TTA’s Realignment Autumn 6: Theranos’ Holmes gets 11 years on fraud, Cerebral ex-CEO’s legal fishing, Amazon Clinic and Primasun debut, Maven rounds up $90M, Sema4 ditches women’s health + 500

 

 

Weekly Update

Legal matters led this week, with Friday’s sentencing of Elizabeth Holmes to over 11 years in Federal prison and Cerebral’s ex-CEO fishing for evidence to use in legal actions. Amazon unveiled Clinic, a low-budget messaging platform for common condition diagnosis. Women’s health Maven rounded up $90M but Sema4 exited that testing field, losing 500. 

Breaking–The Theranos denouement: Elizabeth Holmes sentenced to 11.25 years with an investor loss of ~$121 million (Loss to be finalized at later date, sentence to start 27 Apr 2023)
Ousted Cerebral CEO may sue company, accuses management of scapegoating on Schedule 2 prescribing (Set up for legal action–or more settlement to go away)
The Theranos denouement: ‘Humble, hardworking’ Elizabeth Holmes sentencing Friday; prosecution and defense paint different pictures (updated)
News briefs: ResMed-Verily’s Primasun sleep solution; Maven Clinic’s $90M Series E; Mount Sinai genomics spinoff Sema4 lays off additional 500, exits women’s health
Yes, Virginia, there is an Amazon Clinic, after all; non-face-to-face consults for common conditions (Amazon’s Chevrolet–or Yugo–entry?)

VillageMD makes a quick, pricey deal for Summit Health. Many announcements on new products and partnerships. We stop in Singapore for funding while Oracle restructures its kitty. Amazon let a product ‘slip’. A rationale for a Transcarent-Teladoc tie-up. Telecare progress in Wales. Assessing where are we going, what are we doing in health tech funding after all this….realigning.

Short takes: Will there be an Amazon Clinic?, Transcarent and Teladoc, perfect together?, Get Well partners with Palomar Health, expands with Veterans Health Administration (Speculation can be fun)
Figuring out the future for health tech after 2022’s realignments: new SVB study (Solid weekend reading)
Oracle proceeds with $7B bond sale to restructure debt funding Cerner buy (Easier to manage, but bond rating still falls)
News roundup: cybersecurity benchmarking study, Tyto Care’s Home Smart Clinic, Long Island’s $2.6B life sciences hub, Singapore’s Speedoc raises $28M, NantHealth’s sinking feeling, Hims & Hers revenue up 95% 
TEC Cymru launches telecare programme strategy for Wales to complete digital transition by 2025 (Moving from analog to digital expands telecare)
VillageMD opens the Walgreens purse, set to buy Summit Health for $8.9B (This week’s Big Buy)

A mix of good and not-so-good news. Nearing year’s end, a flurry of fundings and promising partnerships. Walgreens’ VillageMD looking at a huge provider merger. JPM puts its venture money down on healthcare. UK GPs struggle with Data Saves Lives, as do health systems with lawsuits about Meta Pixel. And sadly, digital health layoffs continue at Kry/Livi and Brightline.

News roundup: WakeMed sued on Meta Pixel; Hint Health buys AeroDPC; Neurotrack’s $10M raise, 3 min. cognitive tool intro; layoffs dim Kry, Brightline (Good and bad news)
News roundup UK, AU, NZ: BMA England’s concerns on digital medical records; Australia and NZ’s health connectivity initiatives advance (Data Saves Lives agita)
J.P. Morgan forms life sciences/healthcare VC group; virtual care Ovatient formed by MUSC Health, MetroHealth; Oracle’s putting lots of KC office space on market (JPM sees opportunity, one new partnership, and office space to let!)
A spooky ‘good news’ roundup: AtlantiCare rolling out Orbita AI, Health Wildcatters Pitch Day, RapidSOS, HealthJoy fundings and more (Good News. Boo!)
VillageMD considering $5-$10B merger with Summit Health provider group: reports (A BIG provider consolidation, if it happens)

‘Fixing the holes’ this week. Global digital health funding is in a hole even deeper than the US. Telehealth a wobbly panacea, whether for discharged urban patients or care for the disabled. The pothole of layoffs hit Cerebral plus Israeli and German companies. Oracle’s Cerner acquisition requires more funding rearrangement, while VA deployment further delayed. Theranos tries the ‘mental’ defense as it digs out of that hole. But some light for Teladoc in narrowing its quarterly loss, and for smartwatches in accelerating adoption.

Is there a way out of the digital health funding black hole? Can it rebound to…2020? (So much depends on the next few months)
Telehealth-only follow up increased repeat ED visits by 2.8%, return admissions by 1.1%: JAMA Network study (Puts a hole in the savings points)
Smartwatches lead wearables, adoption now at 29%: Parks Associates study (Slow but sure development)
Pre-weekend short takes: Teladoc posts much smaller Q3 loss, 17% revenue boost; is telehealth threatening disability care quality; $2.8M for Australian wearables; more healthtech layoffs at Antidote, OrCam, Ada Health
Oracle talks to banks to increase loans funding Cerner buy; VA delays Cerner deployments to June 2023 (Oracle’s hornet’s nest?)
News updates: Theranos’ Holmes goes ‘mental’ in last ditch defense; troubled Cerebral telemental health fires another 400 (Theranos defense shows desperation, can Cerebral be saved?)

Perhaps it’s because the investment froth is off and it’s downscaling time, but the industry’s current and future status is a bit ‘Back to the Future’. A version that’s muted yet fractious, like the Conservative Party….

Meta Pixel is now considered a PHI breach that’s all Meta’s fault. Both Theranos trials move towards sentencing, despite defenses pulling ever-scrawnier rabbits out of hats. Back to antitrust action with CVS-Signify, while CVS apparently walks away from an expected deal with Cano Health. What’s moving forward? Smaller fundings, partnerships, and reorgs in a world resembling…2017 or 2018?

Meta Pixel ad tracker collects another 3 million data breaches at Advocate Aurora Health; Zuckerberg getting Senate scrutiny (Not going away despite denials and Zuckerbucks)
Breaking: CVS’ Signify Health buy under DOJ scrutiny in ‘second request’ (DOJ and FTC crave an antitrust win)
News roundup: CVS abandons (?) Cano Health buy; Signify adds home RPM; BioIntelliSense RPM acquires AlertWatch; GE Healthcare, AMC Health partner; Viome raises $67M, other fundings
Rosendorff stands pat on Theranos’ Elizabeth Holmes: “She needs to pay her debt to society” (He’s right–and now he needs a job and a relo)

There’s no escaping realignments in health tech. CVS sells an inherited business from Aetna. Babylon Health exits the practice business, financially maneuvers to avoid NYSE delisting. Layoffs continue to hit the formerly hot companies in health tech. Theranos’ Holmes and Balwani try to avoid the inevitable sentencing. And we have a Perspectives contribution from Avaya on NHS England’s ICS. 

Theranos’ Holmes sentencing now 18 November, defense wants to expand hearing scope; Balwani can’t join in
News roundup: CVS sells bswift; Babylon puts Meritage IPA up for sale, financially realigning to prevent delisting; Redesign Health sheds 20%, Noom 10%
Perspectives: How joined-up communications can enable connected patient care across healthcare Trusts

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Ousted Cerebral CEO may sue company, accuses management of scapegoating on Schedule 2 prescribing

Troubled telemental health provider Cerebral may face a lawsuit from former CEO Kyle Robertson. Ousted in May when the company’s prescriptions for ADHD patients started to be excluded from pharmacies such as Truepill, CVS, and Walmart for Schedule 2 (potential for abuse and misuse) medications such as Adderall, Ritalin, and Vyvanse [TTA 6 May], Robertson has written a letter to Cerebral demanding access to documents. The types of documents requested, according to (paywalled) Insider, include “possible breaches of fiduciary duty, mismanagement and other violations of law.” Usually, these are a setup to determine whether others on the company board and leadership were the real culprits in business mismanagement, and a prelude to a legal filing.

CBS News obtained a copy of the Robertson letter, in which “Robertson says he was pressured by the company’s investors to “sell more stimulants” and believes his ouster was an effort to “scapegoat” him as these investigations arose.  He was urged by one board member  that “the easier you make it for people to get stimulants, the better for the business and its customers.” and also claimed that an investor told Robertson’s partner the company’s “ADHD business is crushing and it’s a cash cow … Kyle’s got to push this thing further.” Other documents obtained by CBS allegedly detail clinical safety issues, staff “practicing with expired (or) suspended license(s),” and duplicate accounts which could set the stage for overprescribing. Other documents allege lack of training, pushing prescriptions to 95% of patients, and disregarding state regulations putting licenses at risk. [TTA 29 June] The current management, led by David Mou, has denied this all.

Multiple investigations are proceeding. From May on, Cerebral came under investigation by the Federal Trade Commission (FTC) on deceptive advertising and marketing practices, the Drug Enforcement Agency (DEA) as part of increased scrutiny of telehealth providers and pharmacies possibly overprescribing telehealth-generated prescriptions, and most significantly, the Department of Justice (DOJ) subpoenas on allegations of overprescribing. A prior wrongful dismissal lawsuit by Matthew Truebe, Cerebral’s former VP of product and engineering, alleged that the company put growth before patient safety, including prescribing ADHD drugs to 100% of diagnosed patients as a retention strategy. The concatenation of evidence from multiple sources makes a lawsuit by Robertson, who also cites other factors, probable–unless this is being used as a tablespoon to sweeten his severance.

Prior to that, Cerebral was one of the leaders in the still-hot digital mental health category. In December 2021, their $300 million Series C raise led by Softbank boosted their valuation past $4.8 billion, employed 4,500, and had 210,000 patients. In October, they released 400 staff but other reports indicate far more. Also FierceHealthcare

DOJ investigates telemental Cerebral on over-prescribing of controlled medications

DOJ dropped an anvil on Cerebral’s head Friday night. Last week’s reports on the Drug Enforcement Agency (DEA) investigation of telemental health provider Cerebral were confirmed on Friday with the official notification that the US Attorney’s Office for the Eastern District of New York had subpoenaed the company as part of their investigation into possible violations of the Controlled Substances Act. According to the Wall Street Journal, the subpoena was issued to Cerebral Medical Group, the corporation it uses to contract with clinicians and provide healthcare services. The company is fully cooperating with the investigation by the Department of Justice, which includes turning over records pertaining to their prescribing of controlled substances such as Adderall and Xanax. This has been reported by FierceHealthcare which is citing (paywalled) Insider.

Last week, Cerebral announced that it would stop prescribing controlled substance prescriptions for new ADHD patients as of 9 May. However, they would continue prescribing controlled substances for other mental health conditions, according to a memo from their chief medical officer to their clinician network.

Cerebral’s Saturday statement in response to the subpoena maintains (from FierceHealthcare):

“To be clear, at this time, no regulatory or law enforcement authority has accused Cerebral of violating any law”

and

“Cerebral has dedicated significant time, energy, and resources to ensuring that its policies and procedures regarding the prescription of controlled substances and other medications both are medically appropriate and comply with all applicable state and federal law,” the statement also said. “As a responsible company, Cerebral is continuously improving its systems and practices. The foundation of this company is built on evidence-based, ethical, and compliant practices so that our patients can receive the highest quality of care and achieve the best clinical outcomes.”

The company has done well with the increased demand for mental health services provided via telehealth including remote evaluating and prescribing. In December, their $300 million Series C raise boosted their valuation past $4.8 billion.

Darkening this rosy picture is, as TTA noted last week, that a former VP of product and engineering, Matthew Truebe, has sued Cerebral for wrongful dismissal. According to him, the company put growth before patient safety, including overprescribing medications for ADHD. Other reports indicate that the DEA interviewed other former Cerebral nurse practitioners who felt pressured to prescribe ADHD medication after a short video call. The Verge

Cerebral has also gained notoriety for dodgy advertising claims pertaining to ADHD and other conditions. In January, advertising on TikTok and Instagram was pulled for claims that obesity is “five times more prevalent” among adults with ADHD, and stated that getting treatment for the mental health disorder could help patients “stop overeating.” These followed inquiries by Forbes and NBC News. Also pulled was their Facebook advertising around prescribing Type 2 diabetes medications, GLP-1 agonists, as a “wonder drug” for weight loss. 

Will this put a damper on the burgeoning area of telemental health and remote prescribing? Stay tuned. Also Becker’s. 

Weekend news and deals roundup: Allscripts closes sale of hospital EHRs, closing out CEO; DEA scrutiny of Cerebral’s ADHD telehealth prescribing; more telehealth fraud; Noom lays off; fundings; and why healthcare AI is only ML

That was fast. Allscripts closed its $700 million March sale of its hospital and large physician practice EHRs to Constellation Software Inc. through N. Harris Group. The Allscripts EHRs in the transaction are Sunrise, Paragon, Allscripts TouchWorks, Allscripts Opal, and dbMotion. They reported their Q1 results today. According to HISTalk earlier this week, CEO Paul Black will be stepping down, with President Rick Poulton stepping in immediately. Update–this was confirmed on their investor call Thursday and the transition is effective immediately. No reasons given, but there were no effusive farewells.  Healthcare Dive

A damper on telemental health? Online mental health provider Cerebral, which provides talk therapy, audio/video telehealth, and prescriptions for anxiety, depression, insomnia, ADHD, and other conditions, is finding itself under scrutiny. This week, its main mail fulfillment pharmacy partner, Truepill, stopped filling prescriptions for Adderall, Ritalin, Vyvanse, and other controlled Schedule 2 pharmaceuticals. Cerebral is redirecting current patients with these prescriptions to local pharmacies and as of 9 May, will not prescribe them to new ADHD patients.

Based on reports, the Drug Enforcement Agency (DEA) is looking at Cerebral in particular as part of a wider scrutiny of telehealth providers and pharmacies filling telehealth-generated prescriptions due to allegations of overprescribing. It also didn’t help that a former VP of product and engineering plus whistleblower claims in a wrongful dismissal lawsuit that Cerebral execs wanted to prescribe ADHD drugs to 100% of diagnosed patients as a retention strategy. Bloomberg Law. Unfortunately, Insider is paywalled but you may be able to see a report in the Wall Street Journal. Becker’s Hospital Review, FierceHealthcare

Also troubling telehealth is recurrent fraud, waste, and abuse cases involving Medicare and Medicaid. Back in 2020 the National Healthcare Fraud Takedown took down over 80 defendants in telemedicine fraud [TTA 2 Oct 20, 30 Jan 21]. The Eastern District of NY based in Brooklyn has indicted another physician, an orthopedic surgeon, in a $10 million fraud involving durable medical equipment (DME). In exchange for kickbacks from several telemedicine companies, he allegedly prescribed without examination and with only a cursory telephone conversation DME such as orthotic braces. DOJ release

Some fundings and a sale of note–and a big layoff at a well-known digital health leader:

  • Blue Spark Technologies, an RPM company with a patented Class II real-time, disposable, continuous monitoring body temperature patch good for 72 hours, TempTraq, raised a $40 million intellectual property-based debt solution (??) to fund growth led by GT Investment Partners (“Ghost Tree Partners”) with support from Aon plc (NYSE: AONRelease
  • Specialty EHR Netsmart acquired TheraOffice, a practice management platform for physical therapy and rehabilitation practices which will be added to its existing CareFabric platform. Neither terms nor management transitions were disclosed in the release.
  • ‘White label’ telehealth/virtual health provider Bluestream Health is implementing its systems in Mankato Clinic, with 13 facilities across southern Minnesota. It’s a rarity–physician-owned and led–and in business since 1916. This also fits into a new telehealth trend–providers working with ‘white label’ telehealth companies and not with the Big 5. Release
  • Ubiquitously advertised (in US) weight-loss app Noom is laying off a substantial number of employees–180 coaches plus 315 more employees. Reportedly they are pivoting away from on-demand text chat to scheduled sessions that don’t require so many people. While profitable in 2020 ($400 million) and with Series F funding of over $500 million in 2021, it’s come under criticism that while its pitch heavily features easy behavioral change achieved through cognitive behavioral therapy (CBT), their real core of weight loss is severe calorie restriction. Engadget
  • Element5, an administrative software provider for post-acute facilities, raised a $30 million Series B from Insight Partners. They claim that their software is AI and RPA (robotic process automation) based. ReleaseMobihealthnews

And speaking of the AI pitch in healthcare, a VC named Aike Ho explains why she doesn’t invest in healthcare AI companies because there’s no such thing in healthcare–it’s just machine learning. On that, Ms. Ho and your Editor agree. She also makes the point that the market they address is ancillary and not core services, plus they have difficulty clinching the sale because they don’t relate well to achieving or can’t prove at this stage improved clinical outcomes. Ms. Ho’s looooong series of Tweets is succinctly summarized over at HISTalk (scroll down halfway).

Weekend short takes: ATA, APA call for permanent in-person evaluation waiver, mental healthtech raised $5.5B in 2021, Allscripts sells hospital/large physician EHRs to Harris Group for $700M, Cognizant-Microsoft extends telehealth-RPM

72 groups asking for permanent telehealth in-person evaluation waiver prior to prescribing controlled substances. The American Telemedicine Association (ATA), ATA Action, and the American Psychiatric Association (APA) plus 69 other healthcare groups have written the Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) to make the temporary waiver of in-person patient evaluation prior to prescribing controlled substances permanent, and to remove restrictions on patient location. The rationale is to increase access to care, specifically for mental health and substance use disorder treatment. Currently, under the soon-to-be ending COVID-19 public health emergency (PHE), mental health providers can prescribe controlled substances remotely through a telemedicine consult. The letter points out that studies confirm efficacy, clinician and dispensing would remain under current restrictions, and that DEA and HHS can work together to prevent drug diversion. Other signatories include Babylon Health, Teladoc, Zipnosis, One Medical, and Northwell Health. ATA release, ATA/APA letter.

Mental healthtech’s banner 2021 totaled $5.5 billion across 324 international deals. Industry researcher CB Insights found that:

  • Investment was up 139% versus 2020
  • Exits were also up 87% (43 versus 23). Of the 43, there were 35 M&As, five SPACs and three IPOs.
  • US companies dominated in mental health, raising $4.5 billion; EU $651 million, and Asia $289 million
  • Mega-rounds ($100 million+) totaled 15, all US and in Q4, versus four in 2020.

State of Mental Health Tech 2021 Report free download available on the CB Insights page. Mobihealthnews

Allscripts is unloading its declining hospital and large physician practice EHRs to Ottawa-based Harris Group for $700 million in a cash plus contingent deal. The Allscripts EHRs in the transaction are Sunrise, Paragon, Allscripts TouchWorks, Allscripts Opal, and dbMotion. Although the unit generated gross revenue of $928 million in 2021, its revenue was expected to decline 3-4% and EBITDA to shrink 10-15% in 2022. Allscripts is retaining Veradigm, which is growing 6-7% annually, and stated that expected after-tax proceeds of $600 million will be used for share repurchase and potential M&A related to Veradigm. Harris Group acquires and manages computer systems companies in North America, Europe, Asia, and Australia covering four sectors: public, private, healthcare, and utilities. It is owned by Toronto-based Constellation Software. HISTalk reports on the Allscripts investor call, Constellation release

Cognizant announced a collaboration with Microsoft Cloud for Healthcare to extend telehealth and remote patient monitoring (RPM) capabilities for their offerings combining remote patient monitoring and virtual health, utilizing connected devices such as smartwatches, blood pressure monitors, and glucose meters to collect and communicate patient health data to providers. Cognizant release