The devil is in the (migrated) data: GAO watchdog barks at the VA’s transition from VistA to Cerner

February 9, 2022 | by

The US Government Accountability Office (GAO) released their “watchdog” report on the Department of Veterans Affairs’ first, failed implementation at Spokane’s Mann-Grandstaff VA Medical Center in October 2020. Their 52-page whopper of a report came to a simple conclusion: the VA didn’t ensure the quality of the data migrating from the EHR warhorse VistA and their Corporate Data Warehouse to Cerner Millenium. Thus clinicians couldn’t use Cerner two ways–one was training in how to use it (as noted in VA’s own analysis) so they could not find the patient information they needed–and the fact that even if they knew how to use it, the data migration apparently was incomplete. The GAO found that the VA did not establish performance measures and goals for migrated data quality based on Federal guidance. The result was inevitable. According to the report, “clinicians experienced challenges with the quality of migrated data, including their accessibility, accuracy, and appropriateness.” 

There is also a method called a stakeholder register which helps to identify and engage all key stakeholders. VA did not use this, so some areas were overlooked in the continuity of reporting and preservation of records. This affects not only patient records, but also scheduling.

The main takeaway is that GAO recommends to VA that they establish performance measures and goals that ensure the quality of migrated data and use a stakeholder register managed by the VA’s deputy secretary to engage all the relevant stakeholders in the migration in reporting needs. VA published its own analysis of its implementation and rollout failures in December. Healthcare IT News

Predictions, predictions for telehealth, digital health, and all those cybersecurity risks

February 3, 2022 | by

crystal-ballJanuary is the month for predicting what’s ahead, and while this Editor has no pretensions to be Sibyl the Soothsayer despite the picture, let’s look at what others see in their cloudy crystal balls.

Frank McGillin, CEO of The Clinic by Cleveland Clinic, works intensively with telehealth in this joint venture between Cleveland Clinic and Amwell. His prediction: telehealth will evolve towards concierge care, as providers reduce “platform sprawl”, coordinate the virtual care experience, and provide multidisciplinary virtual care.

  • Telehealth is now “a permanent mode of access”, though the pandemic created “platform sprawl” as providers reached for any and all modes and providers which could be implemented quickly
  • Healthcare providers and plans now have to scale back and reconcile all this to “design a digital trajectory with intention”
  • This means developing a personalized approach to telehealth delivery and to provide a seamless, highly coordinated care experience
  • Their approach is to focus on multidisciplinary virtual visits and case analysis for patients with complex conditions, such as their Virtual Second Opinions program for conditions such as brain tumors and prostate cancer.
  • Virtual multidisciplinary support reduces the risk of suboptimal treatment plans and can eliminate long travel times and exposure to COVID-19 for vulnerable patients. For payers and employers, this can add up to better outcomes and reduced cost of care.
  • “Intelligent” remote monitoring also removes another layer of risk in providing the right care at the right time
  • Continuation of relaxed interstate licensure requirements are needed to provide fast access to medical experts, particularly for primary care providers.

Interview with Healthcare IT News 

Healthcare Dive has been running a series on industry trends, and this installment focuses on digital health.

  • Healthcare will become more predictive and proactive, with insights fed by connected devices and analytics (commonly lumped under AI) that enable organizations to collect, analyze, and act on massive amounts of data.
  • But algorithms don’t have judgment and data can have bias, leading to poor decisions, such as the distribution of vaccines. Expect more oversight from the Federal level down on AI research and policymaking, 
  • Virtual care will continue to grow in virtual diagnostics, patient-reported outcomes applications, and digital homecare platforms
  • Telehealth and digital health is integrating into the traditional delivery and payment model–partnerships with health systems, payers, and employers.
  • Virtual care access is booming in niche areas such as women’s health, hospital at home, and mental health, with investment dollars flowing in. Telemental health is moving into consolidation.
  • Cybersecurity will become more of a focal point for healthcare companies in 2021, with hackers finding their way into all these contact tracing apps designed in a hurry, plus digital health systems, many of which are poorly protected. Targeted attacks have skyrocketed.

And speaking of cybersecurity, over at HealthITSecurity, they rounded up the experts to opine on All Those Security Risks that fast implementation of telehealth and moving devices out of the hospital walled garden have created. Remote patient management is now an asset, no longer a ‘nice to have’, for providers, setting up a situation where patients are increasingly both the beneficiaries of more convenient health delivery and victims of security breaches and ransomware.

  • ‘Out of hospital’ care means that data is being transmitted between multiple points. Network security isn’t guaranteed. So attacks can originate at the weak points–either the home or hospital environment.
  • The fast implementation of telehealth during the pandemic meant not only did systems not work together well, it also meant multiple points of vulnerability
  • Over 80% of surveyed healthcare providers globally harbor concerns about data security and privacy (Kaspersky/Arlington Research). And a shocking 70% admitted that their practice used outdated legacy operating systems, exposing them to security vulnerabilities.
  • “A culture of security” means maintaining endpoint security and BYOD policies across the organization’s network, identity management and zero trust tactics, and yes, security consciousness on patients’ parts.
  • Patients should not be responsible for security, providers partly, which leaves the responsibility with the vendor. But healthcare organizations are responsible for evaluating their vendors, and how they are interacting with and storing their data.  

Congress calls to extend PHE telehealth flexibilities; FCC’s $48M telehealth funding boost, telehealth’s shortcomings in pediatric asthma treatment

February 2, 2022 | by

Permanent telehealth flexibility and expanded use still being debated, and still stuck in Congress. The expansion of telehealth that came with the US public health emergency (PHE) isn’t permanent, despite some expansion plugged into the Medicare Physician Fee Schedule. That can only come with legislation passed by Congress and signed into law–and it is still being debated. A fresh group of 45 Congresscritters (this Editor can’t restrain a certain sarcasm) is now plumping for a more permanent extension for a set–but undefined– time, as part of February funding legislation. This effort is being led in the Senate by Brian Schatz, D-Hawaii, and Roger Wicker, R-Mississippi. Oh yes, the power of a letter to the House and Senate majority and minority leaders (sigh!) Meanwhile, the CONNECT for Health Act and the Telehealth Modernization Act have languished for months in the Senate Finance committee and in House Ways and Means. Healthcare IT News

Over at the Federal Communications Commission (FCC), they’re doling out the sixth and final tranche of $47.89 million to 100 provider and community health organizations that applied to the COVID-19 Telehealth Program. The total FCC funding in this round 2 was $249.95 million that built on funding that was part of the CARES Act. The full list is in the FCC release (PDF). MHealthIntelligence

A combination of in-person care with telehealth as an adjunct may be the best protocol for treating pediatric asthma, a UC Davis Health study found. The first part of the study analyzed EHR records for asthma patients aged 2-24 treated at UC Davis Health in 2020. Of 502 patients, telemedicine usage was significantly lower among:

  • Patients with a primary language other than English (OR = 0.12, 95% CI: 0.025–0.54, p = 0.006)
  • School-aged children (OR = 0.43, 95% CI: 0.24–0.77, p = 0.005),
  • Those who received asthma care from a primary care provider instead of a specialist (OR = 0.55, 95% CI: 0.34–0.91, p = 0.020).

Focus groups are qualitative and should be used for direction and to surface issues, and they did with telehealth. The 12 parents and five young adult patients who were randomly selected and participated stated that:

  • The parents felt that in-person care built better rapport, was more effective in counseling the child and young adult patients on their medication and condition, and more actively engaged their children
  • Parents did not feel confident in correctly using diagnostic tools like peak flow meters and home spirometers on a telehealth visit
  • Scheduling follow-up telehealth appointments was more difficult than in-person 
  • Where telehealth stepped up was convenience–to see their specialist without travel time. The visit also ‘cut to the chase’ by seeing one physician only, not an entire care team. And it was protective of their children during the pandemic. 

Most of the focus group participants agreed that a combination of telemedicine and in-person visits would be preferred when asthma is well-controlled. Published in the Journal of Asthma. Also MHealthIntelligence, which read the study conclusions a bit different than this Editor.

Will ’22 digital health investment be historic? Or a question mark? The jury is out.

January 29, 2022 | by

Some say historic, or will it be a historic question mark? It’s only January…Earlier this month, a Silicon Valley healthcare VC funding analysis [TTA 14 Jan] looked at 2021 funding — up over 150%–that was skewed to biopharma and health tech. It noted the SPAC slowdown, anemic post-IPO performance, and a decline in M&A value, while consolidation and buying for expansion will be the trend.

Healthcare Dive spoke to some industry mavens, and came up with a split picture. Some see turbulence ahead due to rising interest rates, a fluctuating market, and political instability leading to tighter purse strings, others see blue skies and lots of money flooding in from new investors in love with health, following the Amazons and Microsofts, fearing that they’ll miss out. Certainly, 2021 was more than warm. Both Silicon Valley Bank in the previous analysis and Rock Health came up with just under $30 billion in 2021 investment.

The feather in the wind: Rock Health’s numbers indicated skyrocketing exits–with SPACs nearly double that of IPOs. Funding hit record mega rounds of $100 million+ that spread to early rounds–10 Series B and one Series A. Mega money means mega pressure to perform in young companies. The SPAC highway increasingly narrowed to a two-lane road by end of year based on regulatory scrutiny and even some timing out (SPACs have to consummate a deal in two years). Exits for investors are to take back money or write off losses, if they get shaky about a company or category, even if they find a more attractive squirrel. Yet the fact is that $13 billion raised by VCs this month has to go somewhere–but will it be in health tech? Time will reveal all.  Also Healthcare Dive on the Rock Health year-end report.

News, deals, rumors roundup: Cerner’s DOD and VA go-lives, Akili’s ADHD therapy SPACs, Talkiatry’s $37M raise, Alto sings a $200M supper–and the Cigna-Centene rumors don’t stop

January 28, 2022 | by

While Cerner’s acquisition by Oracle is winding its way through regulatory approvals, their EHR implementations are moving forward through both the Military Health System (Department of Defense) and the Department of Veterans Affairs (VA).

  • Within the MHS, Brooke Army Medical Center and Wilford Hall Ambulatory Surgical Center, both in the San Antonio (Texas) Market, went live with MHS GENESIS on 22 January. The change most visible to patients is the transition from TRICARE Online to the MHS GENESIS Patient Portal which enables 24/7 access for visit notes, secure messaging, test results, appointment scheduling, and online prescription renewal. MHS covers military retirees, active military, and family beneficiaries. According to the MHS’s website, the goal this year is to get to halfway–to implement MHS GENESIS in more than half of all military hospitals and clinics. It’s been taking place since 2017 and, in true military fashion, it’s planned in waves. Coming up are Naval Medical Center Camp Lejeune in South Carolina on 19 March and William Beaumont Army Medical Center in El Paso in summer.
  • VA is moving far more slowly, just getting to its second hospital. The Columbus VA go-live has been pushed back from 5 March to 30 April, citing training slowdowns due to a spike in staff COVID cases. Walla Walla, Washington is set for after Columbus, but the date is to be confirmed. The first, failed implementation at Spokane’s Mann-Grandstaff VA Medical Center in late 2020 was the subject of Federal hearings and a complete redo in VA’s plans and procedures in cutting over from VistA to Cerner Millenium. TTA 28 July and previous. Federal News Network

Akili Interactive, which has developed tech-driven, game-based cognitive therapies for ADHD and other psychiatric and neurological conditions, has gone public through a SPAC via a merger with Social Capital Suvretta Holdings Corp. I, The transaction is expected to close in mid-2022. Akili will be listed on the Nasdaq stock market under the new ticker symbol AKLI.

The SPAC is expected to provide up to $412 million in gross cash proceeds and value the company at over $1 billion. Investors in the $162 million PIPE are Suvretta Capital Management’s Averill strategy, Apeiron Investment Group, Temasek, co-founder PureTech Health, Polaris Partners, Evidity Health Capital, JAZZ Venture Partners, and Omidyar Technology Ventures. The funds raised will support the commercial debut of EndeavorRx, a FDA-cleared and CE-marked prescription digital therapeutic for pediatric ADHD. The technology is termed the Selective Stimulus Management Engine (SSME) and will be rolled out for ADHD, ASD, MS, and MDD treatment.

TTA noted Akili last year in a trial of AKL-T01 at several hospitals for treatment of long-COVID-related cognition problems. Unfortunately, the writing in their SPAC release made this Editor feel like she needed a few treatments.

Mentalhealthtech (psychtech?) continues to attract funding. Psychiatric care startup Talkiatry topped off its July $20 million raise with an additional $17 million from Left Lane Capital for a $37 million Series A financing round. CityMD founder Dr. Richard Park, Sikwoo Capital Partners, and Relevance Ventures also participated. Talkiatry uses an online assessment for a preliminary diagnosis and then matches you with a participating psychiatrist.  It is in-network with payers such as Cigna, Aetna, UnitedHealthcare (Oxford Health Plan), Oscar, and Humana. Funding will be used to expand beyond NYC. Mobihealthnews

Digital pharmacy is also hot. Alto, which promises same-day filling and courier delivery, raised a $200 million Series E led by Softbank Vision Fund. Their total to date is over $550 million. Alto serves selected areas mainly in California, Nevada, Texas, and NYC (Manhattan, Queens, Brooklyn). Competitors Capsule had another raise of $300 million in April for a total of $570 million and Medly raised a $100 million Series B in 2020. Mobihealthnews

In the wake turbulence of Centene’s dramatic management shakeup last month [TTA 18 Dec], rumors continue to surface that insurer Cigna is interested in acquiring all, or possibly part, of Centene. Bloomberg News in publishing its article earlier this week cited ‘people familiar with the matter’ said that talks took place last year, but that they are not ongoing. Seeking Alpha picked this up, adding market activity boosting Centene. Perhaps the disclosure and the ‘denials’ align with what this Editor has heard–that it’s very much ongoing but under wraps.

A Centene buy makes sense, but only with Cigna. While Cigna is almost double the market value of Centene, it does not have the sprawling business model the latter has, nor do their businesses overlap much. However, some divestiture would be needed to do a deal, given the constrained regulatory environment in the US on the Federal and state levels. Any insurer merger is seen as anti-competitive, unless it is an acquisition of a smaller, struggling plan. 

It certainly would vault Cigna into the top rank of insurers with non-Centene branded exchange, Medicare Advantage and Medicaid plans, a provider network, an established MSO, and other lines of business including Magellan behavioral health management. Cigna might also value Centene’s international holdings, such as private hospitals Circle Health in the UK and Ribera in Spain. A sale would also create a quick and profitable ROI for Politan Capital Management, the activist investor company that initiated the retirement of 25 year CEO Michael Neidorff last month, rather than managing and reorganizing the sprawl of Centene’s businesses to make it more profitable.

Two healthcare data breaches of note: International Committee of the Red Cross and Jefferson Health

January 26, 2022 | by

Healthcare data breaches have become so commonplace that this Editor now leaves it to others to report. They all share the same characteristics–international hackers inserting ransomware in compromised systems and demanding billions in bitcoin, disgruntled employees erasing or taking home files, burglaries, inside jobs of various stripes. A steady drumbeat despite many efforts to secure against outside attacks and continously monitor systems, still there are plenty of legacy devices floating around hospitals and clinics using outdated computer software and initial setup passwords.

But this one hits a new high of heartlessness. The International Committee of the Red Cross (ICRC), headquartered in Geneva, reported that on 18 January that servers hosting the personal information of more than 500,000 displaced people receiving aid services from the Red Cross and Red Crescent Movement program had been hacked. The servers were located in Switzerland and were directly targeted. The 515,000 records were of people in the ‘Restoring Family Links’ program which aids missing people and their families, unaccompanied or separated children, detainees, and other people as a result of armed conflict, natural disasters, or migration. The information consisted of names, locations, and contacts.  In addition, log in information of 2,000 workers was also breached. Pray tell, where’s the monetary value in this? Or is there something more nefarious? These systems and their information have been taken offline, hampering this international program. ICRC ‘What We Know’, Becker’s Health IT, Healthcare IT News

A more ‘garden variety’ breach of 9,000 patients’ protected health information (PHI) took place in November at Philadelphia’s Jefferson Health. This was an insurance portal breach that accessed patient billing information with the intent of rerouting the payments from the hospital to themselves. The hacker in the process gained access to patient billing information, names, dates of treatment, treatment codes and costs, but not the jackpot of SSI and other financial information. The article does not disclose whether payments were successfully redirected.  Becker’s Health IT

News, acquisitions, funding roundup: Cerner CEO, CTO’s ‘stay-with-conditions’ deal, Quest buying Pack Health coaching platform, Wheel’s $150M Series C, mental health’s bubbly Lyra Health’s $235M and Big Health’s $75M

January 21, 2022 | by

Cerner CEO, CTO sticking around after Oracle acquisition, but there’s a catch. Cerner’s recently started CEO (August), Dr. David Weinberg, and their chief technology officer, Jerome Labat, both received ‘stay deals’ to remain with Oracle for 12 months from the closing date. The language in the SEC filing discloses the conditions. It’s a typical waiver of the right to leave for ‘good reason’ or ‘constructive termination’ if Oracle adversely changes their authority, duties, position, or responsibilities, which would trigger their ‘change in control’ severance. In return for the waiver, even if assigned to the data center in the Yukon, they will receive their severance benefits ($4.5 million and $2.3 million in cash respectively plus stock vesting) a year and one day later, even if they remain with Cerner. One wonders how far down the top management this goes. Becker’s Hospital Review, HISTalk

Quest Diagnostics is buying Pack Health, a chronic conditions care management, coaching, and patient engagement platform. Term details other than an all-cash equity deal were not disclosed. Pack coaches across 30 chronic conditions to address patient mental health, lifestyle behaviors, access to care, and social determinants of health (SDOH) factors. They market to payers for care management and life science companies for medication adherence. Pack will be added to Quest Extended Care, which includes Quest HealthConnect, a provider of in-person home-based risk assessment and monitoring services to supplement clinical care. The sale is expected to close in Q1. Release

Wheel, an Austin, Texas-based clinical platform that combines turnkey virtual primary care, behavioral health, urgent care, and diagnostic telehealth, announced a $150 million Series C, bringing total funding since 2018 to $215.6 million. The round was co-led by Lightspeed Venture Partners and Tiger Global. New investors Coatue and Salesforce Ventures participated in the round along with existing investors. Funds will be used to scale their platform. In 2021, they claimed 1.3 million patient visits in 2021 and is expected to triple visit volume by the end of 2022. Release

And corporate-focused mental health tech stays frothy with Lyra Health completing a $235 million Series F, bringing their funding to over $900 million with a valuation now pegged at $5.85 billion. Lyra is planning international expansion with all that loot. The round was led by Dragoneer, plus (again) Salesforce Ventures and existing investor Coatue Management. Lyra claims that it presently serves 10 million global employees. FierceHealthcare, release

Not-quite-as Big Health, which also claims millions of corporate and health system users including the NHS (offered for free in Scotland and select postal codes), raised $75 million in a Series C, led by Softbank Vision Fund 2 with ArrowMark Partners and existing investors Octopus Ventures, Gilde Healthcare, Kaiser Permanente Ventures (KPV), and Morningside Ventures. Big Health started in the UK, and our Readers there may be more familiar with their apps–Sleepio (first mentioned here in 2013! for insomnia) and Daylight (for anxiety). Big Health departed the UK for San Francisco and its greener money pastures back in 2015, noted here. Release

How Big Data failed public health during COVID

January 20, 2022 | by

Once upon a time, say about 2012, Big Data and Massive Crunching was going to show us The Way. Better health, diagnosis, prevention, behavior, and a whole lotta other things. Doctors, nurses, engineers, and marketers feared that their jobs would be taken over by the handsome specimen to the left.

So at the start of the COVID pandemic, the hope was that Big Data was going to map the outbreaks and contact trace so that people could go into self-lockdown after a ride on a bus or subway, inform distancing measures, and identify hot spots for public health organizations, no matter how remote. Academic researchers and nonprofit partners mobilized into the non-profit Covid-19 Mobility Data Network that started by analyzing smartphone location data shared by tech companies. The intent was that public health officials could analyze it for insights based on hard data rather than 6′ guesstimates. It would then be expanded with additional data from Big Tech and grow, grow, grow.

Where it ran a cropper was the ad tech companies’ incompatibilities in data gathering, reluctance to share proprietary granular information, and privacy–an international battleground. Facebook turned out to be clueless in mapping mobility as a proxy or input to calculate contact rates, since it released only percent changes in movement or staying at home. The professors also didn’t figure on proprietary non-compatible systems and peculiarities stemming from business needs. Facebook, for instance, released data that mapped only eight-hour chunks in UTC which didn’t, of course, take into account normal bedtimes. Google would state that trends in staying home were up, versus Facebook data that indicated downward trends. Contact tracing, as Readers know, turned out to be a gigantic flop.

While the Covid-19 Mobility Data Network has evolved into a broader project called Crisis Ready, with the goal of creating data-sharing agreements that activate during a public health crisis, closing the gaps in data for epidemiological research remains elusive in areas such as urban versus rural and with specific demographics. STAT, PLOS Digital Health

Connecting JPM and CES dots: Babylon Health tripling revenue in ’22 to $1 billion–how? And Bosch tiptoes back into healthcare.

January 19, 2022 | by

Dig for dots with your Editor….Babylon Health used their JPM forum last week to announce that with some US agreements signed, they expect by the end of this month to top $80 million per month, closing in on $1 billion this year, based on signing US value-based care agreements. The US agreements add an estimated 88,000 organic new members, bringing global managed lives to over 440,000. The $1 billion in revenue is nearly triple their 2021 preliminary closing revenue of $321 million. Interestingly, the US agreements were not specified in the release.

Does this tie in with the Higi acquisition [TTA 7 Jan], or are there others? Looking back on the Higi buy, we see one of the investors coming over from Higi is Glen Tullman, CEO of Transcarent and Managing Partner of VC 7wireVentures. His comments about Babylon in that release glow:

“Babylon’s innovative value and risk sharing models fit well with market leaders and innovators, including Transcarent, because they believe that, with the appropriate use of technology, data science, and good old-fashioned clinical care, you can impact the member satisfaction and quality of care, while, at the same time, reducing costs. This is the formula everyone has been searching for and the combination of Higi and Babylon bring us all one step closer.”

Higi is not large enough (though they claim ‘millions’) to boost Babylon’s revenues into the stratosphere, but some of Transcarent’s business very well might.

  • Transcarent earlier acquired BridgeHealth, a surgical and value-based benefits provider claiming 1 million members.
  • In October, Transcarent inked an agreement with Walmart to provide services for self-insured employers linking them to Walmart’s, including drug prescriptions.
  • Transcarent is on a funding roll of its own, with its own announcement at JPM in landing a $200 million Series C.

We’ll see if this Editor’s dots connect correctly….

Remember Bosch and health tech? Bosch was one of the ur-companies in remote patient monitoring with Health Hero/Health Buddy plus other telehealth/telecare businesses. Once upon an early 2010s time, they were a major supplier to VA Home Telehealth along with Viterion, Cardiocom, and Medtronic. After multiple setbacks, rounded up by TTA here, they exited European telehealth/telecare in January 2015 and shuttered Health Buddy six months later. So it’s déjà vu all over again to see Bosch technology used in a three-way project with Highmark Health in Pennsylvania and their Pediatric Institute of Allegheny Health Network (AHN) in Pittsburgh. AHN will be using Bosch’s SoundSee sensor-based tech to capture patient breathing audio that is then analyzed via Bosch’s proprietary AI and machine learning to detect pediatric pulmonary conditions. Clinical studies at AHN will be starting this quarter. Bosch’s Intelligent IoT group responsible for SoundSee is located at Bosch Research in Pittsburgh. Bosch has patented SoundSee for multiple applications in industrial and healthcare monitoring. Release, FierceHealthcare

Buried in the release is Bosch’s other step back into health tech. Vivatmo me, a breath-gas analyzer device that allows patients to accurately determine levels of inflammation, documenting them via an app–a very interesting concept–has been commercially available from March 2020 in Germany and Austria. It may be introduced in the US.

The Theranos Trials, ch. 1: Holmes sentencing to be 26 September, three mistrial charges dropped, appeal dates set

January 15, 2022 | by

Yesterday, Elizabeth Holmes’ next few months were outlined for her.

Her sentencing for the four charges on which she was convicted [TTA 4 Jan] will be 26 September by the trial judge, Judge Edward Davila. The delay in sentencing due to the ‘ongoing proceeding’ of the Sunny Balwani trial (scheduled to start 15 March) was revealed in a joint filing by the prosecution and Holmes’ defense. The filing confirmed that the prosecution would file a motion today (Friday) to dismiss the three deadlocked charges and that she will remain out of custody on a $500,000 bond secured by personal property, increased by request of the prosecution.

Judge Davila also set a deadline of 4 March for filing post-trial motions he will hear, such as an appeal by Holmes’ defense, with the hearing set for 16 June.  Fox News, Yahoo!News

Meanwhile, the Silicon Valley Home Town Newspaper, the Mercury News, waxed on how difficult life will be for Holmes’ baby after her incarceration, even in a minimum-security Federal prison (colloquially known as Club Fed). It is highly unlikely that she will face the extreme hardships of women facing hard time, imprisoned thousands of miles away from their families, or losing their children to foster care because there are no family caregivers. The Federal Bureau of Prisons tries to place low-risk prisoners like her within 500 miles of home. There is visitation time. Also cushioning this is Holmes’ own family and an affluent partner, Billy Evans, who has stayed by her side. Reportedly, they live with their son at a home rented on an estate in an affluent San Jose suburb, Woodside. But after the appeals (and money) are exhausted, the long sentence will likely be served, and then will come the tough part for the child growing up without a mother. 

What’s next for telehealth in the (almost) aftermath–and rating the US states on policies

January 8, 2022 | by

crystal-ballWhat’s in that cloudy crystal ball?  Last year, especially the first half, saw telehealth acquisitions, stock prices and valuations hit the roof. The roof proved to be high but sturdy, as they bounced right back down, not unexpectedly. 

But gee whiz, Fast Company’s article seems to be shocked, shocked at all this, calling it a bubble. This Editor sincerely doubts that any investor that tracked telehealth over the last 10 years would have NOT expected this ride on the rollercoaster after the urgent care and practice offices reopened starting in mid-2020 and worked slowly through 2021. The rebound, as with health insurance payers, took a few months to work through into 2021. Telehealth usage in 2021 receded steadily to single digits, and at last report to just above 4% of claims as of October 2021 (FAIR Health US claims data).  What remains is the continued dominance of mental health–62% for mental health codes. It’s turned out that Babylon Health‘s SPAC was the last of the major action for 2021, getting in under the wire in October. 

It’s obvious that investors will be more realistic in assessing telehealth companies, looking at the areas that sustained telehealth usage, such as behavioral health. Another surprising niche is LGBTQ telehealth–Grand Rounds’ buy of Included Health in May, which then led to the entire company, including Doctor on Demand, adopting the name [TTA 20 Oct].

The other move that telehealth companies are making is to take more of the patient than a few virtual visits. They’ve moved into offering primary care teams to patients in employer plans (Babylon360 and Teladoc’s Primary360). Amazon Care moved into in-home health and clinics with Crossover Health. Amwell acquired SilverCloud for expanding behavioral health capabilities internationally, and stuck a toe into care management with their Converge platform and acquiring startup Conversa‘s health coaching app. The flip side is retail health migrating into in-person and virtual primary care–CVS Health and Walgreens, via VillageMD.

What also held telehealth back for over a decade of less than 1% was reimbursement by Medicare, Medicaid, and private insurers. The pandemic broke through that barrier. While it has narrowed considerably, CMS will still reimburse audio-only telehealth for behavioral health services, addiction treatment, and in-home health visits. State policies on telehealth practices can positively influence telehealth growth for patients and physicians. Free-market organizations Reason Foundation, Cicero Institute, and the Pioneer Institute have reported on all 50 on several policy metrics: 

  • In-person requirements
  • Modality neutral (asynchronous or synchronous, technology including audio, video, store and forward, and remote patient monitoring.)
  • No state barriers
  • All providers can use telehealth
  • Independent practice (including nurse-practitioners)
  • No coverage or payment mandates
  • Cross-state compacts

Rating the States on Telehealth Best Practices

Short takes: 2022’s big kickoff with Babylon-Higi, Vera-Castlight buys; will funding slow down in ’22, eye-tracking telehealth for MS, vital signs tracking lightbulbs at CES 2022, and three catchups!

January 7, 2022 | by

Babylon Health closed out 2021 by acquiring health kiosk Higi for an undisclosed amount. Babylon had earlier invested in Higi’s Series B [TTA 30 May 20] and was reported in October to be exercising its $30 million option to buy Higi after closing their SPAC. Release

Vera Whole Health, an advanced primary care provider and clinic group based in Seattle, is acquiring Castlight Health, a data and care navigation platform. Vera will acquire Castlight in a $370 million all-cash deal. Strategic partners and investors include Anthem, Morgan Health (the JP Morgan Chase & Co business for the transformation of employee healthcare), Central Ohio Primary Care, and Clayton, Dubilier & Rice funds. Former Aetna chairman and CEO Ron Williams will become chairman. Release.

Which leads to the usual question…will funding in 2022 continue the hot streak of 2021? It’s one opinion, but Lee Shapiro of 7wireVentures, formerly with Livongo, is sensing a slowdown, citing increased interest rates (money), the US midterm elections (which don’t affect the rest of the world), less new money, and investors wising up on the length of time any healthcare or health tech investment takes to pay off. 2021 with 79 digital health M&As plus an abundance of SPACs that tailed off by end of year will be hard to match. Mobihealthnews

XRHealth, a telehealth clinic that provides treatments in patients’ homes based on virtual reality treatment, has integrated Tobii‘s eye-tracking technology into the XR platform and the Pico Neo 3 Pro Eye VR headset. XR Health provides rehabilitative and pain management therapies via VR. The Tobii system will enable treatment using the headset for multiple sclerosis (MS), Parkinson’s, and other neurological conditions. According to the release published in Multiple Sclerosis News Today, “detecting subtle changes in eye movement can help diagnose these diseases at an early stage, as well as assess disease progression and response to treatment. Tobii‘s eye-tracking technology is able to detect those changes in real time, providing data and insights to clinicians during therapy sessions.” Hat tip to Editor Emeritus Steve Hards

CES 2022 is on this week, far less splashy than before as an in-person/virtual hybrid event. Debuting at CES is the Sengled Smart Health Monitoring Light. Looking like a standard LED lamp bulb, it contains sensors that network and can take passive vital signs measurements of sleep quality, breathing, heart rate, and motion of occupants in the home. The more bulbs the better, of course. Whether or not they can detect falls, as the article touts, is likely an inference on motion. They feed into either Alexa or Google Assistant, plus Sengled’s app, using Frequency-Modulated Continuous Wave (FMCW) radar operating in the 2.4 GHz range. Expect it to be coming out towards the end of the year and probably twice the price of conventional LED smart bulbs. TechRadar Hat tip to Adrian Scaife via LinkedIn

Catching up…

Walgreens and VillageMD continue on the ‘go big or go home’ highway with nine more Village Medicals at Walgreens in San Antonio, Texas. Plans are to build 600 Village Medicals at Walgreens in more than 30 markets by 2025, growing to 1,000 by 2027. HealthcareFinance

Centene, the health payer conglomerate, finalized its $2.2 billion acquisition of Magellan Health, a major behavioral health management company. It will likely be CEO Michael Neidorff’s swan song, as an activist investor forced his retirement (at age 78 after over 25 years at the helm) this year and significant board changes. Magellan’s former COO and president Jim Murray will become Centene’s chief transformation officer, a new position, lead what they term the Value Creation Office as well as the Centene Advanced Behavioral Health division. Forbes, Centene release

And suitors with a spare billion or so may be lining up to buy IBM Watson Health. The first offers came in on 4 January with the winner to be announced possibly by end of the month. IBM spent over $4 billion over time to build up Watson Health, but now wants out, badly. Axios

The Trial of Elizabeth Holmes, ch. 17: looking inside the juror decision process

January 7, 2022 | by

How does a juror–and jury–process multiple counts, witnesses, a defendant, and an avalanche of information without drowning? ABC News interviewed Juror #6, Wayne Kaatz, an actor, voice talent, and scriptwriter. We rarely get a glimpse inside the jury box of a high-profile case. It’s well described, which isn’t surprising given that Mr. Kaatz is a writer, mostly for children’s programs. In short, “working class” show biz.

  • They grappled with the ultimately deadlocked three charges–and felt they had failed (Ch. 16)
  • Early on, they discarded the charges involving patients, considering Elizabeth Holmes ‘one step removed’ from them
  • They scored witnesses’ testimonies and Holmes on a 1-4 scale, from not credible to most credible. Adam Rosendorff, the lab director that the defense went after hard, scored a four. Holmes–a two.
  • They were sympathetic towards Holmes, finding her “likable”, with a “positive dream”. 
  • The decision to find her guilty on the four fraud counts centered on her “final approval” and that she “owned everything”.  

About the process, they selected a younger man as their foreman from the eight men and four women. They shared initial verdicts on paper scraps and laid out information on a timeline. The jurors got along well over the months-long trial culminating in 50+ hours of deliberation, working on puzzles and swapping sandwiches. 

Mr. Kaatz closed his thoughts: “It was an honor. It was a duty, I did it. I’m done.” Little drama, not ‘Law and Order’ or ‘Twelve Angry Men’. ABC News–and do read the interesting comments, but only halfway through before it devolves into hair-pulling on a wholly different event.

The Wall Street Journal’s follow-up (paywalled text, but audio is not) focuses on Juror #8 (Susanna Stefanek) finding the “smoking guns” as the altered pharmaceutical “endorsements”, singling out Pfizer’s, and the fictional financial projections.

Vox goes into Holmes as Hollywood will be seeing her, with Hulu and Apple treatments teeing up. The NY Times goes on about Holmes being a product of Silicon Valley culture–the puffery, the one-upmanship, and believing their own press releases. But for now, we can give it a rest…till Sunny Balwani’s trial starts.

Breaking–The Trial of Elizabeth Holmes, ch. 16: guilty on four charges of 11

January 4, 2022 | by

Breaking. Elizabeth Holmes, founder and CEO of Theranos, was found guilty on four charges of wire fraud of the 11 charges brought by the prosecution. The guilty charges are, according to the reports in the New York Times and the Mercury News (paywalled, but keep refreshing), all related to wire fraud against investors. Counts six through eight are fraud against specific investors. The TTA articles relating to each are linked.

  1. Count one of conspiring to commit wire fraud against investors in Theranos between 2010 and 2015
  2. Count six of wire fraud in connection with a wire transfer of $38,336,632 on or about Feb. 6, 2014. This was part of the $96 million PFM Health Sciences investment detailed in Chapter 9.
  3. Count seven of wire fraud in connection with a wire transfer of $99,999,984 on or about Oct. 31, 2014. This was the DeVos family trust investment (RDV Corp.) in Chapter 5.
  4. Count eight of wire fraud in connection with a wire transfer of $5,999,997 on or about Oct. 31, 2014, made by Daniel Mosley, a financial advisor to Henry Kissinger. Mr. Kissinger was an early investor and sat on the Theranos board (Chapter 6).

Each one of these charges carries time up to 20 years, but in Federal financial fraud cases, time is usually served concurrently. Judge Edward Davila of the US District Court, Northern District of California, will sentence at a later date to be announced.

It’s expected that Holmes will appeal. The issues of emotional and physical abuse, with Svengali-like control on her judgment, at the hands of Sunny Balwani were not enough for this jury to dismiss the key financial fraud charges. They clearly decided that Holmes was fully capable of engineering fraud, not just once but several times. But with the defense having seeded a backdrop of abuse, it may prove mitigating on appeal. (No, this Editor does not believe that Judge Davila will even refer to that during sentencing, having strictly advised the jury to not consider that during deliberations.)

Holmes was found not guilty on three fraud charges against patients and a fourth relating to advertising and marketing services to patients:

  • Count two of conspiring to commit wire fraud against patients who paid for Theranos’s blood testing services between 2013 and 2016
  • Count 10 of wire fraud in connection with a patient’s laboratory blood test results on or about May 11, 2015
  • Count 11 of wire fraud in connection with a patient’s laboratory blood test results on or about May 16, 2015. These two counts pertained to false results on HIV and prostate cancer.
  • Count 12 of wire fraud in connection with a wire transfer of $1,126,661 on or about Aug. 3, 2015 to Horizon Media for advertising and marketing services for the Walgreens launch.

Given the above, was The Verge (Chapter 15) correct in stating that patient fraud, with the concomitant distress and potential for injury, is less important than financial fraud? Or was the case less well made? 

No verdict was reached on an additional three charges relating to wire transfers in December 2013 by other investors. These apparently were the charges that the jury deadlocked on earlier today: 

  • Count three of wire fraud in connection with a wire transfer of $99,990 on or about Dec. 30, 2013. This was part of the investments made from 2006 to 2013 by private investor Alan Eisenman detailed in Chapter 8. Eisenman was a contentious and offputting witness, and will not have any satisfaction.
  • Count four of wire fraud in connection with a wire transfer of $5,349,900 on or about Dec. 31, 2013. This was an investment by Black Diamond Ventures headed by Chris Lucas, nephew of Don Lucas who was on the Theranos board (Chapter 6).
  • Count five of wire fraud in connection with a wire transfer of $4,875,000 on or about Dec. 31, 2013. This was an investment by the Hall Group.

One additional charge (nine according to the Times, 10 according to the Mercury News) was dropped. The Times article also provides a preview on the next trial–Sunny Balwani. Man of Mystery, or just a lucky sod who made a bundle of money from a dot.com?

The trial started on 8 September and concluded just before Christmas. Deliberations took about 50 hours. 

Also CNBC and ABC News. Let the opinion slinging begin!

Further insights on and thoughts about the Oracle acquisition of Cerner

December 22, 2021 | by

HISTalk, with its focus on health IT and generally short mentions without opinion on the news, in today’s issue includes some thoughts on the Oracle-Cerner deal, including a rare “Announcements and Requests” inviting reader thoughts on the acquisition’s effect on several issues. Also rare: a lengthy anonymous comment from a healthcare CIO.

A few highlights–your Editor recommends you go to the article for more:

  • Oracle’s free cash is far less than the purchase price at $23 billion. They will need additional financing to complete the Cerner acquisition.
  • Announcements and Requests: will customers on the fence between Epic and Cerner run towards the less uncertain choice? Will the Cerner VA and DOD business be affected? How does this affect Cerner’s implementations of cloud services, currently AWS versus Oracle’s Gen2, as well as healthcare’s usage of  InterSystems Cache versus Oracle’s relational databases? And will Oracle’s Voice Digital Assistant as the user interface to Cerner Millenium really fly?
  • From Change of Control: How key to the deal was CEO David Feinberg MD, who only joined in October? No matter what, he’s now a very wealthy man.
  • From On-Demand: Oracle is buying its way into healthcare. Cerner lost a lot of ground in executive changes and a less than effective CEO. (Editor’s note: This dates back to 2017–the illness and untimely death of Neal Patterson, the co-founder and CEO, at age 67 and president Zane Burke’s departure the following year after 20 years for the CEO spot at Livongo, which undoubtedly made him a wealthy man!)
  • From Anonymous Health System CIO’s Initial Thoughts: Their biggest problems are 1) people and process.”Cerner has struggled to maintain competent staff that understand healthcare and individual customer workflows. Throughout our implementations, we had major challenges with project management, availability of experienced staff, and the ability to help us make informed decisions.”  2) “If Oracle is going to help reduce the cost of healthcare, they also need to help find savings for their customers.” 

All these should be of concern to Cerner as they–and their people–try to maintain momentum until the acquisition closes. Customer uncertainty, staff competence, and Oracle’s lack of background in how healthcare operates (including a history of pulling some ‘fast ones’ around cloud licensing, as well as understanding clinician preferences such as Dragon as a voice assistant) are undoubtedly giving some investors–and hospital systems–pause. Hat tip to HISTalk. Our earlier coverage here.

One final comment from Editor Donna: Never underestimate the power of a CEO’s ego–especially one who is routinely compared to God, at least in TechWorld–in wanting One Last Coup to burnish his escutcheon, before that Long Sail Into The Sunset on his yacht Musashi.

Does the digital telecom switchover threaten the lives of the most remote old and disabled? (UK, updated)

December 21, 2021 | by

The UK’s recent preview of winter (which officially starts today), Storm Arwen followed by Storm Barra, was yet another exposure of the downside of the digital telecom switchover. As our UK Readers know, BT Openreach has been aggressively proceeding with the full conversion to VOIP by 2025 and closing the ‘broadband gap’ in rural and remote areas. Connecting them to the internet and more feature-filled VOIP service, including telecare services, has major advantages, especially where mobile service is sketchy or blank. 

Here’s the problem–power outages. According to the Energy Networks Association, 1 million homes and businesses in the northeast of England and Scotland lost power for days after Storms Arwen and Barra in late November, making it the worst storm in 15 years. Many of these homes were in rural villages and isolated areas. Power lines in these areas go down frequently in lesser storms that don’t have 100 mph winds and snow. When the power goes out, the VOIP goes out unless you have backup power. Phone lines no longer have their own power, as in the Public Switched Telephone Network (PSTN), equivalent to the US POTS (Plain Old Telephone Service or “copper”).

Add to this BT’s shortage of backup batteries. Digital phone systems in the US are usually installed with a backup battery, which isn’t cheap but sustains about 24 hours of basic voice service. Older models had special ‘brick’ batteries that you ordered from your phone provider that were around $50, newer models are powered by 12 D cell flashlight batteries that at least you can buy at the supermarket. Apparently, BT’s backup units are not only unavailable due to a global shortage, but also cost £85, a substantial charge to a pensioner–unless you live in a ‘not spot’ area without mobile service, in which case it’s free.

No power, no phone, no telecare, no PERS. But plenty of danger to thousands of older isolated adults, plus the frail, alone, and disabled. No connections to friends, carers, and emergency services for days, during a late fall snowstorm which made roads impassable. The storm may be early, but if this is a galloping start, there’s a whole winter to get through.

What about mobile service as a backup? Rural areas are, in bright sunny weather, plagued by spotty service. Supposedly nearly all areas in England have a minimum of 2G service sufficient to call 999. But when the cell phone masts go down, as they did in the storm, and the power to charge the phone is out, the backup is out of commission. One unnamed resident of Grizedale in the Lake District put a molto fino point on it. “It’s embarrassing that a supposedly world-leading country has such a shonky infrastructure. I had full 4G in the mountains of Transylvania a few years ago.”

Ofcom, the regulator, positioned the storms as exceptional. “Even in those circumstances, our rules are clear that there should be protections in place for people to call the emergency services” (999). Rules are one thing, reality another. Judge for yourself as we head into winter. BBC News Hat tip to Editor Emeritus Steve Hards.

Editor’s note for our US Readers: The situation is not that different for us. Nationally, POTS service is deteriorating and not being replaced by providers, forcing changes to VOIP. (I can personally speak to this–20 miles from NYC.) And if you believe that we’re well covered everywhere by cell phone service, you haven’t been to Lancaster County, Pennsylvania, much less further west in the area the locals call ‘Pennsyltucky’. That area also skews older–18.2% of state residents are age 65+. The US also has a wide variety of extreme weather–ice storms, blizzards, ‘snow bombs’, hurricanes, tornadoes, and tropical storms.