Breaking: ban on sale of Apple Watches 9 and Ultra 2 stayed by federal appeals court Wed 27 December

Apple Watch 9, Ultra 2 available again for sale–at least well into January, as appeals court decides. It should come as no surprise that Apple quickly appealed the US International Trade Commission (ITC) ruling of 26 October that prohibited Apple from importing either model and won a temporary stay of enforcement. The ITC ruling found that Apple in the Series 6 and later violated Masimo’s patents on pulse oximetry (SpO2) sensors and software. ITC rulings are sent to the US president in a 60-day process that ended in no presidential veto and thus final approval on 25 December. Apple, anticipating compliance and moving in an orderly fashion, pulled both models from online sale 3 pm Eastern Time on Thursday 21 December, while Store sales ended on Christmas Eve. [TTA 21 Dec]

On Tuesday 26 December (Boxing Day), Apple filed for an emergency stay of the ban in the US Court of Appeals for the Federal Circuit which was granted almost immediately, on Wednesday 27 December. This prevents Homeland Security’s Customs and Border Protection (CBP) from enforcing the import ban until the court can consider Apple’s motion to stay the ban pending its full appeal. The timeline now, after this emergency stay, is that the ITC has until 10 January 10 to file its opposition, with Apple’s reply due on 15 January. If the court grants Apple its desire for a full appeal after that and to stay enforcement of the Limited Exclusion Order (LEO) until that appeal is decided, the enforcement timeline then typically pushes forward another 18 months. Masimo is contesting the action saying there was no emergency as Apple had already stopped selling their watches with pulse oximetry features. Apple, as the infringer on Masimo’s patents as found by the ITC, has to show the court that the stay is justified.

With the Court of Appeals ruling in place, Apple is resuming online sales today (Thursday 28 Dec) at noon Pacific Time (3pm Eastern Time).

Yet another wrinkle is that Apple has proposed a modification to both of these watches to the CBP. They are now seeking a judgment that the modified version is outside of the ITC Limited Exclusion Order. The ban also affected owners of older Apple Watches with pulse oximetry readings, as out-of-warranty watches’ hardware would not be considered repairable. 

The most legally comprehensive article on this is by Dennis Crouch at Patently-O. BloombergAxios, and The Guardian. The New York Post has a backgrounder on the relationship between the current president and Masimo’s CEO, which appears to be a close one but, based on another company’s history that follows, is likely to not be pertinent to the ITC decision or approval. (This Editor notes that Apple for decades and currently has been considerably influential in government matters and business policy. It is not unusual here in the US or elsewhere for that matter that company leaders play the donation game. We eschew additional comment.)  

Apple and others’ patents–not perfect together. AliveCor is in a similar situation in its own patent legal actions with Apple: winning in an ITC patent determination approved by the White House, negative PTAB actions, then Apple appealing. AliveCor is currently engaged in an antitrust court action with Apple in the US District Court of Northern California [TTA 19 July and prior] with a decision expected in 2024. Unlike Masimo, Apple licensed AliveCor’s ECG technology in early Apple Watches, then took action when Apple introduced its own ECG in the Apple Watch 4 in 2020.

It also shows that Apple has, shall we say, a certain pattern of updates to its Watch lines that may infringe on the patents of smaller companies. Again, all Apple would need to do is license these patents and pay royalties. It might be cheaper than lawyers and lawsuits.

TTA is off for the holidays–and wishes our Readers a holly, jolly!

Like most of our Readers, TTA will give the keyboard a needed rest and be off from Friday 22 December till Tuesday 2 January. Alert emails will be sent to subscribers (become one here, it’s free) on Friday, Saturday, and Wednesday (skipping Christmas Monday and Boxing Day Tuesday).

Breaking news, comments, or holiday messages may be sent to Editor Donna.

Editor Emeritus Steve and Donna send our very best wishes for a Happy (or Merry) Christmas and a Happy, Healthy, Peaceful, and Prosperous New Year!

Short takes: ransomware op BlackCat busted by FBI, websites shut–for now; health systems lay off IT staffers; retailers collecting way too much PII including health

FBI busts BlackCat/ALPHV ransomware. In an Eliot Ness-like move, the Federal Bureau of Investigation (FBI) got busy and delivered a nice present to healthcare organizations for Christmas. According to two 19 December articles in Bleeping Computer (article 2), the FBI seized operational darknet websites for the ALPHV ransomware operation (article 1) and created a decryptor to help approximately 500 companies recover their data for free, negating $68 million in ransom demands. The details are a little thin, but Bleeping reconstructed in article 2 what they could out of the search warrant. The FBI arranged with a confidential human source (CHS) to become a backend affiliate, meaning the CHS could log in and use ALPHV’s affiliate panel to manage extortion and ransom campaigns. It sounds like a rather nifty platform with lots of management and negotiation tools if you’re extorting a victim company. How the FBI got the decryption keys is another matter they are mum on, as not available through the affiliate panel, but “they obtained 946 private and public key pairs associated with the ransomware operation’s Tor negotiation sites, data leak sites, and management panel”. 

US law enforcement was assisted by their counterparts in Europol, plus law enforcement in Denmark, Germany, UK, Netherlands, Germany, Australia, Spain, and Austria. This is the third breach of the same gang; as Bleeping Computer put it, they’ll “rebrand under a new name as they have done in the past” in a few months.

But maybe faster than that. Some added details from Healthcare IT News sourced from KrebsonSecurity:  BlackCat briefly unseized its darknet site, wiped out the FBI screen above (courtesy Bleeping Computer), and put in a ‘we’re unseized’ notice (in the Krebs article) that they were still open for business at a different location, offering affiliates a 90% payout, and that for affiliates, you could ransomware anything, anywhere (hospitals and nuclear plants cited!) except those located in Russia and the CIS. 

Given ransomware, hacking, cybersecurity threats, and maintaining/upgrading operations, you’d think hospitals would be hiring, not firing, IT workers. But noooooo. Becker’s listed seven health systems that are either pinkslipping IT staff or transferring them to outsourced companies. They are Kaiser–115 nationwide; Novant Health–unknown due to ‘changing up their IT system’; Tower Health (Reading PA)–outsourced staff to a vendor; Mass General Brigham–staff reduction via voluntary buyouts in effect 22 November; Bon Secours Mercy Health–layoffs plus eliminating open roles; Care New England–outsourced staff to health IT provider Kyndryl; Franciscan Health–moved 61 to a vendor. Pennywise, pound foolish.

Here’s more than money you’ve left behind with your online holiday shopping–data, and lots of it. This study from Incogni Research is unnerving, as it goes far beyond what you think you’ve shared–you buy nasal spray in the winter, allergy eyedrops in the spring, etc.– to what retailers are actually collecting on you. This Editor will cite only the companies in healthcare–CVS, Walgreens, Amazon, and Walmart–according to their study:

  • All four collect PII data that includes customers’ identifiers (like their names, online identifiers, and driver’s license numbers), characteristics of protected classifications (like marital status, ancestry, and disabilities), commercial information (like purchase history and property records), and audio/electronic/visual information (like video and/or audio recordings of consumers).
  • Walmart, CVS, and Walgreens additionally collect Social Security numbers, union membership status, and sex-life data.
  • Their apps collect 15 to 20 data points, such as exact location, personal data, financial data, health and fitness, messages, photos and videos, audio files, files and docs, app activity, web browsing, app info and performance, device or other IDs

Users can opt out of some of these, but most do not. And some go to third parties. And all had been breached at one time or another, whether at the retailer or at the vendor level. Prepare to be shocked and dismayed. Release on DR Journal

News roundup: Apple Watch flagships cease sale due to Masimo ITC ruling (updated); Noom, WW enter GLP-1 telehealth business; Oracle sees health side up despite Cerner drag; Cigna has multiple bidders for MA business

Apple Watch Series 9 and Ultra 2 going off sale in the US this week, upholding the ITC patent ruling favoring medical device developer Masimo. On 26 October, the International Trade Commission (ITC) ruled that Apple in the Series 6 and later violated Masimo’s patents on pulse oximetry (SpO2) sensors and software. [TTA 27 Oct] While this is awaiting presidential approval in the 60-day review period which ends on Christmas Day, Apple proactively restricted US sales of its flagship Series 9 and Ultra 2 watches which contain the blood oxygen sensors. (The SE model does not and continues to be available for direct sale.) According to 9to5Mac, online sales end on 3 pm Eastern Time on Thursday 21 December, while in-Apple Store sales stop after Christmas Eve. Of course, this won’t stop resales of existing stock through outlets like Amazon, Best Buy, and eBay. Under the ITC order, Apple cannot import either model after 25 December as the ITC issued a Limited Exclusion Order (LEO) plus a Cease and Desist Order (CDO). 

The ITC is rarely vetoed by the White House in patent actions. After that point, Apple is free to appeal in Federal District Court, which is highly likely and where the deepest pockets usually win. Also HIStalk 20 Dec and Strata-gee 21 Dec

There are other wrinkles with Masimo, though. earlier this month (13 Dec) timelines Masimo’s patent difficulties with the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) ruling against the very same patents, decisions upheld by the Federal Circuit Court. The PTAB also ruled against Masimo in the requested review of two Apple patents. Apple’s retaliation is to threaten lawsuits on Masimo’s new smartwatches. The icing on this messy cake is the November Delaware Chancery Court decision against Masimo, awarding $17.8 million in legal fees to activist investors/shareholders Politan Capital Management and Politan Capital NY LLC in a board fight that culminated in two seats to Politan directors.  One can sense that Apple is biding its time, though they could end all of this by negotiating a royalty to Masimo. Updated: see report on the stay effective 27 December here.

Noom and WW enter the weight loss drug-by-telehealth race. Ozempic and Wegovy, GLP-1 agonists, are increasingly popular in off-label use for obesity to produce weight loss, prescribed and managed by telehealth teams.

  • Noom, previously stressing behavioral change via app coaching direct-to-consumer, in October announced at HLTH Noom Med, a drug-focused program prescribing medications such as Saxenda (liraglutide), Wegovy (semaglutide), and the new Zepbound (tirzepatide), a dual GLP-1/G1P, all of which are injectable medications along with other GLP-1 medications such as Ozempic.
  • WW or WeightWatchers last week announced the WeightWatchers Clinic program. Via their recently acquired telehealth weight loss platform Sequence, it will offer weight loss meds and team management.  

They join Teladoc in developing weight loss programs, though Teladoc supports a physician-based care product for employers [TTA 21 April]. Both Noom and WW emphasize that member patients must qualify for the programs based on weight, BMI, and medical condition. Participants are educated through materials, coaching on behavioral management, managing appetite, and nutrition, especially in maintaining adequate protein as these medications not only induce weight loss, but also muscle loss (sarcopenia). One hopes that their teams are also knowledgeable on how these medications that slow down digestion to induce a feeling of fullness don’t mix well with surgical sedation, and that they issue cautions to patients before elective surgery. MedCityNews, FierceHealthcare, Forbes   

Noom has also replaced most of its top management since its new CEO joined in July. There’s a new CFO, chief technology officer (CTO), general counsel, two senior VPs (corporate development and partnerships, healthcare sales and services) a senior director of brand and communications, chief growth officer, chief product officer, and head of people. FierceHealthcare

Oracle Q2 results miss forecasts in rebuilding Cerner. Oracle Health, including the former Cerner, and slowing cloud growth were the culprits in their fiscal Q2 2024. Total revenue was $12.9 billion, up 5% in US dollars (4% in constant currency). Analysts expected $13.05 billion. Excluding Cerner, growth would have been 6% though Oracle did not separately break out revenue for the Cerner EHR business. Investors have noted two consecutive quarters of off-track growth and a weaker forecast for the remainder of the year. According to CEO Safra Catz and chairman Larry Ellison on the earning call, many upgrades and “modernizations” are being made to Cerner Millenium that will wrap up this FY. Half of Millenium customers will be moving over to Oracle Cloud Infrastructure (OCI) by February. They are also “rewriting” Cerner’s health and data intelligence platform, Cerner HealtheIntent, to get into population-scaled health management. ‘Transforming healthcare’ is an expensive proposition indeed. No word on the VA.  FierceHealthcare, Oracle release

And a quick follow up on Cigna’s sale of their Medicare Advantage business. Two payers so far–Health Care Service Corp. (HCSC) and Elevance–are reported to be bidding for Cigna’s MA business. The value of the business is estimated to be about $3 billion and with just under 600,000 members as of September. Both HCSC and Elevance are much larger players in MA. HCSC has over 1 million MA members in Blue Cross Blue Shield affiliates in Illinois, Texas, New Mexico, Oklahoma, and Montana. Elevance, the former Anthem, has over 2 million MA members. Bidding is expected to close this week. While MA is losing money for Cigna, they could refuse to sell if bids are unsatisfactory. FierceHealthcare, Becker’s

Follow up: Molina reduces Bright Health’s $510M California plan sale to $425M

Not unexpectedly, Molina Healthcare is not going to pay the original purchase price for Bright Health’s California plans in Q1 2024. In July, Bright Health trumpeted a $600 million salvage deal with Molina, one of the few ‘pure’ health plan companies left. For Molina, they would pay $510 million plus a $90 million tax benefit for Bright’s two California Medicare Advantage (MA) plans–Brand New Day and Central Health Plan. One of the caveats of the deal was the ability to reduce the payment due in Q1 2024 based on the purchased plans’ financials and Star ratings. Unfortunately for Bright Health, neither financials nor ratings are good. Molina is reducing their payment accordingly to $425 million, unceremoniously, paying less for more membership in MA. Release

Why Bright is dimming rapidly. Bright’s health plans have failed or closed shop in multiple states [TTA 20 Apr] after disastrous 2022 performances. Most recently, their Texas plans were seized for liquidation. In these plans, the Center for Medicare & Medicaid Services (CMS) assesses risk adjustment payments that Bright owed to other plans in states where they did business [TTA 5 Dec]. That has been calculated as $380 million–$89.6 million alone in Texas. The bottom line: Bright owes money everywhere–not only to other payers for where they operated in 2022 but also to JP Morgan–$380 million to pay off its credit facility due in February. 

Ari Gottlieb of A2 Strategies on LinkedIn plus interviewed in Becker’s and MedCityNews, has been following this closely as this Editor has noted in his earlier coverage of insurtechs. His over/under is that Bright will pay off JP Morgan first, perhaps kick some over to their lender New Enterprise Associates (NEA), and leave CMS and payers owed in multiple states holding a bag of stale or soggy chips. He explains the escrow setup with Molina plus other factors such as management bonuses (!!!) for completing the transaction. A smart move in his eyes is that the Texas Department of Insurance, by liquidating the TX plans and blocking actions by Bright, may be able to claw back over $125 million out of NeueHealth, a Bright subsidiary.

Absent another Loaves-and-Fishes miracle, reserved for our Redeemer, this Editor cannot see how Bright doesn’t go dark in 2024. One possibility to this Editor: NEA ponies up more investment on top of their $60 million credit facility engineered in August. Given the coal scuttle that is the current state of M&A, they may see this as their only alternative with their investment cash, to push for a recovered and small Bright. Absent a Chapter 7 breakup, what company would buy the liabilities to payers and lenders for what is left–NeueHealth? Then have DOJ and FTC turning a microscope on them? Perhaps in June 2024, but not now.

You have to hand it to Bright Health. They have done a masterful job of tying states, CMS, other health plans, and even Molina into Gordian knots that buy time against what seems to be the inevitable.

DOJ and FTC finalize Merger Guidelines, deliver coal for holiday stockings and the New Year (updated)

DOJ and FTC deliver a scuttle of coal for healthcare holiday stockings. The Department of Justice (DOJ) and the Federal Trade Commission (FTC) finalized the Merger Guidelines that were drafted back in July [TTA 20 July]. They update prior guidelines first issued in 1968 that have been revised six times since then. They are not legally binding but demonstrate how each agency will examine any merger or acquisition going forward–and are advance notice on how they can and will stop either. US antitrust law is based on three acts passed by Congress: The Sherman Antitrust Act (1890), the Clayton Act (1914), and the Federal Trade Commission Act of 1914, now in US Code Title 15.

After 30,000 public comments in the 60-day period, the published Guidelines are now down to 11, but in context based on this Editor’s read (caveat, not a lawyer nor play one on TV) are not materially different than the July draft of 13, perhaps considered unlucky. The language in each Guideline restates the draft language in substantially more restrictive language and interpretation. The agencies’ stated purpose is that when two companies propose a merger that “raises concerns” on one or more of these Guidelines, the agencies “closely examine” whether the effect of the merger may be to substantially lessen competition or to tend to create a monopoly (sometimes referred to as a “prima facie case”). Two “C” words are repeated throughout–concentration and consolidation. 

The guidelines are verbatim from the 51-page DOJ/FTC document (PDF link) issued 18 December and are grouped on how the agencies use these guidelines. They are effective immediately.

Distinct frameworks the agencies use to identify that a merger raises prima facie concerns (1-6)

Guideline 1: Mergers Raise a Presumption of Illegality When They Significantly Increase Concentration in a Highly Concentrated Market.
Guideline 2: Mergers Can Violate the Law When They Eliminate Substantial Competition Between Firms.
Guideline 3: Mergers Can Violate the Law When They Increase the Risk of Coordination
Guideline 4: Mergers Can Violate the Law When They Eliminate a Potential Entrant in a Concentrated Market
Guideline 5: Mergers Can Violate the Law When They Create a Firm That May Limit Access to Products or Services That Its Rivals Use to Compete
Guideline 6: Mergers Can Violate the Law When They Entrench or Extend a Dominant Position

How to apply those frameworks in several specific settings (7-11)

Guideline 7: When an Industry Undergoes a Trend Toward Consolidation, the Agencies Consider Whether It Increases the Risk a Merger May Substantially Lessen Competition or Tend to Create a Monopoly
Guideline 8: When a Merger is Part of a Series of Multiple Acquisitions, the Agencies May Examine the Whole Series
Guideline 9: When a Merger Involves a Multi-Sided Platform, the Agencies Examine Competition Between Platforms, on a Platform, or to Displace a Platform
Guideline 10: When a Merger Involves Competing Buyers, the Agencies Examine Whether It May Substantially Lessen Competition for Workers, Creators, Suppliers, or Other Providers
Guideline 11: When an Acquisition Involves Partial Ownership or Minority Interests, the Agencies Examine Its Impact on Competition

The Guidelines are summarized in the Overview. Section 2 explains them more completely with how the agencies apply the Guidelines. Section 3 identifies rebuttal evidence that companies could typically present, and Section 4 presents a non-exhaustive discussion of analytical, economic, and evidentiary tools the Agencies use for evaluation. 

More coal, Ebenezer Scrooge. As this Editor described the draft guidelines in July, it it is hard to see that any merger or acquisition of like companies or even complimentary organizations building out capabilities or platforms could pass. Each one of these Guidelines is a tripwire and once tripped, can trip others. Each one of these can be used by FTC and DOJ to present to a Federal district court, where decisions are now more influential than the body of US Supreme Court decisions. Healthcare Dive notes the Illumina decision in the Fifth Circuit appeals court, liberally cited in the Guidelines document. This is forcing Illumina’s divestiture of cancer test developer Grail, earlier purchased for $7.1 billion. 

So now the coal’s been delivered…what will 2024 and out look like?

  • This will freeze M&A for months as companies try to figure this out. It’s not hard to guess that the imminent publication of the Guidelines nudged the termination of the Cigna-Humana deal. Hospital and health system mergers will continue to find nothing but discouragement.
  • Watch for an acceleration of existing company failures in 2024 and disruption in the current funding structure. Smaller healthcare companies, fattened on the investment binge of 2020-21, but now betting on a buyout from a near competitor, are either going to stick it out on their own or run out of runway. VC and PE companies investing not strategically, but for the purpose of a 18-24 month exit or quick payday, will largely be out of luck. Public companies may languish unless they move quickly to profitability. This may stimulate a new look at investing–strategic investors that look at the very long term–or not. (JP Morgan in January will be verrrrry interesting.)
  • Companies that have grown organically or benefited from previous acquisitions but need to acquire capabilities for a platform to continue to be competitive will also be affected. These could trip Guideline 9 and if found to be anti-competitive, may trip Guideline 8: “If an individual transaction is part of a firm’s pattern or strategy of multiple acquisitions, the Agencies consider the cumulative effect of the pattern or strategy.”
  • The behemoths like UnitedHealth Group, Walgreens Boots Alliance, and CVS Health will have no rivals for many years. The flip side: they will have trouble making additional acquisitions without forcing divestitures, or find buyers when they wish to divest money-losing units.
  • Partnerships may accelerate–with all their risks of purloined IP and monetary disputes. But smaller companies may use it to band together without antitrust risk.
  • The SPAC (special purpose acquisition company) may make a comeback. They will not have any antitrust conflicts but risk a chancy public market, at least in the US. 
  • The conglomerate–unrelated businesses under a holding or investment company–may rise again, as it did in a tight antitrust environment in the 1960s. Remember Gulf + Western and LTV (Ling Temco Vought)–both gone? Berkshire Hathaway is a prime example of a current conglomerate. Foreign investment groups may also find US healthcare an attractive proposition.
  • Offshore reincorporation. Much as Medtronic moved its corporate headquarters from Minneapolis to Dublin, Ireland, companies may move offshore to friendlier climes like Ireland, Estonia, Hungary or the Visegrad nations, and the Channel Islands, effecting their M&A there and making their US branches operational only. 

But…there’s more. Both DOJ and FTC will be reviewing the 2010 Horizontal Merger Guidelines and the 2020 Vertical Merger Guidelines. Fasten your seatbelts, it’s going to be a bumpy year. 

FTC press release (which makes clear what agency is leading!), Crowell (law firm) short analysis, PrivateFundsCFO

Additional sources added 2 January: National Law Review (article by Foley & Lardner), Healthcare Finance News

News roundup: with chronic conditions peaking, Twin Health’s metabolic AI gains $50M, Talkspace and Evernow partner for women’s mental health

Chronic conditions on the rise, according to United Health Foundation. The non-profit philanthropic arm of UnitedHealth Group released its annual America’s Health Rankings 2023 report. The report considers 87 measures from 28 distinct data sources for 2022. Topline results in their summary are concerning. 

  • Eight chronic conditions reached their highest level in AHR’s tracking history: arthritis, depression, diabetes, asthma, cancer, cardiovascular diseases (CVDs), chronic obstructive pulmonary disease (COPD),  and chronic kidney disease (CKD).
  • 29.3 million adults, or 11.2% of the population, reported having three or more chronic conditions.
  • During 2021 and 2022, depression rates grew to 21.7% or 54.2 million people. Diabetes incidence rose to 11.5% or 31.9 million adults.
  • Disparities are pronounced between demographic groups. From the overview:
    • Hispanic adults were 2.1 times and black adults were 1.8 times more likely, respectively, to have uncontrolled A1C compared to multiracial adults.
    • In 2013-2016, asthma-related emergency room visits were 2.5 times higher among black compared with white adults with asthma.
    • White adults with hypertension were 1.5 times more likely to have their blood pressure “controlled” compared to black adults with hypertension.
  • Premature death increased 9% between 2020 and 2021: drug deaths increased 15%, firearm deaths 7%, and homicide increased 33%.

The report also ranked the healthiest states as New Hampshire, Massachusetts, Vermont, Connecticut, and Minnesota. Bottom-ranked: Louisiana, Mississippi, Arkansas, Oklahoma, and Alabama. The annual report includes sub-reports focusing on the health of women and children, mental and behavioral health, seniors, and Covid-19. FierceHealthcare

Twin Health’s AI approach to Type 2 diabetes as a metabolic disease gains a $50 million Series D. This late-year raise in a difficult funding market was led by Temasek with participation from existing investors ICONIQ Growth, Sofina, Peak XV, and Helena, adding to their October 2021 $140 million Series C. Twin Health’s main platform is the Whole Body Digital Twin which models an individual’s metabolism from data points collected daily via wearable sensors, clinical lab parameters, and self-reported preferences. The concept of a ‘digital twin’ to guide both the patient and the care team is a relatively new one, created on an app available to both the patient and their Twin Health licensed clinical care team. Their method is to provide individualized guidance on nutrition, sleep, stress, and activities to heal the metabolism and root causes of diabetes, intending to reverse Type 2 diabetes metrics and medication use within six months. Financially, they also have an attractive model–full risk with employers and health plans, being paid when their employees and members get results. According to their founder and CEO Jahangir Mohammed to Axios, “Twin is currently conducting two randomized controlled trials — one in India and one in the U.S. — analyzing whether people using its approach can successfully enter diabetes remission or “reversal.”  Mobihealthnews, Twin Health release

Addressing both mental and women’s health is an interesting partnership between Talkspace and Evernow. Evernow, which focuses on telemedicine treatment for women 40+ during perimenopause and menopause, is partnering with Talkspace to address mental health issues that are prevalent at that time. Evernorth’s survey using their records of over 100,000 patients found that 61.4% of women surveyed reported feeling symptoms of anxiety and/or depression.

  • Evernow members in multi-month plans will gain free access to Talkspace’s mental health resources in their self-guided program that has 400 self-guided therapy sessions plus on-demand workshops and classes. Virtual therapy offered by Talkspace has a $100 discount.
  • Talkspace members also have discounted access to Evernow programs, with a three-month plan for $129 or a 12-month plan for $348.
  • They are also bundling their programs together for enterprises and employers.

Evernow is also moving into AI capabilities through the Early Access Partnership with Hippocratic AI, a generative AI company developing safety-focused large language models for healthcare. Talkspace recently won a $26 million three-year contract with New York City’s Department of Health and Mental Hygiene for NYC Teenspace, a free therapy program for those aged 13 to 17. Release, Mobihealthnews, MedCityNews

Signs of the next phase in 2024? Veradigm CEO, CFO booted (updated); SmileDirectClub fails, TeleDentists steps up; FruitStreet sues Sharecare for $25M; Walgreens’ former CEO Roz Brewer’s platinum parachute

As your Editor reflects on 2023’s BloodOutOfARock versus 2020-2021’s Alcoholic Bender or the ‘new normal’ touted by the Usual Suspects (with 2022 only a burp on the way), she actually sees some Signs of Hope. 

Having lived through the Digital Health Slough of Despond of 2008-2009 as the marketer for an early telemonitoring company, there are many actions that to the observant are markers that the board is being cleared of the also-rans and never-should-have-beens. They are like dead plants and brush that need to be cleaned out so that new growth can happen. We are cycling through some of them already as we move to a New Reality and winding this up, with some examples. 

  • Early stage companies still in the red, with promising financials, but needing to get to the next stage, suddenly unable to get even modest funding (an early indicator of funding drought)
  • Large companies that can get funding snapping up smaller companies at knock-down rates to fit a ‘vision’. Watch for fill-ins, add-ins, bolt-ons that later are revealed to have taken place ‘just in time’. (And may be sold or spun off later in the cycle.)
  • Large companies veering off into lines of business that look like meadows but are minefields–and hiring expensive senior executives who don’t know one or the other but then have to run both at very high levels. They then depart (or are departed) with expensive packages.
  • VCs and PEs really snapping the purses shut–and shutting. (The latest is OpenView in Boston, not even much of a healthcare player except for a couple in HIT over a decade ago but a recently participant in a Series B for RPM Optimize Health)
  • Public companies moving from party-hearty unicorns to hoarding pens and Post-It notes to locking the doors bankrupt in two to three years. (Cracked SPACs, IPOs, and more)
  • Too many players competing with each other with near-identical services in what turns out to be a limited market–and gaining advantage by cutting patient health, privacy, and regulatory corners. (DTC telemental care and drug prescribing)
  • Layoffs at companies that over-hired in the boom spreading to larger companies that largely did not, cutting their next generation of leaders in response to Mr. Market and creating internal chaos. (Instigating panic at blue-chips like CVS and Walgreens)
  • Stupid (yes) acquisitions being acknowledged and cleaned off the books–none too quietly, but done for survival’s sake. (Somewhere there should be a memorial to Teladoc-Livongo. Sorry, Teladoc.)
  • Increased Federal and state regulation of normal business processes. (FTC’s sudden prominence adding to the usual DOJ antitrust pile-on and senatorial posturing)
  • A general cleansing of the cant and hype infecting a sector. (Look to the conferences and press releases for changes in language.)

In this Editor’s observation, another latter-stage sign is when C-levels don’t survive management failures and are sent packing. Another is seeing a small company sue a larger one over failed partnerships, usually involving IP or program design theft. This past week had examples of these two, plus examples tracking with the above markers.

Veradigm still minus 2022-23 financial statements, boots and replaces its CEO and CFO. The former Allscripts has failed to file financial statements for full year 2022 and to date in 2023 due to a massive flaw in its financial reporting software adopted in 2021 that affected its revenue reporting going back to then. While it is still trading on Nasdaq despite 14 November and earlier 16 August, 18 May, and 20 March notices from the exchange under Nasdaq Listing Rule 5250(c)(1) (Veradigm release), there still is no resolution about when their statements will be filed with the SEC. The company’s latest move was to force the resignations of CEO Richard J. Poulton and CFO Leah S. Jones, replacing them with two interims. From the board, Dr. Shih-Yin (“Yin”) Ho becomes CEO for six months and Lee Westerfield, CFO of Clearsense, becomes CFO. Mr. Poulton, a 10-year veteran, will receive a $1.6 million severance. Ms. Jones will receive a six-month continuation of salary plus additional payments to “provide business-development related services” which is corporate-speak for paying you to transition to her replacement. The board will search for permanent replacements for the CEO and CFO positions.

According to their announcement, the management changes resulted from “the Audit Committee’s previously disclosed, ongoing independent investigation, which is being conducted by legal counsel and relates to the Company’s financial reporting and internal controls over financial reporting and disclosure controls”. Reading it, Job #1 for the new team appears to be reviewing the fiscal 2023 guidance that was released on 18 September and regaining compliance with the Nasdaq Listing Rule. Veradigm also reiterated that they will have a 2020-22 revenue reduction “relating to certain revenue recognition practices.”  

Additional board changes include the chairman, Greg Garrison, as executive chairman and the appointment of Carol Zierhoffer (bio), retired CIO of Bechtel Corporation, as lead independent director. Perhaps Ms. Zierhoffer can help with the conundrum of a software company engaged in vital health and financial information transmitted via practice EHRs and practice management having its own massive accounting software problem derailing them for two years. CFO Dive has more details on the audit and a shareholder suit filed in November.

Update: A Nasdaq panel spared Veradigm’s exchange listing, for now. Mark 27 February 2024 as the date Veradigm is required to provide their 2022-2023 financial reporting to Nasdaq as required under Listing Rule 5250(c)(1). This was reported in Veradigm’s 8-K filing to the SEC on 13 December. Note that Nasdaq’s release states “The Company plans to file its Form 10-K and the Form 10-Qs as soon as possible; however, no assurance can be given as to the definitive date on which such periodic reports will be filed.” (Editor’s emphasis) Stay tuned. Healthcare Dive

No rescue for direct-to-consumer clear dental aligner provider SmileDirectClub. SmileDirect, which along with Byte (acquired 2021 by dental industry giant Dentsply Sirona), NewSmile, SnapCorrect, and several others market DTC aligners and teledentistry, failed to find a buyer or new financing after its Chapter 11 filing in September. The plan centered around the once-billionaire founders buying the company back, but they could not get their main lender HPS Investment Partners and other creditors owed $900 million, nor new investors, on board.

Heavily advertised SmileDirect IPO’d in 2019 with a valuation of $8.9 billion, but never turned a profit from its combination of DIY and teledentistry. Other drains were a patent fight with CandidCare and multiple patient complaints including jaw damage, migraines from misalignment, and tooth loss. Candid, like Invisalign, now works only through dentists who do the impressions, filings for tooth separation if needed, progressive aligner delivery, and tracking progress over what is typically one year for children, teens, and adults (over 60% of business)

In the FAQs on the lone page on its website, SmileDirect no longer will honor customer contracts for aligners and dental checkups or lifetime guarantees, but continues to demand payment from patients on SmilePay contracts. (Good. Luck. With. That!) The Hill, Fortune, HIStalk 11 Dec. For the teledentistry service The TeleDentists, it is a marketing opportunity to join with Byte in prescribing and providing dentist services for their clear aligners (email promotion). The TeleDentists is also partnering with WebMD Care for consumers seeking care after researching a dental condition. (Release

(Editor’s note: Having gone through Invisalign as an adult to correct a growing problem with alignment, your Editor cannot conceive of a DIY approach to a complex process that also required a significant amount of daily self-discipline.)

Fruit Street Health sues former partner Sharecare for $25 million. The interestingly named Fruit Street provided its diabetes management program to digital health conglomerate Sharecare as part of Sharecare’s unified virtual health management platform for individuals and enterprises. Starting in 2018, Fruit Street had a business agreement with Sharecare to offer its CDC-recognized diabetes prevention program (DPP) on Sharecare’s platform. Sharecare now has its own diabetes prevention program, “Eat Right Now”, which Fruit Street claims violates the terms of its agreement. The lawsuit was filed in Fulton County, Georgia. Sharecare claims not only that the lawsuit is without merit, but also that Fruit Street owes them $3 million in payments.

Fruit Street was founded in 2014 as a public benefit corporation [explained here TTA 24 Feb] headquartered in NYC by Laurence Girard. It is modestly funded at $35 million. Atlanta-based Sharecare was founded 2018 by serial entrepreneur and WebMD founder/CEO Jeff Arnold with Mehmet Oz, MD, surgeon, TV celebrity, and former Senate candidate. Sharecare went public on Nasdaq in the palmy days of early 2021 via a SPAC with Falcon Capital Acquisition Corp. It broke out of the gate with a $3.9 billion valuation, but like most SPACs it cracked downward within months and shares now trade at an anemic $0.99. In January, current CEO Arnold will be transitioning to executive chairman. Long-time Centene exec and retired president Brent Layton will move from a board director position to the CEO chair (release). MedCityNews, Axios

Former Walgreens CEO Roz Brewer eyewatering compensation revealed. A final example of our third bullet above is the excellent financial arrangement Ms. Brewer had with Walgreens Boots Alliance. Her package of compensation and stock options awarded by the board was $71 million for about 30 months, which included a $4.5 million signing bonus to lure her from Starbucks, over half a million in moving expenses, and $60 million in three years of compensation. According to the information in The Messenger, a good portion was in stock which fell in value 57% during her time at Walgreens, continuing a trend before her arrival. It was also consistent with an executive termination without cause, which also tied her to non-disparagement and non-disclosure agreements. Was her departure by mutual agreement with the board? That is fairly typical language, but reports in the article attributed the real cause in this statement from a source indicating loss of confidence by the most important man at WBA, Stefano Pessina: “Stefano thought she was a lightweight and unable to do the hard, transformational things he needed her to do.” (Was buying the majority of VillageMD, starting the joint store/practice location plan, buying CareCentrix and specialty pharmacy Shields Health Solutions during her tenure, not quite enough? Perhaps too much spent in a hot market and not enough return, especially by VillageMD on Summit Health and CityMD?) 

Her departure and replacement by a healthcare veteran with directly related management and organizational expertise, Tim Wentworth, is yet another example of this particular cycle coming to completion. And now that we’re in the midst of clearing the field, what happens next?

Cigna-Humana deal fizzles after two weeks after term discussion fails, shareholders nix

That was mercifully fast. After all the speculation and rumors [TTA 2 Dec], Cigna and Humana called off their talks on 10 December after not coming anywhere near terms on the financials. According to the Wall Street Journal, it was also evident that shareholders disliked it nearly immediately by driving down the share prices of both companies by 10%.

Their sources indicated that it would be a share and cash deal by Cigna for Humana, which added to shareholder displeasure. Cigna will be instead buying back up to $10 billion in stock to drive up their valuation. Reportedly, the repurchasing of least $5 billion of stock will take place between now and H1 2024. Cigna will also concentrate on smaller ‘bolt-on’ acquisitions and the sale of its Medicare Advantage business as previously announced. In the past five days, Cigna shares plumped by nearly $50 and Humana’s by about $10.

The WSJ‘s sources stated that Cigna continues to believe in a combination with Humana, something that the two companies have danced around for years, dating back even before the proposed payer megamergers of 2015 which saw Humana’s acquisition by Aetna (and Cigna’s by Anthem, now Elevance) disapproved both by states and at the Federal antitrust level. The two would, at least on paper, be a good fit, with Cigna’s strength in commercial plans plus Evernorth’s services added to Humana’s in Medicare Advantage, Medicaid, and home health services under CenterWell. It would have created a strong rival to UnitedHealth Group and CVS Health at $300 billion in revenue. What may have proved to be the antitrust stumbling block were their respective strengths in pharmacy benefit management (PBM) though with different focuses.

Even more than the increasingly hostile Federal antitrust environment between DOJ and FTC, it also points to the paucity of funding for mergers and acquisitions–M&A down 14% so far this year to about $1.2 trillion according to Dealogic.

In about three years, healthcare funding has gone from money thrown by VC and PE investors at what we recognize now as shaky propositions (Cerebral, Babylon Health, Olive AI, Pear) to no interest (or funds available) in what would be quality matchups. The pendulum swings–and swings back. We hope. Healthcare Dive

23andMe hacking may have affected 6.9 million+ users–not 14,000–in massive PII breach

What was 14,000 may affect up to 6.9 million users. Genetic testing and information company 23andMe is now admitting that the October data breach that affected 0.1% of their 14 million customer base, or 14,000 users per their SEC filing last Friday, may have exposed the records and personally identifiable information (PII) of 6.9 million users, about half their customer database. In later replies to industry publications TechCrunch and WIRED, a 23andMe spokesperson admitted that hackers accessed the PII of about 5.5 million people who opted-in to 23andMe’s DNA Relatives feature. Add into that an additional 1.4 million “had their Family Tree profile information accessed”. an enhancement to DNA Relatives. The DNA Relatives breach stole individual and family names, birth year, relationship labels, the percentage of DNA shared with relatives, ancestry reports, and self-reported location. Family Tree information exposed display names, relationship labels, birth year, self-reported location, and whether the user decided to share their information.

(Editor’s note: The size of the breach is enough to revive this vintage picture of WWF/WWE wrestler Hulk Hogan in his ‘Hulkamania Running Wild’ persona.)

23andMe has attributed the massive breach to credential stuffing–the reuse of leaked login credentials from other websites and services. But many users have gone public with the information that their logins were unique to 23andMe. 23andMe’s credibility on this issue took a beating from none other than the US National Security Agency (NSA) cybersecurity director Rob Joyce. He wrote on his personal X account that “They disclose the credential stuffing attacks, but they don’t say how the accounts were targeted for stuffing. This was unique and not an account that could be scraped from the web or other sites.” In fact, Mr. Joyce creates a unique email for each account. The cause for the wider breach may lie in data sharing with a partner, MyHeritage, in adding functionality to Family Tree. It seems clear that credential stuffing wasn’t the only technique used to break into the 23andMe user data.

23andMe, as well as and MyHeritage, now require or strongly recommend two-factor authentication for access to personal accounts. About time. They have also changed terms of service to “encourage a prompt resolution of any disputes”.

What is distressing is that the hacks on the retail side of 23andMe are only the tip of the iceberg–that the really valuable part of their genetic data goes to pharmaceutical companies. Cyberthieves know that motherlode is incredibly valuable to bad actors like the Chinese and the Chinese Communist Party, both key markets for stolen health data. (Developing)

News roundup: ONC recommends ‘nutrition labeling’ for healthcare AI apps but Google moves forward; CVS’ health services rebranding as Healthspire (updated); Clover Health repots out of ACO REACH

Straining toward a model for AI app information? The latest grope by Federal regulators towards the “trustworthy use of artificial intelligence”, as the American Telemedicine Association terms it, is a labeling system that has been likened to ‘nutrition labeling’. This near-incomprehensible analogy to food labeling was proposed back in April by the Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC), now headed by Micky Tripathi, Ph.D. This disclosure would consist of how the app was trained, how it performs, how it should be used, and how it shouldn’t, which does not sound onerous at all. The disclosures are designed to forestall issues around performance and bias that have previously appeared, such as Epic’s AI system designed to predict sepsis risk and an algorithm designed to flag patients needing assistance with complex treatment regimens. 

An optional proposed disclosure around how the app was trained and tested would be important to healthcare organizations but potentially problematic to developers. There are quite a few caveats expressed by Silicon Valley investors around hurting startups and even giants like Epic through over-disclosure of proprietary information, enabling reverse engineering and poaching of intellectual property. Everyone likes transparency, trust, safety, and efficacy, but the conundrum is to disclose what is needed for proper and cautious use without providing an entreé to IP. Wall Street Journal, Becker’s, ATA release and AI principles 

Google, predictably, damns the torpedoes, full speed ahead with healthcare AI. And intends to write the rules. They’ve deployed AI tools already with Mayo Clinic and HCA Healthcare–Mayo for medical records and research papers, HCA for clinical notes. EHR Meditech is using Google’s AI for clinical documentation and to summarize patient histories. Bayer is also working with Google. Their products include a licensed algorithm for breast and lung cancer detection, a tool for diagnosing diabetic retinopathy, and a question-answering bot. Google makes no secret that they plan to influence Federal efforts at setting standards by hiring lobbyists, most of whom are out of the Food and Drug Administration (FDA), and playing a large role in industry groups such as the Coalition for Health AI (CHAI).  If you believe that Google, Microsoft, Amazon (playing catchup), or other healthcare service companies like UnitedHealth Group’s Optum will twiddle their thumbs and wait for the Feds to set standards and (good grief) enforce disclosure on AI tools, this Editor has several lovely bridges for sale. POLITICO, Becker’s

CVS Health grouping health services and multi-payer assets under CVS Healthspire. Monday’s announcement at the Forbes Healthcare Summit will roll up new $20 billion acquisitions Oak Street Health and Signify Health along with 1,100 MinuteClinics, the CVS Caremark pharmacy benefit manager (PBM), CVS Specialty, and its new Cordavis operation that works with pharmaceutical companies to bring to market  biosimilars. The rebranding, a clever melding of ‘health’ and ‘inspire’, will start this month into 2024. It’s not revealed whether the current names will be sunsetted for CVS Healthspire, or whether they will keep their established brand names. The parallels are with Evernorth (Cigna), Optum (UnitedHealth Group), and Carelon (Elevance, the former Anthem) in creating a vertically integrated healthcare company. At Investor Day, CVS Pharmacy announced a cost-plus arrangement for retail prescriptions built on the cost of the drug, a set markup, and a fee that reflects the care and value of pharmacy services–clearly in competition with Mark Cuban CostPlus.  Forbes, FierceHealthcare, CVS release, Investor Day release  

Clover Health exits the advanced value-based primary care program, ACO REACH. Clover’s exit at the end of the 2023 performance year after two years disbands their practice arrangements for CMS’ advanced original Medicare shared savings program, formerly Direct Contracting, and provision of beneficiary services after completing their required wrapups and reporting. It is part of their recent moves to become profitable, focusing on their Medicare Advantage business and Clover Assistant management. They outsourced their Medicare Advantage plan administration to UST HealthProof for a savings of $30 million and laid off 10% of staff as part of restructuring. A 2021 SPAC on Nasdaq debuting above $16 that survived investigations by the SEC and DOJ now has shares trading currently under the $1.00 minimum for listing. Clover also finally settled seven shareholder lawsuits over its non-disclosure of the DOJ investigation at the time of the SPAC. Cleaning house is all part of living to fight another day, like other ‘insurtechs’ such as Oscar Health. Clover release, FierceHealthcare  Also: Looking back at insurtechs and their ‘disruption’,  Insurtechs in the widening gyre

Stayin’ alive–or trying. Bright Health Texas plan seized for liquidation; Cano Health reverse splits, up for sale

Bright Health’s future continues to dim. Last week, the Texas Department of Insurance (DOI) filed notice in Travis County district court that Bright Health’s subsidiary, Bright Health Insurance Company of Texas as defendant, was financially insolvent and would be liquidated. The insolvency and receivership was declared on 29 November. Bright Health’s Texas assets could not cover liabilities plus a required surplus under law. The Commissioner of the DOI is responsible for the liquidation that was done with the consent of Bright Health as an agreed with the defendant order (PDF link here).

Bright Health had exited the Texas market, ending its ACA plans in July and an agreement with Molina Healthcare to serve Medicaid and ACA Marketplace populations in Florida and Texas starting in 2024, according to July reports [TTA 6 July]. Reading the order, Bright Health and all of its entities including NeueHealth are enjoined from any actions regarding Bright Health Texas.

Is there a bottom short of Chapter 7? Bright Health is not only in major debt, reportedly $500 million, to JP Morgan to pay off its credit facility, but also to the Center for Medicare and Medicaid Services (CMS) to cover risk liabilities from its discontinued ACA (Affordable Care Act-individual plan) insurance businesses. That liability is, according to reports, $380 million in risk-adjustment payments, including $89.6 million in Texas. In the puzzle palace scheme of ACA plans, this is designed to ‘even out’ the differential between higher and lower-risk members in an ACA market. This risk adjustment of nearly $90 million also affects the bottom line of other plans in Texas run by Centene, Molina, and BCBS Texas, as well as smaller local plans, as this payment is distributed to them. But from the liquidation order, no one can collect on this risk adjustment as an asset (see page 7 of the order).

The sale of California plans to Molina in July was estimated at $600 million, and that was contingent on Bright Health surviving into 2024. The value of the plans, with continued losses, is likely reduced as it’s six months later. It is not expected to close until Q1 2024. For the $380 million payment owed to CMS, Bright has entered an interest-only repayment agreement with them, a favorable but ‘skin of the teeth’ arrangement. The credit facility from New Enterprise Associates in August was only $60 million. But their adjusted EBITDA reported at that time for Q2 and H1 were actually in the black: $6.4 million for Q2 and $670,000 for H1. 

The big question to this Editor, as it was to analyst Ari Gottlieb, is how the $89.6 million, now enjoined in Texas, is not considered a default on the risk-adjustment payment agreement and is turned over to the Department of the Treasury for collection. Read Mr. Gottlieb’s POV here on LinkedIn. But this Editor has to hand it to Bright Health. They have done a masterful job of tying states, CMS, and even Molina into Gordian knots that buy time against what seems to be the inevitable.  Becker’s

Cano Health is also trying to stay alive until it gets sold. The board and shareholders on 2 November (release) accepted a 1 for 100 reverse share split, exchanging 100 old shares of Class A and B stock for one Class A share. This is to regain compliance with the New York Stock Exchange’s (NYSE) listing rules. Cano is currently trading at $8.95 (5 Dec @ 13.33pm).

As previously reported, Cano lost $497 million in Q3. Some results showed improvement, with capitated revenue of $770.3 million increasing 23% and 7% PMPM (per member per month) versus Q3 2022. Not good was the adjusted EBITDA of $(66.1) million in Q3 2023 coming in at $(84.3) million lower than Q3 2022 ($18.2 million) due to a higher medical cost ratio (MCR). Reading further into the release, liquidity appears to be low–$53 million, consisting of cash and cash equivalents (excluding restricted cash of approximately $34 million). They also have a revolving line of credit with Credit Suisse, but it is fully drawn. Cano projects operating performance improvement for Q4. It continues to sell assets, lay off staff, and is for sale as a company on what is left, which is their Florida-based clinic network. 9 Nov release

Short takes: a rumor of merger/buy with Cigna and Humana–what are the odds? (updated) And what’s up with the low number of HIMSS 24 exhibitors?

crystal-ballCigna and Humana, perfect together? Only if they can get the deal through the Feds and the states. Late this week, the Wall Street Journal revealed that Cigna and Humana were exploring either a merger or, as some theorize, a buy of Humana ($93 billion in revenue, $60 billion valuation) by much-larger Cigna ($181 billion in revenue, $78 billion valuation). Between them, it is estimated that they would have 35 million members. No transaction cost has been estimated, but the WSJ sources indicate it will be a stock-and-cash deal that could be finalized by the end of the year if all goes well.

On paper, industry observers like it but point out the overlap in one significant area.

  • Cigna earlier announced that it wants to sell its relatively small Medicare Advantage business, concentrating on its leadership in the commercial business and with its service businesses under the Evernorth umbrella.
  • Humana is exiting its commercial health plans to focus on MA and Medicaid, as well as its large footprint in the home health business with CenterWell.
  • Humana’s CEO Bruce Broussard is retiring next year, with newcomer to Humana Jim Rechtin joining as COO in January 2024 as his replacement. Cigna’s CEO David Cordani is a sprightly 57 and likely not to go anywhere.
  • The overlap area that could be problematic is pharmacy benefit management (PBM) with each having about 17-18 million in Express Scripts (Cigna), the second largest in the US, and Humana Pharmacy Solutions. 

Liking it on paper is one thing–FTC, DOJ, and 50 states may not feel so enthusiastic. It’s established through their actions that both Federal agencies are reining in M&A with new and restrictive merger guidelines scheduled to go into effect next year [TTA 20 July]. Healthcare is a major political hot button for this administration for cost–especially drug costs. That is where the reportedly equally sized in revenue PBM operations present the most major conflict to a merger or a buy, both in service and valuation. Both serve their own plan members as well as others, notably Express Scripts with 24% of claims, whereas Humana’s serves primarily its own plan members with 8% of claims. Neither are easy to divest without creating antitrust questions for acquirers and a major dent in Humana’s services. The final factor: Lina Khan, chair of the FTC, has never seen a merger that she’s liked based on her own statements [TTA 24 Aug].

Doomed to repeat history? In 2015, two payer mega-mergers involving these same companies were concocted: Cigna with Anthem and Humana with Aetna. They hit the buzzsaws of DOJ and before that, state approvals. The DOJ pursued them on antitrust in the Federal courts which derailed both by January 2017. Running up to that, every state got an approval vote through review by each state’s Department of Banking and Insurance or equivalent. Many did not approve or with conditions. The other factor is corporate. In the runup to the merger, Anthem-Cigna was marked by escalating animosity from the management suites to the worker cubes. After the deals were scuppered in the Federal District Court, Anthem and Cigna bitterly fought over damages and cancellation fees in Delaware Chancery Court. Aetna and Humana took their lumps and breakup fees, and went on. Aetna went on to merge with CVS, a deal that avoided most of the antitrust flak. Humana went on to acquisitions in other areas.

Our betting line. Both insurers will look at the financials in this hard-to-get-arrested year. Both will feel out the Feds before going forward. Both will calculate whether it’s best to start now or wait till next year and a possible change in administration. Neither company wants to be a political target in an election year. Defensively, Cigna may make noises about other combinations–Centene and Molina have been mentioned–which present their own difficulties and troubles, to strategically try to force the issue. Stay tuned! MedCityNews, Axios

Update: Other analysts suddenly are on board with this Editor’s gimlety view of the matchup, citing antitrust and how Federal regulators are primed to challenge major deals. The FTC is specifically probing the PBM business. The fact that the deal, according to JP Morgan, could take 12 to 24 months is no surprise as par for the course, but Mr. Market didn’t like it, dragging down both companies’ share prices every day since the rumor broke. (Hmmmm….do they read TTA?)  But a small lamp was lit by one analyst: a Cigna-Humana combo could present real competition to the 9,000 lb. elephant of healthcare, UnitedHealth Group, and that might help to put it over. FierceHealthcare

Another concern that occurred to your Editor: Cigna’s international footprint could mean additional approvals by UK and EU regulators.

According to Healthcare Dive’s analysis, the combined entity would have a PBM market share of 32%, right up against CVS Health-Caremark at 33% and UHG’s OptumRx way behind at 22%. It’s a small group with big barriers to entry which makes it a slam-dunk to antitrust regulators.  A whistle in the dark might be UHG’s long-drawn-out buy of Change Healthcare, but there were divestitures of business before closing and both parties managed to prove to the satisfaction of a US District Court that the separation to Optum Insight would not affect business relationships with other health plans. But here, both are health plans, and both have PBMs.

HIMSS 24 exhibitors, where are you? An item in today’s HIStalk on the ‘interesting’ choice as closing keynoter of football coach Nick Saban (U of Alabama Crimson Tide) at a healthcare IT conference went on to compare the number of booked HIMSS exhibitors to date with HIMSS 23’s floor total. This Editor, who for a few years booked the least expensive HIMSS space for the company she worked for back then well in advance, could not believe the low number of exhibitors three months from show time in March. Checking the HIMSS show website, there are 501 exhibitors listed. In 2023, according to HIStalk, there were 1,216. Many of these exhibitors have multiple booths in the Orange County (Orlando) Convention Center, but it still indicates the uncertain state of healthcare, pullbacks in marketing budgets, the rise of real competition in HLTH and ViVE, and perhaps some concerns about the show management transition from HIMSS itself to Informa. Are industry and IT influentials skipping HIMSS next year? Stay tuned or comment below!

Has Amazon lost its ‘edge’ in healthcare? Or finally seeing reality?

Amazon’s long and winding road to Healthcare Reality is no surprise to those tracking Amazon’s moves over the past few years. And Bloomberg agrees. In the eyes of many of the industry, Amazon was one of the top companies revolutionizing healthcare in a consumer-focused, tech-driven model. They were making The Big Moves along with giants CVS and Walgreens with an open wallet, with Walmart lagging and tagging behind. But when you turn a Gimlet Eye to the track record, The Big Moves were marked by hubris, uncertainty, lack of focus, lack of healthcare expertise, and just plain bad judgment.

  • First, there was the sinkhole known eventually as Haven, 2018-2021. This partnership with JP Morgan and Berkshire Hathaway (RIP to the legendary Charlie Munger) generated truckloads of 50,000-foot quotes by JPM’s Jamie Dimon and B-H’s Warren Buffett about the ‘hungry tapeworm’ of healthcare costs and the need to simplify it for their million-odd employees. It was clear that Amazon was relegated to the ‘junior partner’. Their reaction was to go their own way well before the shutdown and make its own acquisitions, acquiring PillPack in mid-2019 as the first move towards a PBM, Amazon Pharmacy, then pushing Amazon Care for large employers. TTA 6 Jan 2021
  • Then there was the brief and mysterious life of Amazon Care, 2019-2022. Their mix of virtual care, in-home, and telehealth services signed up large employers such as Hilton and (of course) Amazon with the eventual vision of delivering in-home care of visits and medications via mobile providers. Despite plenty of pivoting behind the scrim but eventually going nationwide with some, not all, of their services, their vision wasn’t attractive to most large employers. Even before One Medical was acquired in July 2022, Amazon decided to ditch Care by end of 2022. TTA 25 Aug 2022
  • And $3.9 billion later, there is One Medical, acquired earlier this year. It has never made money and won’t for at least two fiscal years. It doesn’t resemble an Amazon-style delivery model either. It’s a membership model practice group with individual paying members plus 9,000 corporate service contracts and telehealth. Of course, memberships including telehealth are being offered to the millions of Amazon Prime members at a drastically discounted rate starting earlier this month.
  • Bubbling under this is Amazon Clinic, an asynchronous virtual consult service leaked in November 2022, formally announced in June 2023 but delayed until August on data privacy issues that attracted Senatorial scrutiny on whether information would be passed to other Amazon services for merchandising [TTA 27 June]. Visits cost an average of $50. Amazon is surprisingly mum on Clinic’s status.

From the collection of articles linked above, plus TTA’s ongoing chronicle of FTC’s (and DOJ’s) consistent scrutiny (some call it vendetta) re Amazon [TTA 24 Aug, 27 Oct], one cannot conclude that Amazon has lived up to its publicity, dominating coverage earlier this year, that it would be a leading Healthcare Transformer. In that last article, this Editor’s obvious doubts were summarized as “What we view as a juggernaut is facing more than their share of distractions and changing circumstance.”

It is awfully nice to know that Bloomberg has taken our small ball of misgivings and run with it. Their article describes, through interviews with current and former employees, patients, competitors, and industry analysts, a “culture of hubris”, believing that “Silicon Valley-style invention could outsmart industry incumbents” and management not listening to the industry people they did hire. The hubris goes back to the very beginning. Even transitioning a young but deep in the red company like PillPack, bought for a truly ridiculous amount of money but that fit easily into the Amazon model, took an inordinate amount of time–about two years. Amazon Pharmacy, built on the PillPack bones, doesn’t seem to be meeting expectations, running headlong into local retailers such as CVS, Walmart, and Walgreens, discounters such as GoodRx, and deliverers such as Mark Cuban Cost Plus. No surprises there when you waste two years. Wall Street doesn’t like it much either, despite the promises from CEO Andy Jassy that healthcare is their long-term growth area, carrying through the vision of former CEO and now chairman Jeff Bezos.

It also doesn’t help to be the corporate target of the FTC, not mentioned in the Bloomberg article.

This Editor will quote herself from a recent article. While it was in the context of learnings from Olive AI, it applies equally to those with lots of success in other businesses or even other parts of healthcare. Know that healthcare, no matter what the conferences say, is an entrenched, over-regulated, risk-averse, and thus extremely slow-moving business. The risk level is high, the reward may be incremental, at best. And the big guys–the payers, big health systems, and their vendors, will always have it all over you.

NODE.Health’s 7th Annual Digital Medicine Conference 6-8 December

7th Annual Digital Medicine Conference 
“Collaboration for Transformation”
Wednesday 6 December – Friday 8 December
Microsoft NYC, 11 Times Square, NYC   Agenda here

This three-day conference dedicated to bringing the promise of digital innovation to the real world of healthcare delivery has 30 sessions with speakers from providers, academia, government, and leading health systems on topics such as public health, digital psychiatry, AI, automation, and UX. Friday is focused on Federal Health Innovation. Included are after-conference receptions on both Wednesday and Thursday. More information and registration.

Another turkey: potential 9M patients affected by medical transcription vendor data breach

Vendors are hot, hot, hot…with hackers. In another notable vendor data incident, Perry Johnson & Associates (PJ&A), a Henderson Nevada-based provider of transcription services for hospitals and physician practices, reported a data security incident to the US Health & Human Services (HHS) Office of Civil Rights (OCR) on 3 November. The breach occurred in the network and files were copied 27 March-2 May, when it was detected. 8.95 million individuals were affected, with over 4 million individuals in NYC and Syracuse at Northwell Health, the largest health provider in New York State, and Crouse Health. Northwell hasn’t had much luck with transcription providers, having been affected by Nuance Communications’ hack earlier this year by one of their vendors–the Progress Software MOVEit file transfer protocol (FTP) theft traced back to ransomwareistes CLOP [TTA 3 Aug].

Personal health information stolen for all included name, date of birth, address, medical record number, hospital account number, admission diagnosis, and date(s) and time(s) of service. While the records didn’t contain financial information, some patients may have had breaches of their Social Security numbers, insurance information and clinical information from medical transcription files, such as laboratory and diagnostic testing results, medications, the name of the treatment facility, and the name of healthcare providers.

PJ&A notified affected providers on 29 September and affected patients on 31 October. In addition to the 4 million+ in New York, 1.2 million individuals were served by Cook County Health in Illinois. The rest have not been identified. TechCrunch, News4NY, PJ&A notice