Digital health’s Q1 according to Rock Health: the New Reality is a flat spin back to 2019

April 11, 2024 | by

Though it’s busier, and no banks collapsed, the New Reality takes us back once again to 2019, before the champagne days of 2021 and first half 2022. Rock Health’s Q1 2024 summary of US digital health deals hasn’t a bit of froth to it and is headlined “Great (reset) expectations”. But the highlights show a bit of revival after 2023, where there was, in the immortal words of Frank Zappa, “no way to delay that trouble comin’ every day”.

  • In Q1 2024, there was $2.7 billion in funding across 133 deals, with an average deal size of $20.6 million. This was a great improvement over Q4 2023’s limp $1.9 billion across 122 deals, the lowest funding quarter since Q3 2019. [TTA 8 Feb]
  • 2024’s Q1 was the lowest first quarter by sector funding since 2019, since 2022 and 2023’s Q1’s were the best of their respective years.
  • Number of deals are up but the deal size remains small at $20.6 million–no blockbusters. Q1’s 133 deals beat out each of the past six quarters, but just edged out Q1 2023’s 132. 
  • Unlabeled rounds grew from 2023: 48% to year 2023’s 44% of the total. Labeled rounds, predicted to make a comeback in 2024, haven’t come back quite yet.
  • Deal structures are getting very, very creative. DecisionRx gave Carlyle Group the option to convert a $100 million debt facility to 25% of outstanding shares, which is trading a lot of equity in the company for not a lot of money. Transcarent has a $125 million Series D that tags a sweetener of 2.5x to funders should the company M&A or IPO. This Editor noted the structure of Dario Health’s February acquisition of Twill as “a dizzying chronicle of funding legerdemain that this Editor hasn’t seen since her airline days”. 

It wasn’t a surprise that AI was ‘the thing this year’ in attracting funding–almost as much as financial success being redefined as bottom-line profitability, conservative (what we used to call sandbagged) forecasts, and an emphasis on outcome data.

  • Companies that claimed AI in their products or services accounted for 45 deals with $1.1 billion of Q1’s funding, or 40%, versus 2023’s 33% of funding. 

Rock Health’s analysis made much of outcomes data and that showing efficacy is now more important--and at earlier stages. It serves to differentiate players in the market (something we marketers have known about forever). For funders it can illuminate the value for their investment. And funders will scrutinize x 3.

  • Companies, unable to satisfy public shareholders so easily pleased in the SPAC and IPO palmy days of 2021-23, are leaving, not entering, public markets. Veradigm had to delist this year because of Nasdaq financial reporting problems from bad software despite being financially healthy–and acquiring ScienceIO. Rock Health does not include the recent pending delistings of Clover Health and Amwell. Both NextGen Healthcare and SOC Telemed went private last year. Others were acquired: Science 37, BenefitFocus, Castlight, Signify Health, and Tabula Rasa. Four went out of business: Babylon Health (Ch. 7 US, administration in UK), Pear Therapeutics (Ch. 11, IP sold), UPHealth (Ch. 11), and Better Therapeutics (closure).
  • Rock Health sees this as an important ‘recalibration’ for valuations, particularly for startups. “Startup valuations stem from expected investor returns at exit, and funders often use comps from publicly-traded players’ market capitalizations to triangulate company potential.”

Rock Health concludes that the expectations around exits have shifted drastically. The predicted return of M&A hasn’t yet. Their latest projection is that companies “may embark on dual-track processes, pursuing IPO and M&A exit pathways concurrently to keep options open”. For now, for digital health, it’s the end of growth-minded forecasting and the start of reporting their financials conservatively, with plenty of outcomes attached–as if they were being publicly traded and had quarterly earnings calls with analysts and journalists on their tail.

Editor’s note: Notably missing from their summary was the usual charts of raises by series stage (A, B, etc.) and digital health sector (mental health, cardiac, etc.).

VillageMD names new president and COO as it shrinks to 620 locations

April 10, 2024 | by

Jim Murray retires from Centene to take the role of VillageMD’s president and chief operating officer. The appointment was effective on 1 April. He will be responsible for leading operations of Village Medical, Summit Medical, and CityMD.  Last October, VillageMD named new divisional heads: Rishi Sikka, MD as president of Village Medical, Dan Frogel, MD as president and chief clinical officer of CityMD, and Becky Levy, JD as president of Summit Health and Starling Physicians.  VillageMD release, Crain’s Chicago Business

As noted previously, VillageMD has been retreating quickly from its aggressive plans circa 2022 for expansion into Walgreens locations to closure of the co-locations and already established free-standing offices. The planned 140 closures are well above the originally estimated 50, then 85 locations, including all in Florida and six in its home state of Illinois. Majority owner Walgreens has already taken a $5.8 billion writedown of its estimated $9-10 billion investment. Industry analyst Brian Tanquilut, a health care services equity research analyst at Jefferies, estimated to Crain’s that VillageMD lost $800 million in 2023.

Jim Murray retired as Centene’s chief transformation officer on 29 March, just in time to move to VillageMD.  His planned retirement was announced by Centene last May. Previously, he had been president and chief operating officer at Magellan Health from January 2020 to its acquisition by Centene in January 2022. Subsequently, Centene sold parts of Magellan such as Specialty Health and Rx. His experience crosses both provider and payer, at Dallas-based PrimeWest Health, the Dallas-based hospital system LifeCare Health Partners, and prior to that, 28 years at Humana, departing as chief operating officer. It does show one how close the circles are at the C-level. St. Louis Today

News roundup: Now Clover Health faces delisting; BlackCat/ALPHV affiliate with 4TB of data puts it up for sale; $58M for Biolinq’s ‘smallest blood glucose biosensor’

April 10, 2024 | by

Clover Health takes another pass at Nasdaq delisting. Once again, Clover’s Class A shares (CLOV) have been trading with an average closing price of below $1.00 over a consecutive 30 trading-day period, which violates Nasdaq’s continued listing minimum price criteria for the Nasdaq Global Select Market. This was announced in their most recent 8-K filed with the SEC 2 April. Clover has until 30 September to remedy the situation. An additional 180-day period may be elected if Clover transfers to the Nasdaq Capital Market. FierceHealthcare, Becker’s

The delisting is a rerun of their situation last year at this time. Clover considered a reverse stock split to be approved by shareholders but the share price improved on its own and the action was not necessary. This year, it may be. Clover is currently trading at $0.7365. Last August, it hit a high of $1.55 before sliding to below $1.00. An example of a SPAC through Social Capital Hedosophia Holdings, it hit a high of over $15 on 8 January 2021 before cracking that year based on revelations that Clover did not reveal a Department of Justice investigation starting the prior year, which prompted an SEC investigation [TTA 9 Feb 2021], triggering seven shareholder lawsuits that were not settled until December 2023. Clover Health exited the advanced value-based primary care program, ACO REACH, at the end of the 2023 performance year after two years to focus on their Medicare Advantage and Clover Assistant businesses [TTA 6 Dec 2023]. Financially, Clover closed 2023 with revenue of $2.033 billion (down from 2022’s $3.5 billion), net loss of $213.4 million, and an adjusted EBITDA loss of $44.7 million, with the losses improved over 2022. Clover release 

As predicted, 4TB of Change Healthcare data is up for sale. In a typical ransomwareiste move, the affiliate making nasty comments about BlackCat/ALPHV and claiming it had 4TB of data now has put the specs out on a dark web site called Ransomhub. The post first accuses ALPHV of stealing the $22 million ransom paid by UnitedHealth Group and not sharing it with the affiliate. It then claims it has highly sensitive data from multiple Change customers including active military PII (from Tricare), patient PII, payment and claims data, and much more. If Change/UHG isn’t interested, it will be up for sale to the highest bidder. Readers will recall the claims of ‘notchy’ early in the Change Healthcare attack [TTA 7 Mar] though UHG has not confirmed any payment to ALPHV. The demand for payment for the 4TB of data that ‘notchy’ claimed to possess was hardly unexpected. DataBreaches.net

A non-invasive “smallest ever” transdermal biosensor in development may turn the CGM business upside down. Biolinq’s latest round of $58 million will fund a pivotal clinical trial and FDA submission of its intradermal glucose sensor. The funding was led by Alpha Wave Ventures, with participation from Niterra’s corporate venture capital fund jointly operated with Pegasus Tech Ventures and existing investors RiverVest Venture Partners, AXA IM Alts, Global Health Investment Corporation, and four others, for a total since 2014 of $254 million. Crunchbase Current blood glucose sensors penetrate the skin with tiny needles. The Biolinq biosensor uses electrochemical sensors to measure glucose levels from the intradermal space just beneath the surface of the skin, on top of the capillary layer avoiding scarring. To access the intradermal layer, the sensors must be “200 times smaller than a human hair filament” according to Biolinq CEO Rich Yang. It also can combine blood glucose information with relative levels of activity in one device to eventually measure other analytes. The device as currently designed displays key information directly on the sensor–yellow light for high blood glucose, blue for normal. Release, MedCityNews

Opinion: Further thoughts on Teladoc, Amwell, and the future of telehealth–what happens next?

April 9, 2024 | by

The end of last week marked an Apocalypse Light in telehealth, but it was coming in this Editor’s opinion. And Pepper the Robot has nothing to do with it, other than representing telehealth’s state, and perhaps this Editor’s.

Two events–the forced exit of 15-year CEO Jason Gorevic from Teladoc and both Teladoc’s and Amwell’s continued market weakness and long roads to breakeven, if ever–have caused many in the field to think hard about our direction and where telehealth is going.

Both Teladoc and Amwell are the pioneers in provider-to-patient telehealth, going back over 20 years. While Amwell is no longer the #2 to Teladoc’s #1, both were in the forefront of how remote consults have transformed healthcare. The ability to remotely diagnose and provide care at distance is now a ‘given’ that has shifted the baseline for providers, patients, and payers. Nearly every entrant has or has acquired a remote in-person or app feature, whether care management, diagnostics, health education, or telemental health.

Because Teladoc’s struggles are writ large in the industry, we might benefit from a closer look at What Happened–and what in this Editor’s opinion might happen next.

What Happened?

The pandemic. Yes, it provided a major boost to any telehealth provider’s business whether corporate or provider-based. It mainstreamed telehealth. Smaller players like MDLive and Included Health snatched market share. But it also introduced ‘silly money’ that led companies to think that all they had to do was hold out the buckets, fill them with cash, and buy business. By late 2020, practices had reopened–and telehealth usage nosedived quickly, stabilizing to around 5% of medical claims, over 60% of which is mental health according to the FAIR Health end of 2023 telehealth tracker. 

The integration of telehealth into multiple platforms is now commonplace. This Editor observed in her work with her then-employer in early 2020 that the population health platform they had introduced already had integrated HIPAA-compliant telehealth platforms as a module–all that was needed to get the practices up and running on it–and coding correctly. Health systems now integrate telehealth into their patient portals. EHRs even for the small practice market now have integrated telehealth. As mentioned, specialized telehealth such as telemental health took off during the pandemic and, after a cleanout period, have largely stayed with us. Asynchronous telehealth has also become acceptable to consumers. (Interestingly, the leading asynchronous diagnoses are for hypertension and respiratory diseases that benefit companies like Amazon Clinic and triage-type systems.)

People use it when needed, but the enterprise payment model is subscriber-based. Teladoc has long claimed its subscriber base is 90 million people–but user data from HHS (ASPE 3/2023) indicates that only one of four use it. For an enterprise, paying for subscribers, this is a big fat line item ready to cut. Payers have also integrated telehealth into their coverage. Teladoc has, to its credit, created payer partnerships such as with Aetna, but so have others.

Bottom line: there’s no more ‘blue water’ market left for a big player like Teladoc with a model dependent on growth and on enterprise sales that are inherently price-driven. It’s a hard and painful change to realize that your technology is no longer the future, and that you have to slug it out in the mud with everyone else. 

A closer look at Teladoc. 

After 20 years, why wasn’t it profitable? A look back on our Teladoc coverage prior to the pandemic indicated growth was created by buying up smaller competitors, domestic and international, at premium prices. InTouch Health was a notable one, acquired January 2020 for $600 million. But Teladoc was way overdue on turning a profit before 2020, at which point it should have firmly moved into the black. And then reality hit by early 2022.

Where was the board in all this? This Editor does not pretend to know the minds of those far more experienced in the financial aspect of business than she. But after 15 years of CEO Jason Gorevic and the 2022 $6.6 billion write-down of Livongo which precipitated the long 90%+ loss in market value slide, why was he given walking papers only last Friday? Boards are supposed to be wise heads, looking out for the business and the shareholders. Did they get caught in the hype or hope that BetterHelp would save the company? Did something else happen? (Fun fact: Mr. Gorevic remains on the board.)

A track record of flawed judgment and recovery. In December 2018, their COO/CFO was dismissed after charges of insider trading and sexual misconduct. There have been two COOs since then, the first, David Sides, moving to CEO of NextGen Healthcare in 2021. In May 2019, Teladoc’s NCQA accreditation, first won in 2013, was placed under an unusual “corrective action” by NCQA which was termed by the CEO ‘much ado about nothing’. Au contraire, it was a black eye at the time and the industry never quite knew what happened. And then there was Livongo….

The Livongo deal killed Teladoc; saying the quiet part out loud. As this Editor stated at the time, the $18.5 billion purchase price of Livongo was dangerous for Teladoc (see ‘Gimlet Eyes’ from August 2020 here and here). It was a too-fast too-much too-soon deal that closed in three months at the summer peak of the pandemic and lockdowns looking like forever. The very notion that Livongo would open doors in hospitals and cross-selling to enterprises was suspect even at the time. The deal that Gorevic and 7WireVentures’ Glen Tullman and Livongo CEO Zane Burke concocted was ‘Grand Theft Auto’–for Livongo and their leadership, especially if they sold their Teladoc shares. It was never a merger of equals nor was it additive in value. Teladoc then made multiple, continuing transitioning and management errors, including not retaining Livongo executives, which have been well documented. And again–where was the board on this?

Where are the analysts? They seem to accept a storyline that ‘all is OK’ for 2024 now that Gorevic is gone. But standing pat on the Q1 and 2024 guidance as nearly all have done is suspect. Unlike Amwell, Teladoc has not forecast when it will achieve breakeven, much less profitability.

What’s Next? Given all the above, when will the aftershocks hit? Sooner or later?

If one looks to Walgreens as an example, where disaster hit quickly and hard last summer, a board member, Ginger Graham, took the acting CEO position. She took front and center on investor calls and executing reorganizations, which for an interim is unusual. Almost immediately, the cleanout began at the CIO and CFO levels and moved downward. Tim Wentworth joined as CEO in mid-October 2023 seven weeks after Roz Brewer was separated. VillageMD was identified quickly as a large part of the problem. He took the writedown even before locations were fully closed and made multiple moves to cut costs starting at the corporate level before moving into the field. This is not to make light of the human damage and the jury remains out on the wisdom of some of the moves. But Wentworth has moved quickly, decisively, and positioned it realistically in saying ‘this is not a 12-month turnaround’ and wisely caveating that board alignment around the strategic review was essential. Timid he is not.

Teladoc needs to move quickly, and intelligently–now, not later. While acting CEO Mala Murthy, backed by the board, makes decisive moves, Teladoc must find and appoint a Tim Wentworth-type at the helm for the turnaround. Quickly. It’s important not only for Teladoc but also for the telehealth industry.  But neither Mr. Market, judging on share price, nor this Editor, based on their track record, are hopeful.

News roundup: Amwell faces NYSE delisting; Walmart Health slows Health Centers, except Texas; Novosound’s ultrasound patent; Eko’s Low EF AI; Universal Brain; Elizabeth Holmes in ‘Dropout’ + update

April 5, 2024 | by

Amwell on a six-month NYSE notice to get stock price above $1.  Telehealth provider Amwell received an NYSE notice on 2 April that their Class A stock, in having an average closing price of below $1.00 over a consecutive 30 trading-day period, violated NYSE’s continued listing minimum price criteria. It dipped below $1.00 on 12 March and stayed there. The stock will not be delisted at this time and is now in a six-month ‘cure period’. Amwell has already confirmed its intent to cure the deficiency, including proposing at its upcoming 2024 annual meeting a reverse stock split, subject to stockholder and board of directors approval. Amwell (AMWL) closing price today was $0.72 which represents a 65% decline over the prior year. Amwell is largely owned by institutional shareholders–289–holding 149.2 million shares (Fintel). Amwell IPO’d in the palmy days for telehealth in September 2020, raising $742 million at the time with shares debuting over $25 [TTA 18 Sept 2020]. Amwell’s 2023 was as hard pressed as rival Teladoc’s with a $679 million net loss in 2023, up 150% from 2022’s $272 million loss. The 2024 is not much sunnier, 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. Amwell has also released 10% of staff since 2023. Eh, have times changed? Amwell release, Healthcare Dive

Walmart Health pressing the brakes on its Health Centers, concentrating on Texas. Walmart, generally superb at reading the weather, has decided to slow down openings of its primary and urgent care centers, located only in Walmart Supercenters. The previous plan was to open 30 or more centers in 2024, reduced now to 22. 18 of these will be in Texas: eight in the Houston metro starting this month and 10 in the Dallas/Fort Worth region. The remaining four will be in the Kansas City metro. The Health Centers target patients with no or poor insurance coverage in underserved areas and offer a range of services including labs, X-rays, and dental care. The goal of 75 centers has moved forward to early 2025. Healthcare Dive, Drug Store News

A potpourri of news around smaller companies and innovations:

Scotland’s Novosound has patented a wearable, WiFi-enabled ultrasound digital platform, its 21st. The Slanj (phonetic for sláinte, meaning health in Scottish Gaelic) uses thin film printed gel-free, disposable high-resolution sensors to be integrated into other wearables such as smartwatches and other monitors. Novosound’s patent covers both the US and UK. In 2022, they inked a commercial partnership with diagnostics and digital health company PAVmed Inc. for intravascular imaging. Novosound was the first spinoff from the University of the West of Scotland. Mobihealthnews

Also in cardiac, the FDA cleared Eko Health’s Low EF detection AI. This enables a provider to quickly diagnose Low EF (ejection fraction) in a physical exam to assess possible heart failure. The Eko stethoscope and module connects to a tablet and provides a reading within 15 seconds. Trained on a proprietary dataset of over 100,000 ECGs and echocardiogram pairs from unique patients, clinically validated in a multi-site, prospective clinical study of 3,456 patients, it requires only a minimum of specialized training as part of the SENSORA Cardiac Early Detection Platform that can be used just about anywhere. The Eko Low EF was developed in conjunction with the Mayo Clinic. Eko release, MedCityNews

Universal Brain, which has developed a range of wearables that measure brain activity, named three new executives:  Greg Hajcak, PhD, as tChief Scientific Advisor, Vangelis Lympouridis, PhD as Chief Product Officer, and K.T. Venkateswara-Rao, PhD, as Head of Operations. For psychiatric clinical drug trials and psychiatric diagnosis, there is an EEG wearable paired with a digital ERP interface, Neurotique. They also developed a patient neurofeedback treatment system (EEG wearable + digital therapeutic) to augment standard treatment by providing real-time feedback for depressive symptoms.  Release

And for UK Readers weekend viewing pleasure in the UK, the Elizabeth Holmes biopic, ‘The Dropout’ is now available on BBC iPlayer. Hulu produced and originally aired the eight-episode series in March of 2022 (our review here). Hat tip to Editor Emeritus Steve. For US Readers, it is still available on Hulu. Or if you have a VPN, you can set it to a UK-based server and sign up for BBC iPlayer. The only recent (January) news about Ms. Holmes is that the Department of Health and Human Services (HHS) Office of Inspector General (OIG) banned her and Sunny Balwani from all Federal health programs for 90 years, which does strike one as overkill as beyond their reasonable lifetimes. Ars Technica

Based on a Reddit posting on a pop culture chat, celeb Jen Shah, also at FPC Bryan, and Holmes were snapped ‘hanging out’ in the yard. Shah was convicted of heading a telemarketing financial scam that preyed on the elderly. She is serving 78 months in Federal prison and has to pay $6.6 million in restitution–numbers that could fit easily in Holmes’ 135-month sentence and $452 million restitution. And Sunny Balwani, about whom there are no pictures, no Reddit, is apparently still serving his time at Terminal Island near San Pedro, California, not in Atlanta.

Teladoc CEO Jason Gorevic steps down immediately in shock announcement

April 5, 2024 | by

Teladoc Health announced this morning the immediate departure of CEO Jason Gorevic. The release from Teladoc hit the wires at 6:30am Eastern Daylight Time. Chief financial officer Mala Murthy has taken the CEO position on an interim basis while the board of directors conducts an executive search for a permanent replacement. She will retain CFO responsibilities during the search.

From LinkedIn: Ms. Murthy has been with Teladoc since June of 2019, joining as CFO from seven years at American Express as CFO of their Global Commercial Services segment. Previously she was with Pepsico. 

The industry for some time anticipated Mr. Gorevic’s departure after 15 years due to Teladoc’s lackluster 2023 and a dismal forecast for 2024. Teladoc never really recovered from a disastrous 2020 $18.5 billion acquisition of Livongo engineered by Mr. Gorevic with Glen Tullman, followed by its 2022 $6.6 billion writedown. The share price never really recovered, reaching a high over $293 in February 2021 but eroding quickly after that. It currently languishes at below $15, losing 34% YTD and 95% since 2021. The crash in Teladoc’s value as the pandemic closures of practices resolved was replicated by other telehealth companies such as Amwell, MDLIVE, Included, and most others. But the picture didn’t seem to be clearing. Telemental health provider BetterHelp, which last year was touted as the company’s salvation, wasn’t, falling flat in 2023 revenue. Teladoc’s 2024 forecast was downbeat as well [TTA 22 Feb], but management in the announcement reinforced that they are standing pat on their Q1 and full year 2024 financial guidance.

The usual anodyne statements followed. “We thank Jason for his many achievements and contributions during the 15 years he led Teladoc Health. We wish him success in his future endeavors,” said David B. Snow, Jr., Chairman of the Teladoc Health Board of Directors. To CNBC, Mr. Gorevic said, “I am proud of the impact we’ve made on the healthcare system, and our many accomplishments in advancing innovation and transforming virtual health care from an unrealized promise into a valued reality for our 90 million members.” 

The impression left by Teladoc from press and related news articles, as well as by analysts, was this move was sudden. The precipitating action to remove Mr. Gorevic is yet to be revealed. The release was timed for the usual pro forma Friday, but the morning timing was designed for the markets to lift the stock in week-end trading. Teladoc’s financials have been hammered for the past two years, but no differently than its now extensive competition, with health systems and practices now incorporating telehealth and virtual health software. Another confirmation that this was a sudden move: a quick view of the Teladoc website at 12.30 ET was that Mr. Gorevic was still listed as the CEO; this changed with a second view at 1pm. To be continued…  FierceHealthcare, Axios, HealthcareDive

More New Reality: NeueHealth (Bright Health) CEO’s $1.9M bonus (updated), 2023 financials–and does Cano Health have a future?

April 5, 2024 | by

After 2023, how did NeueHealth’s CEO earn a bonus of $1.90, much less $1.9 million? As our Readers know from our last episode of ‘Facing the Music of the New Reality’ [TTA 14 Feb, 24 Jan], Bright Health Group at the top of 2024 rebranded with the oh-so-chic name of its value-based care medical practice division, moving its HQ from poky, cold, failing Minneapolis to Doral, Florida. All its health plans, launched some years back in a blaze of flashes, either were sold (Medicare Advantage to Molina) or collapsed in a heap of losses. Aside from owing money to Texas ($85 million) on ACA plans, Neue owes mucho money to the Center for Medicare and Medicaid Services on Repayment Agreements, reportedly around $400 million, due on or before 14 March 2025. But in a masterful move, using the Molina money to keep the investors at bay, NeueHealth has managed to pay off JP Morgan for a credit line, dodge all the bill collectors–and award its CEO Mike Mikan a $1.9 million bonus, up from $1.69 million in 2022. Now, like some other of the C-suite, Mr. Mikan took most of his 2023 compensation of $9.9 million in stock-based pay, most of which is (glub glub) underwater. But one has to wonder about a board of directors, including major investor New Enterprise Associates, that would reward Mr. Mikan for steering Bright Health into a brick wall, even if it came out the other side as Neue. And Neue still needs funding to continue as a going concern this year (see page 12 (page 18 of PDF) of their March 10-K). AOL News, Ari Gottleib on LinkedIn, FierceHealthcare 4 April update  Cash bonuses of $875,000 were paid to CFO Jay Matushak and Executive Vice President of Consumer Care Tomas Orozco.

Another surprise in their 10-K is on pages 115-116 of the document (PDF pages 121-122) of a ‘material weakness’ in their financial reporting that has existed since 2022, not remediated in 2023, but is planned to be remediated in 2024. “Our disclosure controls and procedures were not effective due to a material weakness in our internal control over financial reporting”.

Their Q4 and 2023 financials reported in March were also underwater, with net losses of $62.8 million for the quarter and $627.7 million for the year, with an adjusted EBITDA loss of $8.5 million. But for 2024, they present a bright (ahem) picture for NeueHealth’s two divisions: NeueCare (owned clinics and partnerships with affiliated providers) and NeueSolutions, a management services entity that organizes independent providers and physician groups into performance-based ACA Marketplace, Medicare, and Medicaid-based ACO models, including the advanced performance ACO REACH program. Projected revenue is $1 billion and adjusted EBITDA between $15 million and $25 million. NeueHealth release, FierceHealthcare 

Perhaps investors New Enterprise Association ($1 billion in) and CalSTRS are letting their chips ride on what most could see as a losing number–what is the alternative? At the risk of repeating myself, they’ve managed to play multiple ends against the middle and tie masterful Gordian knots (pick your analogy) around CMS and their investors, hoping to stay alive until 2025 and better times. Or, as Ari Gottlieb speculates, NeueHealth may file a Chapter 11 before the CMS payments are due in March 2025. And then what?

This Editor also notes that former GE CEO Jeff Immelt is on Neue’s BOD and is a venture partner in NEA. The late ‘Neutron Jack’ Welch was once heard to regret naming Mr. Immelt as his successor, given that once-mighty GE is now split into three relatively small companies after maximum losses and management turmoil at legacy GE.

(5 March updates in red) 

After a disastrous 2023, does Cano Health even have a future? The telenovela is not fin, but little has been heard from Cano since it entered Chapter 11 bankruptcy on 4 February. A 26 February story in local Florida news, the Sun-Sentinel, has a few updates:

  • Cano’s goal is to exit Chapter 11 by the end of Q2 (June)
  • Class A shareholders, who accepted a 1 to 100 reverse share split in December 2023, will be left with no value–including the ‘Cano 3’ of Barry Sternlicht, Elliot Cooperstone, and Lewis Gold who owned 35% of the shares.
  • They have $150 million in operating cash until then
  • In the reorganization, they have two tracks: continue as an independent company or sell
  • The focus will be on core operations, including Florida Medicare Advantage
  • They plan to close 80 locations. Their filing contains 72 ‘dark leases’ mainly in Florida. Cano has 95 medical centers operating in Florida so it is not clear whether the closures take into account the dark leases.

Cano is now operating in Florida only, having offloaded or closed operations in Texas, Nevada, California, New Mexico, Illinois, and Puerto Rico. According to the filing, they currently employ 3,000 people, including 2,800 full-time staffers including executives, clinical, and administrative staffers, including 300 doctors, nurses, and physician assistants. In addition, Cano has affiliate relationships with approximately 630 provider practices. 

If you wonder what happened to Cano’s former CEO….founder and former CEO Marlow Hernandez, with two other Cano former executives, started a new company called Soran Health based in Hollywood/Miramar, Florida. It provides patient and medical management services including care delivery systems.  Dr. Hernandez and the other former Cano executives were sued in January by Cano for allegedly breaching their non-compete agreements and taking proprietary information. While they have a website and a LinkedIn page, they are remarkably content-less, but listed by CMS as a group practice.

ATA requests expediting of revised proposed rule on controlled substance telehealth prescribing; announces Nexus 2024 meeting 5-7 May

April 4, 2024 | by

ATA and 200 organizations request from DEA a revised proposed rule on controlled substance teleprescribing–stat. The American Telemedicine Association (ATA), in a 2 April letter (PDF link) with over 200 signatories, requests that the DEA quickly issue a revised proposed rule for industry comment.

Last October, the Drug Enforcement Administration (DEA) and Health and Human Services (HHS) extended for the second time pandemic flexibilities for prescribing controlled substances through 2024. The proposed rule issued in May had 38,000 comments, which overwhelmed DEA and HHS. The two agencies were unable to come up with a revised proposed rule by end of year and punted to 2024. The final rule is scheduled to be issued by this fall.

The 2 April letter advocates continuing many of the pandemic flexibilities due to care shortages and disruptions to patient care. If DEA were to create a special registration process for telehealth prescribers as many have proposed, transitioning and training would be needed to minimize disruptions in care to providers and patients in time for the new rule to take effect in 2025.

The controversy is around permitting and regulating the prescribing of controlled substances through telehealth. The pandemic rules suspended the Ryan-Haight Act restrictions that required in-person evaluations/visits prior to prescribing. Legally, that cannot continue. The extension of pandemic flexibilities permitted clinicians to prescribe Schedule II–V controlled medications via audio-video telemedicine encounters, including Schedule III–V narcotic controlled medications approved by the Food and Drug Administration (FDA) for maintenance and withdrawal management treatment of opioid use disorder. ATA release   HealthcareDive 4 April

ATA is also resuming an in-person spring conference, Nexus 2024, 5-7 May, at the Phoenix Convention Center in Arizona. It will have 300 speakers on 30+ topics. The meeting is being pitched to primarily care delivery and provider organizations. An overview of the conference is in the ATA release. More content information here (PDF link). Online registration (attendee and exhibitor) or email AmericanTelemedicine@​xpressreg.net

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

April 4, 2024 | by

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

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

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

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

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

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

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

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

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

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

Perspectives: Working with a PR Agency–How to Make the Most of the Partnership

April 3, 2024 | by

TTA has an open invitation to industry leaders to contribute to our Perspectives non-promotional opinion and thought leadership area. Today’s contribution is from Jodi Amendola, CEO of Amendola, a full-service PR and marketing agency that focuses on healthcare, health tech, and life sciences. Your Editor personally knows Amendola as a leading US agency representing many leading companies ably and well in both earned and paid media. In this article, Jodi explains some best practices in working with your PR and/or marketing agency–why their specialized skills in dealing with the media are necessary–and getting the most out of your mutual commitment.

After leading a public relations agency for nearly two decades, I’ve learned a few things.

From the right way to shape a client’s message to the best reporters and media outlets to target for exposure to crafting the proper talking points for interviews, PR can deliver real results to help clients achieve their growth objectives.

However, some of the most useful knowledge and experience PR professionals can acquire pertains to building successful and mutually beneficial relationships with clients.

While there is undoubtedly a lot of optimism when a PR agency signs a new client, a successful partnership requires more than enthusiasm and high hopes. Without a clear focus and realistic objectives, the relationship may never produce the anticipated benefits for either party.

To that end, here are some important tips on what clients should do to maximize return on investment and reach the strategic goals of their public relations partnerships.

It’s all about alignment: At the beginning of the engagement, ensure that both client and agency are fully aligned on goals and key performance indicators (KPIs). Specifically, those KPIs need to help the client accomplish its goals, not the agency’s.

Think long- and short-term from the beginning: Agencies can produce better results when clients are invested in the process. Within the first few weeks, set both short- and long-term objectives to enable better tracking of the client’s KPIs. Solicit a wide range of input to make sure everyone is on the same page.

Communicate openly and transparently: By engaging in open and transparent communication, the client-agency relationship gains trust around shared values. Agencies should help create a collaborative environment that enables honest sharing of expectations and concerns, a step that is essential to generating a long-lasting working relationship.

Share what makes you special: To place a client in the appropriate light for media, customers, and other stakeholders, it is critical that the agency develops a deep understanding of what makes the client’s business unique. When clients demonstrate what sets them apart from others in a (most likely) crowded market space, agencies can tell better stories that are more likely to break through the noise.

Listen: Remember why you hired a PR team in the first place. The PR agency likely possesses skill sets and a level of expertise in media relations and content that your internal team may lack (since they specialize in other things). That’s okay and a testament to your good judgment! Let your PR team do what you are paying them to do and listen to their advice.

One touchpoint: Clients should identify a dedicated liaison to act as a single touchpoint and centralized hub for all agency contacts. Ideally, this person should have some PR and marketing savvy and should be as interested in moving the needle as the agency is. Often, media requests need to be turned around within only a few hours, so designating a single contact can expedite connections when every minute matters.

Timely, effective PR can help companies access new employees, customers, markets, partners, and investors that they otherwise would not have attracted the attention of. Trust me, I’ve seen it happen time and time again. Follow the above steps when working with your PR firm, and it could happen to you, too!

Mid-week news roundup: US offers $10M for BlackCat/ALPHV info; most Change systems still down; Risant closes Geisinger buy; SureScripts exploring sale; DarioHealth 2023 revenue -23%; Amazon Pharmacy same-day delivery NYC and LA

April 3, 2024 | by

US State Department pays well for Big Breach information. Interestingly, this US agency through the Diplomatic Security Service has a special program, Rewards for Justice (RFJ), for cyberattacks that are deemed “malicious cyber activities against U.S. critical infrastructure in violation of the Computer Fraud and Abuse Act (CFAA)”. The activities of the now-disappeared (ha ha!) BlackCat/ALPHV  ransomware-as-a-service (RaaS) group, identified on 29 February as the culprits in the massive Change Healthcare/Optum system takedown, are now listed as qualifying for a reward, presumably as disruptive to US healthcare and not just UnitedHealth Group. Contact Rewards for Justice via the Tor-based tips-reporting channel at: he5dybnt7sr6cm32xt77pazmtm65flqy6irivtflruqfc5ep7eiodiad.onion (Tor browser required). That is, if you dare! Rewards for Justice release, Becker’s

Six weeks later, most Change services are still X-d on the Optum Solution Status page. A quick rundown of the hundred or so programs that Change provides to enterprises has a long line of Xs with some triangles containing ! (partial outage) or yellow boxes (degraded performance). The green checkmarks are clustered in high-priority areas such as pharmacy solutions and clinical decision support. Otherwise, they are scattered across categories. The summary on the top of page (dropdown) lists workarounds for specific programs such as batch processing and transitioning over to Optum systems unaffected by the attack. This Editor bets that most of these Change legacy systems will come back only partially if at all–many will be abandoned and replaced by Optum systems. Hat tip to HIStalk 29 March

Risant Health, the non-profit community hospital system founded by but separate from Kaiser Permanente, has closed its acquisition of Pennsylvania-based Geisinger Health as of 2 April.  Jaewon Ryu, MD, JD, currently Geisinger’s president and CEO, will move to CEO of Risant Health, with Terry Gilliland, MD, replacing him at Geisinger. The Risant plan announced last April is that Kaiser will fund $5 billion to Risant, which will acquire now four or five health systems over the next four to five years. The health systems will retain their names and operational areas. The purpose of Risant is to bring community systems it acquires greater access to capital, technology, and resources for facility improvements, innovation, and investment in patient care. Keeping an eye on 109-year-old Geisinger. Risant release

Mega e-prescription system Surescripts is exploring a sale. Silicon Valley investment bank TripleTree is handling the search for buyers. Currently, Surescripts is owned 50% by CVS Caremark and Cigna-owned Express Scripts, with two trade groups, the National Association of Community Pharmacies and the National Association of Chain Drug Stores, owning the other 50%. It isn’t disclosed in the Business Insider ‘reveal’ what group(s) is interested in selling all or part of its ownership. Since Surescripts holds 95% of the e-prescribing market, any buyer or investor would need be mega flush to buy into it. 

DarioHealth didn’t have a great 2023. Net revenue was down 23% versus 2022: $20.4 million to the prior year’s $27.7 million. The chronic condition management company managed to narrow its 2023 net loss of $59.4 million from $62.2 million in 2022. A lot of the problems seemed to center on their Q4, with net revenue that declined to $3.6 million from $6.8 million in Q4 2022 and a net loss that increased to $14.3 million from $12.6 million in Q4 2022.  Dario’s gross profits for 2023 were down 38% to $6 million, a decrease of 38% versus 2022’s $9.7 million. The changing financial picture was attributed to a new private label platform with Aetna launching in 2024, changing from a B2C to a B2B2C model, and February’s “transformational acquisition” of Twill (Happify) in telemental health. As this Editor noted then, it was a feat of funding legerdemain that rivaled a Frank Lorenzo deregulation-era airline acquisition. Their information around 2023 earnings isn’t much different. Dario provides a combined app and in-person approach to musculoskeletal (MSK) therapy, diabetes (including GLP-1 drugs), hypertension, weight management, and behavioral health. Mobihealthnews, Dario release

And speaking of pharmacy, Amazon Pharmacy expanded same-day medication-delivery offerings to NYC residents and the greater Los Angeles area. This adds to same-day prescription delivery available in Phoenix, Austin, Seattle, Indianapolis, Miami, and Texas, including free drone delivery in College Station. How it works: Amazon has small facilities and pharmacists near the areas, ready to fill and deliver medications in minutes using genAI and machine learning tools. Delivery in NYC/Manhattan will be by bike and in LA, electric vans or other commercial vehicles. (Editor’s note: bike delivery in the outer boroughs is like LA–impractical.) Amazon Prime members have additional benefits. Competition here are online companies like Mark Cuban Cost Plus and GoodRx’s prescription service. But perhaps it’s a good time to sell Surescripts? Mobihealthnews

Facing Future 2: Walgreens writes down $5.8B for VillageMD in Q2, lowers 2024 earnings on ‘challenging’ retail outlook

March 28, 2024 | by

Walgreens unsparing in FY 2024 Q2 results, affected by VillageMD closures, weak retail, and inflation. In a financial report released Thursday, remarkably devoid of happy talk, Walgreens Boots Alliance (WBA) presented a ‘picture adjustment’ that wrote down VillageMD’s losses even while locations are being closed. WBA also factored in for full year 2024 the ‘challenging retail environment in the US’ as well as the blurry picture of the US Healthcare division that includes VillageMD, Summit Health/CityMD, Shields Health Solutions (pharmacy), and CareCentrix (home care). 

For WBA in total, the first six months of their fiscal year, through 29 February 2024, reflected a tidy increase in sales: 8.1% from the year-ago period (7.2% in constant currency) to $73.8 billion. Operating loss was $13.2 billion, versus prior year/same period loss of $6 billion.

  • Most of the operating loss was attributable to VillageMD’s exits from Florida, Indiana, Chicago, Boston, Rhode Island, and Las Vegas. The total number of locations will be 140, not the earlier reports of 50 that grew to 85. Both were confirmed by a company spokesperson to Forbes.
  • Financially, the impact is a $12.4 billion non-cash impairment charge related to VillageMD goodwill, resulting in a $5.8 billion charge attributable to WBA, net of tax and non-controlling interest.
  • The six-month net loss: $6.0 billion versus $3.0 billion in prior year/same period, again taking into account non-cash impairment charges.
  • This totals to a loss per share of $6.93 compared to loss per share of $3.50 in prior year/same period.

As noted earlier, this Editor’s math is that Walgreens in the US sank close to $10 billion in VillageMD including their minority then majority interest, plus subsidizing their purchase of Summit Health. This write-off is well over half. The fact that the write-off of closing markets, locations, and goodwill is not being delayed past the fiscal mid-year is aggressive. Contrast this to Teladoc, which waited a full year to write down Livongo.

US Healthcare as a whole for Q2 rose 33.2% in sales, narrowed operating loss to $34 million versus last year’s $159 million, and came up positive in EBITDA with $17 million, a $127 million increase versus the same quarter prior year. For the full year, WBA is projecting a breakeven of plus/minus $50 million.

Retail sales continued to weaken, with a 4.5% decrease for the quarter ending 29 February. Comparable retail sales decreased 4.3% versus same quarter in prior year. Pharmacy sales were higher, driven partially by higher drug costs, with a 8.7% rise.

Rounding out the picture, for the full year, WBA’s earnings per share guidance lowered to $3.20 to $3.35.  WBA earnings release, FierceHealthcare,CNBC    CEO Tim Wentworth will have an interesting next six months to turn this ship around.

Short takes: PocketHealth, Brightside fundings; VA OIG reports hit Oracle Cerner; Change cyberattack/legal updates; UHG-Amedisys reviewed in Oregon; Optum to buy Steward Health practices

March 28, 2024 | by

It’s a relatively quiet week before the Easter holiday, with a few fundings, more drama at the VA around Oracle Cerner, updating Change Healthcare’s comeback, and the continuing scrutiny around UnitedHealth’s acquisitions:

PocketHealth garners a US$33 million Series B. The Toronto-based company markets an AI-assisted platform to health systems and providers that allows patients to access their medical imaging and reports as well as for providers to easily share imaging information. The funding was an all-equity round by Round13 Capital with participation from Deloitte Ventures, Samsung Next, and existing investors Questa Capital and Radical Ventures to bring total funding since 2020 to $55.5 million. The fresh funding will be used to grow further within the US and Canada and develop new platform functions. Patients have access to three platforms:  Report Reader to explain medical terms in the patient’s report, Follow-Up Navigator for follow-up imaging recommendations, and MyCare Navigator to equip patients with relevant, personalized questions to ask their doctor. The platform is available in 775 hospitals and imaging centers across North America and is used by more than 1.5 million patients.  PocketHealth release, Mobihealthnews

Brightside Health moves to a Series C of $33 million. This round for the telemental health company was led by S32, along with Kennedy Lewis, Time BioVentures, and Anne Wojcicki (Redwood Pacific) with existing investors ACME, Mousse Partners, and Triventures. Total funding since 2018 is $114 million. Brightside provides telemental health through payers in 50 states such as CareOregon, Blue Cross and Blue Shield of Texas, and Centene. The new funding will be used to expand into the usual new markets and offerings. Trip Hofer, who was former CEO of Optum Behavioral Health Solutions and now with .406 Ventures, will join the Brightside board of directors. Their most recent moves are expansion into Medicare and Medicaid programs for psychiatry, therapy, and their Crisis Care program for individuals with elevated suicide risk. Release

The Department of Veterans Affairs Office of Inspector General (OIG) released three reports last Thursday (20-21 March) that were sharply critical of the new Oracle Cerner EHR. While Oracle Cerner Millenium operates in only five VA locations, not including the joint MHS/Genesis Lovell FHCC, each one has been problematic from training to implementation–and are on hold. The OIG reports available here on the Electronic Health Records Modernization (EHRM) are scathing on the EHR’s scheduling and pharmacy features leading to patient safety and staff usability issues.

  • At VA Central Ohio Healthcare System (facility) in Columbus and elsewhere, this led to inaccurate medication and allergy information transmission from new EHR sites to legacy EHR sites that staff and pharmacists had to work around to provide adequate safety checks.
  • Also at VA Central Ohio, the Cerner EHR system error in 2022 led to a patient’s missed appointment since it was not routed to a queue to prompt rescheduling efforts. Subsequently, a nurse practitioner never evaluated the medication refill request, nor did a psychologist evaluate mental status and critical clinical information. The veteran patient died by accidental overdose approximately seven weeks after that missed appointment.
  • Regarding future implementations, the OIG was specific on what had to be fixed on both: “These concerns include the need for additional staffing and overtime to meet or exceed pre-deployment appointment levels, displaced appointment queue functionality, challenges related to providers and schedulers sharing information, inaccurate patient information, difficulties changing appointment type, and the inability to automatically mail appointment reminder letters. At facilities currently relying on the EHR, these issues have resulted in inconsistent workarounds and additional work, increasing the risk for scheduling errors.” 

Healthcare IT News, Healthcare Dive, EHR Intelligence, TTA 22 Feb

Change Healthcare’s systems are gradually returning. Since our last update on 14 March, UnitedHealth Group confirmed that 99% of pharmacy network services were up and running–and that they have fronted $2 billion to providers. Separately, they launched workaround software for medical claims preparation.

  • On 15 March, the electronic payments platform was restored.
  • On 20 March, UHG restored Amazon Web Services. It was backed up from Assurance, a claims and remittance management program, and claims clearinghouse Relay Exchange.
  • Relay Exchange went back online by 24 March to begin processing $14 billion in medical claims.

But on the legal and Federal fronts, UHG will be keeping its legal department busy. Starting the week of 11 March, the first class action lawsuit was filed by a women’s health practice in Albany, MS–Advanced Obstetrics & Gynecology PC. Another class action suit was filed on 18 March by Gibbs Law Group on behalf of providers to be named. Patients who have had compromised PII and PHI will be next from the 4 or 6 terabytes of payer information held by ‘notchy’ and other affiliates from the BlackCat/ALPHV masterminded attack as this is confirmed. Expect these to multiply like weeds in May. HIPAA Journal  And the American Hospital Association, Senators and House Representatives are jumping all over Health and Human Services (HHS) to ensure that payments are made to Medicare, Medicaid, and Medicare Advantage plans–as well as calls for investigating UnitedHealth. Becker’s, FierceHealthcare

As expected, UHG’s acquisition of Amedisys home health is running into more opposition at the state level. In this case, it’s the Oregon Health Authority (OHA) that will be conducting a full review. The Department of Justice (DOJ) has been investigating the acquisition on antitrust grounds almost since it was announced in June 2023. Shareholders approved the $3.3 billion buy the following September, but it has not closed. UHG’s plan is to merge it into Optum’s home health providers Contessa Health and LHG Group, creating a home health juggernaut. As noted earlier this month when DOJ announced a further antitrust probe of UHG around the UnitedHealth plan relationships with Optum services, “DOJ has a long memory, a Paul Bunyan-sized ax to grind, and doesn’t like losing. One wonders if now UHG has buyer’s remorse after fighting for two years to buy Change.” (And winning versus DOJ!) Fierce Healthcare

Yet UHG goes on buying providers, DOJ scrutiny or not. Optum is bidding for Steward Health Care’s Stewardship Health practices over nine states. For-profit Steward, headquartered in Dallas, needs to raise funds as it is in debt overall and facing major problems in Massachusetts, with several hospitals at risk of closure. In any case, the company wants to exit the state. A purchase price was not announced. The transaction is under review by Massachusetts’ Health Policy Commission (HPC) over the next 30 days. The Stewardship transaction would add to OptumCare’s total of 90,000 physicians–10% of US physicians, a number that is raising red flags on the state and Federal levels. FierceHealthcare, WBUR

Can digital health RPM achieve meaningful change with type 2 diabetics? New metastudy expresses doubt.

March 27, 2024 | by

A metastudy from the Peterson Health Technology Institute (PHTI) has reservations about the efficacy of digital diabetes management tools. Over $50 billion has been invested in the sector between development, investments, mergers, and acquisitions. Generally, the claim around digital management tools for diabetes to aid self-management and prevent poor outcomes, particularly for those at high risk, has been that they can 1) deliver meaningful and lasting clinical benefits in reduction of HbA1c (glycemic control) and 2) reduce long-term costs of poor control, benefiting patients. In the US, diabetes affects 11% of the population and is an expensive chronic condition. It also disproportionately affects people of color and those with lower income, especially as they age.

The systematic literature review of 1,100-plus studies was augmented by interviews with physicians, patients, digital health experts, along with companies. They included 120 clinical references from DarioHealth, Omada, and Virta. The PHTI grouped digital tools into three types of solutions for Type 2 diabetes in adults. All used standard glucometers, not continuous glucose monitors/CGM as well as apps to provide real time feedback to a virtual or actual coach or care team:

  1. Remote patient monitoring (glucometer plus feedback): Glooko
  2. Behavior/Lifestyle modification (glycemic feedback plus coaching features): DarioHealth, Omada Health, Perry Health, Teladoc (Livongo), Verily (Onduo), and Vida
  3. Nutritional ketosis (dietary guidance that restricts carbohydrates and monitors the patient’s glycemic and ketone levels): Virta Health

The findings did not meet their expectations in demonstrating “clear, substantial, and durable progress toward glycemic control in people with type 2 diabetes, resulting in a lower prevalence of uncontrolled type 2 diabetes across the population.”

  • They did not deliver clinically meaningful benefits compared to ‘usual care’. Only three out of 10 comparative HbA1C studies achieved a meaningful difference of 0.5 percentage points (Minimal Clinically Important Difference or MCID) in patients. Their range was 0.23 to 0.60 percentage points compared to usual care.  The nutritional ketosis program had greater benefits as long as patients maintained the rigorous requirements of the therapeutic regimen.
  • The average price impact of the solution exceeds the savings achieved from the clinical benefits. The PHTI analysis looked at commercial insurance, Medicare, and Medicaid over three years. Provider reimbursement and pricing exceed cost savings from avoided care.

So where is the worth? The PHTI study recommended that:

  • Payers use these solutions for the highest risk and diverse/underserved populations
  • Regularly analyzing outcomes and tie contracts to clinical performance
  • Focus on patients with higher starting HbA1c newly starting insulin
  • Payers could also recommend nutritional ketosis as the Virta program had greater benefits.
  • Solutions could also evolve to include GLP-1 drugs, CGMs, and nutritional ketosis.

PHTI study (free download of full report, four sections, and appendices). PHTI press release.

PHTI is also offering a free webinar on Thursday 28 March at 2pm US Eastern Time on assessing digital diabetes management tools–registration here.

2023 US data breaches topped 171M records, up 187% versus 2022: Protenus Breach Barometer

March 22, 2024 | by

2023’s US healthcare data breaches hit an all time high, both in reported breaches and number of records affected. Protenus, which publishes an annual Breach Barometer, uses multiple data sources including Health and Human Services’ public breach tool. The numbers are shocking for both:

  • HHS 2023 reported 725 reports and about 135 million records
  • Protenus‘ numbers are significantly higher: 1,161 reports and 171,139,241 breached records. In 2022, the totals were respectively 1,138 reports affecting a total of 59,664,152 breached records. Breached records were up 187% in 2023.

The variance in reporting is due to factors including not knowing the true scope of the breach in reporting to HHS, state reports being incomplete, and business associate reports covering all or only some of their clients.

Also included in their report is a discussion on how HHS through the Office of Civil Rights (OCR) response to breaches contained in HHS’s 2022 annual report released last month. In investigating, they seem to prefer voluntary resolutions and corrective actions. Only three  resolution agreements with monetary penalties and corrective action plans were imposed.

The Protenus Breach Barometer report is available for free download here. DataBreaches.net collaborated with Protenus in the report.

Why is the US DOJ filing an antitrust lawsuit against Apple–on monopolizing the smartphone market?

March 22, 2024 | by

The Department of Justice’s antitrust filing against Apple on the iPhone is a many-splendored thing–and will take many years to work through the courts. It was filed Thursday 21 March in the US District Court for the District of New Jersey, alleging monopolization or attempted monopolization of smartphone markets in violation of Section 2 of the Sherman Act. New Jersey’s US District Courts are in beautiful Newark, Camden, and Trenton. The DOJ was joined by 16 states in the lawsuit including NJ. Apple has promised to fight it tooth and nail, correctly realizing this goes to the core of its business. “This lawsuit threatens who we are and the principles that set Apple products apart in fiercely competitive markets” and “We believe this lawsuit is wrong on the facts and the law, and we will vigorously defend against it.”

On the face of this, the DOJ antitrust lawsuit seems almost ludicrous. While iPhones have a 60% market share in the US (Backlinko), there’s plenty of Android phones from Samsung and others (sadly, no longer LG) at competitive prices from every carrier. This Editor never looked twice at an iPhone for personal use and wasn’t impressed by a short-lived company phone, a totally locked-down iPhone 6. (On the other hand, my second computer at work where I really self-learned computing was an easy-to-use Mac 2si, a long time ago.) There are about 140 million iPhone owners in the US. Obviously, Apple makes a product and ecosystem, including the Apple Watch, that people, especially US upper-income users, prefer. There are features that Androids have and iPhones have, and sometimes the twains don’t meet, but for most of us it doesn’t matter.

But does Apple act in an anticompetitive, monopolistic way?

The DOJ says yes. The complaint states that Apple uses its control over the iPhone to engage in a broad, sustained, and illegal course of conduct, using its monopoly power to extract as much revenue as possible. The specifics include some centering on the Apple Watch:

  • Apple has exclusive software features–apps–that Android manufacturers don’t have or don’t work as well, for instance Apple Pay, iMessage, Find My Phone, FaceTime, and AirTags.
  • Apple Pay blocks other financial institutions from instituting their own cross-platform payment systems.
  • Apple’s control over app developers in their ‘walled garden’, locking them in especially in the cloud gaming area, but generally imposing contractual restrictions on and withholding critical access from developers in the name of security and privacy. Reportedly there are 30% commissions on app sales. Blocking ‘super apps’ restricts not only developers but also users from switching to Android since they will lose use of the app.
  • Apple’s messaging systems are only partly interoperable with Android and have unique features not available on Android
  • App Store commissions and rules are prohibitive for many developers
  • Locking in consumers with features not available on Android
  • Lack of interoperability of the Apple Watch with Android phones, and other manufacturers’ watches with iPhones 

What is interesting is that in the Apple Watch charges, there’s nothing about how Apple has essentially stolen features from other developers such as AliveCor and Masimo as found in other Federal courts. That IP theft is outside of antitrust and being litigated in other courts.

Much of the heated commentary has to do with the Apple Brand Promise and how they deliver apps. Apple is an integrator and people like the ‘walled garden’. The phone ‘just works’. Quoting Alex Tabarrok in Marginal Revolution, Apple is a gatekeeper that promises its users greater security, privacy, usability, and reliability. Users trade off control for a seamless experience and it delivers. It’s desirable. However, many of us don’t need or want to give over all that much control and desire flexibility in a more open platform. Not all of us need or want ‘seamless’ features like Apple Pay and live very well without that or games. 

What will keep DOJ and Apple entertaining each other in court for the next few years are court decisions over the years that have favored Apple:

  • Monopoly has been defined in repeated decisions as market share in the 70-80% range, not 60%
  • The concept of ‘procompetitive’ means that if you can choose between open access and the Apple ‘walled garden’, Apple has a legitimate competitive feature.
  • Companies don’t have a ‘duty to deal’ with other companies
  • Apple as a monopoly has already been dismissed in other cases

The push towards the DOJ action has apparently been stimulated by the EU Digital Markets Act, which Apple will comply with, as well as Apple competitors in the US who have tried and failed to restrict Apple in integrating its services. Will DOJ succeed in forcing Apple to be more like Android? The debate will rage on. DOJ release, 88 page filing, The Verge, 9to5 Mac, Medium.com, AP, Epoch Times