’s interview with Spirion’s CEO on healthcare data security

A short but must-read if you care about data security and your customers/patients/residents. Where this HISTalk interview with Kevin Coppins, CEO of Spirion, excels is leading the reader through areas that are usually filled with fog and IT jargon. The view is from his company and a healthcare organization sitting in a conference room and scoping the problem without ‘paralysis by analysis’ or a turnkey ‘solution’ that may not be one. What’s different here is the clear, and few, logic steps, particularly the first three listed, that Mr. Coppins takes to get the ball rolling rather than befogging the discussion with too many factors or the punitive consequences of regulatory non-compliance.

“The concept of data and sensitive data is at the core of both security and privacy.”

  1. How much data do you have? (Nobody really knows, admit it)
  2. Of that data, what would you consider ‘sensitive’, and how do you define ‘sensitive’? Not only by regulation/compliance directives, but what your patients, clients and the board would consider ‘sensitive’.
  3. How much of that data is actually critical? 
  4. What’s the impact? How personal is it to your organization, not just in a compliance way but in your community, etc.
  5. How do I reduce the risk of loss?
  6. If I lost the data due to hacking or ransomware, what’s the backup? How fast can this happen?

This Editor notes that these points (quantity, definition, risk of loss and recovery, and community impact) can be applied to other situation analyses.

The litany of ransomware attacks that have ramped up during the pandemic waves has pushed data security issues to the ‘gotta tackle’ list. According to Emsisoft, a security company, there were 41 attacks on healthcare organizations in first half 2020. This didn’t stop during the summer, with a rash of them at end of October and a hit list of 400 hospitals, according to Becker’s.) Hacking attacks persist but aren’t getting the headlines.

And his conclusion is pertinent: “When it comes to security and privacy and all the drama and all the noise that you hear about it and read about it, just boil it down to this — am I doing everything I can today to protect what matters most to the constituents I serve?”

Early detection of Parkinson’s via AI (and a surprising medium); Ed Marx on the digital transformation (or not) of health systems and COVID treatment at home

Somewhat off our normal beat….but of interest.

Ardigen and The BioCollective are collaborating on early detection research for Parkinson’s Disease, based on a microbiome-based biomarker. Ardigen has developed an Artificial Intelligence (AI) Microbiome Translational Platform. The BioCollective has a bank of metagenomic and patient metadata generated from an unexpected source: Parkinson’s patients’ stool samples. Release

The BioCollective is headed by Martha Carlin, who came from well outside of healthcare and pulled together a research group to address her husband’s diagnosis. A visit to this website is worth an examination on how these samples are collected for microbiome extraction. An interesting twist is the marketing of a probiotic mix developed using their BioFlux metabolic model for ‘gut health’.

Ed Marx, the former CIO of the Cleveland Clinic, has written a new book, ‘Healthcare Digital Transformation: How Consumerism, Technology, and the Pandemic are Accelerating the Future’. It’s billed as a wake-up call for healthcare systems and hospitals under challenge by Big Retail, Big Pharma, and Big Tech. This Editor met Mr. Marx when he premiered his entertaining memoir, ‘Extraordinary Tales from a Rather Ordinary Guy’, a few years ago. On treatment for COVID patients, except for the very sickest, he advocates it being done from home. From the release: “When the pandemic hit, a lot of progressive organizations would send most of their Covid patients home with monitoring equipment hooked up to phones unless they needed a ventilator. It’s a lot cheaper than staying in the hospital.”

Shock news: a very muted HIMSS 2021 set for 9-13 August, Las Vegas

Yes, Virginia, there will be a HIMSS21, of sorts, we think. The news of a HIMSS21 in Las Vegas next August (when it will be 110° in the shade) is like the forecast of rain for this parched-of-business convention city and the parched-of-contact health tech community. The basics, mostly from the FAQ:

  • Registration will open in January (date TBD). If you paid your registration for the canceled 2020 conference, your registration will automatically be carried over to the 2021 conference, with details to come. If you cannot attend, no refunds.
  • Programming, exhibits, and events will be held at the Venetian-Sands Expo Center, Caesars Forum Conference Center, and Wynn 
  • The program and topics are sketched in (see the website dropdowns).
  • Proposals for the education track are closed, but open till mid-January for the optional events.  

Exhibitor registrations and paid badges will be carried over (unless you don’t plan on exhibiting, then again, no refunds). For whatever reason, the exhibit floor will be worthy of a Woman’s Christian Temperance Union (WCTU) convention in Des Moines, based on the published rules:

  • NO SOLICITING OUTSIDE THE CONFINES OF YOUR BOOTH (replicating their capitals, including hotels–what fun is this?)
  • All demos and promo activities must be performed five feet set into your booth space. It’ll get cozy for the small, poor exhibitors in a 10 x 10! In fact, straying outside your booth for anything is apparently prohibited.
  • No megaphones, loudspeakers, or what is quaintly called ‘sideshow’ tactics, for instance, clowns, whistles, or high school marching bands in the aisle. Noise must be less than 75db. If there are speakers, they must face into the booth–and better be small.
  • Tchotchkes must have logos on them, so no running out for brand-name candy needed to fuel a looong floor day
  • You have to stay in your booth during exhibit AND non-exhibit hours. (I guess this means no food, event attendance, bathroom breaks–or scoping out/chatting up the competition, a key activity at any trade show.) And don’t wear lights or signage of any type on your clothes.
  • Speaking of clothes, they’re NOT optional–tops and bottoms required. At all times. Even though it’s HIMSS. And Las Vegas.
  • No cameras or video equipment on the floor. (I guess this means you can’t shoot reference pictures, booths you like, or cute videos to share on your blog, Twitter feed, and LinkedIn. Sounds like a closed shop for HIMSS Media.)
  • Exhibitors must use the official booker (onPeak), or you can lose your badges and booth. No economizing! Rough on the small, poor companies.
  • “Event Participants are expected to behave responsibly and to treat each other – and treat the community – with respect, kindness, and compassion.” If you don’t, you lose Exhibitor Points. (No comment!)

This Editor wonders that with all these restrictions and the mid-summer timing, how many exhibitors will simply walk away from HIMSS21 and its high expense? Or wait till March 2022 in Orlando? After all, 2020 booth expense was in last year’s budget and written off. Is going to HIMSS worth it to you?  Hat tip to HISTalk.

Perspectives: How Advanced Communications Technology Has Created A ‘New Normal’ In Healthcare

TTA has an open invitation to industry leaders to contribute to our Perspectives non-promotional opinion area. Today, we have a contribution from Dave O’Shaughnessy, Avaya’s Healthcare Leader for EMEA and APAC, with a brief discussion of how AI and advanced communications technology can help healthcare in the long term. (It’s hard to say ‘a post-COVID world as France and Germany are experiencing second round lockdowns, and UK may not be far behind.) Interested contributors should contact Editor Donna. (We like pictures and graphs too)

Across industries, we see working patterns being transformed to create the ‘new normal’ as a result of COVID-19 and our reactions to the pandemic. The healthcare sector has been no different. The pandemic and its restrictions have brought a great number of new challenges to healthcare systems. And as has been the case across so many other sectors, communications technology has stepped in to plug the gaps caused by the pandemic.

The good news is that, not only have communications solutions successfully plugged the gaps, but they’ve also provided a blueprint for the future of healthcare. As we’ve found in other industries, we’ve actually seen the intelligent adoption of this technology lead to better experiences for patients, and better outcomes for providers, than were present before.

The most important (and immediate) area where this is most obvious is in contact tracing – tracking the physical, interpersonal interactions of those who have tested positive for COVID-19. This helps identify people who may need to be quarantined more quickly, therefore reducing the spread of the virus.

Helping government and healthcare organizations across the world with their contact tracing efforts, what we’ve found is that the most effective contact tracing efforts make use of artificial intelligence and automation. After all, the effort involves mountains of meticulous information gathering and analysis—all required to meet standards set by global health and government agencies. Acting upon that data manually just isn’t feasible, given the immediate needs at hand.

Therefore, the best systems employ AI virtual agents for initial patient contact, as well as for the simple data collection interactions – only falling back to live agents when the interaction becomes more complex. AI is also employed to deliver cloud-based, proactive notifications to automatically reach out to individuals or groups with optional response tracking, text interaction, and auto-forms to capture critical information.

Patients benefit from a smoother experience while providing the tracing information required, while healthcare providers and governments are able to collect more information with the resources they have.

Even without these focused AI technologies, however, our customers are putting their advanced contact centers to good use in combating the pandemic. In Saudi Arabia, for instance, one medical facility adopted a multi-experience approach, making it easy for patients to get the COVID-19-related information they need through a wide range of communications channels. This provided demonstrated results for improved knowledge on coronavirus safety measures in the community.

Going forward, we see tremendous use cases for extending this technology to make it easier for patients to directly engage with their doctors through asynchronous messaging. Such capabilities are of particular interest to mental health providers, who have found themselves unable to conduct in-person therapy sessions in the face of increased demand.

All of these solutions were implemented because of specific, pandemic-related challenges. But once the pandemic subsides, they’ll continue providing value, making it easier for patients to consume healthcare services, while delivering increased efficiency for providers.

Hat tip to Mary Burtt of AxiCom UK

Telemedicine office visits versus in-person recede to 6%, concentrating in behavioral health. Will the gains hold?

Has the telehealth wave receded to a ‘new normal’ tide? An updated Commonwealth Fund/Phreesia/Harvard University study, including data through 4 October, confirms that we are far past the point of telemedicine dominance of the office visit. Office visits to providers have largely returned to the 1-7 March baseline and even slightly above for ages 6 and above. But telemedicine visits, from their high in this study of 13.9 percent on 18 April during the peak of the COVID-19 pandemic, have continuously dropped and have leveled off to 6.3 percent. (Telemedicine here includes both video and telephonic visits; the sample is 50,000 providers that are Phreesia clients.)

To put this in proper perspective, the pre-pandemic baseline of telemedicine in practice use was an infinitesimal .1 percent.

Larger organizations use more telemedicine than smaller ones. Primary care practices with 6 or more physicians in the group account for 9.4 percent of telemedicine visits, while practices of 1 to 5 physicians account for 4.3 percent.

Even so, by September, only 9 percent of practices were heavy users (20 percent +) of telehealth, compared to 35 percent in April. Minimal use (5 percent or less) moved up to 39 percent. One-third never used telemedicine at all–did they shut down completely?

For those seeking to segment the overall telehealth market, the chart detailing telemedicine in visits to medical specialists is of interest. It confirms the anecdotal information this Editor has heard that telehealth remains highly popular and used in behavioral health (psychiatry)–41 percent of visits. By comparison, the next most popular are rheumatology and endocrinology at 14 percent of visits. The pandemic apparently has forever changed the mental health visit and acceptance of non-face-to-face delivery, with interesting (isolating?) consequences for both patients and doctors.

crystal-ballCan telehealth hold this gain, and develop from this base? What will it look like for the average practice? Pay the lady with the crystal ball! CMS will eventually roll back the waivers on usage of non-HIPAA platforms such as Facetime (appropriately so for security and privacy reasons). Reimbursement by Medicare and commercial plans will be a major hot button. A recent survey of health system executives presented at the HLTH virtual conference indicated yawning uncertainty at the top level:

  • 30 percent of respondents said they were unsure what their plans are if telehealth reimbursements return to pre-COVID levels
  • 13 percent said they’d return to face-to-face visits
  • 20 percent said they’d continue doing virtual visits regardless
  • 17 percent said they’d analyze the financial viability of continued use

(Nokia-UPMC Center for Connected Medicine and Klas Research, Healthcare Dive)

More on this: The hazy post-pandemic future of telehealth and From back-to-work to telehealth to retail rebranding: HLTH 2020 takeaways   

Previously: As practices reopen, telemedicine visits continue to plunge from 69% to 21%: Epic (September), COVID effect on US practices: in-person visits down 37%, telehealth peaks at 14% (Commonwealth Fund through July)

Weekend reading: contact tracing in assisted living/LTC facilities via sensor-based ADL technology raises ethical issues

Contact tracing for COVID-19 is still ‘not quite there’ in many countries, especially those countries like the UK which had created centralized models and were slow to move to the decentralized systems based on Apple and Google’s APIs, the (Gapple? AppGoo?) Exposure Notification system now in use in Ireland and Germany. For the most vulnerable in assisted living, who aren’t using smartphones that ping adjacency to other smartphones and are moving around most of the time within the residence, other approaches have been developed. Already in place in many communities are sensor-based trackers for activities of daily living (ADLs) for both safety and predictive health analytics, as well as provide conveniences such as apartment entry for residents.

As we noted in July, a number of ADL and location trackers have repurposed themselves into highly accurate contact tracers since they retain the history of resident and staff movement. Profiled are CarePredict (ADLs), ZulaFly (location tracking), and CenTrak (location tracking). Residents in many facilities with these systems are early adopters of contact tracing, even if they don’t know it.

While the article is detailed and fairly laudatory about how these systems can assist residents and staff in arresting the spread of COVID-19 which has ripped through nursing homes and senior living, it then diverges into other issues, some worth considering even if some of the verbiage is over the top:

  • These location monitoring systems haven’t been used for infectious disease outbreaks before, but the article admits that the pandemic has presented extraordinary circumstances
  • Use of these systems cannot substitute for effective infection control: staff and resident handwashing, mask wearing, and staff PPE. (Something like wearing a used mask and not washing your hands for the rest of us)
  • These systems are dependent on facility-wide internet/Wi-Fi. Many LTCPAC facilities do not have it, thus creating a digital divide in care even in residences proven to have high-quality care.
  • Resident rights and privacy. Residents apparently have only limited choices in using these technologies, even if they are restricted to their rooms. Not all see the need for monitoring technology for their safety and intrusive ‘alarms’ that bring in staff. There is a real issue around older adults’ autonomy and privacy rights which tends to be forgotten in the balance of privacy and safety, with prediction of illness based on behavior a step further.

Interviewed for this article, Laurie Orlov of Aging in Place Technology Watch, believes “It’s pretty darn useful if you’re in independent living, and you decide to go for a walk. If it’s night, and there’s ice, having a full detection capability that knows where you are is really useful. I think with fall detection, and anything that can help when you’re alone, the benefits exceed the cost of the privacy — assuming that you’re with it enough to opt in.”  Senior Sensors (The Verge)  (Disclosure: Editor Donna consulted for CarePredict in 2017-18)

A counterpoint to this article is also by Laurie Orlov and published on her website, reviewing the future of remote care technology and older adults in 2020. It’s a preview of a to-be-released later this year report.

The Theranos Story, ch. 67: the Holmes/Balwani indictments stay, Holmes’ defense strategy fails

What Elizabeth Holmes needs is Perry Mason and a good scriptwriter from the 1960s. On Tuesday, Judge Edward Davila hit the ‘REJECT’ button on Holmes and ‘Sunny’ Balwani’s six motions since August to have the July indictments by a grand jury–a second indictment of 14 July, then a third and operative charging document of 28 July, dismissed. In a single compact, well-reasoned order, all six motions were denied for both cases:

  1. Pre-indictment delay. The first indictment was made in June 2018. The findings were that the delays were due to defense motions which were agreed to by the government and the judge, then the pandemic which suspended all in-person court proceedings and then became remote. The separate trial dates were moved to October 2020 and then at defense requests due to preparation and witness travel, moved to March 2021. 
  2. Statute of limitations on the fraud counts from investors. Even the definition of investor was narrowly defined here as securities purchasers. However, the broader interpretation, for example business partners such as Safeway [TTA 8 Oct] and board members, are also included as investors. 
  3. The indictments did not provide fair notice of the charges. Fair notice was found. Again, investors include business partners and even their board members who had promissory or convertible notes.
  4. Duplicity of the multiple counts was not found.
  5. Failure to omit doctors as victims of the Theranos scheme; doctors were omitted after the first indictment. The judge did find some lapses in prosecution language.
  6. All the dismissal requests for the first indictment applied to the later two.

It seems as if the defense, particularly Holmes’, threw a lot at the wall to lessen charges against their clients, and none of it stuck. One wonders how Holmes (who did marry a wealthy man) but particularly Balwani, are affording all this legal churn.

Unless there are publicly released findings on Holmes’ mental defect defense, alleging her inability to discern right from wrong (a/k/a insanity defense lite, Twinkie Defense II, High Anxiety) [TTA 18 Sept], hold off on popcorn purchases till next spring. San Jose Mercury News (which incorrectly reverses the analogy, sorry), Wall Street Journal, and the Register (UK), which helpfully provides a PDF of the court order.

Digital health investment smashes the ceiling: $9.4 bn invested through 3rd Q

$9.4 bn is a whole lot of bubbly! To no one’s surprise in the industry, kick-started by telehealth, Rock Health’s tracking of US digital health company investment through 3rd Q smashed through 2018’s full-year high point ($8.2 bn) with a cannonball of a total. Adding $4.0 bn to first half’s $5.4 bn, it represents 311 deals and is 27 percent above last year’s oddly fading-in-the-stretch $7.4 bn [TTA 7 Feb]. Rock Health projects the year total to be about $12 million and 400 deals. 

  • Average deal size topped $30.2 million, 150 percent greater than the $19.7 million average in 2019.
  • Driving this total were “mega deals” of $100 million or more, accounting for 41 percent of all deals (compared with 30 percent for year 2019). Even with the inclusion of fitness companies that this Editor does not consider true health tech, such as Zwift (interactive fitness entertainment), ClassPass (online fitness), and Tonal (more online fitness), the 20+ remaining companies indicate a concentration of Big Capital into Big Deals. The Big Deals concentrate in three sectors: on-demand virtual care delivery, R&D process enablement, and fitness/wellness.
  • Not surprisingly, telehealth and telemedicine are soaring: $1.6 bn in funding compared to $662 million same period 2019
  • Also pointing to concentration: 64 percent of this year’s investors have previously made investments in digital health, which exceeds any prior year. Institutional venture firms have the largest share of transactions (62 percent), with corporate venture capital accounting for 15 percent of transactions.
  • Given COVID and election year craziness, IPO action has moved right along and matched 2019’s six. Accolade and GoHealth in July; Amwell, Outset Medical, and GoodRx in September. Hims Inc. is merging with a blank-check company as SOC Telemed did in August. MDLive may be going public in early 2021.
  • What is down so far this year is merger and acquisition activity. Through September, there are only 63 acquisitions, which will likely trail by year’s end 2019’s 113. Teladoc is the 9,000 Elephant in M&A, with InTouch Health closing in August ($1 bn final due to the stock value soaring) and Livongo at $18.5 bn dwarfs the remainder. Optum-AbleTo has been reported in ‘advanced talks’ but there’s no confirmation of closing; it was reported to be at $470 million. 

Note: Rock Health only counts US deals in excess of $2 million, so international activity by companies like Doro are not included.

Also Mobihealthews.

The Theranos Story, ch. 66: Walgreens and Safeway aren’t investors, they’re business partners!

The difference is not hair-splitting in the defense effort to have charges tossed. In Federal District Court on Tuesday (6 October) in San Jose, Elizabeth Holmes’ defense made the case to Judge Edward Davila on dismissing some of the prosecution’s charges against her. As petitioned in late August, the defense maintains that two of the entities, Walgreens Boots and Safeway (a Western regional supermarket chain), were unfairly classified as investors versus ‘business partners’. As investors, the prosecution could charge Holmes with fraud crimes with a longer statute of limitations. If they were to be classified as business partners and ‘transactions’, while there were crimes committed, the statute of limitations has expired.

The prosecution’s rebuttal is that Walgreens and Safeway could be considered as both investors and partners. The defense response was that the government took too much time to file the charges and failed to get the proper consent, which may be the hair that splits the ability of the prosecution to use these charges.

Let’s look back at both companies’ involvement with Theranos

  • Walgreens reportedly invested over $140 million in Theranos. This consisted of direct funding (a $40 million loan convertible into equity), and an “innovation fund’ designed to fund the rollout of Theranos Wellness Centers in Walgreens US locations starting in 2013. Walgreens filed suit against Theranos in November 2016 to recoup that investment based on breach of contract, after civil lawsuits were filed against them jointly, halted development, and settled for $25 to 30 million in late July 2017 when Theranos assets were dwindling to barely breathing status [TTA 3 Aug 17]. More details on their Partnership from Hell are recapped here from the 2016 lawsuit.
  • Safeway’s involvement as the exclusive supermarket partner was planned to be even more extensive. Their 2012 deal was $350 million for building 800 clinic locations in Safeway stores. This was dropped in November 2015 [TTA 20 Nov 15], around the same time as Walgreens halted the expansion of the Theranos Centers. According to reports at the time, Safeway had already built out the 800 locations, later repurposing them for flu shots and similar. Direct investment was estimated at $10 million (WSJ). Safeway settled with Theranos for $30 million in June 2017. 

The publicly available history shows that both funded Theranos directly in addition to being business partners. Both took substantial additional risk investments from building out facilities to showcase Theranos’ services for their customers. Both settled civilly for amounts far below the fair recoupment of their investment.

While this sounds like legal nitpicking, the defense strategy, in this Editor’s layperson’s calculation, is to erode the number of charges against Holmes and their seriousness so that her inevitable sentence becomes lighter. Another move in this vein is the mental defect defense [TTA 18 Sept] alleging Holmes’ psychic inability to discern right from wrong in her business dealings. Start with something over the top like ‘insanity defense lite’, and then chip away at the rest of the charges. Fox Business, Mercury News

Tunstall Healthcare (UK) and Group Holdings’ 2019 year end reports filed: highlights

With all the changes at Tunstall Healthcare Group [TTA 2 Sep, 10 Apr], their Companies House filings due 30 September for the 2019 fiscal year might tell us more about their status prior to the entry of their new funders Barings, M&G, and a possible third investor. Tunstall files three main reports: one for Tunstall Healthcare (UK) Limited, for Tunstall Healthcare Group Limited, and Tunstall Group Holdings Limited, the holding company. The UK unit and Tunstall Group Holdings filed by the 30 September deadline; the Healthcare Group has not filed as of today.

Tunstall UK’s report is in PDF here. Revenue in the UK crested the £100 million level, up over £3 million from 2018. Of this, the core UK revenue amounted to £68.2 million, up 0.8%, with the remainder export trade with other Tunstall companies. Operating profit was, before adjustment for EBITDA, £27.4 million, adjusted to £16.8 million, down from 2018’s £19.4 million.

  • The report also notes revenue growth for Connected Care Managed Services and Group Living Services. 2019 was challenging for Group Living Installations and Digital Health with continued declines, though the report adds some optimism for 2020 due to cloud-based services, for customers to use their own devices, and–of course–to COVID-19 and remote monitoring’s rise in most areas.
  • COVID-19 rears its gloomy head here even though outside the report period. On page 5 is an assessment of the company as a ‘going concern’; even factoring in a gloomy second late 2020 COVID lockdown scenario, the directors believe that the company will continue to operate and comply with its covenants. On page 6 under ‘events after the financial period’ is a further explanation of this.
  • Finally, the new financing is referred to on page 7. Tunstall Group Holdings has been purchased by a Jersey-based group. It was restructured to reduce its existing debt and establish a new available loan facility of over €20 million.

Tunstall Group Holdings’ (TGH) report is in PDF here. Their global revenue amounted to £216.7 million with an operating profit of £47.9 million before adjustment for EBITDA, £19.5 million adjusted. Both were reduced from 2018. The consolidated income statement, as in 2018, shows a consolidated loss of £71.1 million, reduced by £15 million from 2018. An additional note on the restructuring is the forgiveness of the balance of £531 million owed to the financing arm TGH Acquisitions Limited (page 11).

  • The Americas sale is detailed on page 85. It is easy to see why the unit was sold, as in 2018 it had an operating loss of £4.3 million on £31 million in revenue. Factoring in asset disposal and other parts of discontinued operations, it’s fortunate it’s a one-time only event.

Jersey-based organizations, of course, enjoy far more favorable taxation structures. This Editor’s limited understanding of UK filings is that the Group will have to file with the Jersey Companies Registrar, but the UK group will have to file with Companies House as operating in the UK. If any Reader can clarify this, please comment below.

Charterhouse now finally lists Tunstall as one of their ‘realised’ exits. A long and unprofitable road from 2008 to 2020.

Hat tip on the reports to a Reader in the UK industry who wishes to remain anonymous.

The Theranos Story, ch. 65: Elizabeth Holmes’ “mental disease or defect” defense revealed

Going the ‘Twinkie Defense’ one better? While this Editor was enjoying a much-needed break from the Insanity of the World, hurtling across the wires was the revelation that Elizabeth Holmes’ pricey defense attorneys have prepared a defense for her that includes evidence “relating to a mental disease or defect or any other mental condition of the defendant bearing on the issue of guilt.” Interpreted, her mental state may have affected her intent and judgment in her business dealings. 

According to the filing, the defense is introducing testimony from Mindy Mechanic, Ph.D., a clinical psychologist and professor at California State University at Fullerton. According to her bio, her “work focuses on the psychosocial consequences of violence, trauma, and victimization with an emphasis on violence against women and other forms of interpersonal violence. Her work has addressed the mental health consequences of violence, such as Post-Traumatic Stress Disorder and depression as well as other important physical and social health outcomes.” 

The defense attempted to introduce this evidence without further examination by the Federal prosecution. Unfortunately, US District Judge Edward Davila did not agree. Ms. Holmes will be examined by two experts for the prosecution: Daniel Martell, Ph.D., a forensic neuropsychologist for the forensic litigation consulting firm Park Dietz & Associates, and University of California San Francisco psychiatrist Renee Binder, MD. Over the objections of the defense, the examination will be videotaped. The trial will commence with jury selection on 9 March 2021 [TTA 27 Aug].

Most of our Readers who care about this will be wondering, after they’ve picked themselves off the floor laughing at the above notion, that any person with a mental defect of this type could have fooled the savviest Sand Road VCs, Stanford/Hoover Institution luminaries, an admiral, a Marine general later Secretary of Defense, and Rupert Murdoch for years, to the tune of nearly $1 bn. That they should be gulled and fooled is disturbing enough. What is equally disturbing is the desperation of the defense to attempt an ‘insanity defense lite’ that sources and justifies Ms. Holmes’ inability to discern right from wrong.

This then proceeds to exactly what was the ‘interpersonal violence’ or post-traumatic stress that caused her judgment to warp quite this way. Was it her upbringing, which apparently was a bit upper-middle-class flaky–the ‘it’s not High Anxiety, it’s parents!’ reason? Was it a head trauma (the Howard Hughes defense), drugs, or surgery gone wrong? Did Sunny get Blue (in more than one way) on her? Stock up on the popcorn–la scandale Theranos has just gotten even more interesting. CBS Bay Area, Bloomberg News, Forbes, MedCityNews

A historical footnote. The term ‘Twinkie Defense’ came into usage in 1978 during the defense of the murderer of San Francisco mayor George Moscone and the better-known supervisor Harvey Milk. While not used per se by the defense team, the testimony of a psychiatrist for the defense that the murderer excessively consumed junk food, including Twinkies, as an indicator of depression and a sign of diminished capacity was hyped by the press as the ‘Twinkie Defense’. The term has passed into the vernacular. Ironically, both trials are occurring in the Bay Area.  Hat tip to The Crime Report.

Anthem-Cigna merger lawsuit finally wraps with ‘No damages for you! Or you!’

Not with a bang, but a whimper and a large bill. The long, drawn-out (May 2017!) lawsuit and countersuit in Delaware Chancery Court between payers Anthem and Cigna ended with the decision by Vice Chancellor J. Travis Laster to refuse to award damages to either party in the litigation.

Cigna, which was seeking nearly $15 bn from Anthem, seemed to receive the worst of his judgment. In his decision (PDF), VC Laster stated that Cigna was unable to prove that Anthem breached the Efforts Covenants and in fact, Cigna sought to derail the deal by pulling back on integration efforts, thus itself breaching the covenants. Thus, Cigna was not entitled to the $1.85 bn breakup fee or additional damages. Anthem proved that they sought to complete the merger and Cigna did not, thus seeking $20 bn in damages. In counterpoint, Cigna was able to prove that the deal would have been blocked regardless of their actions to demo the deal.

VC Laster’s conclusion, “In this corporate soap opera, the members of executive teams at Anthem and Cigna played themselves. Their battle for power spanned multiple acts….Each party must bear the losses it suffered as a result of their star-crossed venture.” The testimony revealed the deep divisions and battle lines between both companies during the merger preliminaries, until the Federal courts and DOJ put paid to it.

Yet the denouement of this Merger Made In Hell may not be fini. Anthem said in a statement to Fierce Healthcare that it feels “this decision is in the best interests of Anthem and our stakeholders.” But a Cigna spokesperson said they are not finished and considering a potential appeal. “We are pleased that the Court agreed with us that Cigna did not cause the merger to fail. We continue to strongly believe in the merits of our case, and we are evaluating our options with respect to appeal.” Certainly not the peaceful-in-public parting after the Federal denial of their merger by Aetna (acquired by CVS) and Humana (still in play).

The chief beneficiaries of this three-year drama? The law firms listed on page 1 of the opinion. Also Wall Street Journal (paywalled in part).

As practices reopen, telemedicine visits continue to plunge from 69% to 21%: Epic (US)

The extreme high tide has receded–but still way up than before the pandemic.  The Epic Health Research Network (yes, that Epic EHR), updated its earlier study through 8 May [TTA 22 July] to compare in-office to telehealth visits through 12 July. The trend that EHRN spotted (as well as Commonwealth Fund/Phreesia/Harvard) continued with telemedicine visits declining as practices reopened. As of mid-July, telehealth visits, as a  percentage of national ambulatory visits, declined to 21.2 percent compared to 78.8 percent in-office. 

The new EHRN study used a broader sampling than previously. They surveyed healthcare providers of data: 37 healthcare organizations representing 203 hospitals and 3,513 clinics in 50 states. The decline in telehealth visits noted in early May continued, with May finishing with a national 50/50 split.

But in context, telehealth visits immediately before the COVID-19 pandemic were a whopping .01 percent

Regionally, the Northeast leads in July telehealth visits with 25 percent. The South has the least adoption of telehealth with only 13 percent. In terms of total office visits, neither the South nor West have rebounded to pre-pandemic levels, whereas the Northeast and Midwest have.

The key to the future of the telehealth bubble bath is if telehealth usage versus in-person stabilizes for several months. But there’s another factor which has come about through higher telehealth usage. Noted in our July article was speculation on the reasons why the sudden decline, other than practices reopening, most of which pointed to practice training, reimbursement, and older/sicker patients falling into the smartphone/digital divide. The STAT article has statements from telehealth providers which are quite bubbly and quotable, with the CEO of MDLive stating that new bookings are up 300 percent and mental health hasn’t declined. But a problem now surfacing is providing patients with the right care at the right time–and fitting it into the office schedule. What visits can best be handled as telehealth and which require an in-person visit? This Editor recalls that Zipnosis, a white-labeled telehealth system we haven’t heard from in a while, incorporated for health system applications a triage intake which would direct the patient to the right level of care. Can this be rolled out in a similar way to the practice level?

Is the NHS ready to adopt telemedicine through and through–and is telemedicine ready?

This analysis by Dominic Tyer in Pharmaphorum discusses the rapid adoption of telehealth during the COVID pandemic, both telephonic and online, to keep people in touch with their doctors. Health Secretary Matt Hancock quantified the changes wrought as “I’ve lost count of the number of times someone said to me: ‘what would have taken months took minutes’.” The article goes on to quote him as saying that COVID-19 has “catalysed deep structural shifts in healthcare that were already underway”, citing as examples data-driven decision-making, working as a system, and telemedicine. In fact, to Secretary Hancock, “From now on, all consultations should be teleconsultations unless there’s a clinical reason not to.”

For all the advances, Mr. Tyer points out flaws such as safeguarding sensitive health issues, particularly for young people, use by rare disease patients and those with a genetic condition, and reaching the 10 percent of the population who do not use the internet. All of these are significant. He concludes that “in the UK there’s clearly the political will and healthcare backing for wider use of telemedicine by the NHS, despite some, as-yet not entirely resolved, technological and safety issues.”

Will the UK revert to ‘underuse’, as the US has rolled back as well as practices have reopened? (What is ‘underuse’ defined as anyway?) Will these issues be resolved or ignored in a push forward for telehealth? And teleconsultations as a norm, with in-person an exception, is perhaps at this time, and in improving health outcomes, an overreach? Hat tips to Roy Lilley of the nhsManagers.net newsletter and Steve Hards

QuivvyTech: a ‘telehealth’ company, sued by Humana in telemarketing scheme (US)

It was inevitable–the first alleged fraud and lawsuit involving a ‘telehealth’ company. The interestingly named QuivvyTech, which has styled itself as a telehealth company with “virtual care in general medicine, mental health, and complex care”, has been sued by insurance giant Humana. The grounds are that QuivvyTech telemarketers cold-called Humana members, who are generally members of Medicare plans, asked them about common ailments, and claimed they were working with Humana. They then recorded information that was sent to QuivvyTech physicians who would prescribe the members pricey and unnecessary creams (content undisclosed) fulfilled by co-conspirator pharmacies with QuivvyTech. The physicians listed in the suit electronically signed prescriptions for the members without reviewing patient history or having a prior relationship with the patient.

Humana not only is alleging harm in the payer-member relationship, but also lost millions in fraudulent claim payments for visits and medications. 

The lawsuit by Humana seeks treble damages, plus interest and fees, from QuivvyTech. It was filed in the US Southern District of Florida as many of the scammed members lived in Florida. QuivvyTech is based in Boca Raton.

Defendants in the suit include Frank Michelin, associated with QuivvyTech; Reliable Medical Supplies and Reliable Document Solutions, a telemedicine company with about 200 physicians; and physicians Jeffrey Mahon, MD, Elie Hercule, MD, Samuel Teniola, MD, Louis Mojicar, MD, Ananda De Silva, MD, and Jeffrey Stern, MD.

One wonders where QuivvyTech obtained Humana members’ phone numbers and information. 

QuivvyTech is still recruiting for physicians on job boards such as ZipRecruiter and StaffPhysicians.com. Becker’s Hospital Review, Healthcare Finance, Fierce Healthcare