TTA’s Summer #1: Hims buys Zava for EU/UK, Omada’s IPO, Wojcicki tries harder to buy 23andMe, UnitedHealth’s miseries explored, Centene sued on AZ network, more!

5 June 2025

Warmer temps, warmer news, a little earlier this week. We lead with Hims & Hers buying with their free cash UK/Europe’s similar Zava. Omada rumored to go public on Friday or shortly thereafter, while Anne Wojcicki takes a last-ditch run at buying her bankrupt company with an unnamed backer. UnitedHealth’s miseries remain very much in the news, with other opinions at variance, but all agree it’s a deep hole they’ve dug. Nonetheless, UHG shareholders seem to have some confidence in their new CEO, but aren’t yet giving him combat pay. And a lawsuit against Centene in AZ uncovers inaccurate provider ‘ghost networks’.

This just in: Hims acquires Zava, adds 1.3 million European/UK telemed customers (A way to grow and defy the bears?)

Need to knows: Omada’s $158M IPO at flat valuation, AZ lawsuit on Centene plan’s ‘ghost network’ fatality, UHG shareholders OK reduced package for CEO Hemsley, new ASTP/HIT-ONC leader, NJ’s Cooper Health patient data breach, Net Health buys Limber Health (Omada listing up on Friday, possibly)

Anne Wojcicki asks 23andMe bankruptcy court to reopen bidding on 12 June with fresh offer (Why, Anne, why??)

Two other views on UnitedHealth Group’s annus horribilis, for your consideration (Going inside the black box)

From last week: Our big article this week is your Editor’s think-piece on breaking up UnitedHealth Group in order to save it–and healthcare. We also look at post-GLP-1 weight gain–and what it means for providers, in-person and telehealth, ‘soft’ robotics out of Scotland, NZ’s telehealth war with GPs, and what’s doing at companies like Midi Health, AssistIQ, Ambience, Auxira, and Yosi Health. And plenty of weekend reading and viewing!

Weekend reading/viewing (for me too): Rural telehealth blackouts and value-based care’s ‘utopia’ (Set aside the time)

Short takes: Midi Health’s longevity care for women covered by (some) insurance, NZ government 24/7 telehealth scored by GPs, Auxira tele-cardiology follow-up launches (Two disappointments that look like advances)

News roundup: GLP-1 weight regain real, soft robots walk off 3D printer, Ambience’s AI coding beats doctors by 27%, Get a Second Opinion debuts, $11.5M for AssistIQ (Reality bites GLP-1s and a soft robot wee bairn)

Job Posting: Yosi Health seeks Demand Generation Manager and Manager, Data Analytics & Reporting

Should free-falling UnitedHealth Group be broken up? Or break itself up to survive, before it becomes another GE? (updated) (Not a rant, more a ‘get going’ to avoid disaster!)

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

Telehealth & Telecare Aware – covering news on latest developments in telecare, telehealth and eHealth, worldwide.

Need to knows: Omada’s $158M IPO at flat valuation, AZ lawsuit on Centene plan’s ‘ghost network’ fatality, UHG shareholders OK reduced package for CEO Hemsley, new ASTP/HIT-ONC leader, NJ’s Cooper Health patient data breach, Net Health buys Limber Health

Omada Health nears a dip in the chilly IPO waters. Chronic care manager Omada Health started last week to road-show its long-anticipated public offering to interested investors. It’s been a long time in the making, with their first IPO S-1 filing back in October 2024.   Their 9 May SEC Form S-1 registration and preliminary prospectus, updated 29 May in their S-1/A, now reveals the extent of the offering–7.9 million shares. With an initial offering price of $18-$20/share, that is a raise of $142.2 to $158 million for OMDA (Nasdaq Global Market). The IPO may take place later this week, according to CNBC, with other sources saying Friday 6 June.

Morgan Stanley, Goldman Sachs & Co., and JP Morgan are acting as lead book-running managers for the proposed offering–a high-level crew for what was in the past a relatively small offering, but times have certainly changed with a dearth of IPOs continuing. 

Omada has raised $528.5 million through 11 rounds since the Ur-Health days of 2011, with a $192 million Series E in 2022 and the last round in 2023 an $80 million debt financing (Crunchbase). Investments came from major VCs such as Andreessen Horowitz, Fidelity, Norwest Venture Partners, Wellington Management, Intermountain, New Enterprise Associates, and Founder Collective. Their repositioning into ‘between-visit care model’ expanding from diabetes into obesity, hypertension, and MSK patients has met with success. With 2,000+ customers and over 679,000 total members enrolled in one or more programs, their 2024 revenue grew 38% from $122.8 million in 2023 to $169.8 million in 2025 , with Q1 2025 by 57% to $55.0 million from Q1 2024’s $35.1 million. Their prospectus revealed that they are closely tied to investor Cigna, with one health plan or PBM accounting for 31% of revenue, then a second health plan or PBM accounted for 29% of its revenue. according to FierceHealthcare. 

Unlike much-larger Hinge Health, Omada isn’t taking a valuation haircut, just a small trim when adjusted for inflation. The market capitalization versus valuation at its last letter raise is essentially flat: $1.1 billion versus $1.02 billion. Omada release, Mobihealthnews, Axios

Centene’s Health Net/Ambetter hit with ‘ghost network’ lawsuit on member fatality. Finding out that your provider isn’t in network is usually an annoyance, though it can be an expensive one. In this case, the consequences were fatal. 36-year-old Ravi Coutinho purchased an Affordable Care Act plan through Ambetter in 2023 and was being treated for mental health and addiction treatment in Phoenix. Both Coutinho and his mother, Barbara Webber, tried to find therapists who contracted with Arizona Ambetter who met Coutinho’s needs. Ambetter failed repeatedly, Coutinho’s condition deteriorated without care, and he was found dead in his apartment in 2023.

Ms. Webber filed a lawsuit last month in Maricopa County. Centene is accused of violating state and federal laws requiring network accuracy and adequacy, as well as negligence and fraud. Keeping provider networks current, especially in ACA plans, has been a known problem for years and under Congressional investigation. Studies from 2023 have indicated that 80% of provider listings contain inaccuracies, with only one-third of provider listings contacted by Senate subcommittee staffers were accurate. This is especially acute in mental health, with a shocking 3 in 4 insured adults who receive mental healthcare experience insurance problems, according to a 2023 survey (KFF). Health plans receive no incentives to keep their network listings current and accurate, though the ACA, state and other Federal laws such as the ‘No Surprises Act’ require plans to keep accurate lists of network providers. This also is not the first roundup on this issue for Centene’s plans. Healthcare Dive, FierceHealthPayer

UHG’s Stephen Hemsley will be seeing a pay cut, compared to his predecessor. UnitedHealth Group’s shareholders on Monday approved a compensation package for their new CEO. Mr. Hemsley will receive a base salary of $1 million per year. For stock options, he will receive only a one-time, $60 million equity award in nonqualified stock options with cliff vesting in three years. There will be no further awards for three years. It’s expected that Mr. Hemsley, 73, who was board chairman, will not remain CEO for the long term in this second round in the top spot. Another task he has is to find a leader who enjoys investor confidence–and who is capable of leading the company through what this Editor considers to be an inevitable change of model, likely a downsizing.

Shareholders are cutting the comp, not quite the 50% that the shares have fallen. This is considerably less than Sir Andrew Witty’s $26.3 million package for 2024, which was top of the pack from 2022 on. That year’s compensation started with a $1.5 million base salary, plus $17.25 million in stock options and $5.75 million in option awards. He also received $1.5 million in non-equity compensation plus ‘other’ of $339,000. Whether he will enjoy all of this based on 2024’s disappointing performance is not disclosed, as he resigned effective 13 May 2025 after Q1 results and a suspended forecast for 2025 were disclosed. Runner-up was Karen Lynch, who departed CVS Health last year but with a comp package of $23.4 million. FierceHealthcare 2 June, 12 May

Short takes:

The Trump Administration has named Thomas Keane, a software engineer and interventional radiologist, as Assistant Secretary for Technology Policy, formerly the Office of the National Coordinator for Health IT (ONC). According to his ASTP bio, Dr. Keane previously served in ASTP and also as a Senior Advisor to the Deputy Secretary of HHS. Among other duties, he was an administrator of the COVID-19 Provider Relief Fund and lead the development of the AHRQ National Nursing Home COVID Action Network. ASTP oversees Federal technology, data and artificial intelligence policy. More changes may be coming as Secretary Robert F. Kennedy Jr. will be reorganizing most areas of HHS. FedScoop, Healthcare Dive

Moving north to Camden, NJ, last March the Cooper Health system detected a data breach dating back to 2024. Personal health information (PHI) was apparently “accessed and acquired” without permission by an unknown actor around 14 May 2024. Abnormal network activity was noticed at the time and their systems were secured. However, the incident review which wrapped in March 2025 confirmed the PHI acquisition and Cooper has since notified the suspected individuals. Information accessed on individuals may include names, dates of birth, Social Security numbers, health insurance information, treatment information, medical record numbers. and medical history information. Mobihealthnews

Net Health acquires Limber Health. Net Health, a provider of specialized EHR software plus diagnostic and predictive analytics, including wound care and rehabilitation, is adding Limber Health’s MSK remote therapeutic monitoring and analytics to its platform. Acquisition cost was not disclosed but from the release at least some of the team will be transferring over to Net Health’s Pittsburgh team. Net Health is a 35-year-old portfolio company of The Carlyle Group, Level Equity, and Silversmith Capital Partners. Limber’s last raise was a $16 million Series A in October 2022 from Glenview Capital Management, Ironwood Ventures, and The Blue Venture Fund. (Crunchbase).  Release

Two other views on UnitedHealth Group’s annus horribilis, for your consideration

After this Editor’s call for breaking up UnitedHealth Group–two more views, for your consideration (as Rod Serling used to say before we entered ‘The Twilight Zone’).

MedCityNews examines The No Good, Very Bad Year for UnitedHealth. It’s a more, shall we say, measured view, than mine, though we plow many of the same furrows in UHG’s fertile ground. 

Additional points are made by the astute Ari Gottlieb (A2 Strategy, who had the best takes on both Cano and NeueHealth), the critical Robert Pearl, MD (formerly CEO of the Permanente Medical Group and presently a professor at Stanford University School of Medicine and Stanford Graduate School of Business), and Dr. Adam Brown (emergency physician and founder of healthcare advisory firm ABIG Health).

  • Mr. Gottleib focuses on UHG attributing its challenges to Medicare Advantage issues such as increased utilization. Yet other major insurers are stating they anticipated this and it’s trending about how they expected. He believes that UHG will manage their way out of this, much as (smaller, less complex) CVS Health apparently has, which was looking at a breakup in October 2024. But it will take time.
  • Dr. Pearl hits upon a point that I had not thought of, which is that UHG’s strategy was out of an old playbook that doesn’t work today:    “(to) become successful is you increase the medical loss ratio (MLR), by which I mean you lower the value, meaning that you invest less in actual care delivery. He (Witty) does that by a lot of prior authorization {denial}, a tremendous amount of claims denial.” In his view, UHG hasn’t moved beyond that nor is anticipating the future. In this Editor’s view, CFO John Rex’s 13 May statement of UHG’s challenges reinforces this ostrich-head-in-sand approach.
  • Finally, Dr. Brown’s fine point is taken (Editor’s emphasis): “I do believe it’s a bit of a reckoning where United, over the past several years, has been building an empire on Medicare Advantage and on vertical integration. And remember, Medicare Advantage is taxpayer dollars. … I think regulators, politicians — we see it even in a bipartisan manner — and of course patients are asking similar questions: Have we gone too far in vertical integration, and have we handed over too much of healthcare to one single entity?” He also sees them at risk due to scrutiny from the DOJ, FTC, HHS, and Congress, as well as public perception.

Takeaways: other insurers are challenged but UHG, for 40 years the best managed of the lot, is stumbling and falling into a hole of its own shoveling; it hasn’t moved beyond ‘squeezing the rock’ of MLR and reducing care delivery; vertical integration has gone too far; and it’s too much for one company.

A Substacker provides more quantification of the deep hole UHG has dug for itself in its endgame. And it’s damning. Published on 28 April before the Sir Andrew Witty resignation, and not read by this Editor before today, healthcare analyst Jeff Goldsmith on Substack analyzed the sudden end of, as he put it, UHG’s 40-year growth saga, from a primarily financial perspective. The bloom is not only off the rose, but it’s wilting. Some highlights from this Must-Read:

  • “The company is a $400 billion black box. The main United businesses-health insurance, care delivery, pharmacy benefits management and business intelligence/services–are so intertwined with one another that only United CFO John Rex and a few other senior managers actually know from whence United’s earnings actually flow.”
  • Two decades of growth were fueled by United buying other companies out of its astonishing cash flow ($3 billion per month!) 
  • They have literally run out of profitable or near-profitable companies, “accretive transactions”, to buy and add to Optum. They cannot buy other health plans without running into the antitrust buzzsaw. They can’t buy up many more physician groups as over one-third are owned by hospitals–and they are money losers (e.g. they wisely passed on Steward Health’s practices).
  • They sit on a swelling mountain of cash, which is starting to attract the Wrong Kind of Attention.
  • OptumHealth’s margin is shrinking. At seven years ago, a quarter of its present size, its margins were 10%. They are now 25% less. It also bought high-quality practice groups like Kelsey Seybold that had profitable contracts with competitors like state Blues’ Medicare Advantage or their own plans (Kelsey)–which aren’t so profitable anymore.
  • OptumInsight was decimated by hasty acquisitions–Equian, Change Healthcare, and naviHealth. It went from a 28% margin business to 16.5%. (Change Healthcare alone was responsible for a $2.9 billion loss.)
  • Then Change’s ransomwaring and hacking proved that UHG was negligent in running that type of business. As stated before in writing about Change, UHG did not do its due diligence on the only partly digested meal-via-acquisition that Change really was, nor spent the two years before the cyberattack reviewing and hardening Change’s systems. His conclusion–United can’t run that type of business competently. (Too true of ‘black boxes’)

He also returns to the brutality of UHG’s ‘denial machine’ of AI-driven claims and prior authorizations, killing them not only politically but also in a research metric commonly used to rate plans. United has a minus 12 ‘net promoter’ score, which is as bad as it sounds.

It confirms that no one except perhaps (!) at the C-level really had their arms around all of UHG’s businesses. The facts are far more than inconvenient, more like damning. While the tide was lifting all the boats, it was keen and peachy. But when the end hits the fan…will one of the strategy’s architects, Stephen Hemsley, try to save it whole or dismantle it?  Hat tip to Matthew Holt via LinkedIn.

TTA’s Unofficial Summer kickoff: breaking up UnitedHealth to save it, post-GLP-1 weight gain, soft robots, NZ telehealth controversy, Midi Health widening women’s health, AssistIQ, Ambience, more!

30 May 2025

Brrrr….it’s unofficially summer as we leave May behind. Our big article this week is your Editor’s think-piece on breaking up UnitedHealth Group in order to save it–and healthcare. We also look at post-GLP-1 weight gain–and what it means for providers, in-person and telehealth, ‘soft’ robotics out of Scotland, NZ’s telehealth war with GPs, and what’s doing at companies like Midi Health, AssistIQ, Ambience, Auxira, and Yosi Health. And plenty of weekend reading and viewing!

Weekend reading/viewing (for me too): Rural telehealth blackouts and value-based care’s ‘utopia’ (Set aside the time)

Short takes: Midi Health’s longevity care for women covered by (some) insurance, NZ government 24/7 telehealth scored by GPs, Auxira tele-cardiology follow-up launches (Two disappointments that look like advances)

News roundup: GLP-1 weight regain real, soft robots walk off 3D printer, Ambience’s AI coding beats doctors by 27%, Get a Second Opinion debuts, $11.5M for AssistIQ (Reality bites GLP-1s and a soft robot wee bairn)

Job Posting: Yosi Health seeks Demand Generation Manager and Manager, Data Analytics & Reporting

Should free-falling UnitedHealth Group be broken up? Or break itself up to survive, before it becomes another GE? (updated) (Not a rant, more a ‘get going’ to avoid disaster!)

From last week: The major news the week before US Memorial Day was the Hinge Health IPO, the first for digital health in two years–but the downside was that it was at a lower valuation. Denouements abounded with most 23andMe genetic assets bought by Regeneron, without a drink of Lemonaid. WeightWatchers’ time may have passed, new heads for Calibrate and Oak Street, and two more ‘arranged marriages’, Smarter Technologies and Fuze Health. An update on the VA EHRM in the budget. Masimo’s recovering, as is Ted of Strata-gee

News roundup 22 May: an inflight ‘save’ and AliveCor’s KardiaMobile, rolling out the VA/Oracle EHR in ‘waves’, Fuze Health formed from LetsGetChecked/Truepill, hacking and ransomware 92% of PHI data breaches (A renaming of a 2024 ‘arranged marriage’–can it be saved?)

News roundup: Hinge Health public @$32/share, lower valuation. Is WeightWatchers game over? Calibrate replaces CEO, new prez for Oak Street, NMC gets ‘Smarter’ rolling up 3 portfolio companies, another splash of investor ‘cold water’ (The first health tech IPO in 2 years and ‘smushing’ when they can’t)

Update: Masimo’s website status and an analysis of the Sound United sale (Getting up and running post-attack, but what happened?)

23andMe sold to Regeneron for $256M in court-supervised bankruptcy, sans Lemonaid. And is it worth it? (We come up with a number, it’s likely)

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Advertise on Telehealth and Telecare Aware
Support not only a publication but also a well-informed international community.

Contact Editor Donna for more information.

Help Spread the News

Please tell your colleagues about this free 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

Telehealth & Telecare Aware – covering news on latest developments in telecare, telehealth and eHealth, worldwide.

Should free-falling UnitedHealth Group be broken up? Or break itself up to survive, before it becomes another GE? (updated)

Breaking up is hard to do. But should be done if UHG wants to survive and thrive.

Our proposition: UnitedHealth Group has become a victim of its own giantism, conflicts, and focus on financials–and its failure will drag down healthcare.

How big? By far, it is the largest US health insurance company based on 2023 enrollments with a 15% market share, 29 million members, and $371.6 billion in revenue. It leads by far Elevance Health (formerly Anthem, 12%), CVS Health/Aetna (12%), Cigna (11%) and Health Care Service Corporation (7%). A more realistic picture of its size is that it is now is the US’ fourth-largest firm by revenues, just behind Walmart, Amazon, and Apple. (Visual Capitalist 17 Dec 2024, based on American Medical Association data). Their growth has been led by acquisition into Optum, their health services division. It houses their owned physician practices as the largest owner of practices in the US with 90,000 physicians, their ACO relationships, data analytics, Change Healthcare, the largest billing and claims management company, home care/hospice, the third largest PBM Optum Rx, a venture investment arm, and much more. Optum is the massive symbol of the integration envisioned by former and current CEO Stephen (Steve) Hemsley. Other health plan companies have health services units, for instance PBMs–CVS has Caremark and Cigna Express Scripts, both larger than OptumRx, and analytics–but not to the vertical and horizontal integration depth and extent of UHG’s continuing search for revenue and profit.

The road this vision took under Mr. Hemsley and later Sir Andrew Witty took diversions along the way that have escalated into a cadence of legal troubles, a near-perfect storm of corporate misery, that have damaged them among customers, shareholders, and regulators. A list of the recent highlights (bold type links are new information; standard type links refer to earlier TTA articles):

  • The contentious two-year-long purchase for an eye-blinking $7.8 billion or $13 billion of Change Healthcare that finally closed in 2022. While opposed by the Department of Justice (DOJ), the District Court disagreed and said it wasn’t anti-competitive or prevented competitive entry. 
  • Change Healthcare was a House That Jack Built that collapsed spectacularly in February 2024 with the ALPH-V/BlackCat ransomware attack. It was evident that Optum didn’t conduct basic due diligence on Change Healthcare’s multiple systems, built up over multiple acquisitions, nor set to work fixing them after the closing, leaving the largest claims/payment system vulnerable. UHG’s response managed to anger patients, providers, and HHS. It took Optum most of 2024 to fix it at a loss of at least $2.3 billion
  • DOJ has been investigating certain relationships between the company’s UnitedHealthcare insurance unit and its Optum services unit, specifically around Optum’s ownership of physician groups. This started in March 2024.
  • The $3.3 billion acquisition of Amedisys home health has taken over two years (since June 2023) and has taken multiple rounds of divestitures–and still DOJ is grinding its Paul Bunyan-sized ax against it, filing their suit in Maryland along with four state attorneys general in November 2024.
  • DOJ’s insider trading investigations may have started as early as October 2023. The $300 million Hollywood (Florida) Firefighters Pension Fund filed a class action lawsuit in mid-December 2024 alleging that the sales were made while the Department of Justice (DOJ) was considering an anti-trust action against UHG that would revisit the so-called ‘firewall’ between it and Change Healthcare. Named in the lawsuit were Brian Thompson, head of UnitedHealthcare, Andrew Witty, and Steve Hemsley. (Sir Andrew resigned from UHG’s board effective 20 May, Becker’s and SEC Form 8-K)
  • DOJ is reportedly investigating UHG for criminal Medicare Advantage fraud, according to the WSJ earlier this month, reported in HealthcareFinance.
  • The latest accusation: kickbacks to nursing homes to reduce patient transfers to hospitals and thus costs, based on an investigative report from the UK Guardian reported in FierceHealthcare last week.

The Brian Thompson assassination earlier in December uncapped a boiling volcano of resentment against the health care system that crossed political lines, then focused on UHG itself and its claims treatment. Next it revealed something that UHG undoubtedly didn’t want known–that UHG’s AI-powered claims review system had a 33% rate of claims denial on marketplace plans across 20 states, the second highest in the US (first was BCBS Alabama, a single-state plan) (KFF). This eruption unleashed a tsunami of heartrending social media stories of denied care and approved then denied care by UnitedHealthcare, including one for a patient delivered to a surgeon post-operation.

  • Instead of examining their methods, UH doubled down on featuring ever-so-trendy AI. Revealed recently to the WSJ, half of their 1,000 + AI-powered apps use generative AI and the remainder a more “traditional” form, without explanation of “traditional” according to chief digital and technology officer Sandeep Dadlani, Their software, not necessarily AI-powered but usually rules-based or using algorithms, ‘auto adjudicate’ 90% of UHG claims. And this wasn’t new. UHG was sued in Federal Court as far back as 2023 in using an AI-powered application to evaluate and deny claims.

This is above and beyond the business conditions that have affected every insurer: high utilization costs resulting from accelerated care activity, more (and more expensive) benefit offerings, and higher costs associated with Medicare Advantage beneficiaries, along with a minor reduction in MA benchmark rates.

One healthcare observer’s–and marketer’s–opinion, drawn from her experience not only in healthcare but also outside it.

UHG has pursued profit and growth to justify an immense share price and return to its shareholders. It has become unmoored from its business customers, instead trapped in an ever-widening gyre of increasing its revenue, profit, share price, and dividend every quarter, every year, to satisfy investors. It remains profitable, yet its share price has collapsed from over $600 on 3 December 2024–the day before the Thompson murder–to $378 on 12 May, the day prior to Witty’s resignation, to today’s close of $295. This is despite massive share purchases by Mr. Hemsley and other UHG executives, presumably to demonstrate confidence. Last week, three major investment banks downgraded their recommendations on UHG.

It’s time to sell off businesses and refocus on either being an insurer or being a healthcare services company. Not both. 

  • If UHG chooses to be an insurer, refocus on a service mission, not the shareholders. Respect their members (and commercial businesses) who pay the premiums. Focus on member health, first preventative, then managing chronic care. Stop treating patients and providers as always trying to game the system or grift them. People depend on insurance at the time of need, when they are sick, and treatment is complicated. Make it easier for both members and their providers.
    • Bring back humans evaluating prior authorizations and claim approvals–and get better tools with a final review by humans. Treat providers in and out of network better.
    • Get back to being the insurer of choice for individuals and groups. Contract for the services you need, not own them and try to manage them too. UHG would not be the first insurer who has faced this–both Molina and Centene have divested all or many of their service businesses.
  • If UHG chooses to be Optum, it needs to focus on their services and how well they integrate. Divorcing Optum from UnitedHealthcare resolves a lot of conflicts around interest but there are still others.
    • Owning and controlling practices creates multiple conflicts and a closed system. The feedback from doctors in Optum-owned practices that this Editor has seen is that they are micro-managed down to the penny, escalating administrative costs and taking focus from patient care. Optum practice locations that this Editor has seen have a ‘bad look’–underused, often repurposed locations.
    • Abandon the Amedisys acquisition and rethink (or spin off) the entire home care business for the same reason as owning practices.
    • Refocus their ACOs from ‘captives’ to management services provisioning that more naturally integrates with Optum services–or get out of the business.
    • Expand analytics into providing the best and most convenient tools for hospital and practice management, which likely will require some acquisitions.
    • Optum Rx is facing its own challenges from new competitors and eroding market share–and simplification can help management focus on it. If Change Healthcare is kept, rework and reform how they process and pay claims across healthcare; harden it against the cyberattack/ransomware that cost the economy and healthcare billions. Optum Ventures and its role should also be examined for conflicts with the main business.

UHG is a company now demonstrating the end stage of integration: too many complex parts, too much administration needed to keep the juggernaut going, too many inherent conflicts, no central theme, too little focus, culminating in failure to customers and shareholders. It has become toxic in reputation to its own members, providers, and to businesses who sign commercial contracts. It’s become a falling knife, a rolling failure such as GE before its breakup or (returning to my airline days) Texas Air Corporation, once the world’s largest airline holding company. Unlike GE or TAC, UHG’s business size and outsized vertical integration choking off alternatives have created multiple situations, such as Change Healthcare’s failure, which can damage the entire healthcare system. It’s time that their new CEO and their C-levels sit down and have a long think about what their future, and the future of their role in being a healthcare leader, should be. Think…smaller.

Update 28 May: The American Hospital Association (AHA) has also provided comments to the Trump Administration, DOJ, and FTC, as part of the administration’s 10:1 deregulation initiative*, addressing payer vertical integration and its effects on providers. Payer control, concentrated among four payers that control half the market (UnitedHealth, Elevance, Aetna, Cigna) , far outstrip those of health systems, and have led to higher premiums and constraints on care. The AHA is demanding review of regulations within the Affordable Care Act (ACA) that permit insurers to circumvent medical loss ratio (MLR) requirements through high-priced practice acquisitions yet enjoy exclusions in the Stark Law (physician self-referral) that health systems cannot. Their comments also included simplification of prior authorization processes and other utilization management practices, and swiped at the increased Premarket Notification process for M&A, something that the new administration is already reviewing. FierceHealthcare published 27 May.

*For every new regulation passed, canning 10 rules, regulations or guidance documents

TTA’s Blooming Spring 4: UnitedHealth’s CEO change doesn’t stop market pummeling, Omada’s IPO, Theranos redux, Holmes loses appeal, Synchron BCI and Apple, exec security cost, raises, more!

 

16 May 2025

One after another surprise this week. UnitedHealth Group changed out CEOs suddenly. The new one is a surprising ‘blast from the profitable past’ but that didn’t stop Mr. Market from taking the stock down down down. Another blast involves Elizabeth Holmes’ partner Billy Evans fronting a diagnostic testing-in-a-box startup. “Surprise, surprise!” No surprise that Holmes lost her appeal of an appeal–nor Omada Health filing for an IPO. Unfortunately, our investigator on all things Masimo met his own surprise walking on a sunny day–fortunately, Ted’s on the mend. More about BCIs with Apple integration, a chronic pain management startup, Parkinson’s data, two good raises, and what payers pay to keep their execs safe.

Short takes: Synchron BCI integrates with Apple devices, Shields Health partners with Duke on specialty pharmacy, raises for Cohere Health, Olio (More BCI action with Apple getting into it)

Theranos’ revenge? Holmes’ partner Billy Evans founds a startup for diagnostic testing, denies it is ‘Theranos 2.0’; Holmes loses Federal rehearing appeal. (Is Holmes advising long distance? Letters from a Texas Jail?)

News roundup: Omada Health files for IPO, UPMC-Redesign partner on chronic pain management, OK and PA AGs warn 23andMe users to delete data, Verily to build Parkinson’s dataset, what payers paid for exec security (Omada follows Hinge. But the last is surprising–between a lot and a little)

This just in: UnitedHealth Group CEO Andrew Witty steps down immediately, replaced by former CEO Stephen Hemsley (updated 15 May) (UHG may change out CEOs, but continues to be hammered by Mr. Market)

Best wishes to Strata-gee’s Ted Green on a fast recovery! (Ted, our ace Masimo investigator, was put rather suddenly in a bad place…use your eyes when you drive!)

From last week: This week’s drama was all about Masimo, developing literally as this Editor was writing. Their website outage was revealed to be from a cyberattack that took down nearly all their systems. Not good for a monitoring/tech company. But their good news was that they sold Sound United to Samsung–2/3rds off. The others deserving of more attention are Neuralink’s successful BCI implant in an ALS subject and UHG’s 1,000 app bet on AI. Not so dramatic: WeightWatchers’ prepackaged, quick bankruptcy, the NIH/CMS autism data project, and Amedisys divesting to salvage their UHG sale. 

Short takes: HHS forms NIH/CMS autism data project; Oscar Health beats Street w/Q1 $275M net; Centene’s $1.3B earnings; UHG has class action suit on earnings, 1K AI apps in production; Cedars-Sinai and Redesign Health partner on development; FDA, Lilly, Novo Nordisk win vs. compounders (Big step forward for autism research)

News roundup: WeightWatchers in 45-day prepackaged Ch. 11, Neuralink BCI successful in ALS subject, telehealth VR reduced TMD pain–study, AliveCor maxes up KardiaMobile 6L, TytoCare-Allina Health partnership, UHG-Amedisys divest some more (WW losing runway, a Neuralink win, Amedisys divesting to save their two-year-old UHG deal)

Breaking–Masimo Mystery SOLVED–cyberattack, website down for days, new websites up–and where’s the public explanations? Sound United sold. (Another cleanup on Aisle 10–the Sound United albatross flies off)

Holding this over: The weekend read: why SPACs came, went, and failed in digital health–the Halle Tecco analysis/memorial service; why OpenAI is going to be a bad, bad business (Grab the cuppa and lunch for a good read and podcast. Updated–Also Tecco’s blog post on why she quit being an angel investor.) 

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Telehealth & Telecare Aware – covering news on latest developments in telecare, telehealth and eHealth, worldwide.

This just in: UnitedHealth Group CEO Andrew Witty steps down immediately, replaced by former CEO Stephen Hemsley (updated 15 May)

This was drastic. This morning (13 May), UnitedHealth Group announced that CEO Andrew Witty is stepping down immediately “for personal reasons” which are not specified. Replacing him is former (2006-2017) Stephen (Steve) Hemsley, who will remain chairman of UHG’s board of directors. Mr. Witty has been named as “senior adviser to Hemsley” which is a typical resignation/separation workout for CEO/president departures, indicating continuity to soften the immediacy of the change.

The quotes in the release are also typical of these ‘friendly’ transitions. Mr. Witty:  “Leading the people of UnitedHealth Group has been a tremendous honor as they work every day to improve the health system, and they will continue to inspire me.”  Mr. Hemsley: “We are grateful for Andrew’s stewardship of UnitedHealth Group, especially during some of the most challenging times any company has ever faced. The Board and I have greatly valued his leadership and compassion as chief executive and as a director and wish him and his family the best.

Mr. Hemsley is 72. There is no mention in the release that he is interim or of an executive search.

Sir Andrew Witty, aged 60, is British, knighted in 2012 for his leadership of GlaxoSmithKline. He became CEO of UHG in February 2021 after three years as Optum CEO starting in 2018. Previously, he was CEO of GSK from 2008 to 2017. Witty led the National Health Service’s Accelerated Access Collaborative for a year after, 2017-2018, and had been chancellor of the University of Nottingham while heading GSK 2013-2017. Certainly he experienced many challenges during his UHG/Optum tenure that accelerated in the past two years: the Covid pandemic, the assassination of Brian Thompson, Change Healthcare’s massive cyberattack that disrupted the entire provider payment structure for months and exposed patient data, and the continuing Federal opposition to the Amedisys home health buy. Notably, Witty was one of the pioneers aggressively pursuing the ‘payvider’ structure. According to STAT News, by 2024 almost 10% or 90,000 US physicians were affiliated with Optum, either via 10,000 owned practices, or 80,000 affiliated through various value-based care arrangements.

At 8am EDT, UHG held an investor call, so there will be developing news from it. At the very bottom of the release is that UHG has now suspended its revised its 2025 outlook due to high utilization costs: accelerated care activity, more benefit offerings, and higher costs associated with Medicare Advantage beneficiaries. These primarily affect the UnitedHealthcare unit but also have knock-on affects on the non-insurance business (25% of the company) that presumably Mr. Hemsley and company are calculating. Also FierceHealthPayer

An exceedingly tart take on Mr. Witty’s tenure at UHG was posted today by Sergei Polevikov today in his ‘AI Health Uncut’ Substack, ‘UnitedHealth Bleeds, CEO Witty Steps Down’. In his view, Witty left a trail of damage during his tenure that includes far more than my challenges above, that include discrimination, claims denials, class action lawsuits around earnings manipulations, and the ever-popular insider trading–but UHG always seems to get away with minimal damage. Till today. UHG stock closed down today (Tuesday 13 May) 22% from its price on Monday.

A thought among many is that UHG should be broken up as a healthcare monopoly–the end game of integration. That seems to be a lead taken by Substack commenters and on other social media. MedCityNews takes a look at the impact today. And almost as an aside–what will be the future of top management identified as part of the Witty tenure? Exits done with prejudice at the top are usually the start.

Update 15 May: This Editor underestimated Mr. Market’s continued agita. The share price of UnitedHealth Group (UNH) has gone from one month ago at $585 (16 April 4pm close) to 11:07am today (15 May) at $258 and change. That is a slide of 56%. What is worse is since that the CEO changeover was announced on Tuesday, the price has continued to slide from $311 to today, a 17% drop. The management change did not stabilize the price even in a bouncy market. For some reason unknown to the general audience and certainly to us chickens, UNH is being pummelled. Hard. We will see what happens next week.

TTA’s Blooming Spring 3: Masimo’s cyberattack takes it down, WW’s Chapter 11, Neuralink’s ALS success, UHG’s 1K bet on AI apps, NIH/CMS autism data project, a look at payer earnings, more!

9 May 2025

This week’s drama was all about Masimo, developing literally as this Editor was writing. Their website outage was revealed to be from a cyberattack that took down nearly all their systems. Not good for a monitoring/tech company. But their good news was that they sold Sound United to Samsung–2/3rds off. The others deserving of more attention are Neuralink’s successful BCI implant in an ALS subject and UHG’s 1,000 app bet on AI. Not so dramatic: WeightWatchers’ prepackaged, quick bankruptcy, the NIH/CMS autism data project, and Amedisys divesting to salvage their UHG sale. 

Short takes: HHS forms NIH/CMS autism data project; Oscar Health beats Street w/Q1 $275M net; Centene’s $1.3B earnings; UHG has class action suit on earnings, 1K AI apps in production; Cedars-Sinai and Redesign Health partner on development; FDA, Lilly, Novo Nordisk win vs. compounders (Big step forward for autism research)

News roundup: WeightWatchers in 45-day prepackaged Ch. 11, Neuralink BCI successful in ALS subject, telehealth VR reduced TMD pain–study, AliveCor maxes up KardiaMobile 6L, TytoCare-Allina Health partnership, UHG-Amedisys divest some more (WW losing runway, a Neuralink win, Amedisys divesting to save their two-year-old UHG deal)

Breaking–Masimo Mystery SOLVED–cyberattack, website down for days, new websites up–and where’s the public explanations? Sound United sold. (Another cleanup on Aisle 10–the Sound United albatross flys off)

From last week: Cherry blossoms are starting to fall, much like Teladoc’s revenue for Q1 in our lead story. Can their acquisition of a small virtual mental health provider with insurance coverage help turn around BetterHelp? And what about their main business? Novo Nordisk would rather partner than fight with teleprescribers Hims & Hers, Ro, and LifeMD for GLP-1 Wegovy–will this be a trend? Commure adds to its ‘house that Jack built’ tech stack with a HealthTap partnership. And Masimo’s latest episode of its ongoing soap opera is that its former CEO (and major shareholder) is claiming ownership of shares as part of his severance–but they haven’t been granted and very much in dispute. (Irony alert: they’ve increased in value since his departure!)

This just in: Teladoc acquires UpLift for $30M, bolstering struggling BetterHelp telemental health; Q1 revenue down 3% (Can this telemental health be saved with one acquisition?)

News roundup: Hims, Ro, LifeMD and Novo Nordisk partner on Wegovy prescribing (updated); Commure partners with HealthTap for virtual care after hours; WebMD Ignite adds texting to member health ed; hellocare.ai raises $47M for virtual nursing  (When you can’t beat ’em in weight loss meds, join ’em. With a side of Commure’s interesting M.O. on acquisitions.)

Masimo updates: former CEO Kiani claims 13.2% ownership, and a review of the new management’s style (updated) (The soap opera continues)

Holding this over: The weekend read: why SPACs came, went, and failed in digital health–the Halle Tecco analysis/memorial service; why OpenAI is going to be a bad, bad business (Grab the cuppa and lunch for a good read and podcast. Updated–Also Tecco’s blog post on why she quit being an angel investor.) 

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Donna Cusano, Editor In Chief
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Telehealth & Telecare Aware – covering news on latest developments in telecare, telehealth and eHealth, worldwide.

Short takes: HHS forms NIH/CMS autism data project; Oscar Health beats Street w/Q1 $275M net; Centene’s $1.3B earnings; UHG has class action suit on earnings, 1K AI apps in production; Cedars-Sinai and Redesign Health partner on development; FDA, Lilly, Novo Nordisk win vs. compounders

NIH, CMS to create autism data platform to enable research. The National Institutes of Health (NIH) and the Centers for Medicare & Medicaid Services (CMS), both under Health & Human Services (HHS), are partnering to enable NIH to build a real-world data platform. The purpose is to advance research around the root causes of autism spectrum disorder (ASD) that now affects 1 in 31 US children, according to HHS. The data gathered include claims data, electronic medical records, and consumer wearables focused on Medicare and Medicaid enrollees with a diagnosis of ASD. The first step establishes a data use agreement under CMS’ Research Data Disclosure Program.

Researchers will focus on autism diagnosis trends over time, health outcomes from specific medical and behavioral interventions, access to care and disparities by demographics and geography, plus the economic burden on families and healthcare systems.

The pilot program, intended to be a model for other conditions, will create a secure tech-enabled mechanism to enhance data sharing with timely, privacy and security compliant data exchange.  HHS release, FierceHealthcare

Payers, other than UnitedHealth, had an upbeat Q1.

  • Oscar Health, the feisty provider of ACA exchange individual and small group plans, notched a Q1 net income of $275 million with adjusted EBITDA of $329 million on revenue of $3 billion, up 42% from Q1 2024. Membership exceeded 2 million, up 41% from prior year. The ever-feisty CEO Mark Bertolini (center) railed on the earnings call against a shortened Federal enrollment period cutting off at 15 December versus January, as well as other enrollment changes. Oscar release, FierceHealthcare
  • Centene Corporation, one of the main rivals to UnitedHealth Group and a significant player in Medicaid state plans, had a decent Q1 turnaround with $1.3 billion in earnings and a  17% jump in premium and service revenues to $42.5 billion from $36.3 billion in Q1 2024. Their current membership versus Q1 prior year was down about 500,000 with the losses in Medicaid and traditional Medicare. They also increased their 2025 premium and service revenues guidance range by $6.0 billion to a range of $164.0 billion to $166.0 billion due to ACA exchange plans and Medicare Advantage (MA) revenue forecast performance. However, it’s projected by analysts that Centene will exit the Medicare Advantage market after this year in Alabama, Massachusetts, New Hampshire, New Mexico, Rhode Island and Vermont–about 3% of MA membership. CEO Sarah London criticized proposed cuts to Medicaid. Centene release, HealthcareFinance
  • UnitedHealth Group, after an anemic Q1 financial report driven by increased utilization and rising costs, cut its 2025 earnings per share (EPS) guidance by 12% to between $26 and $26.50 (Healthcare Dive). This just in: a shareholder group filed in Federal Court in the Southern District of New York on violations of securities laws affecting share price. It centers on the 2025 financial guidance provided prior to Brian Thompson’s assassination and how group CEO Andrew Witty did not account for: 1) the impact of that act but doubled down on the EPS forecast, 2) the increased scrutiny around the company for denials of claims even prior to the act, and 3) the general ill will generated as more information reached the general public. The affected group are those shareholders purchasing UHG stock between 3 December 2024 and 16 April 2025. Healthcare Dive, SDNY filing
  • Meanwhile, UHG has doubled down on AI development, totaling over 1,000 apps. According to a report in the Wall Street Journal, the company has these apps in production in their health delivery and pharmacy units, transcribing conversations from clinician visits, summarizing data, helping process claims, powering customer-facing chatbots, and in engineering to write software. According to chief digital and technology officer Sandeep Dadlani, half of the apps use generative AI and the remainder a more “traditional” form, without explanation of “traditional”. According to Dadlani in the article, “AI has a role to play in the claims evaluation process, but it will never be allowed to deny a claim”. Software, not necessarily AI powered but usually rules-based or using algorithms, ‘auto adjudicate’ 90% of UHG claims. UHG was sued in Federal Court as far back as 2023 in using an AI-powered application to evaluate and deny claims.

Redesign Health gets freshened up with a Cedars-Sinai partnership. Redesign Health is a combination funder and company builder which has launched over 60 healthcare-related companies, some clear successes such as Calibrate (weight loss) and Jasper Health (cancer care navigation), with others on the development curve such as Vault Health and Uptiv Health. They announced a partnership with the Cedars-Sinai health system in Los Angeles to add their clinical expertise and innovative research. Other strategic value additions through the new partnership are tapping into funding support, access to clinical environments within Cedars-Sinai’s network, and their dataset for validation of technologies and design. Redesign release

And in the pharma compounders versus Big Pharma war, the former have lost two battles. The compounder’s trade group, the Outsourcing Facilities Association (OFA), had separate lawsuits filed in Texas to force the FDA to reclassify both tirzepatide and semaglutide as still in shortage, which would permit compounding pharmacies to produce weight loss drugs with these active ingredients. The Texas judge found yesterday (7 May) for both FDA and Eli Lilly, the producer of Zepbound, that tirzepatide was no longer in shortage, which closed the door on the OFA. At the end of April, the same Federal judge ruled against the continued compounding of semaglutide, the active drug in Novo Nordisk’s Wegovy and Ozempic [TTA 27 Feb]. 22 May is the end date for the large compounding pharmacies for semaglutide, while smaller state-based compounders must cease immediately. Biospace 8 May, 25 April  Novo Nordisk’s new partnerships for Wegovy-based weight loss prescribing: TTA 1 May, 8 May

News roundup: WeightWatchers in 45-day prepackaged Ch. 11, Neuralink BCI successful in ALS subject, telehealth VR reduced TMD pain–study, AliveCor maxes up KardiaMobile 6L, TytoCare-Allina Health partnership, UHG-Amedisys divest some more

WeightWatchers (WW) unburdens itself of debt in a prepackaged Chapter 11 bankruptcy. The reorganization under the bankruptcy filed yesterday in the US Bankruptcy Court for the District of Delaware will take $1.15 billion of a total $1.62 billion (as of March 2025) in debt off their books while providing it with enough capital to reemerge in an estimated 45 days or around 1 July, or less. The Chapter 11 plan retains $175 million from their revolving credit facility, reduces its annual interest payments by $50 million, and extends their debt maturity dates. With bankruptcy court approval, their lenders receive new secured debt and equity. In the company statement, CEO Tara Comonte expressed confidence about WW’s future:  “The decisive actions we’re taking today, with the overwhelming support of our lenders and noteholders, will give us the flexibility to accelerate innovation, reinvest in our members, and lead with authority in a rapidly evolving weight management landscape.” The first day hearing is on 8 May. WW release, Kroll case information

WW entered the GLP-1 prescription weight loss drug race relatively late, last October, with compounding semaglutide, which boosted their fortunes for a time. They acquired telehealth provider/clinical weight manager Sequence in mid-2023 [TTA 2 Mar 2023], then formed the WeightWatchers Clinic program by December [TTA 21 Dec 2024] Results this year were projected at 140-160,000 subscribers. But that was not enough to correct WW’s problems, which were a profound loss of total subscribers: in Q1 2025 3.4 million subscribers versus 4 million in Q1 2024, with 2.8 million of them. Stock had traded on Nasdaq for some months below $1, with today’s trading below $0.50. Shares had lost 71.9% over the past 12 months, making it a (money) loss for nearly all common stock holders. Morningstar

The (physical) weight loss segment now dominated by Hims & Hers, Ro, LifeMD–now with prescription deals for Novo Nordisk’s Wegovyand other telehealth providers and teleprescribers such as Teladoc, FuturHealth, RemedyMeds, Eden, and many others, made WW a latecomer. Even CVS Caremark got into the partnering act when it switched over to Wegovy from Lilly’s Zepbound in its standard formulary. This move may lure more members to its weight management program. As with Ro and LifeMD, the lowered cash pricing is $499/month. Healthcare Dive. For WW, is this a lasting cure or just kicking the can down the floor?

Brain-computer interfaces (BCI) notch a big win. At the end of April, Neuralink confirmed its third successful implant, this one in an ALS patient, Brad Smith. The disease rendered him non-verbal, on a ventilator, and paralyzed below the shoulders. With the Neuralink brain implant, about the size of five quarters, he can now communicate verbally through his MacBook Pro and play video games only with his thoughts–essentially telepathy. He created a video using a voice cloned from previous recordings when he could speak, and using a mouse to create the narration. Previously, he used an eye gaze controller to communicate. This is truly miraculous and flying under the radar. Mobihealthnews, RedState  The previous recipients, Noland and Alex, are both paraplegics[TTA 21 Feb 2024].

Next up is Blindsight, which Elon Musk has said that will be tested in humans by the end of 2025 [TTA 10 Apr]. There is also a Canadian clinical trial, the “Canadian Precise Robotically Implanted Brain-Computer Interface” (CAN-PRIME) for subjects with tetraparesis or tetraplegia resulting from cervical spinal cord injury or the neurological disease ALS [TTA 27 Nov 2024].  A competitor of Neuralink, Precision Neuroscience, closed a Series C at $102 million last December.

A telehealth virtual reality (VR) solution effective for reducing chronic pain. A study published last month in Nature/NPI Digital Medicine demonstrated significan reductions in a 54-participant group, with some receiving telehealth-based immersive VR intervention on chronic orofacial pain (temporomandibular disorders or TMD) versus an audio-only (MP3) same-content control intervention and non-intervention on five-day ‘waves’. Pain intensity, unpleasantness, anxiety, sleep disturbance, and mood were monitored. There was significant reductions achieved with the immersive VR on pain intensity and other factors, with lesser results achieved with the MP3 intervention. The study directionally confirms results in other studies on lower back pain and other pain studies. Researchers were based in the University of Maryland School of Medicine, School of Nursing, and Towson University.

Short takes:

AliveCor is adding to its new KardiaMobile 6L Max KardiaAlert. KardiaAlert is now integrated into KardiaCare, a subscription service for the KardiaMobile 6L Max AI-assisted ECG monitor. The consumer purchase of the KardiaMobile 6L Max includes the device and a one-year subscription to KardiaCare, which now includes the KardiaAlert feature. The six-lead KardiaMobile 6L Max identifies up to 20 arrhythmias with a clinician review. Introductory price is $169. Release

Allina Health deploying TytoCare at 12 urgent care locations. The Midwest health system is adding the TytoCare Pro Smart Clinic service to a dozen of its urgent health locations in order to shorten wait times and offer additional remote treatment. For Allina, this allows their urgent cares to see more patients, offer hybrid care, and additional services such as heart and lung exams (featuring AI-driven wheeze and crackle detection), throat and ear assessments, skin exams and body temperature measurements. Allina Health, with hospitals in Minnesota and western Wisconsin, already uses TytoCare remote monitoring in hospital settings. TytoCare release

UnitedHealth Group and Amedisys persist. The long-running and DOJ-challenged acquisition by UHG of Amedisys home care is once again trying to remove the anti-competitive stumbling block by divesting more home care and hospice operations, this time to BrightSpring Health Services and Pennant Group. This was disclosed in Amedisys’s SEC Form 8-K. It is contingent of course on the closing of the UHG buy. BrightSpring is based in Kentucky and Pennant in Idaho. Pennant’s own SEC filing lists their purchase price as $102.5 million. The total number of operations to be sold is not disclosed. UHG and Amedisys extended their runway on closing to 31 December in JanuaryHealthcare Dive, Home Health Care News

The Department of Justice has been prominently blocking the $3.3 billion UHG acquisition, announced in what seems an eon ago in June 2023, on anti-trust grounds nearly immediately after the Hart-Scott-Rodino Act (HSR Act) premarket notification was filed, but most recently in a civil lawsuit filed last November in District Court in Maryland. The DOJ was joined by the Attorneys General of Maryland, Illinois, New Jersey, and New York. It alleges elimination of competition, harm in over 100 markets, falsely certifying compliance with HSR Act requirements, withholding documents, and much more. Additional background on that lawsuit is here. As this Editor said when UHG won in Federal court on acquiring Change Healthcare, a win they have 190 million reasons why to regret, “DOJ has a long memory, a Paul Bunyan-sized ax to grind, and doesn’t like losing.”

News roundup: DOJ investigating UHG on Medicare Advantage billing upcoding; Teladoc’s BetterHelp therapists using AI?–a short seller alleges; Hims whacked by FDA ending compounded GLP-1s (updated); some fired FDA staffers in CDRH reinstated

UHG’s annus horribilis gets more horribilis. News broke on Friday 21 February via the Wall Street Journal (paywalled) that UnitedHealth Group is reportedly under investigation by the US Department of Justice–again.  The DOJ is looking at UHG’s billing practices for members covered by UnitedHealthcare Medicare Advantage (MA) plans on diagnoses that were made to generate extra payments, a practice known in the industry as upcoding. This also involves the many practices that UHG owns or has relationships through Optum, about 10% of primary care practices. These practices are receiving visits from DOJ investigators, certainly something that would strike some fear into any doctor’s or practice manager’s heart. 

The WSJ reported that two providers cited in their article provided documentation, while another person said that the Department of Health and Human Services’ Office of Inspector General (HHS-OIG) is involved in the probe.

It’s a real Mound of Misery for UHG.

  • MA plans and their set rates for additional benefits not covered under original Medicare have been under HHS/CMS scrutiny in the past year, and health plans have been running higher costs than anticipated as covered patients have returned back to care.
  • UHG’s OptumRx unit last year was reported as under investigation on antitrust grounds.
  • Optum’s Change Healthcare (contested by DOJ but approved) is still recovering from an unprecedented hacking and ransomwaring, with the huge expense of restoring systems plus notification and providing a reported 100 million with free credit monitoring services.
  • The proposed $3.3 billion deal with Amedisys for home care continues to be delayed by the DOJ antitrust suit.
  • Their UnitedHealthcare president was assassinated in New York, and his (alleged) killer is starting his trial here, a spectacle which will go into the summer. But the issue that supposedly tipped off the murder–claim denials and denials of care due to policies and the use of AI, isn’t going away–jumping in the fray is megainvestor Bill Ackman.

While Federal involvement with health plans comes with the territory, the adversarial relationship with DOJ far exceeds the norm. The share price reflects it, having cracked 26% in the past six months. Those accepting the 30,000 buyouts on offer may be grateful if they take them. CNBC, FierceHealthcare

Another backwash from the use of AI? Teladoc is receiving some bad publicity it can ill afford. There are allegations of their therapists using AI-drafted responses with patients–and this apparently is becoming more frequent. It’s been percolating on social media boards such as Reddit (see example here) for some time. The latest is a report from a short seller* of Teladoc, Blue Orca Capital, that alleges that BetterHelp therapists not only use ChatGPT for text responses outside of live sessions (messaging), but also during live chat sessions. This goes against Teladoc’s own stated policy against AI therapy as ‘dehumanizing’  in a lengthy blog post ranging from social media to job loss as a result as AI. Blue Orca includes first hand information from two BetterHelp patients, an allegation from a competitor that BetterHelp doesn’t care, and that therapists are actually incentivized on the word length of responses they give to a patient, overloading their schedule, and being available 24/7 to patients paying a reported $400/month. Given BetterHelp’s prominence in Teladoc’s earnings–according to them “accounting for 40% of the Company’s revenues and adjusted EBITDA since FY21”, adding in their other financial factors, their dim view is jarring if you like or own TDOC.  Developing. Hat tip to HIStalk 2/24/25

*Editor’s note: Blue Orca Capital, as a short seller, profits when a stock goes down. Blue Orca has a short position in TDOC. So our Readers should take their position into account. Short sellers are also prohibited by securities law from spreading false information about a stock for the purposes of profiting from its decline (Rule 10b-5 under the Securities Exchange Act of 1934.)

The Feds giveth and taketh away Hims’ weight loss business. Updated information. Friday’s good news was that FDA has reclassified the shortage of semaglutide, the active ingredient in GLP-1 drugs, as ‘resolved’, meaning It’s Over and it’s easier to get your Wegovy, Ozempic, Zepbound, etc. prescription. The bad news is that online prescribers that were authorized by FDA to use less expensive compounding to approximate or customize the branded versions of these drugs for weight loss, are now prohibited from doing so. They have till April or May to transition to branded injectable versions. This affects the bottom line of all these telemedicine prescribers such as Ro, Weight Watchers, Future Health (a heavy local radio advertiser), 23andMe, and Hims & Hers. Hims, the showiest in class, took a breathtaking 25% hit on their stock between Friday and Monday.

It is not only cost of branded drugs but also that so many competitors have jumped into the field, creating another shortage of the branded drugs, that looms. Suppliers of compounded drugs, the high volume compounding pharmacies (not your corner pharmacy that does compounding based on Rx), may be reluctant to continue supplying telemedicine prescribers in reasonable fear of FDA action or pharma lawsuits that could put them out of business.

Hims also publicly took the hardest line against the pharma companies, implying in their now infamous Super Bowl commercial that their obesity drugs are priced “for profits, not patients”, unlike Hims’, of course. Novo Nordisk, the Ozempic and Wegovy manufacturer, in turn has taken a hard stance against the compounders pointing out that a compounded version isn’t standardized nor FDA-approved for safety and efficacy.

A custom, compounded version of a drug can only be sold when there is a shortage or if the branded drug is in some way inappropriate for the patient requiring a customized version, e.g. with adjusted dosage, method of dosing, or added/deleted ingredients. Look for Hims and other telemedicine prescribers to start pushing this POV. FierceHealthcare, MedCity News

Some FDA reviewers reinstated after DOGE cuts. The ~230 probationary and other employees who were let go with severance then partially reinstated are reported to be reviewers in the CDRH (Center for Devices and Radiological Health). The 183 reinstated reviewers are actually funded by the industry through the Medical Device User Fee Amendment (MDUFA) agreements to help speed the review and approval process. There is considerable confusion about this because phone calls went out over the weekend but as of today (Monday) there is no written confirmation from HR or the Office of Personnel Management (OPM). It remains murky as do layoffs in the rest of HHS. FierceHealthcare, Endpoints

News roundup: UnitedHealthcare names new president, Neuroflow buys Quartet Health, Owlet intros Owlet 360

The inevitable conclusion to a tragic event. UnitedHealth Group veteran Tim Noel was named this week to the CEO position of UHG’s UnitedHealthcare health insurance division. Mr. Noel replaces Brian Thompson, who was murdered on 4 December 2024 as he entered the New York Hilton to join that morning’s UHG Investor Day. Mr. Noel is a UHG veteran in several positions since 2007, most recently as head of Medicare and retirement plans at UnitedHealthcare, including Medicare Advantage, covering 13.7 million lives. The division’s plans cover over 50.7 million lives and is the largest US insurer. His promotion was unusually not announced in a press release, nor was his photograph or bio supplied to press–the new policy. 

He will certainly have his work cut out for him in lifting a shaken unit as well as negotiating the skyrocketing costs of Medicare Advantage. The comparisons will be inevitable, as well as reminders of Mr. Thompson’s death and the revival of public anger at UnitedHealthcare as the trials of Luigi Mangione proceed forward this year. For Mr. Noel, this diminished announcement must have a mixture of regret and sadness. Healthcare Dive, CNBC, Healthcare Finance News, FierceHealthcare

Behavioral health analytics and management workflow platform provider NeuroFlow acquires Quartet Health. Quartet, which is also in behavioral health but focusing on enablement and delivery, will expand NeuroFlow’s capabilities in referral and care navigation. Transaction cost nor management transitions were disclosed. NeuroFlow is based in Philadelphia, Quartet in NYC. NeuroFlow will be supporting Quartet’s existing payer and provider customers including Independence Blue Cross. Closing is expected in the next few days. NeuroFlow Release

Last week, Iris Telehealth separately acquired innovaTel telepsychiatry, owned by Quartet Health since 2021. Quartet’s announcement covers both acquisitions. Quartet had raised $267 million over seven rounds of funding. NeuroFlow has only $58 million in funding listed on Crunchbase. It is not known why Quartet sold itself and innovaTel. Behavioral Health Business

Telehealth ‘for the bassinet set’ Owlet announces subscription service Owlet 360. The $5.99/monthly service, initiated and billed through the Dream App, uses data generated by Owlet’s Dream Sock, Dream Duo or Cam 2. It provides information to parents comparing their baby’s information with data collected from other Owlet babies–a surprising 1.7 million. The additional information on their app is designed to expand parents’ knowledge of their baby and his or her environment:

  • Monitoring key health metrics by tracking daily and weekly trends for pulse rate, oxygen level, movement, and comfort temperature.
  • Compare health and sleep data to the vast Owlet infant health data set, offering meaningful context and reassurance.
  • Understand sleep and gain daily insights and guidance on sleep patterns.
  • Track comfort temperature to let parents know if their baby is too warm or too cold and to adjust the sleeping environment.
  • Watch, share, and save more video clips of precious moments or important notifications, like when their baby is moving or crying is detected.
  • View sleep environment insights like temperature and humidity trends in the room.

Basic monitoring information on pulse rate, oxygen, wakings, and sleep trends remains free of charge. Release

Updates: ATA on telehealth policy priorities, UHG investor group demands denied care report, DOJ sues Walgreens on illegal Rx dispensing, VA nominee supports Oracle EHR deployment, RFK Jr. HHS nomination hits Senate

ATA urges nine telehealth priorities for the Trump Administration’s consideration. Acknowledging that HHS expanded Medicare telehealth flexibilities at the start of the pandemic in 2020 in the previous Trump Administration, the American Telemedicine Association’s list is long and detailed.

#1 was to withdraw last week’s Drug Enforcement Administration’s (DEA) proposed rule, “Special Registration for Telemedicine and Limited State Telemedicine Registrations”. This would create a framework for the remote prescribing of controlled substances that in ATA’s view, would create “untenable restrictions and significant barriers to care”.

The remaining eight include flexibilities that were part of the 2020 rules.

  1. Permanently Allow for the Remote Prescribing of Controlled Substances
  2. Work with Congress to Make Permanent the Medicare Telehealth Flexibilities
  3. Ensure Affordable Telehealth Services for the Commercially Insured
  4. Ensure Affordable Telehealth Coverage for Part-Time, Contracted Workers Who Don’t Qualify for Health Care Coverage
  5. Ensure All Provider Home Addresses Remain Confidential
  6. Expand the Medicare Diabetes Prevention Program
  7. Reinstate Virtual Cardiopulmonary Rehabilitation Programs
  8. Release Updated Regulatory Guidance on Medicare Telehealth Flexibilities

Additional details are in the ATA Action letter to President Trump and Vice-President Vance and the ATA release.

An institutional investor interest group demands a report on delayed and denied care from UnitedHealth Group. This takes the form of a proposal for the 2025 proxy that the UHG board of directors prepare a report on these practices that create increased costs and ‘macroeconomic risks’.  The proxy is usually filed in April for a meeting that is typically in June. UHG will respond at that time it files the proxy.

The group proposing the report is the Interfaith Center on Corporate Responsibility (ICCR). ICCR represents 300 faith-based institutional investors, such as asset managers, pension funds, and foundations, with over $4 trillion in invested capital. This institutional shareholder action is in the aftermath of the Brian Thompson assassination, which revealed widespread consumer anger about UnitedHealthcare’s practices in high rates of claims denials, including their use of AI in the review process, and prior authorizations to restrict utilization. UHG ignores this at its peril. By the time proxies are released and the shareholder meeting occurs in June, the trial of the assassin may be underway, putting this issue back in top news.  ICCR release, Healthcare Dive

Walgreens’ Mound of Misery gained a few hundred cubic yards with a lawsuit filed 16 January by the Department of Justice (DOJ) over improper dispensing of opioids and and other unlawful medications over more than a decade. The civil lawsuit filed in the US District Court for the Northern District of Illinois alleges that Walgreens and subsidiaries dispensed millions of unlawful prescriptions, violating the Controlled Substances Act (CSA). Since Walgreens then sought reimbursement from Federal healthcare programs, they violated the False Claims Act (FCA). The time frame is from August 2012 to the present. Specific allegations include that Walgreens pressured pharmacists to fill prescriptions despite clear ‘red flags’, in excessive quantities, and lacking a legitimate medical purpose and that they ignored the pharmacists and their own internal data. One of the red flags were prescriptions for the ‘trinity’ of an opioid, a benzodiazepine and a muscle relaxant. There are also four different whistleblower actions against Walgreens under the qui tam (on behalf of the government) provisions of the FCA that have been consolidated. If successful, Walgreens could face civil penalties of up to $80,850 for each unlawful prescription filled in violation of the CSA, plus treble damages and applicable penalties for each prescription paid by Federal programs in violation of the FCA. Timing and Walgreens’ response are not yet available. This lawsuit could be a massive stumbling block to the rumored Walgreens/WBA saleDOJ release, Healthcare Finance 

The VA Secretary nominee recommits to resuming the 2026 rollout of the Oracle Cerner EHR. Former House Representative for Georgia Doug Collins told members of the Senate Veterans’ Affairs Committee at his nomination hearing Tuesday that he would look at the Oracle Cerner EHR deployment with ‘fresh eyes’ and that “there’s no reason in the world we cannot get this done.” On 20 December, the VA formally stated that they were starting planning now for deployment in four Michigan facilities — Ann Arbor, Battle Creek, Detroit, and Saginaw–for implementation by mid-2016. He was critical of what has transpired to date in the limited deployment as ‘not acceptable’ and pointing out that VA facilities needed modernization of their computer systems. But perhaps a little overoptimistically, he’d like to see a faster implementation in 2016, though it should be done properly and not rushed. NextGov/FCW, Healthcare IT News

And in the Warp Speed World that is now DC, Robert F. Kennedy Jr. is scheduled to testify next Wednesday (29 January) before the Senate Finance Committee on his nomination as Health and Human Services Secretary. At HHS, he would supervise the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH). He has promised major reforms including food safety and chemical additives, as well as the relationships between FDA and pharmaceutical companies. Healthcare Dive  Meanwhile, during the transition, HHS froze external communications or work-related appearances by staff. This is fairly standard procedure until review procedures are set up, but apparently no one planned for this in advance. This has derailed two conferences (AFCEA HIT Summit and the HHS Industry Summit) that were scheduled for this month and February. Exceptions to this are ‘mission critical’ and emergency communications. NextGov/FCW

2024 earnings roundup, after a dramatic year: UnitedHealth Group and Masimo

UnitedHealth Group’s annus horribilus closed out with a decent, but not up to earlier projections, financial report.

Having opened in February with the massive (and massively expensive) ransomware/hack of Change Healthcare, UHG didn’t have a lot of bright spots. Elevated utilization rates increased expenses; changes in Medicare Advantage reimbursements and the STAR ratings metholodogy changes reduced bonus payments.

Then, in the early, dim morning of their 4 December investor day in NYC, UnitedHealthcare’s CEO Brian Thompson was murdered while entering the New York Hilton Hotel. The manhunt and the controversy set off by the perpetrator’s so-called ‘manifesto’ exploded into a hurricane of severe public criticism on how plans process claims and treat members, a traditional and social media/online storm that only diminished around Christmas and the rise of other news. In literal fear for their lives, health plan executives took the lowest profiles they could manage. 

UHG’s earnings, while positive overall, reflected this uncertainty with lower Q4 revenue causing them to miss Street estimates. Share price fell over 6% today (Thursday). 

  • UHG’s Q4 revenues were $100.8 billion versus $94.4 billion in the prior year, up 6.8%. Profit of $5.5 billion was flat versus prior year. UHG’s 2024 revenues were $400.3 billion, 7.7% higher than 2023’s $371.6 billion. 
  • Health plan unit UnitedHealthcare’s 2024 revenues were $292 billion, up 6%, with operating earnings of $15.2 billion. US commercial members grew by 2.1 million.
  • Their 2024 medical cost ratio — the percentage of premiums spent on medical care — rose to 85.5%, far higher than 2023’s 83.2%, exceeding analysts’ projections of 84.96% and far above the targeted 80%.
  • Optum’s revenue, affected by the Change Healthcare hack and ransomware payments, still rose to $253 billion, up $26.3 billion or 12% versus prior year. The Optum Insight unit, which includes Change, had revenues of $18.8 billion, declining 1% because of the $867 million loss due to business disruption.

UHG release, FierceHealthcare, CNBC 

UHG also announced:

  • The Optum Rx unit will now pass through 100% of rebates negotiated with drugmakers to their clients–insurers, states and unions. This is up from 98% since 2% have preferred other rebate models. FierceHealthcare
  • UHG and Amedisys filed last week in the US District Court of Maryland to have the November Department of Justice suit dismissed. They cited that the DOJ did not adequately prove that the $3.3 billion acquisition would be anti-competitive. For one, the DOJ did not adequately define or provide detail on the geographic markets that would become be non-competitive. FierceHealthcare  They extended their deal deadline to the end of 2025 last month.
  • Change Healthcare stated yesterday that it has ‘substantially’ completed notifying affected consumers of their breach. Interestingly, if you use a search engine to try to find the breach notice, you’ll have a great deal of trouble–because the source code contains a hidden “noindex” code on the notice. ‘Noindex’ code tells search engines to ignore the web page–and has been there, apparently, since 20 November 2024. UHG has also not publicly disclosed a more exact number of those affected beyond the long-ago estimate of 100 million. TechCrunch   The state of Nebraska has sued UHG, Optum, and Change over the breach [TTA 19 Dec 2024

Masimo, ending a dramatic year of its own, now firmly in the control of Politan Capital Management despite flying lawsuits with former CEO Joe Kiani and an SEC investigation announced last month, issued its preliminary 2024 closing financials and their 2025 guidance. What’s hot–their consumer and professional medical devices, including smartwatches, that measure vital signs including pulse oximetry. What’s not–their audio business under Sound United, which is on the block.

  • 2024 healthcare revenue was up smartly by 9% to $1.395 billion. 
  • 2025 healthcare revenue is projected to increase 8-11% in the range of $1.5 billion to $1.53 billion. Non-GAAP operating profit is projected for 2025 at $398 million to $406 million.
  • Non-healthcare revenue (a/k/a Sound United) was $699 million. That declined 10% decline on a reported basis. 
  • Non-GAAP EPS for 2024 was $4.10. 

For 2025, Masimo is ending reporting for the Sound United business nor providing 2025 guidance since they are selling it. The only guidance they are giving is on the healthcare business. If one does the math–selling off Sound United will take out $700 million from their revenue. One more thing…updated results will be postponed until their investor call, delayed until Tuesday, 25 February. Mass Device, Masimo release

News roundup #1: UHG-Amedisys extended, NeueHealth going private in NEA’s ‘deal deal’, Commure buying Memora Health, VA resuming Oracle rollouts–now mid-’26

The end of year is a favorite time to slip in news that deserves wider notice. Sometimes it’s by design so as not to be noticed…and sometimes it’s timing. Or both. Here’s a potpourri of analyses of late December moves of note.

UnitedHealth Group and Amedisys home health agreed to extend their deal window to 31 December 2025. Amedisys filed regulatory paper on 26 December (file here) that moved the acquisition termination date to end of this year, or alternatively to 10 business days after a final court ruling blocking the merger. The latter is a distinct possibility since the Department of Justice back on 12 November filed a lawsuit to prevent the acquisition [TTA 14 Nov 24] on anti-trust grounds, joined by the attorneys general of four states. Amedisys, a major competitor to UHG/Optum, would be merged into Optum’s existing home health operations.

This long-running acquisition started back in June 2023 as an all-cash deal for $3.3 billion and went into DOJ review by August. The target closing at that time was end of 2024 as both companies knew that divestitures would be necessary. The penalty for non-completion was also upped to $325 million if needed divestitures to the VitalCaring Group proposed last July aren’t completed by 1 May. Even with a new Attorney General coming in after Senate confirmation, the wheels are already in motion for this antitrust action that throws a completion into doubt. Becker’s, Healthcare Dive

Gimlet EyeNeueHealth to be taken private by New Enterprise Associates (NEA) and other investors. The latest episode of the long-running NeueHealth (formerly BrightHealth) show dropped on 23 December. Existing investor NEA and 12 other investors with preferred shares in the company will take it private at an enterprise value of approximately $1.3 billion and roll over their shares for equity in the private company. Other holders of common stock will be cashed out, receiving $7.33 per share, a premium of 70% over the $4.31 closing on 23 December. The final price may change as common shares went up sharply the next day and remain up–today (8 January) opened at $7.49. Closing timing of this ‘deal deal’ is dependent on shareholder and regulatory approvals. Management will remain and roll over their shares into the company. Hercules Capital’s loan facility remains in place.  

Buried in the release is this caveat: “The merger agreement includes a 30-day “go-shop” period that will expire at 12:01 AM New York City time on January 23, 2025, which permits the Special Committee and its financial advisors to solicit and consider alternative acquisition proposals.” These proposals will be kept under wraps. But in this Editor’s view, outside offers are highly unlikely given the company’s death-defying history, continuing losses, and Ticking Time Bombs (see below). Their Q3 results had projected full-year 2024 adjusted EBITDA between $15 million and $25 million–but they lost $40 million in Q3 with the 2024 loss to date over $102 million.

As Ari Gottlieb dryly noted in his LinkedIn post, the company is $1.4 billion in debt. $7.33 per share is quite a comedown from the June 2021 IPO at $18 and an $11 billion valuation. The payout to the 36% of shares held by the other public shareholders is a paltry $21 million. Bottom line–NEA and the preferred investors are buying the company for $21 million–such a deal!

This Editor has previously and Gimletly noted NeueHealth’s high-wire act. It has truly Dodged Disaster with aplomb, skillfully creating its Own New Reality. But its Ticking Time Bombs remain: $300 million in CMS Repayment Agreements due on or before 14 March 2025 and $89 million owed to Texas from last year to cover risk liabilities for its shuttered ACA plans [TTA 14 Feb]. To be continued…   Release, Star-Tribune, FierceHealthcare

Commure bought digital health navigation platform Memora Health. Neither acquisition cost nor management transitions were disclosed on 20 December. Commure has one of the more interesting stories out there as the current company emerged from a General Catalyst-engineered estimated $6 billion merger between Commure and Athelas, with Athelas taking the upper hand in the reorganization [TTA 23 Oct 2024]. It should then be no surprise that Memora has significant investment from General Catalyst, which led its last round of funding in April 2023, making this another investor-arranged deal.

Commure’s primary products are the Strongline duress systems for worker distress and patient elopement and the Patient Keeper EHR, with Athelas in revenue cycle management and sensor-based remote patient monitoring. The combined company now features AI-aided workflows, RCM, duress systems, and a software development platform accessible to outside vendors. What Memora is primarily known for is automating practice follow-up texts before and after procedures. The Memora acquisition is positioned as reinforcing CommureOS’ clinical documentation, RCM, and real-time location services (RTLS). In October, Commure closed their acquisition of Augmedix, an AI-assisted physician scribe used by 20 health systems, for $139 million ($2.39/share), giving it a huge leg up into those providers. Augmedix IPO’d via a SPAC in 2021 at $4/share. About 400,000 physicians are claimed to be users of the Commure suite of products.  Release, Mobihealthnews, Endpoints, FierceHealthcare (Augmedix)

And what end of year would it be without a hopeful note from the VA about the Oracle Cerner rollout–now continuing in mid-2026? The Department of Veterans Affairs (VA) on 20 December officially targeted mid-2026 for four Oracle Cerner implementations, 18 months from now. It’s carefully hedged that they are beginning ‘early-stage planning’ for deployment in four Michigan facilities — Ann Arbor, Battle Creek, Detroit, and Saginaw. Meanwhile, improvements will continue at the five sites that use Oracle Cerner plus the sixth joint implementation with the MHS (Lovell). Interestingly, the current VA secretary, Denis McDonough, announced at an 11 December press conference that new implementations would start before the end of 2025 [TTA 19 Dec 2024]. This Editor assumes that the staff sharpened their pencils and recalculated right before Christmas. What’s also hopeful for Oracle and the VA are continuing  improvements in veteran outpatient trust and clinician satisfaction scores, as well as effectively eliminating outages for 200 days as of the release date. VA release, Healthcare Dive 

News roundup: Precision’s $102M raise, more on BCI; Withings clears BPM Pro 2; Nebraska 1st state to sue Change/UHG, related insider trading update; VA Oracle go-lives may resume; ATA intros CODE; ClearDATA HITRUST certified

One more funding. A competitor of Elon Musk’s Neuralink, Precision Neuroscience. closed their Series C at $102 million. This round was led by General Equity Holdings, with participation from firms including B Capital; Duquesne Family Office, the investment firm of Stanley F. Druckenmiller; and Steadview Capital, bringing their total funding to $155 million. The total brings them according to their release as one of the best-funded brain-computer interface (BCI) company after Neuralink, whose funding is unknown. The funding will be used to advance its clinical research and expedite development of its cutting-edge brain implant. 

Precision is the developer of the Layer 7 Cortical Interface to treat motor paralysis. At the time of their last funding in January 2023, this Editor noted that their difference was to treat neurological illnesses and events such as stroke, traumatic brain injury, and dementia. Their focus remains largely there: severe spinal cord injury, stroke, ALS. So far, the investigational device has been tested its device in 27 patients through research partnerships and was designated by FDA as a Breakthrough Device.

More on BCI in this must-read article by Timmy Broderick for STAT. The upcoming issues around BCI now center around the engagement of CMS (Centers for Medicare and Medicaid Studies) for coding, coverage, and payment for devices after the investigational stage; privacy issues about neural data; and continued support after implantation. This last one is acute as these companies are young. There has already been the example of Second Sight’s bankruptcy, leaving subjects stranded with useless retinal devices in their eyes. BCI to this Editor will develop through 2025–and be a major focus of investment by 2026-2027.

Withings gains FDA clearance, intros BPM Pro 2. A professional-level product for hypertension and chronic heart failure (CHF) targeted to care teams to connect with their patients, the FDA clearance covers blood pressure and pulse rate measurement in adults with arm circumferences of 9 to 17 inches (22 cm to 42 cm) or 16 to 20 inches (40 to 52 cm). What is really interesting about the connected (Wi-Fi, cellular, BT) device is that care teams can program the device through the Patient Insights feature for the patient to interact with the device in real time. Through a small screen, it asks questions that help to track the patient’s condition, reinforce medication adherence, and assess their satisfaction. It also has a Retake Measure feature to retake a reading if results exceed predetermined thresholds and increases accuracy. Withings plans to upgrade the device to take a 1-lead ECG to detect atrial fibrillation; this is a separate clearance and expected to become available in 2025. The device is not yet CE Marked. Withings was named a CES 2025 Innovation Awards Honoree in the Digital Health category. (Photo, Withings website) Release, Mobihealthnews, MedCityNews

UHG’s Mound of Misery multiplies with Nebraska’s Change Healthcare lawsuit, plus separate but related insider trading. 

  • Nebraska became the first state to sue UnitedHealth Group, Optum, and Change Healthcare over those affected by the late February ALPHV/BlackCat hack of Change’s systems. In Nebraska alone, it affected 575,000 individuals. (It is actually hard to find someone who was not affected by the hacking of the leading exchange for major claims clearing and payments.) Nebraska’s attorney general Mike Hilgers is suing because of the company’s carelessness in handling data and, even worse, in its slow notification of those affected. Our Readers will recall that Change/UHG initially tried to push off notification on healthcare providers. When HHS threw the ball back to Change [TTA 5 June], notices didn’t go out until August-September. The charges in state law center on consumer law: financial data protection and consumer protection statutes, deceptive trade practices, and Federal standards on privacy (HIPAA, and HIT protection. The lawsuit was filed by the AG in the District Court of Lancaster County, Nebraska. Nebraska Examiner
  • The Change acquisition and later problems were possibly the catalyst for stock sales by senior/C-level UHG executives, including UnitedHealthcare CEO Brian Thompson. The $300 million Hollywood (Florida) Firefighters Pension Fund initiated a class action lawsuit alleging that the sales were made while the Department of Justice (DOJ) was considering an anti-trust action against UHG that would revisit the so-called ‘firewall’ between it and Change.  The complaint specifically mentions that UHG executives were aware of it as early as October 2023. The Wall Street Journal revealed the investigation on 27 February 2024–the same time as the Change breach was revealed, cracking the stock almost immediately. Executives including Thompson ($15 million), UHG CEO Andrew Witty, and board chairman Stephen Hemsley ($102 million) were named. The class action covers the period for stock purchased between 14 March 2022 and 27 February 2024. UHG has until 1 March 2025 to answer the complaint. Healthcare Finance News  (This is likely to affect the settlement of the Thompson estate–Ed.)

VA confirms that additional Oracle EHR implementations may go live in 2025, after 18 months of dead stop. The Oracle Cerner EHR is reportedly ‘running better’ at the current six sites where it is operating: five VA only (including 20 community clinics and about 100 support sites), and the sixth at Lovell jointly with the Military Health System (MHS). The restart of EHR Modernization (EHRM) was confirmed earlier during budget hearings by Kurt DelBene, assistant secretary for information and technology and chief information officer. Crash and lag downtimes are reduced by half and incident tickets by 60% since the last updates in August.  Timing remains indefinite for 2025 (FY ends 30 September 2025) but current VA Secretary Denis McDonough confirmed that primarily VA staff will continue to work on it under the Trump Administration. “The overwhelming majority of VA professionals who work on EHRM will be working on EHRM on January 21st, just as they were on January 19th,” McDonough said at an 11 December press conference. Federal News Network

Short takes:

  • The American Telemedicine Association (ATA) launched its new ATA Center of Digital Excellence (CODE) last week. CODE is constructed as an alliance with leading health systems for the development and implementation of digital health best practices that prioritize patient-centered care, equitable access, and improved clinical and operational outcomes. Tools span enhancement of workflows and patient engagement to improve healthcare accessibility. ATA release
  • ClearDATA’s CyberHealth platform and cloud managed services have earned Certified status by HITRUST for information security. ClearDATA provides healthcare specific managed cloud security, compliance and operations solutions. HITRUST, the Health Information Trust Alliance, is a non-profit that sets standards for data organizations through the HITRUST CSF framework. Release