TTA welcomes Spring: WBA’s Pessina takes big stake in Walgreens buyout, Foodsmart’s new CEO, NHS England to be abolished, Veradigm’s interesting outlook, telehealth flexibilities extended, more!

March 21, 2025 | by | No Comments

 

21 March 2025

Spring–time to clean up the picnic table. The Walgreens financing took an interesting turn, with WBA chairman Pessina doubling his table stakes. Foodsmart lays out a spread for a new CEO from Amwell. A semi-independent NHS England proved to be an unsteady table for the UK Government–off it goes to the thrift store. Veradigm closed its 2022 books–but their table is a bit wobbly. Elsewhere, two mergers, and Congress keeps limited Federal telehealth flexibilities into September. And our guest Perspectives returns with another view on telehealth and accessibility to addiction treatment.

Short takes: interesting takeaways from the Veradigm earnings call, VA cuts ~6 EHRM contracts; mergers for DispatchHealth-Medically Home, Wysa-April Health (‘Standalone’ for Veradigm may be a bumpy road, as costs are cut at VA, and mergers mark ‘hot’ hospital-at-home and telementalhealth)

News roundup: NHS England to be abolished, absorbed into UK DHSC, while IT glitch shorts 5,200 from screenings; Veradigm *finally* files 2022 financials (updated), VA-Oracle EHR now promises 13 installs in 2026 (Government change whacks NHS England, Veradigm reports 2022 at last, and VA to resume more Oracle installs in 2026)

Breaking: Stefano Pessina to near-double stake in Walgreens after Sycamore Partners takeover–reports (Sr. Pessina surprisingly puts a LOT more chips on the table)

Can kicked down road: telehealth flexibilities extended to 30 September (That takes care of the next six months, but the real story is what the FY2026 budget portends for telehealth expansion)

Perspectives: Telehealth Expands Access to Addiction Treatment and Specialized Care, But Navigating Regulations Remains Key (More on how telehealth prescribing affects addiction care)

Breaking: telehealth nutrition provider Foodsmart taps former Amwell COO Kurt Knight as CEO (Moving from traditional telehealth to lead a newly ‘hot’ part of healthcare)

Last week: Financings come alive and we dig dig dig into them, between the huge LBO for Walgreens, the Hinge Health preliminary IPO filing, and ModMed’s majority stake sale. Anne Wojcicki keeps trying to buy her own company for dimes, but put a slightly sweeter offer on the table–if you like waiting. Elizabeth Holmes is waiting for the courts to see it her way. And our guest Perspectives from the field presents a view of improving telehealth policy on opioid use treatments.

News roundup: MSK is ‘it’ with Hinge Health’s IPO filing, Vori Health’s $53M raise, Dario Health’s 33% revenue increase; CoachCare buys VitalTech, ModMed investor sells majority stake, Health NZ uses Excel–only; Holmes gets rehearing extension (IPO, investment unfreezes despite market turmoil, and two ‘I can’t believe it’ stories from NZ and Ms. Holmes’ continuing appeals)

Sycamore Partners taking on 83% debt in financing their Walgreens leveraged buyout–some observations (Another season for leveraged buyouts, including a walk back to the LBO Golden Age of the 1980s. Can Walgreens do better than this?)

Update: Wojcicki increases 23andMe per share offer to $2.94 from $0.41–but there’s three contingency ‘catches’, and more (Another amazing penny-ante offer for 23andMe. Will the board succumb? Is there a choice?)

Perspectives: How the DEA Telehealth Extension Impacts Patient Access to Opioid Use Disorder Treatments & Buprenorphine Prescriptions (A clinician’s view from the field) 

The $10 billion Walgreens take-private deal with Sycamore: what you need to know (We look into the deal’s devilish details, and what Walgreens might look like in a year or two)

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Short takes: interesting takeaways from the Veradigm earnings call, VA cuts ~6 EHRM contracts; mergers for DispatchHealth-Medically Home, Wysa-April Health

March 21, 2025 | by | No Comments

The Veradigm earnings call following the 2022 financial release had to be…interesting, perhaps in what wasn’t said. HIStalk’s reporter took away several key points succinctly; a full reading at their site is recommended (scroll down). In brief:

  • “The financial impact of the internal control failures was $239 million in asset reduction and $46 million in fees.”
  • The company will not be current on its financial reporting until 2026
  • The core provider and life sciences businesses went wobbly
  • ScienceIO, bought in February 2024, generated no revenue. The AI/LLM acquisition was touted as being incorporated into other business lines, trimmed with jargon.

The accumulation of things that just aren’t tucked, tied, and moving forward gives the impression of uncertainty. And uncertainty is a bad place to be in a billion-dollar business. Veradigm consists of a complex mix of businesses. Yet the CEO, Tom Langan, is still ‘interim’ after 10 months which affects the leadership. Months ago, the company was for sale, yet all the interested bidders who could have well afforded Veradigm took a pass. Now they are facing a ‘standalone future’.  Right after that announcement, an activist investor intervened and is now calling the shots on board members [TTA 19 Mar, 22 Feb]. Stay tuned….

VA cutting contracts, including six EHRM sub-vendors–a wrench in the EHRM works? According to this Federal News Network report, the total number of canceled contracts, originally announced as 875 contracts, was later reduced to 585. Included in the cuts were at least six small contractors tied into the EHR Modernization (EHRM) with Cerner. While VA is ‘walking back’ the termination of some of these EHRM contractors working on essential pieces such as interoperability and HIPAA compliance, these small, generally veteran-owned companies with specialized workers have already laid off staff. What’s really telling is the statement from FNN’s source, which this Editor doubts you’d hear outside of government or a huge global company: “For every FTE in government, there’s maybe two, three, even four support resources that are assisting. The government is just there for decision-making. The groundwork, and all the other work, is being done by this contract support team. Right now, they’re just trying to do damage control.” In addition, 24 on the EHRM team either were laid off or took the buyout. Having once worked for a contracting RPM company for the Veterans Health Administration which had its contract terminated after over 10 years, this Editor can testify to 1) the devastating effect and 2) the specialized skills of people making up these support teams.  Hmmmm….

Hospital-at-home DispatchHealth and Medically Home to merge, effective mid-year. Terms of the transaction, headquarters location, and employee transitions were not disclosed. According to Healthcare Dive, Jennifer Webster, CEO for DispatchHealth, will lead the combined organization under the DispatchHealth name. Both offer same-day in home medical care, recovery services, and hospital-level care at home. DispatchHealth, headquartered in Denver, raised $403.2 million through a March 2021 Series D. Medically Home in Boston raised $197 million through a January 2022 Series D. They don’t have investors in common, unusually for mergers of late. Medically Home focuses on health systems and physician groups for serious and complex care decentralized management, while DispatchHealth base is with insurance companies, value-based entities, as well as health systems. Coverage for the combined entity is stated as nearly 40 health systems, as well as most major health plans and value-based care entities, with 2,200 employees, over half in frontline care. Release. 

Over in Telemental Health Land, Wysa and April Health are merging. Wysa primarily features an AI LLM chatbot for cognitive behavioral therapy, targeted to individuals and employers, while April Health partners with primary care providers for behavioral care management with live managers. The Wysa chatbot in 2022 received FDA Breakthrough Device Designation for use by patients 18 years old and older with a diagnosis of chronic musculoskeletal pain, depression and anxiety. April Health has already integrated the Wysa chatbot with its services for LifePoint Healthcare and The Newton Clinic (affiliated with MercyOne). Terms of the transaction, headquarters location, and management transitions are not disclosed. Wysa has raised about $35 million in funding, with the last round in 2023, while April Health has seed funding only. Release, Behavioral Health Business, Mobihealthnews 

News roundup: NHS England to be abolished, absorbed into UK DHSC, while IT glitch shorts 5,200 from screenings; Veradigm *finally* files 2022 financials (updated), VA-Oracle EHR now promises 13 installs in 2026

March 19, 2025 | by | No Comments

The semi-independent entity of NHS England is scheduled to be absorbed by the UK Government within two years. Formed in 2012 under the David Cameron-led Government, NHS England (formally the NHS Commissioning Board) with the enactment of the 2012 Health and Social Care Act reforms, will now be directly controlled by the Department of Health and Social Care under the Secretary of State for Health and Social Care, Wes Streeting, who said, “We need more doers and fewer checkers, which is why I’m devolving resources and responsibilities to the NHS frontline.” The intent, according to Prime Minister Starmer’s announcement on 13 March, is to institute a centralized model that eliminates over-regulation, duplication, and slashes the £200 billion it currently takes to operate semi-independently. 

NHS England staff were warned of cuts up to 50%, and incoming chair Dr. Penny Dash, said in an agency statement that she will “work to bring together NHS England and DHSC to reduce duplication and streamline functions.” NHS England has doubled staff since 2010 when it peaked in user satisfaction and waiting times, declining ever since. Healthcare IT News

NHS England has a guide here on ‘what you need to know’ about the two-year abolishment announcement and key points from both the Starmer and Streeting speeches along with answers to MPs’ questions. Notably, “integrated care boards (ICBs) and provider trusts have been told to make further cuts, with ICBs asked to make 50 per cent reductions in their running costs by Q3 2025/26 and trusts being told to cut their “corporate services” budgets back to pre-pandemic levels.” The greatest concerns center around cuts to frontline staff though budgets are for now in place.

Separately, an IT glitch in NHS England’s GP patient registrations meant that 5,261 people weren’t notified of routine screenings. When GP practices did not fully complete patient registrations, the IT admin error meant their information was not passed into NHS screening program systems. Thus the reminders were not sent out for routine bowel, breast and cervical cancer, and abdominal aortic aneurysm screenings. This apparently started in 2008 but wasn’t identified till last year. It’s estimated that 10 patients may have died since that time. Digital Health UK

Veradigm files its delayed 2022 financials, at long last–and still unaudited. These were the infamous financials that delisted the company from Nasdaq due to a software problem that was reported that year. It made subsequent years non-auditable though the company reported profit on its complex operations. Veradigm stock fell, it failed to sell itself for the estimated $1 billion last year to one of the five most interested bidders [TTA 31 Jan], and now is essentially controlled by an activist investor, Kent Lake PR LLC, which has added four independent board directors [TTA 22 Feb]. The 2022 financials plus restatements of 2021 and 2020 financials were filed in their SEC Form 10-K. 2022’s net loss was $86.4 million, 2021’s net income was $139.7 million, and 2020’s was $696 million. Non-GAAP income per share was for the respective years ($0.77), $1.01, and $4.37. Now for 2023 and 2024….  Veradigm release is a long read

Updated: Healthcare Dive confirmed Veradigm’s flat revenue projection for 2025. Two new board directors and a chairman were appointed: Jonathan Sacks, a partner at Stonehill Capital Management, and Bruce Felt, CFO at cloud software company Domo on the board, and Lou Silverman as chairman. Mr. Silverman joined the board last month and replaces Greg Garrison, who last month announced his retirement after the 2022 financials were filed. Under the agreement with investor Kent Lake PR LLC, all had to be approved by them [TTA 22 Feb].

The Department of Veterans Affairs (VA) will roll out the Oracle EHR to a planned total of 13 sites in 2026. The announcement last week added nine sites to the previously announced four sites in Michigan. The additional nine will be announced later this year. VA also announced that the complete deployment and presumed replacement of VistA will be as early as 2031. On Oracle’s part, the EHR is being moved to the cloud (Oracle Cloud Infrastructure/OCI) with the first phase completed this year and full migration by end of 2026. 

Two statements closing the VA’s release are interesting (Editor’s emphasis in bold); interpreting them, deployments will be regionally implemented and procedures standardized for each, versus the extremely customized approach taken with the first six deployments:

VA is pursuing a market-based approach to site selection for its deployments going forward. This will enable the department to scale up the number of concurrent deployments, while also enabling staff to work as efficiently as possible. 

VA will adopt a standard baseline of products, workflows, and integrations aligned with subject-matter-expert recommendations. The standardized national baseline will ensure successful Federal EHR implementation, accelerate deployments, simplify decision-making, and support future optimizations.

Healthcare IT News, TTA 26 Feb on the most recent Congressional hearings

Has VA ‘done its homework’ and ready to restart the Oracle Cerner EHR Modernization? Timing and costs still not set. And 1,400 ‘non-mission critical employees fired. (updated 27 Feb)

February 26, 2025 | by

New Congress, new hearings of the House Committee on Veterans’ Affairs Subcommittee on Technology Modernization on the EHRM, and a new chairman. Rep. Tom Barrett’s  (R-Mich. 7th CD) opening remarks for the 24 February were more than an introduction of him as a new Congressman and subcommittee chairman. He is a 22-year Army veteran, a patient of the Battle Creek MI Medical Center, and had used the Montgomery GI Bill to pay for his college education. What he was less than sanguine about was the Oracle Cerner EHR–the problems, the budget, the timing for the restart, and whether all medical centers can be cut over by 2028, the contract’s end.

It’s seven years into VA’s original 10-year contract with Cerner, then Oracle. The implementation is in less than 4% of VA’s medical centers–only six including the joint MHS-VA Lovell Medical Center in Chicago. The contract in May 2023 was modified to five years of annual renewals expiring in May 2028. Rep. Barrett questions whether all the problems have been fixed or on the way to be fixed in order to meet the previous VA Secretary, Denis McDonough’s pronouncement last year that the VA would restart the Oracle implementation in spring 2026 [TTA 18 Dec 2024–the original statement was within FY 2025].

Two more open questions are cost and timing. Congress has no current schedule, nor a cost estimate for the entire project. The last independent cost estimate is three years old and $32.7 billion–more than double the original estimate of $16 billion.

The hearing confirmed that the homework is not done yet and not ready to be turned in, in Rep. Barrett’s words. During the hearing, the committee pressed VA about both those issues. The Government Accountability Office (GAO)’s Information Technology and Cybersecurity Director Carol Harris cited another estimate above $50 billion, which was contested by Oracle Health’s EVP, Seema Verma (former CMS Administrator during Trump 45), who believes that with the progress made during the hiatus, that the costs would be less and the Oracle EHR is much improved from the near-disastrous five original implementations. But Neil Evans, the acting program executive director of the EHRM Office, stated that the implementation would not be completed by the contract end in May 2028. Moreover, the EHRM Office still has to develop a detailed integrated master schedule and updated life cycle cost estimate. Both were emphasized as needed by acting VA Inspector General David Case. A hearing with few revelations, other than VA and Oracle need to get a move on. House Committee press release, NextGov/FCW  The full two-hour hearing is on YouTube here.  Hat tip to HIStalk.

Updated 27 Feb: Additional information from the GAO, EHRM Office and Oracle Health’s Seema Verma testimony from Healthcare IT News 27 Feb:

  • GAO (Carol Harris): The VA still has to address over 1,800 requested configuration changes, along with the cost and schedule and the continued user dissatisfaction with the system. Improvements: trouble tickets resolution timeliness thresholds were met since the implementation of financial consequences in September 2023, and that many but not all patient safety and pharmacy issues have been closed–and should be before further deployments.
  • EHRM Office (Neil Evans): A series of complex projects are moving forward, dubbed “Big Rocks”. These include standardizing user roles, improving new EHR user training for new users and addressing coordination between clinicians and pharmacists.
  • Oracle Health (Seema Verma): Presented plans to scale the EHR to the remaining 164 (sic) locations. She pushed for faster implementations, stating that the current pace is unacceptable. They are investing into automating implementations that would reduce manual testing efforts, user onboarding and training. She recommended to VA that they use “web-based tools” to gather site-specific information faster. On “Big Rocks” projects, Oracle worked with VA on pharmacy, referrals, Quick Orders, and other aspects of the EHR. 

And what about accessibility? Last June, Laurette Santos, a visually impaired clinical social worker at VA’s White City, Oregon, facility, sued VA in the DC Federal Court on the Oracle EHR violating accessibility standards. These have been part of every Federal contract since the Rehabilitation Act of 1973, specifically in Section 508. She has standing in court as a VA Visual Impairment Services Team (VIST) Coordinator since 2019 and user of the Job Access With Speech (JAWS) screen reader application within VistA. There is no Oracle equivalent.  TTA 8 July 2024

Updated 26 Feb: VA has not been exempt from the firings of probationary employees. 1,000 were terminated on 13 February followed by another 1,400 this week. They were categorized in the VA release as “non-mission critical includ(ing) DEI-related positions, among other roles” and “bargaining-unit probationary employees who have served less than a year in a competitive service appointment or who have served less than two years in an excepted service appointment.” The estimated savings of $83 million annually will be redirected towards care and services for VA beneficiaries. What’s often not mentioned in press coverage is that there are 40,000 probationary employees across VA, the vast majority are in mission-critical positions such as benefits and services for VA beneficiaries–and that VA has open 300,000 mission-critical positions exempt from hiring freezes. Another buffer is that a Senior Executive Service (SES) or SES-equivalent leader in a dismissed employee’s chain of command can request that the employee be exempted from removal and that those in the deferred resignation program are also exempt. The Hill is notable for what is included and excluded.

News roundup: PSI awarded $156M contract for VA EHR testing; $50M for Fay nutrition; General Catalyst’s wealth management expansion; UniDoc’s HealthCube debuts in Ukraine

February 13, 2025 | by

VA awards Planned Systems International a potential five-year, $156.1 million contract to support the VA’s EHRM (Electronic Health Record Modernization). The Independent Enterprise Testing and Support Services (IETSS) contract supports the EHRM-IO (Integration Office) team that is restarting the transition from VistA to the Oracle Cerner EHR. PSI will test and evaluate software, infrastructure, and environments, plus the operations of the independent verification and validation test center and test center environments hosted in VA Enterprise Cloud. It covers PSI’s project management, test and evaluation support, testing and technology support, test systems engineering and implementation support, and test process and quality management support. The five-year contract, as is typical with Federal contracts, is for an initial year then renewable for four 12-month terms. Another confirmation that EHRM-IO is moving forward on their plan announced before Christmas 2024, when the VA formally stated that they were planning for deployment in four Michigan facilities — Ann Arbor, Battle Creek, Detroit, and Saginaw–for implementation by mid-2016 [TTA 8 Jan]. GovConWire

Food as medicine is catching on. San Francisco-based Fay has scored a $50 million Series B round, led by Goldman Sachs with participation from previous investors General Catalyst and Forerunner, bringing their investment since 2024 to $75 million. The fresh funding will pay for growth and network expansion. They are claiming a valuation of $500 million.

Fay at present has a network covering most states of 2,300 registered dietitians (RDs) that integrate through Fay’s platform with major payers including United Healthcare, Aetna CVS Health, Blue Cross, Anthem, Cigna, Optum, and Humana, plus large employers such as Amazon, Microsoft, and Pepsi. The RDs provide personalized, in-person or virtual nutrition and lifestyle counseling to members or employees at little to no cost, while the platform automates processes such as insurance claims, scheduling, and patient follow-ups for the RDs. In addition, Fay can help RDs build their private practice and get credentialed with insurance. Over half of Americans struggle with diet-related chronic conditions (Frontiers in Public Health). Fay is in an especially sweet spot, as nutrition and quality of food, with the pending confirmation of Robert F. Kennedy, Jr. as HHS Secretary, is front and center. Release, MedCityNews

Speaking of General Catalyst, they are expanding beyond being one of the few dominant venture capital groups in a consolidating investment sector by expanding GC Wealth into a wealth management firm for entrepreneurs and others who have Struck It Rich (or have the potential to) in hot sectors such as AI. Running it out of San Francisco (where else?) is Dave Breslin, a former First Republic Bank executive who headed their private wealth unit. He recently hired several First Republic alums based out of Boston. According to the BBJ, it now has $2.3 billion in assets under management–and clients were invited last year to invest in General Catalyst’s seventh fund.  Founders should think long and hard about having your funder also manage your personal wealth–so it seems to this Editor. Boston Business Journal. Axios previously reported that General Catalyst is quietly exploring selling a share in its holding company. It currently has $32 billion in assets.

The ‘doc-in-a-box’ idea now has a fresh life in very specific uses. Canada’s UniDoc Health’s H3 Health Cubes have some interesting placements with the Italian Government to serve rural areas as a remote virtual clinic in locations such as the Municipality of Aliano’s Territorial Health Center. Also in Italy, the Aiutamoli a Vivere Foundation aid organization will place up to 15 units in Ukraine and the Gaza strip (though one suspects that events have eclipsed the latter placements).

For Ukraine, the H3 Health Cube funded by the Italian Agency for Development Cooperation (AICS), was delivered to a hospital in Yasinya in Ukraine scheduled to reopen on 14 February. It was received in mid-January by the Mayor of the City of Yasinia. along with additional aid such as food and hospital beds. It will connect doctors in that hospital, which treats wounded coming from the war zone as well as the local community, with Prof. Carlo Ventura’s team from I.N.B.B. of Bologna. Another Ukrainian hospital placement scheduled, in partnership with HP Inc., is for Okhmatdyt, Ukraine’s largest children’s hospital. A video of the HealthCube is on the UniDoc website.

Updates: ATA on telehealth policy priorities, UHG investor group demands denied care report, DOJ sues Walgreens on illegal Rx dispensing, VA nominee supports Oracle EHR deployment, RFK Jr. HHS nomination hits Senate

January 24, 2025 | by

ATA urges nine telehealth priorities for the Trump Administration’s consideration. Acknowledging that HHS expanded Medicare telehealth flexibilities at the start of the pandemic in 2020 in the previous Trump Administration, the American Telemedicine Association’s list is long and detailed.

#1 was to withdraw last week’s Drug Enforcement Administration’s (DEA) proposed rule, “Special Registration for Telemedicine and Limited State Telemedicine Registrations”. This would create a framework for the remote prescribing of controlled substances that in ATA’s view, would create “untenable restrictions and significant barriers to care”.

The remaining eight include flexibilities that were part of the 2020 rules.

  1. Permanently Allow for the Remote Prescribing of Controlled Substances
  2. Work with Congress to Make Permanent the Medicare Telehealth Flexibilities
  3. Ensure Affordable Telehealth Services for the Commercially Insured
  4. Ensure Affordable Telehealth Coverage for Part-Time, Contracted Workers Who Don’t Qualify for Health Care Coverage
  5. Ensure All Provider Home Addresses Remain Confidential
  6. Expand the Medicare Diabetes Prevention Program
  7. Reinstate Virtual Cardiopulmonary Rehabilitation Programs
  8. Release Updated Regulatory Guidance on Medicare Telehealth Flexibilities

Additional details are in the ATA Action letter to President Trump and Vice-President Vance and the ATA release.

An institutional investor interest group demands a report on delayed and denied care from UnitedHealth Group. This takes the form of a proposal for the 2025 proxy that the UHG board of directors prepare a report on these practices that create increased costs and ‘macroeconomic risks’.  The proxy is usually filed in April for a meeting that is typically in June. UHG will respond at that time it files the proxy.

The group proposing the report is the Interfaith Center on Corporate Responsibility (ICCR). ICCR represents 300 faith-based institutional investors, such as asset managers, pension funds, and foundations, with over $4 trillion in invested capital. This institutional shareholder action is in the aftermath of the Brian Thompson assassination, which revealed widespread consumer anger about UnitedHealthcare’s practices in high rates of claims denials, including their use of AI in the review process, and prior authorizations to restrict utilization. UHG ignores this at its peril. By the time proxies are released and the shareholder meeting occurs in June, the trial of the assassin may be underway, putting this issue back in top news.  ICCR release, Healthcare Dive

Walgreens’ Mound of Misery gained a few hundred cubic yards with a lawsuit filed 16 January by the Department of Justice (DOJ) over improper dispensing of opioids and and other unlawful medications over more than a decade. The civil lawsuit filed in the US District Court for the Northern District of Illinois alleges that Walgreens and subsidiaries dispensed millions of unlawful prescriptions, violating the Controlled Substances Act (CSA). Since Walgreens then sought reimbursement from Federal healthcare programs, they violated the False Claims Act (FCA). The time frame is from August 2012 to the present. Specific allegations include that Walgreens pressured pharmacists to fill prescriptions despite clear ‘red flags’, in excessive quantities, and lacking a legitimate medical purpose and that they ignored the pharmacists and their own internal data. One of the red flags were prescriptions for the ‘trinity’ of an opioid, a benzodiazepine and a muscle relaxant. There are also four different whistleblower actions against Walgreens under the qui tam (on behalf of the government) provisions of the FCA that have been consolidated. If successful, Walgreens could face civil penalties of up to $80,850 for each unlawful prescription filled in violation of the CSA, plus treble damages and applicable penalties for each prescription paid by Federal programs in violation of the FCA. Timing and Walgreens’ response are not yet available. This lawsuit could be a massive stumbling block to the rumored Walgreens/WBA sale.  DOJ release, Healthcare Finance 

The VA Secretary nominee recommits to resuming the 2026 rollout of the Oracle Cerner EHR. Former House Representative for Georgia Doug Collins told members of the Senate Veterans’ Affairs Committee at his nomination hearing Tuesday that he would look at the Oracle Cerner EHR deployment with ‘fresh eyes’ and that “there’s no reason in the world we cannot get this done.” On 20 December, the VA formally stated that they were starting planning now for deployment in four Michigan facilities — Ann Arbor, Battle Creek, Detroit, and Saginaw–for implementation by mid-2016. He was critical of what has transpired to date in the limited deployment as ‘not acceptable’ and pointing out that VA facilities needed modernization of their computer systems. But perhaps a little overoptimistically, he’d like to see a faster implementation in 2016, though it should be done properly and not rushed. NextGov/FCW, Healthcare IT News

And in the Warp Speed World that is now DC, Robert F. Kennedy Jr. is scheduled to testify next Wednesday (29 January) before the Senate Finance Committee on his nomination as Health and Human Services Secretary. At HHS, he would supervise the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH). He has promised major reforms including food safety and chemical additives, as well as the relationships between FDA and pharmaceutical companies. Healthcare Dive  Meanwhile, during the transition, HHS froze external communications or work-related appearances by staff. This is fairly standard procedure until review procedures are set up, but apparently no one planned for this in advance. This has derailed two conferences (AFCEA HIT Summit and the HHS Industry Summit) that were scheduled for this month and February. Exceptions to this are ‘mission critical’ and emergency communications. NextGov/FCW

News roundup #1: UHG-Amedisys extended, NeueHealth going private in NEA’s ‘deal deal’, Commure buying Memora Health, VA resuming Oracle rollouts–now mid-’26

January 8, 2025 | by

The end of year is a favorite time to slip in news that deserves wider notice. Sometimes it’s by design so as not to be noticed…and sometimes it’s timing. Or both. Here’s a potpourri of analyses of late December moves of note.

UnitedHealth Group and Amedisys home health agreed to extend their deal window to 31 December 2025. Amedisys filed regulatory paper on 26 December (file here) that moved the acquisition termination date to end of this year, or alternatively to 10 business days after a final court ruling blocking the merger. The latter is a distinct possibility since the Department of Justice back on 12 November filed a lawsuit to prevent the acquisition [TTA 14 Nov 24] on anti-trust grounds, joined by the attorneys general of four states. Amedisys, a major competitor to UHG/Optum, would be merged into Optum’s existing home health operations.

This long-running acquisition started back in June 2023 as an all-cash deal for $3.3 billion and went into DOJ review by August. The target closing at that time was end of 2024 as both companies knew that divestitures would be necessary. The penalty for non-completion was also upped to $325 million if needed divestitures to the VitalCaring Group proposed last July aren’t completed by 1 May. Even with a new Attorney General coming in after Senate confirmation, the wheels are already in motion for this antitrust action that throws a completion into doubt. Becker’s, Healthcare Dive

Gimlet EyeNeueHealth to be taken private by New Enterprise Associates (NEA) and other investors. The latest episode of the long-running NeueHealth (formerly BrightHealth) show dropped on 23 December. Existing investor NEA and 12 other investors with preferred shares in the company will take it private at an enterprise value of approximately $1.3 billion and roll over their shares for equity in the private company. Other holders of common stock will be cashed out, receiving $7.33 per share, a premium of 70% over the $4.31 closing on 23 December. The final price may change as common shares went up sharply the next day and remain up–today (8 January) opened at $7.49. Closing timing of this ‘deal deal’ is dependent on shareholder and regulatory approvals. Management will remain and roll over their shares into the company. Hercules Capital’s loan facility remains in place.  

Buried in the release is this caveat: “The merger agreement includes a 30-day “go-shop” period that will expire at 12:01 AM New York City time on January 23, 2025, which permits the Special Committee and its financial advisors to solicit and consider alternative acquisition proposals.” These proposals will be kept under wraps. But in this Editor’s view, outside offers are highly unlikely given the company’s death-defying history, continuing losses, and Ticking Time Bombs (see below). Their Q3 results had projected full-year 2024 adjusted EBITDA between $15 million and $25 million–but they lost $40 million in Q3 with the 2024 loss to date over $102 million.

As Ari Gottlieb dryly noted in his LinkedIn post, the company is $1.4 billion in debt. $7.33 per share is quite a comedown from the June 2021 IPO at $18 and an $11 billion valuation. The payout to the 36% of shares held by the other public shareholders is a paltry $21 million. Bottom line–NEA and the preferred investors are buying the company for $21 million–such a deal!

This Editor has previously and Gimletly noted NeueHealth’s high-wire act. It has truly Dodged Disaster with aplomb, skillfully creating its Own New Reality. But its Ticking Time Bombs remain: $300 million in CMS Repayment Agreements due on or before 14 March 2025 and $89 million owed to Texas from last year to cover risk liabilities for its shuttered ACA plans [TTA 14 Feb]. To be continued…   Release, Star-Tribune, FierceHealthcare

Commure bought digital health navigation platform Memora Health. Neither acquisition cost nor management transitions were disclosed on 20 December. Commure has one of the more interesting stories out there as the current company emerged from a General Catalyst-engineered estimated $6 billion merger between Commure and Athelas, with Athelas taking the upper hand in the reorganization [TTA 23 Oct 2024]. It should then be no surprise that Memora has significant investment from General Catalyst, which led its last round of funding in April 2023, making this another investor-arranged deal.

Commure’s primary products are the Strongline duress systems for worker distress and patient elopement and the Patient Keeper EHR, with Athelas in revenue cycle management and sensor-based remote patient monitoring. The combined company now features AI-aided workflows, RCM, duress systems, and a software development platform accessible to outside vendors. What Memora is primarily known for is automating practice follow-up texts before and after procedures. The Memora acquisition is positioned as reinforcing CommureOS’ clinical documentation, RCM, and real-time location services (RTLS). In October, Commure closed their acquisition of Augmedix, an AI-assisted physician scribe used by 20 health systems, for $139 million ($2.39/share), giving it a huge leg up into those providers. Augmedix IPO’d via a SPAC in 2021 at $4/share. About 400,000 physicians are claimed to be users of the Commure suite of products.  Release, Mobihealthnews, Endpoints, FierceHealthcare (Augmedix)

And what end of year would it be without a hopeful note from the VA about the Oracle Cerner rollout–now continuing in mid-2026? The Department of Veterans Affairs (VA) on 20 December officially targeted mid-2026 for four Oracle Cerner implementations, 18 months from now. It’s carefully hedged that they are beginning ‘early-stage planning’ for deployment in four Michigan facilities — Ann Arbor, Battle Creek, Detroit, and Saginaw. Meanwhile, improvements will continue at the five sites that use Oracle Cerner plus the sixth joint implementation with the MHS (Lovell). Interestingly, the current VA secretary, Denis McDonough, announced at an 11 December press conference that new implementations would start before the end of 2025 [TTA 19 Dec 2024]. This Editor assumes that the staff sharpened their pencils and recalculated right before Christmas. What’s also hopeful for Oracle and the VA are continuing  improvements in veteran outpatient trust and clinician satisfaction scores, as well as effectively eliminating outages for 200 days as of the release date. VA release, Healthcare Dive 

News roundup: Precision’s $102M raise, more on BCI; Withings clears BPM Pro 2; Nebraska 1st state to sue Change/UHG, related insider trading update; VA Oracle go-lives may resume; ATA intros CODE; ClearDATA HITRUST certified

December 19, 2024 | by

One more funding. A competitor of Elon Musk’s Neuralink, Precision Neuroscience. closed their Series C at $102 million. This round was led by General Equity Holdings, with participation from firms including B Capital; Duquesne Family Office, the investment firm of Stanley F. Druckenmiller; and Steadview Capital, bringing their total funding to $155 million. The total brings them according to their release as one of the best-funded brain-computer interface (BCI) company after Neuralink, whose funding is unknown. The funding will be used to advance its clinical research and expedite development of its cutting-edge brain implant. 

Precision is the developer of the Layer 7 Cortical Interface to treat motor paralysis. At the time of their last funding in January 2023, this Editor noted that their difference was to treat neurological illnesses and events such as stroke, traumatic brain injury, and dementia. Their focus remains largely there: severe spinal cord injury, stroke, ALS. So far, the investigational device has been tested its device in 27 patients through research partnerships and was designated by FDA as a Breakthrough Device.

More on BCI in this must-read article by Timmy Broderick for STAT. The upcoming issues around BCI now center around the engagement of CMS (Centers for Medicare and Medicaid Studies) for coding, coverage, and payment for devices after the investigational stage; privacy issues about neural data; and continued support after implantation. This last one is acute as these companies are young. There has already been the example of Second Sight’s bankruptcy, leaving subjects stranded with useless retinal devices in their eyes. BCI to this Editor will develop through 2025–and be a major focus of investment by 2026-2027.

Withings gains FDA clearance, intros BPM Pro 2. A professional-level product for hypertension and chronic heart failure (CHF) targeted to care teams to connect with their patients, the FDA clearance covers blood pressure and pulse rate measurement in adults with arm circumferences of 9 to 17 inches (22 cm to 42 cm) or 16 to 20 inches (40 to 52 cm). What is really interesting about the connected (Wi-Fi, cellular, BT) device is that care teams can program the device through the Patient Insights feature for the patient to interact with the device in real time. Through a small screen, it asks questions that help to track the patient’s condition, reinforce medication adherence, and assess their satisfaction. It also has a Retake Measure feature to retake a reading if results exceed predetermined thresholds and increases accuracy. Withings plans to upgrade the device to take a 1-lead ECG to detect atrial fibrillation; this is a separate clearance and expected to become available in 2025. The device is not yet CE Marked. Withings was named a CES 2025 Innovation Awards Honoree in the Digital Health category. (Photo, Withings website) Release, Mobihealthnews, MedCityNews

UHG’s Mound of Misery multiplies with Nebraska’s Change Healthcare lawsuit, plus separate but related insider trading. 

  • Nebraska became the first state to sue UnitedHealth Group, Optum, and Change Healthcare over those affected by the late February ALPHV/BlackCat hack of Change’s systems. In Nebraska alone, it affected 575,000 individuals. (It is actually hard to find someone who was not affected by the hacking of the leading exchange for major claims clearing and payments.) Nebraska’s attorney general Mike Hilgers is suing because of the company’s carelessness in handling data and, even worse, in its slow notification of those affected. Our Readers will recall that Change/UHG initially tried to push off notification on healthcare providers. When HHS threw the ball back to Change [TTA 5 June], notices didn’t go out until August-September. The charges in state law center on consumer law: financial data protection and consumer protection statutes, deceptive trade practices, and Federal standards on privacy (HIPAA, and HIT protection. The lawsuit was filed by the AG in the District Court of Lancaster County, Nebraska. Nebraska Examiner
  • The Change acquisition and later problems were possibly the catalyst for stock sales by senior/C-level UHG executives, including UnitedHealthcare CEO Brian Thompson. The $300 million Hollywood (Florida) Firefighters Pension Fund initiated a class action lawsuit alleging that the sales were made while the Department of Justice (DOJ) was considering an anti-trust action against UHG that would revisit the so-called ‘firewall’ between it and Change.  The complaint specifically mentions that UHG executives were aware of it as early as October 2023. The Wall Street Journal revealed the investigation on 27 February 2024–the same time as the Change breach was revealed, cracking the stock almost immediately. Executives including Thompson ($15 million), UHG CEO Andrew Witty, and board chairman Stephen Hemsley ($102 million) were named. The class action covers the period for stock purchased between 14 March 2022 and 27 February 2024. UHG has until 1 March 2025 to answer the complaint. Healthcare Finance News  (This is likely to affect the settlement of the Thompson estate–Ed.)

VA confirms that additional Oracle EHR implementations may go live in 2025, after 18 months of dead stop. The Oracle Cerner EHR is reportedly ‘running better’ at the current six sites where it is operating: five VA only (including 20 community clinics and about 100 support sites), and the sixth at Lovell jointly with the Military Health System (MHS). The restart of EHR Modernization (EHRM) was confirmed earlier during budget hearings by Kurt DelBene, assistant secretary for information and technology and chief information officer. Crash and lag downtimes are reduced by half and incident tickets by 60% since the last updates in August.  Timing remains indefinite for 2025 (FY ends 30 September 2025) but current VA Secretary Denis McDonough confirmed that primarily VA staff will continue to work on it under the Trump Administration. “The overwhelming majority of VA professionals who work on EHRM will be working on EHRM on January 21st, just as they were on January 19th,” McDonough said at an 11 December press conference. Federal News Network

Short takes:

  • The American Telemedicine Association (ATA) launched its new ATA Center of Digital Excellence (CODE) last week. CODE is constructed as an alliance with leading health systems for the development and implementation of digital health best practices that prioritize patient-centered care, equitable access, and improved clinical and operational outcomes. Tools span enhancement of workflows and patient engagement to improve healthcare accessibility. ATA release
  • ClearDATA’s CyberHealth platform and cloud managed services have earned Certified status by HITRUST for information security. ClearDATA provides healthcare specific managed cloud security, compliance and operations solutions. HITRUST, the Health Information Trust Alliance, is a non-profit that sets standards for data organizations through the HITRUST CSF framework. Release

News roundup: VA’s 2025 EHR budget + vendor breach, Neuralink robot arm study, linking mood prediction to sleep, CoachCare buys Revolution Health RPM/CCM, Seen Health’s $22M launch, Spectrum.Life in Deloitte Ireland’s Fast 50

December 5, 2024 | by

It’s $869 million for the EHR budget. The total budget for the Department of Veterans Affairs for FY2025, which started back on 1 October but is still unapproved by Congress, is $369 billion.

  • The overall EHR budget of $869 million includes current operations of VistA, Oracle Health, and exchange with the DOD/MHS system
  • Drilling down, the budget section for Oracle Cerner for the EHRM (EHR Modernization) has $375 million earmarked for the federal EHR contract. This addresses clinicians’ issues and supports healthcare deployment strategies that optimize resources throughout procedures.

VA decided in FY2023 that there would be no further deployments of Oracle Health’s EHR until the current multiple issues present at the existing six facilities using the Oracle Cerner EHR as well as the James Lovell joint MHS/VA implementation completed earlier this year were at least on a pathway to resolution. However, VA Secretary Denis McDonough said in April during early House Veterans’ Affairs Committee hearings on FY 2025 and 2026 budgets that there was the possibility that implementation may resume before the end of FY2025 using carryover funding, not FY2025 allocated funding. Whether Secretary McDonough will be remaining under the Trump Administration is, of course, subject to change.

In June, VA extended its contract with Oracle Health for another 11 months, not having much of a choice. In July, VA was sued by Laurette Santos, a VA clinical social worker in the White City, Oregon facility, over worker accessibility standards and lack of Federally mandated assistive technology in the Oracle EHR.

Additional funds are on request for IT–$6.2 billion for IT systems–and $10 million for AI research and development. ExecutiveGov

VA’s breach problem. It’s located with a vendor for medical transcription, DBP, Inc. According to the Veterans Health Administration release, the attack on DBP’s server encrypted files that were then potentially copied by the hacker. DBP shut down the server and disconnected it from the internet, preventing additional attacks. The vendor purchased new hardware and implemented new security controls. 2,302 veterans were affected with some or all the following information exposed: full name, medical record information, or Social Security number. It was also geographically wide: Maine, Boston, Connecticut, Baltimore Amarillo TX, and Minneapolis MN.

Neuralink moves forward with feasibility study with a robotic arm. Four months after Elon Musk proposed the N1 implant be capable of moving an Optimus (Tesla Bot) robotic arm or leg, Neuralink has an approved feasibility study, code named CONVOY, to investigate whether the N1 implant can move an Optimus robotic arm. Start date is not disclosed. This follows on the announcement of the clinical trial with Health Canada for the “Canadian Precise Robotically Implanted Brain-Computer Interface” (CAN-PRIME) for N1 brain implant and its R1 robot, which is used to place the 64-thread implant into the brain, and approval last month for Blindsight, an implant for sight restoration. [TTA 27 Nov]. Mobihealthnews

Quantifying the link between sleep and predicting moods. This relatively lean bit of research from South Korea uses machine learning (ML) to predict mood episodes in mood disorder patients using only sleep and circadian rhythm data from wearable devices including smartphones used by 168 patients generating 267 days of data. The researchers derived 36 sleep and circadian rhythm features to enable accurate next-day predictions for depressive, manic, and hypomanic episodes. A key finding that daily circadian phase shifts were the most significant predictors: delays were linked to depressive episodes, advances to manic episodes. The study has implications for symptom evaluation and for treatment effectiveness. Mobihealthnews, NPJ Digital Medicine

Acquisitions and funding:

CoachCare acquires Revolution Health Solutions in the busy RPM/CCM space. Both companies offer chronic care management (CCM) services enhanced by remote patient monitoring (RPM) and outsourced teams. CoachCare’s acquisition cost and staff transitions were not disclosed. CoachCare, based in NYC, has raised about $49 million over five rounds in an unusual way–four under $1 million, then in July a private equity round of $48 million from Topmark Partners and Integrity Growth Partners. They claim 150,000 patients and hundreds of healthcare organizations along with five other acquisitions. Revolution Health Solutions, based in Dallas, had no funding rounds listed on Crunchbase. They were founded and led by Jenn Gillette Tompkins who positions it as a partnership (her LinkedIn post).  Release

Seen Health comes out of stealth with $22 million. The Series A has five investors: Virtue, 8VC, Basis Set Ventures, Prime Time Partners, and Astrana Health. Seen is leveraging off the PACE model (Program of All-Inclusive Care for the Elderly) that helps chronically ill and infirm older adults remain in their homes and out of a nursing home by constructing a care team containing a social worker, nurse, dietician, primary care provider, and others. PACE models that started in San Francisco’s Asian and Pacific Islander communities in the 1970s have also been supplemented with digital health telemonitoring, such as QuietCare in 2006-9 (Editor’s note). Despite their advantages, PACE programs only cover 5% of older adults. Twin brothers Xing and Yang Su decided to build on PACE, creating culturally apt physical centers and equipping them with technology such as an EHR and geofencing that prevents wandering. Their programs will also include care at home coordinated with local agencies to provide low or no-cost care. The financing will be used to build out their first center in Los Angeles County’s San Gabriel Valley that focuses on the Asian and Pacific Islander (API) communities along with the needed technology and to build out their team. MedCityNews

Some nice recognition for Ireland’s Spectrum.Life. It ranked #41st in Deloitte Ireland’s 2024 Technology Fast 50 Awards, which recognize the fastest growing Irish tech companies. Spectrum.Life’s digital platform supports digital health, mental health, and wellbeing for employers and employees in the workplace, insurers, and educators. Their services are used by 9.8 million insurance members, 3,000 corporate clients, 60+ universities and 650,000 university students. WireNews

News roundup: Oak Street’s Pykosz departs CVS, Musk’s Neuralink gains Canadian clinical trial, VA healthcare improvement bill omits EHR oversight measures, 23andMe’s Mirador precision medicine partnership

November 27, 2024 | by

Another CVS departure. As Glenview Capital taps its feet waiting for CVS financials to improve, Mike Pykosz, appointed less than a year ago to head up their Health Care Delivery unit, is departing. His replacement is Dr. Sreekanth Chaguturu. Unsurprisingly, Dr. Chaguturu will be working two jobs–president of Health Care Delivery as well as EVP and chief medical officer of CVS Health, saving an executive salary. This may be the capper of a two-month 52-card pickup that started with rumors of a breakup that would split off Aetna, replacement of CEO Karen Lynch, a new head of Aetna, and four new board seats given to Glenview. [TTA 19 Nov]

No date was given for Mr. Pykosz’s departure, but the wording in the release made it appear that it was effective immediately. His LinkedIn post from last Tuesday indicated that he was moving on by end of November, this week. According to new CEO David Joyner, Pykosz had informed management earlier in the year that he was planning to depart and had worked to ensure a smooth transition. Mike Pykosz had previously been CEO and co-founder of Oak Street Health, acquired by CVS for $10 billion in May 2023. In the following months, OSH integrated with elements of Signify Health, in-store Minute Clinics, and grew from 170 units to 250 locations. Whether any of them are profitable is not disclosed and likely not probable, though CVS made much of OSH’s and Signify’s 36% increase in quarterly revenue versus prior year. There is also no disclosure of Mr. Pykosz’s future plans though his LinkedIn post mentions that he was “excited to be able to dedicate time to investing in, advising, and supporting innovative healthcare companies, helping them meet their strategic goals and build better healthcare solutions as well as spend more time with family and friends.” including coaching grade 3 basketball. Bet on hearing from Mr. Pykosz after what is likely a prolonged non-compete agreement and a good rest. Healthcare Dive

Elon Musk’s brain-computer implant, Neuralink, to enter a clinical trial with Health Canada. This is the first outside-US trial for Neuralink. It comprises the N1 brain implant and R1 robot, which is used to place the 64-thread implant into the brain. The study will be performed by the University Health Network (UHN) hospital at its Toronto Western Hospital. The “Canadian Precise Robotically Implanted Brain-Computer Interface” (CAN-PRIME) subjects will be Canadian-resident patients with tetraparesis or tetraplegia resulting from cervical spinal cord injury or the neurological disease ALS who also have a life expectancy of at least 12 months. Earlier this year, an American implant patient moved a mouse by thought [TTA 21 Feb] and is now playing video games and online chess. Neuralink received approval last month for Blindsight, an implant for sight restoration. Mobihealthnews

VA service improvement bill manages to omit Oracle EHR oversight measures. The bipartisan omnibus bill titled ‘The Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act” (H.R. 8371) passed the House last week. It introduced many benefits to VA healthcare workers and to veterans, but managed to pass the House without the ‘guardrails’ that the House Veterans Affairs committee deemed necessary to continue the Oracle EHR rollout, replacing the obsolete VistA system. The committee spokesman, Mark Takano, D-Calif., attributed the omission of requirements included under the EHR Program RESET Act to “a lack of political viability in both the House and Senate”. The chair of the Technology subcommittee, Matt Rosendale (R-Montana), went considerably further and voted against the entire bill. Both blamed Oracle: Takano attributed it to “the army of lobbyists that Oracle unleashed to kill it” and Rosendale stated that “Oracle Cerner bought and bullied their way into getting this bill passed without their company being scrutinized.” The bill now goes to the Senate in the minimal time before the ending of the 118th Congress next month.   

The requirements in the omitted RESET Act included most of what has been discussed in both Senate and House to remedy Oracle Cerner Millenium’s stopped-dead implementation in the VA.

  • Increased Congressional oversight of EHR deployments, ensuring that each implementation of the new EHR “met or exceeded”  pre-deployment efficiencies before moving to the next one
  • Requiring VA to provide lawmakers with quarterly reports with additional data “on user adoption and employee satisfaction” with the Oracle Cerner system
  • Requiring VA to supply data on “employee retention and turnover at medical facilities where such electronic health record system is in use.”

Nextgov.com

Rep. Rosendale issued a press release blasting H.R. 8371. “…this bill ignored years of bipartisan work focused on requiring Oracle Cerner to fix its EHR System, that has resulted in veteran deaths, before it could be expanded to new VA Medical Centers and the company can continue to collect on its multibillion-dollar contract.” Omnibus bills like this are always shotgunned together as well. “The House Veterans’ Affairs Committee ignored regular order with this legislation which, by uniparty design, prohibited scrutiny and debate on the final product. That decision spearheaded a bad process for passing this bill which resulted in an unacceptable final product for our veterans. When a uniparty agreement comes together overnight, like it did with the Dole Act, it means a small group of individuals negotiated it and the American people – and in this case our nation’s heroes – get the short straw.”  

(Editor’s note: Senator Elizabeth Dole, who is still with us at 88, was a single-term Senator from North Carolina 2002-2006, but Cabinet member in two prior administrations as well as the widow of Senator Bob Dole from Kansas.)

Signs of life at 23andMe? The troubled genetic data company, which earlier this month shuttered what remained of its drug therapeutics unit and laid off 40% of its remaining employees, announced this week a research partnership with Mirador Therapeutics, a precision medicine company focused on immunology and inflammation. Mirador is using a targeted set of aggregated, de-identified genetic and phenotypic data from the 23andMe research database to combine with its Mirador 360 development “engine”. Most of the release is boilerplate with the requisite quote from the Mirador CEO, mixed with copy hyping previous 23andMe collaborations and their patient privacy policy which carefully omits the fact that you, personally, can withdraw from the research program, but your genetic data and limited identifiers cannot [TTA 8 Nov]. No financials or agreement duration are disclosed. 23andMe release, Endpoints News (paywalled)

Government updates: GAO scores HHS on cybersecurity issues; patient issues largely omitted from EHR notes in VA study

November 20, 2024 | by

The Government Accountability Office (GAO) latest report remains critical of HHS’ leadership on cybersecurity issues. Using the immense Change Healthcare data breach as a glaring example, GAO’s latest report released 13 November outlines HHS’s continued ‘challenges’ in ensuring that, among Federal agencies, it takes the lead in strengthening cybersecurity in the healthcare sector. For instance, HHS coordinates with the Cybersecurity and Infrastructure Security Agency (CISA), which is the national coordinating agency for critical infrastructure security and resilience. Where HHS comes up short (again) against GAO prior reports and recommendations is:

  • Weakness in tracking how healthcare organizations are effectively mitigating ransomware 
  • Not yet assessing how healthcare organizations are adopting the ransomware-specific practices outlined in the NIST (National Institute of Standards and Technology) cybersecurity framework centered on identifying, detect, protect, respond, and recover.
  • Inability to document the effectiveness of support HHS provides to healthcare organizations, such as guidance documents, training, job aids, and threat briefings to help the sector manage ransomware risks.   
  • Not conducting a comprehensive sector-wide cybersecurity risk assessment addressing IoT (Internet of Things) and OT (operational technology) devices and systems common in healthcare.
  • Using their Administration for Strategic Preparedness and Response (ASPR) to fully and consistently monitor its working groups supporting the healthcare sector on progress against goals, responsibilities, and on their collaboration.
  • The Centers for Medicare and Medicaid Services (CMS) has had requirements since 2020 with parameters that conflicted with those established by other federal agencies that share data with states, such as the Social Security Administration.
  • CMS has policies to assess states’ cybersecurity but does not coordinate with other federal agencies on the assessments.

GAO’s latest report recommended that:

  • HHS, in coordination with CISA and sector entities, determines the sector’s adoption of leading cybersecurity practices that help reduce ransomware risk.
  • HHS, in coordination with CISA and sector entities, develops evaluation procedures to measure the effectiveness of its support in helping to reduce ransomware risk.
  • HHS includes IoT and OT devices as part of the risk assessments of the sector’s cyber environment.
  • ASPR takes action to fully and consistently demonstrate leading collaboration practices .
  • CMS 1) solicits input from relevant federal agencies on revisions to its security policy to ensure consistency across cybersecurity requirements for state agencies. 2) revises its assessment policies to maximize coordination with other federal agencies.

Highlights and full report 

EHR notes also come up short when it comes to issues brought up by patients–and include information outside the clinician-patient transcript. This observational study from the Regenstrief Institute by two Indiana University medical researchers at the VA found multiple discrepancies in EHR notes that are supposed to recap the actual conversation between patient and clinician during a primary care appointment versus the actual transcript. It took place at four primary care clinics at a midwestern Veterans Affairs (VA) Medical Center and one associated VA community-based outpatient clinic, all using the current VistA EHR. Video and audio recordings were used to create transcripts that were compared with the EHR notes.

The discrepancies were bi-directional. According to the study, “fewer than half of issues that patients initiated in discussion were included in notes, and nearly half of notes referred to information or observations that could not be verified.” There was also a difference in recording by who brought it up. For instance, psychosocial issues were common in patient-clinician discussions. “The researchers found that when the clinician initiated discussion about these issues, 92 percent of notes in the EHR included them, but when the patient initiated discussion, only 45 percent did.”

There were also gaps in quality that were questioned in the study:

  • 8% of notes lacked an assessment and plan. Were some assessments truly incomplete, and some important plans actually skipped?
  • 18% of notes were missing follow-up plans. Were some follow-up plans never arranged?
  • 26% lacked reports of diagnostic test results. Were such results simply absent or unimportant, or were important findings unavailable, difficult to access, or overlooked?

“We recognize that certain variations in EHR documentation stem from authors’ preferences or styles about how to organize or structure notes. At the same time, notes should not lack critical elements.” Reasons for omissions could include “lack of recognition of the significance of a problem by clinicians, forgetfulness while writing notes, insufficient time to complete records accurately and thoroughly; belief that the issue had already been addressed; or prioritization of other concerns.”

Both Drs. Michael Weiner and Richard Frankel are researchers in various aspects of health information technology to improve patient outcomes and doctor-patient communication. They are affiliated with the US Department of Veterans Affairs Health Services Research and Development Center for Health Information and Communication, as well as professors of medicine at Indiana University’s medical school. Regenstrief Institute article 12 Nov, BMC Primary Care published study 18 July 2024

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

October 1, 2024 | by

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

July 31, 2024 | by

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

July 24, 2024 | by

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: UHG’s cyberattack hit now $2.3B, Senate bill on cyberattacks intro’d, VA’s AI tech sprint awards, AliveCor’s new CPT codes

July 18, 2024 | by

UHG reported earnings, profit reduced by $1 billion due to Change Healthcare cyberattack costs. On Tuesday 16 July UnitedHealth Group reported Q2 (ending 30 June) earnings of $98.9 billion, up $6 billion or 7% versus Q2 last year. Profit though didn’t move the same way, instead taking a hit at $7.9 billion, down from last year’s $8.1 billion. Despite strong performances in the UnitedHealthcare and Optum units, the drag from the Change Healthcare cyberattack is now estimated at an additional $1 billion from last quarter’s guesstimate, now at $2.3 billion. Also affecting the profit bottom line is inflating healthcare costs that are reflected in rising medical loss ratios (MLRs). Change is also obliged to do the patient notification which will start by the end of this month [TTA 21 June], having already started notifications of hospitals, providers, insurers, and other customers. Release, Healthcare Dive

But hey, now the Senate has a bill to coordinate agencies with the purpose of reducing those darn cyberattacks. The Healthcare Cybersecurity Act, sponsored by Senators Jacky Rosen (D-Nev.), Todd Young (R-Ind.), and Angus King (I-Me.), would direct the Cybersecurity and Infrastructure Security Agency (CISA) and the Department of Health and Human Services (HHS) to collaborate on improving cybersecurity. One important change would be creating an HHS liaison within CISA to coordinate incident response specifically for healthcare entities. An earlier version introduced by Sen. Rosen in 2022, S. 3904 (117th Congress), never made it into committee.  Sen. Jacky Rosen release, Healthcare Finance   But aren’t there other agencies involved in cyberattacks and ransomware like the FBI and the Department of Justice? And international agencies like the NCA and Europol since so many come from the darker parts of Europe and Asia? (The devil’s in the details…)

The Department of Veterans Affairs (VA) is taking a modest dip into the AI ocean. The award late last week of pilots for an AI-assisted healthcare dictation tool went to Abridge AI and Nuance Communications. The non-competitive, fixed-price contracts are as a result of the two companies winning the first track of the VA’s AI Tech Sprint which launched last October. The tools are designed to generate transcriptions from ambient recordings of patient encounters within specialty care, mental health care, and primary care settings, as well as integrating into the Oracle Cerner EHR. The notice does not specify start or end date. There is also a second sprint around developing an AI system to process documents generated in patient-provider encounters and other complex medical documents for continuity of care and sharing information with VA providers. FedScoop

AliveCor received CPT codes applicable to the company’s Kardia 12L ECG System. The Category III Current Procedural Terminology (CPT) codes are assigned by the American Medical Association (AMA).  The 12-lead system a few weeks ago gained FDA clearance for the combination of the Kardia 12L ECG System (left), a single cable with five electrodes that acquires 8 high-quality diagnostic bandwidth leads, with their KAI 12L AI-assisted diagnostic technology for clinician use only. The three new codes will be effective 1 January 2025 and will be published in the 2025 CPT Code book. Release

VA sued in Federal court on Oracle Cerner EHR accessibility issues

July 8, 2024 | by

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

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

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

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