Short takes: states curbing healthcare cyberattack liability, North Korean hospital ransomwareiste indicted, Walmart leases out 23 clinics to Humana’s CenterWell, Nuro robot delivery revives, $100M Series E for Spring Health

News that class-action specialist law firms won’t like. States are considering limiting hospital cyberattack liability if they adopt cybersecurity measures. Currently, four states–Tennessee, Connecticut, Ohio, and Utah–have laws that curb liability for cyberattacks and data breaches. A fifth state, Florida, is considering it with the governor, Ron DeSantis, pushing for a tougher version to encourage strong cybersecurity adoption. The state lawmakers’ rationale centers on the admission that cyberattacks on hospitals are inevitable and that when hospitals have security in place, they are not negligent. On the opposite side, law firms that specialize in consumer class-action lawsuits argue that hospitals would rather profit than put into place expensive protection for consumer data. 

This Editor’s view tends to be even stronger than that of Governor DeSantis. How can state regulators actually know that a hospital has strong, effective cybersecurity? Hospitals not only have to spend money to constantly update their monitoring, but also have to hire the humans to implement it. In other words, what people or agency on the state level can assess that a hospital or health system has adequate cybersecurity in place and is acting in good faith to protect consumers against predatory data breaches or ransomware? The article in Politico is unfortunately very scant on how these laws work, the liability limitations, and the mechanisms for judging hospital cybersecurity. More to come on this. Also DataBreaches.net–this Editor’s go-to spot for research.

A North Korean ransomwareiste indicted, but he’ll be hard to serve if convicted.  A grand jury in the Federal District Court for the District of Kansas has indicted Rim Jong Hyok of ransomware attacks on 17 hospitals and systems across 11 states plus attacks on government entities from May 2021 through April 2023. The US Department of Justice (DOJ) charge is that Mr. Rim was working for the North Korean intelligence agency, the Reconnaissance General Bureau (RGB), in a cyberhacking group known as Andariel. Andariel developed the Maui ransomware type and used it to attack healthcare and governmental entities.  The ransoms collected from the hospitals were then used to fund cyber attacks and data exfiltration on government agencies, military bases, and multiple companies supporting the US military. The State Department is offering a reward of up to $10 million to locate Rim and others infiltrating US systems. It is highly unlikely that even with a conviction, Rim will serve any US time, but a conviction could initiate sanctions and other national measures. FierceHealthcare, US District Court indictment, US State Department ‘Rewards for Justice’ release

Walmart gives Humana a crack at reopening in-store clinics. After their well-publicized failure in retail health, Walmart is leasing out nearly half of their former Supercenter clinics over to Humana’s CenterWell healthcare services operation. By first half 2025, 23 of the 51 closed Walmart Health clinics in Florida, Georgia, Missouri, and Texas will convert to CenterWell Senior Primary Care and Conviva Care Centers. The focus will be on senior coordinated care with a staff of board-certified physicians, nurse practitioners, medical assistants, social workers, and other staff. Clinics are planned for Tampa/St Petersburg, Orlando, Jacksonville, Atlanta, Dallas/Fort Worth, and Kansas City. Medicare Advantage plans and Original Medicare will be accepted, though no mention is made of the ‘duals’ who are on both Medicare and Medicaid. Walmart will continue to operate pharmacy and optical locations. The CenterWell/Conviva network at present serves 318,000 seniors in about 300 centers across 15 states. Financial terms of the agreement were not disclosed. In retrospect, they should have done this several years ago. CenterWell release, MedCityNews

Another revival–the Nuro robot vehicle delivery service. Some years back, these driverless cars were envisioned to carry everything from pharmacy deliveries to groceries to prepared food, but the robot vehicles had problematic fully autonomous driving software that proved to be unsuitable for crowded urban areas as well as satisfactorily retrofitting or specially designed EVs. Now in another AI-assisted generation with the R3, about 100 retrofitted Toyota Priuses able to go up to 45 mph will be tested in the California Bay Area in Mountain View, Palo Alto, Los Altos, and Menlo Park. Other vehicles to be upgraded to the new software are from Chinese EV manufacturer BYD, which has become famous for exploding cars in its home market. Timing after the California Motor Vehicle approval now is set for Uber Eats deliveries in test in early fall. TechCrunch

Telemental health fundings continue on a roll with Spring Health. Their $100 million Series E has increased their valuation from $2.5 billion to $3.3 billion. This round was led by Generation Investment Management with participation from existing investors, including Kinnevik, William K Warren Foundation, RRE, and Northzone. Their $71 million Series D was in drought-ridden April 2023. Their total funding now is $466.5 million. Spring Health’s concentration is in mental health support and care management as part of employer benefits and for payers, covering 10 million lives through 450 directly contracted employers, strategic payer relationships, and 27,000 groups that access the solution through a channel partner. As noted in Rock Health’s H1 report [TTA 30 July], the competitive telemental health category still leads by far as the most funded clinical category, with about $700 million in raises, over double that of cardiovascular and oncology, and will likely surpass 2023. Release, Mobihealthnews, FierceHealthcare

News roundup: 4.3M HealthEquity member data breach, CrowdStrike health fallout, more Congress pounding of VA/Oracle; Flo app now unicorn (UK), fundings for Clarapath, CoachCare; AvaSure buying Ouva

Health savings account (HSA/FSA) provider HealthEquity had a three-month breach that compromised 4.3 million member accounts. The breach originated with an undisclosed third-party vendor, in a pattern that has become familiar. According to HealthEquity’s filing with the Maine attorney general (though HQ’d in Utah), the breach occurred in that vendor’s “unstructured data repository” at HealthEquity, outside of their core systems, after the hacker stole the password out of a vendor user account. Unfortunately for HealthEquity, the hack that started in March wasn’t discovered until 26 June, giving the hacker free rein in that database for three months. What’s surprising is that the breach wasn’t worse.

HealthEquity is a third-party administrator for companies of FSA/HRA, Commuter, COBRA, and Lifestyle plans.

The Maine AG filing states that information stolen may include customer names, addresses, phone numbers, their Social Security number, information about the person’s employer, benefit type, diagnoses, prescription details, the person’s dependent (if any), and some payment card information. With HealthEquity claiming 15 million+ members, the breach affects a substantial 29% of its membership. Actions they are taking are to notify members and provide them with credit monitoring services through Equifax with a reference guide. HealthEquity notification page, TechCrunch, HealthcareITNews

CrowdStrike’s antivirus software update that went waaaay sideways continues its fallout. As most know, it happened when they pushed an update and patch to Falcon, a cloud-based anti-cyber attack product that uses AI to detect intrusions. Well, Falcon’s AI wings were fractured on that 19 July push where testing was apparently lacking. BSOD became their new thing. What made the news was the devastating effect on 8.5 million Windows devices, only about 1%–on Delta Air Lines’ aircraft scheduling and the shutdown of many systems such as 911 and police within cities and states, but apparently a curtain was drawn around the healthcare bed. EHRs were affected at major systems such as Kaiser Permanente, Providence, Henry Ford Health, Nationwide Children’s Hospital, the Dana-Farber Cancer Institute, Mass General Brigham, RWJBarnabas Health, Penn Medicine, and Seattle Children’s Hospital, causing postponements of medical procedures. At Providence, it totaled 15,000 of the organization’s servers, as well as about 40,000 of its 150,000 computers. It was the equivalent of a cyberattack without being a cyberattack. According to industry analyst Parametrix, US Fortune 500 companies (excluding Microsoft) lost a total of $5.4 billion. MedCityNews

With this kind of devastation, it’s no surprise that these companies and the government are rethinking their approach to cloud computing. They’re very concerned about the oligopoly of three providers: Google, Microsoft, and Amazon. Microsoft has 40% of the cybersecurity market with CrowdStrike 15% concentrated in larger organizations.“We’re reaching the point where over-centralization makes us less ‘healable,’ and less resilient,” Robert Thomas, owner of cybersecurity company 180A Consulting said. “We’re losing our resiliency as a nation.”  Systems are still not back up and neither is the CrowdStrike stock. Rumors do persist that they were hacked. Epoch Times   Microsoft also published a recovery tool for IT administrators to expedite the repair process. FierceHealthcare

The House Committee on Veterans’ Affairs Subcommittee on Technology Modernization hearing on 22 July had some further flak-gathering from committee members. Most of the criticism concentrated on the joint MHS/VA rollout at Lovell Federal Health Care Center and the amount of work it required to get the Oracle Cerner EHR to work mostly right. While VA and Oracle leaders insist that Lovell went better than anyone expected, the resources used at Lovell cannot be duplicated at the remaining VA facilities. VA is already facing a $15 billion shortfall for FY 2024 and 2025. The Lovell center had a persistent problem in processing prescriptions, with 60% going unfilled. In member Sheila Cherfilus-McCormick (D-Fla.) words, “I think we are far from ready to endorse further go-live activities. The two departments threw more resources at this go-live than will ever be available at any future VA facility.” Healthcare Dive  Earlier coverage TTA 24 July

The UK women’s health app Flo is now a unicorn. Their Series C of $200m (£156m), funded solely (and unusually) by General Atlantic, put them at a valuation of over $1 billion. Their total funding is $275 million. Two General Atlantic executives will be joining Flo’s board, Tanzeen Syed, managing director, and Jessie Cai, principal. Flo helps users track ovulation and menstrual periods, enabling calendaring of fertility, and monitoring of over 70 symptoms. It also assists with pregnancy health guidance. The raise will be used to expand into new user segments including perimenopause and menopause. Its current base is 70 million monthly active users (MAUs) and close to 5 million paid subscribers. Flo is marketed in 66 countries, including the US, India, Indonesia, and Nigeria, with centers in Lithuania and the Netherlands.  Release, UK Tech News

Funding/M&A wrap:

Clarapath, a medical robotics developer based in White Plains, NY, scored $36 million in a Series B-1 funding round from Northwell Ventures with participation from new investors Ochsner Ventures, CU Healthcare Innovation Fund, and Mayo Clinic. Clarapath automates pathology lab work. Its SectionStar platform sections biopsy tissue with improved accuracy. It is pre-revenue with a total of $75 million in funding. Axios, Mobihealthnews

CoachCare, a remote patient monitoring/virtual health monitoring developer for practices and health systems, added $48 million in an unlettered venture round funding led by Integrity Growth Partners with participation from Topmark Funding. The platform combines software and connected devices with outreach for RPM, chronic care management, and other virtual care for about 150,000 patients. Funding to date is $49 million. It has acquired four companies in the past year: NVOLVE, CareSpan Health, Alertive (formerly part of Carbon Health), and WebCareHealth. Release, Mobihealthnews

Another virtual care company, AvaSure, is acquiring Ouva’s smart hospital room solutions. Ouva has been partnering with AvaSure to supply AI-enhanced care automation technology. The acquisition will expand the ambient AI capabilities of AvaSure’s Intelligent Virtual Care Platform and double in-house AI engineering resources. AvaSure’s primary market is hospitals. Ouva will continue as a separate company with its pediatric and wayfinding business. Cost is not disclosed. Release, HIStalk 7/31

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

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

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. ABPLive, EM360Tech

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

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.

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

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

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

Walmart Health’s virtual care telehealth services, originally known as MeMD, sold to care enablement/workflow integrator Fabric. The transaction is effective immediately though no purchase price, management transition, or change in website were disclosed. The sale is no surprise as Walmart Health in shutting their clinics starting at end of May depicted the shutdown as total, lambasting low reimbursement and the cost of business as factoring into an unsustainable model. Fabric, based in NYC, uses conversational AI to triage patients, evaluate with decision support, and optimize resource allocation and patient flow.

Fabric claims that MeMD has 30,000 corporate, institutional, and health plan partners and 5 million members, Walmart bought it for an undisclosed amount in May 2021 during the telehealth boom. It expanded to include not only urgent care, but men’s and women’s health issue support, mental health and psychiatric support. Fabric’s funding since their founding in 2021 as Florence Labs is $80 million, the most recent a February Series A round of $60 million with General Catalyst, Thrive Capital, GV (Google Ventures), and four others. They bought a telehealth Ur-company, Zipnosis, from then-Bright Health in May 2023 [TTA 24 May 2023] and GYANT, an AI-assisted enablement company, in January. Release, Mobihealthnews

Geisinger, the lead health system within Kaiser Permanente’s Risant Health, experienced a data breach that potentially exposed 1.2 million records. The former employee of Nuance Communications, an IT provider in clinical documentation, accessed records two days after his termination. Geisinger discovered the breach on 29 November 2023, Because of the ongoing investigation, patients were not notified until 24 June.

Breached information varies by patient, but it included names combined with one or more of the following: date of birth, address, admit and discharge or transfer code, medical record number, race, gender, phone number and facility name abbreviation. No claims or insurance information, credit card or bank account numbers, other financial information, or Social Security numbers were accessed.

The former Nuance employee has been arrested and is facing federal charges. Nuance had no comment. Release, Healthcare Dive

In an important development for the UK’s rapidly implementing digital switchover, now extended to January 2027, Careium has developed an ‘intelligent’ SIM card for devices. It partnered with CSL to develop a “resilient’ rSIM that actively monitors connectivity and will switch either profile for maximum uptime on all UK networks. rSIM is available for all Careium 4G products in the Eliza smartcare hub and is compatible with current devices. Careium is marketed and covers about 400,000 seniors in the UK, Sweden, Norway, the Netherlands, Germany, and France.  Release

Two fundings of note–and one shutdown:

K Health, a NYC-based digital primary care startup, received $50 million in venture round funding from lead investor Claure Group. Additional investors were Pablo Legorreta, founder and CEO of Royalty Pharma, Mangrove Capital Partners, Valor Equity Partners and Atreides Management LP. Total funding to date is over $380 million through a Series E plus two venture rounds. Valuation is estimated at $900 million. K Health supports users through an app with AI-assisted diagnostics as well as partnerships with leading health systems in 48 states including Cedars-Sinai and health plans Elevance and UnitedHealthCare. Conditions supported are primary care, weight management, urgent care, and mental health. Release, FierceHealthcare

Alyve Health, a Mumbai, India-based digital health provider, raised a Series A of $5,5 million. It was led by Axilor Ventures with participants 1Crowd Fund, InHealth Ventures, and Trifecta Capital. Alyve provides services to corporate markets to simplify the health plan experience for members across multiple healthcare experiences such as doctor consultations, diagnostics, medicine purchases, dental procedures, gym memberships, and proactive well-being. According to the release, the raise will be used to improve its data, security, and AI capabilities, as well as expand operations, hire more talent, and enhance services. Mobihealthnews

Pain management technology company Upside Health closed. Founder Rachel Trobman posted the closure on her personal feed on LinkedIn. Their Branch Health app helped chronic pain sufferers better manage their pain and connected them to clinical and educational resources. Their website and LinkedIn pages are shuttered. According to her post, they had a base of 30,000 patients. Their funding listed on Crunchbase was $635,000.

Follow up roundup: Amwell to reverse stock split to avoid delisting (updated), Amazon Clinic folded into One Medical, Amedisys divesting to close UHG deal, latest on Steward Health’s antics and $7M spying, Masimo’s shareholder fight (latest)

Amwell will reverse stock split to fix their pending delisting on the NYSE. The board of directors approved on 28 June a 1 for 20 reverse split. This will remedy their non-compliance with NYSE regulations requiring an average closing price of above $1.00 over a consecutive 30 trading-day period [TTA 5 Apr]. Shareholders approved the move at their meeting on 18 June. The NYSE notice was given on 2 April and the reverse split will happen at the market open on 11 July, well within the six-month window. Amwell Class A shares closed yesterday at $0.27 so that condensing 20 shares will bring the share price around $5.40. Amwell’s 2024 is forecast with revenue in the range of $259 to $269 million and adjusted EBITDA in the (less) red between ($160) million to ($155) million, with no breakeven in sight until 2026. Their Q1 posted a $73.4 million net loss. Amwell has also released 10% of staff since the palmier days of 2023. Amwell, like Teladoc, continues to struggle in a stand-alone urgent care model that is now obsolete. Release, Healthcare Dive

Update 11 July: Amwell shares opened today at $6.52, and as of midday were trading at $7.51. So short term, the reverse split is working to plump up the shares.

Amazon says goodbye to Amazon Clinic by folding it into One Medical. This should come as no surprise to Readers who noted the  May departure of Clinic’s general manager Nworah Ayogu, MD to VC Thrive Capital with no replacement or search. Amazon’s announcement on 27 June was typically upbeat in renaming the service as One Medical’s Pay-per-visit telehealth. The improvements they claim are:

  • Pay-per-visit telehealth for 30+ common but minor conditions, like pink eye, the flu, or a sinus infection
  • A One Medical monthly or annual membership plan that includes on-demand virtual care and same or next-day appointments at 150+ One Medical primary care offices
  • More affordable–messaging/asynchronous visits are now $29, formerly $35, and video visits at $49, formerly $75. 

The catch–existing Clinic members have to log into One Medical to access their records and the service. Amazon is also propping up One Medical through Prime membership, offering a better deal at $99/year and non-Prime individuals for $199 per year. Amazon does not disclose users, growth, or revenue for either Clinic or One Medical. Healthcare Dive

The long-delayed UnitedHealth-Amedisys home health deal moves closer to closing. Amedisys and UHG’s home health operation under Optum will be divesting some of their locations to VitalCaring Group to avoid Department of Justice anti-trust concerns. The divestiture is contingent on the acquisition closing, now projected in second half of this year. The number of locations was not disclosed though earlier speculation had estimated it at 100. UHG’s offer to acquire Amedisys was made in June 2023 for $3.3 billion in an all-cash deal. It would be additive to its earlier $5.4 billion buy of LHC Group, now part of Optum. With the divestiture, analysts do not see any impediments to a closing, though it had faced opposition in Oregon in March and DOJ opposition since it was announced. This Editor remains sanguine about a successful closing. After UHG won versus DOJ in the Change Healthcare acquisition, “DOJ has a long memory, a Paul Bunyan-sized ax to grind, and doesn’t like losing.” Expect a few more impediments tossed in their direction over the next months. FierceHealthcare , Zack’s Research

The latest episodes in the continuing soap opera of Steward Health involve both Optum and James Bond moves on their critics. Optum had offered back in March to buy their practice groups under Stewardship Health, which stalled with first the Massachusetts Health Policy Commission (HPC), then their bankruptcy. That offer is now off, leaving Steward in the lurch. It was critical to $75 million of Steward’s debtor-in-possession (DIP) financing as recently as 13 June [TTA 14 June]. The deal would have been problematic anyway for Optum as they are under DOJ scrutiny not only for Amedisys but also because Optum controls or has arrangements with 10% of US physicians, 90,000 to date. Healthcare Dive They also settled recently with DOJ for $20 million on Optum Rx’s filling orders from a mail-order pharmacy in Carlsbad, California between 2013 and 2015 for Schedule II drugs: opioids, benzodiazepines, and muscle relaxants. Healthcare Dive

Adding to Steward’s piles of misery are the latest revelations that Steward financed a $7 million spy operation on their critics. This loony aspect to the Steward endgame involved contracting with UK investigators on surveilling a critical former executive, a British financial analyst, and a Maltese politician to find compromising actions between 2018 and 2023. The investigations were allegedly authorized and prioritized by Steward’s top executives while Steward struggled to pay bills for its hospitals and practices. Payments to the investigators were routed through Steward’s Malta operation against their critics in Malta and elsewhere. Steward at the time was embroiled in a dispute around their management of hospitals in Malta, which was eventually investigated and terminated by a Maltese court last year.

One example: the UK firm Audere “collected embarrassing personal information and photographs of a former Steward employee after Steward feared he would leak financial information to its auditor.” Another was the investigation and harassment of a British financial analyst, Fraser Perring, critical of Steward’s actions in its dealings with Medical Properties Trust (MPT). He was followed, his home CCTV was disabled, his home was broken into, family members and his partner were followed. Perring was also being smeared on Twitter through an account set up by Audere. There is much more on this in OCCRP’s report, published (paywalled) in the Boston Globe and Times of Malta. OCCRP’s full report and findings are here. FierceHealthcare

Electronics, audio, and medical device company Masimo continues to fight a hostile activist investor, Politan Capital Management. In December 2023, Masimo notched a significant win via the International Trade Commission versus Apple’s Series 6 and later Watches that forced Apple to disable its pulse oximetry (SpO2) sensors and software that violated Masimo’s smartwatch patents [TTA 28 Dec 2023]. Politan descended on Masimo in April accusing CEO and chairman Joe Kiani and others of mismanagement, including the 2022 acquisition of Sound United’s audio brands. It won two seats on the Masimo board of directors at the last shareholders’ meeting and is demanding two more seats at this year’s meeting on 25 July which would give it effective control.

The latest in the proxy fight is that the chief operating officer, Bilal Muhsin, will depart after 24 years at Masimo if Joe Kiani is forced out. The brief conditional resignation was sent to Masimo’s lead independent director, Craig Reynolds. Mentioned in the resignation was that he would refuse to work with Quentin Koffey, a Masimo director and chief investment officer of Politan Capital. More letters like this may be coming as reportedly Masimo management has urged employees to sign similar letters. Strata-gee, MedTech Dive  

Politan was the investment group that upended Centene Corporation and ousted most of Centene’s board plus 25-year CEO Michael Neidorff in 2022 shortly before his death on 7 April 2022 [TTA 18 Dec 2021]

Update: 300 engineers in Masimo’s healthcare division expressed specific support for Joe Kiani against Politan and Quentin Koffey in an open letter. “We wish to convey our deepest concern if Quentin Koffey and Politan Capital take control and Joe Kiani is removed. We are committed to Masimo because of the vision and innovation he pushes and drives us to deliver. The prospect of losing our founder and CEO threatens to derail the progress we have made and jeopardize the future of Masimo.” They also expressed that they may leave. “We, the undersigned from Masimo Healthcare Engineering, wanted you to be aware that we may not continue with the company if Joe Kiani is replaced by Quentin Koffey and Politan Capital.” This follows on other letters written by international regional managers and presidents in June also stating their support and warning that they may leave if Kiani leaves. The annual shareholder meeting is scheduled for 25 July.   MedTech Dive

However, Masimo is also embattled on other fronts: earlier in June, DOJ and FDA announced their investigation of problems with their Rad-G and Rad-97 SpO2 devices leading to a recall and the SEC is investigating potential accounting irregularities and internal control deficiencies. MedTechDive

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

The funding spigot seems to be on, even up to a Series C.

Talkiatry closed a $130 million Series C for a total funding of $245 million. The round was led by Andreessen Horowitz (a16z) with participation from Perceptive Advisors. Debt financing was provided by Banc of California. Talkiatry’s offering in virtual behavioral or telemental health is psychiatrically-based with a national network of 300 psychiatrists performing to date over 1 million patient visits. Their differentiation is stronger outcomes and reduced utilization of higher levels of care. Their footprint is in health plans: Aetna, Blue Cross Blue Shield, United Healthcare, Cigna, and Humana, covering more than 70% of commercial lives in the US–but plans to expand to provider networks. Release, FierceHealthcare

Heyday Health‘s raise of $12.5 million was from Gradient Ventures (Google’s early stage fund), Lionbird, a large national payor, Great Oaks Capital, and Kate Ryder, CEO of Maven Clinic. Heyday’s technology provides 24/7 in-person’s home, telehealth, and phone visits for Medicare and Medicare Advantage beneficiaries in Ohio and Kentucky. Each person is connected to a personalized care team comprised of a physician, a nurse practitioner, and a Health Ally that works with them to design and manage care plans. The funding will be used for geographic expansion into the Cincinnati/Dayton area in Southwest Ohio and the Louisville area in Kentucky. Release, FierceHealthcare

CipherHealth received an undisclosed capital investment from Atalaya Capital Management for growth and expansion. Cipher provides communication solutions for patient engagement such as secure texting, appointment setting, rounding, and patient feedback. Release 

Brightside Health, another telemental health provider that had its own $33 million Series C in April, announced that it has expanded its reach to Medicare Part B recipients in all 50 states and the District of Columbia, making it the first and only telepsychiatry provider to do so. With this, they now have a total reach of 130 million covered lives. Older adults are an underserved market for mental health support, with 15% utilizing ERs for care, one in four recipients living with a mental illness, and those 65+ having the highest rate of suicidal ideation. Release

We don’t often hear of digital health coming out of Luxembourg, but startup Neurabody located there is combining sensor-based data with AI to address the causes of and therapy for lower back pain. The current Posture AI device is a smart posture estimation sensor and an optional posture correction ergonomic shirt that provides personalized feedback and advice on improving posture and reducing pain via a smartphone or tablet app. If the user begins to slouch, the sensor detects it and buzzes to remind the user to sit up straight. Future products in the next two years are a smart posture seat and smart lumbar support devices. Co-founder William Choi is a serial entrepreneur, an investor and founding member of BackJoy Orthotics, an Inc 500 Fastest Growing Company. Right now the app is available on Google Play and the Apple App Store. The shirts are listed at $149 but the sensor and chest strap are not listed for sale and the shirt purchase pages are not functional. The pages need some work (e.g. typos, ‘coming soon’ pages). Release

But layoffs are still with use, even for the powerful ‘giants’.

Med device giant Medtronic has been quietly proceeding with a global layoff. The only publications that have been on this are Mass Device, which initially was unable to receive confirmation but pursued, and the local Minneapolis Star-Tribune. The layoffs started in April and May, with posts from former employees on LinkedIn and on TheLayoff, which are coded in Medtronic-speak. The company confirmed earlier this month to the Strib that it was laying off staff but would not give details, from the number of employees affected to impacted business divisions or geographic locations.

At the end of 2023, Medtronic offered employees an early retirement program, usually a first sign of major layoffs. Then, at the start of 2024, Medtronic announced the closure of five manufacturing plants and six distribution centers as part of an effort to improve the company’s supply chain, but again refused to disclose where or when. Medtronic relocated to Dublin years ago but maintains an operational HQ near Minneapolis. 11,000 employees of 90,000 total work there, making Medtronic the world’s largest medical device company and still a major employer in Minnesota. None of the layoffs are showing up on state WARN sites either because they are below the thresholds or Medtronic is simply not filing, though states do not except foreign companies.

Did they really think that they could keep this on the QT and Strictly Hush-Hush in the age of social media and layoff trackers (apologies to James Ellroy)?

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

AliveCor shrinks 12-lead ECG to a single cable with AI-assisted detection for 35 cardiac determinations. The just-cleared by FDA system for clinicians combines the Kardia 12L ECG System (left), a single cable with five electrodes that acquires 8 high-quality diagnostic bandwidth leads, with the KAI 12L AI-assisted diagnostic technology. KAI uses a deep neural network-machine learning AI model to interpret ECG data acquired and validated on more than 1.75 million ECGs from leading US medical centers. It can make 35 cardiac determinations–14 arrhythmias and 21 morphologies–that include acute myocardial infarction (MI) and the most common types of cardiac ischemia. The Kardia 12L is battery-powered, weighs about 1/3 of a pound, and fits into a typical lab coat pocket.

12-lead ECG is considered the standard of ECG readings. A pocket system of this type puts this in reach of clinics, rural health, urgent care offices, and employer clinics. It requires minimal self-guided training and doesn’t require patients to fully disrobe. Release, Mass Device

Telehealth provider eVisit acquiring UPMC’s inpatient teleconsult technology–along with investments from UPMC and MedStar Health. This ‘hat trick’ adds hospital inpatient telehealth capability to eVisit’s health system-focused telehealth triage, provider-to-provider consults, and scheduled telehealth visits. The teleconsults serve inpatient care across five services: stroke, neurology, critical care, psychology, and toxicology. Both UPMC and current client MedStar Health (from the 2023 Bluestream Health acquisition, TTA 27 Apr 2023) are also investing in eVisit, adding an undisclosed amount to eVisit’s 2021 $45 million Series B. (Another way of saying ‘unlettered raise’?) Release, FierceHealthcare

And would this month be complete without items from the Dean of Dodging Disaster, Creating its Own New Reality, the one and only NeueHealth? The first is that Hercules Capital is giving them a second term loan facility (Loan and Security Agreement) of up to $150 million over three years that is, to be polite, hedged with qualifications. 

  • Tranche #1 is available on closing: $30 million
  • Tranche #2, $25 million, will be available only for a limited time– 10 November through 31 December 2024. It is also dependent on Molina making its final payment to NeueHealth for the Medicare Advantage plans they bought–a payment dependent in turn on those plans achieving plan performance ratings ( the “2025 Stars Condition”).
  • Tranche #3 of $45 million will be available from 5 February 2025 to 15 September 2025. But it is contingent after paying off what is owed in connection with the ACO REACH Model for performance years 2023 and earlier, payment in full of the CMS Settlement (as defined in the Loan and Security Agreement) and the Company having at least $22.5 million of unrestricted cash and cash equivalents.
  • Tranche #4: up to $50.0 million and available until 21 June 2027
  • The loan matures on 1 June 2028

Release 24 June, SEC Form 8-K, FierceHealthcare

The second is that the loan could not have come at a more needed time, as NeueHealth received a non-compliance notice from the NYSE on 16 June. It fell below an average market capitalization of $50 million for 30 consecutive trading days, with their last reported stockholders’ equity also below $50 million. It has 45 days to submit a business plan to remedy it within 18 months. NeueHealth’s preferred stock had a value of $920.4 million as of 31 March 2024 but is excluded from the NYSE calculations of common stockholder equity. NeueHealth closed today at $5.23.

This is in addition to a $30 million loan from current 60% majority shareholder NEA [TTA 16 Apr].

Along with tying Gordian knots masterfully and playing multiple ends against the middle, one wonders what management does all day at their new offices in Doral, Florida? Avoiding Chapter 11? Golfing? Surfing?

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 EyeSharecare finally gets itself bought and taken private, less than three years after its SPAC. One-time health tech darling Sharecare, now a patient navigation and employee benefits platform and once valued at $3.9 billion, will be acquired by healthcare-focused private equity company Altaris LLC for $1.43 in cash per share, or about $518 million. The shares on the buy date, 20 June, were trading at $0.77 so the offer is about an 86% premium, though shares are now trading at around $1,38. (Notably, Sharecare was below the $1.00 threshold for Nasdaq since February.) The transaction is expected to close in Q2 subject to formal shareholder approval and regulatory agencies. In terms of management, the executive team is expected to continue at least for now, with founder Jeff Arnold voting his shares in favor of the transaction and continuing as a shareholder. Release, FierceHealthcare, Mobihealthnews

Founded in 2010 by WebMD founder Jeff Arnold and celebrity doc/former political candidate Dr. Mehmet Oz, Sharecare had IPO’d a decade later via a SPAC, Falcon Capital Acquisition Corporation. It announced in February 2021’s Pandemic Palmy Days then hit markets on 2 July. At that time as essentially a personal care management app, it debuted at above $9.00 and received $571 million in gross proceeds with a reported valuation of $3.9 billion. A month later, it acquired CareLinx, an on-demand home care provider, from Europ Assistance in a $65 million cash/shares deal. By late 2021, Sharecare entered the Cracked SPAC Track as shares cratered. Dr. Oz is no longer on the board of directors or the advisory board. As share values fell precipitously, in November 2023 Mr. Arnold turned over the CEO reins to Brent Layton, a 20+ year Centene veteran and its retired president, picking him from the BOD and moving to chairman.

Shortly thereafter, Fruit Street sued Sharecare, a former partner, for $25 million charging that their diabetes prevention program (DPP) was supplanted by Sharecare’s own, breaching their contract and appropriating intellectual property. [TTA 14 Dec 2023] This suit is apparently still wending its way through the infamous Fulton County, Georgia courts. Sharecare also faced an escalating number of shareholder class action lawsuits alleging false and misleading statements on their financial condition (KRON 4).

What can we learn from IPOs as they are reviving? The first, of course, is that SPACs have gone the way of the dodo and passenger pigeon. The second is that there are quality IPOs, and then there are the ones to watch out for even if you are not an investor.

Remember first and foremost that VC and PE investors want to exit, profitably. And quickly. Exit=Sell to Someone Else. “Someone else” can be an IPO or another investor. An IPO means offloading the risk to the investing public. Please do keep in mind that what follows 1) is not investment advice, only observations and 2) your Editor is only a marketer, but one who has seen investments go up, down, and sideways since her days at the Frank Lorenzo School of Airline (Mis)Management, a/k/a New York Air (right, below) including a year observing up front and personally the dismal fate of Eastern Airlines. (Somewhere she has her old Texas Air share certificates…)

The investment scene in health tech and AI strongly resembles the Wild West days of airlines post-deregulation 30 years ago. Investor money in, now fleeing for the exits, whether the bankruptcy court or passing the hot potato to others with money.

Waystar IPO’d earlier this month at $21.50 per share. Checking in today, it’s trading at $21.55, essentially in a narrow and flat trading range in a down market. The IPO gave Waystar a fully diluted valuation of $3.69 billion. It’s early days, but three factors in favor of WAY staying the course at least short term are:

  1. They waited to IPO for the better part of a year and pulled it back when their initial valuation of $8 billion made Mr. Market ROTFL.
  2. Their investors have held on tight: EQT AB, Canada Pension Plan Investment Board (CPPIB), and Bain Capital will beneficially own approximately 29.2%, 22.3%, and 16.8%, which is over 68% of the company.
  3. They occupy a boring part of healthcare and aren’t new kids on the block. Payments and revenue cycle management (RCM) aren’t sexy or trendy. Waystar is the combination of ZirMed (1999) and Navicure (2001) which merged and renamed in 2018. 

The downsides: Competition. Lots of it. The usual unprofitability. Waystar lost money the past two years. Last quarter, those losses accelerated (Google Finance). Will that show up later this year in share price?

Tempus AI also IPO’d mid-month at an eyewatering $37/share, at the top of its offering range, and a valuation in excess of $6 billion. It’s AI! It’s backed by Google! And it rose 15% on its first day of trading, 14 June! Precision Medicine! Intelligent Diagnostics!

But where are shares today on 26 June? It closed yesterday at $24.96. That’s a downer of 32% from the IPO price–38% if you take it against the first-day close above $40. I’m sure the first-day investors, unless they have cast-iron stomachs, have already reached for the antacids.

So what’s going on here? Tempus AI’s business combines AI for data analytics and a vast database to guide doctors in therapy and treatment, identify clinical trials, guide treatments, and close gaps in care. The analysis is done on blood samples, buccal swabs, and liquid tests. It’s a familiar pitch that multiple companies are using around AI and their ‘vast databases’ from the time of IBM Watson’s lofty ambitions.

  • Their CEO has already traversed the hype circuit. “We’re on a really good trajectory,” Tempus AI CEO Eric Lefkofsky, the founder of Groupon, said on CNBC’s “Squawk Box” Friday morning before shares started trading. “As revenues have been growing quickly, we’re not investing all that gross profit dollar growth back into the business. We’re generating improved leverage every quarter.” (Exactly what does that mean? Probably that money is sent down to the profit line.) Setting expectations–within the next year, the company is expected to be cash flow and EBITDA positive within the next year. It’s twice been on CNBC’s Disruptor 50 list of private companies which historically has been a mixed bag.
  • In their favor is that they already have as of today 510(k) clearance from FDA for its Tempus ECG-AF device to identify patients who may be at increased risk of atrial fibrillation/flutter (AF). It’s the first FDA clearance for an AF indication in the category known as “cardiovascular machine learning-based notification software”. But it needs to be integrated into resting 12-lead ECG recordings collected at a healthcare facility and analyzed against other patient data. What is that timeline and market?
  • Tempus has already survived and evolved from one major pivot. Looking back, they started in the genomic testing business in 2015, primarily concentrating on oncology. In 2020, it branched out to then-trendy Covid-19.  CNBC 17 June 2020  Genomics is now subsumed on the site by terms such as pharmacogenomics (PGx) coupled with patient-reported outcome (PRO) software.

Investors up to the IPO were listed as Google, Baillie Gifford, Franklin Templeton, NEA, Softbank, and T. Rowe Price. Who’s sticking around? The underwriters are Morgan Stanley, JP Morgan, Bank of America Securities, and Allen & Company. Reuters  Customers include AstraZeneca and GSK (GSK.L). One of its competitors, Guardant Health, which has patents in DNA blood testing for cancer, is suing on infringement on five patents. Reuters

All in all, Tempus AI started off way high–and there is only one way to go from there. They have a great story and a potentially good business, but it bears watching, not investing, at this point.

Week-end short takes: Change Healthcare/UHG breach notification starting (updated); fundings for Pomelo Care, Marigold Health, Humata Health

Change Healthcare finally starting notifications, but not yet to consumers. A press statement today from Change/UnitedHealth Group confirmed that the long process of notifications has started with hospitals, insurers, and other customers. Individuals and practices will not be notified until late July. Change confirmed that the Blackcat/ALPHV cyberattack exposed names, addresses, health insurance information, and personal information like Social Security numbers, but at the individual level investigation isn’t finalized. At this point, they have reviewed over 90% of impacted files and have not seen signs that doctors’ charts or full medical histories were taken. Technically, UHG has made the 21 June deadline stated in the Hassan/Blackburn Senate letter [TTA 19 June] but not within the 60-day HHS-OCR window, which opens them up to an HHS fine. After paying a cyberransom of $22 million in bitcoin and uncounted (to us) millions in rebuilding systems, HHS’ fine may look like the lesser cost of doing business. The Change website also contains a very carefully worded ‘HIPAA Substitute Notice’ that reads like a consumer data breach notification. AP via Yahoo! News UK   One wonders if there’s a fair amount of ‘buyer’s regret’ going on at UHG in fighting so hard to buy Change. Due diligence would have helped over that year-plus.

Update: The Centers for Medicare & Medicaid Services (CMS) announced earlier this week that the provider financial assistance program will be ending 12 July as billing activities have largely resumed. It has advanced over $2.55 billion in payments to Medicare Part A providers and $717.2 million to Part B providers. FierceHealthcare

Fundings this week:

Virtual maternity support platform Pomelo Care scored $46 million in Series B funding. Lead investors are Andreessen Horowitz (a16z) and First Round Capital with participation from Stripes, BoxGroup, Operator Partners, and SV Angel. Pomelo’s markets for virtual fertility, pregnancy and newborn care from preconception through a baby’s first year services are employers, health plans and providers. The company claims 3 million covered lives across 46 states through their commercial and Medicaid health plan partners. Release, Mobihealthnews

Telemental health provider Marigold Health now has an $11 million Series A. Marigold is structured as an anonymous social network where people with mental health and substance use conditions provide peer-based support. Lead investors for the Series A are Rock Health and Innospark Ventures. Additional participants are the Commonwealth Care Alliance (CCA), Wavemaker360, Stand Together Ventures Lab, Epsilon Health Investors, Koa Labs, VNS Health Plan and KdT Ventures. Their substance use disorder (SUD) programs are currently available to 25,000 members in Delaware, Rhode Island, and Massachusetts. The new funding will be used for expansion to at least four additional states by the end of 2025. Release (Marketwatch), Mobihealthnews

Humata Health, which has developed AI-based technology to automate prior authorizations for payers and providers, closed an unlettered $25 million funding round. Lead investors are Blue Venture Fund (representing the majority of BCBS plans) and LRVHealth (representing nearly 30 health systems and payers), with participation from Optum Ventures, .406 Ventures, Highmark Ventures, and VentureforGood. The funding will be used to broaden its generative AI technologies, expand their provider base, and begin to partner with payers and delegated entities. Humata bought the base prior authorization technology from Olive AI out of its bankruptcy [TTA 31 Oct 2023]. Its founding chairman and CEO is Jeremy Friese, MD, who had been Olive AI’s president for their payer business after selling Verata Health, also in the prior authorization automation area, to Olive.  Release, FierceHealthcare

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

To no one’s surprise, the Department of Veterans Affairs (VA) extended its contract with Oracle Cerner for another 11 months. This is per the new contract relationship that started last year, resetting from the original five-year contract that started in 2018 to five one-year terms, with mandatory annual reviews and renewals [TTA 18 May 2023]. Technically, the contract expired in May but VA extended it for one month as discussions continued over the next one-year term. This second option period expiring May 2025, according to the VA release, is focused on the following for the EHR modernization (EHRM):

  • Supporting the existing six facilities with the Oracle Cerner EHR
  • Achieving the goals of the reset and driving towards future deployments
  • Increased accountability across a variety of key areas, including minimizing outages and incidents, resolving clinician requests, improving interoperability with other health care systems, and increasing interoperability with other applications to ensure an integrated health care experience
  • Supporting value-added services, such as system improvements and optimizations
  • Achieving better predictability in hosting, deployment, and sustainment
  • Fiscal responsibility 

The plan is to resume site deployments in FY 2025, likely in year 2025, after reset goals are met. Seema Verma, Oracle Health’s new executive vice president and general manager, said that “VA’s intent to resume deployments in the next fiscal year is a significant milestone that reflects the hard work our collective teams have done to improve the system today, as well as confidence in our shared ability to continually evolve the EHR over time to meet the needs of both practitioners and patients.” NextGov/FCW, FierceHealthcare, Healthcare Dive, Oracle release

Is there much choice for the VA in the matter? Not really. VistA can be updated but remains non-interoperable with the Military Health System’s (MHS) Cerner-Leidos EHR. But can Oracle Cerner be fixed up and debugged to work for VA’s vastly different needs and smoothly deployed within the contract duration? That jury is still out in the view of the VA and Congress.

The Brothers Schoenberg swap positions at Amwell. Roy Schoenberg, MD, MPH, will transition immediately from his role as president and co-CEO to move to executive vice chairman of Amwell’s board of directors. Ido Schoenberg, MD, will become the sole CEO. The brothers co-founded the company in 2006. Ido’s quote closing the release is interesting in demonstrating the shift from investment without profits to getting on the path to profitability:  “This transition represents a natural evolution for our company as we shift from a period of intense R&D investment to an operational focus aimed at achieving greater efficiencies, optimizing cash flow and delivering profitable growth while maintaining our dedication to enabling our clients’ aspirations.” Roy is credited with developing Converge which is their next-generation integrated platform. If Teladoc is finding it difficult to transition from the stand-alone, transactional, urgent care service they and Amwell pioneered, into an evolved market that has incorporated virtual capabilities into multiple types of care models, whither Amwell’s future? More thoughts in TTA 2 May, 9 April

Alphabet (Google)’s once-visionary Verily now jumps on the GLP-1 bandwagon with Lightpath. Verily’s latest pivot to the highly trendy weight loss area is termed as a metabolic solution as part of a “personalized chronic care solution for health plans and members”.  Lightpath will start as Lightpath Metabolic, a four-part program that includes Metabolic Intensive (diabetes management), Weight Loss Intensive, Metabolic Improvement, and Metabolic Achievement. The Verily platform integrates data from health records, connected devices, and other care points to deliver “personalized pathways, suggestions, and nudges to health plan members” virtually along with health coaches and an advanced licensed clinical team. The current virtual chronic care management platform, Onduo, will be retired by 2025.

Once upon a time (2021, sigh), Verily was Google’s skunk works for advanced health tech with Google Health being the marketing and merchandising arm for clinical and consumer products. Google Health was broken up in August 2021 and Verily faded into the Alphabet background with the occasional joint venture and clinical pilots, with Onduo being their most marketable product. Google seems to have little direction for Verily other than to keep it alive. And given the competition plus a greater understanding of the long term effects of the GLP-1 drugs in the weight loss area, the GLP bandwagon is up for a shaky ride in the next year. Release, FierceHealthcare

And very strangely, UnitedHealth Group hasn’t notified Health and Human Services’ Office of Civil Rights (HHS-OCR) about the ransomware data breach at Change Healthcare, nor the individuals affected. The notification to OCR is required under HIPAA to be within 60 days of the date of the incident. UHG is over the deadline by two months, calculating from 21 February. CEO Andrew Witty wilted before double-barreled Senate and House hearings in May and UHG lost a fight to put the notifications for the breach onto providers [TTA 5 June]. Senators Margaret Wood Hassan (D-NH) and Marsha Blackburn (R-TN) sent a joint letter on 7 June to Andrew Witty, CEO of UnitedHealth Group, urging him to send a breach notification letter that notifies OCR, state regulators, Congress, the media, and health care providers that it intends to complete all breach notifications on behalf of all HIPAA-covered entities, individuals and businesses affected, by 21 June. That’s Friday. UHG continues to maintain that they still do not know the extent of the breach. The Medical Group Management Association (MGMA) also sent a letter to Mr. Witty on 12 June.  Don’t hold your breath for UHG sending millions of letters. Becker’s, HealthExec