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?”

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.

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.

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

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

The Theranos Story, ch. 64: Holmes’ trial moved to March 2021

What a difference two years makes. Once the subject of breathless headlines and breaking news, the latest news on the trials of Elizabeth Holmes and Ramesh ‘Sunny’ Balwani in la scandale Theranos earned hardly any notice in the healthcare press. Only this Editor’s search for an update found information that the Federal court trials, due to the pandemic and corresponding difficulty with trial preparation and jury selection, have been moved to 2021. Pretrial hearings for both have been moved to October and December.

So not to further punish our Readers who are dreaming of mountain lakes and ocean beaches, your Editor, a/k/a Glutton for Punishment, has summarized the Court’s next steps. 

  • The Holmes and Balwani trials have been severed–legalspeak for separated
  • Holmes will go first starting on 9 March 2021 with jury selection in the Federal Court, San Jose, Judge Edward J. Davila presiding. Balwani’s trial will not start until Holmes’ trial is concluded.
  • The next court hearings for Holmes will be 6 October (pretrial motion), 2 December (status), and 16 February 2021 (status)
  • Balwani will have a status hearing on 8 December

In early August, the Department of Justice (DOJ) prosecutor added a 12th fraud charge to Holmes’ list, relating to a patient’s blood test. A grand jury was empaneled in June during the midpoint of the pandemic, leading to Holmes’ legal team attempting to obtain 21 broad categories of documents on the jury selection. Their intent is to overturn the indictment as improper.

No need to stock up on popcorn till a month before Easter 2021, but it will be munch-worthy as rumored witnesses will be ‘faces’ such as General James Mattis (ret.), former board member and customer; Henry Kissinger; and Rupert Murdoch. This Editor’s bet is that these aged titans will not appear, with the exception of the youngest, General Mattis. More likely to be called to appear, in this Editor’s view, are executives from Walgreens who did the deal with Theranos, the last-ditch investors at Fortress Investment Group, major investors such as Partner Fund Management, and early unrepentant backer Tim Draper of Silicon Valley VC Draper Fisher Jurvetson.

The Federal charges are summarized in TTA 13 May]The full sturm und drang by chapter are here.

CNBC, US Department of Justice, Northern District of California published notice  The 14 June indictment (15 pages)

‘Before the Ashes Fall’: the story behind the book and the movie in development about dementia

Editor’s Note: The author of the post below, David Serafine, is a corporate security professional in the US. He is not like most of our Readers, a professional in healthcare technology or social care. What compelled him to write a novel about a father and son, and a family affected by the onset of Alzheimer’s Disease, is his own family’s story. We deal with dementia as professionals, but it has also touched and affected our family lives, and in many cases, our work lives. 

David reached out to me through a post on LinkedIn and after some discussion, I have decided to share his message with you. He and his production team are now reaching out to people like us to find financing for a film treatment, to be shot in Western New York State. Through the film, they will tell not only a story, but also to use the film to promote education and societal awareness, especially among minority and underserved communities heavily impacted by this disease.

Through our networks and our companies, you may know a funder, or funders, who are interested in backing this cause. More information on the production is attached (Release–PDF). You may contact David at serafinedavid@gmail.com, phone 512.571.0418, or via LinkedIn .


Before the Ashes Fall by David Serafine

I first encountered Dementia in June 2016.  It was my wife’s grandfather, a sturdy and tough as nails Texas farmer, who was diagnosed with Alzheimer’s.   The man’s diagnosis came only a  year removed from tending crops beneath the relentless noon sun while seamlessly conversing with a razor-sharp precision. “And we need to hide his truck keys for good”. The words, stinging with an exactness and finality, didn’t quite measure up.  The man still looked normal.

One year later, I observed half of the same man blankly staring at a birthday cake, not realizing it was his. The celebration carried on around him, with each attendee recalling stories of his life. I stared hard at his face, almost willing a quiver or smile, anything to suggest the words resonated. Nothing moved. Finally, I noticed his jutting collarbones which resembled a cheap wooden hanger. My eyes traced the sharp rise and fall around his shoulders and the blanched fabric which hung from them.

I contemplated whether Alzheimer’s solely left this wake of damage. Or, was it exacerbated by his daughter’s own Frontotemporal Dementia diagnosis, relegating her final days to a Memory Care Facility?  I never knew the answer as two months later, the man succumbed to Alzheimer’s complications.  To this day, his daughter was never told that he died.   That type of message, with a woman in her condition,  could be a potential catalyst for further emotional distress. 

Sometime during that journey, I wrote a fictional novel called ‘Before the Ashes Fall’.   In short, the novel is a race for “Love, Forgiveness, and Redemption” between a father and son beneath the cloud of Alzheimer’s. The process was as equally heartbreaking as cathartic. I mostly bled and cried into pages for a year, completed it, and put it to bed.

However, the book elicited correspondence from Malaysia, Ireland, Brazil, and Chile. The messages always began the same: “I had a (insert family member) die from various forms of Dementia.  Thank you for writing this story”. Two observations became clear over time. First, ‘Dementia’ didn’t stay in lanes, either geographically or demographically.  It was global and touched everyone either directly or indirectly.

Secondly, and arguably the crueler facet, is the insidious nature of Dementia.  In many circumstances, the readers’ initially described  Dementia as a ‘normal’ part of aging.  It wasn’t until an unequivocal tipping point- “my husband left the stovetop gas on’’-that it was no longer ‘normal’. That same moment generated guilt within the de facto caretaker (spouse, daughter, etc.) of what could have been prevented.

I researched the diseases of Dementia -Alzheimer’s is but one diagnosis and it alone will cost over $1 trillion (globally) in 2020 alone.  I also learned life choices and even traumatic events had a dramatic impact on the diseases’ progression.  Those two points are the most critical: we have some control and hope with increased awareness.

In July of 2020,  my book was adapted for film by a multiple award-winning Director. The story and approach are unique, unlike the other Dementia-based films. As we will target 60 global film festivals, three primary goals materialized.

First, and the most unique aspect of the approach, is our desire to facilitate pragmatic and current medical forums.  The engagements will include not only allopathic guidance but more importantly, non-allopathic guidance.  We seek to educate communities on life choices – diet, exercise, early testing before the disease has advanced. There are informed choices we can make that can delay and lessen the impact of Dementia. This is least understood globally.

Secondly, we will use film and outreach to galvanize communities.  A search of Dementia-themed films will yield 2  most recognizable (Still Alice and The Notebook).  Our film will feature a different demographic, one illustrating the ‘absence of lanes’ with the disease.  This will be represented in the cast, crew, and artwork produced by local Dementia patients.

These goals have been welcomed by medical practitioners, podcasters, and Corporate Social Responsibility Executives.  In addition to a strong storyline, we believe film fans will sense a collective ownership of this film during its production and engagement in their communities.   Additionally, it’s supportive and empowering to overcome tragedy alongside others, particularly those who strive for a better future.

Finally, and unique to the film industry, we seek to re-invest 50% of all profits into Dementia-related awareness campaigns.  If funded, we believe “Before the Ashes Fall” has a 3X delivery back into the programs we seek to support.

“Before the Ashes Fall” is a fiscally sponsored film through the Film Collaborative and individual or corporate donations are tax-deductible.   It’s an amazing opportunity to shape the future for current and generations to come, all desiring the same goal: a cure for Alzheimer’s. 

[More information on the production here: PDF]

Will the rise of technology mean the fall of privacy–and what can be done? UK seeks a new National Data Guardian.

Can we have data sharing and interoperability while retaining control by individuals on what they want shared? This keeps surfacing as a concern in the US, UK, Europe, and Australia, especially with COVID testing.

In recent news, last week’s acquisition of Ancestry by Blackstone [TTA 13 August] raised questions in minds other than this Editor’s of how a business model based on the value of genomic data to others is going to serve two masters–investors and its customers who simply want to know their genetic profile and disease predispositions, and may not be clear about or confused about how to limit where their data is going, however de-identified. The consolidation of digital health companies, practices, and payers–Teladoc and Livongo, CVS Health and Aetna, and even Village MD and Walgreens–are also dependent on data. Terms you hear are ‘tracking the patient journey’, ‘improving population health’, and a Big ’80s term, ‘synergy’. This does not include all the platforms that are solely about the data and making it more available in the healthcare universe.

A recent HIMSS virtual session, reported in Healthcare Finance, addressed the issue in a soft and jargony way which is easy to dismiss. From one of the five panelists:  

Dr. Alex Cahana, chief medical officer at ConsenSys Health.”And so if we are in essence our data, then any third party that takes that data – with a partial or even complete agreement of consent from my end, and uses it, abuses it or loses it – takes actually a piece of me as a human.”

Dignity-Preserving Technology: Addressing Global Health Disparities in Vulnerable Populations

But then when you dig into it and the further comments, it’s absolutely true. Most data sharing, most of the time, is helpful. Not having to keep track of everything on paper, or being able to store your data digitally, or your primary care practice or radiologist having it and interpretation accessible, makes life easier. The average person tends to block the possibility of misuse, except if it turns around and bites us. So what is the solution? Quite a bit of this discussion was about improving “literacy” which is a Catch-22 of vulnerability– ‘lacking skill and ability’ to understand how their data is being used versus ‘the system’ actually creating these vulnerable populations. But when the priority, from the government on to private payers, is ‘value-based care’ and saving money, how does this prevent ‘nefarious use’ of sharing data and identifying de-identified data for which you, the vulnerable, have given consent, to that end? 

It’s exhausting. Why avoid the problem in the first place? Having observed the uses and misuses of genomics data, this Editor will harp on again that we should have a Genomic Data Bill of Rights [TTA 29 Aug 18] for consumers to be fully transparent on where their data is going, how it is being used, and to easily keep their data private without jumping through a ridiculous number of hoops. This could be expandable to all health data. While I’d prefer this to be enforced by private entities, I don’t see it having a chance. In the US, we have HIPAA which is enforced by HHS’ Office of Civil Rights (OCR), which also watchdogs and fines for internal data breaches. Data privacy is also a problem of international scope, what with data hacking coming from state-sponsored entities in China and North Korea, as well as Eastern European pirates.

Thus it is encouraging that the UK’s Department of Health and Social Care is seeking a new national data guardian (NDG) to figure out how to safeguard patient data, based on the December 2018 Act. This replaces Dame Fiona Caldicott who was the first NDG starting in 2014 well before the Act. The specs for the job in Public Appointments are here. You’ll be paid £45,000 per annum, for a 2-3 day per week, primarily working remote with some travel to Leeds and London. (But if you’d like it, apply quickly–it closes 3 Sept!). It’s not full time, which is slightly dismaying given the situation’s growing importance. The HealthcareITNews article has a HIMSS interview video with Dame Fiona discussing the role of trust in this process starting with the clinician, and why the Care.data program was scrapped. Of related interest is Public Health England’s inter-mortem of lessons learned in data management from COVID-19, while reportedly Secretary Matt Hancock is replacing it with a new agency with a sole focus on health protection from pandemics. Hmmmmm…..HealthcareITNews.

Reflections in a Gimlet Eye: further skeptical thoughts on the Teladoc acquisition of Livongo (updated)

Gimlet EyePerhaps it’s Reflections in a Gimlet Eye, but this Editor remains bemused and slightly dyspeptic about the acquisition of ‘health signals’ remote patient monitoring management platform Livongo by telehealth giant Teladoc.

Here’s the latest, courtesy of Credit Suisse equity research analyst Jailendra Singh on deal rationale and the potential synergies, based on his Q&A with Teladoc and Livongo management (link here):

  • Livongo: “The company was not for sale, and LVGO did not view the transaction with TDOC as a sale. Instead, management views the deal as a merger of the two leaders in virtual care.” 
  • It had nothing to do with pressure from CVS and UnitedHealth Group (UNH). 
  • There are major cross-selling opportunities, starting with an overlap of 25 percent of their clients. There are also opportunities with the InTouch Health client base in acute care, Aetna plus UNH on the health plan side, and employer administrative services only (ASO) plans. This is part of the calculation of synergies totaling $500 million in 2025 which they believe are conservative given the math.
  • They are also seeking to approach their client base before the closing through a reseller agreement, as Teladoc was able to do with InTouch.

Mr. Singh’s analysis is conservative and sober from a strictly financial viewpoint. His two-page analysis is, as usual, worth the read. 

But then we stumble across one particularly helium-charged claim. It’s projected that Teladoc and Livongo would have a combined company market cap of $38 bn, whereas the pre-pandemic value of the companies was $8 bn. (Steve Kraus, Partner at Bessemer Venture Partners, now on the board of Ginger, as quoted in Forbes). That is optimistic, considering that patient primary care virtual visits have flattened down to about 7.4 percent of visits as of June (Commonwealth Fund/Harvard/Phreesia study). It’s assuming a great deal that people will continue to shy away from in-person care going forward. Perhaps to a degree this will, as in-person fear is only starting to flatten, but not everything can be done virtually, even RPM. Telehealth and RPM also present challenges for practices in value-based care models, in workflows, and even with the liberalization of Medicare reimbursements, financially.

Livongo’s great asset, which was understandably compelling for Teladoc, is chronic condition management, RPM, and all that patient data, which can be broadened past their diabetes base (with a small one in behavioral health courtesy of their myStrength acquisition) into other chronic conditions which was Livongo’s strategy anyway. To be determined is how compelling this will be for Teladoc’s customer base and for new customers, particularly if the economic environment is constrained and health plans don’t get on board. 

So why is Mr. Market not mad about this ‘merger’? TDOC has taken a spill since its (adjusted) close on 4 August at $249, and is trading below $200 at $193. LVGO took a lesser hit, from $144 to $121. Another Bessemer Venture Partners investor, Morgan Cheatham, in the Forbes article linked above, was quoted that Livongo had clear market leadership in the employer and health plan market, then expressed surprise at why Livongo agreed to be acquired: “The company had a real shot at becoming a $100 billion business by running the ‘digital hospital’ playbook. In some ways, the acquisition feels premature.” Teladoc’s COO David Sides promised that the combined company will aid practices in the transition from hospital to home care, touting the consumer focus of both companies. (Have they consulted already burdened and strained providers how this can be made easier for them and fit into value-based care models as well as their financials?) But they may have to make more acquisitions to facilitate this. So $18.5 billion plus $1 bn for InTouch isn’t enough to get the job done?

Is it synergy, the wave of the future, or an overloaded Christmas Tree of features, not benefits?

Reminder: to date, neither company has been profitable.

So, what does this mean for other digital health companies? Initially, it’s quite positive that Teladoc could round up nearly $20bn in six months. John Halamka MD, a well-known digital health visionary now at Mayo Clinic, sees it as a bridge to the digital health ecosystem including other companies. A contrarian view was expressed by Mr. Cheatham.  Teladoc-Livongo is a challenge for other digital health companies in that they won’t, and cannot, be Teladocs and Livongos–in other words, an unrealistically high bar for them. “Why can’t Telavongo build this?”

Finally, a personal and slightly jaundiced view from this Editor. Let’s take a good hard look at the Human Factors that make companies go. This is an acquisition by Teladoc of smaller Livongo, despite the merger statements. Employees in both companies are wondering who will go, who will stay, who they will report to if they stay, and where they will be. They have about four to six months to mull what their future might look like at a tough economic time. This will — not may, will–have an effect on operations and attitudes, especially at Livongo.

There are some doubleplus ungood signs that make the assertion that this is a “merger” of companies questionable:

  • Jennifer Schneider, MD, president of Livongo, has stated that both companies are currently hiring and don’t plan layoffs as a result of the merger (Becker’s Health IT). Blanket statements like this are usually made at the start to assure employees. Anyone who has been through a merger knows there are overlapping areas such as HR, marketing, and financial. There are only so many chairs at the organizational table especially at the director and above level. The happy talk doesn’t change the reality that not everyone will be given the option to stay.
  • Statements on similar cultures notwithstanding, the fact is that both companies have different cultures and experiences because they have radically different histories and personalities running them. This Editor would suspect that Livongo employees, having come up in a young and smaller company, in an intense entrepreneurial environment, with employees who were among the first 50 or 100, have a great identification with Livongo and pride in their success.
  • Not one Livongo senior executive was named publicly as taking a new operational role in the merged entity. (Board seats don’t count. But then again, they will be walking away with a major payday, reputed to be in the hundreds of millions for the top executives. What they will do with their future is a major unknown.)
  • The HQ will be in Purchase. Most Livongo employees are in California.
  • The company will be named Teladoc and will not be renamed. That says a lot, even though industry wags are calling it Telavongo and other names.

One would hope that both companies make every effort to reorganize the company staffs in a way where layoffs are minimal, those who are packaged out are treated generously, but better, valued employees from both companies are retained and incentivized to stay–sooner rather than in 4th quarter–in a fair and unbiased evaluative process in how they support their businesses presently and going forward as part of the combined companies future. But this is not typically the case.

One would also hope that the clients and individuals who pay the bills were told, timed with the public announcement, that this was happening and what it means for them. Leaving them to read the announcement online is usually what happens. It’s not automatic, and I’ve seen this treated as an afterthought in both large companies and small, with line of business folks scrambling to put together customer messages, and delayed in getting them approved as after all they have to go through both corporate and investor communications. This is typically the case, as communications cease to be a priority at the market/LOB level when the SEC or DOJ are involved.

Reminder: the Human Factors will fly this aircraft–or auger it in. 

Agree? Disagree? Comments welcomed.  TTA’s earlier ‘skeptical take’ commentary here.