Short takes: Amazon dims to black Halo wearable line, eVisit acquires Bluestream Health, Moving Health Home launches to lobby Congress, government

Amazon shuttering Halo health and fitness product line and services. On Wednesday, Amazon emailed Halo users that the line (View, Band, and brand new Rise sleep tracker) and services, including apps, will be switched off on 31 July. Users will be able to download or delete health and other data. Subscriptions will be refunded as well as all purchases made in the last 12 months. Remaining staff in the Halo unit will be laid off. This was not unanticipated given that Amazon cut jobs at Halo back in February as part of their mass layoff of 18,000 then and another 9,000 last month. Amazon is being quite ruthless in reacting to its 2022 loss and changing up its bets in healthcare to buying F2F care, like One Medical–as the Federal Trade Commission cleans its sights to hunt big game [TTA 23 Feb, 23 March] and the Department of Justice lurks in the wings, despite the sale closing. Engadget, Amazon notice, The Verge, Becker’s

Virtual care platform eVisit acquires virtual care platform Bluestream Health. Bluestream adds ‘white labeled’ telehealth as a customized “front door” for health systems along with virtual care workflow and LanguageLine translation to eVisit’s capabilities in automating patient care management for large health systems. eVisit picks up Bluestream’s 50,000 providers and 500 health systems to add to its 100 healthcare delivery organizations, 2,000 sites of care, and access by over 275,000 clinicians.  Acquisition cost and leadership/workforce transition are not disclosed. eVisit is based in Phoenix while Bluestream is HQ’d in NYC. This Editor first met with founder Brian Yarnell about 2015 or possibly earlier, when the company was operating out of two offices in shared workspace. Release, eVisit Bluestream acquisition page. FierceHealthcare

A new industry organization launches to lobby Congress and government for home health. Moving Health Home announced in March that it was forming to unify healthcare organizations to advocate for home health and to make the home a reimbursable site of care from insurers and Medicare. This spans prevention such as fall risk assessment and nutrition as well as direct care in the home including hospital at home. Members include Amazon, Hackensack Meridian Health, DaVita, Signify Health, Dispatch Health, and many others from the clinical, vendor, and provider areas. It’s headed by Krista Drobac, who has been for some time an activist in the connected health and health policy areas. Earlier this month, they announced that there will be a House bill, Expanding Care in the Home Act (ECHA) which is similar to prior bills both in the House and Senate.

Mid-week roundup: Kaiser Permanente to buy Geisinger, setup separate system; GoodRx co-CEOs step down; strong earnings for Centene, Humana; Clover Health stock woes, settles $22M lawsuit

Today’s big news was that Kaiser Permanente will be acquiring Geisinger Health. Technically, the acquisition is being made by Risant Health, a separate non-profit organization founded by the Kaiser Foundation Hospitals that will acquire other non-profit community health systems. Acquisition costs and a timetable for the transaction were not disclosed and will be subject to the usual state and Federal regulatory review and requirements.

Geisinger will be the founding system of Risant Health, a non-profit that will be headquartered in the Washington, D.C. area. Its current president, Jaewon Ryu, MD, JD, will become CEO when the acquisition closes. Risant’s purpose will be to advance value-based care by acquiring and connecting other multi-payer, multi-provider, community-based health systems in areas such as care model design, pharmacy, consumer digital engagement, health plan product development, and purchasing. 

Kaiser Permanente is a giant integrated care system with 12.6 million members based in California. It operates in eight states (California, Colorado, Georgia, Hawaii, Maryland, Oregon, Virginia, and Washington) and the District of Columbia. Geisinger Health is Pennsylvania-based, has 10 hospital campuses, its own health plan that covers more than 500,000 members, and the Geisinger College of Health Sciences with schools of medicine, nursing, and graduate education. Geisinger was also a pioneer in incorporating telehealth and remote patient monitoring into its healthcare system. The benefit to Geisinger joining Risant is that as the lead system, it will help to shape their operational model. Reportedly, Kaiser will spend $5 billion and acquire five to six health systems over the next five years. The health systems will retain their names and operational areas.

On the face of it, this seems to be a novel solution to both health systems’ challenges. Both have had operating losses and net losses in recent years and difficulty expanding out of their geographic areas. Kaiser has a tightly integrated health plan and service model that is location-dependent. Geisinger has been squeezed in Pennsylvania by UPMC and Penn Medicine along with other community systems. In 2020, it ended its effort to expand into southern New Jersey via a merger with AtlantiCare. However, this current administration and state regulators have not favored health system mergers, which has seemingly been anticipated by Kaiser in forming the Risant Health organization. Healthcare Dive, FierceHealthcare, Kaiser/Geisinger/Risant release

GoodRx names Scott Wagner as interim chief executive officer. Current co-CEOs and founders Doug Hirsch and Trevor Bezdek will be stepping down but staying with the company as chief mission officer and chairman respectively. Wagner was formerly CEO of GoDaddy and is a board member of other digital and advertising businesses. In February, GoodRx was the first ‘victim’ of the newly aggressive Federal Trade Commission policies on Meta Pixel and other ad trackers collecting user health-related data and sharing for revenue with Facebook, Google, Criteo, and other advertising sites. The FTC used the Health Breach Notification Rule, created in 2009, to GoodRx in a Federal court with misuse of consumer health information. Even though GoodRx is not a HIPAA-covered entity and they ended the practice in 2019, they settled with the FTC for $1.5 million. But the likely reason for the CEO change is that the company is still unprofitable. It ended 2022 with a net loss of $32.81 million and laid off 16% of staff last September. Mobihealthnews, FierceHealthcare

It’s earnings report season for payers. The news has been good for some, not for others. 

  • Centene reported year-over-year gains, with Q1 revenue of $38.9 billion versus prior year $37.2 billion. Q1 profitability also gained at $1.1 billion versus prior year $849 million, which missed Wall Street projections. Their outlook was scaled back due to Medicaid redeterminations, 2024 Medicare bids and investments. They also attributed the increased profitability through the strategic sale of Magellan Rx and internal reorganizations. Fierce Healthcare
  • Humana’s Q1 was also profitable and met Wall Street analyst expectations with earnings of $1.24 billion, or $9.87 a share (adjusted to $9.38/share), up from prior year $930 million, or $7.29 a share. This reflects investments in their Medicare Advantage business. Humana is projecting an aggressive target of a 17% membership increase, reversing from last year’s losses.  Fierce Healthcare
  • Clover Health’s Nasdaq notice, settles $22 million in SPAC class action lawsuit. Nasdaq notified Clover on 20 April that since their stock traded below $1.00 for 30 days, they have 180 days to 17 October to regain compliance with the Minimum Bid Price Requirement. This was disclosed in Clover’s SEC 8-K filing last week. There are other ways to maintain a listing (e.g. transferring to Nasdaq Capital Markets) but the anemic share price (closing today at $0.73, a drop of over 90% from the SPAC high) shows no signs of reviving. On Monday, Clover announced a $22 million settlement in a class action lawsuit filed in Tennessee around the company’s January 2021 SPAC. The following month, Hindenburg Research published that Clover did not disclose a Department of Justice (DOJ) investigation in 2020, claiming it was ‘non-material’ [TTA 9 Feb 2021]. The share price fell off the roof and kicked off multiple similar class action suits which are proceeding in New York and Delaware. Release

Breaking: Elizabeth Holmes’ surrender stayed by 9th Circuit Court of Appeals

This just in. As expected, Elizabeth Holmes will not be surrendering to Federal prison tomorrow, 27 April. Her defense filed yesterday for an emergency stay in the Ninth Circuit Court of Appeals. The court granted it on 25 April, yesterday. Since she was free on bail at the time of the filing, this emergency stay keeps it in effect until her motion for continued bail pending appeal is ruled on.

The PDF of the two-page notice is here.

While the surrender will be stayed based on the court’s rules, if the court follows the similar circumstances of Sunny Balwani’s stay and appeal, Holmes will have perhaps a month more freedom on bail before a further extension of bail is rejected. The main 100+ page appeal based on prosecutorial misrepresentations and actions by Judge Edward Davila in the presentation of evidence, plus oversentencing. will be reviewed by the court [TTA 19 April], which may take about a year. Neither the extension of bail or the appeal are given much chance of success.

Now what happens? The Daily Mail revealed that she and Billy Evans are living in an oceanfront San Diego rental, with their two children William and newborn Invicta, born on 9 February in San Diego. The residence is supposedly priced at $9 million. They have departed the rental in Silicon Valley and moved to Mr. Evans’ sunnier home town where the family will remain. Evans and his parents are readying a $3 million townhouse. They will be caring for the two children while the inevitable long trip to Bryan, TX–if Bryan will be the Federal facility–happens. To be updated.

VA completely halts Oracle Cerner EHR implementation for ‘reset’; House introduces new–fourth–bipartisan reform bill–and another outage

The Department of Veterans Affairs (VA) pulls on the parking brake for Oracle Cerner, but doesn’t turn off the engine. Last Friday (21 April), the VA formally announced ) that it would cease further deployments of the Oracle Cerner EHR until they can “prioritize improvements at the five sites that currently use the new EHR, as part of a larger program reset.” They have pledged to fix the issues that were identified during the “assess and address” review that started in late summer and fall 2022. No date was given on a restart which would come after which is presumably the ‘address’ part of the process.

In the release, VA will be redirecting resources to “focus on optimizing” Oracle Cerner where it is currently rolled out: Spokane VA Health Care System (Mann-Grandstaff), VA Walla Walla Health Care, Roseburg VA Health Care System, VA Southern Oregon Health Care, and VA Central Ohio Health Care System. The only exception is the deployment at the Captain James A. Lovell Federal Health Care Center in Chicago – which is the only fully-integrated VA and Department of Defense (Military Health System) healthcare system. That will proceed with a go-live of March 2024.

FedScoop reported that in a live briefing call with reporters, Dr. Neil Evans, who is the acting program executive director for the EHR Modernization (EHRM) Integration Office, would not give specific details about the contract negotiations with Oracle Cerner. “The original contract was a five-year base period with a five-year option, but everything has been on the table as part of the contract negotiations. I anticipate we’ll be able to share more as we near the end of those negotiations.” and “We are working towards an amended contract that will hold Oracle Cerner accountable to delivering the high-functioning, high-reliability EHR system that veterans deserve and will lay the groundwork for our expectations around improvements to the system that we think are necessary.”

The release also revealed a little surprise: “VA estimates FY 2023 costs will be reduced by $400 million.” This Editor noted last week that the March Senate VA Committee disclosed that the VA paid Oracle Cerner $4.4 billion on the contract to date, with a refund of $325,000 paid as compensation for ‘incomplete technology and poor training’. Obligations through the contract were $9.4 billion. The VA will be working with Congress on resource requirements.

Speaking of Congress, the House has now proposed a fourth bill, H.R. 2809, requiring the VA to reform the EHRM program. This bill takes the ‘hold rollout till issues’ position versus “pull the plug” (H.R. 608, which hasn’t moved out of subcommittee). This would require:

  • establishment of program management within the Veterans Health Administration
  • reorganizing the management of the current reporting structure for the EHR functional champion and deputy CIO
  • restricting the monetization or selling of veterans’ data by any internal or external entity conducting work for the VA
  • requiring that performance baselines are met or exceeded at the five live sites before it goes live in other systems

Unlike the VA release, there’s a time limit and a kicker. 180 days after legislation enactment, if VA and Oracle Cerner cannot meet the requirements for the five sites, the bill directs VA to consider terminating or canceling the contract. ‘Consider’ is a bit of a weasel word, but is probably as far as the House wants to go. Another difference is that it is bipartisan, proposed by Democrat Mike Takano of California with six other Democrat House members but with the co-sponsorship of three Republicans, including Rep. Mike Bost of Illinois who is the chairman of the House Committee on Veterans’ Affairs which will review the bill.  TTA’s most recent coverage of VA’s troubles with Oracle Cerner: 19 April, 20 April

And yet another outage. On 25 April, the Oracle Cerner EHR was unusable for at least five hours. It affected Spokane, Wash.-based Mann-Grandstaff VA Medical Center, Fairchild Air Force Base, and military hospitals across the country, which means it affected VA and MHS where it has largely replaced AHLTA. The Spokane Spokesman-Review obtained an email from Mann-Grandstaff Director Robert Fischer confirming the outage Tuesday while it was happening. Dr. Feinberg, the Cerner integration is going great, right? Fixing this should be Job#1.  Becker’s HealthIT

Weekend recap from HIMSS23: Glen Tullman’s 5 predictions, HIStalk’s random four-day walk, Oracle Cerner integration ‘going great’, Seema Verma to Oracle, Caregility’s debuts three enhancements

From the reports on HIMSS23, it seemed almost–normal. Companies were there, attendance was back to near pre-pandemic levels, a normal exhibit hall, and while it was Chicago complete with snow flurries, and there were differences–no aisle carpet in the exhibit hall ‘for the environment’, suits were a rarity, Cerner disappeared into Oracle Health, and the industry was through a cycle of boom then bust–it was almost Old Times. 

So what’s next? Filling that hunger for a future view was Glen Tullman, late of Allscripts and Livongo, now 7wireVentures founder and CEO of Transcarent. His five predictions were:

  1. Consumers are in charge. They have an array of options unless in an emergency. The industry must build a new and different relationship with them
  2. AI will inform the experience. Eliminate paperwork, simplify documentation, analytics to optimize staffing levels, improve use of real-time data in care.
  3. Care will happen in 60 seconds. Quick and convenient response to care has to be the norm, especially for chronic conditions. Without this, three undesirables will happen: avoidance of care, wait until their condition is so serious that their healthcare costs become much higher, or wind up in the emergency department.
  4. Health systems will be the hub…maybe. They can own the consumer health experience. But health systems will need to change their payment model. 
  5. At risk is no risk. Health systems must “lead the way” to value-based care, care quality, and what appropriate care plans should look like.

Interestingly, payers aren’t mentioned in this model–and they see themselves as the hub, not health systems, through their acquisitions are providers and home health. MedCityNews

HIStalk’s random HIMSS23 walk. Perhaps the best ‘you are there’ take on HIMSS23 was published over four days by HIStalk, including Dr. Jayne’s commentary. They need no commentary from your Editor, including surviving Chicago’s weather, the distances, the no-aisle carpet exhibit hall, long lines for coffee, and local dining delights including wet beef and tavern pizza (avoid deep dish). Pro tips: if you’re an exhibitor, book meetings in advance to assure your ROI, and nothing beats F2F–true of both HIMSS and ViVE, booths were packed.  They were there so you and I didn’t have to be. Where do you think HIMSS24 will be?

Monday: Mr. HIStalk, Dr. Jayne

Tuesday: Mr. HIStalk, Dr. Jayne

Wednesday: Mr. HIStalk, Dr. Jayne

Thursday: Mr. HIStalk, Dr. Jayne  (see in Mr. H’s comments about how Microsoft has quietly taken the lead in health tech with Azure, Nuance, and now generative AI. Watch out Larry Ellison.) 

Healthcare Dive interviewed David Feinberg, now chairman of Oracle Health. According to him, everything is going great with the Cerner integration. “The integration has been pretty smooth” and they are well on their way to creating “a cloud-enabled health platform that brings all kinds of information together to make individuals and communities healthier around the world” and in building an EHR-agnostic health records database to link thousands of separate hospital databases. No mention of the troubled VA EHR implementation. (Ahem)

Announced during HIMSS as an exclusive to Healthcare Dive, Seema Verma, formerly Centers for Medicare and Medicaid Services (CMS) administrator during the Trump administration, is joining Oracle Life Sciences, the company’s clinical trials business, as senior VP and general manager. She has spent the last two years as senior adviser to private equity firms TPG and Cressey, and serving on the board of directors for health tech companies Lumeris, Monogram, Wellsky, and Lifestance.

And to this Editor, Caregility, a cloud-based virtual care and telehealth platform that connects virtual visits, clinical consultations, tele-ICU, remote patient monitoring, and point-of-care observation in hospitals, announced that they have a new portfolio of AI-enhanced hybrid care solutions built on best-in-KLAS (non-EMR) Caregility Cloud. According to the release, “A computer vision application analyzes live video streams of patients and their environment to detect movement and changes that could lead to adverse events such as falls or self-harm. A contactless monitoring system continuously captures patient vital signs, detecting variations in heart rate, breathing patterns, and movement that could be indicative of physiological events like awakening from sleep or an induced coma. An ambient clinical intelligence algorithm generates documentation from live clinician and patient conversations for the patient’s electronic health record.”

Theranos’ Sunny Balwani reports to Federal prison

Ramesh ‘Sunny’ Balwani started serving his sentence at a Federal penitentiary in California. He surrended Thursday afternoon and will begin serving his 12 year and 9 month sentence at the Terminal Island Federal Correctional Institution (FCI) near San Pedro. Last December, he was convicted on all 12 counts of fraud and patient fraud.

His defense is continuing to appeal his conviction but lost on 6 April in the 9th Circuit Court of Appeals which ruled that Balwani would not remain free while appeals are pursued. Additionally, he is appealing his assignment to the Atlanta federal prison (USP). Both Terminal Island and the facility he would be sent to in Atlanta are classified as low-security facilities. However, Atlanta has a history of corruption, inmate suicides, and abuse, which may come from the fact that it also has a high-security facility. Atlanta was investigated by Congress in 2021 and 2022. It is also a very old facility dating back 120 years, hardly a country club or ‘Club Fed’.

Terminal Island FCI dates back to 1938 and is located near the ports of Los Angeles and Long Beach, situated on Federal land that includes a Coast Guard base. The island was a farming, fishing, and shipbuilding center and once housed Howard Hughes’ monster Hercules H-4 seaplane, a/k/a The Spruce Goose. Commercial businesses include canneries, docks, and SpaceX. Because of the prison’s location, it’s held more than its share of famous/infamous prisoners: mobsters Al Capone, Mickey Cohen, and ‘Goodfella’ Henry Hill; Watergate’s G. Gordon Liddy, LSD advocate Timothy Leary, murderer Charles Manson, and car executive John Z. DeLorean. During World War II, it was used to hold court-martialed Navy prisoners. It is relatively small as Federal prisons go and holds about 1,000 inmates. 

The coverage from CNN to local media tends to be light on details and heavy on a rerun of Theranos and Balwani’s involvement with Holmes. Holmes is due to surrender next week on 27 April, unless the Circuit Court of Appeals stays the start of sentence. KRON4, CNN, KTVU2

News roundup: Cano Health board fight, board shakeup; Memora Health’s $30M raise; Teladoc enters weight management race

The continuing drama at Florida-based primary care provider Cano Health focuses on the board and CEO. The three board members who resigned in late March [TTA 7 April]–Barry Sternlicht, Elliot Cooperstone, and Lewis Gold (who we’ll dub the Cano 3)–are now demanding that the company board reopen the window for director nominations at the 2023 Annual Meeting of Stockholders. In a letter/press release targeted to fellow shareholders released on Monday, the group cited “drastically changed circumstances”, exclusion of the three from decision-making prior to their resignation, and “the emergence and disclosure of additional self-dealing and concerning related-party transactions that were not previously disclosed – have cast serious doubt on the credibility and fitness of the current Board and CEO Marlow Hernandez.” The letter/release also focuses on the company’s negative (-83%!) performance over the past year. The three own 36% of the common stock of Cano Health, which means they have a very loud voice.

Cano management responded on Monday with a very long letter/press release of its own rebutting the “destructive actions” of the Cano 3  with a lengthy but somewhat anodyne six-point action plan to move the company toward profitability, improve performance, and increase liquidity. Point 6 was quite the kicker: appointing a non-executive chairman of the board, Solomon (Sol) Trujillo. This separated the chairman and CEO roles, with the highly controversial founder Dr. Marlow Hernandez remaining as CEO. Not addressed were the issues around Dr. Hernandez. He has been accused of self-dealing in two instances: $23 million to the CEO’s father for general contracting work, and $8.5 million to a dental care company owned by Mrs. Hernandez. Earlier coverage included dubious transactions with Miami medical claims recovery company MSP Recovery (also known as LifeWallet).

What’s interesting about this is that it may turn into a battle royal between two major figures: chairman Sol Trujillo against Barry Sternlicht. Mr. Trujillo is highly experienced in board/CEO roles in high-stress turnaround situations, such as at Orange SA and most recently Australia’s Telstra Communications. Mr. Sternlicht is well known as the CEO of Starwood Hotels and is a major real estate and private investor.

Cano Health was founded in 2009 and went public via a SPAC in 2021. It lost $426 million in 2022. The shareholder meeting date hasn’t been released yet, but in 2022 it was in May. Stay tuned. Healthcare Dive, MarketWatch

Memora Health raises $30 million. This venture round was led by General Catalyst and joined by several health systems including Northwell plus existing investors Andreessen Horowitz, Transformation Capital, and Frist Cressey Ventures. Memora has AI-based technology for complex care management and digitizes clinical and administrative workflows. FierceHealthcare, Crunchbase

Teladoc to premier weight management program using GLP-1 agonist drugs. This will be part of their physician-based care product for employers, and will target patients needing additional assistance in weight loss and diabetes prevention. The program provides access to a Teladoc-employed doctor for a personalized care plan, along with daily coaching with digital tools. Debut is projected during Q3. GLP-1 drugs such as the widely advertised (in US) Ozempic injectable were originally designed for diabetes management but have found a different market in weight loss. Companies such as Calibrate, Ro, and Sequence (acquired recently by Weight Watchers) are competitors. Healthcare Dive

Insurtechs in the widening gyre: Bright Health sued for claims non-payment, fined $1M by Colorado; Clover Health lays off 10%, outsources operations

When the centre cannot hold, more revelations are at hand.

Bright Health, facing insolvency and a violation of a liquidity covenant by the end of this month, is now facing a lawsuit by health system SSM Health in the US District Court for the Western District of Oklahoma. At issue: payment of $13.1 million for 2,541 unpaid claims incurred for services SSM provided to Bright Health members between 1 January 2020 and 7 February 2023. This three-year plus timespan is not a simple glitch. SSM alleges in the suit that it provided $15.6 million worth of services in total to Bright Health plan members across facilities in three regions. In Oklahoma, SSM Health’s base, Bright exited Oklahoma’s Affordable Care Act exchange in December 2022 while under investigation by regulators. SSM has no contract with Bright to discount services in return for access to Bright’s network so charges the ‘rack rate’. The lawsuit docket is listed here though PACER is restricted access. FierceHealthcare

Bright Health is also under serious challenge at the state level. It was fined $1 million by the Colorado Division of Insurance (DOI) for violations during 2021-22. According to the DOI release, the complaints and violations centered on four areas: 1) failure to pay provider claims according to Colorado law; 2) failure to communicate with their members; 3) inability to accurately process consumer payments and accounts; 4) untimely processing of claims for physical and behavioral health coverage. $500,000 must be paid now, with the remainder held for specific improvement and compliance with metrics. Department of Regulatory Agencies (DORA) release  Bright is also under investigation in Tennessee, Texas, and Florida; it is under regulatory supervision in Florida and Tennessee with Texas considering receivership. Bright Health shares today closed at $0.164 and is on the verge of being delisted from the NYSE. Our recent coverage here.

New Jersey’s Clover Health, while not near the extremis that Bright is in, is cutting and outsourcing its way to profitability. Announced on Monday was a ‘corporate restructuring’ cut of 10% or 66 employees, based on public estimates of 656 (Pitchbook). Simultaneously, Clover’s CEO, Andrew Toy, announced outsourcing of core Medicare Advantage health plan operations to UST HealthProof in a move to increase operational efficiencies and reduce administrative costs. Both the layoffs and the UST implementation are expected to incur a 2023 first-half charge of $7-9 million, shifting to a $30 million savings beginning in 2024. Both moves were predictable as the company posted an $84 million loss in Q4 2022, a slight narrowing over prior year. Clover release, FierceHealthcare    Clover shares on Nasdaq were also below the delisting threshold at $0.80. Also industry analyst Ari Gottlieb on its overdue-ness on LinkedIn.

VA, GAO push back against proposed House overhaul measures

Today’s House Veterans’ Affairs Subcommittee on Oversight and Investigations meeting didn’t bode well for House bills demanding reform or restart. The Democrat-backed bill, dubbed the Manage VA Act, and the second Republican bill, Terminate VA’s EHRM Program (there is also a third, proposed by Republicans, the Electronic Health Record Modernization Improvement Act) were criticized by both VA and GAO representatives at the meeting.

The Manage VA Act proposes the creation of a VA undersecretary for management, who would serve as the Chief Management Officer (CMO). This would not only be for the Oracle Cerner EHR Modernization (EHRM) but also consolidate and standardize acquisition and IT functions across VA. VA and GAO criticized the new position as duplicative of the current VA structure and would run into obstacles similar to a CMO effort within the Department of Defense (DOD), such as lack of clarity and conflict with the CIO plus lack of funding for cross-functional teams and initiatives proposed by the CMO. To FedScoop, Shelby Oakley of the GAO representative expressed a dim view of how the VA has been handling things. “There needs to be much more discipline in the VA’s EHRM approach right now and it’s not clear that the CMO position would change that.” 

The Terminate VA EHRM Program bill, not unexpectedly, was derided as impractical and impossible. Fact: VistA is 40 years old and previous upgrade attempts have failed. Yet a VA deputy CIO just a month ago at an industry meeting, the Association for Federal IRM (AFFIRM), admitted that VistA is being moved to the cloud and being ‘containerized.’ Another VA software executive said it may be needed for another 10 years. You have to wonder if the House or Senate VA committees even know this and appreciate what it really is saying. 

Theranos’ Holmes files appeal seeking to overturn ‘unjust’ conviction, ‘excessive’ sentence (updated)

With the clock ticking down on her freedom, the Holmes defense appeals. Elizabeth Holmes’ last-ditch appeal was filed on Monday in the Ninth Circuit US Court of Appeals. The defense filing claims that her conviction was ‘unjust’ and should be thrown out on multiple grounds, based on prosecutorial misrepresentations and actions by Judge Edward Davila in the presentation of evidence.

  • Holmes did not falsely represent the Theranos blood lab technology to investors–that ‘highly credentialed Theranos scientists told Holmes in real time the technology worked’ and that ‘Outsiders who reviewed the technology said that it worked’.

What the jury heard was that the company’s lab machines could only perform a few tests and even in those, had significant accuracy problems. Yet Holmes claimed in her testimony that the labs could perform multiple tests with high accuracy. She admitted falsifying documents with pharmaceutical company logos (Merck/Schering-Plough, Pfizer) on internal reports to add credence to these claims, which was documented in other testimony, notably from a former Schering-Plough employee. 

  • Judge Davila ‘flouted the Federal Rules of Evidence’ by allowing certain testimony to be heard and excluding other testimony, such as from Sunny Balwani during his pre-trial testimony that he was responsible for the fraudulent financial projections.

The appeal claims that the jury heard testimony from a supposed layman who was actually an expert witness, a federal regulator’s report on Theranos that was ‘unfairly prejudicial’ (CMS closing the lab in July 2016?), and that Theranos voided test results from its labs [see TTA 19 May 2016], confusing the jury in that it was an admission that the Theranos Edison labs didn’t work. Excluding Balwani’s testimony on the Theranos financials and projections given to investors was labeled abuse of judicial discretion.

“These errors—together with the exclusion of prior testimony from Holmes’ co-defendant taking sole responsibility for the company’s financial model—produced an unjust conviction,” the appeal reads.

The problem with this part of the appeal is that all these ‘misrepresentations’ were factual. Holmes as CEO was well acquainted with both the faulty labs and the financials. With that CEO title comes a sign that The Buck Stops Here.  

Plan B–the ‘excessive’ prison sentence. If the appeals court does not throw out the conviction, the appeal turns to over-sentencing. Returning to Judge Davila, he used the wrong legal standard about the number of victims and the amount of investor losses, using a “preponderance of evidence” standard instead of “clear and convincing”. The sentence was also excessive for a woman whom “unlike other white-collar defendants–neither sought nor gained any profit from the purported loss and was trying to improve patient health.” To this Editor’s recollection, Judge Davila bent over nearly backward to exclude from the trial the prosecutorial desire to highlight Holmes’ fame and high flying lifestyle, including expenses for air, hotel, and clothing.

The Ninth Circuit Court of Appeals will need to get eye prescriptions updated, since there are 10,000 pages of trial transcripts and 16,000 pages from other court records to review. This review may take months, a year–or more–and has only a small chance of success. Mercury News (may be paywalled)    Updated. The full appellant filing of 132 pages is located here.

To this Editor, who is not a lawyer nor plays one on TV, the effort to throw out the conviction is absurd. The prosecution piled high the fraud evidence to support each count. It was not difficult as there were a lot of investors. In the run-up to the trials, Judge Davila was meticulous and even-handed with both prosecution and defense. He was conservative in all aspects, from conduct during the trial to preventing over-aggressiveness by both sides in witness questioning to reining in the ‘Sunny as Svengali’ defense tack. Aside from this trial (but outside the appeal), there are other Theranos fraud cases at the Federal and state levels where awards were made to plaintiffs when the company still had money (see below; also Walgreens settled, see our Ch. 44). The appeals court might seriously consider the sentence issues. On the face of it, she was convicted of but four counts versus Balwani’s 12, yet is receiving very nearly the same length of sentence; however, these four counts were the heaviest (Ch. 16).  Though Judge Davila strictly considered the Federal sentencing guidelines and steered a middle course of 11.25 years between the 15 years (of 20 maximum) recommended by the prosecution and the nine years recommended by the probation officers, to be served concurrently, the appeals court may see an error, somewhere around losses–but it is unlikely, and even if there are errors, they may make no difference.

But to this Editor, one testimony says it all about the fraud. It was from Brian Grossman, then and now chief investment officer and CIO of PFM Health Sciences, a San Francisco firm that manages billions in public and private funds for early-stage healthcare investment. It is particularly damning. The firm invested $96 million based on the projections, the claims that it was a miniaturized lab capable of replacing thousands of feet of lab space into a box (the ‘steak’), of four-hour turnaround on lab results in retail, one hour in hospitals, and that a Stanford researcher of some prestige vetted it. From our article:

While Balwani nixed Grossman speaking with Walgreens and UnitedHealth, Channing Robertson of Stanford, who helped Holmes start Theranos, vetted their labs as extremely advanced technology–one with which competitors would spend years catching up–for a serious investor, sauce, potato, vegetables, and trimmings on that sizzling steak.

Unlike the picture the defense is painting of Balwani controlling Holmes, Grossman took care to note that Holmes, not Balwani, did most of the talking at the time. While he found the company highly secretive, he, unfortunately, discounted it. So in went PFM’s $96 million in February 2014, which included $2.2 million from a designated ‘friends and family fund’ which had investments from low-income people.

Three years later, PFM also won its own fraud case against Theranos, settling its lawsuit for about half–an estimated $40-50 million….The timing was good–it was while the company still had some money to claw back. 

Holmes is scheduled to surrender herself to the US Bureau of Prisons (BOP) on 27 April, less than two weeks from now. She will not be able to remain free while this appeal is pending, unless the defense files with the Ninth Circuit Court for a delay (expected) and the court agrees to stay the surrender for some time. A similar appeal was denied for Sunny Balwani, who surrendered on 20 April, a month later than his original date, to Terminal Island and will be held there indefinitely. Another major issue for the Balwani defense and being appealed is his assignment to the scandal-plagued Atlanta Federal Penitentiary. Judge Davila recommended that Holmes serve her sentence at Bryan, Texas, but the BOP has not confirmed that.

Still pending are the restitutions to be made by both Holmes and Balwani, separately, neither of whom have the $381 million (Judge Davila’s calculation for Holmes) or the $878 million that the prosecution has tallied. TTA 22 March

This Editor would like to give a hat tip with flourishes and trumpets to the moderator of the r/Theranos Reddit sub forum, mattshwink, and poster OldSchoolCSci, for clarification on many legal points of my analysis.  

VA pulls out the stick in contract renegotiation with Oracle Cerner, slams brakes on further EHRM rollouts–and is this trouble? (updated)

VA puts away the carrot, pulls out the stick with Oracle Cerner on the VA EHR modernization. Last Friday’s report in the Wall Street Journal (paywalled) confirms that the Department of Veterans Affairs (VA) is actively renegotiating its contract with Oracle at what is now the five-year mark. Until an agreement is reached, VA is pausing the rollout, which according to previous reports has been largely paused anyway due to multiple critical problems in the slow rollout to date. The WSJ report is cited in Becker’s.

Reports in March during Senate VA committee hearings indicated that the $16 billion contract was due for renegotiation anyway by 17 May. Typically, VA vendor contracts are for five years and the original contract was signed in 2017 with Cerner. VA’s contracting officer, Michael Parrish, testified in those Senate hearings that he will push for a more favorable contract [TTA 18 March].

The Oracle Cerner Millenium EHR was to replace the crusty, still working but not interoperable VistA EHR. The Department of Defense had already contracted with Cerner and Leidos to develop an EHR for the Military Health System (MHS), Genesis, replacing AHLTA. That has largely been completed in a smaller system, though not without its glitches. Billions had been spent in multiple multi-year efforts to make the two existing systems interoperable, for instance to cover records of service members transitioning from active service to reserve or veteran status and for military retirees.

Oracle closed its $28.4 billion acquisition of Cerner last June to much fanfare, but has not had a pleasant moment with the VA or Congress since. During 2021-22, failures of the Oracle Cerner system included hundreds of outages, the ‘unknown queue’ creating at least 150 instances of harm (including one averted suicide) at one VA health system (Mann-Grandstaff), four veteran deaths, training program troubles, more in a GAO Inspector General audit, and the VA’s EHRM Sprint Team itself identifying 14 main and multiple sub-issues in safety and medical research integration in the EHR Modernization Sprint Report (PDF) released on 10 March delving deeply into the initial implementations. 

In 2023, there have been three Senate and three House bills proposed with mandates ranging from ‘hold rollout till issues fixed’ to ‘pull the plug and start over’. The VA had two resignations tied to the EHRM failures, VA deputy secretary Donald Remy and EHRM director Terry Adirim, MD. Implementations were delayed at Michigan’s Ann Arbor (including medical research, TTA 1 Mar) and Saginaw (this month) systems to later this year or even 2024. None of this has been cheap. The Senate VA Committee hearings in March revealed that the VA has paid Oracle Cerner $4.4 billion on the contract so far, with a refund of $325,000 paid as compensation for ‘incomplete technology and poor training’. Obligations through the contract are at least $9.4 billion. The new system has been implemented to date in five VA medical centers out of 171. [TTA 18 Mar]

Updated. Another five-hour outage of both VA and DOD-MHS systems occurred on Monday 17 April. Affected systems included PowerChart, RevCycle, and other applications with latency issues and freezing. This may have been a result of transitioning to a larger database over the weekend. Today (Wednesday 19 April), the House Veterans’ Affairs Subcommittee on Oversight and Investigations will hold hearings on the proposals contained in the two House bills.  FedScoop

If Oracle really wants to transform healthcare, it can start with the VA as Job #1. Or give the keys to Epic. The VA is between the proverbial rock and a hard place. VA has to end VistA even though the old system is still being upgraded during the transition. Terminating the deal with Oracle and reverting five health systems would be perilous, if even possible. But the stakes for Oracle are even higher. Let’s start with billions in Federal contracts in other parts of government systems outside of healthcare. To get into healthcare EHRs, Oracle bought a Pandora’s Box with Cerner. The stakes are not only for our veterans but also to salvage its credibility in healthcare versus Epic–and with its lenders who financed the heavily leveraged Cerner acquisition plus $90 billion in debt load [TTA 10 Nov 22]. 

Mid-week roundup: Pear Therapeutics’ Chapter 11; Workit Health pinkslips 100; Outcome Health principals convicted of $1B fraud

Pear Therapeutics ran out of runway and is in the drink. On Friday, CEO Corey McCann announced in a post on LinkedIn that the company filed for Chapter 11 bankruptcy and has laid off 170 employees, including him. Dr. McCann will continue on the board and as a compensated consultant, while chief operating and financial officer Christopher D.T. Guiffre will remain through the Chapter 11 process along with about 15 employees to manage the asset sale process, limited operations, and transition on behalf of the debtors.

According to their Securities & Exchange Commission (SEC) 8-K filing, terminated employees were paid through April 7, 2023, received two weeks’ salary as severance, and were asked to sign a separation agreement, which includes a general release of claims against the company resulting in a $1.2 million charge.

Only last month, Pear announced that it was exploring ‘strategic alternatives’ including a sale or being acquired. According to the release, the debtors are still seeking a sale of the whole business or to part out specific assets. Now such sales and the bidding process must be approved by the US Bankruptcy Court in Delaware. Release  The sale is anticipated for May.

Another behavioral health casualty in a model that proved unworkable. Pear developed and marketed Prescription Digital Therapeutics (PDTs) concentrated in behavioral health and substance use including opioid use disorder. While these seemed to be accepted by providers, patients, and some payers, payment didn’t materialize from the last, according to Dr. McCann’s LinkedIn post. According to Forbes, “There were more than 45,000 prescriptions written for Pear’s products in 2022, but only around half were filled and the company was able to collect payment for only 41% of those.” The other factors were price and reimbursement. Pear’s products averaged $1,195, which took them out of private payment. Only a limited number of commercial insurers and Medicaid plans would pay for them. Medicare did not. In 2022, Pear reported an operating loss of $123.4 million on $12.7 million in revenue, which doesn’t fly in 2023.

This is quite a change from the heady days of 2021, when Pear went public on Nasdaq via a SPAC in December, raising about $175 million in additional funding. A sign of trouble was that the raise was far less than the anticipated $400 million. At that time, Pear was valued at about $1.6 billion. Prior to the SPAC, they had raised about $284 million through Series D funding (Crunchbase)  Mobihealthnews, MedCityNews

Another virtual behavioral health company facing loss of business is Workit Health, This is due to the Drug Enforcement Administration’s (DEA) planned return to the in-person visit requirement for Schedule III-V non-narcotic controlled medications. Workit is a virtual therapy/treatment company for alcohol, stimulant, and opioid abuse, a crowded field. The company, rationally, is cutting 100 staff in anticipation of a drop in activity. To date, it has over $130 million in funding through a Series C, not a lot.  Behavioral Health Business  Also TTA 15 March on the DEA rule debate

Outcome Health–the other late 2010’s scandal after Theranos–had its denouement in a Federal court in Chicago yesterday (11 April). Convicted of $1 billion in fraud were:

  • Rishi Shah, 37, the co-founder and former CEO of Outcome Health: five counts of mail fraud, 10 counts of wire fraud, two counts of bank fraud, and two counts of money laundering
  • Shradha Agarwal, 37, the former president of Outcome: five counts of mail fraud, eight counts of wire fraud, and two counts of bank fraud
  • Brad Purdy, 33, former chief operating officer and chief financial officer: five counts of mail fraud, five counts of wire fraud, two counts of bank fraud, and one count of false statements to a financial institution

Each count carries specific maximums of between 10 to 30 years which are usually served concurrently. Sentencing for the three executives and for three other employees who had pleaded guilty to lesser charges will be at a date to be determined. SEC charges are pending against the executives, along with Ashik Desai, former chief growth officer, who testified against his former bosses in the criminal trial and was one of the three who pleaded guilty.

Outcome delivered patient education on screens in doctor’s offices and circa 2016 was one of the hottest companies in Chicago. During the pandemic, it merged with PatientPoint. Their problem was inflating their ad delivery numbers to their sponsors such as Pfizer, Biogen, and Sanofi. This puffery included third-party analyses of the ads’ effectiveness, e.g. for prescriptions written. This was exposed by the Wall Street Journal in October 2017. Advertiser makegoods and clawbacks from lenders in the millions resulted. TTA 29 Jan 2018   But the executive crew above plus the other three employees concealed the under-delivery problem, faked revenue numbers, and presented them for debt financing plus equity funding in 2016-17 that rewarded them richly–thus the Federal fraud charges. Mobihealthnews, FierceHealthcare, DOJ release  TTA’s coverage from that time here

Let’s hope for more cheerful news out of HIMSS next week.

The Theranos Two lose their fight for freedom on appeal as Federal prison surrender dates near

It was not a happy Easter weekend for either Elizabeth Holmes or Sunny Balwani. 

Late on Monday, Judge Edward Davila of the Federal Court, Northern District of California, ruled that Elizabeth Holmes would not be able to remain free on bail while appealing her trial and sentence. In his 11-page ruling, he dismissed the defense claims that evidence around Theranos’ technology was not presented to the jury and affirmed that the key charges were related to financial fraud, the company’s financial status, and the false claim that the technology was validated by pharmaceutical companies. “Whether the jury heard more or less evidence that tended to show the accuracy and reliability of Theranos technology does not diminish the evidence the jury heard of other misrepresentations Ms. Holmes had made to investors.” He also noted that her defense had not introduced anything to make a reversal of the decision or a new trial likely, such as new evidence.

It’s anticipated that Holmes’ defense will quickly file an appeal of Judge Davila’s decision to the 9th Circuit Court of Appeals. However, this is the same court that denied Sunny Balwani’s same appeal last Friday. Holmes’ surrender to Federal prison is scheduled for 2pm on 27 April, a little over two weeks from now. She will be serving her 11+ year sentence at the Federal prison in Bryan, Texas unless the Bureau of Prisons changes this recommendation to another Federal prison. 

Her defense has filed multiple appeals of Judge Davila’s rulings and the jury’s guilty verdict on four counts of fraud of 11 on various grounds, including errors made during the trial [TTA 15 Dec 22], with the goal of securing a new trial. Those appeals are with the 9th Circuit and could go on for years. What it now looks like is that Holmes will be serving her time in Texas while these appeals go through, not free or under house arrest. Serving time will not be easy for her in a cell with three other women and duties such as stuffing bag lunches. Mercury News (paywalled), CBS Bay Area, The Hill, TechCrunch

Sunny Balwani had a long Good Friday, receiving the bad news late Thursday that the 9th Circuit Court of Appeals denied his bid to remain free while on appeal. The court denied the appeal on the basis that Balwani had not raised any substantial questions of law or new evidence resulting in a reversal on some of the charges that would shorten his sentence. He was found guilty on all 12 counts and was sentenced to 12 years and nine months. Balwani’s lawyers now have requested from Judge Davila a new surrender date of 20 April, stating that their client needs time to get his “affairs in order”. His original surrender date was 16 March, delayed by the appeal. Where Balwani will serve his sentence is still up in the air. Judge Davila had recommended the Federal facility at Lompoc in Santa Barbara County, but the Bureau of Prisons recommended the Atlanta penitentiary which has been dogged by years of scandals, security lapses, and prisoner abuse allegations. His defense is appealing this assignment. As of now, Balwani will surrender to Terminal Island near San Pedro in Southern California in a little over a week. Mercury News (paywalled), CBS News Bay Area 

Some reports have indicated that Judge Davila has finished with all his rulings, but what is still not finalized is the restitution both Holmes and Balwani must make to investors. Those rulings are scheduled for this month. The amounts being debated are largely theoretical as neither Holmes nor Balwani has much in the way of assets left. TTA 22 March

When ‘the centre cannot hold’: three board members exit at Cano Health, failure looms at Bright Health Group

Surely some revelation is at hand? The first: the high-profile board troubles at primary care provider Cano Health. Last Friday, three directors resigned loudly from the board: Barry Sternlicht, Elliot Cooperstone, and Lewis Gold. Sternlicht, the chairman of Starwood Capital Group and for some years the CEO of Starwood Hotels in the 1990s, is a ‘name’ real estate and private investor. The other two are hardly slouches: Cooperstone is founder and managing partner of private equity firm InTandem Capital Partners; Gold is co-founder and board chairman of behavioral health company Advanced Recovery Systems. They resigned as a group due to differences with the CEO and management. 

The trio filed a 13-D with the Securities and Exchange Commission as a partnership to change things, “including, but not limited to, the replacement of the CEO, sale of non-core assets and enhancement of shareholder value.” Sternlicht’s release detailed their grievances with CEO Marlow Hernandez, including dubious transactions with a Miami medical claims recovery company, MSP Recovery (also known as LifeWallet), but mainly around the burn-through of the $800 million PIPE raised along with the June 2021 SPAC via Sternlicht’s JAWS Acquisition Corp.–an eye-watering total of $1.4 billion for a valuation at that time of $4.4 billion. From his release, Sternlicht apparently could not get the time of day from Hernandez. “I have never witnessed such poor corporate governance at any company, let alone a public company, and I have been involved in at least nine and served as chairman or CEO of six.”

Certainly, there is a case around shareholder value. The stock has cracked by over 90% from the initial price of $15. Sternlicht also had $50 million reasons to be mad as an investor of that amount in the PIPE. Cano Health called his “method of resignation particularly reckless.” But one wonders what Cano’s physicians are thinking, as well as the health plans with which they work, when three high-profile board members bolt the company, one of them with a stellar track record and some fame, with prejudice. Yet the majority of the board members were seemingly fine with how the company was run.

Last October, Cano, a 4,000 employee value-based primary care provider to mainly underserved markets, had its tires kicked by CVS Health [TTA 21 Oct 22] but the deal never got beyond discussions, and Humana, which has a right-of-first-refusal, made no moves. Share price fell from that time from just above $8 to today’s close of $1.25 on the NYSE. The time may be right for a payer or a provider group to make a cheap pickup, but not if the company has intractable troubles–and now there is a deep-pocketed rival. MedCityNews, New Times (Miami)  The New Times article digs deeper into the MSP Recovery relationship and CEO John Ruiz. MSP Recovery specializes in collecting from primary insurers that don’t pay and put the burden on commercial or public plans like Medicare or Medicaid. As of December 2022, the company owed Cano roughly $60 million in receivables, not a drop in their bucket.

Now to Bright Health Group, an insurtech which may well be on the brink of utter failure and the dubious distinction of being one of the largest failures of a Minnesota business, if their local media (Star-Tribune, unfortunately tightly paywalled) is accurate. Reports one month ago were dire: investors were told that Bright was facing credit insolvency, having run through $350 million in revolving credit. It also violated a liquidity covenant and desperately needed $300 million to cover it by end of April.  This did not stop the company from paying out about $4 million in bonuses to its management team–outrageously at 100%. Two of the bonuses are to ex-company members. Meanwhile, hundreds of their once 2,800+ employee group are being discharged.

18 months ago, Bright Health seemed to be the most promising insurtech out there, with a healthy Medicare Advantage (MA) plan base, family and individual plans, substantial growth, acquisitions of Zipnosis (‘white label’ telehealth triage for health systems), development of the NeueHealth value-based care provider management network, and a blue-chip management group. But it also lost $1.5 billion in 2022 on top of $1.2 billion in 2021 and has $1.2 billion in debt. Bright exited individual and family plans in six states plus cut back MA expansion plans and will no longer offer individual, family, or Medicare Advantage plans outside of California.

With Bright Health shares down to $0.20 and delisting looming, Bright asked shareholders to attend a 4 May meeting to approve a reverse stock switch “at a ratio of not less than 1-for-15 and not greater than 1-for-80.” It’s just a small problem of the share price….

Far more disastrously for Bright, state departments of banking and insurance are taking action. Tennessee and Florida placed the company under supervision; reportedly Illinois is considering the same. Texas may precipitate matters. According to strategic analyst Ari Gottlieb, the Texas Department of Insurance is preparing to place Bright Health’s Texas subsidiary into receivership. Such an action will constitute an immediate Event of Default under Bright’s Credit Agreement. Bright can then choose default–or seek bankruptcy protection.

Shockingly, over a million Americans have had to find a new health plan due to what is happening at Bright. Now, where’s the Barry Sternlicht they need on the board to take action? Are the directors from investors like Bessemer and New Enterprise Associates in cloud-cuckoo land with management?

FierceHealthcare. Both Fierce’s and this article quote liberally from Ari Gottlieb’s posts on LinkedIn, the most incisive coverage this Editor has seen so far: Since Bright Health’s executive compensation approach is best described as pay-for-failure from one month ago, Bright Health’s $4 million pay-for-failure cash bonuses… from two weeks ago, and from earlier this week, The Texas Department of Insurance is preparing for anticipated litigation…  Others are listed in his feed here

TTA Bright: THINKMD, Save the Children partner for digital child health assessment

Putting digital diagnostics in the pocket of healthcare workers, worldwide. Isn’t a story that is bright and cheerful, about doing something good, needed right now? THINKMD is a digital clinical intelligence platform that uses machine learning (ML) to analyze key clinical data and to provide a dynamic evaluation similar to a physician’s assessment. It uses a web app that works offline as well. What THINKMD does is to basically transfer a knowledge base plus how a physician would logically approach the medical situation, followed by a care plan, to a health worker without those advanced skills in a remote area. Product demo

THINKMD already works with Save the Children in Bangladesh, Indonesia, and Kenya. Save the Children is a well-known, century-old international organization that is on the ground in 120 countries working for the welfare and health of children. Since 2017, in the existing partnership, they have achieved over 366,000 high-quality clinical assessments performed by over 400 frontline health workers. The agreement is to license THINKMD’s platform to Save the Children in order to expand the existing partnership between the organizations, enabling adoption and scaling of THINKMD’s platform to improve the health of children globally. It is the first such agreement for Save the Children. THINKMD is currently being used in a total of 10 countries. Hat tip to Nick Olsson of ‘We Are Explorers’. THINKMD release plus a blog post by co-founder Dr. Barry Finette about the agreement

Digital health’s funding time machine dialed back to 2019–before the SVB implosion: Rock Health

Rock Health’s 2023 Q1 report tries to put a good face on an implosion. The good: Q1 followed their Retro Time projection; the 2020-first half 2022 bubble was over, but digital health was snapping back to 2019 funding levels. The bad: while things were snapping back, Silicon Valley Bank (SVB), the favored bank of most Silicon Valley VCs and the companies they funded, imploded due to mismanagement.  This Editor would add two corollary nervous-making bank failures on SVB’s heels: Signature Bank (some East Coast healthcare, but too many uninsured deposits and a lot in crypto, taken over by Flagstar Bank/NYCB) and Credit Suisse (pending a Swiss government shotgun marriage with UBS). Add another unnecessary Federal Reserve rate hike to kill growth and the end of the pandemic PHE regulation suspensions that fueled telemental health, plus inflation at about 8-10%…. Like that 1949 Studebaker Starlight coupe, are we coming, or going?

Sidebar: This Editor has heard from other sources (not Rock Health) that ‘dry powder’ (funds) are low for VCs and barely existent on the provider (health system) side. Their own investors, now leery, are cutting back on their exposure. Where there is dry powder, fintech and biopharma are seen as better bets. VCs sense the bottom hasn’t yet been found in digital health valuations. Payers like UHG and CVS are making big deals but not in digital health. If they are, they are small ‘pocket lint’ pickups. Private equity? Largely kicking tires. Family offices and high net worth individuals are generally staying out of the healthcare picture unless there are other compelling (usually personal) reasons to invest. (Theranos still hangs heavy over these last two funders.)

Back to Rock Health, total Q1 funding was $3.4 billion across 132 deals. Yet only six mega deals (over $100 million) accounted for 40% of the funding early in the quarter: Monogram Health (in-home care, $375M), ShiftKey (PRN nurse scheduling, $300M), Paradigm (drug trials, $203M), ShiftMed (another healthcare workforce scheduler, $200M), Gravie (broker benefit solution, $179M) and Vytalize Health (MSO for providers, $100M). To call these ‘mega deals’ is an overstatement. In 2021 or even in 2022 these would have been seen as outstanding Series A and decent Series B-D+ raises. In 2021, the top mega deals crested $500 million.

The remaining 126 sliced up the remainder ($2.043 billion) of the pie, with a median value of only $16 million per deal. Throwing in the six ‘mega deals’, the overall median increased to $25.9 million. That tracks closely with 2019/2022, allowing for some inflation. Comparisons with full year medians: 2019–$19.8 million, 2020–$31.9 million,  2021–$39.9 million, 2022–$26.7 million. 

The IPO window remains closed tight. No easy exits for investors in late-stage companies. Those that went public during the bubble, with few exceptions, have cracked. From the report: “Digital health stocks started 2023 trading almost 50% lower than they did at the start of 2021, pushing some recently-exited players like Pear Therapeutics to explore going private.” (Under $1.00 per share, Pear is currently exploring a sale in toto, in parts, or merger.) According to this chart shown by Arundhati Parmar, MedCity News’ editor-in-chief, during his VC panel at ViVE [TTA 31 Mar], only two of 17 publicly traded digital health companies that went public have share prices in excess of their IPO: Progyny (also profitable) and HealthEquity. Many are near or below the critical $1.00 mark. (This chart does not include Babylon Health which is trading around $5 and reorganizing to become a US company.) He also pointed out that only two of the 17 are profitable.

These deals now also come with strings attached: valuation adjustments and operational revamps which usually mean staff layoffs, but can also be operational in closing/selling off lines of business. Growth is not the key metric anymore–profitability or a road to it is. Recent examples are Komodo Health and Carbon Health, where their substantial fundings ($200 and $100 million respectively) were tied to jettisoning LOB and staff. 

Last but certainly not least in putting a damper on digital health funding and growth is the end of the prolonged pandemic PHE. This relaxed rules for telehealth platforms around HIPAA compliance and also in mental health prescribing without in-person visits of DEA-controlled substances in Schedule 2 and 3-V. This puts a definite halt to telemental health’s expansion, fueled by drug prescriptions and none-too-fussy signups (see: Cerebral) but also too many virtual players in one niche (Mindstrong ceasing business with remaining assets bought out by SonderMind). New telehealth platforms largely complied with HIPAA but penalties for non-compliance are returning and platforms have to secure data. FTC is an added factor with its own privacy microscope.

Even the eternally optimistic Rock Health likens 2023 in digital health to a stormy sea with “turbulent waters’ resulting in “patched up ships and resilient mindsets.” Now that is a stunning mix of metaphors. Your Editor chooses a classic phrase penned by Joseph L. Mankiewicz and uttered with flair by Bette Davis in ‘All About Eve‘: “Fasten your seatbelts; it’s going to be a bumpy night.” And it’s only Q1. Also Mobihealthnews