TTA’s Thanksgiving Windup: Steward heads investigated, CVS head departs, Congress’ controls over Oracle VA EHR depart, NeuroNinja needs funding, Teladoc, Cortica, 23andMe, Neuralink, more!

November 27, 2024 | by | No Comments

 

 

It’s a short holiday week in the US and the stories range from Potential Big International Fraud to Neuralink’s Big Brain Implant Potential. Yet another CVS head departs. Congressional VA EHR controls also depart in new bill. And help fund the adventures of NeuroNinja, a comic superhero who just happens to be living with Parkinson’s. 

Happy Thanksgiving! New articles resume Monday 2 December.

Short takes: Teladoc intros hospital bed fall risk detector, Veradigm’s AI scribe, Lucid’s pill-sized esophageal cancer diagnostic, Cortica’s $80M raise for autism treatment, LG NOVA startup winners
News roundup: Oak Street’s Pykosz departs CVS, Musk’s Neuralink gains Canadian clinical trial, VA healthcare improvement bill omits EHR oversight measures, 23andMe’s Mirador precision medicine partnership (Another CVS head departs, stage left)
Help fund the NeuroNinja comic–a superhero with Parkinson’s! (An unusual approach)
Breaking: Federal agents seize Steward Health’s CEO, international head’s mobile phones in widening US investigations (It’s big, it’s developing, it’s international)

An unusual pre-Thanksgiving week focused on significant developments on ongoing Major Stories but little new. CVS Health bends the knee to investor Glenview. Controlled substances telehealth gets a 3rd extension. Revere Medical out of Steward ashes snaps up a broken MSO. Oura partners with Dexcom CGM and gets paid for it! What’s kind of new? HHS comes up short on cybersecurity leadership while accurate EHR notes are short in new VA study.

Government updates: GAO scores HHS on cybersecurity issues; patient issues largely omitted from EHR notes in VA study (Coming up consistently short)
News roundup: CVS Health cedes 4 new board seats to Glenview, Oscar’s strong Q3, telehealth controlled substance prescribing in 3rd extension, new Revere Medical to buy CareMax assets, Oura picks up $75M Dexcom financing and partnership (Further developments on Big Stories)

Cue the music…it’s the good, bad, and a ration of ugly this week. An under-the-radar company makes big buys in primary care and MSO. Veradigm might finally get itself sold. DOJ drags UHG to court over Amedisys–after the election. 23andMe continues to perhaps Destination Oblivion. Forward meets Oblivion after eight years. And Ali Parsa, one year after Babylon’s failure, serves up a new AI venture that gets a Gimlety view.

Bad News Roundup updates: UHG/Optum defends Amedisys buy fast via a website, digging deeper into Forward’s fast demise, former Masimo CEO Kiani booted–and sued (One lesson after another)
Bad News roundup: DOJ drops the hammer on UHG-Amedisys, 23andMe lays off 40% and closes therapeutics, Lyra Health lays off 2% in restructuring, Forward primary care + kiosks shuts down abruptly (We aren’t past it yet)
Babylon Health’s Parsa founds new AI medical assistant venture, Quadrivia, one year after Babylon Health’s failure (Parsa’s new AI-powered deal)
M&A action news: Astrana Health buys up Prospect Health for $745M after Centene MSO unit buy, Veradigm nears $1B+ sale, Sword Health lays off 17% of clinicians prepping for IPO using AI instead, Cigna is not buying Humana–really! truly! (M&A comes alive, with a new player)

The Big Race is over, 45 is now 47 come January, and health tech (plus related) news faces future. HLTH’s future is with UK’s Hyve Group. Cerebral faces an expensive DOJ/DEA Judgment Day for its Bad Behavior during the pandemic. 23andMe, CVS, and Walgreens face future survival. And what if in future healthcare sets a goal of zero failures, like aircraft makers and airlines?

News roundup: Cerebral forfeits $3.7M on federal Rx charges, Aetna president named, Stewardship Health sold to Rural Healthcare, Oura buys data company Sparta Science, Brook Health-Linus Health remote cognitive assessment 
Weekend reading: 23andMe’s up in the air future, including genetic data; Walgreens debates What To Stop and Start; what if healthcare pursued a zero-failure rate? (Some reckonings and a future view)
Surprise! HLTH conference group sold to UK’s Hyve Group Limited (Las Vegas barely a wrap)

A post-HLTH deluge of news–as the US rolls up to a major national election. CVS replaces its CEO and debates breaking up. Amwell takes on a new CFO. Decent-sized raises seem to have returned. Cigna isn’t buying Humana–as of now. And has Teladoc turned a corner?

News roundup: Teladoc’s improved Q3, PursueCare resuscitates Pear’s apps, AMA removes 16-day RPM requirement in 2026, PatientPoint intros Innovation Network, PeopleOne’s $32B raise, Cigna-Humana again a no-go (Earnings season and post-HLTH announcements)
Some thoughts on the takeaways from HLTH (Not that many, strangely)
News roundup 23 Oct: views on a CVS breakup and CEO replacement, Amwell’s interesting new CFO, CopilotIQ/Biofourmis merge (updated), raises by HealthEx, Counsel Health, Oshi Health (Will changes at top fix problems?)

As the weather chills, so do prospects for some very well known companies–and investment. Walgreens plans to shrink its retail footprint by 1,200 over the next three years, “monetize” VillageMD. CVS is exiting most of its infusion business. UHG stock, earnings hammered on Change Healthcare hack, Federal payment cuts. Masimo v. Apple patent slugfest continues with wins for both. DEA kicks the can on telehealth waivers into next year–maybe. FTC and DOJ chill M&A with more demanding Premarket Notification rule for M&A. The spot of good news–baby monitoring Owlet has its mojo back.

News roundup 16 Oct: Walgreens shuts 1,200 stores–500 in ’25, CVS exiting core infusion biz, Masimo v. Apple update, DEA recommends 3rd telehealth extension, Change hack costing UHG $705M, Owlet back in NYSE compliance (So many denouements..and only one good)
FTC drops the hammer on premerger notification requirements–what will be M&A and investment effects? (We told..and tell you so, no frills)

It’s unconfirmed, but CVS may be considering a breakup. Teladoc’s latest reorg puts its COO out to pasture. IPOs may revive by next year for ‘overdue for exit’ companies. In CEO Land, one former CEO strikes back at the Senate holding him in contempt, while another one, having lost her board, now can easily take 23andMe private. ATA announces 2025 Nexus and call for papers. And some new fundings and products…and why can’t VA stop stubbing its toe on Oracle EHR issues, or staff diving into politicians’ health records?

News roundup: Omada Health files S-1 for IPO in 2025–and a look at 2024 healthcare IPOs, Philips debuts new smart baby monitor, ActiveAlert launches in UK, ATA Nexus 2025 calls for speakers, abstracts (An small IPO revival?)
Breaking: another exit at Teladoc, with COO resigning effective 31 December (Something about ships? Spirals? Musical chairs?)
Industry news short takes: fundings for Qure.AI, Centivo, Rippl, Surescripts; M&A closings for GE Healthcare-Intelligent Ultrasound, LetsGetChecked-Truepill. And is Hinge Health going public soon?
Two ‘oops’ at VA: OIG finds VA, Oracle performance misalignments, makes 9 recommendations; VP candidates’ EHR records improperly accessed by VA employees (Enough already!)
Two follow ups: Steward Health CEO resigns–and sues the Senate HELP committee, Wojcicki will take 23andMe private (Time to take the yachts for a long trip?)
Now CVS Health may be reviewing ‘options’–including a possible breakup–report (PBM and health plan troubles)

Steward’s CEO will likely face prosecution on criminal contempt of Congress for not showing up at a hearing, Stefano Pessina’s net worth down by 97% as Walgreens tanks, and Joe Kiani, after founding Masimo 35 years ago, is booted from the board and ankles–now it’s up to Politan.  

What’s next for: Steward CEO now in criminal contempt of Congress; Walgreens’ Pessina’s fortune vanishes by 97%; Masimo’s Kiani now a man without a company

It’s the last week of summer and this Editor has been catching up all over. While away, there have been buys, M&A, and yet another PE ‘smush’ merger. In developing stories, the Masimo-Politan proxy war ends and Steward’s CEO no-show may result in charges–both on Thursday. Congress and the industry argue over continuing telehealth prescribing waivers. And it’s hard to see a future for a broke 23andMe controlled by its founder/CEO–and with a board that just exited today. 

News roundup: Owlet expands to EU, mPulse buys Zipari, New Mountain PE merges 3 payment integrity firms in $3B smush, Candid Health’s $29M raise, Oura buys Veri, Bloomer Tech’s cardio bra (M&A activity revives, as does Owlet. Oura doing just fine)
23andMe settles 6.9M data breach lawsuit for $30M. Breaking–all seven independent directors quit ($30M the best they could get–and the board throws the towel at Wojcicki)
Rounding up follow ups: Walgreens shareholder suit on pharmacy performance, Steward CEO no-shows Senate committee, Masimo-Politan proxy fight has court win for Politan–vote on for 19 September (Walgreens’ misery never ends. Masimo nears its end.)
US telehealth controlled substances prescribing waiver may expire at year’s end; DEA may further restrict (Controversy on continuing virtual prescribing of Schedule II)

One more jumbo deal announced before Labor Day–Evolent Health’s acquisition bids from payer Elevance Health as well as at least three large private equity firms, in a deal that could top $4 billion. (Sensibly, their CEO is cleaning up his stock option portfolio.)

Evolent Health talking major acquisition by payer Elevance, private equity (Could be over $4B)

Counting down before the Labor Day holiday, one large deal of note sneaks through–LetsGetChecked’s $525M deal for Truepill. SVB’s latest report confirms the ‘valuation trap’ for the overvalued companies of the 2020-22 period but that investment is crawling back. Generative AI is much talked about but no one is comfortable with it. And two surprising survivals–NeueHealth and Stewardship Health.

Truepill to be acquired by LetsGetChecked for $525 million (Throwing in together to survive?)
Signs of life: another view on healthcare investments and exits as of mid-year (SVB’s 14th POV)
Are patients and physicians ready for generative AI? How will it be most acceptable? (Resembles telehealth’s early days on the early curve)
“I will survive” updates: NeueHealth survives Q2 with small net loss, Steward sells off Stewardship Health practices to private equity firm for $245M (Dodging disaster)

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Short takes: Teladoc intros hospital bed fall risk detector, Veradigm’s AI scribe, Lucid’s pill-sized esophageal cancer diagnostic, Cortica’s $80M raise for autism treatment, LG NOVA startup winners

November 27, 2024 | by | No Comments

Turkey bites before Thanksgiving:

Teladoc debuts Virtual Sitter, a hospital bed system for fall detection risk. It uses AI to assess the risk of a patient falling from a hospital bed. The risk is determined by the patient moving within or outside set spatial boundaries (Bounding Box). It can also determine limb movements, whether the patient is sitting up or lying down, and can screen out other people in the room. The AI is coupled with human observation by a nonclinical trained staff monitor who can speak with the affected patient. Virtual Sitter integrates with Teladoc’s TV Pro devices and enables the live monitor to view up to 25% more patients. Falls out of beds are a major cause of hospital injury with over 1 million patients affected and 30% experiencing lasting injuries. TV Pro and Virtual Sitter are in Teladoc’s integrated care unit that has done fairly well in recent quarters. FierceHealthcare, Teladoc release in Yahoo Finance

Veradigm introduces a virtual scribe. The Veradigm Ambient Scribe is designed to ease the burden of EHR documentation. It uses  generative AI from AvodahMed to automatically capture and transcribe real-time patient-provider interactions into structured medical notes. It integrates into the Veradigm EHR. Veradigm release. Meanwhile, the long-drawn-out Veradigm sale has not advanced but betting is that it will be wrapped by year’s end [TTA 13 Nov].

Lucid Diagnostics introduces a diagnostic for detecting esophageal cancer cells without endoscopy. Esophageal cancer is deadly (50% mortality in Stage 1), difficult to detect but is common in those suffering from gastroesophageal reflux disease (GERD). Endoscopy for these high-risk patients is highly invasive, requires IV anesthetic, and its complexity is a barrier to detection of pre-cancerous cells, where it is most curable via ablation. The noninvasive EsoGuard biomarker test uses a detection device about the size of an easily swallowed vitamin pill and is attached to a thin catheter. The catheter collects cells in about a minute which are then analyzed for genetic markers associated with esophageal precancer and cancer. It was FDA-cleared in 2019 and is the only test of its type, but awaits coverage by Medicare and commercial insurers. MedCityNews 

Cortica raises $80 million for its childhood autism diagnosis and treatment offering. The raise was a venture round from Morgan Health, a unit of JP Morgan, Nexus NeuroTech, and Autism Impact Fund.  It provides applied behavior analysis, diagnostic testing, speech-language therapy, occupational therapy, counseling and other services through its 24 centers in eight states and also via virtual counseling in schools and homes. Its purpose is to integrate the often fragmented care autistic and neurodivergent children receive.  The current funding will be used to expand the number of center locations, for value-based contracts with insurers, and to integrate guarantees focused on faster evaluation, diagnosis and treatment, as well as clinical outcomes. Since 2018 it has raised $255 million. MedCity News, FierceHealthcare

And winding it up….

Korean electronics company LG throws its cap into the startup competition business. LG’s NOVA is not salmon or Brazilian music but the North America Innovation Center of LG Electronics. Ten startups presented at LG’s InnoFest in San Francisco, focusing on  life sciences, open innovation, health tech, AI, smart life, and cleantech. The three winners were chosen as the most promising in driving impactful change. 

  • First Place ($15,000): mDETECT Inc. – Developer of highly-sensitive cancer blood tests using DNA sequencing, offering a universal approach to monitoring therapy response and detecting cancer progression. 
  • Second Place ($10,000): Glidance – Independent mobility for people who are blind or have low vision with Glide, the first AI-powered intelligent guide, which enhances confidence, safety, and autonomy. 
  • Innovation for Impact ($10,000): Oncoustics – Transforming low-cost point-of-care ultrasound devices into powerful diagnostic tools for early detection and monitoring of liver diseases using AI. 

The winners’ next step is collaborating in LG NOVA’s Mission for the Future Program which includes marketing, partnerships, and additional resources.  LG release

News roundup: Oak Street’s Pykosz departs CVS, Musk’s Neuralink gains Canadian clinical trial, VA healthcare improvement bill omits EHR oversight measures, 23andMe’s Mirador precision medicine partnership

November 27, 2024 | by | No Comments

Another CVS departure. As Glenview Capital taps its feet waiting for CVS financials to improve, Mike Pykosz, appointed less than a year ago to head up their Health Care Delivery unit, is departing. His replacement is Dr. Sreekanth Chaguturu. Unsurprisingly, Dr. Chaguturu will be working two jobs–president of Health Care Delivery as well as EVP and chief medical officer of CVS Health, saving an executive salary. This may be the capper of a two-month 52-card pickup that started with rumors of a breakup that would split off Aetna, replacement of CEO Karen Lynch, a new head of Aetna, and four new board seats given to Glenview. [TTA 19 Nov]

No date was given for Mr. Pykosz’s departure, but the wording in the release made it appear that it was effective immediately. His LinkedIn post from last Tuesday indicated that he was moving on by end of November, this week. According to new CEO David Joyner, Pykosz had informed management earlier in the year that he was planning to depart and had worked to ensure a smooth transition. Mike Pykosz had previously been CEO and co-founder of Oak Street Health, acquired by CVS for $10 billion in May 2023. In the following months, OSH integrated with elements of Signify Health, in-store Minute Clinics, and grew from 170 units to 250 locations. Whether any of them are profitable is not disclosed and likely not probable, though CVS made much of OSH’s and Signify’s 36% increase in quarterly revenue versus prior year. There is also no disclosure of Mr. Pykosz’s future plans though his LinkedIn post mentions that he was “excited to be able to dedicate time to investing in, advising, and supporting innovative healthcare companies, helping them meet their strategic goals and build better healthcare solutions as well as spend more time with family and friends.” including coaching grade 3 basketball. Bet on hearing from Mr. Pykosz after what is likely a prolonged non-compete agreement and a good rest. Healthcare Dive

Elon Musk’s brain-computer implant, Neuralink, to enter a clinical trial with Health Canada. This is the first outside-US trial for Neuralink. It comprises the N1 brain implant and R1 robot, which is used to place the 64-thread implant into the brain. The study will be performed by the University Health Network (UHN) hospital at its Toronto Western Hospital. The “Canadian Precise Robotically Implanted Brain-Computer Interface” (CAN-PRIME) subjects will be Canadian-resident patients with tetraparesis or tetraplegia resulting from cervical spinal cord injury or the neurological disease ALS who also have a life expectancy of at least 12 months. Earlier this year, an American implant patient moved a mouse by thought [TTA 21 Feb] and is now playing video games and online chess. Neuralink received approval last month for Blindsight, an implant for sight restoration. Mobihealthnews

VA service improvement bill manages to omit Oracle EHR oversight measures. The bipartisan omnibus bill titled ‘The Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act” (H.R. 8371) passed the House last week. It introduced many benefits to VA healthcare workers and to veterans, but managed to pass the House without the ‘guardrails’ that the House Veterans Affairs committee deemed necessary to continue the Oracle EHR rollout, replacing the obsolete VistA system. The committee spokesman, Mark Takano, D-Calif., attributed the omission of requirements included under the EHR Program RESET Act to “a lack of political viability in both the House and Senate”. The chair of the Technology subcommittee, Matt Rosendale (R-Montana), went considerably further and voted against the entire bill. Both blamed Oracle: Takano attributed it to “the army of lobbyists that Oracle unleashed to kill it” and Rosendale stated that “Oracle Cerner bought and bullied their way into getting this bill passed without their company being scrutinized.” The bill now goes to the Senate in the minimal time before the ending of the 118th Congress next month.   

The requirements in the omitted RESET Act included most of what has been discussed in both Senate and House to remedy Oracle Cerner Millenium’s stopped-dead implementation in the VA.

  • Increased Congressional oversight of EHR deployments, ensuring that each implementation of the new EHR “met or exceeded”  pre-deployment efficiencies before moving to the next one
  • Requiring VA to provide lawmakers with quarterly reports with additional data “on user adoption and employee satisfaction” with the Oracle Cerner system
  • Requiring VA to supply data on “employee retention and turnover at medical facilities where such electronic health record system is in use.”

Nextgov.com

Rep. Rosendale issued a press release blasting H.R. 8371. “…this bill ignored years of bipartisan work focused on requiring Oracle Cerner to fix its EHR System, that has resulted in veteran deaths, before it could be expanded to new VA Medical Centers and the company can continue to collect on its multibillion-dollar contract.” Omnibus bills like this are always shotgunned together as well. “The House Veterans’ Affairs Committee ignored regular order with this legislation which, by uniparty design, prohibited scrutiny and debate on the final product. That decision spearheaded a bad process for passing this bill which resulted in an unacceptable final product for our veterans. When a uniparty agreement comes together overnight, like it did with the Dole Act, it means a small group of individuals negotiated it and the American people – and in this case our nation’s heroes – get the short straw.”  

(Editor’s note: Senator Elizabeth Dole, who is still with us at 88, was a single-term Senator from North Carolina 2002-2006, but Cabinet member in two prior administrations as well as the widow of Senator Bob Dole from Kansas.)

Signs of life at 23andMe? The troubled genetic data company, which earlier this month shuttered what remained of its drug therapeutics unit and laid off 40% of its remaining employees, announced this week a research partnership with Mirador Therapeutics, a precision medicine company focused on immunology and inflammation. Mirador is using a targeted set of aggregated, de-identified genetic and phenotypic data from the 23andMe research database to combine with its Mirador 360 development “engine”. Most of the release is boilerplate with the requisite quote from the Mirador CEO, mixed with copy hyping previous 23andMe collaborations and their patient privacy policy which carefully omits the fact that you, personally, can withdraw from the research program, but your genetic data and limited identifiers cannot [TTA 8 Nov]. No financials or agreement duration are disclosed. 23andMe release, Endpoints News (paywalled)

Help fund the NeuroNinja comic–a superhero with Parkinson’s! (Update–it funded!)

November 26, 2024 | by | No Comments

Turning Parkinson’s into an adventure story. Steven Greene, an old friend of your Editor Donna and owner of a marketing agency, was diagnosed in 2009 with Parkinson’s. He has had all sorts of treatments and therapies during 15 years with it, including brain stimulation surgery. Steve’s experiences led him to develop a comic series, NeuroNinja, targeted to the Parkinson’s community. Our hero Steven, during surgery, experiences a freak accident involving an MRI machine and a quantum computer (left/above). Their convergence causes his brain to fuse with a cutting-edge technology, transforming him into NeuroNinja! He remains unsteady, unpredictable, and has Parkinson’s tremors. But NeuroNinja is, in Steve’s words, “a hero who reflects their daily reality, someone who embodies resilience, strength, and hope in the face of adversity. NeuroNinja is more than just a comic; it’s a symbol of perseverance, a reminder that even with a chronic illness, we can be heroes in our own lives. He uses his symptoms and unique abilities to fight evil, navigate challenges, and help others. His ultimate power? The strength to fight through his own struggles, because sometimes the greatest battles are the ones we face within ourselves.”

The series, completed through key panels and the first issue, is being funded through a Kickstarter that so far has raised just above $6,100, exceeding its $6,000 goal. It has three days left to go, so please look at Steve’s video and the entire proposal–and donate!

Update–NeuroNinja is funded! The Kickstarter exceeded its $6,000 goal at $6,350 backed by 54 people. Kickstarter has a feature called ‘late pledge’–click on the ‘back this project’ button. There are rewards available at the $65 and $200 levels and pledges of other amounts are welcomed too for the next 50-odd days.

Breaking: Federal agents seize Steward Health’s CEO, international head’s mobile phones in widening US fraud investigations

November 26, 2024 | by | No Comments

This fowl is coming home to roost, and it’s not going to be much of a Thanksgiving at Steward’s former CEO Ralph de la Torre and international CEO Armin Ernst’s tables as a result. Last week, reports emerged that Federal agents served search warrants and seized mobile phones belonging to both Steward executives, though neither has been formally charged with crimes in the US. Since July, rumors have prevailed that the US Attorney’s office based in Boston had opened an investigation, citing fraud and violations of the Foreign Corrupt Practices Act about its business dealings in Malta between 2018 and 2023–and perhaps more [TTA 25 July]. These rumors were confirmed when a former US Senator, John Boehner, a Steward board director, testified on 14 November to a Federal grand jury in Boston. Boehner had access to financial information that could have revealed potential fraud and corruption within the operations of Steward Health, which collapsed into bankruptcy in May. Prosecutors were reportedly zeroing in on financial transactions that could have personally benefited de la Torre and their top executives. The former senator was best known of late for his lobbying and advocacy of marijuana legalization, which makes his board appointment even more interesting. Other former Steward executives have also been questioned by Federal investigators, according to the Boston Globe‘s (paywalled) reports.  Becker’s and Becker’s, both 25 November. Also Times of Malta 26 Nov

In the US, federal search warrants are not issued lightly. Credible evidence must be presented by a federal law enforcement officer or a US attorney to a magistrate judge with authority in any district where the crimes may have occurred. There must be probable cause to search for and seize a person or property. That includes electronic storage media such as servers, computers, and phones.

The Boston Federal investigation is separate from the outgoing Congress’ Health, Education, Labor and Pensions (HELP) Committee’s subpoena and criminal/civil contempt charges referred in September to the Department of Justice [TTA 1 Oct and prior], complete with de la Torre’s immediate countersuit, nor the Malta Government’s ongoing actions against Steward (as Vitals Global) in the privatization of three hospitals in that island nation. Times of Malta 26 Nov  Steward’s business in Malta included a loony, gaudy spy operation against their critics there and elsewhere. That reported cost was $7 million, diverting much-needed funds while Steward defaulted on its bills and payrolls.  [TTA 2 July]  The Malta investigations have also been stymied by the non-appearance of both de la Torre and Ernst, on the grounds of facing US charges and an ill wife, respectively. Former Malta prime minister Joseph Muscat, under investigation, previously had his phone seized but refused to give the password, which may take a year to crack. Times of Malta 21 Nov

An extensive critique of Steward’s board of directors by the Globe’s reporters from October is available here courtesy of the Weinberg Center for Corporate Governance. It is a worthwhile dive into how Steward’s “unusual” business practices were facilitated by its tight-knit and inexpert board, drawing parallels with Theranos. Board members also enjoyed de la Torre’s considerable largesse, unlike Theranos.

Investigations by the Boston Globe’s reporters also reported that additional Steward funds were diverted to de la Torre’s personal pursuits, such as a private jet for friends, a donation to his children’s school, and a Madrid apartment. The last is interesting to this Editor as Spanish courts do not extradite easily for crimes not committed or charged in Spain, requiring review and approval of all requests by the National Court. de la Torre also has reported residences in Costa Rica where extradition via a bilateral treaty is easier. 

This Editor’s extra-legal advice to de la Torre remains that he should go on his $40 million oceangoing yacht for a trip into international waters and not even try to brazen this through. (And if anyone believes that the corporate phone hasn’t been tossed overboard or any phones seized hadn’t been thoroughly cleansed, I have a bridge over the Hudson River to sell you!)

TTA’s November Futures 3: the good, bad, & ugly continues–CVS adds Glenview to board, controlled Rx telehealth extended, Revere Medical buys CareMax MSO, Oura’s $75M, HHS cybersec scored by GAO, incomplete EHR notes, more!

November 22, 2024 | by | No Comments

 

 

It’s an unusual pre-Thanksgiving week focused on significant developments on ongoing Major Stories but little new. CVS Health bends the knee to investor Glenview. Controlled substances telehealth gets a 3rd extension. Revere Medical out of Steward ashes snaps up a broken MSO. Oura partners with Dexcom CGM and gets paid for it! What’s kind of new? HHS comes up short on cybersecurity leadership while accurate EHR notes are short in new VA study.

Government updates: GAO scores HHS on cybersecurity issues; patient issues largely omitted from EHR notes in VA study (Coming up consistently short)
News roundup: CVS Health cedes 4 new board seats to Glenview, Oscar’s strong Q3, telehealth controlled substance prescribing in 3rd extension, new Revere Medical to buy CareMax assets, Oura picks up $75M Dexcom financing and partnership (Further developments on Big Stories)

TTA’s desk is closing early next week due to Thursday’s US Thanksgiving holiday. New articles resume the week of 2 December.

Cue the music…it’s the good, bad, and a ration of ugly this week. An under-the-radar company makes big buys in primary care and MSO. Veradigm might finally get itself sold. DOJ drags UHG to court over Amedisys–after the election. 23andMe continues to perhaps Destination Oblivion. Forward meets Oblivion after eight years. And Ali Parsa, one year after Babylon’s failure, serves up a new AI venture that gets a Gimlety view.

Bad News Roundup updates: UHG/Optum defends Amedisys buy fast via a website, digging deeper into Forward’s fast demise, former Masimo CEO Kiani booted–and sued (One lesson after another)
Bad News roundup: DOJ drops the hammer on UHG-Amedisys, 23andMe lays off 40% and closes therapeutics, Lyra Health lays off 2% in restructuring, Forward primary care + kiosks shuts down abruptly (We aren’t past it yet)
Babylon Health’s Parsa founds new AI medical assistant venture, Quadrivia, one year after Babylon Health’s failure (Parsa’s new AI-powered deal)
M&A action news: Astrana Health buys up Prospect Health for $745M after Centene MSO unit buy, Veradigm nears $1B+ sale, Sword Health lays off 17% of clinicians prepping for IPO using AI instead, Cigna is not buying Humana–really! truly! (M&A comes alive, with a new player)

The Big Race is over, 45 is now 47 come January, and health tech (plus related) news faces future. HLTH’s future is with UK’s Hyve Group. Cerebral faces an expensive DOJ/DEA Judgment Day for its Bad Behavior during the pandemic. 23andMe, CVS, and Walgreens face future survival. And what if in future healthcare sets a goal of zero failures, like aircraft makers and airlines?

News roundup: Cerebral forfeits $3.7M on federal Rx charges, Aetna president named, Stewardship Health sold to Rural Healthcare, Oura buys data company Sparta Science, Brook Health-Linus Health remote cognitive assessment 
Weekend reading: 23andMe’s up in the air future, including genetic data; Walgreens debates What To Stop and Start; what if healthcare pursued a zero-failure rate? (Some reckonings and a future view)
Surprise! HLTH conference group sold to UK’s Hyve Group Limited (Las Vegas barely a wrap)

A post-HLTH deluge of news–as the US rolls up to a major national election. CVS replaces its CEO and debates breaking up. Amwell takes on a new CFO. Decent-sized raises seem to have returned. Cigna isn’t buying Humana–as of now. And has Teladoc turned a corner?

News roundup: Teladoc’s improved Q3, PursueCare resuscitates Pear’s apps, AMA removes 16-day RPM requirement in 2026, PatientPoint intros Innovation Network, PeopleOne’s $32B raise, Cigna-Humana again a no-go (Earnings season and post-HLTH announcements)
Some thoughts on the takeaways from HLTH (Not that many, strangely)
News roundup 23 Oct: views on a CVS breakup and CEO replacement, Amwell’s interesting new CFO, CopilotIQ/Biofourmis merge (updated), raises by HealthEx, Counsel Health, Oshi Health (Will changes at top fix problems?)

As the weather chills, so do prospects for some very well known companies–and investment. Walgreens plans to shrink its retail footprint by 1,200 over the next three years, “monetize” VillageMD. CVS is exiting most of its infusion business. UHG stock, earnings hammered on Change Healthcare hack, Federal payment cuts. Masimo v. Apple patent slugfest continues with wins for both. DEA kicks the can on telehealth waivers into next year–maybe. FTC and DOJ chill M&A with more demanding Premarket Notification rule for M&A. The spot of good news–baby monitoring Owlet has its mojo back.

News roundup 16 Oct: Walgreens shuts 1,200 stores–500 in ’25, CVS exiting core infusion biz, Masimo v. Apple update, DEA recommends 3rd telehealth extension, Change hack costing UHG $705M, Owlet back in NYSE compliance (So many denouements..and only one good)
FTC drops the hammer on premerger notification requirements–what will be M&A and investment effects? (We told..and tell you so, no frills)

It’s unconfirmed, but CVS may be considering a breakup. Teladoc’s latest reorg puts its COO out to pasture. IPOs may revive by next year for ‘overdue for exit’ companies. In CEO Land, one former CEO strikes back at the Senate holding him in contempt, while another one, having lost her board, now can easily take 23andMe private. ATA announces 2025 Nexus and call for papers. And some new fundings and products…and why can’t VA stop stubbing its toe on Oracle EHR issues, or staff diving into politicians’ health records?

News roundup: Omada Health files S-1 for IPO in 2025–and a look at 2024 healthcare IPOs, Philips debuts new smart baby monitor, ActiveAlert launches in UK, ATA Nexus 2025 calls for speakers, abstracts (An small IPO revival?)
Breaking: another exit at Teladoc, with COO resigning effective 31 December (Something about ships? Spirals? Musical chairs?)
Industry news short takes: fundings for Qure.AI, Centivo, Rippl, Surescripts; M&A closings for GE Healthcare-Intelligent Ultrasound, LetsGetChecked-Truepill. And is Hinge Health going public soon?
Two ‘oops’ at VA: OIG finds VA, Oracle performance misalignments, makes 9 recommendations; VP candidates’ EHR records improperly accessed by VA employees (Enough already!)
Two follow ups: Steward Health CEO resigns–and sues the Senate HELP committee, Wojcicki will take 23andMe private (Time to take the yachts for a long trip?)
Now CVS Health may be reviewing ‘options’–including a possible breakup–report (PBM and health plan troubles)

Steward’s CEO will likely face prosecution on criminal contempt of Congress for not showing up at a hearing, Stefano Pessina’s net worth down by 97% as Walgreens tanks, and Joe Kiani, after founding Masimo 35 years ago, is booted from the board and ankles–now it’s up to Politan.  

What’s next for: Steward CEO now in criminal contempt of Congress; Walgreens’ Pessina’s fortune vanishes by 97%; Masimo’s Kiani now a man without a company

It’s the last week of summer and this Editor has been catching up all over. While away, there have been buys, M&A, and yet another PE ‘smush’ merger. In developing stories, the Masimo-Politan proxy war ends and Steward’s CEO no-show may result in charges–both on Thursday. Congress and the industry argue over continuing telehealth prescribing waivers. And it’s hard to see a future for a broke 23andMe controlled by its founder/CEO–and with a board that just exited today. 

News roundup: Owlet expands to EU, mPulse buys Zipari, New Mountain PE merges 3 payment integrity firms in $3B smush, Candid Health’s $29M raise, Oura buys Veri, Bloomer Tech’s cardio bra (M&A activity revives, as does Owlet. Oura doing just fine)
23andMe settles 6.9M data breach lawsuit for $30M. Breaking–all seven independent directors quit ($30M the best they could get–and the board throws the towel at Wojcicki)
Rounding up follow ups: Walgreens shareholder suit on pharmacy performance, Steward CEO no-shows Senate committee, Masimo-Politan proxy fight has court win for Politan–vote on for 19 September (Walgreens’ misery never ends. Masimo nears its end.)
US telehealth controlled substances prescribing waiver may expire at year’s end; DEA may further restrict (Controversy on continuing virtual prescribing of Schedule II)

One more jumbo deal announced before Labor Day–Evolent Health’s acquisition bids from payer Elevance Health as well as at least three large private equity firms, in a deal that could top $4 billion. (Sensibly, their CEO is cleaning up his stock option portfolio.)

Evolent Health talking major acquisition by payer Elevance, private equity (Could be over $4B)

Counting down before the Labor Day holiday, one large deal of note sneaks through–LetsGetChecked’s $525M deal for Truepill. SVB’s latest report confirms the ‘valuation trap’ for the overvalued companies of the 2020-22 period but that investment is crawling back. Generative AI is much talked about but no one is comfortable with it. And two surprising survivals–NeueHealth and Stewardship Health.

Truepill to be acquired by LetsGetChecked for $525 million (Throwing in together to survive?)
Signs of life: another view on healthcare investments and exits as of mid-year (SVB’s 14th POV)
Are patients and physicians ready for generative AI? How will it be most acceptable? (Resembles telehealth’s early days on the early curve)
“I will survive” updates: NeueHealth survives Q2 with small net loss, Steward sells off Stewardship Health practices to private equity firm for $245M (Dodging disaster)

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Government updates: GAO scores HHS on cybersecurity issues; patient issues largely omitted from EHR notes in VA study

November 20, 2024 | by | No Comments

The Government Accountability Office (GAO) latest report remains critical of HHS’ leadership on cybersecurity issues. Using the immense Change Healthcare data breach as a glaring example, GAO’s latest report released 13 November outlines HHS’s continued ‘challenges’ in ensuring that, among Federal agencies, it takes the lead in strengthening cybersecurity in the healthcare sector. For instance, HHS coordinates with the Cybersecurity and Infrastructure Security Agency (CISA), which is the national coordinating agency for critical infrastructure security and resilience. Where HHS comes up short (again) against GAO prior reports and recommendations is:

  • Weakness in tracking how healthcare organizations are effectively mitigating ransomware 
  • Not yet assessing how healthcare organizations are adopting the ransomware-specific practices outlined in the NIST (National Institute of Standards and Technology) cybersecurity framework centered on identifying, detect, protect, respond, and recover.
  • Inability to document the effectiveness of support HHS provides to healthcare organizations, such as guidance documents, training, job aids, and threat briefings to help the sector manage ransomware risks.   
  • Not conducting a comprehensive sector-wide cybersecurity risk assessment addressing IoT (Internet of Things) and OT (operational technology) devices and systems common in healthcare.
  • Using their Administration for Strategic Preparedness and Response (ASPR) to fully and consistently monitor its working groups supporting the healthcare sector on progress against goals, responsibilities, and on their collaboration.
  • The Centers for Medicare and Medicaid Services (CMS) has had requirements since 2020 with parameters that conflicted with those established by other federal agencies that share data with states, such as the Social Security Administration.
  • CMS has policies to assess states’ cybersecurity but does not coordinate with other federal agencies on the assessments.

GAO’s latest report recommended that:

  • HHS, in coordination with CISA and sector entities, determines the sector’s adoption of leading cybersecurity practices that help reduce ransomware risk.
  • HHS, in coordination with CISA and sector entities, develops evaluation procedures to measure the effectiveness of its support in helping to reduce ransomware risk.
  • HHS includes IoT and OT devices as part of the risk assessments of the sector’s cyber environment.
  • ASPR takes action to fully and consistently demonstrate leading collaboration practices .
  • CMS 1) solicits input from relevant federal agencies on revisions to its security policy to ensure consistency across cybersecurity requirements for state agencies. 2) revises its assessment policies to maximize coordination with other federal agencies.

Highlights and full report 

EHR notes also come up short when it comes to issues brought up by patients–and include information outside the clinician-patient transcript. This observational study from the Regenstrief Institute by two Indiana University medical researchers at the VA found multiple discrepancies in EHR notes that are supposed to recap the actual conversation between patient and clinician during a primary care appointment versus the actual transcript. It took place at four primary care clinics at a midwestern Veterans Affairs (VA) Medical Center and one associated VA community-based outpatient clinic, all using the current VistA EHR. Video and audio recordings were used to create transcripts that were compared with the EHR notes.

The discrepancies were bi-directional. According to the study, “fewer than half of issues that patients initiated in discussion were included in notes, and nearly half of notes referred to information or observations that could not be verified.” There was also a difference in recording by who brought it up. For instance, psychosocial issues were common in patient-clinician discussions. “The researchers found that when the clinician initiated discussion about these issues, 92 percent of notes in the EHR included them, but when the patient initiated discussion, only 45 percent did.”

There were also gaps in quality that were questioned in the study:

  • 8% of notes lacked an assessment and plan. Were some assessments truly incomplete, and some important plans actually skipped?
  • 18% of notes were missing follow-up plans. Were some follow-up plans never arranged?
  • 26% lacked reports of diagnostic test results. Were such results simply absent or unimportant, or were important findings unavailable, difficult to access, or overlooked?

“We recognize that certain variations in EHR documentation stem from authors’ preferences or styles about how to organize or structure notes. At the same time, notes should not lack critical elements.” Reasons for omissions could include “lack of recognition of the significance of a problem by clinicians, forgetfulness while writing notes, insufficient time to complete records accurately and thoroughly; belief that the issue had already been addressed; or prioritization of other concerns.”

Both Drs. Michael Weiner and Richard Frankel are researchers in various aspects of health information technology to improve patient outcomes and doctor-patient communication. They are affiliated with the US Department of Veterans Affairs Health Services Research and Development Center for Health Information and Communication, as well as professors of medicine at Indiana University’s medical school. Regenstrief Institute article 12 Nov, BMC Primary Care published study 18 July 2024

News roundup: CVS Health cedes 4 new board seats to Glenview, Oscar’s strong Q3, telehealth controlled substance prescribing in 3rd extension, new Revere Medical to buy CareMax assets (updated), Oura picks up $75M Dexcom financing and partnership

November 19, 2024 | by | No Comments

This pre-Thanksgiving week stuffs the turkey, not with giblets and savory fillings, but with Big Developments on the Big Stories of the past few weeks.

CVS feeds the crocodile, gives Glenview Capital four new seats on the board. CVS’ startling move with the hedge fund Glenview Capital Management that adds Leslie Norwalk, Glenview CEO Larry Robbins, Guy Sansone, and Doug Shulman, expands their board of directors to an unwieldy 16. According to the CVS release, Norwalk, from Epstein Becker Green, will join the Health Services Committee. Sansone, CEO of H2 Health, will join the Audit Committee.  Shulman, chairman/CEO of OneMain Holdings, will join the Management Planning and Development Committee. It’s unknown whether Robbins will need to join a committee given his prime position.

Despite CVS’ lack of confirmation after their reported breakup/spinoff discussions that kicked off October [TTA 1 Oct], it’s apparent to anyone with clean glasses that Glenview is driving multiple changes at the company including the ouster of CEO Karen Lynch even after she took direct control of Aetna. She was replaced by a CVS ‘lifer’, David Joyner, head of CVS Caremark. Glenview owns 1% of CVS stock as of last report in October, according to the Wall Street Journal, but that 1% accounts for over $700 million of its $2.5 billion war chest. That gives them cause for concern–and leverage.

The board appears to be looking towards maximizing performance now, not later. The new executive chair of CVS Health, Roger Farah, from the release: “In our discussions with the leadership at Glenview, we agreed that we can deliver greater value from our integrated businesses to all of our stakeholders, including our customers, consumers, colleagues, and shareholders.” New faces tasked with quick turnarounds include group president Prem Shah and at the head of shaky Aetna, Steve Nelson from ChenMed [TTA 8 Nov]. That means achieving profitability and cash flow at a very tough time for nearly all insurers. CNBC, Becker’s

How Centene did it after a similar move by Politan Capital Management. Since early 2022, Centene has been selling off in pieces what turned out to be an abundance of ancillary, only partly digested businesses, such as Ribera Health, Magellan, Apixio, and most recently their MSO/ACO organizer Collaborative Health Systems [TTA 13 Nov, 5 May 2023, 30 July 2022], along with a deep portfolio of real estate such as a projected Charlotte HQ, all bought by the late CEO Michael Neidorff. These ‘fat pads’ were easy cuts along with several thousand people. CVS Health, however, may not have the padding that Centene had to generate ready cash from willing buyers as it has the reputation of being fairly lean. Their big missteps may have been in 2022 (FOMO Time) pursuing a management-led Big Objective of entering brick-and-mortar and buying never-profitable Oak Street Health primary care for $10 billion, buying home health’s Signify Health for $8 billion, and investing $100 million in Carbon Health, all at inflated post-pandemic prices with the latter two having significant issues within their lines of business. 

The proposal of splitting up the company sounds drastic to achieve profitability. It may be a ‘worst case scenario’ thrown out to keep the crocodile sated. Much depends on how both Glenview Capital and Mr. Market behave next year with the opportunities presented, while facing a new administration and HHS and CMS heads without ties to or fondness for payers. 

Meanwhile, Oscar Health, helmed by Aetna’s former and ousted head Mark Bertolini, posted a strong Q3 closing September 30. Versus prior year, their revenue went up 68% to $2.4 billion, medical loss ratio remained fairly stable at 84.6%, up 80 basis points (bps=.01%), and expenses improved by 3.6%, but importantly they narrowed their net loss to $54.6 million, or $(0.22)  of earnings per share, a $10.8 million improvement. Revenue for the year was adjusted upward to the $9.2 billion to $9.3 billion range, $200 million above the prior range of $9.0 billion to $9.1 billion. It’s quite a turnaround from the dancing-with-disaster Oscar of only 18 months ago. Look hard, there’s a schadenfreude-ish smile on the middle guy’s face….  Oscar release

DEA extended telehealth prescribing of controlled substances for a third round. The kicking the can down the road was easily predicted last month. The “Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” exited the registry of the White House Office of Management and Budget (OMB) 14 November. On the 15th, the rule was posted to the Federal Register and officially published today (19 Nov). It gives the Drug Enforcement Administration (DEA) a clean extension of the pandemic time flexibilities on Schedule II-V remote prescribing. The industry will wait and see if the incoming Trump 47 administration will bring this up to Congress to repeal, as by a whisker the extension fell outside the 60-day vacate window. But it’s not a hot button issue and is very likely to continue into 2025. FierceHealthcare, ATA release

CareMax goes into Chapter 11, agrees to sell to the new Revere Medical. The senior healthcare provider based in Miami filed Chapter 11 on 17 November but already has entered an agreement to sell assets to Revere Medical, formerly Stewardship Health, sold out of Steward Health’s bankruptcy to Brady Health Buyer, an entity of Rural Healthcare Group-Kinderhook Industries [TTA 8 Nov]. The sale that had to be planned for some time is part of a restructuring plan approved by the company’s secured lenders, commonly called a pre-packaged bankruptcy. Revere is acquiring CareMax’s management services organization (MSO) and ACO assets, including the Medicare shared savings program (MSSP) part of its MSO business that supports about 80,000 Medicare beneficiaries. CareMax will wind down and exit their Medicare Advantage and ACO REACH businesses which will take some time, likely 2026. The operating clinic business assets will go to a third-party buyer. Further restructuring is part of a restructuring support agreement (the “RSA”) with lenders holding 100 percent of the Company’s secured debt obligations, according to the 17 November release. Becker’s  Update: CareMax was related to Steward Health as the exclusive value-based managed service organization (MSO) for Steward Health Care’s Medicare network. Steward’s failure was the final crack that broke CareMax’s back, as it had been losing money for several years, according to Paul Rundell, CareMax’s chief restructuring officer. Not helpful was their leasing many of their properties from real estate investment trust Medical Properties Trust, same as Steward.  HealthcareDive   And where in the world is Dr. de la Torre, Steward’s CEO?

Finland’s Oura health tracker ring now discloses where the money’s coming from. Oura picked up $75 million from Dexcom in a Series D funding round, their first since a $100 million Series C in May 2021 and an undisclosed venture round the following year. Their total financing is $223 million and the valuation at $5 billion. Dexcom and Oura are also in partnership to integrate Dexcom glucose data with vital signs, sleep, stress, heart health, and activity data from Oura Ring. The two-way integration will flow data between Dexcom and Oura products, including Dexcom glucose biosensors, Dexcom apps, Oura Ring and the Oura App. Oura release, FierceHealthcare Oura purchased Sparta Science earlier this month and metabolic tracker Veri in September. Veri, however, works with the Abbott FreeStyle Libre to guide users to the right foods, habits, and timing versus common health metrics such as sleep for their bodies. 

TTA’s November Futures 2: the good, bad, ugly with Astrana, Veradigm, 23andMe, Ali Parsa, Forward, UnitedHealth, Sword Health, Masimo, more!

November 15, 2024 | by

 

 

It’s the good, bad, and a ration of ugly this week. An under-the-radar company makes a big buy and Veradigm might finally get itself sold. DOJ drags UHG to court over Amedisys–after the election. 23andMe continues to perhaps oblivion. Forward meets oblivion after eight years. And Ali Parsa, one year after Babylon’s failure, serves up a new AI venture that gets a Gimlety view.

Bad News Roundup updates: UHG/Optum defends Amedisys buy fast via a website, digging deeper into Forward’s fast demise, former Masimo CEO Kiani booted–and sued (One lesson after another)
Bad News roundup: DOJ drops the hammer on UHG-Amedisys, 23andMe lays off 40% and closes therapeutics, Lyra Health lays off 2% in restructuring, Forward primary care + kiosks shuts down abruptly (We aren’t past it yet)
Babylon Health’s Parsa founds new AI medical assistant venture, Quadrivia, one year after Babylon Health’s failure (Parsa’s new AI-powered deal)
M&A action news: Astrana Health buys up Prospect Health for $745M after Centene MSO unit buy, Veradigm nears $1B+ sale, Sword Health lays off 17% of clinicians prepping for IPO using AI instead, Cigna is not buying Humana–really! truly! (M&A comes alive, with a new player)

The Big Race is over, 45 is now 47 come January, and health tech (plus related) news faces future. HLTH’s future is with UK’s Hyve Group. Cerebral faces an expensive DOJ/DEA Judgment Day for its Bad Behavior during the pandemic. 23andMe, CVS, and Walgreens face future survival. And what if in future healthcare sets a goal of zero failures, like aircraft makers and airlines?

News roundup: Cerebral forfeits $3.7M on federal Rx charges, Aetna president named, Stewardship Health sold to Rural Healthcare, Oura buys data company Sparta Science, Brook Health-Linus Health remote cognitive assessment 
Weekend reading: 23andMe’s up in the air future, including genetic data; Walgreens debates What To Stop and Start; what if healthcare pursued a zero-failure rate? (Some reckonings and a future view)
Surprise! HLTH conference group sold to UK’s Hyve Group Limited (Las Vegas barely a wrap)

A post-HLTH deluge of news–as the US rolls up to a major national election. CVS replaces its CEO and debates breaking up. Amwell takes on a new CFO. Decent-sized raises seem to have returned. Cigna isn’t buying Humana–as of now. And has Teladoc turned a corner?

News roundup: Teladoc’s improved Q3, PursueCare resuscitates Pear’s apps, AMA removes 16-day RPM requirement in 2026, PatientPoint intros Innovation Network, PeopleOne’s $32B raise, Cigna-Humana again a no-go (Earnings season and post-HLTH announcements)
Some thoughts on the takeaways from HLTH (Not that many, strangely)
News roundup 23 Oct: views on a CVS breakup and CEO replacement, Amwell’s interesting new CFO, CopilotIQ/Biofourmis merge (updated), raises by HealthEx, Counsel Health, Oshi Health (Will changes at top fix problems?)

As the weather chills, so do prospects for some very well known companies–and investment. Walgreens plans to shrink its retail footprint by 1,200 over the next three years, “monetize” VillageMD. CVS is exiting most of its infusion business. UHG stock, earnings hammered on Change Healthcare hack, Federal payment cuts. Masimo v. Apple patent slugfest continues with wins for both. DEA kicks the can on telehealth waivers into next year–maybe. FTC and DOJ chill M&A with more demanding Premarket Notification rule for M&A. The spot of good news–baby monitoring Owlet has its mojo back.

News roundup 16 Oct: Walgreens shuts 1,200 stores–500 in ’25, CVS exiting core infusion biz, Masimo v. Apple update, DEA recommends 3rd telehealth extension, Change hack costing UHG $705M, Owlet back in NYSE compliance (So many denouements..and only one good)
FTC drops the hammer on premerger notification requirements–what will be M&A and investment effects? (We told..and tell you so, no frills)

It’s unconfirmed, but CVS may be considering a breakup. Teladoc’s latest reorg puts its COO out to pasture. IPOs may revive by next year for ‘overdue for exit’ companies. In CEO Land, one former CEO strikes back at the Senate holding him in contempt, while another one, having lost her board, now can easily take 23andMe private. ATA announces 2025 Nexus and call for papers. And some new fundings and products…and why can’t VA stop stubbing its toe on Oracle EHR issues, or staff diving into politicians’ health records?

News roundup: Omada Health files S-1 for IPO in 2025–and a look at 2024 healthcare IPOs, Philips debuts new smart baby monitor, ActiveAlert launches in UK, ATA Nexus 2025 calls for speakers, abstracts (An small IPO revival?)
Breaking: another exit at Teladoc, with COO resigning effective 31 December (Something about ships? Spirals? Musical chairs?)
Industry news short takes: fundings for Qure.AI, Centivo, Rippl, Surescripts; M&A closings for GE Healthcare-Intelligent Ultrasound, LetsGetChecked-Truepill. And is Hinge Health going public soon?
Two ‘oops’ at VA: OIG finds VA, Oracle performance misalignments, makes 9 recommendations; VP candidates’ EHR records improperly accessed by VA employees (Enough already!)
Two follow ups: Steward Health CEO resigns–and sues the Senate HELP committee, Wojcicki will take 23andMe private (Time to take the yachts for a long trip?)
Now CVS Health may be reviewing ‘options’–including a possible breakup–report (PBM and health plan troubles)

Steward’s CEO will likely face prosecution on criminal contempt of Congress for not showing up at a hearing, Stefano Pessina’s net worth down by 97% as Walgreens tanks, and Joe Kiani, after founding Masimo 35 years ago, is booted from the board and ankles–now it’s up to Politan.  

What’s next for: Steward CEO now in criminal contempt of Congress; Walgreens’ Pessina’s fortune vanishes by 97%; Masimo’s Kiani now a man without a company

It’s the last week of summer and this Editor has been catching up all over. While away, there have been buys, M&A, and yet another PE ‘smush’ merger. In developing stories, the Masimo-Politan proxy war ends and Steward’s CEO no-show may result in charges–both on Thursday. Congress and the industry argue over continuing telehealth prescribing waivers. And it’s hard to see a future for a broke 23andMe controlled by its founder/CEO–and with a board that just exited today. 

News roundup: Owlet expands to EU, mPulse buys Zipari, New Mountain PE merges 3 payment integrity firms in $3B smush, Candid Health’s $29M raise, Oura buys Veri, Bloomer Tech’s cardio bra (M&A activity revives, as does Owlet. Oura doing just fine)
23andMe settles 6.9M data breach lawsuit for $30M. Breaking–all seven independent directors quit ($30M the best they could get–and the board throws the towel at Wojcicki)
Rounding up follow ups: Walgreens shareholder suit on pharmacy performance, Steward CEO no-shows Senate committee, Masimo-Politan proxy fight has court win for Politan–vote on for 19 September (Walgreens’ misery never ends. Masimo nears its end.)
US telehealth controlled substances prescribing waiver may expire at year’s end; DEA may further restrict (Controversy on continuing virtual prescribing of Schedule II)

One more jumbo deal announced before Labor Day–Evolent Health’s acquisition bids from payer Elevance Health as well as at least three large private equity firms, in a deal that could top $4 billion. (Sensibly, their CEO is cleaning up his stock option portfolio.)

Evolent Health talking major acquisition by payer Elevance, private equity (Could be over $4B)

Counting down before the Labor Day holiday, one large deal of note sneaks through–LetsGetChecked’s $525M deal for Truepill. SVB’s latest report confirms the ‘valuation trap’ for the overvalued companies of the 2020-22 period but that investment is crawling back. Generative AI is much talked about but no one is comfortable with it. And two surprising survivals–NeueHealth and Stewardship Health.

Truepill to be acquired by LetsGetChecked for $525 million (Throwing in together to survive?)
Signs of life: another view on healthcare investments and exits as of mid-year (SVB’s 14th POV)
Are patients and physicians ready for generative AI? How will it be most acceptable? (Resembles telehealth’s early days on the early curve)
“I will survive” updates: NeueHealth survives Q2 with small net loss, Steward sells off Stewardship Health practices to private equity firm for $245M (Dodging disaster)

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Thanks for asking for update emails. Please tell your colleagues about this news service and, if you have relevant information to share with the rest of the world, please let me know.

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donna.cusano@telecareaware.com

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Bad News Roundup updates: UHG/Optum defends Amedisys buy fast via a website, digging deeper into Forward’s fast demise, former Masimo CEO Kiani booted–and sued (updated)

November 15, 2024 | by

The other shoe drops, as UnitedHealth Group/Optum take their defense public a day later. This unorthodox approach to defending an acquisition against a Department of Justice lawsuit [TTA 13 Nov] is visible on a specially set up Optum page. ImprovingHomeCare.com predictably highlights the benefits of an Amedisys merger along with the divestitures to VitalCaring Group. The gauntlet thrown is unadorned: “The Amedisys combination with Optum would be pro-competitive and further innovation, leading to improved patient outcomes and greater access to quality care. We will vigorously defend against the Department of Justice’s overreaching interpretation of the antitrust laws.”

  • Setup is around present and future demand–and that providers have to be capable of investing and scaling to meet it. “70% of adults 65 or older will likely need some form of long-term care during their lives.” and 3 million Americans received home health services in 2020 (Editor’s note–in a pandemic year when visits were certainly curtailed).
  • Home health is highly fragmented both nationally and locally, thus the acquisition isn’t anti-competitive. “In metropolitan areas with approximately 500,000 residents, there are an average of 26 agencies serving the metro area. The combination of Optum and Amedisys would be a fraction of both home health and hospice–and there would be strong competition in both metro and rural areas.
  • The divestiture to VitalCaring would further preserve competition, and that VitalCaring is a quality competitor. The DOJ release made much of VitalCaring’s inadequacies, such as their lower quality scores, financial difficulties, and leadership. VitalCaring, headquartered in Austin, Texas, currently operates in six states with 58 locations with plans to expand. Their CEO April Anthony is cited as building multiple home health companies ‘from scratch’ such as Encompass Care.
  • Additional proof points stress streamlining of care across Optum’s areas of expertise, integrating technology, and improving value-based care coordination.

FierceHealthcare

Forward’s shut down continues to reverberate in a classic tale of overreach and misdirection. Their bet on kiosks, plus a ‘forward-tech’ approach to a concierge-on-the-cheap, no- insurance-accepted model of primary care over eight years, apparently led to what pilots call a death spiral–it begins wide and imperceptible until it tightens and accelerates fatally in a final dive. Business Insider, true to its name, spoke with 11 anonymous and now former employees who attributed the failure to putting all their chips on 3,200 CarePods installed in one year. Their CEO, Adrian Aoun, was obsessed with technology to the point where he wanted to replace his offices and doctors with CarePods and started to strip the clinics of services, despite only two CarePods installed. 

Most advanced, yet unacceptable*. Patients didn’t try out or use the CarePods, finding them less than inviting. Logistical challenges delayed placements in large markets like New York and Chicago. Then technical problems mounted: automated blood draws failed, lab tests were withdrawn. The coup de grace–patients kept getting trapped in the CarePods. They were insanely expensive–the first two CarePods cost over $1 million each. Then the huge units were unattractive to landlords who didn’t want to fight local building codes nor saw a profit in them. By the end of the summer, there were only two CarePods in place at a mall in Sacramento and in Chandler, Arizona, both gathering dust. (*Shout out to Raymond Loewy, Never Leave Well Enough Alone)

In the increasingly empty Forward clinic offices, the futuristic tech and breadth of services touted in social media adverts weren’t quite as advertised. The whole-body scanner glitched requiring manual checks. Their lab tests became limited to those that could be done in-house, eliminating genetic testing via 23andMe along with services such as simple dermatology removals.

Christina Farr in Second Opinion has a set of takeaways worth noting, with this Editor’s comments (in parentheses):

  • Subscription-based, out-of-pocket healthcare is possible–but hard. (WAY hard when basics are up 25%+! And insurance is almost a given, even if taken in part.)
  • Brick-and-mortar clinics make only limited sense–and space must be used economically, not easy to do in health tech. (Retail and in-person are perhaps anathema in the concepts of those in health tech.)
  • We’re not focusing on those who really need care (But they’re not sexy, wealthy, or relatable to the creators of said tech. Many of them are also on Medicare and Medicaid–truly not sexy.)
  • Primary care is a tough starting point for subscription care (Except the very highest, most exclusive end as she notes!) Specialties may be more amenable to this model. (But volume?) And different age groups want different relationships within this type of care.
  • Timing is everything. Perhaps if Forward had started its clinics today it would have had a far better chance of success? (Then look at bullets 1-4 and see how truly daunting a tech-first clinic setup can be for the tech mindset untempered by research and UX-minded marketing.)

Forward is yet another sad and expensive example of 1) a founder hyperfocusing on whiz-bang technology, 2) losing touch with the customers using it, 3) not improving delivery based on customer needs, and 4) forgetting where he ostensibly started–the mission of improving healthcare. This Editor is sure that his 30-odd investors, especially Vinod Khosla, will have something to say to him about running through $100 million in one year–and over $300 million over eight years.

Masimo’s now-former CEO booted from his company and sued–to boot! (updated) The new management formally terminated founder Joe Kiani on 24 October, as noted in an October SEC filing. In a classic ‘you’re fired..no, I quit!’ situation, after he lost the proxy fight for control of the company, he resigned on 19 September. Kiani immediately filed a lawsuit against Masimo in California state court to obtain a $400 million payout per his employment contract. It is reported to be a declaratory relief suit that hinges on a ‘resignation for good reason’. This is usually specified in the contract. An example is that the executive ceases to be part of senior management, along with others.

The new board of directors has now turned the tables. Masimo is now suing Kiani and RTW Investments in the US District Court for the Southern District of New York. The complaint alleges collusion to violate Federal securities laws by secretly manipulating the shareholder vote through an ’empty voting’ scheme. Empty voting is done through put options or by selling the shares after the record date but before the shareholder meeting. It’s a way for an investor to build up share control and sway the outcome of a shareholder vote at little cost. The suit proposes that Kiani and RTW did precisely that, rigging the vote by acquiring control of over 19% of shares. Evidently, the BOD has proof. The lawsuit and more details are in Strata-gee.

(Editor’s opinion: this is a bare-knucks attempt to claw back Kiani’s contract payout by the new controlling company, Politan Capital Management. And both lawsuits could be true. Pass the popcorn.)

Insult upon injury for Joe Kiani is that shareholders now have some hope that management can save the company by concentrating on healthcare tech. Shares are up. Masimo’s Q3 results reported on 5 November were strong though net income declined. Sound United, the main anchor dragging down the company, is now termed ‘a discontinued operation’. Exhaustive detail on their results is in Strata-gee here.

Bad News roundup: DOJ drops the hammer on UHG-Amedisys, 23andMe lays off 40% and closes therapeutics, Lyra Health lays off 2% in restructuring, Forward primary care + kiosks shuts down abruptly

November 14, 2024 | by

Shoe drop! The long-anticipated Department of Justice (DOJ) lawsuit against UnitedHealth Group and Optum to prevent the acquisition of  home health and hospice operator Amedisys was filed yesterday (12 November) in the District of Maryland. UHG’s offer to acquire Amedisys was made in June 2023 for $3.3 billion in an all-cash deal, but approval was held up in DOJ review ever since. Even with location divestitures proposed in July to VitalCaring Group to reduce anti-trust concerns with Optum’s home health operations (acquired with LHC Group), UHG remained a DOJ target. The civil lawsuit was filed by DOJ together with the Attorneys General of Maryland, Illinois, New Jersey, and New York. No timeline is provided in the release.

The rationale cited is of course anti-trust and elimination of competition between Amedisys and UHG’s Optum. “We are challenging this merger because home health and hospice patients and their families experiencing some of the most difficult moments of their lives deserve affordable, high quality care options,” said Attorney General Merrick B. Garland. The fact that the US Attorney General was quoted first in their release indicates the importance of the case to the DOJ. It’s also a race to the finish as come 20 January 2025, there will be a new president appointing a new AG immediately.

The DOJ states that both companies are “fierce competitors” and that the divestiture is insufficient. “The proposed divestiture does not alleviate harm in over 100 home health, hospice, and labor markets, which generate at least a billion dollars in revenue annually, serve at least 200,000 patients, and employ at least 4,000 nurses.”  Their case is well-built in this Editor’s view. From the release:

 UnitedHealth’s market share after the transaction would make the merger presumptively illegal in:

    • Hundreds of local home health care markets, with an annual volume of commerce exceeding $1.6 billion annually, in 23 states and the District of Columbia;
    • Dozens of local hospice markets, with an annual volume of commerce exceeding $300 million annually, in 8 states; and
    • Hundreds of local markets for home health and hospice nurse labor, employing at least 8,000 nurses, in 24 states.

The lawsuit also seeks civil penalties against Amedisys for falsely certifying compliance with its obligations under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) by failing to produce millions of documents or disclosing the deletion of other documents. For each day that Amedisys was in violation of the HSR, DOJ is seeking a fine of up to $51,744 daily. Amedisys was originally set to be acquired by OptionCare, which does not directly compete in home health, but UHG won a bidding war.

As this Editor said at the time of the Change Healthcare acquisition win against DOJ in Federal court (and we know how that turned out long term), “DOJ has a long memory, a Paul Bunyan-sized ax to grind, and doesn’t like losing.” FierceHealthcare

23andMe continues their long jump down to…who knows where? CEO Anne Wojcicki is minusing out 200+ employees or 40% of its remaining workforce, and fully shuttering its therapeutics development unit. The latter is running two clinical trials which will be wound down ‘as quickly as practical.’ These cuts will save $35 million annually but incur $12 million in one-time severance and termination-related costs. The much-touted therapeutics discovery unit was shut in late summer [TTA 14 August].

What’s left? Not much–the Lemonaid remote prescribing unit, with an entree into GLP-1 prescribing, some published studies, a new AI chatbot called “DaNA”, and a longevity service dubbed Total Health. During their Q2 FY2025 earnings call and release, revenue sank to $44 million versus prior year’s $50 million (-12%)–slightly from Q1’s $40 million–operating expenses reduced 17% to $84 million versus prior year’s $101 million, but the company remained firmly in the red with a GAAP loss of $59 million, 21% less than last year’s $75 million and reduced versus Q1’s $69 million loss. The board, as previously noted, now consists of three financial non-healthcare people, replacing the seven who resigned. Meanwhile, customers wonder about the security and use of their genetic and personal information [TTA 8 Nov]. Release, AP, Healthcare Dive

Another telemental health unicorn, Lyra Health, laid off 2% of staff in a restructuring. 77 people on non-clinical operational teams were released. Some may receive severance for 12 weeks with health benefits, according to one of the anonymous released. Noted in the FierceHealthcare article are reported changes at Lyra, including larger provider caseloads demanded and deletion of seven core values that put clients and clinicians first. Lyra’s last raise was a $235 million Series F in January 2022 for a total of over $910 million (Crunchbase). That high valuation of $5.6 billion has been tough to maintain in the current funding environment–and to not take a down round that affects valuation. 

Health kiosk/primary care practice Forward goes backward, shuts immediately. Nearly on the first anniversary of a $100 million Series E raise from Khosla Ventures and four other investors to deploy self-serve kiosks (left) in major cities [TTA 17 Nov 23], tech-driven primary care practice Forward announced its sudden closure today, effective immediately. What remains on their website is a goodbye-and-good-luck note to patients canceling appointments and zeroing out its app. Patients can email clinicians for care support until 19 December. There is no information available on accessing records nor transferring to new providers, leaving patients in the lurch. 200 employees will lose their jobs immediately as well.

Forward had primary care practices in 14 markets such as New York, San Francisco, and others. Last year it claimed 100+ primary clinicians at 19 locations, with patients paying $150/monthly (no insurance accepted) for un­lim­it­ed vis­its to For­ward’s pri­ma­ry clin­ics. (Refunds, anyone?) The CarePods self-serve kiosks were designed to be self-contained units placed in malls, offices, and gyms. Inside, subscribing patients could access AI-powered health apps for disease detection, biometric body scans, blood testing in disease areas, including diabetes, hypertension, weight management, and mental health (depression and anxiety). They were scheduled last year to be deployed in the San Francisco Bay Area, New York, Chicago, and Philadelphia. Nice idea, but like the earlier HealthSpot Station of 2012-2016, they are equally defunct.

In its eight-year life, Forward had raised $325 million (Crunchbase), which also reported last year’s Series E as only $75 million. At the time of their Series D, Forward was valued at over $1 billion and had a roster of flashy investors such as music’s The Weeknd, Salesforce’s founder Marc Benioff, actor Matthew McConaughey, Eric Schmidt, and Softbank. What’s stunning? Reports indicated that it only gen­er­at­ed un­der $100 mil­lion in to­tal rev­enue since its founding. There has to be more to this, like lawsuits….    FierceHealthcare, Endpoints News

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

November 13, 2024 | by

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

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

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

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

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

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

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

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

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

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

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

M&A action news: Astrana Health buys up Prospect Health for $745M after Centene MSO unit buy, Veradigm nears $1B+ sale, Sword Health lays off 17% of clinicians prepping for IPO using AI instead, Cigna is not buying Humana–really! truly!

November 13, 2024 | by

A company most have never heard of is snapping up provider networks, health plans, and management services. Astrana Health, a Southern California-based value-based care (VBC) company formerly known as Apollo Medical Holdings, has agreed to acquire most of the assets of Prospect Health for $745 million:

  • Prospect Health System: 3,000 primary care providers and 10,000 specialists across Southern California, Texas, Arizona, and Rhode Island. It currently has 610,000 members across Medicare Advantage, Medicaid, and commercial lines of business.
  • Prospect Health Plan, licensed in California 
  • One hospital, Alta Newport Hospital dba Foothill Regional Medical Center in Tustin, California (Santa Ana area), a fully accredited acute care hospital with 177 licensed beds
  • Prospect Medical Systems, a management service organization (MSO) that provides administrative support to Prospect-owned affiliates and managed medical groups/independent physician associations (IPAs).
  • RightRx pharmacy

FTR: “Astrana plans to leverage its proven Care Enablement platform, a set of care management tools and technology, including value-based contracting and credentialing, AI-driven population health analytics, its NCQA-certified Healthcare Effectiveness Data and Information Set gaps in care engine, care management and disease management platform, and other administrative services to further advance improvements in patient outcomes.”

According to William Blair analysts Ryan Daniels and Jack Senft, quoted in FierceHealthcare, “Prospect is expected to generate $1.2 billion in revenue and $81 million in adjusted EBITDA on an annual basis in 2024, implying a transaction value at about 9.2 times adjusted EBITDA.” The $745 million purchase was financed by cash on hand and a $1,095 million 364-day senior secured bridge commitment provided by Truist Bank and JP Morgan. It’s not expected to close until mid-2025 and is subject to the usual Federal and multi-state regulatory reviews and approvals. Sounds like a deal that evades the new premarket notifications as complementary and not competitive. But we’ll see. Release, Healthcare Finance News

One wonders about that cash on hand as Astrana previously bought Collaborative Health Systems, a 17-state MSO with 129,000 original Medicare beneficiaries managed in 10 primary care shared savings accountable care organizations (ACOs in the REACH and MSSP models), a Maryland Care Transformation Organization CMS/state primary care model, and three independent physician associations (IPAs). CHS came with Centene’s acquisition of WellCare Health Plans in 2020 and was originally organized by Universal American in 2012. That closed in October at an undisclosed price paid to Centene, continuing its divestment of what they consider ancillary businesses to maximize cash. It was also positioned as Astrana remaining a key partner in Centene’s Medicare business, now known as Wellcare (Releases 25 July, 7 Oct).

Prior to that acquisition, Astrana was a relatively concentrated California/Western States diversified health services organization with about 10,000 providers and claiming a million patients, with one ACO in the ACO REACH program and another in the MSSP model. In absorbing CHS, they also divested a substantial number of people, mostly senior managers and leadership, who managed a wide number of ACOs in demanding CMS models at scale. (Disclaimer: Editor Donna was marketing director for CHS 2018-2020). One wonders if CHS will be merged into Prospect’s MSO, though in reality they offer vastly different services.

Back in August and prior, MSO Evolent Health put itself up for sale for an estimated $4 billion, with the most interested parties being Elevance and assorted private equity organizations. Nothing has publicly moved since then. But it did confirm that major money is now interested in this decidedly unsexy corner of the healthcare business.

Veradigm’s long-drawn-out sale may be reaching a conclusion. Reports this week state that McKesson, Oracle, and private equity bidder Thoma Bravo are all bidders for the company. CVS considered it but passed. It may be finalized by Thanksgiving for an estimated price in excess of $1 billion, its current market cap.

Veradigm put itself up for sale last May. In August, reported bidders included private equity Thoma Bravo, which took NextGen EHR private in September 2023, Roche, and Vista Equity Partners, owner of the Greenway EHR. Thoma Bravo is the only carryover from this initial list. Apparently, Roche and Vista have dropped out. As reported then, the company is apparently in good shape but unwieldy, with healthcare data services and systems that make it an interesting buy for one or more companies. Though outwardly crippled by years of financial reporting problems due to a still unsorted software problem, which led to its Nasdaq delisting last February, it has been profitable (though unaudited) and is trading OTC above $11. Axios  Hat tip to HIStalk 13 Nov

Virtual MSK provider Sword Health lays off 13 physical therapists, about 17% of its clinicians, as it preps for a mid-2025 IPO. Therapists contacted by Business Insider stated that the layoffs also coincided with a doubling-plus of clinician caseload from an average 2-300 at the start of 2024 to 700 by year-end. In a statement to BI, Sword maintained the cuts were ‘performance based’ and that they had open positions.

Information obtained by BI in interviews with Sword executives clearly states that they mean for AI to be the ‘master expert’ of their virtual therapy model, vetted (of course) by humans. According to the therapists interviewed by BI, “Sword began using AI-generated messages for patient conversations in the spring. The technology allows physical therapists to accept an AI-generated message, edit it, or reject it.” The big push is to scale Sword for more employer contracts in an outcomes-based model, paralleling Transcarent’s USP. Sword in June received a jumbo round of $130 million and now is valued at around $3 billion. Profitability is projected to be at the end of 2024 to preface the mid-2025 IPO. A competitor also considering its own IPO is Hinge Health [TTA 3 Oct]. MSN  Hat tip to HIStalk 13 Nov

And finally, truly, really–Cigna is NOT buying Humana! This was evident on the investor call 31 October by their CEO David Cordani [TTA 31 Oct] but it seems that the rumors persisted until Cigna issued an official statement that yes, it’s using free cash to buy back shares, yes, it will make strategic acquisitions, and no, it’s not buying Humana as it doesn’t fall into the second category. (It also is under Federal and FTC scrutiny about their pharmacy benefit management business under Express Scripts, TTA 1 Oct.) From the Cigna release: “Additionally, in light of recent and persistent speculation, The Cigna Group expects to communicate that the company is not pursuing a combination with Humana Inc. The Cigna Group remains committed to its established M&A criteria and would only consider acquisitions that are strategically aligned, financially attractive, and have a high probability to close.” You wonder who’s been fluffing along this rumor to this extent, and why. The tale of the tape? Cigna shares are up 4.5% in the past five days, while Humana’s are down 4%. FierceHealthcare

TTA’s November Futures: HLTH sells to Hyve Group, Cerebral’s $3.7M DOJ settlement, changes at CVS/Aetna, 23andMe’s cloudy future, Oura buys Sparta, Steward Health sold, more!

November 8, 2024 | by

 

 

The Big Race is over, 45 is now 47 come January, and health tech (plus related) news faces future. HLTH’s future is with UK’s Hyve Group. Cerebral faces an expensive DOJ/DEA Judgment Day for its Bad Behavior during the pandemic. 23andMe, CVS, and Walgreens face future survival. And what if in future healthcare sets a goal of zero failures, like aircraft makers and airlines?

News roundup: Cerebral forfeits $3.7M on federal Rx charges, Aetna president named, Stewardship Health sold to Rural Healthcare, Oura buys data company Sparta Science, Brook Health-Linus Health remote cognitive assessment 
Weekend reading: 23andMe’s up in the air future, including genetic data; Walgreens debates What To Stop and Start; what if healthcare pursued a zero-failure rate? (Some reckonings and a future view)
Surprise! HLTH conference group sold to UK’s Hyve Group Limited (Las Vegas barely a wrap)

A post-HLTH deluge of news–as the US rolls up to a major national election. CVS replaces its CEO and debates breaking up. Amwell takes on a new CFO. Decent-sized raises seem to have returned. Cigna isn’t buying Humana–as of now. And has Teladoc turned a corner?

News roundup: Teladoc’s improved Q3, PursueCare resuscitates Pear’s apps, AMA removes 16-day RPM requirement in 2026, PatientPoint intros Innovation Network, PeopleOne’s $32B raise, Cigna-Humana again a no-go (Earnings season and post-HLTH announcements)
Some thoughts on the takeaways from HLTH (Not that many, strangely)
News roundup 23 Oct: views on a CVS breakup and CEO replacement, Amwell’s interesting new CFO, CopilotIQ/Biofourmis merge (updated), raises by HealthEx, Counsel Health, Oshi Health (Will changes at top fix problems?)

As the weather chills, so do prospects for some very well known companies–and investment. Walgreens plans to shrink its retail footprint by 1,200 over the next three years, “monetize” VillageMD. CVS is exiting most of its infusion business. UHG stock, earnings hammered on Change Healthcare hack, Federal payment cuts. Masimo v. Apple patent slugfest continues with wins for both. DEA kicks the can on telehealth waivers into next year–maybe. FTC and DOJ chill M&A with more demanding Premarket Notification rule for M&A. The spot of good news–baby monitoring Owlet has its mojo back.

News roundup 16 Oct: Walgreens shuts 1,200 stores–500 in ’25, CVS exiting core infusion biz, Masimo v. Apple update, DEA recommends 3rd telehealth extension, Change hack costing UHG $705M, Owlet back in NYSE compliance (So many denouements..and only one good)
FTC drops the hammer on premerger notification requirements–what will be M&A and investment effects? (We told..and tell you so, no frills)

It’s unconfirmed, but CVS may be considering a breakup. Teladoc’s latest reorg puts its COO out to pasture. IPOs may revive by next year for ‘overdue for exit’ companies. In CEO Land, one former CEO strikes back at the Senate holding him in contempt, while another one, having lost her board, now can easily take 23andMe private. ATA announces 2025 Nexus and call for papers. And some new fundings and products…and why can’t VA stop stubbing its toe on Oracle EHR issues, or staff diving into politicians’ health records?

News roundup: Omada Health files S-1 for IPO in 2025–and a look at 2024 healthcare IPOs, Philips debuts new smart baby monitor, ActiveAlert launches in UK, ATA Nexus 2025 calls for speakers, abstracts (An small IPO revival?)
Breaking: another exit at Teladoc, with COO resigning effective 31 December (Something about ships? Spirals? Musical chairs?)
Industry news short takes: fundings for Qure.AI, Centivo, Rippl, Surescripts; M&A closings for GE Healthcare-Intelligent Ultrasound, LetsGetChecked-Truepill. And is Hinge Health going public soon?
Two ‘oops’ at VA: OIG finds VA, Oracle performance misalignments, makes 9 recommendations; VP candidates’ EHR records improperly accessed by VA employees (Enough already!)
Two follow ups: Steward Health CEO resigns–and sues the Senate HELP committee, Wojcicki will take 23andMe private (Time to take the yachts for a long trip?)
Now CVS Health may be reviewing ‘options’–including a possible breakup–report (PBM and health plan troubles)

Steward’s CEO will likely face prosecution on criminal contempt of Congress for not showing up at a hearing, Stefano Pessina’s net worth down by 97% as Walgreens tanks, and Joe Kiani, after founding Masimo 35 years ago, is booted from the board and ankles–now it’s up to Politan.  

What’s next for: Steward CEO now in criminal contempt of Congress; Walgreens’ Pessina’s fortune vanishes by 97%; Masimo’s Kiani now a man without a company

It’s the last week of summer and this Editor has been catching up all over. While away, there have been buys, M&A, and yet another PE ‘smush’ merger. In developing stories, the Masimo-Politan proxy war ends and Steward’s CEO no-show may result in charges–both on Thursday. Congress and the industry argue over continuing telehealth prescribing waivers. And it’s hard to see a future for a broke 23andMe controlled by its founder/CEO–and with a board that just exited today. 

News roundup: Owlet expands to EU, mPulse buys Zipari, New Mountain PE merges 3 payment integrity firms in $3B smush, Candid Health’s $29M raise, Oura buys Veri, Bloomer Tech’s cardio bra (M&A activity revives, as does Owlet. Oura doing just fine)
23andMe settles 6.9M data breach lawsuit for $30M. Breaking–all seven independent directors quit ($30M the best they could get–and the board throws the towel at Wojcicki)
Rounding up follow ups: Walgreens shareholder suit on pharmacy performance, Steward CEO no-shows Senate committee, Masimo-Politan proxy fight has court win for Politan–vote on for 19 September (Walgreens’ misery never ends. Masimo nears its end.)
US telehealth controlled substances prescribing waiver may expire at year’s end; DEA may further restrict (Controversy on continuing virtual prescribing of Schedule II)

One more jumbo deal announced before Labor Day–Evolent Health’s acquisition bids from payer Elevance Health as well as at least three large private equity firms, in a deal that could top $4 billion. (Sensibly, their CEO is cleaning up his stock option portfolio.)

Evolent Health talking major acquisition by payer Elevance, private equity (Could be over $4B)

Counting down before the Labor Day holiday, one large deal of note sneaks through–LetsGetChecked’s $525M deal for Truepill. SVB’s latest report confirms the ‘valuation trap’ for the overvalued companies of the 2020-22 period but that investment is crawling back. Generative AI is much talked about but no one is comfortable with it. And two surprising survivals–NeueHealth and Stewardship Health.

Truepill to be acquired by LetsGetChecked for $525 million (Throwing in together to survive?)
Signs of life: another view on healthcare investments and exits as of mid-year (SVB’s 14th POV)
Are patients and physicians ready for generative AI? How will it be most acceptable? (Resembles telehealth’s early days on the early curve)
“I will survive” updates: NeueHealth survives Q2 with small net loss, Steward sells off Stewardship Health practices to private equity firm for $245M (Dodging disaster)

An unusually busy mid-August, with early stage fundings for Amulet, Levels, and MD Ally–and a new healthtech VC fund starts up. M&A is also perking with Stryker-Care.ai and Health Catalyst-Lumeon. Announcements are rounding up with 510(k) clearances from SleepioRX and Masimo’s W1 watch, new features from Caregility and Otsuka releasing Rejoyn. What to watch: will 23andMe, once worth $4.8 billion, survive–and who buys Veradigm?

Short takes: Stryker to buy Care.ai, Masimo W1 medical watch clears FDA for oxygen, heart monitoring, Create Health Ventures forms $21M fund (Stryker on a spree and more ‘up’ signs)
Veradigm update report: initial bids collected to take company private (Should be more?)
News roundup: SleepioRx clears FDA 510(k), Caregility adds AI fall detection, Otsuka releases Rejoyn depression app, MD Ally’s $14M Series A, Alcove launches CallConnect247 (UK), Health Catalyst buys Lumeon for $40M
Food–allergy and metabolism–takes center stage with Series A fundings for Amulet and Levels (Health in what you eat)
23andMe drops drug discovery group, expands Lemonaid into GLP-1 weight loss medications, loses $69M in Q1–and board rejects CEO’s buyout offer (Drama watch as founder’s buy bid rejected)

August didn’t start well for Walgreens, conceding that it was best to sell VillageMD and in the meantime, raising needed cash through another sale of Cencora stock. It wasn’t good for Steward in its Ch. 11 asset sale nor Aetna and their president in their Q2 results. But there was good news for Clover and Oscar Health, R1 RCM’s going private, and (perhaps) HHS in reorganizing ONC into ASTP.

Short takes: both Clover and Oscar in the black; Aetna prez booted after 11 months; Ava-VSee bedside robot; updates on Change, OneBlood ransomware, Masimo proxy fight (Upstarts succeed, legacy stumbles)
HHS reorganizing ONC, ASTP in tech funding, talent bid; FDA’s Digital Health Advisory Committee named; GAO scores progress on VA Telehealth Access Program (What the US government is up to)
Breaking: Walgreens considering sale of entire stake in VillageMD (Now really tossing in the towel)                                                                                            Midweek wrap: Walgreens sells off $1.1B Cencora shares, R1 RCM goes private for $8.9B, Steward’s unwinding with 2 hospital closures, 1,200+ laid off, $30M state funding, bids due for physician group, CEO Senate hearing  (Walgreens raising cash, Steward a tough sell)

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News roundup: Cerebral forfeits $3.7M on federal Rx charges, Aetna president named, Stewardship Health sold to Rural Healthcare, Oura buys data company Sparta Science, Brook Health-Linus Health remote cognitive assessment

November 8, 2024 | by

Cerebral settles its controlled substances distribution charges with DOJ and DEA. The $3,652,000 forfeited under the non-prosecution agreement (NPA) with the Department of Justice, Eastern District of NY, and the Drug Enforcement Agency acknowledges that Cerebral, between February 2021 and October 2022, had instituted internal measures to increase the prescriptions of controlled substances for ADHD such as Adderall, which are Schedule II drugs. The internal policies had the goal of boosting patient retention and, by extension, Cerebral’s revenue. “Today’s settlement holds Cerebral responsible for their failure to protect patients from the harms caused by the unnecessary or overprescribing of potentially-addictive ADHD medications. Cerebral’s exploitation of telemedicine flexibilities deceived patients who were legitimately seeking medical care, putting them at risk in exchange for profit,” said DEA Administrator Anne Milgram. 

There is an additional fine of $2,922,000 which Cerebral cannot pay at this time. It is being deferred for the term of the NPA (30 months) as long as Cerebral is in compliance with the NPA and waived at the conclusion, unless Cerebral is determined to be able to pay in part or full. If Cerebral violates the NPA, Cerebral can be prosecuted for any of the conduct that gave rise to the NPA and any newly discovered criminal activity. The DOJ-Eastern District release documents Cerebral’s violations.  Healthcare Dive

CVS Health reports mixed results, names a new Aetna president and CVS group president. Q3 revenue was $95.4 billion, up 6.3% versus prior year. Net income though fell to $71 million, versus $2.3 billion in prior year. The Aetna insurance unit was responsible for much of the reduction due to anticipated losses in Q4 2024 within the Medicare and individual exchange product lines. There were major miscalculations in Medicare Advantage utilization (higher than anticipated) with an increased medical loss ratio, plus lower payments for state Medicaid plan coverages. Release, Healthcare Dive

Named with the Q3 earnings were Aetna’s new president, Steve Nelson,  who will be expected to improve on this situation sooner, not later. He was previously the CEO of value-based primary care company ChenMed and CEO of UnitedHealthcare from 2016 to 2019. Also named as a new group president for CVS Caremark, CVS Pharmacy, and Health Care Delivery businesses is Prem Shah. He was previously EVP/president of Pharmacy and Consumer Wellness. Release

Stewardship Health closes sale out of bankruptcy. Practice group Stewardship Health was finally approved by the Massachusetts Health Policy Commission (HPC) for acquisition by Brady Health Buyer. This is an entity set up by private equity company Kinderhook Industries, LLC, on behalf of its existing investment, Nashville-based Rural Healthcare Group. The sale was originally submitted through the Texas Federal court handling the Steward Health bankruptcy and approved by the judge 22 August for a price of $245 million [TTA 16 Aug]. The practices have been rebranded as Revere Medical. Healthcare Finance

Oura buys Sparta Science. For health tracker ring Oura, it is its third acquisition in two years, following Proxy in 2023 and metabolic health developer Veri this past September. Sparta Science was acquired to bolster Oura’s enterprise offering, Oura Business and the Oura Teams platform. Sparta’s Trinsic platform tracks health vitals for enterprise clients collecting, analyzing, and delivering human health and performance information.  It will be integrated into Oura Teams which combines data from customer EMRs and other third-party data sources. The overall goal is to support population health through measuring and analyzing over 20 biometrics as factors in sleep, activity, readiness, stress, resilience, women’s health, and heart health. Oura Ring 4 was introduced last month. Oura will be sunsetting Sparta’s legacy force plates at the end of the year. Transaction cost nor financing were disclosed. Release, Mobihealthnews, TechCrunch

Brook Health partners with Linus Health for remote cognitive impairment assessments. Boston-based Linus Health, which has developed a series of digital cognitive assessment tools for Alzheimer’s and other dementias, has partnered with remote patient care software company Brook Health for a remote digital cognitive assessment tool that allows primary care physicians to screen and assess patients for mild cognitive impairments (MCI), sending them home with a treatment plan–all on the same day. It also provides support via a 24/7 remote clinical care team. The ability not only to diagnose MCI and initiate treatment are critical in supporting primary care physicians who generally do not have the tools or ability within their practices to perform this preventative screening. Release

Weekend reading: 23andMe’s up in the air future, including genetic data; Walgreens debates What To Stop and Start; what if healthcare pursued a zero-failure rate?

November 8, 2024 | by

While 23andMe figures out a future….what happens to the genetic data?  Troubled 23andMe today announced that it will be reporting its FY2025 Q2 numbers next Tuesday 12 November. An interesting part of their release is that shareholders can submit and upvote questions to management via the Say Technologies portal–and they’re blistering. They ask about the plan for recovery (132 votes, 60K shares represented), whether the company will be sold off piecemeal (128 votes, 73.5K shares) and a sale of the company (78 votes, 47.8K shares. Also questioned (38 votes, 3.4K shares): the addition of three new board members, none of whom have biopharmaceutical experience as all former CFOs outside of healthcare. These replace the seven that ankled on 17 September [TTA 17 Sept]. 

To Wojcicki, of course, with her reported 49.99% of voting control, shareholders’ questions aren’t really going to matter. Whether they will be addressed on Tuesday is anyone’s guess.

Many 23andMe customers have questioned how to remove their personal genetic data from their database, which if en masse will reduce the value of the company. This TechCrunch article explains how that data is not covered by HIPAA privacy regulations, but 23andMe’s own retention rules.

If 23andMe sells, the data goes with it. If there is no sale, apparently recent Wojcicki statements indicate that the model going forward for the company is the sale of that data to pharma developers and researchers, ditching its independent drug discovery, and moving into telehealth prescribing of GLP-1 drugs through its Lemonaid subsidiary. 

For those concerned about their privacy, or wary of a change of ownership, accounts can be easily deleted–but not the genetic information. TechCrunch gives how to delete your account–but apparently that won’t delete your genetic information, date of birth, and gender. 23andMe will also retain limited personal information attached to your account for an undefined time. Individuals can also reverse their consent for sharing that information with researchers, but cannot remove it. 12 million people have reportedly given consent–deliberately or not. A real lesson on oversharing for millions–if they care. 

What can Walgreens reasonably stop or reverse in its multiple series of Bad Decisions? A short interview at HLTH with US Healthcare head Mary Langowski indicates that there’s not much that hasn’t been already announced. We know that VillageMD is shuttering locations and is up for sale. 1,200 retail locations will be closed over the next three years. But what else to stop? “A lot of what I’ve fo­cused on in the first six months, is re­al­ly, it’s okay to stop stuff. What are we gonna stop?” While it’s totally fine to fail ‘at some things’, these weren’t small fails. Wentworth is concentrating on the new chief commercial officer selling Wal­greens’ ser­vices to pay­ers, providers, and life sci­ence com­pa­nies, such as clinical trials capabilities, CareCentrix, and Shields Health. There’s also some push towards “build­ing a stand­alone phar­ma­cy busi­ness rather than a ver­ti­cal­ly in­te­grat­ed busi­ness”. Endpoints News

Thinking about if healthcare adopted a ‘zero-failure’ rate. Michael Alkire’s (CEO, Premier Inc., a health system operational improvement provider) daughter was on Alaska Airlines’ Flight 1282 on 5 January 2024. That was the Boeing 737-9 MAX flight that had a blowout of a mid-cabin exit door plug placed there instead of an emergency exit door. The blowout was due to four improperly installed (loose) bolts. It occurred at 16,000 feet and the lower altitude, combined with no one seated in that row, contributed to a 100% survivability rate and a successful landing, though passengers were injured. Anyone with an interest in aircraft knows that one little thing, like a worn jackscrew on a rudder or an untightened bolt, can lead to a non-survivable crash.

Mr. Alkire’s point is that we should be striving, as the airlines and aircraft manufacturers have done (which failed in this case) for zero failure in healthcare.  He cites the well-known statistic that 98,000 people die each year from medical errors. We don’t have a culture of continuous performance improvement. For one, clinical innovations can take nearly two decades to become standard practice. Yet it works. Simple things, such as clinical surveillance in nursing homes, can reduce adverse drug events by 92%.  Much more to ponder in this Influencer contribution to MedCityNews. (And Boeing has a long way to go to restore trust–buying back Spirit AeroSystems, the former Boeing Wichita, is a necessary start they are finally making.)