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

TTA’s Realignment Autumn 3: wobbly global health funding, telehealth. Oracle funding Cerner buy; Teladoc narrows loss, smartwatches accelerate, Theranos defense reaches ‘mental’ state, more!

 

 

 

Weekly Alert

This week felt like ‘fixing the holes’. 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. 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. 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

Digital health funding jumps off cliff, but UHG and Change a done deal and Theranos’ Holmes gets a new hearing.

Q3 digital health funding craters nearly 50% to $2.2B: Rock Health (2021 was, as it turns out, not the future)
Catchup News Roundup: UHG-Change buy final; Theranos’ Holmes sentencing delayed, ‘limited hearing’ agreed to (A hearing right out of Perry Mason)

Winding up Summer with UHG finally receiving an OK from District Court to complete Change Healthcare buy–unless DOJ pursues appeal. Oracle set to Oracleize Cerner but VA hedges Cerner training with AWS. The Meta Pixel/health data privacy story continues, catching attention from the Senate. Some fundings and buys large and small.

Meta facing some Senate scrutiny on Meta Pixel’s health data collection–and how it’s used (Bad, bad Facebook)
Weekend reading: HHS Office of Information Security presentation on security risks in AI, 5G, nanomedicine, more (Warning, 34 page presentation)
ATA organizes Telehealth Awareness Week this week (And beyond)
Breaking: Judge permits UnitedHealth acquisition of Change Healthcare, denies DOJ motion (updated) (But beware DOJ taking it to appeal)
News roundup: Oracle’s modernizing Cerner’s tech, but VA hedges training with AWS; Redesign Health’s $65M raise; Kyruus buys Epion Health; Zócalo Health raises $5M seed; Cigna Evernorth adds to digital formulary

Back from Two Weeks in Another Town (except for a few extra days), the August-September ‘quiet time’ certainly was not. CVS’ big win in Signify’s auction was on Labor Day. Change may or may not be joining UHG/Optum after October. FTC doesn’t much like Amazon’s acquisitions, including One Medical. And Elizabeth Holmes’ legal team was busily filing–and delaying the (maybe) inevitable, including a declaration straight out of Perry Mason. The passing of a Queen and crowning of a King.

Elizabeth Holmes’ three swings and a miss in overturning her trial verdict reveal a crafty strategy (She’ll be in court long after Sunny Balwani toddles off to prison)
News briefs, catchup edition: UnitedHealth/Change decision October?, CVS wins $8B Signify Health auction, Walgreens majority buy of CareCentrix, FTC requests more info on Amazon-One Medical (Home care wars and a long-awaited decision)
Perspectives: Creating consistent standards isn’t a once and done job (The safety of digital treatment tools)
On the passing of HM Queen Elizabeth II

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Read Telehealth and Telecare Aware: https://telecareaware.com/  @telecareaware

Follow our pages on LinkedIn and on Facebook

We thank our present and past advertisers and supporters: Legrand/Tynetec, Eldercare, UK Telehealthcare, NYeC, PCHAlliance, ATA, The King’s Fund, DHACA, HIMSS, Health 2.0 NYC, MedStartr, Parks Associates, and HealthIMPACT.

Reach international leaders in health tech by advertising your company or event/conference in TTA–contact Donna for more information on how we help and who we reach. 


Telehealth & Telecare Aware: covering the news on latest developments in telecare, telehealth, telemedicine, and health tech, worldwide–thoughtfully and from the view of fellow professionals

Thanks for asking for update emails. Please tell your colleagues about this news service and, if you have relevant information to share with the rest of the world, please let me know.

Donna Cusano, Editor In Chief
donna.cusano@telecareaware.com

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News updates: Theranos’ Holmes goes ‘mental’ in last ditch defense; troubled Cerebral telemental health fires another 400

Blood out of a rock? The Holmes’ defense goes ‘mental’ with Dr. Adam Rosendorff. Reduced to a limited hearing before Judge Edward Davila and the US District Court in San Jose, where Rosendorff not only reaffirmed his testimony but also explained the circumstances around his visit to the home, the Holmes defense filed a motion on Monday, citing an obscure interview published in September by the South African Jewish Report to cast doubt about the veracity and credibility of his testimony. Rosendorff, who was born in South Africa, recounted to the interviewer that the stress from blowing the whistle on Theranos led to a “breakdown, medication, hospitalization, and health problems.”

Rosendorff also stated in the interview that by the time the trials (Holmes and Balwani) were scheduled in early 2020, he was off medication. The trials finally took place in 2021 (Holmes) and this year. When questioned last week by defense lawyer Lance Wade about his mental state, his response was that “I’m finding this line of questioning to be invasive.” and that his “mental state was solid” when he drove to Holmes’ home wanting to speak with her. The prosecution objected to the questioning and Judge Davila upheld it.

The prosecution’s response to the defense filing is that the court record “contains no indication whatsoever that Dr. Rosendorff suffered from a mental health issue that affected his ability to serve as a reliable witness,” and that “newly raised and uncorroborated insinuations about Dr. Rosendorff’s mental health do not justify discounting his testimony or granting a new trial.”

The Mercury News’ money quote from New York defense lawyer Jennifer Kennedy Park: “I think the judge already made the decision that this is not relevant.” Another lawyer quoted, former Santa Clara County prosecutor Steven Clark, said that the stress can be difficult but that it apparently didn’t affect Rosendorff’s capacity to testify–and that he was consistent across two trials.

Unless Judge Davila decides to delay–not likely given the above and the pending sentencing for both Holmes and Balwani–or there are additional magic ‘rabbits out of hats’, Holmes’ sentencing remains scheduled for 18 November, Balwani’s later this year.

And speaking of mental health, beleaguered telemental health provider Cerebral let go of 400 more staff, or another 20% of their remaining workforce. This follows a layoff of ‘hundreds’ of contractors, including nurse practitioners who did counseling and support staff, at end of May. Cerebral is ‘restructuring’ under a new CEO, David Mou, who replaced CEO and co-founder Kyle Robertson  forced out by the Cerebral board after the first round of investigations by the Department of Justice (DOJ) on over-prescribing of controlled substances and the subsequent defection of CVS Health and Walmart, as well as Truepill on mail fulfillment. Their statement cites “operational efficiencies while prioritizing clinical quality and safety across the organization.” Cerebral had at its peak in the spring 4,500 employees.

In addition to the DOJ investigation, the FTC is investigating Cerebral for deceptive advertising [TTA 1 June] and a former VP of product and engineering, Matthew Truebe, is suing for wrongful dismissal, further exposing the inner workings of the company [TTA 16 June]. Employees have gone public with tales of pushing prescriptions to 95% of patients, disregarding state regulations, and generally Running Wild over any semblance of clinical probity [TTA 29 June]. Certainly Softbank cannot be delighted at the rolling crackup of their once-valued $4.8 billion baby for which they’ve led funding of over $426 million. TechCrunch, Healthcare Dive.

Weekend short takes: May telehealth claims up to 5.4%; three health plan breaches, one at its law firm–affecting over 400,000 patients; layoffs hit Calm, Truepill (updated)

FAIR Health’s telehealth claims took two bumps up in both April and May. In April, telehealth medical claims moved slightly upward to 4.9% from March’s 4.6%, but May increased 10% to 5.4%, a percentage not seen since May 2021. Mental health conditions still make up the vast bulk of claims at 62.8%, but 3.6% of telehealth claims involve COVID-19 diagnoses, with 3.2% of claims for respiratory diseases and infections. This is attributed to a regional increase in the Southern and Western states of the latest variants of COVID-19. FAIR Health monthly tracker main page

Priority Health, a Michigan-based nonprofit health plan company, was breached through its law firm Warner Norcross & Judd (WNJ). The October 2021 breach at WNJ wasn’t reported to Priority Health until 6 June. The unauthorized party potentially accessed first and last names, pharmacy and claim information, drug names, and prescription dates from certain prescriptions filled in 2012. 120,000 members were affected. What the information was doing at the plan’s law firm was not disclosed. Priority Health is Michigan’s second-largest plan with over one million members.

In other breaches, Texas-based Behavioral Health Group (BHG), had a data incident that affected 197,507 individuals. The unauthorized party had potentially removed certain files and folders from portions of its network on 5 December 2021.  The files include names, Social Security numbers, driver’s license numbers, financial account information, biometrics, medication information, medical record numbers, dates of service, passports, payment card information, and health insurance information. However, the information accessed doesn’t appear to have been misused.

First Choice Community Healthcare in Albuquerque, New Mexico, also had a data security incident that involved 101,541 patients. The PHI in the 27 March breach included names, Social Security numbers, patient ID numbers, medications, dates of service, diagnosis and treatment information, birth dates, health insurance information, medical record numbers, patient account numbers, and provider information. Again, there appears to be no misuse to date. HealthITSecurity

More health tech companies lay off staff.

  • Calm, one of those incessantly advertised (in US) meditation apps, is discharging 20% (90) staffers, at least 12 in marketing, according to a report in the Wall Street Journal (may be paywalled). From this Editor’s LinkedIn post in response to early reports:
    • Calm was strategically ‘off’ in spending. They overspent on direct to consumer–expensive TV spots on major networks and sponsorships, paid social and search. If you wanted Calm’s full features, you paid for them. Expensive meditation apps are merely a “nice to have” and there are a bunch of free ones available. 
    • There’s also too much app overlap and mistargeting out there. Calm was trying to sell the app to businesses as a benefit (ROTFL) but was hedging its bets with buying Ripple, which designs apps for care coordination and condition management (another crowded area).
    • Another sign–new sole CEO named this summer. Now sole CEO David Ko came from Ripple and the two Calm founders moved over to co-chair roles.
    • This is a company that raised well north of $200 million to become a $2 billion unicorn as early as 2019, another sign of too much cash, too soon, and VCs/equity investors following the fad. ‘Mindfulness’ became a fad as early as 2018.
  • Truepill is up to its third layoff–33% or 175 staff, including all UK staff plus much of the product and data teams.  Their cutbacks relate to multiple failures, the first in betting on ADHD controlled substances, the second in blowing through vast amounts of funding but unable to obtain more (a Series D of $142 million but unable to float a Series E). Truepill’s ADHD med bet fell apart with its relationship with Cerebral, now under Federal investigation [TTA 16 June]. As early as May, Truepill, Cerebral’s primary mail order provider, had stopped filling their prescriptions for Schedule 2 medications [TTA 1 June]. This follows on a June layoff of 15% or 150 people. Truepill had also expanded into telehealth and diagnostics, two areas which will only be lightly supported going forward. TechCrunch

Weekend news roundup: Teladoc adds to Primary360; Novartis, Medtronic support UK digital cardiac startups; Bluestream adds PrimaryOne Health; NoKo ransomware threatens healthcare; more Fed scrutiny on telehealth Rx, billed time may be coming

Teladoc had some positive news this week with additions to Primary360, its new primary care service for the provider/payer market. It added in-network referrals and care coordination capabilities, free, same-day prescription delivery from Capsule, and in-home, on-demand phlebotomy from Scarlet Health. The release notes that about half of patients fail to pick up their prescriptions. In addition, Priority Health, a nonprofit health benefits company serving Michigan, has added Primary360 to its fully insured virtual first plan design for employers. FierceHealthcare

Some good news from the UK in a time of government upheaval. Novartis is supporting cardiac digital health startups through the Novartis Biome UK Heart Health Catalyst 2022. This investor partnership is to identify and scale innovations for non-invasive lipid testing and at-home blood pressure testing using software as a medical device. Partners in support are Medtronic, RYSE Asset Management and Chelsea and Westminster Hospital NHS Foundation Trust and its official charity CW+. Successful applicants will receive support from partners during the competition process, the opportunity of investment up to £3 million provided by RYSE Asset Management, subject to due diligence at RYSE`s discretion, access to the Novartis Biome UK eco-system located in White City, and opportunities to work with our NHS partners to set up and deliver a pilot evaluation of the winning innovation. Applications must be in by 31 August–form is here. FierceBiotech

Bluestream Health adds PrimaryOne Health. Bluestream provides a white-labeled customized virtual care service that will be integrated into PrimaryOne’s services. This medical group of 11 community healthcare facilities across central Ohio serves 48,000 patients with primary care, OB-GYN, pediatric, vision, dental, behavioral health, nutrition, pharmacy, physical therapy, and specialty care.  Release

North Korea’s Maui Ransomware is no Hawaiian vacation. The threat has built enough since May 2021 for the Federal Bureau of Investigation (FBI), Cybersecurity and Infrastructure Security Agency (CISA), and the Department of the Treasury (Treasury) to release a joint Cybersecurity Advisory (CSA) on Thursday warning healthcare and public sector health organizations. It is state-sponsored North Korean malicious cyber activity. The CSA provides a sample of how it executes, what it targets, how it encrypts files, and how to respond. Hackermania, NoKo Style, is Running Wild with breaches piling up [TTA 7 July], and not only in healthcare. Healthcare Dive, Healthcare IT News

And in Dog Bites Man News, a former US assistant district attorney for Massachusetts predicts that Federal entities such as the Department of Justice (DOJ) may not stop with telemental prescribing. They will not only be ramping up their scrutiny of telemental health companies–but also telehealth billing. For Cerebral and Done Health that facilitate the prescribing of Schedule 2 drugs, this assumption of scrutiny has become a no-brainer. What it also is: a caution for mainstream telehealth providers such as Teladoc and Amwell charging into psychiatric telehealth.  But the former ADA, Miranda Hooker, now a health sciences area partner with Troutman Pepper in Boston, makes a broader prediction. Prosecuted telehealth fraud, as this Editor has noted, has grown in other areas, such as prescriptions for durable medical equipment (DME) billed to Medicare [TTA 6 May] and cardiologists moonlighting as Dr. Mabuse, Master Cybercriminal [TTA 19 May]. But the next frontier may be time-specified telehealth consults billed to Medicare under various CPT codes (e.g. 994XX). A 15-minute consult billed as a more lucrative 30-minute consult can be considered fraud. The Cerebral investigation, according to Hooker, marks a shift by the DOJ into investigating the actual provision of telehealth services and whether they are being billed properly. FierceHealthcare

Wednesday news roundup: PicnicHealth $60M Series C, can a downturn be good for digital health, Cerebral ran wild, a tart take on HIMSS and where it’s going

PicnicHealth had a bit of one, even in this down market. This company which uses machine learning to build data sets for life sciences by working directly with patients and giving them single-source access to their data raised a $60 million Series C via new investor B Capital Group, with existing investors Felicis Ventures and Amplify Partners. The new funding will be used to build 30 new patient-centered real-world data cohorts. Adam Seabrook, Partner at B Capital Group, will be joining the PicnicHealth board of directors. Their total raise to date is $97 million since 2014 (Crunchbase). The platform was launched in 2020. FierceBiotech, release

Funding news may be a little light nowadays, and if you’re public, you’re looking at double digit share price losses, but couldn’t you guess–the downturn may be good for digital health founders! That’s the view of Big VC General Catalyst’s Hemant Taneja, said at Collision 2022, a Toronto tech conference. Now before you’ve thought the man has totally gone out of his gourd with $5+ gallon gasoline (US), 10% inflation, and rolling blackouts looming on both coasts and the UK, it is true that businesses founded in downturns tend to be tough–my father’s business was founded at the start of the Great Depression. As Mr. Taneja put it, tighter times make for more mission-driven “better founders, better investors and better executives”. Secular trends are in their favor in tech and digital transformation, but there will be another correction coming as the market is over-capitalized. Is it the dot-com boom/bust all over again? Only time will tell, but the crackups are already piling up. FierceHealthcare

Speaking of crackups, Cerebral. A report in the annoyingly paywalled Business Insider tells a tale of Telemental Health Running Wild. Former employees and ~2,000 leaked documents claim that Cerebral had no more than a nodding acquaintance with clinical standards until the Feds stepped in. For starters, they took on patients they should not have, didn’t train their nurse-practitioners and other employees, pushed prescriptions to 95% of patients, disregarded state regulations putting licenses at risk, and generally had more twists than a barrel of pretzels. And this was a company prescribing Schedule 2 drugs that had at peak 210,000 active patients and 4,500 employees.  HISTalk summarizes the article, with our thanks. But it’s par for the course, according to a new JMIR (Journal of Medical Internet Research) study also mentioned that found that “many digital health companies have a low level of clinical robustness and do not make many claims as measured by regulatory filings, clinical trials, and public data shared online.” 

And returning to HISTalk (29 June news), there’s a group of comments from a “HIMSS insider” about how that organization is being managed that long-time observers of this organization will find interesting. Employees thought that HIMSS22 was “awkward”. New and cool conferences HLTH (which initially faltered) and ViVE (which HIMSS didn’t even bother to scout) have taken much of the ‘must attend’ and buzz away from HIMSS. Now this wasn’t supposed to happen with the buy of hipper Health 2.0, to which your Editor was connected–but H2O was HIMSS-ized and effectively killed off even before the pandemic. Regional conferences have disappeared, along with a fair number of employees. HIMSS Analytics is sold. Now this could be all one person’s opinion–but what do you think?

Thursday news roundup: FTC now investigating Cerebral, Balwani’s Theranos trial rests at last, Proscia pathology AI $37M Series C, health data breaches pile up

Telemental health Cerebral’s miseries pile on. The Federal Trade Commission (FTC) is now investigating Cerebral on deceptive advertising and marketing practices. The Wall Street Journal (may be paywalled) reviewed the 1 June letter sent to the company. The letter requests the usual preservation of documents and asks ‘dozens of questions’ related to their business. Of particular interest to the FTC is the ‘negative option’ practice that continues the subscription fee unless the subscriber takes positive action to cancel it. Subscribers have complained that Cerebral did not cancel their subscriptions after repeated attempts to do so and did not refund their money. Reuters, FierceHealthcare

Also of interest to the FTC will be the dodgy advertising claims about ADHD and obesity which ran on TikTok and Instagram [TTA 10 May]. The WSJ reported that their ad spend topped $65 million for this year–$13 million on TikTok alone from January to May this year, making Cerebral the third-largest advertiser behind HBO and Amazon, according to research firm Pathmatics.

The FTC action follows the Department of Justice (DOJ) investigation of their prescribing of controlled (Schedule 2, high potential for abuse) substances such as Adderall and Xanax, CVS and Walmart refusing their prescriptions, the unceremonious booting of the CEO and co-founder, and a wrongful dismissal lawsuit by a former VP of product and engineering, Matthew Truebe. Certainly, its investors led by SoftBank, which raised $300 million in December less than six months after a raise of $127 million, are unhappy at watching their $4.8 billion baby crash and burn.

The second “rerun” Theranos trial of Sunny Balwani rests. This much-muted trial is winding towards its close. Receiving much less breathless and near-sensational coverage than Elizabeth Holmes’, Theranos president Balwani was tried in the same San Jose Federal district court, with the same prosecutor (Robert Leach), just about the same charges (12 counts of wire fraud), and Judge Davila presiding. Holmes was convicted and her sentencing is scheduled for September.

The prosecution rested on 20 May and the defense on 9 June. The trial took some delays due to at least two jurors falling ill from Covid. The defense strategy rested on Holmes’ founding and operating the company without Balwani for a few years and that he never sold his shares, making him as victimized as any ordinary investor. The prosecution is relying on how close Holmes and Balwani were, that he had great power at Theranos–and used it, plus in his position was well aware of the problems with the lab machines and deliberately sought to defraud investors by covering it up. Unsurprisingly, Holmes did not testify at his trial, although she was a looming presence at his as he was somewhat at hers, especially in her testimony about their relationship. Closing arguments took place on Tuesday (14 June) and the jury will be charged after their conclusion. NBC Bay Area, New York Post, Wall Street Journal

Happier news comes from Proscia, a pathology software company, funding a $37 million Series C. Highline Capital Management, Triangle Peak Partners, and Alpha Intelligence Capital led the round along with participation from five earlier investors. Their total funding is up to $72 million. Their AI-enabled Concentriq platform combines “enterprise scalability with a broad portfolio of AI applications to accelerate breakthroughs and unlock clinical insights that advance precision medicine.” Clients include 10 of the top 20 pharmaceutical companies as well as the Joint Pathology Center, Proscia release, Becker’s 

Adding to the tally of healthcare data breaches are several this week. The year-to-date winner, of course, are the 2 million at Shields Health Care Group in Massachusetts [TTA 10 June], but this week, reports have been breaking out like late spring roses:

  •  A clinical guidance software vendor’s breach reported 10 June has exposed the protected health information (PHI) of patients at Omaha, Nebraska-based CHI Health and Sioux Falls, South Dakota based Avera Health. Avera has about 900 exposed patients, but the number at CHI is not yet known. MCG Health is the vendor. Becker’s
  • Yuma (Ariz.) Regional Medical Center reported an April ransomware attack that while short in duration, exposed PHI of 700,000 patients. An unauthorized user removed files from the hospital’s system that included patient health information such as names, social security numbers, health insurance information, and limited medical information relating to care. The hospital went offline until it was resolved, including reporting to law enforcement. Becker’s, Healthcare Dive
  • UChicago Medicine had its employee accounts hacked in March by an unauthorized user. It exposed about 2,500 patient records that included patient first and last names, social security numbers, health information, legacy Medicare beneficiary identification numbers, health insurance policy numbers, and driver’s license numbers. Becker’s
  • And Kaiser Foundation Health Plan of Washington had about 70,000 patient PHIs exposed on 5 April when an unauthorized user gained access to one employee’s emails with information on patient first and last names, dates of service, laboratory test information, and medical record numbers.

Short, but certainly not sweet, and expensive.

CVS, Walmart refuse Cerebral, Done Health controlled substance prescriptions via telehealth; Cerebral CEO replaced

More hot water dumped by CVS Health and Walmart on Cerebral, Done Health. The two retail giants announced last week that they would refuse to fill prescriptions of all controlled substances by telemental health providers Cerebral and Done Health. Cerebral was already under investigation by DOJ on over-prescribing of controlled substances by its provider network as a business practice, including advertising [TTA 10 May]. It turns out that seed-stage Done Health, a telemental provider specializing in ADHD diagnosis and support, is also facing the same scrutiny and treatment. 

Cerebral had already restricted prescribing controlled substance prescriptions for new ADHD patients as of 9 May. They initially continued to prescribe controlled substances for new patients diagnosed with other mental health conditions, according to a memo from their chief medical officer to their clinician network, but stopped that on 20 May with an exception for opioid use disorder. Truepill, Cerebral’s recommended mail order pharmacy, had stopped filling all Cerebral Schedule 2 prescriptions prior to that date. The CVS and Walmart refusals close off two more pharmacies for patients. FierceHealthcare

Earlier in the month, Cerebral CEO and co-founder Kyle Robertson was forced out by the Cerebral board. His replacement by medical officer and president Dave Mou, MD is effective immediately. According to reports, Robertson is fighting their action, calling it illegal and accusing the board of making him the scapegoat for the company’s problems. FierceHealthcare

Companies like Cerebral and Done grew quickly in 2020-21 due to the pandemic-driven loosening of psychiatric patient evaluations, eliminating the usual initial in-person initial visit and permitting online treatment. Restrictions were also loosened for diagnoses permitting the prescription of Schedule 2 drugs (those judged to have potential for abuse) with solely a video visit and follow up. With fast growth came more need to maintain that growth, according to current and former employees.  

Upon taking the CEO position, in an email to the prescriber team, Dr. Mou announced that patients on controlled substances would be transitioned as follows: a visit prior to 1 August to establish a treatment plan to transition to a non-controlled medication, titrating off of their controlled substance, or transferring their care to a local provider by 15 October. With the pandemic policies around telehealth ending soon, this is called playing defense, though it well may stop growth. Wall Street Journal, The Verge

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).