Chutes & Ladders this week: Carbon Health’s Ch. 11; Centene’s 2-way beat, TrumpRx.com debuts; Doc.com files for $24M Nasdaq listing, $55M for Alaffia Health, big Series Ds for Midi Health and ElevenLabs

One busy week in the game! Chutes first…

Primary care/telehealth provider Carbon Health filed for Chapter 11 dual-track bankruptcy reorganization. San Francisco-based Carbon filed on Tuesday 2 February a pre-packaged Chapter 11. The unusual dual track refers to a simultaneous sale of the company and a court-supervised restructuring backed by up to $19.5M in debtor-in-possession (DIP) financing. The DIP financing, via Future Solutions Investments, is currently approved up to $9 million. DIP financing ensures that operations continue and that employees and vendors are paid.

The bankruptcy was filed in the US Bankruptcy Court for the Southern District of Texas, with liabilities estimated between $100 million and $500 million. According to the company release, “the Chapter 11 plan is premised on a debt-for-equity exchange, and a post-petition marketing and sale process for all or a portion of the Company’s assets.” At this point, there is no projected date for emergence out of bankruptcy.

Carbon started as an app-based telehealth provider in 2015 in SF and now has 93 affiliated primary and urgent care clinics across eight states from California to New Jersey. It is structured as a management services organization (MSO) with a proprietary technology stack to support patient telehealth and the clinics. The company attributes the shortfalls and need for reorganization to post-Covid demand changes and a tight capital market for healthcare. (Editor’s note: operating primary care practices through a MSO model, where you make money selling services, is certainly interesting but presents many hurdles to consistent profit. I’ll cite my experience working for an MSO engaged with Medicare payment model ACOs and IPAs.)

It’s been a tough market for provider groups even when financing was easy, as VillageMD’s difficulties with Walgreens have demonstrated. Primary care provision to patients is too sporadic and competitive to allow for mistakes. Then when consistency and depth are needed, chronic care management becomes all about risk management. Not care. Beckers, FierceHealthcare, ElevenFlo

Between a Chute and a Ladder…

Centene’s horrible 2025 closed with a Q4 net loss of $1.1 billion, but a better forecast for 2026. The Q4 compared to a net profit of $283 million in FY 2024. A major factor was that the health benefits ratio (HBR) of 94.3% for Q4 2025 was sharply up from 89.6% in Q4 2024, as well as expenses relating to rising No Surprises Act billing disputes. The ladder was that the revenue topline of $49.7 billion, up 22% versus prior year, reportedly beat Wall Street expectations as did the full year.

For 2026, CEO Sarah London and CFO Drew Asher are promising a more stable ride. Medicaid profitability has improved plus year-over-year growth with breakeven in the Medicare Advantage market. This rosy outlook contrasts with UnitedHealth Group, Molina Healthcare, and Elevance, and has led to more questions by analysts about its validity.

A crotchety Mr. Market didn’t like the news today (Friday) and whipped the stock down 4% to $38. A year ago, CNC traded above $66. Centene’s primary markets are Medicaid, Medicare and the ACA. They continue to shrink non-core businesses, announcing that it is divesting the remainder of Magellan Health it still holds, resulting in an impairment of $513 million, or $389 million after-tax. (Disclosure: this Editor worked for a company Centene bought and holds CNC stock) Financial release, Healthcare Finance News, Healthcare Dive

On to the Ladders…

TrumpRx.com online site debuts. This provides some relief on pricing for 40 heavily prescribed and expensive drugs from five pharmaceutical manufacturers: AstraZeneca, Eli Lilly, EMD Serono, Novo Nordisk, and Pfizer. The pricing is ‘most favored nation’ (MFN) which means it is in line with the lowest paid by other developed nations. According to the White House release that outlines availability, “Depending on the manufacturer of a given drug, patients with valid prescriptions will be able to access savings through user-friendly coupons that can be printed or downloaded onto their phones or through channels set up by the manufacturer and integrated into TrumpRx.gov.” In return, the manufacturers are exempted for three years from pharmaceutical tariffs. Many of these drugs are already available at reduced prices through the drug companies’ DTC outlets, such as Zepbound and Wegovy. While for those in commercial plans or Medicare Part D there may not be much difference in pricing, the trend here is that manufacturers continue to unabashedly create outlets for drugs that bypass the beleaguered PBMs.  Healthcare Dive

It was also a Big Week for a future IPO and company financings.

Mexican telehealth Doc.com files for Nasdaq listing. Their filing is for 3 million shares of its Class A common stock priced at $8, for a total value of $24 million. (SEC Form 1-A) The stock will list under DOCC. Doc.com is a little different in claiming to use both blockchain to secure transactions and AI for workflows and operations to provide telehealth services that connect underserved markets with doctors, nurse-practitioners, psychologists, mental health specialists, and even veterinarians. It’s currently offered in Latin America and the US (as of last year), headquartered in NYC. Current financing is $300.7 million raised in January 2024 from Silver Rock Group private equity, and a $700,000 debt financing. (Crunchbase).  2025 annual report, Mobihealthnews

Alaffia Health scores a $55 million Series B. Lead investor was Transformation Capital with participation from previous investors including FirstMark Capital, Tau Ventures, and Twine Ventures. Their total raise is $73 million. Alaffia has developed agentic AI for health plan claims operations. The AI tools offered scale clinical review capacity for health plans and evaluate claims against the complete patient medical record, for a claimed 20%+ average savings on high-cost facility claims and 5x+ ROI for leading health plans. The fresh financing will be used for the usual R&D, developing additional agentic AI, and growth. Alaffia release, MedCityNews

Midi Health is a new unicorn, closing a $100 million Series D financing and a valuation over $1 billion. Even more unusual, it’s another strong raise for a women’s health company, this one in telehealth for women in perimenopause and menopause. Last week, Pomelo Care raised a $92 million Series C to move from the maternity segment into menopause and older women’s health. The Series D was led by Goodwater Capital with participation from new investors Foresite Capital and Serena Ventures, as well as continued support from Advance Venture Partners, GV (Google Ventures), Emerson Collective, SemperVirens, and McKesson Ventures.  MedCityNews

ElevenLabs closed its own Series D at $500 million, topping $781 million in funds for its generative AI in text-to-speech and an $11 billion valuation. Its scope is apparently near-universal for developers and companies in multiple industries. For healthcare systems, it has platforms for private practitioners and clinics that provide HIPAA-compliant, intelligent voice agents that triage, route urgent calls and respond to patients. The agents can sync with EHR and HIS systems as well as nurse-call and messaging systems. It can also update records, log triage outcomes and book appointments automatically integrated with EHRs. The fresh financing will assist in their international expansion and ElevenAgents, its enterprise platform for voice and conversational AI. Mobihealthnews, ElevenLabs release

TTA’s wintry roundup: UHG’s stock crash, buys/funding Sword Health, OpenEvidence, more; AI studies indicate caution, dodgy eMed, SVB’s 2025 healthcare investment roundup, Done Global convictions, more!

29 January 2026   Happy New Year!

 

Editor Donna is (mostly) back and here’s a roundup of our articles over the past couple of weeks. News, including the Big Crash of UnitedHealth Group. Some big buys kicking off 2026. A couple of major analyses of AI studies and 2025 healthtech investment. Must Reads too!

Please feel free to comment and pass along. Let me know if this is worth it to you!

Chutes & Ladders: UnitedHealth’s disastrous day and industry portents; Sword Health buys Kaia for $285M and gains German entry, $250M Series D for OpenEvidence, Pomelo’s $92M Series C, NOCD buys Rebound Health

One-two punch: AI moves hard into clinical healthcare and consumer medical with OpenAI/ChatGPT and Claude for Healthcare debuts

AI failing–at present–to lower costs, grow revenue, improve efficiencies. Yet it’s full speed ahead: Deloitte, PwC surveys

Short takes: Owlet’s baby sleep survey, MediBioSense’s Infinity Watch, telehealth extensions move to Senate, EBG’s telemental laws app ’26 update, Done Global indicted with principals convicted

This week’s Must Read: a deep dive on football’s Tom Brady’s involvement with GLP-1 e-Rx eMed

2025 healthcare investment off 12% versus 2024, with AI nearly half: Silicon Valley Bank roundup (updated for Scheffel interview))

From our last Alert: Congratulations to James Batchelor MBE (Well Deserved!)

And a read with even more relevance now: Should free-falling UnitedHealth Group be broken up? Or break itself up to survive, before it becomes another GE? (updated) (See Chutes & Ladders above)

And on a personal note, the 40th anniversary of the Challenger explosion was yesterday. A short and personal remembrance on where I was and what I was doing that day is published here

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

 

AI failing–at present–to lower costs, grow revenue, improve efficiencies. Yet it’s full speed ahead: Deloitte, PwC surveys

When the business process outsourcing (BPO) leaders pour lukewarm water over AI, one hears the air leaking from a bubble. BPOs have been a key part of the hype around AI as a business solution. The McKinseys, Genpacts, Deloittes, and PwCs for years have touted AI and as a result, made large consultancy fees. AI now proliferates for every business problem. Whether it’s generative, (still kicking around) machine learning, NLP, LLMs, agentic, robotic process, and now sovereign AI (domestically developed and powered)–it’s been positioned as the solution for simplifying processes and reducing administrative burden. Of course, a fair chunk of this involves getting rid of those pesky human factors in overseeing whether these new systems and software actually work, or reducing them to the lowest cost possible, to pay for all the AI spend.

Unfortunately for the BPOs, their customers are telling them that AI Is Not Quite All That. In fact, for the money they have spent, it hasn’t performed. Yet. But they remain optimistic, a neat bit of cognitive dissonance or perhaps justification.

The Deloitte global survey of 3,235 business and IT leaders confirms the gloomy news to date–yet it’s full speed ahead. Only 20% have experienced revenue growth as a result of AI. Transformation is coming along slowly; 25% of those surveyed believe that AI is transforming their organizations, which corresponds to 84% not redesigning jobs or work around AI capabilities. In this area, there’s a lot of resistance. While 55% of workers are reportedly open to AI technology, only 13% of workers are highly enthusiastic about AI, 21 percent would prefer to avoid it, and 4% actively distrust it. There’s also a lot of pilot-itis. Only 25% report shifting 40% or more of their AI experiments into live use, though optimistically they project that will increase to 54% in three to six months.

Yet they’re justifying AI. Totally. 66% reported that it improves productivity and efficiency, which contradicts the low revenue growth. 58% of companies are already using it to some extent, with adoption to hit 80% within two years. 74% of companies plan to deploy agentic AI within two years, even though only 23% are using it now and 21% have a model for governance of autonomous agents–a high risk level. 42% believe their strategy is ‘highly prepared’ for AI adoption. Another part of AI adoption has surfaced–sovereign AI, to reduce dependency on foreign sourcing, vendors, and infrastructure. 83% reported that this was at least moderately important to them. The Register 21 Jan, Deloitte’s State of AI in the Enterprise report (PDF, January 2026) 

PwC’s larger survey of 4,454 business leaders in their 29th Annual Global CEO Survey contains gloomier and more detailed feedback for AI advocates. “Most CEOs say their companies aren’t yet seeing a financial return from investments in AI.” Only 30% reported increased revenue and 26% saw lowered costs. More than half–56%–did not see either lower costs and higher revenue. 22% reported an increase in costs due to AI.

Another finding is that isolated AI projects aren’t delivering value. Companies lack a clear strategy in building AI foundations such as clearly defined road maps and sufficient levels of investment​​.

A relatively small proportion of their surveyed CEOs say they’re applying AI to a large or very large extent to areas such as demand generation (22%); support services (20%); the company’s products, services, and experiences (19%); direction setting (15%); or demand fulfilment (13%). In a previous survey, only a tiny minority of workers–14%–are using generative AI daily. PwC’s report goes on to identify many other factors reshaping global business and influencing growth, in context confirming that depending on AI as a quick fix is not paying off.  The Register 20 January, PwC 29th Annual Global CEO Survey (January 2026).

Reality tends to bite. Many of last year’s corporate layoffs were attributed to heavy AI investments that weren’t paying off, but books needed to balance by year’s end and it was taken out of human capital. Layoffs are projected to continue across all industries in 2026. Books balance another way, though. The AI bubble is deflating from Inflated Expectations into the early stages of the Trough of Disillusionment. How long it will take to move to the Slope of Enlightenment is anyone’s guess–two years, five, a decade? The useful tool of the Gartner hype cycle strikes again–as it did with telehealth and health tech. Separately, we’ll be looking at OpenAI’s ChatGPT for Healthcare and Anthropic’s Claude for Healthcare.

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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Support not only a publication but also a well-informed international community.

Contact Editor Donna for more information.

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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.

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

Teladoc responds to Blue Orca’s report on BetterHelp’s AI ‘therapy’ (updated)

Teladoc formally responds to the Blue Orca Capital research report [TTA 25 Feb]. Their letter (PDF) via its legal counsel (King & Spalding) yesterday refutes Blue Orca’s allegations in a report on their stock (TDOC) that a “meaningful” number of BetterHelp patients are receiving AI therapy from therapists in the form of text/asynchronous and live messages, calling them “vague and unsubstantiated”.

The policy stated by Teladoc, quoted directly from this letter (Editor’s notes):

  • BetterHelp expressly prohibits therapists from disclosing any member personal or health information to third-party AI. (Editor’s emphasis)
  • BetterHelp has a Trust and Safety team dedicated to the detection and prevention of non-compliant use of AI and, if anything, has structured its platform (and its incentives to therapists) to promote live video calls over asynchronous messaging. (Another point made by Blue Orca)
  • BetterHelp’s Privacy Policy provides further disclosures to members concerning its AI practices. (The Privacy Policy is at the end of Section 1 Data Collection and Processing, and is specific as to AI being used for ‘manual, repetitive tasks’ in processing and to “help therapists manage and document sessions more effectively”.)

Readers will note that this Editor called Blue Orca’s statements in its report about AI therapy “allegations”. I also noted that Blue Orca was a short seller. I later clarified what a ‘short seller’ is and that short sellers profit when the stock goes down. 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 Teladoc counsel letter to Blue Orca Capital addresses other allegations in the Blue Orca report about their changes in reporting practices in FY 2022 that supposedly inflated Teladoc’s profitability. These are outside the scope of both articles and will not be commented on here.

Disclosure: Teladoc reached out to this Editor, supplying information about their response including the King & Spalding letter.

This Editor hopes, and would like to see confirmation, that any BetterHelp therapist using third-party AI to respond to patients in providing direct therapy, versus Teladoc/BetterHelp supplied management tools, customer service information, or security tools, is disciplined and released. The integrity, privacy, and security of a telementalhealth platform is essential to its operation and the confidence of its patients–and should be publicly confirmed.

Update: In response to this article, a spokesperson from Teladoc Health further elaborated:

“To be clear, BetterHelp expressly prohibits therapists from disclosing any member personal or health information to third-party AI. BetterHelp has clear, rapid processes for members to report negative experiences, switch therapists, and cancel memberships, when requested. If a therapist is found to be practicing in an unethical manner, they are investigated and terminated from the platform. The overwhelming majority of members stay with their matched therapist, even though they are free to switch their therapist at any time.” 

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

A year’s end newsletter to our Readers: a few wishes for Under the Tree, a few Quirky Predictions for 2025

It’s hard for your Editor to believe, but this is actually the 15th year since Steve Hards was most kind and invited me to contribute a few articles to what was then simply Telecare Aware.

A lot has happened since then, professionally and personally. I’m grateful for the opportunity that TTA has given me to Cover the Healthcare Waterfront, relying on multiple sources from super-local to Mainstream News to the Usual Sources. 

Most of all, this forum (and it is one!) stays true to the course that now Editor Emeritus Steve set some years ago:

Telecare Aware’s editors concentrate on what we perceive to be significant events and technological and other developments in telecare and telehealth. We make no apology for being independent and opinionated or for trying to be interesting rather than comprehensive.

In that, though I’ve occasionally gone far afield (and down some rabbit holes) into exclusively US issues such as how healthcare gets paid, its politics, and the financial landscape (from bubble to devastation to recovery), I believe they hold true in the UK and in other countries. 

So one wish I have from Santa for 2025 is for More Comments. I’m very interested in knowing what you think about topics that are covered and your take on them. Using hits as a guide, it is hard to predict. Sometimes it is breaking news, a major data breach, or Walgreens’ continuing soap opera. Perhaps you want more audio commentary or article audio files, which I’ve experimented with via Soundcloud. So…What do you think?

A second wish: for other writers to join me here as lead/topic providers or better, contributors, for news outside the US. Specifically, I believe Readers want to know what is going on in the UK and Europe, but ‘standard sources’ are either not focused on health tech, paywalled, or overly specific ‘inside baseball’. Steve and I have long recommended Roy Lilley’s newsletter and UK Telehealthcare.

So…if you know of reporting on UK or EU issues, please direct me there. Better yet, contribute an article! Or two! We are small and cannot pay, but if the facts are there and the writing is sound, you’ll be published and can republish elsewhere. (This is exclusive of Perspectives, which are non-promotional thought pieces contributed by companies’ marketing areas. And we thank them!)

A third wish: speaking of marketing, I am a marketing and communications consultant by trade. Yet I am very shy about putting my shingle out there and asking Readers for leads to companies that might need marketing help, short-term or long term. My LinkedIn profile has most of my CV and key information on what I’ve done and where I’ve worked, but for a full overview about my capabilities across branding, program, planning, and products, email me here

Now for the Quirky Predictions–I’ll keep it short and open to debate:

2025 will continue international rebuilding of companies in healthcare and health tech. But the tear-downs will continue to clear the table. Overall, there’s optimism in the air with a new administration. It doesn’t feel like a rerun of 2023 where everyone thought it was going to be Romping Unicorns post-pandemic and the Big Guns were snapping up Big Buys like Signify Health and Oak Street Health for Big Bucks. We know now how that worked out for Walgreens, CVS, Walmart, and even Amazon (which I predict will be rethinking–and retrenching). We are starting from a low level and hopefully leveling up from there.

That doesn’t mean that there won’t be more Shotgun Mergers by VCs that avoid the new merger guidelines and a few Chapter 7s and 11s (UK=administration) along the way. There will be more layoffs. Funding rounds for both healthcare and digital health will be moderate. Down rounds that reduce valuation will still be with us. Investors will push for more control–witness what is happening at Walgreens and CVS, and what happened at Centene.  There will be more big changes at Walgreens, CVS, Elevance, Centene, Cigna, and many others considered mainstays of healthcare–and don’t rule out Amazon and Walmart. But by the end of year, barring a Bird Flu Pandemic, space aliens landing from the Plague of Drones in US and international skies, or an Unraveling of Sanity, overall we will be doing a lot better.

Robert F. Kennedy Jr. will be turning up the heat on Health. He will be confirmed as head of Health and Human Services and will, within a year, refocus it along its name. Health rather than Sick Care. A lot of substances ranging from vaccines to PFAS to various dyes and additives in food will be questioned at FDA, restricted, and brought to the national consciousness. As a personality, he is extremely intelligent and dynamic–knows how to absorb the most complex information and move on it. He knows that Make America Healthy Again is his Main Chance and also to be true to his legendary father’s legacy. It will make a lot of drug and chemical companies rather…nervous. (I am less sanguine about Dr. Mehmet Oz as head of CMS and his ability to clean up that puzzle palace, but hopeful.)

Speaking of heat, I wouldn’t want to be a C-level at any of the major health plans that are in multiple lines of integrated business.  The assassination of Brian Thompson and earlier the massive Change Healthcare hack ripped the cast and bandages off the entire system. The sheer hostility to payers was startling enough for UHG CEO Andrew Witty to write a massively defensive op-ed in the NY Times–and the hostility has hardly dimmed with the jailing of Luigi Mangione who has turned into a folk hero to some. (Yeesh! I cannot think of anything less moral.) The incoming administration and Congress are restive and major changes will be coming from there. Already there is a bipartisan Congressional bill (the PBM Bill) requiring the divestiture of pharmacy benefit management (PBM) companies from insurers within three years. While it will not be passed by the 118th Congress, it will be reintroduced by the 119th after 3 January if you look at who is backing it. This is the kind of movement to simplify how healthcare is delivered and paid for that crosses ideologies and finds a wide spectrum of support from Bernie Sanders to RFK, Jr. and presumably the re-elected President. 

Once the PBM string is pulled, what then comes into focus is insurer ownership and control of providers. UHG/Optum owns or is affiliated (meaning ACO or partial ownership) with 10% of US practices. DOJ is already after UHG for the Change Healthcare acquisition on security grounds. The more aggressive posture around anti-trust will not change in this administration and only slightly moderate with a new FTC chair. (Lina Khan’s term has expired though she may try to hang on, but her bête noire Amazon is still in trouble with their One Medical Bad Bet.)  The few payer organizations that only offer health plans, like Molina, Oscar, and Clover, will start to look very smart indeed. Perhaps smaller and less controlling is actually…better. And more profitable.

Running in parallel: the lack of trust in Big Pharma and the cost of drugs from them. They’re next.

We will need to get much more realistic about AI, what it is capable of, and its social effects. It is spreading into everything like kudzu (try entering into most browsers) but what we will be finding out is that a lot of what is ‘AI’ sold to companies as labor-saving is half-baked. It doesn’t work well. Some of it falls into the ‘uncanny valley’ of unease as too humanoid. If a company or service relies on it for decision making, it may not make those decisions better than humans. Reportedly UnitedHealthcare uses AI for a claims decision model, something that is cited as flawed. Bad decisions incite human anger, and lack of human contact is like being in a perpetual voice jail.

There is also growing evidence that in writing and researching, over-dependence on AI prompts and drafts destroys the ability to remember and creatively connect both on the fly and under consideration, in the ability to move an argument logically to a conclusion utilizing persuasive writing and speech skills. This especially affects the young. I’m hearing reports on this from the hiring front, where young grads cannot write without AI assistance and are stunted in their verbal skills. AI in writing gets to be a crutch (I use a tool for grammar–and about 10% of the time it’s off.). And have we forgotten that AI is dependent on content….GIGO from the early computing days still applies. We don’t want to be the Eloi, do we? (Look up your H.G. Wells)

And one last prediction. The mass market weight loss fad hyping GLP-1 drugs (Wegovy, Ozempic, Mounjaro, Zepbound) will implode. These drugs are now readily available, less expensive (but certainly not cheap), and cheerily advertised on social media, radio, and TV by drug manufacturers and telehealth prescribers. These are promoted for weight loss alone, not for weight loss to better manage Type II diabetes or true obesity. What will pop the bubble? Side effects of slow digestion like stomach paralysis. Diarrhea, nausea, intestinal distress, even pancreatitis and suicidal ideation. Little known is that 80-90% of clinical trial participants experienced at least one adverse event. If you survive these, a weight gain rebound often happens once off the injections.

The telehealth prescribers like Ro and Hims make it so easy–and do they go through blood and other testing, and histories, to ensure that the patient is a suitable candidate?  Metabolic modifications ain’t beanbag.

A side business popping up: nutritional  supplements and ‘special drinks’ to prevent malnutrition (because of the low food intake) and muscle loss. (Another sign that GLP-1 is hitting a peak.)

Perhaps waiting in the wings are the class action lawyers, ready to jump on any massive side effects or, God forbid, deaths.

No ‘craze’–and this is one–is unalloyed bliss. If you have a diversified telehealth company like Teladoc and you get into this business, it may not make a difference (?)–but sole providers like Calibrate (among many) will feel the pain. And destruction. (Does anyone remember the much-touted Alli/Orlistat that reduced the fat absorbed by the digestive tract and those side effects?)

May you and your loved ones have a Merry Christmas, Happy Hanukkah, and a Happy New Year…however you and yours celebrate! We will be on a two-week break and return, along with many of you, on 6 January.

Rounding up last of 2024’s M&A/fundings: Redesign Health’s $175M, HEALWELL AI buys Orion Health, startup Tuva Health’s $5M

The largest of the year-end fundings (so far) goes to Redesign Health. Best described as a designer and funder of startup health companies which are then spun off, Redesign gained a $175 million investment for a new fund from Declaration Partners, Euclidean Capital, and True North Advisors. Unlike your typical seed funder or incubator, Redesign takes an activist role in forming startups before spinning them off. Its model includes in-house experts to advise on formation, connecting the startup to existing relationships with healthcare organizations and demand generation systems, and access to networks of investors and talent experts. Redesign has used this model with more than 60 companies. These companies have had over 15 million patients and generated >$1 billion of revenue. The fresh funding will be used to start up new companies in eight areas, including ‘preparing for an aging population’. Release, MedCityNews 

Once spun off, the organizations are on their own. Some have been acquired: Jabra Enhance in hearing aids (GN Hearing) and Vault Workforce Screening (Sterling). One notably got into trouble–Calibrate, which was sold for $20 million in an October 2023 ‘reorganization’ to private equity firm Madryn Asset Management along with other investors [TTA 26 Oct 2023]. A pioneer in DTC telehealth programs for GLP-1 weight loss drugs, Calibrate was caught in the squeeze between scarcity of those drugs (Ozempic, Wegovy) and the entry of Teladoc, unable to fulfill its programs nor, at that time, to get insurance reimbursement. It is now benefiting from being in a very hot sector of weight loss drugs. Prior to the sale, Calibrate raised about $160 million in funding [TTA 15 Feb]. Interestingly, Calibrate is still listed in the Redesign portfolio including career openings.

Redesign itself had some rocky times earlier this year with their layoff of 77 from their New York-based staff of 200 to 250 (estimated). The cuts were from the areas that support new venture creation. The new funding is the first sign that Redesign is getting back into the business of forming new companies versus maintaining the portfolio.

New Zealand’s Orion Health to be acquired by Canada’s HEALWELL AI. The final price is NZ$200 million/CA$165 million (US$115 million) for 100% of Orion’s private shares. CA$86 million will be paid in cash and the balance will be paid in HEALWELL stock plus CA$20.5 million in a 3-year performance-based arrangement. Closing is anticipated to be April 2025, after Orion divests itself of non-strategic assets and the usual approvals by shareholders, regulators, and the Toronto Stock Exchange.

Orion Health’s products–Orchestral, Amadeus, and Virtuoso–are data exchange, patient record, and analytics platforms to benefit clinicians and patients. Their largest customers are in Canada, Australia, and New Zealand, plus the NHS in the UK, giving HEALWELL AI an international footprint. HEALWELL AI is based in Toronto and is an artificial intelligence company focused on preventative care through the early identification and detection of disease. Their release announcing the transaction is interesting because of the complexity of the funding (dare we say leveraged?). HEALWELL has $47.6 million in funding over six rounds (Crunchbase). It trades in the vicinity of CA$ 2.00 which gives it a valuation of CA$354 million. Mobihealthnews

Orion Health was last mentioned here with their win two years ago of Saudi Arabia’s health information exchange. The founder, Ian McCrae for the past 30 years, stepped down in August 2022 for health reasons. Replacing him was Brad Porter, his son-in-law. 

On the other end of the spectrum, Tuva Health emerges from stealth with $5 million. The round was led by Virtue, with participation from Box Group and Y Combinator, and notable health tech angel investors. New York-based Tuva has an open-source data model for healthcare analytics and data management to be used by healthcare providers, payers, life sciences companies, and research institutions as an open standard for healthcare data transformation. Their software gives users the ability to transform claims and EHR datasets into analytics-ready data tables via an open-source data model with built-in normalization, data quality testing, and enrichment. 1,500 experts are currently working in collaboration on the model. Their initial partnerships are with Oscar Health and CareAbout Health.  The principals and founders, Aaron Neiderhiser and Coco Zuloaga, are former senior executives from Health Catalyst and Strive Health. Release, FierceHealthcare

Babylon Health’s Parsa founds new AI medical assistant venture, Quadrivia, one year after Babylon Health’s failure

Ali Parsa back in the news, just over one year after Babylon Health’s implosion.  Babylon’s CEO/founder Ali Parsa has a new and stealthy AI-related venture called Quadrivia. It was announced, unusually, by a personal post on LinkedIn yesterday (12 Nov). As one might surmise, it’s AI-related (this year’s flavor) and provides an AI assistant to clinicians. The company is incorporated in Jersey (Channel Islands) and is UK-based. It is seed funded by Norrsken, a Swedish VC. The amount is undisclosed. (More on this below from Sifted-FT and JFSC registry research)

Information on Quadrivia’s capabilities is limited to Parsa’s posting, their website, and a ‘first-person AI assistant’ narrated demo video embedded in the post and the home page of the website. Qu, the personal medical assistant in beta, is designed to support clinicians in multiple tasks as diverse as type 2 diabetes check-in, daily care coordination, menopause hormone therapy, flu vaccination education, and chronic kidney disease (CKD) follow-up. Quadrivia promises that its “AI agent for healthcare” capabilities will extend across the entire healthcare ecosystem for the clinician and patient, including hypotheses around diagnosis, investigation, clinician selection, treatment plans, monitoring, and more. According to Quadrivia’s information in TechFundingNews, the platform has a dual structure based on types of cognitive reasoning processes: “System 1 includes tasks that rely on quick decision-making, such as answering direct questions or following standard procedures. System 2 involves more complex, analytical tasks, like assessing patient symptoms and considering multiple possible diagnoses.”

Quadrivia attributes Qu’s capabilities to its clinical knowledge base, the patient’s medical records in the EHR, natural language (but not real time) text/audio conversation, and proactive/reactive care. Beyond providers, Qu can be used by payers, pharma for research, and startups, much as Babylon Health was originally positioned.

Clinicians are invited to test drive Qu using a signup form featured on the website. Seven clinicians listed on the website constitute Quadrivia’s Global Clinical Advisory Council and are investigating various use cases. Per the website, the assistant will not be released until it meets regulatory and safety requirements. Though the website states that “Qu is tested rigorously to ensure clinical accuracy and safety in every action it takes,” it does not state whether eventually it will be submitted to the FDA, Health Canada, or for EU CE Marking.

In the US, there is growing concern about the rigor of FDA testing for AI assistants and interpretative/diagnostic models, with many falling into what is lately being seen as the looseness of 2016’s 21st Century Cures Act ‘breakthrough device’ category

Returning to Quadrivia financials, Sifted’s research indicates that the Jersey filing for Quadrivia Limited is for the parent company of a UK-based entity. Parsa is termed as a “person with significant control”. The VC Norrsken holds 638k shares in the company.

This Editor then took a dive into the Jersey Financial Services Commission (JFSC) registry for Quadrivia. Both listings filed in 2023 establish the company, the first for a “reserved name company” on 10 October 2023 (essentially empty) and then on 31 October 2023 for a “registered company private”. The incorporation documents are singularly unrevealing and procedural save for the Special Resolution document (PDF) of 24 May 2024 that determines that the company now has 9,440,000 A shares of no par value and the more revealing Entity Profile that confirms Norrsken holds 638,297 shares between NVC Fund 2 (D) plus (E) and ALP Partners Limited holds 9,444,000 shares. A check of ALP Partners Limited’s LEI (Legal Entity Identifier code) identifies its registration in St. Helier, Jersey. Its other entity name is Babylon Partners (Jersey) Limited.

Returning to Sifted’s article, Parsa was listed at HLTH as CEO of the company and was scheduled to speak before canceling. Based on Companies House (UK) filings, Parsa is a resident of Spain and holds more than 75% of the company, which corresponds to the 9.4 million share owned by ALP Partners and not owned by Norrsken. Two former Babylon research scientists, Damir Juric and Adam Baker, are early hires and the company is hiring others. Of note: Swedish investors have a long relationship with Ali Parsa. Major Babylon backers that owned–and lost–over 42% of the company included Kinnevik, VNV Global, pension fund AMF, and Swedbank Robur.

This Editor’s opinion–and to be clear, it is only my opinion: The speed of development–less than a year–and the scope of the AI assistant service does leave this Editor in a state of mystified wonder. For starters, accurate, responsive AI and vast stores of data are extremely difficult to build up to a clinically testable form in a year, much less clinical validity. The company is still at seed/stealth, yet inviting clinicians to test it.

Let’s look back at the Babylon Health parallel. It started to gain notice as early as 2014 at various UK conferences and won over GPs with its chatbot app. By 2017, GP At Hand debuted in parts of London allied to select GPs and was promoted in a flurry of tube adverts and billboards. It received huzzahs from none other than UK Health Secretary Matt Hancock in 2018. It also claimed a great deal in automated diagnosis of routine illnesses, not all of which were valid and problems surfaced fairly quickly. By 2020, with the pandemic barely on, Babylon’s accuracy was debunked at multiple stages by Dr. David Watkins, a consultant oncologist, better known as @DrMurphy11, cardiac activists on both sides of the Atlantic, and Hugh Harvey, Babylon’s former regulatory affairs head from 2016 to 2017 [recap and links TTA 14 Sept 2023]. Babylon moved into the US market, never gained FDA approval, IPO’d via a SPAC that later cracked, bought up a supermarket blood pressure tester (Higi), a few practices, worked with the government of Rwanda to bring care to rural residents, cut deals with major insurers…and then by August-September 2023, went thoroughly, completely belly up in US and UK. It left 2.4 million Rwandans in the lurch. GP At Hand survives with an NHS practice group in London and the rest acquired by eMed.

Based on the dates, it took no time–less than one month–for Ali Parsa to step out of the Babylon wreckage and create a new AI-based diagnostic and care assistant entity–and find another Swedish backer within that next year. One year to a new AI-powered concept. The resilience is…amazing. And leads to more than a few questions.

Some thoughts on the takeaways from HLTH

HLTH, which was in Las Vegas last week (19-22 Oct), has moved from an ‘also-ran’ to a lead dog in healthcare conferences for the innovation oriented set, along with sister conference ViVE (with CHIME) for digital health in February. They offer an alternative to the broadly tech-focused CES and the HIMSS leviathan, which seems to have lost a bit of its mojo since HIMSS turned the management keys over to Informa

Like all industry meetings, there were the usual rash of announcements, panel meeting interpretations, and tea leaves reading by reporters on the scene. Both MedCity News and Healthcare Dive covered HLTH. MedCity News’ Katie Adams had seven hot takes resulting from conversations she had with various leaders from health systems, digital health, and VCs/investors. They were candid and as she put it, ‘refreshingly honest’. Your Editor’s comments follow.

AI could be worsening health disparities. This came from FDA commissioner Robert Califf who believes that health systems are using AI to segregate profitable patients from those who are not. “What we need is for AI to bring up the people who are currently disadvantaged.” Absent any proof at this stage that health systems are actually doing this while they are in at best early stages of attempting to integrate AI into an absurdly complicated network of systems without breaking them, this strikes me as Chicken Little-ism and Finger Wagging. 

Retail companies should stop trying to be something they’re not. A hospital CEO is quoted as stating that retailers are trying to apply their model to the healthcare space because healthcare delivery is wholesale. This deduction has some truth and then veers into the woods. Yes, Walgreens and CVS tried to apply a transactional model to primary care and got into Big Trouble. From the customer (patient) perspective, that person wants to get in, get fixed or examined–and get out with maximum speed and convenience. This didn’t happen. Will Amazon, a far bigger retailer, pull this off with One Medical brick-and-mortars, or run it as a membership ‘division’ linked with Amazon Prime? Their building of relationships with 20+systems like Cleveland Clinic for specialty care referrals (and in return primary care referrals) indicates they have the flexibility that Walgreens and CVS lack.

And since when is healthcare wholesale? It surely isn’t to the end user, the patient. This mindset is puzzling.

Strict abortion laws are likely already resulting in economic consequences. It seems that states with few to no limits on abortion are attracting OB/GYN residents and practices versus states with restrictions. This is a sad commentary on both the state of medical practice and public perception in dealing with human lives. There are alternatives.

Many investors have realized they backed products, not companies. The bloated investments and valuations that we saw in 2021 and 2022 (in actuality, 2020 into early 2022) could not be sustained. Well, yes, and the bubble burst last year. There was more to this. Easy IPOs through SPACs and the Fear of Missing Out (FOMO) led otherwise sensible retailers into buying brick-and-mortar primary care practices as extensions of their stores, investors into another iteration of ‘value-based care’, copycat virtual mental health providers, and digital health businesses that were essentially sinkholes, like Babylon Health. The companies may have had a good product or a nucleus of same. Then investors woke up and started to think about how impossible their exits were.

Healthcare leaders should remember they’re in the customer service industry. Exactly the opposite of the ‘wholesale’ delivery model. Patients are customers–but a special type of customer.

Next year, exit activity will likely still be lifeless in the digital health space. “Private equity firms might start acquiring more healthcare businesses.” Agreed. We’ll be seeing a lot more mergers of convenience to rationalize services and in some cases, survival–below the line of DOJ/FTC scrutiny.

We need to stop treating AI like a buzzword. In this view, it’s a tool that can transform healthcare delivery and make it better for both providers and consumers in speed and efficiency. In this Editor’s view, AI still needs to prove it can do this in a way that it is trustworthy, secure, and easily integrated into present systems.

Healthcare Dive highlighted a report by Silicon Valley Bank (SVB) and a Monday panel discussion on the decline of healthcare sector funding after the highs it reached during the Covid pandemic. It was a ‘sugar high’ that drew in non-healthcare sector “tourist” investors. Even at that time, it was not considered sustainable. Now the funding buzzwords are ‘pruning’ and ‘consolidation’. Investors are also looking for senior leaders with financial acumen and for companies that can create a fast path to profitability. SVB’s Megan Scheffel said that “One opportunity is for private equity firms to buy up multiple companies to create a platform” and create synergies. However, as this Editor has previously noted, this is yet another area where the DOJ and FTC are also scrutinizing. 

Big Tech–Microsoft, Google, Amazon, GE Healthcare and Nvidia–also saw opportunities at HLTH to promote their AI offerings, emphasizing use cases and partnerships with health systems, to solve a range of problems in documentation and scheduling, creating platform solutions customized to a specific health system. The big questions out there are readiness of clinicians to use the tools and how to offer them to systems responsibly. The tech providers do step back from telling health systems what to do. As Google’s Greg Corrado put it in the Healthcare Dive article, “It does need to be pioneered by healthcare systems that are willing and able to do the research on the ground, and not every health system can do that.” Exactly, as well as the implementation research and modifications.

One last thought–it was surprising how little news was generated at HLTH, versus before and after.

Mid-week news roundup: HarmonyCares $200M round, Risant to buy Cone Health, Courier Health’s $16.5M Series A; Coalition for Health AI loses HHS/FDA members; Weekend Read–reining in AI’s Wild West?

In further Signs Of Life in healthcare funding and acquisitions:

In-home primary care provider HarmonyCares obtained $200 million in an unlettered round. Lead investors are General Catalyst, McKesson Ventures, and interestingly, an unnamed large national payer. Other investors are K2 HealthVentures with existing investors Rubicon Founders, Valtruis, HLM Capital, and Oak HC/FT. HarmonyCares provides in-home primary care to 70,000 patients in 15 states via 175-plus providers. Care teams include nurse care managers, social workers, and pharmacists, reinforced by 24-7 on-call support. The integrated model serves higher-needs patients through value-based care partnerships with Medicare Advantage plans and Medicare ACO programs via Centene, Aetna, and others. The fresh funding will be used for market expansion and scale up new technology for clinical outcomes and patient satisfaction. The company was founded as US Medical Management in 2013, became majority owned by Centene Corporation, which then sold it off as part of their 2021 divestitures. Release, FierceHealthcare, MedCityNews

Risant Health, the nonprofit/community-based hospital system initiative of Kaiser, intends to acquire Cone Health of Greensboro, North Carolina. Cone has five hospitals and an insurance plan. Purchase price was not disclosed, but Cone’s 2023 operating revenue was $2.8 billion. Closing the deal is dependent on the usual approvals. Cone plans to continue to operate independently. It is the second of five planned acquisitions with a $5 billion war chest that kicked off with Pennsylvania-based Geisinger that closed in April, The systems are being chosen for value-based care and population health models–as well as financial health and geographic expansion. Geisinger added $4.6 billion in a one-time gain to Kaiser’s bottom line last quarter.  MedCityNews, Healthcare Dive

Geisinger also experienced a massive data breach initiated by a former Nuance Communications employee that potentially exposed 1.2 million records. While it took place in late 2023, it was reported only last week. TTA 2 July

Courier Health added a $16.5 million Series A from Norwest Venture Partners and existing investor Work-Bench to its existing $4 million in seed funding. NYC-based Courier is a customer relationship management (CRM) platform to manage specialty medications across the patient journey, coordinating information for biopharma companies from patients and providers for field access, patient services, and marketing teams. Release, Endpoints

The Coalition for Health AI (CHAI) is losing two members out of HHS: Micky Tripathi and Troy Tazbaz. They were named in March to the CHAI board of directors as non-voting Federal liaisons. Both withdrew from the BOD due to potential Federal regulatory conflicts surfaced by Congress with this primarily private and for-profit organization. Dr. Tripathi is head of the Office of the National Coordinator for Health Information Technology (ONC-HIT) and Acting Chief Artificial Intelligence Officer at the US Department of Health and Human Services (HHS). Mr. Tazbaz is Director of the Digital Health Center of Excellence (DHCoE) at FDA. An FDA spokesperson told Healthcare Dive that Mr. Tazbaz is stepping down after the agency decided it no longer needed to participate in CHAI as a non-voting member. Hmmmm…..

Weekend Read: despite CHAI and other well-meaning agencies, including Federal, AI still resembles The Wild West. The author of this MedCityNews influencer piece points out that a faulty algorithm can make the difference between life and death. While he credits AI scribes for lightening provider load, AI is no quick fix or a bucket of cherries. FTA:

  • Bold claims abound but aren’t backed up by clinical research or regulatory oversight
  • Healthcare has become saturated with AI solutions that blur the line between what’s regulated and what isn’t. Clinicians have been left in the dark and are pushing back–the nurses’ protest against Kaiser is but one example.
  • AI development should be viewed through a regulatory-grade lens. The ability to demonstrate that a solution is positively impacting the care of a patient and not creating patient safety issues is crucial.
  • Clinical AI needs to go through the FDA approval process and developers need to understand that process.
  • The solution is not there to replace the clinician

Of course, this is all happening as healthcare is targeted by ransomware bad actors–and while health systems are laying off experienced IT staff, who have to be part of this evaluation. The above-mentioned Kaiser laid off well over a hundred in the past few months. Becker’s

Breaking news: Veradigm may sell, merge, or seek ‘strategic alternatives’; appoints new interim CEO effective June (updated)

Breaking: Veradigm puts itself up for sale or ‘strategic alternatives’–but in the meantime replaces its interim CEO. The pre-holiday week and weekend break was undoubtedly a busy one at healthcare data systems/services Veradigm, the former Allscripts.

Sale? Merger? Something else? Crossing the wires today (Tuesday) at 7am Eastern Time US was the announcement that Veradigm is exploring “potential strategic alternatives that may include, but are not limited to, a sale, merger, strategic business combination or other transaction.” What was a puzzle was the next line in the carefully worded release: “The Company cannot assure that its exploration will result in Veradigm pursuing a transaction or that any transaction, if pursued, will be completed on attractive terms, if at all.” The release goes on to explain that there is no timetable for “any transaction” and that it was the last word until if and when something happens.

The doubt around ‘attractive terms’ seems unwarranted, as the same release also reaffirms their 2024 guidance of annual revenue between $620 million and $635 million and adjusted EBITDA between $104 million and $113 million. As of calendar Q1 close, they had cash/equivalents on hand of $343 million, funded debt of $208 million (the principal of 2019 convertible notes), creating net cash of $135 million. 

Veradigm appears in good shape, despite their delisting from Nasdaq earlier this year due to financial reporting problems two years running (2022, 2023, and 2024 to date), created by bad software, leading to continuing violations of Nasdaq listing rules. This led to the December resignations of CEO Richard J. Poulton and CFO Leah S. Jones and their replacement for a six-month term by Dr. Shih-Yin (“Yin”) Ho, coming from the board, as CEO, and Lee Westerfield from Clearsense as CFO. At that time, the board announced a search for permanent replacements [TTA 14 Dec 2023].  

Shares trade on the ‘pink sheets’ (OTC Markets OTCPK) under MDRX closing today at $8.70, up over $1.00 from last Friday.

Interim CEO departs, interim CFO stays. A second release today announced that Dr. Ho will depart the interim CEO slot on 7 June but interim CFO Lee Westerfield will continue. Dr. Ho’s place as interim CEO will be taken by Tom Langan, Veradigm’s president and chief commercial officer (CCO), reporting directly to executive chairman Greg Garrison and the board. No interim president/COO was named. From the release, Dr. Ho will not be returning to the board or any other function with Veradigm which is a most interesting exit. During her time, the company in February acquired ScienceIO, a generative AI/LLM company to add AI capabilities, and in January bought Koha Health, which fit into their revenue cycle management functions for MSK [TTA 27 Feb]. Lee Westerfield will be continuing as interim CFO until 24 December. Another change: this release made it clear that no permanent executive appointments will be made “while the separately announced exploration of strategic alternatives is in process.”

What does this mean? This Editor projects that offers for parts or all of Veradigm’s business are in the pipeline, whether they are relisted on Nasdaq or not. In a company of this size, breadth, and apparent good health, the jobs of CEO, president, and chief commercial officer (CCO), typically two to three positions, are never collapsed into one person. In this unique situation, this eliminates one or two C-level compensation packages. Going back to December 2023, a CEO had to be temporarily slotted in as the company was still listed on Nasdaq. Leaving a vacancy would not have been acceptable. Regarding the CFO position, in a sale or other “strategic alternative to maximize shareholder value”, a CFO is more important than even a CEO in working out the financial details, which for Veradigm are more complicated than usual. 

In fact, this move could be seen as telegraphed in February. When accepting its Nasdaq delisting, Veradigm’s board adopted a limited duration stockholder rights plan that issues by means of a dividend one preferred share purchase right for each outstanding share of Company common stock to stockholders of record on the close of business on 8 March 2024. This becomes exercisable only if a person or group secures beneficial ownership of 10% or more of the outstanding shares in the next year. The rights plan is obviously designed to compensate shareholders in the event of a takeover not approved by the board (i.e. a hostile takeover) via accumulation of stock and make a sale to an unapproved buyer less attractive, though it hasn’t stemmed the filing of various shareholder class-action lawsuits. Crain’s Chicago BusinessHealthcare Innovation

Editor’s further note: It is not unknown to break up a company in order to maximize shareholder value. The parts can be worth more than the whole. GE is the most recent example. More akin to Veradigm, Cendant Corporation, in which this Editor was once part of as a manager/director in the Avis Rent A Car unit, was sold or spun off in parts in 2005-6. Once a giant in hotel, car rental, timesharing, real estate brokerage, online booking, and other parts of travel, by 2005 the primary shareholder/CEO decided that the share value was not reflective of the company value, and proceeded to sell and spin off its businesses–rather smartly before the real estate crash in 2007-8. Perhaps Veradigm does not see a way forward in running its diverse healthcare businesses even where it has a strong and currently profitable position or there is pressure from its largest shareholders to cash out. It is always worth looking at shareholders. Close to 22% of its shares are institutionally held but widely distributed among them. The largest holders are Silver Point Capital (2.29%), Tyro Capital Management (1.5%), and a host of Vanguard and DFA funds totaling under 10%. Insiders hold only 1.3%  Yahoo Finance

Our Readers should not be surprised at any one of several outcomes in the coming months.

Another icy bucket: who is liable when a healthcare AI system fails?

When AI contributes to patient injury, who will be held responsible? That is the question that an article in the New England Journal of Medicine (NEJM, 18 Jan, subscription required). It examines over 800 cases, pulling out the most relevant information on the 51 cases with software creating physical injury.  If you are in a healthcare provider or vendor legal department and strategic sourcing, this article deserves your greatest scrutiny.

AI and even software represent a relatively new area of tort law (an act or omission that leads to injury or harm). Responsibility is not clear because there is a lack of clear direction in existing case law, plus cases involving AI are few to date. The study reviews aspects of AI that may elevate or minimize risk. Ultimately, it comes down to minimizing risk in the adoption of AI tools as it was in clinical decision support systems and EHRs–because not adopting them may eventually be construed as malpractice. 

Cases involving medical software and AI have generally clustered around three situations. From the study:

  1. Harms to patients caused by defects in software that is used to manage care or resources. Typically, plaintiffs bring product-liability claims against the developer.
  2. Physicians having consulted software in making care decisions (e.g., to screen patients for certain conditions or generate medication regimens). In cases of harm, those physicians’ decisions are evaluated against what other specialists would have done–standard of care.
  3. Apparent malfunctions of software embedded within devices, such as implantables, surgical robots, or monitoring tools. Plaintiffs may assert malpractice claims against physicians and hospitals, alleging negligent use, installation, or maintenance of these devices, including human error in reprogramming. Plaintiffs may also sue developers, alleging defects in manufacturing, design, and warnings.

Moving ahead, the study’s recommendations on weighing liability risk against the benefits of adoption of AI in direct patient care with a “human in the loop” (not fully autonomous software) are, from the study:

  • Resist the temptation to lump all applications of AI together. Some tools are riskier than others.
  • The hallmarks of risk are: low opportunity to catch the error, high potential for patient harm, and unrealistic assumptions about clinician behavior
  • In tools that can create high risk, expect to allocate substantial time and resources to safety monitoring and gather considerable information from model developers and implementation teams. Lower risk tools should be monitored in a more general, lower-touch way. 
  • Organizations can bargain, in a buyer’s market, for terms that minimize purchasers’ liability risk. Licensing agreements should, for instance, require developers to provide information necessary for effective risk assessment and monitoring, including developers’ assumptions regarding the data that models will ingest, processes for validating models, and recommendations for auditing model performance.
  • Purchasers should also insist on favorable terms governing liability, insurance, and risk management in AI licensing contracts–in other words, indemnification. If developed in-house, ensure that you have adequate insurance to cover claims.
  • Apply lessons learned from older forms of decision support. Courts examine whether the recommendation was evidence-based and whether the physician should have heeded it for the patient in question.
  • Document, document, document
  • Legal defenses for AI require different expertise and expert witnesses than typical malpractice cases.
  • It also may be prudent to inform patients when AI models are used in diagnostic or treatment decisions–informed consent

POLITICO commentary 

Two Must Reads: Is AI the next hype bubble replacing crypto–and capable of great harm?

crystal-ballTwo articles that consider the current state of AI to read and ponder. On one hand, far less than what it’s hyped to business–especially healthcare–and on the other, more malevolent with great potential for harm.

The first article by Gintaras Radauskas in Cybernews confirmed this Editor’s misgivings on exactly what is artificial intelligence (AI) and the unrealistic expectations around it. It seems that a lot of the thinking around AI is doubletalk–gibberish, as he put it, leading off with analyzing a recent interview of Sam Altman of Microsoft-backed OpenAI and its chatbot ChatGPT. 

“To me, AI looks like a solution to a problem that’s not a problem – or, actually, a non-solution to the very real problems that are not going away.”

  • He draws parallels to cryptocurrency, which was widely hyped in the past few years as a secure alternative currency that was off the dollar and global bank grid. Even large banks, financial institutions, and big VCs like Sequoia Capital were sucked in. And real people did lose real money–famous football quarterback Tom Brady to African and Indian students.

This Editor knew the high and nonsensical point of the bubble was when she was in her local Shoprite perhaps two years ago and after checkout, next to the NJ Lottery machine and containers of sidewalk deicer, there was a machine that would convert my very real US greenbacks to crypto. The end of the bubble was the FTX bankruptcy in November 2022, then the arrest followed by last year’s trial and conviction of FTX’s Sam Bankman-Fried. Gaining little notice was that FTX was itself hacked and drained in a SIM-card swapping scheme in late 2022 before its collapse that emptied the accounts of 50 people. Those three perpetrators were indicted earlier this month. CNBC

  • When crypto imploded, ChatGPT took its place in the TechWorld Hype Universe. Bank of America terms it a ‘defining moment–like the internet in the ’90s’. For those of us who were around then, there were bulletin boards (!), multiple platforms (AOL), something called search engines (AltaVista, Dogpile), and lots of websites that surfaced and then went under the waves. A lot of money changed hands and a lot of parties were thrown before the dot.com bust. Unlike the internet boom, AI is already dominated by the tech giants like Microsoft (OpenAI) and Google (Bard, now Gemini) so it’s actually less of a risk for the large companies eager to use it.

But then why are these large companies not on board yet? “Only 3.8% of businesses reported using AI to produce goods and services, according to November’s Business Trends and Outlook Survey. It’s safe to say we’re very, very far away from mass adoption and use of AI.”

Perhaps it’s this. AI has already been parodied as a highly sophisticated long-form autocomplete tool. Your Editor has experimented with generative AI via Microsoft’s Bing. Example: an article on a non-healthcare topic, antique auto restoration. It was largely but not entirely accurate. But it was written at about a fifth-grade level in a style that was flat and uninteresting–the dumbing-down of the value of copy to inform and persuade continues. (Companies look at writers and marketers as an expense to be eliminated, not managed. As a marketer from the start of my career, and who worked for or with some of the best-known US agencies renowned for creativity, I would not recommend that career path to anyone today.) 

  • And finally, the ultimate use of AI is to get rid of people. That is what automation does. And while it can increase accuracy, speed, and take away drudgery in tasks like healthcare billing and coding, healthcare is about people–and while it can make it appear more responsive, when the humans are gone, will only the chatbots be left, with coding that endlessly replicates itself, like the automated phone menus that leave you in the ether with your questions unanswered–except it’s your diagnosis or information that your doctor’s trying to obtain? And what happens to the professionals trained to do these tasks and who already use automation tools to do their work? What happens when AI picks up and propagates a wrong treatment or surgical technique? This is not quite the analogy of the blacksmith and horseshoes or film versus video. We are ill equipped to deal with the societal effects of training people for jobs that no longer exist and concentration of technology into a very few companies.

And if we leave these tasks to AI without human intervention and supervision, what will happen?

The second article, linked to in the first, could be titled after the 1960s movie ‘Experiment in Terror’. Imagine asking AI about you. It tells you you’ve died and gives links to your obituary. Alexander Hanff, a founder of IT companies, computer scientist, and privacy technologist did. And ChatGPT repeatedly told him he was dead, complete with fake links to his obit in the Guardian and very convincing text. Now imagine you’re applying for a job, a loan, a mortgage, or a passport. The AI tool tells the employer, the bank, and the Feds that you’re dead. Hanff was already warned by a professional colleague who conducted the same exercise and received a bio back with false information. This deep fakery, origin unknown and undiscoverable, is huge potential for harm. Conclusion:

“Based on all the evidence we have seen over the past four months with regards to ChatGPT and how it can be manipulated or even how it will lie without manipulation, it is very clear ChatGPT is, or can be manipulated into being, malevolent. As such it should be destroyed.” ®

Hanff has company with Steve Wozniak of Apple on this [TTA 5 May 2023]. Read this one all the way through. And be scared. The Register

Sell NHS medical records to fund AI, biotech? Not quite what’s in the Blair-Hague report. (updated)

A ‘sale’ not quite what the press reports. The former political rivals of the 1990s and early 2000s, Sir Tony Blair and Lord William Hague, joined forces again last week to release their third report.  “A New National Purpose: Leading the Biotech Revolution”, the third joint report available on Lord Hague’s website, would be to capitalize on what they described as “the fastest and most far-reaching [technological] revolution in the history of human civilisation” to make Britain a world leader in developing “gene therapies, of discovering new antibiotics and of building molecular factories.”

The three major points of the report are:

  1. Formation of a new laboratory, the Laboratory of Biodesign, to focus on the invention of new biotechnology, biomolecules, and therapeutics that are at too early a stage for commercial investors.
  2. Establishment of an NHS Data Trust (NHSDT, pages 33-36),designed for public benefit, with a controlling stake owned by NHS England and additional investments from companies. 
  3. For scaling up biotech, an expansion of the work of the British Business Bank, improved rules for Venture Capital Trusts and consideration of scale-up grants where companies will list in Britain. The recommendations go further into reforms in venture capital funds and capital markets.

#2 is the point making the headlines in the Independent and Sky News. The reports do not explain that the sale of the NHS medical records would be done through the NHSDT.  It would negotiate data-sharing agreements with external organizations and be capable of joining profit-sharing arrangements, while guarding that data would not be sold to third parties and be strictly anonymized. The plain language of the recommendation: “Provide research entities with access to the anonymised data in return for financial profit, which would benefit the NHS. This could happen via a range of mechanisms, varying from direct financial payment to negotiating cost-price access for the NHS to any medicines developed based on the data provided.” (page 35) Profits would be reinvested into the NHS. The analogy is to the for-profit parts of the BBC.

The report goes on to stress producing high-scale companies that stay in the UK, versus the current situation of exporting technology to the US. It also proposes a Biosecurity Task Force “to keep Britain and the rest of the world safe from biotech accidents and bad actors.”

It also addresses how the UK should address a future pandemic as a national security issue (pages 55-58) and restructure the UK Health Security Agency.

In AI, the report recommends the formation of the MediMind laboratory network that would work towards relieving pressure on the NHS through creating personalized AI doctors. This would be done in partnership with industry and the NHS. Last June’s report concentrated on AI.

(Update 2 Feb, Editor’s note: It dismays me again that professional reporters writing for reputable news websites misinterpreted the report as advocating the straight-up sale of NHS medical data. All one had to do was what this poor Yank marketer/writer did–search within the report, past the executive summary, into that section. But ‘selling NHS data’ is more ‘clickbaity’. 

Unfortunately, this Editor believes that these reports will be read, filed, and the same mistakes will be made, putting the UK further behind the proverbial 8-Ball…standard operating procedure.

Open forum below for our UK (and elsewhere) Readers.)