Week-end short takes: Change Healthcare/UHG breach notification starting (updated); fundings for Pomelo Care, Marigold Health, Humata Health

Change Healthcare finally starting notifications, but not yet to consumers. A press statement today from Change/UnitedHealth Group confirmed that the long process of notifications has started with hospitals, insurers, and other customers. Individuals and practices will not be notified until late July. Change confirmed that the Blackcat/ALPHV cyberattack exposed names, addresses, health insurance information, and personal information like Social Security numbers, but at the individual level investigation isn’t finalized. At this point, they have reviewed over 90% of impacted files and have not seen signs that doctors’ charts or full medical histories were taken. Technically, UHG has made the 21 June deadline stated in the Hassan/Blackburn Senate letter [TTA 19 June] but not within the 60-day HHS-OCR window, which opens them up to an HHS fine. After paying a cyberransom of $22 million in bitcoin and uncounted (to us) millions in rebuilding systems, HHS’ fine may look like the lesser cost of doing business. The Change website also contains a very carefully worded ‘HIPAA Substitute Notice’ that reads like a consumer data breach notification. AP via Yahoo! News UK   One wonders if there’s a fair amount of ‘buyer’s regret’ going on at UHG in fighting so hard to buy Change. Due diligence would have helped over that year-plus.

Update: The Centers for Medicare & Medicaid Services (CMS) announced earlier this week that the provider financial assistance program will be ending 12 July as billing activities have largely resumed. It has advanced over $2.55 billion in payments to Medicare Part A providers and $717.2 million to Part B providers. FierceHealthcare

Fundings this week:

Virtual maternity support platform Pomelo Care scored $46 million in Series B funding. Lead investors are Andreessen Horowitz (a16z) and First Round Capital with participation from Stripes, BoxGroup, Operator Partners, and SV Angel. Pomelo’s markets for virtual fertility, pregnancy and newborn care from preconception through a baby’s first year services are employers, health plans and providers. The company claims 3 million covered lives across 46 states through their commercial and Medicaid health plan partners. Release, Mobihealthnews

Telemental health provider Marigold Health now has an $11 million Series A. Marigold is structured as an anonymous social network where people with mental health and substance use conditions provide peer-based support. Lead investors for the Series A are Rock Health and Innospark Ventures. Additional participants are the Commonwealth Care Alliance (CCA), Wavemaker360, Stand Together Ventures Lab, Epsilon Health Investors, Koa Labs, VNS Health Plan and KdT Ventures. Their substance use disorder (SUD) programs are currently available to 25,000 members in Delaware, Rhode Island, and Massachusetts. The new funding will be used for expansion to at least four additional states by the end of 2025. Release (Marketwatch), Mobihealthnews

Humata Health, which has developed AI-based technology to automate prior authorizations for payers and providers, closed an unlettered $25 million funding round. Lead investors are Blue Venture Fund (representing the majority of BCBS plans) and LRVHealth (representing nearly 30 health systems and payers), with participation from Optum Ventures, .406 Ventures, Highmark Ventures, and VentureforGood. The funding will be used to broaden its generative AI technologies, expand their provider base, and begin to partner with payers and delegated entities. Humata bought the base prior authorization technology from Olive AI out of its bankruptcy [TTA 31 Oct 2023]. Its founding chairman and CEO is Jeremy Friese, MD, who had been Olive AI’s president for their payer business after selling Verata Health, also in the prior authorization automation area, to Olive.  Release, FierceHealthcare

A lighter update: Pepper the Robot’s comeback at San Diego State University–now AI-equipped for mental health

Our old friend Pepper and sidekick Bernard are back…this time with AI. A new research initiative at San Diego State University’s James Silberrad Brown Center for Artificial Intelligence (JSBAIC) is equipping Pepper (left, SDSU photo) and Bernard (right, file photo) with AI capabilities targeted to early recognition of mental health concerns.  The JSBAIC, with the help of a $5 million grant from the James Silberrad Brown Foundation, has already equipped Pepper with functionality that can recognize changes in emotional states, such as speech patterns, voice pitch, or even eye pupils. The purpose would be to assist clinicians with a robotic early warning system for a potential mental health episode. JSBAIC researchers are working with Sharp HealthCare in San Diego (also a beneficiary of the Brown Foundation) in a clinical trial focusing on children with bipolar disorder. The JSBAIC is a spinoff from SDSU’s Fowler School of Business’ Management Information Systems area. JSBAIC interview with NBC San Diego, Daily Aztec  Hat tip to HIStalk 6/19/24

Pepper and Bernard were originally created by Aldebaran Robotics (now Softbank). TTA has been following their development since at least 2016 when tested as robotic greeters at the Ostend, Belgium AZ Damiaan hospital. Softbank is actively marketing Pepper for uses in healthcare, education, hospitality, banking, and retail. Bernard (NAO) is a personal teaching assistant. Pepper has also appeared before the House of Commons select committee on education [left, TTA 25 Oct 2018] to mixed reviews and earlier fainted during a star turn at CES.

 

 

 

News roundup: VA extends Oracle Cerner for 11 months; Amwell founders swap jobs; Alphabet’s Verily pivots to Lightpath with GLP-1, retiring Onduo; UnitedHealth hasn’t notified on Change breach

To no one’s surprise, the Department of Veterans Affairs (VA) extended its contract with Oracle Cerner for another 11 months. This is per the new contract relationship that started last year, resetting from the original five-year contract that started in 2018 to five one-year terms, with mandatory annual reviews and renewals [TTA 18 May 2023]. Technically, the contract expired in May but VA extended it for one month as discussions continued over the next one-year term. This second option period expiring May 2025, according to the VA release, is focused on the following for the EHR modernization (EHRM):

  • Supporting the existing six facilities with the Oracle Cerner EHR
  • Achieving the goals of the reset and driving towards future deployments
  • Increased accountability across a variety of key areas, including minimizing outages and incidents, resolving clinician requests, improving interoperability with other health care systems, and increasing interoperability with other applications to ensure an integrated health care experience
  • Supporting value-added services, such as system improvements and optimizations
  • Achieving better predictability in hosting, deployment, and sustainment
  • Fiscal responsibility 

The plan is to resume site deployments in FY 2025, likely in year 2025, after reset goals are met. Seema Verma, Oracle Health’s new executive vice president and general manager, said that “VA’s intent to resume deployments in the next fiscal year is a significant milestone that reflects the hard work our collective teams have done to improve the system today, as well as confidence in our shared ability to continually evolve the EHR over time to meet the needs of both practitioners and patients.” NextGov/FCW, FierceHealthcare, Healthcare Dive, Oracle release

Is there much choice for the VA in the matter? Not really. VistA can be updated but remains non-interoperable with the Military Health System’s (MHS) Cerner-Leidos EHR. But can Oracle Cerner be fixed up and debugged to work for VA’s vastly different needs and smoothly deployed within the contract duration? That jury is still out in the view of the VA and Congress.

The Brothers Schoenberg swap positions at Amwell. Roy Schoenberg, MD, MPH, will transition immediately from his role as president and co-CEO to move to executive vice chairman of Amwell’s board of directors. Ido Schoenberg, MD, will become the sole CEO. The brothers co-founded the company in 2006. Ido’s quote closing the release is interesting in demonstrating the shift from investment without profits to getting on the path to profitability:  “This transition represents a natural evolution for our company as we shift from a period of intense R&D investment to an operational focus aimed at achieving greater efficiencies, optimizing cash flow and delivering profitable growth while maintaining our dedication to enabling our clients’ aspirations.” Roy is credited with developing Converge which is their next-generation integrated platform. If Teladoc is finding it difficult to transition from the stand-alone, transactional, urgent care service they and Amwell pioneered, into an evolved market that has incorporated virtual capabilities into multiple types of care models, whither Amwell’s future? More thoughts in TTA 2 May, 9 April

Alphabet (Google)’s once-visionary Verily now jumps on the GLP-1 bandwagon with Lightpath. Verily’s latest pivot to the highly trendy weight loss area is termed as a metabolic solution as part of a “personalized chronic care solution for health plans and members”.  Lightpath will start as Lightpath Metabolic, a four-part program that includes Metabolic Intensive (diabetes management), Weight Loss Intensive, Metabolic Improvement, and Metabolic Achievement. The Verily platform integrates data from health records, connected devices, and other care points to deliver “personalized pathways, suggestions, and nudges to health plan members” virtually along with health coaches and an advanced licensed clinical team. The current virtual chronic care management platform, Onduo, will be retired by 2025.

Once upon a time (2021, sigh), Verily was Google’s skunk works for advanced health tech with Google Health being the marketing and merchandising arm for clinical and consumer products. Google Health was broken up in August 2021 and Verily faded into the Alphabet background with the occasional joint venture and clinical pilots, with Onduo being their most marketable product. Google seems to have little direction for Verily other than to keep it alive. And given the competition plus a greater understanding of the long term effects of the GLP-1 drugs in the weight loss area, the GLP bandwagon is up for a shaky ride in the next year. Release, FierceHealthcare

And very strangely, UnitedHealth Group hasn’t notified Health and Human Services’ Office of Civil Rights (HHS-OCR) about the ransomware data breach at Change Healthcare, nor the individuals affected. The notification to OCR is required under HIPAA to be within 60 days of the date of the incident. UHG is over the deadline by two months, calculating from 21 February. CEO Andrew Witty wilted before double-barreled Senate and House hearings in May and UHG lost a fight to put the notifications for the breach onto providers [TTA 5 June]. Senators Margaret Wood Hassan (D-NH) and Marsha Blackburn (R-TN) sent a joint letter on 7 June to Andrew Witty, CEO of UnitedHealth Group, urging him to send a breach notification letter that notifies OCR, state regulators, Congress, the media, and health care providers that it intends to complete all breach notifications on behalf of all HIPAA-covered entities, individuals and businesses affected, by 21 June. That’s Friday. UHG continues to maintain that they still do not know the extent of the breach. The Medical Group Management Association (MGMA) also sent a letter to Mr. Witty on 12 JuneDon’t hold your breath for UHG sending millions of letters. Becker’s, HealthExec

Done CEO, president arrested, charged with $100M fraud on Adderall distribution in first Federal case on telemedicine prescribing (updated)

Done effectively done at the C-level, but not done in business yet. Last Thursday, Ruthia He, the founder/CEO, and David Brody, listed as the clinical president of Done Global (Done), were arrested in California on a Federal indictment filed in the US District Court for the Northern District of California. They are charged with providing easy online teleprescription access to Adderall and other Schedule II stimulants through patients paying a monthly subscription fee and skirted the normal restrictions provided in the Controlled Substances Act (CSA) and other regulations. By providing easy access and raising subscription fees, He and Brody are charged with generating over $100 million in revenue by arranging for the prescription of over 40 million pills from 2020 into 2023, during the pandemic when the Ryan Haight requirements were temporarily suspended by the DEA. 

Given the multiple counts of conspiracy to distribute controlled substances and distribution of controlled substances, the charges may earn them a maximum 20 years in Federal prison. One would also expect a clawback of payments made by subscribers, health plans, and Federal programs. The latter two, according to the DOJ release, amount to $14 million alone.

The Done indictment is the first Federal prosecution of criminal drug distribution related to telemedicine prescribing by a digital health company. In the 2020-2023 period, Done was a seed stage company, cited in the indictment as misrepresenting its size. Its current backers are Craft Ventures, F7 Ventures, and Offline Ventures but no additional rounds are listed on Crunchbase or other sources. He was a former product designer at Facebook and she was involved as an investor in or founder of various startups before Done according to her LinkedIn profile. David Brody, MD, is a psychiatrist listed as the chief medical officer of Connectix Health and as a self-employed consultant in Collaboration Care, with no reference to a position at Done. 

According to the Department of Justice release, He and Brody:

  • Targeted drug-seeking users through social media buys in the tens of millions of dollars.
  • Intentionally structured the Done platform to facilitate access to Adderall and other stimulants. This is evident from their current website which emphasizes ADHD. 
  • Instructed Done prescribers to prescribe Adderall and other stimulants even if the Done member did not qualify or they were not medically necessary. They also mandated that initial encounters would be under 30 minutes. 
  • He put into place a monthly auto-refill function for subscribers without further check-ins.
  • Discouraged Done prescribers from follow-up care. The compensation structure for prescribers solely paid on the number of patients receiving prescriptions–not for medical visits, telemedicine consults, or time spent after the initial consult.  
  • Conspired to defraud pharmacies, Medicare, Medicaid, and commercial insurers by dispensing Adderall and other stimulants to Done members, who also continued to pay subscription fees.

Further, “He and Brody allegedly persisted in the conspiracy even after being made aware that material was posted on online social networks about how to use Done to obtain easy access to Adderall and other stimulants, and that Done members had overdosed and died.” 

Done was singled out in June of 2022 when Cerebral was facing Federal investigation and a grand jury subpoena, actions that continue today but haven’t proceeded to an indictment. At that time, Truepill (also under DEA scrutiny on Schedule II, TTA 22 Dec 2022), CVS, and Walmart Health refused to fill prescriptions by both Cerebral and Done. With Cerebral facing investigation, Done wasn’t far behind. By September 2022, according to The Wall Street Journal, Done was being investigated by the Drug Enforcement Agency (DEA). The Verge

He and Brody are charged with reacting to that investigation by obstructing justice: deleting documents and other communications, encrypting their messages versus using company email, and failing to produce documents to a Federal grand jury.

Despite Cerebral’s far higher profile and volume, even with an ongoing investigation not only on prescribing but also on ad trackers [TTA 9 Feb 2023], the prosecution of Done’s head executives on criminal drug distribution charges is the first brought by the Justice Department against a digital health company for violations related to the CSA and drug prescribing regulations plus fraud.

In this Editor’s view, the relaxation of teleprescribing Schedule II drugs for three years invited abuse. Done may be the first, but it won’t be the last. See the prediction 8 July 2022 made by a former state ADA that both the Feds and states won’t stop at prescribing but will go on to telehealth billing (scroll to last item).

Done has not made any statements directly to press to date, save a short statement on their website:

Done Global strongly disagrees with the criminal charges filed last week against our founder, Ruthia He, and Dr. David Brody, which are based on events that principally occurred between February 2020 and January 2023. Since our founding, Done Global has worked to make mental health care accessible for tens of thousands of Americans trapped in a spiraling national crisis. Done Global will continue to operate – and do everything in our power to ensure that tens of thousands Americans that rely on us do not lose access to their mental health care. At the same time, we will continue to support our clinicians as they exercise independent clinical judgment, practice evidence-based medicine, and provide best-in-class health care.

Update: This statement has been expanded since our original article. Notably, the company declares that “Done is fully aligned with the Drug Enforcement Administration and the Department of Justice on eliminating drug abuse in America” and that they have protocols in place to prevent abuse. Done is also committed to continuing normal operations. Full text is here. David Brody is still listed as clinical president on the medical team page. Ruthia He is not listed on the website at all nor are other company leaders. Press releases posted on the site end in 2022.

Mobihealthnews and Fierce Healthcare essentially recap the DOJ release. The Verge includes the text of the 22-page indictment at the end of their article. 

Editor’s Note: On 30 May, TTA included a Perspectives article on collaborative care authored by Sussan Nwogwugwu, DNP, PMHNP, Clinical Leader at Done. This contributed article was non-promotional and primarily about alleviating clinician burnout. It briefly mentions technology in telehealth with one mention of ADHD as an example.

UK pathology services Synnovis hacked by Qilin ransomwareistes, demand $50M, justify attack due to UK involvement in “wars”

Pathology services provider Synnovis ransomwared, services continue to be disrupted. The Bloomberg report states that the Russia-based ransomware group Qilin is demanding a $50 million payment, in exchange for a code to unlock affected computers and software, which is the usual M.O. The ‘or else’ is that the hackers will post online the patient data stolen in the attack, according to a ‘spokesman’ quoted by Bloomberg, using a messaging account associated with the Qilin gang. FTA:

  • “A representative for the hackers said that they were very sorry for the people who suffered, but refused to accept responsibility for the human cost.”
  • Qilin is no longer in contact with Synnovis since the ransom wasn’t paid within their 120-hour deadline
  • The vulnerability to gain access to the Synnovis computers/software was not disclosed, but is known as a “zero day”. This could not be independently verified by Bloomberg.

Synnovis partners in pathology services with two London-based hospital trusts, King’s College Hospital, Guy’s and St Thomas’, including the Royal Brompton and the Evelina London Children’s Hospital. GP services affected are in the boroughs of Bexley, Greenwich, Lewisham, Bromley, Southwark and Lambeth. The incident started on 3 June and was announced 4 June. This affected patient tests such as blood, bowel and various swabs that are routine and needed in EDs and surgeries, causing mass reschedulings and diversion of services. TTA 5 June

Procedures continue to be disrupted according to Synnovis’ own Monday update.“We have delivered temporary workarounds including the redirection of non-urgent blood tests and result processing to other pathology labs to allow us to focus on urgent samples received from GPs, to ensure there is sufficient capacity for urgent testing and to respond to the highest priority cases at St Thomas’ Hospital and King’s College Hospital. Changes to processing of testing and results are being communicated directly to GPs and other service users to ensure a smooth transition.” Their analyzers are back online. There is no timetable for full restoration of services.

Synnovis states that they are continuing to work with law enforcement and the UK Information Commissioner, as well as the National Cyber Security Centre (NCSC) and NHS England’s (NHSE) Cyber Operations Team. This story will be updated with further developments.

Short takes: Dexcom G7 now directly connects to Apple Watch, Brightside Health acquires Lionrock, Aktiia CALFREE gains CE Mark for optical BP monitoring not requiring calibration

Further consolidation in telemental health–and digital health device improvements.

The Dexcom G7 CGM now connects directly to the Apple Watch. The wearable Dexcom sensor will now send information direct to the user’s Watch without the iPhone intermediary, which makes it very convenient for users. According to Dexcom’s statement, the Bluetooth capabilities built into the system were designed to communicate blood glucose readings to multiple display devices  simultaneously and independently. The Dexcom connectivity to the Apple Watch will be available in the US, UK, and Ireland, to launch in additional markets later this month. One wonders when they’ll expand to non-Apple watches. The G7 sensor remains a prescription item, unlike the OTC Stelo which received FDA clearance in March with a launch later this summer [TTA 12 Mar]. Mobihealthnews

Telemental health provider Brightside acquires Lionrock Recovery, expands into substance use disorder therapy. Brightside, which concentrates on providing virtual psychiatric and therapeutic treatments for anxiety and depression, adds virtual intensive outpatient programs (IOP) and outpatient addiction treatments (OP) for substance use disorder (SUD). Founded in 2010, Lionrock is accredited by the Joint Commission and takes a personalized approach to care, leveraging technology to provide therapeutic approaches for those struggling with alcohol and drug use. Participants in IOP attend individual and group therapy sessions, engage in evidence-based lessons, obtain psychiatric treatment and medication as needed, and have access to lab testing and additional peer support communities. No purchase price nor management transitions were disclosed. Back in March, Brightrock added $33 million of Series C funding. Release

Aktiia’s new non-calibration optical blood pressure monitoring system receives Europe CE Mark. Switzerland-headquartered Aktiia’s new CALFREE optical blood pressure (BP) monitoring system, using input from common optical sensors, is the first in their lineup that does not require prior calibration with a traditional BP cuff. Their earlier systems required monthly calibration. The Aktiia system works off data from optical sensors of the type used in smartphone cameras and smart watches. The business objective is integrating medical-grade blood pressure tracking not requiring BP cuff calibration into a wide range of consumer devices. Aktiia presently claims 70,000 customers in seven countries. It is not yet FDA cleared but their website for the US indicates that they are coming in 2025. Release, Mobihealthnews

Oracle’s Q4/FY 23 earnings push Cerner to background, stock price soars on AI deals; 81% of VA clinicals really can’t stand Cerner

Oracle keeps blue side up but disappoints Mr. Market, Cerner results now fall into the background as stock price soars despite misses. Oracle kept it upbeat in reporting its Q4 and FY2023 results this past Tuesday 11 June, and it paid off.

  • Its Q4 revenue of $14.3 billion was up 3%, with Q4 GAAP earnings per share was $1.11 while non-GAAP (adjusted) earnings per share was $1.63.
  • FY23 revenue totaled $53.0 billion, up 6%, with GAAP earnings per share at $3.71, while non-GAAP earnings per share was $5.56. 

Overall results were disappointing for Wall Street analysts. The blue side is that the stock has surged big time with a YTD high yesterday, closing above $140. The secret sauce? New AI-related contracts and demand for Oracle Cloud Infrastructure. On the call and in the release Oracle CEO Safra Catz announced new cloud sales to Google and Microsoft for OpenAI and ChatGPT. OpenAI will run deep learning and AI workloads on Oracle Cloud. Oracle also sold 30 contracts worth $12 billion in Q4.

The surprise on the call for this Editor? The Cerner business will no longer be identified and broken out, which is major league unusual for a specific, large product line. From HIStalk News 6/12/24: CEO Safra Catz said, “I will no longer be breaking out the Cerner business in my results. And even though it will begin to grow modestly throughout the year in both revenue and operating margins, it’s not necessary to break it out anymore because it is now operating in a growth mode.” A way of concealing ongoing bad news? Major hat tip to HIStalk on the earnings call summary, Investors Business Daily, Oracle earnings release

Not that many at the VA, MHS, or elsewhere actually like Cerner. An internal and unpublished survey for the Department of Veterans’ Affairs (VA) by KLAS, obtained by Bloomberg News, reported results for Oracle Cerner, and they were close to disastrous. On the metric “Users who feel the health software enables “high-quality care”, here were the results on positive answers by the doctors, nurses, and other users of Oracle’s EHR:

  • 19% for VA Oracle Cerner
  • 30% for DOD Oracle Cerner (MHS–Ed.)
  • 49% Average US Oracle Cerner
  • 71% Average Epic Systems Customer

That means that 81% of VA users, in the five facilities and offsite center where it’s been deployed, now for over a year and with consultants over it like paint on a brand new car, believe the Oracle Cerner system does not do Job #1 of healthcare–enabling high-quality healthcare. “There is a trend toward improvement, however, most users still indicate a negative experience,” according to VA researchers quoted in the report.

The other big surprise is that 70% of MHS users believe exactly the same. MHS is the ‘success story’ implementation, jointly with Leidos, and now complete. (Ken Glueck, please take note)

KLAS also contrasted this to their existing information for US EHR users. 49% of Cerner US users believe it facilitates high-quality care–contrasting unfavorably with 71% of Epic customers. However, these numbers are not comparable to either the VA or MHS as most hospital systems have been in place for years/decades, and have had abundant time to shape them against system needs plus work out the inevitable ‘bugs’. But the performance of Cerner versus Epic on this metric translates to preference in the small world of healthcare. 

Drilling down into the survey:

  • About 22% of VA respondents said their training on the new system was helpful
  • About 45% said they had received communication about why the VA was moving to the new EHR

The survey was conducted in March-April 2024 as part of VA’s ongoing evaluation of the Oracle Cerner EHR. Responders were 2,000 Cerner EHR users, with a 25% response rate of those solicited. The report was for VA leadership and for Congress. In a response to Bloomberg, Terrence Hayes, press secretary for the VA, said “That’s why we conduct surveys like this: to better understand the experience of our providers in the field, so we can make the EHR better for staff and veterans alike.”

Seema Verma has a long and troubled row to hoe to make this work for VA, MHS, and all Cerner users. Nowhere to go but up. Becker’s

News roundup: Teladoc’s new CEO from major payer, Steward Health lives with $250M injection, Waystar’s IPO raises $968M, NeuroFlow acquires Owl

Teladoc wraps up CEO search in record time–two months. On Monday, Charles “Chuck” Divita joined the company as chief executive officer with a board of directors seat. Divita comes from GuideWell, where he was executive vice president, commercial markets, earlier chief financial officer, and previously group VP and chief accounting officer at Florida Blue for a total of over 12 years. GuideWell is the parent of Blue Cross Blue Shield health plans in Florida and covers 38 million people in 50 states through Florida Blue, Triple-S Salud (Puerto Rico), Truli for Health, Florida Health Care Plans, and Capital Health Plans. Interim CEO Mala Murthy resumes her CFO position

Long-time CEO Jason Gorevic departed in early April in a haze of red ink. Mr. Divita will find the turnaround situation facing him at Teladoc a real challenge compared to Blue Health Plan World. Undoubtedly he was hired due to his extensive CFO experience plus understanding of the payer market. Teladoc needs to achieve profitability, something never accomplished in 20 years. It also faces heavy competition, the growing obsolescence of its foundational model accelerated by the boom/bust pandemic, self-inflicted damage created by the Livongo acquisition, the underperforming BetterHelp, and frankly, its mixed track record in good judgment and accountability [further analysis–TTA 9 Apr]. Mr. Market barely responded with a continuing deterioration in share price. Do not be surprised when (not if) there are major changes and cuts at Teladoc, including removing its HQ from high-tax Purchase, New York to Florida, the new CEO’s home state.  Release, FierceHealthcare, Healthcare Dive

Steward Health beats deadline of 14 June, finds $250 million to pay the bills. The lenders announced Tuesday 11 June are existing FILO (first in last out) private credit lenders Sound Point Capital and Brigade Agency Services, Chamberlain Commercial Funding, WhiteHawk Finance LLC, Owl Creek Investments I LLC, OneIM Fund I LP, MidOcean Credit Fund Management; Brigade Capital Management, LP which are now debtors in possession (DIP). They will be presented to the US Bankruptcy Court, Southern District of Texas, later this week, which is conducting Steward Health’s dissolution with sales starting in July. The FILO lenders were approached earlier, starting in March and up through last week, but could not come to an offer until now. The $250 million is structured as $75 million of the loan immediately upon court approval, with the remaining $150 million “available in draws not to exceed $50 million per draw.” The funds will keep Steward operations going and ‘maximize value’ until they can be sold in July and August. Healthcare Dive, FierceHealthcare, Release

Waystar finally drops IPO, raises $967.5 million. The offering of 45 million shares debuted at $21.50 a share on Nasdaq, midpoint in the indicated range and giving Waystar a fully diluted valuation of $3.69 billion.  It is the largest health tech IPO since 2022. Back in October 2023, Waystar projected an $8 billion valuation which was a non-starter [TTA 29 May]. WAY closed near-flat today at $21.70. Previous funders will continue with shares in the company, with EQT AB, Canada Pension Plan Investment Board (CPPIB), and Bain Capital will beneficially own approximately 29.2%, 22.3%, and 16.8%. Its payment and RCM tools claim 30,000 customers representing approximately 1 million distinct providers, but lost money in 2022 and 2023. FierceHealthcare, Reuters

Behavioral health platform NeuroFlow acquires Owl. Purchase price was not disclosed. Both companies are in the data insights and analytics portion of telemental health delivery and integration into care management programs. The combination now integrates NeuroFlow’s platform across primary and specialty care settings to provide a 360-degree view of a population’s behavioral health risk. In 2023, NeuroFlow acquired Capital Solution Design, the parent company of Behavioral Health Lab and BHL Touch which have provided workflow support to clinical teams at the Department of Veterans Affairs for over 15 years and other care organizations. The combined organizations will cover 17 million lives on the platform with payers and providers in all 50 states, including Atlantic Health System (NJ), Emory Healthcare (GA), and Colorado Access, Centennial State’s Medicaid plan. Eric Meier, Owl’s chief executive officer, will transition to NeuroFlow’s president of behavioral health markets. Other transitions and headquartering are not disclosed.Their funding topped $52 million between 2019 and 2022. Release, Mobihealthnews

Theranos’ Holmes and Balwani appeal fraud convictions, $450M investor restitution

An interesting Tuesday at the Ninth Circuit Court of Appeals in San Jose, California. A three-judge Federal appeals court held hearings yesterday (11 June) on separate appeals on the convictions found and restitution imposed on both Elizabeth Holmes and Ramesh ‘Sunny’ Balwani, the former CEO and president of Theranos. The Holmes hearing was 50 minutes before Judges Jacqueline Nguyen, Ryan Nelson, and Mary Schroeder.

Holmes is seeking a complete overturn of the trial and jury verdict primarily on the basis of Judge Edward Davila including evidence favorable to the prosecution and not including defense-favorable evidence. She was not there as serving her time to mid-August 2032 in Bryan, Texas. Representing her for the defense was Amy Saharia of Williams & Connolly LLP, considered to be one of the US’ top appellant litigators.

  • Favorable to the prosecution was Theranos’ chief scientist Kingshuk Das, MD’s testimony. Dr. Das was the final Theranos lab director who worked there March 2016 to June 2018–and voided two years of Edison Lab tests. Saharia is claiming that the prosecution was improper in putting him on the stand since he was not qualified by the court as an ‘expert witness’ and was allowed to express his opinion, specifically in statements allowed by Judge Davila including “I found these instruments to be unsuitable for clinical use.”

Going back to TTA’s original coverage of 11 Nov 2021 (which the coverage below largely has not), Dr. Das was hired to respond to CMS’ deficiency report that went to the prior lab director two months before. The subject line: “CONDITION LEVEL DEFICIENCIES – IMMEDIATE JEOPARDY.” The report went on to say that “it was determined that your facility is not in compliance with all of the Conditions required for certification in the CLIA program.” and concluded that “the deficient practices of the laboratory pose immediate jeopardy to patient health and safety.” After speaking with Holmes and dealing with her position that it wasn’t an instrument failure, but rather a quality control and quality assurance issue, he voided every Edison lab test made in 2014 and 2015–between 50,000 and 60,000. Holmes was told, but she didn’t believe Das or previous lab directors about the Edison problems. Also testifying was a contract offsite co-lab director in 2014-15 who expressed her reservations to one of Dr. Das’ predecessors –who also happened to be Sunny Balwani’s dermatologist. 

Judge Nelson said during the hearing that “There’s a pretty good story here for Ms. Holmes” and “They do have a pretty good basis for some unfairness here.” in how Judge Edward Davila allowed this testimony.  Judge Nguyen also seemed to agree with the defense position that Judge Davila went too far in allowing opinions from Dr. Das that under the rules would require his being vetted as an expert. Judge Nelson added that the conviction was supported by “pretty overwhelming evidence.” For Dr. Das, the conundrum was that he was called in as the former lab director to testify on Holmes’ knowledge of the problems the Edison lab had but he also had a level of expertise involving the labs. The Federal prosecutor on the appeal, Kelly Volkar, countered with how Judge Davila “carefully parsed” the Das testimony and sustained defense objections during the trial. While having concerns that Das strayed into opinions and Judge Davila allowed it, Judges Nguyen and Schroeder stated that much of Das’ testimony concerned what he observed at the company.

Reportedly, much of the hearing time focused on this one point. Saharia again insisted that “She [Holmes] in good faith believed in the accuracy of this technology” and did not knowingly misrepresent it.

  • Not including defense-favorable testimony was another alleged Davila mistake. In the defense presentation, Judge Davila allowed testimony from former laboratory director Adam Rosendorff without including more evidence of government investigations of his work after quitting Theranos in 2014. These were direct attacks on his competence in running a lab facility. However, in our 6 October 2021 coverage, the defense grilled Rosendorff on his work at uBiome and PerkinElmer; both came under Federal investigation during his tenure.

A final Holmes defense point was made on how these ‘errors’ made by Judge Davila unfairly shaped the jury decision, where she was found guilty by a jury on only four counts of the prosecution’s 11.

The panel did not provide any timeline for issuing a ruling, other than in ‘due course’. This can be anywhere from a few weeks to over a year. The track record for Federal Court appeals tends to be dismal for the defense. 

Far less coverage was given to the separate Sunny Balwani hearing. This centered on the fact that the restitution of $450 million to investors ordered by Judge Davila’s order was incorrect and part of the “nature of investing in a private company.”  His defense counsel, Patrick Looby, also representing Holmes, made a most interesting spin on how fraud did not rob Theranos of ‘residual value’. “The fact that the investors may have had difficulty selling their shares is not owing to the fraud.” Volkar for the prosecution stated that the investors had no opportunity to do any recouping of their losses. Looby also contended that the prosecution presented distorted evidence against Balwani in a different narrative than against Holmes. Balwani was convicted on all 12 charges and is serving 12.9 years at the Federal Terminal Island facility. No timeline for a ruling was reported.

Mercury News, AP, Yahoo Finance  The Ninth Circuit also has an unusual web page on the Holmes appeal with case information plus notifications of public proceedings.

Short takes: Holmes legal team appealing Tuesday 11 June; Steward Health asset sale OK’d, needs funding; fundings for Sword Health, Eko Health

Elizabeth Holmes may be in Bryan, Texas serving time, but the appeals go on. Her legal team will appear before the US Court of Appeals for the Ninth Circuit at 9am next Tuesday 11 June. Her initial appeal was filed in December 2022 [TTA 15 Dec 2022] with full 132-page legal briefs in April 2023 [TTA 19 Apr 2023].

Holmes’ team is seeking a complete overturn of the trial and verdict. The appeals center on an unjust conviction based on prosecutorial misrepresentations, such as Holmes being told that the Theranos technology worked and thus not misrepresenting it to investors at that time, and actions by Judge Edward Davila in the presentation of evidence in including evidence favorable to the prosecution and not including defense-favorable evidence. The appeal also includes, according to earlier reports, an accusation that Judge Edward Davila used the wrong legal standard in sentencing Ms. Holmes and thus over-sentenced her. Holmes will not be present for the appeal as is customary.

Her 11 year sentence is currently, based on Bureau of Prisons standards for good behavior, cut down to about 9 years. Her chances are slim that the appeal will succeed, based on overall rates, Judge Davila’s reputation for thoroughness, and his presiding over two identical cases, the other for ‘Sunny’ Balwani with the same evidence and a similar but longer sentence. There is no public word on whether Mr. Balwani is also appealing. He is serving his time at Terminal Island, California. Mercury News  Our back file on Theranos is best accessed through TTA’s search tab, keyword Theranos or Holmes.

Another fine legal mess is unfolding in Texas with the US Bankruptcy Court, Southern District of Texas, hearings on Steward Health’s dissolution.

  • On Monday 3 June, Judge Christopher Lopez approved a two part plan for the asset sale. Part 1 would be about the Massachusetts assets, with most of the system’s hospitals (eight) and its physician group. Bid deadline is 24 June and the first sale hearing is timed for 11 July. Massachusetts is the most contentious of the states Steward operated in, with state regulators taking the most actions against the company. Part 2 is the Florida and Texas asset sale, timed for a bid deadline of 12 August and first sale hearing of 22 August.
  • The US Department of Justice filed an objection 30 May to the sale, stating that it does not allow enough time for their regulatory review of the physician group sale to UnitedHealth Group’s Optum [TTA 18 Apr] and insisting that it must be reviewed before any sale. This effectively holds up the Part 1 sale. FierceHealthcare
  • The other spanner in the works for the DOJ is that Steward is flat out of money to run their hospital and practice assets. Without additional funds, on 14 June they will be broke, busted, skint by two Fridays from now. Steward’s lenders were before Judge Lopez yesterday (4 June) to try working that out. Current debtor-in-possession (DIP) Medical Properties Trust, which put up $75 million, won’t put up any more money until assets are sold. Other lenders want to put up only limited amounts of money. To lure lenders, Judge Lopez approved an emergency motion on Monday to permit a “commitment fee” offer of up to $6.75 million to third-party lenders and up to $750,000 to reimburse one or more lenders for expenses incurred during due diligence. Healthcare Dive. Will that attract another DIP? Only time, and not a lot of it, will tell.

In happier news, there are fundings for two health tech companies:

  • Sword Health announced a $130 million round in an unlabeled mix of primary and secondary sale. Their total funding is now $340 million, with lead from Khosla Ventures. Valuation is up to $3 billion, up 50% from its Series D valuation. The funding announcement was made in conjunction with a product announcement by the digital/remote MSK therapy company for Phoenix, the AI Care Specialist, which will be integrated across their entire offerings. Release
  • Eko Health’s Series D raised $41 million from ARTIS Ventures, Highland Capital Partners, NTTVC, and Questa Capital. Eko’s device and platform enhance the early detection of cardiac and pulmonary diseases during physical exams. Most recently, the FDA cleared Eko’s Low EF detection AI [TTA 5 Apr]. The new funding will be used for US expansion and expansion into key international markets, supported by new strategic investments from Double Point Ventures in the U.S., Singapore-based global investor EDBI (the corporate investment arm of the Singapore Economic Development Board), and LG Technology Ventures, backed by the LG Group of South Korea. Cardiac detection powered by AI are ‘perfect together’, at least for investors. Release, Axios

Breaking: multiple London hospitals, borough GPs declare ‘critical incident’ from ransomware attack via third party pathology vendor

Breaking News. A group of London hospitals, plus GP services across several boroughs, have been affected by a third-party ransomware attack and have declared a critical incident. The vendor, Synnovis, is a provider of pathology services in a partnership between two London-based hospital trusts and SYNLAB UK & Ireland. The attack started on Monday 3 June. Synnovis reported in its statement yesterday that it affected all its IT systems and interrupted many Synnovis pathology systems. Synnovis “was the victim of a ransomware cyberattack”, according to chief executive Mark Dollar. Affected patient tests via Synnovis include blood, bowel and various swabs.

The hospitals affected are King’s College Hospital, Guy’s and St Thomas’, including the Royal Brompton and the Evelina London Children’s Hospital. These hospital trusts are partners in Synnovis with SYNLAB UK & Ireland, Europe’s largest provider of testing services. GP services affected are in the boroughs of Bexley, Greenwich, Lewisham, Bromley, Southwark and Lambeth. The critical incident has affected primary care and delayed operations on patients plus blood transfusions, with reported diversions of emergency patients, though reports are varying on the last.

According to the Synnovis statement, the incident has been reported to law enforcement and the Information Commissioner, and they are working with the National Cyber Security Centre and the Cyber Operations Team. There is no information yet available attributing a ransomware organization.  Infosecurity-magazine.com, Sky News, BBC News

This is a developing story

News roundup: Change responsible for data breach notices; 37% of healthcare orgs have no cybersec contingency plan; health execs scared by Ascension breach; CVS continues betting on health services; Plenful’s $17M Series A

HHS agrees with providers that the data breach notification is on Change Healthcare, not them. Health and Human Services’ Office for Civil Rights (OCR) moved quickly to formally change the FAQs that kicked off the 100+ provider letter [TTA 23 May]. Now “Covered entities affected by the Change Healthcare breach may delegate to Change Healthcare the tasks of providing the required HIPAA breach notifications on their behalf.” “Covered entities” in this case refers to the providers. Only one entity–Change or the provider–“needs to complete breach notifications to affected individuals, HHS, and where applicable the media.” Providers must contact Change Healthcare for the delegation. 

Chad Golder, general counsel and secretary at the American Hospital Association (AHA) said in their statement, “As we explained then, not only is there legal authority for UnitedHealth Group to make these notifications, but requiring hospitals to make their own notifications would confuse patients and impose unnecessary costs on providers, particularly when they have already suffered so greatly from this attack.” HHS notice, Healthcare Dive

Meanwhile, UHG still does not know the extent of the breach which started in late February. Knowing the extent of the breach is needed to start notifications. It has not formally notified HHS of the breach long past the 60-day mandated window (see #3 in the HHS FAQs). This may create an ‘unreasonable delay’ (see #6). Not all Change systems are back up either–see the Optum Solutions page that has plenty of red Xs.

Only 63% of healthcare organizations have a cybersecurity response plan in place, leaving 37% without a plan. This is based on a survey of 296 IT/data security/management executive respondents working at healthcare organizations in the US performed by Software Advice, an advisory and consulting firm. Other findings:

  • Nearly 1 in 3 have had a data breach in the last three years
  • 42% of practices have experienced a ransomware attack, and of those, 48% say the attack impacted customer data
  • 34% failed to recover data after the ransomware attack
  • 55% of medical practices allow access to more data than employees need to do their job which makes them more vulnerable to attacks
  • While 41% of data breaches are attributable to malicious hacking, another 39% are due to malware, 37% are due to social engineering and phishing scams, 36% are due to software vulnerabilities, and 30% are due to employee error.

It would have been helpful if Software Advice in its report had broken down the type of practices surveyed. Healthcare Dive

Meanwhile, healthcare executives were ‘scared’ by the Ascension Health breach, as they should have been. Katie Adams’ piece in MedCityNews explores reactions from five different C-suite hospital executives about the recent attack on Ascension. The IT and data officers are from MD Anderson, Yale New Haven Health, CommonSpirit Health, Allegheny Health Network, and UPMC. The overall take was that threats are more common than ever, bad actors are abundant and getting better (using tools that can make amateurs into pretty good “bad actors” via “LLM products and have them help you build ransomware code.”), managing weaknesses in third-party vendors that live in the cloud is a Herculean task, phishing, and the need for ‘government’ to be involved. 

This Editor notes that the rush for providers into generative AI, given this environment, is perhaps premature. Yet here they go; researchers from Mount Sinai’s Icahn School of Medicine used structured data, such as vital signs, and unstructured data, such as nurse triage notes, to develop models predicting hospital admissions using ChatGPT-4. It supposedly can learn from fewer examples than other machine-learning models currently used and use data from traditional models. Becker’s

Ascension is slowly coming back, now projecting that all their locations will have their EHRs restored by the week of 14 June. Currently, only Florida, Alabama and Austin are up and running. Ascension Rx retail, home delivery and specialty pharmacy sites are now open as well. They will have some ‘splainin’ to do to HHS OCR. Ascension update site

CVS is confident in the future of its retail health despite their struggles with Minute Clinics and Oak Street.  Despite the struggle of retail health clinics at other providers such as Walgreens/VillageMD and the shutdown of Walmart Health, Sree Chaguturu, MD, CVS Health’s executive vice president and chief medical officer, expressed complete confidence at a recent industry conclave, thINc360 – The Healthcare Innovation Congress. This is despite the closures of dozens of Minute Clinics in Southern California and New England [TTA 31 May] out of their 1,100 total plus that CVS seeking an investment partner for Oak Street [TTA 29 May]. Dr. Chaguturu returned time and again to the 10,000-odd CVS Pharmacy locations and their leverage within communities, leaning very hard on the 5 million people coming in daily and the ‘opportunity for their pharmacists to engage’. As a CVS customer at a small location, those busy pharmacists aren’t engaging with me unless I have a script to fill or need an OTC decongestant that’s on the state signoff list due to an ingredient. In fact, CVS locations have rather few people nowadays, including behind checkout counters. Then again, it was a meeting speech. FierceHealthcare

Concluding on a brighter note, Plenful’s Series A came in at a tidy $17 million. Plenful developed and markets an AI-assisted workflow-automation platform for pharmacy and healthcare operations, claiming that it automates over 95% of the work for disparate administrative workflows. Features include 340B audit, document processing, contracted rates optimization and inventory planning, and pharmacy cycle revenue and reporting. Founded in 2021, the company has already lined up some impressive clients. Lead investor TQ Ventures was joined by Mitchell Rales (cofounder and chairman of Danaher), Susa Ventures, Waterline Ventures, and Bessemer Partners, the lead for last September’s $9 million seed funding for a total of $26 million. Crunchbase, Mobihealthnews

NHS electronic patient records linked to 100 ‘serious harm’ issues, with ~50% of NHS England trusts reporting patient issues: BBC News

EHR harm is not exclusive to the VA, or the US. An investigation published last week by BBC News uncovered problems with IT systems used by NHS England regional trusts to manage patient records. Through a Freedom of Information (FOI) request, it uncovered multiple problems with Electronic Patient Record (EPR) systems that could affect patient care or lead to potential harm. Their investigation found that “IT system failures have been linked to the deaths of three patients and more than 100 instances of serious harm at NHS hospital trusts in England.”

The NHS has spent £900 million over the past two years in pushing trusts to procure EPR systems and to go entirely paperless. The original deadline of end of 2024 has long since been modified to 2026.

Currently, each trust manages its own IT adoption. Teaching hospitals are at the top with the best IT, whether EPRs or operational and clinical systems. Acute care hospitals come next with current systems and infrastructure. The trusts also commission and pay for community and mental health organizations plus general practitioners. They tend to be at the end of the technology chain, without data centers but maybe a computer room. There are lots of variations between trusts, plenty of custom systems, and paper. And as in the US, systems were not necessarily interoperable. (Background courtesy of Rackspace)

The NHS published last November that 90%, or 189, trusts had contracted for and adopted EPRs. EPRs adopted by the trusts include Oracle Cerner, Epic, Meditech, and Dedalus Orbis (replacing the ancient Lorenzo).

What the BBC found through the FOI:

  • 89 trusts confirmed they monitored and logged instances when patients could be harmed as a result of problems with their Electronic Patient Record (EPR) systems. Almost half recorded instances of potential patient harm linked to their systems.
  • Nearly 60 trusts reported IT problems that could affect patient care.
  • There were 126 instances of serious harm linked to IT issues across 31 trusts
  • There were three deaths across two trusts related to EPR problems
  • At the County Durham and Darlington NHS Foundation Trust, more than 2,000 incidents of potential patient harm and three other serious incidents were connected to their new Cerner EPR

Additionally, hundreds of thousands of medical letters went unsent to patients. From the FOI, 200,000 letters were not sent across 21 trusts. Last September, a separate BBC investigation found that 24,000 letters from Newcastle hospitals had not been sent from their EPR system, with more than 400,000 letters lost in computer systems at hospitals in Nottingham.

Separate from the FOI, the BBC report goes into two of the deaths relating to EPR lost information.

  • At Sheffield Teaching Hospitals Trust, a sickle cell anemia and cerebral palsy patient, Darnell Smith, aged 22, was admitted to the Royal Hallamshire Hospital with cold like symptoms in November 2022. His personal care plan was not easily visible in the hospital’s computerized records. He didn’t get the hourly checks he needed for heart rate, blood pressure and temperature. After the records were found, Mr. Smith was then moved to critical care, put on a ventilator the next morning, and died from pneumonia two weeks later. The coroner in this case warned of a “real risk of further deaths” if care teams couldn’t access needed medical information.
  • At University Hospital of North Durham, Emily Harkleroad collapsed and was taken to A&E, where a pulmonary embolism was diagnosed. However, due to errors in the newly installed Cerner EPR, she didn’t receive the blood thinners she needed and died the morning after admission. The coroner found that the EPR did not clearly identify which patients were the most critically ill and needed to be prioritized, a complaint that clinicians at the hospital had previously expressed.  

Clinicians who came forward to the BBC pointed to EPRs making critical information difficult or impossible to find–it could be “buried anywhere”, creating medication errors, and “incorrect patient details on theatre (sic) lists, incorrect operations listed, incorrect allergy status”. 

Professor Joe McDonald, a former NHS clinical leader, dubbed the current rollout of EPRs across trusts “a broken jigsaw” because very few are interoperable. His conclusion: “There is undoubtedly a culture of cover-up in the NHS and nowhere is that stronger than in the health IT sector. It’s not safe. It’s really not safe.”

BBC News also included a response from Professor Erika Denton, national medical director for transformation at NHS England. She stated that EPRs represent an improvement over paper and patchwork systems and have been shown to improve safety and care for patients. “However, like any system, it’s essential that they are introduced and operated to high standards, and NHS England is working closely with trusts to review any concerns raised and provide additional support and guidance on the safe use of their systems where required.”  Also Daily Mail and Yahoo News Canada (reprint of the BBC News article if blocked).

Short takes: Virtual Therapeutics, Akili in $34M merger; why health clinics are struggling; Dollar General, DocGo call it quits; Clover Assistant AI debuts; fundings for Wanda Health (UK), Updoc (AU); Telstra buys out Fred IT (AU)

Two mental health companies with complementary digital therapeutics plan to merge. Virtual Therapeutics, which approaches mental health through VR-enabled games, and Akili Interactive, with online prescription games designed for ADHD and other cognitive impairments, yesterday announced plans to merge. The new company will retain the Virtual Therapeutics name and go private, with Akili operating as a subsidiary. The cash buyout to Akili shareholders will be based on $0.4340 per share of common stock (Nasdaq) or $34 million, a premium around 4%. Akili had announced on 29 April that it was seeking “strategic alternatives”. Shares were trading then at $0.235 so the offering is over an 80% premium to that time. In May, Akili announced a reduced Q1 2024 net loss compared to Q4 2023. The transaction is expected to close in Q3, subject to Akili retaining a specified cash position and a tender conversion. Management transitions have not been disclosed. Release, MedTechDive

Why are all the health tech clinics struggling–at once? CNBC polls a group of experts and deduces that what it calls the “2.0 version of primary care” in Walmart Health, CVS Minute Clinics (closing dozens of Minute Clinics in Southern California and New England), and  Walgreens’ VillageMD, is foundering under:

  • Thin to non-existent margins–reimbursements are low, but the expenses of running them are high
  • Lack of ‘volume selling’
  • Lack of workforce–doctors don’t want to go to rural areas, which was Walmart’s bet. Nurse-practitioners can’t care for patients (and bill) if they also are detailed to do cleanup 
  • Cross-selling a flop–if you’re in for a pint of milk, Advil, or shampoo, you’re not going into the clinic, and vice versa

A 3.0 model may have a lot of variants, such as One Medical’s subscription model ($9/month for Amazon Prime members). Walgreens is opening a few in-store health clinics in the Hartford, Connecticut area to be run by Hartford HealthCare. In Arizona, a local Be Well Health Clinic near Arizona State University operates in a Walgreens and treats only sexual health issues. Kroger’s Atlanta-area Little Clinics will focus only on senior care.

One 3.0 experiment, DocGo’s vans in Dollar General parking lots, is over. Last year’s headscratching move to place DocGo’s urgent, preventative, and chronic care vans at specified hours in rural Dollar General parking lots [TTA 24 Jan 2023] was canceled some weeks ago. It never expanded beyond the three Tennessee locations, two in Clarksville and one in Cumberland Furnace that started last year. Endpoints

Health plan Clover to separately market their Assistant AI tool for clinical decision-making. Counterpart Assistant will be offered to other payers outside Clover Medicare Advantage along with providers in ACOs and value-based care enablers (sic) as an AI-assisted service, in a hybrid SaaS and per member per month (PMPM) shared-savings model. The pitch is to lower per-life customer acquisition cost and allow physicians to use one tool for all MA patients. FierceHealthcare

Fundings in UK and Australia:

UK’s Wanda Health adding a 30% investment from VC investment group NetScientific plc. Wanda Connected Health Systems Ltd. has operations in Bristol and Seattle.  It’s a second-time-around for NetScientfic, as it was an early Wanda investor but sold its 90% interest in Wanda US to Deeptech Disruptive Growth Investments Ltd in 2019. Wanda Health provides remote patient monitoring feeding into a virtual care platform. Insider Media

Australia’s Updoc telehealth raised A$20 million ($13.2 million) in investment from ASX-listed capital investor Bailador. It offers virtual consultations, online prescriptions, specialist referrals, pathology referrals, and medical letters for a single payment or on subscription. The funding will be used for international expansion and technology development. To date, it has served 200,000 Australians.  Mobihealthnews

In more news from Down Under, Telstra Health buys out the remainder of Fred IT Group. Telstra already owned 50% of the pharmacy IT solutions provider and is buying out the Victoria branch of the Pharmacy Guild of Australia and Paul Naismith, Fred IT co-founder and CEO. The CEO, management, and employees will remain in place. Fred IT, through eRx, is the only national electronic prescription delivery service in Australia since last year. Right Said Fred? Mobihealthnews

Oracle’s Glueck kicks back hard at Business Insider’s ‘deadly gamble’ article, Epic’s Faulkner (now with additional audio commentary)

Oracle is making great progress at the VA. And they want EHR interoperability. Epic doesn’t. Take that, Business Insider! And Judy Faulkner! Ken Glueck, an EVP at Oracle, authored an Oracle blog post (or at least one written under his name) that has generated much industry controversy. It first goes after Business Insider for daring to criticize the problems on the Oracle Cerner rollout that made it into five (count ’em, five) VA regional systems, calling it a ‘regurgitated story’. It calls the ‘deadly gamble’ headline ‘clickbait’, moves to patting itself on the back for the apparently non-problematic EHR rollout in about 3,900 locations in the DOD-Military Health System (partnering with Leidos), then swerves to stating the obvious in kicking around poor old, outdated VistA that meets very different needs and a massive population at the VA, and ends with a tap dance around the Oracle Cerner EHR problems at the VA citing all the progress that Oracle is making. It builds to a final slam fest, taking a minor quote in the article regarding why Oracle’s Larry Ellison preferred to buy Cerner–a ‘more relaxed approach to data privacy’–and expanding that to hard personal takedowns of Epic and its founder Judy Faulkner.  It then gets personal with BI, depicting the publication as “rooting against us” which he finds “invigorating”.

One can understand the craving for Oracle management to respond to BI. It’s a media outlet that apparently doesn’t have the most friendly relationship with Oracle. (But since when is that a feature of the Fourth Estate?) The article vividly takes Oracle to task, weaving together an accessible story out of dry facts and the many technical failures well documented by the VA, the OIG, and in Congressional hearings. It’s framed in the noble ambitions of Oracle’s founder Larry Ellison to transform healthcare which, in this Editor’s view, are treated sympathetically. The extremely well-read review last week of the BI article notes all, as well as the lack of contrast with the non-eventful DOD-Military Health System’s implementation and why it went largely according to plan, including the joint Lovell MHS/VA EHR. While this Editor tends to cast a gimlet eye at the clichéd mention of ‘transforming healthcare’, she still has some hope that progress in simplification, transparency, better-informed decisions, and truly intelligent assistance that enables human providers to heal their patients will be made in the next decade. And in that, she is on the side of Mr. Ellison as well as most founders and companies in health tech chronicled in TTA’s articles since 2005.

You have to give Mr. Glueck some credit for not holding back on how he really feels. Unfortunately, he was writing a corporate communication even if it was slotted in Oracle’s blog pages. He’s worked in corporate for decades and early in his career in government in the late Senator Joe Lieberman’s (D-CT) office. From the blunt view of a marketer, he should know better. Tone matters. And the frostier the tone, the better. If even a response is needed. Consider: is responding to this a smart move? What are the knock on effects?

In fact, it’s almost a textbook on how not to respond to negative press.

  • The headline sets up a straw man argumentBusiness Insider is not responsible for healthcare modernization, nor conceivably will ever be. It’s a cheap shot. 
  • The overly personal tone, written (one can guess) as he was seething about the BI article, undermines the response.
  • Nearly all of the same points could have been made in a concise, objective, fact-by-fact rebuttal that would be far more powerful in its restraint.
  • It meanders. It’s defensive. It’s easy to read into the Congressional Record or at the next hearing of the Veterans Affairs committee by a House member or Senator who’d like to see Oracle Cerner derailed at the VA. 
  • Where it truly goes off the rails is the personal invective directed at their competition. “…Epic’s CEO Judy Faulkner is the single biggest obstacle to EHR interoperability. She opposes interoperability because it threatens Epic’s franchise.” Mr. Glueck goes further in stating that Oracle enables provider collaboration across silos, while “Epic’s contracts expressly appropriate all patient EHR data as Epic’s own.” This is a fair criticism if true but maybe Epic’s hospital customers like it that way for their own reasons like security.

The blog comes across as barely restrained and defensive, especially versus Epic, the #1 EHR. When your EHR is losing ground to the competition, this is not a good look. It hands Epic another club to beat Oracle with. When your audience consists of professional hospital and practice executives, plus the VA and Congress, who right now aren’t overly happy with your EHR and are firing Oracle or considering it, this is almost guaranteed to backfire. It also gives a provocative article in a small online publication (ask Elon Musk) what Oracle doesn’t want–very long legs and a long shelf life. Plus now, there is even more reason for BI to beat up on Oracle.

Perhaps ignoring it, coupled with a sober internal communication (email/intranet/Slack) on the progress being made with the VA EHR (given that internal comms leak onto Reddit and similar), would have been the best response choices. And what about a conversation with BI? 

Like the old Sicilian saying about revenge, dishes like this should be served cold. 

Some interesting responses to the Oracle blog post are in HIStalk Reader Comments 5-31-24   Also Becker’s

And if anyone at Oracle wants a free tutorial in what not to do to respond to negative press, from the perspective of someone who’s had to deal with it in two industries….donna.cusano@telecareaware.com

Listen to Editor Donna provide extra commentary–a take on this take–on the Ken Glueck blog and this article. Now on Soundcloud (~18 minutes).

Perspectives: How Collaborative Care Combats Physician Burnout

TTA has an open invitation to industry leaders to contribute to our Perspectives non-promotional opinion and thought leadership area. Today’s contribution is from Sussan Nwogwugwu, DNP, PMHNP, Clinical Leader at Done. In this article, Dr. Nwogwugwu discusses physician burnout, how it can affect delivery of care, and how collaborative and comprehensive care can mitigate burnout.

Done is a leading provider of telehealth services for individuals with ADHD, dedicated to delivering comprehensive, patient-first care. With a network that spans more than 35 states, Done connects individuals with ADHD to experienced, board-certified providers for personalized treatment plans and medication management. 

Physician burnout is a significant concern, as it affects not only physician well-being but the quality of care they deliver.

The state of primary physician burnout
The American Medical Association found that at the end of 2021, nearly 63% of physicians had reported burnout symptoms. This was roughly a 66% increase from the preceding year, highlighting the urgent need for systemic changes to support physician mental and emotional health. Increasing burnout is attributed to excessive workload, administrative burdens and lack of support and resources.

Collaborative care and its benefits
Collaboration between a team of multidisciplinary healthcare professionals decreases clinician workload and leads to enhanced job satisfaction. Additionally, feelings of isolation and burnout among physicians are reduced. Most importantly, the continued skill building and exchange of knowledge contribute to professional growth.

For mental health patients, collaborative care ensures holistic care and access to specialized services and continuity of care, particularly for patients managing chronic conditions.

Comprehensive care supports providers
A collaborative care model is designed to reduce the burden on primary care providers; and enhance clinician well-being and patient care by integrating comprehensive behavioral health support within the primary care framework. Comprehensive care supports providers in several ways:

Impact analysis
Impact analysis, primarily powered by data analytics software, provides insights into treatment effectiveness. It is particularly helpful in guiding interventions.

Impact analysis further addresses burnout and other issues by identifying areas for improvement, ultimately guaranteeing effective resource allocation and helping track the progress of interventions over time for better adjustments.

Evidence-based interventions (EBI)
EBI enables providers to use resources efficiently by enlightening them on what works and does not. It also enhances job satisfaction and morale, ultimately leading to better patient outcomes. Finally, using evidence-based treatments reduces the chances of facing legal action if something goes wrong.

Physicians leverage technology to learn more about EBIs across various medical fields; that can include digital libraries/databases, clinical decision support systems, mobile applications, telehealth platforms and online resources.

Frequent reviews and an inclusive patient approach
Frequent reviews help identify and address areas for practice improvement due to informative feedback they provide. An inclusive patient approach reduces burnout and provides a sense of fulfillment among providers by nurturing greater patient engagement and increasing satisfaction.

Comprehensive care supports patients
In addition to benefiting health care providers, comprehensive care benefits patients, too.

Impact analysis
Impact analysis fosters an in-depth understanding of a patient’s needs and responses to treatment, leading to more personalized care. Patients can also make informed decisions about their health and treatment options, guided by physician recommendations on helpful online resources.

Evidence-based interventions
EBI supports patients, reduces the risk of adverse effects, and ascertains that patients receive appropriate, high-quality, rigorously tested and proven care. Additionally, since EBI is founded on research and clinical evidence, it guarantees better health outcomes.

Frequent reviews and an inclusive patient approach
Frequent reviews enable personalized care and continuous treatment plan adjustment per each patient’s progress and feedback. Remote patient monitoring technologies like smart watches or mobile health apps help to track key health metrics and symptoms, thereby fostering patient empowerment and ensuring adherence to treatment plans by involving them in their own care.

Why medicine is shifting toward value-based care
Medicine is gradually shifting to a value-based care model to deliver patient-centered, effective, cost-efficient healthcare. This is in response to the conventional fee-for-service model that incentivizes quantity over quality, which results in unnecessary procedures, fragmented care and unsustainable healthcare costs.

Technology, a key defining factor in value-based care, leverages EHRs, telemedicine platforms and data analytics tools to refine ADHD care and eliminate draining tasks that lead to burnout.

Telemedicine platforms enable remote consultations, making it easier for patients to access specialized services without the need for physical visits. Additionally, data analytics tools track patient outcomes and identify trends, allowing for more personalized and effective treatment plans.

Through integrating EHRs, telemedicine platforms and advanced data analytics, multidisciplinary healthcare teams can streamline communication and coordination. EHRs provide team members access to up-to-date patient information, thereby reducing errors and enhancing continuity of care.

Collaborative + comprehensive care = value-based care
Collaborative and comprehensive care, combined with technology tools, contribute to value-based care by enhancing patient experience and treatment outcomes; and optimizing resource utilization.

These care models collectively promote improved population health, foster accountability and transparency and encourage continuous improvement.

Through collaborative care models, the value of health care is maximized and aligns with value-based care goals, alleviating increasing levels of physician burnout.