Two ‘oops’ at VA: OIG finds VA, Oracle performance misalignments, makes 9 recommendations; VP candidates’ EHR records improperly accessed by VA employees

Another OIG audit still finds plenty of inconsistencies between VA and Oracle Health in the EHRM implementation–and makes another set of recommendations. The VA’s Office of Inspector General (OIG) conducted a review of the ongoing EHR Modernization (EHRM) at the VA, and once again found shortcomings in processes not addressed in the May 2023 revision of the 10 year contract.

It’s all about controls and consistency in response. The report identified that VA and Oracle Health still do not have adequate controls to prevent system changes from causing major incidents. Regarding response, both organizations are not uniform nor thorough. Controls were not adequate to mitigate incident impact by providing standard procedures and interoperable downtime equipment. VA lacked a formal process for linking delays to specific major performance incidents.

The auditors analyzed 360 major performance incidents—outages, performance degradations, and incomplete functionality—that occurred between 24 October 2020 and 31 August 2022, plus additional incidents through March 2024. Even though deployments halted in VA facilities except for the joint MHS/VA rollout at Lovell Federal Health Care Center in March, major performance incidents continued, including at Lovell which experienced a major problem in filling 60% of prescriptions.

The OIG made nine recommendations in their report. Grouped together, they include the following actions:

  1. Real-time data sharing to give VA greater awareness of potential problems in system operations
  2. Prioritizing major performance incident response in a clear and consistent manner
  3. Developing and enforcing response and other performance metrics to hold the contractor accountable
  4. Requiring sufficient detail in post-resolution reports
  5. Raising staff awareness of procedures
  6. Acquiring appropriate backup systems for downtime
  7. Better identifying and addressing major performance incidents linked to negative patient outcomes.
  8. Identifying the appropriate backup system and develop a training strategy to ensure clinicians can use the system during downtime.
  9. Assessing facilities’ patient safety reports identified during this audit, determining if additional actions need to be taken and, if so, providing an action plan.

VA release, Healthcare IT News

Some VA employees got very naughty in looking up information on the two VP candidates. Both Ohio Senator JD Vance and Minnesota Governor Tim Walz are both veterans (Marines and Army National Guard, respectively). The breaches were discovered in August during a security sweep of high-profile health accounts held in the VA’s EHR. 

  • 12 employees used their VA computers to access information on Vance and Walz.
  • These included physicians and a contractor viewing for an “extended time”.
  • The curious employees may face charges including dismissal and criminal charges. The length of access and intent will be taken into account.
  • Unknown is whether any of the information was shared outside of VA.

Their respective campaigns were notified and the investigation continues. The VA sent a memo to all employees on 30 August from VA Secretary Denis McDonough with a restatement of official data privacy and conduct directives plus the results of a failure to comply. Original reports were in the Washington Post and CNN. Healthcare IT News, Becker’s

News roundup: 4.3M HealthEquity member data breach, CrowdStrike health fallout, more Congress pounding of VA/Oracle; Flo app now unicorn (UK), fundings for Clarapath, CoachCare; AvaSure buying Ouva

Health savings account (HSA/FSA) provider HealthEquity had a three-month breach that compromised 4.3 million member accounts. The breach originated with an undisclosed third-party vendor, in a pattern that has become familiar. According to HealthEquity’s filing with the Maine attorney general (though HQ’d in Utah), the breach occurred in that vendor’s “unstructured data repository” at HealthEquity, outside of their core systems, after the hacker stole the password out of a vendor user account. Unfortunately for HealthEquity, the hack that started in March wasn’t discovered until 26 June, giving the hacker free rein in that database for three months. What’s surprising is that the breach wasn’t worse.

HealthEquity is a third-party administrator for companies of FSA/HRA, Commuter, COBRA, and Lifestyle plans.

The Maine AG filing states that information stolen may include customer names, addresses, phone numbers, their Social Security number, information about the person’s employer, benefit type, diagnoses, prescription details, the person’s dependent (if any), and some payment card information. With HealthEquity claiming 15 million+ members, the breach affects a substantial 29% of its membership. Actions they are taking are to notify members and provide them with credit monitoring services through Equifax with a reference guide. HealthEquity notification page, TechCrunch, HealthcareITNews

CrowdStrike’s antivirus software update that went waaaay sideways continues its fallout. As most know, it happened when they pushed an update and patch to Falcon, a cloud-based anti-cyber attack product that uses AI to detect intrusions. Well, Falcon’s AI wings were fractured on that 19 July push where testing was apparently lacking. BSOD became their new thing. What made the news was the devastating effect on 8.5 million Windows devices, only about 1%–on Delta Air Lines’ aircraft scheduling and the shutdown of many systems such as 911 and police within cities and states, but apparently a curtain was drawn around the healthcare bed. EHRs were affected at major systems such as Kaiser Permanente, Providence, Henry Ford Health, Nationwide Children’s Hospital, the Dana-Farber Cancer Institute, Mass General Brigham, RWJBarnabas Health, Penn Medicine, and Seattle Children’s Hospital, causing postponements of medical procedures. At Providence, it totaled 15,000 of the organization’s servers, as well as about 40,000 of its 150,000 computers. It was the equivalent of a cyberattack without being a cyberattack. According to industry analyst Parametrix, US Fortune 500 companies (excluding Microsoft) lost a total of $5.4 billion. MedCityNews

With this kind of devastation, it’s no surprise that these companies and the government are rethinking their approach to cloud computing. They’re very concerned about the oligopoly of three providers: Google, Microsoft, and Amazon. Microsoft has 40% of the cybersecurity market with CrowdStrike 15% concentrated in larger organizations.“We’re reaching the point where over-centralization makes us less ‘healable,’ and less resilient,” Robert Thomas, owner of cybersecurity company 180A Consulting said. “We’re losing our resiliency as a nation.”  Systems are still not back up and neither is the CrowdStrike stock. Rumors do persist that they were hacked. Epoch Times   Microsoft also published a recovery tool for IT administrators to expedite the repair process. FierceHealthcare

The House Committee on Veterans’ Affairs Subcommittee on Technology Modernization hearing on 22 July had some further flak-gathering from committee members. Most of the criticism concentrated on the joint MHS/VA rollout at Lovell Federal Health Care Center and the amount of work it required to get the Oracle Cerner EHR to work mostly right. While VA and Oracle leaders insist that Lovell went better than anyone expected, the resources used at Lovell cannot be duplicated at the remaining VA facilities. VA is already facing a $15 billion shortfall for FY 2024 and 2025. The Lovell center had a persistent problem in processing prescriptions, with 60% going unfilled. In member Sheila Cherfilus-McCormick (D-Fla.) words, “I think we are far from ready to endorse further go-live activities. The two departments threw more resources at this go-live than will ever be available at any future VA facility.” Healthcare Dive  Earlier coverage TTA 24 July

The UK women’s health app Flo is now a unicorn. Their Series C of $200m (£156m), funded solely (and unusually) by General Atlantic, put them at a valuation of over $1 billion. Their total funding is $275 million. Two General Atlantic executives will be joining Flo’s board, Tanzeen Syed, managing director, and Jessie Cai, principal. Flo helps users track ovulation and menstrual periods, enabling calendaring of fertility, and monitoring of over 70 symptoms. It also assists with pregnancy health guidance. The raise will be used to expand into new user segments including perimenopause and menopause. Its current base is 70 million monthly active users (MAUs) and close to 5 million paid subscribers. Flo is marketed in 66 countries, including the US, India, Indonesia, and Nigeria, with centers in Lithuania and the Netherlands.  Release, UK Tech News

Funding/M&A wrap:

Clarapath, a medical robotics developer based in White Plains, NY, scored $36 million in a Series B-1 funding round from Northwell Ventures with participation from new investors Ochsner Ventures, CU Healthcare Innovation Fund, and Mayo Clinic. Clarapath automates pathology lab work. Its SectionStar platform sections biopsy tissue with improved accuracy. It is pre-revenue with a total of $75 million in funding. Axios, Mobihealthnews

CoachCare, a remote patient monitoring/virtual health monitoring developer for practices and health systems, added $48 million in an unlettered venture round funding led by Integrity Growth Partners with participation from Topmark Funding. The platform combines software and connected devices with outreach for RPM, chronic care management, and other virtual care for about 150,000 patients. Funding to date is $49 million. It has acquired four companies in the past year: NVOLVE, CareSpan Health, Alertive (formerly part of Carbon Health), and WebCareHealth. Release, Mobihealthnews

Another virtual care company, AvaSure, is acquiring Ouva’s smart hospital room solutions. Ouva has been partnering with AvaSure to supply AI-enhanced care automation technology. The acquisition will expand the ambient AI capabilities of AvaSure’s Intelligent Virtual Care Platform and double in-house AI engineering resources. AvaSure’s primary market is hospitals. Ouva will continue as a separate company with its pediatric and wayfinding business. Cost is not disclosed. Release, HIStalk 7/31

The DOD-MHS/VA Lovell ‘success story’ can’t process 60% of pharmacy prescriptions: House Committee

Here we go again. The Department of Defense’s Military Health System (MHS), the Department of Veterans Affairs (VA), and Oracle have all cited the Captain James A. Lovell Federal Health Care Center in North Chicago as a successful joint implementation. It is the only joint, fully integrated MHS/VA facility, was the only exception to the full pause on Oracle Cerner implementations in going live on 9 March, and so stands alone in complexity and importance. Oracle EVP Ken Glueck, in excoriating Business Insider, pointed to Lovell as a successful implementation to prove It Could Be Done! [TTA 31 May].

Except…except. House Representative Matt Rosendale (R-Mont.), the chairman of the House Committee on Veterans’ Affairs Subcommittee on Technology Modernization, a skeptic from Day One, investigated with other committee members. Several unnerving findings: 

  • “The pharmacy is completely reliant on outside help to operate”. 
  • “The Oracle Cerner pharmacy software functions so poorly that the permanent pharmacy staff can only process about 40% of the prescriptions.”. That means 60% of prescriptions go unfilled.
  • “The Committee staff visited James A. Lovell twice, and the employees are reporting the same frustration, hypervigilance, and burnout that the managers of the other four facilities testified about last September.”
  • 100 new staff have been hired at Lovell, with another 100 on the way.
  • About 800 experienced staff from other facilities and VA’s central office pitched in after the 9 March go-live.

Rosendale, in his opening remarks, expressed great concern that VA Secretary McDonough could realistically resume Oracle Cerner EHRM go-live at any scale, given the Lovell experience. He also noted that “the Veterans Health Administration is facing a $12 billion budget deficit, the financial impacts of the EHR on the organization’s staffing have never been budgeted or seriously reckoned with.” 

His conclusion was strong language: “Veterans and taxpayers deserve to know how large the Oracle Cerner bill truly is. Congress as well as the public need all of the information in order to make an informed decision about whether this is worth it, and whether the inevitable sacrifices are truly justified. Anything less is dereliction of duty.” Hat tip to HIStalk 7/24/24

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

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: 100+ medical orgs pile on Change/UHG; Teladoc hit with second class-action suit; Congress demands Oracle EHR improvement–or else; Transcarent intros WayFinding; Centivo buys Eden Health

The fallout from the Change cyberhack hangs like smog over UHG. On Monday, the American Medical Association (AMA), along with about 100 other signatories from nationwide medical associations including CHIME and AHIMA, sent a strongly worded letter to Health and Human Services Secretary Xavier Becerra. It requested a clear delineation of responsibilities for breach reporting requirements created by the 21 February Change Healthcare ALPHV/Blackcat ransomware attack. Reporting is required by HHS’ Office of Civil Rights (OCR) under HIPAA.

Specifically, the AMA letter requested 1) more public clarity around reporting responsibilities to patients for the data breach and 2) that all reporting and notification responsibilities will be handled by Change Healthcare, not the providers. “OCR should publicly state that its breach investigation and immediate efforts at remediation will be focused on Change Healthcare, and not the providers affected by Change Healthcare’s breach”. To date, this doesn’t seem to be OCR’s position.

  • The AMA and signatory organizations maintain that it “is the responsibility of the covered entity which experienced the breach—UHG—to fulfill its obligations in regard to reporting the breach to OCR, notifying each affected individual, as well as any further HIPAA breach reporting requirements that may be applicable, such as notifying state Attorneys General and media outlets.”
  • OCR, on the other hand, has gone on the record in April as stating in their FAQs that “while the covered entity is ultimately responsible for ensuring individuals are notified, the covered entity may delegate the responsibility of providing individual notices to the business associate. Covered entities and business associates should consider which entity is in the best position to provide notice to the individual, which may vary, depending on the circumstances, such as the functions the business associate performs on behalf of the covered entity and which entity has the relationship with the individual.” (Providers can be considered business associates)

In other words, the providers want the full responsibility of contacting patients, state attorneys general, media, and others (e.g. class action lawyers) to be Change Healthcare’s. They do not want to be forced to contact their patients and, in all fairness, at this point do not know which patients were affected because they are not privy to Change Healthcare’s information. UHG has not yet produced a breach report to OCR. AMA letter to Becerra, Healthcare Finance News

When the stock falls, blame the marketing spend! The latest class-action lawsuit filed against Teladoc blames the company for spending money in digital and other media advertising promoting BetterHelp, their telementalhealth unit. The suit cites Teladoc’s public statements such as a “long runway” for BetterHelp’s membership growth and that spending would be inefficient due to the saturated category. Yet spending increased in 2023. The lawsuit charges that this directly deteriorated the company’s revenue, leading to a substantial fall in its stock price. Charged are Teladoc, and at the time CEO Jason Gorevic and CFO Mala Murthy. Stary v. Teladoc Health, Inc. et al., was filed on May 17 in the US District Court for the Southern District of New York. No response yet from Teladoc. Docket on Justia, Mobihealthnews

The House and Senate Veterans’ Affairs Committees jointly introduce legislation on VA’s EHR modernization. The Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act would require the Department of Veterans Affairs to exercise even greater oversight of the Oracle Cerner implementation in these areas:

  • The quarterly reports to Congress would include additional quality metrics on user adoption, employee satisfaction, and employee retention/turnover where the Oracle Cerner EHR is introduced. This adds to existing required reporting on spending and performance.
  • Regarding additional rollouts, the VA secretary must certify that the sites are ready. He also must furnish corroborating data to Congress “demonstrating that all facilities currently using the Oracle Cerner EHR system have recovered to normal operational levels.”
  • If there is no improvement (presumably to this standard) at Oracle Cerner locations within two years of the bill’s enactment, the program will be terminated.
  • VA must also report on the status of VistA with details about “the operation and maintenance costs and development and enhancement costs” of the software and “a list of modules, applications or systems” within VistA that VA plans to retire or continue to use. 

HIStalk 17 May, NextGov/FCW

‘Not for sale’ Transcarent introduces an AI-assisted platform, WayFinding. The platform designed for end users of Transcarent’s enterprise health navigator combines generative AI with instant access to care providers to integrate benefits navigation, clinical guidance, and care delivery on a single platform. The personalized guidance enables the member to find a provider, find out costs, and guides to the best clinical action to take next. It then connects them to medical professionals or provides direct access into digital point solutions. It integrates information on details of the employer plan, ancillary benefits, the member’s medical history, and connection to clinical specialists. There is no information in the overly padded release on when the new platform will be available or how it will be offered to existing and new customers. This follows on Transcarent’s $124 million Series D funding two weeks ago.  FierceHealthcare, Mobihealthnews, TTA 8 May

Centivo acquires Eden Health virtual care. The purchase price was not disclosed. Centivo, headquartered in Buffalo NY, is  a health plan for self-funded employers. Eden, also providing services to employers, is a concierge provider that offers through a mobile app primary care, mental health, and care navigation services, plus workplace pop-up clinics. Eden also has technology that connects providers’ EMRs to their app. Eden’s services will be fully integrated into Centivo, which will enable it to expand to 50 states and increase from its current 120 employer base to 160. The combined organizations cover about 2 million eligible patients in companies ranging from Fortune 100 size to small businesses. Eden’s CEO will serve as a senior advisor to Centivo, but there is no other indication of employee transition.  Release, FierceHealthcare

Short takes: VA seeks vendor to support EHR testing; Defense Health seeks ‘digital front door’ vendor; GAO recommendations to Oracle; Nonin partners with Finland’s Medixine; Lumeris gains $100M equity funding

VA needs support for testers of the Oracle Cerner EHR. Formally, this is called the Independent Enterprise Testing and Support Services Contract for the Department of Veterans Affairs. This will support the testing community overseen by the VA Electronic Health Record Modernization (EHRM) Integration Office Program which is part of the transition/deployment to the Oracle Cerner EHR. The IETSS covers project management, test and evaluation support, testing and technology support, test systems engineering and implementation support and test process, and quality management support. As is typical of Federal/VA contracts, it is a hybrid firm-fixed-price and time-and-materials contract with a 12-month base period of performance, four 12-month options, with an optional transition support period at the end of the period of performance. Responses are due by 3 May. ExecutiveGov, contract/application details on SAM.gov

The Defense Health Agency (DHA) wants to build a ‘digital front door’ for health services. Partnering with the Defense Innovation Unit (DIU) at the Pentagon, what’s required is creation of a “technology-enabled framework” in a “new model for delivering care’ integrated with or replacing their current system and that “removes administrative, cognitive and repetitive burdens from the workforce.” This can be supplied by a single vendor or a team of vendors. The change areas are patient experience, provider-supported technology in the health ecosystem, and data management support. NextGov/FCW, DHA press release  The Digital Front Door Plus solicitation with details has a response due by 1 May

The US Government Accountability Office (GAO) has recommendations coming out of their ongoing user satisfaction study of MHS Genesis that impact the joint MHS/VA implementation at the MHS Genesis Lovell FHCC implementation. This went live in March. The recommendation for the VA side is that “the Secretary of Veterans Affairs should direct the Federal EHR Modernization Office to identify and address specific barriers to maximizing integration at the FHCC, consistent with the FHCC executive agreement.” GAO report summary

Shifting away from government work…

Finnish health tech company Medixine is expanding its partnership with Nonin’s med monitors. Medixine will be co-developing with Nonin Medical remote digital monitoring services for patient diagnoses of chronic conditions. The first usage combines the Medixine monitoring platform with Nonin’s pulse oximetry devices in areas such as sleep screening using overnight sleep oximetry. This can determine if patients need and qualify for supplemental oxygen or require further testing for sleep apnea in a single night’s test. Medixine release

 

Lumeris completes a $100 million equity capital raise. The 2 April round announced on Monday was led by lender Deerfield Management and new investor Endeavor Health. Also participating were existing investors Kleiner Perkins, Sandbox Industries, BlueCross BlueShield Venture Partners, and JDLinx (an investment company owned by John Doerr). Total funding now tops $325 million (Crunchbase). Lumeris describes itself as a care strategy, technology, and operations provider for large provider groups to manage all value-based populations, including Medicare Advantage, traditional Medicare, commercial, and Medicaid. The new funding will support expanded partnerships with health systems and physician groups to move them into value-based care models. Mobihealthnews, release

News roundup: VillageMD sued on Meta Pixel trackers; Cerebral pays $7.1M FTC fine on data sharing, cancellation policy; VA may resume Oracle Cerner implementation during FY2025; Epic-Particle Health dispute on PHI sharing

It’s all about personal health data–sharing, bad sharing, and bad transfers in this roundup.

VillageMD takes another hit, this time on Meta Pixel ad tracker issues. A class-action lawsuit filed on 10 April charges VillageMD (formally Village Practice Management Company), via its Village Medical website, of using the Meta Pixel ad tracker for disclosing user-protected health information (PHI) and other identifiable information generally classified as PII. This included visitors to their website villagemedical.com seeking information and patient users of Village Medical’s web-based tools for scheduling and the patient portal. The lawsuit by a “John Doe”, a patient since January 2023 resident in Quincy, Massachusetts but brought by three Midwest law firms in the US District Court for the Northern District of Illinois, states that VillageMD used trackers that transferred this personal information to Meta Networks’ Facebook and Instagram, as well as other third parties like Google, for use in targeted advertising, in violation of HIPAA and other regulations. The lawsuit seeks 1) an injunction stopping Village Medical from using ad trackers and 2) monetary redress via damages–actual, compensatory, statutory, and punitive for the entire affected class. The suit also alleges that VillageMD violated its own internal procedures. Crain’s Health Pulse, Healthcare Dive

Readers will recall that in June 2022, STAT and The Markup published a study and follow-ups on Meta Pixel and ad tracker use by healthcare organizations. Ostensibly, the ad trackers were there to better track website performance and to tailor information for the patient [TTA 17 June, 21 June 2022], but they sent information to third parties that violated HIPAA and privacy guidelines. Ad trackers were also monetized. Meta blamed the health systems [TTA 16 May 2023] for misuse though they used the data for ad serving.  Congressional hearings, FTC, and DOJ followed later in 2022 and 2023. Multiple class action lawsuits against providers large and small have ensued. Providers have pushed back on FTC and HHS rules on ad trackers, stating the restrictions hamper their ability to build better websites based on customer usage and to serve individuals with useful information. 

Another ‘oversharing’ company, troubled telemental Cerebral, whacked with $7.1 million FTC fine on disclosing consumer information via ad trackers plus ‘negative option’ cancellation policy. The proposed order for a permanent injunction filed by the Department of Justice (DOJ) and docketed on 15 April has to be approved by the Federal District Court for the Southern District of Florida. The fine for the company only penalized the following:

  • Cerebral released 3.2 million consumers’ information to third parties such as practices, LinkedIn, and TikTok. This included PHI and PII such as names, medical histories, addresses, IP addresses, payment methods including insurance, sexual orientation, and more. Even more outrageously, they also used the mail for postcards that had sensitive information such as diagnosis printed on them. The insult on injury was that Cerebral failed to disclose or buried information on data sharing to consumers signing up for their ‘safe, secure, and discreet’ services. Cerebral now has to restrict nearly all information to third parties.
  • Cerebral also set up their service cancellation as a ‘negative option’ cancellation policy, which in reality meant that it was renewed indefinitely unless the customer took action to cancel. It was not adequately disclosed in violation of the federal Restore Online Shoppers’ Confidence Act (ROSCA). Then Cerebral made it extremely difficult to cancel by instituting a complex procedure that required multiple steps and often took several days to execute. They even eliminated a one-step cancel button at their then-CEO Kyle Robertson’s direction. The order requires this to be corrected including deleting the negative option.
  • Former employees were not blocked from accessing patient medical records from May to December 2021. It also failed to ensure that providers were only able to access their patients’ records.

Cerebral’s settlement with the FTC and DOJ breaks down to $5.1 million to provide partial refunds to consumers impacted by their deceptive cancellation practices. They also levied a civil penalty of $10 million, reduced to $2 million as Cerebral was unable to pay the full amount. The decision and fine do not cover charges to be decided by the court against the former Cerebral CEO Robertson due to his extensive personal involvement in these practices. Those have not been settled and apparently were severed from the company as a separate action (FTC case information). Since 2022, Mr. Robertson has consistently blamed company management and investors for pushing for bad practices such as prescribing restricted stimulant drugs. Cerebral countersued him for defaulting on a $49.8 million loan taken in January 2022 to buy 1.06 million shares of Cerebral common stock. More to come, as the order also does not address other Federal violations under investigation, such as those under the Controlled Substances Act.  FTC release, FierceHealthcare  

VA to possibly resume Oracle Cerner EHR implementation at VA sites before the end of FY 2025, even if not in budget. During House Veterans’ Affairs Committee hearings on FY 2025 and 2026 budgets, VA Secretary Denis McDonough last Thursday (11 April) said that the VA intends to resume deploying the Oracle Cerner EHR as part of VA’s Electronic Health Records Modernization (EHRM) before the end of FY 2025. As Federal years go from October to September, FY 2025 starts October 2024 and ends September 2025. When asked if VA plans to maintain the “program reset” as they termed it in April 2023 for all of FY25, Secy. McDonough said that “we do not.”However, there is no budget allocated for additional implementations in either FY. The plan is to use carryover funding.

Oracle Cerner’s Millenium EHR was implemented at five VA locations before suspending in April 2023 for a massive re-evaluation which involved reworking systems such as the Health Data Repository which created critical scheduling and pharmacy problems detailed by the Office of Inspector General (OIG)  [TTA 28 Mar]. The joint VA and MHS/Genesis Lovell FHCC implementation, which went live in March, is not included.  NextGov/FCW, Healthcare Dive

And in another dispute about data sharing, leading EHR Epic cut off requests made by some Particle Health customers, expressing concern about privacy risks. Particle Health is a health data exchange API platform for developers. Both Epic and Particle are part of Carequality, a large scale data exchange group that connects 600,000 care providers, 50,000 clinics, and 4,200 hospitals to facilitate the exchange of patient medical records On 21 March, Epic filed a dispute with Carequality that some of Particle’s users “might be inaccurately representing the purpose associated with their record retrievals.” and stopped responding to some Particle Health customer queries. This has now degenerated into a ‘who said what‘ dispute, with Particle and their CEO alleging that Epic implied that it completely disconnected Particle Health and its customers from Epic’s data, while Epic has said that after a review by its 15-member Care Everywhere Governing Council, they flagged three companies who were using Particle’s Carequality connection to access data not related to patient care or treatment. There’s also a larger concern being brought up by providers on the use of these mass data exchanges for fraudulent extraction of data or use that would violate HIPAA guidelines. FierceHealthcare, CNBC, Becker’s, Morningstar

Short takes: PocketHealth, Brightside fundings; VA OIG reports hit Oracle Cerner; Change cyberattack/legal updates; UHG-Amedisys reviewed in Oregon; Optum to buy Steward Health practices

It’s a relatively quiet week before the Easter holiday, with a few fundings, more drama at the VA around Oracle Cerner, updating Change Healthcare’s comeback, and the continuing scrutiny around UnitedHealth’s acquisitions:

PocketHealth garners a US$33 million Series B. The Toronto-based company markets an AI-assisted platform to health systems and providers that allows patients to access their medical imaging and reports as well as for providers to easily share imaging information. The funding was an all-equity round by Round13 Capital with participation from Deloitte Ventures, Samsung Next, and existing investors Questa Capital and Radical Ventures to bring total funding since 2020 to $55.5 million. The fresh funding will be used to grow further within the US and Canada and develop new platform functions. Patients have access to three platforms:  Report Reader to explain medical terms in the patient’s report, Follow-Up Navigator for follow-up imaging recommendations, and MyCare Navigator to equip patients with relevant, personalized questions to ask their doctor. The platform is available in 775 hospitals and imaging centers across North America and is used by more than 1.5 million patients.  PocketHealth release, Mobihealthnews

Brightside Health moves to a Series C of $33 million. This round for the telemental health company was led by S32, along with Kennedy Lewis, Time BioVentures, and Anne Wojcicki (Redwood Pacific) with existing investors ACME, Mousse Partners, and Triventures. Total funding since 2018 is $114 million. Brightside provides telemental health through payers in 50 states such as CareOregon, Blue Cross and Blue Shield of Texas, and Centene. The new funding will be used to expand into the usual new markets and offerings. Trip Hofer, who was former CEO of Optum Behavioral Health Solutions and now with .406 Ventures, will join the Brightside board of directors. Their most recent moves are expansion into Medicare and Medicaid programs for psychiatry, therapy, and their Crisis Care program for individuals with elevated suicide risk. Release

The Department of Veterans Affairs Office of Inspector General (OIG) released three reports last Thursday (20-21 March) that were sharply critical of the new Oracle Cerner EHR. While Oracle Cerner Millenium operates in only five VA locations, not including the joint MHS/Genesis Lovell FHCC, each one has been problematic from training to implementation–and are on hold. The OIG reports available here on the Electronic Health Records Modernization (EHRM) are scathing on the EHR’s scheduling and pharmacy features leading to patient safety and staff usability issues.

  • At VA Central Ohio Healthcare System (facility) in Columbus and elsewhere, this led to inaccurate medication and allergy information transmission from new EHR sites to legacy EHR sites that staff and pharmacists had to work around to provide adequate safety checks.
  • Also at VA Central Ohio, the Cerner EHR system error in 2022 led to a patient’s missed appointment since it was not routed to a queue to prompt rescheduling efforts. Subsequently, a nurse practitioner never evaluated the medication refill request, nor did a psychologist evaluate mental status and critical clinical information. The veteran patient died by accidental overdose approximately seven weeks after that missed appointment.
  • Regarding future implementations, the OIG was specific on what had to be fixed on both: “These concerns include the need for additional staffing and overtime to meet or exceed pre-deployment appointment levels, displaced appointment queue functionality, challenges related to providers and schedulers sharing information, inaccurate patient information, difficulties changing appointment type, and the inability to automatically mail appointment reminder letters. At facilities currently relying on the EHR, these issues have resulted in inconsistent workarounds and additional work, increasing the risk for scheduling errors.” 

Healthcare IT News, Healthcare Dive, EHR Intelligence, TTA 22 Feb

Change Healthcare’s systems are gradually returning. Since our last update on 14 March, UnitedHealth Group confirmed that 99% of pharmacy network services were up and running–and that they have fronted $2 billion to providers. Separately, they launched workaround software for medical claims preparation.

  • On 15 March, the electronic payments platform was restored.
  • On 20 March, UHG restored Amazon Web Services. It was backed up from Assurance, a claims and remittance management program, and claims clearinghouse Relay Exchange.
  • Relay Exchange went back online by 24 March to begin processing $14 billion in medical claims.

But on the legal and Federal fronts, UHG will be keeping its legal department busy. Starting the week of 11 March, the first class action lawsuit was filed by a women’s health practice in Albany, MS–Advanced Obstetrics & Gynecology PC. Another class action suit was filed on 18 March by Gibbs Law Group on behalf of providers to be named. Patients who have had compromised PII and PHI will be next from the 4 or 6 terabytes of payer information held by ‘notchy’ and other affiliates from the BlackCat/ALPHV masterminded attack as this is confirmed. Expect these to multiply like weeds in May. HIPAA Journal  And the American Hospital Association, Senators and House Representatives are jumping all over Health and Human Services (HHS) to ensure that payments are made to Medicare, Medicaid, and Medicare Advantage plans–as well as calls for investigating UnitedHealth. Becker’s, FierceHealthcare

As expected, UHG’s acquisition of Amedisys home health is running into more opposition at the state level. In this case, it’s the Oregon Health Authority (OHA) that will be conducting a full review. The Department of Justice (DOJ) has been investigating the acquisition on antitrust grounds almost since it was announced in June 2023. Shareholders approved the $3.3 billion buy the following September, but it has not closed. UHG’s plan is to merge it into Optum’s home health providers Contessa Health and LHG Group, creating a home health juggernaut. As noted earlier this month when DOJ announced a further antitrust probe of UHG around the UnitedHealth plan relationships with Optum services, “DOJ has a long memory, a Paul Bunyan-sized ax to grind, and doesn’t like losing. One wonders if now UHG has buyer’s remorse after fighting for two years to buy Change.” (And winning versus DOJ!) Fierce Healthcare

Yet UHG goes on buying providers, DOJ scrutiny or not. Optum is bidding for Steward Health Care’s Stewardship Health practices over nine states. For-profit Steward, headquartered in Dallas, needs to raise funds as it is in debt overall and facing major problems in Massachusetts, with several hospitals at risk of closure. In any case, the company wants to exit the state. A purchase price was not announced. The transaction is under review by Massachusetts’ Health Policy Commission (HPC) over the next 30 days. The Stewardship transaction would add to OptumCare’s total of 90,000 physicians–10% of US physicians, a number that is raising red flags on the state and Federal levels. FierceHealthcare, WBUR

News roundup: Cerner goes live at VA, DOD Lovell Center; WebMD expands education with Healthwise buy; Dexcom has FDA OK for OTC glucose sensor; Centene may have buyer for abandoned Charlotte HQ

In news other than Walgreens and Optum/Change Healthcare–with more to come out of HIMSS in Orlando this week…

The DOD/VA Cerner EHR went live on Saturday 9 March in the Capt. James A. Lovell Federal Health Care Center (Lovell FHCC), right on scheduled time. This EHR which will serve both active duty service members in the Military Health System (MHS) and veterans through the VA is being watched closely. While MHS Genesis has been rolled out in most military health facilities in the US and overseas, the VA’s has stalled at five. As of now, Lovell is the only VA implementation planned for this year and its functionality and interoperability with MHS is under a microscope. Training has been intensive and VA reports having made many changes from the earlier implementations. The MHS Genesis team from DOD have also been a key part of the training.

VA has shown improvement with no full outages in 300+ days and with the nagging smaller incidents greatly reduced. But the VA’s deputy inspector general reported significant and dangerous faults in the Oracle Cerner Millenium medication record system only last month to the House Subcommittee on VA Technology Modernization [TTA 22 Feb]. While the fixes are in effect in the five VA locations with Millenium, Genesis at Lovell will not have them yet.

Lovell FHCC is located in north Chicago, has a combined DOD/VA staff of 3,200, and serves 75,000 patients per year: 25,000 veterans, over 10,000 TRICARE enrollees, and 30,000 Navy recruits from Great Lakes with a 300-bed main facility and clinics in the Chicago area. Federal News Network

WebMD buys health education developer Healthwise. The company’s patient education assets including content and technology that integrate into care management platforms for both health systems and payers will become part of WebMD Ignite, which was formed last April to unite Krames, also in health education, Mercury Health data analytics, Wellness Network videos, Vitals provider scheduling, in addition to Medscape and WebMD. According to the release, the combination of Krames and Healthwise will reach 650 healthcare organizations, comprising more than 50% of hospitals in the U.S. and 85% of the top 20 payers, which is a dominant market share with limited other competition such as Wellframe, owned by HealthEdge. Transaction cost, surviving name, and management/staff transitions were not disclosed.

Healthwise is unusual in that it was formed as a non-profit in Boise, Idaho in 1975. In the 2024 Best in KLAS Report, Healthwise was ranked first in health education for value-based care. While the education assets are being sold to WebMD, the non-profit will go on, according to Healthwise. Healthcare IT News (Editor’s disclaimer: Donna was a consultant for Krames on marketing projects during 2021-22, prior to Ignite.)

WebMD is also integrating into Ignite personalized medication instructions from First Databank (FDB)’s Meducation through WebMD Ignite’s Krames On FHIR platform. It will then go into prescribers’ EHRs and patient portals. FDB release

Dexcom receives FDA clearance for Stelo, the first over-the-counter (OTC) continuous glucose monitor cleared in the US. Like the prescription version, the biosensor attaches to the arm to monitor blood glucose without skin penetration and connects to a Dexcom phone app. The sensor is the same as the prescription Dexcom G7, with a battery life of about 15 days. Stelo was cleared for use by adults 18+ who have Type 2 diabetes but not on insulin therapy–over 25 million people in the US. Release is scheduled for online-only release this summer as a cash-pay purchase (cost not disclosed), with insurance reimbursement TBD over the next few years. Mobihealthnews, Healthcare Dive

Centene may be close to selling its ‘dream’ Charlotte, North Carolina headquarters building. The now near-complete 800,000-square-foot building in Charlotte’s University City would have been Centene’s East Coast HQ. It was planned by the previous CEO in 2020 to be the center of a campus with over 6,000 employees, 3,200 to be hired locally. The plan was abandoned in August 2022 due to a shrinking office-based workforce primarily in St. Louis with some in plan locations throughout the country. Cushman & Wakefield is marketing the building with word being that a single company is interested in purchase. New Class A space is reportedly relatively rare in Charlotte, though the vacancy rate in the immediate area is at 25%. There is also undeveloped land on the site that has attracted interest from a locally active multifamily developer, although that would require a rezoning. Centene purchased the land in 2020 for $19 million, not including a separate 51-acre parcel purchased later in 2020. In addition to reducing its real estate pattern, Centene has also been reducing its staff with two 2,000-person layoffs in 2023, one in the summer and the second in December.  Charlotte Business Journal, Becker’s

Short takes: Oracle Cerner still has major hurdles, says VA, Congress; One Medical adds Hackensack Meridian to specialist network, HTA to employer benefits; NHS trialing AI tracking of home behavioral patterns for at-risk patients

VA’s All Quiet on the EHR Front doesn’t mean nothing is happening. With the House hard at work with a new speaker, negotiating budget extensions, and generally trying to get work done before the Christmas-New Year recess, the work of subcommittees goes on. Rep. Matt Rosendale (R-Montana), chairman of the House Committee on Veterans’ Affairs’ Subcommittee on Technology Modernization, yesterday (15 Nov) in what was titled “Electronic Health Record Modernization Deep Dive: System Uptime” got an update on the status of Oracle Cerner from Kurt DelBene, the VA’s chief information officer. His testimony wasn’t exactly reassuring. “Overall we still think there’s a ways to go. I don’t want to present the system as all set and ready to go.” In a rare show of bipartisanship, ranking member Rep. Sheila Cherfilus-McCormick, D-Florida, said that “[Oracle] training and change management are still woefully inadequate and user satisfaction is still critically low.” And despite being invited by Chairman Rosendale, Oracle’s Mike Sicilia didn’t show up or send regrets, which made Rep. Cherfilus-McCormick a little livid. FedScoop  HISTalk in its recap also pointed out that Rep.Rosendale “cited a report saying that it will take Oracle Health 15 more years to match VistA’s functionality. [VA deputy CIO Laura Prietula] responded that she doesn’t think it will take that long.” Oracle Cerner, in the few VA locations where it is operative, has not had a complete system outage in six months. Hearing and 1 hour 46 min. video (YouTube), hearing documents

Amazon continues to build out One Medical to, perhaps, ubiquity. On the East Coast, Amazon’s One Medical adds a major New Jersey health system relationship, Hackensack Meridian Health. Like its newly inked relationship with CommonSpirit Health, it will add integrated specialty providers to One Medical’s primary care focus. Specific locations based on patient needs are not specified yet nor financials. Implementation timing is unusually long–by the end of 2024. On a faster track may be One Medical’s deal with Health Transformation Alliance (HTA), a consortium of large US employers comprising 67 employers including Coca-Cola, Intel, Boeing, and many others totaling nearly 5 million employees. Timing and financials were not disclosed. This adds to One Medical’s current contracts with 8,500 companies that offer its primary care services as an employee health benefit. Becker’s, FierceHealthcare

NHS experiments with predictive health indicators and AI modeling for at-risk patients to prevent unnecessary admissions. Four GP practices in Somerset will be using an AI system that will flag registered patients who have complex health needs first, and are most at risk of hospital admission or who rarely contact their GP. Monitored in Buckinghamshire, the most interesting part of this is that the AI is linked to electronic sensors on kettles and fridges that spot changes in Somerset patients’ eating and drinking habits, obviously as an indicator of changes in health. (Does this remind anyone of 3rings or QuietCare?) Changes are reported to an Onward Care team of health coaches, nurses, and GPs who speak to patients and ask about any health or living issues. They can provide, based on patient input, deliveries of food parcels, arranging for cleaning or shopping services, home alterations to help to avoid falls, or to link them up with local voluntary groups to reconnect them with community resources or simply to help avoid loneliness. Clinical care can also be scheduled including specialist care. The NHS reports that GP practices can use this system to solve 95% of their issues or escalate anything clinical. Why this is important: hard winter and isolation, even with the holidays, loom after an autumn of wild weather and the persistent shortage of hospital beds and GP capacity/timeliness of appointments.  DigitalHealth.net

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

Mid-week short takes: Amwell lowers 2023 outlook, DocGo goes up, Imprivata + PFH win Ireland HSE contract, Oracle Health’s Nashville move, layoffs at 23andMe, Doximity

Amwell missed Wall Street earnings analyst estimates and lowered its 2023 outlook. Q2 revenue of $62.4 million was a 3% drop versus prior year. Net loss was $93.5 million, added to a nearly $400 million net loss in Q1. Both quarters included goodwill impairment charges totaling nearly $400 million to reflect losses in stock value and market capitalization. Amwell is projecting downgraded revenue between $257 and $263 million compared with earlier guidance of $275 million to $285 million. Their adjusted EBITDA range for the year was also downgraded to lose $160-165 million from $150-160 million. Much of this is due to payer and provider migrations to their new platform, Converge, which will consolidate its offerings plus third-party tools, in a process that is losing providers and reducing visits. Release, Healthcare Dive

DocGo, a telehealth and medical transportation provider, upped its outlooks. First, they reported a tidy bump in Q2 revenue of $125.5 million, up from $109.5 million in prior year. Once known for mass Covid testing which has largely disappeared, which was $28 million in Q2 2022, non-testing revenue grew 53% versus prior year. Revenue is split between transportation ($45 million) and mobile health ($80 million). Adjusted EBITDA was $9.1 million for Q2, rising from $5.6 million in Q1. With $325 million in contracts not fully rolled out and wins with the NYC Department of Housing, their full-year 2023 revenue guidance is now projected to increase from $500-$510 million to $540-$550 million and monitoring over 50,000 patients. Release, Mobihealthnews

Ireland’s Health Service Executive (HSE) awarded a national framework contract to Imprivata and regional partner PFH Technology Group. Imprivata OneSign is a single sign-on (SSO) enterprise access solution for clinicians logging into various systems which eliminates repeated username/password entries. Logins will be via entering their password once per shift and reauthenticating with a tap of their ID badge, potentially saving 50 minutes per shift. Initial rollout will be to the following: Tallaght University, Beaumont, Rotunda, Galway University, Cork University Maternity, National Forensic Mental Health Service, and National Rehabilitation Hospitals. Imprivata release

Oracle Health on the move. Apparently Oracle Health, largely the former Cerner, will be moving to Nashville, Tennessee. This is a commitment that Oracle made in 2021 before purchasing Cerner. Oracle is building a $1.35 billion facility at a riverfront site, planning to locate 8,500 jobs in Nashville by 2031. Nashville has become a southeastern hub of healthcare companies and development. Oracle Health chair David Feinberg, MD and Seema Verma, a SVP there, were at a healthcare meet and greet there last week.  This adds to the de-Kansas City-ing of Oracle and perhaps more attrition among long-time employees. Becker’s

Two healthcare companies reported layoffs and revenue rethinks this week:

  • Genetic tester and data merchandiser 23andMe announced layoffs of 11%. This affects 71 employees primarily in their therapeutics segment, a cut of 47% in that segment and 11% of the company’s workforce. The staff downsizing reflected the end of a five-year partnership in therapeutics development with GSK and adds to April cuts of 75 jobs. The new cuts will be in Q2 of their 2024 fiscal year ending 31 March 2024 which will be by September this year. Revenues also fell in the quarter ending 30 June (their Q1) 6% to $60.9 million from $64.5 million in prior year, with a net loss of $104.6 million. Interestingly, 70% of their revenue is from direct-to-consumer services in genetic testing, subscriptions, and telehealth.  StreetInsider, GenomeWeb
  • Doximity also is laying off 10% of staff, or about 100 people. A digital platform for medical professionals with online networking tools, scheduling, CMEs, secure messaging and telehealth for consults, it is facing slowing growth and renewals among paying customers that include hospitals, health systems, pharmaceutical companies, and medical recruiting firms that purchase subscriptions for services on Doximity. The company adjusted its FY2024 (March end) financials downward to $452 to $468 million and $468 million from $500-$506 million, with adjusted EBITDA for the year to $193-$209 million from $216-$222 million. Release, FierceHealthcare

 

House appropriates $1.9B for Oracle Cerner VA EHR modernization, $5.2B for telehealth, plus other technologies; Oracle lays off more Cerner staff

House appropriations for the VA in FY 2024 were passed last week, including requirements for the VA/Oracle Cerner EHR Modernization program. The House allocated $1.9 billion in total for VA’s Oracle Cerner EHRM program. According to the report in FedScoop, the topline amount is broken down as follows: $1.2 billion for the Oracle Cerner-operated contract, $424 million for infrastructure readiness, and $253 million for program management. 

The budget is part of the Military Construction, Veterans Affairs, and Related Agencies Appropriations Bill 2024 (full bill). The bill goes to the Senate after the summer recess. See pages 53 and 54 for the EHRM.

Key points:

  • This appropriation is the sole source of funding for the EHR modernization program. “No authority is provided for funds from other VA accounts to be transferred into this account nor for funds from this account to be transferred out to other accounts.”
  • Reaffirms “quarterly reporting of obligations, expenditures, and deployment schedule by facility and the Office of Deputy Secretary to administer the initiative”
  • There is also a 25% contingency upon the VA Secretary to report any outstanding issues impacting the stability and usability of the system, certifying and detailing any changes to the deployment timeline, certifying the status of outstanding issues, and whether
    the system is ready and optimized for further deployment at VA sites. 
  • ” The Government Accountability Office is directed to continue quarterly performance reviews of EHRM deployment and to report to the Committees each quarter.”

Reports will start within 30 days of the enactment of the appropriations bill looking back on “each new requirement and customized interface added in fiscal years 2022 and 2023, including the cost of each, reasons for inclusion, and whether they were outside of the scope of the contract within 30 days of enactment of this Act.” At 45 days, the bill requires a briefing on how the Department plans to set enterprise standards. The bill also confirms that no new deployments are scheduled for FY2024 and the 25% of funds set aside for FY2023 in deployment will not be released. Also EHR Intelligence

The bill also allocates $5.2 billion for telehealth and connected care (page 42). This covers services in home telehealth, home telehealth prosthetics, and clinic-based telehealth. The bill encourages expanding telehealth capacity to address backlogs for disability exams and healthcare appointments when appropriate. Our top story on 9 June was the award of Home Telehealth monitoring contracts to incumbent Medtronic and newcomers Cognosante, Valor Healthcare, and DrKumo.

Included in other budget lines are healthcare technologies (pages 33-34) such as bioelectronic medicine/AI, early detection diagostics, focused ultrasound therapy, medical image exchange, migraine prevention and treatment, and respiratory illness diagnostics using 4-dimensional images of lung function. 

Meanwhile, Oracle is laying off more Cerner employees. Your Editor is basing this on a Reddit 1 August thread that has no totals but indicates that employees were told yesterday (1 August), given two weeks notice to 15 August, and that the layoffs hit areas such as revenue cycle, 10% of CernerWorks, and properties. CernerWorks hosts, manages, and monitors client systems by providing data center hosting services for Cerner EHRs and other SaaS. Whether any of this affects the VA is to be determined, but their Federal service area had 500 to a rumored 1,200 layoffs in June. This was not much of a surprise with the near-completion of the DOD Military Health System EHR implementation and the holdup save one of the VA’s implementations (except the joint VA-MHS Lovell facility in Chicago). Our Readers have heard this here first.

News roundup: MHS Genesis EHR completes US rollout, telehealth selective savings by disease, CarePredict’s $29M funding, Amazon Alexa *Spying on You*

At least one part of Oracle Cerner’s work is done. The Military Health System (MHS), which covers 9.6 million active duty beneficiaries and 205,000 medical providers, announced yesterday that the rollout of the Genesis EHR is complete in the continental US. The final go-live was at Wright-Patterson Air Force Base, which covers 6,800 clinicians and providers in military hospitals and clinics across Ohio, Virginia, Maryland, Indiana, Texas, and Kentucky. It was also deployed at the National Oceanic and Atmospheric Administration, NOAA Corps, which is under the Department of Commerce. The final 14% of the MHS system is overseas. That rollout will start in September 2023, including Landstuhl Regional Medical Center in Germany and Royal Air Force Lakenheath in the UK. Bases in Guam, South Korea, and Japan will follow in October. DOD’s one joint facility with the VA, the James A. Lovell Federal Health Care Center in Chicago, will deploy in March 2024. All other VA healthcare centers are on hold indefinitely. With the wrapup of MHS Genesis and the pause on VA’s Millenium rollout, Oracle has reportedly laid off over 500 staff on these Federal projects [TTA 16 June]. DVIDS release

 Telehealth’s selective savings. A new study out of the University of Texas-Austin McCombs School of Business found, like other studies such as Epic Research’s, that telehealth visits reduced future outpatient visits, in their study within 30 days, by 14%. This saved $239 per patient in outpatient costs. But telehealth was more effective for some specialties than others. It had the most impact on cost reduction for behavioral health, metabolic disorders, dermatology, and musculoskeletal (MSK) disorders, with a significant reduction of 0.21 outpatient visits per quarter (an equivalent cost reduction of $179). This suggested to the researchers a substitution of telehealth versus traditional clinic visits. But telehealth’s impact was nearly nil when it came to circulatory, respiratory, and infectious diseases, not significantly reducing the number of future visits or costs. The study sampled hospital-based outpatient clinics in Maryland from 2012 (not a typo) to 2021. Becker’s, UT News, Informs Pubonline (abstract only)  

Senior living monitoring system CarePredict adds $29 million from four main investors. This is a Series A-3, which one assumes adds on to an existing Series A, which was $9.5 million in 2019. The round was co-led by SV Health Investors’ Medtech Convergence Fund and Aspire Healthtech Partners with existing institutional investors Secocha Ventures and Las Olas Venture Capital plus private family offices and individual investors. CarePredict pioneered a wearable bracelet, the Tempo, that wirelessly tracks residents’ activities of daily living (ADLs) in assisted living (AL), independent living (IL), and continuing care (CCRC) settings. Interpretation of ADLs in a platform can predict changes in health and wellbeing leading to better health and extended residence. CarePredict has expanded its platform reporting with other tracking such as context beacons, visitor and wander management, PinPoint digital contact tracing, and family communication apps. CarePredict release, Mobihealthnews

How much does Amazon have on you? If you are a user of Amazon’s Echo system, you already know that Alexa is always listening to you. What you may not know is that Amazon stores that information in a database, including parts of overheard conversations that have nothing to do with Alexa, since Alexa is always on. Even if you (like your Editor) don’t have an Echo but have a Kindle (unlike your Editor) or use the app residing on most smartphones, Amazon knows what you read, what you flip through, and your start and stop times. The Amazon Sidewalk mesh network, used with Alexa and Ring cameras, extends the reach of your router and shares your network with your neighbors. This is in addition to your shopping and even what you look at. In the context of the rollout of Amazon Clinic pending, delayed to 19 July [TTA 27 June], where Amazon is 1) only an intermediary to providers but 2) demand access to all your PHI and PII before allowing access to them, can we as professionals admit this is a glaring privacy violation and that the FTC is actually right?

Kim Komando, well known for her radio and online shows advising non-techies on tech, has an excellent article on how Amazon is piling up information on us all. This is based on a 2021 Reuters investigation and also contains a link to her interview with the two Reuters reporters. The article also describes how to find out what Amazon has on you. Warning–they don’t make it easy. She also addresses the Amazon clinic issue in a FoxNews article.