Roundup: Virgin Pulse, NextGen close fast; Elucid, Eleos, Vida, Neteera funding; One Medical-CommonSpirit; Indian Health $2.5B EHR to General Dynamics+Oracle; losses, layoffs at Cano Health, 15% digital cuts at Mass General Brigham

No surprise that some big deals in digital health closed at year’s end before we roll out the turkey and the holiday decorations.

  • The Virgin Pulse-HealthComp merger that adds benefits analytics to Virgin’s employee wellness platform closed last Thursday (9 November). It was announced only in late September [TTA 29 Sep]. This creates what they estimate is a $3 billion company. Ownership is also changing to New Mountain Capital, the owner of HealthComp, now as the majority owner of the new company with Marlin Equity Partners in minority ownership with others including Blackstone and Morgan Health. Other than Chris Michalak becoming CEO of Virgin Pulse and HealthComp, there is no confirmation of financing nor management/employee transitions or headquarters (Virgin is in Providence Rhode Island, HealthComp in Fresno California). Virgin release
  • EHR NextGen closed its $1.8 billion taking-private by private equity firm Thoma Bravo after shareholders approved it the previous Tuesday for $23.95/share in cash. This was announced around US Labor Day and closed in record time on Friday 10 November. As previously noted, this ended 41 years of public trading for a company that was one of the pioneers of EHRs and practice management. In its release, Thoma Bravo will “leverage its operational and software expertise” and “adding new products and capabilities, both organically and inorganically, to continue enabling NextGen Healthcare’s customers to deliver exceptional patient outcomes.” Healthcare Dive, FierceHealthcare (also Virgin Pulse)

Are these lights at the end of the dark M&A tunnel for health tech and related? Or avoiding the oncoming train of FTC and DOJ regulations that collide head-on with M&A with the pending imposition of the Draft Merger Guidelines and the Premerger Notification rules under Hart-Scott-Rodino (HSR)?

It seems like top digital health law firm Epstein Becker Green has caught up with Editor Cassandra [TTA 20 July, 20 June]  in this Diagnosing Health Care Podcast of 10 November. Fun estimate: the time in filing a premerger notification may be increased by 289%. The cloudy crystal ball was clear indeed….

Last week was also a busy time for smaller companies’ fundings–even letter rounds! 

  • Elucid scored $80 million in Series C funding led by led by Elevage Medical Technologies, bringing total funding for this AI-assisted cardiovascular imaging company. They have the “only FDA-cleared non-invasive tool able to accurately characterize arterial plaque, simulating what pathologists would see under a microscope and establishing a histologic ground truth. The company is also pursuing an indication for non-invasive measurement of fractional flow reserve (FFRCT), uniquely derived from its PlaqueIQ technology, to measure coronary blockages and the extent of ischemia.” Release
  • In behavioral health, Eleos Health now has $40 million in Series B funding to add to previous funding of $28 million. The Series B was led by Menlo Ventures, with participation from F-Prime Capital, Eight Roads, Arkin Digital Health, SamsungNEXT, and ION. Eleos has developed AI-assisted solutions for group therapy sessions, compliance automation, case management, concurrent documentation, and value-based care support. They will use the additional funding for further development as well as network expansion and EHR partnerships. Release
  • Vida Health, which offers health coaching for chronic conditions, primarily obesity and diabetes management, gained $28.5 million in an unlettered round led by existing investors Ally Bridge, Canvas Ventures, General Atlantic, Hercules Capital, and others. Vida also announced a change of CEOs. Joe Murad succeeds Stephanie Tilenius, who is stepping down after nine years as founder/CEO, transitioning to an advisory capacity. Mr. Murad joins the company’s board. He was previously with WithMe Health, where he was president/CEO for nearly five years and previously headed PokitDoc before its acquisition by Change Healthcare in 2018. Release  Also Mobihealthnews on Elucid, Eleos, and Vida.
  • Israeli RPM company Neteera now has an additional $6.7 million as part of a Series B extension. Their unique RPM uses sub-THZ radar to monitor vital signs through bedding and clothing, then analyzes the data and produces reports on its platform. Neteera partners with Foxconn on their RPM and currently sells to long-term care facilities in the US.  Pulse 2.0

Amazon’s One Medical announced a partnership with CommonSpirit Health’s Virginia Mason Franciscan Health (VMFH) in the Seattle Puget Sound metro. This will add integrated specialty care in that area to One Medical’s primary care focus. VMFH has 2,000 providers in an integrated network of providers, outpatient facilities, and hospitals. Financials weren’t disclosed, but according to Becker’s, in another One Medical partnership, a health system disclosed that it “reimburses One Medical for providing care on its behalf and collects the fee-for-service revenue from the patient visits. One Medical previously collaborated with Seattle-based Swedish (part of Renton, Wash.-based Providence) in the region.” VMFH release, FierceHealthcare

The federal Indian Health System (IHS) is modernizing its EHR and moving to a General Dynamics IT-managed Oracle Cerner system. Its current system is the 40+-year-old Resource and Patient Management System–based on (surprise!) VistA. What is most interesting in the release is that General Dynamics Information Technology (IT) is listed as the primary contractor that will “build, configure, and maintain a new IHS enterprise Electronic Health Record system utilizing Oracle Cerner technology.” One very interesting bit of verbiage! The IHS used an “Indefinite Delivery, Indefinite Quantity” contract structure for this requirement which is explained as “the IHS will issue specific task orders for technical support and services. This gives the IHS the ability to adjust what it purchases, incorporate lessons learned, user input, and availability of new technology.” Reports indicate its ultimate value to General Dynamics IT in the 10-year contract to be close to $2.5 billion. IHS provides healthcare services for 2.8 million American Indians and Native Alaskans belonging to over 570 tribes. IHS release, Healthcare IT News

Cano Health continues its hemorrhage. Q3 loss was $497.1 million in Q3, with a cut of 21% of its workforce, or approximately 842 staff. Their loss was 4x times the year-prior Q3 on revenue of $788.1 million. Adding to operating losses, they were hit with a $354 million impairment charge and poor operating results from higher third-party medical costs. 52% of the staff cuts reflect the sales of operating units such as in Texas and Nevada to Humana CenterWell and exits in California, New Mexico, and Illinois. The remaining 48% is from restructuring. Now a Florida-only operation except for Puerto Rico (ending early 2024), they are concentrating on ACO REACH and Medicare Advantage there. Their clinics are now 126, down from 169 at the end of June. Cano is still looking for a buyer, which indicates that they anticipate further rough going. Healthcare Dive, Cano Health Q3 Financial Powerpoint

And winding up the bad news, Mass General Brigham, which is partnering with Best Buy for their Healthcare at Home programs, will be doing it with at least 15% fewer digital staff. They are offering voluntary separation packages to those employees in the hope of finding enough takers. The offer is a not especially generous two weeks of severance for every year of service. If the magic number of 15% is not reached, layoffs will start after Thanksgiving. Reportedly a state agency, the Massachusetts Health Policy Commission, has deemed that MGB’s cost growth is too much. MGB is the largest private employer in Massachusetts with 80,000 workers. The offers were floated starting from 1 November and will close on 15 November, with layoffs if needed to be announced on 4 December. The targeting of digital is claimed to be for modernization. The area is responsible for multiple areas of IT and maintaining patients’ electronic health records. Boston Herald, Healthcare Dive

Catching up on Oracle Cerner and the VA, plus the AI ‘tech sprint’

Since Congress passed appropriations for the VA in September/October [TTA 3 Aug on House bill] after a busy and acrimonious summer, things have been very, very quiet. The appropriations require multiple mandatories around reporting by Oracle and the VA, which have kept them busy. Prior to this, VA screeched to a halt any further implementations of the Cerner EHR until the five current ones are fixed. The exception–the Captain James A. Lovell Federal Health Care Center in Chicago, the only fully-integrated VA and Department of Defense (Military Health System) healthcare system, with a projected go-live of March 2024.. As MHS, a much smaller and focused system, is just about completed with Cerner and the VA implementation is now postponed, Oracle decided to lay off former Cerner staff in fairly substantial numbers–500 to a rumored 1,200 layoffs in June.

Additional updates:

  • As of a September report on FedScoop, VA and Oracle Cerner plan to resume implementations during the summer of 2024, according to Dr. Neil Evans, acting program executive director of the VA’s EHRM Office, during a House Appropriations Oversight hearing on implementation of the VA’s EHRM initiative with Oracle Cerner that included Oracle’s Mike Sicilia.
  • At that hearing, VA reported that the first round of fixes were completed on the EHR on 31 August in the first round of three-month increments.
  • But during the Appropriations Oversight hearing, leaders of the VA medical facilities already using the Oracle-Cerner EHR testified that productivity is still less than when they were on VistA. Workers are putting in longer hours to cover the workload. Overal, the five the medical centers have hired on extra staff to compensate and have reported “exhausted, sometimes tearful, and frankly distressed” staff in dealing with multiple errors.
    • Robert Fischer, director of the flashpoint Mann-Grandstaff VA medical center in Spokane, Washington, testified that they hired 20% more staff and 15% more clinicians to handle the same workloads. “I would say one of the root causes is related to Oracle-Cerner’s lack of appreciation for the complexity of VA operations,” Fischer said.
    • Since implementation, employees have investigated 1,600 Oracle-Cerner-related patient safety events, 15,000 “break-fix” IT help tickets, and 28,000 medical orders that “did not execute successfully as anticipated.
    • Example: at the VA Ambulatory Care Center in Columbus, Ohio, “Imagine being a doctor in Columbus, and receiving a critical message about a patient you have never seen, who’s been admitted to a Department of Defense site thousands of miles away, because his provider has a similar name,” Meredith Arensman, their chief of staff, testified. “Imagine being an optometrist and finding an eyeglass prescription that has your signature, that you know you never signed … These are not possibilities. It has been the reality.” Federal News Network
  • Perhaps as a backup, the VA inked a deal made public today (31 October) with 13 community hospital systems for data sharing.  The stated intent is by data sharing, they will improve veterans’ care in or outside the VA system, facilitate veterans taking advantage of VA and community resources, and connect veterans with VA benefits, including new benefits for toxic exposure-related conditions under the PACT Act. However, it’s also well known that VA offloads to community health systems. The systems are listed in the VA release. Work has already started and proof-of-concept is due in early 2024. FedScoop

VA also has to cover the now executive-ordered (EO’d) $1 million ‘tech sprint’ for healthcare innovation to 1) reduce staff burnout and 2) create AI-centered tools to save time for clinicians, such as clinicians’ note-taking and integration into veterans’ medical records. This one will consist of two three-month AI Tech Sprint competitions. More distraction. FedScoop

The Cerner blues, VA and health system driven, are affecting the Oracle share price. But Oracle chairman’s Larry Ellison need not worry. His net worth of $130.9 billion makes him the second wealthiest person in healthcare, topped only by Jeff Bezos of Amazon and followed by Thomas Frist and family, according to Forbes. Becker’s

Short takes and updates: FTC may not be done with CVS-Oak Street, VistA moves to cloud–why?, Oracle Cerner lays off 10%. at least

The CVS-Oak Street Health buy may be finalized on paper for $10.6 billion, but it’s not a done deal. While the papers are signed and the preparations may be underway for a closing at the end of the year, it’s still subject to Federal and state approvals [TTA 9 Feb]. This week, Senator Elizabeth Warren, a one-time presidential candidate who cherishes her bully pulpit as a member of two finance committees (but chair of none), sent a letter (office release) to the Federal Trade Commission (FTC) to “carefully scrutinize” the deal.  In addition, she urges FTC to “retrospectively review similarly consummated deals and challenge in court any mergers that have reduced competition in violation of antitrust laws”. FTC is a prime candidate for a nudge because their newly activist stance needs little encouragement for the commissioners to pull out the cudgels.

CVS may very well find itself challenged as well by the Department of Justice (DOJ)–a more complicated action since it requires preparing a case, going to Federal Court, filing papers, and convincing a judge that it involves true antitrust issues worthy of further examination. CVS  may well be spending time in Federal and state courts before the closing, and likely expects it. Even so, DOJ appears to be positioned on the sidelines. There is a memorandum of understanding between DOJ and Health and Human Services sharing concerns about antitrust.  DOJ may also be tired of complicated, labor-intensive suits like UnitedHealth Group and Change Healthcare that wound up in favor of the defendants and with egg on DOJ’s face [TTA 23 Mar]. Unlike DOJ, FTC has more latitude and they have been using it. Thus Sen. Warren’s appeal is a strategic one. FierceHealthcare

Yet where does it end? Horizontal integration or consolidation–businesses buying similar businesses–has obvious limits. But vertical integration–owning part or all of the care continuum or means of production–is less obvious. It can make healthcare more available and effective. But it may reduce competitive opportunity and create a ‘one or none’ business model. That is where the Feds tend to step in unless it’s a bank (of late). 

VistA’s new tune is ‘I’m Still Here’–in the cloud. Yes, VistA, facing phase-out at the VA, is moving its system to the cloud, and has major reasons why. Reginald Cummings, the deputy chief information officer for VA’s infrastructure operations,  explained during a panel discussion of the Association for Federal IRM (AFFIRM) that the ‘lift and shift’ (the hip IT term for this) was done for two things: to move it away from being multiple systems running at each facility, and to ‘containerize’ it,  packaging the application together with the resources it needs to operate, such as the operating system itself, the storage and interfaces. This improves security and portability. The real news is that VA is now admitting that it will take years to transition to Oracle Cerner. According to Daniel McCune, a VA software executive, VA may need VistA for another 10 years. (Perhaps 15?) Supposedly, this isn’t modernization…but it does keep a legacy system running indefinitely, like the Energizer Bunny, which would 1) suit many at VA, and 2) perhaps avoid dealing with the Oracle Cerner issues. No mention is made in the article if this makes transitioning to Oracle Cerner easier, which this Editor finds odd. The chair of the panel discussion, Tom Temin, is also the article author on Federal News Network. As some of our international Readers know, VistA is used in countries such as India as open-source software (WorldVista.org).

And speaking of Oracle Cerner, the layoffs are on. Rumors have it as high as 10% of Oracle Cerner’s global workforce of about 28,000. It is surmised that at Cerner’s former HQ sites in Kansas City, the layoffs may be several hundred, though no WARN notices for group layoffs have been filed with Missouri. These notices are required when layoffs are at least 50-499 employees if they represent at least 33% of the total active workforce, excluding any part-time employees; or 500 or more employees (excluding any part-time employees) in which case the 33% does not apply. (DOL WARN Act guide) The Cerner workforce in the KC area was about 12,000 at one point. Severance packages were reported to be four weeks plus one week per year of service.

In addition, Oracle employees who were working from an Oracle office but transitioned to remote work during the pandemic must return to in-office work at their previous campus. They will be notified by managers in the next 30 days whether they will be full time in office, ‘flex’ or hybrid without an assigned space, or continuing as remote. Perhaps this is why WARN notices were not filed. Many workers moved out of area, and refusal to return to office can be called quitting. HISTalk, Becker’s

Short takes for Thursday: Diagnostic Robotics $45M raise; Sage’s $9M seed; VA names EHR ‘functional champion’; Aussie telehealth startup Coviu arrives in US

Tel Aviv-based Diagnostic Robotics gained a $45 million Series B. The company has developed AI predictive analytics for health plans, providers, government, and employers for clinical assessment and decision support. The Series B was led by StageOne investors, with participation from Mayo Clinic, thus becoming a Mayo Clinic Platform portfolio company, plus Technion – Israel Institute of Technology, as well as other existing investors. Total funding since 2019 is $69 million (Crunchbase) Release, Mobihealthnews

NYC-based Sage received $9 million in seed funding to further develop and market its app that rethinks the nurse call system in use in senior living. The platform provides caregivers with data to coordinate incident responses and triage quickly and effectively, plus provide care managers with tools to better understand resident needs, provide proactive care, and view staff performance. The round was led by Goldcrest Capital, with existing investors ANIMO Ventures, Distributed Ventures, and Merus Capital. Release

VA names ‘functional champion’ for their VistA to Oracle Cerner transition. Dr. David Massaro will work as the clinical executive representing the Veterans Health Administration (VHA). He will lead functional initiatives to support the department’s medical personnel during the transition. Dr. Massaro is a long-time VA-er, previously acting chief health informatics officer for the Office of Community Care and before then director of integrated health practice within the Office of Health Informatics, as well as a practicing physician who joined VA in 2006. FedScoop

Coviu, an Australian telehealth startup, is launching its platform in the jammed US market. It’s marketing as an ‘all-in-one virtual engagement platform’ and is clearly appealing to primary care practices that need a less expensive solution. Its difference is apparently with modular apps that can extend a provider’s clinical work: behavioral health, speech pathology, and audiology. Base pricing starts at $25 monthly with the highest level package $65/month. Integrated apps are the Wechsler Individual Achievement Test, pulse oximeter remote monitoring, and a checklist for PTSD. They are also developing a new digital wound care toolkit in collaboration with the Commonwealth Scientific and Industrial Research Organisation and the Western NSW Primary Health Network, for release in 2026 (!!). Coviu claims use by 90,000 clinicians worldwide who deliver a daily average of over 14,000 telehealth consultations. Their US base is in Dover, Delaware and is HQd in Brisbane and Sydney. Release, Mobihealthnews

Thursday news roundup: bet on Oracle-Cerner closing next week, VA EHR progress reports mandated, Homeward-RiteAid rural care, Medtronic-DaVita kidney JV, Withings reenters RPM, Lightbeam buys Jvion AI

The Oracle acquisition of Cerner will close as early as Monday next week, no later than mid-June. Mid-June is the prediction of Seeking Alpha. They based it on Oracle-Cerner already passing Australia’s Foreign Investment Review Board, no questions posed by the UK antitrust authority, and the US waiting period expiring in February. As rumored [TTA 25 May], European Commission regulators approved it today (Barrons, paywalled) which predicts the close will be next Monday. Hat tip to HISTalk for their alert yesterday.

Scrutiny of Cerner’s $16 billion EHR implementation with the Department of Veterans Affairs by Congress ramps up. New legislation due to be signed by the president shortly will require the VA Secretary to submit regular reports 30 days after the last day of each fiscal quarter on the VA’s Electronic Health Record Modernization (EHRM) program. Content will include spending, performance metrics, outcomes, safety, transitioning from VistA to Cerner Millenium, interoperability, and progress or issues with all. Text of Senate bill, FierceHealthcare  TTA’s previous article on Cerner EHR interoperability problems with DOD and VA

Bringing healthcare to rural America is Homeward with a freshly inked deal with RiteAid. Founded by former Livongo president Jennifer Schneider, MD, Homeward will set up distinctive purple mobile van clinics at up to 700 Rite Aid location parking lots in rural communities starting Q3 this year. Michigan will be the first market. Homeward will accept regional Medicare Advantage plans and Medicare.

The company is targeting the 60 million Americans who live in rural areas and have been losing access to basic medical care as local practices and clinics close. Their technology enablement will be for appointments, checkins, telehealth, remote patient monitoring, and scheduling home visits. Homeward announced its launch at the recent ViVE2022 in March including $20 million in funding from General Catalyst. Other Livongo alumni with the new company are Brian Vandenberg, former general counsel, Amar Kendale, former chief product officer, and Bimal Shah, MD, former chief medical officer at Livongo. Nice to know that they have moved to another healthcare chapter of real need, versus cruising the Caribbean in very large yachts. FierceHealthcare, Homeward release

Medical device giant Medtronic and DaVita are establishing a joint venture by next year to advance kidney care therapies and technologies, including new products to be used in clinics and in the home. The intent of the JV is to increase the availability of kidney care including dialysis. 10% of adults worldwide–700 million people–have chronic kidney disease. 2.6 million have kidney failure. The JV is expected to be formed in early 2023 with each company owning an equal share. Initial investment is not disclosed. According to the release:

  • Medtronic will contribute its Renal Care Solutions (RCS) business including the current product portfolio (renal access, acute therapies, and chronic therapies), product pipeline, and global manufacturing R&D teams and facilities.
  • Both companies will provide an initial investment to fund the new company (NewCo) and future certain operating capital.

FierceBiotech, Medtronic release

Withings reenters remote patient monitoring with Withings RPM. Their initial entry was with MedProCare back in 2019 but apparently in the repositioning of the company since the buyback from Nokia in 2018, it was back-burnered. The new RPM will be based on an app that will:

  • track time for CMS-compliant billing reports and uploadable to the provider EHR
  • support billing for CMS codes 99453, 99454, 99457, 99458
  • a digital patient-facing assistant
  • full connectivity to Withings devices such as scales, blood pressure monitors, and sleep monitors
  • implementation support by their Health Solutions teams

Withings RPM page, Outsourcing-Pharma

Looking hard for an M&A that relates to us in this very quiet market, Lightbeam Health Solutions, a population health software company, is acquiring Jvion Inc. Jvion has AI-enabled prescriptive analytics and social determinants of health (SDoH) solutions which will be combined with Lightbeam’s health analytics and outcomes for payers and providers. Terms of the acquisition and leadership transitions were not disclosed. Lightbeam release

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

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

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

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

Volte-face: VA now puts their Cerner EHR implementation on hold

The US Department of Veterans Affairs has pulled a 180° on the Cerner EHR implementation. In a move worthy of the old-time moonshine runners, VA Secretary Denis McDonough went before the Senate Veterans Affairs Committee on Wednesday to announce that the deployment of the Cerner system in the VA is on hold. This is after maintaining two weeks ago [TTA 2 July] that they were sticking with Cerner and the implementation, pending a further review.

In the interim, the VA Office of Inspector General (OIG) issued two reports that criticized the unreliable estimating process for various upgrades to the system, including lack of complete documentation, and the implementation of the Cerner EHR at Mann-Grandstaff VA Medical Center in Spokane, Washington, starting in October 2020. HealthcareITNews

In a classic ‘falling on one’s sword’ in the Wednesday hearing, Secretary McDonough told the committee that the project review found multiple “governance and management challenges” as well as patient safety concerns and system errors. He attributed them to VA and Cerner leadership, or lack thereof. For instance, VA clinicians couldn’t easily find help from Cerner on the initial rollout at Mann-Grandstaff VA Medical Center. The clinician using it called the help desk, reaching a Cerner employee there but a week. The Cerner EHR also generated duplicate prescriptions and confused patients.

The approach to implementing the modernized Cerner EHR approach will be ‘reimagined’ (DC-speak for redoing what should have been done right the first time, which started in 2017). This will start with a new, enterprise-wide governance structure to manage the project and integrate it with other modernizations, according to the Secretary. He admitted that the original plan to roll out the EHR by geographic area was a mistake. It will also not be synchronized with the Department of Defense rollout, which has proceeded without serious hitches. Go-lives will now be based on evidence of readiness, such as training, infrastructure, and management.

The Deputy Secretary has been designated to be directly in charge of the project. Acting undersecretary for health Richard Stone, MD, who had been in charge of the Cerner implementation, resigned in June after not being considered for the deputy secretary post. Secretary McDonough pitched the senators on quickly confirming nominee Donald Remy, with whom he will be speaking on big decisions. (One would hope. Mr. Remy, who was confirmed on 15 July. )

The final straw for the senators was budget. HISTalk summarizes: “The cost of the project, which was originally estimated at $10 billion when Cerner was awarded a no-bid contract in 2017, has risen to over $20 billion. McDonough has ordered a new budget estimate for the entire project, which will include the several billion dollars of infrastructure upgrades that the original estimate missed.”

Looks like the Old Gray Mare of EHRs, VistA, will be lingering for awhile. This Editor lays even money that the senators will be discussing the same issues, such as revenue cycle management, in 2025. Becker’s Hospital Review, Federal News Network

News Roundup (updated): Proteus files Ch. 11, VA’s EHR tests now fall–maybe, making US telehealth expansion permanent, Rennova’s rural telehealth bet, Oysta’s Lite, Fitbit’s Ready to Work jumps on the screening bandwagon

Proteus Health, the company which pioneered what was initially derided as a ‘tattletale pill’, filed Chapter 11 bankruptcy today (16 June). As early as December, their layoffs of nearly 300 and closure of several sites was a strong clue that, as we put it, Proteus would be no-teous without a big win. Exactly the opposite happened with the unexpected early end of their Otsuka partnership with Abilify [TTA 17 Jan]. Proteus had raised about $500 million in venture capital from Novartis plus technology investors and family offices. Their combination of a pill with an ingestible sensor, a patch that detects ingestion and that sends information to a smartphone app was ingenious, but in a business model was meant for high-cost medications. Proteus’ current partnerships include TennCare (TN Medicaid), plus Xealth and Froedtert to integrate medication information into electronic health records. At one point, Proteus was valued at $1.5 bn by Forbes, making it one of the early healthcare unicorns.  CNBC, FierceHealthcare

VA further delayed in implementing Cerner-Leidos EHR. POLITICO’s Morning eHealth earlier this month reported from congressional sources that further testing would be delayed to the fall at the earliest and possibly 2021. The project to replace VistA stands at $16 bn. Contributing to delay was an April COVID outbreak in Spokane at a veterans’ home, which pushed patients into the VA medical center. 

In further DC news, several senators are advocating that the relaxing of restrictions on telehealth during COVID should largely be made permanent. According to the lead senator, Brian Schatz (D-HI), Medicare beneficiaries using telehealth services increased 11,718% in 45 days. Many telehealth requirements were waived, including geographic, coding of audio-video and telephonic telehealth billing, and HIPAA platform requirements. Other senators are introducing bills to support remote patient monitoring programs in community health centers’ rural health clinics. FierceHealthcare

The climate for telehealth has improved to the point where smaller players with side bets are now betting with bigger chips. Rennova Health, a mid-South healthcare provider with a side in software, is merging its software and genetic testing interpretation divisions, Health Technology Solutions, Inc. (HTS) and Advanced Molecular Services Group, Inc., (AMSG) with TPT Global Tech. The combined company will be called InnovaQor after an existing subsidiary of TPT and plans to create a next-generation telehealth platform targeted to rural health systems. Release, Becker’s Hospital Review

Oysta Technology has launched the Oysta Lite with an SOS button, GPS, safety zone mapping for travel, and two-way voice. The SOS connects to their IntelliCare platform which provides status monitoring, reporting, and device management plus connecting to the telecare service provider. They are specifically targeting post-lockdown monitoring of frail elderly.  Press flyer/release.

Fitbit jumps on the crowded COVID workplace screening bandwagon with Ready to Work, a employer-sponsored program that uses individual data collected via the Fitbit device such as resting heart rate, heart rate variability and breathing rate. Combined with self-reported symptoms, temperature, and potential exposure, the Daily Check-In app then provides guidance on whether the employee should go to work or remain at home. According to the Fitbit release, a higher heart rate–as little as two beats a minute–can be indicative of an immune system response before the onset of symptoms. TTA has earlier reported [19 May] on other COVID workplace screeners such as UHC/Microsoft’s ProtectWell app, Appian, and (in-house) PWC. FierceHealthcare also lists several others on the cart: Castlight Health, Collective Health, Carbon Health, VitalTech, and Zebra Technologies. However, at this stage, few employees are leaving remote work for in office, and fewer still may even return to the office.

VA running at least one month late on Cerner implementation launch

Only a week after Veterans Affairs secretary Robert Wilkie reassured the press that the rollout of the Cerner EHR to replace VistA was right on time, FCW was advised by a VA spokesperson that the implementation is only 75-80 percent complete, and more time is needed for the system build and staff training. The 28 March rollout at Spokane, Washington’s Mann-Grandstaff VA Medical Center will have a new ‘go-live’ date according to the spokesperson. Another source said to FCW that the interfaces between Cerner, VA IT, and VistA has been a worse ‘slog’ than anyone imagined, so it made little sense to train anyone on a unfinished system. The date is now estimated to be end of April.

Apparently key Congresscritters on the House Veterans Affairs Committee and IT subcommittees were prepared for the delay by Secretary Wilkie–a wise move–and they applauded the recognition that more preparation and training are required.

VA’s fiscal 2021 budget, revealed on 10 Feb, requested $2.6 billion for the Cerner EHR modernization project, up from $1.5 billion in the prior year. There’s $500 million more for infrastructure readiness and $62 million hike in program management support.

Comings and goings, wins and losses: VA’s revolving door spins again, NHS sleep pods for staff, Aetna’s Bertolini booted, Stanford Med takes over Theranos office

VA’s revolving door spins again with #2 person fired, but VistA replacement implementation moves on. James Byrne, deputy secretary, was fired on 3 Feb “due to loss of confidence in Mr. Byrne’s ability to carry out his duties” according to secretary Robert Wilkie. Mr. Byrne, a Naval Academy graduate and former Marine officer, had been VA general counsel, acting deputy secretary starting August 2018, then confirmed five months ago.

Mr. Byrne’s responsibilities included the Cerner implementation replacing VistA and other IT projects (HISTalk), of which Mr. Wilkie stated in a press conference today (5 Feb) “will not impact it at all” (FedScoop). The termination comes in the wake of a House staff member on the House Veterans Affairs committee, herself a Naval Reserve officer, stating that she was sexually assaulted at the VA Medical Center in Washington (NY Times). Axios claims that the White House was disappointed in the way the VA handled the investigation. At today’s presser, Mr. Wilkie denied any connection but attributed the dismissal to ‘not gelling’ with other team members. The launch of Cerner’s EHR is still on track for late March. The turnover at the VA’s top has been stunning: four different secretaries and four more acting secretaries in the last five years. Also CNBC, Military Times.

NHS’ sleep pods for staff to catch a few ZZZZs. A dozen NHS England hospitals are trialing futuristic-looking ‘sleep pods’ for staff to power nap during their long shifts and reduce the possibility of errors and harm by tired clinicians. Most of the locations are in the A&E unit, doctors’ mess, and maternity department. They are available to doctors, nurses, midwives, radiographers, physiotherapists, and medics in training. The pods are made by an American company, MetroNaps, and consist of a bed with a lid which can be lowered along with soothing light and music to aid relaxation. The pods may cost about £5,500 each but are being well-used. Other hospitals are fitting areas out with camp beds and recliner chairs. The sleep breaks take place both during and end of shifts before returning home and average about 17-24 minutes. Everything old is new again, of course–dorm areas were once part of most hospitals some decades back and doctors’ lounges with sofas were popular snooze-gathering areas. Guardian (photo and article)

Mark Bertolini bumped off CVS-Aetna Board of Directors. The former Aetna CEO, who was the engineer of the sale to CVS Health two years ago, isn’t going quietly out the door with his $500 million either. The high-profile long-time healthcare leader told the Wall Street Journal that he was forced off the BOD. He maintains the integration of the Aetna insurance business is incomplete, contradicting CVS’ statement that it’s done. Mr. Bertolini and two other directors are being invited out as CVS-Aetna reduces its board following, it says, best practices in corporate governance. Looking back at our coverage, Mr. Bertolini had hits, bunts (ActiveHealth Management) and quite a few misses (Healthagen, CarePass, iTriage). According to the WSJ, the contentious nature of the statement plus the departure of the company’s president of pharmacy is raising a few eyebrows. And recently, an activist shareholder, Starboard Value LP, has taken a stake in the company. CVS is demonstrating some innovation with rolling out 1,500 HealthHubs in retail locations as MinuteClinics on steroids, so to speak.  Hartford Courant (Aetna’s hometown news outlet) adds a focus on how many jobs will be remaining in the city with a certain skeptical context on CEO Larry Merlo’s promises. 

Stanford taking over Theranos Palo Alto HQ space. HISTalk’s Weekender had this amusing note (scroll down to ‘Watercooler Talk’) that the 116,000-square-foot office building in Stanford Research Park will now house the Stanford medical school. Theranos had been paying over $1 million per month in rent for the facility. The writer dryly notes that Elizabeth Holmes’ bulletproof glass office remains. This Editor humbly suggests the floor-to-ceiling application of industrial-strength bleach wipes and disinfectant, not only in the lab facility but also in that office where her wolf-dog used to mess.

The LA Times reports that Ms. Holmes is also defending herself without counsel in the Phoenix civil class-action lawsuit against Theranos. On 23 January, she dialed in to the court hearing’s audio feed and spoke for herself during that hour. One has to guess that she doesn’t have much to do other than read legal briefs. (Perhaps she sees herself as a cross between Saint Joan and Perry Mason?) Last fall, Ms. Holmes was dropped by Cooley LLP for non-payment of fees [TTA 9 Oct 19]. Williams & Connolly continues to represent her in the criminal DOJ suit, where prison time looms. 

Digital health: why is it a luxury good in a world crying for health as a commodity?

Why digital health still struggles to find its stride. Those of us in the healthcare field, especially Grizzled Pioneers, have been wondering for the past decade why Digital Health’s Year is always Next Year. Or Next Decade. 

Looking back only to 2000, we’ve had 9-11, a dot-com bust, a few years in between when the economy thrived and the seed money started to pollinate young companies, a prolonged recession that killed off many, and now finally a few good economic years where money has flooded into the sector, to good companies and those walking the fine line of mismanagement or fraud. We’ve seen the rise/fall/rise of sensors, wearables, and remote monitoring, giants like Google and Microsoft out and back in, the establishment of EHRs, acceptance by government and private payers, quite a bit of integration, and more. All one has to look is at the investment trends breaking all records, with funding rounds of over $10 million raising barely a notice–enough to raise fears of a bubble. Then there’s another rising tide–that of cyberattack, ransomware, insider and outsider hacking.

Is it this year? It may not be. Despite the sunshine, interoperability holds it all back. Those giant EHRs–Cerner, Epic, Athenahealth, Allscripts–are largely walled gardens and so customized by provider application that they barely are able to talk to their like systems. There are regional health exchanges such as New York’s SHIN-NY, Maryland’s CRISP, and others, but they are limited in scope to their states. The VA’s VistA, the granddaddy of the integrated system, died of old age in its garden. Paul Markovich, CEO of Blue Shield of California cites the lack of interoperability and being able to access their personal health data as a major barrier to both patients and to the large companies who want to advance AI and need the data for modeling. (China and its companies, as we’ve noted, neatly solve this problem by force. [TTA 17 Apr]) Apple is back in with Health Records, but Mr. Markovich estimates it may take 10 years to gather the volume of data it needs to establish AI modeling. Some wags demand that Apple buy Epic, as if Epic was up for sale. BSC, like others, is testing interoperability workarounds like Notable, Ooda Health, and Manifest MedEx. Mr. Markovich cites interoperability and scaling as reasons why healthcare is expensive. CNBC

And what about those thriving startups? Hold on. During the Google Cloud/Rock Health 3 June event, one of the panelists–from Partners HealthCare, which works both side of the street with Pivot Labs–noted that hospitals have figured out their own revenue models, and co-development with hospitals is key. Even if validated, not every tech is commercially ready or lowers cost. And employers are far worse than hospitals at buying in because they ultimately look at financial value, even if initially they adopt for other reasons. In addition, the bar moved higher. The new validation standard is now provider-centric–workload, provider satisfaction, and implementation metrics, because meeting clinical outcomes is a given. Mobihealthnews

And still another barrier–data breaches and cyberattack–is still with us, and growing. Quest Diagnostics’ data breach affects nearly 12 million patients. It was traced to an individual at a vendor, American Medical Collection Agency, and it involved Optum360, a Quest contractor and part of healthcare giant Optum. The unauthorized person had access to the network for eight months – between 1 August 2018, and 30 March 2019–and involved both financial and some health records. Quest now is in the #2 slot behind the massive 79 million person Anthem breach, which, based on a Federal grand jury indictment in Indianapolis in May, was executed by a Chinese group in 2015 using spearfishing and backdoors that gathered data and sent it to China. There were three other US businesses in the indictment which are not identified. Securing health data is expensive — and another limitation on the cost-lowering effects of interoperability. Healthcare IT News

Digital Health’s Year, for now, will remain Next Year–and digital health for now will remain fractional, unable to do much to commoditize healthcare or lower major costs.

Rounding up September’s start: AliveCor’s hyperkalemia detector, Apple’s ECG Watch, Tunstall Nordic’s EWII, steps towards a bionic eye, Philips licenses BATDOK, VistA’s international future

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2017/12/Lasso.jpg” thumb_width=”120″ /]AliveCor gets a fast track for its bloodless hyperkalemia (high blood potassium) detector through the FDA Breakthrough Device program. Working with doctors at the Mayo Clinic, they developed a way to read patterns in electrocardiograms (ECG/EKG) that track increasing potassium levels without drawing blood. While attributed in the CNBC article to AI, it seems closer to machine learning. Hyperkalemia is a condition that is seen in type 1 diabetes, chronic kidney disease, and other kidney related conditions. The device and software is at least one year away from approval including a clinical trial, even on this program which further speeds up the Expedited Access Pathways (EAP) program under the 21st Century Cures legislation. AliveCor currently markets the Kardia Band that reads ECGs.

Meanwhile, the Series 4 iteration of the Apple Watch moves further into the medical device area–and AliveCor’s ECG niche–with a built-in atrial fibrillation-detecting algorithm and an ECG, along with fall detection via the new accelerometer and gyroscope. The Apple Watch will start shipping September 21. Mobihealthnews.

Danish energy and broadband provider EWII has sold its subsidiary EWII Telecare A/S to Tunstall Nordic. EWII Telecare provides telemedicine and telehealth services on a tablet platform dubbed Netcare (video here). The EWII Telecare website is already down. Telecompaper, Tunstall Nordic release

Foundational technology for a bionic eye? The University of Minnesota has developed a method using 3D printing to create light receptors on a hemispherical surface. Printing a base of silver ink, the next layer was photodiodes of a semiconducting polymer which convert light into electricity. ZDNet

Philips Healthcare is licensing the Battlefield Airmen Trauma Distributed Observation Kit (BATDOK) technology for remote monitoring of vital signs by combat paramedics. Terms were not disclosed. BATDOK was developed by the US Air Force Research Laboratory, which sought commercialization. [TTA 6 Sept 17]  Mobihealthnews

What is generally not known about the VA’s eventually departing EHR is that it has for some years an open source version called OSEHRA VistA. Plan VI will expand VistA capability by making it compatible with different languages using Unicode and creating a reference implementation for global use. Working with non-profit OSEHRA are research groups in South Korea, China, and the Kingdom of Jordan. Release

VA moves closer to doing Cerner EHR deal, real Choice for veterans (updated)

The Cerner EHR deal with the VA edges closer to closing. Another VA contractor, MITRE, reviewed the agreement and recommended 50 changes that, according to POLITICO Morning eHealth’s source, address many of the interoperability-related usability features “that irritate EHR users” such as reconciling data coming from outside sources (Home Telehealth, perhaps?–Ed.). VA officially updated the status with Congressional Veterans Affairs staff on Tuesday. The deal could be inked as early as next week, but never bet on this when the Secretary seems doubtful of the agreement date. In any case, it will be a decade before VA is fully transitioned from VistA. Speaking of the Secretary, Dr. Shulkin’s crisis of last week seems to have passed with a White House vote of confidence. He can ‘cashier’ his critics and according to him, everyone’s on board with a clear direction. We’ll see. 

Updated. Well, it’s 2 March and still no word on closing the Cerner contract. Meanwhile, the VA ‘revolt’ continues, with either true or false reports of demands for Dr. Shulkin’s resignation. It’s exhausting, and meanwhile who pays? Staff and veterans. See POLITICO from 1 March here.

Modern Healthcare reported that important reforms in the VA Choice legislation are closer to reality with the Senate Veterans Affairs committee. They are proposing changes, supported by the White House, that would open up VA Choice eligibility to nearly all veterans by “making VA facilities responsible for meeting access standards set by the VA secretary. If a facility can’t, the patient can seek out a community provider if both patient and a VA provider or an authorized provider in the community working closely with VA deem that a better option than a VA facility.” This is a step beyond the earlier proposed access standards which would have given the VA Secretary discretion to relax restrictions to community care provision. Currently the VA Choice program is used by only 1 million veterans who have to prove that they are facing wait times of 30 days or more, or 40-mile travel time to a VA clinic. While the tone in the article is slightly disparaging, firm standards and opening the VA to limited market pressures to this Editor is a good thing–and getting effective care faster to veterans, many of whom live in exurban or rural areas, is beyond all considerations, absolutely necessary. How this affects veterans monitored by telehealth programs–and interoperability of their records–are open questions.

VA’s Shulkin: Cerner rollout start by mid-2019?

An interesting short (free) article on POLITICO Morning eHealth today was an interview with VA Secretary David Shulkin, MD on the Cerner transition, stating that if all went well with negotiations later this year, VA clinicians could be using the Cerner system by mid-2019. “There’s a lot of understandable concern about whether the Cerner EHR will have the same functionality as VistA, which has evolved to the physician’s needs over the past 35 years.” One of the problems with VistA was that it wasn’t one system, it was 130 systems, which is echoed in many EHRs. POLITICO goes on to quote Dr. Shulkin: “I don’t hear as many concerns about that as I do relief about finally making a decision because people felt this was the slow death of a system that they have poured their hearts and souls into. Knowing we’re committed to doing a transition as well as we can is reassuring to people.” Sadly, the rest of the interview is paywalled on POLITICO PRO. Earlier analysis: VA says goodbye to VistA, hello to Cerner. We wonder what the involvement and engagement of the four Home Telehealth winners of the 5-year contract will be.

VA says goodbye to VistA, hello to Cerner for new EHR–and possible impacts (updated)

The new sheriff just turned the town upside down. Veterans Affairs’ new Secretary, Dr. David J. Shulkin, as expected moved quickly on the VA’s EHR modernization before the July 1 deadline, and moved to the same vendor that the Department of Defense (DoD) chose in 2015 for the Military Health System, Cerner. VA will adapt MHS GENESIS, based on Cerner Millenium. The rationale is seamless interoperability both with DoD and with private sector community providers and vendors, which base their services on commercial EHRs. The goal is to have one record for a service member through his or her lifetime and to eliminate the transition gap after discharge or retirement. (Transition gaps are also repeated when reservists or National Guard are called up for active duty then returned to their former status.) Another priority for VA is preventing the high rate of suicide among vulnerable veterans.

Updates: VA confirmed that Epic and Leidos will keep the development of the online medical appointment scheduling program, awarded in 2015 and currently in pilot, to be completed in 18 months. The contract is worth $624 million over five years. Wisconsin State Journal  The House Appropriations subcommittee on Veterans Affairs likes the Cerner EHR change. The Senate Veterans Affairs Committee is meeting Wednesday to discuss the VA budget sans the EHR transition. The EHR numbers are expected to be sooner rather than later. POLITICO Morning eHealth 

Dr. Shulkin is well acquainted with the extreme need for a modernized, interoperable system serving the Veterans Health Administration (VHA), having been on the US Senate Hot Grill for some years as Undersecretary of Health for VA. The foundation for the move from homegrown VistA to Cerner was laid last year during the prior Administration through an August RFI for a COTS (commercial off the shelf) EHR [TTA 12 Aug 16] and in later hearings. “Software development is not a core competency of VA” and it has been obvious in system breakdowns like scheduling, maintaining cybersecurity and the complex interoperability between two different systems. To move to Cerner immediately without a competition, which took DoD over two years, Dr. Shulkin used his authority to sign a “Determination and Findings” (D&F) which provides for a public health exception to the bidding process. The value of the Cerner contract will not be determined for several months.

For those sentimental about VistA, he acknowledged the pioneering role of the EHR back in the 1970s, but that calls for modernization started in 2000 with seven ‘blue ribbon’ commissions and innumerable Congressional hearings since. He understated the cost in the failed efforts on interoperability with DoD’s own AHLTA system, VA’s own effort at a new architecture, and modernizing the outpatient system. This Editor tallied these three alone at $3 billion in GAO’s reckoning [‘Pondering the Squandering’, TTA 27 July 13]. 

It is still going to take years to implement–no quick fixes in something this massive, despite the urgency.

  • Both MHS and VA will be running two systems at once for years (more…)

VA Digital Health Platform proof-of-concept unveiled; new VA head nominated

Back in April 2016, the Department of Veterans Affairs (VA) in Congressional hearings hinted at an end of year preview of a ‘state-of-the-art’ digital health platform which would integrate veteran health information from multiple sources. That debut was revealed this week in analytics vendor Apervita‘s announcement that they are participating in a proof-of-concept of the VA Digital Health Platform (DHP). According to their release, in the first three weeks, they and the DHP partners demonstrated that they could organize and extract insights from veteran data originating from VA, military, and commercial electronic health records, plus e-prescribing, apps, devices, and wearables. The end outcome is to provide a unified view or dashboard that integrates data, implements a care plan, tracks clinical encounters, optimizes medications, responds to patient needs, and more. The prime contractor in DHP is Georgia Tech, which brought on board Apervita, Salesforce (workflow user engagement), and MuleSoft (API). Next steps are not disclosed. Mobihealthnews, Health Data Management

One of the sparkplugs behind the DHP and also interoperability of DOD’s and VA’s badly outdated VISTA EHR is current VA Undersecretary for Health David Shulkin, MD. Today, at an eventful press conference, President-Elect Donald J. Trump nominated him for the VA secretary position. Dr Shulkin was previously CEO of Beth Israel Medical Center in NYC and president of the Atlantic Health System ACO. He will also be, upon Senate approval, the first non-veteran head of the VA. What is apparent is that P-E Trump has not moved one iota from the promise he made during the campaign to move fast on modernizing, improving quality and speeding up veterans health services–and for that he needs an insider.  Health Data Management