Midweek news roundup: Steward cancels hospital auction, investigations mount; GE HealthCare’s Intelligent Ultrasound $51M buy; $100M for Headway; $80M for CytoReason AI

Steward Health Care’s bankruptcy hits a wall. They canceled auctions for hospitals located in Ohio, Pennsylvania, Arkansas, and Louisiana according to documents filed last Sunday. They successfully had bids on one hospital each in the latter two states: Glenwood Regional Medical Center in Louisiana for $500,000, and Pafford Health Systems has bid on Arkansas-based Wadley Regional Medical Center for $200,000. The low prices reflect the assumption of the facilities’ existing liabilities. They will also exit rental agreements with Steward’s landlord arm, Medical Properties Trust. Most of the 31 Steward facilities are failing to find any interest, and Optum weeks ago exited its pre-bankruptcy bid for the practice arm, Stewardship Health. According to the filing, Steward will announce an alternate approach to the sales process. The debtors-in-possession, which provided financing to continue to operate the hospitals during the bankruptcy process, are awaiting. Healthcare Dive, FierceHealthcare

Three Senators demand an investigation into Steward’s practices. Bernie Sanders (I-VT), Bill Cassidy MD (R-LA), and Ed Markey (D-MA). They are respectively the chairman, ranking member, and subcommittee on primary health chairman of the Health, Education, Labor and Pensions (HELP) Committee. There will be a vote this busy week on subpoenaing CEO Ralph de la Torre about the financial arrangements leading up to its insolvency. Dr. de la Torre has refused previous requests to appear before the HELP committee. Becker’s, FierceHealthcare

The US Attorney’s office based in Boston has reportedly jumped into the Steward investigation act, citing fraud and violations of the Foreign Corrupt Practices Act about its business dealings in Malta between 2018 and 2023. Steward operated three hospitals for the Maltese government and also engaged in a $7 million spy operation of its critics through its operation there. Malta stripped Steward of their hospital management contracts in 2023 [TTA 2 July]. CBS News 

M&A/funding roundup

GE HealthCare is buying Intelligent Ultrasound’s clinical AI software for a tidy $51 million. Intelligent Ultrasound is already partnering with GEHC with tools available on their Voluson Expert and Voluson Signature ultrasound devices. The buy is scheduled to close in Q4 and GEHC is funding with cash on hand. Intelligent will continue in business with software for ultrasound simulation technology. GEHC release, Healthcare Finance

Mental health remains hot with $100 million heading to Headway–more on this from last week’s sketchy reports. It’s not an unlettered round but a Series D. Also confirmed: their valuation is now $2.3 billion, surely making backers Spark Capital, a16z, Thrive Capital, Accel, and new investor Forerunner Ventures, most happy. The raise will be used for service expansions to all 50 states and to members in Medicare Advantage, commercial, and Medicaid plans. Headway closed a $125 million Series C round in droughty October 2023. Release,  Mobihealthnews

AI is even hotter, with Israeli startup CytoReason scoring $80 million in an unlettered round. CytoReason develops computational disease models for predictive asset insights, increasing the speed and accuracy of R&D decisions for biotech companies. It already has partnerships with Pfizer and three other pharmas, and claims six of the world’s top ten pharma companies use their technology for immunology, inflammation, immuno-oncology, metabolism, and other therapeutic areas. Funders are Pfizer, OurCrowd, NVIDIA and Thermo Fisher Scientific. They plan to open a US headquarters in Cambridge, Massachusetts later this year. Release, Mobihealthnews

Class action legal action by pharmacists, providers ramps up against Change Healthcare/UnitedHealth Group

More litigants in a legal pile-on in Minnesota. The National Community Pharmacists Association (NCPA), with 19,000 pharmacy members, and around 40 providers have filed suit against UnitedHealth Group, Optum, and Change Healthcare in the US District Court for the District of Minnesota. The 140-page document charges that UHG/Optum/Change had substandard network security in their clearinghouse operations, leading to the Blackcat/ALPHV breach, and that the plaintiffs might have chosen another clearinghouse and revenue cycle management platform had they known this. The pharmacists and providers all suffered monetary damages from the outage that are still unresolved.

From the press statement, NCPA CEO B. Douglas Hoey: “NCPA was against UnitedHealth’s acquisition of Change from the start. This breach proves that bigger is not better and that consolidation often leads to inefficiencies. Companies are so big they cannot protect every entry point and cannot respond quickly due to internal bureaucracy. The fact issues remain unresolved is a testament to this point. This breach has cost our members a significant amount of money and time and it is still not resolved months later.” He also pointed to the pharmacies’ losses remaining unpaid, financial losses, and taking losses for vulnerable patients with high-cost prescriptions.

According to Healthcare Dive, the multiple lawsuits against UHG must be centrally filed in Minnesota, as ordered by a Federal judicial panel, since UHG is headquartered there. Nothing will move quickly, as class action suits typically take two or more years to be heard and then appealed.

Change started its HHS-OCR mandated process of notifications around 20 June with hospitals, insurers, and other customers. Individuals and practices were not scheduled to be notified until late July but no date has been announced. The Change website also contains a very carefully worded ‘HIPAA Substitute Notice’ that reads like a consumer data breach notification. TTA 21 June

The DOD-MHS/VA Lovell ‘success story’ can’t process 60% of pharmacy prescriptions: House Committee

Here we go again. The Department of Defense’s Military Health System (MHS), the Department of Veterans Affairs (VA), and Oracle have all cited the Captain James A. Lovell Federal Health Care Center in North Chicago as a successful joint implementation. It is the only joint, fully integrated MHS/VA facility, was the only exception to the full pause on Oracle Cerner implementations in going live on 9 March, and so stands alone in complexity and importance. Oracle EVP Ken Glueck, in excoriating Business Insider, pointed to Lovell as a successful implementation to prove It Could Be Done! [TTA 31 May].

Except…except. House Representative Matt Rosendale (R-Mont.), the chairman of the House Committee on Veterans’ Affairs Subcommittee on Technology Modernization, a skeptic from Day One, investigated with other committee members. Several unnerving findings: 

  • “The pharmacy is completely reliant on outside help to operate”. 
  • “The Oracle Cerner pharmacy software functions so poorly that the permanent pharmacy staff can only process about 40% of the prescriptions.”. That means 60% of prescriptions go unfilled.
  • “The Committee staff visited James A. Lovell twice, and the employees are reporting the same frustration, hypervigilance, and burnout that the managers of the other four facilities testified about last September.”
  • 100 new staff have been hired at Lovell, with another 100 on the way.
  • About 800 experienced staff from other facilities and VA’s central office pitched in after the 9 March go-live.

Rosendale, in his opening remarks, expressed great concern that VA Secretary McDonough could realistically resume Oracle Cerner EHRM go-live at any scale, given the Lovell experience. He also noted that “the Veterans Health Administration is facing a $12 billion budget deficit, the financial impacts of the EHR on the organization’s staffing have never been budgeted or seriously reckoned with.” 

His conclusion was strong language: “Veterans and taxpayers deserve to know how large the Oracle Cerner bill truly is. Congress as well as the public need all of the information in order to make an informed decision about whether this is worth it, and whether the inevitable sacrifices are truly justified. Anything less is dereliction of duty.” Hat tip to HIStalk 7/24/24

TTA’s Steamy Summer 2: fundings come alive for Huma, Thyme Care, Headway, others; Steward’s bottomless mismanagement; Masimo v. Politan rolls on; Walgreens needs a lift; Meta’s Reality Labs gone sideways; VA and AI, more!

 

 

It may be 90º+ out, but summer doldrums haven’t set in yet! Masimo v. Politan will be a summer-long soap opera, fundings have suddenly heated up, VA’s dipping a toe into AI, and payer earnings are looking OK despite the Change and utilization hits. But Walgreens needs some help, stat–there’s no bottom to Steward’s mismanagement–and Meta’s Reality Labs seems to be going sideways.

(What’s EiPaaS? Find out here!)

Perspectives: Embracing the Power of EiPaaS in 2024 and Beyond (A POV from Vorro)
Short takes: fundings for Huma, Truvian, Headway, ThymeCare, Freshpaint; Headspace’s new CEO; UK M&A RLDatix-Carebeans; Elevance earnings news, another Steward shocker; Meta’s Reality Labs AR unit sinking–is Meta? (Funding continues its roll)
News roundup: UHG’s cyberattack hit now $2.3B, Senate bill on cyberattacks intro’d, VA’s AI tech sprint awards, AliveCor’s new CPT codes
Masimo v. Politan goes into extra innings with two-month shareholder meeting delay, mucho maneuvering
(Now playing into September)
Walgreens’ Mound of Misery piles higher with shareholder class action lawsuit, skeptical industry opinion (Needs light at end of tunnel, stat!)

Three themes that will play out into the fall: fundings and M&A are picking up after a deathly 2023, healthcare AI skepticism is on the increase—and the VA faces a Section 508 and 501 Federal lawsuit on accessibility and discrimination in choosing Oracle Cerner. Masimo’s proxy battle drama will crescendo on 25 July, but latest move is to sell off their consumer business. Bubbling under this– Amazon and One Medical’s possible mishandling of older patients.

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? (Signs of funding life–and AI skepticism)
Two debuts of note: Samsung’s Galaxy Ring, Watch upgrades; Alivecor’s InstantQT+KardiaMobile 6L Europe launch 
News roundup: Masimo has offer to JV consumer business for $950M or more, Get Well sold to SAI, One Medical scored on poor handling of urgent calls from Iora patients (Masimo’s many maneuvers before shareholder meeting–and One Medical’s little problem with older adults, a market they may not want)
VA sued in Federal court on Oracle Cerner EHR accessibility issues (A small lawsuit but legitimate big problem for Oracle)

Lots of follow ups this week on the Feds charging more people at Done, Walgreens finally giving up on VillageMD clinic concept in selling off, Boots’ managing director departs, Amwell’s reverse stock split, One Medical absorbing Amazon Clinic, Steward Health’s $7M spy business, MeMD sold to burgeoning Fabric, Masimo’s proxy fight continues.

Done Global Federal probe expands to five more people; company suspended from Google, TikTok ad platforms (Another shoe drops)
Short takes: Fabric buys Walmart’s MeMD telehealth arm, Geisinger data breach via vendor exposed ~1.2M records, UK’s Careium develops resilient rSIM, $50M funding for K Health, India’s Alyve’s $6M Series A, Upside Health closes
Follow up roundup: Amwell to reverse stock split to avoid delisting, Amazon Clinic folded into One Medical, Amedisys divesting to close UHG deal, latest on Steward Health’s antics and spying, Masimo’s shareholder fight 
Walgreens gives up on VillageMD, will sell to reduce stake below majority, closing underperforming stores, revising profit outlook– and in abandoning Boots sale, managing director James quits (Walgreens still sinking–why?)

AliveCor’s Kardia 12L compresses a 12-lead ECG into a single cable assisted by AI. There’s M&A activity at long last with eVisit and Sharecare going private along with some decent raises for Talkiatry, CipherHealth and Heyday. Medtronic tries but fails to keep its layoffs on the QT and Strictly HushHush. NeueHealth resurfaces with another daring loaner. And the Gimlet Eye resurfaces with a take on Cracked SPACS and recent IPOs.

Short takes/wrapup: fundings for Talkiatry, Heyday Health, CipherHealth; Brightside Health now 50 states for Medicare Part B; Neurabody’s sensor based posture therapy; below the radar global layoffs at Medtronic
News roundup: AliveCor launches FDA-cleared Kardia 12L ECG, eVisit buys UPMC’s inpatient teleconsult, UPMC and MedStar invest; NeueHealth gains $150M loan–with caveats–and NYSE non-compliance notice
A Gimlet Eye view on IPOs and Cracked SPACs: Altaris’ buys Sharecare for $518M, takes it private; a look at Waystar and Tempus AI post-IPO (Gimlet returns from the Remote Pacific Island–virtually, of course)

The first Federal prosecution on telemedicine prescribing against the leaders of Done. VA extended Oracle Cerner’s EHR implementation for another year. The UK Synnovis hack was ransomware, still affecting London hospitals. Still around Verily gets in on the GLP-1 craze. Pepper the Robot resurfaces in San Diego for mental health. And closing the week, Change/UHG finally getting required data breach notifications out along with three fundings.

Week-end short takes: Change Healthcare/UHG breach notification starting; fundings for Pomelo Care, Marigold Health, Humata Health (Green funding shoots?)
A lighter update: Pepper the Robot’s comeback at San Diego State University–now AI-equipped for mental health
News roundup: VA extends Oracle Cerner for 11 months; Amwell founders swap jobs; Alphabet’s Verily pivots to Lightpath with GLP-1, retiring Onduo; UnitedHealth hasn’t notified on Change breach
Done CEO, president arrested, charged with $100M fraud on Adderall distribution in first Federal case on telemedicine prescribing (updated) (First of many?)
UK pathology services Synnovis hacked by Qilin ransomwareistes, demand $50M, justify attack due to UK involvement in “wars” (One system, lots of vulnerability)

A week of ‘further developments’. Teladoc replaces its CEO in two months–record time. Waystar finally IPOs after two years. Steward Health gets the DIP bucks at the last minute to continue until it’s sold off. Devices and app systems like Dexcom and Aktiia make significant improvements that improve their marketability. Category consolidations in telemental health and behavioral health risk analytics. And are these the last appeals for Theranos’ Holmes and Balwani?

Short takes: Dexcom G7 now directly connects to Apple Watch, Brightside Health acquires Lionrock, Aktiia CALFREE gains CE Mark for optical BP monitoring not requiring calibration (Further telemental consolidation and digital health device upgrades)
Oracle’s Q4/FY 23 earnings push Cerner to background, stock price soars on AI deals; 81% of VA clinicals really can’t stand Cerner (Can this EHR be saved?)
News roundup: Teladoc’s new CEO from major payer, Steward Health lives with $250M injection, Waystar’s IPO raises $968M, NeuroFlow acquires Owl (A record time for CEO replacement)
Theranos’ Holmes and Balwani appeal fraud convictions, $450M investor restitution (One last try on appeal?)

NHS England made a lot of not-good news this week, with ‘serious harm’ linked to their multiple EPRs and by midweek, a third-party vendor ransomware attack crashing pathology systems in London hospital trusts. Theranos’ Elizabeth Holmes’ defense in court next week for appeal. Steward Health running out of operating money while being sold off in Federal Bankruptcy Court. Ascension breach scares health execs, but 1/3 don’t have contingency plans especially for vendor hacks. On the sunny side–some strong fundings for Eko, Sword, and Plenful.

Short takes: Holmes legal team appealing Tuesday 11 June; Steward Health asset sale OK’d, needs funding; fundings for Sword Health, Eko Health (Them’s that got, has $)
Breaking: multiple London hospitals, borough GPs declare ‘critical incident’ from ransomware attack via third party pathology vendor (Who’s responsible?)
News roundup: Change responsible for data breach notices; 37% of healthcare orgs have no cybersec contingency plan; health execs scared by Ascension breach; CVS continues betting on health services; Plenful’s $17M Series A
NHS electronic patient records linked to 100 ‘serious harm’ issues, with ~50% of NHS England trusts reporting patient issues: BBC News (Many fixes needed here before AI arrives)

 


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Perspectives: Embracing the Power of EiPaaS in 2024 and Beyond

TTA has an open invitation to industry leaders to contribute to our Perspectives non-promotional opinion and thought leadership area. Today’s article is by Scott Sirdevan, co-founder and CEO at Vorro. In this article, Mr. Sirdevan explains the concept of EiPaaS and how it can integrate the digital programs and tools used by healthcare providers, securely, to enable customers to bring together data from any system to the point of decision. He holds a master’s degree in computer information systems from Kansas State University and was the lead inventor on Vorro’s three BridgeGate patents.

Vorro empowers businesses with seamless integration solutions to connect, transform, and automate their data processes, ensuring efficiency and innovation in the digital landscape.

Despite the increasing risk of using digital tools in healthcare due to faulty systems and cyberattacks, the booming health tech sector is becoming more vital for healthcare systems than ever before, delivering efficient, proactive, and more accurate solutions to providers.

Today, one of the most popular health tech solutions is Enterprise Integration Platform as a Service (EiPaaS), with its market expected to reach $10.26 billion by 2027. Essentially a data integration solution, EiPaaS streamlines healthcare provider processes by creating a centralized space in the cloud for all programs and tools to work in unison.

EiPaaS has become increasingly critical as healthcare systems seek increased collaboration between insurance companies, suppliers, and patients and deal with more software programs than ever. This integration connects all operations, making tasks automated, timelier, and safer.

Let’s examine three reasons modern healthcare providers should embrace EiPaaS:

1.    Seamless Data Integration

Delivering seamless data integration in healthcare is crucial for patient care. Fragmented care, often due to delayed communications between suppliers, providers, and insurance companies or human error, creates adverse effects on patients with chronic illnesses.

EiPaaS in healthcare operations ensures efficient communication and minimizes human errors, from typos to delayed manual processes. Providers can seamlessly share information with suppliers quickly, ensuring low-latency system responses.

Access to up-to-date patient data, such as allergies, prescriptions, and other patient information, helps physicians make informed decisions.

2.    Enhanced Scalability & Security

Cybercrime rates have skyrocketed since 2020, with 2023 witnessing the most attacks on record. Cybersecurity is paramount in healthcare, and EiPaaS solutions address these concerns by providing robust security measures. The “enterprise” in EiPaaS signifies a higher grade of fault tolerance, scalability, and cybersecurity, meeting standards like HIPAA and other government-mandated compliance requirements.

Often, healthcare providers hire vendors without vetting their cybersecurity stance, which puts their services and patients’ information at risk. In 2023, there were 725 large data breaches in the healthcare sector, exposing over 133 million records. Hacking incidents accounted for 79.72% of these breaches​ (The HIPAA Journal)​​ (HHS.gov)​​ (The HIPAA Journal)​. EiPaaS solutions feature up-to-date compliance, secure data sharing, and encryption, ensuring that digital services are safe and trusted.

Scalability is another significant advantage of EiPaaS. One of the biggest benefits is the ability to grow and shrink based on customer demand. This flexibility allows healthcare providers to handle large data loads efficiently. For instance, several of our customers have needed to load a large amount of data in a short time, and EiPaaS can scale up to support these large one-time bulk loads and conversions. This scalability ensures that healthcare providers can dynamically manage their data needs without compromising performance or security.

3.    Optional Fully Managed Services

A significant advantage of EiPaaS is its optional fully managed services. These services are beneficial for healthcare organizations in many ways. Healthcare organizations can focus on their core business, utilizing the EiPaaS provider to handle all Integration responsibilities and support. Managed services are more cost-effective and in sync with the specific systems healthcare organizations use daily.

As health tech solutions become more critical and scrutinized by regulators, data integration services like EiPaaS are taking center stage. EiPaaS’s robust cybersecurity practices, full audited chain of custody of data, and fault-tolerance scalability integration are what modern healthcare systems need today, leveraging technological advances to elevate service quality, resulting in excellent patient care.

For Perspectives editorial and other promotional opportunities, contact Editor Donna.

Short takes: fundings for Huma, Truvian, Headway, ThymeCare, Freshpaint; Headspace’s new CEO; UK M&A RLDatix-Carebeans; Elevance earnings news, another Steward shocker; Meta’s Reality Labs AR unit sinking–is Meta?

Rounding up the fundings first, as signs of life persist through AI disruptions, hacking, and layoffs:

Huma, the former Medopad, now up to a Series D and over $322 million in total funding. The $80 million funding represents a share issuance. Funders included AstraZeneca, Hat Technology Fund 4 by HAT SGR, HV Fund by Hitachi Ventures and Leaps by Bayer. London/New York-based Huma’s last major round was in May 2021 with a jumbo $130 million Series C, not unusual for that time. That round had a $70 million add-on option; looking at Crunchbase, there was a corporate round of £25 million and a debt financing of $30 million between the Series C and D. In 2020, Huma renamed, relogo’d, and pivoted then from something ill-defined around predictive diagnostics to a platform that supports ‘hospital at home’ plus pharma and research companies in large, decentralized clinical trials.

With the funding, Huma also announced the Huma Cloud Platform, designed to benefit their own projects and those of digital health developers with a library of pre-built modules and device-connectivity capabilities. The platform is FDA Class II, EU MDR Class IIb and Saudi FDA Class C cleared.  Huma release, Mobihealthnews

Truvian Health, developer of an automated digital benchtop blood-testing and diagnostics system, scored a $74 million raise in a venture round. The round was led by Great Point Ventures and Wittington Ventures, with participation from existing investors Medical Excellence Capital, Tao Capital, DNS Capital, 7wireVentures and TYH Capital. The company has raised over $208 million through this round and a 2021 (!) $105 million Series C. Truvian’s analyzer is not FDA cleared as of yet and the raise will be used to obtain that clearance. Truvian is also partnering with Shoppers Drug Mart, Canada’s largest pharmacy, as a commercial partner, having worked with Truvian last year on an onsite evaluation versus standard lab testing. Echoes of Theranos, except that it may work?  Release, Mobihealthnews

Behavioral health platforms are still getting financing, with Headway benefiting from a $100 million unlettered venture round. Spark Capital led the round with previous investors participating including Thrive Capital, Accel, Andreessen Horowitz and Global Founders Capital for a total funding of $325 million and a $2.3 billion valuation. Their last round was a $125 million Series C in October 2023 which was pretty impressive in the middle of a funding drought. Reports are a little scarce including no mention on their website, but Behavioral Health Business has what’s available via Bloomberg News. Headway’s niche is exclusively partnering with health plans to provide members with therapy and psychiatry.

One of Headway’s competitors, Headspace, named a new CEO, Tom Pickett, as their new CEO, effective 12 August. He joins from DoorDash, where he served as chief revenue officer, which is quite a leap. Prior to that, he was in digital media and the US Navy as F/A-18 pilot and “Top Gun” graduate. Pickett replaces Russell Glass, who resigned in March. Headspace has had a rocky time of it versus competition, with layoffs of 15% last July and a $105 million senior debt financing to get by [TTA 27 July 2023]. Release

Value-based cancer care platform Thyme Care announced a capital raise of $95 million. The Series B round of equity funding was led by Concord Health Partners with participation from all existing investors, including CVS Health Ventures, Town Hall Ventures, a16z Bio + Health, AlleyCorp, Echo Health Ventures, Frist Cressey Ventures, and Foresite Capital. Adding to this was a $40 million debt financing from Banc of California. The fresh funding brings their total to $178 million. According to MedCityNews, “Thyme Care manages over half a billion dollars in medical spend through its risk-based contracts and anticipates tripling that amount within the next year. The company has also doubled its oncology partnerships in the last six months and intends to expand nationwide by securing new contracts with health plans, employers and primary care groups that bear financial risk”. Release, Mobihealthnews 

Freshpaint took a slightly different tack with its announcement of a $30 million Series B round. Their CEO/co-founder’s blog for this healthcare-focused performance marketing/data infrastructure security company interestingly asks the question why they decided to obtain additional financing. Well, they want to cover the waterfront (Editor’s term) of healthcare beyond hospitals to payers, other providers, and retail health. The financing was led by Threshold with additional participation from SignalFire, Intel Capital, Zero Prime, and Y Combinator. Their Series A back in November 2022 was a modest $9.5 million, for a total since their start of $42 million. 

On the M&A front, we have the UK’s RLDatix acquiring Carebeans. Transaction cost and staff transitions were not disclosed. The two systems will be integrated with single sign in. RLDatix is a healthcare operations platform that captures data across risk, safety, compliance, provider lifecycle and workforce management. Carebeans also provides care management services software primarily in the domicilary, care planning, supported care, and social care management sectors. Release

Elevance (the former Anthem) had a decent quarter. Their Q2 notched $2.3 billion in profit but the company turned around and lowered their full year guidance due to weakness in the health insurance business that reduced total revenue slightly to $43.2 billion. While beating Mr. Market, the ongoing weaknesses in the payer market have analysts seeing yellow and red flags. Elevance’s Medicaid enrollment declined 5%: 2.2 million to 45.8 million. As UHG stated in their earnings results, they are swimming against a general trend toward elevated utilization rates and higher acuity populations, particularly in Medicaid, which was offset by increased premiums. For Medicare Advantage, they believe their plans will benefit from CMS’ rerun of the Star ratings and balance out reimbursement cuts. Healthcare Dive, FierceHealthcare

As if the Steward Healthcare story couldn’t get any more seamy (not steamy–that was earlier this month), 14 executives paid themselves $1 million + salaries and bonuses in the year prior to the company’s Chapter 11. MedCityNews did the math on the bankruptcy filing addendum (Statement of Financial Affairs Amendment). The CEO earned a $3.7 million salary, the president of Steward Health Care a $1.73 million salary plus a $500,000 bonus, and the EVP for human resources a $842,000 salary with a $300,000 bonus. Extremely high C-level/EVP salaries in healthcare are not unusual even for smaller organizations, but Steward was in trouble plenty for some years, and being sued right and left by vendors for long-delayed payments and bouncing checks. You wonder what the debtors-in-possession will make of all of this

Last but certainly not least are reports of layoffs and major restructuring at Meta (Facebook)’s Reality Labs, which is their unit for augmented reality (AR)/virtual reality (VR) headset and software development unit. It’s now separated into two units, Wearables (headsets, glasses such as smart Ray-Bans) and Metaverse (platform and Quest headsets). Reports that are primarily paywalled have said that multiple leaders have been laid off from the company, with The Information (paywalled) stating the late June layoff affected a dozen VPs and directors. Teams also have to cut spending 20% by 2026, with the bulk of the cuts this year. Meta, despite billions in investment and Metaverse hype by Mark Zuckerberg including a corporate name change, has largely failed against Apple’s Vision Pro and others. ABPLiveEM360Tech

Whither Meta? An Editor’s Opinion: This Editor believes that Meta requires a real housecleaning which may be beyond the abilities or interests of its controlling shareholder. The Reality Labs reorganization resembles rearranging deck chairs on a listing ship as AR/VR users in healthcare invariably use Apple and other headsets. While claiming 175 million users of an X-like platform called Threads, does anyone actually use it? Facebook is suffering from an aging user base and Gen X defection. Ads are down in overall share though still around 10%. Effectiveness in the past few years is also dropping due to fatigue factor. As a Facebook admin for a non-profit organization, their tools feel a decade old–clunky and hard to use. Facebook Marketplace is a modest success as an e-commerce adjunct to Facebook, but resembles CraigsList. Zuckerberg seems to care more for his charities and political influence, so perhaps it’s time for him to leave management to others–and retire.  

News roundup: UHG’s cyberattack hit now $2.3B, Senate bill on cyberattacks intro’d, VA’s AI tech sprint awards, AliveCor’s new CPT codes

UHG reported earnings, profit reduced by $1 billion due to Change Healthcare cyberattack costs. On Tuesday 16 July UnitedHealth Group reported Q2 (ending 30 June) earnings of $98.9 billion, up $6 billion or 7% versus Q2 last year. Profit though didn’t move the same way, instead taking a hit at $7.9 billion, down from last year’s $8.1 billion. Despite strong performances in the UnitedHealthcare and Optum units, the drag from the Change Healthcare cyberattack is now estimated at an additional $1 billion from last quarter’s guesstimate, now at $2.3 billion. Also affecting the profit bottom line is inflating healthcare costs that are reflected in rising medical loss ratios (MLRs). Change is also obliged to do the patient notification which will start by the end of this month [TTA 21 June], having already started notifications of hospitals, providers, insurers, and other customers. Release, Healthcare Dive

But hey, now the Senate has a bill to coordinate agencies with the purpose of reducing those darn cyberattacks. The Healthcare Cybersecurity Act, sponsored by Senators Jacky Rosen (D-Nev.), Todd Young (R-Ind.), and Angus King (I-Me.), would direct the Cybersecurity and Infrastructure Security Agency (CISA) and the Department of Health and Human Services (HHS) to collaborate on improving cybersecurity. One important change would be creating an HHS liaison within CISA to coordinate incident response specifically for healthcare entities. An earlier version introduced by Sen. Rosen in 2022, S. 3904 (117th Congress), never made it into committee.  Sen. Jacky Rosen release, Healthcare Finance   But aren’t there other agencies involved in cyberattacks and ransomware like the FBI and the Department of Justice? And international agencies like the NCA and Europol since so many come from the darker parts of Europe and Asia? (The devil’s in the details…)

The Department of Veterans Affairs (VA) is taking a modest dip into the AI ocean. The award late last week of pilots for an AI-assisted healthcare dictation tool went to Abridge AI and Nuance Communications. The non-competitive, fixed-price contracts are as a result of the two companies winning the first track of the VA’s AI Tech Sprint which launched last October. The tools are designed to generate transcriptions from ambient recordings of patient encounters within specialty care, mental health care, and primary care settings, as well as integrating into the Oracle Cerner EHR. The notice does not specify start or end date. There is also a second sprint around developing an AI system to process documents generated in patient-provider encounters and other complex medical documents for continuity of care and sharing information with VA providers. FedScoop

AliveCor received CPT codes applicable to the company’s Kardia 12L ECG System. The Category III Current Procedural Terminology (CPT) codes are assigned by the American Medical Association (AMA).  The 12-lead system a few weeks ago gained FDA clearance for the combination of the Kardia 12L ECG System (left), a single cable with five electrodes that acquires 8 high-quality diagnostic bandwidth leads, with their KAI 12L AI-assisted diagnostic technology for clinician use only. The three new codes will be effective 1 January 2025 and will be published in the 2025 CPT Code book. Release

Masimo v. Politan goes into extra innings with two-month shareholder meeting delay, mucho maneuvering

In the history of proxy battles and hostile takeovers, Masimo v. Politan may be one for the business and law school case histories. The latest moves by health tech monitoring (and sound) company Masimo are to sue–both metaphorically for extra time and literally in a Federal court.

  • Masimo postponed on Tuesday 16 July their shareholder meeting, originally scheduled for next week–Thursday 25 July–to Thursday 19 September. The revised proxy statement will be filed with the Securities and Exchange Commission (SEC). This not only allows shareholders additional time to review materials but also, as requested by Politan Capital Management, a later ‘record date’  (deadline for share ownership) of 12 August. 
  • The downside of the postponement is that any shareholders who have already voted their proxies must vote again. Downside #2:  in this Editor’s view, conceding this allows Politan to accumulate additional shares beyond their current 9%.
  • Another reason for the delay: in a California Federal court, Masimo has filed for an injunction that seeks to force Politan Capital to correct “material misstatements and omissions” in its proxy materials.
  • Masimo also alleges in the complaint that Quentin Koffey, Politan’s chief investment officer and the company’s representative on Masimo’s board of directors, has assisted Politan’s counsel in litigation against Masimo.

The fight on the Masimo board of directors for two open seats pits the Masimo slate of CEO Joe Kiani and outside candidate Christopher Chavez, against Politan’s Darlene Solomon and William Jellison. Politan already holds two seats and with a win of two additional seats will control the company. Two outside proxy advisors, ISS and Glass Lewis have recommended that Masimo shareholders support both Politan nominees. Glass Lewis in particular accuses Masimo and Kiani in a form of proxy manipulation called ’empty voting’ by a 9.9% shareholder named RTW, a $5.9 billion fund described by Joe Kiani on the RTW website as a decades-long ‘trusted partner.’

Countering this are multiple conditional resignations from managers to leadership that would be effective if Politan controls the company, which would constitute a pyrrhic victory.

The bone of contention started in 2022 with the tussle over Masimo’s $1 billion purchase of Sound United’s consumer audio business, which made their share price crater. Masimo announced last week [TTA 10 July] plans to sell a substantial portion of that consumer audio and healthcare business to a to-date unnamed investor. MedTech Dive, Strata-gee.com, Masimo release

A few days earlier, Strata-gee summarized Masimo’s preliminary financials for Q2 2024 as strong for the Healthcare division with revenues of $344 million, up 22% at $63 million or 22% versus $281 million in Q2 2023. But the Sound United unit sank these good results with a 13% decline in revenues to $152 million–a decline that has been fairly consistent. Masimo needs to find another investor or sell off Sound United.

Stay tuned!

Walgreens’ Mound of Misery piles higher with shareholder class action lawsuit, skeptical industry opinion

Walgreens Boots Alliance (WBA) faces shareholder, analyst discontent. The securities class action lawsuit filed by investor Rizwan Bhailain on 12 July in the US District Court for the Northern District of Illinois alleges that WBA misled investors with “overwhelmingly positive statements” about its pharmacy division while “concealing material (sic) adverse facts” such as the pharmacy division being “not truly equipped to handle ongoing challenges in its industry” and that “Walgreens would require significant restructuring to create a sustainable model.” The proposed class is for those who purchased shares between 12 October 2023, right before CEO Tim Wentworth started, to 26 June 2024. Wentworth, CFO Manmohan Mahajan, and chief pharmacy officer Rick Gates are also named in the lawsuit. The law firms involved are Lubin Austermuehle P.C., the Law Office of Terrence Buehler, both in Illinois, and Levy & Korsinsky, LLP in NYC. Crain’s Chicago Business, Scribd (lawsuit full text)

Industry stock analysts aren’t crazy about what is happening either. As the stock remains in the doldrums below $12, Walgreens’ billion-dollar ‘cut and sell’ strategy under Tim Wentworth has not led to optimism. Full year guidance was lowered only weeks ago after Q3 results were in. [TTA 2 July] The assumption based from the Q3 call that one-quarter of Walgreens’ 8,700 US store locations are candidates for closure by 2027 hasn’t bolstered confidence from one influential firm, Raymond James, where an analyst remarked in a recent report: “We are unaware of any retailer successfully adopting a ‘shrink to survive’ strategy.”

MedCityNews’s dismal headline, “Walgreens’ Finances Are in Dire Straits — But All Hope Is Not Lost”, interestingly had no counter from Walgreens per author Katie Adams’s requests. She tried to find some optimistic voices but the best she could manage was a sanguine view from Stephanie Davis, senior equity research analyst at Barclays. She approved of shrinking VillageMD as the largest drag on Walgreens’ financials, but acknowledged that the ‘headwinds’ in retail pharmacy justified an underweight or sell rating.

UpScript Health’s CEO Peter Ax was quoted at length pointing out other factors affecting both the ‘front’ of the store and pharmacy. In the front, there’s theft, lack of staff, supply chain shortages, and consumer wallet shortages. Over in the pharmacy section, shrinking margins, lack of pharmacists, and the squeeze between the current cost of capital and Walgreens’ financials will likely hamper reconfiguring stores and adopting efficient technologies. Another factor is that the patient blending between the pharmacies and primary care has proved to be extremely difficult. Walgreens, in trying to create a pharmacy/VillageMD closed system, now sees it as low margin/high cost, and wants to offload the cost onto additional investors. (Not much different than CVS with Oak Street Health, except that CVS got to the JV point faster. TTA 29 May

Even when locations are closed, some leases may be difficult to terminate or ‘repurpose’–and in these closures, Walgreens will be dealing with the anger of communities believing they will be shortchanged in access to pharmacy and healthcare, which knock on to the political and bad publicity that’s not needed.

The ride continues to be rough for Wentworth and Company. What Mr. Market is saying is that some very good news needs to be forthcoming, quickly. If Walgreens is ‘too big to fail’, as the Trilliant analyst quoted in the article put it, well, that hasn’t proved true for other companies in similar situations.

TTA’s Steamy Summer: fundings/M&A on the rise, as is AI skepticism; VA and Oracle hit with accessibility violations; Masimo’s consumer business JV sale; One Medical mishandling older patients?, more!

 

 

Three themes that will play out into the fall: fundings and M&A are picking up after a deathly 2023, healthcare AI skepticism is on the increase—and the VA faces a Section 508 and 501 Federal lawsuit on accessibility and discrimination in choosing Oracle Cerner. Masimo’s proxy battle drama will crescendo on 25 July, but latest move is to sell off their consumer business. Bubbling under this– Amazon and One Medical’s possible mishandling of older patients.

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? (Signs of funding life–and AI skepticism)
Two debuts of note: Samsung’s Galaxy Ring, Watch upgrades; Alivecor’s InstantQT+KardiaMobile 6L Europe launch 
News roundup: Masimo has offer to JV consumer business for $950M or more, Get Well sold to SAI, One Medical scored on poor handling of urgent calls from Iora patients (Masimo’s many maneuvers before shareholder meeting–and One Medical’s little problem with older adults, a market they may not want)
VA sued in Federal court on Oracle Cerner EHR accessibility issues (A small lawsuit but legitimate big problem for Oracle)

Lots of follow ups this week on the Feds charging more people at Done, Walgreens finally giving up on VillageMD clinic concept in selling off, Boots’ managing director departs, Amwell’s reverse stock split, One Medical absorbing Amazon Clinic, Steward Health’s $7M spy business, MeMD sold to burgeoning Fabric, Masimo’s proxy fight continues.

Done Global Federal probe expands to five more people; company suspended from Google, TikTok ad platforms (Another shoe drops)
Short takes: Fabric buys Walmart’s MeMD telehealth arm, Geisinger data breach via vendor exposed ~1.2M records, UK’s Careium develops resilient rSIM, $50M funding for K Health, India’s Alyve’s $6M Series A, Upside Health closes
Follow up roundup: Amwell to reverse stock split to avoid delisting, Amazon Clinic folded into One Medical, Amedisys divesting to close UHG deal, latest on Steward Health’s antics and spying, Masimo’s shareholder fight 
Walgreens gives up on VillageMD, will sell to reduce stake below majority, closing underperforming stores, revising profit outlook– and in abandoning Boots sale, managing director James quits (Walgreens still sinking–why?)

AliveCor’s Kardia 12L compresses a 12-lead ECG into a single cable assisted by AI. There’s M&A activity at long last with eVisit and Sharecare going private along with some decent raises for Talkiatry, CipherHealth and Heyday. Medtronic tries but fails to keep its layoffs on the QT and Strictly HushHush. NeueHealth resurfaces with another daring loaner. And the Gimlet Eye resurfaces with a take on Cracked SPACS and recent IPOs.

Short takes/wrapup: fundings for Talkiatry, Heyday Health, CipherHealth; Brightside Health now 50 states for Medicare Part B; Neurabody’s sensor based posture therapy; below the radar global layoffs at Medtronic
News roundup: AliveCor launches FDA-cleared Kardia 12L ECG, eVisit buys UPMC’s inpatient teleconsult, UPMC and MedStar invest; NeueHealth gains $150M loan–with caveats–and NYSE non-compliance notice
A Gimlet Eye view on IPOs and Cracked SPACs: Altaris’ buys Sharecare for $518M, takes it private; a look at Waystar and Tempus AI post-IPO (Gimlet returns from the Remote Pacific Island–virtually, of course)

The first Federal prosecution on telemedicine prescribing against the leaders of Done. VA extended Oracle Cerner’s EHR implementation for another year. The UK Synnovis hack was ransomware, still affecting London hospitals. Still around Verily gets in on the GLP-1 craze. Pepper the Robot resurfaces in San Diego for mental health. And closing the week, Change/UHG finally getting required data breach notifications out along with three fundings.

Week-end short takes: Change Healthcare/UHG breach notification starting; fundings for Pomelo Care, Marigold Health, Humata Health (Green funding shoots?)
A lighter update: Pepper the Robot’s comeback at San Diego State University–now AI-equipped for mental health
News roundup: VA extends Oracle Cerner for 11 months; Amwell founders swap jobs; Alphabet’s Verily pivots to Lightpath with GLP-1, retiring Onduo; UnitedHealth hasn’t notified on Change breach
Done CEO, president arrested, charged with $100M fraud on Adderall distribution in first Federal case on telemedicine prescribing (updated) (First of many?)
UK pathology services Synnovis hacked by Qilin ransomwareistes, demand $50M, justify attack due to UK involvement in “wars” (One system, lots of vulnerability)

A week of ‘further developments’. Teladoc replaces its CEO in two months–record time. Waystar finally IPOs after two years. Steward Health gets the DIP bucks at the last minute to continue until it’s sold off. Devices and app systems like Dexcom and Aktiia make significant improvements that improve their marketability. Category consolidations in telemental health and behavioral health risk analytics. And are these the last appeals for Theranos’ Holmes and Balwani?

Short takes: Dexcom G7 now directly connects to Apple Watch, Brightside Health acquires Lionrock, Aktiia CALFREE gains CE Mark for optical BP monitoring not requiring calibration (Further telemental consolidation and digital health device upgrades)
Oracle’s Q4/FY 23 earnings push Cerner to background, stock price soars on AI deals; 81% of VA clinicals really can’t stand Cerner (Can this EHR be saved?)
News roundup: Teladoc’s new CEO from major payer, Steward Health lives with $250M injection, Waystar’s IPO raises $968M, NeuroFlow acquires Owl (A record time for CEO replacement)
Theranos’ Holmes and Balwani appeal fraud convictions, $450M investor restitution (One last try on appeal?)

NHS England made a lot of not-good news this week, with ‘serious harm’ linked to their multiple EPRs and by midweek, a third-party vendor ransomware attack crashing pathology systems in London hospital trusts. Theranos’ Elizabeth Holmes’ defense in court next week for appeal. Steward Health running out of operating money while being sold off in Federal Bankruptcy Court. Ascension breach scares health execs, but 1/3 don’t have contingency plans especially for vendor hacks. On the sunny side–some strong fundings for Eko, Sword, and Plenful.

Short takes: Holmes legal team appealing Tuesday 11 June; Steward Health asset sale OK’d, needs funding; fundings for Sword Health, Eko Health (Them’s that got, has $)
Breaking: multiple London hospitals, borough GPs declare ‘critical incident’ from ransomware attack via third party pathology vendor (Who’s responsible?)
News roundup: Change responsible for data breach notices; 37% of healthcare orgs have no cybersec contingency plan; health execs scared by Ascension breach; CVS continues betting on health services; Plenful’s $17M Series A
NHS electronic patient records linked to 100 ‘serious harm’ issues, with ~50% of NHS England trusts reporting patient issues: BBC News (Many fixes needed here before AI arrives)

 


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

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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

Two debuts of note: Samsung’s Galaxy Ring, Watch upgrades; Alivecor’s InstantQT+KardiaMobile 6L Europe launch

Samsung’s big reveal at Unpacked in Paris today was the new Galaxy Ring device and health enhancements to the Galaxy Watch. Lots of health tracking features powered by Galaxy AI are packed into both that work best (of course) in the Samsung Health ecosystem, such as ring and watch together with Galaxy phones. General availability is 24 July. A topline review:

Galaxy Ring

–Accelerometer, optical heart rate sensor (including green, red, and infrared LEDs), and skin temperature sensor
–Sleep monitoring: movement during sleep, sleep latency, heart and respiratory rate. Quality of sleep analysis.
–Menstrual cycle via skin temperature tracking.
–Heart rate when unusually high or low, plus real time heart rate checking
–Exercise and the kind of workout or activity a person is doing
–Pricing at $399.99, available today at Samsung, Amazon, and Best Buy today, all other retailers 24 July. Size of ring is around 2.3 to 3 grams, depending on ring size (Samsung provides sizers). It’s also charged in a special dock and a single charge can last up to seven days.

Galaxy Watch 7 ($299) and Galaxy Watch Ultra (for athletes, $649)

–BioActive sensors for preventative care, capabilities to obtain more accurate health measurements, advanced athletic tracking capabilities and an emergency siren.
–Modifications to the photodiodes for more accurate data capture
–Blood oxygen levels, sleep quality, stress levels, heart rate

Data from both the Ring and Watch tie into Samsung Health apps that monitor blood pressure (CE Marked for EU), FDA-cleared ECG, and de novo clearance for detecting signs of sleep apnea. There is also a biomarker index, Advanced Glycation End Products (AGEs) Index, that indicates metabolic health and biological age markers.

More details: CNBC, The Verge, Mobihealthnews, Samsung release

Alivecor launches InstantQT in Europe. Used with Alivecor’s KardiaMobile 6L device and the KardiaStation app, InstantQT remotely records a point-of-care ECG and evaluates patients for potential cardiac abnormalities – all in less than one minute.  QT represents the time it takes for the heart muscle to contract and then recover (the electrical activity between the Q and T waves). Many medications can prolong that time leading to arrhythmias and potentially sudden heart failure. For monitoring those on antipsychotic medications and some cancer treatments, the quick evaluation by the patient using the KardiaMobile 6L device with the KardiaStation professional app can be performed on iOS devices. The InstantQT measurements are made using the EK12 ECG algorithm from GE HealthCare. Release

 

News roundup: Masimo has offer to JV consumer business for $950M or more, Get Well sold to SAI, One Medical scored on poor handling of urgent calls from Iora patients

Slow early July? Not quite.

Masimo’s maneuvering continues with a potential $950 million offer to buy into its consumer audio and health business. The unnamed offeree listed in Masimo’s latest Form 8-K is a potential joint venture (JV) investor negotiating with Masimo since 7 May. Masimo would sell off the majority stake of its consumer audio and consumer health businesses to the partner, that would make 1) a cash payment to Masimo and 2) contribute cash. The 2 July update confirms that the potential partner is offering in the range of $850 million to $950 million on a cash and debt free basis. It’s by no means a done deal as Masimo is pressing for more cash and for retaining certain intellectual property rights. For instance, Masimo’s IP would be for use solely within the consumer field, not healthcare. The Apple litigation on IP infringement on their pulse oximetry (SpO2) sensors and software would remain with Masimo.

The consumer audio business would include the international audio brands acquired in the $1 billion buy of Sound United in 2022: Bowers & Wilkins, Denon, Polk Audio, Marantz, Definitive Technology, Classé, and Boston Acoustics. Their consumer healthcare includes smartwatches and the Stork baby monitor.  MedTechDive

This is an interesting Act 3 Curtain Raiser to Masimo’s ongoing proxy fight with ‘activist investor’ Politan Capital Management, which is attempting to take two more seats on the board of directors and wrest control from the current board controlled by CEO/founder Joe Kiani. Hundreds of Masimo staff have threatened to resign if Politan takes over. The shareholder meeting is on 25 July. TTA 2 July

Get Well, a patient engagement platform, has been acquired by SAIGroup for an undisclosed amount. Get Well serves health plans and systems with patient engagement at point of care, digital care plans, and AI-enabled care navigation. SAI will integrate their existing advanced predictive + generative Eureka AI platform into Get Well’s offerings. SAIGroup has two other AI-related companies in its portfolio: ConcertAI and generative AI RhythmX AI. Michael O’Neil will continue as Get Well Founder and CEO. Release    Hat tip to HIStalk 7/10/24

A story highly critical of Amazon’s One Medical broke over the holiday weekend with a PBS News story about patients put at risk by sloppy call handling. The patients were former Iora Health members, acquired with One Medical, who are older 65+ adults in Medicare Advantage and Medicare Shared Savings Programs (MSSP) ACOs including the advanced ACO REACH model. In March, calls to Iora Health offices were shifted to what Amazon termed ‘mission control’ in Tempe, Arizona. The call center reps did not have access to their records and were not medically trained. The patients were calling with acute symptoms–one of 17 ‘red flag’ symptoms such as symptoms of a blood clot, sudden rib pain, stomach pain and blood in their stool. At the call center, they were not triaged to immediate assistance and instead were given appointments later that day or later in the week. Amazon is claiming that as far as they know, no patients were harmed. Becker’s

As TTA backgrounded on 6 March, the former Iora offices were rebranded, if not closed, as One Medical Senior and they would shift to existing One Medical offices. FTA: Existing patients, many with multiple chronic conditions, reported cutbacks in callbacks, appointment length, physician load, and services provided such as transportation. One clinic had 20 staff cut back to five with patients pushed out to virtual visits–hardly appropriate for a high needs, older, less technologically savvy patient population in value-based care, quality-measured models.

How will these high care needs patients in tightly monitored, intensive programs such as MA and ACO REACH, mesh with the cheap efficient approach that Amazon takes with everything–including One Medical?

VA sued in Federal court on Oracle Cerner EHR accessibility issues

What you may have missed over the holiday–another one to add to the VA’s Mound of Misery with the Oracle Cerner rollout. The Department of Veterans Affairs (VA) is being sued on the choice of Oracle Cerner as the successor to VistA and its inability to accommodate Federal accessibility requirements. The new EHR apparently does not accommodate assistive technology, such as screen readers that enable the visually impaired to read and direct input on computer screens and thus perform their work. The lawsuit was filed on 21 June in the US Federal District Court for the District of Columbia by Laurette Santos, a clinical social worker at VA’s White City, Oregon, facility.

Ms. Santos is a 10+ year veteran of the VA. In her job as Visual Impairment Services Team (VIST) Coordinator since 2019, she relies on the Job Access With Speech (JAWS) screen reader application. Like the veterans she counsels, she is also legally blind and has been since 1988.  She requires access to the EHR in order to obtain veterans’ histories, determine their needs, and input notes. JAWS converts the screens into spoken words (or Braille output through a connected device) and allows blind users to access and interact with applications using the computer keyboard. In planning for the Oracle Cerner transition in June of 2022, she reported in 2019 that the JAWS screen reader did not work with the new EHR and didn’t even allow her to sign in. At work, she continues to use VistA in a read-write-only format but cannot use Oracle Cerner and must delegate tasks to sighted employees. Bottom line, she cannot independently perform her work whereas previously she was able.

The lawsuit charges that the VA did not ensure that the Oracle Cerner EHR complied with the Section 508 accessibility standards per the contract and that it worked before its implementation. Section 508 has been part of every Federal contract since 1998, when the Rehabilitation Act of 1973 was amended to make electronic and information technology accessible to people with disabilities. Between November 2020 and November 2021, the VA’s Section 508 Office conducted several audits and found the Cerner EHR was inaccessible. The lawsuit alleges that this constitutes ongoing violations of both Section 508 and Section 501 of the Rehabilitation Act; Section 501 prohibits discrimination against individuals with disabilities. Veterans also cannot use features tied into Oracle Cerner as they are non-compliant.

In the lawsuit, Ms. Santos is represented by The National Federation of the Blind and Brown Goldstein & Levy partners Eve Hill and Chelsea Crawford. The VA does not comment on pending litigation. HIT Consultant, Federal News Network

TTA’s Summer’s Here 3: Done’s Federal charges increase, Walgreens looking to sell off VillageMD interest, Amwell reverse stock split, Steward Health’s spying, One Medical absorbs Amazon Clinic, MeMD sold, more!

 

 

A lot of follow ups this week on the Feds charging more people at Done, Walgreens finally giving up on VillageMD clinic concept in selling off, Boots’ managing director departs, Amwell’s reverse stock split, One Medical absorbing Amazon Clinic, Steward Health’s $7M spy business, MeMD sold to burgeoning Fabric, Masimo’s proxy fight continues.

With the US Independence Day holiday and UK national elections, we are wrapping the week early–with an early Alert on Wednesday, then Friday, Saturday, and Monday. 

Done Global Federal probe expands to five more people; company suspended from Google, TikTok ad platforms (Another shoe drops)
Short takes: Fabric buys Walmart’s MeMD telehealth arm, Geisinger data breach via vendor exposed ~1.2M records, UK’s Careium develops resilient rSIM, $50M funding for K Health, India’s Alyve’s $6M Series A, Upside Health closes
Follow up roundup: Amwell to reverse stock split to avoid delisting, Amazon Clinic folded into One Medical, Amedisys divesting to close UHG deal, latest on Steward Health’s antics and spying, Masimo’s shareholder fight 
Walgreens gives up on VillageMD, will sell to reduce stake below majority, closing underperforming stores, revising profit outlook– and in abandoning Boots sale, managing director James quits (Walgreens still sinking–why?)

AliveCor’s Kardia 12L compresses a 12-lead ECG into a single cable assisted by AI. There’s M&A activity at long last with eVisit and Sharecare going private along with some decent raises for Talkiatry, CipherHealth and Heyday. Medtronic tries but fails to keep its layoffs on the QT and Strictly HushHush. NeueHealth resurfaces with another daring loaner. And the Gimlet Eye resurfaces with a take on Cracked SPACS and recent IPOs.

Short takes/wrapup: fundings for Talkiatry, Heyday Health, CipherHealth; Brightside Health now 50 states for Medicare Part B; Neurabody’s sensor based posture therapy; below the radar global layoffs at Medtronic
News roundup: AliveCor launches FDA-cleared Kardia 12L ECG, eVisit buys UPMC’s inpatient teleconsult, UPMC and MedStar invest; NeueHealth gains $150M loan–with caveats–and NYSE non-compliance notice
A Gimlet Eye view on IPOs and Cracked SPACs: Altaris’ buys Sharecare for $518M, takes it private; a look at Waystar and Tempus AI post-IPO (Gimlet returns from the Remote Pacific Island–virtually, of course)

The first Federal prosecution on telemedicine prescribing against the leaders of Done. VA extended Oracle Cerner’s EHR implementation for another year. The UK Synnovis hack was ransomware, still affecting London hospitals. Still around Verily gets in on the GLP-1 craze. Pepper the Robot resurfaces in San Diego for mental health. And closing the week, Change/UHG finally getting required data breach notifications out along with three fundings.

Week-end short takes: Change Healthcare/UHG breach notification starting; fundings for Pomelo Care, Marigold Health, Humata Health (Green funding shoots?)
A lighter update: Pepper the Robot’s comeback at San Diego State University–now AI-equipped for mental health
News roundup: VA extends Oracle Cerner for 11 months; Amwell founders swap jobs; Alphabet’s Verily pivots to Lightpath with GLP-1, retiring Onduo; UnitedHealth hasn’t notified on Change breach
Done CEO, president arrested, charged with $100M fraud on Adderall distribution in first Federal case on telemedicine prescribing (updated) (First of many?)
UK pathology services Synnovis hacked by Qilin ransomwareistes, demand $50M, justify attack due to UK involvement in “wars” (One system, lots of vulnerability)

A week of ‘further developments’. Teladoc replaces its CEO in two months–record time. Waystar finally IPOs after two years. Steward Health gets the DIP bucks at the last minute to continue until it’s sold off. Devices and app systems like Dexcom and Aktiia make significant improvements that improve their marketability. Category consolidations in telemental health and behavioral health risk analytics. And are these the last appeals for Theranos’ Holmes and Balwani?

Short takes: Dexcom G7 now directly connects to Apple Watch, Brightside Health acquires Lionrock, Aktiia CALFREE gains CE Mark for optical BP monitoring not requiring calibration (Further telemental consolidation and digital health device upgrades)
Oracle’s Q4/FY 23 earnings push Cerner to background, stock price soars on AI deals; 81% of VA clinicals really can’t stand Cerner (Can this EHR be saved?)
News roundup: Teladoc’s new CEO from major payer, Steward Health lives with $250M injection, Waystar’s IPO raises $968M, NeuroFlow acquires Owl (A record time for CEO replacement)
Theranos’ Holmes and Balwani appeal fraud convictions, $450M investor restitution (One last try on appeal?)

NHS England made a lot of not-good news this week, with ‘serious harm’ linked to their multiple EPRs and by midweek, a third-party vendor ransomware attack crashing pathology systems in London hospital trusts. Theranos’ Elizabeth Holmes’ defense in court next week for appeal. Steward Health running out of operating money while being sold off in Federal Bankruptcy Court. Ascension breach scares health execs, but 1/3 don’t have contingency plans especially for vendor hacks. On the sunny side–some strong fundings for Eko, Sword, and Plenful.

Short takes: Holmes legal team appealing Tuesday 11 June; Steward Health asset sale OK’d, needs funding; fundings for Sword Health, Eko Health (Them’s that got, has $)
Breaking: multiple London hospitals, borough GPs declare ‘critical incident’ from ransomware attack via third party pathology vendor (Who’s responsible?)
News roundup: Change responsible for data breach notices; 37% of healthcare orgs have no cybersec contingency plan; health execs scared by Ascension breach; CVS continues betting on health services; Plenful’s $17M Series A
NHS electronic patient records linked to 100 ‘serious harm’ issues, with ~50% of NHS England trusts reporting patient issues: BBC News (Many fixes needed here before AI arrives)

This was a big post-holiday week, with Veradigm’s surprising bid for a buyer or ‘strategic alternatives’, a $1B Waystar IPO at last, a $34 million digital therapeutics merger, and an over-the-top Oracle response to last week’s Business Insider article. Clover markets Counterpart Assistant SaaS to other payers, CVS looks for an Oak Street investor, 23andMe looks to go private. Fundings for Wanda Health (UK) and Australia’s Updoc. And Done Health guests on Perspectives.

Short takes: Virtual Therapeutics, Akili in $34M merger; why health clinics are struggling; Dollar General, DocGo call it quits; Clover Assistant AI debuts; fundings for Wanda Health (UK), Updoc (AU); Telstra buys out Fred IT (AU)
Oracle’s Glueck kicks back hard at Business Insider’s ‘deadly gamble’ article, Epic’s Faulkner (A response written at maximum seethe)
Perspectives: How Collaborative Care Combats Physician Burnout (From Done Telehealth)
News roundup: Waystar $1B IPO is on (updated); CVS looking for Oak Street PE partner; 23andMe net loss doubles to $667M, may go private; Otsuka dives into digital therapeutics; HoneyNaps’ $12M no snooze (A big IPO after a year)
Breaking news: Veradigm may sell, merge, or seek ‘strategic alternatives’; appoints new interim CEO effective June (updated) (Parts worth more than whole?)


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Done Global Federal probe expands to five more people; company suspended from Google, TikTok ad platforms

The first telemedicine prescribing Federal prosecution adds charges against five additional employees. The charges are similar to those for Ruthia He, the founder/CEO, and David Brody, listed as the clinical president of Done Global (Done)–providing easy online teleprescription access to Adderall and other Schedule II stimulants, skirting the normal restrictions provided in the Controlled Substances Act (CSA) and other regulations [TTA 19 June].

These new charges center on an alleged scheme to defraud federal health care benefit programs including Medicare and Medicaid and are part of the Department of Justice’s 2024 National Health Care Fraud Enforcement Action.

Those charged are Riley Levy, 30, Done’s executive leader, operations and strategy; prescribers Christopher Lucchese, DO, 58; and nurse practitioners Yina Cruz, 37, Katrina Pratcher, 70, and Erin Kim, 54. Levy, Lucchese, Cruz, and Pratcher were charged in the Northern District of California (US Attorney’s office release). Erin Kim was charged in the Middle District of Florida (Case Summary). 

Prescribers were paid based on initial consultations–if they took place–then auto-refills without follow up. Prescribers are also charged with writing prescriptions where Adderall, for instance, was not medically necessary and issued to people who did not have ADHD. Follow up meetings were not compensated and frowned upon.

  • Nurse-practitioner Erin Kim from Florida prescribed over 1.5 million pills since 2021 and earned over $800,000. Done’s system with auto refills even prescribed to patients who had died. As of the end of May, her patient roster was still over 1,100.
  • Nurse-practitioner Yina Cruz from New Jersey made about $20,000 a month prescribing primarily stimulants to 2,300 patients, according to a 2022 interview with The Wall Street Journal. She renewed prescriptions based on forms patients filled out online, sometimes as fast as two renewals a minute. 

Done didn’t respond to a request for comment from the WSJ. A spokesman for the founder, Ruthia He, said she hasn’t entered a plea. The senior doctor, David Brody, has pleaded not guilty. Done maintains a statement on its website of disagreement with the charges and continuance of normal operations.

Done Global knocked off of TikTok and Google ad services–but not Meta. In 2022, Done lost certification by LegitScript, a clearance service for telehealth companies. Advertising continued on Google, Meta, and TikTok into June. Last week, Google and TikTok told the WSJ that Done was suspended. Advertising continues on Meta (Facebook) as long as the ads promote a service, not prescription drugs. The numbers in a suffering online ad market aren’t small, either. Done spent $7 million on Meta ads since November 2022, $20 million on Google, and about $3 million on TikTok ads. based on documents reviewed by the WSJ. Wall Street Journal, The San Francisco Standard