Pull the plug on Oracle Cerner in the VA! Two House Representatives urge return to VistA, send bill to Veterans’ Affairs committee

Hold your hand up if this comes as a complete surprise. A Congressman who was the top Republican on a subcommittee overseeing technology at the Department of Veterans Affairs (VA) has evidently had quite enough of the Oracle Cerner problems in implementing Cerner Millenium. Rep. Matt Rosendale of Montana has introduced H.R.608, titled “To terminate the Electronic Health Record Modernization Program of the Department of Veterans Affairs”. It would pull the plug on Oracle within 180 days, dissolve the VA Electronic Health Record Modernization Integration Office, and restore VistA/CPRS. In other words, back to the drawing board.

It was co-sponsored by Rep. Mike Bost of Illinois who is the chairman of the House Committee on Veterans’ Affairs, where the bill was referred on 27 January. Rep. Rosendale is now the chair of the House Veterans Affairs Subcommittee on Technology Modernization. 

This follows on last week’s two-day slowdown of both the VA and MHS Genesis systems, last summer’s Congressional hearings and the roasting that Oracle Health’s head Mike Sicilia and VA heads received over the OIG report on the ‘unknown queue’ that created 149 adverse events, and October’s delay in further Oracle Cerner rollouts in the VA from January 2023 to June.

While the likelihood that the bill would pass both House and Senate, and be signed into law, is low, H.R. 608 is one very heavy and clever cudgel for getting Oracle–and the VA staff involved with the conversion–to Pay Attention! Fix The Problems! There’s also leverage far beyond the VA EHR. Oracle has multiple Federal contracts which could be jeopardized or defunded. Stay tuned to further developments in VA’s Tower of Trouble and Oracle’s Mound of (Acquired) Misery.  Hat tip to HISTalk for the heads up, actually obtaining a screenshot of part of the bill which has not yet been posted on Congress.gov.  FCW.

Using wearables to monitor biomarkers related to neuropsychiatric symptoms post-traumatic event

Tracking biomarkers related to post-traumatic outcomes via a wrist-worn wearable. A January study published in JAMA Psychiatry (full text) monitored 2,021 participants who experienced traumatic stress exposure, mainly from car accidents but also physical assault, sexual assault, serious falls, and a mass casualty incident. 

The Advancing Understanding of Recovery After Trauma (AURORA) study examined adverse posttraumatic neuropsychiatric outcomes after traumatic stress exposure, especially among socioeconomically disadvantaged patients. Qualifying patients used the (Alphabet) Verily Life Sciences’ Study Watch for a minimum of 21 hours a day over the eight-week tracking period, starting with screening and qualification in the emergency department (ED). 

  • Participants used smartphones to complete a rotating battery of questionnaires consisting of 10 common adverse post-traumatic neuropsychiatric sequelae (APNS) symptom domains: pain, depressive symptoms, sleep discontinuity, nightmares, somatic symptoms, difficulty with concentration, thinking, or fatigue, avoidance of trauma reminders, trauma reexperiencing, anxiety, and hyperarousal.
  • Using the wearable’s accelerometer feature, it monitored eight significant biomarkers for pain, sleep, and anxiety. A reduction in 24-hour activity variance was associated with greater pain severity. Six others were associated with rest-activity measures indicative of changes in pain over time and one with repeated sleep-wake disruption indicative of changes in pain, sleep, and anxiety.

Depending on the data plus self-reporting on the questionnaires, the patient could be recovering or worsening post-event. The study concluded that “wrist-wearable device biomarkers may have utility as screening tools for pain, sleep, and anxiety symptom outcomes after trauma exposure in high-risk populations.” This Editor notes that over time, wearable monitoring was coupled with plentiful subjective information.

The group was selected from an initial 19,019 patient pool drawn from 27 emergency departments. 3,040 patients met the study criteria including being within 72 hours of the trauma, aged 18 to 65 years, and were able to speak and read English. They also provided informed consent and completed baseline assessments for a final completion group of 2,021. Most of the participants were female, half of the study were African American, 34% were white and 11% were Hispanic. Nearly 80% of the study did not have a college degree, while 64% earned $35,000 per year or less. The study was headed by a team at the University of North Carolina at Chapel Hill.  Also Mobihealthnews

CVS, Walgreens, Walmart….Dollar General health clinics?

Can Dollar Tree and Family Dollar be far behind? A possible new entrant to the onsite clinic wars may be Dollar General in piloting DocGo clinic vans in three Tennessee stores. DG Wellbeing will be providing urgent, preventative, and chronic care at three locations, two days a week each, with two in Clarksville and one in Cumberland Furnace, from 10am to 8pm based on current FAQs. DocGo vans will be located adjacent to the stores, in the parking lot. Appointments and walk-ins, Medicaid, Medicare, TRICARE, some commercial insurances, and cash are accepted.

Certain lab tests plus blood work are done either onsite or sent out. Medical staff on the van can write prescriptions. Some referrals (e.g. imaging) are done while other referrals are not available.

As to their strategy, you have to hand it to Dollar General. They get some good press from this. They are starting small in working through the details, outsourcing the healthcare part, and seeing if there’s sufficient demand to 1) expand and if promising 2) model the customer demographics–what we marketers call customer personas. If it doesn’t work, no Theranos-sized holes in their budgets–it’ll be GoneGone to DocGo.

Dollar General started to make moves into health about two years ago by noting the scarcity of health products in rural and underserved areas. They started to add more healthcare products (what they know about) on their shelves as part of the initial phase of the DG Wellbeing initiative and appointed a chief medical officer, Dr. Albert Wu. Currently, Wellbeing is in 3,200 stores (of 18,000+) with up to of 400 items per store. This past July, DG created a healthcare advisory panel including Dr. Patrick Carroll, chief medical officer of Vida Health; Dr. Katy Lanz, chief strategy and product officer at Personal Care Medical Associates and former chief clinical officer at Aspire Health; Dr. Von Nguyen, clinical lead of public and population health at Google; and Dr. Yolanda Hill, a board-certified physician in pediatrics and adolescent medicine. On Dollar General’s third quarter earnings call last December, CEO Jeff Owen noted the expansion of stores and the test of the DocGo vans to expand their services into rural health. Watch out Walmart, CVS, and Walgreens! Healthcare DiveForbes, Mobihealthnews

Their healthcare provider, DocGo, last week announced a partnership with Redirect Health, a platform offering directed to enterprises that provides on-demand, urgent mobile care to businesses in New Jersey and New York. DocGo SPAC’d on Nasdaq in 2021 and, unlike other SPACs, hasn’t cracked. Other than one wobbly point last year, it’s generally held its share price within a dollar or two of its initial offering range, which in this past year has to be considered good news.

Interesting pickups from JPM on CVS, Talkspace, Veradigm backs Holmusk, ‘misunderstood’ Babylon Health; six takeaways

Out of a decidedly soggy JPMorgan healthcare conference that concentrated mainly on pharma and biotech, there was some news in the downtrodden health tech and related areas. Selected from FierceHealthcare’s Heather Landi’s take:

CVS Health’s open checkbook for the right companies in primary care, provider enablement, and home health was a throwback to the palmy days of 2020-21. A big announcement at JPM was their investment in in-home kidney care and end-stage renal disease management provider Monogram Health. Their Series C raise of $375 million was lead-funded by CVS Health, Cigna Ventures, Humana, Memorial Hermann Health System, and SCAN.  Release, Mobihealthnews This added up to a busy January for CVS with leading Carbon Health‘s $100 million series D [TTA 11 Jan] and $25 million for Array Behavioral Care [TTA 12 Jan].

Talkspace, the cracked telemental health SPAC most recently rumored to be in buy talks with Amwell, touted their “defined, very significant path to profitability within a short period of time.” New CEO Jon Cohen, MD, a surgeon and veteran healthcare exec, touted the strength of the telemental health model, the effectiveness of their asynchronous messaging therapy for depression and anxiety,  and their market change from consumer to employers and health plans. Talkspace has some distance to go, quickly, with a loss through Q3 2022 of $61 million on revenues of $89 million and a share price today of $0.74, which means eventual delisting from Nasdaq. Is a quick buy in their future?

Veradigm, still settling in on their new corporate name, has its own bet on behavioral health data on the analytics side, with a lead investment in Holmusk‘s $45 million Series B. Holmusk will pull in de-identified patient data from Veradigm to their NeuroBlu Database.  Release

And on to Babylon Health, where Ali Parsa must feel like Eric Burdon of the 1960s blues group The Animals in the depth of being ‘misunderstood’Dr. Parsa promises a path to breakeven by end of 2024.  Babylon’s revenue is on target to hit over $1 billion. They operate in over 15 countries with well over 5 million transactions. But their SPAC cracked too from a high of $272 per share after listing in October 2021 to today’s price just above $11, leaving a lot of investors in the lurch. Even though Q3 revenue increased by $288.9 million versus $74.5 million in 2021, an increase of $214.4 million or 3.9x, and the Q3 loss correspondingly widened to $89.9 million, the loss was significantly lower as a percentage of revenue. They are also converting from a foreign private issuer to a domestic, planning a reverse share split, and selling non-core businesses like the Meritage IPA [TTA 22 Nov 22] It’ll either be more correctly understood by Mr. Market or…be bought?

Arundhati Parmar in MedCityNews had a tart take on the proceedings, leading with the convergence of therapeutics with devices and data, Primary Care-Primary Care-Primary Care, billion-dollar bolt-on acquisitions that may be good for biopharma (but not necessarily so in health tech where integration is leading), and innovative therapies that don’t save but actually cost mo’ money. All of which is no surprise to our Readers. And why is there a JPM every year? Healthcare insanity may be catching.

Teladoc laying off 6%, reducing real estate, in move to “balanced growth” and profitability

Following on Teladoc’s mildly upbeat announcement of improved Q4 2022 revenue, now the layoffs. Today, employees were informed that 300 positions, about 6% of Teladoc’s workforce, will be departing. Timing was not disclosed. Based on the employee memo and disclosure in their Securities and Exchange Commission (SEC) 8-K filing, the cuts will affect only non-clinical staff and eliminate ‘redundant’ positions acquired in their 2020 merger with Livongo. CEO Jason Gorevic’s statement to employees cited the “challenged economic environment”, transitioning to “balanced growth of revenue and profitability,” and bottom-line growth. Gorevic cited a path to profitability via refocusing on commercial business under the ‘whole person care’ concept covering Primary 360, chronic care management, and mental health, as well as the BetterHelp consumer behavioral health business. 

Released employees will receive severance including payouts based on years of service and grade level, 2022 bonuses, subsidized healthcare benefits under COBRA, BetterHelp therapy access, and job search assistance. Their office space footprint is also being reduced in select markets.  These and other Q4 actions will not have a material impact on 2022 financial operating results.

This Editor, who as a marketer been made redundant a few times due to company acquisitions and once in a business closure, is puzzled that Teladoc carried overlapping Livongo staff for two years after the August 2020 acquisition. The typical non-senior executive in the acquired company usually gets anywhere from ‘depart close of business’ to six months depending on their function or project assignment. Rarely, one finds a berth and even that can be temporary until the next reorg. Perhaps Livongo staff were needed for enterprise customers or Teladoc staff didn’t have the app expertise. The Livongo integration was reportedly an exceptionally bumpy one as well. This Editor also recalls Mr. Gorevic’s statements last May at the time of their Q1 2022 $6.6 billion writeoff of the Livongo acquisition: the competition in telemental health, the rising cost of paid search advertising, expensive keywords driving towards direct-to-consumer telehealth driving up the cost of acquisition, and the long cycle of closing B2B deals [TTA 4 May 22]. Amazing how these costly factors were not cited. In fact, Teladoc has launched TV advertising for Livongo, and for enterprise customers has created a new app that debuted at CES earlier this month that integrates primary care, mental health, and chronic condition management.

In any case, talking about profitability is now fashionable, based on the memes at JPM around partnerships and robust ecosystems. Even if profitability remains way off there on the distant horizon. Also Healthcare Dive, Mobihealthnews

Weekend short takes: Theranos’ Holmes post-prison mental health + more on Shultz and Balwani; global M&A, funding roundup

It’s been a bumpy road this second week of the New Year, with the passing away of genius guitarist Jeff Beck, Lisa Marie Presley, and historian Paul Johnson, the unrelenting Harry Hullabaloo, a rain-soaked downer of a JP Morgan healthcare conference, plus a certain 1967 Chevrolet Corvette convertible (Goodwood Green, 327 ci/350 hp) keeping garage company with…classified files.

Elizabeth Holmes’ post-prison future already being planned–and it’s all about her. But not as before. After her 11 years and three months (pending appeal) in (whatever) Federal prison she will be assigned to, her three years of supervised release are being planned for her. In an ‘exclusive’, celebrity website TMZ reports that Holmes will be required to complete a mental health program that she will pay for (details undisclosed). If her probation officer has any reasonable suspicion that she’s violating the terms of her release, her home, office, vehicle, and property will be subject to police search, including DNA collection. No details in the article beyond that. At this point, Holmes should be working with prison consultants (yes, there are such people, and they are not your legal team) in setting her expectations for Club Fed Life, planning her day-to-day in prison, and readying a reentry plan draft that can make her probation a bit easier on all.

In related Theranos news, a soon-to-be published biography of George Shultz, a government supremo during the Nixon and Reagan Administrations, claims that by then aged 90+ emeritus supported Holmes to the point of fixation. In a nearly 20-year tenure at Stanford’s Hoover Institution, respected and honored by all but with no medical expertise, he suddenly became a huge backer of Holmes, helped her get financing through his network of contacts, joined the board, and invited her to family gatherings. Grandson Tyler Shultz, who joined Theranos with his grandfather’s encouragement, became one of several whistleblowers, leading to a family rift never quite mended at the elder’s death at 100. More in the Guardian

Sunny Balwani also filed a motion this week to stay out of prison during his appeal process, arguing he presents no flight or public safety risk. The Law360 article on the 10 January 25-page filing is unfortunately paywalled.

London-based Huma is buying Frankfurt-based Alcedis, a data specialist for clinical trials. Huma will form an advanced clinical trials division with digital solutions across the entire development pipeline, from early stage through to Phase IV hybrid and fully decentralized trials. Terms were not disclosed. Formerly the mysterious Medopad [TTA 28 May 21], Huma seems to have settled into decentralized clinical trials and disease management using wearable tech and apps. Last March, AstraZeneca took a $33 million [£25 million] share in the company, with Huma acquiring their asthma and heart failure patient platform. Release, Crunchbase, Mobihealthnews

In Singapore, Amplify Health is acquiring AiDA Technologies. AiDA has developed machine learning tech to automate underwriting, claims processing, and detect fraud, waste, and abuse. Amplify has similar lines of business plus digital health programs for chronic disease management. Terms were not disclosed. Fintech Singapore. Also covered in the same Mobihealthnews article are:

  • India’s Dozee receiving funding from the UK government’s British International Investment (BII) for India’s MillionICU initiative. The BII investment will be used to convert 6,000 conventional hospital beds in about 140 public hospitals’ ICUs to stepdown beds. The MillionICU initiative’s goal is to convert one million ICU beds. Express Healthcare (India)
  • Taiwan’s largest hospital, Chang Gung Memorial, has adopted TPIsoftware’s SysTalk.Chat for AI-powered text and smart voice-enabled customer service. The Apo voice and text agent assists 80,000 ‘person-times’ per month in patient intake and setting appointments, admissions, and medical information. This saves 50% of time in appointment scheduling via texts or calls that happen within 2~3 minutes.  AsiaOne (PRNewswire release)

Rock Health puts a kind-of-positive spin on digital health’s ‘annus horribilis’ 2022–a boring 2023

Your Editor will be blunt. 2022 was a bucket of cold water, a bursting of bubbles, and generally an annus horribilis (as the late Queen Elizabeth referred to 1992, 30 years prior) for digital health, healthcare tech, and healthcare in general.

Here are the highlights of Rock Health’s 2022 full-year report on digital health funding for US-based digital health companies, published late last week and presented this week at JPM, through the gimlet eye of your Editor: 

Total funding for 2022 was $15.3 billion. There were 572 deals, averaging a deal size of $27 million.

  • 2022 was just over half in activity compared to 2021’s “to the moon”: $29.3 billion over 738 deals averaging $39.7 million.
  • 2022 also barely made it past the pandemic year of 2020 with $14.7 billion over 480 deals averaging $30.6 million.
  • 2022 Q4 fell into a hole: $2.7 billion versus 2021’s $7.4 billion

If 2021 matched prior growth trends instead of the bubble it was, 2022 would have been viewed as flat or slightly down. 

Late stage mega deals fell into the same hole. In 2022, 35 digital health startups raised rounds of $100M or more, compared to 2021’s 88 and even 2020’s 43. 

The Covid-driven investment boom across digital health that characterized 2021 is over. The economy with a 6-8% rate of inflation, energy shortages in much of the world, supply chain disruptions, rising interest rates on money, and the rising possibility of recession led to investor cold feet. It ended the 2019-2021 takeoff and started a down cycle.

Recalibration to a ‘more sustainable run rate’ when it comes to investment

“Disrupting healthcare” may sound good, but it has a spotty track record of success. What’s attractive long term? Incremental transformation within conventional healthcare operations that in this Editor’s view cut time, cost, increase reliability, simplify processes and/or workflows, improve interoperability, reduce operational burden, or improve communication. Preferably, a combination of several of the previous!

D2C startups are particularly vulnerable to the economy–they run hot, multiple companies jump in, and then they’re cold. They have to invest a lot of money to establish a presence with consumers and that money is no longer cheap or available. Some with a decent consumer footprint can focus on B2B entry, though that is a long-buy cycle move.

Most companies will be focusing on the near term, with some of the smarter ones planting some ‘seeds’ for the future

A witty note in their report: “In the current VC climate, strong horses will beat out unicorns…though investors run the risk of betting on the wrong equine.” (Editor’s note–it may be hard to tell the difference. And unicorns have horns that poke bubbles.)

What was hot?

  • Series A deals, the conservative bets of VCs. Yet, in Rock Health’s view, these may be riskier: “investors are more likely to pay more on a risk-adjusted basis for a startup than its later-stage funders, twisting the risk-adjusted valuation upside down.” 
  • In clinical indications, mental health stayed top of the pops. Cardiovascular and oncology rose along with dark horse reproductive and maternal health. What fell? Diabetes.
  • In value propositions (sic), on-demand healthcare and R&D flipped positions from 2021. Dark horses nonclinical workflow, disease monitoring, and care coordination moved into the top 5

And what players had problems? Health systems and the tech giants seeking to move into healthcare and away from ad-based or transactional revenue. As we’ve seen, Amazon dumped Care and is facing scrutiny over One Medical, Alphabet is cutting Verily, and Meta is overall pulling back. Microsoft seems to be concentrating on incrementals and Apple has other concerns over sourcing and patents.

Rock Health’s conclusion is ‘kind-of-positive’. (What, you expected doom and gloom?) “We expect that 2023 will be built up on slow, steady, and maybe even boring strategies for healthcare startups and enterprises alike: managing cash, re-structuring to accommodate revenue volatility, and investing in technology infrastructure.”

Mid-week roundup: Teladoc gets BetterHelp to boost Q4 ’22 revenue; fundings for Array, Paytient, Telesair, three others; layoffs hit at Alphabet’s Verily, Cue Health

Teladoc may finish 2022 better than expected, at least in revenue. At the JPMorgan (JPM) annual healthcare conference, CEO Jason Gorevic shared a revised but still preliminary projection that Q4 would finish up a tick higher than expected–between $633 million and $640 million in revenue, versus their projection during Q3 that the low side would be $625 million. FY2022 revenue was updated to be the $2.403 billion to $2.41 billion range. The big contributor? Their mental health app BetterHelp. Their growth, according to Mr. Gorevic, is “staggering’. Silicon Valley Bank (SVP) analyst Stephanie Davis calculated a growth rate of 43% for the business, up from previous management targets. Teladoc’s optimism is tempered by the no/slow growth economy projected for this year, both direct to consumer and corporate. To help boost the latter, it is launching a new app for health plan members and company employees access to all of Teladoc’s clinical programs. Healthcare Dive, Becker’s

Despite the uncertain economy, funding continues in various rounds, especially in still-hot areas such as remote/virtual behavioral therapy and payments, but nowhere near the bubbly level of 2021:

CVS Health’s open piggybank helped to fund NJ-based Array Behavioral Care’s $25 million Series C. Other investors included HLM Venture Partners, OSF Healthcare System, Wells Fargo, and three others. Array will use the funds to scale its virtual behavioral therapy platform.  Mobihealthnews, Crunchbase

In that interesting area called healthcare fintech, the cleverly-named Paytient now has an additional $40.5 million in Series B funding, bringing their total to $63 million. Paytient provides corporate employees, health plan members, and health system patients with a card-based Health Payment Account (HPA) that includes a line of credit. Release, Mobihealthnews 

In hospital-to-home respiratory care, still in stealth Telesair raised $22 million in Series A funding, led by Pasaca Capital with participation from existing and new investors such as Honeywell Investors, ZhenCheng Capital, Shangbay Capital plus three others. According to the release, funding will be used for the commercialization of the Bonhawa Respiratory Humidifier for use in the ICU and the development of a second-generation, revolutionary product for hospital-to-home. Mobihealthnews   

Also highlighted in Mobihealthnews‘ article is a $10 million Series B for ModifyHealth, which delivers prepared, medically tailored meals and provides advice from dieticians. ModifyHealth provides certified low FODMAP meals for those with irritable bowel syndrome or small intestinal bacterial overgrowth (SIBO), as well as Mediterranean, low-sodium, and gluten-free (celiac disease) diet meals. Censinet, a developer of healthcare cybersecurity software, also landed $9 million in a funding round led by MemorialCare Innovation Fund, Rex Health Ventures, and Ballad Ventures plus five others for a total of over $22 million.  Release  CARI Health, a San Diego startup developing a wearable sensor for medication management, gained $2.3 million in seed funding from the San Diego Angel Conference plus four other funds. Release

The pace of layoffs may have slowed, but the numbers have not.

Alphabet’s Verily health tech development unit is discharging 15% of current staff, estimated at 240 people.  This is part of a reorganization designed to move to financial independence from Alphabet/Google. It’s categorized among Google units as ‘Other Bets’ which is appropriate given that so far, their bets haven’t hit any jackpots. An example we covered back in 2015-16 was a glucose monitoring contact lens developed with Alcon, an on-the-face of it Preposterous Idea that died about that time. Current discontinued areas include remote patient monitoring for heart failure and micro needles for drug delivery. Employees were told to leave the office for the remainder of the week; further information including separation would be sent to them via email. Since 2017, it has raised over $2 billion. You wonder where it went. CNBC

Cue Health, a home diagnostics company, is cutting 388 employees, about 26% of its workforce, effective March. This is in addition to an 170-person manufacturing worker layoff during the summer. Cue bet heavily on growth of its at-home molecular Covid testing packs sold direct on a membership plan [TTA 12 Nov 2021], plus to pharmacies and to businesses. It expanded from about 100 workers in 2020 to more than 1,500. That growth has cratered along with the entire testing market for a pandemic that is no longer there. According to Mobihealthnews, they have submitted to the FDA for new test such as an EUA for a combination flu and COVID-19 diagnostic as well as de novo clearances for its flu and COVID-19 standalone tests. 

 

CVS works their plan in Oak Street Health buy talks, Carbon Health $100M investment + clinic pilot; VillageMD-Summit finalizes (updated)

CVS, Walgreens, Amazon, Walmart all chasing the same type of companies to expand their service continuum. During their Q2 2022 earnings call, CVS Health announced that they were determined to enhance their services in three categories: primary care, provider enablement, and home health. And CVS’ CEO Karen Lynch was pretty blunt about it: “We can’t be in the primary care without M&A” (sic). So CVS’ latest moves should come as no surprise.

Oak Street Health: CVS is in talks with this value-based care primary care provider for primarily older adults in Medicare and Medicare Advantage plans. With 100 offices nationally, it’s not too small, not too large to combine with other operations. As a public company traded on the NYSE but puttering along in the $13-$22 per share range since the fall from a high of $30 in August, the news of CVS’ interest has boosted them above $28 and a market cap of just under $7 billion. Although Oak Street has previously maintained that they have no interest in a sale, it has never been profitable and is on track to lose $200 million this year. That is not a good look for CVS but they are working a strategy. Previously, CVS walked away from primary care group Cano Health [TTA 21 Oct 22]. Bloomberg News (paywalled) reported that CVS could pay $10 billion which would be over $40 a share. Healthcare Dive, Reuters

Carbon Health: CVS leads their Series D with a $100 million investment plus piloting Carbon Health operations in primary and urgent care clinics in their retail stores. However, the deal came at a price. Last week, prior to the investment announcement, Carbon announced that it would wind down lines of business in public health, remote patient monitoring, hardware, and chronic care programs, cutting 200 jobs in addition to a June cut of 250, at the time about 8% of their workforce. Carbon will now concentrate on their clinic core business. 100 are presently located across Arizona, Nevada, Colorado, Kansas, Florida, Massachusetts, and California (San Francisco, Bay Area, and San Jose).

In the last two years, Carbon raised $350 million and grew by acquiring four clinic chains. It diversified by buying Steady Health (chronic care management in diabetes) and Alertive Health (remote patient management)–both businesses they are departing. Reportedly last month they bought Inofab Health, an Istanbul-based digital health platform for patients with asthma, chronic obstructive pulmonary disorder, and cystic fibrosis. Crunchbase, FierceHealthcare, Mobihealthnews, SF BizJournal,

CVS is still working its Signify Health acquisition past the Department of Justice (DOJ) and the Federal Trade Commission (FTC). It went into a Second Request for information in late October under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR), which adds 30 days to the review timetable after the Second Request has been complied with. There is some competitive overlap between CVS and Signify in home health management and accountable care organization (ACO) operations, and some divestitures may be necessary. A closing in Q1 as planned seems optimistic. Acquiring Oak Street may complicate matters since their clinics operate as a Direct Contracting Entity (DCE, now ACO REACH). This present administration is not friendly towards healthcare consolidation of any type, especially with entities participating in Federal programs. (See UHG’s acquisition of Change Healthcare, with court approval being appealed by DOJ.) Reaching (so to speak) deep into CMS programs could be a red flag.

Walgreens’ VillageMD finalized their Summit Health acquisition for $8.9 billion yesterday (9 Jan) (updated). Now with 680 provider locations in 26 markets and 20,000 employees, the group adds to VillageMD’s primary care practices specialty practices in neurology, chiropractic, cardiology, orthopedics, and dermatology plus 150 City MD urgent care locations. 200 VillageMD locations are already adjacent to Walgreens locations. Walgreens Boots Alliance (WBA) and Evernorth, the health services business of Cigna, were the two investors. WBA raised full-year sales guidance from $133.5 billion to $137.5 billion. The current chair and former chief executive officer of Summit Health, Jeffrey Le Benger, MD, will be the interim president until VillageMD finds a permanent president reporting to VillageMD CEO Tim Barry. Release, RevCycleIntelligence, Forbes  At this point, Walgreens hasn’t moved forward with the rumored acquisition of ACO management services organization Evolent Health [TTA 1 Oct 22], which would be far more complex. 

Amazon is still awaiting Federal approval for One Medical as well as in multiple states (Oregon only the first; expect scrutiny). It is also closing Amazon Care and opening asynchronous non-face-to-face telehealth service Amazon ClinicWalmart continues on an internal strategy of opening Walmart Health clinics in underserved areas. Earlier in 2022, they announced the opening of more health ‘superstores’ in Florida, having established 20 in Arkansas, Illinois, and Georgia starting in 2019. Walmart’s approach to retailing health services and products, since getting serious about it in 2018, has wavered with multiple changes of strategy and executive departures [TTA 22 Nov 22]

Theranos trial updates: Holmes’ freedom on appeal bid opposed; Balwani files appeal to conviction

Lost between the holiday and Happy New Year merriment were two year-end court filings by legal teams for Theranos’ Elizabeth Holmes and Ramesh ‘Sunny’ Balwani, who hope to stay free for at least part of 2023.

Elizabeth Holmes: In a joint filing on 30 December, Federal prosecutors and Holmes’ defense requested a hearing by Judge Edward Davila of the District Court on Holmes’ request to remain free on bail until her appeal in the Ninth Circuit Court of Appeals is resolved. In the filing, the prosecutors agreed to file their objections to her freedom by 19 January. Holmes’ defense had filed her three-page appeal on 3 December with 10 reasons why there should be a new trial. The full legal brief is due on 3 March. Both prosecution and defense had requested that the hearing by Judge Davila take place on 17 March.

Holmes was convicted on four counts of defrauding investors, with her sentence of 11 years and three months taking place on 18 November 2022. She remains free on bail until 27 April, her surrender date. The US Bureau of Prisons has not made public where she will spend her sentence. There is also a question of restitution of $121 million yet to be decided in court. SiliconValley.com

Sunny Balwani: His appeal was filed on 20 December, on the two-week deadline after sentencing, also in the Ninth Circuit Court of Appeals. Unlike Holmes, Balwani was convicted on 12 counts, including two counts of patient fraud. The appeal reportedly will be on the grounds of Judge Davila’s rulings and decisions adverse to Balwani during the case. Other possible factors: the weakest counts are the two on patient fraud where testimony and proof were indirect–Balwani had little to do with patients–and that he left in 2016 before the collapse. His sentence was 12.9 years (155 months). Like Holmes, his restitution is yet to be decided. Balwani is currently free on bail, with his surrender date 15 March. No motion to remain free on bail while the appeal is in progress has been disclosed, nor the Federal prison location decision. Yahoo!Finance

For those craving a recap of l’affaire Theranos and perhaps to reflect on it, Yahoo!Finance has produced an hour-long video documentary, ‘Culture of Hype’, on Theranos as a product of Silicon Valley culture. It was produced before their convictions and sentencings. It ends with discussion of how the multiple conflicts between an admittedly naïve founder vision, transparency, and the need to finance said vision in multiple iterations in any startup or early stage company can lead to borderline executive behavior and company collapse. (And yes, your Editor has seen it happen firsthand.) Was Elizabeth Holmes a victim, a sociopath, or something in between? She will have time to contemplate it, as this Editor continues to maintain that her chances of reversing her conviction and going free are as small as that nanotainer she is modeling above.

Amazon-One Medical gains conditional OK in Oregon–a preview of coming scrutiny?

Amazon has approval for the $3.9 billion One Medical acquisition from the Oregon Health Authority (OHA)–but with conditions.  OHA’s task is to review transactions such as these in how they affect patient cost, access, quality, and equity. OHA’s key comments were positive on cost and access, equivocal on quality, and expressed concern on equity (28 December PDF here):

Cost: “…the transaction will not meaningfully change Amazon and One Medical’s market share for primary care services in Oregon. Commercial insurance payment rates for One Medical are negotiated through the partnership with Providence [Health & Services].” In the Conclusions, they noted that “Amazon, with its advanced supply chain and purchasing power, may generate efficiencies and savings for One Medical, though any savings would not necessarily be passed to consumers.

Access: The few One Medical clinics were found to be in urban areas where there is good access to healthcare. “The entities have also stated that they plan to expand One Medical’s network of clinics, which may provide additional access to services.”

Quality: “OHA has limited insight into quality for One Medical locations, since its [five] Portland clinics opened in 2020 and 2021 and One Medical does not participate in some programs that require regular quality reporting.” However, they noted that “Amazon’s business model also has the potential to impact quality.”

Equity: concern on “One Medical siphoning off commercially insured patients with higher payment rates from clinics that serve more Medicaid and Medicare-covered patients.”

Conditions for approval are in reporting on these areas. Amazon is to report on the services it provides and the quality of care, plus any governance or organizational changes, every six months for five years after the acquisition closes. OHA then must perform follow-up analyses on the impact of the transaction on the commitments Amazon makes on cost, access, and quality of care. 

One Medical’s limited Oregon footprint proved to be helpful to Amazon in gaining OHA approval–but may be a Preview of Coming Difficulties. One Medical operates in 29 markets including NYC, Los Angeles, Boston, and Atlanta, with 815,000 members and 8,000 company clients. States like New York, Massachusetts, Connecticut, and California are not exactly pushovers for approval, with California alone having two approval entities. Then there are the Feds. Back in September, Amazon disclosed the Federal Trade Commission (FTC) was scrutinizing the acquisition, with no resolution announced yet. One Medical also owns Iora Health, which has a full-risk value-based care model for patients in Medicare Advantage (MA) and Medicare shared savings across seven states–HHS and CMS territory. Two more shoes yet to drop: the SEC and the Department of Justice (DOJ). DOJ of late casts a gimlet eye on any healthcare merger–just ask UnitedHealth Group and Change Healthcare, which they are still fighting.

This Editor will stand by last year’s prediction: Iora will be sold either before or immediately after closing. The higher cost/higher care needs Medicare market doesn’t fit with Amazon’s monetization model. It is less profitable and requires advanced risk management, a skill set that Amazon doesn’t have and likely doesn’t want. MA and MSSP (Medicare Shared Savings Program) routinely face regular Federal scrutiny, which Amazon doesn’t do well either. Amazon can use the cash; it is facing major league bad press with its planned layoff of 18,000 workers, about 6% of its 300,000-person corporate staff. One wonders if many of its shareholders (other than Jeff Bezos) approve of this massive investment in a relatively small provider organization.  Reuters 

Mobihealthnews, FierceHealthcare

Telehealth extensions signed into US law with Federal FY 2023 omnibus bill

Jammed into the final moments of the now-ended 117th Congress before Christmas was the passage of the FY2023 ‘omnibus’ $1.7 trillion Federal budget bill. This bill did at least several good things for those of us concerned with US telehealth, as it extended provisions for Medicare reimbursement that become guidelines for commercial health plans and help to cement telehealth as a permanent part of health care delivery. There is also a tax provision that affects high-deductible health plans. 

Their passage is important as the Covid-19 Public Health Emergency (PHE) is set to expire on 11 January and no movement has been publicly discerned for its renewal. In the fall, the Department of Health and Human Services (HHS) notified US state governors that there would be at least a 60-day notice before the PHE ends. It is unknown whether this notice has been given.

To summarize the two-year extensions that go to the end of 2024:

  • Expanding originating and geographic site to include anywhere the patient is located, including the patient’s home
  • Expanding eligible practitioners qualified to furnish telehealth services, including occupational therapists, physical therapists, speech-language pathologists, and audiologists
  • Extending the ability for federally qualified health centers (FQHCs) and rural health clinics (RHCs) to furnish telehealth services
  • Delaying the in-person requirement for mental health services furnished through telehealth, including the in-person requirements for FQHCs and RHCs
  • Extending coverage and payment for audio-only telehealth services
  • Extending the Acute Hospital Care at Home (AHCAH) initiative, pioneered by Johns Hopkins two decades ago. It also requires the HHS Secretary to publish a report comparing AHCAH programs with traditional inpatient care delivery. 
  • Extending the ability to use telehealth services to meet the face-to-face recertification requirement for hospice care
  • Extending high deductible health plan (HDHP) safe harbor exceptions for telehealth services in high-deductible health plans.

The final bill did not extend the Ryan Haight in-person waiver for the remote prescription of controlled substances. As mentioned in our earlier article, this is a wise move in this Editor’s view given the abuse of this waiver by certain telehealth organizations. ATA/ATA ACTION release.

The HHS Secretary will be required to submit a report to Congress on the utilization of the above services. The interim report is due in October 2024 and the final report in April 2026, according to the American Hospital Association. Affecting hospitals and practices in the bill:

  • It delayed the statutory Pay-As-You-Go (PAYGO) Medicare 4% sequester for two years, preventing the $38 billion in Medicare cuts that otherwise would have taken effect in January.
  • Partial relief from a 4.5% reduction in physician reimbursement rates starting on 1 January. The legislation reduced the cut to 2% for 2023 and around 3% for 2024.

HealthcareFinance

Other features of this bill having an effect on healthcare and telehealth (from Infrastructure Report Card):

  • $455 million for the expansion of broadband service, including $348 million for the ReConnect program, a series of grants administered by the US Department of Agriculture for the construction, improvement, or acquisition of facilities and equipment needed to provide broadband service in eligible rural areas. This could help rural areas and hospitals in provider-patient and provider-to-provider consults.
  • $1.65 billion for the National Institute of Standards and Technology (NIST), an increase of $424 million, or 34%, above the FY 2022 enacted level. Specific funding is allocated for the measurement labs and research at $953 million, a $103 million or 12% increase above the FY 2022 enacted level. The goal is to spur research advances in cutting-edge fields like carbon dioxide removal, artificial intelligence, quantum information science, and cybersecurity.

The bill was signed into law by the president on vacation in St. Croix, USVI. Given the bumpy start of the 118th Congress today, these are at least not up for grabs.

Split decision! ITC rules that Apple violated AliveCor patents; enforcement held for PTAB appeal

David v. Goliath slugfest continues. The International Trade Commission (ITC) confirmed its Initial Determination [TTA 28 June] that Apple Watches infringed AliveCor patents on ECG readings. This Final Determination counters the US Patent and Trademark Office’s Patent Trial and Appeal Board’s (PTAB) December ruling that found not only in favor of Apple’s patents but also invalidating AliveCor’s three patents in question [TTA 8 Dec].  

The ITC’s findings come under a 60-day presidential review from 22 December. The penalty on Apple comes under a Limited Exclusion Order (LEO), a cease and desist order. It sets a bond in the amount of $2 per unit of infringing Apple Watches imported or sold during this review period. However, enforcement of the ruling will be delayed until the review of AliveCor’s appeal of the PTAB ruling wends its way through that process in the Northern District of California, which is expected to take place in early 2024, a year from now.

A running dispute since 2020. Once upon a time, AliveCor and Apple worked together to give ECG functionality to the Apple Watch. This ended after the Apple Watch 4 incorporated ECG readings. This resulted in court actions related to patents starting in early 2021 [TTA 29 Apr 21, 9 July 21]. Apple is now up to the Watch 8, incorporating more and more cardiac and health monitoring features. AliveCor has also moved on with financing with a GE Healthcare-backed Series F this past August, the KardiaMobile 6L, and the KardiaMobile Card. As of today, it has over 170 patents.

As this Editor remarked in December, going after a rival’s patents is an often necessary but risky business that can backfire. Right now, David has moved Goliath to a draw now, with further matchups this year into next. AliveCor release, Mobihealthnews      Hat tip to Dr. Dave Albert, founder and Reader.

News roundup: DDoS attacks may be ‘smokescreen’, DEA slams Truepill with ‘show cause’, telehealth claims stabilize at 5.4%, Epic squashes patent troll, Cerner meeting exits KC, MedOrbis, Kahun partner on AI intake

Readers won’t get out of 2022 without one last cybercrime…article. DDoS attacks–distributed denial of service–escalated worldwide with Russia’s invasion of Ukraine in February. (Ukraine and military aid is a hot topic this week with President Zelenskyy’s visit to the US and Congress speech.) Xavier Bellekens, CEO of Lupovis, a cybersecurity company and a cyberpsychologist (!), postulates that DDoS attacks, as nasty as they are, may be a smokescreen for far more nefarious and damaging attacks. While IT goes into crisis mode over the DDoS, other attacks and information gathering on systems preparing for future attacks are taking place. Russian cyber groups focus on large organizations and move down the line into the most vulnerable, using both manual and automated approaches. Worth reading given the vulnerability and IT short staffing in healthcare organizations. Cybernews

The fallout from Cerebral and Schedule 2 telehealth misprescribing expands. The Drug Enforcement Agency (DEA) issued a ‘Show Cause’ to online pharmacy Truepill for inappropriate filling of ADHD Schedule 2 medications, including Adderall. A ‘Show Cause’ order is an administrative action to determine whether a DEA Certificate of Registration should be revoked, which could put Truepill out of business. The red flag for the DEA: 60% of  Truepill’s prescriptions–72,000–filled between September 2020 and September 2022 were for controlled substances, including generic Adderall. Truepill was Cerebral’s primary mail order provider, though they also used CVS and Walmart. The company stopped filling Cerebral’s ADHD prescriptions in May 2022.

In the order, the DEA cites that “Truepill dispensed controlled substances pursuant to prescriptions that were not issued for a legitimate medical purpose in the usual course of professional practice. An investigation into Truepill’s operations revealed that the pharmacy filled prescriptions that were: unlawful by exceeding the 90-day supply limits; and/or written by prescribers who did not possess the proper state licensing.”

The company stated in an emailed statement that they were fully cooperating with the investigation. If it does move to a hearing, Truepill’s chances of a successful defense are statistically low.

Truepill also fills prescriptions for Hims & Hers, GoodRx and Mark Cuban Cost Plus Drug Company. It was valued in its 2021 funding round at $1.6 billion. Companies in telemental health and prescribing of Schedule 2 ADHD medications, such as Cerebral and Done Health, are under enhanced scrutiny over their business practices [TTA 1 June]. Mobihealthnews, DEA press release, HISTalk, Digital Health Business & Technology

Telehealth medical claims stabilize. FAIR Health’s latest reports for August and September report that the percent of medical claims coded as telehealth are back up to 5.4%. June and July dropped slightly to 5.2% and 5.3% respectively. Also steady are that the vast majority of claims are for mental health services. In September, they were 66% of diagnoses far ahead of ‘acute respiratory diseases and infections’ at 3.1%. In procedure codes, psychotherapy accounts for over 43%.

A patent troll Epically bites the dust. Back in the early to mid-2010s [TTA’s index here], patent trolls (technically non-practicing entities which have no active business) presented a significant threat to early and growth-stage health tech companies. One, MMR Global (which apparently no longer exists), was notorious for buying up EHR and PHR-related patents and then filing patent infringement lawsuits against both small and large healthcare organizations with similar patents–and their users–that were generally monetarily settled. But NPEs are still active. One in south Florida, Decapolis Systems, used the same techniques as MMR Global had, suing in this case multiple Epic customers for patent infringement. Epic not only defended its customers but also sued Decapolis in the US District Court, Southern District of Florida. The court found that both Decapolis patents were invalid, ending what Epic termed ‘vexatious patent litigation’. Decapolis had successfully sued 24 other entities, including other EHRs, which settled. Owned by an inventor, this company will have to find another line of honest business. Epic release, Thomson Coburg

Oracle’s message to Kansas City: no more Cerner meetings for you. And maybe more. Cerner’s site for its annual customer/partner conference since 2007 has been in Kansas City, attracting about 14,000 visitors. Not only will it be integrated into Oracle CloudWorld in Las Vegas, 18-21 September, it’s been retitled Oracle Health with no mention of Cerner. The loss to local KC business is substantial–estimated to be in the $18 million range. While it’s logical to integrate it into the massive CloudWorld conference, it’s also another message to KC after Oracle’s sudden real estate downsizing that Cerner’s presence there will shrink…and shrink..as it’s absorbed into Oracle Health, and further confirmation that the Cerner name is gradually being sunsetted. KansasCity.com, HISTalk

A new (to this Editor) specialty care telehealth company, MediOrbis, is partnering with Kahun for an AI-enabled digital intake tool. This is a chatbot capable of conducting an initial medical assessment. Based on the patient’s answers and Kahun’s database of about 30 million evidence-based medical knowledge insights, it provides a summary for the physician before the telehealth visit and highlights areas of concern. Mobihealthnews  MediOrbis also has partnered with remote care/engagement Independa to add its capabilities to Independa’s HealthHub on their LG TVs.

Telehealth two-year extensions included in US Federal ‘omnibus’ budget bill

Expanded telehealth access extended for two years. The ‘omnibus’ fiscal 2023 spending bill before Congress Thursday contains extensions for four areas of improved national telehealth access developed during the COVID-19 Public Health Emergency (PHE) starting in January 2020. Because they apply to Medicare and high-deductible health plans (HDHP), they become guidelines for commercial health plans and help to cement telehealth as a permanent part of health care delivery.

The two-year extensions include:

  • Retained expanded reimbursable access to telehealth for Medicare beneficiaries put into place during the PHE
  • A two-year delay in implementing the Medicare telemental health in-person requirement
  • Extension of safe harbor provisions to offer telehealth as part of HDHPs with Health Savings Accounts (HSAs)
  • Extension of the Acute Hospital Care at Home Program. This waiver permits some emergency department and inpatient hospital patients to be treated from their homes. 

At this time, the PHE is set to expire on 11 January 2023. It has been extended every 90 days since January 2020 and may be extended again. The bill did not extend the Ryan Haight in-person waiver for the remote prescription of controlled substances, a wise move in this Editor’s view given the abuse of this waiver by certain telehealth organizations. It does request the Drug Enforcement Agency (DEA) to promulgate final regulations specifying the circumstances in which a Special Registration for telemedicine may be issued for controlled substances, and the procedure for obtaining the registration.

Another wise move on Congress’ part in this monster 4,000+ page, $1.7 trillion spending bill is to further prohibit the creation of a national patient ID for healthcare that supposedly would facilitate EHR interoperability. 

The bill is supposed to come before a lame-duck Congress at the eleventh hour before their Christmas leave on Thursday. Some opposition has coalesced due to wasteful earmarks covering pet projects that are included in the (unread by most representatives) bill and the fact that a new Congress with a change of party control in the House will be seated in January. However, for those of us in the US telehealth business, these inclusions are not controversial nor wasteful, and if the omnibus bill fails for some reason, will likely be included in any short-term extensions which are typical in keeping the government running. ATA release, POLITICO Future Pulse

Few specialty telehealth visits require in-person follow up within 90 days: Epic Research study 2020-2022

35 million visits make the case that virtual visits can stand alone, even in medical specialties–but how much was the pandemic a factor? Epic Research, a public benefit corporation owned by Epic Systems Corporation, analyzed telehealth consults over 26 months in a dual team study. The study found that most patients did not require an in-person follow-up appointment in that specialty within 90 days. The dual team study (two teams working independently) reviewed US EHR data collected from 1 March 2020 through 31 May 2022.

There was an extremely wide spread by specialty both in the number of visits and in-person follow-up within the three-month window. 

Looking at the study findings:

  • The lowest in-person follow-up percentage was in genetics at 4%, followed by nutrition at 10%; the highest–unsurprisingly–was obstetrics at 92%.
  • Far and away, the specialty with the greatest number of telehealth visits, over 4.3 million, was mental health and psychiatry. Their in-person follow-up was 15% of that number. That ‘cadence of care’ cited in the study report could be in part due to state medical regulations and insurance guidelines requiring in-person review, especially when prescribing Schedule 2 (those with a high possibility of abuse and dependence) or even Schedule 4 drugs.
  • Other specialties falling below 25% of in-person follow-up were endocrinology and neurology (both with 1 million telehealth visits), plus diabetes services, nephrology, pulmonology, medication management, gastroenterology, rheumatology, and addiction.
  • Cardiology and surgery, with both at 1.4 million telehealth visits, surprisingly had follow-up percentages around 43%
  • Above 50% in follow-up are geriatrics and fertility, both of which require more in-person examination. Geriatrics also covers a broad range of chronic condition care management in patients.

In looking at the numbers, this Editor will point to three situational factors unique to the pandemic period and its aftermath that may skew these findings on in-person follow-up visits to a lower range: 

  1. Most medical offices in the US closed from the start of the pandemic (about March 2020) and did not reopen until mid-year. Many health specialty practices and psychiatric clinics did not reopen for in-person visits until the fall or even later.
  2. Online mental health consults took off like a rocket–and are coming back to earth with greater scrutiny of prescribed Schedule 2 drugs (see Cerebral Health, Talkspace, et al.)
  3. Continuing patient apprehension on in-person visits into this year
  4. The continuing of public health emergency (PHE) compensation for telehealth visits into 2022 both in Medicare and private insurance

A flaw in the article is that these points are not considered in influencing in-person visits in the future.