VA sued in Federal court on Oracle Cerner EHR accessibility issues

What you may have missed over the holiday–another one to add to the VA’s Mound of Misery with the Oracle Cerner rollout. The Department of Veterans Affairs (VA) is being sued on the choice of Oracle Cerner as the successor to VistA and its inability to accommodate Federal accessibility requirements. The new EHR apparently does not accommodate assistive technology, such as screen readers that enable the visually impaired to read and direct input on computer screens and thus perform their work. The lawsuit was filed on 21 June in the US Federal District Court for the District of Columbia by Laurette Santos, a clinical social worker at VA’s White City, Oregon, facility.

Ms. Santos is a 10+ year veteran of the VA. In her job as Visual Impairment Services Team (VIST) Coordinator since 2019, she relies on the Job Access With Speech (JAWS) screen reader application. Like the veterans she counsels, she is also legally blind and has been since 1988.  She requires access to the EHR in order to obtain veterans’ histories, determine their needs, and input notes. JAWS converts the screens into spoken words (or Braille output through a connected device) and allows blind users to access and interact with applications using the computer keyboard. In planning for the Oracle Cerner transition in June of 2022, she reported in 2019 that the JAWS screen reader did not work with the new EHR and didn’t even allow her to sign in. At work, she continues to use VistA in a read-write-only format but cannot use Oracle Cerner and must delegate tasks to sighted employees. Bottom line, she cannot independently perform her work whereas previously she was able.

The lawsuit charges that the VA did not ensure that the Oracle Cerner EHR complied with the Section 508 accessibility standards per the contract and that it worked before its implementation. Section 508 has been part of every Federal contract since 1998, when the Rehabilitation Act of 1973 was amended to make electronic and information technology accessible to people with disabilities. Between November 2020 and November 2021, the VA’s Section 508 Office conducted several audits and found the Cerner EHR was inaccessible. The lawsuit alleges that this constitutes ongoing violations of both Section 508 and Section 501 of the Rehabilitation Act; Section 501 prohibits discrimination against individuals with disabilities. Veterans also cannot use features tied into Oracle Cerner as they are non-compliant.

In the lawsuit, Ms. Santos is represented by The National Federation of the Blind and Brown Goldstein & Levy partners Eve Hill and Chelsea Crawford. The VA does not comment on pending litigation. HIT Consultant, Federal News Network

Done Global Federal probe expands to five more people; company suspended from Google, TikTok ad platforms

The first telemedicine prescribing Federal prosecution adds charges against five additional employees. The charges are similar to those for Ruthia He, the founder/CEO, and David Brody, listed as the clinical president of Done Global (Done)–providing easy online teleprescription access to Adderall and other Schedule II stimulants, skirting the normal restrictions provided in the Controlled Substances Act (CSA) and other regulations [TTA 19 June].

These new charges center on an alleged scheme to defraud federal health care benefit programs including Medicare and Medicaid and are part of the Department of Justice’s 2024 National Health Care Fraud Enforcement Action.

Those charged are Riley Levy, 30, Done’s executive leader, operations and strategy; prescribers Christopher Lucchese, DO, 58; and nurse practitioners Yina Cruz, 37, Katrina Pratcher, 70, and Erin Kim, 54. Levy, Lucchese, Cruz, and Pratcher were charged in the Northern District of California (US Attorney’s office release). Erin Kim was charged in the Middle District of Florida (Case Summary). 

Prescribers were paid based on initial consultations–if they took place–then auto-refills without follow up. Prescribers are also charged with writing prescriptions where Adderall, for instance, was not medically necessary and issued to people who did not have ADHD. Follow up meetings were not compensated and frowned upon.

  • Nurse-practitioner Erin Kim from Florida prescribed over 1.5 million pills since 2021 and earned over $800,000. Done’s system with auto refills even prescribed to patients who had died. As of the end of May, her patient roster was still over 1,100.
  • Nurse-practitioner Yina Cruz from New Jersey made about $20,000 a month prescribing primarily stimulants to 2,300 patients, according to a 2022 interview with The Wall Street Journal. She renewed prescriptions based on forms patients filled out online, sometimes as fast as two renewals a minute. 

Done didn’t respond to a request for comment from the WSJ. A spokesman for the founder, Ruthia He, said she hasn’t entered a plea. The senior doctor, David Brody, has pleaded not guilty. Done maintains a statement on its website of disagreement with the charges and continuance of normal operations.

Done Global knocked off of TikTok and Google ad services–but not Meta. In 2022, Done lost certification by LegitScript, a clearance service for telehealth companies. Advertising continued on Google, Meta, and TikTok into June. Last week, Google and TikTok told the WSJ that Done was suspended. Advertising continues on Meta (Facebook) as long as the ads promote a service, not prescription drugs. The numbers in a suffering online ad market aren’t small, either. Done spent $7 million on Meta ads since November 2022, $20 million on Google, and about $3 million on TikTok ads. based on documents reviewed by the WSJ. Wall Street Journal, The San Francisco Standard

Short takes: Fabric buys Walmart’s MeMD telehealth arm, Geisinger data breach via vendor exposed ~1.2M records, UK’s Careium develops resilient rSIM, $50M funding for K Health, India’s Alyve’s $6M Series A, Upside Health closes

Walmart Health’s virtual care telehealth services, originally known as MeMD, sold to care enablement/workflow integrator Fabric. The transaction is effective immediately though no purchase price, management transition, or change in website were disclosed. The sale is no surprise as Walmart Health in shutting their clinics starting at end of May depicted the shutdown as total, lambasting low reimbursement and the cost of business as factoring into an unsustainable model. Fabric, based in NYC, uses conversational AI to triage patients, evaluate with decision support, and optimize resource allocation and patient flow.

Fabric claims that MeMD has 30,000 corporate, institutional, and health plan partners and 5 million members, Walmart bought it for an undisclosed amount in May 2021 during the telehealth boom. It expanded to include not only urgent care, but men’s and women’s health issue support, mental health and psychiatric support. Fabric’s funding since their founding in 2021 as Florence Labs is $80 million, the most recent a February Series A round of $60 million with General Catalyst, Thrive Capital, GV (Google Ventures), and four others. They bought a telehealth Ur-company, Zipnosis, from then-Bright Health in May 2023 [TTA 24 May 2023] and GYANT, an AI-assisted enablement company, in January. Release, Mobihealthnews

Geisinger, the lead health system within Kaiser Permanente’s Risant Health, experienced a data breach that potentially exposed 1.2 million records. The former employee of Nuance Communications, an IT provider in clinical documentation, accessed records two days after his termination. Geisinger discovered the breach on 29 November 2023, Because of the ongoing investigation, patients were not notified until 24 June.

Breached information varies by patient, but it included names combined with one or more of the following: date of birth, address, admit and discharge or transfer code, medical record number, race, gender, phone number and facility name abbreviation. No claims or insurance information, credit card or bank account numbers, other financial information, or Social Security numbers were accessed.

The former Nuance employee has been arrested and is facing federal charges. Nuance had no comment. Release, Healthcare Dive

In an important development for the UK’s rapidly implementing digital switchover, now extended to January 2027, Careium has developed an ‘intelligent’ SIM card for devices. It partnered with CSL to develop a “resilient’ rSIM that actively monitors connectivity and will switch either profile for maximum uptime on all UK networks. rSIM is available for all Careium 4G products in the Eliza smartcare hub and is compatible with current devices. Careium is marketed and covers about 400,000 seniors in the UK, Sweden, Norway, the Netherlands, Germany, and France.  Release

Two fundings of note–and one shutdown:

K Health, a NYC-based digital primary care startup, received $50 million in venture round funding from lead investor Claure Group. Additional investors were Pablo Legorreta, founder and CEO of Royalty Pharma, Mangrove Capital Partners, Valor Equity Partners and Atreides Management LP. Total funding to date is over $380 million through a Series E plus two venture rounds. Valuation is estimated at $900 million. K Health supports users through an app with AI-assisted diagnostics as well as partnerships with leading health systems in 48 states including Cedars-Sinai and health plans Elevance and UnitedHealthCare. Conditions supported are primary care, weight management, urgent care, and mental health. Release, FierceHealthcare

Alyve Health, a Mumbai, India-based digital health provider, raised a Series A of $5,5 million. It was led by Axilor Ventures with participants 1Crowd Fund, InHealth Ventures, and Trifecta Capital. Alyve provides services to corporate markets to simplify the health plan experience for members across multiple healthcare experiences such as doctor consultations, diagnostics, medicine purchases, dental procedures, gym memberships, and proactive well-being. According to the release, the raise will be used to improve its data, security, and AI capabilities, as well as expand operations, hire more talent, and enhance services. Mobihealthnews

Pain management technology company Upside Health closed. Founder Rachel Trobman posted the closure on her personal feed on LinkedIn. Their Branch Health app helped chronic pain sufferers better manage their pain and connected them to clinical and educational resources. Their website and LinkedIn pages are shuttered. According to her post, they had a base of 30,000 patients. Their funding listed on Crunchbase was $635,000.

Follow up roundup: Amwell to reverse stock split to avoid delisting (updated), Amazon Clinic folded into One Medical, Amedisys divesting to close UHG deal, latest on Steward Health’s antics and $7M spying, Masimo’s shareholder fight (latest)

Amwell will reverse stock split to fix their pending delisting on the NYSE. The board of directors approved on 28 June a 1 for 20 reverse split. This will remedy their non-compliance with NYSE regulations requiring an average closing price of above $1.00 over a consecutive 30 trading-day period [TTA 5 Apr]. Shareholders approved the move at their meeting on 18 June. The NYSE notice was given on 2 April and the reverse split will happen at the market open on 11 July, well within the six-month window. Amwell Class A shares closed yesterday at $0.27 so that condensing 20 shares will bring the share price around $5.40. Amwell’s 2024 is forecast with revenue in the range of $259 to $269 million and adjusted EBITDA in the (less) red between ($160) million to ($155) million, with no breakeven in sight until 2026. Their Q1 posted a $73.4 million net loss. Amwell has also released 10% of staff since the palmier days of 2023. Amwell, like Teladoc, continues to struggle in a stand-alone urgent care model that is now obsolete. Release, Healthcare Dive

Update 11 July: Amwell shares opened today at $6.52, and as of midday were trading at $7.51. So short term, the reverse split is working to plump up the shares.

Amazon says goodbye to Amazon Clinic by folding it into One Medical. This should come as no surprise to Readers who noted the  May departure of Clinic’s general manager Nworah Ayogu, MD to VC Thrive Capital with no replacement or search. Amazon’s announcement on 27 June was typically upbeat in renaming the service as One Medical’s Pay-per-visit telehealth. The improvements they claim are:

  • Pay-per-visit telehealth for 30+ common but minor conditions, like pink eye, the flu, or a sinus infection
  • A One Medical monthly or annual membership plan that includes on-demand virtual care and same or next-day appointments at 150+ One Medical primary care offices
  • More affordable–messaging/asynchronous visits are now $29, formerly $35, and video visits at $49, formerly $75. 

The catch–existing Clinic members have to log into One Medical to access their records and the service. Amazon is also propping up One Medical through Prime membership, offering a better deal at $99/year and non-Prime individuals for $199 per year. Amazon does not disclose users, growth, or revenue for either Clinic or One Medical. Healthcare Dive

The long-delayed UnitedHealth-Amedisys home health deal moves closer to closing. Amedisys and UHG’s home health operation under Optum will be divesting some of their locations to VitalCaring Group to avoid Department of Justice anti-trust concerns. The divestiture is contingent on the acquisition closing, now projected in second half of this year. The number of locations was not disclosed though earlier speculation had estimated it at 100. UHG’s offer to acquire Amedisys was made in June 2023 for $3.3 billion in an all-cash deal. It would be additive to its earlier $5.4 billion buy of LHC Group, now part of Optum. With the divestiture, analysts do not see any impediments to a closing, though it had faced opposition in Oregon in March and DOJ opposition since it was announced. This Editor remains sanguine about a successful closing. After UHG won versus DOJ in the Change Healthcare acquisition, “DOJ has a long memory, a Paul Bunyan-sized ax to grind, and doesn’t like losing.” Expect a few more impediments tossed in their direction over the next months. FierceHealthcare , Zack’s Research

The latest episodes in the continuing soap opera of Steward Health involve both Optum and James Bond moves on their critics. Optum had offered back in March to buy their practice groups under Stewardship Health, which stalled with first the Massachusetts Health Policy Commission (HPC), then their bankruptcy. That offer is now off, leaving Steward in the lurch. It was critical to $75 million of Steward’s debtor-in-possession (DIP) financing as recently as 13 June [TTA 14 June]. The deal would have been problematic anyway for Optum as they are under DOJ scrutiny not only for Amedisys but also because Optum controls or has arrangements with 10% of US physicians, 90,000 to date. Healthcare Dive They also settled recently with DOJ for $20 million on Optum Rx’s filling orders from a mail-order pharmacy in Carlsbad, California between 2013 and 2015 for Schedule II drugs: opioids, benzodiazepines, and muscle relaxants. Healthcare Dive

Adding to Steward’s piles of misery are the latest revelations that Steward financed a $7 million spy operation on their critics. This loony aspect to the Steward endgame involved contracting with UK investigators on surveilling a critical former executive, a British financial analyst, and a Maltese politician to find compromising actions between 2018 and 2023. The investigations were allegedly authorized and prioritized by Steward’s top executives while Steward struggled to pay bills for its hospitals and practices. Payments to the investigators were routed through Steward’s Malta operation against their critics in Malta and elsewhere. Steward at the time was embroiled in a dispute around their management of hospitals in Malta, which was eventually investigated and terminated by a Maltese court last year.

One example: the UK firm Audere “collected embarrassing personal information and photographs of a former Steward employee after Steward feared he would leak financial information to its auditor.” Another was the investigation and harassment of a British financial analyst, Fraser Perring, critical of Steward’s actions in its dealings with Medical Properties Trust (MPT). He was followed, his home CCTV was disabled, his home was broken into, family members and his partner were followed. Perring was also being smeared on Twitter through an account set up by Audere. There is much more on this in OCCRP’s report, published (paywalled) in the Boston Globe and Times of Malta. OCCRP’s full report and findings are here. FierceHealthcare

Electronics, audio, and medical device company Masimo continues to fight a hostile activist investor, Politan Capital Management. In December 2023, Masimo notched a significant win via the International Trade Commission versus Apple’s Series 6 and later Watches that forced Apple to disable its pulse oximetry (SpO2) sensors and software that violated Masimo’s smartwatch patents [TTA 28 Dec 2023]. Politan descended on Masimo in April accusing CEO and chairman Joe Kiani and others of mismanagement, including the 2022 acquisition of Sound United’s audio brands. It won two seats on the Masimo board of directors at the last shareholders’ meeting and is demanding two more seats at this year’s meeting on 25 July which would give it effective control.

The latest in the proxy fight is that the chief operating officer, Bilal Muhsin, will depart after 24 years at Masimo if Joe Kiani is forced out. The brief conditional resignation was sent to Masimo’s lead independent director, Craig Reynolds. Mentioned in the resignation was that he would refuse to work with Quentin Koffey, a Masimo director and chief investment officer of Politan Capital. More letters like this may be coming as reportedly Masimo management has urged employees to sign similar letters. Strata-gee, MedTech Dive  

Politan was the investment group that upended Centene Corporation and ousted most of Centene’s board plus 25-year CEO Michael Neidorff in 2022 shortly before his death on 7 April 2022 [TTA 18 Dec 2021]

Update: 300 engineers in Masimo’s healthcare division expressed specific support for Joe Kiani against Politan and Quentin Koffey in an open letter. “We wish to convey our deepest concern if Quentin Koffey and Politan Capital take control and Joe Kiani is removed. We are committed to Masimo because of the vision and innovation he pushes and drives us to deliver. The prospect of losing our founder and CEO threatens to derail the progress we have made and jeopardize the future of Masimo.” They also expressed that they may leave. “We, the undersigned from Masimo Healthcare Engineering, wanted you to be aware that we may not continue with the company if Joe Kiani is replaced by Quentin Koffey and Politan Capital.” This follows on other letters written by international regional managers and presidents in June also stating their support and warning that they may leave if Kiani leaves. The annual shareholder meeting is scheduled for 25 July.   MedTech Dive

However, Masimo is also embattled on other fronts: earlier in June, DOJ and FDA announced their investigation of problems with their Rad-G and Rad-97 SpO2 devices leading to a recall and the SEC is investigating potential accounting irregularities and internal control deficiencies. MedTechDive

Short takes/wrapup: fundings for Talkiatry, Heyday Health, CipherHealth; Brightside Health now 50 states for Medicare Part B; Neurabody’s sensor based posture therapy; below the radar global layoffs at Medtronic

The funding spigot seems to be on, even up to a Series C.

Talkiatry closed a $130 million Series C for a total funding of $245 million. The round was led by Andreessen Horowitz (a16z) with participation from Perceptive Advisors. Debt financing was provided by Banc of California. Talkiatry’s offering in virtual behavioral or telemental health is psychiatrically-based with a national network of 300 psychiatrists performing to date over 1 million patient visits. Their differentiation is stronger outcomes and reduced utilization of higher levels of care. Their footprint is in health plans: Aetna, Blue Cross Blue Shield, United Healthcare, Cigna, and Humana, covering more than 70% of commercial lives in the US–but plans to expand to provider networks. Release, FierceHealthcare

Heyday Health‘s raise of $12.5 million was from Gradient Ventures (Google’s early stage fund), Lionbird, a large national payor, Great Oaks Capital, and Kate Ryder, CEO of Maven Clinic. Heyday’s technology provides 24/7 in-person’s home, telehealth, and phone visits for Medicare and Medicare Advantage beneficiaries in Ohio and Kentucky. Each person is connected to a personalized care team comprised of a physician, a nurse practitioner, and a Health Ally that works with them to design and manage care plans. The funding will be used for geographic expansion into the Cincinnati/Dayton area in Southwest Ohio and the Louisville area in Kentucky. Release, FierceHealthcare

CipherHealth received an undisclosed capital investment from Atalaya Capital Management for growth and expansion. Cipher provides communication solutions for patient engagement such as secure texting, appointment setting, rounding, and patient feedback. Release 

Brightside Health, another telemental health provider that had its own $33 million Series C in April, announced that it has expanded its reach to Medicare Part B recipients in all 50 states and the District of Columbia, making it the first and only telepsychiatry provider to do so. With this, they now have a total reach of 130 million covered lives. Older adults are an underserved market for mental health support, with 15% utilizing ERs for care, one in four recipients living with a mental illness, and those 65+ having the highest rate of suicidal ideation. Release

We don’t often hear of digital health coming out of Luxembourg, but startup Neurabody located there is combining sensor-based data with AI to address the causes of and therapy for lower back pain. The current Posture AI device is a smart posture estimation sensor and an optional posture correction ergonomic shirt that provides personalized feedback and advice on improving posture and reducing pain via a smartphone or tablet app. If the user begins to slouch, the sensor detects it and buzzes to remind the user to sit up straight. Future products in the next two years are a smart posture seat and smart lumbar support devices. Co-founder William Choi is a serial entrepreneur, an investor and founding member of BackJoy Orthotics, an Inc 500 Fastest Growing Company. Right now the app is available on Google Play and the Apple App Store. The shirts are listed at $149 but the sensor and chest strap are not listed for sale and the shirt purchase pages are not functional. The pages need some work (e.g. typos, ‘coming soon’ pages). Release

But layoffs are still with use, even for the powerful ‘giants’.

Med device giant Medtronic has been quietly proceeding with a global layoff. The only publications that have been on this are Mass Device, which initially was unable to receive confirmation but pursued, and the local Minneapolis Star-Tribune. The layoffs started in April and May, with posts from former employees on LinkedIn and on TheLayoff, which are coded in Medtronic-speak. The company confirmed earlier this month to the Strib that it was laying off staff but would not give details, from the number of employees affected to impacted business divisions or geographic locations.

At the end of 2023, Medtronic offered employees an early retirement program, usually a first sign of major layoffs. Then, at the start of 2024, Medtronic announced the closure of five manufacturing plants and six distribution centers as part of an effort to improve the company’s supply chain, but again refused to disclose where or when. Medtronic relocated to Dublin years ago but maintains an operational HQ near Minneapolis. 11,000 employees of 90,000 total work there, making Medtronic the world’s largest medical device company and still a major employer in Minnesota. None of the layoffs are showing up on state WARN sites either because they are below the thresholds or Medtronic is simply not filing, though states do not except foreign companies.

Did they really think that they could keep this on the QT and Strictly Hush-Hush in the age of social media and layoff trackers (apologies to James Ellroy)?

News roundup: AliveCor launches FDA-cleared Kardia 12L ECG, eVisit buys UPMC’s inpatient teleconsult, UPMC and MedStar invest; NeueHealth gains $150M loan–with caveats–and NYSE non-compliance notice

AliveCor shrinks 12-lead ECG to a single cable with AI-assisted detection for 35 cardiac determinations. The just-cleared by FDA system for clinicians combines the Kardia 12L ECG System (left), a single cable with five electrodes that acquires 8 high-quality diagnostic bandwidth leads, with the KAI 12L AI-assisted diagnostic technology. KAI uses a deep neural network-machine learning AI model to interpret ECG data acquired and validated on more than 1.75 million ECGs from leading US medical centers. It can make 35 cardiac determinations–14 arrhythmias and 21 morphologies–that include acute myocardial infarction (MI) and the most common types of cardiac ischemia. The Kardia 12L is battery-powered, weighs about 1/3 of a pound, and fits into a typical lab coat pocket.

12-lead ECG is considered the standard of ECG readings. A pocket system of this type puts this in reach of clinics, rural health, urgent care offices, and employer clinics. It requires minimal self-guided training and doesn’t require patients to fully disrobe. Release, Mass Device

Telehealth provider eVisit acquiring UPMC’s inpatient teleconsult technology–along with investments from UPMC and MedStar Health. This ‘hat trick’ adds hospital inpatient telehealth capability to eVisit’s health system-focused telehealth triage, provider-to-provider consults, and scheduled telehealth visits. The teleconsults serve inpatient care across five services: stroke, neurology, critical care, psychology, and toxicology. Both UPMC and current client MedStar Health (from the 2023 Bluestream Health acquisition, TTA 27 Apr 2023) are also investing in eVisit, adding an undisclosed amount to eVisit’s 2021 $45 million Series B. (Another way of saying ‘unlettered raise’?) Release, FierceHealthcare

And would this month be complete without items from the Dean of Dodging Disaster, Creating its Own New Reality, the one and only NeueHealth? The first is that Hercules Capital is giving them a second term loan facility (Loan and Security Agreement) of up to $150 million over three years that is, to be polite, hedged with qualifications. 

  • Tranche #1 is available on closing: $30 million
  • Tranche #2, $25 million, will be available only for a limited time– 10 November through 31 December 2024. It is also dependent on Molina making its final payment to NeueHealth for the Medicare Advantage plans they bought–a payment dependent in turn on those plans achieving plan performance ratings ( the “2025 Stars Condition”).
  • Tranche #3 of $45 million will be available from 5 February 2025 to 15 September 2025. But it is contingent after paying off what is owed in connection with the ACO REACH Model for performance years 2023 and earlier, payment in full of the CMS Settlement (as defined in the Loan and Security Agreement) and the Company having at least $22.5 million of unrestricted cash and cash equivalents.
  • Tranche #4: up to $50.0 million and available until 21 June 2027
  • The loan matures on 1 June 2028

Release 24 June, SEC Form 8-K, FierceHealthcare

The second is that the loan could not have come at a more needed time, as NeueHealth received a non-compliance notice from the NYSE on 16 June. It fell below an average market capitalization of $50 million for 30 consecutive trading days, with their last reported stockholders’ equity also below $50 million. It has 45 days to submit a business plan to remedy it within 18 months. NeueHealth’s preferred stock had a value of $920.4 million as of 31 March 2024 but is excluded from the NYSE calculations of common stockholder equity. NeueHealth closed today at $5.23.

This is in addition to a $30 million loan from current 60% majority shareholder NEA [TTA 16 Apr].

Along with tying Gordian knots masterfully and playing multiple ends against the middle, one wonders what management does all day at their new offices in Doral, Florida? Avoiding Chapter 11? Golfing? Surfing?

A Gimlet Eye view on IPOs and Cracked SPACs: Altaris buys Sharecare for $518M, takes it private; a look at Waystar and Tempus AI post-IPO

Gimlet EyeSharecare finally gets itself bought and taken private, less than three years after its SPAC. One-time health tech darling Sharecare, now a patient navigation and employee benefits platform and once valued at $3.9 billion, will be acquired by healthcare-focused private equity company Altaris LLC for $1.43 in cash per share, or about $518 million. The shares on the buy date, 20 June, were trading at $0.77 so the offer is about an 86% premium, though shares are now trading at around $1,38. (Notably, Sharecare was below the $1.00 threshold for Nasdaq since February.) The transaction is expected to close in Q2 subject to formal shareholder approval and regulatory agencies. In terms of management, the executive team is expected to continue at least for now, with founder Jeff Arnold voting his shares in favor of the transaction and continuing as a shareholder. Release, FierceHealthcare, Mobihealthnews

Founded in 2010 by WebMD founder Jeff Arnold and celebrity doc/former political candidate Dr. Mehmet Oz, Sharecare had IPO’d a decade later via a SPAC, Falcon Capital Acquisition Corporation. It announced in February 2021’s Pandemic Palmy Days then hit markets on 2 July. At that time as essentially a personal care management app, it debuted at above $9.00 and received $571 million in gross proceeds with a reported valuation of $3.9 billion. A month later, it acquired CareLinx, an on-demand home care provider, from Europ Assistance in a $65 million cash/shares deal. By late 2021, Sharecare entered the Cracked SPAC Track as shares cratered. Dr. Oz is no longer on the board of directors or the advisory board. As share values fell precipitously, in November 2023 Mr. Arnold turned over the CEO reins to Brent Layton, a 20+ year Centene veteran and its retired president, picking him from the BOD and moving to chairman.

Shortly thereafter, Fruit Street sued Sharecare, a former partner, for $25 million charging that their diabetes prevention program (DPP) was supplanted by Sharecare’s own, breaching their contract and appropriating intellectual property. [TTA 14 Dec 2023] This suit is apparently still wending its way through the infamous Fulton County, Georgia courts. Sharecare also faced an escalating number of shareholder class action lawsuits alleging false and misleading statements on their financial condition (KRON 4).

What can we learn from IPOs as they are reviving? The first, of course, is that SPACs have gone the way of the dodo and passenger pigeon. The second is that there are quality IPOs, and then there are the ones to watch out for even if you are not an investor.

Remember first and foremost that VC and PE investors want to exit, profitably. And quickly. Exit=Sell to Someone Else. “Someone else” can be an IPO or another investor. An IPO means offloading the risk to the investing public. Please do keep in mind that what follows 1) is not investment advice, only observations and 2) your Editor is only a marketer, but one who has seen investments go up, down, and sideways since her days at the Frank Lorenzo School of Airline (Mis)Management, a/k/a New York Air (right, below) including a year observing up front and personally the dismal fate of Eastern Airlines. (Somewhere she has her old Texas Air share certificates…)

The investment scene in health tech and AI strongly resembles the Wild West days of airlines post-deregulation 30 years ago. Investor money in, now fleeing for the exits, whether the bankruptcy court or passing the hot potato to others with money.

Waystar IPO’d earlier this month at $21.50 per share. Checking in today, it’s trading at $21.55, essentially in a narrow and flat trading range in a down market. The IPO gave Waystar a fully diluted valuation of $3.69 billion. It’s early days, but three factors in favor of WAY staying the course at least short term are:

  1. They waited to IPO for the better part of a year and pulled it back when their initial valuation of $8 billion made Mr. Market ROTFL.
  2. Their investors have held on tight: EQT AB, Canada Pension Plan Investment Board (CPPIB), and Bain Capital will beneficially own approximately 29.2%, 22.3%, and 16.8%, which is over 68% of the company.
  3. They occupy a boring part of healthcare and aren’t new kids on the block. Payments and revenue cycle management (RCM) aren’t sexy or trendy. Waystar is the combination of ZirMed (1999) and Navicure (2001) which merged and renamed in 2018. 

The downsides: Competition. Lots of it. The usual unprofitability. Waystar lost money the past two years. Last quarter, those losses accelerated (Google Finance). Will that show up later this year in share price?

Tempus AI also IPO’d mid-month at an eyewatering $37/share, at the top of its offering range, and a valuation in excess of $6 billion. It’s AI! It’s backed by Google! And it rose 15% on its first day of trading, 14 June! Precision Medicine! Intelligent Diagnostics!

But where are shares today on 26 June? It closed yesterday at $24.96. That’s a downer of 32% from the IPO price–38% if you take it against the first-day close above $40. I’m sure the first-day investors, unless they have cast-iron stomachs, have already reached for the antacids.

So what’s going on here? Tempus AI’s business combines AI for data analytics and a vast database to guide doctors in therapy and treatment, identify clinical trials, guide treatments, and close gaps in care. The analysis is done on blood samples, buccal swabs, and liquid tests. It’s a familiar pitch that multiple companies are using around AI and their ‘vast databases’ from the time of IBM Watson’s lofty ambitions.

  • Their CEO has already traversed the hype circuit. “We’re on a really good trajectory,” Tempus AI CEO Eric Lefkofsky, the founder of Groupon, said on CNBC’s “Squawk Box” Friday morning before shares started trading. “As revenues have been growing quickly, we’re not investing all that gross profit dollar growth back into the business. We’re generating improved leverage every quarter.” (Exactly what does that mean? Probably that money is sent down to the profit line.) Setting expectations–within the next year, the company is expected to be cash flow and EBITDA positive within the next year. It’s twice been on CNBC’s Disruptor 50 list of private companies which historically has been a mixed bag.
  • In their favor is that they already have as of today 510(k) clearance from FDA for its Tempus ECG-AF device to identify patients who may be at increased risk of atrial fibrillation/flutter (AF). It’s the first FDA clearance for an AF indication in the category known as “cardiovascular machine learning-based notification software”. But it needs to be integrated into resting 12-lead ECG recordings collected at a healthcare facility and analyzed against other patient data. What is that timeline and market?
  • Tempus has already survived and evolved from one major pivot. Looking back, they started in the genomic testing business in 2015, primarily concentrating on oncology. In 2020, it branched out to then-trendy Covid-19.  CNBC 17 June 2020  Genomics is now subsumed on the site by terms such as pharmacogenomics (PGx) coupled with patient-reported outcome (PRO) software.

Investors up to the IPO were listed as Google, Baillie Gifford, Franklin Templeton, NEA, Softbank, and T. Rowe Price. Who’s sticking around? The underwriters are Morgan Stanley, JP Morgan, Bank of America Securities, and Allen & Company. Reuters  Customers include AstraZeneca and GSK (GSK.L). One of its competitors, Guardant Health, which has patents in DNA blood testing for cancer, is suing on infringement on five patents. Reuters

All in all, Tempus AI started off way high–and there is only one way to go from there. They have a great story and a potentially good business, but it bears watching, not investing, at this point.

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

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.

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

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

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).