Theranos, The Trial of Elizabeth Holmes, ch. 7: Edison labs consistent–in deficiency and strange results

November 11, 2021 | by

And Elizabeth Holmes knew. The last two years of Theranos’ existence, were, to put it mildly, fraught, for anyone honest. Job 1 for the very last in a parade of lab directors, Kingshuk Das, MD, was to respond to CMS on substantial deficiencies found in a November 2015 on-site inspection. The CMS deficiency report, sent to the prior lab director in January 2016, two months before Dr. Das’ start, had a subject line that would grab anyone’s immediate attention: “CONDITION LEVEL DEFICIENCIES – IMMEDIATE JEOPARDY.”

The report went on to say that it was determined that your facility is not in compliance with all of the Conditions required for certification in the CLIA program.” and concluded that “the deficient practices of the laboratory pose immediate jeopardy to patient health and safety.”

Dr. Das found some interesting things in his early days on the job, such as the Edison labs producing results detecting abnormal levels of prostate-specific antigen (PSA)–in female patients. When he brought this to Holmes’ attention, she quoted a few journal articles stating that certain rare breast cancers in women might present that result. This didn’t seem quite plausible to Dr. Das. Holmes then told him that it wasn’t an instrument failure, but rather a quality control and quality assurance issue. Nevertheless, Dr. Das went back and voided every Edison lab test made in 2014 and 2015, stating to Holmes that the Edison labs were not performing from the start. Most Theranos results sent to patients were produced on third-party machines made by Siemens and others, often on inadequately sized blood samples. 

As Dr. Das testified to the defense, many skilled people at Theranos earnestly tried to fix the problems with the Edison lab machines, but, as The Verge put it in part, if Holmes didn’t believe Dr. Das, other employees, or multiple preceding lab directors that the machines were really, truly broken, did it matter?

The defense is maintaining that Holmes didn’t really understand the lab details and was heavily influenced (ahem!) by president Sunny Balwani. However, the Babe in the Medical Startup Woods defense falls apart when there’s no Sunny to blame–he departed shortly after Dr. Das’ arrival. 

The actual theme–a long-term pattern of deception aimed at those who wanted to believe, and ponied up Big Bucks--was reinforced by a witness before Dr. Das. Lynette Sawyer was a temporary co-lab director for six months during 2014 and 2015, but never came to the Theranos site. It seems that her main duties were signing off remotely on documents using Docusign and backing up then-lab director Dr. Sunil Dhawan, Balwani’s dermatologist who came to the lab a handful of times. Even more amazingly, she was unaware of Theranos’ signature ‘nanotainers’ and the backup use of third-party devices. After her six-month contract was up, she departed, uncomfortable with Theranos’ procedures.

Kicking off the day was Judge Davila’s regular admonition to those in the public section of the courtroom to type vewy, vewy quietly. Then the video display for exhibits broke down. This led to a two-hour delay while the court found an antique projector to show the images to the jury and the public on a blank wall.

One wonders if the tapping plus the tech breakdown topping off the Parade of Fraud is leaving the jurors numb–or wanting to jump into the well above, even if there is no bottom. CNBC, Wall Street Journal (15 Oct), 5KPIX

TTA’s earlier coverage: Chapter 6, Chapter 5, Chapter 4 (w/comment from Malcolm Fisk), Chapter 3, Chapter 2, Chapter 1

To be continued….

 

 

Short takes: Papa Health’s $150M Series D, Hinge Health’s $600M Series E, Teladoc’s revenue up 81% but continues in the red

November 5, 2021 | by

Senior care provider Papa Health gains a Series D of $150 million, for a total of $240 million. Home care and older person support continues on its hot streak, after the blockbuster Honor-HomeInstead and Humana-Kindred at Home acquisitions plus smaller ones like ModivCare-VRI, Walgreens investment in CareCentrix, and Sharecare-CareLinx. The company’s valuation is now estimated at $1.4 billion. Papa’s technology connects older people with trained Papa ‘Pals’ for companionship and light home work through to Papa ‘Docs’ who serve to coordinate that person’s care. Their business model is to contract with payers such as Aetna and WellCare to offer its service as a benefit. They claim that they have added over 25 health plans as partners in the past seven months. This funding round was led by SoftBank Vision Fund 2 with participation from TCG, Tiger Global Management (which seems to have a bottomless bucket of funding), Canaan, Initialized Capital and Seven Seven Six. Mobihealthnews, Papa release

But Papa should envy Hinge Health, with its $600 million Series E for a total of $1 billion. In January, they had a $300 million Series D [TTA 14 Jan]. Their valuation is now boosted to an eye-blinking $6.2 billion, up from $3 billion. Tech and musculoskeletal seem to be a hot match, with Hinge’s virtual MSK Clinic for back and joint pain care and rehab including access to physical therapists, physicians, health coaches, and wearable sensors to guide exercise therapy. Existing investors Coatue and Tiger Global led the round, with new investors Alkeon and Whale Rock taking a $200 million stake.   FierceHealthcare 

Teladoc’s strong Q3 growth outstripped Wall Street’s forecast, but the competition is ever more fierce–and it continues in the red. Teladoc’s Q3 revenue grew 81%, to $522 million from $289 million prior year, beating a projection of $517 million by Zachs. Organic revenue growth (excluding acquisitions) was 32%. 2021 is now projected to be $2.02 billion, up 85% compared to 2020 revenue, and a 2022 projection of $2.6 billion. However, Teladoc continues to lose money, with an $84.3 million Q3 loss compared to $36 million in last year same quarter. Teladoc stated that it was primarily attributable to increased stock-based compensation and amortization of acquired intangibles, usually the case with acquisitions. Their stock value logically has taken a hit.

As previously reported, Teladoc has entered into the primary care sector with Primary360, now being pitched to health systems as a white-labeled “virtual front door” in addition to existing agreements with Aetna and Centene for 2022 exchange plans in four states. But as FierceHealthcare notes, the competition is equally hot, with care startups such as One Medical, Oak Street Health, Privia Health, and Forward. Accolade, which is a benefits platform, is acquiring PlushCare, and payers are setting up their own virtual-first primary care.

Legrand’s new global brand: Legrand Care

November 5, 2021 | by

Autumn must be the season for relaunches and rebrandings. Legrand is now consolidating its global brands in assisted living and healthcare under one name, Legrand Care. This unifies their separate brands, Intervox, Tynetec (a supporter of TTA for many years as Legrand is now), Aid Call, Jontek, and Neat. All the separate brands bring their technology and history to the new brand, and the release emphasizes the corporate commitment to technology-assisted, connected care. “The coming together of five highly regarded, customer centric, long established assisted living and healthcare brands into Legrand Care is a significant milestone in our journey,” stated CEO Chris Dodd in the release.

The new division will specialize in the innovative development of connected solutions for the health and social care sector, for home, group living, nursing home, and hospital markets. From the website, NOVO Go is their newest product to be introduced shortly, a mobile-connected wrist-worn or pendant form with geo-locating and reminder capabilities. Legrand has businesses in 90 countries with revenue of €6.1 billion in 2020.

In announced management alignments, Arturo Pérez Kramer is now Deputy CEO from his prior position of CEO of Neat, and Caroline Mouminoux will be Sales Director of Legrand Care and Silver Economy manager in France from Director of Intervox. More certainly to come! Hat tip to our Legrand communications manager contact, Kathryn Burton

Theranos, The Trial of Elizabeth Holmes, ch. 6: the decision maker was Holmes–and she was ‘cagey’

November 5, 2021 | by

Judge Davila is speeding up the trial, adding hours and days–perhaps because the damning testimony has become depressingly similar. Were the investors sloppy, or did Theranos–and Holmes–deliberately deceive?

Maybe…both.

Documents and slideshows from Theranos glowed.

  • The company faked memos and reports from both Pfizer and Schering-Plough, which was in the process of being acquired by Merck. Schering-Plough’s Constance Cullen said she found CEO Elizabeth Holmes’ answers to technical questions “cagey” and she was blocked by Holmes from asking questions of other Theranos employees.
  • Presentations describing the Theranos lab capabilities were written in present, not future, tense. Example from the prosecution reading from an investor deck: “Theranos proprietary technology runs comprehensive blood tests from a finger stick.” Another slide was 10-Pinocchio-worthy: “Theranos has been comprehensively validated over the course of the last seven years by 10 of the 15 largest pharmaceutical companies, with hundreds of thousands of assays processed.”

These were good enough for investors like Lisa Peterson of the DeVos family office, who testified last week about their decision to put in $100 million. In fact, investors were Social Networking right to Theranos’ door. The well-connected Daniel Mosley, who invested “a little under $6 million” in Theranos, after his client and friend Henry Kissinger, a Theranos board member and $3 million investor, asked him to evaluate the company, in 2014 recommended it to his other clients–the DeVos, Walton ($150 million), and Cox ($10 million)  families. Black Diamond Ventures founder Chris Lucas invested $7 million in Theranos. He believed that Theranos’ analyzers were being used by the military in the Middle East. Presumably, his uncle Don Lucas, who sat on the Theranos board, backed up the claim. They were additionally impressed by Holmes’ intensity and insistence that the company was on a mission to revolutionize blood testing. Risk can be fashionable for ‘high-quality families’ who aren’t hands-on with their money and won’t experience hardship if the investment doesn’t pan out.

The investors like Peterson and Mosley believed what they were shown was steak, not marshmallow, like projected revenue of $140 million in 2014 after zero revenue in the two prior years. They didn’t examine the books, other key corporate records, or make a technical evaluation of the labs. Why? “We were very careful not to circumvent things and upset Elizabeth,” Peterson of the DeVos office said. “If we did too much, we wouldn’t be invited back to invest.” Ooof. But on their side, in 2014-2015, the winds of hype were blowing fair, the skies were blue on CNBC, and Walgreens plus Safeway were lashed to the mizzenmast. The Verge, CNBC, KTVU Fox 2

The defense keeps pinning blame on the investors for being naïve, which is taken up by the NY Times. With 20/20 hindsight and infinite wisdom, the article blames the investors for not being scrupulous in their due diligence. A fair point made is that in ‘hot’ startup markets, no one looks too closely for the Fear Of Missing Out (FOMO)–something we see this very day.

Holmes’ chances of pinning the blame on president/boyfriend ‘Sunny’ Balwani and evading any lengthy time are low at best.

  • The defense sub-strategy of painting Holmes as controlled by Balwani appears to be augering in. CNBC uncovered a 27 June 2018 videotaped deposition in an investor lawsuit, eventually settled, where Holmes, in between taking the Fifth Amendment, also claimed she was the ultimate decision-maker at Theranos.
  • An analysis published in the Mercury News (PDF), through the paywall, is not sanguine about Holmes beating the odds and walking free, or with minimal time. However, juries do strange things in assessing fraud, even when piled high and wide by the prosecution, out of sheer boredom or cussedness. Holmes is also surrounded by family, friends, baby on breaks, and baby papa, all of which can sway some jurors.

So as the trial passes the halfway corner, we observers are waiting for a final bombshell–or two.

TTA’s earlier coverage: Chapter 5, Chapter 4 (see new comment from Malcolm Fisk), Chapter 3, Chapter 2, Chapter 1

To be continued….

US telehealth usage increases slightly in August, reversing months of decline

November 4, 2021 | by

A permanent or temporary lift for telehealth claims? FAIR Health, which is the non-profit that analyzes healthcare costs and health insurance information, has been tracking telehealth claims monthly since January 2020. This Editor has previously noted the peaks coming during the height of the pandemic (April 2020, 13%) and the rapid deflation after then to settling down during the summer to about 5%. In August, claim volume increased to 4.3% from 4.2% in July. It’s 2.4% mathematically, but still a decline from May’s 5%.

Of all telehealth claims, COVID-19 reappeared in the list of top five telehealth diagnoses nationally in August 2021 at 2%, the first time it had done so since January 2021. The vast number of claims–58.8%–were for mental health conditions, a slight change from July’s 60.7%, and decreased across every region. Also increased: acute respiratory diseases and infections, rising from 3.5% to 4.2%.

The largest increase in telehealth claims occurred in the Southern states, rising from 3.1% percent of medical claim lines in July to 3.5% in August. 

FAIR Health’s monthly tracker includes claims from the private (commercial) insurance population, including Medicare Advantage, and excluding Medicare fee-for-service and Medicaid. FAIR Health release, Becker’s Hospital Review

Wirral Council investing £1.5 million in next-generation digital and ‘preventative’ telecare (UK)

November 3, 2021 | by

Deploying sensor-based digital telecare starting November. Wirral Council announced that as part of their transitioning from analogue to digital next-generation telecare, they will introduce devices that are capable of detecting changes in behaviors such as smart plugs and movement sensors. The pilot will be delivered alongside Wirral’s commissioned community equipment and telecare provider, Medequip Assistive Technology, and care technology specialists, Alcuris.

The new devices and systems from Medequip Connect and Alcuris will support residents living at home plus families and informal carers:

  • Movement sensors, placed within the home, will enable family members and support services to detect activity and ensure the safety and wellbeing of people.
  • Smart plugs will help to indicate whether devices like microwaves and kettles are being used to ensure that vulnerable people are eating and drinking

Wirral’s evaluation of residents indicates that more than 3,500 residents are eligible for these services. Hat tip to Adrian Scaife of Alcuris for sending us the release (PDF) for first past the post break and correcting my fractured headline!

News & deal roundup: Oak Street adds telespecialty RubiconMD, ATA plumps for wider telehealth access, yet claims fall to 4%, West Suffolk NHS adds Zivver mail/file security, Northwell’s $100M for AI–and miss industry shows yet?

October 29, 2021 | by

Primary care network Oak Street Health acquired virtual specialty telehealth provider RubiconMD for $130 million. Oak Street is a 19-state network of physicians in care centers who specialize in Medicare patients. RubiconMD has 230 specialists who provide doctor-to-doctor teleconsults (eConsults) in 120 specialties, with an emphasis on cardiology, nephrology, and pulmonology, which is a strong fit for Oak Street. RubiconMD also has separate offerings for specialty care panels and behavioral health. The $130 million includes up to $60 million in cash or cash/stock, subject to achievement of defined performance milestones. Management transitions were not disclosed. Release, FierceHealthcare

The American Telemedicine Association wants to preserve wider telehealth access into 2022–even if the public health emergency (PHE) for Covid has to be extended. Although the Medicare Physician Fee Schedule proposed by CMS for 2022 includes areas of wider telehealth access and reimbursement (temporary access under Schedule 3 added in 2021) into 2023 regardless of the PHE, Congressional action is required to permanently expand telehealth beyond the existing programs mostly for rural areas. If necessary, ATA is advocating that Health & Human Services (HHS) extend the PHE through 2022 so that telehealth access and reimbursement are preserved. ATA release, FierceHealthcare

While this Editor can understand ATA’s frustration and the sincerity of its aims, it distorts the emergency meaning of a PHE that is just about nonexistent except for mandates. And telehealth claims, even with current access, have sunk down to a tick above 4%, 60% of which are mental health codes (FAIR Health July national data). Too many providers, too little demand? 

The West Suffolk NHS Foundation Trust (WSFT) has selected Zivver UK to secure its mail and file transfer systems, as it migrates from NHS Mail to Microsoft 365. It includes encrypted email to patients as a core requirement meeting NHS digital standards, and ease of use for both sender and recipient in MS Outlook. 4,800 staff at WSFT, which covers 280,000 people who live in West Suffolk. Release. Hat tip to HISTalk for this and the next two stories.

Northwell Health backs AI health startups via joint venture with Aegis Ventures with $100 million stake. The JV between the two New York-based companies “will ideate, launch, and scale AI-driven companies to address healthcare’s most challenging quality, equity, and cost problems” with stakeholders across Northwell’s extremely large system. According to the release, “Northwell has a track record of success in AI research, including the development of a landmark algorithm that predicts patients’ overnight stability to reduce the need to wake them for vital sign checks.” Nice to know that a health system appreciates patient sleep. 

And finally–miss the grip and grin of a F2F industry trade show and presentations? Your Editor, who was once a habitué of meetings from Boston to Florida, does. Really! Virtual conferences, once fun, are now tedious. So enjoy this walk through of HLTH21 by Ben Rooks, the Investor Man, at the Boston Seaport (a great venue, though not precisely central), right down to the barbers, puppy rescue, disco ball, and juice shots. Courtesy of HISTalk

Theranos, The Trial of Elizabeth Holmes, ch. 5: how to easily fool rich people and their investment offices

October 28, 2021 | by

It seems like smart people with big money like to jump into wells with no bottom, too. Yesterday’s testimony by Lisa Peterson in the Elizabeth Holmes trial indicated that Ms. Holmes knew her ‘marks’ as well as any grifter at the horse track. She concentrated on Very Rich People, whose Very Large Private Investment Funds are handled by ‘family offices’. Those offices handled investments for families such as DeVos (one of the top 100 richest families in the US), Walton (Walmart), and Cox (media). Holmes targeted five or six of these family offices, with the come-on line that she was seeking them because, after all, institutional investors wanted to recoup their investment via going public too soon for the Miracle Blood Lab.

Perhaps it was the prospect (and prestige) of backing a revolutionary healthcare technology, or large denominations falling from the sky, or just leaving it to their advisors, but they believed the sizzle, didn’t check that the steak was soy–and lost up to nine-figure sums. For these family offices, and for Rupert Murdoch, the losses were embarrassing, not life-affecting.

The former Secretary of Education Betsy DeVos did not testify either, leaving it to Lisa Peterson, who oversees private equity investments for RDV Corp., the DeVos family office. Ms. Peterson, who wouldn’t have the job if she weren’t decently savvy, drew a picture for the prosecution of being consistently lied to by Ms. Holmes and Theranos executives before committing to a $99 million investment through its legal entity Dynasty Financial II, LLC on 31 October 2014:

  • Holmes and Balwani showed financial projections of $140 million in revenue in 2014 and $990 million in 2015. Peterson testified she did not know that both 2012 and 2013 had zero revenue–a real lapse on her part, in this Editor’s view
  • Theranos claimed validation by ten major pharmaceutical companies, including Pfizer (in last week’s testimony, revealing that their validation was forged)
  • The RDV Corp. group was told multiple times that Theranos would offer hundreds of tests via finger stick with the analyzer at 50% of the cost
  • The DeVos investors supposedly never knew that third-party analyzers were doing all the testing. Both the pharma company validation and testing were critical in the underwriting agreement, Peterson said.
  • Holmes told Peterson the analyzers were being used in military helicopters (false) and that the company did not buy third-party analyzers (false, again).
  • Prior to the investment, three members of the DeVos family and Peterson’s boss Jerry Tubergen met with Holmes at Theranos’ Palo Alto headquarters on 14 October. Cheri DeVos had her blood drawn and tested using the Theranos lab. The family subsequently doubled their investment.

The binders were thick, the press articles at that stage were effusive, and both Safeway and Walgreens were going to roll it out in their stores. All the risk was on those companies for the execution, according to Petersen’s notes. 

So what we see is a classic ‘fake till you make it’ strategy, designed to play on two major retailers looking to buck up their pharmacy areas and select private investors with major funds. The articles in the WSJ and Fortune were fulsome to the point of parody. Holmes made an impact on supposedly cynical writers and Jim Cramer of CNBC’s ‘Mad Money’, who was highly influential on markets and investors at that time. It was to Cramer that Holmes made the famous statement, “This is what happens when you work to change things, and first they think you’re crazy, then they fight you, and then all of a sudden you change the world.” Whether she was scripted or really thought she was The Second Coming of Steve Jobs, it’s an audacious statement worthy of Napoleon or George S. Patton–which she had to walk back to Mr. Cramer and others in the press by early 2016 when the John Carreyrou/WSJ reporting made its own impact. The family offices questioned Holmes, of course, based on the email trail–and Theranos consistently downplayed the news to them as well as denying anything was wrong to the press.

What this Editor would like to know is once the signals went sideways, did any of these private offices’ investment managers get into Theranos to do some overdue due diligence and turn over some rocks, knowing that snakes might well fly out–or just let it ride?  CNBC, KTVU Fox 2 tweetstream 

What is somewhat risky may be the jury. The possibility of a mistrial has increased with halfway to go.  There have been three jurors removed, with their seats filled from the five alternates selected. Three more losses would lead to fewer than 12 jurors. Now the prosecution and defense could agree to go on–not a likely scenario. Judge Davila has increased the jury day by an hour daily to speed the trial up, but reports indicate the usual work and family problems. One juror was recently dismissed for playing a sudoku puzzle in the jury box due to “fidgetiness”. Choosing a jury was difficult in this tech area as few with the background and intelligence to understand financial fraud would be willing, for work and personal safety reasons, to appear on the jury. The defense is looking to unseal the juror questionnaires for their own strategic reasons. But CNN makes a mountain out of a speed bump, since Judge Davila is unlikely to pave any roads towards a mistrial.

Unfortunately, the Mercury News, Bloomberg, and WSJ, which would be primary sources, are paywalled.

TTA’s earlier coverage: Chapter 4 (see new comment from Malcolm Fisk), Chapter 3, Chapter 2, Chapter 1

To be continued….

Google joins the behavioral health wars, adds new senior executive from Headspace

October 28, 2021 | by

Google, having disbanded Google Health as a unit and scattered their products and teams internally, has decided that behavioral health is worth spending on across business lines. Megan Jones Bell, Psy.D., formerly chief strategy and science officer of Headspace, recently purchased by Ginger, rejoins Google this week as their first clinical director of consumer and mental health. 

She will be overseeing Google’s approach to mental health, supervising a team of clinicians, as well as coordinating primarily consumer-facing products such as the controversial verification of health information on Google-owned YouTube, across Google Search, Maps, Fitbit, and Cloud, medical products like the Care Studio EHR search app, depression screeners, and for employee health and safety. FierceHealthcare, Becker’s HealthIT

At least initially, Google does nothing in a small way. At HLTH21, Google’s chief health officer Karen DeSalvo, MD boasted that “Our get up every morning, raison d’être, is impact. It’s helping billions around the world be healthier.” Then followed broad and ambitious statements about social determinants of health (SDOH) and advancing health equity. Both have become a standard script for executive speeches at these conferences, virtual and in-person.

When scattered across multiple lines of business, it’s a little difficult to track ROI. And perhaps, that is the real Googly Goal. This Editor is of the opinion [TTA 24 Aug] that health is only a part-time pursuit for Big Tech, and that the real game is monetizing data–on people and what can be sold to healthcare organizations. When Big Tech tries to solve the problem of health by itself–which surely sounds what Dr. DeSalvo is about–it stumbles. Just ask David Feinberg, who decamped for Cerner after many frustrations at Google.  

Doro AB splitting in two, Doro Care changing name to Careium

October 27, 2021 | by

Sweden’s Doro AB announced today that it is dividing itself into two companies. Doro Phones will continue to be known as Doro. Doro Care will adopt a new name, Careium. This will involve a formal redistribution of shares to current shareholders. The plan is that Careium will be listed on Nasdaq First North Growth Market for Nordic small to mid-sized companies early in December 2021. The actual distribution will be disclosed at an Extraordinary General Meeting on 22 November.

According to Doro’s release on the corporate change, this started in 2020 with the separation of the phone and care business lines. Doro’s board of directors (BOD) believes that the now-former Doro Care “has now achieved the right conditions to act independently and develop outside Doro. A distribution and listing of Careium’s shares is considered to be able to contribute to Careium being able to continue to develop its business model and offering.” 

Careium’s logo is live–but not its website, which has but a discreet notice that it is under construction. There is a link to Doro Care in the UK only highlighting their three companies: Centra, Eldercare, and Welbeing–though what is not stated is the future of these three trade names. For their debut day, a standard marketing procedure (SMP) would be to go live with a home page containing the brand name change statement here. Another mystery: why the Careium website links only to the UK, and not to the websites of all the countries where Doro Care operates: Germany, France, the Netherlands, Norway, Sweden, and Spain.

And speaking of trade names….Careium will have difficulty using that name if their business development eventually includes the US, because there is a small home care company in Illinois called Careium Home Health which may, or may not, have protected that name. 

What do you think of the new name? Does it sound like something out of the Roman Empire, or is it a good choice? (It’s better than Facebook’s new moniker of Meta-whatever)

Hat tip to Adrian Scaife, head of collaboration and marketing at Alcuris.

Serious swerving indeed: 23andMe buys Lemonaid Health for $400 million

October 27, 2021 | by

From genomic testing to telehealth and prescription delivery is quite a swerve. Or a pivot, as they say. 23andMe, the richly financed (via a February SPAC with Virgin Group) and valued ($4.8 billion market cap) DNA tester, originally marketed to trace ancestry and analyze for health information, announced the acquisition of Lemonaid Health. A telehealth company that markets their quick diagnosis of conditions such as mental health, erectile dysfunction, thyroid, and sinus infections with fast delivery of medications, it’s quite a changeup for 23andMe, at least on the surface.

But, as this Editor opined as far back as 2018 in advocating a Genomic Bill of Rights and revisited in 2020, consumer genetic testing for the above as a model was finito just before the pandemic started. (When was the last time you saw a formerly lederhosen-clad actor trumpeting their new kilt or imagining their connection to famous dead people?) There were plenty of questions about the ethics of consumer-driven genomic testing as practiced by 23andMe and Ancestry.com. Consumers found it difficult to opt-out of how their genomic data was being used commercially, and understanding if it was being protected, as it likely was not.

The real gold for 23andMe is, of course, selling all that data to pharmaceutical companies. So in that context, Lemonaid, as really a marketer of meds, is not the stretch that it seems on the surface. But, there’s more. For 23andMe, which has consistently covered its cake of business aims in a thick and sticky icing of customer-focused mission, from their blog and signed by CEO Anne Wojcicki: “We are acquiring Lemonaid Health so that we can bring true personalized healthcare to 23andMe customers. Personalized healthcare means healthcare that is based on the combination of your genes, your environment, and your lifestyle — with recommendations and plans that are specific to you.” Meanwhile, Lemonaid, widely advertised online and on TV with quick telehealth consults, brings in the cash.

The transaction was announced at $400 million in a cash and stock deal, with 25% of the total deal value in cash and the rest in shares. Paul Johnson, CEO and co-founder of Lemonaid Health, will become the General Manager of the 23andMe consumer business and will continue to run Lemonaid Health. Ian Van Every, Managing Director, UK and also a co-founder, will manage and grow UK operations. According to Crunchbase, total investment in Lemonaid was a relatively small $57.5 million in five rounds since 2015, up to a Series B. Release. Reuters

PERS/RPM catchup: VRI bought by ModivCare for $315M; Connect America buys AI-powered RPM 100Plus, opens new SC center

October 27, 2021 | by

ModivCare buys VRI. While your Editor was on holiday leave enjoying the beautiful beaches of late-late summer, the long-rumored sale of PERS and remote patient monitoring provider VRI [TTA 9 July] closed on 22 September. The buyer is a non-emergency medical transportation (NEMT), home care (Simplura), and meal delivery company once known as Circulation and now ModivCare. Purchase price is $315 million, subject to customary purchase price adjustments. VRI generated $56 million of revenue and $21 million of adjusted EBITDA for the twelve-month period ended June 30, 2021. The majority owner of VRI since 2014 was Pamlico Capital. VRI will remain HQ’d in Franklin, Ohio and Sullivan, Illinois. Jason Anderson remains as its CEO under ModivCare. Business Wire release, ModivCare news site. And PERS Insider has an insightful article with a link to the investor presentation

VRI gives ModivCare immediate revenue, as well as impressive capabilities in medical alert systems, established monitoring centers, connecting care in the home plus other residential settings, and cross-selling in ModivCare’s relationships with Medicare Advantage and Medicaid (state) plans. Your Editor became familiar with VRI as far back as 2006 in her QuietCare days, then when Andy Schoonover and Chris Hendricksen ran VRI (and your Editor wished they’d buy the company). Andy Schoonover is now the CEO of CrowdHealth, a community-based provider of health services.

ModivCare has managed 48.2 million trips through the industry’s largest network of contracted transportation companies. They recently signed another agreement with Uber Health to provide on-demand transportation in underserved communities. They claim to be the largest NEMT company in the US with a 40% market share and trades publicly on NASDAQ with a market capitalization of $2.3 billion. NEMT is one of the linchpins of social determinants of health (SDOH). 

And Connect America treated itself to a snack after the big meal of Lifeline. PERS Insider broke the news on their purchase of 100Plus, supposedly the first AI-powered RPM company. Terms, purchase price, and management changes were not disclosed. Their pitch is to providers with an essentially turnkey system: identify eligible patients, perform patient consent and training, ships devices directly to your patients ready to use, and a ‘virtual medical assistant’ to monitor patients. The AI part of this is Ava, an AI-enabled, text message-based chatbot. This strengthens Connect America’s small RPM division, ConnectVitals. Release  

Connect America also announced in August that they will be opening a new facility to consolidate the scattered Lifeline operations into a single purpose-built location. The new $1 million, 25,000 square-foot facility will bring 71 jobs to the area and will open by end of year. PERS Insider, Upstate Business Journal 

Short takes: Google’s Care Studio app debuts, Modern Age’s healthy (aging) $27M Series A, OnSky Health launches pad-based RPM

October 22, 2021 | by

Care Studio, Google’s EHR search tool and patient record organizer, will be available to clinicians as a mobile app. The desktop version is in the process of acceptance testing with Ascension Health and Beth Israel Deaconess Medical Center (BIDMC). The company is looking to pilot the tool in Q4 or Q1 2022. Care Studio is capable of cross-checking information from multiple EHRs, accessing a patient summary, patient location, a “one-liner” provided from a previous note and a link back to the source, vitals and labs. The Google spokesman’s comments emphasize privacy, which is understandable given Care Studio’s earlier incarnation as Project Nightingale at Ascension in 2019. That made headlines since Google accessed 10 million identified patient records without patient or physician consent or knowledge, including patient name, lab results, diagnoses, hospital records, patient names, and dates of birth [TTA 9 April]. Mobihealthnews

Modern Age, which promotes better aging through boosting wellness, raised $27 million from Oak HC/FT, GV, and Juxtapose. The company’s attractive proposition is to use technology to ‘connect the dots’ around health as you age, and to bring together all the tools to ‘feel younger and live longer’. This starts with a personal assessment across variables to determine how old one feels, plus the areas of health and wellness that are most important, concentrating on skin, hair, bones, and hormones. The fresh funding will be used to build out their clinic in New York’s Flatiron district to open in early 2022, and build out their company from the present 17 to about 50. The founder Melissa Eamer is a former vice president at Amazon and COO at Glossier so has a handle in both the tech and appearance worlds. Aging and longevity are attracting investment, according to TechCrunch, with companies like Longevica, Gero AI, and Rosita Longevity gaining funding. Mobihealthnews

San Jose-based startup OnSky Health enters the remote patient monitoring fray with SkyPad, which claims to be the first virtual care solution that provides continuous contact-free vital sign sensing with an optional emergency alert and calling service. The SkyPad is a sensor pad placed under the patient’s or resident’s pillow, then uses machine learning software using sensor data generated through the pad.  The pad and system monitors multiple vital signs: heart rate, respiration rate, sleep-habit / sleep-quality tracking, breathing quality, snoring, and body temperature variation. It also checks for patient safety monitoring and assistance alerts. System monitoring is done through a tablet. The alert system is optional. The parent, OnSky Inc., is an alarm system company based in Ho Chi Minh City, Vietnam (Crunchbase). Release, Mobihealthnews

Amazon Care confirms five more cities, beefs up DC lobbying–but what’s the real game?

October 22, 2021 | by

Amazon Care will be expanding in 2021, confirming five new locations–and maybe more. Kristen Helton, the director of Amazon Care, confirmed at HLTH21 that 2021 rollouts of the virtual + mobile care service would include Dallas, Chicago, Philadelphia, Boston, and Los Angeles, ‘to name a few’. Ms. Helton confirmed that Washington DC and Baltimore region are live. The website does not state active cities, only permitting a zip code search and confirmation. Pharmacy delivery is also available in select, but not stated, areas. Healthcare Dive

Amazon Care originated with Amazon employees as a telehealth service, with in-person available to employees in the Seattle area. By March, they opened the full service (Video and Mobile Care Medical) to other Washington state companies. At that time, they announced that Video Care will be available nationally to companies and all Amazon employees by the summer–and claimed that in-person services would be rolled out to multiple cities by the summer. That did not happen. 

In June, at a Wall Street Journal Tech Health event, while being coy about the rollout, Amazon Care VP Babak Parviz said that the service would look like:

  • Clinician chat/video connected within 60 seconds
  • If an in-person visit is required, a mobile clinician arrives within 60 minutes, who can perform some diagnostic tests, such as for strep throat, provide vaccinations and draw blood for lab work. For other diagnoses, that clinician is equipped with a kit with devices to monitor vital signs which are live-streamed to remote clinicians.
  • Medication delivery within 120 minutes

Basically, what is not being said is that Amazon has been slow walking Amazon Care, probably wisely. With telehealth visits, mobile care, and pharmacy, there are multiple and complex elements to mesh seamlessly, which is after all Amazon’s Promise. What’s not so seamless is paying for it. While for Amazon it is with immediate payment for service, it is not for the patient–obtaining reimbursement, if available, is left up to the patient–at least for now, as reports indicate they are negotiating with Aetna. Amazon Care is also its own closed network.

There’s also the blunt fact that Amazon is moving into territory well staked out by major players that integrate employers, insurance, primary care, and pharmacy: Teladoc, Amwell, Included Health (Grand Rounds + Doctor On Demand), MD Live. They are now joined by UnitedHealth Care’s announcement a few days ago of NavigateNOW, a new virtual-first commercial plan rolling out next month to employers in nine markets and 25 markets by end of 2022. It offers 24/7 primary care, urgent care, and behavioral health care services through Optum as well as UnitedHealthcare’s national provider network. Many services and medications will have $0 copayments. Healthcare Dive, FierceHealthcare

However, if the cost of Washington lobbying is any indicator, Amazon is blasting off in healthcare. According to a report in OpenSecrets.org, “Amazon, which is creating its own health care service, is the biggest corporate lobbying spender so far in 2021. The company has spent nearly $10.2 million on lobbying in the first six months of the year, and spent $18.7 million in 2020.” The (unfortunately paywalled) report in STAT confirms the hire of Claire Winiarek from PCMA to be their new director of health policy.

This Editor’s opinion remains as in June–that Amazon’s business plans for Care and Pharmacy, and generally in healthcare, are really about accumulating data, not user revenue, and are certainly not altruistic no matter what they say. Amazon will accumulate and own national healthcare data on Amazon Care and Pharmacy users far more valuable than whatever is spent on providing care and services. Amazon will not only use it internally for cross-selling, but can monetize the data to pharmaceutical companies, payers, developers, and other commercial third parties in and ex-US. That’s a very different game than traditional insurers and the telehealth giants.

Theranos, The Trial of Elizabeth Holmes, ch. 4: we deceive those who want to believe

October 21, 2021 | by | 1 Comment

The Theranos Cave apparently has no bottom. Reportedly at the halfway mark, Tuesday’s trial focused on the testimony of former Theranos product manager Daniel Edlin. Recommended by his college friend Christian Holmes in 2011, he soon stepped into frontline work, assembling presentations sent to investors such as Rupert Murdoch, conducting VIP tours with demonstrations of the Edison labs, coordinating with the press, and with Elizabeth Holmes, plumping for Department of Defense and pharmaceutical company business. 

According to Mr. Edlin’s testimony, Theranos executives and staff staged demos and blood tests for investors and VIPs. Sometimes the blood tests worked fine, sometimes they didn’t (as in Rupert Murdoch’s case). Investors and reporters often were more interested in seeing Edison and MiniLab machines “work” without seeing any test results. All routine for an early-stage technology company. What was not routine was that other test results others were “corrected” (for Walgreens executives), reference ranges changed, or tests removed on the direction of Dr. Daniel Young, a Theranos VP.  The MiniLab never was used for patient blood testing as it had trouble performing general chemistry or ELISA tests adequately.

Rupert Murdoch’s (listed as a witness) investor presentation binder was entered into evidence. According to CNBC, one section of the binder read: “Theranos offers tests with the highest level of accuracy.” Another section said the blood-testing technology “generates significantly higher integrity data than currently possible.” Mr. Edlin testified that Ms. Holmes vetted every investor deck and binder, including the ones shown to DOD. The website, overseen by Ms. Holmes, made statements such as “At Theranos we can perform all lab tests on a sample 1/1000 the size of a typical blood test.” However, even Theranos’ general counsel advised against using these superiority claims:

  • “Please remove reference to “all” tests and replace with statements such as “multiple” or “several.” It is highly unlikely that the laboratory can perform every conceivable test, both from a logistical standpoint and because the CLIA certification designates specific specialties of test the lab performs.
  • For a similar reason, replace “full range” with “broad range.”
  • Replace “highest quality” with “high quality”
  • What substantiation do you have for “have results to you and your doctor faster than previously possible?”
  • Remove “unrivaled accuracy.”

To be fair, some of this language did change over time. The defense, for instance, had a try at shifting blame to one of Theranos’ marketing agencies.

But overstatements were a way of ‘fake it till you make it’ life at Theranos. The infamous Fortune article (later retracted by the author), the glowing 8 September 2013 Wall Street Journal article by Joseph Rago made at the time of the Walgreens pilot were felt to be overstatements by Theranos insiders, but never corrected. Walgreens and Safeway executives previously testified that they were told that Theranos devices were in use in Army medical evacuation units. But the truth was, according to Mr. Edlin who managed the DOD relationship, that AFRICOM (US Army African Command) deployed the Edison device in Cameroon, Uganda, and South Sudan to run as an experiment to test the viability of the machine. It was never deployed in the Middle East (CENTCOM). The Edison 4.0 was deemed too heavy and put off until lighter-weight units were developed. Nonetheless, Theranos received a 12-month service contract. 

The prosecution strategy here is to show that Ms. Holmes was hands-on when it came to marketing and investor communications, approved the overstated claims, and was not “controlled” by Sunny Balwani as the defense maintains. If anything, he deferred to her. 

CNN Business, KTVU Fox 2 running commentary, Daily Mail, California News Times  Unfortunately, the Mercury News, Bloomberg, and WSJ are paywalled.

TTA’s earlier coverage: Chapter 3, Chapter 2, Chapter 1

To be continued….

News roundup: Grand Rounds rebrands as Included Health, HealthEdge buys Wellframe, TytoCare rings Google Chime

October 20, 2021 | by

Grand Rounds Health rebranding to Included Health. Virtual care and navigation telehealth company Grand Rounds, which merged with Doctor On Demand back in May, is adopting the new and inclusive name, Included Health. Aside from the full rebranding as a company that is “turning the existing model on its head” for those who “feel marginalized by today’s healthcare, and it’s all about subtraction, taking things away from us,” as Owen Tripp, CEO stated in the announcement at HLTH21, it’s also a convenient name. Around the time the merger was being finalized, this Editor noted that Grand Rounds had acquired a small care concierge/health navigation targeting the LGBTQ+ community called…Included Health [TTA 28 May]. Release, FierceHealthcare

HealthEdge acquires Wellframe. HealthEdge, which specializes in payer administrative and clinical systems connectivity and automation software, announced their intent to acquire digital health and care management company Wellframe. Terms were not disclosed. Wellframe currently serves more than 33 million members. HealthEdge stated that they would be integrating their GuidingCare and HealthRules Payor with Wellframe’s systems, along with Wellframe co-founder and CEO Jake Sattelmair, his leadership team, and approximately 150 employees. While there’s some overlap, the two companies greatly complement each other in integrating payer systems to work more efficiently end-to-end in member and care management.  Release

TytoCare Chimes In. Telehealth diagnostic TytoCare upgraded its two-way video capabilities using the Amazon Chime platform. Its new video features include enhanced video quality, multi-party calls, and the ability for clinicians to conduct remote visits on any tablet, including iPads. TytoCare enables users to perform remote physical exams of the heart, skin, ears, throat, abdomen, and lungs, plus measure blood oxygen levels, heart rate, and body temperature. Release