TTA’s April Showers: NeueHealth’s big loss + big CEO bonus, Cano Health’s reorg update, Davids keep facing the Apple Goliath, ATA presses DOJ on controlled substance telehealth, advice on working with PR, more!

April 5, 2024 | by | No Comments

 

 

A damp start to April leads with puzzling news. NeueHealth loses plans and big money in ’23–but gives a big bonus to its CEO. Cano Health reorganizing or selling by June. ATA kicks DOJ about expediting controlled substance telehealth regs. Apple keeps kicking around the ‘Davids’, but they won’t stop either. And if you work with a PR or marketing agency, our Perspectives has some advice for you.

More New Reality: NeueHealth (Bright Health) CEO’s $1.9M bonus, 2023 financials–and does Cano Health have a future? (Two stories gone way sideways)
ATA requests expediting of revised proposed rule on controlled substance telehealth prescribing; announces Nexus 2024 meeting 5-7 May (DEA needs to get moving now, not later)
Davids (AliveCor, Masimo) v. Goliath (Apple): the patent infringement game *not* over; Masimo’s messy proxy fight with Politan (updated) (Seeing value in Masimo?)
Perspectives: Working with a PR Agency–How to Make the Most of the Partnership (Expert advice if you manage communications)

It was a pre-Easter week that started as quiet and got VERY LOUD at the end. Walgreens took the hard road, writing down VillageMD even before the closures were final and lowering forecasts. An important metastudy+ casts doubt on the efficacy of present digital health diabetes solutions but provides solid direction forward. And it’s definitely an early sunny spring for funding, but there’s continued bad weather forecast for UnitedHealth Group and Oracle Cerner’s VA implementation.

Facing Future 2: Walgreens writes down $5.8B for VillageMD in Q2, lowers 2024 earnings on ‘challenging’ retail outlook (Biting bullet early and hard)
Short takes: PocketHealth, Brightside fundings; VA OIG reports hit Oracle Cerner; Change cyberattack/legal updates; UHG-Amedisys reviewed in Oregon; Optum to buy Steward Health practices (UHG carries on as does company funding)
Can digital health RPM achieve meaningful change with type 2 diabetics? New metastudy expresses doubt. (Major digital health findings from PHTI)

This week’s Big Quake was DOJ’s antitrust suit against Apple for smartphone monopoly and control over apps. Another quake: 2023 data breaches were up 187%–when a medical record is worth $60, it’s logical. Early-stage funding and partnerships are back with a roar when AI’s in your portfolio. And Walgreens shrinks both VillageMD and distribution.

2023 US data breaches topped 171M records, up 187% versus 2022: Protenus Breach Barometer (And that was LAST year!)
Why is the US DOJ filing an antitrust lawsuit against Apple–on monopolizing the smartphone market? (One wonders)
Mid-week roundup: UK startup Anima gains $12M, Hippocratic AI $53M, Assort Health $3.5M; Abridge partners with NVIDIA; VillageMD sells 11 Rhode Island clinics; $60 for that medical record on the dark web (Funding’s back and AI’s got it)
Walgreens’ latest cuts affect 646 at Florida, Connecticut distribution centers (More in next week’s financial call)

A lighter week with the Change hacking starting to recede (pharmacy back up on Wed 13 March) and most industry types at HIMSS, we caught up with the first VA go-live in a year, Dexcom’s cleared OTC CGM, WebMD doubles down on health ed with Healthwise buy, Centene may sell abandoned HQ building. And Friday’s news is on a big cyberattack of an NHS Scotland region.

Weekend roundup: NHS Dumfries (Scotland) cyberattacked; delisted Veradigm’s strong financials; One Medical NY patients’ coverage clash; Suki voice AI integrates with Amwell; Legrand and Possum extended; Zephyr AI’s $111M Series A

News roundup: Cerner goes live at VA, DOD Lovell Center; WebMD expands education with Healthwise buy; Dexcom has FDA OK for OTC glucose sensor; Centene may have buyer for abandoned Charlotte HQ (Back to normal news!)
Updates on Change cyberattack: UHG’s timeline for system restorations, key updates around claims and payments in next weeks (updated) (Saving the analysis for later)

The Change Healthcare/Optum cyberattack entered a second week with no restoration of services in sight; how providers and pharmacies are coping without their primary means of processing patient claims and furnishing care–and the psychological toll; and the uncertain future of Walgreens, WBA, and the rapid downsizing of their provider arm, VillageMD. To add further insult to UHG, now DOJ is putting them under antitrust scrutiny.

Is BlackCat/ALPHV faking its own ‘death’? (updated) HHS and CMS come to Change affected providers’ assistance with ‘flexibilities’
Update: VillageMD lays off 49 in first two of six Village Medical closures in Illinois
Reality Bites Again: UHG being probed by DOJ on antitrust, One Medical layoffs “not related” to Amazon, the psychological effects of cyberattacks
Facing Future: Walgreens CEO moves company into strategic review–will he get WBA board alignment? (‘Go big’ now in reverse)
Week 2: Change Healthcare’s BlackCat hack may last “for the next couple of weeks”, UHG provides temp funding to providers, AHA slams it as a ‘band aid”–but did Optum already pay BlackCat a $22M ransom? (updated) (When will it end? Providers. staff, and patients are hurting)

Three major stories lead this packed week. Change Healthcare’s and Optum’s week-long struggle to get 100 or so BlackCat hacked systems up and running again for pharmacies and hospitals–no end in sight. Walgreens keeps closing Village MD locations–up to 85. But the funding freeze seems to be thawing, with M&A and lettered funding rounds suddenly poking through like daffodils–though the structure of one (Dario-Twill) is puzzling and another may be contested (R1 RCM). And Veradigm finally delists–while buying ScienceIO.

BlackCat is back, claims theft of 6TB of Change Healthcare data (Latest breaking news)

Breaking: VillageMD exiting Illinois clinics–in its home state–as closures top 80 locations (Something not good in the Village)
Short takes on a springlike ‘defrosting’: Redi Health’s $14M Series B, Dario Health buys Twill for ~$30M (About time for a Spring thaw)
Roundup: Walgreens’ new chief legal officer; Digital Health Collaborative launched; fundings/M&A defrosting for b.well, R1 RCM, Abridge, Reveleer; Veradigm likely delists, buys ScienceIO–mystery? (updated)
Change Healthcare cyberattack persists–is the BlackCat gang back and using LockBit malware? BlackCat taking credit. (update 28 Feb #2) (100 systems down, BlackCat’s back)

A few surprises at week’s end, with what appears to be a cyberattack taking down Change Healthcare’s systems and Walgreens’ VillageMD exiting Florida. There’s life in funding and stock buybacks but Oracle Cerner’s in the same-old with the VA. Teladoc on slow recovery road, telemental health coming back, LockBit busted, Musk’s Neuralink implant, and a few thoughts on AI. 

Weekend reading: AI cybersecurity tools no panacea, reality v. illusion in healthcare AI, RPM in transitioning to hospital-at-home, Korean study on older adult health tech usage (AI obsession?)
Breaking: Walgreens’ VillageMD shutting in Florida; Change Healthcare system websites cyberattacked (updated) (Two shockers)
Mid-week roundup: Cotiviti’s $10.5B stake to KKR; Cigna buys back $3.2B shares; VA Oracle Cerner faulty med records; LockBit ransomware websites cold-busted at every level, principals indicted; Trualta partners with PointClickCare
Teladoc closes 2023 with improved $220M loss, but weak forecast for 2024 leads to stock skid (Teladoc in recovery)
Telemental news roundup: Brightside Health expands Medicaid/Medicare partners; Blackbird Health gains $17M Series A; Nema Health’s PTSD partnership with Horizon BCBSNJ (A comeback badly needed)
Neuralink BCI human implant subject moving computer mouse by thought: Elon Musk (Controversy)

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Davids (AliveCor, Masimo) v. Goliath (Apple): the patent infringement game *not* over; Masimo’s messy proxy fight with Politan (updated)

April 4, 2024 | by | No Comments

Apple’s legal department certainly hasn’t been maxing their relaxing this year, what with DOJ and pesky upstarts taking them to court. The big one keeping them busy is the US Department of Justice (DOJ) giving Apple a dose of its own medicine in filing an antitrust lawsuit against Apple for monopolizing smartphone markets [TTA 22 Mar]. Apple also continues to fight antitrust and intellectual property (patent) infringement in Federal district courts, the US Patent and Trademark Office (USPTO)’s Patent Trial and Appeal Board (PTAB), and the International Trade Commission (ITC), brought by ECG reader AliveCor and Masimo‘s pulse oximetry reader and software. Masimo succeeded in disrupting Apple’s sales of the Watch Series 9 and Ultra 2 right at the Christmas holiday sales season [TTA 28 Dec 23], forcing Apple to disable the pulse ox feature [TTA 18 Jan] in future imports in one of Apple’s few losses.

The DOJ lawsuit does not address Apple’s copycat activities against either AliveCor or Masimo. Both companies worked with Apple.  AliveCor integrated its early KardiaBand (2016) with early Apple Watches, only to have cardiac readings integrated into the Apple Watch two years later (2018). Masimo and Apple were in mid-stages of a 2021 partnership that Apple broke off, but Masimo then accused Apple of hiring its employees working on the project [TTA 27 Oct 23].

AliveCor hasn’t been quite so successful as Masimo in challenging Apple, but it has been fighting Apple as a David v Goliath on multiple fronts for years. In February, AliveCor lost a round in the US District Court for the Northern District of California on the heart rate algorithm changes Apple made in 2018 that made their SmartRhythm app provided to Apple non-functional. That decision reportedly is still under seal. However, AliveCor has multiple Federal patent infringement lawsuits going against Apple. The differing rulings of the PTAB against and an ITC ruling finding for AliveCor went to the Federal circuit court level. According to CEO Priya Abani in an excellent MedCityNews article, AliveCor expects to see action on this by summer. Abani also scored Apple’s annoying (understatement) habit of IP infringement and broken partnerships. “Apple’s vast resources allow them to squash small innovators,” she said. “They have more lobbyists and lawyers on their payroll than we have employees.”

AliveCor and Masimo aren’t the only ones battling Apple. In the MedCityNews article, NYU Langone cardiologist Joseph Wiesel has sued Apple on patent infringement on his atrial fibrillation app (2021), also involving the USPTO, an action that is wending its way through courts now. While this Editor has long been mystified by Apple’s continued combativeness against small innovative companies when certainly it would be cheaper (and more respectful) to pay a license or settlement, FTA in MedCityNews citing Dr. Wiesel’s attorney Andrew Bochner, “Apple is known among the legal community to have a certain modus operandi: they do “not entertain any sort of real settlement discussions” and instead battle “tooth and nail” in order to wear out their rivals with fewer resources.” The shocker here is that Apple, in this case, stated to Bochner that it filed “roughly 10%” of the USPTO’s total post-grant proceedings, which take place after a patent has been granted and generally challenge a patent’s validity. One wonders whether DOJ will even take note of this anticompetitive activity involving Apple Watches in its blunderbuss action on iPhones and the US smartphone market.

Masimo itself is being roiled by a shareholder proxy fight over who controls the company. Masimo is a publicly-traded (Nasdaq) electronics company that is primarily focused on health devices, including smartwatches, and data software monitoring for the clinical and consumer markets, notably pulse oximetry.

  • Last week, activist investor group Politan Capital Management accused CEO Joe Kiani and others of mismanagement, announcing the nomination of two more independent candidates from Politan for the board of directors. Politan already has two seats on the BOD and a win here would give Politan majority control.
  • The bone being picked is Masimo’s February 2022 $1 billion acquisition of consumer audio brand Sound United (Polk, Marantz, Denon, and others) which didn’t mesh well with their health tech business. This drove down the share price from that time, with Politan subsequently swooping in and picking up shares, successfully winning two BOD seats in 2023.
  • Masimo announced on 22 March that their consumer ‘hearables’ division would be spun off.
  • Politan’s response on 26 March was to object to the spinoff on governance grounds, nominate the additional directors, and heavily criticize CEO Kiani’s ‘control and influence’. Strata-gee 26 March

Yesterday’s follow-up is that Kiani and Masimo are rebutting all of Politan’s claims and more. Strata-gee 2 April, Masimo release 1 April, MedTechDive

This Editor notes that products in their personal monitoring line combine both audio and vital signs monitoring–the (out of stock) Stork, that appears with its baby sock to be directly competitive with Owlet’s Dream Sock.

This will all play out at the yet-to-be-announced 2024 Shareholders Meeting. This Editor notes that Politan picks its battles and is rarely defeated. Our Readers may recall that Politan swooped in on Centene Corporation in late 2021, and in short order ousted long-time directors, added new friendly ones, shook up management and forcibly retired 25+ year CEO Michael Neidorff (since deceased). Masimo’s victory over Apple may go down as either not mattering much–or that Apple will be fighting a much deeper-pocketed backer that knows how to win.

Update: It gets stranger. Masimo’s Consumer (audio) division’s brand president and general manager Joel Sietsema announced on Tuesday that he is no longer with the company. He came to Masimo through the Sound United acquisition being with them for a decade. He announced his departure on LinkedIn. It was apparently a mutual decision that preceded the current turmoil. Strata-gee 4 April

News, deals, rumors roundup: Cerner’s DOD and VA go-lives, Akili’s ADHD therapy SPACs, Talkiatry’s $37M raise, Alto sings a $200M supper–and the Cigna-Centene rumors don’t stop

January 28, 2022 | by

While Cerner’s acquisition by Oracle is winding its way through regulatory approvals, their EHR implementations are moving forward through both the Military Health System (Department of Defense) and the Department of Veterans Affairs (VA).

  • Within the MHS, Brooke Army Medical Center and Wilford Hall Ambulatory Surgical Center, both in the San Antonio (Texas) Market, went live with MHS GENESIS on 22 January. The change most visible to patients is the transition from TRICARE Online to the MHS GENESIS Patient Portal which enables 24/7 access for visit notes, secure messaging, test results, appointment scheduling, and online prescription renewal. MHS covers military retirees, active military, and family beneficiaries. According to the MHS’s website, the goal this year is to get to halfway–to implement MHS GENESIS in more than half of all military hospitals and clinics. It’s been taking place since 2017 and, in true military fashion, it’s planned in waves. Coming up are Naval Medical Center Camp Lejeune in South Carolina on 19 March and William Beaumont Army Medical Center in El Paso in summer.
  • VA is moving far more slowly, just getting to its second hospital. The Columbus VA go-live has been pushed back from 5 March to 30 April, citing training slowdowns due to a spike in staff COVID cases. Walla Walla, Washington is set for after Columbus, but the date is to be confirmed. The first, failed implementation at Spokane’s Mann-Grandstaff VA Medical Center in late 2020 was the subject of Federal hearings and a complete redo in VA’s plans and procedures in cutting over from VistA to Cerner Millenium. TTA 28 July and previous. Federal News Network

Akili Interactive, which has developed tech-driven, game-based cognitive therapies for ADHD and other psychiatric and neurological conditions, has gone public through a SPAC via a merger with Social Capital Suvretta Holdings Corp. I, The transaction is expected to close in mid-2022. Akili will be listed on the Nasdaq stock market under the new ticker symbol AKLI.

The SPAC is expected to provide up to $412 million in gross cash proceeds and value the company at over $1 billion. Investors in the $162 million PIPE are Suvretta Capital Management’s Averill strategy, Apeiron Investment Group, Temasek, co-founder PureTech Health, Polaris Partners, Evidity Health Capital, JAZZ Venture Partners, and Omidyar Technology Ventures. The funds raised will support the commercial debut of EndeavorRx, a FDA-cleared and CE-marked prescription digital therapeutic for pediatric ADHD. The technology is termed the Selective Stimulus Management Engine (SSME) and will be rolled out for ADHD, ASD, MS, and MDD treatment.

TTA noted Akili last year in a trial of AKL-T01 at several hospitals for treatment of long-COVID-related cognition problems. Unfortunately, the writing in their SPAC release made this Editor feel like she needed a few treatments.

Mentalhealthtech (psychtech?) continues to attract funding. Psychiatric care startup Talkiatry topped off its July $20 million raise with an additional $17 million from Left Lane Capital for a $37 million Series A financing round. CityMD founder Dr. Richard Park, Sikwoo Capital Partners, and Relevance Ventures also participated. Talkiatry uses an online assessment for a preliminary diagnosis and then matches you with a participating psychiatrist.  It is in-network with payers such as Cigna, Aetna, UnitedHealthcare (Oxford Health Plan), Oscar, and Humana. Funding will be used to expand beyond NYC. Mobihealthnews

Digital pharmacy is also hot. Alto, which promises same-day filling and courier delivery, raised a $200 million Series E led by Softbank Vision Fund. Their total to date is over $550 million. Alto serves selected areas mainly in California, Nevada, Texas, and NYC (Manhattan, Queens, Brooklyn). Competitors Capsule had another raise of $300 million in April for a total of $570 million and Medly raised a $100 million Series B in 2020. Mobihealthnews

In the wake turbulence of Centene’s dramatic management shakeup last month [TTA 18 Dec], rumors continue to surface that insurer Cigna is interested in acquiring all, or possibly part, of Centene. Bloomberg News in publishing its article earlier this week cited ‘people familiar with the matter’ said that talks took place last year, but that they are not ongoing. Seeking Alpha picked this up, adding market activity boosting Centene. Perhaps the disclosure and the ‘denials’ align with what this Editor has heard–that it’s very much ongoing but under wraps.

A Centene buy makes sense, but only with Cigna. While Cigna is almost double the market value of Centene, it does not have the sprawling business model the latter has, nor do their businesses overlap much. However, some divestiture would be needed to do a deal, given the constrained regulatory environment in the US on the Federal and state levels. Any insurer merger is seen as anti-competitive, unless it is an acquisition of a smaller, struggling plan. 

It certainly would vault Cigna into the top rank of insurers with non-Centene branded exchange, Medicare Advantage and Medicaid plans, a provider network, an established MSO, and other lines of business including Magellan behavioral health management. Cigna might also value Centene’s international holdings, such as private hospitals Circle Health in the UK and Ribera in Spain. A sale would also create a quick and profitable ROI for Politan Capital Management, the activist investor company that initiated the retirement of 25 year CEO Michael Neidorff last month, rather than managing and reorganizing the sprawl of Centene’s businesses to make it more profitable.