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

August 15, 2024 | by

Big Health’s SleepioRx digital insomnia therapeutic gains 510(k) FDA clearance. The 90-day treatment is based on a prescription device delivering Cognitive Behavioral Therapy for Insomnia (CBT-I). The treatment adjunct is tailored to symptoms and provides daily sleep tracking, enables goal setting, and content for help falling asleep. Sleepio was originally developed in the UK (we covered in 2013!) but moved to San Francisco in 2015.  Their original Sleepio is marketed to employers and health plans to support treatment for sleep disorders and insomnia, along with other products for digital support for anxiety and depression. Their last funding was a Series C of $75 million raised in the palmy days of January 2022 and a year later acquired Limbix, provider of SparkRx, a depression management app targeted to adolescents. Release, Mobihealthnews

In my home state of NJ, Caregility announced an AI-powered fall detection upgrade to their acute care clinical observation platform. iObserver is used by hospital care teams for observation of patients at risk for falls or self-harm. Interestingly, the fall detection system is run on computer vision, which means it runs entirely on telehealth edge devices in the patient room with the AI capable of identifying and deriving information from objects and people in images and videos. Edge device use means that processing is done within the devices themselves, which eliminates bandwidth issues and upstreaming to the cloud, a failure point for privacy and as we now see, hacking risk. According to the release, the computer vision capability is available for use on every one of the more than 15,000 Caregility edge devices currently installed in hospitals around the globe. 

Otsuka Precision Health (OPH) launches Rejoyn digital therapeutic for depression.  As previewed earlier this summer [TTA 29 May], OPH launched Rejoyn, the first and sole prescription digital therapeutic cleared by the FDA for the adjunctive treatment of major depressive disorder (MDD) symptoms. Rejoyn was developed in conjunction with Click Therapeutics. It is for use by those aged 22+ on antidepressive medication. After being prescribed from the patient’s provider or Wheel Health, the Rejoyn app can be downloaded from major app stores after keying in an access code that is furnished to the provider by BlinkRx. It is currently being priced on a cash-pay basis at $50 for the six-week course, which will increase later to $200 for insurer coverage, though it is not yet covered. In a six-week trial, the use of Rejoyn reduced depression symptoms and improvement across multiple scales typically used by patients and clinicians to track depression improvement. The Otsuka release and commitment are significant as it’s also the first true involvement of a major pharmaceutical company in telemental health with a highly targeted clinical app that isn’t tied to one of their medications. It’s a long road with a lot of bumps, as Otsuka experienced with Proteus Digital Health’s smart pill tech for its Abilify MyCite, as well as failed companies like Pear and Babylon Health.  Release, Healthcare Dive

In funding news, emergency services telehealth company MD Ally now has $14 million in a Series A to add to its previous $11 million.  The raise was led by Frist Cressey Ventures, founded by Senator Bill Frist and Bryan Cressey, and anchored by General Catalyst, with participation from Techstars, Seae Ventures, Red & Blue Ventures, and Alumni Ventures. MD Ally’s value proposition centers on the non-emergency 911 call. Dispatchers and first responders, after determining the non-emergency status, can divert the call to other telehealth and community-based resources to assist the person plus a ‘care assistant’ for treatment plans and long term outcome management. MD Ally is currently in test in Phoenix and locations in Florida, Arizona, and California serving about 5 million patients. Release, Mobihealthnews

In UK related news:

Alcove expands TEC services with CallConnect247. It is a state-of-the-art 24/7 Alarm Receiving Centre (ARC) designed for communities and local authorities who are modernizing their call services for alarm management to incorporate virtual care and video welfare calls. It includes AI-powered and automated services to reduce false alarms and minimize the ‘white noise’ calls that often inundate traditional ARCs. It’s expected to grow coverage up to 8,000 users by October. Alcove release, Thiis.co.uk

Health Catalyst buys US/UK care management company Lumeon Ltd for $40 million. The $40 million purchase price was funded with a mix of $2.5 million in stock and $37.5 million in cash plus a potential recurring revenue-based earn-out of up to $25 million that, if achieved, would be paid solely in cash. (page 42 of SEC Form 10-Q). No information was provided concerning staff transitioning at Lumeon’s current HQs in Boston and London, where it adds a UK/EU footprint to Health Catalyst’s current data analytics and software businesses. Lumeon’s Care Orchestration automates care coordination processes for providers in outpatient, acute care, and post-acute settings.

Health Catalyst’s earnings were also reported in the 10-Q. Revenue for Q2 was up slightly from last year to $75.9 million, but burdened with a net loss of $13.5 million which was more than 50% reduced from Q2 2023’s $32.6 million. Q2 adjusted EBITDA improved to $7.5 million versus $3.5 million in prior year. Release, Mobihealthnews

23andMe drops drug discovery group, expands Lemonaid into GLP-1 weight loss medications, loses $69M in Q1–and board rejects CEO’s buyout offer

August 14, 2024 | by

Troubled 23andMe disbands drug discovery group, moves into weight loss meds, loses $69 million in FY25 Q1–and soundly rejects CEO buyout offer. The next shoes have dropped in the 23andMe drama.

The latest from both the Q1 earning announcement and their SEC filing, both 8 August:

  • 23andMe has abandoned its drug discovery dreams and closed the unit, terminating 30 employees in the Therapeutics Discovery unit including Bill Richards, the head of Therapeutics Discovery (package details in the 8-K), effective 9 August.  SEC Form 8-K 
  • 23andMe will retain their Therapeutics Development unit for the two drugs currently in early-stage clinical trials. They are also collaborating with Nightingale Health to pilot a metabolomics blood biomarker panel with a cohort of 23andMe+ members.
  • The Lemonaid telehealth unit is moving into prescribing GLP-1 semaglutide weight loss drugs through a membership program and receive either brand-name or compounded medications. (Editor’s note: why anyone would be a member of 23andMe after their epic user and member data breach last year–that they blamed on users’ passwords–is beyond me.)
  • This is coupled with what the company terms in its Q1 press release “a large-scale genetic research study to help identify the genetic mechanisms that may drive the efficacy and potential side effects of GLP-1 medications”

Their Q1 FY 2025 was singularly depressing, with revenue sinking 34% to $40 million, well below the $52 million projected by Street analysts. The drop was attributed to the loss of the GSK genetics collaboration in mid-2023.  The only bright spot was that losses also shrank 34% to $69 million from $105 million in the prior year. 

Stock delisting pending. ME closed on Tuesday at $0.35. The company received an extension from Nasdaq to 4 November and is seeking shareholder approval for a reverse stock split to raise the price above $1.00 as required. Endpoints, MedWatch, FierceHealthcare

CEO’s buyout rejected. On 2 August, the $0.40 per common share non-binding offer from CEO and controlling shareholder Anne Wojcicki offered on 29 July [TTA 1 Aug] was soundly, roundly rejected by the impressively named Special Committee of the Board of Directors of 23andMe. From the letter:

“We are disappointed with the proposal for multiple reasons, including because it provides no premium to the closing price per share on Wednesday, July 31st, it lacks committed financing, and it is conditional in nature. Accordingly, we view your proposal as insufficient and not in the best interest of the non-affiliated shareholders. Therefore, we are not prepared to move forward under the terms provided. Importantly, we request that you immediately withdraw your stated intent to oppose any alternative transaction so that we can fully assess whether there is interest from third parties in a transaction that would maximize value for all shareholders.” (Editor’s emphasis)

It closes with a demand:

“In the absence of a revised offer at a more appropriate price per share that meets the other requirements set forth above, we will pursue other alternatives in striving to maximize value for all shareholders. In that regard, given both the lack of certainty regarding a path forward with you and your potential investors and the current liquidity position of the Company, in parallel with your work to submit a revised bid, we intend to immediately begin the process of engaging a consultant to advise the Special Committee on a revised business plan that would provide the Company with a path to a more sustainable financial profile and achieving profitability. In your capacity as CEO, we expect your full support in these efforts.“

Given that she reportedly holds 22.5% of the company’s outstanding Class A common stock and 59.2% of outstanding Class B common stock (according to analyst TD Cowen)–other reports state that she has in total 49.99% of the voting power–that is quite a defiant statement. Based on her supervoting privileges–a trick picked up from her Silicon Valley tech friends back when–Wojcicki could kill any buy not in her interest. Or any interest, period. Developing.  

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

August 8, 2024 | by

Clover Health’s milestone–a first-ever profitable operating quarter. Not only that, but it was an impressive turnaround from the prior year. With results in their Q2 operating net income of $7.2 million, versus a $28.9 million loss in 2023, these results were far more favorable directionally than the adjusted EBITDA which was $36.2 million versus $9.9 million for the prior year. Insurance revenue was also up 11% to $349.9 million, attributed to member retention and an improved medical cost ratio (MCR) of 71.3%, down from 77.9% in the prior year. Additional revenue from other operations, such as the recently introduced Assistant AI, is minimal. The 2024 forecast stays ‘in the clover’ with raised forecast revenue of $1.35 to $1.375 billion and adjusted EBITDA of $50 million to $65 million. Also helpful is their lifted Star rating from 3 to 3.5 for 2025. FierceHealthcare, Clover earnings release

Rival Oscar Health also stayed Back in Black for the second quarter running–CEO Bertolini wouldn’t have it any other way (or else–see below right). Q2 net income rose to $56.2 million which was a a $71.7 million improvement versus prior year. Adjusted EBITDA also nicely improved to $104.1 million, a $68.6 million improvement. Revenue increased to $2.2 billion, a 46% increase over the prior year. Their MCR went down .9 points. The overall forecast for the year wasn’t provided. Membership was up over 600,000 in their main business of individual and small group insurance, with Bertolini pointing out that this was powered by plan growth in 80% of the states where they operate. Oscar exited Medicare Advantage at the end of 2023, and is shifting to marketing ICHRA, or individual coverage health reimbursement arrangements that permit small businesses to offer employees individual health plans subsidized by employer contributions. After this year, the 58,000 members left in the unprofitable Cigna co-branded small group program will exit [TTA 10 May]. Oscar release, FierceHealthcare

Back in Mr. Bertolini’s old stand, Aetna, results weren’t so cheerful–and their president walked the plank after less than one year. The reorganization announcement was made on the earnings call yesterday, effective immediately. CVS Health CEO Karen Lynch will oversee the daily operations of the health benefits segment along with Aetna’s CFO. CVS VP/chief strategy officer Katerina Guerraz will move over to become Aetna’s chief operating officer.

What initiated it: while health benefits’ revenue stayed in the black, going the wrong way were operating income decreasing 39.1%, the medical benefits ratio (MBR) soaring to 90% from 86% in prior year and the medical loss ratio (MLR) going up to 89.6% from 86.2%. These were attributed to increased utilization, the decline in Medicare Advantage Star ratings, Medicaid acuity, and a revised risk adjustment in the individual exchange business. Something in this immediately doomed now former president Brian Kane, who joined only last September. His last post was at Humana as chief financial officer and leader of their primary care business. CVS Health release, FierceHealthcare, Healthcare Finance

Marrying robots with telemedicine, VSee is partnering with Ava Robotics to create an autonomous robot for telepresence use in hospital intensive care units. This would enable remote emergency physicians to be present at the point of patient care, interact with patients, consult with onsite staff and make treatment decisions. The projected market is smaller regional hospitals and ICUs.  VSee already markets telemedicine carts and portable diagnostic and home care kits. Availability is not disclosed. VSee release, Mobihealthnews

VSee also announced a partnership with Wichita, Kansas community health provider Stand Together for its Aimee telehealth services. Telehealth at their centers will be available to participants for a monthly charge of $4.99 or a single virtual urgent care appointment for $9.99. VSee release

Ransomware strikes again. Non-profit blood donation organization OneBlood was hit on 29 July by a despicable ransomware attack that disabled much of its blood collection services for over 250 hospitals in the southeastern US. They continued to operate at reduced capacity and called for donors of O positive blood, O negative blood and platelet donations. The perpetrator, ransom demands, and breached information were not disclosed. On Monday 5 August, systems were partially restored in time for Tropical Storm Debby’s assault on many southeastern states. From a OneBlood spokesperson: “Our critical software systems have cleared reverification and are operating in a reduced capacity. As we begin to transition back to an automated production environment, manual labeling of blood products will continue. Additionally, we are beginning to return to using our electronic registration process for donors.” DataBreaches.net, FierceHealthcare, HealthcareITNews

Hard-hit Change Healthcare is still playing games with reporting to HHS’ Office of Civil Rights (OCR). Parent UnitedHealth Group reported the ransomware shutdown and data breach to OCR, a full five months after its occurrence. The number reported is the OCR minimum of 500, when it is well known that it affected millions of patients. UHG started direct patient notification on 31 July after weeks of delay, but stated to OCR that they are still determining the number of individuals affected. Provider notifications started in late June [TTA 21 June]. This followed after a hostile dispute earlier that month where UHG tried to push patient notifications onto providers, which HHS decided was 100% UHG’s responsibility. [TTA 5 June]. OCR FAQ update, HealthcareITNews

Masimo and activist shareholder Politan Capital continue to slug it out down to the 19 September shareholders meeting. Back in mid-July, Masimo postponed the meeting, originally scheduled for 25 July. At that time, Masimo filed a complaint in the US District Court for the Central District of California against the two Politan representatives on their board of directors plus Politan’s two nominees that proxy materials contained false statements and violations of the Exchange Act. The suit added that board member Quentin Koffey, also Politan’s chief investment officer, was secretly conspiring with a plaintiffs’ bar law firm currently in litigation with Masimo.

The latest revelation per Strata-gee 7 August: Politan’s countersuit in the Delaware Court of Chancery states that the charges filed by Masimo in the District Court are based on ‘unnamed sources received from a third-party opposition research firm…’ and Masimo’s outside counsel does not know the identity nor ever spoke to the sources. This was filed against CEO Joe Kiani, independent director Craig Reynolds, and director Bob Chapek as a breach of Delaware law.

To date, Masimo has not confirmed their sources to the Delaware court. 

As previously reported [TTA 17 July], the proxy fight was triggered by the value of the company, reduced substantially after Masimo’s snakebit 2022 acquisition of Sound United’s consumer audio brands, Politan’s move to control the company, and kick out the CEO Joe Kiani.  The fight on the Masimo board of directors for two open seats pits the Masimo slate of CEO Joe Kiani and outside candidate Christopher Chavez, against Politan’s Darlene Solomon and William Jellison. Politan already holds two seats and with a win of two additional seats will control the company. Masimo plans to sell the consumer audio and healthcare (baby monitoring) businesses to another unnamed investor, retaining their professional healthcare and pulse oximetry products.

Stay tuned to the next episode of this soap opera.

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

August 7, 2024 | by

Retrenching is the theme this (crazy) week.

Walgreens sells another 2% of Cencora shares, raising $1.1 billion of much-needed cash. Walgreens reduced its ownership share of the drug distributor formerly known as Amerisource Bergen to 10% by selling the remainder of their unencumbered shares, approximately 2% of the common stock. Known as a Rule 144 sale of restricted or control stock, the proceeds as of 1 August are $818 million followed by a concurrent share repurchase by Cencora of $250 million. This is the third sale this year: in May Walgreens sold 1% for $400 million and in February 2% for $990 million. All these sales were to fund operations and pay down debt. Despite the further reduction, Ornella Barra, COO International of Walgreens Boots Alliance, will continue on Cencora’s board. The partnership agreement remains in place. Release, Healthcare Dive, Reuters

Revenue cycle management company R1 RCM finally found investors to take it private.  TowerBrook Capital Partners and Clayton, Dubilier and Rice are the winners, acquiring R1 for $8.9 billion. They will purchase outstanding shares at $14.30 per share in an all-cash deal expected to close by the end of 2024. Private equity investor TowerBrook already owns 36% of the company. This shuts out rival New Mountain Capital as their 23 February bid was offered at a lower $13.75 per share. At that time, New Mountain owned 32%; that bid valued the company at nearly $6 billion. The purchase will be financed with a combination of committed debt financing and equity from investment funds affiliated with TowerBrook and CD&R. Large shareholders Ascension Health Alliance (also R1’s major customer) and Coliseum Capital Management were not mentioned in the acquisition release.

In March, a special committee was formed by their board to evaluate strategic alternatives, code for ‘we believe it’s undervalued’. The company is currently traded on Nasdaq and closed today at $13.96. R1 closed 2023 profitably with net income of $3.3 million, flipping a $63 million 2022 loss, on a revenue increase of nearly 25% to $2.3 billion. Q1 and Q2 2024 are a more mixed picture. Q1 had revenue of $603.9 million, up 11% year-over-year, but with a net loss of $35.1 million caused in part by $10 million in losses created by the Change Healthcare ransomware attack. Q2 continued the trend, with revenues of $627.9 million up 12% versus prior year, but a widening net loss of $7.6 million versus $1 million in the prior year. Q2 earnings release, Q1 earnings release, FierceHealthcare, Healthcare Dive

Seeking ‘strategic alternatives’ for current investors and going private seems to be the new fashion in the crowded healthcare business process outsourcing (BPO) and RCM sectors. Profitable but problematic companies such as Veradigm [TTA 28 May] and GeBBS [TTA 17 Apr] both up for sale or investment. To date, Veradigm has not gone public with any offers, but GeBBS was scheduled last month to have binding offers submitted by Carlyle Group, Hillhouse Investment, and CVC Capital Partners. ChrysCapital, India’s largest private equity firm, owns 80% of GeBBS. Economic Times (India)

The messy unwinding of Steward Health Care in the US Bankruptcy Court for the Southern District of Texas continues.

  • The court approved the closure of two Massachusetts hospitals, Carney Hospital in Dorchester and Nashoba Valley Medical Center in Ayer, at the end of August. Neither hospital received qualifying bids in the sale process and both hospitals, serving primarily low-income patients, are among the worst performers in Steward’s anemic portfolio.
  • Based on WARN notices filed with the state, over 1,200 people will lose their employment as well as communities losing services. 
  • Yesterday, the Commonwealth of Massachusetts agreed to provide $30 million to keep the six remaining hospitals in the state running in two tranches: $11.3 million on 9 August and $18.7 million on 16 August. 
  • Those hospitals are being handed over to NYC-based Apollo Global Management, a global alternative asset manager, to facilitate their sale from current landlords Medical Properties Trust and partner Macquarie Infrastructure Partners to new operators.
  • Auctions pushed forward include the Arizona hospitals, with a new bid deadline of 12 August with a 19 August sale objection deadline and a 22 August sale hearing. Other hospitals in Ohio, Pennsylvania, Arkansas, and Louisiana have not been rescheduled after their canceled auctions.
  • The Stewardship Health practice group now has a bid deadline of 6 August, with the sale objection deadline now 9 August and the sale hearing set for 13 August. Optum walked away from its deal back in April with the Chapter 11 filing and there is no word if they are bidding in bankruptcy.

Additional updates: the Senate investigation of Steward is going forward with a subpoena issued to CEO Ralph de la Torre. The public hearing of the HELP Committee and his appearance are scheduled for 12 September. FierceHealthcare No further developments in the US Attorney’s Boston office investigation of violations of the Foreign Corrupt Practices Act about Steward’s business dealings in Malta between 2018 and 2023. One wonders whether Dr. de la Torre will sail off on his 190-foot superyacht to one of the few places where extradition is difficult, such as Ecuador, Bolivia, Venezuela, or Iceland.

Healthcare Dive, Becker’s 31 July, Becker’s 6 August  Most recently in TTA 2 July, 18 July, 25 July

Breaking: Teladoc’s Q2 sinks on $790M BetterHelp impairment; Wojcicki files to take 23andMe private

August 1, 2024 | by

Teladoc posts Q2 loss of $838 million, takes $790 million impairment on BetterHelp’s sinking performance. New CEO Chuck Divita had nothing but bad news to deliver to Mr. Market (right below). It was so bad that they withdrew their FY2024 outlook for both consolidated operations and BetterHelp stated in April and all three-year outlooks. TTA Q1 Teladoc results and outlook  

  • Q2 revenue declined 2% versus prior year to $642.4 million. Integrated Care (main business) segment revenue increased 5% to $377.4 million while BetterHelp declined 9% to $265 million. Readers will recall that previous CEO Jason Gorevic assured investors that BetterHelp would carry Teladoc to profitability. Au contraire, along with his job.
  • The bright spot was that adjusted EBITDA increased to $89.5 million, up 24% versus prior year, but adjustments reflect all sorts of financial legerdemain, including impairments.
  • First half results were essentially flat versus prior year, with revenue up 1% to $1,288 million with Integrated Care up 7% to $754.5 million–but BetterHelp again sinking results with a decrease of 7% to $534.0 million.

BetterHelp’s rolling failure is almost inexplicable, with telemental health being the ‘IT’ clinical category in digital health funding. Spring Health just scored a $100 million Series E [TTA 31 July]. Younger companies such as Talkiatry and Brightside Health seem to have no problem raising funds or gaining partners/customers. One would think that with established customers in the enterprise space, Teladoc would have no problem adding on telemental services. This Editor has previously analyzed the problems that have led to the decline of both Teladoc and Amwell, but Teladoc stands apart in one factor. It is still recovering in its huge failure in buying and failing to integrate Livongo. But in the telemental health space, the profitable companies are largely in the enterprise and payer space. Even DTC, they have slicker solutions and extensive networks. It’s a cost-sensitive market, both to benefit admins and to prospective members. 

Here’s the pivot. On the earnings call, CEO Divita and CFO (former acting CEO) Mala Murthy announced a pivot for BetterHelp to international, non-English-speaking markets, where customer acquisition costs are lower. (This Editor would add that competition is also less.) They also blamed advertising cost inflation and jacked-up acquisition costs during a US election year–something that is completely predictable and should be baked in the 2024 marketing expenses. Unbelievably, if advertising costs remain high, Murthy stated that they expect a low double-digit revenue decline, whatever that means.

The shocker here is that it finally dawned on them that the big problem with BetterHelp is that it does not accept insurance and has a high DTC cost. Their leavers in research cite both as reasons why. Hellooooo? What took so long?  So their fix is to negotiate insurance coverage–but that won’t take effect till 2025. 

From FierceHealthcare in an on-point close of their article: “Divita was adamant that Teladoc runs BetterHelp well and that it’s an important part of the company.”  Morningstar (Teladoc release)  How much more can Mr. Market stomach? This story is developing.

As we predicted, CEO/founder Anne Wojcicki has made an offer to take 23andMe private. She has filed with the Securities and Exchange Commission (SEC) amendments to their Schedule 13D form that confirm that on 29 July, she sent a non-binding proposal to the Special Committee that has been looking at alternatives since late March [TTA 20 April]. The Exploding Plastic Inevitable offer of $0.40 per share is to shareholders of Class A and B common stock. It became public yesterday (31 July). The current price is around $0.40, so there is no premium. 23andMe is also on a six-month delisting deadline with Nasdaq from November, which they have since passed but may have been extended due to the Special Committee formation.

Wojcicki holds supervoting privileges that have always given her effective control of the company. According to analyst TD Cowen, she currently holds 22.5% of the company’s outstanding Class A common stock and 59.2% of outstanding Class B common stock. In going private, she would be right in line to be paid out by outside funders (Other People’s Money). Other alternatives to her buyout, such as Chapter 11 or 7 bankruptcies, are even more bleak and would leave shareholders with effectively 0.

As TTA noted in our April coverage, the company is yet another cracked SPAC (2021) hitting a $4.8 billion valuation, acquiring companies, and falling precipitously. It never found a recurring revenue model, being largely ‘one and done’ on ancestry and genetic reports. Recently, it lost a lucrative contract with GSK for research data. It stumbled badly after a major data breach in Fall 2023 that exposed 6.9 million records. Then, they blamed members for their poor cyberhygiene and lack of security. This once bright light has burnt out; is it even relevant anymore other than giving the CEO a job? Yahoo Finance, CNBC, MedCityNews  Developing. Our recent 23andMe coverage: 29 May (FY24 earnings and the committee’s poor choices), 2 Feb (data breach timeline, financials)

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

August 1, 2024 | by

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

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

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

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

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

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

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

July 31, 2024 | by

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

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

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

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

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

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

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

Funding/M&A wrap:

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

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

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

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

July 25, 2024 | by | 1 Comment

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

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

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

M&A/funding roundup

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

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

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

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

July 24, 2024 | by

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

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

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

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

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

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

July 18, 2024 | by

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

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

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

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

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

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

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

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

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

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

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

Last but certainly not least are reports of layoffs and major restructuring at Meta (Facebook)’s Reality Labs, which is their unit for augmented reality (AR)/virtual reality (VR) headset and software development unit. It’s now separated into two units, Wearables (headsets, glasses such as smart Ray-Bans) and Metaverse (platform and Quest headsets). Reports that are primarily paywalled have said that multiple leaders have been laid off from the company, with The Information (paywalled) stating the late June layoff affected a dozen VPs and directors. Teams also have to cut spending 20% by 2026, with the bulk of the cuts this year. Meta, despite billions in investment and Metaverse hype by Mark Zuckerberg including a corporate name change, has largely failed against Apple’s Vision Pro and others. ABPLive, EM360Tech

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

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

July 18, 2024 | by

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

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

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

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

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

July 17, 2024 | by

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

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

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

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

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

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

VA sued in Federal court on Oracle Cerner EHR accessibility issues

July 8, 2024 | by

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

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

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

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

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

July 3, 2024 | by

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

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

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

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

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

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

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

Short takes: Fabric buys Walmart’s MeMD telehealth arm, Geisinger data breach via vendor exposed ~1.2M records, UK’s Careium develops resilient rSIM, $50M funding for K Health, India’s Alyve’s $6M Series A, Upside Health closes

July 2, 2024 | by

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

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

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

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

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

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

Two fundings of note–and one shutdown:

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

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

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

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

July 2, 2024 | by

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

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

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

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

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

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

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

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

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

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

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

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

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

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